Page Range | 63671-64047 | |
FR Document |
Page and Subject | |
---|---|
81 FR 64045 - Continuation of the Exercise of Certain Authorities Under the Trading With the Enemy Act | |
81 FR 63671 - To Modify Duty-Free Treatment Under the Generalized System of Preferences | |
81 FR 63808 - Sunshine Act Meeting | |
81 FR 63673 - Termination of Emergency With Respect to the Situation in or in Relation to Côte d'Ivoire | |
81 FR 63759 - Sunshine Act Meeting | |
81 FR 63790 - Notice of Realty Action: Application for Conveyance of Federally Owned Mineral Interests in Escambia County, FL | |
81 FR 63837 - Avante Mezzanine Partners SBIC II, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest | |
81 FR 63836 - Indiana Disaster #IN-00059 | |
81 FR 63852 - Sixteenth RTCA SC-209 Working Session and Plenary Session Joint With EUROCAE WG 49, WG 51, and RTCA SC-186 | |
81 FR 63732 - Approval of California Air Plan Revisions, South Coast Air Quality Management District | |
81 FR 63849 - Notice of Public Meeting in Preparation for the Sixty-Sixth Session of the International Maritime Organization Technical Cooperation Committee | |
81 FR 63810 - Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit Nos. 2 and 3 | |
81 FR 63849 - Culturally Significant Objects Imported for Exhibition Determinations: “Word and Image: Martin Luther's Reformation” Exhibition | |
81 FR 63804 - Use of Outer Continental Shelf (OCS) Sand Resources for the Mississippi Coastal Improvements Program (MsCIP) Comprehensive Barrier Island Restoration in Hancock, Harrison, and Jackson Counties, Mississippi | |
81 FR 63849 - Culturally Significant Objects Imported for Exhibition Determinations: “The Rama Epic: Hero, Heroine, Ally, Foe” Exhibition | |
81 FR 63839 - Culturally Significant Objects Imported for Exhibition Determinations: “The Art of Alchemy” Exhibition | |
81 FR 63785 - 60-Day Notice of Proposed Information Collection: Multifamily Project Construction Change | |
81 FR 63784 - 60-Day Notice of Proposed Information Collection: Final Endorsement of Credit Instrument | |
81 FR 63710 - Ammonium Persulfate; Exemption From the Requirement of a Tolerance | |
81 FR 63694 - Visas: Diversity Immigrants | |
81 FR 63781 - Agency Information Collection Activities: African Growth and Opportunity Act Certificate of Origin | |
81 FR 63695 - TRICARE; Mental Health and Substance Use Disorder Treatment | |
81 FR 63759 - Environmental Impact Statements; Notice of Availability | |
81 FR 63714 - Implementing Public Safety Broadband Provisions of the Middle Class Tax Relief and Job Creation Act of 2012 | |
81 FR 63786 - Federal Property Suitable as Facilities To Assist the Homeless | |
81 FR 63839 - Notice of Information Collection Under OMB Emergency Review: Affidavit of Relationship (AOR) for Minors Who Are Nationals of El Salvador, Guatemala, or Honduras | |
81 FR 63707 - Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; Temporary Exemptions From the Requirement of a Tolerance | |
81 FR 63697 - Special Local Regulations; Ironman 70.3 Augusta Triathlon, Savannah River | |
81 FR 63799 - Information Collection: General Oil and Gas and Sulphur and Production Requirements in the Outer Continental Shelf; Proposed Collection for OMB Review; Comment Request | |
81 FR 63840 - 60-Day Notice of Proposed Information Collection: Request for Advisory Opinion | |
81 FR 63766 - Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability | |
81 FR 63774 - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices | |
81 FR 63791 - National Historic Landmarks Committee of the National Park System Advisory Board Meeting | |
81 FR 63798 - Notice of Open Public Meetings for the National Park Service Alaska Region Subsistence Resource Commission Program | |
81 FR 63796 - Notice of November 17-18, 2016, Meeting of the National Park System Advisory Board | |
81 FR 63767 - Clinical Investigator Training Course | |
81 FR 63764 - Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Guidance for Industry; Availability | |
81 FR 63770 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON | |
81 FR 63773 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO | |
81 FR 63771 - Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM | |
81 FR 63762 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 63768 - Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System | |
81 FR 63775 - Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised Guidance for Industry; Availability | |
81 FR 63716 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area | |
81 FR 63776 - Menu Labeling Public Workshop; Public Meeting | |
81 FR 63747 - Withdrawal of Notice of Intent To Prepare a Supplemental Environmental Impact Statement for the Raritan Bay and Sandy Hook Bay, New Jersey Feasibility Report for Hurricane and Storm Damage Reduction Union Beach, New Jersey Final Feasibility Report | |
81 FR 63743 - New England Fishery Management Council; Public Meeting | |
81 FR 63739 - Agenda and Notice of Public Meeting of the Maine Advisory Committee | |
81 FR 63743 - Gulf of Mexico Fishery Management Council; Public Meeting | |
81 FR 63739 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings | |
81 FR 63740 - Western Pacific Fishery Management Council; Public Meetings | |
81 FR 63759 - Notice of Open Meeting of the Advisory Committee of the Export-Import Bank of the United States (Ex-Im Bank) | |
81 FR 63811 - Submission for Review: 3206-0208, Representative Payee Survey, RI 38-115 | |
81 FR 63735 - Pale Cyst Nematode; Update of Quarantined Areas | |
81 FR 63735 - Notice of Availability of a Treatment Evaluation Document; Cold Treatment of Grapefruit From Australia | |
81 FR 63784 - Advisory Committee on Family Residential Centers | |
81 FR 63745 - Procurement List; Deletions | |
81 FR 63744 - Procurement List; Proposed Deletions | |
81 FR 63787 - Endangered Species; Receipt of Applications for Permit | |
81 FR 63782 - Accreditation and Approval of Saybolt LP as a Commercial Gauger and Laboratory | |
81 FR 63747 - Record of Decision for the Remaining Balanced Vision Plan and Interior Drainage Plan Features Feasibility Report and Environmental Impact Statement, Dallas County, TX | |
81 FR 63700 - Drawbridge Operation Regulation; South Branch of the Elizabeth River, Atlantic Intracoastal Waterway, Chesapeake, VA | |
81 FR 63698 - Special Local Regulation; Ohio River, Madison, IN | |
81 FR 63738 - Nez Perce-Clearwater National Forests; Idaho; Johnson Bar Fire Salvage Project | |
81 FR 63788 - Reinstate Agency Information Collection for the Johnson O'Malley Act Requirements | |
81 FR 63763 - Submission for OMB Review; Comment Request | |
81 FR 63793 - Notice of Inventory Completion: Tennessee Valley Authority, Knoxville, TN | |
81 FR 63795 - Notice of Intent To Repatriate Cultural Items: Washington State Parks and Recreation Commission, Olympia, WA | |
81 FR 63791 - Notice of Inventory Completion: Washington State Parks and Recreation Commission, Olympia, WA | |
81 FR 63780 - Accreditation and Approval of Saybolt LP as a Commercial Gauger and Laboratory | |
81 FR 63750 - Agency Information Collection Extension | |
81 FR 63808 - Intent To Renew the Bureau of Labor Statistics Technical Advisory Committee | |
81 FR 63806 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Securing Financial Obligations Under the Longshore and Harbor Workers' Compensation Act and its Extensions | |
81 FR 63807 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Disability Employment Initiative Evaluation | |
81 FR 63853 - Buy America Waiver Notification | |
81 FR 63783 - Accreditation and Approval of AmSpec Services, LLC, as a Commercial Gauger and Laboratory | |
81 FR 63782 - Accreditation and Approval of Amspec Services, LLC, as a Commercial Gauger And Laboratory | |
81 FR 63749 - Agency Information Collection Activities; Comment Request; Common Core of Data (CCD) School-Level Finance Survey (SLFS) 2016-2018 | |
81 FR 63854 - Buy America Waiver Notification | |
81 FR 63700 - Drawbridge Operation Regulation; James River, Isle of Wight and Newport News, VA | |
81 FR 63858 - Corporate Senior Executive Management Office; Notice of Performance Review Board Members | |
81 FR 63806 - Cold-Rolled Steel Flat Products From Brazil, India, Korea, Russia, and the United Kingdom; Determinations | |
81 FR 63805 - Certain Krill Oil Products and Krill Meal for Production of Krill Oil Products; Institution of Investigation | |
81 FR 63790 - Filing of Plats of Survey: Oregon/Washington | |
81 FR 63789 - Notice of Public Meeting for the Steens Mountain Advisory Council | |
81 FR 63728 - McCormick & Company, Inc.; Filing of Color Additive Petition | |
81 FR 63809 - Notice of Intent To Extend an Information Collection | |
81 FR 63850 - National Express LLC-Acquisition Of Control-New Dawn Transit, Llc | |
81 FR 63760 - Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification Rules | |
81 FR 63695 - Special Local Regulation; Ohio River, Owensboro, KY | |
81 FR 63728 - Security Zones; Port of Palm Beach, Port Everglades, Miami, and Key West, Florida | |
81 FR 63780 - CARA Act's Required Training of Nurse Practitioners and Physician Assistants | |
81 FR 63837 - Agency Information Collection Activities: Proposed Request and Comment Request | |
81 FR 63779 - National Cancer Institute; Notice of Closed Meetings | |
81 FR 63777 - National Cancer Institute; Notice of Meeting | |
81 FR 63778 - Office of the Director, Notice of Meeting | |
81 FR 63778 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings | |
81 FR 63778 - National Institute on Deafness and Other Communication Disorders; Notice of Meeting | |
81 FR 63723 - Raisins Produced From Grapes Grown in California and Imported Raisins; Removal of Language | |
81 FR 63756 - Alaska Electric Light & Power Company; Notice of Application Tendered for Filing With the Commission and Soliciting Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments | |
81 FR 63754 - Notice of Commission Staff Attendance | |
81 FR 63751 - Great Lakes Hydro America, LLC; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final Amendments | |
81 FR 63752 - Notice of Commission Staff Attendance at MISO Meetings | |
81 FR 63753 - Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
81 FR 63756 - ITC Pipeline Company, LLC; Notice of Request for Waiver | |
81 FR 63754 - Van Orden, Tracy; Notice of Filing | |
81 FR 63756 - Coalition of MISO Transmission Customers v. Midcontinent Independent System Operator, Inc.; Notice of Complaint | |
81 FR 63755 - Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization | |
81 FR 63754 - Dominion Carolina Gas Transmission, LLC; Notice of Revised Schedule for Environmental Review of the Transco to Charleston Project | |
81 FR 63676 - Tart Cherries Grown in the States of Michigan, et al.; Revision of Optimum Supply Requirements and Establishment of Inventory Release Procedures | |
81 FR 63831 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change To Provide for the Clearance of Additional Credit Default Swap Contracts | |
81 FR 63811 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 67-Equities To Modify Certain Data Collection Requirements of the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
81 FR 63815 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4770 | |
81 FR 63833 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 3317 | |
81 FR 63818 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 7.46 To Modify Certain Data Collection Requirements of the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
81 FR 63825 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 67 To Modify Certain Data Collection Requirements of the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
81 FR 63821 - Self Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Article 20, Rule 13(b) To Modify Certain Data Collection Requirements of the Regulation NMS Plan To Implement a Tick Size Pilot Program | |
81 FR 63828 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4770 | |
81 FR 63718 - Walnuts Grown in California; Increased Assessment Rate | |
81 FR 63679 - Pistachios Grown in California, Arizona, and New Mexico; Decreased Assessment Rate | |
81 FR 63721 - Walnuts Grown in California; Proposed Amendment to Marketing Order | |
81 FR 63675 - Amendment to the Definition of “Condition” and Prerequisite Requirement for Shell Eggs Eligible for Grading and Certification Stated in the Regulations Governing the Voluntary Grading of Shell Eggs | |
81 FR 63748 - National Advisory Council on Indian Education; Announcement of an Open Public Meeting | |
81 FR 63736 - Notice of Intent To Request New Information Collection | |
81 FR 63746 - Proposed Information Collection; Comment Request | |
81 FR 63747 - Reopening and Extension of the Application Deadline Date for the Fiscal Year 2016 Competition; Promise Neighborhoods Program | |
81 FR 63738 - Submission for OMB Review; Comment Request | |
81 FR 63704 - Air Plan Approval; SC Infrastructure Requirements for the 2010 1-Hour NO2 | |
81 FR 63705 - Air Plan Approval/Disapproval; MS Infrastructure Requirements for the 2010 NO2 | |
81 FR 63701 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compounds Emissions From Fiberglass Boat Manufacturing Materials; Withdrawal of Direct Final Rule | |
81 FR 63701 - Air Plan Approval; Alabama: Volatile Organic Compounds | |
81 FR 63758 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information Collection for Importation of On-Highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment; EPA ICR Number 2583.01, OMB Control Number 2060-NEW | |
81 FR 63734 - Air Plan Approval; Alabama: Volatile Organic Compounds | |
81 FR 63841 - Registration for the Diversity Immigrant (DV-2018) Visa Program | |
81 FR 63803 - Gulf of Mexico (GOM) Outer Continental Shelf (OCS) Central Planning Area (CPA) Oil and Gas Lease Sale 247; MMAA104000 | |
81 FR 63804 - Notice of Availability of the Proposed Notice of Sale for the Central Gulf of Mexico Planning Area Outer Continental Shelf Oil and Gas Lease Sale 247; MMAA104000 | |
81 FR 63855 - Agency Information Collection Activities: Request for Comments; Renewal of an Information Collection(s): U.S. Department of Transportation, Individual Complaint of Employment Discrimination Form | |
81 FR 63725 - Airworthiness Directives; Mitsubishi Heavy Industries, Ltd. Airplanes | |
81 FR 63691 - Airworthiness Directives; Airbus Airplanes | |
81 FR 63688 - Airworthiness Directives; Dassault Aviation Airplanes | |
81 FR 63853 - Notice of Opportunity for Public Comment for Land Exchange at New Bedford Airport in New Bedford, MA | |
81 FR 63852 - Notice of Opportunity for Public Comment on Land Use Change From Aeronautical to Non-Aeronautical Use at Hanscom Field in Bedford, MA | |
81 FR 63853 - Commercial Space Transportation Advisory Committee-Open Meeting | |
81 FR 63856 - Privacy Act of 1974; Systems of Records | |
81 FR 63682 - Regulatory Capital Rules: The Federal Reserve Board's Framework for Implementing the U.S. Basel III Countercyclical Capital Buffer | |
81 FR 63859 - Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Economic Research Service
Forest Service
Rural Housing Service
National Oceanic and Atmospheric Administration
Engineers Corps
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
U.S. Customs and Border Protection
U.S. Immigration and Customs Enforcement
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Labor Statistics Bureau
Federal Aviation Administration
Federal Highway Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Agricultural Marketing Service, USDA.
Final rule.
The Agricultural Marketing Service (AMS) will amend the Regulations Governing the Voluntary Grading of Shell Eggs to clarify the definition of “condition” and revise the prerequisite requirement for shell eggs eligible for voluntary USDA grading and certification.
This final rule is effective September 16, 2016.
David Bowden, Chief, Standardization Branch, Quality Assessment Division; Livestock, Poultry, and Seed Program, Agricultural Marketing Service, U.S. Department of Agriculture; 1400 Independence Avenue SW.; Room 3932-S, STOP 0258; Washington, DC 20250, by facsimile to (202) 690-2746; or via email to
Section 203(c) of the Agricultural Marketing Act of 1946 (AMA) (7 U.S.C. 1621-1627) directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” The U.S. Department of Agriculture (USDA) is committed to carrying out this authority in a manner that facilitates the marketing of agricultural products while maintaining the integrity of the USDA grademark. Shell egg grading is a voluntary program provided under AMA and offered on a fee-for-service basis. It is designed to assist in the orderly marketing of shell eggs by providing the official certification of egg quality, size, condition, and other factors.
This amendment is in accordance with recommendations stated in the 2012 Audit Report,
AMS will revise the definition of “condition” to remove any food safety implications resulting from the use of the term “wholesomeness” and clarify that AMS' role in grading and certification of shell eggs is solely for a quality determination. The revised definition will remove the term “wholesomeness” and state that “condition” is a characteristic detected by a sensory examination. The presence of microorganisms, specifically Salmonella Enteritidis (SE) or other pathogens, in the content of an egg cannot be detected during such an examination. The Food and Drug Administration (FDA) and the USDA Food Safety and Inspection Service not AMS, maintain jurisdiction for food safety related issues associated with shell eggs.
AMS will also revise the prerequisite requirement of shell eggs eligible for USDA grading and certification. The revision will prohibit the use of SE-adulterated or recalled shell eggs from being presented to USDA for grading and certification. This action protects the integrity of the USDA grademark for quality and is consistent with current AMS policy implemented subsequent to the referenced 2012 OIG audit.
A proposed rule to amend the definition of “condition” and prerequisite requirements for shell eggs eligible for grading and certification stated in the Regulations Governing the Voluntary Grading of Shell Eggs was published in the
USDA is issuing this final rule in conformance with Executive Orders 12866, 13175 and 13563. This rule has been reviewed under Executive Orders 12866, 13175 and 13563. The rule has determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. The rule does not promote policies with tribal implications. Consistent with the requirements of Executive Order 13563, the public has had the opportunity to review and comment on the rule; and, the rule also incorporates existing AMS policy on shell eggs eligible for USDA grading and certification.
In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, AMS has performed an initial regulatory flexibility analysis regarding economic effects of this final rule on small entities.
AMS is amending the Regulations Governing the Voluntary Grading of Shell Eggs, 7 CFR part 56, to revise the definition of the term “condition” to clarify that it relates solely to a quality determination and not food safety. The current regulation definition for “condition” includes the term “wholesomeness” which denotes a food safety connotation. AMS' role in grading and certification of shell eggs is for a quality determination only. By removing any food safety related terms from the current definition of “condition,” AMS will remove confusion or misunderstanding over use of the term.
Since this change is a technical correction and editorial in nature, and will not result in a change to the way service is provided to our customers, AMS has determined it will not have a financial impact on small entities that utilize our services.
AMS will also revise the prerequisite requirement of shell eggs eligible for USDA grading and certification. The revision will prohibit the use of SE-adulterated shell eggs or recalled shell eggs from being presented to USDA for grading and certification.
The FDA prohibits the use of SE-adulterated shell eggs from being sold to consumers. When shell eggs are suspected of being adulterated with SE, the packing facility is obligated to test the shell eggs to assure only safe product is distributed to consumers. If shell eggs are found to be adulterated with SE, the FDA will issue a request to the packing facility to voluntarily recall the product, or will exercise its mandatory recall authority to return the product to the origin facility. The product must either be destroyed or reconditioned under FDA supervision.
Since SE-adulterated shell eggs or shell eggs that have been recalled are no longer eligible for distribution to consumers, but are either destroyed or reconditioned under the direction of the FDA, changing the AMS regulation will not have an impact on small entities since those shell eggs are deemed unfit for human consumption.
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. When this final rule is adopted: (1) All State and local laws and regulations that are inconsistent with the rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
AMS is committed to compliance with the Government Paperwork Elimination Act, which requires government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
AMS is committed to complying with the E-Government Act of 2002 to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes.
Agriculture, Eggs and egg products, Food grades and standards, Food labeling, Food packaging, Reporting and recordkeeping requirements, Voluntary standards.
For the reasons set forth in the preamble, 7 CFR part 56 is amended as follows:
7 U.S.C. 1621
(c) * * *
(2) Not possess any undesirable odors or flavors;
(3) Not have previously been shipped for retail sale;
(4) Not originate from a layer house environment determined positive for the presence of Salmonella Enteritidis (SE), unless the eggs from the layer house have been sampled and have tested negative for the presence of SE in the eggs; and
(5) Not originate from eggs testing positive for SE, or not have been subject to a product recall.
Agricultural Marketing Service, USDA.
Final rule.
This rule implements recommendations from the Cherry Industry Administrative Board (Board) to add inventory release procedures and revise optimum supply provisions under the marketing order for tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin (order). The Board locally administers the order and is comprised of growers and handlers operating within the area of production. This final rule establishes procedures for releasing inventory from reserves and increases the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds. These changes provide clear procedures should an inventory release be necessary and provides more flexibility when calculating optimum supply.
Effective September 19, 2016.
Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-
This final rule is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This final rule adds inventory release procedures and revises the optimum supply and exemption provisions under the order. This rule establishes procedures for releasing inventory from reserves and increases the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds. These changes provide clear procedures should an inventory release be necessary and provides more flexibility when calculating optimum supply. The Board voted to recommend these changes to the Secretary at its meeting on June 25, 2015.
Section 930.50 prescribes procedures for calculating an optimum supply based on sales history to determine free and restricted percentages under volume regulation. As part of the process, the Board is required to determine the volume of fruit they anticipate would be necessary to have on hand at the end of the crop year. The order refers to this volume as carry-out inventory. This section currently specifies, in part, that the Board can consider a carry-out inventory of up to 20 million pounds, or another amount with the approval of the Secretary. This rule amends Section 930.151 to increase the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds.
Section 930.54 of the order governs the use or disposition of inventory reserve cherries. Under this authority, the Board can recommend to the Secretary that a portion or all of inventory reserve cherries be released if there is not sufficient fruit on the market to meet commercial demand. Sections 930.55 and 930.57 outline the provisions and requirements of the primary and secondary reserves, respectively. Further, no cherries in the secondary reserve may be released until all cherries in the primary reserve have been released. This rule creates section 930.154 to establish procedures for releasing inventory from reserves.
When volume regulation is in place, the restricted portion of the crop is either held in reserve by handlers or can be sold for exempt uses as authorized in the rules and regulations of the order. Reserves can be held over multiple crop years and are released when there is a shortfall in supply. While the Board maintains record of the volume in reserve, handlers maintain ownership of the reserve fruit.
All inventory reserves were released to meet demand following a crop disaster in 2012. The following year, the industry was still recovering and the Board did not recommend a volume regulation. When the Board recommended a volume regulation for the 2014-15 season to the Secretary, and cherries were again being added to the reserve, the Board established a committee to review the procedures for releasing restricted inventory from reserves. The committee recommended to the Board that the procedures as previously developed by the Board be maintained, and that any release should first come from inventory currently in the primary reserve and then from any cherries designated for reserve from the current season if necessary.
Under these procedures, once the additional volume needed for release is established, the release should be apportioned among handlers based on each handler's prior three-year average of volume handled as a percentage of the industry's three-year average. For example, if a handler handled five percent of the previous three years' production, and the Board recommended a release of 20 million pounds, that handler would be authorized to release one million pounds of established reserves (.05 X 20 million). If a handler receives a release larger than what they have in the primary reserve, the excess amount would be reapportioned to those handlers with remaining primary reserve. If the handler in the scenario above had only 750,000 pounds in the primary reserve, the remaining 250,000 pounds would be reallocated to those handlers who still have inventory in the primary reserve.
The committee that reviewed the procedures for releasing restricted inventory from the reserves recognized that inventory reserves can be accumulated over a period of years. Therefore, the committee agreed releases should be based on the average amount handled during the three previous crop years, rather than using a year-to-year basis. The existing release procedures were crafted by the Board through a series of actions in past years and meetings. However, the procedures were not codified in the rules and regulations under the order. This rule adds the inventory release procedures to the regulations.
This recommendation was also thought to be the most equitable way to conduct releases. One Board member believed the releases should come from the current year's reserves prior to releasing from existing reserves, and did not support the recommendation. However, the Board recognized that during the crop year, complete information on reserves and shipment data would not be available. Thus, the Board recommended codifying inventory release procedures as recommended by the committee. The Board supported the recommendation by a vote of 17-1. This rule adds a new Section 930.154 to the regulations to establish procedures for releasing inventory from reserves.
In addition to reviewing inventory release procedures, the Board discussed changes to some of its practices regarding calculation of optimum supply. Optimum supply is defined as the average free sales of the prior three years plus desirable carry-out inventory. Desirable carry-out is the amount of fruit needed by the industry to be carried into the succeeding crop year to meet marketing demand until the new crop is available. Desirable carry-out is set each year by the Board after considering market circumstances and needs. Section 930.50(a) currently specifies that desirable carry-out can range from 0 to a maximum of 20
Since the promulgation of the order, the industry has seen new products and new segments emerge, such as dried tart cherries. As a result, at the end of a season there are multiple product lines that need to be supplied with tart cherries before the next harvest, which has impacted desirable carry-out. Desirable carry-out is the amount of fruit needed by the industry to be carried into the succeeding crop year to meet marketing demand until the new crop is available.
In 2014, the Board used its authority to recommend to the Secretary a carry-out volume above the order-prescribed 20 million pound maximum for the 2014-2015 crop year. At that time, the Board estimated it was necessary to have 50 million pounds available at the end of the crop year to fulfill the needs of the industry. In discussing volume regulation for the 2015-2016 crop year, the Board agreed an increased carry-out was again necessary and recommended to the Secretary a 55 million pound carry-out when calculating the optimum supply.
In order to facilitate future carry-out needs without engaging in annual rulemaking, the Board recommended permanently increasing the maximum carry-out to 100 million pounds. Some members considered the 100 million pound upper limit to be too high, and voted against the recommendation. However, this action only increases the available range for the carry-out value from 0 to 20 million pounds to 0 to 100 million. This change will provide the Board with additional flexibility when considering the carry-out, but in itself does not establish a carry-out amount. The Board will still discuss and recommend a desirable carry-out value that represents current industry needs each crop year. Consequently, the Board supported the recommendation by a vote of 12-5. This rule amends section 930.151 of the regulations to increase the maximum carry-out volume possible when calculating optimum supply from 20 million pounds to 100 million pounds.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000 and small agricultural service firms have been defined as those having annual receipts of less than $7,500,000 (13 CFR 121.201).
According to the National Agricultural Statistics Service and Board data, the average annual grower price for tart cherries during the 2014-15 crop year was $0.35 per pound, and total utilization was around 300 million pounds. Therefore, average receipts for tart cherry producers were around $175,800, well below the SBA threshold for small producers. In 2014, The Food Institute estimated an f.o.b. price of $0.96 per pound for frozen tart cherries, which make up the majority of processed tart cherries. Using this data, average annual handler receipts were about $6.9 million, which is also below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.
This final rule creates § 930.154 of the rules and regulations, establishing procedures for release of inventory reserves. This final rule also revises § 930.151 to allow the Board to consider a carry-out of up to 100 million pounds when calculating optimum supply. These changes are intended to provide clear direction in the event an inventory release becomes necessary and allow the Board to be more responsive to tart cherry market demand. The authority for these actions is provided in §§ 930.50 and 930.54 of the order.
It is not anticipated that this action will impose additional costs on handlers or growers, regardless of size. The implemented changes are administrative in nature and intended to align the provisions of the order with current industry practices. The addition of rules and regulations regarding inventory releases is a codification of administrative procedures the Board has had in place for many years. The expanded carry-out upper limit will allow the Board additional flexibility in meeting market needs without additional rulemaking.
The benefits of this rule are not expected to be disproportionately greater or less for small handlers or producers than for larger entities.
The Board discussed alternatives to these changes to the order, including releasing reserves from the current crop year or releasing cherries in the order in which the fruit was put into reserve. A committee was established to review the reserve procedures, and it proposed using a three-year average percentage for each handler and releasing the previous crop years' reserves. The Board agreed that the committee's recommendation would be the most equitable solution. Regarding the carry-out limit, the Board considered not recommending a permanent change. However, the Board anticipates needing more than 20 million pounds of carry-out for the foreseeable future. A member suggested changing the motion to 80 million pounds, but that suggestion did not receive support. Thus, the suggested alternatives were rejected.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
Accordingly, this action will not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this final rule.
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
The Board's meeting was widely publicized throughout the tart cherry industry and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 25, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on these issues.
A proposed rule concerning this action was published in the
One comment was received during the comment period in response to the proposal. The commenter is an individual who supports the proposed action. The commenter described the proposed changes as positive for the industry. Accordingly, no changes will be made to the rule as proposed, based on the comment received.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant matter presented, including the information and recommendation submitted by the Board and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Marketing agreements, Reporting and recordkeeping requirements, Tart cherries.
For the reasons set forth in the preamble, 7 CFR part 930 is amended as follows:
7 U.S.C. 601-674.
(a) * * *
(b) Beginning with the crop year starting July 1, 2016, for the purposes of determining an optimum supply volume, the Board may recommend a desirable carry-out inventory not to exceed 100 million pounds.
(a) As provided in § 930.54, the Board may recommend a release of a portion or all of the primary and/or secondary reserve cherries. The total available reserves will be determined at the beginning of the crop year. The primary reserve as defined in §§ 930.55 and 930.150 must be depleted before the secondary reserve can be released. If a release is recommended, the recommended volume shall be apportioned to handlers on the basis of each handler's proportion of the total volume handled in the preceding three crop years.
(b) If a handler has less volume in reserve than is apportioned, the excess volume shall be reapportioned to those who still have volume in reserve until the total release is complete.
Agricultural Marketing Service, USDA.
Interim rule with request for comments.
This rule implements a recommendation from the Administrative Committee for Pistachios (Committee) for a decrease in the assessment rate established for the 2016-17 and subsequent production years from $0.0035 to $0.0010 per pound of assessed weight pistachios handled under the marketing order (order). The Committee locally administers the order and is comprised of producers and handlers of pistachios operating within the area of production. Assessments upon pistachio handlers are used by the Committee to fund reasonable and necessary expenses of the program. The production year begins September 1 and ends August 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Effective September 19, 2016; Comments received by November 15, 2016 will be considered prior to issuance of a final rule.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Peter R. Sommers, Marketing Specialist,
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This rule is issued under Marketing Agreement and Order No. 983, both as amended (7 CFR part 983), regulating the handling of pistachios grown in California, Arizona, and New Mexico, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California, Arizona, and New Mexico pistachio handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable pistachios beginning September 1, 2016, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule decreases the assessment rate for the 2016-17 and subsequent production years from $0.0035 to $0.0010 per pound of assessed weight pistachios.
The California, Arizona, and New Mexico pistachio order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of California, Arizona, and New Mexico pistachios. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2015-16 and subsequent production years, the Committee recommended and USDA approved an assessment rate that would continue in effect from production year to production year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.
The Committee met on July 12, 2016, and unanimously recommended 2016-17 expenditures of $922,500, and an assessment rate of $0.0010 per pound of assessed weight pistachios. In comparison, last year's budgeted expenditures were $1,056,402, and the assessment rate was $0.0035 per pound of pistachios. The assessment rate of $0.0010 is $0.0025 lower than the rate currently in effect.
The major expenditures recommended by the Committee for the 2016-17 production year include $333,000 for salaries and benefits, $250,000 for research, and $19,500 for general and administrative expenses. Budgeted expenses for these items in the 2015-16 production year were $316,500, $560,000, and $19,500, respectively.
The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of California, Arizona, and New Mexico pistachios. Pistachio shipments for the production year are estimated at 750 million pounds which should provide $750,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses. Funds in the reserve will be kept within the maximum limit permitted by the order, which is two production years' budgeted expenses.
The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.
Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each production year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2016-17 production year budget and those for subsequent production years will be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 1,152 producers of pistachios in the production area and 19 handlers subject to regulation under the marketing order. The Small Business Administration defines small agricultural producers as those having annual receipts less than $750,000, and small agricultural service firms as those whose annual receipts are less than $7,500,000. (13 CFR 121.201)
Based on Committee data, it is estimated that about 53 percent of the handlers annually ship less than $7,500,000 worth of pistachios, and it is also estimated that 68 percent of the producers have annual receipts less
This rule decreases the assessment rate collected from handlers for the 2016-17 and subsequent production years from $0.0035 to $0.0010 per pound of pistachios handled. The Committee unanimously recommended 2016-17 expenditures of $922,500 and an assessment rate of $0.0010 per pound of assessed weight pistachios, which is $0.0025 lower than the 2015-16 rate currently in effect. The quantity of assessable pistachios for the 2016-17 production year is estimated at 750 million pounds. Thus, the $0.0010 rate should provide $750,000 in assessment income. Income derived from handler's assessments, along with interest and funds from the Committee's authorized reserve, should be adequate to cover expenses for the 2016-17 production year.
The major expenditures recommended by the Committee for the 2016-17 production year include $333,000 for salaries and benefits, $250,000 for research, and $19,500 for general and administrative expenses. Budgeted expenses for these items in the 2015-16 production year were $316,500, $560,000, and $19,500, respectively.
The assessment rate decrease is necessary to reduce expected income from an assessment rate set at $0.0035 per pound. The income from that assessment rate would result in the Committee's financial reserve being higher than is permitted under the order. The $0.0035 rate was established to provide sufficient income when the crop was expected to be approximately half of a normal crop. For these reasons, the Committee unanimously voted to decrease the assessment rate from $0.0035 to $0.0010. The income generated from the lower recommended rate combined with funds from the financial reserve should provide sufficient income to cover anticipated 2016-17 expenses and maintain the financial reserve within the limit specified under the marketing order.
Prior to arriving at this budget and assessment rate, the Committee considered information from various sources. Alternative expenditure levels were discussed, based upon the relative value of various activities to the pistachio industry. The Committee ultimately determined that the 2016-17 production year expenses of $922,500 were prudent, and the assessment income provided by the reduced rate and funds from the financial reserve would permit the committee to meet its expenses.
According to data from the National Agricultural Statistics Service, the season average producer price was $3.57 per pound of assessed weight pistachios in 2014 and $2.48 per pound in 2015. A review of historical and preliminary information pertaining to the upcoming production year indicates that the producer revenue for the 2016-17 production year could range between $1,860,000,000 and $2,677,500,000. Therefore, the estimated assessment revenue for the 2016-17 production year as a percentage of total producer revenue could range between 0.0004 and 0.00028 percent.
This action decreases the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Committee meeting was widely publicized throughout the California, Arizona, and New Mexico pistachio industry, and all interested persons were invited to attend the meetings and encouraged to participate in Committee deliberations on all issues.
Like all Committee meetings, the July 12, 2016, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Industry members also discussed various assessment rates, potential crop size, and estimated expenses at this meeting. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0215, “Vegetable and Specialty Crop Marketing Orders.” No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This action imposes no additional reporting or recordkeeping requirements on either small or large California, Arizona, and New Mexico pistachio handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Pistachios, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 983 is amended as follows:
7 U.S.C. 601-674.
On and after September 1, 2016, an assessment rate of $0.0010 per pound is established for California, Arizona, and New Mexico pistachios.
Board of Governors of the Federal Reserve System.
Final policy statement.
The Board of Governors of the Federal Reserve System (Board) is adopting a final policy statement (Policy Statement) describing the framework that the Board will follow under its Regulation Q in setting the amount of the U.S. countercyclical capital buffer for advanced approaches bank holding companies, savings and loan holding companies, and state member banks.
The Policy Statement is effective October 14, 2016.
William Bassett, Deputy Associate Director, (202) 736-5644, or Rochelle Edge, Deputy Associate Director, (202) 452-2339, Division of Financial Stability; Sean Campbell, Associate Director, (202) 452-3760, Division of Banking Supervision and Regulation; Benjamin W. McDonough, Special Counsel, (202) 452-2036, Mark Buresh, Senior Attorney, (202) 452-5270, or Mary Watkins, Attorney, (202) 452-3722, Legal Division.
In December 2015, the Board invited public comment on a proposed policy statement describing the framework that the Board would use to set the amount of the U.S. countercyclical capital buffer (CCyB) under the Board's capital rules (Regulation Q).
The proposed policy statement outlined the factors the Board would consider in setting the level of the CCyB, and the indicators it would monitor to help determine whether an adjustment to the CCyB is appropriate. The proposed policy statement also described the effects the Board will monitor in determining whether the CCyB is achieving the desired purposes of the CCyB.
The Board received two comments on the proposed policy statement. Commenters raised concerns about the process that the Board would follow in setting the CCyB pursuant to the policy statement, the potential economic impact of the CCyB, and the efficacy and appropriateness of the CCyB as a policy tool. Commenters also made various specific suggestions as to the indicators and standards that the Board should consider in determining whether to activate the CCyB.
After reviewing comments, the Board is revising the final Policy Statement to clarify the following key items: (1) That the Board expects that the CCyB will be activated when systemic vulnerabilities are meaningfully above normal and that the Board generally intends to increase the CCyB gradually, (2) that the Board expects to remove or reduce the CCyB when the conditions that led to its activation abate or lessen and when the release of CCyB capital would promote financial stability. The discussion in Sections II and IV below responds to comments on the proposal regarding the Board's process for setting the CCyB. In particular, as indicated below, the Board would seek comment on any proposed change to the CCyB amount and include a discussion of the reasons for the change.
The CCyB is designed to increase the resilience of large banking organizations when the Board sees an elevated risk of above-normal losses. Increasing the resilience of large banking organizations should, in turn, improve the resilience of the broader financial system. Above-normal losses often follow periods of rapid asset price appreciation or credit growth that are not well supported by underlying economic fundamentals. As stated in the proposed policy statement, the circumstances in which the Board would most likely use the CCyB as a supplemental, macroprudential tool to augment minimum capital requirements and other capital buffers would be to address circumstances when systemic vulnerabilities are somewhat above normal. By requiring institutions to hold a larger capital buffer during periods when systemic risk is increasing and reducing the buffer requirement as vulnerabilities diminish, the CCyB also has the potential to moderate fluctuations in the supply of credit over time.
The CCyB functions as an expansion of the Capital Conservation Buffer (CCB), which is applicable to all banking organizations subject to Regulation Q. To avoid limits on capital distributions and certain discretionary bonus payments,
The CCyB was introduced for large, internationally active banking organizations (advanced approaches institutions) in June 2013 as part of the revised regulatory capital rules issued by the Board in coordination with the Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC).
Because the CCyB is intended to address elevated risks from activity that is not well supported by underlying economic fundamentals, the location of the activity and the economic conditions where the activity take place provide important context. Accordingly, the CCyB applies based on the location of private-sector credit exposures by national jurisdiction.
Regulation Q established the initial CCyB amount with respect to private-sector credit exposures located in the United States (U.S.-based credit exposures) at zero percent.
In order to provide banking organizations with sufficient time to adjust to any change in the CCyB, Regulation Q provides that a determination to increase the countercyclical capital buffer amount generally will be effective 12 months from the date of announcement. However, economic conditions may warrant an earlier or later effective date.
Regulation Q states that a decision by the Board to decrease the amount of the CCyB for U.S.-based credit exposures would become effective the day after the Board decides to decrease the CCyB or the earliest date permissible under applicable law or regulation, whichever is later.
The Board expects to make decisions about the appropriate level of the CCyB on U.S.-based credit exposures jointly with the OCC and FDIC. In addition, the Board expects that the CCyB amount for U.S.-based credit exposures would be the same for covered insured depository institutions as for covered depository institution holding companies. The CCyB is designed to take into account the broad macroeconomic and financial environment in which banking organizations function and the degree to which that environment impacts the resilience of advanced approaches institutions. Therefore, the Board's determination of the appropriate level of the CCyB for U.S.-based credit exposures would be most directly linked to the condition of the overall financial environment rather than the condition of any individual banking organization. However, the impact of the CCyB requirement on a particular banking organization will vary based on the organization's particular composition of private-sector credit exposures located across national jurisdictions.
The final policy statement (Policy Statement) describes the framework that the Board would follow in setting the amount of the CCyB for U.S.-based credit exposures. The framework consists of a set of principles for translating assessments of financial system vulnerabilities that are regularly undertaken at the Board into the appropriate level of the CCyB. Those assessments are informed by a broad array of quantitative indicators of financial and economic performance and a set of empirical models. In addition, the framework includes a discussion of how the Board would assess whether the CCyB is the most appropriate policy instrument (among available policy instruments) to address the highlighted financial system vulnerabilities.
The Policy Statement is organized as follows. Section 1 provides background on the Policy Statement. Section 2 is an outline of the Policy Statement and describes its scope. Section 3 provides a broad description of the objectives of the CCyB, including a description of the ways in which the CCyB is expected to protect large banking organizations and the broader financial system. Section 4 provides a broad description of the factors that the Board considers in setting the CCyB, including specific financial system vulnerabilities and types of quantitative indicators of financial and economic performance, and outlines of empirical models the Board may use as inputs to that decision. Further, section 4 describes a set of principles that the Board expects to use for combining judgmental assessments with quantitative indicators to determine the appropriate level of the CCyB. Section 5 discusses how the Board will communicate the level of the CCyB and any changes to the CCyB. Section 6 describes how the Board plans to monitor the effects of the CCyB, including what indicators and effects will be monitored.
The Board has revised the Policy Statement to clarify that (1) the Board expects that the CCyB will be activated when systemic vulnerabilities are meaningfully above normal and the Board generally intends to increase the CCyB gradually, and (2) the Board
As noted, the Board received two comments regarding the proposed policy statement. Commenters expressed concerns about the process that the Board would follow in setting the CCyB pursuant to the Policy Statement, the potential economic impact of the CCyB, and the appropriate uses of the CCyB.
Commenters expressed concern that the Board would apply the CCyB without completing the procedures required by the Administrative Procedure Act (APA).
The Board's rule implementing the CCyB specifically provides that the Board will adjust the CCyB amount in accordance with applicable law.
A commenter suggested that the Board should commit to act jointly with the OCC and FDIC in any decision to activate the CCyB. Consistent with Regulation Q and the proposal, the Board expects that any decision to adjust the CCyB will be made jointly by the OCC, FDIC, and Board. However, the Board will make decisions regarding the appropriate amount of the CCyB for the firms that it supervises based on its judgment of the facts and circumstances presented.
A commenter argued that the Board generally should not reciprocate decisions by foreign jurisdictions regarding the level of the CCyB in such jurisdictions. If the Board did decide to incorporate CCyB decisions of foreign jurisdictions, the commenter argued that the Board should implement a de minimis threshold below which U.S. banking organizations would not have to recognize the CCyB established in the foreign jurisdiction. The Policy Statement describes the framework that the Board will follow in determining the CCyB for U.S. private-sector credit exposures. The Board will address separately CCyB adjustments made by foreign jurisdictions as needed.
A commenter argued that the CCyB should be increased only when credit growth was considered excessive, rather than when systemic vulnerabilities were somewhat above normal, as suggested by the proposal.
The CCyB is a macroprudential policy tool intended to strengthen banking organizations' resilience against the build-up of systemic vulnerabilities and reduce fluctuations in the supply of credit. As stated in the proposed policy statement, activation of the CCyB at a time when systemic vulnerabilities are somewhat above normal reflects the prophylactic and countercyclical goals of this tool as well as the process and 12-month phase-in period that generally applies before any activation of the CCyB amount would take effect. Moreover, activation of the CCyB at a time when systemic vulnerabilities are somewhat above normal rather than delaying until systemic vulnerabilities are excessive would allow gradual increases in the CCyB, which would provide additional flexibility (over and above the 12-month phase-in period) to banking organizations as they adjust to any increases. That is, activation of the CCyB at a time when systemic vulnerabilities are somewhat above normal would likely not be associated with an activation of the CCyB to the upper end of its possible range. Further, the Board considers “systemic vulnerabilities” to be the appropriate reference point because the CCyB could be an effective tool in addressing a variety of financial system vulnerabilities, not merely credit growth.
To further clarify when the Board would expect to increase the CCyB, the Policy Statement has been modified to state that the CCyB would be increased when systemic vulnerabilities are “meaningfully above normal.” For these purposes “meaningfully above normal” would reflect an assessment by the Board that financial system vulnerabilities were above normal and were either already at, or expected to build to, levels sufficient to generate material unexpected losses in the event of an unfavorable development in financial markets or the economy. The text in the policy statement has also been modified to clarify that systemic vulnerabilities being meaningfully above normal would correspond to the Board beginning to increase the CCyB above zero and to provide additional discussion of when and how the Board would deactivate or reduce the CCyB.
Commenters argued that the Board should conduct and release analyses of the economic impact and costs and benefits of the CCyB in connection with the proposed policy statement as well as with any decision to increase the level of the CCyB. Commenters contended that such analyses should take into account other existing prudential regulation, including other regulatory capital requirements, and consider whether alternative policy tools may be more effective for a particular situation. The commenters expressed concern that there could be material adverse economic consequences to activation of the CCyB. Similarly, one commenter argued that the Board should conduct a comprehensive analysis of the costs and benefits of regulatory capital requirements, including the CCyB, as well as prudential liquidity regulations and regulations established by other agencies.
Commenters also argued that the Board should provide additional detail regarding the data, models, and metrics that would inform a decision to activate the CCyB, as well as the standards that would be applied to determine the calibration of the CCyB. Additionally, commenters raised issues with certain of the indicators identified in the Policy Statement. For instance, a commenter cautioned that no academic consensus had been reached with regard to the usefulness of a credit-to-GDP ratio gap as an indicator of economic conditions.
The final Policy Statement provides additional information to the public regarding the framework that the Board will follow in setting the CCyB. The Policy Statement itself does not change either the CCyB or the capital requirements applicable to advanced approaches banking organizations. As described above, the Board generally would expect to provide notice to the public and seek comment on the proposed level of the CCyB as part of
One commenter stated that the FFIEC 009 reporting form requires firms to report information that is not aligned with the information needed to determine the CCyB amount applicable to a firm and that the Board should amend the FFIEC 009 to align with CCyB in order to reduce burden. The Board may consider reporting for purposes of the CCyB at a later date.
The Board recognizes that no single data point or indicator can provide a comprehensive understanding of economic conditions or systemic vulnerabilities. The items for consideration listed in the Policy Statement are a non-exclusive list of quantitative and qualitative indicators that may inform the Board's assessment of economic conditions and determinations regarding the appropriate level of the CCyB. As explained in the proposed and final Policy Statement, some academic research has shown the credit-to-GDP ratio to be useful in identifying periods of financial excess followed by a period of crisis. However, the Board does not expect this indicator to be used in isolation. Furthermore, as noted, any proposal to increase the CCyB will include a discussion of the indicators informing the proposal, and will seek comment on the interpretation of these indicators. As noted above, the Board expects that the types of indicators and models considered will evolve over time, based on advances in research and the experience of the Board with this tool.
Commenters argued that the CCyB would not be effective in containing asset bubbles or excessive credit risks because these tend to occur within sectors as opposed to across the financial system equally. A commenter suggested that targeted guidance for particular sectors would likely be more effective at containing risks of this type than a broad based capital charge imposed by the CCyB.
Commenters also argued that the CCyB would not be effective in addressing many systemic vulnerabilities because it applies only to advanced approaches banking organizations, which, while significant, represent a relatively small percentage of the total provision of credit in the U.S. economy. A commenter contended that activation of the CCyB might exacerbate risk in the financial system by shifting lending activity away from large and closely regulated commercial banks and into the shadow banking system. In addition, a commenter argued that advanced approaches banking organizations were subject to significant capital, liquidity, and other prudential requirements such that they were likely to be resilient in the event of adverse economic conditions. As a result, the commenter argued, advanced approaches banking organizations were unlikely to be made materially more resilient as a result of imposition of the CCyB.
As reflected in the Policy Statement, the pace and magnitude of changes in the CCyB will depend on the underlying conditions in the financial sector and the economy, the desired effects of the proposed change in the CCyB, and consideration of whether the CCyB is the most appropriate of the Board's available policy instruments to address the financial system vulnerabilities. A natural corollary to this analysis would be consideration of whether the CCyB could be expected to increase other systemic vulnerabilities. The CCyB is one of several policy tools available to the Board. In determining whether or not to change the CCyB, the Board will consider whether the CCyB is the most appropriate of available policy tools, and whether the CCyB would be most effective if used in conjunction with other policy tools.
Section 722 of the Gramm-Leach-Bliley Act (Pub. L. 106-102, 113 Stat. 1338, 1471, 12 U.S.C. 4809) requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The Board received no comments on the use of plain language.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3506), the Board has reviewed the Policy Statement to assess any information collections. There are no collections of information as defined by the Paperwork Reduction Act in the proposal.
The Board is providing a final regulatory flexibility analysis with respect to this Policy Statement. The Regulatory Flexibility Act, 5 U.S.C. 601
The Board sought comment on whether the proposal would impose undue burdens on, or have unintended consequences for, small banking organizations. The Board received one comment on this aspect of the proposal, which argued that the Board's initial regulatory flexibility analysis was flawed in asserting that small banking organizations would not be affected by the proposal because of the broader impact that the CCyB could have on lending and economic growth in general.
This Policy Statement will be added as an appendix to Regulation Q to describe the framework that the Board will follow in setting the amount of the CCyB for U.S.-based credit exposures. The CCyB only applies to bank holding companies, savings and loan holding companies, and state member banks that are advanced approaches Board-regulated institutions for purposes of the Board's Regulation Q (advanced approaches banking organizations). The Regulatory Flexibility Act requires consideration only of the impact of the proposed rule on small entities that are subject to the requirements of the rule, as opposed to small entities indirectly affected by the rule through its impact on the national economy.
Therefore, there are no significant alternatives to the final rule that would have less economic impact on small bank holding companies. As discussed above, there are no projected reporting, recordkeeping, and other compliance requirements of the final rule. The Board does not believe that the final rule duplicates, overlaps, or conflicts with any other Federal rules. In light of the foregoing, the Board does not believe that the final rule would have a significant economic impact on a substantial number of small entities.
In light of the foregoing, the Board does not believe that the final rule will have a significant impact on small entities.
Administrative practice and procedure, Banks, banking. Holding companies, Reporting and recordkeeping requirements, Securities.
For the reasons stated in the preamble, the Board of Governors of the Federal Reserve System amends 12 CFR part 217 as follows:
12 U.S.C. 248(a), 321-338a, 481-486, 1462a, 1467a, 1818, 1828, 1831n, 1831o, 1831p-l, 1831w, 1835, 1844(b), 1851, 3904, 3906-3909, 4808, 5365, 5368, 5371.
(a) In 2013, the Board of Governors of the Federal Reserve System (Board) issued a final regulatory capital rule (Regulation Q) in coordination with the Office of the Comptroller of the Currency (OCC) and the Federal Deposit Insurance Corporation (FDIC) that strengthened risk-based and leverage capital requirements applicable to insured depository institutions and depository institution holding companies (banking organizations).
(b) The CCyB is a supplemental, macroprudential policy tool that the Board can increase during periods of rising vulnerabilities in the financial system and reduce when vulnerabilities recede. It is designed to increase the resilience of large banking organizations when there is an elevated risk of above-normal losses. Increasing the resilience of large banking organizations will, in turn, improve the resilience of the broader financial system. Above-normal losses often follow periods of rapid asset price appreciation or credit growth that are not well supported by underlying economic fundamentals. The circumstances in which the Board would most likely begin to increase the CCyB above zero percent to augment minimum capital requirements and other capital buffers would be when systemic vulnerabilities are meaningfully above normal. By requiring large banking organizations to hold additional capital during those periods of excess and removing the requirement to hold additional capital when the vulnerabilities have diminished, the CCyB also is expected to moderate fluctuations in the supply of credit over time. Moderating the supply of credit may mitigate or prevent the conditions that contribute to above-normal losses, such as elevated asset prices and excessive leverage, and prevent or mitigate reductions in lending to creditworthy borrowers that can amplify an economic downturn. In this way, implementation of the CCyB also responds to the Dodd-Frank Act's requirement that the Board seek to make its capital requirements countercyclical.
(c) Regulation Q established the initial CCyB amount with respect to private sector credit exposures located in the United States (U.S.-based credit exposures) at zero percent and provided that the maximum potential amount of the CCyB for credit exposures in the United States was 2.5 percent of risk-weighted assets.
This Policy Statement describes the framework that the Board will follow in setting the amount of the CCyB for U.S.-based credit exposures. The framework consists of a set of principles for translating assessments of financial system vulnerabilities that are regularly undertaken by the Board into the appropriate level of the CCyB. Those assessments are informed by a broad array of quantitative indicators of financial and economic performance and a set of empirical models. In addition, the framework includes an assessment of whether the CCyB is the most appropriate policy instrument (among available policy instruments) to address the highlighted financial system vulnerabilities.
(a) The objectives of the CCyB are to strengthen banking organizations' resilience against the build-up of systemic vulnerabilities and reduce fluctuations in the supply of credit. The CCyB supplements the minimum capital requirements and the capital conservation buffer, which themselves are designed to provide substantial resilience to unexpected losses created by normal fluctuations in economic and financial conditions. The capital surcharge on global systemically important banking organizations adds an additional layer of defense for the largest and most systemically important institutions, whose financial distress can have outsized effects on the rest of the financial system and the real economy.
(b) The CCyB is expected to help provide additional resilience for advanced approaches institutions, and by extension the
(c) The second and related goal of the CCyB is to promote a more sustainable supply of credit over the economic cycle. During a credit cycle downturn, better-capitalized institutions have been shown to be more likely than weaker institutions to have continued access to funding. Better-capitalized institutions also are less likely to take actions that lead to broader financial-sector distress and its associated macroeconomic costs, such as large-scale sales of assets at prices below their fundamental value and sharp contractions in credit supply.
(d) During a period of cyclically increasing vulnerabilities, advanced approaches institutions might react to an increase in the CCyB by raising lending standards, otherwise reducing their risk exposure, augmenting their capital, or some combination of those actions. They may choose to raise capital by taking actions that would increase net income, reducing capital distributions such as share repurchases or dividends, or issuing new equity. In this regard, an increase in the CCyB would not prevent advanced approaches institutions from maintaining their important role as credit intermediaries, but would reduce the likelihood that banking organizations with insufficient capital would foster unsustainable credit growth or engage in imprudent risk taking. The specific combination of adjustments and the relative size of each adjustment will depend in part on the initial capital positions of advanced approaches institutions, the cost of debt and equity financing, and the earnings opportunities presented by the economic situation at the time.
(a) The Board regularly monitors and assesses threats to financial stability by synthesizing information from a comprehensive set of financial-sector and macroeconomic indicators, supervisory information, surveys, and other interactions with market participants.
(b) The Board intends to monitor a wide range of financial and macroeconomic quantitative indicators including, but not limited to, measures of relative credit and liquidity expansion or contraction, a variety of asset prices, funding spreads, credit condition surveys, indices based on credit default swap spreads, option implied volatilities, and measures of systemic risk.
(c) However, no single indictor or fixed set of indicators can adequately capture all the vulnerabilities in the U.S. economy and financial system. Moreover, adjustments in the CCyB that were tightly linked to a specific model or set of models could be imprecise due to the relatively short period that some indicators are available, the limited number of past crises against which the models can be calibrated, and limited experience with the CCyB as a macroprudential tool. As a result, the types of indicators and models considered in assessments of the appropriate level of the CCyB are likely to change over time based on advances in research and the experience of the Board with this new macroprudential tool.
(d) The Board will determine the appropriate level of the CCyB for U.S.-based credit exposures based on its analysis of the above factors. Generally, a zero percent U.S. CCyB amount would reflect an assessment that U.S. economic and financial conditions are broadly consistent with a financial system in which levels of system-wide vulnerabilities are within or near their normal range of values. The Board could increase the CCyB as vulnerabilities build. A 2.5 percent CCyB amount for U.S.-based credit exposures, which is the maximum level under the Board's rule, would reflect an assessment that the U.S. financial sector is experiencing a period of significantly elevated or rapidly increasing system-wide vulnerabilities. Importantly, as a macroprudential policy tool, the CCyB will be activated and deactivated based on broad developments and trends in the U.S. financial system, rather than the activities of any individual banking organization.
(e) Similarly, the Board would remove or reduce the CCyB when the conditions that led to its activation abate or lessen. Additionally, the Board would remove or reduce the CCyB when release of CCyB capital would promote financial stability. Indeed, for the CCyB to be most effective, the CCyB should be deactivated or reduced in a timely manner. Deactivating the CCyB in a timely manner could, for example, promote
(f) The pace and magnitude of changes in the CCyB will depend importantly on the underlying conditions in the financial sector and the economy as well as the desired effects of the proposed change in the CCyB. If vulnerabilities are rising gradually, then incremental increases in the level of the CCyB may be appropriate. Incremental increases would allow banks to augment their capital primarily through retained earnings and allow policymakers additional time to assess the effects of the policy change before making subsequent adjustments. However, if vulnerabilities in the financial system are building rapidly, then larger or more frequent adjustments may be necessary to increase loss-absorbing capacity sooner and potentially to mitigate the rise in vulnerabilities.
(g) The Board will also consider whether the CCyB is the most appropriate of its available policy instruments to address the financial system vulnerabilities highlighted by the framework's judgmental assessments and empirical models. The CCyB primarily is intended to address cyclical vulnerabilities, rather than structural vulnerabilities that do not vary significantly over time. Structural vulnerabilities are better addressed through targeted reforms or permanent increases in financial system resilience. Two central factors for the Board to consider are whether advanced approaches institutions are exposed—either directly or indirectly—to the vulnerabilities identified in the comprehensive judgmental assessment or by the quantitative indicators that suggest activation of the CCyB and whether advanced approaches institutions are contributing—either directly or indirectly—to these highlighted vulnerabilities.
(h) In setting the CCyB for advanced approaches institutions that it supervises, the Board plans to consult with the OCC and FDIC on their analyses of financial system vulnerabilities and on the extent to which advanced approaches banking organizations are either exposed to or contributing to these vulnerabilities.
(a) The Board expects to consider at least once per year the applicable level of the U.S. CCyB. The Board will review financial conditions regularly throughout the year and may adjust the CCyB more frequently as a result of those monitoring activities.
(b) Further, the Board will continue to communicate with the public in other formats regarding its assessment of U.S. financial stability, including financial system vulnerabilities. In the event that the Board considered that a change in the CCyB were appropriate, it would, in proposing the change, include a discussion of the reasons for the proposed action as determined by the particular circumstances. In addition, the Board's biannual Monetary Policy Report to Congress, usually published in February and July, will continue to contain a section that reports on developments pertaining to the stability of the U.S. financial system.
(a) The effects of the U.S. CCyB ultimately will depend on the level at which it is set, the size and nature of any adjustments in the level, and the timeliness with which it is increased or decreased. The extent to which the CCyB may affect vulnerabilities in the broader financial system depends upon a complex set of interactions between required capital levels at the largest banking organizations and the economy and financial markets. In addition to the direct effects, the secondary economic effects could be amplified if financial markets extract a signal from the announcement of a change in the CCyB about subsequent actions that might be taken by the Board. Moreover, financial market participants might react by updating their expectations about future asset prices in specific markets or broader economic activity based on the concerns expressed by the regulators in communications announcing a policy change.
(b) The Board will monitor and analyze adjustments by banking organizations and other financial institutions to the CCyB: whether a change in the CCyB leads to observed changes in risk-based capital ratios at advanced approaches institutions, as well as whether those adjustments are achieved passively through retained earnings, or actively through changes in capital distributions or in risk-weighted assets. Other factors to be monitored include the extent to which loan growth and interest rate spreads on loans made by affected banking organizations change relative to loan growth and loan spreads at banking organizations that are not subject to the buffer. Another consideration in setting the CCyB and other macroprudential tools is the extent to which the adjustments by advanced approaches institutions to higher capital buffers lead to migration of credit market activity outside of those banking organizations, especially to the nonbank financial sector. Depending on the amount of migration, which institutions are affected by it, and the remaining exposures of advanced approaches institutions, those adjustments could cause the Board to favor either a higher or a lower value of the CCyB.
(c) The Board will also monitor information regarding the levels of and changes in the CCyB in other countries. The Basel Committee on Banking Supervision is expected to maintain this information for member countries in a publically available form on its Web site.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2008-19-08, for all Dassault Aviation Model Falcon 10 airplanes. AD 2008-19-08 required repetitive replacement of the flexible hoses installed in the wing (slat) anti-icing system with new hoses. This new AD requires reducing the life limit of these flexible hoses, which reduces the repetitive replacement intervals. This AD was prompted by additional reports of collapse of the flexible hoses installed in the slat anti-icing systems on airplanes equipped with new, improved hoses. We are issuing this AD to prevent collapse of the flexible hoses in the slat anti-icing system, which could lead to insufficient anti-icing capability and, if icing is encountered in this situation, could result in reduced controllability of the airplane.
This AD is effective October 21, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 11, 2007 (72 FR 51161, September 6, 2007).
For service information identified in this final rule, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; Internet
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2008-19-08, Amendment 39-15675 (73 FR 54492, September 22, 2008) (“AD 2008-19-08”). AD 2008-19-08 applied to all Dassault Aviation Model Falcon 10 airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0104, dated May 7, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on all Dassault Aviation Model Falcon 10 airplanes. The MCAI states:
Occurrences were reported involving an in-service Falcon 10 aeroplane, where wing anti-ice hoses collapsed. The subsequent investigation revealed that the flexible hose, Part Number (P/N) FAL1005, collapsed because of an internal ply separation.
This condition, if not corrected, could lead to failure of the ice-protection system to remove ice accretion on the wing, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, EASA issued AD 2005-0020 and AD 2006-0114 [which correspond to AD 2008-19-08], respectively, imposing flight limitations and requiring replacement of the flexible hosesP/N FAL1005 with improved hoses P/N FAL1007.
Since those [EASA] ADs were issued, further occurrences were reported concerning aeroplanes with improved hoses, which led to the conclusion that the life limit of the flexible hose P/N FAL1007 must be reduced.
For the reasons above, this [EASA] AD retains the requirements of EASA AD 2006-0114, which is superseded; supersedes EASA AD 2005-0020; requires replacement of flexible hoses having P/N FAL 1000, P/N 1001, P/N FAL1005, or P/N FAL1005D, and reduces the life limit of the flexible hosesP/N 1007 [which would reduce the repetitive replacement intervals].
We gave the public the opportunity to participate in developing this AD. We considered the comment received. The commenter, Catherine Corn, supported the NPRM.
We have changed the “Definition of Serviceable Flexible Hose” specified in paragraph (j) of this AD from “350 flight hours or less” to “less than 350 flight hours” to clarify the intent of the flight hours for the life-limit of the flexible hose specified in paragraph (i) of this AD.
We have also revised paragraph (g) of this AD to clarify that accomplishing the replacement required by paragraph (i) of this AD terminates the replacements required by paragraph (g) of this AD.
We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting this AD with the change described previously, and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We estimate that this AD affects 124 airplanes of U.S. registry.
The actions that are required by AD 2008-19-08, and retained in this AD, take about 8 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $880. Based on these figures, the estimated cost of the actions that are required by AD 2008-19-08 is up to $1,560 per product, per replacement cycle.
We also estimate that it takes about 4 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $936 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $158,224, or $1,276 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States,
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective October 21, 2016.
This AD replaces AD 2008-19-08, Amendment 39-15675 (73 FR 54492, September 22, 2008) (“AD 2008-19-08”).
This AD applies to all Dassault Aviation Model Falcon 10 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 30, Ice and Rain Protection.
This AD was prompted by reports of collapse of the flexible hoses installed in the slat anti-icing systems on airplanes equipped with new, improved hoses. We are issuing this AD to prevent collapse of the flexible hoses in the slat anti-icing system, which could lead to insufficient anti-icing capability and, if icing is encountered in this situation, could result in reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (h) of AD 2008-19-08, with revised compliance language. As of October 27, 2008 (the effective date of AD 2008-19-08): Replace the flexible hoses installed in the slat anti-icing system with new hoses having part number (P/N) FAL1007, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F10-313, Revision 1, dated May 10, 2006, within 700 flight hours since the last replacement or within 100 flight hours after October 27, 2008, whichever occurs later, and thereafter at intervals not to exceed 700 flight hours. Accomplishing the replacement required by paragraph (h) or (i) of this AD ends the repetitive replacements required by this paragraph.
Within 65 days after the effective date of this AD: Replace any flexible hose having part number (P/N) FAL1000, P/N FAL1001, or P/N FAL1005D with a new, improved flexible hose having P/N FAL1007, using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation's EASA Design Organization Approval (DOA).
At the later of the times specified in paragraphs (i)(1) and (i)(2) of this AD, replace any flexible hose having part number P/N FAL1007 with a serviceable flexible hose having P/N FAL1007, using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Dassault Aviation's EASA DOA. Thereafter, before the accumulation of 350 flight hours on any flexible hose having P/N FAL1007, replace the flexible hose with a serviceable flexible hose having P/N FAL1007.
(1) Before the accumulation of 350 flight hours on the flexible hose P/N FAL1007 since first installation on an airplane.
(2) At the earlier of the times specified in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD.
(i) Within 200 flight hours after the effective date of this AD.
(ii) Before the accumulation of 700 flight hours on the flexible hose P/N FAL1007 since first installation on an airplane, or within 65 days after the effective date of this AD, whichever occurs later.
For the purpose of this AD, a serviceable flexible hose is a flexible hose having P/N FAL1007 that has accumulated less than 350 flight hours since first installation on an airplane.
After accomplishing the replacement required by paragraph (h) of this AD, no person may install a flexible hose in the slat anti-icing system on any airplane, unless that hose is a serviceable flexible hose having P/N FAL1007, and thereafter repetitive hose replacements are done as required by paragraph (i) of this AD.
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149. Information may be emailed to:
(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Dassault Aviation's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0104, dated May 7, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on October 11, 2007, (72 FR 51161, September 62, 2007).
(i) Dassault Service Bulletin F10-313, Revision 1, dated May 10, 2006.
(ii) Reserved.
(4) For service information identified in this AD, contact Dassault Falcon Jet
(5) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A330-200, Model A330-300, Model A340-200, and Model A340-300 series airplanes. This AD requires an inspection to determine the part number and serial number of certain escape slides on the left and right sides of the airplane, and replacement if necessary. This AD was prompted by a report indicating that the aspirator on certain escape slides might have been damaged because of incorrect packing during overhaul. We are issuing this AD to detect and correct damaged aspirators on escape slides. Failure of an aspirator to inflate an escape slide could prevent deployment of the escape slide during an emergency, possibly resulting in reduced evacuation capacity from the airplane and consequent injury to occupants.
This AD becomes effective October 3, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 3, 2016.
We must receive comments on this AD by October 31, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016-0137R1, dated July 21, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200 Freighter, Model A330-200, Model A330-300, Model A340-200, and Model A340-300 series airplanes. The MCAI states:
It has been reported that some door 3, Type 1, escape slides Part Number (P/N) 7A1509-series may have sustained damage to the slide aspirator, due to an incorrect packing during last overhaul. This damage affects the air inlet end of the slide aspirator by either permanently deforming the inlet, or leading to cracks in the supply line to the aspirator nozzle.
This condition, if not detected and corrected, could lead to failure of the slide aspirator to perform its intended function to inflate the evacuation slide, preventing slide deployment during an emergency, possibly resulting in reduced evacuation capacity from the aeroplane and consequent injury to occupants.
Prompted by these findings, Airbus issued Alert Operators Transmission (AOT) A25L009-16 to provide instructions to identify and replace the affected slides.
Consequently, EASA issued AD 2016-0137, requiring identification of the door 3, Type 1, slide installed on the aeroplane, and, depending on findings, the replacement of the slide with a serviceable part.
Since that [EASA] AD was issued, it was identified that affected slides cannot be installed on aeroplanes embodying optional Airbus mod 40161.
For the reason described above, this [EASA] AD is revised to reduce the Applicability, by excluding aeroplanes that have embodied Airbus mod 40161 in production.
Airbus has issued Alert Operators Transmission A25L009-16, dated July 7, 2016. The service information describes procedures for the identifying the part number and serial number of door 3, Type 1, escape slides and replacing the escape slides. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure of an aspirator to inflate a door 3, Type 1, escape slide could prevent deployment of the escape slide during an emergency, possibly resulting in reduced evacuation capacity from the airplane and consequent injury to occupants. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 104 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacement that will be required based on the results of the inspection. We have no way of determining the number of airplanes that might need this replacement:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective October 3, 2016.
None.
This AD applies to the Airbus airplanes, certificated in any category, identified in paragraphs (c)(1) through (c)(4) of this AD, all manufacturer serial numbers, except those that have embodied Airbus Modification 40161 in production.
(1) Airbus Model A330-201, -202, -203, -223, and -243 airplanes.
(2) Airbus Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(3) Airbus Model A340-211, -212, and -213 airplanes.
(4) Airbus Model A340-311, -312, and -313 airplanes.
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by a report indicating that the aspirator on certain door 3, Type 1, escape slides might have been damaged because of incorrect packing during overhaul. We are issuing this AD to detect and correct damaged aspirators on door 3, Type 1, escape slides. Failure of an aspirator to inflate a door 3, Type 1, escape slide could prevent deployment of the escape slide during an emergency, possibly resulting in reduced evacuation capacity from the airplane and consequent injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Within 30 days after the effective date of this AD: Do an inspection to determine the part number and serial number of the door 3, Type 1, escape slides on the left and right sides of the airplane, in accordance with the instructions of Airbus Alert Operators Transmission (AOT) A25L009-16, dated July 7, 2016. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the door 3, Type 1, escape slides can be conclusively determined from that review.
Airbus AOT A25L009-16, dated July 7, 2016, lists the corresponding airplane manufacturer serial numbers on which the affected slides (specified in table 1 to paragraphs (g), (i), and (j) of this AD) were re-installed after the last maintenance. That list of airplane manufacturer serial numbers is for information only because a potentially affected slide might have been removed from an airplane and later re-installed on another airplane.
If, during the inspection required by paragraph (g) of this AD, any door 3, Type 1, escape slide having a part number and a serial number identified in table 1 to paragraphs (g), (i), and (j) of this AD is found: At the applicable compliance time specified in paragraph (h)(1) or paragraph (h)(2) of this AD, replace each affected door 3, Type 1, escape slide with a serviceable escape slide, in accordance with the instructions of Airbus Alert Operators Transmission A25L009-16, dated July 7, 2016.
(1) For affected slides on both the left and right sides of the airplane: Within 30 days after the effective date of this AD, after identification as required by paragraph (g) of this AD, replace at least one slide; and, within 10 months or 4,100 flight hours, whichever occurs first after the effective date of this AD, replace the second slide.
(2) For one affected slide on either the left or right side of the airplane: Within 10 months or 4,100 flight hours, whichever occurs first after the effective date of this AD, replace the slide.
For the purpose of this AD, a serviceable escape slide is a brand new escape slide or one that has a part number and serial number identified in table 1 to paragraphs (g), (i) and (j) of this AD and was overhauled after May 1, 2016.
As of the effective date of this AD, an affected slide having a part number and serial number identified in table 1 to paragraphs (g), (i), and (j) of this AD may be installed on any airplane at the door 3, Type 1, position, provided it can be positively determined that the slide was overhauled after May 1, 2016.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2016-0137R1, dated July 21, 2016, for related information. You may examine the MCAI on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Alert Operators Transmission A25L009-16, dated July 7, 2016.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
State Department.
Final rule.
This final rule is promulgated to clarify that photographs submitted as part of a diversity visa lottery entry package must have been taken no more than six months before the date the entry is made and prohibit applicants from wearing eyeglasses in photographs.
This rule is effective on October 17, 2016.
Andrea Lage, Legislation and Regulations Division, Visa Services, Bureau of Consular Affairs, Department of State, 600 19th St. NW., Washington, DC 20006, (202) 485-7585.
The Diversity Immigrant Visa Program is administered annually by the Department of State (“Department”). Section 203(c) of the Immigration and Nationality Act (INA), 8 U.S.C. 1153(c), provides for a class of immigrants known as “diversity immigrants” from countries with historically low rates of immigration to the United States. From millions of applicants, certain individuals are selected through a randomized computer drawing (“selectees”) for consideration for one of the 50,000 available diversity visa numbers. These selectees are then given the opportunity to apply for a diversity immigrant visa or if present in the United States to apply for adjustment of status. To qualify for a visa, these “selectees” must meet certain requirements provided for at INA 203(c), 8 U.S.C. 1153(c), and 22 CFR 42.33.
Previously, 22 CFR 42.33(b)(2) required that photographs submitted with the diversity visa petition to be “recent.” 22 CFR 42.33(b)(2)(vii) only prohibited the wearing of sunglasses and other paraphernalia in photographs. The Department is amending the rule by adding a new subparagraph at § 42.33(b)(2)(iv) to require that the photograph be taken no more than six months prior to the date of the submission, and amending the photograph requirement to prohibit eyeglasses. The Department is also making a minor change by replacing “electronic entry form” with “petition” in the opening sentence of § 42.33(b)(2) to be consistent with the other parts of § 42.33(b).
The Department receives unauthorized entries for the diversity visa lottery each year, including entries submitted by criminal enterprises. Requiring a new photograph be submitted each year reduces the ability for a third party to submit entries without an applicant's knowledge. The added specificity also will support the Department's practice of automatically disqualifying any applications for which a duplicate photograph was submitted, which also reduces the possibility of fraud, including fraud committed by criminal enterprises.
This regulation is exempt from the Administrative Procedure Act (APA) as it involves a foreign affairs function of the United States and, therefore, in accordance with 5 U.S.C. 553(a)(1), is exempt from the requirements of 5 U.S.C. 553. Since this rulemaking is exempt from section 553, the provisions of 5 U.S.C. 553(d) do not apply, and this rulemaking is effective immediately.
Because this final rule is exempt from notice-and-comment rulemaking under 5 U.S.C. 553, it is exempt from the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (codified at 2 U.S.C. 1532) generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.
This rule is not a major rule as defined by 5 U.S.C. 804. The Department is aware of no monetary effect on the U.S. economy that will result from this rulemaking.
The Department has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866, and has determined that the benefits of this regulation outweigh any cost. The Department has considered this rule in light of Executive Order 13563 and affirms that this regulation is consistent with the guidance therein. The Department does not consider this rule to be a significant rulemaking action.
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132.
The Department has reviewed the regulation in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Section 5 of Executive Order 13175 do not apply to this rulemaking.
This rule does not impose any new information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Immigration, Passports and visas.
For the reasons stated in the preamble, the Department amends 22 CFR part 42 as follows:
22 U.S.C. 2651a; 8 U.S.C. 1104; Pub. L. 105-277, 112 Stat. 2681-795 through 2681-801; 8 U.S.C. 1185 note (section 7209 of Pub. L. 108-458, as amended by section 546 of Pub. L. 109-295).
The revisions and addition read as follows:
(b) * * *
(2)
(iv) The image must have been taken no more than six months prior to the date of the petition submission.
(viii) The person in the photograph must not wear eyeglasses, sunglasses, or other paraphernalia that obstruct the view of the face.
Office of the Secretary, Department of Defense (DoD).
Final rule; technical amendment.
On September 2, 2016, the Department of Defense published a final rule (81 FR 61068-61098) titled TRICARE; Mental Health and Substance Use Disorder Treatment. DoD is making a technical amendment due to the discovery of two errors. We noted in the preamble of the final rule that we had removed the requirements regarding capacity (30 percent) and length of time licensed and at full operational status (6 months) for substance use disorder rehabilitation facilities (SUDRFs). However, we did not remove the necessary sentence in the regulatory text.
In a response to a public comment in the preamble of the final rule, we said that TRICARE will require opioid treatment programs (OTPs) to be licensed and operate in substantial compliance with state and federal regulations. However, we did not make the necessary change in the regulatory text. This technical amendment corrects those errors.
This rule is effective on October 3, 2016.
Ms. Patricia Toppings, 571-372-0485.
This technical amendment amends 32 CFR part 199 to read as set forth in the amendatory language in this final rule.
Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Mental health, Mental health parity, Military personnel, Substance use disorder treatment.
Accordingly, 32 CFR part 199 is amended as follows:
5 U.S.C. 301; 10 U.S.C. chapter 55.
(b) * * *
(4) * * *
(xix) * * *
(A) * * *
(
(
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation on the Ohio River from mile 755.0 to mile 759.0 in Owensboro, KY on September 30, 2016 through October 2, 2016. This special regulation is necessary to provide for the safety of life on these navigable waters near Owensboro, KY, during the Owensboro Air Show. This rulemaking prohibits transit into, through, and within the regulated area unless authorized by the Captain of the Port Ohio Valley or a designated representative.
This rule is effective from 12 p.m. on September 30, 2016 through 4:30 p.m. on October 2, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer James Robinson, Sector Ohio Valley, U.S. Coast Guard; telephone 502-779-5347, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event is being held outside of the date and location currently contemplated in the publication. It is impracticable to publish an NPRM because we must establish this special local regulation by September 30, 2016.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Ohio Valley (COTP) has determined that potential hazards associated with the air show starting September 30, 2016 will be a safety concern for anyone within the regulated area. The purpose of this rule is to ensure safety of life on the navigable waters in the temporary regulated area before, during, and after the Owensboro Air Show.
The Coast Guard will establish a special local regulation from September 30, 2016 through October 2, 2016. The special local regulation will cover all navigable waters from mile 755.0 to 759.0 on the Ohio River in the vicinity of Owensboro, KY. Transit into and through this area is prohibited from 12 p.m. to 3:30 p.m. on September 30, 2016, 12 p.m. to 4:30 p.m. on October 01, 2016, and 12 p.m. to 4:30 p.m. on October 2, 2016. The duration of the regulation is intended to protect participants, spectators, and other persons and vessels before, during, and after the scheduled air show. No vessel or person will be permitted to enter the special local regulation without obtaining permission from the COTP or a designated representative. Deviation requests will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7475 or can be reached by VHF-FM channel 16. Public notifications will be made to the local maritime community prior to the event through the Local Notice to Mariners, and Broadcast Notice to Mariners.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the special local regulation. The temporary special local regulation will only be in effect for less than five hours each day. The Coast Guard expects minimum adverse impact to mariners from the special local regulation's activation as the event has been advertised to the public. Also, mariners may request authorization from the COTP Ohio Valley or the designated representatives to transit the regulated area.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section V. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for Federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, KY the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation lasting less than five hours a day that will prohibit entry on all waters of the Ohio River, surface to bottom, extending from mile 755.0 to 759.0. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) The Coast Guard will patrol the regulated area under the direction of a designated Coast Guard Patrol Commander. The Patrol Commander may be contacted via VHF-FM radio channel 16 or by phone at 502-587-8633.
(3) The Patrol Commander may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(d)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Ironman 70.3 Augusta Triathlon, Savannah River, Special Local Regulation from 7 a.m. through 11 a.m. on September 25, 2016. This action is necessary to ensure safety of life on navigable waterways of the United States during this event. During the enforcement period, and in accordance with previously issued special local regulations, vessels may not enter, transit through, anchor in, remain within the designated area unless authorized by the Captain of the Port (COTP) Savannah or a designated representative.
The regulation in 33 CFR 100.701, Table to § 100.71, Item (f)3 will be enforced from 7 a.m. through 11 a.m. on September 25, 2016.
If you have questions about this notice of enforcement, call or email MST1 Cliffton Hendry, Marine Safety Unit Savannah Office of Waterways Management, Coast Guard; telephone 912-652-4353, extension 243, or email
The Coast Guard will enforce the special local regulation for the Ironman 70.3 Augusta Triathlon, Savannah River, in 33 CFR 100.701 from 7 a.m. through 11 a.m. on September 25, 2016.
This action is to provide enforcement action of the regulated area that will encompass portions of the navigable waterways. The location of the regulated area for this 1.2 mile long swim course, as stated in the latitude/longitude figures in 33 CFR 100.701, Table to § 100.701, Item (f)3, begins at the 5th Street Marina in Augusta, GA, and proceeds downriver to The Boathouse, 101 Riverfront Drive, Augusta, GA. Under the provisions of 33 CFR 100.701, all persons and vessels are prohibited from entering the regulated areas unless permission to enter has been granted by the COTP or designated representatives.
This notice of enforcement is issued under authority of 33 CFR 100.701 and 5 U.S.C. 552 (a). The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives. If the COTP Savannah determines that the regulated area need not be enforced for the full duration stated in this publication, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation for all waters of the Ohio River, surface to bottom, extending from Ohio River mile 557.5 to 558.5 in Madison, IN on September 17 and September 18, 2016. This action is necessary to provide for the safety of life on these navigable waters near Madison, IN during the high-speed boat race on September 17 and September 18, 2016. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Ohio Valley or a designated representative.
This rule is effective from 8 a.m. on September 17, 2016 to 6 p.m. September 18, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Joshua Herriott, Sector Ohio Valley, U.S. Coast Guard; telephone 502-779-5343, email
On February 03, 2016, the “5 to the 5” Vintage Hydros Organization notified the Coast Guard that it will be sponsoring a high-speed boat race from 8:00 a.m. to 6:00 p.m. on September 17 and September 18, 2016. The race will take place at Ohio River mile 557.5 to 558.5 in the vicinity of Madison, IN. The Captain of the Port Ohio Valley (COTP) has determined that potential hazards associated with the high-speed regatta would be a safety concern for anyone within in the proposed regulated area.
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because there is not time to complete the NPRM process due to unforeseen administrative delays. This event has been advertised to the local community and waterway users and it would be impracticable solicit public comment for this event because it must be in place on September 17 and September 18, 2016.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Ohio Valley (COTP) has deemed the potential hazards associated with the high-speed boat races to occur September 17 and September 18, 2016 will be a safety concern for anyone within the regulated area. The purpose of this rulemaking is to ensure the safety of vessels and spectators within the regulated area before, during, and after the scheduled event.
As noted above, the Coast Guard will establish a special local regulation from 8:00 a.m. to 6:00 p.m. on September 17 and September 18, 2016. The special local regulation will cover all navigable waters from mile 557.5 to 558.5 on the Ohio River in the vicinity of Madison, IN. The duration of the regulated area is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the special local regulation without obtaining permission from the COTP or a designated representative. Deviation requests will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7475 or can be reached by VHF-FM channel 16. Public notifications will be made to the local maritime community prior to the event through the Local Notice to Mariners, and Broadcast Notice to Mariners.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss the First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and
This regulatory action determination is based on the size, location, duration, and time-of-day of the regulated area. Vessel traffic will be able to safely transit through the affected area before and after the scheduled event. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulated area and the rule allows vessels to seek permission to enter the area.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section V. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for Federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental Federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for Federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, IN the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation lasting from 8:00 a.m. to 6:00 p.m. on September 17 and September 18, 2016. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) Persons or vessels desiring entry into or passage through the area must request permission from the Captain of the Port Ohio Valley or a designated representative. U.S. Coast Guard Sector
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Gilmerton (US13/460) Bridge across the South Branch of the Elizabeth River, mile 5.8, on the Atlantic Intracoastal Waterway, at Chesapeake, VA. This deviation is necessary to avoid bridge failure and perform emergency bridge repairs. This deviation allows the bridge to remain in the closed-to-navigation position.
This deviation is effective without actual notice from September 16, 2016 through 5 a.m. on September 19, 2016. For the purposes of enforcement, actual notice will be used from September 13, 2016 at 9 a.m., until September 16, 2016.
The docket for this deviation, [USCG-2016-0674] is available at
If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6222, email
The City of Chesapeake, that owns and operates the Gilmerton (US13/460) Bridge, across the South Branch of the Elizabeth River, mile 5.8, on the Atlantic Intracoastal Waterway, at Chesapeake, VA, has requested a temporary deviation from the current operating regulations to avoid bridge failure and perform emergency repairs to the bridge due to failure of operating mechanism components, requiring non-standard manual operation of the bridge until repair is completed. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 36 feet above mean high water. The vertical clearance of the bridge in the open-to-navigation position of 136 feet above mean high water will be reduced to approximately 110 feet above mean high water from 9 p.m. on September 16, 2016, through 5 a.m. on September 19, 2016.
The current operating schedule is set out in 33 CFR 117.997(c). Under this temporary deviation, the bridge will remain in the closed-to-navigation position, except for scheduled openings at 9 a.m., noon, 3 p.m. and 7 p.m., Monday through Friday; and 9 a.m. and 3 p.m. on Saturday and Sunday. The scheduled openings at 9 a.m. and 3 p.m. on Saturday and Sunday, September 17, 2016, and September 18, 2016; and emergency openings from 9 p.m. on September 16, 2016, through 5 a.m. on September 19, 2016, will provide a reduced vertical clearance of approximately 110 feet above mean high water.
The South Branch of the Elizabeth River is used by a variety of vessels including U.S. government and public vessels, commercial vessels, tug and barge traffic, and recreational vessels. The Coast Guard has carefully coordinated the restrictions with waterway users in publishing this temporary deviation.
Vessels able to safely pass through the bridge in the closed position may do so at any time. On Saturday and Sunday, September 17, 2016, and September 18, 2016, vessels able to safely pass through the bridge in the closed position should contact the bridge tender to ensure safe passage through the bridge. There is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The bridge will open on signal for emergency vessels, if at least one hour notice is given. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transit to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the James River Bridge (US17) across the James River, mile 5.0, at Isle of Wight and Newport News, VA. The deviation is necessary to perform bridge maintenance and repairs.
This deviation is effective from 5 a.m. on September 19, 2016, to 7 p.m. on October 16, 2016.
The docket for this deviation, [USCG-2016-0866] is available at
If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6222, email
The Virginia Department of Transportation, that owns and operates the James River Bridge (US17), across the James River, mile 5.0, at Isle of Wight and Newport News, VA, has requested a temporary deviation from the current operating regulations to perform repairs to the aerial electrical cable connecting the north tower to the south tower. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 60 feet above mean high water.
The current operating schedule is open on signal as set out in 33 CFR 117.5. Under this temporary deviation, the bridge will remain in the closed-to-
The James River is used by a variety of vessels including deep draft ocean-going vessels, U. S. government vessels, small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with waterway users.
During closure periods a 55-foot by 150-foot crane barge will be positioned alongside the bridge at various locations within the main navigation span of the bridge with the centerline of the barge perpendicular to the bridge. Vessels able to safely pass through the bridge in the closed position with the crane barge positioned alongside the bridge may do so at anytime. Vessels planning to transit through the bridge in the closed position with the crane barge positioned alongside the bridge shall contact the bridge tender to request information concerning the position of the crane barge to ensure safe passage.
Vessels able to safely pass through the bridge in the closed position that require the crane barge to clear the main navigation span of the bridge, may do so at noon, daily, if at least two hours advance notice is given to the bridge tender. The bridge will open on signal for vessels that require an opening of the bridge and are unable to transit through the bridge during non-closure times due to draft and/or daylight restrictions, if notice is provided by 5 p.m. the day before the required bridge opening. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transit to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to the receipt of a comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule published on August 1, 2016, to approve the State of Maryland's adoption of the requirements in EPA's control technique guidelines (CTG) for fiberglass boat manufacturing materials.
The direct final rule published at 81 FR 50336 on August 1, 2016, is withdrawn effective September 16, 2016.
Gavin Huang, (215) 814-2042, or by email at
In the direct final rule published on August 1, 2016 (81 FR 50336), we stated that if we received comment by August 31, 2016, the rule would be withdrawn and not take effect. EPA received a comment before the August 31, 2016 deadline. EPA will address the comment received in a subsequent final action based upon the proposed action also published on August 1, 2016 (81 FR 50427). EPA will not institute a second comment period on this action.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Ozone, Volatile organic compounds.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving a portion of a revision to the Alabama State Implementation Plan (SIP) submitted by the Alabama Department of Environmental Management (ADEM) on May 8, 2013. The revision modifies the definition of “volatile organic compounds” (VOC). Specifically, the revision adds one compound to the list of those excluded from the VOC definition on the basis that this compound makes a negligible contribution to tropospheric ozone formation. This action is being taken pursuant to the Clean Air Act (CAA or Act).
This direct final rule is effective November 15, 2016 without further notice, unless EPA receives adverse comment by October 17, 2016. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0473 at
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 or via electronic mail at
Tropospheric ozone, commonly known as smog, occurs when VOC and nitrogen oxides (NO
Section 302(s) of the CAA specifies that EPA has the authority to define the meaning of “VOC,” and hence what compounds shall be treated as VOC for regulatory purposes. It has been EPA's policy that compounds of carbon with negligible reactivity need not be regulated to reduce ozone and should be excluded from the regulatory definition of VOC.
EPA issued a final rule approving the addition of trans-1,3,3,3-tetrafluropropene (also known as HFO-1234ze) to the list of those compounds excluded from the regulatory definition of VOC.
On May 8, 2013, ADEM submitted a SIP revision
This change is consistent with section 110 of the CAA and meets the regulatory requirements pertaining to SIPs. Pursuant to CAA section 110(l), the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. The revision to Rule 335-3-1-.02(gggg) is approvable under section 110(l) because it reflects changes to federal regulations based on findings that the aforementioned compound is negligibly reactive.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Alabama Regulation section 335-3-1-.02 “Definitions,” effective November 24, 2015, which is the most up to date version of the definition of VOC.
Pursuant to section 110 of the CAA, EPA is approving the revision to the Alabama SIP changing the VOC definition. EPA has evaluated Alabama's May 8, 2013, submittal and has determined that it meets the applicable requirements of the CAA and EPA regulations and is consistent with EPA policy.
EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this
If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on November 15, 2016 and no further action will be taken on the proposed rule.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 15, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve portions of the State Implementation Plan (SIP) submission, submitted by the State of South Carolina, through the South Carolina Department of Health and Environmental Control (SC DHEC) on April 30, 2014, to demonstrate that the State meets certain infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour nitrogen dioxide (NO
This rule will be effective October 17, 2016.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0251. All documents in the docket are listed on the
Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8726. Mr. Richard Wong can also be reached via electronic mail at
On January 22, 2010, (published at 75 FR 6474, February 9, 2010), EPA promulgated a new 1-hour primary NAAQS for NO
In a proposed rulemaking published on June 27, 2016 (81 FR 41498), EPA proposed to approve South Carolina's 2010 1-hour NO
With the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J) and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), EPA is taking final action to approve South Carolina's infrastructure SIP submission for the 2010 1-hour NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this action for the state of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, South Carolina statute 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” However, EPA has determined that this rule does not have substantial direct effects on an Indian Tribe because this action is not approving any specific rule, but rather approving that South Carolina's already approved SIP meets certain CAA requirements. EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 15, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42.U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve in part, and disapprove in part, portions of the State Implementation Plan (SIP) submission, submitted by the State of Mississippi, through the Mississippi Department of Environmental Quality (MDEQ) on February 28, 2013, to demonstrate that the State meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour nitrogen dioxide (NO
This rule will be effective October 17, 2016.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2014-0751. All documents in the docket are listed on the
Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8726. Mr. Richard Wong can also be reached via electronic mail at
On January 22, 2010, (published at 75 FR 6474, February 9, 2010), EPA promulgated a new 1-hour primary NAAQS for NO
In a proposed rulemaking published on May 24, 2016, EPA proposed to approve Mississippi's 2010 1-hour NO
With regard to the state board majority requirements respecting significant portion of income, EPA is finalizing a disapproval of Mississippi's February 28, 2013, infrastructure submission. Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of a CAA Part D Plan, or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP call), starts a sanctions clock. The portion of the submittal being disapproved in this notice (the portion addressing certain provisions of section 110(a)(2)(E)(ii)) was not submitted to meet requirements for Part D or a SIP call, and therefore, no sanctions will be triggered. However, this final action will trigger the requirement under section 110(c) that EPA promulgate a Federal Implementation Plan (FIP) no later than two years from the date of the disapproval unless the State corrects the deficiency, and EPA approves the plan or plan revision before EPA promulgates such FIP. With the exceptions described above, EPA is taking final action to approve Mississippi's infrastructure SIP submission for the 2010 1-hour NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 15, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42.U.S.C. 7401
(e) * * *
(d)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes temporary exemptions from the requirement of a tolerance for residues of
This regulation is effective September 16, 2016. Objections and requests for hearings must be received on or before November 15, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0742, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0742 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 15, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0742, by one of the following methods:
•
•
•
In the
EPA changed the commodity name reflected in the tolerance exemption expression from “corn” to “food and feed commodities of corn, field; corn, pop; and corn, sweet” and changed “tolerance exemption” to “tolerance exemptions”. The reasons for these changes are explained in Unit III.C.
Section 408(r) of FFDCA authorizes EPA to establish a temporary exemption from the requirement of a tolerance for residues covered by an experimental use permit issued under the Federal Insecticide, Fungicide, and Rodenticide Act. That section states that the provisions of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA section 408(r). Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an
EPA evaluated the available toxicity and exposure data on
Based upon its evaluation, EPA concludes that
Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of
An analytical method is not required for enforcement purposes for the reasons contained in the August 18, 2016, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for
Two modifications have been made to the requested tolerance exemption. EPA changed “corn” to “food and feed commodities of corn, field; corn, pop; and corn, sweet” to align with the Agency's food and feed commodity vocabulary. EPA also changed “tolerance exemption” to “tolerance exemptions” as four different active ingredients are covered with this action.
This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemptions in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Temporary exemptions from the requirement of a tolerance are established for residues of
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of ammonium persulfate (CAS Reg. No.7727-54-0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, etc.) at a concentration not to exceed 0.05% by weight. Exponent, Inc., on behalf of Becker Underwood, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ammonium persulfate under the approved conditions.
This regulation is effective September 16, 2016. Objections and requests for hearings must be received on or before November 15, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0237, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0237 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 15, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0237, by one of the following methods:
•
•
•
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ammonium persulfate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with ammonium persulfate follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by ammonium persulfate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
The acute oral and dermal rat lethal dose (LD)
Several subchronic studies were available for review for the sodium, potassium and ammonium salts of persulfate. In a 28 day oral (diet) toxicity study in rats, toxicity was manifested as decreased relative adrenal weight at 600 parts per million (ppm) (82 mg/kg/day). The NOAEL was 300 ppm; equal to 41 mg/kg/day. In a 3 months oral (diet) toxicity study in dogs, toxicity was not observed at doses up to 333 mg/kg/day, the highest dose tested. In a toxicity study in rats, ammonium persulfate was administered via inhalation for 13 weeks then allowed a 6-week recovery period. Toxicity was manifested as rales, increased respiratory rate, inflammation of the trachea and bronchi/bronchioles, decreased body weight, and increased lung weight at 25 mg/m
The reproductive and developmental toxicity of ammonium persulfate has been tested in rats. Parental, offspring and reproduction toxicity was not observed at doses up to 250 mg/kg/day, the highest dose tested.
Available mutagenicity and genotoxicity studies included the Ames test, gene mutation and chromosomal aberration assays. Ammonium persulfate produced negative results in all of these studies.
Oral and inhalation studies of the carcinogenic and promoting potential of ammonium persulfate do not exist; however, the carcinogenic and promoting potential of ammonium persulfate was tested in a non-guideline study via the dermal route of exposure. In a tumor promotion study, mice were treated dermally with ammonium persulfate biweekly for 51 weeks. In another study, mice were treated topically with a solution of 200 mg/milliliter (mL) ammonium persulfate for 51 weeks. The incidence of tumors did not increase in either study.
Neurotoxicity and immunotoxicity studies were not available for review. However, evidence of neurotoxicity and immunotoxicity of ammonium persulfate was not observed in the submitted studies.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some
There was no hazard attributable to a single exposure seen in the toxicity database for ammonium persulfate. Therefore, ammonium persulfate is not expected to pose an acute risk.
The NOAEL for ammonium persulfate was established at 300 ppm; equal to 41 mg/kg/day based on the 28-day repeat dose oral toxicity study in rats based on decreased relative adrenal weight at 600 ppm (82 mg/kg/day). The chronic risk assessment for ammonium persulfate is based on this endpoint and the chronic reference dose (cRfD) is 0.41 mg/kg/day. The additional Food Quality Protection Act (FQPA) uncertainty factor of 3X is applied for use of short-term study for a long-term risk assessment. EPA concluded that the uncertainty factor of 3X is adequate because the end point selected for the risk assessment is very conservative since no effects on absolute adrenal weight was observed; relative weight could be due to slight decrease in body weight; no other systemic toxicity was seen at this dose level and there were no systemic toxicity observed in a 90-day toxicity study in dogs which considered as long term study. Since the FQPA safety factor (SF) has been reduced to 3X, the cPAD is 0.14 mg/kg/day. The NOAEL for inhalation exposure has been established as 10.3 mg/m
1.
An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM-FCID
2.
3.
While there are no current or proposed residential uses for ammonium persulfate, it is possible that ammonium persulfate may be used as an inert ingredient in pesticide products for which short-term and intermediate-term residential exposures may result. In the absence of specific residential exposure scenarios, risk estimates for residential exposures to ammonium persulfate can be modeled based on occupational exposure assessments. Occupational exposure assessments for ammonium persulfate for occupational mixer/loader/applicator exposure and occupational post-application exposure for comparable use scenarios (
4.
EPA has not found ammonium persulfate to share a common mechanism of toxicity with any other substances, and ammonium persulfate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ammonium persulfate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
i. The toxicity database for ammonium persulfate is partially complete. The additional uncertainty FQPA factor of 3X is applied for use of short-term study for long term risk assessment.
ii. There is no indication that ammonium persulfate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that ammonium persulfate results in increased susceptibility in rats in utero or in young in the reproductive and developmental screening study.
iv. There is no evidence of any triggers for immunotoxicity in the available database, therefore there is no need for an immunotoxicity study at this time or an additional UF factor to account for lack of an immunotoxicity study.
v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to ammonium persulfate in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by ammonium persulfate.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
4.
5.
Although EPA is establishing a limitation on the amount of ammonium persulfate that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for ammonium persulfate.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for ammonium persulfate (CAS Reg. No. 7727-54-0) when used as an inert ingredient (preservative) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest at a concentration not to exceed 0.05% by weight.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (Commission) addresses the 758-769/788-799 MHz band, which the Commission licensed to the First Responder Network Authority (FirstNet) on a nationwide basis pursuant to the provisions of the Middle Class Tax Relief and Job Creation Act of 2012. We provide a mechanism to facilitate the relocation of the public safety narrowband incumbents currently operating on FirstNet's spectrum. We also affirmatively decline at this time to impose specific build-out requirements on FirstNet as a condition of renewal of its license.
Effective October 17, 2016.
Roberto Mussenden, Policy and Licensing Division, Public Safety and Homeland Security Bureau, (202) 418-1428.
This is a summary of the Commission's Report and Order in PS Docket No. 12-94, FCC 16-117, adopted on August 24, 2016 and released on August 25, 2016. The document is available for download at
1. In 2013, the Commission's Notice of Proposed Rulemaking (NPRM) sought comment on implementation of certain provisions of the Public Safety Spectrum Act, including how to relocate narrowband incumbents operating on the spectrum licensed to FirstNet, and how to address FirstNet's renewal expectations, including whether FirstNet should be subject to Commission-initiated build-out requirements.
2. In the Report and Order, the Commission permits narrowband incumbents to remain on FirstNet's licensed spectrum until August 31,
3. The Commission states specifies that under existing rules, any TV studio-transmitter links, TV relay stations, and TV translator relay stations operating on the FirstNet spectrum under Part 74, subpart G of the Commission's rules must cease operations within 120 days of receiving notice from FirstNet.
4. The Commission concludes that there is no need or legal basis at this time for it to play a role in resolving disputes between FirstNet and incumbent licensees over relocation costs. The Commission also finds there is no need at this time to establish additional Commission rules to ensure rural coverage or any of the other requirements for renewal of FirstNet's license.
5. The Final Regulatory Flexibility Analysis required by section 604 of the Regulatory Flexibility Act, 5 U.S.C. 604, is included in Appendix D of the Report and Order.
6. The Report and Order document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13.
7. As required by the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the NPRM of this proceeding. The Commission sought written public comment on the IRFA. The RFA requires that an agency prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). The present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.
8. In the Report and Order, we regulate the transition of different classes of incumbents now occupying portions of the spectrum to be licensed to FirstNet. These actions are based on our established authority under the Communications Act to regulate use of the spectrum consistent with the public interest, convenience and necessity and our authority under the Public Safety Spectrum Act “to take all actions necessary to facilitate the transition” of the existing public safety broadband spectrum to FirstNet.
9. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA.
10. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
11.
12.
13.
14.
15. Our actions will not require any reporting, recordkeeping or other compliance requirements.
16. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
17. Nonetheless, we recognized there may arguably be a significant number of small entities currently operating in FirstNet's spectrum that would need relocation. Thus, one mechanism the Commission considered to minimize the economic burden on incumbent operators was to consider whether FirstNet or some third party source could fund relocation, thereby relieving any incumbent small entities of this potentially substantial economic burden. It also evaluated whether FirstNet could accommodate incumbent narrowband operations within a portion of its licensed spectrum, either indefinitely or on a transitional basis.
18. None.
19. The Commission will not send a copy of this Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
20. Accordingly,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is exchanging allocations of Amendment 80 cooperative quota (CQ) for Amendment 80 acceptable biological catch (ABC) reserves. This action is necessary to allow the 2016 total allowable catch of flathead sole, rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Effective September 16, 2016, through December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 13,753 metric tons (mt), 44,990 mt, and 110,113 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). The 2016 flathead sole, rock sole, and yellowfin sole
The Alaska Seafood cooperative has requested that NMFS exchange 3,900 mt of flathead sole and 1,025 mt of rock sole Amendment 80 allocations of the TAC for 4,925 mt of yellowfin sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 3,900 mt of flathead sole and 1,025 mt of rock sole Amendment 80 allocations of the TAC for 4,925 mt of yellowfin sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and as revised (81 FR 62833, September 13, 2016) are further revised as follows:
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Alaska Seafood cooperative the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 7, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would implement a recommendation from the California Walnut Board (Board) to increase the assessment rate established for the 2016-17 and subsequent marketing years from $0.0379 to $0.0465 per kernelweight pound of assessable walnuts. The Board locally administers the marketing order and is comprised of growers and handlers of walnuts operating within the area of production. Assessments upon walnut handlers are used by the Board to fund reasonable and necessary expenses of the program. The marketing year begins September 1 and ends August 31. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Comments must be received by October 17, 2016.
Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Terry Vawter, Senior Marketing Specialist, or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposed rule is issued under Marketing Order No. 984, as amended (7 CFR part 984), regulating the handling of walnuts grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the order now in effect, California walnut handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable walnuts beginning on September 1, 2016, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule would increase the assessment rate for the 2016-17 and subsequent marketing years from $0.0379 to $0.0465 per kernelweight pound of assessable walnuts.
The order provides authority for the Board, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. All members of the Board, but one, are growers and handlers of California walnuts. They are familiar with the Board's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2015-16 and subsequent marketing years, the Board recommended, and USDA approved, an assessment rate of $0.0379 per kernelweight pound of assessable walnuts that would continue in effect from year to year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other information available to USDA.
The Board met on June 9, 2016, and unanimously recommended 2016-17 expenditures of $23,143,050 and an assessment rate of $0.0465 per kernelweight pound of assessable walnuts. In comparison, last year's budgeted expenditures were $22,668,980. The assessment rate of $0.0465 is $0.0086 per pound higher than the rate currently in effect. The quantity of assessable walnuts for the 2016-17 marketing year is estimated at 553,000 tons inshell or 497,700,000 kernelweight pounds, which is the five-year average of walnut production. At
The Board noted that sales of California walnuts in the domestic market have been declining in recent years, and embarked upon an enhanced market development and promotion program that would reverse the trend. Noting that making such a commitment for a single year would likely not result in long-term gains, they voted to continue such market development and promotion programs yet another year. Thus, they are maintaining their programs at a level near that of the 2015-16 marketing year.
In addition, personnel changes will result in an overlap of duties and expenses, as some positions will be added so that experience and continuity can be maintained in spite of staff retirements. Thus, employee costs are expected to be higher this marketing year. Added to that, the implementation of the Food Safety Modernization Act (FSMA) may result in added costs to the industry, and in some cases, to the Board as well. For that reason, the Grades and Standards Committee and the Research Committee requested increased budgets.
The following table compares major budget expenditures recommended by the Board for the 2015-16 and 2016-17 marketing years:
The assessment rate recommended by the Board was derived by dividing anticipated assessment revenue needed by estimated shipments of California walnuts certified as merchantable. The 553,000 ton (inshell) estimate for merchantable shipments is an average of shipments during three prior years. Pursuant to § 984.51(b) of the order, this figure is converted to a merchantable kernelweight basis using a factor of 0.45 (553,000 tons × 2,000 pounds per ton × 0.45), which yields 497,700,000 kernelweight pounds. At $0.0465 per pound, the new assessment rate should generate $23,143,050 in assessment income, which is equal to estimated expenses.
Section 984.69 of the order authorizes the Board to carry over excess funds into subsequent marketing years as a reserve, provided that funds already in the reserve do not exceed approximately two years' budgeted expenses. Current reserve funds total $9,827,284 and are well within that requirement.
The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other available information.
Although this assessment rate would be effective for an indefinite period, the Board would continue to meet prior to or during each marketing year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Board meetings are available from the Board or USDA. Board meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Board recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Board's 2016-17 budget and those for subsequent marketing years would be reviewed, and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 5,700 growers of California walnuts in the production area and approximately 90 handlers subject to regulation under the order. The Small Business Administration (SBA) defines small agricultural businesses (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $7,500,000.
According to USDA's National Agricultural Statistics Service's (NASS's) 2012 Census of Agriculture, approximately 86 percent of California's walnut farms were smaller than 100 acres. Further, NASS reports that the average yield for 2014 was 1.97 tons per acre, and the average price received for 2014 was $3,230 per ton.
A 100-acre farm with an average yield of 1.97 tons per acre would therefore have been expected to produce about 197 tons of walnuts during 2014-15 marketing year. At $3,230 per ton, that farm's production would have had an approximate value of $636,310. Since Census of Agriculture information indicates that the majority of California's walnut farms are smaller than 100 acres, it could be concluded that the majority of the growers had receipts of less than $636,310 in 2014-15, which is well below the SBA threshold of $750,000. Thus, the majority of California's walnut growers would be considered small growers according to SBA's definition.
According to information supplied by the Board, approximately two-thirds of California's walnut handlers shipped
This proposed rule would increase the assessment rate and collected from handlers for the 2016-17 and subsequent marketing years from $0.0379 to $0.0465 per kernelweight pound of assessable walnuts. The Board unanimously recommended 2016-17 expenditures of $23,143,050 and an assessment rate of $0.0465 per kernelweight pound of assessable walnuts. The proposed assessment rate of $0.0465 is $0.0086 higher than the 2015-16 rate. The quantity of assessable walnuts for the 2016-17 marketing year is estimated at 553,000 tons inshell weight, or 497,700,000 kernelweight pounds. Thus, the $0.0465 rate should provide $23,143,050 in assessment income.
The increased assessment rate is due to continuing domestic marketing and promotion programs, as well as to increased personnel and committee expenses. The Board believes that California walnut sales can be improved in the domestic market through continued promotional activities. In addition, the Grades and Standards and Research Committees have asked for additional funds in case the implementation of FSMA requires new methods or processes for growing, harvesting, and shipping walnuts.
The major expenses for the 2016-17 marketing year include: $2,292,000 for employee expenses; $206,000 for travel, board expenses, and annual audit expenses; $262,000 for office expenses; $10,000 for controlled purchases; $0 for the crop acreage survey; $130,000 for the crop estimate; $175,000 for the salary of the Production Research Director; $1,800,000 for production research; $75,000 for sustainability; $800,000 for grades and standards research; $18,398,040 for domestic market development projects; and $59,010 for the contingency reserve.
By comparison, the major expenses for the 2015-16 marketing year include: $1,846,500 for employee expenses; $191,000 for travel, board expenses, and annual audit expenses; $254,000 for office expenses; $10,000 for controlled purchases; $100,000 for the crop acreage survey; $130,000 for the crop estimate; $94,500 for the salary of the Production Research Director; $1,700,000 for production research; $75,000 for sustainability; $600,000 for grades and standards research; $18,478,440 for domestic market development projects; and $32,790 for the contingency reserve.
The Board reviewed and unanimously recommended 2016-17 expenditures of $23,143,050. Prior to arriving at this budget, the Board considered a recommendation from the Budget and Personnel Committee (committee), which also reviewed the proposed budget. The committee debated the relative value of the increased assessment rate, given the focus on domestic promotion programs. They also considered information from various other committees, who deliberated and formulated their own budgets of expenses and made their recommendations to the committee. Those committees include the Market Development, Production Research, and Grades and Standards Committees.
The Budget and Personnel Committee considered alternative expenditure levels, such as reducing the proposed budgets recommended by the other committees, and changing the funding for domestic marketing projects, as well as not increasing the assessment rate. The committee ultimately decided that the proposed expenditures and assessment rate were reasonable and necessary to assist in improving domestic sales, maintaining staff continuity, and preparing for potential FSMA mandates. Thus, the committee unanimously agreed to recommend the proposed budget to the Board.
The assessment rate of $0.0465 per kernelweight pound of assessable walnuts was derived by dividing anticipated assessment revenue needed by expected shipments of California walnuts certified as merchantable. Merchantable shipments for the year are estimated at 497,700,000 pounds. It was determined that $23,143,050 in assessment income was needed, and assessment income would equal expenses of $23,143,050.
Unexpended funds may be retained in a financial reserve, provided that funds in the financial reserve do not exceed approximately two years' budgeted expenses.
According to NASS, the season average grower prices for the years 2013 and 2014 were $3,710 and $3,230 per ton, respectively. These prices provide a range within which the 2016-17 season average price could fall. Dividing these average grower prices by 2,000 pounds per ton provides an inshell price per pound range of $1.62 to $1.86. Dividing these inshell per pound prices by the 0.45 conversion factor (inshell to kernelweight) established in the order yields a 2016-17 price range estimate of $3.60 to $4.13 per kernelweight pound of assessable walnuts.
To calculate the percentage of grower revenue represented by the assessment rate, the assessment rate of $0.0465 per kernelweight pound is divided by the low and high estimates of the price range. The estimated assessment revenue for the 2016-17 marketing year as a percentage of total grower revenue will thus likely range between 1.13 and 1.29 percent.
This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs would be offset by the benefits derived by the operation of the marketing order. In addition, the Board's meeting was widely publicized throughout the California walnut industry, and all interested persons were invited to attend the meeting and encouraged to participate in Board deliberations on all issues. Like all Board meetings, the June 9, 2016, meeting was a public meeting and all entities, both large and small, were free to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 (Walnuts Grown in California). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California walnut handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because: (1) The 2016-17 marketing year begins on September 1, 2016, and the marketing order requires that the rate of assessment for each marketing year apply to all assessable walnuts handled during the year; and (2) handlers are aware of this action, which was unanimously recommended by the Board at a public meeting and is similar to other assessment rate actions issued in past years.
Marketing agreements, Nuts, Reporting and recordkeeping requirements, Walnuts.
For the reasons set forth in the preamble, 7 CFR part 984 is proposed to be amended as follows:
7 U.S.C. 601-674.
On and after September 1, 2016, an assessment rate of $0.0465 per kernel weight pound is established for California merchantable walnuts.
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites public comments on a proposed amendment to Marketing Order No. 984, which regulates the handling of walnuts grown in California. The California Walnut Board (Board), which is responsible for the local administration of the order and is comprised of walnut producers and handlers operating within the production area, recommended an amendment that would authorize the Board to borrow from a commercial lending institution to fund operations and marketing/research expenses. Allowing the Committee to utilize this customary business practice would provide flexibility for the Board while increasing its effectiveness.
Comments must be received by November 15, 2016.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Geronimo Quinones, Marketing Specialist, or Michelle P. Sharrow, Rulemaking Branch Chief, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; 1400 Independence Avenue SW., Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
Small businesses may request information on complying with this regulation by contacting Antoinette Carter, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposal is issued under Marketing Order No. 984, as amended (7 CFR part 984), regulating the handling of walnuts grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) (Pub. L. 110-246) amended section 18c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR part 900 (73 FR 49307; August 21, 2008). The additional supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend Federal fruit, vegetable, and nut marketing agreements and orders. USDA may use informal rulemaking to amend marketing orders based on the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and any other relevant matters.
AMS has considered these factors and has determined that the amendment proposal is not unduly complex and the nature of the proposed amendment is appropriate for utilizing the informal rulemaking process to amend the order. A discussion of the potential regulatory and economic impacts on affected entities is discussed later in the “Initial Regulatory Flexibility Analysis” section of this rule.
The proposed amendment was unanimously recommended by the Board following deliberations at a public meeting held on February 19,
Section 984.69 of the order, Assessments, authorizes the Board to collect assessments from handlers to administer the program.
This proposal would provide the Board with authority to borrow from a commercial lending institution during times of cash shortages. In the past, the Board has utilized reserve funds collected through handler assessments, to help finance the advertising/marketing program. However, due to the increased size of the domestic advertising program; relying on reserve funds as a means to meet obligations would make the program unsustainable in the long term. History shows, the most costly part of the program runs during the first six months of the marketing year and those expenditures must be paid by mid-year. Since the payments must be made before all assessment fees are invoiced and collected, a cash shortage may occur during the year. Authorizing the Board to borrow from a commercial lending institution would help manage and sustain the program during times of low income while also ensuring continuity of operations.
Therefore, for the reasons stated above, it is proposed that § 984.69, Assessments, be amended by adding a new paragraph that would provide the Board with authority to borrow from a commercial lending institution when no other funding is available.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 5,700 growers of California walnuts in the production area and approximately 90 handlers subject to regulation under the marketing order. The Small Business Administration (SBA) defines small agricultural producers as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $7,500,000. (13 CFR 121.201)
According to USDA's National Agricultural Statistics Service's (NASS's) 2012 Census of Agriculture, approximately 86 percent of California's walnut farms were smaller than 100 acres. Further, NASS reports that the average yield for 2014 was 1.97 tons per acre, and the average price received for 2014 was $3,230 per ton.
A 100-acre farm with an average yield of 1.97 tons per acre would therefore have been expected to produce about 197 tons of walnuts during 2014-15 marketing year. At $3,230 per ton, that farm's production would have had an approximate value of $636,310. Since Census of Agriculture information indicates that the majority of California's walnut farms are smaller than 100 acres, it could be concluded that the majority of the growers had receipts of less than $636,310 in 2014-15, which is well below the SBA threshold of $750,000. Thus, the majority of California's walnut growers would be considered small growers according to SBA's definition.
According to information supplied by the Board, approximately two-thirds of California's walnut handlers shipped merchantable walnuts valued under $7,500,000 during the 2014-15 marketing year; and would, therefore, be considered small handlers according to the SBA definition.
The proposed rule would authorize the Board to borrow from commercial lending institutions. This would help to ensure continuity in operations.
The Board reviewed and identified the most costly portion of its domestic advertising program. That portion of the program operates during the first six months of the Board's marketing year and costs must be paid by mid-year. Since assessment revenues are collected throughout the marketing year, not enough is on hand when these large payments are due. In the past, the Board has used reserve funds to help pay for marketing and advertising expenses. However, due to the increased size of the advertising program, the Board cannot rely on reserve funds to cover the costs. Based on this fact, the Board believes the program could become unsustainable in the long term.
While this action could result in a temporary increase in handler assessment costs, these increases would be small and uniform on all handlers and proportional to the size of their businesses. These costs are expected to be offset by the benefits derived from a sustained marketing and advertising program. Additionally, these costs would help to ensure that the Board has sufficient funds to meet its financial obligations. Such stability is expected to allow the Board to conduct a program that would benefit all entities, regardless of size. California walnut producers should see an improved business environment and a more sustainable business model because of the improved business efficiency.
Alternatives were considered to this proposal, including making no change at this time. However, the Board believes it would be beneficial to have the means and funds necessary to effectively administer the program.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178, “Vegetable and Specialty Crops.” No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California walnut handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
The Board's meeting was widely publicized throughout the California walnut production area. All interested persons were invited to attend the meeting and encouraged to participate in Board deliberations on this issue. Like all Board meetings, the February 19, 2016, meeting was public, and all entities, both large and small, were encouraged to express their views on the proposal.
Finally, interested persons are invited to submit comments on the proposed amendment to the order, including comments on the regulatory and informational impacts of this action on small businesses.
Following analysis of any comments received on the proposed amendment, AMS will evaluate all available information and determine whether to proceed. If appropriate, a proposed rule and referendum order would be issued, and producers would be provided the opportunity to vote for or against the proposed amendment. Information about the referendum, including dates and voter eligibility requirements, would be published in a future issue of the
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of the marketing order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.
1. The marketing order as hereby proposed to be amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;
2. The marketing order as hereby proposed to be amended regulates the handling of walnuts grown in California and is applicable only to persons in the respective classes of commercial and industrial activity specified in the marketing order;
3. The marketing order as hereby proposed to be amended is limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;
4. The marketing order as hereby proposed to be amended prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of walnuts produced or packed in the production area; and
5. All handling of walnuts produced or packed in the production area as defined in the marketing order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.
A 60-day comment period is provided to allow interested persons to respond to the proposal. Any comments received on the amendment proposed in this rule will be analyzed, and if AMS determines to proceed based on all the information presented, a producer referendum would be conducted to determine producer support for the proposed amendment. If appropriate, a final rule would then be issued to effectuate the amendment favored by producers participating in the referendum.
Marketing agreements, Nuts, Reporting and recordkeeping requirements, Walnuts.
For the reasons set forth in the preamble, 7 CFR part 984 is proposed to be amended as follows:
7 U.S.C. 601-674.
(d) To provide funds for the administration of the provisions of this part during the part of a fiscal period when neither sufficient operating reserve funds nor sufficient revenue from assessments on the current season's certifications are available, the Board may accept payment of assessments in advance or may borrow money from a commercial lending institution for such purposes.
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites comments on a recommendation by the Raisin Administrative Committee (Committee) to the remove the term “midget” from the minimum grade standards of the California raisin marketing order (order). The marketing order regulates the handling of raisins produced from grapes grown in California, and is administered locally by the Committee. Recently, the U.S. Standards for Grades of Processed Raisins (standards) were amended to remove the word “midget.” The proposed change would make the marketing order consistent with the amended standards. Furthermore, this rule would make a corresponding change to the raisin import regulation as required by the Agricultural Marketing Agreement Act of 1937, as amended, when changes are made to the size, grade, maturity, or quality requirements of the order.
Comments must be received by October 17, 2016.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Maria Stobbe, Marketing Specialist, or Jeffery Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposal is issued under Marketing Agreement and Marketing Order No. 989, both as amended (7 CFR part 989), regulating the handling of raisins produced from grapes grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
This proposed rule is also issued under section 8e of the Act, which provides that whenever certain specified commodities, including raisins, are regulated under a Federal marketing order, imports of these commodities into the United States are prohibited unless they meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically-produced commodities.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of import regulations issued under section 8e of the Act.
This proposal invites comments on the removal of the term “midget” from § 989.702(a) of the order and § 999.300(b)(1) of the import regulations. This action would make the order and the import regulations consistent with the recent change to the standards.
The Committee unanimously recommended that the term “midget” be removed from the order at a meeting on June 26, 2014. At a subsequent meeting on August 14, 2014, the committee also unanimously recommended that the word “midget” be removed from the standards. As required under the Act, the import regulations must be consistent with the changes to the order. In this instance, the order must be consistent with changes to the standards.
Paragraph (a) of § 989.702 of the order specifies minimum grade standards for packed Natural (sun-dried) Seedless (NS) raisins, requiring that small (midget)-sized raisins shall meet U.S. Grade C tolerances with respect to pieces of stem, and underdeveloped and substandard raisins. The word “midget” is redundant to the term “small,” and its removal is insignificant.
Pursuant to the recommendation of the Committee and consistent with the recent amendment of the standards, the word “midget” is proposed to be removed from the order language.
The Committee's recommendation to delete the word “midget” from the order and the standards necessitates a corresponding change to the import requirements.
Under the raisin import regulations, in paragraph (b)(1) of § 999.300, raisins imported into the United States are required to meet the same or comparable grade, size, quality, or maturity requirements as those in effect for the domestically-produced commodities, when such commodities are regulated under an order. With the removal of the word “midget” from both the standards and the order, removal of “midget” is required under the import regulations.
Removal of the word “midget” should not impact the application of the order or the import regulations, since the word “midget” is redundant and appears in parentheses after the word “small.” Thus, removing the word “midget” has no effect on interpretation of the order or the import regulations; and, therefore, has no effect on raisin importers.
The final rule removing the word “midget” from the standards was published in the
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 3,000 California raisin producers and 24 handlers subject to regulation under the marketing order. The Small Business Administration defines small agricultural producers as those having annual receipts less than $750,000, and defines small agricultural service firms, such as handlers and importers, as those whose annual receipts are less than $7,500,000. (13 CFR 121.201.)
Based on shipment data and other information provided by the Committee, most producers and approximately 13 handlers of California raisins may be classified as small entities. This action should not have any impact on handlers' or growers' benefits or costs.
There are approximately 52 raisins importers. This action should not have any impact on importers' costs.
This proposal would remove the word “midget” from the order regulations in § 989.702(a) and from the import regulations in § 999.300(b)(1), bringing the order and the import regulations into conformance with the recent amendment to the standards.
AMS is committed to complying with the E-Government Act, to promote the
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178, “Vegetable and Specialty Crops.” No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would not impose any additional reporting or recordkeeping requirements on either large or small raisin handlers or on raisin importers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this proposal.
Further, the Committee's meetings were widely publicized throughout the California raisin industry and all interested persons were invited to attend the meetings and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the June 26, 2014, and August 14, 2014, meetings were public meetings and all entities, both large and small, were encouraged to express their views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposal. Thirty days is deemed appropriate because: (1) This proposed rule should be implemented as soon as possible since the standards have already been amended; (2) the Committee discussed this change at two public meetings, and unanimously recommended it; and (3) the proposed change is insignificant and should not impact handlers or importers. All written comments received during the comment period will be considered before a final determination is made on this matter.
Grape, Marketing agreements, Raisins, Reporting and recordkeeping requirements.
Dates, Filberts, Food grades and standards, Imports, Nuts, Prunes, Raisins, Reporting and recordkeeping requirements, Walnuts.
For the reasons set forth in the preamble, 7 CFR parts 989 and 999 are proposed to be amended as follows:
7 U.S.C. 601-674.
7 U.S.C. 601-674.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Mitsubishi Heavy Industries, Ltd. Models MU-2B-10, MU-2B-15, MU-2B-20, MU-2B-25, MU-2B-26, MU-2B-26A, MU-2B-30, MU-2B-35, MU-2B-36, MU-2B-36A, MU-2B-40, and MU-2B-60 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as reports of cracks found in the wing spacer plates. We are issuing this proposed AD to require actions to detect and correct cracks in the wing spacer plates, which could result in reduced structural integrity of the wings and loss of control.
We must receive comments on this proposed AD by October 31, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Mitsubishi Heavy Industries America, Inc., c/o Turbine Aircraft Services, Inc., 4550 Jimmy Doolittle Drive, Addison, Texas 75001; telephone: (972) 248-3108, ext. 209; fax: (972) 248-3321; Internet:
You may examine the AD docket on the Internet at
Andrew McAnaul, Aerospace Engineer, FAA, ASW-143 (c/o San Antonio MIDO), 10100 Reunion Place, Suite 650, San Antonio, Texas 78216; phone: (210) 308-3365; fax: (210) 308-3370; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The Japan Civil Aviation Bureau (JCAB), which is the aviation authority for Japan, has issued AD No. TCD-8783-2016, dated June 28, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for certain Mitsubishi Heavy Industries, Ltd. (MHI) Models MU-2B-20, MU-2B-25, MU-2B-26, MU-2B-30, MU-2B-35, and MU-2B-36, airplanes. You may examine the MCAI on the Internet at
As part of the MHI MU-2B aging aircraft program, one-piece and three-piece main wings were subjected to detailed teardown inspections, and cracks were found in the wing spacer plates attached to the forward lower spar area at wing station 580. It was determined that the cracks resulted from fatigue caused by flight loads.
Japan is the State of Design for MHI Models MU-2B-20, MU-2B-25, MU-2B-26, MU-2B-30, MU-2B-35, and MU-2B-36 airplanes, which the MCAI AD applies to, and the United States is the State of Design for MHI Models MU-2B-26A, MU-2B-36A, MU-2B-40, and MU-2B-60 airplanes.
Mitsubishi Heavy Industries, Ltd. has issued MU-2 Service Bulletin No. 245, dated April 21, 2016, and MU-2 Service Bulletin No. 107/57-005, dated May 3, 2016. These service bulletins describe procedures for doing a fluorescent penetrant inspection of the wing spacer plates for cracks and replacing cracked wing spacer plates with an improved part. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The Models MU-2B-20, MU-2B-25, MU-2B-26, MU-2B-30, MU-2B-35, and MU-2B-36 airplanes have been approved by the aviation authority of another country, and are approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
The procedures described in this proposed AD meet the FAA's expectations for flight with known cracks described in Chapter 6 in FAA Advisory Circular (AC) 23-13A Fatigue, Fail-Safe and Damage Tolerance Evaluation of Metallic Structure for Normal, Utility, Acrobatic, and Commuter Category Airplanes.
In addition, we are including the Models MU-2B-26A, MU-2B-36A, MU-2B-40, and MU-2B-60 airplanes for which the United States is the State of Design and the unsafe condition exists and is likely to exist or develop in other products of the same type design.
The Models MU-2B-10 and MU-2B-15 are not included in Japan Civil Aviation Bureau (JCAB) AD No. TCD-8783-2016, dated June 28, 2016, or any of the service bulletins referenced in this proposed AD. The FAA does not believe there are any of these airplanes currently in operation, but are including them as a part of this proposed AD.
We estimate that this proposed AD will affect 209 products of U.S. registry. We also estimate that it would take about 8 work-hours per product to comply with the fluorescent penetrant inspection requirement of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of the fluorescent penetrant inspection requirement of this proposed AD on U.S. operators to be $142,120, or $680 per product.
In addition, we estimate the following to do any necessary follow-on actions:
It would take about 200 work-hours and require parts costing $500, for a cost of $17,500, per product to replace a cracked wing spacer plate on one side of the airplane.
It would take about 250 work-hours and require parts costing $1,000, for a cost of $22,250, per product to replace a cracked wing spacer plate on both sides of the airplane.
We have no way of determining the number of products that may need this action.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by October 31, 2016.
None.
This AD applies to the following Mitsubishi Heavy Industries, Ltd. (MHI) models airplanes that are certificated in any category:
(1) MU-2B-10 and MU-2B-15: Serial Numbers (S/Ns) 101 and 103 through 120.
The Models MU-2B-10 and MU-2B-15 are not included in Japan Civil Aviation Bureau (JCAB) AD No. TCD-8783-2016, dated June 28, 2016, or any of the service bulletins referenced in this AD. The FAA does not believe there are any of these airplanes currently in operation, but are including them as a part of this AD.
(2) MU-2B-20, MU-2B-25, and MU-2B-26: S/Ns 102 and 121 through 347, except 313 and 321;
(3) MU-2B-25, MU-2B-26, MU-2B-26A, and MU-2B-40: S/Ns 313SA, 321SA, and 348SA through 459SA;
(4) MU-2B-30, MU-2B-35, and MU-2B-36: S/Ns 502 through 696, except 652 and 661; and
(5) MU-2B-36A and MU-2B-60 airplanes: S/Ns 661SA, and 697SA through 1569SA.
Air Transport Association of America (ATA) Code 57: Wings.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as reports of cracks found in the wing spacer plates. We are issuing this AD to detect and correct cracks in the wing spacer plates, which could result in reduced structural integrity of the wings and loss of control.
Comply with paragraphs (g)(1) through (3) of this AD using the following service bulletins within the compliance times specified below, unless already done. The Models MU-2B-10 and MU-2B-15 currently do not have service bulletins associated with them. The FAA does not believe any of these airplanes are currently in operation. If they do become operational, an alternative method of compliance must be obtained to comply with this AD.
(1) For Models MU-2B-20, MU-2B-25, and MU-2B-26: S/Ns 102 and 121 through 347, except 313 and 321, and MU-2B-30, MU-2B-35, and MU-2B-36: S/Ns 502 through 696, except 652 and 661: Use Mitsubishi Heavy Industries, Ltd. (MHI) MU-2 Service Bulletin No. 245, dated April 21, 2016.
(2) Models MU-2B-25, MU-2B-26, MU-2B-26A, and MU-2B-40: S/Ns 313SA, 321SA, and 348SA through 459SA, and MU-2B-36A and MU-2B-60 airplanes: S/Ns 661SA, and 697SA through 1569SA: Use MHI MU-2 Service Bulletin No. 107/57-005, dated May 3, 2016.
(1) Do an initial fluorescent penetrant inspection of the wing spacer plates at whichever of the following compliance times that occurs later, and repetitively inspect thereafter at intervals not to exceed 2,000 hours time-in-service (TIS). Do the inspections following the Instructions section of the service bulletins identified in paragraph (f) of this AD, including all subparagraphs, as applicable.
(i) At or before accumulating 7,500 hours TIS; or
(ii) Within the next 200 hours TIS after the effective date of this AD or within the next 12 months after the effective date of this AD, whichever occurs first.
(2) During any inspection required in paragraph (g)(1) of this AD, including all subparagraphs, if any crack is found that is 0.6-inch or more in length, before further flight after the inspection in which the crack is found, replace the cracked wing spacer plate with an improved wing spacer plate, part number (P/N) 017A-11102-13 or 017A-11102-14. Do the replacement following the Instructions section of the service bulletins identified in paragraph (f) of this AD, including all subparagraphs, as applicable. Installing the improved wing spacer plates terminates the repetitive inspections required in paragraph (g)(1) of this AD.
(3) During any inspection required in paragraph (g)(1) of this AD, including all subparagraphs, if any crack is found that is less than 0.6-inch in length, repetitively fluorescent penetrant inspect for crack growth every 600 hours TIS after the inspection in which the crack was found. Do the inspections following the Instructions section of the service bulletins identified in paragraph (f) of this AD, including all subparagraphs, as applicable. If it is found during any required inspection that the crack has grown to0.6-inch in length or more, before further flight, replace the wing spacer plate as specified in paragraph (g)(2) of this AD.
(4) Installing improved wing spacer plates, part number (P/N) 017A-11102-13 or 017A-11102-14, terminates the repetitive inspections required in paragraph (g)(1) of this AD. You may install the improved wing spacer plates at any time to terminate the repetitive inspection requirement of this AD.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI JCAB AD No. TCD-8783-2016, dated June 28, 2016, for related information. You may examine the MCAI on the Internet at
Food and Drug Administration, HHS.
Notice of petition.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs at levels consistent with good manufacturing practice.
The color additive petition was filed on August 24, 2016.
Celeste Johnston, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1282.
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 6C0306), submitted by McCormick & Company, Inc., c/o Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036. The petition proposes to amend the color additive regulations in § 73.530 (21 CFR 73.530)
We have determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to update and modify security zones in the Port of Palm Beach, Port Everglades, Port of Miami, and the Port of Key West, Florida. The revisions create a new section for the Sector Key West security zones that previously were annotated as belonging to Sector Miami; clarify when the Port Everglades fixed security zones will be in effect; modify and lengthen a portion of the Port Everglades fixed security zone; and update language and definitions throughout the regulation. The proposed amendments are largely administrative in nature, but the clarification of terms and geographic application of security zones between Sector Key West and Sector Miami ports will allow for more effective implementation of these regulations to protect the public and ports from potential subversive acts.
Comments and related material must be received by the Coast Guard on or before November 15, 2016.
You may submit comments identified by docket number USCG-2016-0327 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Ruth Sadowitz, Sector Miami Waterways Management Division, U.S. Coast Guard; telephone (305) 535-4307, email
On January 23, 2003, Captain of the Port Miami published a final rule entitled “Security Zones; Port of Palm Beach, Port Everglades, Port of Miami, and Port of Key West, Florida” in the
The purpose of these proposed amendments is to protect the public and Ports from potential subversive acts. The amendments establish separate regulatory authority for Sector Key West, clarify when the Port Everglades fixed security zones will be in effect, modify and lengthen a portion of one of the Port Everglades fixed security zones, and update language throughout the regulation.
The legal basis for the proposed amendments is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
The fixed security zone from Mid-Port to North-Port (Pier 7 to the northern-most section of the Port) including all waters westward at Port Everglades would be an established permanent fixed security zone that will be in effect at all times. Berthing from Pier 7 to North-Port Port Everglades regularly serves passenger vessels, vessels carrying cargoes of particular hazards, and vessels carrying liquefied hazardous gas. This permanent fixed security zone, which parallels the Intracoastal Waterway, would not limit persons or vessels from using the main entrance channel (Bar Cut) or from using the
The fixed security zone that runs from Mid-Port south to Berth 29, just south of the John U. Lloyd launching ramps, along Port Everglades and the Intracoastal Waterway, would decrease in size to encompass only the waters westward of the Intracoastal Waterway extending to and including the pier face of Port Everglades. The fixed security zone would also lengthen southward from Berth 29, just south of the John U. Lloyd launching ramps to the northern tip of the Dania Cut-Off Canal. Persons and vessels would be allowed to operate along the Intracoastal Waterway, as they are now; however, persons and vessels would not be authorized to enter the security zone westward of the Intracoastal Waterway between Mid-Port and the northern tip of the Dania Cut-Off Canal without authorization. When a passenger vessel, vessel carrying cargoes of particular hazards, or vessel carrying liquefied hazardous gas moors along this section of Port Everglades, vessels transiting along the Intracoastal Waterway would be required to transit eastward of law enforcement vessels. This extension is needed to provide continuous protection for the public and Port because Port Everglades has expanded the entrance of the Dania Cut-Off Canal and its operations south over the years.
The term “cruise ship tenders” would be removed from the entire regulation because cruise ship tenders no longer provide security zone assistance.
The term “cruise ship” would be removed and “passenger vessels” will be redefined. Also, a “vessel carrying cargoes of particular hazards” and a “vessel carrying liquefied hazardous gas” will be defined.
As discussed above, since the implementation of Sector Miami security zones in 2003, Sector Key West was delegated its own Captain of the Port authority. Therefore, a separate section would be implemented by this proposed regulation to establish the security zone authority for Sector Key West.
These amendments are necessary for administrative reasons as noted above and to protect the public and Ports from potential subversive acts.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
The economic impact of this proposed updates and modifications to the rule is not significant for the following reasons: (1) Persons and vessels would still be able to operate in waters surrounding the proposed security zones; (2) the permanent fixed security zone encompassing Port Everglades from Mid-Port to North-Port is within the natural boundaries of the Port and is limited in size; (3) notification of the security zones will be made to the local maritime community via posted signs and Broadcast Notice to Mariners when applicable; and (4) persons and vessels may operate within the security zone if authorized by Captain of the Port of Miami or a designated representative.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
The proposed amendments may affect the following entities, some of which may be small entities: People and the owners or operators of vessels intending to transit or remain within the security zone(s) when they are in effect. For reasons discussed in the Regulatory Planning and Review section above, these proposed amendments would not have a significant economic impact on a substantial number of small entities.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves amending security zones and lengthening part of a security zone. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(2) As used in this section, a vessel carrying cargoes of particular hazard is defined in 33 CFR part 126 and a vessel carrying liquefied hazardous gas is defined in 33 CFR part 127.
(b) Location. The following areas are security zones. All coordinates are North American Datum 1983.
(1)
(2)
(i) When the security zone is in effect, persons and vessels shall not enter or transit the security zone along the Miami Main Channel unless authorized by Captain of the Port of Miami or a designated representative.
(ii) Persons and vessels may transit the Miami Main Channel when only one passenger vessel, one vessel carrying cargoes of particular hazard, or one vessel carrying LHG is berthed.
(iii) Law enforcement vessels can be contacted on VHF Marine Band Radio, Channel 16 (156.8 MHz).
(3)
(i) Persons and vessels may transit the Intracoastal Waterway; however, persons and vessels are not authorized to enter the fixed security zone westward of the Intracoastal Waterway without authorization from Captain of the Port Miami or a designated representative. On occasion, a passenger vessel, vessel carrying cargoes of particular hazard, or vessel carrying LHG may moor and encroach into the Intracoastal Waterway. When this occurs, persons and vessels shall transit the Intracoastal Waterway east of the on scene law enforcement vessel.
(ii) Periodically, vessels may be required to temporarily hold their positions while large commercial traffic operates in this area. Vessels near the security zone must follow the orders of the Captain of the Port or the designated representative.
(iii) Law enforcement vessels can be contacted on VHF Marine Band Radio, Channel 16 (156.8 MHz).
(c)
(2) In accordance with the general regulations § 165.33 of this part, entry into these zones is prohibited except as authorized by the Captain of the Port Miami or a designated representative. Vessels such as pilot boats, tug boats, and contracted security vessels may assist the Coast Guard Captain of the Port by monitoring these zones strictly to advise mariners of the restrictions. The Captain of the Port will notify the public of the security zone via signs or by Marine Safety Radio Broadcasts on VHF Marine Band Radio, Channel 16 (156.8 MHz) when applicable.
(3) Persons and vessels desiring to enter or transit the fixed or moving security zones may contact the Captain of the Port Miami at (305) 535-4472 or on VHF Marine Band Radio, Channel 16 (156.8 MHz) to seek permission to transit the area. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port or the designated representative.
(4) The Captain of the Port Miami may waive any of the requirements of this subpart for any vessel upon finding that the vessel or class of vessel, operational conditions, or other circumstances are such that application of this subpart is unnecessary or impractical for the purpose of port security, safety, or environmental safety.
(a)
(2) As used in this section, a vessel carrying cargoes of particular hazard is defined in 33 CFR part 126 and a vessel carrying liquefied hazardous gas is defined in 33 CFR part 127.
(b)
(c)
(2) In accordance with the general regulations § 165.33 of this part, entry into these zones is prohibited except as authorized by the Captain of the Port Key West or a designated representative. Vessels such as pilot boats, tug boats, and contracted security vessels may assist the Coast Guard Captain of the Port by monitoring these zones and advising mariners of the restrictions. The Captain of the Port will notify the public of the security zone via signs or by Marine Safety Radio Broadcasts on VHF Marine Band Radio, Channel 16 (156.8 MHz) when applicable.
(3) Persons and vessels desiring to enter or transit the fixed or moving security zones may contact the Captain of the Port Key West at (305) 292-8727 or on VHF Marine Band Radio, Channel 16 (156.8 MHz) to seek permission to transit the area. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port or the designated representative.
(4) The Captain of the Port Key West may waive any of the requirements of this subpart for any vessel upon finding that the vessel or class of vessel, operational conditions, or other circumstances are such that application of this subpart is unnecessary or
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of oxides of nitrogen (NO
Any comments must arrive by October 17, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0444 at
Nicole Law, EPA Region IX, (415) 947-4126,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rules addressed by this action with the dates that they were adopted by the local air agency and submitted by the California Air Resources Board (CARB).
On April 9, 2013 and April 30, 2015, the EPA determined that the submittals for SCAQMD Rule 1147 and SCAQMD Rule 1153.1 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
There are no previous versions of Rule 1153.1. We approved an earlier version of Rule 1147 into the SIP on August 4, 2010 (75 FR 46845).
NO
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each major source of NO
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
We believe these rules are consistent with CAA requirements and relevant guidance regarding enforceability, RACT and SIP revisions. SCAQMD previously adopted stringent future-effective emission limits that had not been widely implemented for all affected sources. SCAQMD intended to encourage wider adoption of low-emitting technology, but understood that some sources might not be able to comply on schedule for these and similar future-effective limits in other rules. As a result, SCAQMD did not take credit for (“set aside”) some emission reductions in certain attainment demonstrations. SCAQMD subsequently determined that some sources cannot comply with Rules 1147 and 1153.1 on schedule despite reasonable efforts and therefore delayed certain compliance dates. We do not believe that these changes impact the 2015 impracticability demonstration for the 2006 NAAQS for PM
The TSDs describe additional rule revisions that we recommend for the next time the local agency modifies the rules but are not currently the basis for rule disapproval.
As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rules because we believe they fulfill all relevant requirements. We will accept comments from the public on this proposal until October 17, 2016. If we take final action to approve the submitted rules, our final action will incorporate these rules into the federally enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SCAQMD rules described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve State law as meeting federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a portion of a revision to the Alabama State Implementation Plan submitted by the Alabama Department of Environmental Management on May 8, 2013. The revision modifies the definition of “volatile organic compounds” (VOC). Specifically, the revision adds one compound to the list of those excluded from the VOC definition on the basis that this compound makes a negligible contribution to tropospheric ozone formation. This action is being taken pursuant to the Clean Air Act.
Written comments must be received on or before October 17, 2016.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0473 at
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 or via electronic mail at
In the Rules and Regulations section of this
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that we have made changes to the areas in the State of Idaho that are quarantined to prevent the spread of pale cyst nematode. The description of the quarantined area has been updated several times since the last notice was published on September 8, 2010.
Mr. Jonathan M. Jones, National Program Manager, Emergency and Domestic Programs, PPQ, 4700 River Road, Unit 160, Riverdale, MD 20737; (301) 851-2128.
The pale cyst nematode (PCN,
In 7 CFR part 301, the PCN quarantine regulations (§§ 301.86 through 301.86-9, referred to below as the regulations) set out procedures for determining the areas quarantined for PCN and impose restrictions on the interstate movement of regulated articles from quarantined areas.
Section 301.86-3 of the regulations sets out the procedures for determining the areas quarantined for PCN. Paragraph (a) of § 301.86-3 states that, in accordance with the criteria listed in § 301.86-3(c), the Administrator will designate as a quarantined area each field that has been found to be infested with PCN, each field that has been found to be associated with an infested field, and any area that the Administrator considers necessary to quarantine because of its inseparability for quarantine enforcement purposes from infested or associated fields.
Paragraph (d) provides for the removal of fields from quarantine. An infested field will be removed from quarantine when a protocol approved by the Administrator as sufficient to support the removal of infested fields from quarantine has been completed and the field has been found to be free of PCN. An associated field will be removed from quarantine when the field has been found to be free of PCN according to a protocol approved by the Administrator as sufficient to support removal of associated fields from quarantine. Any area other than infested or associated fields that has been quarantined by the Administrator because of its inseparability for quarantine enforcement purposes from infested or associated fields will be removed from quarantine when the relevant infested or associated fields are removed from quarantine.
Paragraph (a) of § 301.86-3 further provides that the Administrator will publish a description of the quarantined area on the Plant Protection and Quarantine (PPQ) Web site. The description of the quarantined area will include the date the description was last updated and a description of the changes that have been made to the quarantined area. The description of the quarantined area may also be obtained by request from any local office of PPQ; local offices are listed in telephone directories. Finally, paragraph (a) establishes that, after a change is made to the quarantined area, we will publish a notice in the
Therefore, we are publishing this notice to inform the public of changes to the PCN quarantined areas in Bonneville and Bingham Counties in the State of Idaho. The changes are as follows:
• In 2011, we added 15,044 acres and removed 667 acres, resulting in 14,641 acres regulated, of which 1,467 acres were infested;
• In 2012, we added 4,356 acres and removed 5,363 acres, resulting in 14,740 acres regulated, of which 1,915 acres were infested;
• In 2013, we added 688 acres and removed 4,651 acres, resulting in 10,774 acres regulated, of which 2,300 acres were infested;
• In 2014, we added 1,315 acres and removed 2,094 acres, resulting in 7,734 acres regulated of which 2,897 acres were infested; and
• In 2015, we added 2,586 acres and removed 321 acres, resulting in 9,999 acres regulated, of which 2,897 acres were infested.
The current map of the quarantined area can be viewed on the PPQ Web site at
7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice of availability and request for comments.
We are advising the public that we have determined that it is warranted to amend cold treatment
We will consider all comments that we receive on or before November 15, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Ms. Dorothy C. Wayson, Senior Regulatory Policy Specialist, Imports, Regulations and Manuals, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-1231; (301) 851-2036.
The regulations in 7 CFR chapter III are intended, among other things, to prevent the introduction or dissemination of plant pests and noxious weeds into or within the United States. Under the regulations, certain plants, fruits, vegetables, and other articles must be treated before they may be moved into the United States or interstate. The phytosanitary treatments regulations contained in 7 CFR part 305 (referred to below as the regulations) set out standards for treatments required in 7 CFR parts 301, 318, and 319 for fruits, vegetables, and other articles.
In § 305.2, paragraph (b) states that approved treatment schedules are set out in the Plant Protection and Quarantine (PPQ) Treatment Manual.
Currently, grapefruit is authorized for importation from Australia into the United States if it was produced in fruit fly free areas in Riverina, Riverland, or Sunraysia, or if the fruit has been subjected to cold treatment to mitigate the risks from Mediterranean fruit fly (Medfly,
The cold treatment currently used, T107-d, requires fruit to be subject to refrigeration at or below 2.22 °C for up to 22 days with no option to treat at 3 °C. We are proposing to amend the treatment schedule T107-d-3 to add grapefruit to the schedule. With this change, exporters would have the option to have grapefruit cold-treated at up to 3 °C for no more than 14 days to meet U.S. entry requirements.
In March 2011, APHIS approved cold treatment at or below 3 °C for lemons, oranges, tangerines, and tangors from Australia to meet U.S. entry requirements.
PPQ's Center for Plant Health Science and Technology (CPHST) reviewed a research study conducted in New South Wales for Queensland fruit fly in grapefruit.
After the review, CPHST found that during the most tolerant stage testing (small scale), no insects were found alive after 10 days at either 2 °C or 3 °C and that the most tolerant life stage was determined to be the larval stage, first instar. Additionally, in the confirmatory stage testing (large scale), no insects were found alive after 14 days at either 2 °C or 3 °C.
We believe, therefore, that it is appropriate to amend T107-d-3 to add grapefruit from Australia.
The reasons for this change to the treatment manual are described in detail in the treatment evaluation document (TED) we have prepared to support this action. The TED may be viewed on the
After reviewing the comments we receive, we will announce our decision regarding the revised treatment schedule described in the TED in a subsequent notice, in accordance with paragraph (a)(2) of § 305.3. If we do not receive any comments, or the comments we receive do not change our determination that the proposed changes are effective, we will affirm these changes to the PPQ Treatment Manual and make available a new version of the PPQ Treatment Manual reflecting these changes. If we receive comments that cause us to determine that the changes described in this notice are not appropriate, we will issue another notice informing the public of our determination.
7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Economic Research Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) implementing regulations, the U.S. Department of Agriculture Economic Research Service (ERS) invites the general public and other Federal agencies to take this opportunity to comment on a proposed new information collection for a study of “Risk Preferences and Demand for Crop Insurance and Cover Crop Programs.”
Written comments on this notice must be received on or before November 15, 2016 to be assured of consideration.
Address all comments concerning this notice to Stephanie Rosch, Market and Trade Economics Division, Economic Research Service,
All written comments will be open for public inspection at the office of the Economic Research Service during regular business hours (8:30 a.m. to 5:00 p.m., Monday through Friday) at 355 E St. SW., Room 5-149B, Washington, DC 20024-3221.
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments and replies will be a matter of public record. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
For further information contact Stephanie Rosch at the mailing address in the preamble. Tel. 202-694-5049.
Commodity support programs, including crop insurance, and programs to promote use of cover crops all significantly alter the farm revenue risk profile for the farmers who adopt them. Whether farmers will choose to adopt insurance and/or soil conversation programs depends on the individual risks faced by each farmer, which can vary across different regions, crops, and time periods, as well as how farmers assess the costs of the risks that they face. ERS currently models the demand for commodity support programs, federal crop insurance, and cover crop promotion programs as part of multiple research objectives. These economic models rely on traditional theories of farmer decision-making under risk, and over-predict participation rates for all crop insurance and cover crop programs.
The information to be collected in this proposed initiative is necessary to test alternate theories of decision-making under risk. This research is difficult to conduct without experiments and relying only on observational or administrative data due to the variety of U.S. farms and production practices, the variety and complexity of real-world programs, and the limited variation in premium subsidies across the U.S. farming population. By using experiments, we will be able identify alternate theories of decision-making under risk that provide more accurate predictions of crop insurance enrollments for student subjects. We plan to use these experiments to develop future follow-on experiments with farmer subjects—the results of which will be used to update existing ERS models to provide better estimates of the impact of subsidies on key subpopulations such as producers with marginal lands and producers of high value crops.
This experiment will be conducted with student subjects from the University of Rhode Island. Participation will be voluntary, and subjects will be recruited using email communications and classroom solicitations. During each session, subjects will perform three simple tasks involving risky decisions and complete a brief demographic questionnaire. Sessions will be conducted at the Department of Environmental and Natural Resource Economics' Policy Simulation Laboratory (SimLab) at the University of Rhode Island. All experimental tasks will conducted using SimLab computers and custom-designed software.
Each session will last for a maximum of 90 minutes. Subjects will receive a show-up fee of $10 as is consistent with standard practice at SimLab. They will receive this payment even if they decline to participate in the experiment. In addition to the show-up fee, subjects will receive compensation based on the decisions they make during the course of the experiment. We expect to pay subjects, on average, between $20-25 per person, including the show-up fee. In designing our experimental procedures and payment levels, we took into consideration academic standards, statistical power considerations, budgetary limitations, and discussions between OMB and ERS regarding this and other approved experimental research.
These data will be collected under the legal authority of 7 U.S.C. 2204(a).
ERS intends to protect respondent information under the Privacy Act of 1974 and 7 U.S.C. 2276. ERS has decided not to invoke the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA). The complexity and cost necessary to invoke CIPSEA is not justified given the nature of the collection; the collection will be conducted by the University of Rhode Island and hosted in non-government owned computer systems, where CIPSEA compliance cannot be assured.
Copies of this information collection can be obtained from Stephanie Rosch at the address in the preamble.
Forest Service, USDA.
Notice of Intent (NOI) to prepare a Supplemental Environmental Impact Statement (SEIS) for the Johnson Bar Fire Salvage Project.
The U.S. Forest Service is giving notice of its intent to prepare a SEIS for the Johnson Bar Fire Salvage Project on the Nez Perce-Clearwater National Forests, Moose Creek Ranger District, Idaho. A complaint was filed on 11 March 2016 against the February 2016 Johnson Bar Salvage Record of Decision (ROD) and a Preliminary Injunction was granted by the United States District Court for the State of Idaho on 12 May 2016. This SEIS will provide additional analysis in response to the Preliminary Injunction.
Sheila D. Lehman, NEPA Planner/Interdisciplinary Team Leader, (208) 935-4256.
The U.S. Forest Service is announcing its intent to prepare a SEIS for the Johnson Bar Fire Salvage Project. The SEIS will supplement the analysis from the Johnson Bar Fire Salvage EIS by providing an updated analysis of the environmental effects. The Johnson Bar Fire Salvage Final EIS evaluated the potential effects of four alternatives, which included the No Action, Proposed Action, and two additional alternatives. The units possessing viable harvest potential will be carried forward for analysis in this SEIS.
The Nez Perce-Clearwater Forest Supervisor will issue a new ROD after evaluating the SEIS and public comments. An objection period for the new ROD will be provided, consistent with 36 CFR part 218.
The SEIS will be advertised for public comment as required by 40 CFR 1503.1. The Draft SEIS will be announced for public review and comment in the
The USDA Forest Service is the lead agency for this proposal. The Nez Perce—Clearwater Forest Supervisor is the responsible official.
Decision to Be Made is whether to adopt the proposed action, in whole or in part, or another alternative; and what mitigation measures and management requirements will be implemented.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by October 17, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Commission on Civil Rights.
Announcement of monthly planning meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Maine State Advisory Committee to the Commission will convene by conference call at 1:30 p.m. (EST) a planning meeting on the following dates: Tuesday, October 18, 2016; Tuesday, November 15, 2016; Tuesday, December 20, 2016; Tuesday, January, 17, 2017 and Tuesday, February 21, 2017. The purpose of each planning meeting is to discuss project planning as the Committee moves to selecting a topic as its civil rights project and once the project is selected to continue working on the project. The Committee may also select additional officers, as necessary.
The following dates: Tuesday, October 18, 2016; Tuesday, November 15, 2016; Tuesday, December 20, 2016; Tuesday, January, 17, 2017 and Tuesday, February 21, 2017. Each meeting starts at 1:30 p.m. (EST).
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-670-2260 and conference call ID: 3837382. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number herein.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call number: 1-888-670-2260 and conference call ID: 3837382.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
The meetings will be held Tuesday, October 4, 2016 through Thursday, October 6, 2016. For agenda details, see
The meeting will be held at: Stockton Seaview Hotel, 401 South New York Road, Galloway, NJ 08205, telephone: (609) 652-1800.
Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's Web site,
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's Web site when possible).
Review 2016 and proposed 2017 implementation plans.
Review updated decision document and develop Committee
Review background materials and approve range of alternatives.
Reports will be received from the NOAA Office of Law Enforcement and the U.S. Coast Guard.
Review previously set 2017 specifications and consider any modifications if necessary.
Review Monitoring Team Report for SMZ designation of 13 NJ artificial reefs.
Review Committee recommendations and decide whether to develop an amendment to add RH/S as Council-managed stocks.
Review and discuss draft Communication and Outreach Plan
Presentation of Amendment 10 HMS FMP by Jennifer Cudney of HMS, NMFS Southeast Fisheries Science Center (SEFSC) for Council review and comment.
Organization Reports; Liaison Reports; Executive Director's Report; Science Report; Committee Reports; and Continuing and New Business.
Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Western Pacific Fishery Management Council (Council) will hold its 124th Scientific and Statistical Committee (SSC) meeting, Fishing Industry Advisory Committee and its 168th Council meeting to take actions on fishery management issues in the Western Pacific Region.
The meetings will be held between October 4 and October 14. For specific dates, times and agendas, see
The 124th SSC will be held at the Council office, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, telephone: (808) 522-8220. The Fishing Industry Advisory Committee meeting will be held via teleconference, 1(888)482-3560; pass code 522-8220. The Council's Pelagic and International Standing Committee and Executive and Budget Standing Committee will also be held at the Council Office, 1164 Bishop Street, Suite 1400, Honolulu, HI, telephone: (808) 522-8220. The 168th Council meeting will be held at the Laniakea YWCA, Fuller Hall, 1040 Richards St., Honolulu, HI, telephone: (808) 538-7061. A Fishers Forum will be held at the Ala Moana Hotel, Garden Lanai room, 410 Atkinson Dr., Honolulu, HI 96814, telephone: (808) 955-4811.
Kitty M. Simonds, Executive Director, phone: (808) 522-8220.
The 124th SSC meeting will be held between 8:30 a.m. and 5 p.m. on October 4-6, 2016. The Fishing Industry Advisory Committee will be held between 4:00 p.m. and 6 p.m. (Hawaii Standard Time) on October 4, 2016. The Pelagic and International Standing Committee will be held between 9 a.m. and 12 noon on October 11, 2016. The Executive and Budget Standing Committee will be held on October 11, 2016 from 3 p.m. to 5 p.m. The first day of the 168th Council meeting will be on October 12, 2016, held from 8:30 a.m. to 11 a.m. The second and third days of the 168th Council meeting will be October 13-14, 2016, held from 8:30 a.m. to 5 p.m. On October 12, 2016, the Council will host a Fishers Forum between 6 p.m. and 9 p.m. at the Ala Moana Hotel, Garden Lanai Room. In addition to the agenda items listed here, the Council and its advisory bodies will hear recommendations from Council advisors. An opportunity to submit public comment will be provided throughout the agendas. The order in which agenda items are addressed may change and will be announced in advance at the Council meeting. The meetings will run as late as necessary to complete scheduled business. Background documents will be available from, and written comments should be sent to, Kitty M. Simonds, Executive Director; Western Pacific Fishery Management Council, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, phone: (808) 522-8220 or fax: (808) 522-8226.
Non-emergency issues not contained in this agenda may come before the Council for discussion and formal Council action during its 168th meeting. However, Council action on regulatory issues will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Monday, October 3, 2016 at 9:30 a.m.
The meeting will be held at the Hilton Garden Inn Boston Logan Airport, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789; fax: (617) 561-0798.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee will discuss Framework Adjustment 56 specifications, management measures, and draft alternatives and make recommendations to the Council. They will receive a progress report from the Plan Development Team on the white paper on monitoring strategies and develop recommendations to the Council. The Committee will also discuss possible groundfish priorities for 2017 and develop final recommendations to the Council. Other business will be discussed as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Reef Fish Advisory Panel (AP).
The meeting will convene on Tuesday, October 4, 2016, from 8:30 a.m. to 5 p.m. and Wednesday, October 5, 2016, from 8:30 a.m. to 4 p.m. EDT.
The meeting will take place at the Gulf of Mexico Fishery Management Council Office, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; telephone: (813) 348-1630.
Dr. Carrie Simmons, Deputy Director, Gulf of Mexico Fishery Management Council;
The Chairman will start the meeting with introductions and adoption of agenda. The AP will review and approve the minutes of two previous meetings held September 16-17, 2015 and April 1, 2016, respectively. The AP will review and discuss the Draft Proposed Fishing Regulations for Flower Garden Banks National Marine Sanctuary Expansion and a Draft Scoping Document to Evaluate Recommended Coral Areas as Habitat Areas of Particular Concern (HAPCs). The AP will review and comment on Reef Fish Amendment 36A Commercial IFQ Modifications; Reef Fish Amendment 46 Gray Triggerfish Rebuilding Plan; a Draft Framework Action to Modify Mutton Snapper Annual Catch Limits and Management Measures including an Action to Modify the Commercial Gag Minimum Size Limit. The AP will also hear a presentation on the results of the Vermilion Snapper Stock Assessment and Scientific and Statistical Committee Recommendations. The AP will review and comment on Draft Options to Modify Vermilion Snapper ACLs and Maximum Sustainable Yield Proxies. The AP will also receive a presentation on the Goliath Grouper Assessment and
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on the Council's file server. To access the file server, the URL is
The meeting will be webcast over the internet. A link to the webcast will be available on the Council's Web site,
Although other non-emergency issues not on the agenda may come before the AP for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the AP will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed deletions from the Procurement List.
The Committee is proposing to delete products and services from the Procurement List that was previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following products and services are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Deletions from the Procurement List.
This action deletes products from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 8/12/2016 (81 FR 53466), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.
Accordingly, the following products are deleted from the Procurement List:
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.
Currently, CNCS is soliciting comments concerning the data elements and questions that will be collected on its Grantee Progress Report (GPR) for the following grant programs: AmeriCorps State and National operating grants, AmeriCorps State and National planning grants, School Turnaround AmeriCorps grants, Volunteer Generation Fund grants, Commission Investment Funds grants, and State Commission Support grants. All grantees of these programs are required to complete a full annual GPR and an abbreviated mid-year GPR six months prior to the annual GPR. Grantees also complete an abbreviated final GPR, which is identical to the mid-year GPR, at the end of their overall grant period. The GPR provides information for CNCS staff to monitor grantee progress and to respond to requests from Congress and other stakeholders.
Copies of the information collection request can be obtained by contacting the office listed in the
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the CNCS mailroom at Room 4300 at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.
Carla Ganiel, 202-606-6773, or by email at
CNCS is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Currently, all grantees of the AmeriCorps State and National, School Turnaround AmeriCorps, the Volunteer Generation Fund, and Commission Support programs complete the annual GPR, mid-year GPR, and final GPR, which provide information for CNCS staff to monitor grantee progress and to respond to requests from Congress and other stakeholders. The information is collected electronically through the eGrants system.
CNCS seeks to renew the current information collection for programs which currently complete the GPR, and expand the use of the GPR to include two additional grant programs, the Commission Investment Funds and AmeriCorps State and National Planning Grants. CNCS has revised its GPRs to ensure consistency and reduce duplication across these grant programs. The information collection will otherwise be used in the same manner as the existing GPR. CNCS also seeks to continue using the current application until the revised GPR information collection is approved by OMB. The current GPR information collections are due to expire as follows: AmeriCorps State and National expires January 31, 2017; School Turnaround AmeriCorps expires March 31, 2017; Volunteer Generation Fund expires November 30, 2017; Commission Support Grant expires December 31, 2017.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of Intent; Withdrawal.
The U.S. Army Corps of Engineers, New York District (NY District), is withdrawing its intent to prepare a Draft Supplemental Environmental Impact Statement (SEIS) for the Study. The Notice of Intent to prepare the SEIS was published in the Friday, January 24, 2014, issue of the
U.S. Army Corps of Engineers, New York District, Planning Division, Environmental Analysis Branch, 26 Federal Plaza, Room 2151, New York, NY 10278-0090.
Matthew Voisine, Project Biologist, at
The U.S. Army Corps of Engineers, NY District published a notice of intent to prepare a Supplemental Environmental Impact Statement in the January 24, 2014 issue of the
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice.
The U.S. Army Corps of Engineers (USACE), Fort Worth District, is issuing this notice to advise Federal, state, and local governmental agencies and the public that USACE has signed a Record of Decision (ROD) for the Remaining Balanced Vision Plan (BVP) and Interior Drainage Plan (IDP) Features
The USACE Fort Worth District Commander, Colonel Calvin C. Hudson II, signed the ROD and Section 408 Permission on July 28, 2016.
U.S. Army Corps of Engineers, Regional Planning and Environmental Center, CESWF-PEC-CC (Attn: Mr. Jason Story), P.O. Box 17300, Room 3A12, Fort Worth, TX 76102-0300.
Jason Story, Environmental Resources Specialist, Regional Planning and Environmental Center. Email address:
The City of Dallas has requested permission to construct the Dallas Floodway Project remaining BVP and IDP features in Dallas County, TX. These remaining BVP and IDP features will constitute an alteration of the existing Dallas Floodway, a USACE federally authorized civil works project that requires Title 33 United States Code, Section 408 (Section 408) compliance. The proposed alterations within the Dallas Floodway consist of ecosystem restoration, recreation, and interior drainage improvements. These alterations were analyzed in the
Office of Innovation and Improvement, Department of Education.
Notice.
The Assistant Deputy Secretary for Innovation and Improvement reopens the competition and extends the deadline date for transmittal of applications for new awards for fiscal year (FY) 2016 under the Promise Neighborhoods program. The Assistant Deputy Secretary takes this action to allow more time for the preparation and submission of applications by prospective eligible applicants. We are reopening the competition and extending the application deadline date, from September 6, 2016 to September 16, 2016, for all applicants, due to the impact of severe weather-related issues across the country.
On July 8, 2016, we published in the
In accordance with the application notice, an eligible organization for the Promise Neighborhoods program—
(1) Is representative of the geographic area proposed to be served;
(2) Is one of the following:
(a) A nonprofit organization that meets the definition of a nonprofit under 34 CFR 77.1(c), which may include a faith-based nonprofit organization.
(b) An institution of higher education as defined by section 101(a) of the Higher Education Act of 1965, as amended.
(c) An Indian tribe as defined in the NIA;
(3) Currently provides at least one of the solutions from the applicant's proposed continuum of solutions in the geographic area proposed to be served; and
(4) Operates or proposes to work with and involve in carrying out its proposed project, in coordination with the school's LEA, at least one public elementary or secondary school located within the identified geographic area that the grant will serve.
Except for the deadline date, all information in the application notice for this competition remains the same.
Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202. Telephone: (202) 453-5638. Email address:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
National Advisory Council on Indian Education (NACIE), Department of Education.
Announcement of an open public meeting.
This notice sets forth the schedule of an upcoming public meeting conducted by the National Advisory Council on Indian Education (NACIE). Notice of the meeting is required by Section 10(a)(2) of the Federal Advisory Committee Act and is intended to notify the public of its opportunity to attend.
The NACIE meeting will be held on September 28-29, 2016, 8:30 a.m.-4:00 p.m. each day, Eastern Daylight Saving Time. The meeting will be held at the Residence Inn by Marriott located at 333 E Street SW., Washington, DC 20024. Phone 202-484-8280.
Tina Hunter, Designated Federal Official, Office of Elementary and Secondary Education, U.S. Department of Education, 400 Maryland Avenue SW., Washington, DC 20202. Telephone: 202-205-8527. Fax: 202-205-0310.
You may also access documents of the Department published in the
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before November 15, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
U.S. Energy Information Administration (EIA), Department of Energy.
Agency information collection activities: Information collection extension with change, comment request.
The EIA, pursuant to the Paperwork Reduction Act of 1995, intends to submit an information collection request for the Coal Markets Reporting System, OMB Control Number 1905-0167, with the Office of Management and Budget (OMB). EIA is soliciting comments on the proposed revisions and requests a three-year extension to Forms:
No changes are proposed for Forms:
The EIA proposes to make moderate changes to questions, response options, and instructions to Forms EIA-3, EIA-7A, and EIA-8A and requests an extension to Forms EIA-6 and EIA-20 with no substantive changes. EIA is proposing to require submission of Form EIA-3 and EIA-8A through the U.S. Energy Information Administration Data xChange Portal and will eliminate unsecured reporting modes. The Data xChange Portal:
• Serves as a single point of entry for authorized users to respond to EIA surveys, access EIA data, and build customized reports.
• Provides expanded communication methods to include phone and email contact information of centralized data collection team
• Uses security protocols to protect the information against unauthorized access during transmission.
• Requires data submission through an online web form, eliminating unsecured reporting methods.
Comments must be filed by November 15, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the EIA-7A Survey Manager at EIA of your intention to make a submission as soon as possible. The Survey Manager may be contacted by email at
Written comments should be sent to: Attn: JenAlyse Arena, EIA-7A Survey Manager, U.S. Energy Information Administration, EI-24, 1000 Independence Avenue SW., Washington, DC 20585.
Requests for additional information or copies of any forms and instructions should be directed to Ms. JenAlyse Arena at the contact information listed above. The proposed forms and instructions are available on the Internet at:
This information collection request contains:
The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
EIA surveys are conducted to collect coal market data. The data elements include production, consumption, receipts, stocks, sales, and prices. Information pertaining to the quality of the coal is also collected. Aggregates of this collection are used to support public policy analyses of the coal industry, economic modeling, forecasting, coal supply and demand studies, and in guiding research and development programs. EIA publications, including the
In addition, the EIA uses the data in short-term and long-term models such as the Short-Term Integrated Forecasting System (STIFS) and the National Energy Modeling System (NEMS) Coal Market Module. The forecast data also appear in the
Please refer to the proposed forms and instructions for more information about the purpose, who must report, when to report, where to submit, elements to be reported, detailed instructions, provisions for confidentiality, and uses of the information.
(4a)
• Change the title of the survey to “Quarterly Survey of Industrial, Commercial, & Institutional Coal Users”
• In Part 2, Question 6, revise reporting for co-fired sites to allow reporting of more than one additional fuel source.
• In Part 3, Question 2, remove Adjustments to total cost of coal received during the reporting cycle.
• In Part 5, Questions 2-3, revise coking plant disposition categories and
• In Part 8, Question 2, revise coal refining plant disposition categories to allow for accurate accounting of refined coal.
EIA proposes adding the following questions to Form EIA-3:
• In Part 2, Question 2, add the question:
• In Part 3, Question 3A, add the question
• In Part 5, question 7, revise reporting categories of coal mine sales to simplify question wording while adding export categories to include open market export sales, captive market export sales, and broker export sales. The new categories will provide more accurate information on coal exports by type of sale and seller by eliminating potential double-counting of export coal sales on Form EIA-8A. It will improve EIAs assessments on production trends and coal supply by basin. It will also facilitate EIA's comparison of coal supply by basin with export data collected by the U.S. Census Bureau.
EIA proposes adding the following questions to Form EIA-7A:
• In Part 3, Question 5A, add the question
• In Part 5, delete question 2
• In Part 5, delete question 5
• In Part 2, Question 2, revise list of locations where U.S. produced coal stocks are located to include “IT—In Transit”
• In Part 3, Question 2, add new field requesting port of export and destination country for export sales to gather more detailed export data and assist in cross-survey comparison with the EIA-7A and coal trade data collected by the U.S. Census Bureau to quantify and eliminate double-counting of export coal sales.
• No substantive changes will be made to these forms.
• Is the proposed collection of information necessary for the proper performance of the functions of the agency and does the information have practical utility?
• What actions could be taken to help ensure and maximize the quality, objectivity, utility, and integrity of the information to be collected?
• Are the instructions and definitions clear and sufficient? If not, which instructions need clarification?
• Can the information be submitted by the respondent by the due date?
• Can information be submitted using the proposed collection method?
• EIA-3 will consist of 432 respondents
• EIA-7A will consist of 848 respondents
• EIA-8A will consist of 48 respondents
• EIA-6 (standby) will consist of 610 respondents
• EIA-20 (standby) will consist of 491 respondents
Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, codified at 15 U.S.C. 772(b), and the DOE Organization Act of 1977, Pub. L. 95-91, codified at 42 U.S.C. 7101
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b. Project No.: 2520-076.
c.
d.
e.
f.
g.
h.
i.
j. This application is not ready for environmental analysis at this time.
k.
The Mattaceunk Project is operated with minimal fluctuations of the reservoir surface elevation. Flexibility on reservoir elevations is required to provide for safe installation of the project's flashboards and to allow an adequate margin for wave action, debris loads, or sudden pool increases that might cause flashboard failure. The existing license requires a reservoir surface elevation no lower than 1.0 foot below the dam crest elevation of 236.0 feet when the 4-foot-high flashboards are not in use, and no lower than 2.0 feet below the top of flashboard elevation of 240.0 feet when the 4-foot-high flashboards are in use. The existing license also requires a year-round continuous minimum flow of 1,674 cubic feet per second (cfs) or inflow, whichever is less, and a daily average minimum flow of 2,392 cfs from July 1 through September 30 and 2,000 cfs from October 1 through June 30, unless inflow is less than the stated daily average minimum flows (in which case outflow from the project must equal the inflow to the project). Great Lakes Hydro proposes to: (1) Install a seasonal upstream eel ramp; (2) install an upstream passage structure for American shad, alewife, and blueback herring; (3) install trashracks having 1-inch clear spacing to the full depth of the turbine intakes during the fish passage season; and (4) improve the recreation facility at the downstream angler access area.
l.
m. You may also register online at
n.
o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
The Federal Energy Regulatory Commission (Commission) hereby gives notice that Commission staff may attend the following MISO-related meetings:
Unless otherwise noted all of the meetings above will be held at either:
The above-referenced meetings are open to the public.
The discussions at each of the meetings described above may address matters at issue in the following proceedings:
For more information, contact Patrick Clarey, Office of Energy Markets Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or
On August 26, 2016, the Commission issued an order in Docket No. EL16-71-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the PJM Transmission Owners are complying with their Order No. 890 obligations.
The refund effective date in Docket No. EL16-71-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL16-71-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
This notice identifies the Federal Energy Regulatory Commission staff's revised schedule for the completion of the Environmental Assessment (EA) for Dominion Carolina Gas Transmission, LLC's Transco to Charleston Project. The previous Notice of Schedule, issued on July 25, 2016, identified September 19, 2016 as the EA issuance date. However, Dominion Carolina Gas Transmission, LLC filed a supplement on August 22, 2016 which identified several route adjustments and workspace modifications. As a result, staff has revised the schedule for issuance of the EA.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the project's progress.
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription (
Take notice that on September 7, 2016, Tracy Van Orden filed an application for authorization to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b), and Part 45 of the Regulations of the Federal Energy Regulatory Commission (Commission), 18 CFR Part 45.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the PJM Interconnection, L.L.C. (PJM):
The above-referenced meetings will be held at:
The above-referenced meetings are open to stakeholders. Further information may be found at
The discussions at the meetings described above may address matters at issue in the following proceedings:
For more information, contact the following:
Take notice that on August 29, 2016, Columbia Gas Transmission, LLC (Columbia), 5151 San Felipe, Suite 2500, Houston, Texas 77056, filed in Docket No. CP16-497-000, a prior notice request pursuant to sections 157.205, 157.213, and 157.216 of the Commission's regulations under the Natural Gas Act (NGA). Columbia seeks authorization to: (i) Convert a storage well in Wayne County, Ohio from injection/withdrawal status to observation status and abandon its associated pipeline and appurtenances, and (ii) plug and abandon two storage wells, and their associated appurtenances, located in Ashland, and Vinton Counties, Ohio, respectively. Columbia proposes to perform these activities under its blanket certificate issued in Docket No. CP83-76-000, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may be viewed on the web at
Any questions regarding this application should be directed to William A. Sala, Jr., Senior Counsel, Columbia Gas Transmission, LLC, 5151 San Felipe, Suite 2500, Houston, Texas 77056, or by calling (713) 386-3743 (telephone), or (713) 386-3755 (fax)
Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
Take notice that on July 14, 2016, pursuant to Rule 207(a)(5) of the Federal Energy Regulatory Commission's (Commission), ITC Pipeline Company, LLC (“ITC Pipeline”) requests waiver of the portion of 18 CFR 342.4(c)(2016), that would require ITC Pipeline to submit a verified statement in support of (1) the incentive rates (“Incentive Rates”) agreed to by ITC Pipeline's current shippers, as opposed to its prospective shippers who will begin shipping once ITC Pipeline goes into service, and (2) any changes to the Incentive Rates that ITC Pipeline makes in a subsequent tariff filing with the Commission provided such changes are made in accordance with the written terms of the applicable dedication agreement described in the transmittal letter of ITC Pipeline's initial rules and rates tariff filed concurrently therewith.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214 (2014)) on or before 5:00 p.m. Eastern time on the specified comment date. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on September 8, 2016, pursuant to sections 206, 306, and 309 of the Federal Power Act, 16 U.S.C. 824e, 825e, and 825h (2012), and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2014), the Coalition of MISO Transmission Customers (Complainant) filed a formal complaint against Midcontinent Independent System Operator, Inc. (MISO or Respondent) alleging that Respondent's calculation of the export limit for the 2016-2017 Planning Resource Auction from the MISO South region to the MISO Midwest region was unjust and unreasonable, all as more fully explained in the complaint.
Complainant states that copies of the complaint were served on the contacts for Respondent listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l. Deadline for filing additional study requests and requests for cooperating agency status: October 31, 2016.
The Commission strongly encourages electronic filing. Please file requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
n. The proposed Salmon and Annex Creek Project consists of two developments, one on Salmon Creek and one on Annex Creek.
The Salmon Creek development consists of the following existing facilities: (1) The 165-acre Salmon Creek reservoir impounded by a 648-foot-long, 168-foot-high dam, with ten 5-foot-wide spillway bays; (2) a 1,500-foot-long segment of a canal used to periodically divert water from tributary streams into Salmon Creek Reservoir; (3) a 10-foot-wide, 11-foot-high intake structure with trashracks at the base of the dam; (4) a 3-foot-diameter conduit that conveys flows from the dam to the project valvehouse located immediately downstream; (5) the project valvehouse containing two penstocks: (i) An 11,030-foot-long, 3.5-foot-diameter penstock that narrows to a 2.5-foot-diameter immediately before entering the Lower Powerhouse, and (ii) a 4,290-foot-long, 3.3- to-2.5-foot-diameter penstock that conveys flows to the decommissioned Upper Powerhouse; (6) the 57-foot-long, 44-foot-wide, 32-foot-high, Lower Powerhouse, which contains a 6.9-megawatt (MW) impulse turbine; (7) an approximately 250-foot-long tailrace that flows underneath Egan Drive and empties into a pond adjacent to the Douglas Island Pink and Chum, Inc., hatchery; and (8) appurtenant facilities.
The Annex Creek development consists of the following existing facilities: (1) The 264-acre Upper Annex Lake, impounded by a 118-foot-long, 20-foot-high dam with a 57-foot-wide spillway that discharges flows in excess of those needed for generation into the Lower Annex Lake; (2) a small timber saddle dam, 61 feet long and 6 feet high, located just west of the main dam; (3) the natural 27-acre Lower Annex Lake; (4) a lake tap intake on Upper Annex Lake; (5) a 1,433-foot-long power tunnel that narrows from 8 feet wide and 8 feet high at the intake to a 6.5-foot-diameter tunnel at the project valvehouse; (6) the project valvehouse containing the penstock intake; (7) the 7,097-foot-long, 3.5-foot-diameter penstock that narrows to a 2.8-foot-diameter before it bifurcates at the powerhouse to provide flows to two impulse turbine units with a total installed capacity of 3.675 MW; (8) the 67-foot-long, 48-foot-wide, 40-foot-high, powerhouse; (9) a tailrace that discharges flows over a weir into Taku Inlet; (10) a 12.5-mile-long, 23-kilovolt (kV) transmission line that conveys power to the Thane substation; and (11) appurtenant facilities.
The project currently operates to provide base load generation with an estimated annual output of 53.8 gigawatt-hours. No changes to project operation or facilities are proposed.
o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
p.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Comments must be submitted on or before November 15, 2016.
Submit your comments referencing Docket ID No. EPA-HQ-OAR-2016-0094 online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Holly Pugliese, Compliance Division, Office of Transportation and Air Quality, Environmental Protection Agency, 2000 Traverwood, Ann Arbor, Michigan, 48105; telephone number: 734-214-4288; fax number: 734-214-4869; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
EPA does not collect the forms, but rather makes them available to importers and CBP to facilitate entry of goods at the port. EPA may ask for them upon request to assist CPB and/or EPA enforcement personnel for any given import for which there are questions or issues. The forms are primarily used by CBP at the time of importation to assist CBP in making determination if entry should be allowed. CBP regulations require that the forms be submitted as applicable at the time of entry; see 19 CFR 12.73 and 12.74.
Revision to FR Notice published 07/29/2016; extending comment period from 09/29/2016 to 10/19/2016.
The Advisory Committee was established by Public Law 98-181, November 30, 1983, to advise the Export-Import Bank on its programs and to provide comments for inclusion in the report on competitiveness of the Export-Import Bank of the United States to Congress.
Wednesday, September 28, 2016 from 11:00 a.m.-3:00 p.m.. A break for lunch will be at the expense of the attendee. Security processing will be necessary for reentry into the building. The meeting will be held at EXIM Bank in the Main Conference Room—11th floor, 811 Vermont Avenue NW., Washington, DC 20571.
Discussion will focus on the Advisory Committee's final recommendations for EXIM Bank staff based on the Committee's work during this fiscal year. The Advisory Committee will also hear from external speakers and EXIM Bank officials.
The meeting will be open to public participation, and 10 minutes will be set aside for oral questions or comments. Members of the public may also file written statement(s) before or after the meeting. If you plan to attend, a photo ID must be presented at the guard's desk as part of the clearance process into the building, you may contact Tia Pitt at
For members of the Press planning to attend the meeting, a photo ID must be presented at the guard's desk as part of the clearance process into the building please email Tia Pitt at
For further information, contact Tia Pitt, 811 Vermont Ave. NW., Washington, DC 20571, at
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors will meet in open session at 3:30 p.m. on Tuesday, September 20, 2016, to consider the following matters:
No substantive discussion of the following items is anticipated. These matters will be resolved with a single vote unless a member of the Board of Directors requests that an item be moved to the discussion agenda.
Disposition of minutes of previous Board of Directors' Meetings.
Summary reports, status reports, reports of the Office of Inspector General, and reports of actions taken pursuant to authority delegated by the Board of Directors.
Update of Projected Deposit Insurance Fund Losses, Income, and Reserve Ratios for the Restoration Plan.
The meeting will be held in the Board Room located on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.
This Board meeting will be Webcast live via the Internet and subsequently made available on-demand approximately one week after the event. Visit
If you need any technical assistance, please visit our Video Help page at:
The FDIC will provide attendees with auxiliary aids (
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202-898-7043.
Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the
The following transactions were granted early termination—on the dates indicated—of the waiting period provided by law and the premerger notification rules. The listing for each transaction includes the transaction number and the parties to the transaction. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.
Theresa Kingsberry, Program Support Specialist, Federal Trade Commission Premerger Notification Office Bureau of Competition, Room CC-5301, Washington, DC 20024, (202) 326-3100.
By direction of the Commission.
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by October 17, 2016.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number,
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Qualification of Biomarker—Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” This guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a “progressive decline” in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs)without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comment as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Marianne Noone, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301-796-2600.
FDA is announcing the availability of a guidance for industry entitled “Qualification of Biomarker—Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.” In the
In the
This guidance provides recommendations for the use of TKV, measured at baseline, as a prognostic enrichment biomarker to select patients with ADPKD at high risk for a “progressive decline” in renal function, defined as a confirmed 30 percent decline in the patient's eGFR, for inclusion in interventional clinical trials. This biomarker may be used in combination with the patient's age and baseline eGFR as an enrichment factor in these interventional clinical trials. Specifically, this guidance provides the COU for which this biomarker is qualified through the CDER Biomarker Qualification Program. “Biomarker qualification” is a conclusion that within the stated COU, the biomarker can be relied upon to have a specific interpretation and application in drug development and regulatory review. This biomarker can be used by drug developers for the qualified COU in submission of INDs, NDAs, and BLAs without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. After a biomarker is qualified for the specific COU, its qualification is not limited to a single, specific drug development program. Making the qualification recommendations widely known and available for use by drug developers will contribute to drug innovation, thus supporting public health.
Innovative and improved DDTs can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment and/or disease. DDTs include, but are not limited to, biomarkers, clinical outcome assessments and animal models under the animal rule. Refer to DDTs Qualification Programs at
CDER has initiated this formal qualification process to work with developers of these biomarker DDTs to guide them as they refine and evaluate DDTs for use in the regulatory context. Once qualified, biomarker DDTs will be publicly available for use in any drug development program for the qualified COU. As described in the January 2014 guidance, biomarker DDTs should be developed and reviewed using this process.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the use of TKV, measured at baseline, as a prognostic enrichment biomarker to select patients with ADPKD at high risk for a “progressive decline” in renal function, defined as a confirmed 30 percent decline in the patient's eGFR, for inclusion in interventional clinical trials. This biomarker may be used in combination with the patient's age and baseline eGFR as an enrichment factor in these interventional clinical trials. This guidance does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance contains an information collection that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The information collection has been approved under the OMB control numbers 0910-0001 and 0910-0014. The information requested in this guidance is currently submitted to FDA to support medical product effectiveness (see 21 CFR 312.30, 21 CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.” The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),” dated April 2008.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a document entitled “Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.” The guidance provides IND sponsors, with recommendations concerning IND submissions for microbial vectors used for MVGTs in early phase clinical trials. The guidance focuses on the CMC information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on recommendations for MVGTs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 211 and 610 have been approved under OMB control number 0910-0139 and in 21 CFR part 312 under OMB control number 0910-0014.
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is announcing a 3-day training course for clinical investigators on the scientific, ethical, and regulatory aspects of clinical trials for medical products. This training course is intended to provide clinical investigators, such as clinicians, nurses, pharmacists, and other health care providers involved in conducting clinical trials, with expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. Senior FDA staff, along with other experts, will present on issues critical for successful conduct of clinical research.
The training course will be held on November 7, 2016, from 8:20 a.m. to 5:30 p.m. (registration begins at 7:30 a.m.); on November 8, 2016, from 8:30 a.m. to 4:45 p.m.; and on November 9, 2016, from 8:30 a.m. to 3:30 p.m.
The course will be held at the Silver Spring Civic Building at Veterans Plaza, One Veterans Place, Silver Spring, MD 20910. GPS device address: 8525 Fenton St., Silver Spring, MD 20910. For additional information, please refer to
Nicole Silva, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6323, Silver Spring, MD 20993, 301-796-3419,
Clinical trial investigators play a critical role in the development of medical products. They bear the responsibility for ensuring the safe and ethical treatment of study subjects and for acquiring adequate and reliable data to support regulatory decisions. This course is intended to train clinical investigators in all elements of clinical trials, including the preclinical and clinical information needed to support the investigational use of medical products; the statistical design of trials; and scientific, regulatory, and ethical considerations related to conduct of clinical trials. The course lecturers will include a diverse representation of senior FDA staff and other experts, enabling communication on issues critical for successful conduct of clinical research.
The training course is designed to provide clinical investigators with an overview of the following information:
• The essential toxicological, pharmacological, and manufacturing data to support investigational use in humans;
• Fundamental issues in the design and conduct of clinical trials;
• Statistical and analytic considerations in the interpretation of trial data;
• Appropriate safety evaluation during studies; and
• The ethical considerations and regulatory requirements for clinical trials.
In addition, the course aims to:
• Foster a cadre of clinical investigators with knowledge, experience, and commitment to investigational medicine;
• Promote communication between clinical investigators and FDA;
• Enhance investigators' understanding of FDA's role in experimental medicine;
• Improve the quality of clinical trial data; and
• Enhance protection of subjects in clinical trials.
The course will be conducted over 3 days and will be presented mainly by senior FDA staff with other lecturers presenting on selected topics. The agenda is available at
The course is targeted toward clinicians, nurses, pharmacists and other health care professionals responsible for, or involved in, the conduct and/or design of clinical trials.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by November 15, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
In accordance with the collection of information entitled “Unique Device Identification System (UDI),” medical device labelers, unless excepted, are required to design and use medical device labels and device packages that bear a UDI, present dates on labels in a particular format, and submit data concerning each version or model of a device to the Global Unique Device Identification Database (GUDID) no later than the date the label of the device must bear a UDI. Once a device becomes subject to UDI requirements, respondents will be required to update the information reported whenever the information changes.
The recordkeeping, reporting, and third-party disclosure requirements referenced in this document are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but other types of labelers include a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. Respondents may also include any private organization that applies for accreditation by FDA as an issuing agency.
FDA has identified the following requirements as having burdens that must be accounted for under the PRA; the burdens associated with these requirements are summarized in the table that follows:
Section 801.18 requires that whenever a labeler of a medical device includes an expiration date, a date of manufacture, or any other date intended to be brought to the attention of the user of the device, the labeler must present the date on the label in a format that meets the requirements of this section.
Section 801.20 requires every medical device label and package to bear a UDI.
Under § 801.35, any labeler of a device that is not required to bear a UDI on its label may include a UDI on the label of that device and utilize the GUDID.
Under § 801.45, any device that has to be labeled with a UDI also has to bear a permanent marking providing the UDI on the device itself if the device is intended for more than one use and intended to be reprocessed before each use.
Section 801.50 requires stand-alone software to comply with specific labeling requirements that identify the software.
Section 801.55 authorizes additional, case-by-case, labeling exceptions and alternatives to standard UDI labeling requirements.
If a labeler relabels or modifies a label of a device that is required to bear a UDI, under § 830.60 it has to keep a record showing the relationship of the original device identifier to the new device identifier.
Section 830.110 requires an applicant seeking initial FDA accreditation as a UDI-issuing agency to furnish FDA an application containing certain information, materials, and supporting documentation.
Under § 830.120, an FDA-accredited issuing agency is required to disclose information concerning its system for the assignment of UDIs; maintain a list of labelers that use its system for the assignment of UDIs, and provide FDA a copy of such list; and upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs.
Sections 830.310 and 830.320 require the labeler to provide certain information to the GUDID concerning the labeler and each version or model of a device required to be labeled with a UDI, unless the labeler obtains a waiver.
Section 830.360 requires each labeler to retain records showing all UDIs used to identify devices that must be labeled with a UDI and the particular version or model associated with each device identifier, until 3 years after it ceases to market a version or model of a device.
Respondents who are required to submit data to the Agency under certain other approved information collections (listed below) are required to include UDI data elements for the device that is the subject of such information collection. Addition of the UDI data elements is included in this burden estimate for the conforming amendments in the following 21 CFR parts:
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for LUMASON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical
FDA has approved for marketing the human drug product, LUMASON (sulfur hexafluoride microbubbles). LUMASON is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Subsequent to this approval, the USPTO received a patent term restoration application for LUMASON (U.S. Patent No. 5,686,060) from Bracco Suisse SA, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 22, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LUMASON represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for LUMASON is 7,199 days. Of this time, 6,174 days occurred during the testing phase of the regulatory review period, while 1,025 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device RESQCPR SYSTEM. RESQCPR SYSTEM is indicated for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. Subsequent to this approval, the USPTO received a patent term restoration application for RESQCPR SYSTEM (U.S. Patent No. 5,454,779) from University of California and Advanced Circulatory Systems, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of RESQCPR SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for RESQCPR SYSTEM is 3,608 days. Of this time, 2,247 days occurred during the testing phase of the regulatory review period, while 1,361 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for ENTYVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patents and Trademarks Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows:
Submit electronic comments in the following way:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
For Determination of Regulatory Review Period for Purposes of Patent Extension: ENTYVIO. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
•
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial
FDA has approved for marketing the human biologic product, ENTYVIO (vedolizumab). ENTYVIO is indicated for adult ulcerative colitis and adult Crohn's disease. Subsequent to this approval, the USPTO received a patent term restoration application for ENTYVIO (U.S. Patent No. 7,147,851) from Millenium Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 6, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ENTYVIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ENTYVIO is 5,066 days. Of this time, 4,731 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,526 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA or Agency) is announcing a public workshop regarding “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs).” This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.
If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see
FDA is announcing a public workshop pertaining to the coordinated development of antimicrobial drugs and ASTs. Discussions will focus on assisting drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who seek to coordinate development of these products.
The goals of the workshop are to: (1) Outline the regulatory considerations for submitting separate applications to the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health for antimicrobial drugs and ASTs, respectively; (2) identify the challenges related to obtaining data supporting the clearance of an AST device coincident with or soon after antimicrobial drug approval; and (3) discuss ideas for addressing these challenges.
The Agency encourages individuals, industry, device manufacturers, health care professionals, researchers, public health organizations and other interested persons to attend this public workshop. Workshop updates will be made available on the internet at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #171 entitled “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft revised guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft revised guidance by November 15, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Charli Long, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0850,
FDA is announcing the availability of a draft revised guidance for industry #171 entitled “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” This draft revised guidance document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for submitting data demonstrating the bioequivalence of animal drugs in soluble powder oral dosage form products and Type A medicated articles. It expands upon CVM's Bioequivalence Guidance,
This level 1 draft revised guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft revised guidance, when finalized, will represent the current thinking of FDA on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This draft revised guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information referred to in the guidance entitled “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” have been approved under OMB control number 0910-0575.
Persons with access to the Internet may obtain the draft revised guidance at either
Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA or we) is announcing a third public meeting to discuss menu labeling requirements. We announced the first two public meetings in a separate
See “How to Participate in the Public Meeting” in the
See “How to Participate in the Public Meeting” in the
For questions about registering for this meeting or for special accommodations due to disability, contact Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, email:
For general questions about the public meeting, contact Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
In the
On December 18, 2015, the President signed the Consolidated Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the Consolidated Appropriations Act states that none of the funds made available under the Consolidated Appropriations Act may be used to implement, administer, or enforce the final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” until 1 year after the date of publication of a Level 1 guidance with respect to nutrition labeling of standard menu items in
In the
We have made education of the menu labeling requirements a high priority, and this is our third menu labeling workshop to educate interested members of the public, especially the regulated industry, about the menu labeling requirements. We announced the first two public meetings in a separate
The purpose of this public meeting is to help the regulated industry comply with the requirements of the menu labeling final rule. On the morning of day one of the meeting, we will give a slide presentation on the menu labeling requirements. (Please note the slide presentation will only be presented on day one.) The afternoon of day one and all of day two will consist of consultation sessions with FDA staff where individual companies (limited to two members per company) may discuss their specific questions and concerns. Each consultation session is limited to 15 minutes to help ensure that enough time is available to accommodate each company that requests a consultation. We recommend that participants in the consultation session prepare their questions in advance due to the limited time available.
We encourage all persons who wish to attend the meeting to register in advance of the meeting and to indicate whether they are requesting a consultation session. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. Early registration is recommended to facilitate planning of the consultation sessions and because seating is limited. We encourage you to use electronic registration if possible (see the address in table 1).
Table 1 provides information on participation in the public meeting.
Transcripts of the workshop will not be prepared.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a virtual meeting of the Frederick National Laboratory Advisory Committee to the National Cancer Institute.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NCI Shady Grove has instituted stringent procedures for entrance into the NCI Shady Grove building. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the NIH Clinical Center Research Hospital Board.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The portions of the meeting devoted to the identification and evaluation of specific candidates for consideration for leadership positions in the Clinical Center will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B) and 552b(c)(6), title 5 U.S.C., as amended. Premature disclosure of potential candidates and their qualifications, as well as the discussions by the committee, could significantly frustrate NIH's ability to recruit these individuals and the consideration of personnel qualifications, performance, and the competence of individuals as candidates would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDCD.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Deafness and Other Communication Disorders, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Substance Abuse and Mental Health Services Administration, United States Department of Health and Human Services (HHS).
Notice of public meeting.
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public meeting on October 1, 2016, to discuss the training requirements for nurse practitioners (NPs) and physician assistants (PAs) that have been stipulated in the Comprehensive Addiction and Recovery Act (CARA). The session will be held in Newark, NJ.
The meeting will be held on October 1, 2016, from 9:00 to 11:00 a.m.
SAMHSA will post additional logistical information on how to participate in person, by phone, or on the Web at:
For additional information concerning the meeting, please contact: Dr. Mitra Ahadpour, Director, Division of Pharmacological Therapies, Center for Substance Abuse Treatment, SAMHSA, (240) 276-2134 or
On July 22, 2016 CARA was signed into law by President Obama. The new law authorizes dispensing privileges of covered medications in office-based settings by NPs and PAs for five years (until October 1, 2021). At this meeting, SAMHSA will be seeking input on how to best implement the requirements that all NPs and PAs must have twenty-four hours of training before obtaining a waiver to prescribe covered medications. The meeting will include the organizations listed in statute and is also open to the public. Specifically, SAMHSA is seeking input on existing training programs that may meet the statutory requirements for training and within the twenty-four hours of training, the number of hours that NPs and PAs should complete on each topic listed in the CARA Act (Pub. L. 114-198).
The agenda will include:
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Saybolt LP as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Saybolt LP has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of June 14, 2016.
The accreditation and approval of Saybolt LP as commercial gauger and laboratory became effective on June 14, 2016. The next triennial inspection date will be scheduled for June 2019.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Saybolt LP, 2610 Federal Highway, Ft. Lauderdale, FL 33316, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Saybolt LP is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
Saybolt LP is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: African Growth and Opportunity Act Certificate of Origin (AGOA). CBP is proposing that this information collection be extended with a change to the burden hours. There is no change to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before October 17, 2016 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Regulations and Rulings, Office of Trade, 90 K Street, NE., 10th Floor, Washington, DC 20229-1177, or via email (
This proposed information collection was previously published in the
For preferential treatment under AGOA, the exporter is required to prepare a certificate of origin and provide it to the importer. The certificate of origin includes information such as contact information for the importer, exporter and producer; the basis for which preferential treatment is claimed; and a description of the imported merchandise. The importers are required to have the certificate in their possession at the time of the claim, and to provide it to Customs and Border Protection (CBP) upon request. The collection of this information is provided for in 19 CFR 10.214, 10.215, and 10.216.
Instructions for complying with this regulation are posted on CBP.gov Web site at:
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of AmSpec Services, LLC, as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that AmSpec Services, LLC, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of February 17, 2016.
The accreditation and approval of AmSpec Services, LLC, as commercial gauger and laboratory became effective on February 17, 2016. The next triennial inspection date will be scheduled for February 2019.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that AmSpec Services, LLC, 1203 East Highway 30, Gonzales, LA 70737, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. AmSpec Services, LLC is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
AmSpec Services, LLC is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Saybolt LP as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Saybolt LP has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of March 16, 2016.
The accreditation and approval of Saybolt LP as commercial gauger and laboratory became effective on March 16, 2016. The next triennial inspection date will be scheduled for March 2019.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Saybolt LP, 1123 Highway 43, Saraland, AL 36571, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Saybolt LP is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of AmSpec Services, LLC, as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that AmSpec Services, LLC, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 6, 2016.
The accreditation and approval of AmSpec Services, LLC, as commercial gauger and laboratory became effective on April 6, 2016. The next triennial inspection date will be scheduled for April 2019.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that AmSpec Services, LLC, 2310 Hwy 69N, Nederland, TX 77627, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. AmSpec Services, LLC is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
AmSpec Services, LLC is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or
Immigration and Customs Enforcement, DHS.
Notice of Federal Advisory Committee meeting.
The U.S. Immigration and Customs Enforcement (ICE) Advisory Committee on Family Residential Centers (ACFRC) will meet in Washington, DC to discuss ACFRC subcommittee reports and vote on potential recommendations. This meeting will be open to the public. Due to limited seating, individuals who wish to attend the meeting in person are required to register online at
The ICE Advisory Committee on Family Residential Centers will meet on Friday, October 7, 2016, from 9:00 a.m. to 5:00 p.m. Please note that these meetings may conclude early if the Committee has completed all business.
The meeting will be held in the Julie Myers Conference Center at ICE Headquarters, 500 12th St. SW., Washington, DC 20536.
For information on facilities, services for individuals with disabilities, or to request special assistance at the meeting, contact Mr. John Amaya, Designated Federal Officer, at
Mr. John Amaya, Designated Federal Officer for the Advisory Committee on Family Residential Centers, at
Notice of this meeting is given under the
Written statements may be submitted to the ACFRC Designated Federal Officer (DFO) (see
The agenda for the Advisory Committee on Family Residential Centers meeting is as follows:
The meeting agenda, Committee tasking, and all meeting documentation will be made available online at:
During public oral comment periods, speakers are requested to limit their comments to 2 minutes. Please note that the public comment period may end before the time indicated, following the last call for comments.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Daniel J. Sullivan, Acting Director, Office of Multifamily Productions, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Daniel J. Sullivan, Acting Director, Office Multifamily Productions, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Collette Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), call the toll-free Title V information line at 800-927-7588 or send an email to
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 12-07, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 or send an email to
For more information regarding particular properties identified in this Notice (
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before October 17, 2016.
•
•
When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Brenda Tapia, 703-358-2104 (telephone); 703-358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
On August 18, 2016, we published a
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: Blue-throated macaw (
The applicant requests renewal of their permit to export and reimport nonliving museum specimens of endangered and threatened species previously accessioned into the applicant's collection for scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Bureau of Indian Affairs, Interior.
Reinstate information collection and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Education is seeking comments and will ask the Office of Management and Budget (OMB) for approval to reinstate the collection of information, Johnson O'Malley Act Requirements, 25 CFR 273, previously authorized by OMB Control Number 1076-0096.
Submit comments on or before November 15, 2016.
You may submit comments on the information collection to Ms. Juanita Mendoza, Program Analyst, Bureau of Indian Education, U.S. Department of the Interior, 1849 C Street NW., MS: #4656 MIB, Washington, DC 20240; or email to:
To request a copy of the information collection request, any explanatory information, and related material, see the contact information provided in the
This information collection was authorized for several years under OMB Control Number 1076-0096. In 2005, the information collection was discontinued. However, the Bureau of Indian Education (BIE) would like to reinstate this collection of information for the reasons described below.
The Johnson O'Malley Act (JOM), 25 U.S.C. 455-457, authorizes the BIE to enter into contracts for the purpose of financially assisting those efforts designed to meet the specialized and unique educational needs of eligible Indian students enrolled in public schools and previously private schools. The JOM programs offered to American Indian and Alaska Native students vary and may include such programs as culture, language, academics, and dropout prevention. These include
The information allows the BIE to obtain the information necessary to determine applicant eligibility, evaluate applicant education plans, and review annual reports submitted by States, school districts, Indian corporations, and Tribal organizations who apply for and enter into contracts for the JOM Program. For purposes of this information collection, only State, school district, Indian corporations, and Tribal organizations are required to submit an application to determine eligibility to receive JOM Program funds. Federally recognized Tribes who wish to participate in the JOM Program are able to apply for funding under the Indian Self-Determination and Education Assistance Act Programs, 25 CFR 900, OMB Control Number 1076-0136.
The regulations at 25 CFR 273, Johnson O'Malley Act, implement the Act. The information collected is subject to the system of records notice “Native American Student Information System, BIA-22” referenced as 73 FR 40605 dated July 15, 2008. The burden hours for this new collection of information are reflected in the Estimated Total Annual Hour Burden in this notice.
The BIE requests your comments on this collection concerning: (a) The necessity of this information collection for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) The accuracy of the agency's estimate of the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (c) Ways we could enhance the quality, utility, and clarity of the information to be collected; and (d) Ways we could minimize the burden of the collection of the information on the respondents.
Please note that an agency may not conduct or sponsor, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number.
It is our policy to make all comments available to the public for review at the location listed in the
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, and the U.S. Department of the Interior, Bureau of Land Management (BLM), the Steens Mountain Advisory Council (SMAC) will meet as indicated below:
Thursday, September 29, 2016 from 9 a.m. to 5 p.m., and Friday, September 30, 2016 from 8:30 a.m. to 2 p.m., at the BLM's Burns District Office, 28910 Hwy 20 W, in Hines, Oregon. Daily sessions may end early if all business items are accomplished ahead of schedule, or go longer if discussions warrant more time.
Tara Thissell, Public Affairs Specialist, BLM Burns District Office, 28910 Highway 20 West, Hines, Oregon 97738, (541) 573-4519, or email
The SMAC was initiated August 14, 2001, pursuant to the Steens Mountain Cooperative Management and Protection Act of 2000 (Pub. L. 106-399). The SMAC provides representative counsel and advice to the BLM regarding new and unique approaches to management of the land within the bounds of the Steens Mountain Cooperative Management and Protection Area, recommends cooperative programs and incentives for landscape management that meet human needs, and advises the BLM on maintenance and improvement of the ecological and economic integrity of the area. Agenda items for the September 29 and 30 session include: Discussions regarding the Steens Mountain No Livestock Grazing Area Fencing and Inholder Access Envionmental Assessments; the Steens Mountain Running Camp Special Recreation Use Permit; and public access in the Pike Creek Canyon Area; updates from the Andrews/Steens Resource Area Field Manager and the Recreation, Wildfire and Wild Horse and Burro Program; and regular business items such as approving the previous meeting's minutes, member round-table, and planning the next meeting's agenda. Any other matters that may reasonably come before the SMAC may also be addressed. Public comment periods are available each day. Unless otherwise approved by the SMAC Chair, the public comment period will last no longer than 30 minutes, and each speaker may address the SMAC for a maximum of five
Bureau of Land Management, Interior.
Notice.
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
A copy of the plats may be obtained from the Public Room at the Bureau of Land Management, Oregon State Office, 1220 SW 3rd Avenue, Portland, Oregon 97204, upon required payment.
Kyle Hensley, (503) 808-6124, Branch of Geographic Sciences, Bureau of Land Management, 1220 SW 3rd Avenue, Portland, Oregon 97204. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
A person or party who wishes to protest against this survey must file a written notice with the Oregon State Director, Bureau of Land Management, stating that they wish to protest. A statement of reasons for a protest may be filed with the notice of protest and must be filed with the Oregon State Director within thirty days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. Before including your address, phone number, email address, or other personally identifying information in your comment, you should be aware that your entire comment—including your personally identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Land Management, Interior.
Notice of realty action.
The Bureau of Land Management (BLM) is processing an application under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA) to convey the undivided mineral interest owned by the United States in 70 acres located in Escambia County, Florida, to the surface owner, Airway Development, LLC. Publication of this notice temporarily segregates the federally owned mineral interests in the land covered by the application from all forms of appropriation under the public land laws, including the mining laws, for up to 2 years while the BLM processes the application.
Interested persons may submit written comments to the BLM at the address listed below. Comments must be received no later than October 31, 2016.
Bureau of Land Management, Eastern States State Office, 20 M Street SE., Suite 950, Washington, DC 20003. Detailed information concerning this action is available for review at this address.
Frankie Morgan, Land Law Examiner, by telephone at 202-912-7738 or by email at
Airway Development, LLC, the surface owner, has applied to purchase federally owned mineral interests located in Escambia County, Florida, described as follows:
The area described contains 70.00 acres.
Under certain conditions, Section 209(b) of FLPMA authorizes conveyance of the federally owned mineral interests in land to the current or prospective surface owner. As required under Section 209(3)(i) of FLPMA, the applicant deposited a sum of money determined sufficient to cover administrative costs including, but not limited to, the cost for the Mineral Potential Report. The objective of Section 209 is to allow consolidation of the surface and mineral interests when either one of the following conditions exist: (1) There are no known mineral values in the land; or (2) where continued Federal ownership of the mineral interests interferes with or precludes appropriate non-mineral development and such development is a more beneficial use of the land than mineral development. Airway Development, LLC, filed an application for the conveyance of federally owned mineral interests in the above-described tract of land. Subject to valid existing rights, on September 16, 2016 the federally owned mineral interests in the lands described above are hereby segregated from all forms of appropriation under the public land laws, including the mining laws, while the application is being processed to determine if either one of the two specified conditions exists and, if so, to otherwise comply with the procedural requirements of 43 CFR part 2720. The segregation shall terminate upon: (1) Issuance of a patent or other document of conveyance as to such mineral interests; (2) final rejection of the application; or (3) on September 17, 2018, whichever occurs first. Please
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made available to the public at any time. While you can ask in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
43 CFR 2720.1-1(b).
National Park Service, Interior.
Notice of meeting.
Notice is hereby given in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), and Part 65 of title 36 of the Code of Federal Regulations, that a meeting of the National Historic Landmarks Committee of the National Park System Advisory Board will be held beginning at 10:00 a.m. on October 18, 2016, at the Charles Sumner School Museum and Archives. The meeting will continue beginning at 9:30 a.m. on October 19, 2016.
The meeting will be held on Tuesday, October 18, 2016, from 10:00 a.m. to 4:30 p.m.; and Wednesday, October 19, 2016, from 9:30 a.m. to 4:30 p.m. (EASTERN).
The Charles Sumner School Museum and Archives, 3rd Floor, The Richard L. Hurlbut Memorial Hall, 1201 17th Street NW., Washington, DC 20036.
Proposed Amendments to Existing Designations:
Patricia Henry, Historian, National Historic Landmarks Program, National Park Service, 1849 C Street NW., Washington, DC 20240, telephone (202) 354-2216, or email:
The purpose of the meeting of the National Historic Landmarks Committee of the National Park System Advisory Board is to evaluate nominations of historic properties in order to advise the National Park System Advisory Board of the qualifications of each property being proposed for National Historic Landmark designation, and to make recommendations regarding the possible designation of those properties as National Historic Landmarks to the National Park System Advisory Board at their meeting on November 17-18, 2016, in Philadelphia, Pennsylvania. The Committee also makes recommendations to the National Park System Advisory Board regarding amendments to existing designations and proposals for withdrawal of designation. The members of the National Historic Landmarks Committee are:
The meeting will be open to the public. Pursuant to 36 CFR part 65, any member of the public may file, for consideration by the National Historic Landmarks Committee of the National Park System Advisory Board, written comments concerning the National Historic Landmarks nominations, amendments to existing designations, or proposals for withdrawal of designation.
Comments should be submitted to J. Paul Loether, Chief, National Historic Landmarks Program and National Register of Historic Places, National Park Service, 1849 C Street NW., Washington, DC 20240, email:
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice.
The Washington State Parks and Recreation Commission [hereafter State Parks], has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the State Parks. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the State Parks at the address in this notice by October 17, 2016.
Alicia Woods, Washington State Parks and Recreation Commission, P.O. Box 42650, Olympia, WA 98504-2650, telephone (360) 902-0939, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the State Parks. The human remains and associated funerary objects were removed from Cama Beach State Park, Island County, WA.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the State Parks professional staff in consultation with representatives of the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation of Washington); and Upper Skagit Indian Tribe.
Between 2004 and 2006, human remains representing, at minimum, three individuals were removed from the Cama Beach Shell Midden Site on Camano Island in Island County, WA. No known individuals were identified. The 483 associated funerary objects are 170 lots of unmodified shell, 1 perforated shell, 124 lots of unmodified bone, 8 modified bone objects, 73 lots of fire modified rock, 13 stone tools, 1 modified wood object, 3 lots of ochre, 42 lots of charcoal, 30 lots of bulk material, 16 historic objects, and 2 lots of botanical material.
Between 2002 and 2006, State Parks contracted Cascadia Archaeology to survey and subsequently perform excavation and data recovery of site 45-IS-2 for the purposes of upgrading sewer and utility lines. Historically the site is a 1930s-1980s fishing and vacation resort with cabins for visitors and housing for owners and management. During excavation and data recovery it was determined the site's prehistoric use was as a seasonal Native American fishing site. During the survey and excavation phases of the project four burials were discovered. The burials were left in-situ and avoided per the request of tribal representatives in consultation with State Parks' staff on-site. The human remains and funerary objects listed in this notice were identified as human in the lab during the analysis phase between 2005 and 2008.
Camano Island is located in Puget Sound between Whidbey Island and mainland Washington State; the Cama Beach Shell Midden site is on the western shores of the island. Saratoga Passage is a waterway between the two islands. Along Saratoga Passage, the shores of both islands are rich in prehistoric Native American seasonal resources sites.
Historical and anthropological sources indicate that the Kikiallus, Swinomish, Lower Skagit and Stillaguamish peoples occupied, and had village sites in, the Penn Cove area of Whidbey Island and on the northwestern shore of Camano Island. The Snohomish people (a predecessor group to, and represented by, the present-day Tulalip Tribes of Washington) had a permanent village at the southernmost end of the island.
Through kinship ties and alliances, and by invitation, the Kikiallus, Upper Skagit, Lower Skagit, Snohomish, Stillaguamish, and Swinomish peoples utilized the waterways, resource grounds, and the beaches of Camano and Whidbey Islands. These peoples shared the same language, and maintained similar economic traditions, social and ceremonial customs, as well as trade and defense alliances.
State Parks staff has determined these human remains and associated funerary objects to be culturally affiliated with the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); the Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); the Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation of Washington); and the Upper Skagit Indian Tribe.
Officials of the Washington State Parks and Recreation Commission have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of, at minimum, three individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 483 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation of Washington); and Upper Skagit Indian Tribe, Washington.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written
The State Parks is responsible for notifying the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); the Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); the Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation of Washington); and the Upper Skagit Indian Tribe that this notice has been published.
National Park Service, Interior.
Notice.
The Tennessee Valley Authority (TVA) has completed an inventory of human remains and associated funerary objects in consultation with the appropriate federally recognized Indian tribes, and has determined that a cultural affiliation between the human remains and associated funerary objects and any present-day federally recognized Indian tribes cannot be reasonably traced. Representatives of any federally recognized Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to TVA. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the federally recognized Indian tribe stated in this notice may proceed.
Representatives of any federally recognized Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to TVA at the address in this notice by October 17, 2016.
Dr. Thomas O. Maher, TVA, 400 West Summit Hill Drive, WT11D, Knoxville TN 37902-1401, telephone (865) 632-7458, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of TVA. The human remains and associated funerary objects were removed from archeological sites in Jackson and Marshall Counties, AL.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains and associated funerary objects was made by TVA professional staff in consultation with the University of Alabama and representatives of the Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Cherokee Nation; Coushatta Tribe of Louisiana; Eastern Band of Cherokee Indians; Eastern Shawnee Tribe of Oklahoma; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); The Chickasaw Nation; The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
The sites listed in this notice were excavated as part of TVA's Guntersville Reservoir project by the Alabama Museum of Natural History (AMNH) at the University of Alabama, using labor and funds provided by the Works Progress Administration. Details regarding these excavations and sites may be found in a report,
From January to April 1939, human remains representing, at minimum, 30 individuals were removed from the Crow Creek Island site, 1JA155, in Jackson County, AL. Excavations commenced after TVA acquired this land on June 30, 1938. Excavations revealed multiple occupations including Middle Woodland (Copena phase), Late Woodland (Flint River phase), and Mississippian (Crow Creek phase). The human remains include adults, juveniles, and infants of both sexes. No known individuals were identified. The 50 associated funerary objects include 48 shell beads, 1 shell ear plug, and 1 ground stone steatite bowl.
From October 1938 to January 1939, human remains representing, at minimum, 44 individuals were removed from the Sublet Ferry site, 1JA102, three miles southeast of Hollywood in Jackson County, AL. Excavation commenced after TVA acquired a permit for archeological exploration on June 11, 1938. This land was subsequently purchased on October 17, 1938. Excavations revealed this to be a shell midden overlying a dark midden soil. Both Woodland and Mississippian occupations were identified. The human remains include adults, juveniles, and children of both sexes. No known individuals were identified. The 27 associated funerary objects include 24 shell barrel beads, 1 Hamilton projectile point, 1 bone pin, and 1 bone awl.
From June 11 to 23, 1938, human remains representing, at minimum, six individuals were removed from the Langston site, 1JA9, in Jackson County, AL. Excavation commenced after TVA had purchased the land encompassing it on December 30, 1936. The site, eight miles southeast of Scottsboro, AL, was composed of a mound (designated 1JA9a) and a village. These brief excavations focused on the low mound. Artifacts from the mound and
From November 21 to 29, 1938, human remains representing, at minimum, two individuals were removed from site 1MS106, 11 miles northeast of the city of Guntersville in Marshall County, AL. Excavation commenced after TVA purchased the land on April 21, 1937. Little is known about this site except a one paragraph reference to the excavation in a progress report which indicates it was a rapid exploration that recovered three burials. Further, ceramics from this site indicate occupations during both the Woodland and Mississippian periods. The culturally unidentifiable human remains are of two adult males. No known individuals were identified. No associated funerary objects are present.
From December 10, 1936, to February 2, 1937, human remains representing, at minimum, four individuals were removed from the Cartright site, 1MS109, 11 miles northeast of the city of Guntersville in Marshall County, AL. Excavation commenced shortly before TVA purchased the land on April 21, 1937. Evidence at the surface indicated that this site was 50 x 60 feet with four underlying strata. Ceramics from this site indicate occupations during both the Woodland and Mississippian periods. The human remains are of one child of indeterminate sex and three adults, two of which are female. No known individuals were identified. No associated funerary objects are present.
From October 25 to December 7, 1938, human remains representing, at minimum, four individuals were removed from the Stephenson site, 1MS111, 11 miles northeast of the city of Guntersville in Marshall County, AL. Excavation commenced after TVA purchased the land on April 21, 1937. Limited excavation in the village area revealed three underlying strata. Steatite stone vessel sherds in the lowest strata indicate a Late Archaic occupation. Further, ceramics from the upper strata of this site indicate occupations during both the Late Woodland and Mississippian periods. The human remains are of one child of indeterminate sex and three adults, two of which are female. No known individuals were identified. No associated funerary objects are present.
From June 1938 to May 1939, human remains representing, at minimum, 261 individuals were removed from the Columbus City Landing site, 1MS91, 9 miles northeast of the city of Guntersville in Marshall County, AL. Excavation commenced after TVA purchased the land on March 8, 1937. There were excavations in both the village (Unit I) and adjacent mounds (Unit II). Artifacts recovered from this excavation revealed that the primary occupations were during the Middle Woodland (A.D. 100-500), Mississippian (A.D. 1200-1500), and historic periods. The human remains include adults, juveniles, children, and infants of both sexes. No known individuals were identified. The 214 associated funerary objects include 7 glass beads; 1 biface; 4 bone bodkins; 3 bone pins; 2 copper bangles; 1 Hilabee Schist celt; 15 pieces of clay (unfired); 4 clay foot rests; 2 clay head rests; 1 copper axe head; 2 copper coil earbobs; 7 copper ear spools; 2 copper reel gorgets; 51 galena nodules; 1 ground hematite; 62 Long Branch Fabric Marked sherds; 1 Mississippi Plain sherd disk fragment; 1 Mud Creek projectile point or knife; 24 Mulberry Creek Plain sherds; 2 projectile points or knives; 1 red ochre; 6 rolled copper tubular beads; 2 shell beads; 2 shell ear bobs; 1 shell gorget; 3 tempered clay samples; 1 wood fragment; 1 shell fragment; 2 unmodified hematite fragments; 1 yellow clay sample and 1 yellow pigment.
TVA determined that cultural affiliation between human remains and associated funerary objects and any present day federally recognized tribes cannot be reasonably traced. Accordingly, these items are culturally unidentifiable and TVA intends to transfer control of these items pursuant to 43 CFR 10.11(c).
At the time of the excavation and removal of these human remains and associated funerary objects, the land from which the remains and objects were removed was not the tribal land of any federally recognized Indian tribe. On March 10, 2016, TVA consulted with all federally recognized Indian tribes who are recognized as aboriginal to the area from which these Native American human remains and associated funerary objects were removed. These tribes are the Cherokee Nation, Eastern Band of Cherokee Indians, and United Keetoowah Band of Cherokee Indians in Oklahoma. None of these Indian tribes agreed to accept control of the human remains and associated funerary objects. After further consultation with the parties that were a part of this overall consultation, TVA has decided to transfer control of the human remains and associated funerary objects to the Alabama-Coushatta Tribe of Texas, the Alabama-Quassarte Tribal Town, the Coushatta Tribe of Louisiana, and the Muscogee (Creek) Nation.
Officials of TVA have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 351 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 313 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and associated funerary objects and any present-day Indian tribe.
• Pursuant to 43 CFR 10.11(c)(1)(i), at the time of excavation of the human remains and associated funerary objects, the land from which the cultural items were removed was not the tribal land of any federally recognized Indian tribe.
• Pursuant to 43 CFR 10.11(c)(1)(ii), the following tribes are aboriginal to the area from which the cultural items were excavated: Cherokee Nation, Eastern Band of Cherokee Indians, and the United Keetoowah Band of Cherokee Indians in Oklahoma. None of these tribes agreed to accept control of the human remains or associated funerary objects.
• Pursuant to 43 CFR 10.11(c)(2)(i), TVA has decided to transfer control of the culturally unidentifiable human remains to the Alabama-Coushatta Tribe of Texas, the Alabama-Quassarte Tribal Town, the Coushatta Tribe of Louisiana, and the Muscogee (Creek) Nation.
• Pursuant to 43 CFR 10.11(c)(4), TVA has decided to transfer control of the culturally unidentifiable associated funerary objects to the Alabama-Coushatta Tribe of Texas, the Alabama-Quassarte Tribal Town, the Coushatta Tribe of Louisiana, and the Muscogee (Creek) Nation.
Representatives of any federally recognized Indian tribe not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Dr. Thomas O. Maher, TVA, 400 West
TVA is responsible for notifying the Alabama-Coushatta Tribe of Texas (previously listed as the Alabama-Coushatta Tribes of Texas); Alabama-Quassarte Tribal Town; Cherokee Nation; Coushatta Tribe of Louisiana; Eastern Band of Cherokee Indians; Eastern Shawnee Tribe of Oklahoma; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); The Chickasaw Nation; The Choctaw Nation of Oklahoma; The Muscogee (Creek) Nation; Thlopthlocco Tribal Town; and the United Keetoowah Band of Cherokee Indians in Oklahoma that this notice has been published.
National Park Service, Interior.
Notice.
The Washington State Parks and Recreation Commission (hereafter State Parks), in consultation with the appropriate Indian tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of sacred objects. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the State Parks. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the State Parks at the address in this notice by October 17, 2016.
Alicia Woods, Washington State Parks and Recreation Commission, P.O. Box 42650, Olympia, WA 98504-2650, telephone (360) 902-0939, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the State Parks that meet the definition of sacred objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
Between 2004 and 2006, six sacred objects were removed from the Cama Beach Shell Midden (45-IS-2) in Island County, WA. State Parks contracted Cascadia Archaeology to perform excavation and data recovery of site 45-IS-2 for the purposes of upgrading sewer and utility lines. Historically the site is a 1930s-1980s fishing and vacation resort, with cabins for visitors and housing for owners and management, most of which still stand. During excavation and data recovery it was determined the site's prehistoric use was as a seasonal Native American fishing site. Both prehistoric and historic material was recovered from the site. Among the material were 3 complete and 3 fragmentary, culturally modified (perforated) Weathervane scallop shells.
According to research, the scallop shells were incorporated into a rattle that would have been one of the cleansing devices used by a dancer in a ceremony of ritual purification during times of change or crisis. The rattles were passed down through families. The rattles are also known to have been used in cleansing ceremonies by shamans. Once identified, the objects remained in Cascadia Archaeology's custody until the overall collection of site material was transferred to the State Parks in 2009.
Camano Island is located in Puget Sound between Whidbey Island and mainland Washington State; the Cama Beach Shell Midden site is on the western shores of the island. Saratoga Passage is a waterway between the two islands. Along Saratoga Passage, the shores of both islands are rich in prehistoric Native American seasonal resources sites.
Historical and anthropological sources indicate that the Kikiallus, Swinomish, Lower Skagit and Stillaguamish peoples occupied and had village sites in the Penn Cove area of Whidbey Island and on the northwestern shore of Camano Island. The Snohomish people (a predecessor group to, and represented by, the Tulalip Tribes of Washington) had a permanent village at the southernmost end of the island.
Through kinship ties and alliances and by invitation the Kikiallus, Upper Skagit, Lower Skagit, Snohomish, Stillaguamish, Snohomish, and Swinomish peoples utilized the waterways, resource grounds, and the beaches of Camano and Whidbey Islands. These peoples shared the same language, and maintained similar economic traditions, social and ceremonial customs, as well as trade and defense alliances.
Based on historical and anthropological sources, State Parks staff has determined these sacred objects are culturally affiliated with the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); the Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); the Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation, Washington); and the Upper Skagit Indian Tribe.
Officials of the State Parks have determined that:
• Pursuant to 25 U.S.C. 3001(3)(C), the 6 cultural items described above are specific ceremonial objects needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the sacred objects and the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); the
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Alicia Woods, Washington State Parks and Recreation Commission, PO Box 42650, Olympia, WA 98504-2650, telephone (360) 902-0939, email
The State Parks is responsible for notifying the Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); the Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); the Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation, Washington); and the Upper Skagit Indian Tribe, that this notice has been published.
National Park Service, Interior.
Meeting notice.
Notice is hereby given in accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 1-16, and part 62 of title 36 of the Code of Federal Regulations that the National Park System Advisory Board will meet November 17-18, 2016, in Philadelphia, Pennsylvania. The agenda will include the review of proposed actions regarding the National Historic Landmarks Program. Interested parties are encouraged to submit written comments and recommendations that will be presented to the Board. Interested parties also may attend the board meeting and upon request may address the Board concerning an area's national significance.
(a) Written comments regarding any proposed National Historic Landmarks matter listed in this notice will be accepted by the National Park Service until November 15, 2016. (b) The Board will meet on November 17-18, 2016.
The meeting will be held in The Liberty View meeting room on the second floor of the Independence Visitor Center, 1 N. Independence Mall W., Philadelphia, Pennsylvania 19106, telephone (215) 965-2300.
(a) For information concerning the National Park System Advisory Board or to request to address the Board, contact Shirley Sears, Office of Policy, National Park Service, MC 0004-Policy, 1849 C Street NW., Washington, DC 20240, telephone (202) 354-3955, email
Matters concerning the National Historic Landmarks Program will be considered by the Board as follows:
NHL Program matters will be considered at the morning session of the business meeting on November 18, during which the Board may consider the following:
The board meeting will be open to the public. The order of the agenda may be changed, if necessary, to accommodate travel schedules or for other reasons. Space and facilities to accommodate the public are limited and attendees will be accommodated on a first-come basis. Anyone may file with the Board a written statement concerning matters to be discussed. The Board also will permit attendees to address the Board, but may restrict the length of the presentations, as necessary to allow the Board to complete its agenda within the allotted time. Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Draft minutes of the meeting will be available for public inspection about 12 weeks after the meeting at the Office of Policy, MC 0004-Policy, 1849 C Street NW., Washington, DC.
National Park Service, Interior.
Meeting notice.
As required by the Federal Advisory Committee Act (16 U.S.C. Appendix 1-16), the National Park Service (NPS) is hereby giving notice that the Lake Clark National Park Subsistence Resource Commission (SRC), Aniakchak National Monument SRC, Wrangell-St. Elias National Park SRC, Cape Krusenstern National Monument SRC, Kobuk Valley National Park SRC, and Gates of the Arctic National Park SRC will hold public meetings to develop and continue work on NPS subsistence program recommendations, and other related regulatory proposals and resource management issues. The NPS SRC program is authorized under Section 808 of the Alaska National Interest Lands Conservation Act (16 U.S.C. 3118), title VIII.
SRC meeting locations and dates may change based on inclement weather or exceptional circumstances. If the meeting dates and locations are changed, the Superintendent will issue a press release and use local newspapers and radio stations to announce the rescheduled meeting.
SRC meetings are open to the public and will have time allocated for public testimony. The public is welcome to present written or oral comments to the SRC. SRC meetings will be recorded and meeting minutes will be available upon request from the Superintendent for public inspection approximately six
60-Day notice.
To comply with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Ocean Energy Management (BOEM) is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements in the regulations under 30 CFR 550, Subparts A,
Submit written comments by November 15, 2016.
Please send your comments on this ICR to the BOEM Information Collection Clearance Officer, Anna Atkinson, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166 (mail); or
Anna Atkinson, Office of Policy, Regulations, and Analysis at 703-787-1025 for a copy of the ICR or the forms.
• BOEM-0127, Sensitive Reservoir Information Report;
• BOEM-0140, Bottomhole Pressure Survey Report;
• BOEM-1123, Designation of Operator; and
• BOEM-1832, Notification of Incident(s) of Noncompliance.
The Independent Offices Appropriations Act (31 U.S.C. 9701), the Omnibus Appropriations Bill (Pub. L. 104-133, 110 Stat. 1321, April 26, 1996), and Office of Management and Budget (OMB) Circular A-25 authorize Federal agencies to recover the full cost of services that confer special benefits. Under the Department of the Interior's (DOI) implementing policy, the Bureau of Ocean Energy Management (BOEM) is required to charge fees for services that provide special benefits or privileges to an identifiable non-Federal recipient above and beyond those that accrue to the public.
This information collection request addresses regulations at 30 CFR 550, Subpart A, General, and Subpart K, Oil and Gas Production Requirements, which deal with regulatory requirements of oil, gas, and sulphur operations on the OCS. This request also covers the related Notices to Lessees and Operators (NTLs) that BOEM issues to clarify and provide guidance on some aspects of our regulations, and forms BOEM-0127, BOEM-0140, BOEM-1123, and BOEM-1832.
The BOEM uses the information collected under the Subparts A and K regulations to ensure that operations in the OCS are carried out in a safe and environmentally sound manner, do not interfere with the rights of other users in the OCS, and balance the protection and development of OCS resources. Specifically, we use the information collected to:
• Determine the capability of a well to produce oil or gas in paying quantities or to determine the possible need for additional wells resulting in minimum royalty status on a lease.
• Provide lessees/operators greater flexibility to comply with regulatory requirements through approval of alternative equipment or procedures and departures if they demonstrate equal or better compliance with the appropriate performance standards.
• Ensure that subsurface storage of natural gas does not unduly interfere with development and production operations under existing leases.
• Determine if an application for right-of-use and easement complies with the OCS Lands Act, other applicable laws, and BOEM regulations; and does not unreasonably interfere with the operations of any other lessee.
• Provide for orderly development or disqualification of leases to determine the appropriateness of lessee/operator performance.
• Approve requests to cancel leases and ascertain if/when the Secretary may cancel leases.
• Ensure the protection of any discovered archaeological resources.
• Form BOEM-0127, Sensitive Reservoir Information Report, is used to regulate production rates from sensitive reservoirs. BOEM engineers and geologists use the information for rate control and reservoir studies. The form requests general information about the reservoir and the company, volumetric
• Form BOEM-0140, Bottomhole Pressure Survey Report, is used to manage reservoirs in our efforts to conserve natural resources, prevent waste, and protect correlative rights, including the Government's royalty interest. Specifically, BOEM uses the information in reservoir evaluations to determine maximum production and efficiency rates and to review applications for downhole commingling to ensure that action does not harm ultimate recovery or undervalued royalties. The form requests information about the well and operator; test data information such as shut-in time, bottomhole temperature, kelly bushing elevation; and bottomhole pressure points that consist of measured depth(s), true vertical depth(s), pressure(s), and pressure gradient(s).
• Form BOEM-1123, Designation of Operator, records the designation of an operator authorized to act on behalf of the lessee/operating rights owner and to fulfill their obligations under the OCS Lands Act and implementing regulations, or to record the local agent empowered to receive notices and comply with regulatory orders issued. This form requires the respondent to submit general information such as lease number, name, address, company number of designated operator, and signature of the authorized lessee. With this renewal, BOEM will add a signature line on the form to allow for the signature of the company designated as the operator. Also, the current instructions for completing form BOEM-1123 apply only to the Gulf of Mexico region. BOEM would like to require the form to be completed in the same way for all regions, so BOEM has deleted all references to the Gulf of Mexico in the instructions.
• Form BOEM-1832, Notification of Incidents of Non-Compliance (INC), is used to determine that respondents have corrected any Incidents of Non-Compliance identified during compliance reviews. The BOEM issues this form to the operator and the operator then corrects the INC(s), signs and returns the form to the BOEM Regional Supervisor.
We will protect proprietary information according to the Freedom of Information Act (5 U.S.C. 552), it's implementing regulations (43 CFR 2), 30 CFR 252, and 30 CFR 550.197, “Data and information to be made available to the public or for limited inspection.” Proprietary information concerning geological and geophysical data will be protected according to 43 U.S.C. 1352. No items of a sensitive nature are collected. Responses are mandatory.
The following table details the individual BOEM components and respective hour burden estimates.
Agencies must also estimate the non-hour cost burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup costs and annual operation, maintenance, and purchase of service costs. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased: (a) Before October 1, 1995; (b) to comply with requirements not associated with the information collection; (c) for reasons other than to provide information or keep records for the Government; or (d) as part of customary and usual business or private practices.
We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB.
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of availability of a final supplemental environmental impact statement.
BOEM is announcing the availability of a Final Supplemental Environmental Impact Statement (SEIS) for Gulf of Mexico (GOM) Outer Continental Shelf (OCS) Central Planning Area (CPA) Oil and Gas Lease Sale 247. The Final SEIS provides a discussion of potential significant impacts of the proposed action, provides an analysis of reasonable alternatives to the proposed action, and identifies the Bureau's preferred alternative.
The Final SEIS is available on the agency Web site at
For more information on the CPA 247 Final SEIS, you may contact Mr. Gary D. Goeke, Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, Office of Environment (GM 623E), 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394 or by email at
This Notice of Availability of a Final Supplemental Environmental Impact Statement is in compliance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4231
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of availability of the Proposed Notice of Sale for Central Planning Area Lease Sale 247.
BOEM announces the availability of the Proposed Notice of Sale (NOS) for the proposed Central Planning Area (CPA) Outer Continental Shelf (OCS) Oil and Gas Lease Sale 247 (CPA Sale 247). This Notice is published pursuant to 30 CFR 556.304(c) as a matter of information to the public. With regard to oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the OCS Lands Act (43 U.S.C. 1331-1356a), provides affected states with the opportunity to review the Proposed NOS. The Proposed NOS sets forth the proposed terms and conditions of the sale, including minimum bids, royalty rates, and rental rates.
Affected states may comment on the size, timing, and location of proposed CPA Sale 247 within 60 days following receipt of the Proposed NOS. The Final NOS will be published in the
David Diamond, Chief, Leasing Division,
The Proposed NOS for CPA 247 and Proposed NOS package containing information essential to potential bidders may be obtained from the Public Information Unit, Gulf of Mexico Region, Bureau of Ocean Energy Management, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394. Telephone: (504) 736-2519. The Proposed NOS and Proposed NOS package are also available on BOEM's Web site at
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of availability of the Record of Decision (ROD).
BOEM is announcing the availability of the ROD that documents BOEM's decision to authorize the use of OCS sand resources by the U.S. Army Corps of Engineers (USACE) Mobile District in the MsCIP Comprehensive Barrier Island Restoration Project (Project) in Hancock, Harrison, and Jackson Counties, Mississippi. The ROD is available at BOEM's Web site at
Terri L. Thomas, Bureau of Ocean Energy Management, Gulf of Mexico Region, Regional Supervisor, Office of Environment, 1201 Elmwood Park Blvd., New Orleans, LA 70123, (504) 736-2963,
In 2009, the USACE Mobile District developed the MsCIP Comprehensive Plan (Plan) and Integrated Programmatic Environmental Impact Statement (2009 PEIS) to support the long-term recovery of Hancock, Harrison, and Jackson Counties, Mississippi from the severe erosion and storm damage caused by Hurricane Katrina and other storm events. The Plan includes a long-term strategy to make the Mississippi coast more resilient to damage from future storms and to compensate for historical navigational dredging and disposal activities that altered sediment availability and sediment transport along the barrier islands. The environmental impacts associated with the dredging of offshore sand resources and the placement of sand along East and West Ship Islands, and Cat Island located in Hancock, Harrison, and Jackson Counties, Mississippi, were evaluated in the MsCIP Comprehensive Barrier Island Restoration, Hancock, Harrison, and Jackson Counties, Mississippi, Final Supplemental Environmental Impact Statement (2016 SEIS), which tiers directly from the 2009 PEIS. The USACE's Mobile District served as the lead agency during the preparation of the 2009 PEIS and 2016 SEIS. BOEM served as a cooperating agency given its jurisdiction over OCS sand resources that were being considered for use in the Project. The borrow option selected by USACE and evaluated in the 2016 SEIS to implement the Plan includes 10 OCS locations with a total volume of 19.6 million cubic yards (MCY) of OCS sand. The USACE signed its own ROD in June 2016 and requested BOEM to authorize use of OCS sand.
BOEM and the USACE will enter into an MOA authorizing the use of up to 19.6 MCY of OCS sand from the identified OCS borrow areas. Under the OCS Lands Act (43 U.S.C. 1337(k)(2)), BOEM can convey, on a noncompetitive basis, the rights to use OCS sand, gravel, or shell resources for use in a program for shore protection, beach restoration, or coastal wetland restoration undertaken by a Federal, state, or local government agency (43 U.S.C. 1337(k)(2)).
As a cooperating agency, BOEM has independently reviewed and adopted the comprehensive analysis presented in the USACE's 2009 PEIS and 2016 SEIS (43 CFR 46.120). The 2009 PEIS and 2016 SEIS assessed the physical, biological, and social/human impacts of
This Notice of Availability is published pursuant to the regulations (40 CFR 1506.6) implementing the provisions of the NEPA of 1969 (42 U.S.C. 4321
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 12, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Aker BioMarine Antarctic AS of Norway and Aker BioMarine Manufacturing, LLC of Houston, Texas. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain krill oil products and krill meal for production of krill oil products by reason of infringement of certain claims of U.S. Patent No. 9,028,877 (“the '877 patent”); U.S. Patent No. 9,078,905 (“the '905 patent”); U.S. Patent No. 9,072,752 (“the '752 patent”); U.S. Patent No. 9,320,765 (“the '765 patent”); and U.S. Patent No. 9,375,453 (“the '453 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order, and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2016).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain krill oil products and krill meal for production of krill oil products by reason of infringement of one or more of claims 1-4, 7-9, 11-13, and 16-18 of the '877 patent; claims 1-4, 6-7, 9-11, 12, and 15-19 of the '905 patent; claims 1, 7, and 11-13 of the '752 patent; claims 1-5, 7, 9-12, 14-15, 19-21, 23, 25-29, 31, 33-36, 38-39, 43-45, and 47 of the '765 patent; and claims 1, 5-10, 12, 14-17, 19-20, 24-26, 28, 30-32, 33-36, 39-43, 46-49, 51-52, 56-58, and 60 of the '453 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainants are:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the
By order of the Commission.
On the basis of the record
The Commission, pursuant to sections 705(b) and 735(b) of the Act (19 U.S.C. 1671d(b) and 19 U.S.C. 1673d(b)), instituted these investigations effective July 28, 2015, following receipt of a petition filed with the Commission and Commerce by AK Steel Corporation (West Chester, Ohio), ArcelorMittal USA LLC (Chicago, Illinois), Nucor Corporation (Charlotte, North Carolina), Steel Dynamics, Inc. (Fort Wayne, Indiana), and United States Steel Corporation (Pittsburgh, Pennsylvania). The final phase of the investigations was scheduled by the Commission following notification of preliminary determinations by Commerce that imports of cold-rolled steel flat products from Brazil, India, Korea, and Russia were subsidized within the meaning of section 703(b) of the Act (19 U.S.C. 1671b(b)) and imports of cold-rolled steel flat products imported from Brazil, India, Korea, Russia, and the United Kingdom were dumped within the meaning of 733(b) of the Act (19 U.S.C. 1673b(b)). Notice of the scheduling of the final phase of the Commission's investigations
The Commission made these determinations pursuant to sections 705(b) and 735(b) of the Act (19 U.S.C. 1671d(b) and 19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations on September 12, 2016. The views of the Commission are contained in USITC Publication 4637 (September 2016), entitled
By order of the Commission.
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, “Securing Financial Obligations Under the Longshore and Harbor Workers' Compensation Act and its Extensions,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before October 17, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the Securing Financial Obligations Under the Longshore and Harbor Workers' Compensation Act (LHWCA) and its Extensions information collection. The LHWCA requires a covered employer to secure the payment of compensation under the Act and its extensions by purchasing insurance from a carrier authorized by the Secretary of Labor to write insurance under the LHWCA, or by becoming an authorized self-insured employer. Each authorized insurance carrier or carrier seeking authorization is required to establish annually that its LHWCA obligations are fully secured through an applicable state guaranty or analogous fund, a deposit of security with the Division of Longshore and Harbor Workers' Compensation (DLHWC), or a combination of both. Similarly, each authorized self-insurer or employer seeking authorization is required fully to secure its LHWCA obligations by depositing security with the DLHWC. These requirements are designed to assure the prompt and continued payment of compensation and other benefits by the responsible carrier or self-insurer to injured workers and their survivors. Forms associated with this information collection [Forms LS-275 IC, Agreement and Undertaking (Insurance Carrier); LS-275 SI, Agreement and Undertaking (Self-Insured Employer); and LS-276, Application for Security Deposit Determination] obtain information used to determine appropriate security deposit amounts and to insure compliance with the security deposit requirements. LHWCA section 32 authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2016. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the Office of Disability Employment Policy (ODEP) sponsored information collection request (ICR) proposal titled, “Disability Employment Initiative Evaluation,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before October 17, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ODEP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-
This ICR seeks PRA authority for the information collection requirements to conduct an evaluation of the Disability Employment Initiative (DEI). The DEI was designed to improve educational, training and employment opportunities and outcomes of youth and adults with disabilities by refining and expanding already identified successful public workforce strategies; improving coordination and collaboration among employment and training and asset development programs implemented at state and local levels; and build effective community partnerships that leverage public and private resources better to serve individuals with disabilities and improve employment outcomes. The study will use two distinct quasi-experimental design study designs to determine the impact of DEI interventions on participant outcomes. Information will be collected through annual site visits, a participant tracking system, and a survey.
This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
The Secretary of Labor is announcing the intent to renew a Federal Advisory Committee. In accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, the Secretary of Labor has determined that the renewal of the Bureau of Labor Statistics Technical Advisory Committee (the “Committee”) is in the public interest in connection with the performance of duties imposed upon the Commissioner of Labor Statistics by 29 U.S.C. 1 and 2. This determination follows consultation with the Committee Management Secretariat, General Services Administration.
The Committee presents advice and makes recommendations to the Bureau of Labor Statistics (BLS) on technical aspects of the collection and formulation of economic measures.
The Committee functions solely as an advisory body to the BLS, on technical topics selected by the BLS. Important aspects of the Committee's responsibilities include, but are not limited to:
a. Provide comments on papers and presentations developed by BLS research and program staff. The comments will address the technical soundness of the research and whether it reflects best practices in the relevant fields.
b. Recommend that BLS conduct research projects to address technical problems with BLS statistics that have been identified in the academic literature.
c. Participate in discussions of areas where the types or coverage of economic statistics could be expanded or improved and areas where statistics are no longer relevant.
The Committee reports to the Commissioner of Labor Statistics, Bureau of Labor Statistics, U.S. Department of Labor.
The Committee consists of approximately sixteen members who serve as Special Government Employees. Members are appointed by the BLS and are approved by the Secretary of Labor. Committee members are economists, statisticians, and behavioral scientists and are chosen to achieve a balanced membership across those disciplines. They are prominent experts in their fields and recognized for their professional achievements and objectivity.
The Committee will function solely as an advisory body, in compliance with the provisions of the Federal Advisory Committee Act. The Charter will be filed under the Federal Advisory Committee Act.
Lisa Fieldhouse, Office of the Commissioner, Bureau of Labor Statistics, telephone: 202-691-5025, email:
The Legal Services Corporation's Board of Directors will
John N. Erlenborn Conference Room, Legal Services Corporation Headquarters, 3333 K Street NW., Washington, DC 20007.
Members of the public who are unable to attend in person but wish to listen to the public proceedings may do so by following the telephone call-in directions provided below.
• Call toll-free number: 1-866-451-4981;
• When prompted, enter the following numeric pass code: 5907707348
• When connected to the call, please immediately “MUTE” your telephone.
Members of the public are asked to keep their telephones muted to eliminate background noises. To avoid disrupting the meeting, please refrain from placing the call on hold if doing so will trigger recorded music or other sound. From time to time, the Chair may solicit comments from the public.
Open.
Katherine Ward, Executive Assistant to the Vice President & General Counsel, at (202) 295-1500. Questions may be sent by electronic mail to
LSC complies with the Americans with Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to accommodate individuals with disabilities. Individuals needing other accommodations due to disability in order to attend the meeting in person or telephonically should contact Katherine Ward, at (202) 295-1500 or
National Science Foundation.
Notice and Request for Comments.
The National Science Foundation (NSF) is announcing plans to request renewal of the Survey of Earned Doctorates (OMB No. 3145-0019). In accordance with the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting that OMB approve clearance of this collection for three years.
Written comments on this notice must be received by November 14, 2016, to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Contact Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 1265, Arlington, Virginia 22230; telephone (703) 292-7556; or send email to
1.
The SED has been conducted annually since 1958 and is jointly sponsored by the National Science Foundation, National Institutes of Health, U.S. Department of Education, and National Endowment for the Humanities in order to avoid duplication. It is an accurate, timely source of information on one of our Nation's most important resources—highly educated individuals. Data are obtained via Web survey or paper questionnaire from each person earning a research doctorate at the time they receive the degree. Data are collected on their field of specialty, educational background, sources of support in graduate school, debt level, postgraduation plans, and demographic characteristics.
The Federal government, universities, researchers, and others use the information extensively. The National Science Foundation, as the lead agency, publishes statistics from the survey in several reports, but primarily in the annual publication series
The survey will be collected in conformance with the Privacy Act of 1974. Responses from individuals are voluntary. NSF will ensure that all individually identifiable information
2.
3.
4.
Based on the average Web survey completion time for the 2017 SED (19 minutes) and the extension of a few questions to an additional subset of respondents, NSF estimates that, on average, 21 minutes per respondent will be required to complete the 2018 or 2019 SED questionnaire. The annual respondent burden for completing the SED is therefore estimated at 18,270 hours in 2018 (52,200 respondents × 21 minutes) and 18,585 hours in 2019 (based on 53,100 respondents).
In addition to the actual questionnaire, the SED requires the collection of administrative data from participating academic institutions. The Institutional Coordinator at the institution helps distribute the Web survey link (and paper surveys when necessary), track survey completions, and submit information to the SED survey contractor. Based on focus groups conducted with Institutional Coordinators, it is estimated that the SED demands no more than 1% of the Institutional Coordinator's time over the course of a year, which computes to 20 hours per year per Institutional Coordinator (40 hours per week × 50 weeks per year × .01). With about 580 programs expected to participate in the SED in 2018 and 2019, the estimated annual burden to Institutional Coordinators of administering the SED is 11,600 hours.
Therefore, the total annual information burden for the SED is estimated to be 29,870 hours in 2018 (18,270 + 11,600) and 30,185 hours in 2019 (18,585 + 11,600). This is higher than the last annual estimate approved by OMB due to the increased number of respondents (doctorate recipients) and the increased number of survey questions being asked of each respondent.
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13)
Nuclear Regulatory Commission.
10 CFR 2.206 request; receipt.
The U.S. Nuclear Regulatory Commission (NRC) is giving notice that by petition dated June 30, 2016, Mr. David A. Lochbaum of the Union of Concerned Scientists (the petitioner) requested that the NRC take action with regard to Indian Point Nuclear Generating Unit Nos. 2 and 3. The petitioner's requests are included in the
Please refer to Docket ID NRC-2016-0197 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
On June 30, 2016, the petitioner requested that the NRC take action with regard to Indian Point Nuclear Generating Unit Nos. 2 and 3 (ADAMS Accession No. ML16187A186). The petitioner requested that the NRC take the following enforcement actions:
1. Issue an Order requiring the Indian Point licensee to inspect the reactor vessel baffle-former bolts and to install the downflow to upflow modification on Unit 2 during its next refueling outage;
2. Issue a Demand for Information requiring the Indian Point licensee to submit an operability determination to the agency regarding continued operation of Unit 3 until its reactor vessel baffle-former bolts can be inspected per Material Reliability Project-227-A; and
3. Issue a Demand for Information requiring the Indian Point licensee to submit an evaluation of the performance, role and operating experience of the metal impact monitoring system in detecting and responding to indications of loose parts (such as broken baffle bolts) within the reactor coolant system.
As the basis for this request, the petitioner cited Licensee Event Report 2016-004-00 “Unanalyzed Condition due to Degraded Reactor Baffle-Former Bolts,” submitted by the licensee on May 31, 2016 (ADAMS Accession No. ML16159A219) that describes an event where there was an unanalyzed condition due to degraded reactor vessel baffle-former bolts at Indian Point Unit 2, which is reportable under § 50.73(a)(2)(ii)(B) of title 10 of the
The request is being treated pursuant to Section 2.206 of Title 10 of the
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management.
60-Day Notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) 3206-0208, Representative Payee Survey. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
Comments are encouraged and will be accepted until November 15, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the U.S. Office of Personnel Management, Retirement Services, 1900 E Street NW., Room 2347E, Washington, DC 20415, Attention: Alberta Butler, or sent by email to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW., Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent by email to
The Representative Payee Survey is used to collect information about how the benefits paid to a representative payee have been used or conserved for the benefit of the incompetent annuitant. The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility;
2. Evaluate the accuracy of OPM's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 67—Equities to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On August 25, 2014, NYSE MKT, and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Appendix C.II requires the Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On March 29, 2016, NYSE MKT filed with the Commission a proposed rule change to adopt NYSE MKT Rule 67(b)—Equities to implement the data collection requirements of the Plan.
NYSE MKT also submitted a proposed rule change to implement the quoting and trading requirements of the Plan.
NYSE MKT now proposes to further amend Rule 67—Equities to modify additional data collection and reporting requirements. First, Appendix B.I.a(21) through B.I.a(27) currently requires that Trading Centers report the cumulative number of shares of cancelled orders during a specified duration of time after receipt of the order that was cancelled. NYSE MKT and the other Participants believe that, for purposes of reporting cancelled orders, it is appropriate to categorize unexecuted Immediate or Cancel orders separately as one bucket irrespective of the duration of time after order receipt,
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. NYSE MKT and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. NYSE MKT therefore proposes to amend Supplementary Material .50 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and NYSE MKT and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). NYSE MKT and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” NYSE MKT, therefore, proposes to amend Supplementary Material .50 to make this change.
In the fourth change, NYSE MKT proposes to add new Supplementary Material .100 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. NYSE MKT and the other Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. NYSE MKT is therefore proposing this change as part of Supplementary Material .100. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. NYSE MKT and the other Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and NYSE MKT is therefore proposing this change as part of Supplementary Material .100.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the-quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the National Best Bid or National Best Offer (NBBO) at the time of or immediately before the trade for both share and trade participation calculations. NYSE MKT and the other Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the NBBO in effect immediately prior to the trade. NYSE MKT therefore proposes to make this change as part of Supplementary Material .100.
Finally, NYSE MKT proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Supplementary Material .90 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. NYSE MKT and the other Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. Accordingly, NYSE MKT is revising Supplementary Material .90 to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
As noted in Item 2 of this filing, NYSE MKT has filed the proposed rule change for immediate effectiveness. NYSE MKT has requested that the SEC waive the 30-day operative period so that the proposed rule change can become operative on August 30, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
NYSE MKT believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist NYSE MKT in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. NYSE MKT believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
NYSE MKT notes that the proposed rule change implements the provisions of the Plan, and is designed to assist NYSE MKT in meeting its regulatory obligations pursuant to the Plan. NYSE MKT also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will only affect how NYSE MKT and Participants that operate Trading Centers collect and report data. NYSE MKT notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected members otherwise would have been required to collect data pursuant to the Plan and NYSE MKT Rule 67—Equities. In addition, the proposed rule change applies equally to all similarly situated members. Therefore, NYSE MKT does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30 day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30 day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NYSEMKT-2016-84 and should be submitted on or before October 7, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 4770 to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On August 25, 2014, Nasdaq and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Appendix C.II requires the Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On December 9, 2015, FINRA, on behalf of the Plan Participants, submitted an exemptive request to the Commission, seeking an exemption from certain data collection and reporting requirements set forth in the Plan.
The Exchange now proposes to further amend Rule 4770 to modify additional data collection and reporting requirements.
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. The Exchange and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. The Exchange therefore proposes to amend Commentary .06 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and the Exchange and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). The Exchange and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” The Exchange, therefore, proposes to amend Commentary .06 to make this change.
In the fourth change, the Exchange proposes to add new Commentary .09 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. The Exchange and the other Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. The Exchange is therefore proposing this change as part of Commentary .09. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. The Exchange and the other Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and the Exchange is therefore proposing this change as part of Commentary .09.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the NBBO at the time of or immediately before the trade for both share and trade participation calculations. The Exchange and the other Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the
Finally, the Exchange proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Commentary .10 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Exchange and the other Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. Accordingly, the Exchange is revising Commentary .10 (which will be re-numbered as Commentary .11) to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will not affect the data collection and reporting requirements for members that operate Trading Centers; the proposed changes will only affect how the Exchange and Participants that operate Trading Centers collect and report data. The Exchange notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected members otherwise would have been required to collect data pursuant to the Plan and Rule 4770. In addition, the proposed rule change applies equally to all similarly situated members. Therefore, the Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.46 to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On August 25, 2014, NYSE Arca, and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Appendix C.II requires the Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On March 29, 2016, NYSE Arca filed with the Commission a proposed rule change to adopt NYSE Arca Rule 7.46(b) to implement the data collection requirements of the Plan.
NYSE Arca also submitted a proposed rule change to implement the quoting and trading requirements of the Plan.
NYSE Arca now proposes to further amend Rule 7.46 to modify additional data collection and reporting requirements. First, Appendix B.I.a(21) through B.I.a(27) currently requires that Trading Centers report the cumulative number of shares of cancelled orders during a specified duration of time after receipt of the order that was cancelled. NYSE Arca and the other Participants believe that, for purposes of reporting cancelled orders, it is appropriate to categorize unexecuted Immediate or Cancel orders separately as one bucket irrespective of the duration of time after order receipt,
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. NYSE Arca and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. NYSE Arca therefore proposes to amend Supplementary Material .50 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and NYSE Arca and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). NYSE Arca and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” NYSE Arca, therefore, proposes to amend Supplementary Material .50 to make this change.
In the fourth change, NYSE Arca proposes to add new Supplementary Material .100 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the-quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the National Best Bid or National Best Offer (NBBO) at the time of or immediately before the trade for both share and trade participation calculations. NYSE Arca and the other Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the NBBO in effect immediately prior to the trade. NYSE Arca therefore proposes to make this change as part of Supplementary Material .100.
Finally, NYSE Arca proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Supplementary Material .90 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. NYSE Arca the other Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. According, NYSE Arca is revising Supplementary Material .90 to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
As noted in Item 2 of this filing, NYSE Arca has filed the proposed rule change for immediate effectiveness. NYSE Arca has requested that the SEC waive the 30-day operative period so that the proposed rule change can become operative on August 30, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
NYSE Arca believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist NYSE Arca in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. NYSE Arca believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
NYSE Arca notes that the proposed rule change implements the provisions of the Plan, and is designed to assist NYSE Arca in meeting its regulatory obligations pursuant to the Plan. NYSE Arca also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will only affect how NYSE Arca and Participants that operate Trading Centers collect and report data. NYSE Arca notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected ETP Holders otherwise would have been required to collect data pursuant to the Plan and NYSE Arca Rule 7.46. In addition, the proposed rule change applies equally to all similarly situated ETP Holders. Therefore, NYSE Arca does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30 day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30 day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
CHX proposes to amend Article 20, Rule 13(b) to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program.
CHX has designated this proposed rule change as non-controversial pursuant to Section 19(b)(3)(A)
The text of this proposed rule change is available on the Exchange's Web site at (
In its filing with the Commission, the CHX included statements concerning the purpose of and basis for the proposed rule changes and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The CHX has prepared summaries, set forth
On August 25, 2014, the Exchange, and several other self-regulatory organizations (the “Plan Participants”
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small-capitalization companies. Each Plan Participant is required to comply, and to enforce compliance by its members, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Plan Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Plan Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Plan Participant. Appendix C.I requires a Plan Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA. Appendix C.II requires the Plan Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On March 28, 2016, the Exchange filed with the Commission a proposed rule change to adopt Article 20, Rule 13(b) to implement the data collection requirements of the Plan, which was immediately effective upon filing.
The Exchange also submitted a proposed rule change to implement the quoting and trading requirements of the Plan.
The Exchange now proposes to further amend Article 20, Rule 13(b) to modify additional data collection and reporting requirements.
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. The Exchange and the other Plan Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. The Exchange therefore proposes to amend Interpretations and Policies paragraph .06 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and the Exchange and the other Plan Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). The Exchange and the other Plan Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” The Exchange, therefore, proposes to amend Interpretations and Policies paragraph .06 to make this change.
In the fourth change, the Exchange proposes to add new Interpretations and Policies paragraph .09 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. The Exchange and the other Plan Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. The Exchange is therefore proposing this change as part of Interpretations and Policies paragraph .09. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. The Exchange and the other Plan Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and the Exchange is therefore proposing this change as part of Interpretations and Policies paragraph .09.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the-quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the National Best Bid or National Best Offer (NBBO) at the time of or immediately before the trade for both share and trade participation calculations. The Exchange and the other Plan Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the NBBO in effect immediately prior to the trade. The Exchange therefore proposes to make this change as part of Interpretations and Policies paragraph .09.
Finally, the Exchange proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Interpretations and Policies paragraph .10 provides that Pre-Pilot Data Collection Securities are the securities designated by the Plan Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Exchange and the other Plan Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. According, the Exchange is revising Interpretations and Policies paragraph .10 (which will be re-numbered as Interpretations and Policies paragraph .11) to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
The Exchange has filed the proposed rule change for immediate effectiveness. The Exchange has requested that the SEC waive the 30-day operative period so that the proposed rule change can become operative on August 30, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will not affect the data collection and reporting requirements for CHX Participants that operate Trading Centers; the proposed changes will only affect how the Exchange and Plan Participants that operate Trading Centers collect and report data. The Exchange notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected CHX Participants otherwise would have been required to collect data pursuant to the Plan and Article 20, Rule 13(b). In addition, the proposed rule change applies equally to all similarly situated CHX Participants. Therefore, the Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Robert W. Errett, Deputy Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 67 to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
On August 25, 2014, NYSE, and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On March 25, 2016, NYSE filed with the Commission a proposed rule change to adopt NYSE Rule 67(b) to implement the data collection requirements of the Plan.
NYSE also submitted a proposed rule change to implement the quoting and trading requirements of the Plan.
NYSE now proposes to further amend Rule 67 to modify additional data collection and reporting requirements. First, Appendix B.I.a(21) through B.I.a(27) currently requires that Trading Centers report the cumulative number of shares of cancelled orders during a specified duration of time after receipt of the order that was cancelled. NYSE and the other Participants believe that, for purposes of reporting cancelled orders, it is appropriate to categorize unexecuted Immediate or Cancel orders separately as one bucket irrespective of the duration of time after order receipt,
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. NYSE and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. NYSE therefore proposes to amend Supplementary Material .50 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and NYSE and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). NYSE and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” NYSE, therefore, proposes to amend Supplementary Material .50 to make this change.
In the fourth change, NYSE proposes to add new Supplementary Material .100 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. NYSE and the other Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. NYSE is therefore proposing this change as part of Supplementary Material .100. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. NYSE and the other Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and NYSE is therefore proposing this change as part of Supplementary Material .100.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the-quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the National Best Bid or National Best Offer (NBBO) at the time of or immediately before the trade for both share and trade participation calculations. NYSE and the other Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the NBBO in effect immediately prior to the trade. NYSE therefore proposes to make this change as part of Supplementary Material .100.
Finally, NYSE proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Supplementary Material .90 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. NYSE and the other Participants believe that it is appropriate to use the Pilot
As noted in Item 2 of this filing, NYSE has filed the proposed rule change for immediate effectiveness. NYSE has requested that the SEC waive the 30-day operative period so that the proposed rule change can become operative on August 30, 2016.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
NYSE believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist NYSE in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. NYSE believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
NYSE notes that the proposed rule change implements the provisions of the Plan, and is designed to assist NYSE in meeting its regulatory obligations pursuant to the Plan. NYSE also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will only affect how NYSE and Participants that operate Trading Centers collect and report data. NYSE notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected members otherwise would have been required to collect data pursuant to the Plan and NYSE Rule 67. In addition, the proposed rule change applies equally to all similarly situated members. Therefore, NYSE does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 4770 to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On August 25, 2014, BX and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA.
Appendix C.II requires the Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On December 9, 2015, FINRA, on behalf of the Plan Participants, submitted an exemptive request to the Commission, seeking an exemption from certain data collection and reporting requirements set forth in the Plan.
The Exchange now proposes to further amend Rule 4770 to modify additional data collection and reporting requirements.
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. The Exchange and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. The Exchange therefore proposes to amend Commentary .06 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and the Exchange and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). The Exchange and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” The Exchange, therefore, proposes to amend Commentary .06 to make this change.
In the fourth change, the Exchange proposes to add new Commentary .09 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. The Exchange and the other Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. The Exchange is therefore proposing this change as part of Commentary .09. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. The Exchange and the other Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and the Exchange is therefore proposing this change as part of Commentary .09.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix
Finally, the Exchange proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Commentary .10 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Exchange and the other Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. Accordingly, the Exchange is revising Commentary .10 (which will be re-numbered as Commentary .11) to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act because the proposal implements and clarifies the requirements of the Plan.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will not affect the data collection and reporting requirements for members that operate Trading Centers; the proposed changes will only affect how the Exchange and Participants that operate Trading Centers collect and report data. The Exchange notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected members otherwise would have been required to collect data pursuant to the Plan and Rule 4770. In addition, the proposed rule change applies equally to all similarly situated members. Therefore, the Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The principal purpose of the proposed rule change is to revise the ICC Rulebook (the “Rules”) to provide for the clearance of additional Standard Emerging Market Sovereign CDS contracts (collectively, “EM Contracts”), 2003 ISDA Definitions of Standard Western European Sovereign CDS contracts (collectively, “SWES Contracts”), and an additional Asia/Pacific Sovereign CDS contract (the “Asia/Pacific Contract”).
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
The purpose of the proposed rule change is to adopt rules that will provide the basis for ICC to clear additional credit default swap contracts. ICC believes the addition of these contracts will benefit the market for credit default swaps by providing market participants the benefits of clearing, including reduction in counterparty risk and safeguarding of margin assets pursuant to clearing house rules.
ICC proposes amending subchapter 26D of its Rules to provide for the clearance of additional EM Contracts, specifically the Republic of Panama, Abu Dhabi, Dubai, the State of Israel and the State of Qatar. ICC plans to offer these additional EM Contracts on the 2003 and 2014 ISDA Credit Derivatives Definitions.
These additional EM Contracts have terms consistent with the other EM Contracts approved for clearing at ICC and governed by subchapter 26D of the Rules. Minor revisions to Subchapter 26D (Standard Emerging Market Sovereign (“SES”) Single Name) are made to provide for clearing the additional EM Contracts. Specifically, in Rule 26D-102 (Definitions), “Eligible SES Reference Entities” is modified to include the Republic of Panama, Abu Dhabi, Dubai, the State of Israel and the State of Qatar in the list of specific Eligible SES Reference Entities to be cleared by ICC.
Additionally, ICC proposes amending subchapter 26I of its Rules to provide for the clearance of 2003 ISDA Definitions of SWES Contracts. ICC currently clears the 2014 ISDA Definitions of ten SWES Contracts,
Minor revisions to subchapter 26I (Standard Western European (“SWES”) Single Name) are made to provide for clearing the 2003 ISDA Definitions of SWES Contracts. Specifically, in Rule 26I-102 (Definitions), the definitions of “Eligible SWES Reference Obligations”, “List of Eligible SWES Reference Entities” and “SWES Contract Reference Obligations” are updated to distinguish between the 2003- and 2014-Type CDS Contracts, and the corresponding Applicable Credit Derivatives Definitions.
Rule 26I-315 (Terms of the Cleared SWES Contract) is revised to provide reference to provisions of the proper ISDA Definitions, and corresponding changes to provision numbering are made as necessary. Rule 26I-315(h) is revised to refer to the Applicable Credit Derivatives Definitions and eligible Seniority Level, as appropriate.
Defined terms in Rule 26I-316 (Physical Settlement Matrix Updates) are updated to refer specifically to SWES contracts. Rule 26I-616 (Contract Modification) is revised to note that it shall not constitute a Contract Modification if the Board (or its designee) updates the List of Eligible SWES Reference Entities (and modifies the terms and conditions of related SWES Contracts) to give effect to determinations of Succession Events.
Finally, ICC proposes amending subchapter 26L of its rules to provide for the clearance of an additional Asia/Pacific Contract, namely the Kingdom of Thailand. ICC plans to offer this contract on the 2003 and 2014 ISDA Credit Derivatives Definitions.
The additional Asia/Pacific Contract has terms consistent with the other Asia/Pacific Contracts approved for clearing at ICC and governed by subchapter 26L of the Rules. Minor revisions to subchapter 26L (Asia/Pacific Sovereign (“SAS”) Single Name) are made to provide for clearing the additional Asia/Pacific Contract. Specifically, in Rule 26L-102 (Definitions), “Eligible SAS Reference Entities” is modified to include the Kingdom of Thailand in the list of specific Eligible SAS Reference Entities to be cleared by ICC.
Section 17A(b)(3)(F) of the Act
Clearing of the additional EM Contracts, Asia/Pacific Contract and 2003 ISDA Definitions of SWES Contracts will also satisfy the requirements of Rule 17Ad-22.
The additional EM Contracts, Asia/Pacific Contract and 2003 ISDA Definitions of SWES Contracts will be available to all ICC participants for clearing. The clearing of these additional EM Contracts, Asia/Pacific Contract and 2003 ISDA Definitions of SWES Contracts by ICC does not preclude the offering of the additional EM Contracts, Asia/Pacific Contract and 2003 ISDA Definitions of SWES Contracts for clearing by other market participants. Accordingly, ICC does not believe that clearance of the additional EM Contracts, Asia/Pacific Contract and 2003 ISDA Definitions of SWES Contracts will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2016-012 and should be submitted on or before October 7, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 3317 to modify certain data collection requirements of the Regulation NMS Plan to Implement a Tick Size Pilot Program.
The Exchange requests that the Commission waive the 30-day operative delay period contained in Exchange Act Rule 19b-4(f)(6)(iii).
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On August 25, 2014, Phlx and several other self-regulatory organizations (the “Participants”) filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stock of small-capitalization companies. Each Participant is required to comply, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
The Plan provides for the creation of a group of Pilot Securities, which shall be placed in a control group and three separate test groups, with each subject to varying quoting and trading increments. Pilot Securities in the control group will be quoted at the current tick size increment of $0.01 per share and will trade at the currently permitted increments. Pilot Securities in the first test group will be quoted in $0.05 minimum increments but will continue to trade at any price increment that is currently permitted.
The Plan also requires a Trading Center
With respect to Market Makers, Appendix B.III requires a Participant that is a national securities exchange to collect daily Market Maker Registration statistics. Appendix B.IV requires a Participant to collect data related to Market Maker participation with respect to each Market Maker engaging in trading activity on a Trading Center operated by the Participant. Appendix C.I requires a Participant to collect data related to Market Maker profitability from each Market Maker for which it is the DEA.
Appendix C.II requires the Participant, as DEA, to aggregate the Appendix C.I data, and to transmit this data to the Commission.
The Commission approved the Pilot on a two-year basis, with implementation to begin no later than May 6, 2016.
On December 9, 2015, FINRA, on behalf of the Plan Participants, submitted an exemptive request to the Commission, seeking an exemption from certain data collection and reporting requirements set forth in the Plan.
The Exchange now proposes to further amend Rule 3317 to modify additional data collection and reporting requirements.
The second change relates to the reporting of daily market quality statistics pursuant to Appendix B.I. Currently, Appendix B.I sets forth categories of orders, including market orders, marketable limit orders, and inside-the-quote resting limit orders, for which daily market quality statistics must be reported. The Exchange and the other Participants have determined that it is appropriate to include an order type for limit orders priced more than $0.10 away from the NBBO for purposes of Appendix B reporting. The Exchange therefore proposes to amend Commentary .06 to provide that limit orders priced more than $0.10 away from the NBBO shall be included as an order type for purposes of Appendix B reporting, and shall be assigned the number (22). These orders are not currently required to be reported pursuant to Appendix B, and the Exchange and the other Participants believe that requiring the reporting of such orders will produce a more comprehensive data set.
The third change relates to the reporting of market quality statistics pursuant to Appendix B.I for a variety of order types, including inside-the-quote resting limit orders (12), at-the-quote resting limit orders (13), and near-the-quote resting limit orders (within $0.10 of the NBBO) (14). The Exchange and the other Participants believe that it is appropriate to require Trading Centers to report all orders that fall within these categories, and not just those orders that are “resting.” The Exchange, therefore, proposes to amend Commentary .06 to make this change.
In the fourth change, the Exchange proposes to add new Commentary .09 to modify the manner in which market maker participation statistics are calculated. Currently, Appendix B.IV provides that market maker participation statistics shall be calculated based on share participation, trade participation, cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation, and outside-the-quote share (trade) participation. The Exchange and the other Participants have determined that it is appropriate to add the count of the number of Market Makers used in the calculation of share (trade) participation to each category. The Exchange is therefore proposing this change as part of Commentary .09. In addition, Appendix B.IV(b) and (c) currently require that, when aggregating across Market Makers, share participation and trade participation shall be calculated using the share-weighted average and trade-weighted average, respectively. The Exchange and the other Participants believe that it is more appropriate to calculate share and trade participation by providing the total count of shares or trades, as applicable, rather than weighted averages, and the Exchange is therefore proposing this change as part of Commentary .09.
The fifth change relates to the NBBO that a Trading Center is required to use when performing certain quote-related calculations. When calculating cross-quote share (trade) participation pursuant to Appendix B.IV(d) and inside-the-quote share (trade) participation pursuant to Appendix B.IV(e), the Plan requires the Trading Center to utilize the NBBO at the time of the trade for both share and trade participation calculations. When calculating at-the-quote share (trade) participation and outside-the quote share (trade) participation pursuant to Appendix B.IV(f) and (g), the Plan allows the Trading Center to utilize the NBBO at the time of or immediately before the trade for both share and trade participation calculations. The Exchange and the other Participants believe that it is appropriate to calculate all quote participation (cross-quote share (trade) participation, inside-the-quote share (trade) participation, at-the-quote share (trade) participation and outside-the-quote share (trade) participation) solely by reference to the NBBO in effect immediately prior to the trade. The Exchange, therefore, proposes to make this change as part of Commentary .09.
Finally, the Exchange proposes to change the end date until which the Pre-Pilot Data Collection Securities shall be used to fulfill the Plan's data collection requirements. Currently, Commentary .10 provides that Pre-Pilot Data Collection Securities are the securities designated by the Participants for purposes of the data collection requirements described in Items I, II and IV of Appendix B and Item I of Appendix C to the Plan for the period beginning six months prior to the Pilot Period and ending on the trading day immediately preceding the Pilot Period. The Exchange and the other Participants believe that it is appropriate to use the Pilot Securities to satisfy the Plan's data collection requirements prior to the commencement of the Pilot. Accordingly, the Exchange is revising Commentary .10 (which will be re-numbered as Commentary .11) to provide that the Pre-Pilot Data Collection Securities shall be used to satisfy the Plan's data collection requirements through thirty-one days prior to the Pilot Period, after which time the Pilot Securities shall be used for purposes of the data collection requirements.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that this proposal is consistent with the Act because it implements and clarifies the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Pilot was an appropriate, data-driven test that was designed to evaluate the impact of a wider tick size on trading, liquidity, and the market quality of securities of smaller capitalization companies, and was therefore in furtherance of the purposes of the Act. The Exchange believes that this proposal is in furtherance of the objectives of the Plan, as identified by
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements the provisions of the Plan, and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that, other than the change to require use of the Pilot Securities beginning thirty days prior to the beginning of the Pilot Period, the proposed changes will not affect the data collection and reporting requirements for members that operate Trading Centers; the proposed changes will only affect how the Exchange and Participants that operate Trading Centers collect and report data. The Exchange notes that, with respect to the change to require the use of the Pilot Securities beginning thirty days prior to the start of the Pilot Period, the proposed change reduces the number of securities on which affected members otherwise would have been required to collect data pursuant to the Plan and Rule 3317. In addition, the proposed rule change applies equally to all similarly situated members. Therefore, the Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to implement the proposed rules immediately thereby preventing delays in the implementation of the Plan. The Commission notes that the Plan is scheduled to start on October 3, 2016. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change to be operative upon filing with the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Indiana dated 09/08/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
Carroll, Cass, Clinton, Grant, Miami, Tipton
The Interest Rates are:
The number assigned to this disaster for physical damage is 14849 C and for economic injury is 14850 0.
The State which received an EIDL Declaration # is Indiana.
Notice is hereby given that Avante Mezzanine Partners SBIC II, L.P., 11150 Santa Monica Boulevard, Suite 1470, Los Angeles, CA 90025, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Avante Mezzanine Partners SBIC II, L.P. proposes to provide debt and equity financings to Learner's Edge LLC, 10523 165th Street West, Lakeville, MN 55044.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Avante Mezzanine Partners SBIC, L.P and Avante Mezzanine Partners SBIC II, L.P. are Associates. Avante Mezzanine Partners SBIC, L.P owns more than 10 percent of Learner's Edge LLC and therefore this transaction is considered
Notice is hereby given that any interested person may submit written comments on this transaction within fifteen days of the date of this publication to the Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW., Washington, DC 20416.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than November 15, 2016. Individuals can obtain copies of the collection instruments by writing to the above email address.
Type of Request: Revision of an OMB-approved information collection.
2.
Type of Request: Revision of an OMB-approved information collection.
II. SSA submitted the information collection below to OMB for clearance. Your comments regarding the information collection would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than October 17, 2016. Individuals can obtain copies of the OMB clearance package by writing to
Type of Request: Revision of an OMB-approved information collection.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice of request for emergency OMB approval and public comment.
The Department of State has submitted the information collection request described below to the Office of Management and Budget (OMB) for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995 (5 CFR 1320.13). The purpose of this notice is to allow for public comment from all interested individuals and organizations. Emergency review and approval of this collection has been requested from OMB by September 30, 2016. If granted, the emergency approval will only be valid for a maximum of 180 days. The Department plans to follow this emergency request with a submission for a three year approval through OMB's normal PRA clearance process (5 CFR 1320.10).
Direct any comments on this emergency request to both the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB) and to the Bureau of Population, Refugees and Migration (PRM), Office of Refugee Admissions.
All public comments must be received by September 26, 2016.
You may submit comments to OMB by the following methods:
•
•
You may submit comments to PRM/Office of Admissions by the following methods:
•
•
•
You should include the DS form number, information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents to Monica Greco, PRM/Office of Admissions, 2025 E Street NW., Washington, DC 20522, who may be reached on 202-453-9251 or at
•
•
•
•
•
•
•
•
•
•
•
•
We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden of this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public until November 15, 2016.
You may submit comments by any of the following methods:
•
•
•
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Steve Derscheid, Directorate of Defense Trade Controls, Department of State, who may be reached at
•
•
•
•
•
•
•
•
•
•
•
•
We are soliciting public comments to permit the Department to:
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Sections 126.9 and 129.9 of the International Traffic in Arms Regulations (ITAR, 22 CFR 120-130) may be used by entities and individuals involved in the brokering, manufacture, export, and temporary import of defense articles and defense services to request an advisory opinion as to whether DDTC would be likely to grant a license or other approval for the export of a particular defense article or defense service to a particular country; for
DDTC has recently acquired an electronic case management system to update its business processes and how it receives and handles information from industry. This system, once deployed, will allow users to electronically submit requests for advisory opinions to DDTC; users will be able to retrieve responses using the same system. DDTC staff members have defined the data fields which are most relevant and necessary for requests for advisory opinions and developed the means to accept this information from the industry in a secure system. The revision of this information collection is meant to conform the current OMB-approved data collection to DDTC's new case management system. DDTC is therefore requesting industry comments on the new advisory opinion form, which will be mirrored in the case management system once deployed. A copy of the draft form may be requested from DDTC using the contact information in the
Bureau of Consular Affairs, Department of State.
Notice.
This public notice provides information on how to apply for the DV-2018 Program.
The Department of State administers the Congressionally-mandated Diversity Immigrant Visa Program annually. Section 203(c) of the Immigration and Nationality Act (INA) provides for a class of immigrants known as “diversity immigrants,” from countries with historically low rates of immigration to the United States. For fiscal year 2018, 50,000 diversity visas (DVs) will be available. There is no cost to register for the DV Program.
Applicants who are selected in the lottery (“selectees”) must meet simple, but strict, eligibility requirements to qualify for a diversity visa. The Department of State determines selectees through a randomized computer drawing. Diversity visa numbers are distributed among six geographic regions and no single country may receive more than seven percent of the available DVs in any one year.
For DV-2018, natives of the following countries are not eligible to apply, because more than 50,000 natives of these countries immigrated to the United States in the previous five years:
Bangladesh, Brazil, Canada, China (mainland-born), Colombia, Dominican Republic, El Salvador, Haiti, India, Jamaica, Mexico, Nigeria, Pakistan, Peru, Philippines, South Korea, United Kingdom (except Northern Ireland) and its dependent territories, and Vietnam.
Persons born in Hong Kong SAR, Macau SAR, and Taiwan are eligible.
Changes in eligibility this year: Ecuador is eligible for DV 2018.
Requirement #1: Individuals born in countries whose natives qualify may be eligible to enter.
If you were not born in an eligible country, there are two other ways you might be able to qualify.
• Was your spouse born in a country whose natives are eligible? If yes, you can claim your spouse's country of birth—provided that both you and your spouse are named on the selected entry, are found eligible for and issued diversity visas, and enter the United States simultaneously.
• Were you born in a country whose natives are ineligible, but in which neither of your parents were born or legally resident at the time of your birth? If yes, you may claim the country of birth of one of your parents if it is a country whose natives are eligible for the DV-2018 program. For more details on what this means, see the Frequently Asked Questions.
Requirement #2: Each applicant must meet the education
• At least a high school education or its equivalent, defined as successful completion of a 12-year course of formal elementary and secondary education; OR
• two years of work experience within the past five years in an occupation that requies at least two years of training or experience to perform. The Department of State will use the U.S. Department of Labor's O*Net Online database to determine qualifying work experience. For more information about qualifying work experience for the principal DV applicant, see the Frequently Asked Questions.
Do not submit an entry to the DV program unless you meet both of these requirements.
Applicants must submit entries for the DV-2018 DV program electronically at
Submit your Electronic Diversity Visa Entry Form (E-DV Entry Form or DS-5501), online at
We strongly encourage you to complete the entry form yourself, without a “visa consultant,” “visa agent,” or other facilitator who offers to help. If someone else helps you, you should be present when your entry is prepared so that you can provide the correct answers to the questions and retain the confirmation page and your unique confirmation number.
After you submit a complete entry, you will see a confirmation screen that contains your name and a unique confirmation number. Print this confirmation screen for your records. It is extremely important that you retain your confirmation page and unique confirmation number. Without this information, you will not be able to access the online system that will inform you of the status of your entry.
You must provide the following information to complete your E-DV entry:
1. Name—last/family name, first name, middle name—exactly as on your passport.
2. Gender—male or female.
3. Birth date—day, month, year.
4. City where you were born.
5. Country where you were born—Use the name of the country currently used for the place where you were born.
6. Country of eligibility for the DV Program—Your country of eligibility will normally be the same as your country of birth. Your country of eligibility is not related to where you live.
If you were born in a country that is not eligible, please review the Frequently Asked Questions to see if there is another way you may be eligible.
7. Entrant photograph(s)—Recent photographs (taken within 6 months) of yourself, your spouse, and all your children listed on your entry. See Submitting a Digital Photograph for compositional and technical specifications. You do not need to include a photograph for a spouse or child who is already a U.S. citizen or a Lawful Permanent Resident, but you will not be penalized if you do. We cannot accept group photographs; you must submit a photograph for each individual. Your entry may be disqualified or your visa refused if the photographs are more than six months old, have been manipulated in any way, or do not meet the specifications explained below. Submitting the same photograph that you submitted with last year's entry (DV-2017) will result in disqualification. See Submitting a Digital Photograph for more information.
8. Mailing Address—In Care Of
Address Line 1
Address Line 2
City/Town
District/Country/Province/State
Postal Code/Zip Code
Country
9. Country where you live today.
10. Phone number (optional).
11. Email address—An email address to which you have direct access, and will continue to have direct access after we notify selectees in May of next year. If your entry is selected and you respond to the notification of your selection through the
12. Highest level of education you have achieved, as of today: (1) Primary school only, (2) Some high school, no diploma, (3) High school diploma, (4) Vocational school, (5) Some university courses, (6) University degree, (7) Some graduate-level courses, (8) Master's degree, (9) Some doctoral-level courses, and (10) Doctorate. See the Frequently Asked Questions for more information about educational requirements.
13. Current marital status—(1) Unmarried, (2) married and my spouse is NOT a U.S. citizen or U.S. LPR, (3) married and my spouse IS a U.S. citizen or U.S. LPR, (4) divorced, (5) widowed, or (6) legally separated. Enter the name, date of birth, gender, city/town of birth, country of birth of your spouse, and a photograph of your spouse meeting the same technical specifications as your photo.
Failure to list your eligible spouse will result in disqualification of the principal applicant and refusal of all visas in the case at the time of the visa interview. You must list your spouse even if you currently are separated from him/her, unless you are legally separated (
14. Number of children—List the Name, date of birth, gender, city/town of birth, and country of birth for all living unmarried children under 21 years of age, regardless. Submit individual photographs of each of your children using the same technical specifications as your own photograph.
Be sure to include:
• All living natural children;
• all living children legally adopted by you; and,
• all living step-children who are unmarried and under the age of 21 on the date of your electronic entry, even if you are no longer legally married to the child's parent, and even if the child does not currently reside with you and/or will not immigrate with you.
Married children and children over the age of 21 are not eligible for the DV. However, the Child Status Protection Act protects children from “aging out” in certain circumstances. If you submit your DV entry before your unmarried child turns 21, and the child turns 21 before visa issuance, it is possible that he or she may be treated as though he or she were under 21 for visa-processing purposes.
A child who is already a U.S. citizen or a Lawful Permanent Resident will not require or be issued a diversity visa, and you will not be penalized for either including or omitting such family members from your entry.
Failure to list all children who are eligible will result in disqualification of the principal applicant and refusal of all visas in the case at the time of the visa interview. See the Frequently Asked Questions for more information about family members.
See the Frequently Asked Questions for more information about completing your Electronic Entry for the DV-2018 Program.
Based on the allocations of available visas in each region and country, the Department of State will randomly select individuals by computer from among qualified entries. All DV-2018 entrants must go to the
If your entry is selected, you will be directed to a confirmation page that will provide further instructions, including information on fees connected with immigration to the United States.
In order to immigrate, DV selectees must be admissible to the United States. The DS-260, Online Immigrant Visa and Alien Registration Application, electronically, and the consular officer, in person will ask you questions about your eligibility to immigrate, and these questions include criminal and security related grounds.
All eligible selectees, including family members, must be issued by September 30, 2018. Under no circumstances can the Department of State issue DVs or approve adjustments after this date, nor can family members obtain DVs to follow-to-join the principal applicant in the United States after this date. See the Frequently Asked Questions for more information about the selection process.
You can take a new digital photograph or scan a recent photographic print, taken within the last 6 months, with a digital scanner, as long as it meets the compositional and technical specifications listed below. Test your photos through the photo validation link on the E-DV Web site, which provides additional technical advice on photo composition and examples of acceptable and unacceptable photos. Do not submit an old photograph. Submitting the same photograph that was submitted with last year's entry will result in disqualification.
Photographs must be in 24-bit color depth. If you are using a scanner, the settings must be for True Color or 24-bit color mode. See the additional scanning requirements below.
•
•
•
•
•
• Taking a New Digital Image. If you submit a new digital image, it must meet the following specifications:
• Scanning a Submitted Photograph. Before you scan a photographic print, make sure it meets the color and compositional specifications listed above. Scan the print using the following scanner specifications:
1. What do the terms “native” and “chargeability” mean?
“Native” ordinarily means someone born in a particular country, regardless of the individual's current country of residence or nationality. “Native” can also mean someone who is entitled to be “charged” to a country other than the one in which he/she was born under the provisions of Section 202(b) of the Immigration and Nationality Act.
Because there is a numerical limitation on immigrants who enter from a country or geographic region, each individual is “charged” to a country. Your “chargeability” refers to the country towards which limitation you count. Your country of eligibility will normally be the same as your country of birth. However, you may choose your country of eligibility as the country of birth of your spouse, or the country of birth of either of your parents if you were born in a country in which neither parent was born and in which the parents were not resident at the time of your birth. These are the only three ways to select your country of chargeability.
If you claim alternate chargeability through either of the above, you must provide an explanation on the E-DV Entry Form, in question #6. Listing an incorrect country of eligibility or chargeability (
2. Can I still apply if I was not born in a qualifying country?
There are two circumstances in which you still might be eligible to apply. First, if your derivative spouse was born in an eligible country, you may claim chargeability to that country. As your eligibility is based on your spouse, you will only be issued a DV-1 immigrant visa if your spouse is also eligible for and issued a DV-2 visa. Both of you must enter the United States together using your DVs. Similarly, your minor dependent child can be “charged” to a parent's country of birth.
Second, you can be “charged” to the country of birth of either of your parents as long as neither of your parents was born in or a resident of your country of birth at the time of your birth. People are not generally considered residents of a country in which they were not born or legally naturalized, if they were only visiting, studying in the country temporarily, or stationed temporarily for business or professional reasons on behalf of a company or government from a different country other than the one in which you were born.
If you claim alternate chargeability through either of the above, you must provide an explanation on the E-DV Entry Form, in question #6. Listing an incorrect country of eligibility or chargeability (
3. Why do natives of certain countries not qualify for the DV program?
DVs are intended to provide an immigration opportunity for persons who are not from “high admission” countries. The law defines “high
4. How many DV-2018 visas will go to natives of each region and eligible country?
United States Citizenship and Immigration Services (USCIS) determines the regional DV limits for each year according to a formula specified in Section 203(c) of the Immigration and Nationality Act (INA). The number of visas the Department of State eventually will issue to natives of each country will depend on the regional limits established, how many entrants come from each country, and how many of the selected entrants are found eligible for the visa. No more than seven percent of the total visas available can go to natives of any one country.
5. What are the requirements for education or work experience?
U.S. immigration law and regulations require that every DV entrant must have at least a high school education or its equivalent or have two years of work experience within the past five years in an occupation that requires at least two years of training or experience. A “high school education or equivalent” is defined as successful completion of a 12-year course of elementary and secondary education in the United States OR the successful completion in another country of a formal course of elementary and secondary education comparable to a high school education in the United States. Only formal courses of study meet this requirement; correspondence programs or equivalency certificates (such as the General Equivalency Diploma G.E.D.) are not acceptable. You must present documentary proof of education or work experience to the consular officer at the time of the visa interview.
If you do not meet the requirements for education or work experience, your entry will be disqualified at the time of your visa interview, and no visas will be issued to you or any of your family members.
6. What occupations qualify for the DV program?
The U.S. Department of Labor's (DOL) O*Net OnLine database will be used to determine qualifying work experience. The O*Net Online Database groups job experience into five “job zones.” While the DOL Web site lists many occupations, not all occupations qualify for the DV Program. To qualify for a DV on the basis of your work experience, you must have, within the past five years, two years of experience in an occupation that is classified in a Specific Vocational Preparation (SVP) range of 7.0 or higher.
If you do not meet the requirements for education or work experience, your entry will be disqualified at the time of your visa interview, and no visas will be issued to you or any of your family members.
7. How can I find the qualifying DV occupations in the Department of Labor's O*Net online database?
When you are in O*Net OnLine, follow these steps to find out if your occupation qualifies:
1. Under “Find Occupations” select “Job Family” from the pull down;
2. Browse by “Job Family”, make your selection, and click “GO”;
3. Click on the link for your specific occupation.
4. Select the tab “Job Zone” to find the designated Job Zone number and Specific Vocational Preparation (SVP) rating range.
As an example, select Aerospace Engineers. At the bottom of the Summary Report for Aerospace Engineers, under the Job Zone section, you will find the designated Job Zone 4, SVP Range, 7.0 to < 8.0. Using this example, Aerospace Engineering is a qualifying occupation.
For additional information, see the Diversity Visa—List of Occupations Web page
8. Is there a minimum age to apply for the DV program?
There is no minimum age to apply, but the requirement of a high school education or work experience for each principal applicant at the time of application will effectively disqualify most persons who are under age 18.
9. When can I submit my entry?
The DV-2018 entry period will run from 12:00 p.m. (noon), Eastern Daylight Time (EST) (GMT-4), Tuesday, October 4, 2016, until 12:00 p.m. (noon), Eastern Standard Time (EDT) (GMT-5), Monday, November 7, 2016. Each year, millions of people submit entries. Holding the entry period on these dates ensures selectees receive notification in a timely manner and gives both the visa applicants and our embassies and consulates time to prepare and complete cases for visa issuance.
We strongly encourage you to enter early during the registration period. Excessive demand at the end of the registration period may slow the system down. We cannot accept entries after noon EST Monday, November 7, 2016.
10. I am in the United States. Can I enter the DV program?
Yes, an entrant may be in the United States or in another country, and the entrant may submit an entry from anywhere.
11. Can I only enter once during the registration period?
Yes, the law allows only one entry by or for each person during each registration period. The Department of State uses sophisticated technology to detect multiple entries.
12. May my spouse and I each submit a separate entry?
Yes, a husband and a wife may each submit one entry if each meets the eligibility requirements. If either spouse is selected, the other is entitled to apply as a derivative dependent.
13. What family members must I include in my DV entry?
The only exception to this requirement is if your spouse is already a U.S. citizen or U.S. Lawful Permanent Resident. A spouse who is already a U.S. citizen or a Lawful Permanent Resident will not require or be issued a DV. Therefore, if you select “married and my spouse IS a U.S. citizen or U.S. LPR” on your entry, you will not be able to include further information on your spouse.
Parents and siblings of the entrant are ineligible to receive DV visas as dependents, and you should not include them in your entry.
If you list family members on your entry, they are not required to apply for a visa or to immigrate or travel with you. However, if you fail to include an eligible dependent on your original entry, your case will be disqualified at the time of your visa interview and no visas will be issued to you or any of your family members. This only applies to those who were family members at the time the original application was submitted, not those acquired at a later date. Your spouse, if eligible to enter, may still submit a separate entry even though he or she is listed on your entry, as long as both entries include details on all dependents in your family (see FAQ #12 above).
14. Must I submit my own entry, or can someone else do it for me?
We encourage you to prepare and submit your own entry, but you may have someone submit the entry for you. Regardless of whether you submit your own entry, or an attorney, friend, relative, or someone else submits it on your behalf, only one entry may be submitted in your name. You, as the entrant, are responsible for ensuring that information in the entry is correct and complete; entries that are not correct or complete may be disqualified. Entrants should keep their own confirmation number so that they are able to independently check the status of their entry using Entrant Status Check at
15. I'm already registered for an immigrant visa in another category. can I still apply for the DV program?
Yes. Your DV registration will not make you ineligible for another immigrant visa classification.
16. When will E-DV be available online?
You can enter online during the registration period beginning at 12:00 p.m. (noon) Eastern Daylight Time (EDT) (GMT-4) on Tuesday, October 4, 2016, and ending at 12:00 p.m. (noon) Eastern Standard Time (EST) (GMT-5) on Monday, November 7, 2016.
17. Can I download and save the E-DV entry form into a word processing program and finish it later?
No, you will not be able to save the form into another program for completion and submission later. The E-DV Entry Form is a Web form only. You must fill in the information and submit it while online.
18. Can I save the form online and finish it later?
No. The E-DV Entry Form is designed to be completed and submitted at one time. You will have sixty (60) minutes starting from when you download the form to complete and submit your entry through the E-DV Web site. If you exceed the sixty minute limit and have not submitted your complete entry electronically, the system discards any information already entered. The system deletes any partial entries so that they are not accidentally identified as duplicates of a later, complete entry. Read the DV instructions completely before you start to complete the form online, so that you know exactly what information you will need.
19. I don't have a scanner. Can I send photographs to someone in the United States to scan them, save them, and mail them back to me so I can use them in my entry?
Yes, as long as the photograph meets the requirements in the instructions and is electronically submitted with, and at the same time as, the E-DV online entry. You must already have the scanned photograph file when you submit the entry online; it cannot be submitted separately from the online application. The entire entry (photograph and application together) can be submitted electronically from the United States or from overseas.
20. According to the procedures, the system will reject my E-DV entry form if my photos don't meet the specifications. Can I resubmit my entry?
Yes, as long as you complete your submission by 12:00 p.m. (noon) Eastern Standard Time (EST) (GMT-5) on Monday, November 7, 2016. If your photo(s) did not meet the specifications, the E-DV Web site will not accept your entry, so you will not receive a confirmation notice. However, given the unpredictable nature of the Internet, you may not receive the rejection notice immediately. If you can correct the photo(s) and re-send the Form Part One or Two within sixty (60) minutes, you may be able to successfully submit the entry. Otherwise, you will have to restart the entire entry process. You can try to submit an application as many times as is necessary until a complete application is submitted and you receive the confirmation notice. Once you receive a confirmation notice, your entry is complete and you should NOT submit any additional entries.
21. How soon after I submit my entry will I receive the electronic confirmation notice?
You should receive the confirmation notice immediately, including a confirmation number that you must record and keep. However, the unpredictable nature of the Internet can result in delays. You can hit the “Submit” button as many times as is necessary until a complete application is submitted and you receive the confirmation notice. However, once you receive a confirmation notice, do not resubmit your information.
22. I hit the “Submit” button, but did not receive a confirmation number. If I submit another entry, will I be disqualified?
If you did not receive a confirmation number, your entry was not recorded. You must submit another entry. It will not be counted as a duplicate. Once you receive a confirmation number, do not resubmit your information.
23. How do I know if I am selected?
You must use your confirmation number to access the Entrant Status Check available on the E-DV Web site at
The Department of State will NOT contact you to tell you that you have been selected (see FAQ #24).
24. How will I know if I am not selected? Will I be notified?
You may check the status of your DV-2018 entry through the Entrant Status Check on the E-DV Web site at
25. What if I lose my confirmation number?
You must have your confirmation number to access Entrant Status Check. A tool is now available in Entrant Status Check (ESC) on the eDV Web site that will allow you to retrieve your confirmation number via the email
U.S. Embassies and Consulates and the Kentucky Consular Center are unable to check your selection status for you or provide your confirmation number to you directly (other than through the ESC retrieval tool). The Department of State is NOT able to provide a list of those selected to continue the visa process.
26. Will I receive information from the Department of State by email or by postal mail?
The Department of State will not send you a notification letter. The U.S. government has never sent emails to notify individuals that they have been selected, and there are no plans to use email for this purpose for the DV-2018 program. If you are a selectee, you will only receive email communications regarding your visa appointment
Only Internet sites that end with the “.gov” domain suffix are official U.S. government Web sites. Many other Web sites (
You may receive emails from websites that try to trick you into sending money or providing your personal information. You may be asked to pay for forms and information about immigration procedures, all which are available free on the Department of State Web site or through U.S. Embassy or Consulate Web sites. Additionally, organizations or Web sites may try to steal your money by charging fees for DV-related services. If you send money to one of these scams, you will likely never see it again. Also, do not send personal information to these Web sites, as it may be used for identity fraud/theft.
These deceptive emails may come from people pretending to be affiliated with the Kentucky Consular Center or the Department of State. Remember the U.S. government has never sent emails to notify individuals that they have been selected, and will not use email to notify selectees for the DV-2018 program. The Department of State will never ask you to send money by mail or by services such as Western Union.
27. How many individuals will be selected for DV-2018?
For DV-2018, 50,000 DV visas are available. Because it is likely that some of the first 50,000 persons who are selected will not qualify for visas or not pursue their cases to visa issuance, more than 50,000 entries will be selected to ensure that all of the available DV visas are issued. However, this also means that there will not be a sufficient number of visas for all those who are initially selected. To maximize use of all available visas, the Department of State may update Entrant Status Check to include additional selectees at any time before the program ends on September 30, 2018.
You can check the E-DV Web site's Entrant Status Check to see if you have been selected for further processing and your place on the list. Interviews for the DV-2018 program will begin in October 2017 for selectees who have submitted all pre-interview paperwork and other information as requested in the notification instructions. Selectees who provide all required information will be informed of their visa interview appointment through the E-DV Web site's Entrant Status Check four to six weeks before the scheduled interviews with U.S. consular officers at overseas posts.
Each month, visas will be issued to those applicants who are eligible for issuance during that month, visa-number availability permitting. Once all of the 50,000 DV visas have been issued, the program will end. Visa numbers could be finished before September 2018. Selected applicants who wish to apply for visas must be prepared to act promptly on their cases. Being randomly chosen as a selectee does not guarantee that you will receive a visa. Selection merely means that you are eligible to apply for a Diversity Visa, and if your rank number becomes eligible for final processing, you potentially may be issued a Diversity Visa. Only 50,000 visas will be issued to such applicants.
28. How will successful entrants be selected?
Official notifications of selection will be made through Entrant Status Check, available starting May 2, 2017, through at least September 30, 2018, on the E-DV Web site
All entries received from each region are individually numbered, and at the end of the entry period, a computer will randomly select entries from among all the entries received for each geographic region. Within each region, the first entry randomly selected will be the first case registered; the second entry selected will be the second case registered, etc. All entries received within each region during the entry period will have an equal chance of being selected. When an entry has been selected, the entrant will receive notification of his or her selection through the Entrant Status Check available starting May 2, 2017, on the E-DV Web site
29. I am already in the United States. If selected, may I adjust my status with USCIS?
Yes, provided you are otherwise eligible to adjust status under the terms of Section 245 of the Immigration and Nationality Act (INA), you may apply to USCIS for adjustment of status to permanent resident. You must ensure that USCIS can complete action on your case, including processing of any overseas spouse or children under 21 years of age, before September 30, 2018, since on that date your eligibility for the DV-2018 program expires. The Department of State will not approve any visa numbers or adjustments of status for the DV-2018 program after midnight EDT on September 30, 2018, under any circumstances.
30. If I am selected, for how long am I entitled to apply for a diversity visa?
If you are selected in the DV-2018 program, you are entitled to apply for visa issuance only during U.S. Government Fiscal Year 2018, which spans from October 1, 2017, through September 30, 2018. We encourage selectees to apply for visas as early as possible, once their lottery rank
Without exception, all selected and eligible applicants must obtain their visa or adjust status by the end of the fiscal year. There is no carry-over of DV benefits into the next year for persons who are selected but who do not obtain visas by September 30, 2018 (the end of the fiscal year). Also, spouses and children who derive status from a DV-2018 registration can only obtain visas in the DV category between October 1, 2017 and September 30, 2018. Applicants who apply overseas will receive an appointment notification from the Department through Entrant Status Check on the E-DV Web site four to six weeks before the scheduled appointment.
31. If a DV selectee dies, what happens to the case?
If a DV selectee dies at any point before he or she has traveled to the United States or adjusted status, the DV case is automatically terminated. Any derivative spouse and/or children of the deceased selectee will no longer be entitled to a DV visa. Any visas that were issued to them will be revoked.
32. How much does it cost to enter the E-DV Program?
There is no fee charged for submitting an electronic entry. However, if you are selected and apply for a Diversity Visa, you must pay all required visa application fees at the time of visa application and interview directly to the consular cashier at the U.S. Embassy or Consulate. If you are a selectee already in the United States and you apply to USCIS to adjust status, you will pay all required application fees directly to USCIS. If you are selected, you will receive details of required DV and immigrant visa application fees with the instructions provided through the E-DV Web site at
33. How and where do I pay DV and immigrant visa fees if I am selected?
If you are a randomly selected entrant, you will receive instructions for the DV visa application process through Entrant Status Check at
If you are selected and you are already present in the United States and plan to file for adjustment of status with USCIS, the instructions page accessible through Entrant Status Check at
34. If I apply for a DV, but don't qualify to receive one, can I get a refund of the visa fees I paid?
No. Visa application fees cannot be refunded. You must meet all qualifications for the visa as detailed in these instructions. If a consular officer determines you do not meet requirements for the visa, or you are otherwise ineligible for the DV under U.S. law, the officer cannot issue a visa and you will forfeit all fees paid.
35. As a DV applicant, can I receive a waiver of any grounds of visa ineligibility? Does my waiver application receive any special processing?
DV applicants are subject to all grounds of ineligibility for immigrant visas specified in the Immigration and Nationality Act (INA). There are no special provisions for the waiver of any ground of visa ineligibility aside from those ordinarily provided in the INA, nor is there special processing for waiver requests. Some general waiver provisions for people with close relatives who are U.S. Citizens or Lawful Permanent Resident aliens may be available to DV applicants in some cases, but the time constraints in the DV program may make it difficult for applicants to benefit from such provisions.
36. How can I report Internet fraud or unsolicited email?
Please visit the
37. How many visas will be issued in DV-2018?
By law, a maximum of 55,000 visas are available each year to eligible persons. However, in November 1997, the U.S. Congress passed the Nicaraguan Adjustment and Central American Relief Act (NACARA), which stipulates that beginning as early as DV-1999, and for as long as necessary, up to 5,000 of the 55,000 annually-allocated DVs will be made available for use under the NACARA program. The actual reduction of the limit began with DV-2000 and will remain in effect through the DV-2018 program, so 50,000 visas remain for the DV program described in these instructions.
38. If I receive a visa through the DV program, will the U.S. Government pay for my airfare to the United States, help me find housing and employment, and/or provide healthcare or any subsidies until I am fully settled?
No. The U.S. government will not provide any of these services to you if you receive a visa through the DV program. If you are selected to apply for a DV, you will need to demonstrate that you will not become a public charge in the United States before being issued a visa. This evidence may be in the form of a combination of your personal assets, an Affidavit of Support (Form I-134) submitted by a relative or friend residing in the United States, an offer of employment from an employer in the United States, or other evidence.
The list below shows the countries whose natives are eligible for DV-2018, grouped by geographic region. Dependent areas overseas are included within the region of the governing country. USCIS identified the countries whose natives are not eligible for the DV-2018 program according to the formula in Section 203(c) of the INA. The countries whose natives are not eligible for the DV program (because they are the principal source countries of Family-Sponsored and Employment-Based immigration or “high-admission” countries) are noted after the respective regional lists.
* Persons born in the areas administered prior to June 1967 by Israel, Jordan, Syria, and Egypt are chargeable, respectively, to Israel, Jordan, Syria, and Egypt. Persons born in the Gaza Strip are chargeable to Egypt; persons born in the West Bank are chargeable to Jordan; persons born in the Golan Heights are chargeable to Syria.
In Africa, natives of Nigeria are not eligible for this year's diversity program.
* Persons born in the areas administered prior to June 1967 by Israel, Jordan, Syria, and Egypt are chargeable, respectively, to Israel, Jordan, Syria, and Egypt. Persons born in the Gaza Strip are chargeable to Egypt; persons born in the West Bank are chargeable to Jordan; persons born in the Golan Heights are chargeable to Syria.
** For the purposes of the diversity program only, persons born in Macau S.A.R. derive eligibility from Portugal, and must select Portugal as their country of eligibility.
Natives of the following Asia Region countries are not eligible for this year's diversity program: Bangladesh, China (mainland-born), India, Pakistan, South Korea, Philippines, and Vietnam. Hong Kong S.A.R. (Asia region), Macau S.A.R. (Europe region, chargeable to Portugal), and Taiwan (Asia region) do qualify and are listed here.
** Macau S.A.R. does qualify and is listed above. For the purposes of the diversity program only, persons born in Macau S.A.R. derive eligibility from Portugal, and must select Portugal as their country of eligibility.
Natives of the following European countries are not eligible for this year's DV program: Great Britain (United Kingdom). Great Britain (United Kingdom) includes the following dependent areas: Anguilla, Bermuda, British Virgin Islands, British Indian Ocean Territory, Cayman Islands, Falkland Islands, Gibraltar, Montserrat, Pitcairn, South Georgia and the South Sandwich Islands, St. Helena, and Turks and Caicos Islands. Note that for purposes of the diversity program only, Northern Ireland is treated separately; Northern Ireland does qualify and is listed among the qualifying areas.
In North America, natives of Canada and Mexico are not eligible for this year's diversity program.
Countries in this region whose natives are not eligible for this year's diversity program: Brazil, Colombia, Dominican Republic, El Salvador, Haiti, Jamaica, Mexico, and Peru.
22 CFR 42.33(b)(3), implementing sections 201(a)(3), 201(e), 203(c), and 204(a)(1)(I) of the Immigration and Nationality Act, as amended, (8 U.S.C. 1151, 1153, and 1154(a)(1)(I)).
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The Department of State will conduct an open meeting at 9:00 a.m. on October 6, 2016, in Room 5L18-01 of the Douglas A. Munro Coast Guard Headquarters Building at St. Elizabeth's, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593. The primary purpose of the meeting is to prepare for the sixty-sixth session of the International Maritime Organization's (IMO) Technical Cooperation Committee to be held at the IMO Headquarters, United Kingdom, October 10-12, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. Upon request to the meeting coordinator, members of the public may also participate via teleconference. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, LCDR Tiffany Duffy, by email at
Surface Transportation Board.
Notice tentatively approving and authorizing finance transaction.
On August 17, 2016, National Express LLC (National Express or Applicant), a non-carrier, filed an application under 49 U.S.C. 14303 to acquire control of New Dawn Transit, LLC (New Dawn). The Board is tentatively approving and authorizing the transaction, and, if no opposing comments are timely filed, this notice will be the final Board action. Persons wishing to oppose the application must follow the rules at 49 CFR 1182.5 & 1182.8.
Comments must be filed by October 31, 2016. Applicant may file a reply by November 15, 2016. If no opposing comments are filed by October 31, 2016, this notice shall be effective on November 1, 2016.
Send an original and 10 copies of any comments referring to Docket No. MCF 21072 to: Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, send one copy of comments to Applicant's representative: Andrew K. Light, Scopelitis, Garvin, Light, Hanson & Feary, P.C., 10 W. Market Street, Suite 1500, Indianapolis, IN 46204.
Nathaniel Bawcombe (202) 245-0376. Federal Information Relay Service (FIRS) for the hearing impaired: 1-800-877-8339.
Applicant, a non-carrier, states that it is a holding company organized under the laws of the state of Delaware that is indirectly controlled by a British corporation, National Express Group, PLC (Express Group). Applicant states that Express Group indirectly controls the following passenger motor carriers (National Express Affiliated Carriers): Beck Bus Transportation Corp. (Beck); Carrier Management Corporation (CMI); Durham School Services, L.P. (Durham); Folmsbee's Transportation Inc. (Folmsbee); MV Student Transportation, Inc. (MV); National Express Transit Corporation (NETC); National Express Transit Services Corporation (NETSC); Petermann Ltd. (LTD); Petermann Northeast LLC (Northeast); Petermann Northwest LLC (Northwest); Petermann Southwest LLC (Southwest); Petermann STSA, LLC (STSA); The Provider Enterprises, Inc. (Provider); Rainbow Management Service Inc. (Rainbow); Safeway Training and Transportation Services Inc. (Safeway); Septran, Inc. (Septran); Smith Bus Service, Inc. (Smith); Suburban Paratransit Service, Inc. (Suburban Paratransit); Trans Express, Inc. (Trans Express); and White Plains Bus Company, Inc. (White Plains).
Applicant alleges the following facts regarding the National Express Affiliated Carriers held by Express Group:
• Beck is a passenger motor carrier primarily engaged in providing student school bus transportation services in the states of Illinois and Indiana under contracts with regional and local school jurisdictions. Beck also provides charter passenger services to the public (MC-143528).
• CMI is a passenger motor carrier doing business as Matthews Bus Company and is primarily engaged in providing student school bus transportation services in the state of Pennsylvania under contracts with regional and local school jurisdictions. CMI also provides intrastate charter passenger services to the public.
• Durham is a passenger motor carrier primarily engaged in providing student school bus transportation services in approximately 32 states under contracts with regional and local school jurisdictions. Durham also provides charter passenger services to the public (MC-163066).
• Folmsbee is a passenger motor carrier primarily engaged in providing unregulated student school bus transportation services in the state of New York under contracts with regional and local school jurisdictions (MC-818630).
• MV is a passenger motor carrier primarily engaged in providing student school bus transportation services in the state of Missouri under contracts with regional and local school jurisdictions. MV also provides charter passenger services to the public (MC-148934).
• NETC is an intrastate passenger motor carrier with its principal place of business in Cincinnati, Ohio.
• NETSC is a passenger motor carrier engaged primarily in providing intrastate transit services in the areas of Westmoreland, Pa.; Arlington, Va.; Greensboro, N.C.; Vallejo, Cal.; and Yuma, Ariz.
• LTD is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Ohio under contracts with regional and local school jurisdictions. LTD also provides charter passenger services to the public (MC-364668).
• Northeast is a passenger motor carrier primarily engaged in providing student school bus transportation services, primarily in the states of Ohio and Pennsylvania under contracts with regional and local school jurisdictions. Northeast also provides charter passenger services to the public (MC-723926).
• Northwest is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services under contracts with regional and local school jurisdictions.
• Southwest is a passenger motor carrier primarily engaged in providing
• STSA is a passenger motor carrier primarily engaged in providing student school bus transportation services, primarily in the state of Kansas under contracts with regional and local school jurisdictions. STSA also provides charter passenger services to the public (MC-749360).
• Provider is a passenger motor carrier doing business as Provider Bus, and is primarily engaged in providing non-regulated school bus transportation services in the state of New Hampshire under contracts with regional and local school jurisdictions.
• Rainbow provides interstate and intrastate charter and special party passenger transportation services in the state of New York (MC-490015).
• Safeway is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of New Hampshire under contracts with regional and local school jurisdictions (MC-522039).
• Septran is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Illinois under contracts with regional and local school jurisdictions (MC-795208).
• Smith is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Maryland and surrounding areas under contracts with regional and local school jurisdictions.
• Suburban Paratransit is a motor carrier providing paratransit services primarily in Westchester County and Bronx, NY.
• Trans Express provides interstate and intrastate passenger transportation services in the state of New York (MC-187819).
• White Plains is a passenger motor carrier that operates primarily as a provider of non-regulated school bus transportation services in the State of New York. White Plains also operates as a motor passenger carrier providing charter service to the public (MC-160624).
Applicant states that New Dawn is a New York limited liability company that holds authority from the Federal Motor Carrier Safety Administration as a motor carrier of passengers (MC-932702). Applicant explains that all of the issued and outstanding membership equity interest of New Dawn is owned and held by Indra Fouche, an individual (the Seller). Applicant further states that the Seller has no direct or indirect ownership interest in any other interstate passenger motor carrier.
According to Applicant, New Dawn operates primarily as a provider of non-regulated school bus transportation services, transporting children to and from school throughout the metropolitan area of New York City. Applicant adds that New Dawn maintains a fleet of 140 buses and has approximately 154 drivers, and that it also operates as a motor passenger carrier providing charter service to the public using its fleet of buses.
Applicant explains that National Express would assume direct 100 percent control of New Dawn through the membership ownership.
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least: (1) The effect of the proposed transaction on the adequacy of transportation to the public; (2) the total fixed charges that result; and (3) the interest of affected carrier employees. Applicant submitted information, as required by 49 CFR 1182.2, including information to demonstrate that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b), and a statement that the aggregate gross operating revenues of the National Express Affiliated Carriers and New Dawn exceeded $2 million for the preceding 12-month period.
Applicant submits that the proposed transaction would have no significant impact on the adequacy of transportation services to the public, as New Dawn would continue to provide the services it currently provides using the same names for the foreseeable future. Applicant states that New Dawn “will continue to operate, but going forward, it will be operating within the National Express corporate family, an organization already thoroughly experienced in passenger transportation operations.” (Appl. 12.)
Applicant states that “[t]he addition of [New Dawn] to the carriers held by National Express is consistent with the practices within the passenger motor carrier industry of strong, well-managed transportation organizations adapting their corporate structure to operate several different passenger carriers within the same market, but in different geographic areas.” (
Applicant further asserts that the acquisition of New Dawn would serve to enhance the viability of the overall National Express organization and the operations of the National Express Affiliated Carriers, which would ensure the continued availability of adequate passenger transportation service for the public. (
Applicant also claims that neither competition nor the public interest would be adversely affected. Applicant states that New Dawn is a relatively small carrier in the overall markets in which it competes: Unregulated metropolitan school bus operations, and provider of charter services. Applicant states that school bus operators typically occupy a limited portion of the charter business because (i) the equipment offered is not as comfortable as that offered by motor coach operators; and (ii) scheduling demands imposed by the primary school bus operation impose major constraints on charter services that can be offered. It further explains that the charter services offered by New Dawn are geographically dispersed from those of the National Express Affiliated Carriers, and that there is limited overlap in service areas and/or in customer bases among the National Express Affiliated Carriers and New Dawn. Thus, Applicant states that the impact of the contemplated transaction on the regulated motor carrier industry would be minimal at most and that neither competition nor the public interest would be adversely affected.
Applicant asserts that there are no fixed charges associated with the contemplated transaction. Applicant also states that it does not anticipate a measurable reduction in force or changes in compensation levels and/or benefits to employees. Applicant submits, however, that staffing redundancies could potentially result in limited downsizing of back-office or managerial level personnel.
The Board finds that the acquisition proposed in the application is consistent with the public interest and should be tentatively approved and authorized. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will
This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at
1. The proposed transaction is approved and authorized, subject to the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective November 1, 2016, unless opposing comments are filed by October 31, 2016.
4. A copy of this notice will be served on: (1) The U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW., Washington, DC 20530; and (3) the U.S. Department of Transportation, Office of the General Counsel, 1200 New Jersey Avenue SE., Washington, DC 20590.
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Under the provisions of Title 49, U.S.C. 47153(d), notice is being given that the FAA is considering a request from the Massachusetts Port Authority (MPA) in East Boston, MA, to waive the surplus property requirements for approximately 7.1 acres of airport property located at Hanscom Field in Bedford, MA.
The subject parcel has been identified for commercial development and MPA will negotiate a long term lease to generate non-aviation revenue for the airport. As such, MPA is requesting a release to change the property from aeronautical use to non-aeronautical use. It has been determined through study and master planning that the subject parcel will not be needed for future aeronautical purposes. Further, the parcel of land is separated by a road and not contiguous to the airport proper. Full and permanent relief of the surplus property requirements on this parcel will allow the airport to generate long term revenue through lease of the land. All lease revenue will continue to be subject to the FAAs revenue-use policy and dedicated to the maintenance and operation of Hanscom Field.
Comments must be received on or before October 17, 2016.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts, Telephone 781-238-7618.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Sixteenth RTCA SC-209 Working Session and Plenary Session joint with EUROCAE WG 49, WG 51, and RTCA SC-186.
The FAA is issuing this notice to advise the public of a meeting of Sixteenth RTCA SC-209 Working Session and Plenary Session joint with EUROCAE WG 49, WG 51, and RTCA SC-186.
The meeting will be held October 17-21, 2016, 09:00 a.m.-04:30 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.
Al Secen at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App.), notice is hereby given for a meeting of the Sixteenth RTCA SC-209 Working Session and Plenary Session joint with EUROCAE WG 49, WG 51, and RTCA SC-186. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person
Federal Aviation Administration (FAA), DOT.
Notice of Commercial Space Transportation Advisory Committee open meeting.
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App. 2), notice is hereby given of a meeting of the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on Tuesday, October 25, 2016, from 1:00 p.m. to 5:00 p.m., and Wednesday, October 26, 2016 from 8:00 a.m. to 5:00 p.m. at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594. This will be the 64th meeting of the COMSTAC.
The proposed schedule for the COMSTAC working group meetings on October 25th and 26th is below:
The full Committee will meet on October 26, from 1:00 p.m. to 5:00 p.m. The proposed agenda for that meeting features speakers relevant to the commercial space transportation industry; and reports and recommendations from the working groups.
Interested members of the public may submit relevant written statements for the COMSTAC members to consider under the advisory process. Statements may concern the issues and agenda items mentioned above and/or additional issues that may be relevant for the U.S. commercial space transportation industry. Interested parties wishing to submit written statements should contact Michael Beavin, COMSTAC Executive Director, (the contact person listed below) and Designated Federal Officer in writing (mail or email) by October 14, 2016, so that the information can be made available to COMSTAC members for their review and consideration before the October 25-26, 2016 meeting. Written statements should be supplied in the following formats: one hard copy with original signature and/or one electronic copy via email.
An agenda will be posted on the FAA Web site at
Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting.
Michael Beavin, telephone (202) 267-9051; email
Complete information regarding COMSTAC is available on the FAA Web site at:
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Under the provisions of Title 49, U.S.C. 47153(d), notice is being given that the FAA is considering a request from New Bedford Airport in New Bedford, MA, to exchange .65 acres of airport land for 1.14 acres of land owned by the Tifereth Israel Congregation in order to construct the Runway Safety Area and provide for a maintenance/emergency road for Runway 14-32 at New Bedford Airport in New Bedford, MA.
The .65 acres of airport land being exchanged by the airport is not required for current of future aviation use. The land is remote, non-contiguous to the airport land and is primarily wooded. The two parcels that will be acquired from Tifereth Israel Congregation will be used to meet FAA design requirements for the Runway 14 Runway Safety Area and provide a maintenance/emergency access road for this runway end.
Comments must be received on or before October 17, 2016.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts, Telephone 781-238-7618.
Federal Highway Administration (FHWA), DOT.
Notice.
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic iron and steel components of electric vehicle DC fast charging stations with
The effective date of the waiver is September 19, 2016.
For questions about this notice, please contact Mr. Gerald Yakowenko, FHWA Office of Program Administration, (202) 366-1562, or via email at
An electronic copy of this document may be downloaded from the
The FHWA's Buy America policy in 23 CFR 635.410 requires a domestic manufacturing process for any steel or iron products (including protective coatings) that are permanently incorporated in a Federal-aid construction project. The regulation also provides for a waiver of the Buy America requirements when the application would be inconsistent with the public interest or when satisfactory quality domestic steel and iron products are not sufficiently available. This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for use of non-domestic iron and steel components of electric vehicle DC fast charging stations with maximum power (50 kw), voltage range (200-500 VDC) and current output (165 ADC) in the State of Massachusetts.
In accordance with Division K, section 122 of the “Consolidated and Further Continuing Appropriations Act, 2015” (Pub. L. 113-235), FHWA published a notice of intent to issue a waiver on its Web site:
In accordance with the provisions of section 117 of the SAFETEA-LU Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572), FHWA is providing this notice as its finding that a waiver of Buy America requirements is appropriate. The FHWA invites public comment on this finding for an additional 15 days following the effective date of the finding. Comments may be submitted to FHWA's Web site via the link provided to the waiver page noted above.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice.
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the obligation of Federal-aid funds for 21 State projects involving the acquisition of vehicles and equipment on the condition that they be assembled in the U.S.
The effective date of the waiver is September 19, 2016.
For questions about this notice, please contact Mr. Gerald Yakowenko, FHWA Office of Program Administration, 202-366-1562, or via email at
An electronic copy of this document may be downloaded from the
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the obligation of Federal-aid funds for 21 State projects involving the acquisition of vehicles (including sedans, vans, pickups, trucks, buses, and street sweepers) and equipment (such as trail grooming equipment) on the condition that they be assembled in the U.S. The waiver would apply to approximately 796 vehicles and equipment acquisitions. The requests for the second quarter of calendar year 2016, available at
Title 23, Code of Federal Regulations, section 635.410 requires that steel or iron materials (including protective coatings) that will be permanently incorporated in a Federal-aid project must be manufactured in the U.S. For FHWA, this means that all the processes that modified the chemical content, physical shape or size, or final finish of the material (from initial melting and mixing, continuing through the bending and coating) occurred in the U.S. The statute and regulations create a process for granting waivers from the Buy America requirements when its application would be inconsistent with the public interest or when satisfactory quality domestic steel and iron products are not sufficiently available. In 1983, FHWA determined that it was both in the public interest and consistent with the legislative intent to waive Buy America for manufactured products other than steel manufactured products. However, FHWA's national waiver for manufactured products does not apply to the requests in this notice because they involve predominately steel and iron manufactured products. The FHWA's Buy America requirements do not have special provisions for applying Buy America to “rolling stock” such as vehicles or vehicle components (see 49 U.S.C. 5323(j)(2)(C), 49 CFR 661.11, and 49 U.S.C. 24405(a)(2)(C) for examples of Buy America rolling stock provisions for other DOT agencies).
Based on all the information available to the agency, FHWA concludes that there are no domestic manufacturers that produce the vehicles and vehicle components identified in this notice in such a way that their steel and iron
In accordance with Division K, section 122 of the “Consolidated and Further Continuing Appropriations Act, 2015” (Pub. L. 113-235), FHWA published a notice of intent to issue a waiver on its Web site at
Based on FHWA's conclusion that there are no domestic manufacturers that can produce the vehicles and equipment identified in this notice in such a way that steel and iron materials are manufactured domestically, and after consideration of the comments received, FHWA finds that application of FHWA's Buy America requirements to these products is inconsistent with the public interest (23 U.S.C. 313(b)(1) and 23 CFR 635.410(c)(2)(i)). However, FHWA believes that it is in the public interest and consistent with the Buy America requirements to impose the condition that the vehicles and the vehicle components be assembled in the U.S. Requiring final assembly to be performed in the U.S. is consistent with past guidance to FHWA Division Offices on manufactured products (see Memorandum on Buy America Policy Response, Dec. 22, 1997,
In accordance with the provisions of section 117 of the “Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users, Technical Corrections Act of 2008” (Pub. L. 110-244), FHWA is providing this notice of its finding that a public interest waiver of Buy America requirements is appropriate on the condition that the vehicles and equipment identified in the notice be assembled in the U.S. The FHWA invites public comment on this finding for an additional 15 days following the effective date of the finding. Comments may be submitted to FHWA's Web site via the link provided to the waiver page noted above.
23 U.S.C. 313; P.L. 110-161, 23 CFR 635.410.
Office of the Secretary, U.S. Department of Transportation.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. 3501
Comments on this notice must be received by November 15, 2016.
You may submit comments [identified by Docket No. DOT-OST-2016-0171] by any of the following methods:
•
•
•
•
Tami L. Wright, Associate Director, Compliance Operations Division (S-34), Departmental Office of Civil Rights, Office of the Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, 202-366-9370 or (TTY) 202-366-0663.
Department of the Treasury.
Notice of Privacy Act system of records.
In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a the Department of the Treasury (“Treasury” or the “Department”) proposes to update and reissue a current Department of the Treasury system of records titled, “Department of the Treasury.004—Freedom of Information Act/Privacy Act Request Records.”
Submit comments on or before October 17, 2016. This new system will be effective October 17, 2016.
Comments should be sent to Ryan Law, Acting Deputy Assistant Secretary for Privacy, Transparency, and Records, Department of the Treasury, 1500 Pennsylvania Ave. NW., Washington, DC 20220. Attention: Revisions to Privacy Act Systems of Records.
Comments can be faxed to (202) 622-3895, or emailed to
For general questions please contact: Ryan Law, Acting Deputy Assistant Secretary for Privacy, Transparency, and Records, Department of the Treasury, 1500 Pennsylvania Ave. NW., Washington, DC 20220, or at (202) 622-0790 (not toll-free).
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of the Treasury proposes to update and reissue a current Treasury system of records titled, “Department of the Treasury.004—Freedom of Information Act/Privacy Act Request Records.” Treasury.004 has been updated to include the Internal Revenue Service (IRS), to facilitate the disclosure of non-tax information to The Office of Government Information Services (OGIS) within the National Archives and Records Administration in accordance with routine use, “(10) To the National Archives and Records Administration, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(b), to review administrative agency policies, procedures and compliance with the Freedom of Information Act (FOIA), and to facilitate OGIS' offering of mediation services to resolve disputes between making FOIA requests and administrative agencies.”
OGIS serves as a mediator between the various federal agencies that administer the FOIA and the requester. In that capacity, OGIS may come to the IRS to discuss specifics of a request and accordingly that discussion will involve access to the specific non-tax records. Adding IRS to the list of system managers authorizes IRS a discretionary authority to disclose to OGIS purely non-tax, Privacy Act protected information about FOIA requests. It will not authorize disclosure of any tax return or return information. Therefore, OGIS must obtain valid IRC 6103(c) disclosure consent from FOIA requesters before IRS can disclose to OGIS any returns or return information pertaining to any FOIA request.
Below is the description of the Treasury.004—Freedom of Information Act/Privacy Act Request Records.” In accordance with 5 U.S.C. 552a(r), Treasury has provided a report of this system of records to the Office of Management and Budget and to Congress.
Freedom of Information Act/Privacy Act Request Records—Treasury.
Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220. The locations at which the system is maintained by Treasury components and their associated field offices are:
(1) Departmental Offices (DO), which includes the Office of Inspector General (OIG), the Community Development Financial Institutions Fund (CDFI), and Special Inspector General for the Troubled Asset Relief Program (SIGTARP);
(2) Alcohol and Tobacco Tax and Trade Bureau (TTB);
(3) Office of the Comptroller of the Currency (OCC);
(4) Bureau of Engraving and Printing (BEP);
(5) Fiscal Service (FS);
(6) United States Mint (MINT);
(7) Financial Crimes Enforcement Network (FinCEN);
(8) Treasury Inspector General for Tax Administration (TIGTA); and
(9) Internal Revenue Service (IRS).
Individuals who have: (1) Requested access to records pursuant to the Freedom of Information Act, 5 U.S.C. 552 (FOIA), or who have appealed initial denials of their requests; and/or (2) made a request for access, amendment, or other action pursuant to the Privacy Act of 1974, 5 U.S.C. 552a (PA).
Requests for records or information pursuant to the FOIA/PA, which includes the names of individuals making written or electronically submitted requests for records under the FOIA/PA; the contact information of the requesting individual such as their mailing address, email address, and/or phone number; and the dates of such requests and their receipt. Supporting records include the written correspondence received from requesters and responses made to such requests; internal processing documents and memoranda; referrals and copies of records provided or withheld; and may include legal memoranda and opinions. Comparable records are maintained in this system with respect to any appeals made from initial denials of access, refusal to amend records, and lawsuits under the FOIA/PA.
Freedom of Information Act, 5 U.S.C. 552; Privacy Act of 1974, 5 U.S.C. 552a; and 5 U.S.C. 301.
The system is used by officials to administratively control and/or process requests for records to ensure compliance with the FOIA/PA and to collect data for the annual reporting requirements of the FOIA and other Departmental management report requirements. In addition, the system allows for online submission to expedite the consideration of requests.
These records may be used to:
(1) Disclose pertinent information to appropriate Federal, foreign, State, local, tribal or other public authorities or self-regulatory organizations responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, or license, where the disclosing agency becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation;
(2) Disclose information to a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations, in response to a court order, or in connection with criminal law proceedings;
(3) Provide information to a congressional office in response to an inquiry made at the request of the individual to whom the record pertains;
(4) Disclose information to another Federal agency to (a) permit a decision as to access, amendment or correction of records to be made in consultation with or by that agency, or (b) verify the identity of an individual or the accuracy of information submitted by an individual who has requested access to or amendment or correction of records;
(5) Disclose information to the Department of Justice when seeking legal advice, or when (a) the agency, or (b) any component thereof, or (c) any employee of the agency in his or her official capacity, or (d) any employee of the agency in his or her individual capacity where the Department of Justice has agreed to represent the employee, or (e) the United States, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by the agency to be relevant and necessary to the litigation;
(6) Disclose information to the appropriate foreign, State, local, tribal, or other public authority or self-regulatory organization for the purpose of (a) consulting as to the propriety of access to or amendment or correction of information obtained from that authority or organization, or (b) verifying the identity of an individual who has requested access to or amendment or correction of records;
(7) Disclose information to contractors and other agents who have been engaged by the Department or one of its bureaus to provide products or services associated with the Department's or bureaus' responsibilities arising under the FOIA/PA;
(8) Disclose information to the National Archives and Records Administration for use in records management inspections;
(9) Disclose information to appropriate agencies, entities, and persons when (a) the Department suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(10) To the National Archives and Records Administration, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(b), to review administrative agency policies, procedures and compliance with the Freedom of Information Act (FOIA), and to facilitate OGIS' offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.
Electronic media, computer paper printout, index file cards, and paper records in file folders.
Retrieved by name, subject, request file number, or other data element as may be permitted by an automated system.
Protection and control of any sensitive but unclassified (SBU) records are in accordance with Treasury Directive Publication 71-10, Department of the Treasury Security Manual; DO P-910, Departmental Offices Information Technology Security Policy Handbook; Treasury Directive Publication 85-01, Treasury Information Technology Security Program; National Institute of Standards and Technology 800-122 and any supplemental guidance issued by individual bureaus; the National Institute of Standards and Technology Special Publication 800-53 Revision 3, Recommended Security Controls for Federal Information Systems and Organizations; and Guide to Protecting the Confidentiality of Personally
The records pertaining to FOIA/PA requests are retained and disposed of in accordance with the National Archives and Records Administration's General Record Schedule 14—Information Services Records.
Department of the Treasury: Official prescribing policies and practices—Departmental Disclosure Officer, Department of the Treasury, 1500 Pennsylvania Avenue NW., Washington, DC 20220.
The system managers for the Treasury components are:
(1) a. DO: Director, Disclosure Services, Department of the Treasury, Washington, DC 20220.
b. OIG: Director, Disclosure Services, Department of the Treasury, Washington, DC 20220.
c. CDFI: Director, Disclosure Services, Department of the Treasury, Washington, DC 20220.
d. SIGTARP: General Counsel, Office of the Special Inspector General for the Troubled Asset Relief Program, 1801 L Street NW., Washington, DC 20220.
(2) Alcohol and Tobacco Tax and Trade Bureau (TTB): 1310 G St. NW., Washington, DC 20220.
(3) BEP: Disclosure Officer, FOIA Office, 14th & C Streets SW., Washington, DC 20228.
(4) FS: Disclosure Officer, 401 14th Street SW., Washington, DC 20227.
(5) Mint: Disclosure Officer, 801 9th Street NW., 8th Floor, Washington, DC 20220.
(6) OCC: Disclosure Officer, Communications Division, 400 7th Street SW., Washington, DC 20024.
(7) FinCEN: P.O. Box 39, Vienna, VA 22183.
(8) TIGTA: Director, Human Capital and Support Services, 1401 H NW., Ste. 469, Washington, DC 20005.
(9) IRS: Internal Revenue Service Centralized Processing Unit—Stop 93A, Post Office Box 621506, Atlanta, GA 30362.
Individuals seeking notification and access to any record contained in the system of records, or seeking to contest its content, may inquire in accordance with instructions pertaining to individual Treasury components appearing at 31 CFR part 1, subpart C, appendices A-M.
See “Notification procedure” above.
See “Notification procedure” above.
The information contained in these files originates from individuals who make FOIA/PA requests and agency officials responding to those requests.
None. Please note that the Department has claimed one or more exemptions (see 31 CFR 1.36) for a number of its other systems of records under 5 U.S.C. 552a(j)(2) and (k)(1), (2), (3), (4), (5), and (6). During the course of a FOIA/PA action, exempt materials from those other systems may become a part of the case records in this system. To the extent that copies of exempt records from those other systems have been recompiled and/or entered into these FOIA/PA case records, the Department claims the same exemptions for the records as they have in the original primary systems of records of which they are a part.
Corporate Senior Executive Management Office, Department of Veterans Affairs.
Notice.
Under the provisions of 5 U.S.C. 4314(c)(4) agencies are required to publish a notice in the
August 25, 2016.
Corporate Senior Executive Management Office, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420.
Contact Tia N. Butler, Executive Director, Corporate Senior Executive Management Office (052), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7865.
The membership of the Department of Veterans Affairs Performance Review Board is as follows:
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, approved this document for publication on August 25, 2016.
5 U.S.C. 4314(c)(4).
(1) In order to reflect in the HTS the restoration of preferential treatment for Burma as a beneficiary developing country under the GSP program, general note 4(a) is modified by adding in alphabetical order “Burma” to the list entitled “Independent Countries” and to the list entitled “Member Countries of the Association of South East Asian Nations (ASEAN).”
(2) In order to reflect in the HTS the designation of Burma as a least-developed beneficiary developing country under the GSP program, general note 4(b)(i) is modified by adding in alphabetical order “Burma.”
(3) The modifications to the HTS made by paragraphs (1) and (2) of this proclamation shall be effective with respect to articles entered, or withdrawn from warehouse for consumption, on or after the date that is 60 days after the date of this proclamation.
(4) Any provisions of previous proclamations and Executive Orders that are inconsistent with the actions taken in this proclamation are superseded to the extent of such inconsistency.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.
Janice Graham, (410) 786-8020.
Mary Collins, (410) 786-3189.
Diane Corning, (410) 786-8486.
Kianna Banks (410) 786-3498.
Ronisha Blackstone, (410) 786-6882.
Alpha-Banu Huq, (410) 786-8687.
Lisa Parker, (410) 786-4665.
We have reviewed existing Medicare emergency regulatory preparedness requirements for both providers and suppliers. We found that many providers and suppliers have emergency preparedness requirements, but those requirements do not go far enough in ensuring that these providers and suppliers are equipped and prepared to help protect those they serve during emergencies and disasters. Hospitals, for example, are currently required to have emergency power and lighting in some specified areas and there must be facilities for emergency gas and water supply. We believe that these existing requirements are generally insufficient in the face of the needs of the patients, staff and communities, and do not address inconsistency in the level of emergency preparedness amongst healthcare providers. For example, while some accreditation organizations have standards that exceed CMS' current requirements for hospitals by requiring them to conduct a risk assessment, there are other providers and suppliers who do not have any emergency preparedness requirements, such as Community Mental Health Centers (CMHCs) and Psychiatric Residential Treatment Facilities (PRTFs). We concluded that current emergency preparedness requirements are not comprehensive enough to address the complexities of the actual emergencies. Over the past several years, the United States has been challenged by several natural and man-made disasters. As a result of the September 11, 2001 terrorist attacks, the subsequent anthrax attacks, the catastrophic hurricanes in the Gulf Coast states in 2005, flooding in the Midwestern states in 2008, the 2009 H1N1 influenza pandemic, tornadoes and floods in the spring of 2011, and Hurricane Sandy in 2012, our nation's health security and readiness for public health emergencies have been on the national agenda. This final rule issues emergency preparedness requirements that establish a comprehensive, consistent, flexible, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present. We recognize that central to this approach is to develop and guide emergency preparedness and response within the framework of our national healthcare system. To this end, these requirements also encourage providers and suppliers to coordinate their preparedness efforts within their own communities and states as well as across state lines, as necessary, to achieve their goals.
We are issuing emergency preparedness requirements that will be consistent and enforceable for all affected Medicare and Medicaid providers and suppliers (referred to collectively as “facilities,” throughout the remainder of this final rule where applicable). This final rule addresses the three key essentials we believe are necessary for maintaining access to healthcare services during emergencies: safeguarding human resources, maintaining business continuity, and protecting physical resources. Current regulations for Medicare and Medicaid providers and suppliers do not adequately address these key elements.
Based on our research and consultation with stakeholders, we have identified four core elements that are central to an effective and comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaid-participating providers and suppliers. The four elements of the emergency preparedness program are as follows:
•
•
•
•
As previously discussed, numerous natural and man-made disasters have challenged the United States over the past several years. Disasters can disrupt the environment of healthcare and change the demand for healthcare services; therefore, it is essential that healthcare facilities integrate emergency management into their daily functions and values. On December 27, 2013, we published a proposed rule titled, “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” (78 FR 79082). In this proposed rule we included a robust discussion about the current state of emergency preparedness and federal emergency preparedness activities that have established a foundation for the development and expansion of healthcare emergency preparedness systems. In addition, the December 2013 proposed rule included an appendix of the numerous resources and documents used to develop the proposed rule. We refer readers to the proposed rule for this background information.
The December 2013 proposed rule included discussion of previous events, such as the 2009 H1N1 influenza pandemic, the 2001 anthrax attacks, the tornados in 2011 and 2012, and Hurricane Sandy in 2012. In 2014, the United States faced a number of new and emerging diseases, such as MERS-CoV and Ebola, and a nationwide outbreak of Enterovirus D68, which was confirmed in 938 people in 46 states between mid-August and October 21, 2014 (
Various sections of the Social Security Act (the Act) define the types of providers and suppliers that may participate in Medicare and Medicaid and list the requirements that each provider and supplier must meet to be eligible for Medicare and Medicaid participation. The Act also authorizes the Secretary to establish other requirements as necessary to protect the health and safety of patients, although the wording of such authority differs slightly between provider and supplier types. Such requirements may include the CoPs for providers, CfCs for suppliers, and requirements for long-term care facilities. The CoPs and CfCs are intended to protect public health and safety and promote high quality care for all persons. Furthermore, the Public Health Service (PHS) Act sets forth additional regulatory requirements that certain Medicare providers and suppliers are required to meet in order to participate.
The following are the statutory and regulatory citations for the providers and suppliers for which we are issuing emergency preparedness regulations:
• Religious Nonmedical Health Care Institutions (RNHCIs)—section 1821 of the Act and 42 CFR 403.700 through 403.756.
• Ambulatory Surgical Centers (ASCs)—section 1832(a)(2)(F)(i) of the Act and 42 CFR 416.2 and 416.40 through 416.52.
• Hospices—section 1861(dd)(1) of the Act and 42 CFR 418.52 through 418.116.
• Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Residential Treatment Facilities (PRTFs)—sections1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 483.350 through 483.376.
• Programs of All-Inclusive Care for the Elderly (PACE)—sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 460.210.
• Hospitals—section 1861(e)(9) of the Act and 42 CFR 482.1 through 482.66.
• Transplant Centers—sections 1861(e)(9) and 1881(b)(1) of the Act and 42 CFR 482.68 through 482.104.
• Long Term Care (LTC) Facilities—Skilled Nursing Facilities (SNFs)—under section 1819 of the Act, Nursing Facilities (NFs)—under section 1919 of the Act, and 42 CFR 483.1 through 483.180.
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)—section 1905(d) of the Act and 42 CFR 483.400 through 483.480.
• Home Health Agencies (HHAs)—sections 1861(o), 1891 of the Act and 42 CFR 484.1 through 484.55.
• Comprehensive Outpatient Rehabilitation Facilities (CORFs)—section 1861(cc)(2) of the Act and 42 CFR 485.50 through 485.74.
• Critical Access Hospitals (CAHs)—sections 1820 and 1861(mm) of the Act and 42 CFR 485.601 through 485.647.
• Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services—section 1861(p) of the Act and 42 CFR 485.701 through 485.729.
• Community Mental Health Centers (CMHCs)—section 1861(ff)(3)(B)(i)(ii) of the Act, section 1913(c)(1) of the PHS Act, and 42 CFR 410.110.
• Organ Procurement Organizations (OPOs)—section 1138 of the Act and section 371 of the PHS Act and 42 CFR 486.301 through 486.348.
• Rural Health Clinics (RHCs)—section 1861(aa) of the Act and 42 CFR 491.1 through 491.11; Federally Qualified Health Centers (FQHCs)—section 1861(aa) of the Act and 42 CFR 491.1 through 491.11, except 491.3.
• End-Stage Renal Disease (ESRD) Facilities—sections 1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 494.180.
The proposed rule responded to concerns from the Congress, the healthcare community, and the public regarding the ability of healthcare facilities to plan and execute appropriate emergency response procedures for disasters. In the proposed rule, we identified four core elements that we believe are central to an effective emergency preparedness system and must be addressed to offer a more comprehensive framework of emergency preparedness requirements for the various Medicare- and Medicaid-participating providers and suppliers. The four elements are—(1) risk assessment and emergency planning; (2) policies and procedures; (3) communication plan; and (4) training and testing. We proposed that these core components be used across provider and supplier types as diverse as hospitals, organ procurement organizations, and home health agencies, while attempting to tailor requirements for individual provider and supplier types to meet their specific needs and circumstances, as well as the needs of their patients, residents, clients, and participants. These proposals are refined and adopted in this final rule.
In response to our December 2013 proposed rule, we received nearly 400 public comments. Commenters included individuals, healthcare professionals and corporations, national associations, health departments and emergency management professionals, and individual facilities that would be impacted by the regulation. Most comments centered around the hospital requirements, but could be applied to the additional provider and supplier types. We also received comments specific to the requirements we proposed for other individual provider and supplier types. In addition, we solicited comments on specific issues. We have organized our responses to the comments as follows: (1) General comments; (2) implementation date; (3) comments specific to hospitals and those that apply to the overall requirements of the regulation; and (4) comments specific to other providers and suppliers.
We received the following comments suggesting improvement to our regulatory approach or requesting clarification of the resources used to develop our proposals:
A few commenters disagreed with our statement that hospitals should have emergency preparedness plans and stated that hospitals are already prepared for emergencies. A commenter objected to the statement that hospital leadership has not prioritized disaster preparedness.
A commenter recommended that the proposed emergency preparedness requirements be reduced and simplified to reflect the minimum requirements that each provider type is expected to meet. Other commenters objected to the entire proposal and the establishment of additional regulations for healthcare facilities.
Upon review of the current emergency preparedness requirements for providers and suppliers participating in Medicare and Medicaid, we concluded that the current requirements are not comprehensive enough to address the complexities of actual emergencies. We believe that, currently, in the event of a disaster, healthcare facilities across the nation will not have the necessary emergency planning and preparation in place to adequately protect the health and safety of their patients. In addition, we believe that the current regulatory patchwork of federal, state, and local laws and guidelines, combined with various accrediting organizations' emergency preparedness standards, falls far short of what is needed for healthcare facilities to be adequately prepared for a disaster. Therefore, we proposed to establish comprehensive, consistent, and flexible emergency preparedness regulations that incorporate lessons learned from the past with the proven best practices of the present. Finalizing these proposals, with the modifications discussed later in this final rule, will help healthcare facilities be better prepared in case of a disaster or emergency. We note that the majority of the comments to the proposed rule agree with the establishment of some type of regulatory
In response to comments that request additional time for compliance or additional funds, we refer readers to the discussion on the implementation date and further discussions on funding in this final rule.
Some commenters stated that the proposed requirements are inappropriate because they mostly apply to hospitals, and cannot be applied to other healthcare settings. A commenter noted that smaller hospitals with limited capabilities, like LTCHs, should be allowed to work with their local emergency response networks to develop emergency preparedness plans that reflect those hospitals' limitations.
We agree with the commenter who stated that smaller hospitals should be allowed to work with their local health department and emergency management agency to develop emergency preparedness plans and we encourage these facilities to engage in healthcare coalitions in their area for assistance in meeting these requirements. However, we note that we are not mandating that smaller facilities confer with local emergency response networks while developing their emergency preparedness plans.
A commenter noted that local emergency management officials are rarely included in emergency planning. The commenter recommended adding a requirement that would require facilities to submit their emergency preparedness plan to their local emergency management agency for review and assessment, and for assistance on sheltering and evacuation procedures.
A commenter recommended that CMS collaborate closely with the Emergency Medical Services for Children (EMSC) program administered by the Health Resources and Services Administration (HRSA). The commenter noted that this program focuses on improving the pediatric components of the EMS system.
We believe that hospitals should have a single emergency plan that addresses all-hazards, including internal emergencies and a man-made emergency (or both) or natural disaster. Hospitals have the discretion to determine when to activate their emergency plan and whether to apply their emergency plan to internal or smaller emergencies or disasters that may occur within their facilities. We encourage hospitals to prepare for all-hazards that may affect their patient population and apply their emergency preparedness plans to any emergency or disaster that may arise. Furthermore, we encourage hospitals that may be dealing with an internal emergency or disaster to maintain communication with external emergency preparedness entities and other facilities where appropriate.
We refer commenters that are interested in recovery of operations planning to the following resources for more information:
• National Disaster Recovery Framework (NDRF):
• Continuity Guidance Circular 1 (CGC 1), and Continuity Guidance for Non-Federal Entities (States, Territories, Tribal, and Local Government Jurisdictions and Private Sector Organizations)
• National Preparedness System (
• Comprehensive Preparedness Guide 101
A commenter recommended that CMS work with other federal agencies, including the Department of Homeland Security (DHS) and the Federal Emergency Management Agency (FEMA) to expand ESAR-VHP and Medical Reserve Corps (MRC) team deployments to a 3 month rotation basis. The commenter also recommended that CMS purchase and pre-position Federal Reserve Inventories (FRI) at healthcare distributorships.
In regards to the comment on the Federal Reserve Inventories, we believe that the commenter may be referring to the Strategic National Stockpile (SNS). The SNS program is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, and medical supplies. It is not within CMS' purview to purchase, administer, or maintain SNS stock. We refer commenters who have questions about the SNS program to the Centers for Disease Control and Prevention (CDC) Web site at
Another commenter questioned why large single specialty and multispecialty medical groups are not discussed as included or excluded in this rule. The commenter noted that these entities have Medicare and Medicaid provider status; therefore, should be included in this rule. Another commenter questioned whether the proposed regulations would apply to residential drug and alcohol treatment centers. The commenter noted that if this is the case, it would be difficult for these centers to meet the proposed requirements due to lack of funding.
In response to the question about a Certificate of Need, we note that facilities must formulate an emergency preparedness plan that complies with state and local laws. A Certificate of Need is a document that is needed in some states and local jurisdiction before the creation, acquisition, or expansion of a facility is allowed. Facilities should check with their state and local authorities in regards to Certificate of Need requirements.
Another commenter recommended that the rule explicitly include and address the threats of fire, wildfires, tornados, and flooding. The commenter notes that these scenarios are not included in the National Planning Scenarios (NPS).
We also believe the emergency preparedness requirements should be included in the CoPs for providers, the CfCs for suppliers, and requirements for LTC facilities. These CoPs, CfCs, and requirements for LTC facilities are intended to protect public health and safety and ensure that high quality care is provided to all persons. Facilities must meet their respective CoPs, CfCs, or requirements in order to participate in the Medicare and Medicaid programs. We are able to enforce and monitor compliance with the CoPs, CfCs, and requirements for LTC facilities through the survey process. Therefore, we believe that the emergency preparedness requirements are included in the most appropriate regulatory chapters.
A commenter suggested that we add the following text to section II.B.1.a. of the proposed rule (78 FR 79085): “HSPD-21 tasked the establishment of the National Center for Disaster Medicine and Public Health (
A commenter recommended that we include the
A commenter suggested the addition of the phrase “private critical infrastructure” to the following statement on page 79086 of the proposed rule: “The Stafford Act authorizes the President to provide financial and other assistance to state and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts.”
A commenter included several articles and referenced documentation on emergency preparedness and proper management and disposal of medical waste materials, while another recommended that CMS reference specific FEMA reference documents. Another commenter referred CMS to the Comprehensive Preparedness Guidelines 101 Template, although the commenter did not specify the source of this template.
While it is not within the scope of this rule to address OSHA, NIOSH, or NIEHS work place regulations, we encourage providers and suppliers to consider developing policies and procedures to protect healthcare workers during an emergency. We refer readers to the following list of resources to aid providers and suppliers in the formulation of such policies and procedures:
In the proposed rule, we proposed that for each separately certified healthcare facility to have an emergency preparedness program that includes an emergency plan, based on a risk assessment that utilizes an all hazards approach, policies and procedures, a communication plan, and a training program.
Commenters explained that an integrated health system could be comprised of two nearby hospitals, a LTC facility, a HHA, and a hospice. The commenters stated that under our proposed regulation, each entity would need to develop an individual emergency preparedness program in order to be in compliance. Commenters proposed that we allow for the development of one universal emergency preparedness program that encompasses one community-based risk assessment, separate facility-based risk assessments, integrated policies and procedures that meet the requirements for each facility, and coordinated communication plans, training and testing. They noted that allowing for a coordinated emergency preparedness program would ultimately reduce the burden placed on the individual facilities and provide for a more coordinated response during an emergency.
As always, each facility will be surveyed individually and will need to demonstrate compliance. Therefore, the unified program will also need to be developed and maintained in a manner that takes into account the unique circumstances, patient populations, and services offered for each facility within the system. For example, for a unified plan covering both a hospital and a LTC facility, the emergency plan must account for the residents in the LTC facility as well as those patients within a hospital, while taking into consideration the difference in services that are provided at a LTC facility and a hospital. In addition, the healthcare system will need to take into account the resources each facility within the system has and any state laws that the facility must adhere to. The unified emergency preparedness program must also include a documented community-based risk assessment and an individual facility-based risk assessment for each separately certified facility within the health system, both utilizing an all-hazards approach. The unified program must also include integrated policies and procedures that meet the emergency preparedness requirements specific to each provider type as set forth in their individual set of regulations. Lastly, the unified program must have a coordinated communication plan and training and testing program. We believe that this approach will allow a healthcare system to spread the cost associated with training and offer a financial advantage to each of the facilities within a system. In addition, we believe that, in some cases this approach will provide flexibility and could potentially result in a more coordinated response during an emergency that will enable a more successful outcome.
The December 2013 proposed rule included an appendix of the numerous resources and documents used to develop the proposed rule. Specifically, the appendix to the proposed rule included helpful reports, toolkits, and samples from multiple government agencies such as ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See Appendix A, 78 FR 79198). In response to our proposed rule, we received numerous comments requesting that we provide facilities with increased funding and technical assistance to implement our proposed regulations.
Commenters suggested that formal technical assistance should be available to facilities to help them successfully implement their emergency preparedness requirements. A commenter recommended that ASPR should lead this effort given its expertise in emergency preparedness planning and its charge to lead the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies. Another commenter suggested that we consider hosting regional meetings for facilities to share information and resources and that we provide region specific resources on our Web site. Commenters encouraged CMS to promote collaborative planning among facilities and provide the support needed for facilities to leverage each other's resources. These commenters believe that networks of facilities will be in a better position than governmental resources to identify cost and time saving efficiencies, but need support from CMS to coordinate their efforts.
In addition, we note that in the proposed rule, we indicated numerous resources related to emergency preparedness, including helpful reports, toolkits, and samples from ASPR, the CDC, FEMA, HRSA, AHRQ, and the Institute of Medicine (See Appendix A, 78 FR 79198). Providers and suppliers should use these many resources as templates and the framework for getting their emergency preparedness programs started. We also refer readers to SAMHSA's Disaster Technical Assistance Center (DTAC) for more information on delivering an effective mental health and substance abuse (behavioral health) response to disasters at
Finally we note that ASPR, as a leader in healthcare system preparedness, developed and launched the Technical Resources, Assistance Center, and Information Exchange (TRACIE). TRACIE is designed to provide resources and technical assistance to healthcare system preparedness stakeholders in building a resilient healthcare system. There are numerous products and resources located within the TRACIE Web site that target specific provider types affected by this rule. While TRACIE does not focus specifically on the requirements implemented in this regulation, this is a valuable resource to aid a wide spectrum of partners with their health system emergency preparedness activities. We strongly encourage providers and suppliers to utilize TRACIE and leverage the information provided by ASPR.
In the proposed rule, we requested comments on the feasibility of tracking staff and patients in outpatient facilities.
After carefully analyzing the issues raised by commenters regarding the process to track staff and patients during and after an emergency, we agree with the commenters that our proposed requirements could be unnecessarily burdensome. We are revising the tracking requirements based on the type of facility. For CAHs, Hospitals, and RNHCIs we are removing the proposed requirement for tracking after an emergency. Instead, in this final rule we require that these facilities must document the specific name and location of the receiving facility or other location for patients who leave the facility during the emergency. We would expect facilities to track their on-duty staff and sheltered patients during an emergency and indicate where a patient is relocated to during an emergency (that is, to another facility, home, or alternate means of shelter, etc.).
Also, since providers and suppliers are required to conduct a risk assessment and develop strategies for addressing emergency events identified by the risk assessment, we would expect the facility to include in its emergency plan a method for contacting off-duty staff during an emergency and procedures to address other contingencies in the event staff are not able to report to duty which may include but are not limited to staff from other facilities and state or federally-designated health professionals.
For PRTFs, LTC facilities, ICF/IIDs, PACE organizations, CMHCs, and ESRD facilities we are finalizing as proposed the requirement to track staff and patients both during and after an emergency. We have clarified that the requirement applies to tracking on-duty staff and sheltered patients. Furthermore, we clarify that if on-duty staff and sheltered patients are relocated during the emergency, the provider or supplier must document the specific name and location of the receiving facility or other location. Unlike inpatient facilities, PRTFs, ICF/IIDs, and LTC facilities are residential facilities and serve as the patient's home, which is why in these settings we refer to the patients as “residents.” Similar to these residential facilities ESRD facilities, CMHCs, and PACE organizations, provide a continuum of care for their patients. Residents and patients of these facilities would anticipate returning to these facilities after an emergency. For this reason, we believe that it is imperative for these facilities to know where their residents/patients and staff are located during and after the
While we pointed out JPATS as a tool for providers and suppliers, we note that we indicated that we were not proposing a specific type of tracking system that providers and suppliers must use. We also indicated that in the proposed rule that a number of states have tracking systems in place or under development and the systems are available for use by healthcare providers and suppliers. We encourage providers and suppliers to leverage the support and resources available to them through local and national healthcare systems, healthcare coalitions, and healthcare organizations for resources and tools for tracking patients.
We have also reviewed our proposal to require ASCs, hospices, and HHAs to track their staff and patients before and after an emergency. We discuss in detail the comments we received specific to these providers and suppliers and revisions to their proposed tracking requirement in their specific section later in this final rule.
We proposed several variations on an implementation date for the emergency preparedness requirements (78 FR 79179). Regarding the implementation date, we requested information on the following issues:
• A targeted approach to emergency preparedness that would apply the rule to one provider or supplier type or a subset of provider types, to learn from implementation prior to requiring compliance for all 17 types of providers and suppliers.
• A phased-in approach that would implement the requirements over a longer time horizon, or differential time horizons for the different provider and supplier types.
Many commenters recommended that CMS require implementation at hospitals or LTC facilities first, so that other facilities could benefit from the experience and lessons learned by these providers. Some of these commenters stated that these providers have the most capacity to implement these requirements. A commenter recommended that hospitals implement the requirements of the rule first, followed by CAHs and other inpatient provider types and LTC facilities. Other provider and supplier types would follow thereafter. The commenter recommended that CMS establish a period of non-enforcement for each implementation phase, while a Phase 1 evaluation is conducted and feedback is given to other facilities.
Several commenters, including major hospital associations, disagreed with CMS' proposal to implement all of the requirements 1 year after the final rule is published. The commenters noted that implementation of all the requirements after 1 year would be burdensome and costly to many facilities. In addition, a few commenters noted that certain facilities, mainly rural and small facilities, may be at a disadvantage because they have not participated in national emergency preparedness planning efforts or because they lack the necessary resources to implement emergency preparedness plans.
A few commenters drew a distinction between accredited and non-accredited facilities and recommended that hospitals implement the requirements within a year or 2 after publication of the final rule. Some of the commenters noted that non-accredited facilities, CAHs, HHAs, and hospices, would need more time. Several of these commenters also stated that hospitals that need more time for implementation should be able to propose to CMS a reasonable period of time to comply. A few commenters stated that the emergency preparedness proposal is unlike the standards utilized by the TJC and that enforcement of these requirements should be at a later date for both accredited and non-accredited facilities.
Some commenters recommended that CMS give ASCs and FQHCs additional time to come into compliance. A commenter recommended that CMS set a later implementation date for the requirements and provide a flexible implementation timeframe based on provider type and resources. A few commenters stated that the implementation timeline is too short for rehabilitation facilities, long-term acute care facilities, LTC facilities, behavioral health inpatient facilities, and ICF/IIDs.
A few commenters recommended that CMS phase-in implementation on a standard-by-standard basis. A commenter recommended that LTC facilities implement the requirements 12 to 18 months after hospitals. Furthermore, the commenter recommended an 18 to 24 month phase-in of emergency systems and a 24 to 38 month phase-in for the training and testing requirements. Another commenter recommended that facilities be allowed to comply with the initial planning requirements within 2 years, and then be allowed to comply with the subsistence and infrastructure requirements in years 3 and 4.
The commenters varied in their recommendations on the timeframe CMS should use for the implementation date. These recommendations ranged from 6 months to 5 years, with a few commenters recommending even longer periods. Some commenters noted that applying a targeted approach, covering one or a subset of provider classes to learn from implementation prior to extending the rule to all groups, would also allow a longer period of time for other provider/supplier types to prepare for implementation. Furthermore, a commenter noted that a phased in approach would help to alleviate the cost burden on facilities that would need to create an emergency plan and train and test staff.
Commenters have stated that hospitals that are TJC-accredited are part of the Hospital Preparedness Program (HPP) program, and those hospitals that follow National Fire Protection Association (NFPA®) standards, have already established most of the emergency preparedness requirements set out in this rule. Based on CDC's National Health Statistics Reports; Number 37, March 24, 2011, page 2 (NCHS-2008PanFluandEP_NHAMCSSurveyReport_2011.pdf), about 67.9 percent of hospitals had plans for all six hazards (epidemic-pandemic, biological, chemical, nuclear-radiological, explosive-incendiary, and natural incidents). Nearly all hospitals (99.0 percent) had emergency response plans that specifically addressed chemical accidents or attacks, which were not significantly different from the prevalence of plans for natural disasters (97.8 percent), epidemics or pandemics (94.1 percent), and biological accidents or attacks. However, we also believe that other facilities will be ready to begin implementation of these rules at the same time as hospitals. We believe that most facilities already have some basic emergency preparedness requirements that can be built upon to meet the requirements set out in this final rule. We note that we have modified or eliminated some of our proposed requirements for certain providers and suppliers, as discussed later in this final rule, which should ease concerns about implementation. Therefore, we believe that all affected providers and suppliers will be able to comply with these requirements 1 year after the final rule is published.
We do not believe a period of non-enforcement is appropriate as it will further prolong the implementation of necessary and life-saving emergency preparedness planning requirements by facilities. A later implementation date will leave the most vulnerable patient populations and unprepared facilities without a valuable, life-saving emergency preparedness plan should an emergency arise. We have not received comments that persuaded us that a later implementation date for these requirements of more than 1 year is beneficial or appropriate for providers and suppliers or their patients.
In response to commenters that opposed our proposal to implement the requirements 1 year after the final rule was published and recommended that we afford facilities more time to implement the requirements, we do not believe that the requirements will be overly burdensome or overly costly to providers and suppliers. We note, as we have heard from many commenters, that many facilities already have established emergency preparedness plans, as required by accrediting organizations. However, we acknowledge that there may be a significant amount of work that small facilities and those with limited resources will need to undertake to establish an emergency preparedness plan that conforms to the requirements set out in this regulation. However, we believe that prolonging the requirements in this final rule by 1 year will provide sufficient time for implementation among the various facilities to meet the emergency preparedness requirements. We encourage facilities to engage and collaborate with their local partners and healthcare coalitions in their area for assistance. Facilities may also access ASPR's TRACIE web portal, which is a healthcare emergency preparedness information gateway that helps stakeholders at the federal, state, local, tribal, non-profit, and for-profit levels have access to information and resources to improve preparedness, response, recovery, and mitigation efforts. ASPR TRACIE, located at:
Some of these commenters stated that hospitals in particular already have emergency preparedness plans in place and are well equipped and prepared to implement the requirements set out in these regulations over the course of a year. Some commenters noted that most hospitals are fully aware of the 4 emergency preparedness requirements set out in the proposed rule through current accreditation standards. Furthermore, the commenters noted that these four requirements would not impose any additional burdens on hospitals. A few commenters acknowledged that some hospitals are not under the purview of an accrediting agency and therefore may need up to 1 year to implement the requirements.
However, we do understand that some facilities, especially smaller and more rural facilities, may experience difficulties developing their emergency preparedness plans. Therefore, we believe that setting an implementation date of 1 year after the effective date of this final rule for these requirements will give these and other facilities
We appreciate that some facilities have existing emergency preparedness plans. However, all facilities will be required to develop and maintain an emergency preparedness plan based on an all-hazards approach and address the four major elements of emergency preparedness in their plan that we have identified in this final rule. Each facility will be required to evaluate its current emergency preparedness plan and activities to ensure that it complies with the new requirements.
A few commenters recommended that providers be allowed a period of time where they are held harmless during a transitional planning period, where providers may be allotted more time to plan and implement the emergency preparedness requirements.
After consideration of the comments received, we are finalizing our proposal, without modification, to require implementation of all of the requirements for all providers and suppliers 1 year after the final rule is published.
Our proposed hospital regulatory scheme was the basis for all other
As previously discussed, many commenters commented on the proposed regulations for hospitals, but indicated that their comments could also be applied to the additional provider and supplier types. Therefore, where appropriate, we collectively refer to hospitals and the other providers and suppliers as “facilities” in this section of the final rule.
Section 1861(e) of the Act defines the term “hospital” and subsections (1) through (8) list requirements that a hospital must meet to be eligible for Medicare participation. Section 1861(e)(9) of the Act specifies that a hospital must also meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution. Under the authority of 1861(e) of the Act, the Secretary has established in regulations at 42 CFR part 482 the requirements that a hospital must meet to participate in the Medicare program.
Section 1905(a) of the Act provides that Medicaid payments may be applied to hospital services. Regulations at §§ 440.10(a)(3)(iii) and 440.140 require hospitals, including psychiatric hospitals, to meet the Medicare CoPs to qualify for participation in Medicaid. The hospital and psychiatric hospital CoPs are found at §§ 482.1 through 482.62.
Services provided by hospitals encompass inpatient and outpatient care for persons with various acute or chronic medical or psychiatric conditions, including patient care services provided in the emergency department. Hospitals are often the focal points for healthcare in their respective communities; thus, it is essential that hospitals have the capacity to respond in a timely and appropriate manner in the event of a natural or man-made disaster. Additionally, since Medicare-participating hospitals are required to evaluate and stabilize every patient seen in the emergency department and to evaluate every inpatient at discharge to determine his or her needs and to arrange for post-discharge care as needed, hospitals are in the best position to coordinate emergency preparedness planning with other providers and suppliers in their communities.
We proposed a new requirement under § 482.15 that would require hospitals to have both an emergency preparedness program and an emergency preparedness plan. To ensure that all hospitals operate as part of a coordinated emergency preparedness system, we proposed at § 482.15 that all hospitals establish and maintain an emergency preparedness plan that complies with both federal and state requirements. Additionally, we proposed that the emergency preparedness plan be reviewed and updated at least annually. As part of an annual review and update, staff are required to be trained and be familiar with many policies and procedures in the operation of their facility and are held responsible for knowing these requirements. Annual reviews help to refresh these policies and procedures which would include any revisions to them based on the facility experiencing an emergency or as a result of a community or natural disaster.
In keeping with the focus of the emergency management field, we proposed that prior to establishing an emergency preparedness plan, the hospital and all other providers and suppliers would first perform a risk assessment based on using an “all-hazards” approach. Rather than managing planning initiatives for a multitude of threat scenarios all-hazards planning focuses on developing capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. Thus, all-hazards planning does not specifically address every possible threat but ensures those hospitals and all other providers and suppliers will have the capacity to address a broad range of related emergencies.
We stated that it is imperative that hospitals perform all-hazards risk assessment consistent with the concepts outlined in the National Preparedness System, published by the United States (U.S.) Department of Homeland Security, as well as guidance provided by Agency for Healthcare Research and Quality (AHRQ), to help hospital planners and administrators make important decisions about how to protect patients and healthcare workers and assess the physical components of a hospital when a natural or manmade disaster, terrorist attack, or other catastrophic event threatens the soundness of a facility. We also provided additional guidance and resources for assistance with designing and performing a hazard vulnerability assessment.
In the proposed rule (78 FR 79094), we stated that in order to meet the proposed requirement for a risk assessment at § 482.15(a)(1), we would expect hospitals to consider, among other things, the following: (1) Identification of all business functions essential to the hospitals operations that should be continued during an emergency; (2) identification of all risks or emergencies that the hospital may reasonably expect to confront; (3) identification of all contingencies for which the hospital should plan; (4) consideration of the hospital's location, including all locations where the hospital delivers patient care or services or has business operations; (5) assessment of the extent to which natural or man-made emergencies may cause the hospital to cease or limit operations; and (6) determination of what arrangements with other hospitals, other healthcare providers or suppliers, or other entities might be needed to ensure that essential services could be provided during an emergency.
We proposed at § 482.15(a)(2) that the emergency plan include strategies for addressing emergency events identified by the risk assessment. For example, a hospital in a large metropolitan city may plan to utilize the support of other large community hospitals as alternate care placement sites for its patients if the hospital needs to be evacuated. However, we would expect the hospital to have back-up evacuation plans for circumstances in which nearby hospitals also were affected by the emergency and were unable to receive patients.
At § 482.15(a)(3), we proposed that a hospital's emergency plan address its patient population, including, but not limited to, persons at-risk. We also discussed in the preamble of the proposed rule that “at-risk populations” are individuals who may need additional response assistance, including those who have disabilities, live in institutionalized settings, are from diverse cultures, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have
We also proposed at § 482.15(a)(3) that a hospital's emergency plan address the types of services that the hospital would be able to provide in an emergency. In regard to emergency preparedness planning, we also proposed at § 482.15(a)(3) that all hospitals include delegations and succession planning in their emergency plan to ensure that the lines of authority during an emergency are clear and that the plan is implemented promptly and appropriately.
Finally, at § 482.15(a)(4), we proposed that a hospital have a process for ensuring cooperation and collaboration with local, tribal, regional, state, or federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the hospital's efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts. We stated that we believed planning with officials in advance of an emergency to determine how such collaborative and cooperative efforts would achieve and foster a smoother, more effective, and more efficient response in the event of a disaster. Providers and suppliers must document efforts made by the facility to cooperate and collaborate with emergency preparedness officials.
Some commenters recommended adding “local” after applicable federal and state emergency preparedness requirements since some states already have local laws and regulations governing their emergency management activities. There was concern voiced that several of CMS' proposals may conflict or overlap with state and local laws and requirements. They recommended that CMS should defer to state and local standards where the proposed CoPs and CfCs would overlap with, be less stringent than, or conflict with those standards.
Some commenters believed that the emergency preparedness policies and procedures based on the emergency plan and risk assessment could be a potential duplication of effort. They recommended that CMS only require healthcare organizations to document how they will meet the emergency preparedness standards in the emergency preparedness plan, and not require separate policies and procedures. They stated that the concept of an emergency preparedness plan is equivalent to a policy, and the emergency preparedness plan states how the hospital will meet a standard.
An emergency plan is one part of a facility's emergency preparedness program. The plan provides the framework, which includes conducting facility-based and community-based risk assessments that will assist a facility in addressing the needs of their patient populations, along with identifying the continuity of business operations which will provide support during an actual emergency. In addition, the emergency plan supports, guides, and ensures a facility's ability to collaborate with local emergency preparedness officials. As a separate standard, facilities will be required to develop policies and procedures to operationalize their emergency plan. Such policies and procedures should include more detailed guidance on what their staff will need to develop and operationalize in order to support the services that are necessary during an actual emergency.
•
•
As is often the case, in times of emergency, people seek assistance at general hospitals for such things as charging batteries for their medical equipment, and obtaining medical supplies such as oxygen, which they need for their care. The commenters' suggestion that community-wide alternate locations be established to handle these needs would need to be arranged with their local emergency preparedness officials. To facilitate that, the proposed rule requires a process for ensuring cooperation and collaboration with local, tribal, regional, state, and federal emergency preparedness officials in order to ensure an integrated response during a disaster or emergency situation. Facilities are encouraged to participate in a local healthcare coalition as it may provide assistance in planning and addressing broader community needs that may also be supported by local health department and emergency management resources. Facilities may include establishing community-wide alternate locations in their facility plan. Individual facilities would not be expected to take care of all the needs in the community during an emergency.
After consideration of the comments we received on the proposed rule, we are finalizing our proposal with the following modifications:
• Revising the introductory text of § 482.15 by adding the term “local” to clarify that hospitals must also coordinate with local emergency preparedness systems.
• Revising § 482.15(a)(4) to remove the word “ensuring” and replacing the word “ensure” with “maintain.”
We proposed at § 482.15(b) that a hospital be required to develop and implement emergency preparedness policies and procedures based on the emergency plan proposed at § 482.15(a), the risk assessment proposed at § 482.15(a)(1), and the communication plan proposed at § 482.15(c). We proposed that these policies and procedures be reviewed and updated at least annually.
We proposed at § 482.15(b)(1) that a hospital's policies and procedures would have to address the provision of subsistence needs for staff and patients, whether they evacuated or sheltered in place, including, but not limited to, at § 482.15(b)(1)(i), food, water, and medical supplies. We noted that the analysis of the disaster caused by the hurricanes in the Gulf States in 2005 revealed that hospitals were forced to meet basic subsistence needs for community evacuees, including visitors and volunteers who sheltered in place, resulting in the rapid depletion of subsistence items and considerable difficulty in meeting the subsistence needs of patients and staff. Therefore, we proposed that a hospital's policies and procedures also address how the subsistence needs of patients and staff that were evacuated would be met during an emergency.
At § 482.15(b)(1)(ii) we proposed that the hospital have policies and procedures that address the provision of alternate sources of energy to maintain: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; (2) emergency lighting; and (3) fire detection, extinguishing, and alarm systems. At § 482.15(b)(1)(ii)(D), we proposed that the hospital develop policies and procedures to address the provisions of sewage and waste disposal including solid waste, recyclables, chemical, biomedical waste, and waste water.
At § 482.15(b)(2), we proposed that the hospital develop policies and procedures regarding a system to track the location of staff and patients in the hospital's care, both during and after an emergency. We stated that it is imperative that the hospital be able to track a patient's whereabouts, to ensure adequate sharing of patient information with other facilities and to inform a patient's relatives and friends of the patient's location within the hospital, whether the patient has been transferred to another facility, or what is planned in respect to such actions. We did not propose a requirement for a specific type of tracking system. We believed that a hospital should have the flexibility to determine how best to track patients and staff, whether it uses an electronic database, hard copy documentation, or some other method. However, we stated that it is important that the information be readily available, accurate, and shareable among officials within and across the emergency response system, as needed, in the interest of the patient and included in their policies and procedures.
We proposed at § 482.15(b)(3) that a hospital have policies and procedures in place to ensure safe evacuation from the hospital, which would include consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with
We proposed at § 482.15(b)(5) that a hospital have policies and procedures that would require a system of medical documentation that would preserve patient information, protect the confidentiality of patient information, and ensure that patient records are secure and readily available during an emergency. In addition to the current hospital requirements for medical records located at § 482.24(b), we proposed that hospitals be required to ensure that patient records are secure and readily available during an emergency. We indicated that such policies and procedures would have to be in compliance with Health Insurance Portability and Accountability Act (HIPAA) Rules at 45 CFR parts 160 and 164, which protect the privacy and security of an individual's protected health information. We proposed at § 482.15(b)(6) that facilities have policies and procedures in place to address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state or federally designated healthcare professionals to address surge needs during an emergency.
We proposed at § 482.15(b)(7) that hospitals have a process for the development of arrangements with other hospitals and other facilities to receive patients in the event of limitations or cessation of operations at their facilities, to ensure the continuity of services to hospital patients. This requirement would apply only to facilities that provide continuous care and services for individual patients; therefore, we did not propose this requirement for transplant centers, CORFs, OPOs, clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language pathology services, or RHCs/FQHCs.
We also proposed at § 482.15(b)(8) that hospital policies and procedures would have to address the role of the hospital under a waiver declared by the Secretary, in accordance with section 1135 of the Act, for the provision of care and treatment at an alternate care site identified by emergency management officials. We proposed this requirement for inpatient providers only. We stated that we would expect that state or local emergency management officials might designate such alternate sites, and would plan jointly with local facilities on issues related to staffing, equipment and supplies at such alternate sites. This requirement encourages providers to collaborate with their local emergency officials in proactive planning to allow an organized and systematic response to assure continuity of care even when services at their facilities have been severely disrupted. Under section 1135 of the Act, the Secretary is authorized to temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements for healthcare providers to ensure that sufficient healthcare items and services are available to meet the needs of individuals enrolled in these programs in an emergency area (or portion of such an area) during any portion of an emergency period. Under an 1135 waiver, healthcare providers unable to comply with one or more waiver-eligible requirements may be reimbursed and exempted from sanctions (absent any determination of fraud or abuse). Additional information regarding the 1135 waiver process is provided in the CMS Survey and Certification document entitled, “Requesting an 1135 Waiver”, located at:
The comments we received on our proposed requirement for hospitals to develop and implement emergency preparedness policies and procedures are discussed later in this final rule. We also proposed that all providers and suppliers review and update their policies and procedures at least annually. We received a few comments on this issue.
Commenters noted that the facility's tracking system may not be compatible with the hospital's IT system. If the system lacks interoperability, it becomes difficult to share information across the emergency management system.
After consideration of the comments we received on the proposed rule, we are finalizing our proposal with the following modifications:
• Revising § 482.15(b)(1)(i) to add that hospitals must have policies and procedures that address the need to stock pharmaceuticals during an emergency.
• Revising § 482.15(b)(2) to remove the requirement for hospitals to track staff and patients after an emergency and clarifying that in the event staff and patients are relocated, hospitals must document the specific name and location of the receiving facility or other location for sheltered patients and on-duty staff who leave the facility during the emergency.
• Revising § 482.15(b)(5) to change the phrase “ensures records are secure and readily available” to “secures and maintain availability of records.”
• Revising § 482.15(b)(5) and (7) to remove the word “ensure.”
• Adding a new § 482.15(f) to allow a separately certified hospital within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
An effective and well maintained communication plan will facilitate coordinated patient care across healthcare providers, and with state and local public health departments and emergency systems to protect patient health and safety in the event of a disaster. For a hospital to operate effectively in an emergency situation, we proposed at § 482.15(c) that hospitals be required to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. We proposed that hospitals be required to review and update the communication plan at least annually. During an emergency, it is critical that hospitals, and all providers/suppliers, have a system to contact appropriate staff, patients' treating physicians, and other necessary persons in a timely manner to ensure continuation of patient care functions throughout the hospital and to ensure that these functions are carried out in a safe and effective manner. Updating the plan annually would facilitate effective communication during an emergency. Providers and suppliers are to have contact information for federal, state, tribal, regional, or local emergency preparedness staff and other sources of assistance. Patient care must be well coordinated across healthcare providers, and with state and local public health departments and emergency systems to protect patient health and safety in the event of a disaster.
At § 482.15(c)(1), we proposed that the communication plan include names and contact information about staff, entities providing services under arrangement, patients' physicians, other hospitals, and volunteers. We stated that, during an emergency, it is critical that hospitals have a system to contact appropriate staff, patients' treating physicians, and other necessary persons in a timely manner to ensure continuation of patient care functions throughout the hospital and to ensure that these functions are carried out in a safe and effective manner. We proposed at § 482.15(c)(2) to require hospitals to have contact information for federal, state, tribal, regional, or local emergency preparedness staff and other sources of assistance.
We proposed at § 482.15(c)(3) to require that hospitals have primary and alternate means for communicating with the hospital's staff and federal, state, tribal, regional, or local emergency management agencies.
We also proposed at § 482.15(c)(4) to require that hospitals have a method for sharing information and medical documentation for patients under the hospital's care, as necessary, with other healthcare facilities to ensure continuity of care.
We proposed at § 482.15(c)(5) that hospitals have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510 of the HIPAA Privacy Rule. Thus, hospitals would need to have a communication system in place capable of generating timely, accurate information that could be disseminated, as permitted, to family members and others. We believe this requirement would best be applied only to facilities that provide continuous care to patients, as well as to those facilities that take responsibility for and have oversight over or both, care of patients who are homebound or receiving services at home.
We proposed at § 482.15(c)(6) to require hospitals to have a means of providing information about the general condition and location of patients under the facility's care, as permitted under 45 CFR 164.510(b)(4) of the HIPAA Privacy Rule. Section 164.510(b)(4), “Use and disclosures for disaster relief purposes,” establishes requirements for disclosing patient information to a public or private entity authorized by law or by its charter to assist in disaster relief efforts for purposes of notifying family members, personal representatives, or certain others of the patient's location or general condition. We did not propose prescriptive requirements for how a hospital would comply with this requirement. Instead, we stated that we would allow hospitals the flexibility to develop and maintain their own system. Lastly, we proposed at § 482.15(c)(7) that a hospital have a means of providing information about the hospital's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
A few commenters disagreed with the proposal to require that communications plans have contact information for all staff physicians, families, patients, and contractors. A commenter stated that this would require an additional full time equivalent (FTE) staff member. Another commenter stated that it would be challenging and overly burdensome to maintain a current contact list, especially for volunteers.
A commenter stated that it could be difficult for children's hospitals to maintain a comprehensive list of people and entities, as required for a hospital's communication plan. The commenter gave an example of a hospital that maintains a listing for most managers
Furthermore, we clarify that we are not requiring hospitals to include in their communication plan contact information for the families of staff, or the families of patients who are not directly involved in the patient's care, or contractors not currently providing services under arrangement.
• Pagers.
• Internet provided by satellite or non-telephone cable systems.
• Cellular telephones (where appropriate). Facilities can also carry accounts with multiple cell phone carriers to mitigate communication failures during an emergency.
• Radio transceivers (walkie-talkies).
• Various other radio devices such as the NOAA Weather Radio and Amateur Radio Operators' (ham) systems.
• Satellite telephone communication system.
We have seen the importance of formulating this type of communication plan in the past to ensure continuity of care. Sharing patient information and documentation was found to be a significant problem during the 2005 hurricanes and flooding in the Gulf Coast states. In 2011, the ability to share information during the Joplin, Missouri tornado both electronically and via hard copy helped patient evacuations and continuity of care. In addition, during Hurricane Sandy in 2012, some hospitals reported receiving evacuated patients from a nearby hospital with little or no medical documentation (HHS OIG, Hospital Emergency Preparedness and Response During Super Storm Sandy. September 2014). In some cases, electronic medical records were unavailable and only oral patient histories could be provided. This lapse in medical documentation is detrimental to patient care. Therefore, we continue to believe that hospitals should include in their communication plan a method for sharing information and medical documentation for patients under the hospital's care, as necessary, with other healthcare providers to ensure continuity of care. We encourage hospitals and other providers and suppliers to engage in coalitions in their area for assistance in effectively meeting this requirement.
We clarify that we are not requiring the use of EHRs within this regulation and we understand that some hospitals and other providers and suppliers may still be using paper medical records. However, we encourage these facilities to consider the use of alternative means of storing patient care information, to ensure that medical documentation is
Facilities should establish an effective communication system, in accordance with the previously referenced provision of the HIPAA Privacy Rule that could generate timely, accurate information that can be disseminated, as permitted, to family members and others. Facilities should also consider including in their communication plan information on what type of patient information is releasable and who is authorized to release this information during an emergency.
We encourage facilities to engage in healthcare coalitions in their area for assistance. We also refer facilities to the following Web sites for more information about emergency communication planning:
A few commenters questioned if the HIPAA privacy laws would be relaxed or waived during an emergency. A commenter requested clarification on privacy rules in emergency situations across all providers and suppliers, first responders, and community aid organizations.
HIPAA requirements are not suspended during a national or public health emergency. However, the HIPAA Privacy Rule specifically permits certain uses and disclosures of protected health information in emergency circumstances and for disaster relief purposes, as described in HHS guidance at
Facilities and their legal counsel should review the HIPAA Privacy Rule carefully before deciding to share patient information. We refer readers to the following resources for more information on the application of the HIPAA Privacy Rule during an emergency:
If a facility using EHRs experiences an emergency where patient information needs to be communicated to a receiving facility that does not support an EHR system, alternate methods such as paper documentation or faxed information can be used. Facilities are encouraged to explore alternate means of communicating this information.
The rule requires a method of sharing patient information and medical documentation to ensure continuity of care as part of their communication plan. Interpretive guidance for this regulation and subsequent surveyor training will be completed after the publication of this rule.
HHS has initiatives designed to encourage HIE among all healthcare providers, including those who are not eligible for the Electronic Health Record (EHR) Incentive Programs, and are designed to improve care delivery and coordination across the entire care continuum. Our revisions to this rule are intended to recognize the advent of electronic health information technology and to accommodate and support adoption of Office of the National Coordinator for Health Information Technology (ONC) certified health IT and interoperable standards. We believe that the use of such technology can effectively and efficiently help facilities and other providers improve internal care delivery practices, support the exchange of important information across care team members (including patients and caregivers) during transitions of care, and enable reporting of electronically specified clinical quality measures (eCQMs). For more information, we direct stakeholders to the ONC guidance for EHR technology developers serving providers ineligible for the Medicare and Medicaid EHR Incentive Programs titled “Certification Guidance for EHR Technology Developers Serving Health Care Providers Ineligible for Medicare and Medicaid EHR Incentive Payments.” (
In addition, we encourage facilities to engage in healthcare coalitions in their area in effort to identify local best practices and potential examples that may assist them in developing communication plans that include a procedure for sharing information and medical documentation, when necessary, with other healthcare facilities to ensure continuity of care.
A commenter stated that some key communication planning items are not included in the proposed rule and are better described in the standard NFPA® 99, “Health Care Facilities Code, 2012 edition.”
We do not believe that we have been overly prescriptive in our communication plan requirements. Facilities are afforded the flexibility to include more detailed and stringent communication plan policies in their emergency preparedness plan, as long as they meet the minimum requirements described here.
Another commenter stated that it is unclear how a facility could demonstrate that any backup system would be sufficiently “geographically remote” from the region and stated that CMS should clearly define the expectations of this section. The commenter also noted that an expectation that facilities establish data farms in extremely remote areas of service was excluded from the ICR burden calculations.
The commenters also expressed concern about the language in the proposed rule which stated that “electronic information would be backed up both within and outside the geographic area where the hospital was located” and questioned what exactly constitutes enough of a geographic separation to meet the intent of the proposed language.
We encourage facilities to determine what federal, state, and local laws apply to their specific facility's locations and develop plans that comply with these federal, state, and local emergency preparedness requirements.
We note that this standard includes the minimum requirements for reviewing and updating a hospital's emergency preparedness communication plan. Hospitals can review and update their communication plan more frequently than annually if they choose to do so. Currently, many hospitals frequently update their contact list to account for staffing changes. Therefore, we continue to believe that hospitals should review and update their communication and emergency preparedness plan at least annually.
Another commenter recommended that facilities reevaluate and update their emergency and communication plan within 180 days of a specific emergency event.
In regards to the recommendation that facilities reevaluate and update their emergency and communication plan within 180 days of a specific emergency event, we note that the emergency preparedness CoPs require that hospitals and other providers and suppliers review and update their plans at least annually at a minimum. We are also requiring, at § 482.15(d)(2)(iv), that hospitals analyze the hospital's response to, and maintain documentation of, all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed. Facilities can choose to review and update their plans more frequently than annually at their own discretion.
After consideration of the public comments we received, we are finalizing our proposal, with the following modifications:
• Revising § 482.15(c) by adding the term “local” to this and parallel provisions throughout the rule to clarify that hospitals must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 482.15(c)(4) by replacing the term “ensure” with “maintain.”
• Revising § 482.15(c)(5) to clarify that hospitals must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
We proposed at § 482.15(d) that a hospital develop and maintain an emergency preparedness training and testing program. We proposed to require the hospital to review and update the training and testing program at least annually.
We stated that a well-organized, effective training program must include providing initial training in emergency preparedness policies and procedures. We proposed at § 482.15(d)(1) that hospitals provide such training to all new and existing staff, including any individuals providing services under arrangement and volunteers, consistent with their expected roles, and maintain documentation of such training. In addition, we proposed that hospitals provide training on emergency procedures at least annually and ensure that staff demonstrate competency in these procedures.
Regarding testing, we proposed at § 482.15(d)(2), to require hospitals to conduct drills and exercises to test their emergency plans. We proposed at § 482.15(d)(2)(i) to require hospitals to participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, we proposed that hospitals should conduct individual, facility-based mock disaster drills at least annually. However, we proposed at § 482.15(d)(2)(ii) that if a hospital experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the actual event.
We proposed at § 482.15(d)(2)(iii) to require hospitals to conduct a paper-based tabletop exercise at least annually. We indicated that the tabletop exercise could be based on the same or a different disaster scenario from the scenario used in the mock disaster drill or the actual emergency. We proposed to define a tabletop exercise as a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
We proposed at § 482.15(d)(2)(iv) that hospitals analyze their response to, and maintain documentation on, all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan as needed.
We received many comments on our proposed changes to require a hospital to develop and maintain an emergency preparedness training and testing program.
A few comments stated that our proposal for annual staff training is inappropriate, redundant in many situations, and a waste of scarce healthcare resources. Some commenters recommended that we only require annual training and exercises for those providers that would be instrumental in a disaster and require less frequent training and exercises for those providers that would not be expected to be operational during a disaster.
Several commenters requested that we clarify who exactly we are referring to in paragraph § 482.15(d)(1)(i), which states that individuals providing services under arrangement must receive initial training in emergency preparedness policies and procedures. Several commenters requested that we provide examples to eliminate any confusion about the use of the phrase. Other commenters stated that they believed that CMS was referring to groups of physicians, other clinicians, and others who provide services essential for adequate care of patients and maintenance of operation of the facilities, but whose relationship with the hospital is by contract rather than through employment or voluntary status. The commenters pointed out that there may be others with whom a hospital would have an arrangement for the provision of services, but these may be services that would not be essential during the course of a disaster. For example, the commenters explained that hospitals often have arrangements for servicing of office equipment, provision of staff training and education, grounds keeping, and so forth. The commenters stated that they do not believe it was our intent for all personnel covered by these arrangements to be trained for emergency preparedness, but would appreciate some clarification.
Several commenters recommended that we allow hospitals the flexibility to identify outsourced services that would be essential during a disaster and allow the hospital to identify which of these contracted individuals should receive training. Furthermore, a commenter posed a set of specific scenarios for us to consider, including whether the employees of a contracted food service, or a contracted plumber or electrician would need to have emergency preparedness training before they are able to work in the hospital. Similarly, this commenter believed that the language, as proposed, needed to be clarified.
In addition, a commenter requested that we further define what we mean by “volunteers” who would need to be trained. The commenter stated that the term was vague and questioned whether every volunteer would need training, and if so, what level of training. The commenter also inquired about a requested time frame for volunteers to complete training and how often volunteers would be required to be retrained. The commenter pointed out that volunteers are under no obligation to report for duty and cannot be relied upon to perform specified responsibilities during a disaster.
Finally, a commenter requested that we include a definition of “staff” in our proposal to require staff training, since many inpatient hospital-based specialists, such as hospitalists or neonatologists, now provide much of the inpatient medical care. The commenter also suggested that we require hospitals to identify individuals on staff and under contract that would need basic training, as well as staff that would likely manage an emergency event. The commenter suggested that we require hospitals to have a documented training plan for individuals with key responsibilities. The commenter also stated that hospitals should not be required to train all staff, contractors, and volunteers given that the costs associated with such training would far exceed the benefit in times of scarce resources.
Many commenters stated that most accrediting organizations and emergency response organizations require that providers test their emergency plans at least twice annually through fully operational exercises; these organizations do not accept a tabletop exercise to satisfy this requirement. These commenters recommended that we require two disaster drills annually and eliminate the requirement for a tabletop exercise. Furthermore, the commenters recommended that one of the drills be a community drill. Commenters also suggested that we exempt those facilities that participate in two annual disaster drills from the tabletop exercise requirement. A commenter suggested that we require a community mock disaster drill 1 year and a tabletop exercise the next year, rather than both in the same year. A commenter stated that conducting a disaster drill would require a good amount of planning and interruption of clinical services, therefore reducing this requirement to every other year would reduce the burden on the facility. Another commenter requested that we allow providers the flexibility to determine the type of drill or exercise needed to test their plan in accordance with their internal policies and procedures.
In summary, after consideration of the public comments, we are finalizing our proposal for hospitals to develop and maintain an emergency preparedness training and testing program as proposed, with the following exceptions:
• Revising § 482.15(d) by adding that each hospital's training and testing program must be based on the hospital's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 482.15(d)(1)(iv) by replacing the phrase “Ensure that staff can demonstrate” with the phrase “Demonstrate staff knowledge.”
• Revising § 482.15(d)(2) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 482.15(d)(2) to allow a hospital to choose the type of exercise it will conduct to meet the second annual testing requirement.
We proposed at § 482.15(e)(1)(i) that hospitals store emergency fuel and associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC) (NFPA®101) of the NFPA®. We note that CMS recently issued a final rule on May 4, 2016 entitled “Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities” (81 FR 26872), to adopt the NFPA® 2012 edition of the LSC and the “Health Care Facilities Code.” The current LSC states that a hospital's alternate source of power (for example, a generator), and all connected distribution systems and ancillary equipment, must be designed to ensure continuity of electrical power to designated areas and functions of a healthcare facility. Also, the LSC states that the rooms, shelters, or separate buildings housing the emergency power supply must be located to minimize the possible damage resulting from disasters such as storms, floods, earthquakes, tornadoes, hurricanes, vandalism, sabotage and other material and equipment failures.
In addition to the emergency power system inspection and testing requirements found in NFPA® 99, “Health Care Facilities Code,” NFPA® 101,“Life Safety Code,” and NFPA® 110, “Standard for Emergency and Standby Power Systems,” we proposed that hospitals test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the hospital anticipates it will require during an emergency.
We also proposed emergency and standby power requirements for CAHs and LTC facilities. As such, we requested information on this proposal, in particular on how we might better estimate costs in light of the existing LSC requirements, as well as other state and federal requirements.
We also appreciate the commenters that pointed out the logistical and budgetary challenges for the healthcare facilities that would be affected by this rule. After carefully considering all of the comments we received and reviewing reports on Hurricane Sandy and Hurricane Katrina (Live Science, “Why power is So Tricky for Hospital During Hurricanes”, Rachael Rettner, November 1, 2012 see
After consideration of the comments we received on the proposed rule, we are finalizing our proposal with the following modifications:
• Revising § 482.15(e)(2)(i) by removing the requirement for an additional 4 hours of generator testing and clarifying that facilities must meet the requirements of NFPA® 99 2012 edition, NFPA® 101 2012 edition, and NFPA® 110 2010 edition.
• Revising § 482.15(e)(3) by removing the requirement that hospitals maintain fuel onsite and clarifying that hospitals must have a plan to maintain operations unless the hospital evacuates.
• Adding a new § 482.15(h) to incorporate by reference the requirements of NFPA® 99, NFPA® 101, and NFPA® 110.
Section 1861(ss)(1) of the Act defines the term “Religious Nonmedical Health Care Institution” (RNHCI) and lists the requirements that a RNHCI must meet to be eligible for Medicare participation.
We have implemented these provisions in 42 CFR part 403, subpart G, “Religious Nonmedical Health Care Institutions Benefits, Conditions of Participation, and Payment.” As of June 2016, there were 18 Medicare-certified RNHCIs that were subject to the RNHCI regulations.
A RNHCI is a facility that is operated under all applicable federal, state, and local laws and regulations, which provides only non-medical items and services on a 24-hour basis to beneficiaries who choose to rely solely upon a religious method of healing and for whom the acceptance of medical services would be inconsistent with their religious beliefs. The religious non-medical care or religious method of healing means care provided under established religious tenets that prohibit conventional or unconventional medical care for the treatment of the patient and exclusive reliance on religious activity to fulfill a patient's total healthcare needs.
The RNHCI does not furnish medical items and services (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs or biologicals) to its patients. RNHCIs must not be owned by, or under common ownership or affiliated with, a provider of medical treatment or services.
We proposed to expand the current emergency preparedness requirements for RNHCIs, which are located within § 403.742, Condition of participation: Physical Environment, by requiring RNHCIs to meet the same proposed emergency preparedness requirements as we proposed for hospitals, subject to several exceptions.
The existing “Physical environment” CoP at § 403.742(a)(1) currently requires that the RNHCI provide emergency power for emergency lights, for fire detection and alarm systems, and for fire extinguishing systems. Existing § 403.742(a)(4) requires that the RNHCI have a written disaster plan that addresses loss of water, sewage, power and other emergencies. Existing § 403.742(a)(5) requires that a RNHCI have facilities for emergency gas and water supply. We proposed relocating the pertinent portions of the existing requirements at § 403.742(a)(1), (4), and (5) at proposed § 403.748(a) and (b)(1).
Proposed § 403.748(a)(1) would require RNHCIs to consider loss of power, water, sewage and waste disposal in their risk analysis. The proposed policies and procedures at § 403.748(b)(1) would require that RNHCIs provide for subsistence needs of staff and patients, whether they evacuate or shelter in place, including, but not limited to, food, water, sewage and waste disposal, non-medical supplies, alternate sources of energy for the provision of electrical power, the maintenance of temperatures to protect patient health and safety and for the safe and sanitary storage of such provisions, gas, emergency lights, and fire detection, extinguishing, and alarm systems.
The proposed hospital requirement at § 482.15(a)(1) would be modified for RNHCIs. We proposed at § 403.748(a)(1) to require RNHCIs to consider loss of power, water, sewage and waste disposal in their risk analysis. At § 403.748(b)(1)(i) for RNHCIs, we proposed to remove the terms “medical and nonmedical” to reflect typical RNHCI practice, since RNHCIs do not provide most medical supplies. At § 482.15(b)(3), we proposed that hospitals have policies and procedures for the safe evacuation from the hospital, which would include consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. At § 403.748(b)(3), we proposed to incorporate this hospital requirement for RNHCIs but to remove the words “and treatment” to more accurately reflect that medical care is not provided in a RNHCI.
We proposed at § 403.748(b)(5) to remove the term “health” from the proposed hospital requirement for “health care documentation” to reflect the non-medical care provided by RNHCIs.
The proposed hospital requirements at § 482.15(b)(6) would require hospitals to have policies and procedures to address the use of volunteers in an emergency or other staffing strategies, including the process and role for integration of state or federally designated healthcare professionals to address surge needs during an emergency. For RNHCIs, we proposed at § 403.748(b)(6) to use the hospital provision, but remove the language, “including the process and role for integration of state or federally designated healthcare professionals” since it is not within the religious framework of RNHCIs to integrate care issues for their patients with healthcare professionals outside of the RNHCI industry.
The proposed hospital requirements at § 482.15(b)(7) would require that hospitals develop arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to hospital patients. For RNHCIs, at § 403.748(b)(7), we added the term “non-medical” to accommodate the uniqueness of the RNHCI non-medical care.
The proposed hospital requirement at § 482.15(c)(1) would require hospitals to include in their communication plan: Names and contact information for staff, entities providing services under agreement, patients' physicians, other hospitals, and volunteers. For RNHCIs, we proposed substituting “next of kin, guardian or custodian” for “patients' physicians” because RNHCI patients do not have physicians.
Finally, unlike the proposed regulations for hospitals at § 482.15(c)(4), we proposed at § 403.748(c)(4), we propose to require RNHCIs to have a method for sharing information and care documentation for patients under the RNHCIs' care, as necessary, with healthcare providers to ensure continuity of care, based on the written election statement made by the patient or his or her legal representative. Also, at proposed § 403.748(c)(4), we removed the term “other” and “health” from the requirement for sharing information with “other health care providers” to more accurately reflect the care provided by RNHCIs.
At § 482.15(d)(2), “Testing,” we proposed that hospitals would be required to conduct drills and exercises to test their emergency plan. Because RNHCIs have such a narrow role and provide such a unique service in the community, we believe RNHCIs would not participate in performing such drills. We proposed that RNHCIs be required only to conduct a tabletop exercise annually. Likewise, unlike our proposal for hospitals at § 482.15(d)(2)(i), we did not propose that the RNHCI conduct a community mock disaster drill at least annually or conduct an individual, facility-based mock disaster drill. Although we proposed for hospitals at § 482.15(d)(2)(ii) that, if the hospital experiences an actual natural or man-made emergency, the hospital would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event, we did not propose this for RNHCIs.
At § 482.15(d)(2)(iv), we proposed to require hospitals to maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed. Again, at § 403.748(d)(2)(ii), for RNHCIs, we proposed to remove reference to drills.
Currently, at § 403.724(a), we require that an election be made by the Medicare beneficiary or his or her legal representative and that the election be documented in a written statement that the beneficiary: (1) Is conscientiously opposed to accepting non-excepted medical treatment; (2) believes that non-excepted medical treatment is inconsistent with his or her sincere religious beliefs; (3) understands that acceptance of non-excepted medical treatment constitutes revocation of the election and possible limitation of receipt of further services in a RNHCI; (4) knows that he or she may revoke the election by submitting a written statement to CMS, and (5) knows that the election will not prevent or delay access to medical services available under Medicare Part A in facilities other than RNHCIs. Thus, at § 403.748(c)(4), we proposed that such election documentation be shared with other care providers to preserve continuity of care during a disaster or emergency.
We did not receive any comments that specifically addressed the proposed rule as it related to RNHCIs. However, after consideration of the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for RNHCIs with the following modifications in response to general comments made with respect to all facilities:
• Revising the introductory text of § 403.748 by adding the term “local” to clarify that RNHCIs must also comply with local emergency preparedness requirements.
• Revising § 403.748(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 403.748(b)(2) to remove the requirement for RNHCIs to track staff and patients after an emergency and clarifying that in the event that staff and patients are relocated during an emergency, the RNHCI must document the specific name and location of the receiving facility or other location for sheltered patients and on-duty staff who leave the facility during an emergency.
• Revising § 403.748(b)(5)(iii) and (b)(7) to remove the term “ensure.”
• Revising § 403.748(c) by adding the term “local” to clarify that the RNHCI must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 403.748(c)(5) to clarify that RNHCIs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 403.748(d) by adding that each RNHCI's training and testing program must be based on the RNHCI's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 403.748(d)(1)(iv) by replacing the phrase “ensure that staff can demonstrate” with the phrase “demonstrate staff.”
Section 1833(i)(1)(A) of the Act authorizes the Secretary to specify those surgical procedures that can be performed safely in an ASC. The surgical services performed in ASCs are scheduled, elective, procedures for non-life-threatening conditions that can be safely performed in a Medicare-certified ASC setting.
Section 416.2 defines an ambulatory surgical center (ASC) as any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which the expected duration of services would not exceed 24 hours following an admission.
As of June 2016 there were 5,485 Medicare certified ASCs in the U.S. The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart C, are the health and safety standards a facility must meet to obtain Medicare certification. Existing § 416.41(c) requires ASCs to have a disaster preparedness plan. This existing requirement states the ASC must: (1) Have a written disaster plan that provides for the emergency care of its
We proposed to require ASCs to meet most of the same proposed emergency preparedness requirements as those we proposed for hospitals, with two exceptions. At § 416.54(c)(7), we proposed that ASCs be required to have policies and procedures that include a means of providing information about the ASCs' needs and their ability to provide assistance (such as physical space and medical supplies) to the authority having jurisdiction (local, state agencies) or the Incident Command Center, or designee. However, we did not propose that these facilities provide information regarding their occupancy, as we proposed for hospitals, since the term “occupancy” usually refers to occupancy in an inpatient facility. Additionally, we did not propose that these facilities provide for subsistence needs of their patients and staff.
Other commenters stated that it would be reasonable for an ASC to develop a communication plan that would require ASCs to maintain contact information for those who work at their facilities and for community emergency preparedness staff.
However, we do agree with the commenters that it may be unreasonable for an ASC to maintain the contact information for other ASCs, given the highly specialized nature of care in most ASC facilities. The procedures performed in an ASC vary depending on the focus of the ASC. Some ASCs specialize solely in eye procedures, while other may specialize in orthopedics, plastic surgery, pain treatment, dental, podiatric, urological, etc. Therefore, we are not finalizing our proposal to require that ASCs maintain the names and contact information for other ASCs in the ASC's communication plan.
After consideration of the comments we received on the proposed emergency preparedness requirements for ASCs and the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for ASCs with the following modifications:
• Revising the introductory text of § 416.54 by adding the term “local” to clarify that ASCs must also comply with local emergency preparedness requirements.
• Revising § 416.54(a)(4) to delete the term “ensuring” and to replace the term “ensure” with “maintain.”
• Revising § 416.54(b)(1) to remove the requirement for ASCs to track all staff and patients after an emergency and requiring that if any on-duty staff or patients are in the ASC during an emergency and transferred or relocated, the ASC must document the specific name and location of the receiving facility or other location.
• Revising § 416.54(b)(4)(iii) by replacing the phrase “ensures records are secure” with the phrase “secures and maintains the availability of records.”
• Removing § 416.54(b)(6) that requires that ASCs develop arrangements with other ASCs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to ASC patients, and renumbering paragraph (b)(7) as paragraph (b)(6).
• Revising § 416.54(c) by adding the term “local” to clarify that the ASC must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 416.54(c)(1)(iv) to remove the requirement that ASCs include the names and contact information for “Other ASCs” in the communication plan.
• Revising § 416.54(c)(5) to clarify that ASCs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 416.54(d) by adding that each ASC's training and testing program must be based on the ASC's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 416.54(d)(1)(iv) by replacing the phrase “ensure that staff can” with the phrase “demonstrate staff.”
• Revising § 416.54(d)(2)(i) by removing the requirement for ASCs to participate in a community-based disaster drill.
• Revising § 416.54(d)(2) to allow an ASC to choose the type of exercise they will conduct to meet the second annual testing requirement.
• Adding § 416.54(e) to allow a separately certified ASC within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Public Law 97-248, added section 1861(dd) to the Act to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. Under the authority of section 1861(dd) of the Act, the Secretary has established the CoPs that a hospice must meet in order to participate in Medicare and Medicaid The CoPs found at part 418, subparts C and D, apply to a hospice, as well as to the services furnished to each patient under hospice care.
Hospices provide palliative care rather than traditional medical care and curative treatment to terminally ill patients. Palliative care improves the quality of life of patients and their families facing the problems associated with terminal illness through the prevention and relief of suffering by means of early identification, assessment, and treatment of pain and other issues.
As of June 2016, there were 412 inpatient hospice facilities nationally. Under the existing hospice CoPs, hospice inpatient facilities are required to have a written disaster preparedness plan that is periodically rehearsed with hospice employees, with procedures to be followed in the event of an internal or external disaster and procedures for the care of casualties (patients and staff) arising from such disasters. This requirement, which is limited in scope, is found at § 418.110(c)(1)(ii) under “Standard: Physical environment.”
For hospices, we proposed to retain existing regulations at § 418.110(c)(1)(i), which state that a hospice must address real or potential threats to the health and safety of the patients, other persons, and property. However, we proposed to incorporate the existing requirements at § 418.110(c)(1)(ii) into proposed § 418.113(a)(2) and (d)(1). We proposed to require at § 418.113(a)(2) that the hospice's emergency preparedness plan include contingencies for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. In addition, we proposed to require at § 418.113(d)(1)(iv) that the hospice periodically review and rehearse its emergency preparedness plan with hospice employees with special emphasis placed on carrying out the procedures necessary to protect patients and others. We proposed that § 418.110(c)(1)(ii) and the designation for paragraph (i) of § 418.110(c)(1) be removed. Otherwise, the proposed emergency preparedness requirements for hospice providers were very similar to those for hospitals.
In the proposed rule, we stated that despite the key differences between hospitals and hospices, we believed the hospital emergency preparedness requirements, with some reorganization and revision are appropriate for hospice providers. Thus, our discussion focused on the requirements as they differed from the requirements for hospitals within the context of the hospice setting. Since hospices serve patients in both the community and within various types of facilities, we proposed to organize the requirements for the hospice provider's policies and procedures differently from the proposed policies and procedures for hospitals. Specifically, we proposed to group requirements that apply to all hospice providers at § 418.113(b)(1) through (5) followed by requirements at § 418.113(b)(6) that apply only to hospice inpatient care facilities.
Unlike our proposed hospital policies and procedures, we proposed at § 418.113(b)(2) to require all hospices, regardless of whether they operate their own inpatient facilities, to have policies and procedures to inform state and local officials about hospice patients in need of evacuation from their respective residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. Such policies and procedures must be in accord with the HIPAA Privacy Rule, as appropriate. This proposed requirement recognized that many frail hospice patients may be unable to evacuate from their homes without assistance during an emergency. This additional proposed requirement recognized the responsibility of the hospice to support the safety of its patients that reside in the community.
We note that the proposed requirements for communication at § 418.113(c) were the same as for hospitals, with the exception of proposed § 418.113(c)(7). At § 418.113(c)(7), for hospice facilities, we proposed to limit to inpatients the requirement that the hospice have policies and procedures that would include a means of providing information about the hospice's occupancy and needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee. The proposed requirements for training and testing at § 418.113(d) were the same as those proposed for hospitals.
A commenter stated that most hospices do not have access to funding to purchase communication networks that link to first responders, hospitals, and county/regional Incident Command Centers. They stated that, aside from land lines and cell phones if they are available, communication could be very challenging, if not impossible. Another commenter stated that it would take more time, and more federal and state support, for hospice providers to meet the proposed requirements.
We expect facilities to develop and maintain policies and procedures for patient care and their overall operations.
After consideration of the comments we received on the proposed emergency preparedness requirements for hospices, and the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for hospices with the following modifications:
• Revising the introductory text of § 418.113 by adding the term “local” to clarify that hospices must also coordinate with local emergency preparedness requirements.
• Revising § 418.113(a)(4) to delete the term “ensuring” and to replace the term “ensure” with “maintain.”
• Revising § 418.113(b)(1) to remove the requirement for home-based hospices to track staff and patients.
• Revising 418.113(b)(1) to clarify that in the event that there is an interruption in services during or due to an emergency, home based hospices must have policies in place for following up with on-duty staff and patients to determine services that are still needed. In addition, they must inform State and local officials of any on-duty staff or patients that they are unable to contact.
• Revising § 418.113(b)(5) to delete the term “ensure” and to replace it with the term “maintain.”
• Revising § 418.113(b)(6)(iii)(A) by adding that hospices must have policies and procedures that address the need to sustain pharmaceuticals during an emergency.
• Revising § 418.113(b)(6) by adding a new paragraph (v) to require that inpatient hospices track on-duty staff and patients during an emergency, and, in the event staff or patients are relocated, inpatient hospices must document the specific name and location of the receiving facility or other location to which on-duty staff and patients were relocated to during the emergency.
• Revising § 418.113(c) by adding the term “local” to clarify that the hospice must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 418.113(c)(5) to clarify that hospices must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 418.113(d) by adding that each hospice's training and testing program must be based on the hospice's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 418.113(d)(1)(ii) to replace the phrase “Ensure that hospice employees can demonstrate” to “Demonstrate staff.”
• Revising § 418.113(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 418.113(d)(2) to allow a hospice to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 418.113(e) to allow separately certified hospices within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Sections 1905(a)(16) and (h) of the Act define the term “Psychiatric Residential Treatment Facility” (PRTF) and list the requirements that a PRTF must meet to be eligible for Medicaid participation. To qualify for Medicaid participation, a PRTF must be certified and comply with conditions of payment and CoPs, at §§ 441.150 through 441.182 and §§ 483.350 through 483.376 respectively. As of June 2016, there were 377 PRTFs.
A PRTF provides inpatient psychiatric services for patients under age 21. Under Medicaid, these services must be provided under the direction of a physician. Inpatient psychiatric services must involve active treatment which means implementation of a professionally developed and supervised individual plan of care. The patient's plan of care includes an integrated program of therapies, activities, and experiences designed to meet individual treatment objectives that have been developed by a team of professionals along with the patient, his or her parents, legal guardians, or others into whose care the patient will be released after discharge. The plan must also include post-discharge plans and coordination with community resources to ensure continued services for the patient, his or her family, school, and community.
The current PRTF requirements do not include any requirements for emergency preparedness. We proposed to require that PRTF facilities meet the same requirements we proposed for hospitals. Because these facilities vary widely in size, we would expect that their emergency preparedness risk assessments, emergency plans, policies and procedures, communication plan, and training and testing will vary widely as well. However, we believe PRTFs have the capability to comply fully with emergency preparedness requirements so that the health and safety of its patients are protected in the event of an emergency situation or disaster.
The commenter also noted that the CMS proposed rule stated that PRTFs are not likely to have formal communication plans. However, the commenter stated that PRTFs accredited by TJC are subject to Standard EM.02.02.01, which requires that the organization include in an emergency preparedness plan details on how the facility will communicate during emergencies.
In addition, we acknowledge that some PRTFs may already have communication plans in place, as required as a condition of TJC accreditation. We appreciate the commenter's feedback and note that facilities that meet TJC accreditation standards should be well-equipped to comply with the communication plan requirements established in these CoPs.
After consideration of the comments we received on the proposed emergency preparedness requirements for PRTFs, and the general comments we received on the proposed rule in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for PRTFs with the following modifications:
• Revising the introductory text of § 441.184 by adding the term “local” to clarify that PRTFs must also comply with local emergency preparedness requirements.
• Revising § 441.184(a)(4) to delete the term “ensuring” and to replace the term “ensure” with “maintain.”
• Revising § 441.184(b)(1)(i) by adding that PRTFs must have policies and procedures that address the need to sustain pharmaceuticals during an emergency.
• Revising § 441.184(b)(2) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered residents. We have also revised paragraph (b)(2) to provide that if on-duty staff and sheltered residents are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 441.184(b)(5) to change the phrase “ensures records are secure and readily available” to “secures and maintain availability of records.”
• Revising § 441.184(b)(7) to replace the term “ensure” with “maintain.”
• Revising § 441.184(c) by adding the term “local” to clarify that the PRTF must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 441.184(c)(5) to clarify that PRTFs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 441.184(d) by adding that each PRTF's training and testing program must be based on the PRTF's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 441.184(d)(1)(iii) to replace the phrase “ensure that staff can demonstrate” to “Demonstrate staff knowledge.”
• Revising § 441.184(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 441.184(d)(2)(ii) to allow a PRTF to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 441.184(e) to allow a separately certified PRTF within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
The Balanced Budget Act (BBA) of 1997 established the Program of All-Inclusive Care for the Elderly (PACE) as a permanent Medicare and Medicaid provider type. Under sections 1894 and 1934 of the Act, a state participating in PACE must have a program agreement with CMS and a PACE organization. Regulations at § 460.2 describe the statutory authority that permits entities to establish and operate PACE programs under section 1894 and 1934 of the Act and § 460.6 defines a PACE organization as an entity that has in effect a PACE program agreement. Sections 1894(a)(3) and 1934(a)(3) of the Act define a “PACE provider.” The PACE model of care includes the provision of adult day healthcare and interdisciplinary team care management as core services. Medical, therapeutic, ancillary, and social support services are furnished in the patient's residence or on-site at a PACE center. Hospital, nursing home, home health, and other specialized services are furnished under contract. A PACE organization provides medical and other support services to patients predominantly in a PACE adult day care center. As of June 2016, there are 119 PACE programs nationally.
Regulations for PACE organizations at part 460, subparts E through H, set out the minimum health and safety standards a facility must meet in order to obtain Medicare certification. The current CoPs for PACE organizations include some requirements for emergency preparedness. We proposed to remove the current PACE organization requirements at § 460.72(c)(1) through (5) and incorporate these existing requirements into proposed § 460.84, Emergency preparedness requirements for Programs of All-Inclusive Care for the Elderly (PACE).
Currently § 460.72(c)(1), Emergency and disaster preparedness procedures, states that the PACE organization must establish, implement, and maintain documented procedures to manage medical and nonmedical emergencies
We proposed incorporating the language from § 460.72(c)(1) into § 460.84(b). Existing § 460.72(c)(2), which defines various emergencies, would be incorporated into § 460.84(b) as well. We did not add the statement in current § 460.72(c)(2), that “an organization is not required to develop emergency plans for natural disasters that typically do not affect its geographic location” because we proposed that PACE organizations utilize an “all-hazards” approach at § 460.84(a)(1).
Existing § 460.72(c)(3), which states that a PACE organization must provide appropriate training and periodic orientation to all staff (employees and contractors) and patients to ensure that staff demonstrate a knowledge of emergency procedures, including informing patients what to do, where to go, and whom to contact in case of an emergency, would be incorporated into proposed § 460.84(d)(1). The existing requirements for having available emergency medical equipment, for having staff who know how to use the equipment, and having a documented plan to obtain emergency medical assistance from outside sources in current § 460.72(c)(4) would be relocated to proposed § 460.84(b)(9). Finally, current § 460.72(c)(5), which states that the PACE organization must test the emergency and disaster plan at least annually and evaluate and document its effectiveness would be addressed by proposed § 460.84(d)(2). The current version of § 460.72(c)(1) through (5) would be removed.
We proposed that PACE organizations adhere to the same requirements for emergency preparedness as hospitals, with three exceptions. We did not propose that PACE organizations provide for basic subsistence needs of staff and patients, whether they evacuate or shelter in place, including food, water, and medical supplies; alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; emergency lighting; and fire detection, extinguishing, and alarm systems; and sewage and waste disposal as we proposed for hospitals at § 482.15(b)(1). The second difference between the proposed hospital emergency preparedness requirements and the proposed PACE emergency preparedness requirements was that we proposed adding at § 460.84(b)(4) a requirement for a PACE organization to have policies and procedures to inform state and local officials at any time about PACE patients in need of evacuation from their residences due to an emergency situation, based on the patient's medical and psychiatric conditions and home environment. Such policies and procedures must be in accord with the HIPAA Privacy Rule, as appropriate.
Finally, the third difference between the proposed requirements for hospitals and the proposed requirements for PACE organizations was that, at § 460.84(c)(7), we proposed to require these organizations to have a communication plan that includes a means of providing information about their needs and their ability to provide assistance to the authority having jurisdiction or the Incident Command Center, or designee. We did not propose requiring these organizations to provide information regarding their occupancy, as we proposed for hospitals (§ 482.15(c)(7)), since the term “occupancy” refers to occupancy in an inpatient facility.
After consideration of the comments we received on the proposed emergency preparedness requirements for PACE organizations, and the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for PACEs with the following modifications:
• Revising the introductory text of § 460.84 by adding the term “local” to clarify that PACE organizations must also coordinate with local emergency preparedness requirements.
• Revising § 460.84(a)(4) to delete the term “ensuring” and to replace the term “ensure” with “maintain.”
• Adding § 460.84(b)(1) to address subsistence needs, and renumbering the rest of the section accordingly.
• Revising § 460.84(b)(2) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered participants. We have also revised paragraph (b)(2) to provide that if on-duty staff and sheltered participants are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 460.84(b)(5) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records;” also revising paragraph (b)(7) to change the term “ensure” to “maintain.”
• Revising § 460.84(c) by adding the term “local” to clarify that the PACE
• Revising § 460.84(c)(5) to clarify that the PACE organization must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 460.84(d) by adding that each PACE organization's training and testing program must be based on the PACE organization's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 460.84(d)(1)(iii) to replace the phrase “Ensure that staff can demonstrate knowledge” to “Demonstrate staff knowledge.”
• Revising § 460.84(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 460.84(d)(2)(ii) to allow a PACE organization to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 460.84(e) to allow a separately a certified PACE organization within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
All transplant centers are located within hospitals. Any hospital that furnishes organ transplants and other medical and surgical specialty services for the care of transplant patients is a transplant hospital (42 CFR 482.70). Therefore, transplant centers must meet all hospital CoPs at §§ 482.1 through 482.57 (as set forth at § 482.68(b)), and the hospitals in which they are located must meet the provisions of § 482.15. The transplant hospital would be responsible for the emergency preparedness program for the entire hospital as set forth in § 482.15, including the transplant center. In addition, unless otherwise specified, heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers must meet all requirements for transplant centers at §§ 482.72 through 482.104.
Transplant centers are responsible for providing organ transplantation services from the time of the potential transplant candidate's initial evaluation through the recipient's post-transplant follow-up care. In addition, if a center performs living donor transplants, the center is responsible for the care of the living donor from the time of the initial evaluation through post-surgical follow-up care.
There are 770 Medicare-approved transplant centers. These centers provide specialized services that are not available at all hospitals. Thus, we believe that it is crucial for every transplant center to work closely with the hospital in which it is located and the designated organ procurement organization (OPO) for that donation service area (DSA) (unless the hospital has a waiver approved by the Secretary to work with another OPO) in preparing for emergencies so that it can continue to provide transplantation and transplantation-related services to its patients during an emergency.
We proposed to add a new transplant center CoP at § 482.78, “Emergency preparedness.” Proposed § 482.78(a) would require a transplant center to have an agreement with at least one other Medicare-approved transplant center to provide transplantation services and other care for its patients during an emergency. We also proposed at § 482.78(a) that the agreement between the transplant center and another Medicare-approved transplant center that agreed to provide care during an emergency would have to address, at a minimum: (1) The circumstances under which the agreement would be activated; and (2) the types of services that would be provided during an emergency.
Currently, under the transplant center CoP at § 482.100, Organ procurement, a transplant center is required to ensure that the hospital in which it operates has a written agreement for the receipt of organs with the hospital's designated OPO that identifies specific responsibilities for the hospital and for the OPO with respect to organ recovery and organ allocation. We proposed at § 482.78(b) to require transplant centers to ensure that the written agreement required under § 482.100 also addresses the duties and responsibilities of the hospital and the OPO during an emergency. We included a similar requirement for OPOs at § 486.360(c) in the proposed rule. We anticipated that the transplant center, the hospital in which it is located, and the designated OPO would collaborate in identifying their specific duties and responsibilities during emergency situations and include them in the agreement.
We did not propose to require transplant centers to provide basic subsistence needs for staff and patients, as we are proposing for hospitals at § 482.15(b)(1). Also, we did not propose to require transplant centers to separately comply with the proposed hospital requirement at § 482.15(b)(8) regarding alternate care sites identified by emergency management officials. This requirement would be applicable to inpatient providers since the overnight provision of care could be challenged in an emergency. The hospital in which the transplant center is located would be required under § 482.15 to provide for any transplant patients and living donors that are hospitalized during an emergency.
Concerning exceptions or modifications to the required statistics and outcome measures for operations during an emergency, we believe that is beyond the scope of this final rule. We would note that the current survey, certification, and enforcement procedures already provide for transplant centers to request consideration for mitigating factors in both the initial and re-approval processes for their center as set forth in § 488.61(f). In addition, there are specific requirements for requests related to natural disasters and public health emergencies (§ 488.61(f)(2)(vii)).
After consideration of the comments we received on those changes in the proposed rule, as discussed earlier and in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for transplant centers with the following modifications:
• Adding a requirement at § 482.15(g) that a transplant center be actively involved in the hospital's emergency preparedness planning and program, and the phrase “as defined by § 482.70”.
• Modifying § 482.68(b) to exempt transplant centers from the requirements in § 482.15.
• Removing the requirement in § 482.78 for transplant centers to have agreements with another transplant center.
• Modifying the requirement in § 482.78(b) to require that a transplant center be responsible for developing and maintaining mutually agreed upon protocols that address the duties and responsibilities of the transplant center, hospital, and OPO during an emergency.
• Adding “as defined by § 482.70” that sets forth the definition of a “transplant hospital” to clarify which hospitals are responsible for complying with § 482.15(g).
Section 1819(a) of the Act defines a skilled nursing facility (SNF) for Medicare purposes as an institution or a distinct part of an institution that is primarily engaged in providing skilled nursing care and related services to patients that require medical or nursing care or rehabilitation services due to an injury, disability, or illness. Section 1919(a) of the Act defines a nursing facility (NF) for Medicaid purposes as an institution or a distinct part of an institution that is primarily engaged in providing to patients: skilled nursing care and related services for patients who require medical or nursing care; rehabilitation services due to an injury, disability, or illness; or, on a regular basis, health-related care and services to individuals who due to their mental or physical condition require care and services (above the level of room and board) that are available only through an institution.
To participate in the Medicare and Medicaid programs, long-term care (LTC) facilities must meet certain requirements located at part 483, Subpart B, Requirements for Long Term Care Facilities. SNFs must be certified as meeting the requirements of section 1819(a) through (d) of the Act. NFs must be certified as meeting section 1919(a) through (d) of the Act. A LTC facility may be both Medicare and Medicaid approved.
LTC facilities provide a substantial amount of care to Medicare and Medicaid beneficiaries, as well as “dually eligible individuals” who qualify for both Medicare and Medicaid. As of June 2016, there were 15,699 LTC facilities and these facilities provided care for about 1.7 million patients.
The existing requirements for LTC facilities contain specific requirements for emergency preparedness, set out at § 483.75(m)(1) and (2). Section 483.75(m)(1) states that a facility must have detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing residents. We proposed that this language be incorporated into proposed § 483.73(a)(1). Existing § 483.75(m)(2) states that a facility must train all employees in emergency procedures when they begin to work in the facility, periodically review the procedures with existing staff, and carry out unannounced staff drills using those procedures. These requirements would be incorporated into proposed § 483.73(d)(1) and (2). Section 483.75(m)(1) and (2) would be removed.
Our proposed emergency preparedness requirements for LTC facilities are identical to those we proposed for hospitals at § 482.15, with two exceptions. Specifically, at § 483.73(a)(1), we proposed that in an emergency situation, LTC facilities would have to account for missing residents.
Section 483.73(c) would requires these facilities to develop an emergency preparedness communication plan, which would include, among other things, a means of providing information about the general condition and location of residents under the facility's care. We proposed to add an additional requirement at § 483.73(c)(8) that read, “A method for sharing information from the emergency plan that the facility has determined is appropriate with residents and their families or representatives.”
Also, we proposed at § 483.73(e)(1)(i) that LTC facilities must store emergency fuel and associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC) of the NFPA®. In addition to the emergency power system inspection and testing requirements found in NFPA® 99, NFPA® 101, and NFPA® 110, we proposed that LTC facilities test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the LTC facility anticipates it would require during an emergency.
However, we also solicited comments on whether there should be a specific requirement for “residents' power needs” in the LTC requirements.
A few commenters recommended that LTC facilities include their state Long-Term Care Ombudsman Program in this planning process. Some commenters also recommended that LTC facilities provide the Program with a completed emergency plan.
We continue to believe that each facility should have the flexibility to determine the information that is most appropriate to be shared with its residents and their families or representatives and the most efficient manner in which to share that information. Therefore, we are finalizing our proposal at § 483.73(c)(8) that LTC facilities develop and maintain a method for sharing information from the emergency plan that the facility has determined is appropriate with residents and their families or representatives. We note that we are not requiring that PACE and HHA providers share information from the emergency plan with families and their representatives. However, these providers can choose to share information with any appropriate party, so long as they comply with federal, state, and local laws.
We are not requiring LTC facilities to share information with stakeholders, or Long-Term Care Ombudsman Program representatives, because we believe
In addition to the CoPs/CfCs, interpretative guidelines (IGs) will be developed for each provider and supplier types. We also note that surveyors will be provided training on the emergency preparedness requirements, so that enforcement of the rule will be based on the regulations set forth here.
That checklist is a resource that facilities may use. In addition, over time CMS may publish updates or other checklists or facilities may choose to use tools from other resources.
After consideration of the comments we received on the proposals, and the general comments we received on the proposed rule, as discussed earlier in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for LTC facilities with the following modifications:
• Revising the introductory text of § 483.73 by adding the term “local” to clarify that LTC facilities must also comply with local emergency preparedness requirements.
• Revising § 483.73(a) to change the term “ensure” to “maintain.”
• Revising § 483.73(b)(1)(i) to state that LTC facilities must have policies and procedures that address the need to sustain pharmaceuticals during an emergency.
• Revising § 483.73(b)(2) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered residents. We have also revised paragraph (b)(2) to provide that if on-duty staff and sheltered residents are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 483.73(b)(5) to replace the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Revising § 483.73(b)(7) to replace the term “ensure” with “maintain.”
• Revising § 483.73(c) by adding the term “local” to clarify that the LTC facility must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 483.73(c)(5) to clarify that the LTC facility must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 483.73(d) by adding that each LTC facility's training and testing program must be based on the LTC facility's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 483.73(d)(1)(iv) to replace the phrase “Ensure that staff can demonstrate knowledge” with “Demonstrate staff knowledge.”
• Revising § 483.73(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 483.73(d)(2)(ii) to allow a LTC facility to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Revising § 483.73(e)(1) and (2) by removing the requirement for additional generator testing.
• Revising § 483.73(e)(2)(i) by removing the requirement for an additional 4 hours of generator testing and by clarifying that LTC facilities must meet the requirements of NFPA® 99, 2012 edition and NFPA® 110, 2010 edition.
• Revising § 483.73(e)(3) by removing the requirement that LTC facilities maintain fuel quantities onsite and clarify that LTC facilities must have a plan to maintain operations unless the LTC facility evacuates.
• Adding § 483.73(f) to allow a separately certified LTC facility within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
• Adding a new § 483.73(g) to incorporate by reference the requirements of 2012 NFPA® 99, 2012 NFPA® 101, and 2010 NFPA® 110.
Section 1905(d) of the Act created the ICF/IID benefit to fund “institutions” with four or more beds to serve people with [intellectual disability] or other related conditions. To qualify for Medicaid reimbursement, ICFs/IID must be certified and comply with CoPs at 42 CFR part 483, subpart I, §§ 483.400 through 483.480. As of June 2016, there were 6,237 ICFs/IID, serving approximately 129,000 clients, and all clients receiving ICF/IID services must qualify financially for Medicaid assistance under their applicable state plan. Clients with intellectual disabilities who receive care provided by ICF/IIDs may have additional emergency planning and preparedness requirements. For example, some care recipients are non-ambulatory, or may experience additional mobility or sensory disabilities or impairments, seizure disorders, behavioral challenges, or mental health challenges.
Because ICF/IIDs vary widely in size and the services they provide, we expect that the risk analyses, emergency plans, emergency policies and procedures, emergency communication plans, and emergency preparedness training will vary widely as well. However, we believe each of them has the capability to comply fully with the requirements so that the health and safety of its clients are protected in the event of an emergency situation or disaster.
Thus, we proposed to require that ICF/IIDs meet the same requirements we proposed for hospitals, with two exceptions. At § 483.475(a)(1), we proposed that ICF/IIDs utilize an all-hazards approach, including plans for locating missing clients. We believe that in the event of a natural or man-made disaster, ICF/IIDs would maintain responsibility for care of their own client population but would not receive patients from the community. Also, because we recognize that all ICF/IIDs clients have unique needs, we proposed to require ICF/IIDs to “address the unique needs of its client population . . .” at § 483.475(a)(3).
In addressing the unique needs of their client population, we believe that ICF/IIDs should consider their individual clients' power needs. For example, some clients could have motorized wheelchairs that they need for mobility, or require a continuous positive airway pressure or CPAP machine, due to sleep apnea. We believe that the proposed requirements at § 483.475(a) (a risk assessment utilizing an all-hazards approach and that the facility address the unique needs of its client population) encompass consideration of individual clients' power needs and should be included in ICF/IIDs risk assessments and emergency plans.
As we stated earlier, the purpose of this final rule is to establish requirements to ensure that Medicare and Medicaid providers and suppliers are prepared to protect the health and safety of patients in their care during more widespread local, state, and national emergencies. We do not believe the existing requirements for ICF/IIDs are sufficiently comprehensive to protect clients during an emergency that impacts the larger community. However, we have been careful not to remove emergency preparedness requirements that are more rigorous than the additional requirements we proposed.
For example, our current regulations for ICF/IIDs include requirements for emergency preparedness. Specifically, § 483.430(c)(2) and (3) contain specific requirements to ensure that direct care givers are available at all times to respond to illness, injury, fire, and other emergencies. However, we did not propose to relocate these existing facility staffing requirements at § 483.430(c)(2) and (3) because they
Current § 483.470, Physical environment, includes a standard for emergency plan and procedures at § 483.470(h) and a standard for evacuation drills at § 483.470(i). The standard for emergency plan and procedures at current § 483.470(h)(1) requires facilities to develop and implement detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing clients. This requirement will be relocated to proposed § 483.475(a)(1). Existing § 483.470(h)(1) will be removed.
Currently § 483.470(h)(2) states, with regard to a facility's emergency plan, that the facility must communicate, periodically review the plan, make the plan available, and provide training to the staff. These requirements are covered in proposed § 483.475(d). Current § 483.470(h)(2) will be removed.
ICF/IIDs are unlike many of the inpatient care providers. Many of the clients can be expected to have long term or extended stays in these facilities. Due to the long term nature of their stays, these facilities essentially become the clients' residences or homes. Section 483.475(c) requires these facilities to develop an emergency preparedness communication plan, which includes, among other things, a means of providing information about the general condition and location of clients under the facility's care. We did not indicate what information from the emergency plan should be shared or the timing or manner in which it should be disseminated. We believe that each facility should have the flexibility to determine the information that is most appropriate to be shared with its clients and their families or representatives and the most efficient manner in which to share that information. Therefore, we proposed to add an additional requirement at § 483.475(c)(8) that reads, “A method for sharing information from the emergency plan that the facility has determined is appropriate with clients and their families or representatives.”
The standard for disaster drills set forth at existing § 483.470(i)(1) specifies that facilities must hold evacuation drills at least quarterly for each shift of personnel under varied conditions to ensure that all personnel on all shifts are trained to perform assigned tasks; ensure that all personnel on all shifts are familiar with the use of the facility's fire protection features; and evaluate the effectiveness of their emergency and disaster plans and procedures. Currently § 483.470(i)(2) further specifies that facilities must evacuate clients during at least one drill each year on each shift; make special provisions for the evacuation of clients with physical disabilities; file a report and evaluation on each evacuation drill; and investigate all problems with evacuation drills, including accidents, and take corrective action. Furthermore, during fire drills, facilities may evacuate clients to a safe area in facilities certified under the Health Care Occupancies Chapter of the Life Safety Code. Finally, at existing § 483.470(i)(3), facilities must meet the requirements of § 483.470(i)(1) and (2) for any live-in and relief staff they utilize. Because these existing requirements are so extensive, we proposed cross referencing § 483.470(i) (redesignated as § 483.470(h)) at proposed § 483.475(d).
After consideration of the comments we received on these provisions of the proposed rule, and the general comments we received, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for ICF/IIDs with the following modifications:
• Revising the introductory text of § 483.475, by adding the term “local” to clarify that ICF/IIDs must also comply with local emergency preparedness requirements.
• Revising § 483.475(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Adding at § 483.475(b)(1)(i) that ICF/IIDs must have policies and procedures that address the need to sustain pharmaceuticals during an emergency.
• Revising § 483.47(b)(2) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered clients. We have also revised paragraph (b)(2) to provide that if on-duty staff and sheltered residents are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 483.475(b)(5) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records;” also revising paragraph (b)(7) to change the term “ensure” to “maintain.”
• Revising § 483.475(b)(1), (b)(1)(ii)(A), and (b)(2) to replace the term “residents” to “clients.” Throughout the preamble discussion, the terms “patients and residents” have been deleted and replaced with the term “client.”
• Revising § 483.475(c) by adding the term “local” to clarify that ICF/IIDs must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 483.475(c)(5) to clarify that ICF/IIDs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 483.475(d) by adding that each ICF/IID's training and testing program must be based on the ICF/IID's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 483.475(d)(1)(iv) to replace the phrase “Ensure that staff can demonstrate knowledge” to “Demonstrate staff knowledge.”
• Revising § 483.475(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 483.475(d)(2)(ii) to allow an ICF/IIDs to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 483.475(e) to allow a separately certified ICF/IID within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Under the authority of sections 1861(m), 1861(o), and 1891 of the Act, the Secretary has established in regulations the requirements that a home health agency (HHA) must meet to participate in the Medicare program. Home health services are covered for qualifying elderly and people with disabilities who are beneficiaries under the Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) benefits of the Medicare program. These services include skilled nursing care, physical, occupational, and speech therapy, medical social work and home health aide services which must be furnished by, or under arrangement with, an HHA that participates in the Medicare program and must be provided in the beneficiary's home. As of June 2016, there were 12,335 HHAs participating in the Medicare program. The majority of HHAs are for-profit, privately owned agencies. There are no existing emergency preparedness requirements in the HHA Medicare regulations at part 484, subparts B and C.
We proposed to add emergency preparedness requirements at § 484.22, under which HHAs would be required to comply with some of the requirements that we proposed for hospitals. We proposed additional requirements under the HHA policies and procedures that would apply only to HHAs to address the unique circumstances under which HHAs provide services.
Specifically, we proposed at § 484.22(b)(1) that an HHA have policies and procedures that include plans for its patients during a natural or man-made disaster. We proposed that the HHA include individual emergency preparedness plans for each patient as part of the comprehensive patient assessment at § 484.55.
At § 484.22(b)(2), we proposed to require that an HHA to have policies and procedures to inform federal, state and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. Such policies and procedures must be in accord with the HIPAA Privacy Rule, as appropriate.
We did not propose to require that HHAs meet all of the same requirements that we proposed for hospitals. Since HHAs provide healthcare services only in patients' homes, we did not propose requirements for policies and procedures to meet subsistence needs (§ 482.15(b)(1)); safe evacuation (§ 482.15(b)(3)); or a means to shelter in place (§ 482.15(b)(4)). We would not expect an HHA to be responsible for sheltering HHA patients in their homes or sheltering staff at an HHA's main or branch offices. We did not propose to require that HHAs comply with the proposed hospital requirement at § 482.15(b)(8) regarding the provision of care and treatment at alternate care sites identified by the local health department and emergency management officials. With respect to communication, we did not propose requirements for HHAs to have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510 as we propose for hospitals at § 482.15(c)(5). We have also modified the proposed requirement for hospitals at § 482.15(c)(7) by eliminating the reference to providing information regarding the facility's occupancy. The term occupancy usually refers to bed occupancy in an inpatient facility. Instead, at § 484.22(c)(6), we proposed to require HHAs to provide information about the HHA's needs and its ability to provide assistance to the local health department authority having jurisdiction or the Incident Command Center, or designee.
We understand that one approach may not work for some and that community involvement will depend on the specific needs and resources of the community. However, we believe that establishing these emergency preparedness requirements for HHAs, and the other provider and suppliers, encourages collaboration and coordination that allows for a consistent, yet flexible regulatory framework across provider and supplier types. We would expect that HHAs will be proactive in their role of collaborating in community emergency preparedness planning efforts on both the national and local level. Through these efforts we believe that stakeholders will gain the opportunities to educate and define their role in state and local emergency planning.
We expect that HHAs already assist their patients with knowing what to do in the event of an emergency and the possibility that they may need to provide self-care if agency personnel are not available. For example, discussions to develop the individualized emergency preparedness plans could include potential disasters that the patient may face within the home such as fire hazards, flooding, and tornados; and how to contact local emergency officials. Discussions may also include education on steps that can be taken to increase the patient's safety. The individualized plan would be the written answers and solutions as a result of these discussions and could be as simple as a detailed emergency card developed with the patient. As commenters have indicated that often time patients choose to negate their plans and evacuate, we would expect that HHAs would use the individualized emergency plan to instruct patients on agency notification protocols for patients that relocate during an emergency and provide patients with information about the HHAs emergency procedures. HHAs could also use the individualized emergency plan to identify out of state contacts for each patient if available. HHA personnel should document that these discussions occurred. We are not requiring that HHAs provide their emergency plan and policies to any long-term care ombudsman programs, but we would encourage cooperation between various agencies.
In response to the request for additional time, we have set the implementation date of these requirements for 1 year following the effective date of this final rule to allow facilities time to prepare. We also refer readers to the many resources that have been referenced in the proposed and
After consideration of the comments we received on these proposals, and the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for HHAs with the following modifications:
• Revising the introductory text of § 484.22 by adding the term “local” to clarify that HHAs must also comply with local emergency preparedness requirements.
• Revising § 484.22(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 484.22(b)(3) to require that in the event that there is an interruption in services during or due to an emergency, HHAs must have policies in place for following up with patients to determine services that are still needed. In addition, they must inform State and local officials of any on-duty staff or patients that they are unable to contact.
• Revising § 484.22(b)(4) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Removing § 484.22(b)(6) that required that HHAs develop arrangements with other HHAs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to HHA patients.
• Revising § 484.22(c) by adding the term “local” to clarify that the HHA must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 484.22(c)(1) to remove the requirement that HHAs include the names and contact information for “Other HHAs” in the communication plan.
• Revising § 484.22(d) by adding that each HHA's training and testing program must be based on the HHA's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 484.22(d)(1)(ii) by replacing the phrase “Ensure that staff can demonstrate knowledge” to “Demonstrate staff knowledge.”
• Revising § 484.22(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 484.22(d)(2)(ii) to allow a HHA to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 484.22(e) to allow a separately certified HHA within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Section 1861(cc) of the Act defines the term “comprehensive outpatient rehabilitation facility” (CORF) and lists the requirements that a CORF must meet to be eligible for Medicare participation. By definition, a CORF is a non-residential facility that is established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, sick, and persons with disabilities, at a single fixed location, by or under the supervision of a physician. As of June 2016, there were 205 Medicare-certified CORFs in the U.S.
Section 1861(cc)(2)(J) of the Act also states that the CORF must meet other requirements that the Secretary finds necessary in the interest of the health and safety of a CORF's patients. Under this authority, the Secretary has established in regulations, at part 485, subpart B, requirements that a CORF must meet to participate in the Medicare program.
Currently, § 485.64 “Conditions of Participation: Disaster Procedures ” includes emergency preparedness requirements CORFs must meet. The regulations state that the CORF must have written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters. The regulation requires that all personnel be knowledgeable with respect to these procedures, be trained in their application, and be assigned specific responsibilities.
Currently, § 485.64(a) requires a CORF to have a written disaster plan that is developed and maintained with the assistance of qualified fire, safety, and other appropriate experts. The other elements under § 485.64(a) require that CORFs have: (1) Procedures for prompt transfer of casualties and records; (2) procedures for notifying community emergency personnel; (3) instructions regarding the location and use of alarm systems and signals and firefighting equipment; and (4) specification of evacuation routes and procedures for leaving the facility.
Currently, § 485.64(b) requires each CORF to: (1) Provide ongoing training and drills for all personnel associated with the CORF in all aspects of disaster preparedness; and (2) orient and assign specific responsibilities regarding the facility's disaster plan to all new personnel within 2 weeks of their first workday.
We proposed that CORFs comply with the same requirements that would be required for hospitals, with appropriate exceptions.
Specifically, at § 485.68(a)(5), we proposed that CORFs develop and maintain the emergency preparedness plan with assistance from fire, safety, and other appropriate experts. We did not propose to require CORFs to provide basic subsistence needs for staff and patients as we proposed for hospitals at § 482.15(b)(1). Because CORFs are outpatient facilities, we did not propose that CORFs have a system to track the location of staff and patients under the CORF's care both during and after the emergency as we propose to require for hospitals at § 482.15(b)(2). At § 485.68(b)(1), we proposed to require that CORFs have policies and procedures for evacuation from the CORF, including staff responsibilities and needs of the patients.
We did not propose that CORFS have arrangements with other CORFs or other providers and suppliers to receive patients in the event of limitations or cessation of operations. Finally, we did not propose to require CORFs to comply with the proposed hospital requirement at § 482.15(b)(8) regarding alternate care sites identified by emergency management officials.
With respect to communication, we would not require CORFs to comply with a proposed requirement similar to that for hospitals at § 482.15(c)(5) that would require a hospital to have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510, although we are clarifying in this final rule that CORFs must establish communications plans that are in compliance with federal laws, including the HIPAA rules. In addition, CORFs would not be required to comply with the proposed requirement at § 482.15(c)(6), which would state that a hospital must have a means of providing information about the general condition and location of patients as permitted under 45 CFR 164.510(b)(4).
We proposed including in the CORF emergency preparedness provisions a requirement for CORFs to have a method for sharing information and medical documentation for patients under the CORF's care with other healthcare facilities, as necessary, to ensure continuity of care (see proposed § 485.68(c)(4)). At § 485.68(c)(5), we proposed to require CORFs to have a communication plan that include a means of providing information about the CORF's needs and its ability to provide assistance to the local health department or authority having jurisdiction or the Incident Command Center, or designee. We did not propose to require CORFs to provide information regarding their occupancy, as we propose for hospitals, since the term occupancy usually refers to bed occupancy in an inpatient facility.
We proposed to remove § 485.64 and incorporate certain requirements into § 485.68. This existing requirement at § 485.64(b)(2) would be relocated to proposed § 485.68(d)(1).
Currently, § 485.64 requires a CORF to develop and maintain its disaster plan with assistance from fire, safety, and other appropriate experts. We incorporated this requirement at proposed § 485.68(a)(5). Currently, § 485.64(a)(3) requires that the training program include instruction in the location and use of alarm systems and signals and firefighting equipment. We incorporated these requirements at proposed § 485.68(d)(1).
We did not receive any comments that specifically addressed the proposed rule as it relates to CORFs. However, after consideration of the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule, we are finalizing the proposed emergency preparedness requirements for CORFs with the following modifications:
• Revising the introductory text of § 485.68, by adding the term “local” to clarify that CORFs must also comply with local emergency preparedness requirements.
• Revising § 485.68(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 485.68(b)(3) to replace the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Revising § 485.68(c), by adding the term “local” to clarify that the CORFs must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 485.68(d) by adding that each CORF's training and testing program must be based on the CORF's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 485.68(d)(1)(iv) to replace the phrase “Ensure that staff can demonstrate knowledge” to “Demonstrate staff knowledge.”
• Revising § 485.68(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 485.68(d)(2)(ii) to allow a CORF to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 485.68(e) to allow a separately certified CORF within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Sections 1820 and 1861(mm) of the Act provide that critical access hospitals participating in Medicare and Medicaid meet certain specified requirements. We have implemented these provisions in 42 CFR part 485, subpart F, Conditions of Participation for Critical Access Hospitals (CAHs). As of June 2016, there are 1,337 CAHs that must meet the CAH CoPs and 121 CAHs with psychiatric or rehabilitation distinct part units (DPUs). DPUs within CAHs must meet the hospital CoPs in order to receive payment for services provided to Medicare or Medicaid patients in the DPU.
CAHs are small, rural, limited-service facilities with low patient volume. The intent of designating facilities as “critical access hospitals” is to ensure access to inpatient hospital services and outpatient services, including emergency services, that meet the needs of the community.
If no patients are present, CAHs are not required to have onsite clinical staff 24 hours a day. However, a doctor of medicine or osteopathy, nurse practitioner, clinical nurse specialist, or physician assistant is available to furnish patient care services at all times the CAH operates. In addition, there must be a registered nurse, licensed practical nurse, or clinical nurse specialist on duty whenever the CAH has one or more inpatients. In the event of an emergency, existing requirements state there must be a doctor of medicine or osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist, with training or experience in emergency care, on call and immediately available by telephone or radio contact and available onsite within 30 minutes on a 24-hour basis or, under certain circumstances for CAHs that meet certain criteria, within 60 minutes. CAHs currently are required to coordinate with emergency response systems in the area to establish procedures under which a doctor of medicine or osteopathy is immediately available by telephone or radio contact on a 24-hours a day basis to receive emergency calls, provide information on treatment of emergency patients, and refer patients to the CAH or other appropriate locations for treatment.
CAHs are required at existing § 485.623(c), “Standard: Emergency procedures,” to assure the safety of patients in non-medical emergencies by training staff in handling emergencies, including prompt reporting of fires; extinguishing of fires; protection and, where necessary, evacuation of patients, personnel, and guests; and cooperation with firefighting and disaster authorities. CAHs must provide for emergency power and lighting in the emergency room and for battery lamps and flashlights in other areas; provide for fuel and water supply; and take other appropriate measures that are consistent with the particular conditions of the area in which the CAH is located. Since CAHs are required to provide emergency services on a 24-hour a day basis, they must keep equipment, supplies, and medication used to treat emergency cases readily available.
We proposed to remove the current standard at § 485.623(c) and relocate these requirements into the appropriate sections of a new CoP entitled, “Condition of Participation: Emergency Preparedness” at § 485.625, which would include the same requirements that we propose for hospitals.
We proposed to relocate current § 485.623(c)(1) to proposed § 485.625(d)(1). We proposed to incorporate current § 485.623(c)(2) into § 485.625(b)(1). Current § 485.623(c)(3) would be included in proposed § 485.625(b)(1). Current § 485.623(c)(4) would be reflected by the use of the term “all-hazards” in proposed § 485.625(a)(1). Section 485.623(d) would be redesignated as § 485.623(c).
Also, as discussed in section II.A.4 of the of this final rule we proposed at § 485.625(e)(1)(i) that CAHs must store emergency fuel and associated equipment and systems as required by the 2000 edition of the Life Safety Code (LSC) of the NFPA®. In addition to the emergency power system inspection and testing requirements found in NFPA® 99 and NFPA® 110 and NFPA® 101, we proposed that CAHs test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the CAH anticipates it will require during an emergency.
We also received a number of comments pertaining to the proposed requirements for CAHs, most commenters addressing both hospitals and CAHs in their responses. Thus, we responded to the comments under the hospital section (section II.C. of this final rule). After consideration of the comments we received on the proposed rule, as discussed in section II.C of this final rule, we are finalizing the proposed emergency preparedness requirements for CAHs with the following:
• Revising the introductory text of § 485.625 by adding the term “local” to clarify that CAHs must also comply with local emergency preparedness requirements.
• Revising § 485.625(a)(4) by deleting the term “ensuring” and replacing the term “ensure with “maintain.”
• Adding at § 485.625(b)(1)(i) that CAHs must have policies and procedures that address the need to sustain pharmaceuticals during an emergency.
• Revising § 485.625(b)(2) to remove the requirement for CAHs to track on-duty staff and patients after an emergency and clarifying that in the event staff and patients are relocated, the CAH must document the specific name and location of the receiving facility or other location to which on-duty staff and patients were relocated to during an emergency.
• Revising § 485.625(b)(5) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records;” also revising paragraph (b)(7) to change the term “ensure” to “maintain”
• Revising § 485.625(c) by adding the term “local” to clarify that the CAHs must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 485.625(c)(1)(iv) by adding the phrase “and hospitals” to clarify that a CAH's communication plan must include contact information for other CAHs and hospitals in the area.
• Revising § 485.625(c)(5) to clarify that CAHs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 485.625(d) by adding that each CAH's training and testing program must be based on the CAH's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 485.625(d)(1)(iv) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising § 485.625(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 485.625(d)(2)(ii) to allow a CAH to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Revising § 485.625(e)(1) and (2) by removing the requirement for additional generator testing.
• Revising § 485.625(e)(2)(i) by removing the requirement for an additional 4 hours of generator testing and clarify that these facilities must meet the requirements of NFPA® 99 2012 edition, NFPA® 101 2012 edition, and NFPA® 110, 2010 edition.
• Revising § 485.625(e)(3) by removing the requirement that CAHs maintain fuel onsite and clarify that CAHs must have a plan to maintain operations unless the CAH evacuates.
• Adding § 485.625(f) to allow a separately certified CAH within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
• Adding § 485.625(g) to incorporate by reference the requirements of 2012 NFPA® 99, 2012 NFPA® 101, and 2010 NFPA® 110.
Under the authority of section 1861(p) of the Act, the Secretary has established CoPs that clinics, rehabilitation agencies, and public health agencies must meet when they provide outpatient physical therapy (OPT) and speech-language pathology (SLP) services. The CoPs are set forth at part 485, subpart H.
Section 1861(p) of the Act describes “outpatient physical therapy services” to mean physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient. The patient must be under the care of a physician.
The term “outpatient physical therapy services” also includes physical therapy services furnished to an individual by a physical therapist (in the physical therapist's office or the patient's home) who meets licensing and other standards prescribed by the Secretary in regulations, other than under arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency, if the furnishing of such services meets such conditions relating to health and safety as the Secretary may find necessary. The term also includes SLP services furnished by a provider of services, a clinic, rehabilitation agency, or by a public health agency, or by others under an arrangement.
As of June 2016, there are 2,135 clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language pathology services. In the remainder of this proposed rule and throughout the requirements, we use the term “Organizations” instead of “clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services” for consistency with current regulatory language.
We believe these Organizations comply with a provision similar to our proposed requirement for hospitals at § 482.15(c)(7), which states that a communication plan must include a means of providing information about the hospital's occupancy, needs, and its ability to provide assistance, to the local health department and emergency management authority having jurisdiction, or the Incident Command Center, or designee. At § 485.727(c)(5), we proposed to require that these Organizations have a communication plan that include a means of providing information about their needs and their ability to provide assistance to the authority having jurisdiction (local and state agencies) or the Incident Command Center, or designee. We did not propose to require these Organizations to provide information regarding their occupancy, as we proposed for hospitals, since the term “occupancy” usually refers to bed occupancy in an inpatient facility.
The current regulations at § 485.727, “Disaster preparedness,” require these Organizations to have a disaster plan. The plan must be periodically rehearsed, with procedures to be followed in the event of an internal or external disaster and for the care of casualties (patients and personnel) arising from a disaster. Additionally, current § 485.727(a) requires that the facility have a plan in operation with procedures to be followed in the event of fire, explosion, or other disaster. Those requirements are addressed throughout the proposed CoP, and we did not propose including the specific language in our proposed rule.
However, existing § 485.727(a) also requires that the plan be developed and maintained with the assistance of qualified fire, safety, and other appropriate experts. Because this existing requirement is specific to existing disaster preparedness requirements for these organizations, we relocated the language to proposed § 485.727(a)(6).
Existing requirements at § 485.727(a) also state that the disaster plan must include: (1) Transfer of casualties and records; (2) the location and use of alarm systems and signals; (3) methods
Currently, § 485.727(b) specifies requirements for staff training and drills. This requirement states that all employees must be trained, as part of their employment orientation, in all aspects of preparedness for any disaster. This disaster program must include orientation and ongoing training and drills for all personnel in all procedures so that each employee promptly and correctly carries out his or her assigned role in case of a disaster. Because these requirements are addressed in proposed § 485.727(d), we did not propose to relocate them but merely to address them in that paragraph. Current § 485.727, “Disaster preparedness,” would be removed.
We did not receive any comments that specifically addressed the proposed rule as it relates to clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services. However, after consideration of the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule, we are finalizing the proposed emergency preparedness requirements for these Organizations with the following modifications:
• Revising the introductory text of § 485.727 by adding the term “local” to clarify that the Organizations must also comply with local emergency preparedness requirements.
• Revising § 485.727(a)(5) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 485.727(b)(3) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Revising § 485.727(c), by adding the term “local” to clarify that the Organizations must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 485.727(d) by adding that the Organization's training and testing program must be based on the organization's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 485.727(d)(1)(iv) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising § 485.727(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 485.727(d)(2)(ii) to allow an Organization to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 485.727(e) to allow a separately certified Organizations within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
A community mental health center (CMHC), as defined in section 1861(ff)(3)(B) of the Act, is an entity that meets applicable licensing or certification requirements in the state in which it is located and provides the set of services specified in section 1913(c)(1) of the Public Health Service Act. Section 4162 of Public Law 101-508 (OBRA 1990), which amended section 1861(ff)(3)(A) and 1832(a)(2)(J) of the Act, includes CMHCs as entities that are authorized to provide partial hospitalization services under Part B of the Medicare program, effective for services provided on or after October 1, 1991. Section 1866(e)(2) of the Act and 42 CFR 489.2(c)(2) recognize CMHCs as providers of services for purposes of provider agreement requirements but only with respect to providing partial hospitalization services. In 2015 there were 362 Medicare-certified CMHCs.
We proposed that CMHCs meet the same emergency preparedness requirements we proposed for hospitals, with a few exceptions. At § 485.920(c)(7), we proposed to require CMHCs to have a communication plan that include a means of providing information about the CMHCs' needs and their ability to provide assistance to the local health department or emergency management authority having jurisdiction or the Incident Command Center, or designee.
We did not receive any comments that specifically addressed the proposed rule as it relates to CMHCs. However, after consideration of the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for CMHCs with the following modifications:
• Revising the introductory text of § 485.920 by adding the term “local” to clarify that CMHCs must also comply with local emergency preparedness requirements.
• Revising § 485.920(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 485.920(b)(1) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered clients. We have also revised paragraph (b)(1) to provide that if on-duty staff and sheltered clients are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 485.920(b)(4) and (6) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.” Also, we made changes in paragraph (b)(6) to replace the term “ensure” to “maintain.”
• Revising § 485.920(c) by adding the term “local” to clarify that CMHCs must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 485.920(c)(5) to clarify that CMHCs must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 485.920(d) by adding that each CMHC's training and testing program must be based on the CMHC's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 485.920(d)(1) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising § 485.920(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 485.920(d)(2)(ii) to allow a CMHC to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 485.920(e) to allow a separately certified CMHC within a healthcare system to elect to be a part of the healthcare systems emergency preparedness program.
Section 1138(b) of the Act and 42 CFR part 486, subpart G, establish that OPOs must be certified by the Secretary as meeting the requirements to be an OPO and designated by the Secretary for a specific donation service area (DSA). The current OPO CfCs do not contain any emergency preparedness
Since potential donors are located within hospitals, at proposed § 486.360(a)(3), instead of addressing the patient population as proposed for hospitals at § 482.15(a)(3), we proposed that the OPO address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
We proposed only 2 requirements for OPOs at § 486.360(b): (1) A system to track the location of staff during and after an emergency; and (2) a system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and ensures records are secure and readily available.
In addition, at § 486.360(c), we proposed only three requirements for an OPO's communication plan. An OPO's communication plan would be required to include: (1) Names and contact information for staff; entities providing services under arrangement; volunteers; other OPOs; and transplant and donor hospitals in the OPO's DSA; (2) contact information for federal, state, tribal, regional, or local health department and emergency preparedness staff and other sources of assistance; and (3) primary and alternate means for communicating with the OPO's staff, federal, state, tribal, regional, or local emergency management agencies. Unlike the requirement we proposed for hospitals at § 482.15(d)(2)(i) and (iii), we proposed at § 486.360(d)(2)(i) that an OPO be required only to conduct a tabletop exercise.
Finally, at § 486.360(e), we proposed that each OPO have agreement(s) with one or more other OPOs to provide essential organ procurement services to all or a portion of the OPO's DSA in the event that the OPO cannot provide such services due to an emergency. We also proposed that the OPO include within its agreements with hospitals required under § 486.322(a) and in the protocols with transplant programs required under § 486.344(d), the duties and responsibilities of the hospital, transplant program, and the OPO in the event of an emergency.
Another commenter also agreed with the importance of providing a communication plan with staff information, but disagreed with the requirement that all entities providing services under arrangement with an OPO should be contacted during an emergency. The commenter recommended that only vendors providing critical services be contacted.
We disagree with the commenters that the requirement for OPOs to have an agreement with another OPO is unnecessary. We believe each OPO should be prepared to continue its operations or at least those activities it deems essential during an emergency as required by § 486.360(e). However, as discussed later in this final rule, based on the comments we received, we have decided to provide alternate ways in which OPOs could satisfy this requirement, which are discussed as follows:
After consideration of the comments we received on these provisions, and the general comments we received on the proposed rule, as discussed in the hospital section (section II.C. of this final rule, we are finalizing the proposed emergency preparedness requirements for OPOs with the following modifications:
• Revising the introductory text of § 486.360 by adding the term “local” to clarify that OPOs must also comply with local emergency preparedness requirements.
• Revising § 486.360(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 486.360(b)(1) by clarifying that tracking during and after the emergency applies to on-duty staff and any staff that are relocated during an emergency. Also, we revised paragraph (b)(1) to provide that if on-duty staff are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• Revising § 486.360(b)(2) to change the phrase “ensures records are secure and readily available” to secures and maintains availability of records.”
• Revising § 486.360(c) by adding the term “local” to clarify that the OPO must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 486.360(d) by adding that each OPO's training and testing program must be based on the OPO's emergency plan, risk assessment using an all hazards approach, policies and procedures, and communication plan.
• Revising § 486.360(d)(1)(iv) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising the requirement in § 486.360(e) to require the development and maintenance of emergency preparedness protocols that are mutually agreed upon by the transplant center, hospital, and OPO.
• Revising § 486.360(e) to state that OPOs can satisfy the agreement requirement by having at least one other location from which they could operate from within their DSA or a plan to set up an alternate location during an emergency as part of its emergency plan as required by § 486.360(a).
• Adding § 486.360(f) to allow a separately certified OPO within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
As of June 2016, there were a combined total of 11,500 RHCs and FQHCs. Section 1861(aa) of the Act sets forth the rural health clinic (RHC) and federally qualified health center (FQHC) services covered by the Medicare and Medicaid program. RHCs must be located in an area that is both a rural area and a designated shortage area.
Conditions for Certification for RHCs and Conditions for Coverage for FQHCs are found at 42 CFR part 491, subpart A. Current emergency preparedness requirements are found at § 491.6(c).
We proposed that the RHCs' and FQHCs' emergency preparedness plans address the type of services the facility has the capacity to provide in an emergency.
Although RHCs and FQHCs currently do not have specific requirements for emergency preparedness, they have requirements for “Emergency Procedures” found at § 491.6, under “Physical plant and environment.” At § 491.6(c)(1), the RHC or FQHC must train staff in handling non-medical emergencies. This requirement would be addressed at proposed § 491.12(d)(1). At § 491.6(c)(2), the RHC or FQHC must place exit signs in appropriate locations. This requirement would be incorporated into our proposed requirement at § 491.12(b)(1), which would require RHCs and FQHCs to have policies and procedures for safe evacuation from the facility which includes appropriate placement of exit signs. Finally, at § 491.6(c)(3), the RHC or FQHC must take other appropriate measures that are consistent with the particular conditions of the area in which the facility is located. This requirement would be addressed throughout the proposed CfC for RHCs and FQHCs, particularly proposed § 491.12(a)(1), which requires the RHCs and FQHCs to perform a risk assessment based on an “all-hazards” approach. Current § 491.6(c) would be removed.
We proposed emergency preparedness requirements based on the requirements that we proposed for hospitals, modified to address the specific characteristics of RHCs and FQHCs. We do not believe all of these requirements are appropriate for RHCs/FQHCs, which serve only outpatients. We did not propose to require RHC/FQHCs to provide basic subsistence needs for staff and patients. Also, unlike that proposed for hospitals at § 482.15(b)(2), we did not propose that RHCs/FQHCs have a system to track the location of staff and patients in the facility's care both during and after the emergency.
At § 482.15(b)(3), we proposed that hospitals have policies and procedures for safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. Therefore, at § 491.12(b)(1), we proposed to require that RHCs/FQHCs have policies and procedures for evacuation from the RHC/FQHC, including appropriate placement of exit signs, staff responsibilities, and needs of the patients.
Unlike the requirement that was proposed for hospitals at § 482.15(b)(7), we did not propose that RHCs/FQHCs have arrangements with other RHCs/FQHCs or other providers and suppliers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to RHC/FQHC patients. We did not propose to require RHC/FQHCs to comply with the proposed hospital requirement at § 482.15(b)(8) regarding alternate care sites.
In addition, we would not require RHCs/FQHCs to comply with the proposed requirement for hospitals
Another commenter opposed CMS' proposed requirements for a communication plan for RHCs and FQHCs. The commenter stated their belief that RHCs and FQHCs should provide some level of patient clinical information during a disaster. The commenter noted the importance of sharing patient information with other hospitals that may be receiving evacuated patients during an emergency or a disaster. Furthermore, the commenter noted that these records should be available online through an EMR or through another procedure for providing patient information.
After consideration of the comments we received on these provisions, and the general comments we received on the proposed rule, as discussed previously and in the hospital section (section II.C. of this final rule, we are finalizing the proposed emergency preparedness requirements for RHCs and FQHCs with the following modifications:
• Revising the introductory text of § 491.12 by adding the term “local” to clarify that RHCs and FQHCs must also coordinate with local emergency preparedness requirements.
• Revising § 491.12(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 491.12(b)(3) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Revising § 491.12(c) by adding the term “local” to clarify that RHCs and FQHCs must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 491.12(d) by adding that a RHC and FQHC's training and testing program must be based on the RHC and FQHC's emergency plan, risk assessment, policies and procedures, and communication plan.
• Revising § 491.12(d)(1)(iv) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising § 491.12(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 491.12(d)(2)(ii) to allow a RHC and FQHC to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 491.12(e) to allow separately certified RHCs and FQHCs within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
Sections 1881(b), 1881(c), and 1881(f)(7) of the Act establish requirements for end-stage renal disease (ESRD) facilities. ESRD is a kidney impairment that is irreversible and permanent and requires either a regular course of dialysis or kidney transplantation to maintain life. Dialysis is the process of cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. As of June 2016, there were 6,648 Medicare-participating ESRD facilities in the U.S.
We addressed emergency preparedness requirements for ESRD facilities in the April 15, 2008 final rule (73 FR 20370) titled, “Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule.” Emergency preparedness requirements are located at § 494.60(d), Condition: Physical environment, Standard: Emergency preparedness. We proposed to relocate these existing requirements to proposed § 494.62, Emergency preparedness.
Current regulations include the requirement that dialysis facilities be organized into ESRD Network areas. Our regulations describe these networks at § 405.2110 as CMS-designated ESRD Networks in which the approved ESRD facilities collectively provide the necessary care for ESRD patients. The ESRD Networks have an important role in an ESRD facility's response to emergencies, as they often arrange for alternate dialysis locations for patients and provide information and resources during emergency situations. As noted earlier, we do not propose incorporating the ESRD Network requirements into this proposed rule. We did not propose to require ESRD facilities to provide basic subsistence needs for staff and patients, whether they evacuate or shelter in place, including food, water, and medical supplies; alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of provisions; emergency lighting; and fire detection, extinguishing, and alarm systems; and sewage and waste disposal as we proposed for hospitals at § 482.15(b)(1).
At § 494.62(b), we proposed to require facilities to address in their policies and procedures, fire, equipment or power failures, care-related emergencies, water
At § 482.15(b)(3), we proposed that hospitals have policies and procedures for the safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. We do not believe all of these requirements are appropriate for ESRD facilities, which serve only outpatients. Therefore, at § 494.62(b)(2), we proposed to require that ESRD facilities have policies and procedures for evacuation from the facility, including staff responsibilities and needs of the patients.
At § 494.62(b)(6), we proposed to require ESRD facilities to develop arrangements with other dialysis facilities or other providers and suppliers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to dialysis facility patients. At § 494.62(c)(7), dialysis facilities would be required to comply with the proposed requirement for hospitals at § 482.15(c)(7), with one exception. At § 494.62(c)(7), we proposed to require dialysis facilities to have a communication plan that include a means of providing information about their needs and their ability to provide assistance to the authority having jurisdiction or the Incident Command Center, or designee. We did not propose to require dialysis facilities to provide information regarding their occupancy, as we proposed for hospitals, since the term occupancy usually refers to bed occupancy in an inpatient facility.
At § 494.62(d)(1)(i), we proposed to require ESRD facilities to ensure that staff can demonstrate knowledge of various emergency procedures, including: informing patients of what to do; where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; and whom to contact if an emergency occurs while the patient is not in the dialysis facility.
We proposed to relocate existing requirements for patient training from § 494.60(d)(2) to proposed § 494.62(d)(3), patient orientation. In addition, the facility would have to ensure that, at a minimum, patient care staff maintained current CPR certification and ensure that nursing staff were properly trained in the use of emergency equipment and emergency drugs.
We proposed to redesignate current § 494.60(d). Current requirements for emergency plans at § 494.60 were captured within proposed § 494.62(a). Current language that defines an emergency for dialysis facilities found at § 494.60(d) would be incorporated into proposed § 494.62(b). We proposed to relocate existing requirements for emergency equipment and emergency drugs found at existing § 494.60(d)(3) to § 494.62(b)(9). We proposed to relocate the existing requirement at § 494.60(d)(4)(i) that requires the facility to have a plan to obtain emergency medical system assistance when needed to proposed § 494.62(b)(8). We proposed to relocate the current requirements at § 494.60(d)(4)(iii) for contacting the local health department and emergency preparedness agency at least annually to ensure that the agency is aware of dialysis facility's needs in the event of an emergency to proposed § 494.62(a)(4). We also proposed to redesignate the current § 494.60(e) as § 494.60(d).
A commenter agreed with the proposal that exempts ESRD facilities from having to provide information regarding occupancy since, according to the commenter, the facilities do not serve outpatient and do not routinely accommodate overnight stays.
After consideration of the comments we received on these provisions, and the general comments we received on the proposed rule, as discussed earlier and in the hospital section (section II.C. of this final rule), we are finalizing the proposed emergency preparedness requirements for ESRD facilities with the following modifications:
• Revising the introductory text of § 494.62 by adding the term “local” to clarify that dialysis facilities must also comply with local emergency preparedness requirements.
• Revising § 494.62(a)(4) by deleting the term “ensuring” and replacing the term “ensure” with “maintain.”
• Revising § 494.62(b)(1) by clarifying that tracking during and after the emergency applies to on-duty staff and sheltered patients. We have also revised paragraph (b)(1) to provide that if on-duty staff and sheltered patients are relocated during the emergency, the dialysis facility must document the specific name and location of the receiving facility or other location.
• Revising § 494.62(b)(4) to change the phrase “ensures records are secure and readily available” to “secures and maintains availability of records.”
• Revising § 494.62(b)(6) to replace the term “ensure” with “maintain.”
• Revising § 494.62(b)(8) to delete the phrase “a process to ensure that” and replacing the term with “How.”
• Revising § 494.62(b)(9) to delete the phrase “ensuring that” and replacing it with the term “by which the staff can confirm.”
• Revising § 494.62(c), by adding the term “local” to clarify that the dialysis facility must develop and maintain an emergency preparedness communication plan that also complies with local laws.
• Revising § 494.510(c)(5) to clarify that the dialysis facility must develop a means, in the event of an evacuation, to release patient information, as permitted under 45 CFR 164.510(b)(1)(ii).
• Revising § 494.62(d) by adding that each dialysis facility's training and testing program must be based on the dialysis facility's emergency plan, risk assessment using an all hazards approach, policies and procedures, and communication plan.
• Revising § 494.62(d)(1)(iii) to replace the phrase “ensure that staff can demonstrate knowledge” to “demonstrate staff knowledge.”
• Revising § 494.62(d)(2)(i) by replacing the term “community mock disaster drill” with “full-scale exercise.”
• Revising § 494.62(d)(2)(ii) to allow a dialysis facility to choose the type of exercise it will conduct to meet the second annual testing requirement.
• Adding § 494.62(e) to allow a separately certified dialysis facilities within a healthcare system to elect to be a part of the healthcare system's emergency preparedness program.
In this final rule, we are adopting the provisions of the December 27, 2013 proposed rule (78 FR 79082) with the following revisions:
• For all provider and supplier types, we are making a technical revision to clarify that facilities must also coordinate with local emergency preparedness systems.
• For RNHCIs, inpatient hospices, CAHs, ASCs, and hospitals, we are removing the requirement for facilities to track all staff and patients after an emergency and clarifying that in the event on-duty staff and sheltered patients are relocated during an emergency, the provider/supplier must document the specific name and location of the receiving facility or other location for staff and patients who leave the facility during the emergency.
• For home based hospices and HHAs, we are removing the tracking requirement and requiring that in the event there is an interruption in services during or due to an emergency, the provider must have policies in place for following up with on-duty staff and patients to determine services that are still needed. In addition, they must inform state and local officials of any on-duty staff or patients that they are unable to contact.
• For ESRD facilities, CMHCs, LTC facilities, ICF/IIDs, PACE organizations, PRTFs, and OPOs we are clarifying that tracking during and after the emergency applies to on-duty staff and sheltered patients. We have also revised the regulations to provide that if on-duty staff and sheltered patients are relocated during the emergency, the facility must document the specific name and location of the receiving facility or other location.
• We did not propose a tracking requirement for CORFs, RHCs, FQHCs, transplant centers, and Organizations and have not made any revisions regarding tracking for these facilities in this final rule.
• For ASCs and HHAs, we are removing the requirement that ASCs and HHAs develop arrangements with other ASCs/HHAs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to patients.
• For ASCs and HHAs, we are removing the requirement that the communication plan include the names and contact information for other ASCs/HHAs.
• For all provider and supplier types, we are making a technical revision to clarify that facilities must develop and maintain an emergency preparedness communication plan that also complies with local law.
• For RNHCIs, ASCs, hospices, PRTFs, PACE organizations, hospitals, LTC facilities, ICF/IIDs, CAHs, CMHCs, and dialysis facilities, we are clarifying that these provider and supplier types must have a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
• For all provider and supplier types with the exception of RNHCIs, OPOs, and transplant centers, we are revising testing requirements by replacing the term “community mock disaster drill” with “full-scale exercise.”
• For ASCs only, we are removing the requirement for participation in a community-based testing exercise and revising the requirement to only require ASCs to conduct an individual, facility-based full scale testing exercise.
• For all provider and supplier types with the exception of RNHCIs, OPOs, and transplant centers, we are revising testing requirements to allow each facility to choose the type of exercise they must conduct to meet the second annual testing requirement.
• For hospitals, CAHs, and LTC facilities, we are revising emergency and standby power system requirements by removing the requirement for an additional 4 hours of generator testing and clarifying that a facility must meet the requirements of NFPA® 99 2012 edition and NFPA® 110, 2010 edition.
• For hospitals, CAHs, and LTC facilities, we are revising emergency and standby power system requirements by removing the requirement that a facility must maintain fuel onsite and clarifying that facilities must have a plan to maintain operations unless the facility evacuates.
• For all provider and supplier types, we are adding a separate standard to the regulations text that will allow a separately certified healthcare facility within a healthcare system to elect to be a part of the healthcare systems unified emergency preparedness program.
In this final rule, we are incorporating by reference the NFPA 101® 2012 edition of the LSC, issued August 11, 2011, and all Tentative Interim Amendments issued prior to April 16, 2014; the NFPA 99® 2012 edition of the Health Care Facilities Code, issued August 11, 2011, and all Tentative Interim Amendments issued prior to April 16, 2014; and the NFPA 110 ® 2010 edition of the Standard for Emergency and Standby Power
• NFPA® 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.
++ TIA 12-2 to NFPA® 99, issued August 11, 2011.
++ TIA 12-3 to NFPA® 99, issued August 9, 2012.
++ TIA 12-4 to NFPA® 99, issued March 7, 2013.
++ TIA 12-5 to NFPA® 99, issued August 1, 2013.
++ TIA 12-6 to NFPA® 99, issued March 3, 2014.
• NFPA® 101, Life Safety Code, 2012 edition, issued August 11, 2011;
++ TIA 12-1 to NFPA® 101, issued August 11, 2011.
++ TIA 12-2 to NFPA® 101, issued October 30, 2012.
++ TIA 12-3 to NFPA® 101, issued October 22, 2013.
++ TIA 12-4 to NFPA® 101, issued October 22, 2013.
• NFPA® 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 2009.
The materials that are incorporated by reference are reasonably available to interested parties and can be inspected at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
The NFPA 101® 2012 edition of the LSC (including the TIAs) provides minimum requirements, with due regard to function, for the design, operation and maintenance of buildings and structures for safety to life from fire. Its provisions also aid life safety in similar emergencies.
The NFPA 99® 2012 edition of the Health Care Facilities Code (including the TIAs) provides minimum requirements for health care facilities for the installation, inspection, testing, maintenance, performance, and safe practices for facilities, material, equipment, and appliances, including other hazards associated with the primary hazards.
The NFPA 110® 2010 edition of the Standard for Emergency and Standby Power Systems (including the TIAs) provides minimum requirements for the installation, maintenance, operation, and testing requirements as they pertain to the performance of the emergency power supply system (EPSS).
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
Please note that under this final rule, a hospital's ICRs will differ from the ICRs of other Medicare or Medicaid provider and supplier types. We have calculated the ICR for each provider and supplier separately and have included a chart summarizing the burden at the end of each section. A significant factor in the burden for each provider or supplier type will be whether the type of facility provides inpatient services, outpatient services, or both. Moreover, even where the regulatory requirements are the same, certain factors will greatly affect the burden for different providers and suppliers, such as the size and location of the provider or supplier, whether or not they participate in any type of network, and whether they already have a substantial emergency preparedness program.
We have determined that the development of an emergency plan is more labor intensive than conducting the risk assessment for a few reasons. In general, the risk assessment process requires following a checklist and/or filling out a table (see:
In each section, where possible, we provide information regarding the characteristics which drive burden for each provider and supplier type. Current Medicare or Medicaid regulations for some providers and suppliers include requirements similar to those in this regulation. For example, existing regulations for RNHCIs and dialysis facilities require both types of facilities to have written disaster plans that address emergencies (42 CFR 403.742(a)(4) and 42 CFR 494.60(d)(4), respectively).
We have determined that the time required to conduct an annual review and update of the emergency preparedness plan is dependent upon whether there are existing emergency preparedness requirements for the providers and suppliers. We believe that the providers and suppliers with existing emergency preparedness requirements have some sort of an emergency preparedness plan that is updated at least annually based on current standards of practice. For these providers and suppliers, no additional burden has been assigned for the annual review and update of the emergency preparedness plan. The following providers and suppliers currently have emergency preparedness requirements: RNCHIs, ASCs, PACE organizations, Hospitals, ICF/IIDs, HHAs, CORFs, CAHs, Organizations, RHCs, FQHCs, inpatient hospice, and ESRD facilities. For those providers and suppliers who do not have existing emergency preparedness requirements, we believe that it is less likely that there is an emergency preparedness plan that is reviewed and updated annually. For these providers and suppliers, we estimate that the time it takes to review and update the plan annually is equal to one-third of the amount of time it takes to develop their emergency preparedness plan. The following
Furthermore, some accrediting organizations (AOs) that have CMS-approved accreditation programs for Medicare providers and suppliers have emergency preparedness standards. Those organizations are: The Joint Commission (TJC), the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP), the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), the American Association for Accreditation for Ambulatory Surgery Facilities, Inc. (AAAASF), and Det Norske Veritas (DNV) GL—Healthcare (DNV GL). Each of these AOs has deeming authority for different types of facilities; for example, TJC has comprehensive emergency preparedness requirements for hospitals. Thus, as noted in the hospital discussion later in this section, we anticipate that TJC-accredited hospitals will have a smaller burden associated with this final rule than many other providers or suppliers.
In addition, many facilities already have begun preparing for emergencies. According to a study by Niska and Burt, virtually all hospitals already have plans to respond to natural disasters (Niska and Shimizu I. “Hospital preparedness for emergency response: United States, 2008.” National Health Statistics Reports. (2011): 1-14).
Hospitals, as well as other healthcare providers, also receive grant funding for disaster or emergency preparedness from the federal and state governments, as well as other private and non-profit entities. However, we were unable to determine the amount of funding that has been granted to hospitals, the number of hospitals that received funding, or whether that funding will continue in a predictable manner. We also do not know how the hospitals spent this funding. Therefore, in determining the burden for this final rule, we did not take into account any funding a hospital or other healthcare provider might have received from sources other than Medicare or Medicaid.
We obtained the data used in this discussion on the number of the various Medicare and Medicaid providers and suppliers from Medicare's Certification and Survey Provider Enhanced Reporting (CASPER) as of June 2016, unless indicated otherwise. We have not included data for healthcare facilities that are not Medicare or Medicaid certified.
Unless otherwise indicated, we obtained all salary information for the different positions identified in the following assessments from the May 2014 National Occupational Employment and Wage Estimates, United States by the Bureau of Labor Statistics at
Salary may be affected by the rural versus urban locations. For example, based on our experience with CAHs, they usually pay their administrators less than the mean hourly wage for Health Service Managers in general medical and surgical hospitals. Thus, we considered the impact of the rural nature of CAHs to estimate the hourly wage for CAH administrators and calculated total compensation by adding in an amount for fringe benefits. Many healthcare providers and suppliers could reduce their burden by partnering or collaborating with other facilities to develop their emergency management plans or programs. Due to a lack of data, we did not consider this in our burden estimates. In estimating the burden associated with this final rule, we took into consideration the many free or low cost emergency management resources healthcare facilities have available to them and assume that many providers will use only these resources in order to meet the requirements of this rule. If we feel an organization may hire a consultant or contractor, we have indicated such. Following is a list of some of the available resources:
Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR).
•
•
Health Resources and Services Administration-Emergency Preparedness and Continuity of Operations.
•
Centers for Medicare and Medicaid Services (CMS).
•
Centers for Disease Control and Prevention—Emergency Preparedness & Response.
•
Food and Drug Administration (FDA)—Emergency Preparedness and Response.
•
Substance Abuse and Mental Health Services Administration (SAMHSA)—Disaster Readiness and Response.
•
National Institute for Occupational Safety and Health (NIOSH)—Business Emergency Management Planning.
•
Department of Labor (DOL), Occupational Safety and Health Administration (OSHA)—Emergency Preparedness and Response.
•
Federal Emergency Management Agency (FEMA)—State Offices and Agencies of Emergency Management—Contact Information.
•
•
Department of Homeland Security (DHS).
•
Therefore, we accounted for the staff time that will be involved to review and update current policies and procedures for alignment with these emergency preparedness requirements.
Section 403.748(a) will require RNHCIs to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We proposed that the plan must meet the requirements specified at § 403.748(a)(1) through (4). We will discuss the burden for these activities individually beginning with the risk assessment requirement in § 403.748(a)(1).
The current RNHCI CoPs already require RNHCIs to have a written disaster plan that addresses “loss of power, water, sewage, and other emergencies” (42 CFR 403.742(a)(4)). In addition, the CoPs also require RNHCIs to include measures to evaluate facility safety issues, including physical environment, in their quality
We have not designated any specific process or format for RNHCIs to use in conducting their risk assessment because we believe they need the flexibility to determine how best to accomplish this task. However, we expect that they will obtain input from all of their major departments in the process of developing their risk assessments.
Based on our experience with RNHCIs, we expect that complying with this requirement will require the involvement of an administrator, the director of nursing, and the head of maintenance. It is important to note that RNHCIs do not provide medical care to their patients. Depending upon the state in which they are located, RNHCIs may not be licensed and may not have licensed or certified staff. RNHCIs do not compensate their staff at the same level we have used to determine the burden for other healthcare providers and suppliers. Therefore, for the purpose of estimating the burden, we have used lower hourly wages for the RNHCI staff than for other providers and suppliers whose staff must comply with licensing and certification standards.
We expect that to perform a risk assessment, the RNHCI's administrator (2 hours), the director of nursing (5 hours), and the head of maintenance (2 hours) will attend an initial meeting; review relevant sections of the current risk assessment; prepare comments; attend a follow-up meeting; perform a final review, and approve the risk assessment. We expect that the director of nursing will coordinate the meetings, review and critique the current risk assessment, coordinate comments, develop the new risk assessment, and ensure that it is approved.
We estimate that it will require 9 burden hours for each RNHCI to complete the risk assessment at a cost of $366. There are 18 RNHCIs. Therefore, it will require an estimated 162 annual burden hours (9 burden hours for each RNHCI × 18 RNHCIs) for all 18 RNHCIs to comply with this requirement at a cost of $6,588 ($366 estimated cost for each RNHCI × 18 RNHCIs).
After conducting a risk assessment, RNHCIs will need to review, revise, and, if necessary, develop new sections for their emergency plans. The current RNHCI CoPs require RNHCIs to have a written disaster plan for emergencies (§ 403.742(a)(4)). However, based on our experience with RNHCIs, their plans likely will address only evacuation from their facilities. We expect that all RNHCIs will need to review, revise, and develop new sections for their plans.
We expect that the same individuals who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we expect that it will require substantially more time to complete the plan than to complete the risk assessment. We estimate that complying with this requirement will require 12 burden hours for each RNHCI at a cost of $498. Therefore, for all 18 RNHCIs to comply with these requirements will require an estimated 216 burden hours (12 burden hours for each RNHCI × 18 RNHCIs) at a cost of $8,964 ($498 estimated cost for each RNHCI × 18 RNHCIs).
Under this final rule, RNHCIs will be required to review and update their emergency preparedness plans at least annually. For the purpose of determining the burden associated with this requirement, we will expect that RNHCIs already review their plans annually. Based on our experience with Medicare providers and suppliers, healthcare facilities have a compliance officer or other staff member who periodically reviews the facility's program to ensure that it complies with all relevant federal, state, and local laws, regulations, and ordinances. While this requirement is subject to the PRA, we expect that complying with the requirement for an annual review of the emergency preparedness plan will constitute a usual and customary business practice as defined in the implementing regulation of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not assigned a burden.
Section 403.748(b) will require RNHCIs to develop and implement emergency preparedness policies and procedures in accordance with their emergency plan based on the emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). These policies and procedures will have to be reviewed and updated at least annually. At a minimum, we proposed that the policies and procedures be required to address the requirements specified in § 403.748(b)(1) through (8). The RNHCIs will need to review their
The current RNHCI CoPs require them to have written policies concerning their services (§ 403.738). Thus, some RNHCIs may have some emergency preparedness policies and procedures. However, based on our experience with RNHCIs, most of their emergency preparedness policies address only evacuation from the facility.
We expect that these tasks will involve the administrator, the director of nursing, and the head of maintenance. All three will need to review and comment on the RNHCI's current policies and procedures. The director of nursing will revise or develop new policies and procedures, as needed, ensure that they are approved, and compile and disseminate them to the appropriate parties. We estimate that it will require 6 burden hours for each RNHCI to comply with this requirement at a cost of $234. Thus, it will require 108 burden hours (6 burden hours for each RNHCI × 18 RNHCIs) for all 18 RNHCIs to comply with the requirements in § 403.748(b)(1) through (8) at a cost of $4,212 ($234 estimated cost for each RNHCI × 18 RNHCIs).
Section 403.748(c) will require RNHCIs to develop and maintain an emergency preparedness communication plan that complies with both federal and state law and must be reviewed and updated at least annually. We proposed that the communication plan include the information specified at § 403.748(c)(1) through (7). The burden associated with complying with this requirement will be the resources required to review and, if necessary, revise an existing communication plan or develop a new plan. Based on our experience with RNHCIs, we expect that these activities will require the involvement of the RNHCI's administrator, the director of nursing, and the head of maintenance. We estimate that complying with this requirement will require 4 burden hours for each RNHCI at a cost of $166. Thus, it will require an estimated 72 burden hours (4 burden hours for each RNHCI × 18 RNHCIs) at a cost of $2,988 ($166 estimated cost for each RNHCI × 18 RNHCIs).
We proposed that RNHCIs will also have to review and update their emergency preparedness communication plan at least annually. We believe that RNHCIs already review their emergency preparedness communication plans periodically. Thus, complying with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulation of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not assigned a burden.
Section 403.748(d) will require RNHCIs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We are proposing that a RNHCI meet the requirements specified at § 403.748(d)(1) and (2). Section 403.748(d)(1) will require RNHCIs to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the RNHCI will have to provide training at least annually. Based on our experience, all RNHCIs have some type of emergency preparedness training program. However, all RNHCIs will need to compare their current emergency preparedness training programs to their risk assessments and updated emergency preparedness plans, policies and procedures, and communication plans and revise or, if necessary, develop new sections for their training programs.
We expect that complying with these requirements will require the involvement of the RNHCI administrator and the director of nursing. We estimate that it will require 7 burden hours for each RNHCI to develop an emergency training program at a cost of $314. Thus, it will require an estimated 126 burden hours (7 burden hours for each RNHCI × 18 RNHCIs) at a cost of $5,652 ($1855 estimated cost for each RNHCI × 18 RNHCI).
We are proposing that RNHCIs also review and update their emergency preparedness training and testing programs at least annually. Based on our experience with Medicare providers and suppliers, healthcare facilities have a compliance officer or other staff member who periodically reviews the facility's program to ensure that it complies with all relevant federal, state, and local laws, regulations, and ordinances. While this requirement is subject to the PRA, we expect that complying with this requirement will constitute a usual and customary business practice as defined in the implementing regulation of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not calculated an estimate of the burden.
Section 403.748(d)(2) will require RNHCIs to conduct a paper-based, tabletop exercise at least annually. The RNHCI must also analyze its response to and maintain documentation of all tabletop exercises and emergency events, and revise its emergency plan, as needed.
The burden associated with complying with this requirement will be the resources RNHCIs will need to develop the scenarios for the exercises and the necessary documentation. Based on our experience with RNHCIs, RNHCIs already conduct some type of exercise periodically to test their emergency preparedness plans. However, we expect that RNHCIs will not be fully compliant with our requirements. We expect that the director of nursing will develop the scenarios and required documentation. We estimate that these tasks will require 3 burden hours at a cost of $102 for each RNCHI. Based on this estimate, for all 18 RNHCIs to comply with these requirements will require 54 burden hours (3 burden hours for each RNHCI × 18 RNHCIs) at a cost of $1,836 ($102 estimated cost for each RNHCI × 18 RNHCI).
Section 416.54(a) will require ASCs to develop and maintain an emergency preparedness plan and review and update that plan at least annually. We proposed that the plan must meet the requirements contained in § 416.54(a)(1) through (4).
We will discuss the burden for these activities individually in this final rule beginning with the risk assessment requirement in § 416.54(a)(1). We expect that each ASC will conduct a thorough risk assessment. This will require the ASC to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. We expect that an ASC will consider its location and geographical area; patient population, including those with disabilities and other access and functional needs; and the type of services the ASC has the ability to provide in an emergency. The ASC also will need to identify the measures it must take to ensure continuity of its operation, including delegations and succession plans.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment. As of June 2016, there are 5,485 ASCs. The current regulations covering ASCs include emergency preparedness requirements.
A significant factor in determining the burden is the accreditation status of an ASC. Of the 5,485 ASCs, 4,071 are non-accredited and 1,414 are accredited. Of the 1,414 accredited ASCs, we estimate that 491 are accredited by The Joint Commission (TJC), 731 by the AAAHC, and additional facilities are accredited by the AOA/HFAP or the AAAASF. The accreditation standards for these organizations vary in their requirements
TJC and AAAHC's accreditation standards contain more extensive emergency preparedness requirements than the accreditation standards of either AOA/HFAP or AAAASF. For example, TJC standards contain requirements for risk assessments and an emergency management plan. AAAHC's standards include requirements for both internal and external emergencies and drills for the facility's internal emergency plan. Therefore, in discussing the individual burden requirements in this final rule, we will discuss the burden for the estimated 1,222 accredited ASCs by either the AAAHC or TJC (731 AAAHC-accredited ASCs + 491 TJC-accredited ASCs) separately from the remaining 4,263 (ASCs that are not accredited by an accrediting organization or accredited by the AOA/HFAP and AAAASF). For some requirements, only the TJC accreditation standards are significantly like those in the final rule. For those requirements, we will analyze the 491 TJC-accredited ASCs separately from the 4,994 non TJC-accredited ASCs (5,485 ASCs−491 TJC-accredited ASCs).
For the purpose of determining the burden for the TJC-accredited ASCs, we used TJC's Comprehensive Accreditation Manual for Ambulatory Care: The Official Handbook 2008 (CAMAC). Concerning the requirement for a risk assessment in § 416.54(a)(1), in the chapter entitled “Management of the Environment of Care” (EC), ASCs are required to conduct comprehensive, proactive risk assessments (CAMAC, CAMAC Refreshed Core, January 2007, (CAMAC), TJC Standard EC.1.10, EP 4, p. EC-9). In addition, ASCs must conduct a hazard vulnerability analysis (HVA) (CAMAC, Standard EC.4.10, EP 1, p. EC-12). The HVA requires the identification of potential emergencies and the effects those emergencies could have on the ASC's operations and the demand for its services (CAMAC, p. EC-12). We expect that TJC-accredited ASCs already conduct a risk assessment that complies with these requirements. If there are any tasks these ASCs need to complete to satisfy the requirement for a risk assessment, we expect that the burden imposed by this requirement will be negligible. For the 491 TJC-accredited ASCs, the risk assessment requirement will constitute a usual and customary business practice. While this requirement is subject to the PRA, we expect that complying with this requirement will constitute a usual and customary business practice as defined in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Therefore, we have not estimated the amount of regulatory burden For ASCs with accreditation from TJC.
For the purpose of determining the burden for the 731 AAAHC-accredited ASCs, we used the Accreditation Handbook for Ambulatory Health Care 2008 (AHAHC). The AAAHC standards do not contain a specific requirement for the ASC to perform a risk assessment. However, in discussing the requirement for drills, the AAAHC notes that such drills should be appropriate to the facility's activities and environment (AHAHC, Accreditation Association for Ambulatory Health Care, Inc., Core Standards, Chapter 8. Facilities and Environment, Element E, p. 37). Therefore, we expect that in fulfilling this core standard that the 731 AAAHC-accredited ASCs have performed some type of risk assessment. However, we do not expect that this will satisfy the requirement for a facility-based and community-based risk assessment that addresses the elements include in the AAAHC-accreditation for ASCs. Therefore, the 731 AAAHC-accredited ASCs will be included in the burden analysis with the ASCs that are non-accredited or are accredited by AOA/HFAP and AAAASF for the risk assessment requirement for 4,994 non TJC-accredited ASCs (5,485 total ASCs−491 TJC-accredited ASCs).
We expect that all ASCs have already performed at least some of the work needed for a risk assessment. However, many probably have not performed a thorough risk assessment. Therefore, we expect that all non TJC-accredited ASCs will perform thorough reviews of their current risk assessments, if they have them, and revise them to ensure they have updated the assessments and that they have included all of the requirements in § 416.54(a).
We have not designated any specific process or format for ASCs to use in conducting their risk assessments because we believe that ASCs, as well as other healthcare providers and suppliers, need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect healthcare facilities to, at a minimum; include input from all of their major departments in the process of developing their risk assessments. Based on our experience working with ASCs, we expect that conducting the risk assessment will require the involvement of an administrator and a registered nurse. We expect that to comply with the requirements of this section, both of these individuals will need to attend an initial meeting, review the current assessment, prepare their comments, attend a follow-up meeting, perform a final review, and approve the risk assessment. In addition, we expect that the quality improvement nurse will coordinate the meetings; perform an initial review of the current risk assessment; provide suggestions or a critique of the risk assessment; coordinate comments; revise the original risk assessment; develop any necessary sections for the risk assessment; and ensure that the appropriate parties approve the new risk assessment. We estimate that complying with this risk assessment requirement will require 8 burden hours for each ASC at a cost of $763. Based on that estimate, it will require 39,952 burden hours (8 burden hours for each ASC × 4,994 non TJC-accredited ASCs) for all non TJC-accredited ASCs to comply with this risk assessment requirement at a cost of $3,810,422 ($763 estimated cost for each ASC × 4,994 ASCs).
After conducting the risk assessment, ASCs will be required to develop and maintain emergency preparedness plans in accordance with § 416.54(a)(1) through (4). All TJC-accredited ASCs must already comply with many of the requirements in § 416.54(a). All TJC-accredited ASCs are already required to develop and maintain a “written emergency management plan describing the process for disaster readiness and emergency management” (CAMAC, Standard EC.4.10, EP 3, EC-13). We expect that the TJC-accredited ASCs already have emergency preparedness plans that comply with these requirements. If there are any activities required to comply with these requirements, we expect that the burden will be negligible. Thus, for 491 TJC-accredited ASCs, this requirement will constitute a usual and customary business practice for these ASCs in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Therefore, we will not include this activity in the burden analysis for those ASCs.
AAAHC-accredited ASCs are required to have a “comprehensive emergency plan to address internal and external emergencies” (AHAC, Chapter 8. Facilities and Environment, Element D, p. 37). However, we do not believe that this requirement ensures compliance with all of the requirements for an emergency plan. We will include the 731 AAAHC-accredited ASCs in the burden analysis for this requirement.
We expect that the 4,994 non TJC-accredited ASCs have developed some type of emergency preparedness plan. However, under this final rule, all of these ASCs will have to review their current plans and compare them to the risk assessments they performed in accordance with § 416.54(a)(1). The ASCs will then need to update, revise, and in some cases, develop new sections to ensure that their plans incorporate their risk assessments and address all of the requirements. The ASC will also need to review, revise, and, in some cases, develop the delegations of authority and succession plans that ASCs determine are necessary for the appropriate initiation and management of their emergency preparedness plans.
The burden associated with this requirement will be the time and effort necessary to develop an emergency preparedness plan that complies with all of the requirements in § 416.54(a)(1) through (4). Based upon our experience with ASCs, we expect that the administrator and the quality improvement nurse who will be involved in the risk assessment will also be involved in developing the emergency preparedness plan. We estimate that complying with this requirement will require 11 burden hours for each ASC at a cost of $937. Therefore, based on that estimate, for the 4,994 non TJC-accredited ASCs to comply with the requirements in this section will require 54,934 burden hours (11 burden hours for each non TJC-accredited ASC × 4,994 non TJC-accredited ASCs) at a cost of $4,679,378 ($937 estimated cost for each non TJC-accredited ASC × 4,994 non TJC-accredited ASCs).
All of the ASCs will also be required to review and update their emergency preparedness plans at least annually. For the purpose of determining the burden for this requirement, we will expect that ASCs will review their plans annually. All ASCs have a professional staff person, a quality improvement nurse, whose responsibility entails ensuring that the ASC is delivering quality patient care and that the ASC is complying with regulations concerning patient care. We expect that the quality improvement nurse will be primarily responsible for the annual review of the ASC's emergency preparedness plan. We expect that complying with this requirement will constitute a usual and customary business practice for ASCs in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Therefore, we will not include this activity in the burden analysis.
Section 416.54(b) proposed that each ASC be required to develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan set forth in paragraph (c). We will require ASCs to review and update these policies and procedures at least annually. These policies and procedures will be required to include, at a minimum, the requirements listed at § 416.54(b)(1) through (7). We expect that ASCs will develop emergency preparedness policies and procedures based upon their risk assessments, emergency preparedness plans, and communication plans. Therefore, ASCs will need to thoroughly review their emergency preparedness policies and procedures and compare them to all of the information previously noted. The ASCs will then need to revise, or in some cases, develop new policies and procedures that will ensure that the ASCs' emergency preparedness plans address the specific elements.
TJC accreditation standards already require many of the specific elements that are required in this section. For example, in the chapter entitled “Leadership” (LD), TJC-accredited ASCs are required to “develop policies and procedures that guide and support patient care, treatment, and services” (CAMAC, Standard LD.3.90, EP 1, p. LD-12a). In addition, TJC-accredited ASCs must already address or perform a HVA; processes for communicating with and assigning staff under
AAAHC standards require ASCs to have “the necessary personnel, equipment and procedures to handle medical and other emergencies that may arise in connection with services sought or provided” (AHAHC, Chapter 8. Facilities and Environment, Element B, p. 37). Although, we expect that AAAHC-accredited ASCs probably already have policies and procedures that address at least some of the requirements, we expect that they will sustain a considerable burden in satisfying all of the requirements. We will include the AAAHC-accredited ASCs with the non-accredited ASCs in determining the burden for the requirements in § 416.54(b).
We expect that all of the 4,994 non TJC-accredited ASCs have some emergency preparedness policies and procedures. However, we expect that all of these ASCs will need to review their policies and procedures and revise their policies and procedures to ensure that they address all of the requirements. We expect that the quality improvement nurse will initially review the ASC's emergency preparedness policies and procedures. The quality improvement nurse will send any recommendations for changes or additional policies or procedures to the ASC's administrator. The administrator and quality improvement nurse will need to make the necessary revisions and draft any necessary policies and procedures. We estimate that for each non TJC-accredited ASC to comply with this requirement will require 9 burden hours at a cost of $717. For the 4,994 ASCs to comply with this requirement, it will require an estimated 44,946 burden hours (9 burden hours for each non TJC-accredited ASC × 4,994 non TJC-accredited ASCs) at a cost of $3,580,698. ($717 estimated cost for each non TJC-accredited ASC × 4,994 ASCs).
Section 416.54(c) will require each ASC to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. We also proposed that ASCs will have to review and update these plans at least annually. These communication plans will have to include the information listed in § 416.54(c)(1) through (7). The burden associated with developing and maintaining an emergency preparedness communication plan will be the time and effort necessary to review, revise, and, if necessary, develop new sections for the ASC's emergency preparedness communications plan to ensure that it satisfied these requirements.
TJC-accredited ASCs are required to have a plan that “identifies backup internal and external communication systems in the event of failure during emergencies” (CAMAC, Standard EC.4.10, EP 18, p. EC-13). There are also requirements for identifying, notifying, and assigning staff, as well as notifying external authorities (CAMAC, Standard EC.4.10, EPs 7-9, p. EC-13). In addition, the facility's plan must provide for controlling information about patients (CAMAC, Standard EC.4.10, EP 10, p. EC-13). If any revisions or additions are necessary to satisfy the requirements, we expect the revisions or additions will be those incurred during the course of normal business and thereby impose no additional burden. Thus, for the TJC-accredited ASCs, the requirements for the emergency preparedness communication plan will constitute a usual and customary business practice for ASCs as stated in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Thus, we will not include this activity by these TJC-accredited ASCs in the burden analysis.
The AAAHC standards do not have a specific requirement for a communication plan for emergencies. However, AAAHC-accredited ASCs are required to have the “necessary personnel, equipment and procedures to handle medical and other emergencies that may arise in connection with services sought or provided (AAAHC, 8. Facilities and Environment, Element B, p. 37) and “a comprehensive emergency plan to address internal and external emergencies” (AAAHC, 8. Facilities and Environment, Element D, p. 37). Since AAAHC does have a specific requirement for a communication plan, we will include the AAAHC-accredited ASCs in with the non-accredited ASCs in determining the burden for these requirements for a total of 4,994 non TJC-accredited ASCs (5,485 total ASCs−491 TJC accredited ASCs).
We expect that all non TJC-accredited ASCs currently have some type of emergency preparedness communication plan. It is standard practice in the healthcare industry to have and maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility, such as cell phones; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. We expect that all ASCs already satisfy the requirements in § 416.54(c)(1) through (4). However, for the requirements in § 416.54(c)(5) through (7), all ASCs will need to review, revise, and, if necessary, develop new sections for their plans to ensure that they include all of the requirements. We expect that this will require the involvement of the ASC's administrator and a registered nurse. We estimate that complying with this requirement will require 4 burden hours at a cost of $323. Therefore, for all non
We also proposed that ASCs must review and update their emergency preparedness communication plans at least annually. We believe that ASCs already review their emergency preparedness communication plans periodically. Therefore, we believe complying with this requirement will constitute a usual and customary business practice for ASCs as stated in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 416.54(d) will require ASCs to develop and maintain emergency preparedness training and testing programs that ASCs must review and update at least annually. Specifically, ASCs must meet the requirements listed at § 416.54(d)(1) and (2).
The burden associated with complying with these requirements will be the time and effort necessary for an ASC to review, update, and, in some cases, develop new sections for its emergency preparedness training program. Since ASCs are currently required to conduct drills, at least annually, to test their disaster plan's effectiveness, we expect that all ASCs already provide training on their emergency preparedness policies and procedures. However, all ASCs will need to review their current training and testing programs and compare their contents to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans.
Section 416.54(d)(1) will require ASCs to provide initial training in their emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. ASCs will have to ensure that their staff can demonstrate knowledge of emergency procedures. Thereafter, ASCs will have to provide the training at least annually. TJC-accredited ASCs must provide an initial orientation to their staff and independent practitioners (CAMAC, Standard 2.10, HR-8). They must also provide “on-going education, including in-services, training, and other activities” to maintain and improve staff competence (CAMAC, Standard 2.30, HR-9). We expect that these TJC-accredited ASCs include some training on their facilities' emergency preparedness policies and procedures in their current training programs. However, these requirements do not contain any requirements for training volunteers. Thus, TJC accreditation standards do not ensure that TJC-accredited ASCs are already fulfilling all of the requirements, and we expect that the TJC-accredited ASCs will incur a burden complying with these requirements. Therefore, we will include these TJC-accredited ASCs in determining the burden for these requirements.
The AAAHC-accredited ASCs are already required to ensure that “all health care professionals have the necessary and appropriate training and skills to deliver the services provided by the organization” (AAAHC, Chapter 4. Quality of Care Provided, Element A, p. 28). Since these ASCs are required to have an emergency plan that addresses internal and external emergencies, we expect that all of the AAAHC-accredited ASCs already are providing some training on their emergency preparedness policies and procedures. However, this requirement does not include any requirement for annual training or for any training for staff that are not healthcare professionals. This AAAHC-accredited requirement does not ensure that these ASCs are already complying with the requirements. Therefore, we will include these AAAHC-accredited ASCs in determining the information collection burden for these requirements.
Based upon our experience with ASCs, we expect that all 5,485 ASCs have some type of emergency preparedness training program. We also expect that these ASCs will need to review their training programs and compare them to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. The ASCs will then need to make any necessary revisions to their training programs to ensure they comply with these requirements. We expect that complying with this requirement will require the involvement of an administrator and a quality improvement nurse. We estimate that for each ASC to develop a comprehensive emergency training program will require 6 burden hours at a cost of $465. Therefore, the estimated annual burden for all 5,485 ASCs to comply with these requirements is 32,910 burden hours (6 burden hours × 5,4855 ASCs) at an estimated cost of $2,550,525 ($465 estimated cost for each ASC × 5,485 ASCs).
We proposed that ASCs will also have to review and update their emergency preparedness training programs at least annually. For the purpose of determining the burden for this requirement, we will expect that ASCs
Section 416.54(d)(2) will require ASCs to participate in a full-scale exercise at least annually. ASCs will also have to participate in one additional testing exercise of their choice at least annually. If the ASC experiences an actual natural or man-made emergency that requires activation of their emergency plan, the ASC will be exempt from the requirement for a full-scale exercise for 1 year following the onset of the actual event. ASCs will also be required to analyze their response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, ASCs will need to develop a scenario for each drill and exercise. ASCs will also need to develop the documentation necessary for recording what happened during the testing exercises and emergency events and analyze their responses to these events.
TJC-accredited ASCs are required to regularly test their emergency management plans at least twice a year, critique each exercise, and modify their emergency management plans in response to those critiques (CAMAC, Standard EC.4.20, EP 1 and 12-16, p. EC-14-14a). In addition, the scenarios for these drills should be realistic and related to the priority emergencies the ASC identified in its HVA (CAMAC, Standard EC.4.20, EP 5, p. EC-14). However, the EPs for this standard do not contain any requirements for the drills to be community-based; for there to be a paper-based, tabletop exercise; or for the ASCs to maintain documentation of these testing exercises or emergency events. These TJC accreditation requirements do not ensure that TJC-accredited ASCs are already complying with these requirements. Therefore, the TJC-accredited ASCs will be included in the burden estimate.
The AAAHC-accredited ASCs already are required to perform at least four drills annually of their internal emergency plans (AAAHC, Chapter 8. Facilities and Environment, Element E, p. 37). However, there is no requirement for a paper-based, tabletop exercise; for a community-based drill; or for the ASCs to maintain documentation of their testing exercises or emergency events. This AAAHC accreditation requirement does not ensure that AAAHC-accredited ASCs are already complying with these requirements. Therefore, the AAAHC-accredited ASCs will be included in the burden estimate.
Based on our experience with ASCs, we expect that all of the 5,485 ASCs will be required to develop scenarios for their testing exercises and the documentation necessary to record and analyze these events, as well as any emergency events. Although we believe many ASCs may have developed scenarios and documentation for whatever type of drills or exercises they had previously performed, we expect all ASCs will need to ensure that the testing of their emergency preparedness plans comply with these requirements. Based upon our experience with ASCs, we expect that complying with this requirement will require the involvement of an administrator and a registered nurse. We estimate that for each ASC to comply will require 5 burden hours at a cost of $394. Therefore, for all 5,485 ASCs to comply with this requirement will require an estimated 27,425 burden hours (5 burden hours for each ASC × 5,485 ASCs) at a cost of $2,161,090 ($394 estimated cost for each ASC × 5,485 ASCs).
Section 418.113(a) will require hospices to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We proposed that the plan meet the criteria listed in § 418.113(a)(1) through (4).
Although § 418.113(a) is entitled “Emergency Plan” and the requirement for the plan is stated first, the emergency plan must include and be based upon a risk assessment. Therefore, since hospices must perform their risk assessments before beginning, or at least before they complete, their plans, we will discuss the burden related to performing the risk assessment first.
Section 418.113(a)(1) will require all hospices to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. We expect that in performing a risk assessment, a hospice will need to consider its physical location, the geographic area in which it is located, and its patient population.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment. There are 4,401 hospices. There are 3,989 hospices that provide care only to patients in their homes (home health based and freestanding hospices) and 412 hospices that offer inpatient care directly (hospital, SNF, and NF based hospices). When we use the term “inpatient hospice,” we are referring to a hospice that operates its own inpatient care facility; that is, the hospice provides the inpatient care itself. By “outpatient hospices”, we are referring to hospices that only provide in-home care, and contract with other facilities to provide inpatient care. The current requirements for hospices contain emergency preparedness requirements for inpatient hospices only (§ 418.110). Inpatient hospices must have “a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that will affect the hospice's ability to provide care,” as stated in § 418.110(c)(1)(ii). Thus, we expect inpatient hospices already have performed some type of risk assessment during the process of developing their disaster preparedness plan. However, these risk assessments may not be documented or may not address all of the requirements under § 418.113(a). Therefore, we believe that all inpatient hospices will have to conduct a thorough review of their current risk assessments and then perform the necessary tasks to ensure that their facilities' risk assessments comply with these requirements.
We have not designated any specific process or format for hospices to use in conducting their risk assessments because we believe hospices need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we believe that in the process of developing a risk assessment, healthcare institutions should include representatives from or obtain input from all of their major departments. Based on our experience with hospices, we expect that conducting the risk assessment will require the involvement of the hospice's administrator and an interdisciplinary group (IDG). The current Hospice CoPs require every hospice to have an IDG that includes a physician, registered nurse, social worker, and pastoral or other counselor. The responsibilities of one of a hospice's IDGs, if they have more than one, include the establishment of “policies governing the day-to-day provision of hospice care and services” (§ 418.56(a)(2)). Thus, we believe the IDG will be involved in performing the risk assessment.
We expect that members of the IDG will attend an initial meeting; review any existing risk assessment; develop comments and recommendations for changes to the assessment; attend a follow-up meeting; perform a final review; and approve the risk assessment. We expect that the administrator will coordinate the meetings, perform an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary staff approves the new risk assessment. We believe it is likely that the administrator will spend more time reviewing and working on the risk assessment than the other individuals in the IDG. We estimate it will require 10 burden hours to review and update the risk assessment at a cost of $759. There are 412 inpatient hospices. Therefore, based on that estimates, it will require 4,120 burden hours (10 burden hours for each inpatient hospice × 412 inpatient hospices) for all inpatient hospices to comply with this requirement at a cost of $312,708 ($759 estimated cost for each inpatient hospice × 412 inpatient hospices).
There are no emergency preparedness requirements in the current hospice CoPs for hospices that provide care to patients in their homes. However, it is standard practice for healthcare facilities to plan and prepare for common emergencies, such as fires, power outages, and storms. Although we expect that these hospices have considered at least some of the risks they might experience, we anticipate that these facilities will require more time than an inpatient hospice to perform a risk assessment. We estimate that each hospice that provides care to patients in their homes will require 12 burden hours to develop its risk assessment at a cost of $899. Therefore, based on that estimate, for all 3,989 hospices that provide care to patients in their homes, it will require 47,868 burden hours (12 burden hours for each hospice × 3,989 hospices) to comply with this requirement at a cost of $3,586,111 ($899 estimated cost for each hospice × 3,989 hospices). Based on the previous calculations, we estimate that for all 4,401 hospices to develop a risk assessment will require 51,988 burden hours at a cost of $3,898,819.
After conducting the risk assessments, hospices will have to develop and maintain emergency preparedness plans that they will have to review and update at least annually. We expect all hospices to compare their current emergency plans, if they have them, to the risk assessments they performed in accordance with § 418.113(a)(1). In addition, hospices will have to comply with the requirements in § 418.113(a)(1) through (4). They will then need to review, revise, and, if necessary, develop new sections of their plans to ensure they comply with these requirements.
The current hospice CoPs require inpatient hospices to have “a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that will affect the hospice's ability to provide care” (§ 418.110(c)(1)(ii)). We believe that all inpatient hospices already have some type of emergency preparedness or disaster plan. However, their plans may not address all likely medical and non-medical emergency events identified by the risk assessment. Furthermore, their plans may not include strategies for addressing likely emergency events or address their patient population; the type of services they have the ability to provide in an emergency; or continuity of operations, including delegations of authority and succession plans. We expect that an inpatient hospice will have to review its current plan and compare it to its risk assessment, as well as to the other requirements we proposed. We expect that most inpatient hospices will need to update and revise their existing emergency plans, and, in some cases, develop new sections to comply with our requirements.
The burden associated with this requirement will be the time and effort necessary to develop an emergency preparedness plan or to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with inpatient hospices, we expect that these activities will require the involvement of the hospice's administrator and an IDG, that is, a physician, registered nurse, social worker, and counselor. We believe that developing the plan will require more time to complete than the risk assessment.
We expect that these individuals will have to attend an initial meeting, review relevant sections of the facility's current emergency preparedness or disaster plan(s), develop comments and recommendations for changes to the facility's plan, attend a follow-up meeting, perform a final review, and approve the emergency plan. We expect that the administrator will probably coordinate the meetings, perform an initial review of the current emergency plan, provide a critique of the emergency plan, offer suggested revisions, coordinate comments, develop the new emergency plan, and ensure that the necessary parties approve the new emergency plan. We expect the administrator will probably spend more time reviewing and working on the emergency plan than the other individuals. We estimate that it will require 14 burden hours for each inpatient hospice to develop its emergency preparedness plan at a cost of $1,159. Based on this estimate, it will require 5,768 burden hours (14 burden hours for each inpatient hospice × 412 inpatient hospices) for all inpatient hospices to complete their plans at a cost of $477,508 ($1,159 estimated cost for each inpatient hospice × 412 inpatient hospices).
As discussed earlier, we have no current regulatory requirement for hospices that provide care to patients in their homes to have emergency preparedness plans. However, it is standard practice for healthcare providers to plan for common emergencies, such as fires, power outages, and storms. Although we expect that these hospices already have some type of emergency or disaster plan, each hospice will need to review its emergency plan to ensure that it addressed the risks identified in its risk assessment and complied with the requirements. We expect that an administrator and the individuals from the hospice's IDG will be involved in reviewing, revising, and developing a facility's emergency plan. However, since there are no current requirements for hospices that provide care to patients in their homes have emergency plans, we believe it will require more time for each of these hospices than for inpatient hospices to complete an emergency plan. We estimate that for each hospice that provides care to patients in their homes to comply with this requirement will require 20 burden hours at an estimated cost of $1,599. Based on that estimate, for all 3,989 of these hospices to comply with this
Hospices will also be required to review and update their emergency preparedness plans at least annually. The current hospice CoPs require inpatient hospices to periodically review and rehearse their disaster preparedness plan with their staff, including non-employee staff (42 CFR 418.110(c)(1)(ii)). For purposes of this burden estimate, we will expect that under this final rule, inpatient hospices will review their emergency plans prior to reviewing them with all of their employees and that this review will occur annually.
Outpatient hospices, either home based or freestanding, on the other hand, currently do not have emergency preparedness requirements in the current hospice CoPs and as such, there is no requirement for an annual review of the plan. Therefore, we will analyze the burden from this requirement for outpatient hospices.
Based on our experience with outpatient hospices, we expect that the same individuals who develop the emergency preparedness plan will annually review and update the plan. These staff would include the administrator, physician, counselor, social worker, and registered nurse. We estimate that for each hospice that provides care to patients in an outpatient setting to comply with this requirement will require 8 burden hours at an estimated cost of $619. Based on that estimate, for all 3,989 of these hospices to comply with this requirement will require 31,912 burden hours (8 burden hours for each hospice × 3,989 hospices) at a cost of $2,469,191 ($619 estimated cost for each hospice × 3,989 hospices).
We expect that all hospices, both inpatient and those that provide care to patients in their homes, have an administrator who is responsible for the day-to-day operation of the hospice. Day-to-day operations will include ensuring that all of the hospice's plans are up-to-date and in compliance with relevant federal, state, and local laws, regulations, and ordinances. In addition, it is standard practice in healthcare organizations to have a professional employee, an administrator, who periodically reviews their plans and procedures. We expect that complying with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Thus, we will not include this activity in the burden analysis.
Section 418.113(b) will require each hospice to develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). It will also require hospices to review and update these policies and procedures at least annually. At a minimum, the hospice's policies and procedures will be required to address the requirements listed at § 418.113(b)(1) through (6).
We expect that all hospices have some emergency preparedness policies and procedures because the current hospice CoPs for inpatient hospices already require them to have “a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that will affect the hospice's ability to provide care” (§ 418.110(c)(1)(ii)). In addition, the responsibilities for at least one of a hospice's IDGs, if they have more than one, include the establishment of “policies governing the day-to-day provision of hospice care and services” (§ 418.56(a)(2)). However, we also expect that all inpatient hospices will need to review their current policies and procedures, assess whether they contain everything required by their facilities' emergency preparedness plans, and revise and update them as necessary.
The burden associated with reviewing, revising, and updating a hospice's emergency policies and procedures will be the resources needed to ensure they comply with these requirements. Since at least one of a hospice's IDGs will be responsible for developing policies that govern the daily care and services for hospice
Although there are no existing regulatory requirements for hospices that provide care to patients in their homes to have emergency preparedness policies and procedures, it is standard practice for healthcare organizations to prepare for common emergencies, such as fires, power outages, and storms. We expect that these hospices already have some emergency preparedness policies and procedures. However, under this final rule, the IDG for these hospices will need to accomplish the same tasks as described earlier for inpatient hospices to ensure that these policies and procedures comply with the requirements.
We estimate that each hospice's compliance with this requirement will require 9 burden hours at a cost of $699. Therefore, based on that estimate, all 3,989 hospices that provide care to patients in their homes to comply with this requirement will require 35,901 burden hours (9 burden hours for each hospice × 3,989 hospices) at a cost of $2,788,311 ($699 estimated cost for each hospice × 3,989 hospices).
Thus, we estimate that development of emergency preparedness policies and procedures for all 4,401 hospices will require 39,197 burden hours at a cost of $3,043,339.
Section 418.113(c) will require a hospice to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Hospices will also have to review and update their plans at least annually. The communication plan will have to include the requirements listed at § 418.113(c)(1) through (7).
We believe that all hospices already have some type of emergency preparedness communication plan. Although only inpatient hospices have a current requirement for disaster preparedness (§ 418.110(c)), it is standard practice for healthcare organizations to maintain contact information for their staff and for outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the organization (for example, cell phones); and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. However, many hospices, both inpatient hospices and hospices that provide care to patients in their homes, may not have formal, written emergency preparedness communication plans. We expect that all hospices will need to review, update, and in some cases, develop new sections for their plans to ensure that those plans include all of the elements we proposed requiring for hospice communication plans.
The burden associated with complying with this requirement will be the resources required to ensure that the hospice's emergency communication plan complied with these requirements. Based upon our experience with hospices, we anticipate that satisfying these requirements will require only the involvement of the hospice's administrator. Thus, for each hospice, we estimate that complying with this requirement will require 3 burden hours at a cost of $240. Therefore, based on that estimate, compliance with this requirement for all 4,401 hospices will require 13,203 burden hours (3 burden hours for each hospice × 4,401 hospices) at a cost of $1,056,240 ($240 estimated cost for each hospice × 4,401 hospices).
Section 418.113(d) will require each hospice to develop and maintain an emergency preparedness training and testing program that will be reviewed and updated at least annually. Section 418.113(d)(1) will require hospices to provide initial training in emergency preparedness policies and procedures to all hospice employees, consistent with their expected roles, and maintain documentation of the training. The hospice will also have to ensure that their employees could demonstrate knowledge of their emergency procedures. Thereafter, the hospice will have to provide emergency preparedness training at least annually. Hospices will also be required to periodically review and rehearse their emergency preparedness plans with their employees, with special emphasis placed on carrying out the procedures necessary to protect patients and others.
Under current regulations, all hospices are required to provide an initial orientation and in-service training and educational programs, as necessary, to each employee (§ 418.100(g)(2) and (3)). They must also provide employee orientation and training consistent with hospice industry standards (§ 418.78(a)). In addition, inpatient hospices must periodically review and rehearse their disaster preparedness plans with their staff, including non-employee staff (§ 418.110(c)(1)(ii)). We expect that all hospices already provide training to their employees on the facility's existing disaster plans, policies, and procedures. However, under this final rule, all hospices will need to review their current training programs and compare their contents to their updated emergency preparedness plans, policies and procedures, and communications plans. Hospices will then need to review, revise, and in some cases, develop new material for their training programs so that they complied with these requirements.
The burden associated with the previously discussed requirements will be the time and effort necessary for a hospice to bring itself into compliance with the requirements in this section. We expect that compliance with this requirement will require the involvement of a registered nurse. We expect that the registered nurse will compare the hospice's current training program with the facility's emergency preparedness plan, policies and procedures, and communication plan, and then make any necessary revisions, including the development of new training material, as needed. We estimate that these tasks will require 6 burden hours at a cost of $360. Based on this estimate, compliance by all 4,401 hospices will require 26,406 burden hours (6 burden hours for each hospice × 4,401 hospices) at a cost of $1,584,360 ($360 estimated cost for each hospice × 4,401 hospices). We are proposing that hospices also be required to review and update their emergency preparedness training programs at least annually.
Section 418.113(d)(2) will require hospices to participate in a full-scale exercise at least annually. Hospices are also required to participate in one additional testing exercise of their choice at least annually. Hospices will also be required to analyze their responses to and maintain documentation of all their drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, a hospice will need to develop scenarios for their drills and exercises. A hospice also will have to develop the required documentation.
Hospices will also have to periodically review and rehearse their emergency preparedness plans with their staff (including nonemployee staff), with special emphasis on carrying out the procedures necessary to protect patients and others (§ 418.110(c)(1)(ii)). However, this periodic rehearsal requirement does not ensure that hospices are performing any type of drill or exercise annually or that they are documenting their responses. In addition, there is no requirement in the current CoPs for outpatient hospices to have an emergency plan or for these hospices to test any emergency procedures they may currently have. We believe that developing the scenarios for these drills and exercises and the documentation necessary to record the events during testing exercises and emergency events will be new requirements for all hospices.
The associated burden will be the time and effort necessary for a hospice to comply with these requirements. We expect that complying with these requirements will require the involvement of a registered nurse. We expect that the registered nurse will develop the necessary documentation and the scenarios for the drills and exercises. We estimate that these tasks will require 4 burden hours at an estimated cost of $240. Based on this estimate, in order for all 4,401 hospices to comply with these requirements, it will require 17,604 burden hours (4 burden hours for each hospice × 4,401 hospices) at a cost of $1,056,240 ($240 estimated cost for each hospice × 4,401 hospices).
Thus, for all 4,401 hospices to comply with all of the requirements in § 418.113, it will require an estimated 265,858 burden hours at a cost of $19,964,108.
Section 441.184(a) will require Psychiatric Residential Treatment Facilities (PRTFs) to develop and maintain emergency preparedness plans and review and update those plans at least annually. We proposed that these plans meet the requirements listed at § 441.184(a)(1) through (4).
Section § 441.184(a)(1) will require each PRTF to develop a documented, facility-based and community-based risk assessment that will utilize an all-hazards approach. We expect that all PRTFs have already performed some of the work needed for a risk assessment because it is standard practice for healthcare facilities to prepare for common hazards, such as fires and power outages, and disasters or emergencies common in their geographic area, such as snowstorms or hurricanes. However, many PRTFs may not have documented their risk assessments or performed one that will comply with all of our requirements. Therefore, we expect that all PRTFs will have to review and revise their current risk assessments.
We do not designate any specific process or format for PRTFs to use in conducting their risk assessments because we believe that PRTFs need maximum flexibility to determine the best way to accomplish this task. However, we expect that PRTFs will include representation from or seek input from all of their major departments. Based on our experience with PRTFs, we expect that conducting the risk assessment will require the involvement of the PRTF's administrator, a psychiatric registered nurse, and a clinical social worker. We expect that all of these individuals will attend an initial meeting, review their current assessment, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the psychiatric registered nurse will coordinate the meetings, perform an initial review, offer suggested revisions, coordinate comments, develop a new risk assessment, and ensure that the necessary parties approve the new risk assessment. We also expect that the psychiatric registered nurse will spend more time reviewing and working on the risk assessment than the other individuals. We estimate that in order for each PRTF to comply, it will require 8 burden hours at a cost of $544. There are currently 377 PRTFs. Therefore, based on that estimate, compliance by all PRTFs will require 3,016 burden hours (8 burden hours for each PRTF × 377 PRTFs) at a cost of $205,088 ($544 estimated cost for each PRTF × 377 PRTFs).
After conducting the risk assessment, § 441.184(a)(1) through (4) will require PRTFs to develop and maintain an emergency preparedness plan. Although it is standard practice for healthcare facilities to have some type of emergency preparedness plan, all PRTFs will need to review their current plans and compare them to their risk assessments. Each PRTF will need to update, revise, and, in some cases, develop new sections to complete its emergency preparedness plan.
Based upon our experience with PRTFs, we expect that the administrator and psychiatric registered nurse who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we expect it will require substantially more time to complete the plan than the risk assessment. We expect that the psychiatric nurse will be the most heavily involved in reviewing and developing the PRTF's emergency preparedness plan. We also expect that a clinical social worker will review the drafts of the plan and provide comments on it to the psychiatric registered nurse. We estimate that for each PRTF to comply with this requirement will require 12 burden hours at a cost of $858. Thus, we estimate that it will require 4,524 burden hours (12 burden hours for each PRTF × 377 PRTFs) for all PRTFs to comply with this requirement at a cost of $323,466 ($858 estimated cost per PRTF × 377 PRTFs).
The PRTFs also will be required to review and update their emergency preparedness plans at least annually. However, under the current CoPs, PRTFs are not required to develop an emergency preparedness plan and as such, there is no requirement for an annual review of the plan. Therefore, we will analyze the burden from this requirement for all PRTFs.
Based on our experience with PRTFs, we estimate that an additional burden will be associated with reviewing the plan at least annually and we anticipate that the same staff that will be involved with developing the emergency preparedness plan will also be involved in the annual review and update of the plan. The staff would include the administrator, clinical social worker, and psychiatric registered nurse. We estimate that for each PRTF to comply with this requirement will require 4 burden hours at an estimated cost of $272. Thus, we estimate that it will require 1,508 burden hours (4 burden hours for each PRTF × 377 PRTFs) for all PRTFs to comply with this requirement at a cost of $130,288 ($272 estimated cost per PRTF × 377 PRTFs).
Section 441.184(b) will require each PRTF to develop and implement emergency preparedness policies and procedures, based on their emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). We also proposed requiring PRTFs to review and update these policies and procedures at least annually. At a minimum, we will require that the PRTF's policies and procedures address the requirements listed at § 441.184(b)(1) through (8).
Since we expect that all PRTFs already have some type of emergency plan, we also expect that all PRTFs have some emergency preparedness policies and procedures. However, we expect that all PRTFs will need to review their policies and procedures; compare them to their risk assessments, emergency preparedness plans, and communication plans they developed in accordance with § 441.183(a)(1), (a) and (c), respectively; and then revise their policies and procedures accordingly.
We expect that the administrator and a psychiatric registered nurse will be involved in reviewing and revising the policies and procedures and, if needed, developing new policies and procedures. We estimate that it will require 9 burden hours at a cost of $663 for each PRTF to comply with this requirement. Based on this estimate, it
Section 441.184(c) will require each PRTF to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. PRTFs also will have to review and update these plans at least annually. The communication plan will have to include the information set out in § 441.184(c)(1) through (7).
We expect that all PRTFs have some type of emergency preparedness communication plan. It is standard practice for healthcare facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their residents. However, most PRTFs may not have formal, written emergency preparedness communication plans. Therefore, we expect that all PRTFs will need to review and, if needed, revise their plans.
Based on our experience with PRTFs, we anticipate that satisfying these requirements will require the involvement of the PRTF's administrator and a psychiatric registered nurse to review, revise, and if needed, develop new sections for the PRTF's emergency preparedness communication plan. We estimate that for each PRTF to comply will require 5 burden hours at a cost of $378. Based on that estimate, for all PRTFs to comply will require 1,885 burden hours (5 burden hours for each PRTF × 377 PRTFs) at a cost of $142,506 ($378 estimated cost for each PRTF × 377 PRTFs).
Section 441.184(d) will require PRTFs to develop and maintain emergency preparedness training programs and review and update those programs at least annually. Section 441.184(d)(1) will require PRTFs to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The PRTF will also have to ensure that their staff could demonstrate knowledge of the emergency procedures. Thereafter, the PRTF will have to provide emergency preparedness training at least annually.
Based on our experience with PRTFs, we expect that all PRTFs have some type of emergency preparedness training program. However, PRTFs will need to review their current training programs and compare them to their risk assessments and emergency preparedness plans, policies and procedures, and communication plans and update and, in some cases, develop new sections for their training programs.
We expect that complying with this requirement will require the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse will review the PRTF's current training program; determine what tasks will need to be performed and what materials will need to be developed; and develop the necessary materials. We estimate that for each PRTF to comply with the requirements in this section will require 10 burden hours at a cost of $640. Based on this estimate, for all PRTFs to comply with this requirement will require 3,770 burden hours (10 burden hours for each PRTF × 377 PRTFs) at a cost of $241,280 ($640 estimated cost for each PRTF × 377 PRTFs).
Section 441.184(d)(2) will require PRTFs to participate in a full-scale exercise at least annually. PRTFs are also required to participate in one additional testing exercise of their choice at least annually. PRTFs will also have to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency
Based on our experience with PRTFs, we expect that all PRTFs have some type of emergency preparedness testing program and most, if not all, PRTFs already conduct some type of drill or exercise to test their emergency preparedness plans. We also expect that they have already developed some type of documentation for testing exercises and emergency events. However, we do not expect that all PRTFs are conducting two testing exercises annually or have developed the appropriate documentation. Thus, we will analyze the burden of these requirements for all PRTFs.
Based on our experience with PRTFs, we expect that the same individual who developed the emergency preparedness training program will develop the scenarios for the testing exercises and the accompanying documentation. We estimate that for each PRTF to comply with the requirements in this section will require 3 burden hours at a cost of $192. We estimate that for all PRTFs to comply will require 1,131 burden hours (3 burden hours for each PRTF × 377 PRTFs) at a cost of $72,384 ($192 estimated cost for each PRTF × 377 PRTFs).
Based on the previous analysis, for all 377 PRTFs to comply with the ICRs in this final rule will require 17,719 burden hours at a cost of $1,234,675.
Section 460.84(a) will require the Program for the All-Inclusive Care for the Elderly (PACE) organizations to develop and maintain emergency preparedness plans and review and update those plans at least annually. We proposed that each plan must meet the requirements listed at § 460.84(a)(1) through (4).
Section 460.84(a)(1) will require PACE organizations to develop documented, facility-based and community-based risk assessments utilizing an all-hazards approach. We believe that the performance of a risk assessment is a standard practice, and that all of the PACE organizations have already conducted some sort of risk assessment based on common emergencies the organization might encounter, such as fires, loss of power, loss of communications, etc. Therefore, we believe that each PACE organization should have already performed some sort of risk assessment.
Under the current regulations, PACE organizations are required to establish, implement, and maintain procedures for managing medical and non-medical emergencies and disasters that are likely to threaten the health or safety of the participants, staff, or the public (§ 460.72(c)(1)). The definition of “emergencies” includes natural disasters that are likely to occur in the PACE organization's area (§ 460.72(c)(2)). PACE organizations are required to plan for emergencies involving participants who are in their center(s) at the time of an emergency, as well as participants receiving services in their homes.
For the purpose of determining the burden, we will assume that a PACE organization's risk assessment, emergency plan, policies and procedures, communication plan, and training and testing program will apply to all of a PACE organization's centers. Based on the existing PACE regulations, we expect that they already assess their physical structure(s), the areas in which they are located, and the location(s) of their participants. However, these risk assessments may not be documented or address all of our requirements. Therefore, we expect that all 119 PACE organizations will have to review, revise, and update their current risk assessments.
We have not designated any specific process or format for PACE
After conducting a risk assessment, PACE organizations will have to develop and maintain emergency preparedness plans that satisfied all of the requirements in § 460.84(a)(1) through (4). In addition to the requirement to establish, implement, and maintain procedures for managing emergencies and disasters, current regulations require PACE organizations to have a governing body or designated person responsible for developing policies on participant health and safety, including a comprehensive, systemic operational plan to ensure the health and safety of the PACE organization's participants (§ 460.62(a)(6)). We expect that an emergency preparedness plan will be an essential component of such a comprehensive, systemic operational plan. However, this regulatory requirement does not guarantee that all PACE organizations have developed a plan that complies with our requirements.
Thus, we expect that all PACE organizations will need to review their current plans and compare them to their risk assessments. PACE organizations will need to update, revise, and, in some cases, develop new sections to complete their emergency preparedness plans.
Based upon our experience with PACE organizations, we expect that the same individuals who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we expect that it will require more time to complete the plan. We expect that the quality improvement nurse will have primary responsibility for reviewing and developing the PACE organization's emergency preparedness plan. We expect that the program director, home care coordinator, and social worker will review the current plan, provide comments, and assist the quality improvement nurse in developing the final plan. Other staff members will work only on the sections of the plan that will be relevant to their areas of responsibility.
We estimate that for each PACE organization to comply with the requirement for an emergency preparedness plan will require 23 burden hours at a cost of $1,798. We estimate that for all PACE organizations to comply will require 2,737 burden hours (23 burden hours for each PACE Organization × 119 PACE organizations) at a cost of $213,962 ($1,798 estimated cost for each PACE organization × 119 PACE organizations).
The PACE organizations will also be required to review and update their emergency preparedness plans at least annually. We believe that PACE organizations are already reviewing their emergency preparedness plans
Section 460.84(b) will require each PACE organization to develop and implement emergency preparedness policies and procedures based on the emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). It will also require PACE organizations to review and update these policies and procedures at least annually. At a minimum, we will require that a PACE organization's policies and procedures address the requirements listed at § 460.84(b)(1) through (9).
Current regulations already require that PACE organizations establish, implement, and maintain procedures for managing emergencies and disasters (§ 460.72(c)). The definition of “emergencies” includes medical and nonmedical emergencies, such as natural disasters likely to occur in a PACE organization's area (§ 460.72(c)(2)). In addition, all PACE organizations must have a governing body or a designated person who functions as the governing body responsible for developing policies on participant health and safety (§ 460.62(a)(6)). Thus, we expect that all PACE organizations have some emergency preparedness policies and procedures. However, these requirements do not ensure that all PACE organizations have policies and procedures that will comply with our requirements.
The burden associated with the requirements will be the resources needed to review, revise, and, if needed, develop new emergency preparedness policies and procedures. We expect that the program director, home care coordinator, and quality improvement nurse will be primarily responsible for reviewing, revising, and if needed, developing any new policies and procedures needed to comply with our requirements. We estimate that for each PACE organization to comply with our requirements will require 12 burden hours at a cost of $860. Therefore, based on this estimate, for all PACE organizations to comply will require 1,428 burden hours (12 burden hours for each PACE organization × 119 PACE organizations) at a cost of $102,340 ($860 estimated cost for each PACE organization × 119 PACE organizations).
We proposed that each PACE organization must also review and update its emergency preparedness policies and procedures at least annually. We believe that PACE organizations are already reviewing their emergency preparedness policies and procedures periodically. Thus, compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 460.84(c) will require each PACE organization to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Each PACE organization will also have to review and update this plan at least annually. The communication plan must include the information set out at § 460.84(c)(1) through (7).
All PACE organizations must have a governing body (or a designated person who functions as the governing body) that is responsible for developing policies on participant health and safety, including a comprehensive, systemic operational plan to ensure the health and safety of the PACE organization's participants (§ 460.62(a)(6)). We expect that the PACE organizations' comprehensive, systemic operational plans will include at least some of our requirements. In addition, it is standard practice in the healthcare industry to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for patients. Thus, we expect that all PACE organizations have some type of emergency preparedness communication plan. However, each PACE organization will need to review its current plan and revise or, in some cases, develop new sections to comply with our requirements.
Based on our experience with PACE organizations, we expect that the home care coordinator and the quality assurance nurse will be primarily responsible for reviewing, and if needed, revising, and developing new sections for the communication plan. We estimate that for each PACE organization to comply with the requirements will require 7 burden hours at a cost of $448. Therefore, based on this estimate, for all PACE organizations to comply with this requirement will require 833 burden hours (7 burden hours for each PACE organization × 119 PACE organizations) at a cost of $53,312 ($448 estimated cost for each PACE organization × 119 PACE organizations).
Each PACE organization must also review and update its emergency preparedness communication plan at least annually. We believe that PACE organizations are already reviewing and updating their emergency preparedness communication plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for PACE organizations and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 460.84(d) will require PACE organizations to develop and maintain emergency preparedness training and testing programs and review and update those programs at least annually. We proposed that each PACE organization will have to meet the requirements listed at § 460.84(d)(1) and (2).
Section 460.84(d)(1) will require PACE organizations to provide initial training on their emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles and maintain documentation of this training. PACE organizations will also have to ensure that their staff could demonstrate knowledge of the emergency procedures. Thereafter, PACE organizations will be required to provide this training annually.
Current regulations require PACE organizations to provide periodic orientation and appropriate training to their staffs and participants in emergency procedures (§ 460.72(c)(3)). However, these requirements do not ensure that all PACE organizations will be in compliance with our requirements. Thus, each PACE organization will need to review its current training program and compare the training program to its risk assessment, emergency preparedness plan, policies and procedures, and communication plan. The PACE organization will also need to revise and, in some cases, develop new sections to ensure that its emergency preparedness training program complied with our requirements. We expect that the quality assurance nurse will review all elements of the PACE organization's training program and determine what tasks will need to be performed and what materials will need to be developed to comply with our requirements. We expect that the home care coordinator will work with the quality assurance nurse to develop the revised and updated training program. We estimate that for each PACE organization to comply with the requirements will require 12 burden hours at a cost of $768. Therefore, it will require an estimated 1,428 burden hours (12 burden hours for each PACE organization × 119 PACE organizations) to comply with this requirement at a cost of $91,392 ($768 estimated cost for each PACE organization × 119 PACE organizations).
The PACE organizations will also be required to review and update their emergency preparedness training program at least annually. We believe that PACE organizations are already reviewing and updating their emergency preparedness training programs periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for PACE organizations and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 460.84(d)(2) will require PACE organizations to participate in a full-scale exercise at least annually. They will also be required to conduct one additional exercise of their choice at least annually. PACE organizations will also be required to analyze their responses to, and maintain documentation of, all testing exercises and any emergency events they experienced. If a PACE organization experienced an actual natural or man-made emergency that required activation of its emergency plan, it will be exempt from engaging in a community or individual, facility-based full-scale exercise for 1 year following the onset of the actual event. To comply with these requirements, PACE organizations will need to develop a specific scenario for each drill and exercise. The PACE organizations will also have to develop the documentation necessary for recording and analyzing their response to all testing exercises and emergency events.
Current regulations require each PACE organization to conduct a test of its emergency and disaster plan at least annually (42 CFR 460.72(c)(5)). They also must evaluate and document the effectiveness of their emergency and disaster plans. Thus, PACE organizations already conduct at least one test annually of their plans. We expect that as part of testing their emergency plans annually, PACE organizations will develop a scenario for and document the testing. However, this does not ensure that all PACE organizations will be in compliance with all of our requirements, especially the requirement for conducting a paper-based, tabletop exercise; performing a community-based full-scale exercise; and using different scenarios for the testing exercises.
The 119 PACE organizations will be required to develop scenarios for testing exercises and the documentation necessary to record and analyze their response to all exercises and any emergency events. Based on our experience with PACE organizations, we expect that the same individuals who developed their emergency preparedness training programs will develop the required documentation. We expect the quality improvement nurse will spend more time on these activities than the healthcare coordinator. We estimate that this activity will require 5 burden hours for each PACE organization at a cost of $320. We estimate that for all PACE organizations to comply with these requirements will require 595 burden hours (5 burden hours for each PACE organization × 119 PACE organizations) at a cost of $38,080 ($595 estimated cost for each PACE organization × 119 PACE organizations).
Section 482.15(a) will require hospitals to develop and maintain emergency preparedness plans. We proposed that hospitals be required to review and update their emergency preparedness plans at least annually and meet the requirements set out at § 482.15(a)(1) through (4). Note that we obtain data on the number of hospitals, both accredited and non-accredited, from the CMS CASPER data system, which are updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited hospitals shown may not equal the number of hospitals at the time of this final rule's publication. In addition, some hospitals may have chosen to be accredited by more than one accrediting organization.
There are approximately 4,793 Medicare-certified hospitals. This includes 121 critical access hospitals (CAHs) that have rehabilitation or psychiatric distinct part units (DPUs) as of June 30, 2016 CASPER data. The services provided by CAH psychiatric or rehabilitation DPUs must comply with the hospital Conditions of Participation (CoPs) (42 CFR 485.647(a)). RNHCIs and CAHs that do not have DPUs have been excluded from this number and are addressed separately in this analysis. Of the 4,793 hospitals reported in CMS' CASPER data system, approximately 3,913 are accredited hospitals and the remainder are non-accredited hospitals. Three organizations have accrediting authority for these hospitals: TJC, formerly known as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the AOA/HFAP, and DNV GL.
Accreditation can substantially affect the burden a hospital will sustain under this final rule. The Joint Commission accredits 3,448 hospitals. Many of our requirements are similar or virtually identical to the standards, rationales, and elements of performance (EPs) required for TJC accreditation. TJC standards, rationales, and elements of performance (EPs) are on the TJC Web site at
The AOA/HFAP and DNV GL hospital accreditation requirements do not emphasize emergency preparedness. In addition, these hospitals account for less than 5 percent of all of the hospitals. Thus, for purposes of determining the burden, we have included the AOA/HFAP-accredited hospitals and the DNV GL-accredited hospitals in with the hospitals that are not accredited. Therefore, unless indicated otherwise, we have analyzed the burden for the 3,448 TJC-accredited hospitals separately from the remaining 1,345 non TJC-accredited hospitals (4,793 hospitals−3,448 TJC-accredited hospitals).
We have used TJC's “Comprehensive Accreditation Manual for Hospitals: The Official Handbook 2008 (CAMH)” to determine the burden for TJC-accredited hospitals. In the chapter entitled, “Management of the Environment of Care” (EC), hospitals are required to plan for managing the consequences of emergencies (CAMH, Standard EC.4.11, CAMH Refreshed Core, January 2008, p. EC-13a). Individual standards have EPs, which provide the detailed and specific performance expectations, structures, and processes for each standard (CAMH, CAMH Refreshed Core, January 2008, p. HM-6). The EPs for Standard EC.4.11 require, among other things, that hospitals conduct a hazard vulnerability analysis (HVA) (CAMH, Standard EC.4.11, EP 2, CAMH Refreshed Core, January 2008, p. EC-13a). Performing an HVA will require a hospital to identify the events that could possibly affect demand for the hospital's services or the hospital's ability to provide services. A TJC-accredited hospital also must determine the likeliness of the identified risks occurring, as well as their consequences. Thus, we expect that TJC-accredited hospitals already conduct an HVA that complies with our requirements and that any additional tasks necessary to comply will be minimal. Therefore, for TJC-accredited hospitals, the risk assessment requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 482.15(a)(1) will require that hospitals perform a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. We expect that most non TJC-accredited hospitals have already performed at least some of the work needed for a risk assessment. The Niska and Burt article indicated that most hospitals already have plans for natural
We have not designated any specific process or format for hospitals to use in conducting a risk assessment because we believe that hospitals need the flexibility to determine how best to accomplish this task. However, we expect that hospitals will obtain input from all of their major departments when performing a risk assessment. Based on our experience, we expect that conducting a risk assessment will require the involvement of at least a hospital administrator, the risk management director, the chief medical officer, the chief of surgery, the director of nursing, the pharmacy director, the facilities director, the health information services director, the safety director, the security manager, the community relations manager, the food services director, and administrative support staff. We expect that most of these individuals will attend an initial meeting, review relevant sections of their current risk assessment, prepare and send their comments to the risk management director, attend a follow-up meeting, perform a final review, and approve the new risk assessment.
We expect that the risk management director will coordinate the meetings, review and comment on the current risk assessment, suggest revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the hospital administrator will spend more time reviewing the risk assessment than most of the other individuals.
We estimate that the risk assessment will require 34 burden hours to complete at a cost of $4,232 for each non-TJC accredited hospital. There are approximately 1,345 non TJC-accredited hospitals. Therefore, it will require an estimated 45,730 burden hours (34 burden hours for each non TJC-accredited hospitals × 1,345 non TJC-accredited hospitals) for all non TJC-accredited hospitals to comply at a cost of $5,692,040 ($4,232 estimated cost for each non TJC-hospital × 1,345 non TJC-accredited hospitals).
Section 482.15(a)(1) through (4) will require hospitals to develop and maintain emergency preparedness plans. We expect that all hospitals will compare their risk assessments to their emergency plans and revise and, if necessary, develop new sections for their plans. TJC-accredited hospitals must develop and maintain written Emergency Operations Plans (EOPs) (CAMH, Standard EC.4.12, EP 1, CAMH Refreshed Care, January 2008, p. EC-13b). The EOP should describe an “all-hazards” approach to coordinating six critical areas: Communications, resources and assets, safety and security, staff roles and responsibilities, utilities, and patient clinical and support activities during emergencies (CAMH, Standard EC.4.13-EC.4.18, CAMH Refreshed Core, January 2008, pp. EC-13b-EC-13g). Hospitals also must include in their EOP “[r]esponse strategies and actions to be activated during the emergency” and “[r]ecovery strategies and actions designed to help restore the systems that are critical to resuming normal care, treatment and services” (CAMH, Standard EC.4.11, EPs 7 and 8, p. EC-13a). In addition, hospitals are required to have plans to manage “clinical services for vulnerable populations served by the hospital, including patients who are pediatric, geriatric, disabled or have serious chronic conditions or addictions” (CAMH, Standard EC.4.18, EP 2, p. EC-13g). Hospitals also must plan how to manage the mental health needs of their patients (CAMH, Standard EC.4.18, EP 4, EC-13g). Thus, we expect that TJC-accredited hospitals have already developed and are maintaining EOPs that comply with the requirement for an emergency plan in this final rule. If a TJC-accredited hospital needed to complete additional tasks to comply with the requirement, we believe that the burden will be negligible. Therefore, for TJC-accredited hospitals, this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
We expect that most, if not all, non TJC-accredited hospitals already have some type of emergency preparedness plan. The Niska and Burt article noted that the majority of hospitals have plans for natural disasters; incendiary incidents; and biological, chemical, and radiological terrorism. In addition, all hospitals must already meet the requirements set out at 42 CFR 482.41, including emergency power, lighting, gas and water supply requirements as well as specified Life Safety Code provisions. However, those existing plans may not be fully compliant with our requirements. Thus, it will be necessary for non TJC-accredited hospitals to review their current plans and compare them to their risk assessments and revise, update, or, in some cases, develop new sections for their emergency plans.
Based on our experience with hospitals, we expect that the same individuals who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we
Under this final rule, a hospital also will be required to review and update its emergency preparedness plan at least annually. We believe that hospitals already review their emergency preparedness plans periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for hospitals and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Under § 482.15(b), we will require each hospital to develop and implement emergency preparedness policies and procedures based on its emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). We will also require hospitals to review and update these policies and procedures at least annually. At a minimum, we will require that the policies and procedures address the requirements at § 482.15(b)(1) through (8).
We will expect all hospitals to review their emergency preparedness policies and procedures and compare them to their emergency plans, risk assessments, and communication plans. We expect that hospitals will then review, revise, and, if necessary, develop new policies and procedures that comply with our requirements.
The CAMH's chapter entitled, “Leadership” (LD), requires TJC-accredited hospital leaders to “develop policies and procedures that guide and support patient care, treatment, and services.” The policies and procedures are to guide all patient care, including during and after emergencies (CAMH, Standard LC.3.90, EP 1, CAMH Refreshed Core, January 2008, p. LD-15). Thus, we expect that TJC-accredited hospitals already have some policies and procedures related to our requirements. In addition to meeting TJC standards, hospitals are required to meet state and local and licensing requirements. Based on these requirements, hospitals have been operating within this framework in the delivery of patient care services. State and local laws require fire, emergency, and safety codes that have an impact on operations during an emergency or a disaster. As discussed later, many of the requirements in § 482.15(b) has a corresponding requirement in the TJC hospital accreditation standards. Hence, we will discuss each section individually.
Section 482.15(b)(1) will require hospitals to have policies and procedures for the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited hospitals are required to make plans for obtaining and replenishing medical and non-medical supplies, including food, water, and fuel for generators and transportation vehicles (CAMH, Standard EC.4.14, EPs 1-8 and 10-11, p. EC-13d). In addition, hospitals must identify alternative means of providing electricity, water, fuel, and other essential utility needs in cases when their usual supply is disrupted or compromised (CAMH, Standard EC.4.17, EPs 1-5, p. EC-13f). Thus, we expect that TJC-accredited hospitals will be in compliance with our provision of subsistence requirements in § 482.15(b)(1).
Section 482.15(b)(2) will require hospitals to have policies and procedures to track the location of on-duty staff and sheltered patients in the hospital's care during an emergency. TJC-accredited hospitals must plan for communicating with patients and their families at the beginning of and during an emergency (CAMH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-13c). We expect that TJC-accredited hospitals will be in compliance with § 482.15(b)(2).
Section 482.15(b)(3) will require hospitals to have policies and procedures for a plan for the safe evacuation from the hospital. TJC-accredited hospitals are required to make plans to evacuate patients as part of managing their clinical activities (CAMH, Standard EC.4.18, EP 1, p. EC-13g). They also must plan for the evacuation and transport of patients, as well as their information, medications, supplies, and equipment, to alternative care sites (ACSs) when the hospital cannot provide care, treatment, and services in their facility (CAMH, Standard EC.4.14, EPs 9-11, p. EC-13d). Section 482.15(b)(3) also will require hospitals to have “primary and alternate means of communication with external sources of assistance.” TJC-accredited hospitals must plan for communicating with external authorities once the hospital initiates its emergency response measures (CAMH, Standard EC.4.13, EP 4, p. EC-13c). Thus, TJC-accredited hospitals will be in compliance with most of the requirements in § 482.15(b)(3). However, we do not believe these requirements will ensure
Section 482.15(b)(4) will require hospitals to have policies and procedures that address a means to shelter in place for patients, staff, and volunteers who remain at the facility. The rationale for CAMH Standard EC.4.18 states, “a catastrophic emergency may result in the decision to keep all patients on the premises in the interest of safety” (CAMH, Standard EC.4.18, p. EC-13f). We expect that TJC-accredited hospitals will be in compliance with our shelter in place requirement in § 482.15(b)(4).
Section 482.15(b)(5) will require hospitals to have policies and procedures that address a system of medical documentation that preserves patient information, protects the confidentiality of patient information, and ensures that records are secure and readily available. The CAMH chapter entitled “Management of Information” requires TJC-accredited hospitals to have storage and retrieval systems for their clinical/service and hospital-specific information (CAMH, Standard IM.3.10, EP 5, CAMH Refreshed Core, January 2008, p. IM-10) and to ensure the continuity of their critical information “needs for patient care, treatment, and services (CAMH, Standard IM.2.30, Rationale for IM.2.30, CAMH Refreshed Core, January 2008, p. IM-8). They also must ensure the privacy and confidentiality of patient information (CAMH, Standard IM.2.10, CAMH Refreshed Core, January 2008, p. IM-7) and have plans for transporting and tracking patients' clinical information, including transferring information to ACSs (CAMH Standard EC.4.14, EP 11, p. EC-13d and Standard EC.4.18, EP 6, pp. EC-13d and EC-13g, respectively). Therefore, we expect that TJC-accredited hospitals will be in compliance with the requirements we proposed in § 482.15(b)(5).
Section 482.15(b)(6) will require hospitals to have policies and procedures that address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state and federally-designated healthcare professionals to address surge needs during an emergency. TJC-accredited hospitals must already define staff roles and responsibilities in their EOPs and ensure that they train their staffs for their assigned roles (CAMH, Standard EC.4.16, EPs 1 and 2, p. EC-13e). The rationale for Standard EC.4.15 indicates that the “hospital determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated.” In addition, in the chapter entitled “Medical Staff” (MS), hospitals “may grant disaster privileges to volunteers that are eligible to be licensed independent practitioners” (CAMH, Standard MS.4.110, CAMH Refreshed Care, January 2008, p. MS-27). Finally, in the chapter entitled “Management of Human Resources” (HR), hospitals “may assign disaster responsibilities to volunteer practitioners” (CAMH, Standard HR.1.25, CAMH Refreshed Core, January 2008, p. HR-5). Although TJC accreditation requirements partially address our requirements, we do not believe these requirements will ensure compliance with all requirements in in § 482.15(b)(6).
Section 482.15(b)(7) will require hospitals to have policies and procedures that will address the development of arrangements with other hospitals or other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hospital patients. TJC-accredited hospitals must plan for the sharing of resources and assets with other healthcare organizations (CAMH, Standard EC.4.14, EPs 7 and 8, p. EC-13d). However, we will not expect TJC-accredited hospitals to be substantially in compliance with the requirements we proposed in § 482.15(b)(7) based on compliance with TJC accreditation standards alone.
Section 482.15(b)(8) will require hospitals to have policies and procedures that address the hospital's role under an “1135 waiver” (that is, a waiver of some federal rules in accordance with § 1135 of the Social Security Act) in the provision of care and treatment at an ACS identified by emergency management officials. TJC-accredited hospitals must already have plans for transporting patients, as well as their associated information, medications, equipment, and staff to ACSs when the hospital cannot support their care, treatment, and services on site (CAMH, Standard EC.4.14, EPs 10 and 11, p. EC-13d). We expect that TJC-accredited hospitals will be in compliance with the requirements we proposed in § 482.15(b)(8).
In summary, we expect that TJC-accredited hospitals have developed and are maintaining policies and procedures that will comply with the requirements in § 482.15(b), except for § 482.15(b)(3), (6), and (7). Later we will discuss the burden on TJC-accredited hospitals with respect to these provisions. We expect that any modifications that TJC-accredited hospitals will need to make to comply with the remaining requirements will not impose a burden above that incurred as part of usual and customary business practices. Thus, with the exception of the requirements set out at § 482.15(b)(3), (6), and (7), we believe the requirements constitute usual and customary business practices and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
The burden associated with § 482.15(b)(3), (6), and (7) will be the resources required to develop written policies and procedures that comply with the requirements. We expect that the risk management director will review the hospital's policies and procedures initially and make recommendations for revisions and development of additional policies or procedures. We expect that representatives from the hospital's major departments will make revisions or draft new policies and procedures based on the administrator's recommendation. The appropriate parties will then need to compile and disseminate these new policies and procedures. We estimate that complying with these requirements will require 17 burden hours for each TJC-accredited hospital at a cost of $2,061. For all 3,448 TJC-accredited hospitals to comply with these requirements will require an estimated 58,616 burden hours (17 burden hours for each TJC-accredited hospital × 3,448 TJC-accredited hospitals) at a cost of $7,106,328 ($2,061 estimated cost for each TJC-accredited hospital × 3,448 TJC-accredited hospitals).
The 1,345 non TJC-accredited hospitals will need to review their policies and procedures, ensure that their policies and procedures accurately reflect their risk assessments, emergency preparedness plans, and communication plans, and incorporate any of our requirements into their policies and procedures. We expect that the risk management director will coordinate the meetings, review and comment on the current policies and procedures, suggest revisions, coordinate comments, develop the policies and procedures, and ensure that the necessary parties approve it. We expect that the hospital administrator will spend more time reviewing the policies and procedures than most of the other individuals.
We estimate that complying with this requirement will require 33 burden hours for each non TJC-accredited hospital at an estimated cost of $3,831. Based on this estimate, for all 1,345 non TJC-accredited hospitals to comply with these requirements will require 44,385 burden hours (33 burden hours for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals) at a cost of $5,152,695 ($3,831 estimated cost for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals).
In addition, we expect that there will be a burden as a result of § 482.15(b)(7). Section 482.15(b)(7) will require hospitals to develop and maintain policies and procedures that address a hospital's development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hospital patients. We expect that hospitals will base those arrangements on written agreements between the hospital and other hospitals and other providers. Thus, in addition to the burden related to developing the policies and procedures, hospitals will also sustain a burden related to developing the written agreements related to those arrangements.
All 4,793 hospitals will need to identify other hospitals and other providers with which they could have agreements, negotiate and draft the agreements, and obtain all necessary authorizations for the agreements. For the purpose of determining the burden, we will assume that hospitals will have written agreements with two other hospitals and other providers. Based on our experience with hospitals, we expect that complying with this requirement will primarily require the involvement of the hospital's administrator and risk management director. We also expect that a hospital attorney will assist with drafting the agreements and reviewing those documents for any legal implications. We estimate that complying with this requirement will require 8 burden hours for each hospital at an estimated cost of $1,037. Thus, it will require an estimated 38,344 burden hours (8 burden hours for each hospital × 4,793 hospitals) for all hospitals to comply with this requirement at a cost of $4,970,341 ($1,037 estimated cost for each hospital × 4,793 hospitals).
Section 482.15(b) will also require hospitals to review and update their emergency preparedness policies and procedures at least annually. We believe hospitals are already reviewing and updating their emergency preparedness policies and procedures periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for both TJC-accredited and non TJC-accredited hospitals and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Section 482.15(c) will require each hospital to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The plan will have to be reviewed and updated at least annually. The communication plan will have to include the information listed at § 482.15(c)(1) through (7).
We expect that all hospitals currently have some type of emergency preparedness communication plan. We expect that under this final rule, hospitals will review their current communication plans, compare them to their emergency preparedness plans and emergency policies and procedures, and revise their communication plans, as necessary. It is standard practice for healthcare facilities to maintain contact information for staff and outside sources of assistance; have alternate means of communication in case there is an interruption in phone service to the facility; and have a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for patients. However, under this final rule, all hospitals will need to review and update their plans to ensure compliance with our requirements.
TJC-accredited hospitals are required to establish emergency communication strategies (CAMH, Standard EC.4.13, p. EC-13b). In addition, TJC-accredited hospitals are specifically required to ensure communication with staff, external authorities, patients, and their families (CAMH, Standard EC.4.13, EPs 1-5, p. EC-13c). TJC-accredited hospitals also are required to establish “back-up communications systems and technologies” for such activities (CAMH, Standard EC.4.13, EP 14, p. EC-13c). Moreover, TJC-accredited hospitals are required specifically to define “the circumstances and plans for communicating information about patients to third parties (such as other healthcare organizations) . . .” (CAMH, Standard EC.4.13, EP 12, p. EC-13c). Thus, we expect that that TJC-accredited hospitals will be in compliance with § 482.15(c)(1) through (4). In addition, the rationale for EC.4.13 states, “the hospital maintains reliable surveillance and communications capability to detect emergencies and communicate response efforts to hospital response personnel, patient and their families, and external agencies (CAMH, Standard EC.4.13, pp. EC-13b—13c). We expect that most, if not all, TJC-accredited hospitals will be in compliance with § 482.15(c)(5) through (7). Therefore, we expect that TJC-accredited hospitals already have developed and are currently maintaining emergency communication plans that will satisfy the requirements contained in § 482.15(c). Therefore, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Most, if not all, non TJC-accredited hospitals will be substantially in compliance with § 482.15(c)(1) through (4). However, non TJC-accredited hospitals will need to review, update, and in some cases, develop new sections for their emergency communication plans to ensure they are in compliance with all of the requirements in this section. We expect that this activity will require the involvement of the hospital's administrator, the risk management director, the facilities director, the health information services director, the security manager, and administrative support staff. We estimate that complying with this requirement will require 10 burden hours at a cost of $1,111 for each of the 1,345 non TJC-accredited hospitals. Therefore, based on this estimate, for non TJC-accredited hospitals to comply with this requirement will require 13,450 burden hours (10 burden hours for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals) at a cost of $1,494,295 ($1,068 estimated cost for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals).
Section 482.15(c) also will require hospitals to review and update their emergency preparedness communication plans at least annually. We believe that hospitals are already reviewing and updating their emergency preparedness communication plans periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 482.15(d) will require hospitals to develop and maintain emergency preparedness training and testing programs and review and update those plans at least annually. The hospital will be required to meet the requirements in § 482.15(d)(1) and (2).
Section 482.15(d)(1) will require hospitals to provide initial and thereafter annual training on their emergency preparedness policies and procedures to all and new existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. Hospitals must also maintain documentation of all of this training.
The burden for § 482.15(d)(1) will be the time and effort necessary to develop a training program and the materials needed for the required initial and annual training. We expect that all hospitals will review their current training programs and compare them to their risk assessments, emergency plans, policies and procedures, and communication plans as set forth in § 482.15(a)(1), (a), (b), and (c), respectively. Hospitals will need to revise and, if necessary, develop new sections or material to ensure that their training programs comply with our requirements.
TJC-accredited hospitals are required to define staff roles and responsibilities in their EOP and train their staff for their assigned roles during emergencies (CAMH, EC.4.16, EPs 1-2, p. EC-13e). In addition, the TJC-accredited hospitals are required to provide an initial orientation, which includes information that the hospital has determined are key elements the staff need before they provide care, treatment, or services to patients (CAMH, Standard HR.2.10, EPs 1-2, CAMH Refreshed Core, January 2008, p. HR-10). We will expect that an orientation to the hospital's EOP will be part of this initial training. TJC-accredited hospitals also must provide on-going training to their staff, including training on specific job-related safety (CAMH, Standard HR-2.30, EP 4, CAMH Refreshed Core, January 2008, p. HR-11), and we expect that emergency preparedness is part of such on-going training.
Although TJC requirements do not specifically address training for individuals providing services under arrangement or training for volunteers consistent with their expected roles, it is standard practice for healthcare facilities to provide some type of training to all personnel, including those providing services under contract or arrangement and volunteers. If a hospital does not already provide such training, we will expect the additional burden to be negligible. Thus, for the TJC-accredited hospitals, the requirements will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Based on our experience with non TJC-accredited hospitals, we expect that the non TJC-accredited hospitals have some type of emergency preparedness training program and provide training to their staff regarding their duties and responsibilities under their emergency plans. However, under this final rule, non TJC-accredited hospitals will need to compare their existing training programs with their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. They also will need to revise, update, and, if necessary, develop new sections and new material for their training programs.
There are many ways in which a hospital may develop a training program. For example, to develop their training programs, hospitals could draw upon the resources of federal, state, and local emergency preparedness agencies, as well as state and national healthcare associations and organizations. Hospitals could also participate in a local healthcare coalition, a partnership with other hospitals, healthcare facilities and local health departments to develop the necessary training. In addition, hospitals could develop partnerships with other hospitals and healthcare facilities to develop the necessary training. Some hospitals might also choose to purchase off-the-shelf emergency training programs or hire consultants to develop the programs for them. However, because many hospitals have a hospital emergency manager and safety office, we anticipate that the training program would likely be developed using the hospital's own staff. It is our experience with hospitals that a majority of them conduct some type of preparedness activities and training and, as such, are most likely to have staff versed in these issues that can assist with training. Additionally, hospitals and other healthcare providers commonly participate in trainings that are provided by their local healthcare coalition, local and state public health and emergency management agencies conducting community based exercises (for example, American Red Cross). The estimation of a burden for these requirements is based on this assumption.
Based on our experience with hospitals, we expect that complying with this requirement will require the involvement of the hospital administrator, the risk management director, a healthcare trainer, and administrative support staff. We estimate that it will require 40 burden hours for each hospital to develop an emergency preparedness training program at a cost of $3,000 for each non TJC-accredited hospital. We estimate that it will require 53,800 burden hours (40 burden hours for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals) to comply with this requirement at a cost of $4,035,000 ($3,000 estimated cost for each hospital × 1,345 non TJC-accredited hospitals).
Section 482.15(d) will also require hospitals to review and update their emergency preparedness training program at least annually. We believe that hospitals are already reviewing and updating their emergency preparedness training programs periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Hospitals also will be required to maintain documentation of their training. Based on our experience, we believe it is standard practice for hospitals to document the training they provide to their staff, individuals providing services under arrangement, and volunteers. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for the hospitals and not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 482.15(d)(2) will also require hospitals to participate in a full-scale exercise and one additional exercise of their choice at least annually. Hospitals also will be required to analyze their responses to, and maintain documentation of, all exercises and emergency events. If a hospital experienced an actual emergency which required activation of its emergency plan, it will be exempt from the requirement for a community or individual, facility-based disaster drill for 1 year following the onset of the emergency (§ 482.15(d)(2)(ii)). Thus, to satisfy the burden for these requirements, hospitals will need to develop a scenario for each exercise, as well as the documentation necessary for recording what happened. If a hospital participated in a full-scale exercise, it probably will not need to develop a scenario for that drill. However, for the purpose of determining the burden, we will assume that hospitals will need to develop at least two scenarios annually, one for each testing exercise requirement.
TJC-accredited hospitals are required to test their EOP twice a year (CAMH, Standard EC.4.20, EP 1, p. EC-14a). In addition, TJC-accredited hospitals must analyze all exercises, identify deficiencies and areas for improvement, and modify their EOPs in response to the analysis of those tests (CAMH, Standard EC.4.20, EPs 15-17, p. EC-14b). Therefore, we expect that TJC-accredited hospitals have already developed scenarios for testing exercises and have the documentation needed for the analysis of their responses. We expect that it will be a usual and customary business practice for the TJC-accredited hospitals to comply with the requirement to prepare scenarios for emergency preparedness testing exercises and to develop the necessary documentation. Thus, we believe compliance with this requirement will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Based on our experience with non TJC-accredited hospitals, we expect that the remaining non TJC-accredited hospitals have some type of emergency preparedness training program and that most, if not all, of them already conduct some type of drill or exercise to test their emergency preparedness plans. In addition, many hospitals participate in drills and exercises held by their communities, counties, and states. A 2006 study of 678 hospitals found that 88 percent of the participating hospitals were engaged in community-wide emergency preparedness drills and exercises (Braun BI, Wineman NV, Finn NL, Barbera JA, Schmaltz SP, Loeb JM. Integrating hospitals into community emergency preparedness planning. Ann Intern Med. 2006 Jun;144(11):799-811. PubMed PMID: 16754922.) We also expect that many of these hospitals have already developed the required documentation for recording the events, and analyzing their responses to, their testing exercises and emergency events. However, we do not believe that all non-TJC accredited hospitals will be in compliance with our requirements. Thus, we will analyze the burden for non TJC-accredited hospitals.
The non TJC-accredited hospitals will be required to develop scenarios for the testing exercises and the documentation necessary to record and analyze their responses to the exercises and emergency events. Based on our experience with hospitals, we expect that the same individuals who developed the emergency preparedness training program will develop the scenarios for the testing exercises and the accompanying documentation. We expect that the healthcare trainer will spend more time developing the scenarios and documentation. Thus, for each of the 1,345 non TJC-accredited hospitals to comply with these requirements, we estimate that it will require 9 burden hours at a cost of $752. Based on this estimate, for all 1,345 non TJC-accredited hospitals to comply will require 12,105 burden hours (9 burden hours for each non TJC-accredited hospital × 1,345 non TJC-accredited hospitals) at a cost of $1,011,440 ($752 estimated cost for each non TJC-accredited hospital × 1,345 non TJC-accredited hospital).
As discussed in section II.I. of this final rule, we have revised our requirements for transplant centers. Section 482.78 will require that transplant programs be included in the emergency preparedness planning and the emergency preparedness program for the hospital in which it is located. We note that a transplant center is not individually responsible for the emergency preparedness requirements set forth in § 482.15, except as detailed. Section 482.78(a) will require transplant centers to have policies and procedures that address emergency preparedness. Section 482.78(b) will require transplant centers to develop and maintain mutually-agreed upon protocols that address the duties and responsibilities of the transplant center, the hospital in which the transplant center is located, and the OPO during an emergency.
All of the Medicare-approved transplant centers are located within hospitals and, as part of the hospital, should be included in the hospital's emergency preparedness plans. We expect that since transplants are part of the hospital, they are usually involved in the hospital's programs as part of their normal business practices. Thus, compliance with these requirements will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). We refer readers to the discussion in section H above regarding the burden estimate for hospitals.
Section 483.73 sets forth the emergency preparedness requirements for long term care (LTC) facilities. We would usually be required to estimate the information collection requirements (ICRs) for these requirements in accordance with chapter 35 of title 44, United States Code. However, sections 4204(b) and 4214(d), which cover skilled nursing facilities (SNFs) and nursing facilities (NFs), respectively, of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) provide for a waiver of PRA requirements for the regulations that implement the OBRA '87 requirements. Section 1819(d) of the Act, as implemented by section 4201 of OBRA '87, requires that SNFs “be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident (consistent with requirements established under subsection (f)(5)).” Section 1819(f)(5)(C) of the Act, requires the Secretary to establish criteria for assessing a SNF's compliance with the requirement in subsection (d) with respect for disaster preparedness. Nursing facilities have the same requirement in sections 1919(d) and (f)(5)(C) of the Act, as implemented by OBRA '87.
All of the requirements in this rule relate to disaster preparedness. We believe this waiver applies to those revisions we have made to existing requirements in part 483, subpart B. Thus, the ICRs for the requirements in § 483.73 are not subject to the PRA. However, the waiver does not apply to the requirements of Executive Orders 12866 and 13563 under the Regulatory Impact Analysis (RIA) section. Therefore, to provide readers with sufficient context regarding the RIA discussion of the estimated costs to LTC facilities associated with this final rule, we have provided a discussion of the ICRs for LTC facilities in this COI section. We note that the estimates discussed in this section are not included in Table 128 “Total Burden Hour Estimates for All Providers and Suppliers to Comply with the ICRs Contained in the Final Rule: Emergency Preparedness”, per the wavier discussed previously. Emergency preparedness plan that must be reviewed and updated at least annually. The plan will have to meet the requirements set out at § 483.73(a)(1) through (4).
Section 483.73(a)(1) requires LTC facilities to develop documented, facility-based and community-based-risk assessments utilizing an all-hazards approach. We expect that all LTC facilities will need to identify the medical and non-medical emergency events they could experience in their facilities themselves and the communities in which they are located. We expect that in performing a risk assessment, a LTC facility will need to consider its physical location, the geographic area in which it is located, and its resident population.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment that complies with the requirements of this final rule. Existing requirements for LTC facilities already mandate that LTC facilities have “detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing residents” (see existing § 483.75(m)(1)). We expect that all LTC facilities already have performed some type of risk assessment during the process of developing their emergency and/or disaster plans and procedures. However, these risk assessments may not be as thorough as we require in this final rule, nor address all of the elements required by § 483.73(a)(1). With the exception of severe weather, the existing requirements at § 483.75(m)(1) discussed previously address emergencies and disasters that primarily arise within, or closely surrounding, a LTC facility. In addition,
We have not identified any specific process or format for LTC facilities to use in conducting their risk assessments because we believe that they need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, healthcare institutions should include representatives from, or obtain input from, all of their major departments. Based on our experience with LTC facilities, we expect that reviewing, revising, and updating a facility's existing risk assessment will require the involvement of the LTC facility's administrator, director of nursing, and the facilities director. We expect that these individuals will attend an initial meeting, review relevant sections of the previous assessment, if any, develop comments and recommendations, attend a follow-up meeting, perform a final review along with the administrator, and approve the new risk assessment.
In addition, we expect that the administrator will likely coordinate the meetings, perform an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop a new risk assessment, and ensure that the necessary parties approve the new risk assessment. Therefore, we expect that the administrator will spend more time than the other participants working on the risk assessment.
We estimate that complying with this requirement will require 8 burden hours at a cost of $692. There are 15,699 LTC facilities in the United States. Therefore, it will require an estimated 125,592 burden hours (8 burden hours for each LTC facility × 15,699 LTC facilities) for all LTC facilities to comply with this requirement at a cost of $10,863,708 ($692 estimated cost for each LTC facility × 15,699 LTC facilities).
After conducting the risk assessment, each LTC facility will then have to develop and maintain an emergency preparedness plan that addresses the requirements in § 483.73(a)(1)-(4) and review and update this plan at least annually. Existing requirements for LTC facilities require them to have “detailed written plans and procedures to meet all potential emergencies and disasters” (see existing § 483.75(m)(1)). We expect all LTC facilities already have some type of emergency preparedness and/or disaster plan. However, as discussed previously, we expect these plans and procedures will primarily cover disasters and emergencies that will affect the facilities themselves and, with the exception of severe weather, not necessarily the communities in which they are located. We also expect that all LTC facilities will need to review their current plans, compare them to their revised risk assessments, and update, revise, and, if necessary, develop new sections for their plans to ensure their emergency plans address the risks identified in their risk assessments and the specific elements we are issuing in this final rule.
The burden associated with this requirement will be the resources needed to review, revise, and, if needed, develop new sections for the LTC facility's existing emergency plan. Based upon our experience with LTC facilities, we expect that the same individuals who were involved in the risk assessment will be involved in these activities. We also expect these tasks will require more time to complete than the risk assessment.
We expect that the administrator, director of nursing, and the facilities director will have to attend an initial meeting, review the facility's current emergency preparedness plan, develop comments and recommendations, attend a follow-up meeting, perform a final review, and approve the new emergency preparedness plan. We expect that the administrator will develop the emergency preparedness plan and ensure that the necessary parties approved it. We also expect that the administrator will spend more time than the other participants reviewing and working on the emergency preparedness plan.
We estimate that complying with this requirement will require 12 burden hours at a cost of $1,038 for each LTC facility. There are 15,699 LTC facilities. Therefore, it will require an estimated 188,388 burden hours (12 burden hours for each LTC facility × 15,699 LTC facilities) to complete the plan at a cost of $ ($1,038 estimated cost for each LTC facility × 15,699 LTC facilities).
We require LTC facilities to review and update their emergency preparedness plans at least annually. The current emergency preparedness requirements for LTC facilities mandate that they “periodically review the procedures with their existing staff” (§ 483.75(m)(2)). We also expect that all LTC facilities will review and update their emergency preparedness plans annually. Thus, compliance with this requirement will constitute a usual and customary business practice for LTC facilities and will not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
Section 483.73(b) requires each LTC facility to develop and maintain emergency preparedness policies and procedures based on their emergency preparedness plan, risk assessment, and communication plan as set forth at § 483.73(a), (a)(1), and (c), respectively. LTC facilities are also required to review and update these policies and procedures at least annually. These policies and procedures will have to address, at a minimum, the requirements set forth at § 483.73(b)(1) through (8).
We expect that all LTC facilities have some emergency preparedness policies and procedures in place because existing regulations require them to have written disaster and emergency preparedness plans and procedures that address all potential disasters and emergencies (see exiting § 483.75(m)(1)). However, under this final rule, all LTC facilities will need to review their policies and procedures, assess whether their policies and procedures incorporate all the elements of their emergency preparedness plan, and if necessary, take the appropriate steps to ensure that their policies and procedures encompass the requirements in this final rule.
The burden associated with these requirements will be the time and effort necessary to review, revise, and, if necessary, develop new emergency policies and procedures. We expect that the administrator, the director of nursing, and the facilities director will be involved with reviewing, revising, and, if needed, developing any new policies and procedures. The administrator will brief any other staff and create assignments for purposes of making necessary revisions or drafting new policies and procedures and disseminate them to the appropriate parties. We estimate that complying with this requirement will require 10 burden hours at a cost of $868. Therefore, for all LTC facilities to comply with this requirement will require an estimated 156,990 burden hours (10 burden hours for each LTC facility × 15,699 LTC facilities) at a cost of $13,626,732 ($868 estimated cost for each LTC facility × 15,699 LTC facilities).
LTC facilities will be required to review and update their emergency preparedness policies and procedures at least annually. We believe that LTC facilities already review their policies and procedures periodically. Hence, these activities will constitute a usual and customary business practice for LTC facilities and will not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
Section 483.73(c) will require each LTC facility to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The LTC facility will also have to review and update its plan at least annually. The communication plan will have to include the information listed in § 483.73(c)(1) through (7).
We expect that all LTC facilities will compare their current emergency preparedness communications plans, if they have one, to these requirements. The LTC facilities will then need to perform any tasks necessary to ensure that their communication plans were documented and in compliance with these requirements.
We expect that all LTC facilities will have some type of emergency preparedness communication plan. Existing requirements for LTC facilities already require them to have written disaster plans and procedures (see existing § 483.75(m)(1)). Since the ability to communicate with staff, residents' families, and external sources of assistance during an emergency is critical for all healthcare organizations, we believe that communication will be an integral part of any LTC facility's disaster plan. In addition, it is standard practice for healthcare organizations to maintain contact information for their staff and for outside sources of assistance; alternate means of communications in case there is a disruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their residents. Thus, we expect that all LTC facilities already comply with the requirements of § 483.73(c)(1) through (3). However, we also expect that many LTC facilities may not have formal, written emergency preparedness communication plans or their plans may not be in compliance with the elements required in § 483.73(c)(4) through (7). Therefore, we expect that under this final rule, all LTC facilities will need to review, update, and in some cases, develop new sections for their emergency communication plans, to ensure those plans include all of these elements.
The burden associated with complying with this requirement will be the resources needed to review, update, and, if necessary, develop new sections for the LTC facility's existing communication plans. Based upon our experience with LTC facilities, we expect that satisfying the requirements of this section will require the involvement of the LTC facility's administrator and the director of nursing. We estimate that complying with this requirement will require 6 burden hours for each facility at a cost of $510. For all LTC facilities to comply with this requirement will require an estimated 94,194 burden hours (6 burden hours for each LTC facility × 15,699 LTC facilities) at a cost of $8,006,490 ($510 estimated cost for each LTC facility × 15,699 LTC facilities).
LTC facilities will also have to review and update its emergency preparedness communication plan at least annually. We believe that LTC facilities already review and update their plans and procedures periodically. Thus, the requirement for an annual review of the emergency preparedness communications plan constitutes a usual and customary business practice for LTC facilities and will not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
Section 483.73(d) will require LTC facilities to develop and maintain emergency preparedness training and testing programs. These training and testing programs will have to be reviewed and updated at least annually. LTC facilities will have to comply with the requirements in § 483.73(d)(1) and (2).
With respect to § 483.73(d)(1), each LTC facility will have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of that training. Thereafter, each LTC facility will have to provide the training at least annually.
Existing requirements for LTC facilities require facilities to “train all employees in emergency procedures when they begin to work in the facility” and “periodically review the procedures with existing staff” (See existing § 483.75(m)(2)). Therefore, we expect that LTC facilities already provide some type of emergency preparedness training program for new employees, as well as ongoing training for all staff. However, to ensure compliance with the requirements of this final rule, all LTC facilities will need to review their current training programs to ensure that they met all of the requirements in this final rule.
Each LTC facility will need to compare its current emergency preparedness training program's contents to its updated emergency preparedness plan, risk assessment, policies and procedures, and communication plan and then review, revise, and, if necessary, develop new sections for its training program to ensure that it complied with these requirements.
The burden associated with complying with this requirement will be the time and effort necessary for a LTC facility to compare its current emergency preparedness training program's contents to its updated emergency preparedness plan, risk assessment, policies and procedures, and communication plan and then review, revise, and, if necessary, develop new sections for its training program to ensure that it complies with the requirements of this final rule. We believe that these activities will require the involvement of an administrator and the director of nursing. We expect that the director of nursing will likely spend more time than the administrator working on the training program. We estimate that complying with this requirement will require 10 burden hours for each LTC facility at an estimated cost of $850. For all 15,699 LTC facilities to comply with this requirement, it will require an estimated 156,990 burden hours (10 burden hours for each LTC facility × 15,699 LTC facilities) at a cost of $13,344,150 ($850 estimated cost for each LTC facility × 15,699 LTC facilities).
Each LTC facility will be required to review and update its emergency preparedness training program at least annually. We believe that LTC facilities already review and update their training programs periodically. Thus, compliance with this requirement will constitute a usual and customary business practices for LTC facilities and will not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
Section 483.73(d)(2) will require LTC facilities to participate in a full-scale exercise at least annually. LTC facilities are also required to participate in one additional testing exercise of their choice at least annually. LTC facilities will also have to analyze their responses to, and maintain documentation of all exercises and emergency events. If a LTC facility experienced an actual emergency which required activation of its emergency plan, the LTC facility will be exempt from the requirement for a community or individual, facility-based disaster exercise for 1 year following the onset of the actual event (§ 483.73(d)(2)(ii)).
To comply with these testing requirements, a LTC facility will need to develop a scenario for each exercise. A LTC facility will also need to develop the necessary documentation to record and analyze their response to all testing exercises and emergency events.
Existing requirements for LTC facilities already mandate that these facilities “periodically review the procedures with existing staff, and carry out unannounced staff drills” (§ 483.75(m)(2)). We expect that all LTC facilities are already developing and conducting drills or exercises for their disaster plans. It is also standard practice in the healthcare industry to document what happens during a drill, exercise, or emergency event and analyze the facility's response to those events. However, the LTC facility requirements do not specify how often
To comply with these requirements we expect it will mainly require the involvement of the director of nursing. We expect that the director of nursing will develop the required documentation, as well as the scenarios for the testing exercises. We expect that the administrator will provide some assistance and approve the scenarios. We estimate that these tasks will require 5 burden hours at a cost of $425. Based on this estimate, it will require 78,495 burden hours (5 burden hours for each LTC facility × 15,699 LTC facilities) for all 15,699 LTC facilities to comply with these requirements at a cost of $6,672,075 ($425 estimated cost for each LTC facility × 15,699 LTC facilities).
Section 483.475(a) will require intermediate care facilities for individuals with intellectual disabilities (ICF/IID) to develop and maintain an emergency preparedness plan that will have to be reviewed and updated at least annually. We proposed that the plan will include the elements set out at § 483.475(a)(1) through (4). We will discuss the burden for these activities individually beginning with the risk assessment.
Section 483.475(a)(1) will require each ICFs/IID to develop a documented, facility-based and community-based risk assessment utilizing an all-hazard approach, including missing clients. We expect an ICF/IID to identify the medical and non-medical emergency events it could experience in the facility and the community in which it is located and determine the likelihood of the facility experiencing an emergency due to the identified hazards. In performing the risk assessment, we expect that an ICF/IID will need to consider its physical location, the geographical area in which it is located, and its client population.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment. The current CoPs for ICFs/IID already require ICFs/IID to “develop and implement detailed written plans and procedures to meet all potential emergencies and disasters such as fires, severe weather, and missing clients” (42 CFR 483.470(h)(1)). During the process of developing these detailed written plans and procedures, we expect that all ICFs/IID have already performed some type of risk assessment. However, as discussed earlier in the preamble, the current requirement is primarily designed to ensure the health and safety of the ICF/IID clients during emergencies that are within the facility or in the facility's local area. We do not expect that this requirement will be sufficient to protect the health and safety of clients during more widespread local, state, or national emergencies. In addition, an ICF/IID current risk assessment may not address all of the elements required in § 483.475(a). Therefore, all ICFs/IID will have to conduct a thorough review of their current risk assessments, if they have them, and then perform the necessary tasks to ensure that their risk assessments comply with the requirements of this section.
We have not designated any specific process or format for ICFs/IID to use in conducting their risk assessments because we expect ICFs/IID will need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, an ICF/IID will include representatives from, or obtain input from, all of the major departments in their facilities. Based on our experience with ICFs/IID, we expect that conducting the risk assessment will require the involvement of the ICF/IID administrator and a professional staff person, such as a registered nurse. We expect that both individuals will attend
Under this final rule, ICFs/IID will be required to develop emergency preparedness plans that addressed the emergency events that could affect not only their facilities but also the communities in which they are located. An ICF/IID current disaster plan might not address all of the medical and non-medical emergency events identified by its risk assessment, include strategies for addressing those emergency events, or address its patient population. It may not specify the type of services the ICF/IID has the ability to provide in an emergency, or continuity of operations, including delegation of authority and succession plans. Thus, we expect that each ICFs/IID will have to review its current plans and compare them to its risk assessments. Each ICF/IID will then need to update, revise, and, in some cases, develop new sections to comply with our requirements.
The burden associated with this requirement will be the resources needed to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with ICFs/IID, we expect that the same individuals who were involved in the risk assessment will be involved in developing the facility's new emergency preparedness plan. We also expect that developing the plan will be more labor intensive and will require more time to complete than the risk assessment. We estimate that it will require 9 burden hours at a cost of $750 for each ICF/IID to develop an emergency plan that complied with the requirements in this section. Based on this estimate, it will require 56,133 burden hours (9 burden hours for each ICF/IID × 6,237 ICFs/IID) to complete the plan at a cost of $4,677,750 ($750 estimated cost for each ICF/IID × 6,237 ICFs/IID).
The ICF/IID also will be required to review and update its emergency preparedness plan at least annually. We believe that ICFs/IID already review their emergency preparedness plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 483.475(b) will require each ICF/IID to develop and implement emergency preparedness policies and procedures, based on its emergency plan set forth in paragraph (a), the risk assessment at paragraph (a)(1), and the communication plan at paragraph (c). We will also require the ICF/IID to review and update these policies and procedures at least annually. At a minimum, the ICF/IID policies and procedures will be required to address the requirements listed at § 483.475(b)(1) through (8).
We expect all ICFs/IID to compare their current emergency preparedness policies and procedures to their emergency preparedness plans, risk assessments, and communication plans. They will then need to revise and, if necessary, develop new policies and procedures to ensure they comply with the requirements in this section.
We expect that all ICFs/II already have some emergency preparedness policies and procedures. As discussed earlier, the current CoPs for ICFs/IID require them to have “written . . . procedures to meet all potential emergencies and disasters” (§ 483.470(h)(1)). In addition, we expect that all ICFs/IID already have procedures that comply with some of the other requirements in this section. For example, as will be discussed later, current regulations require ICFs/IID to perform drills, evaluate the effectiveness of those drills, and take corrective action for any problems they detect (§ 483.470(i)). We expect that all ICFs/IID have developed procedures for safe evacuation from and return to the ICF/IID (§ 483.475(b)(4)) and a process to document and analyze drills and revise their emergency plan when they detect problems.
We expect that each ICF/IID will need to review its current disaster policies and procedures and assess whether they incorporate all of the elements we are proposing. Each ICF/IID also will need
The burden incurred by reviewing, revising, updating and, if necessary, developing new emergency policies and procedures will be the resources needed to ensure that the ICF/IID policies and procedures complied with the requirements of this section. We expect that these tasks will involve the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comply will require 9 burden hours at a cost of $750. Based on this estimate, for all 6,237 ICFs/IID to comply with this requirement will require 56,133 burden hours (9 burden hours for each ICF/IID × 6,237 ICFs/IID) at a cost of $4,677,750 ($750 estimated cost for each ICF/IID × 6,237 ICFs/IID).
We expect ICFs/IID to review and update their emergency preparedness policies and procedures at least annually. We believe that ICFs/IID already review their policies and procedures periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 483.475(c) will require each ICF/IID to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The ICF/IID will also have to review and update the plan at least annually. The communication plan must include the information set out at § 483.475(c)(1) through (7).
We expect all ICFs/IID to compare their current emergency preparedness communications plans, if they have them, to the requirements in this section. The ICFs/IID also will need to perform any tasks necessary to ensure that they document their communication plans and that those plans comply with the requirements of this section.
We expect that all ICFs/IID have some type of emergency preparedness communication plan. The current CoPs require ICFs/IID to have written disaster plans and procedures for all potential emergencies (§ 483.470(h)(1)). We expect that an integral part of these plans and procedures will include communication. Furthermore, it is standard practice for healthcare organizations to maintain contact information for both staff and outside sources of assistance; have alternate means of communication in case there is an interruption in phone service to the facility (for example, cell phones); and have a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their clients. However, many ICFs/IID may not have a formal, written emergency preparedness communication plan, or their plan may not comply with all the elements we are requiring.
The burden associated with complying with this requirement will be the resources required to ensure that the ICF/IID emergency communication plan complied with the requirements. Based upon our experience with ICFs/IID, we anticipate that meeting the requirements in this section will primarily require the involvement of the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comply with the requirement will require 6 burden hours at a cost of $500. Therefore, for all 6,237 ICFs/IID to comply with this requirement will require an estimated 37,442 burden hours (6 burden hours for each ICF/IID × 6,237 ICFs/IID) at a cost of $3,118,500 ($500 estimated cost for each ICF/IID × 6,237 ICFs/IID).
The ICFs/IID will also have to review and update their emergency preparedness communication plans at least annually. We believe that ICFs/IID already review their plans, policies, and procedures periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 483.475(d) will require ICFs/IID to develop and maintain emergency preparedness training and testing programs that will have to be reviewed and updated at least annually. Each ICF/IID will also have to meet the requirements for evacuation drills and training at § 483.470(i).
To comply with the requirements at § 483.475(d)(1), an ICF/IID will have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the ICF/IID will have to provide emergency preparedness training at least annually.
The ICFs/IID will need to compare their current emergency preparedness training programs' contents to their risk assessments and updated emergency preparedness plans, policies and procedures, and communication plans and then revise and, if necessary, develop new sections for their training programs to ensure they complied with the requirements. The current ICFs/IID
The burden will be the time and effort necessary to comply with the requirements. We expect that a registered nurse will be primarily involved in reviewing the ICF/IID current training program and the ICF/IID updated emergency preparedness plan, policies, and procedures, and communication plan; determining what tasks will need to be performed to comply with the requirements of this section; accomplishing those tasks, and developing an updated training program. We expect the administrator will work with the registered nurse to update the training program. We estimate that it will require 7 burden hours for each ICF/IID to develop an emergency training program at a cost of $506. Therefore, it will require an estimated 43,659 burden hours (7 burden hours for each ICF/IID × 6,237 ICFs/IID) to comply with this requirement at a cost of $3,155,922 ($506 estimated cost for each ICF/IID × 6,237 ICFs/IID).
The ICFs/IID will have to review and update their emergency preparedness training program at least annually. We believe that ICFs/IID already review their emergency preparedness training programs periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 483.475(d)(2) will require ICFs/IID to participate in a full-scale exercise and one additional exercise of their choice at least annually. The ICFs/IID will also be required to analyze their responses to and maintain documentation of all testing exercises and emergency events, and revise their emergency plans, as needed. If an ICF/IID experienced an actual natural or man-made emergency that required activation of its emergency plan, the ICF/IID will be exempt from engaging in a full-scale exercise for 1 year following the onset of the actual event. To comply with this requirement, an ICF/IID will need to develop scenarios for each testing exercise. An ICF/IID also will have to develop the required documentation.
The current ICF/IID CoPs require them to hold evacuation drills at least quarterly for each shift and under varied conditions to evaluate the effectiveness of emergency and disaster plans and procedures (§ 483.470(i)(1)). In addition, ICFs/IID must “actually evacuate clients during at least one drill each year on each shift . . . file a report and evaluation on each evacuation drill . . . and investigate all problems with evacuation drills, including accidents, and take corrective action” (42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/IID already conduct quarterly drills. However, the current CoPs do not indicate the type of drills ICFs/IID must perform. In addition, although the CoPs require that a report and evaluation be filed, this requirement does not ensure that ICFs/IID have developed the type of paperwork we proposed requiring or that scenarios are used for each drill or tabletop exercise. For the purpose of determining a burden for these requirements, all ICFs/IID will have to develop scenarios and all ICFs/IID will have to develop the necessary documentation.
The burden associated with these requirements will be the resources the ICF/IID will need to comply with the requirements. We expect that complying with these requirements will likely require the involvement of a registered nurse. We expect that the registered nurse will develop the required documentation. We also expect that the registered nurse will develop the scenarios for the each testing exercise. We estimate that these tasks will require 4 burden hours at a cost of $256. Based on this estimate, for all 6,237 ICFs/IID to comply, it will require 24,948 burden hours (4 burden hours for each ICF/IID × 6,237 ICFs/IID) at a cost of $1,596,672 ($256 estimated cost for each ICF/IID × 6,237 ICFs/IID).
Section 484.22(a) will require home health agencies (HHAs) to develop and maintain emergency preparedness plans. Each HHA also will be required to review and update the plan at least annually. Specifically, we proposed that the plan meet the requirements listed at § 484.22(a)(1) through (4). We will discuss the burden for these activities individually, beginning with the risk assessment.
Accreditation may substantially affect the burden a HHA will experience under this final rule. HHAs are accredited by three different accrediting organizations (AOs): The Joint Commission (TJC), The Community Health Accreditation Program (CHAP), and the Accreditation Commission for Health Care, Inc. (ACHC). After reviewing the accreditation standards for all three AOs, neither the standards for CHAP nor the ones for ACHC appeared to ensure substantial compliance with our requirements in this rule. Therefore, the HHAs accredited by CHAP and ACHC will be included with the non-accredited HHAs for the purposed of determining the burden for this final rule.
As of June 2016, there are currently 12,335 HHAs. There are 4,330 TJC-accredited HHAs. A review of TJC deeming standards indicates that the 4,330 TJC-accredited HHAs already perform certain tasks or activities that will partially or completely satisfy our requirements. Therefore, since TJC accreditation is a significant factor in determining the burden, we will analyze the burden for the 4,330 TJC-accredited HHAs separately from the 8,005 non TJC-accredited HHAs (12,335 HHAs-4,330 TJC-accredited HHAs), as appropriate. Note that we obtain data on the number of HHAs, both accredited and non-accredited, from the CMS CASPER data system, which is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited HHAs may not equal the total number of HHAs.
Section 484.22(a)(1) will require that HHAs develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. To perform this risk assessment, an HHA will need to identify the medical and non-medical emergency events the HHA could experience and how the HHA's essential business functions and ability to provide services could be impacted by those emergency events based on the risks to the facility itself and the community in which it is located. We will expect HHAs to consider the extent of their service area, including the location of any branch offices. An HHA with an existing risk assessment will need to review, revise and update it to comply with our requirements.
For TJC accreditation standards, we used TJC's CAMHC Refreshed Core, January 2008 pages from the Comprehensive Accreditation Manual for Home Care 2008 (CAMHC). In the chapter entitled, “Environmental Safety and Equipment Management” (EC), TJC accreditation standards require HHAs to conduct proactive risk assessments to “evaluate the potential adverse impact of the external environment and the services provided on the security of patients, staff, and other people coming to the organization's facilities” (CAMHC, Standard EC.2.10, EP 3, p. EC-7). These proactive risk assessments should evaluate the risk to the entire organization, and the HHA should conduct one of these assessments whenever it identifies any new external risk factors or begins a new service (CAMHC, Standard EC.2.10, p. EC-7). Moreover, TJC-accredited HHAs are required to develop and maintain “a written emergency management plan describing the process for disaster readiness and emergency management . . . ” (CAMHC, Standard EC.4.10, EP 3, p. EC-9). In addition, TJC requires that these plans provide for “processes for managing . . . activities related to care, treatment, and services (for example, scheduling, modifying, or discontinuing services; controlling information about patients; referrals; transporting patients) . . . logistics relating to critical supplies . . . communicating with patient” during an emergency (CAMHC, Standard EC.4.10, EP 10, p. EC-9-10). We expect that any HHA that has conducted a proactive risk assessment and developed an emergency management plan that satisfies the previously described TJC accreditation requirements has already conducted a risk assessment that will satisfy our requirements. Any tasks needed to comply with our requirements will not result in any additional burden. Thus, for the 4,330 TJC-accredited HHAs, the risk assessment requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
It is standard practice for healthcare facilities to prepare for common internal and external medical and non-medical emergencies, based on their location, structure, and the services they provide. We believe that the 8,005 non TJC-accredited HHAs have conducted some type of risk assessment. However, those risk assessments are unlikely to satisfy all of our requirements. Therefore, we will analyze the burden for the 8,005 non TJC-accredited HHAs to comply.
We have not designated any specific process or format for HHAs to use in conducting their risk assessments because we believe that HHAs need the flexibility to determine the best way to accomplish this task. However, we expect that HHAs will include representatives from or input from all of their major departments. Based on our
After conducting a risk assessment, HHAs will have to develop an emergency preparedness plan that complied with § 484.22(a)(1) through (4). As discussed earlier, TJC already has accreditation standards similar to the requirements we proposed at § 484.22(a). Thus, we expect that TJC-accredited HHAs have an emergency preparedness plan that will satisfy most of our requirements. Although the current HHA CoPs require that there be a qualified person who “is authorized in writing to act in the absence of the administrator” (§ 484.14(c)), the TJC standards do not specifically address delegations of authority or succession plans. Furthermore, TJC standards do not address persons-at-risk. Therefore, we expect that the 1,815 TJC-accredited HHAs will incur some burden due to reviewing, revising, and in some cases, developing new sections for their emergency preparedness plans. However, we will analyze the burden for TJC-accredited HHAs separately from the 8,005 non TJC-accredited HHAs because we expect the burden for TJC-accredited HHAs to be substantially less.
We expect that the 8,005 non TJC-accredited HHAs already have some type of emergency preparedness plan, as well as delegations of authority and succession plans. However, we also expect that their plans do not comply with all of our requirements. Thus, all non TJC-accredited HHAs will need to review their current plans and compare them to their risk assessments. They also will need to update, revise, and, in some cases, develop new sections for their emergency plans.
Based on our experience with HHAs, we expect that the same individuals who were involved in the risk assessment will be involved in developing the emergency preparedness plan. We estimate that complying with this requirement will require 10 burden hours for each TJC-accredited HHA at a cost of $862. Therefore, for all 4,330 TJC-accredited HHAs to comply will require an estimated 43,300 burden hours (10 burden hours for each TJC-accredited HHA × 4,330 TJC-accredited HHAs) at a cost of $3,732,460 ($862 estimated cost for each HHA × 4,330 TJC-accredited HHAs).
We estimate that complying with this requirement will require 15 burden hours for each of the 8,005 non TJC-accredited HHAs at a cost of $1,293. Therefore, for all 8,005 non TJC-accredited HHAs to comply will require an estimated 120,075 burden hours (15 burden hours for each non TJC-accredited HHA × 8,005 non TJC-accredited HHAs) at a cost of $10,350,465 ($1,293 estimated cost for each non TJC-accredited HHA × 8,005 non TJC-accredited HHAs).
Based on these estimates, for all 12,335 HHAs to develop an emergency preparedness plan that complies with our requirements will require 163,375 burden hours at a cost of $14,082,925. We will also require HHAs to review and update their emergency preparedness plans at least annually. We believe that HHAs are already reviewing and updating their emergency preparedness plans periodically. Hence, we believe compliance with this requirement will constitute a usual and customary business practice for HHAs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 484.22(b) will require each HHA to develop and implement emergency preparedness policies and procedures based on the emergency plan, risk assessment, communication plan as set forth in § 484.22(a), (a)(1), and (c), respectively. The HHA will also have to review and update its policies and procedures at least annually. We will require that, at a minimum, these policies and procedures address the requirements listed at § 484.22(b)(1) through (6).
We expect that HHAs will review their emergency preparedness policies and procedures and compare them to their risk assessments, emergency preparedness plans, and emergency communication plans. HHAs will need to revise or, in some cases, develop new policies and procedures to ensure they complied with all of the requirements.
In the chapter entitled, “Leadership,” TJC accreditation standards require that each HHA's “leaders develop policies and procedures that guide and support patient care, treatment, and services” (CAMHC, Standard LD.3.90, EP 1, p. LD-13). In addition, TJC accreditation standards and EPs specifically require each HHA to develop and maintain an emergency management plan that provides processes for managing activities related to care, treatment, and services, including scheduling, modifying, or discontinuing services (CAMHC, Standard EC.4.10, EP 10, EC-9); identify backup communication systems in the event of failure due to an emergency event (CAMHC, Standard EC.4.10, EP 18, EC-10); and develop processes for critiquing tests of its emergency preparedness plan and modifying the plan in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11).
We expect that the 4,330 TJC-accredited HHAs already have emergency preparedness policies and procedures that address some of the requirements at § 484.22(b). However, we do not believe that TJC accreditation requirements ensure that TJC-accredited HHAs' policies and procedures address all of our requirements for emergency policies and procedures. Thus, we will include the 4,330 TJC-accredited HHAs with the 8,005 non TJC-accredited HHAs in our analysis of the burden for § 484.22(b).
Under § 484.22(b)(1), the HHA's individual plans for patients during a natural or man-made disaster will be included as part of the comprehensive patient assessment, which will be conducted according to the provisions at § 484.55. We expect that HHAs already collect data during the comprehensive patient assessment that they will need to develop for each patient's emergency plan. At § 484.22(b)(2), we proposed requiring each HHA to have procedures to inform state and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patients' medical and psychiatric condition and home environment.
Existing HHA regulations already address § 484.22(b)(1) and (2). For example, regulations at § 484.18 make it clear that HHAs are expected to accept patients only on the basis of a reasonable expectation that they can provide for the patients' medical, nursing, and social needs in the patients' home. Moreover, the plan of care for each patient must cover any safety measures necessary to protect the patient from injury § 484.18(a). Thus, the activities necessary to be in compliance with § 484.22(b)(1) and (2) will constitute usual and customary business practices for HHA and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
We expect that all 12,520 HHAs have some emergency preparedness policies and procedures. However, we also expect that all HHAs will need to review their policies and procedures and revise and, if necessary, develop new policies and procedures that complied with our requirements set out at § 484.22(3) through (6). We expect that a professional staff person, most likely the director of nursing, will review the HHA's policies and procedures and make recommendations for changes or development of additional policies and procedures. The administrator or director of nursing will brief representatives of most of the HHA's major departments and assign staff to make necessary revisions and draft any new policies and procedures. We estimate that complying with this requirement will require 18 burden hours for each HHA at a cost of $1,584. Thus, for all 12,335 HHAs to comply with all of our requirements will require an estimated 222,030 burden hours (18 burden hours for each HHA × 12,335 HHAs) at a cost of $19,538,640 ($1,584 estimated cost for each HHA × 12,335 HHAs).
We are also proposing that HHAs review and update their emergency preparedness policies and procedures at least annually. The current CoPs require HHAs to establish and annually review the agency's policies governing scope of services offered, admission and discharge policies, medical supervision and plans of care, emergency clinical records and program evaluation. (42 CFR 484.16). Thus, we believe that complying with this requirement will constitute a usual and customary business practice for HHAs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
In § 484.22(c), each HHA will be required to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. We proposed that each HHA review and update its communication plan at least annually. We will require that the emergency communication plan include the information listed at § 484.22(c)(1) through (6).
It is standard practice for healthcare facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method of sharing information and medical documentation with other healthcare providers to ensure continuity of care for patients.
All TJC-accredited HHAs are required to identify backup communication systems for both internal and external communication in case of failure due to an emergency (CAMHC, Standard EC.4.10, EP 18, p. EC-10). They are required to have processes for notifying their staff when the HHA initiates its emergency plan (CAMHC, Standard EC.4.10, EP 7, p. EC-9); identifying and assigning staff to ensure that essential functions are covered during emergencies (CAMHC, Standard EC.4.10, EP 9, p. EC-9); and activities related to care, treatment, and services, such as controlling information about their patients (CAMHC, Standard EC.4.10, EP 10, p. EC-9). However, we do not believe these requirements ensure that all TJC-accredited HHAs are already in compliance with our requirements. Thus, we will include the 4,330 TJC-accredited HHAs with the 8,005 non TJC-accredited HHAs in assessing the burden for this requirement.
We expect that all 12,335 HHAs maintain some contact information, an alternate means of communication, and a method for sharing information with other healthcare facilities. However, this will not ensure that all HHAs will be in compliance with our requirements for communication plans. Thus, we will analyze the burden for this requirement for all 12,335 HHAs.
The burden associated with complying with this requirement will be the time and effort necessary for each HHA to review its existing communication plan, if any, and revise it; and, if necessary, to develop new sections for the emergency preparedness communication plan to ensure that it complied with our requirements. Based on our experience with HHAs, we expect that these activities will require the involvement of the HHA's administrator, director of nursing, director of rehabilitation, and office manager. We estimate that complying with this requirement will require 10 burden hours for each HHA at a cost of $826. Thus, for all 12,335 HHAs to comply with these requirements will require an estimated 123,350 burden hours (10 burden hours for each HHA × 123,350 HHAs) at a cost of $10,188,710 ($826 estimated cost for each HHA × 123,350 HHAs).
We proposed requiring HHAs to review and update their emergency preparedness communication plans at least annually. We believe that HHAs already review their emergency preparedness plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for HHAs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). Section 484.22(d) will require each HHA to develop and maintain an emergency preparedness training and testing program. Each HHA will also have to review and update its training and testing program at least annually. Section 484.22(d)(1) states that each HHA will have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the HHA will have to provide emergency preparedness training at least annually. Each HHA will also have to ensure that their staff could demonstrate knowledge of their emergency procedures.
Based on our experience with HHAs, we expect that all 12,335 HHAs have some type of emergency preparedness training program because this a key component of emergency preparedness and as stated earlier, it is standard
However, we expect that under § 484.22(d), all HHAs will need to compare their training and testing programs with their risk assessments, emergency preparedness plans, emergency policies and procedures, and emergency communication plans. We expect that most HHAs will need to revise and, in some cases, develop new sections for their training programs to ensure that they complied with our requirements. In addition, HHAs will need to provide an orientation and annual training in their facilities' emergency preparedness policies and procedures to individuals providing services under arrangement and volunteers, consistent with their expected roles. Hence, we will analyze the burden of these requirements for all 12,335 HHAs.
Based on our experience with HHAs, we expect that complying with this requirement will require the involvement of an administrator, the director of training, director of nursing, director of rehabilitation, and the office manager. We expect that the director of training will spend more time reviewing, revising or developing new sections for the training program than the other individuals. We estimate that it will require 16 burden hours for each HHA to develop an emergency preparedness training and testing program at a cost of $1,132. Thus, for all 12,335 HHAs to comply will require an estimated 197,360 burden hours (16 burden hours for each HHA × 12,335 HHAs) at a cost of $13,963,220 ($1,132 estimated cost for each HHA × 12,335 HHAs).
We also proposed that HHAs should review and update their emergency preparedness training programs at least annually. The current CoPs require HHAs to establish and annually review the agency's policies governing scope of services offered, admission and discharge policies, medical supervision and plans of care, emergency care clinical records, and program evaluation. We believe that HHAs already review their training and testing programs periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for HHAs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 484.22(d)(2) will require each HHA to conduct exercises to test its emergency plan. Each HHA will have to participate in a full-scale exercise and one additional exercise at least annually. If an HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, it will be exempt from engaging in a full-scale exercise for 1 year following the onset of the actual event. Each HHA will also be required to analyze its responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise its emergency plan as needed. For the purposes of determining the burden for these requirements, we expect that all HHAs will have to comply with all of the requirements. The burden associated with complying with this requirement will be the time and effort necessary to develop the scenarios for the testing exercises and the required documentation. All TJC-accredited HHAs are required to test their emergency management plan once a year; the test cannot be a tabletop exercise (CAMHC, Standard EC.4.20, EP 1 and Note 1, p. EC-11). The TJC also requires HHAs to critique the drills and modify their emergency management plans in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11). Therefore, TJC-accredited HHAs already prepare scenarios for drills, develop documentation to record the events during drills, critique them, and modify their emergency preparedness plans in response. However, TJC standards do not describe what type of drill HHAs must conduct or require a tabletop exercise annually. Thus, TJC accreditation standards will not ensure that TJC-accredited HHAs will be in compliance with our requirements. Therefore, we will include the 4,330 TJC-accredited HHAs with the 8,005 non TJC-accredited HHAs in our analysis of the burden for these requirements.
Based on our experience with HHAs, we expect that the same individuals who are responsible for developing the HHA's training and testing program will develop the scenarios for the testing exercises and the accompanying documentation. We expect that the director of nursing will spend more time on these activities than will the other individuals. We estimate that it will require 7 burden hours for each HHA to comply with the requirements at an estimated cost of $586. Thus, for all 12,335 HHAs to comply with the requirements in this section will require an estimated 86,345 burden hours (7 burden hours for each HHA × 12,335 HHAs) at a cost of $7,228,310 ($586 estimated cost for each HHA × 12,335 HHAs).
Section 485.68(a) will require all Comprehensive Outpatient Rehabilitation Facilities (CORFs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We proposed that the plan meet the requirements listed at § 485.68(a)(1) through (5).
Section 485.68(a)(1) will require a CORF to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. The CORFs will need to identify the medical and non-medical emergency events they could experience. The current CoPs for CORFs already require CORFs to have “written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters” (§ 485.64). We expect that all CORFs have performed some type of risk assessment during the process of developing their disaster policies and procedures. However, their risk assessments may not meet our requirements. Therefore, we expect that all CORFs will need to review their existing risk assessments and perform the tasks necessary to ensure that those assessments meet our requirements.
We have not designated any specific process or format for CORFs to use in conducting their risk assessments because we believe they need the flexibility to determine how best to accomplish this task. However, we expect that CORFs will obtain input from all of their major departments. Based on our experience with CORFs, we expect that conducting the risk assessment will require the involvement of the CORF's administrator and a therapist. The type of therapists at each CORF varies, depending upon the services offered by the facility. For the purposes of determining the burden, we will assume that the therapist is a physical therapist. We expect that both the administrator and the therapist will attend an initial meeting, review relevant sections of the current assessment, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrator will coordinate the meetings, review and critique the risk assessment, coordinate comments, develop the new risk assessment, and ensure that it was approved.
We estimate that complying with this requirement will require 8 burden hours at a cost of $722. There are currently 205 CORFs. Therefore, it will require an estimated 1,640 burden hours (8 burden hours for each CORF × 205 CORFs) for all CORFs to comply at a cost of $148,010 ($722 estimated cost for each CORF × 205 CORFs).
After conducting the risk assessment, each CORF will need to review, revise, and, if necessary, develop new sections for its emergency plan so that it complied with our requirements. The current CoPs for CORFs require them to
Based on our experience with CORFs, we expect that the administrator and physical therapist who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we expect that it will require more time to complete the emergency plan than to complete the risk assessment. We estimate that complying with this requirement will require 11burden hours at a cost of $1,013 for each CORF. Therefore, it will require an estimated 2,255 burden hours (11 burden hours for each CORF × 205 CORFs) for all CORFs to complete an emergency preparedness plan at a cost of $207,665 ($1,013 estimated cost for each CORF × 205 CORFs).
The CORF also will be required to review and update its emergency preparedness plan at least annually. We believe that CORFs already review their plans periodically. Therefore, compliance with the requirement for an annual review of the emergency preparedness plan will constitute a usual and customary business practice for CORFs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.68(b) will require CORFs to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in § 485.68(a), (a)(1), and (c), respectively. We will also require CORFs to review and update these policies and procedures at least annually. We will require that a CORF's policies and procedures address, at a minimum, the requirements listed at § 485.68(b)(1) through (4).
We expect that all CORFs have some emergency preparedness policies and procedures. As discussed earlier, the current CoPs for CORFs already require CORFs to have “written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters” (42 CFR 485.64). However, all CORFs will need to review their policies and procedures and compare them to their risk assessments, emergency preparedness plans, and communication plans. Most CORFs will need to revise their existing policies and procedures or develop new policies and procedures to ensure they complied with all of our requirements.
We expect that both the administrator and the therapist will attend an initial meeting, review relevant policies and procedures, make recommendations for changes, attend a follow-up meeting, perform a final review, and approve the policies and procedures. We expect that the administrator will coordinate the meetings, coordinate the comments, and ensure that they are approved.
We estimate that it will take 9 burden hours for each CORF to comply with this requirement at a cost of $819. Therefore, it will take all 205 CORFs 1,845 burden hours (9 burden hours for each CORF × 205 CORFs = 1,845 burden hours) to comply with this requirement at a cost of $167,895 ($819 estimated cost for each CORF × 205 CORFs).
Section 485.68(b) also proposes that CORFs review and update their emergency preparedness policies and procedures at least annually. We believe that CORFs already review their policies and procedures periodically. Therefore, we believe that complying with this requirement will constitute a usual and customary business practice for CORFs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.68(c) will require CORFs to develop and maintain emergency preparedness communication plans that complied with both federal and state law and that will be reviewed and updated at least annually. We proposed that a CORF's communication plan include the information listed in § 485.68(c)(1) through (5). Current CoPs require CORFs to have a written disaster plan that must include, among other things, “procedures for notifying community emergency personnel” (§ 486.64(a)(2)). In addition, it is standard practice in the healthcare industry to maintain contact information for staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. However, many CORFs may not have formal, written emergency preparedness communication plans. Therefore, we expect that all CORFs will
Based on our experience with CORFs, we anticipate that satisfying the requirements in this section will primarily require the involvement of the CORF's administrator with the assistance of a physical therapist to review, revise, and, if needed, develop new sections for the CORF's emergency preparedness communication plan. We estimate that it will take 8 burden hours for each CORF to comply with this requirement at a cost of $722. Therefore, it will take 1,640 burden hours (8 burden hours for each CORF × 205 CORFs) for all CORFs to comply at a cost of $148,010 ($722 estimated cost for each CORF × 205 CORFs).
We proposed that each CORF will also have to review and update its emergency preparedness communication plan at least annually. We believe that compliance with this requirement will constitute a usual and customary business practice for CORFs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.68(d) will require CORFs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We proposed that each CORF will have to satisfy the requirements listed at § 485.68(d)(1) and (2).
Section 485.68(d)(1) will require that each CORF provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, each CORF will have to provide emergency preparedness training at least annually. Each CORF will also have to ensure that its staff could demonstrate knowledge of its emergency procedures. All new personnel will have to be oriented and assigned specific responsibilities regarding the CORF's emergency plan within two weeks of their first workday. In addition, the training program will have to include instruction in the location and use of alarm systems and signals and firefighting equipment.
The current CORF CoPs at § 485.64 require CORFs to ensure that all personnel are knowledgeable, trained, and assigned specific responsibilities regarding the facility's disaster procedures. Section 485.64(b)(1) specifies that CORFs must also provide ongoing training and drills for all personnel associated with the facility in all aspects of disaster preparedness. In addition, § 485.64(b)(2) specifies that all new personnel must be oriented and assigned specific responsibilities regarding the facility's disaster plan within 2 weeks of their first workday.
In evaluating the requirement for § 485.68(d)(1), we expect that all CORFs have an emergency preparedness training program for new employees, as well as ongoing training for all staff. However, under this final rule, all CORFs will need to compare their current training programs to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. CORFs will then need to revise, and in some cases, develop new material for their training programs.
We expect that these tasks will require the involvement of an administrator and a physical therapist. We expect that the administrator will review the CORF's current training program to identify necessary changes and additions to the program. We expect that the physical therapist will work with the administrator to develop the revised and updated training program. We estimate it will require 8 burden hours for each CORF to develop an emergency training program at a cost of $722. Therefore, for all CORFs to comply will require an estimated 1,640 burden hours (8 burden hours for each CORF × 205 CORFs) at a cost of $148,010 ($722 estimated cost for each CORF × 205 CORFs).
We also proposed that each CORF review and update its emergency preparedness training program at least annually. We believe that CORFs already review their training programs periodically. Thus, we believe complying with the requirement for an annual review of the emergency preparedness training program will constitute a usual and customary business practice for CORFs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.68(d)(2) will require CORFs to participate in a full-scale exercise and a paper-based, tabletop exercise at least annually. If a full-scale exercise was not available, the CORF will have to conduct a full-scale exercise at least annually. If a CORF experienced an actual natural or man-made emergency that required activation of its emergency plan, it will be exempt from engaging in a full-scale exercise for 1 year following the onset of the actual event. CORFs will also be required to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency
Based on our experience with CORFs, we expect that the same individuals who develop the emergency preparedness training program will develop the scenarios for the drills and exercises, as well as the accompanying documentation. We expect that the administrator will spend more time on these tasks than the physical therapist. We estimate that for each CORF to comply with the requirements will require 6 burden hours at a cost of $546. Therefore, for all 205 CORFs to comply will require an estimated 1,230 burden hours (6 burden hours for each CORF × 205 CORFs) at a cost of $111,930 ($528 estimated cost for each CORF × 221 CORFs).
Based on the previous analysis, for all 205 CORFs to comply with the ICRs contained in this final rule will require 10,250 total burden hours at a total cost of $931,520.
Section 485.625(a) will require critical access hospitals (CAHs) to develop and maintain a comprehensive emergency preparedness program that utilizes an all-hazards approach and will have to be reviewed and updated at least annually. Each CAH's emergency plan will have to include the elements listed at § 485.625(a)(1) through (4).
Section 485.625(a)(1) will require each CAH to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. CAHs will need to review their existing risk assessments and perform any tasks necessary to ensure that it complied with our requirements.
As of June 2016, there are approximately 1,337 CAHs. CAHs with distinct part units were included in the hospital burden analysis. Approximately 445 CAHs are accredited either by TJC (338), DNV GL (76), or by the AOA/HFAP (31); the remainder are non-accredited CAHs.
Many of the TJC and AOA/HFAP accreditation standards for CAHs are similar to the requirements in this final rule. For purposes of determining the burden, we have analyzed the burden for the 338 TJC-accredited and 31 AOA/HFAP-accredited CAHs separately from the non-accredited CAHs. DNV GL's accreditation standards do not meet the requirements for emergency preparedness of this final rule and as a result, we have included the DNV GL-accredited CAHs with the non-accredited CAHs in our burden analysis. Note that we obtained data on the number of CAHs, both accredited and non-accredited, from the CMS CASPER database, which is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited CAHs may not equal the total number of CAHs.
For purposes of determining the burden for TJC-accredited CAHs, we used TJC's Comprehensive Accreditation Manual for Critical Access Hospitals: The Official Handbook 2008 (CAMCAH). In the chapter entitled, “Management of the Environment of Care” (EC), Standard EC.4.11 requires CAHs to plan for managing the consequences of emergency events (CAMCAH, Standard EC.4.11, CAMCAH Refreshed Care, January 2008, pp. EC-10-EC-11). CAHs are required to perform a hazard vulnerability analysis (HVA), which requires each CAH to, among other things, “identify events that could affect demand for its services or its ability to provide those services, the likelihood of those events occurring, and the consequences of those events” (Standard EC.4.11, EP 2, p. EC-10a). The HVA “should identify potential hazards, threats, and adverse events, and assess their impact on the care, treatment, and services [the CAH] must sustain during an emergency,” and the HVA “is designed to assist [CAHs] in gaining a realistic understanding of their vulnerabilities, and to help focus their resources and planning efforts”
For purposes of determining the burden for AOA/HFAP-accredited CAHs, we used the AOA/HFAP's Healthcare Facilities Accreditation Program: Accreditation Requirements for Critical Access CAHs 2007 (ARCAH). In Chapter 11 entitled, “Physical Environment,” CAHs are required to have disaster plans, external disaster plans that include triaging victims, and weapons of mass destruction response plans (ARCAH, Standards 11.07.01, 11.07.02, and 11.07.05-6, pp. 11-38 through 11-41, respectively). In addition, AOA/HFAP-accredited CAHs must “coordinate with federal, state, and local emergency preparedness and health authorities to identify likely risks for their area . . . and to develop appropriate responses” (ARCAH, Standard 11.02.02, p. 11-5). Thus, we believe that to develop their plans, AOA/HFAP-accredited CAHs already perform some type of risk assessment. However, the AOA/HFAP standards do not require a documented facility-based and community-based risk assessment, as we proposed. Therefore, we will include the 31 AOA/HFAP-accredited CAHs with non-accredited CAHs in determining the burden for our risk assessment requirement.
The CAH CoPs currently require CAHs to assure the safety of their patients in nonmedical emergencies (§ 485.623) and to take appropriate measures that are consistent with the particular conditions in the area in which the CAH is located (§ 485.623(c)(4)). To satisfy this requirement in the CoPs, we expect that CAHs have already conducted some type of risk assessment. However, that requirement does not ensure that CAHs have conducted a documented, facility-based, and community-based risk assessment that will satisfy our requirements.
We believe that under this final rule, the 999 non TJC-accredited CAHs (1,337 CAHs−338 TJC-accredited CAHs) will need to review, revise, and, in some cases, develop new sections for their current risk assessments to ensure compliance with all of our requirements.
We have not designated any specific process or format for CAHs to use in conducting their risk assessments because we believe that CAHs need the flexibility to determine the best way to accomplish this task. However, we expect that CAHs will include representatives from or obtain input from all of their major departments in the process of developing their risk assessments.
Based on our experience with CAHs, we expect that these activities will require the involvement of a CAH's administrator, medical director, director of nursing, facilities director, and food services director. We expect that these individuals will attend an initial meeting, review relevant sections of the current risk assessment, provide comments, attend a follow-up meeting, perform a final review, and approve the new or updated risk assessment. We expect the administrator will coordinate the meetings, perform an initial review of the current risk assessment, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approved it.
We estimate that the risk assessment requirement for non TJC-accredited CAHs will require 15 burden hours to complete at a cost of $1,495. We estimate that for the 999 non TJC-accredited CAHs to comply with the risk assessment requirement will require 14,985 burden hours (15 burden hours for each CAH × 999 non TJC-accredited CAHs) at a cost of $1,493,505 ($1,495 estimated cost for each non TJC-accredited CAH × 999 non TJC-accredited CAHs).
After conducting the risk assessment, CAHs will have to develop and maintain emergency preparedness plans that comply with § 485.625(a)(1) through (4). We will expect all CAHs to compare their emergency plans to their risk assessments and then revise and, if necessary, develop new sections for their emergency plans to ensure that they complied with our requirements.
TJC-accredited CAHs must develop and maintain an Emergency Operations Plan (EOP) (CAMCAH Standard EC.4.12, p. EC-10a). The EOP must cover the management of six critical areas during emergencies: Communications, resources and assets, safety and security, staff roles and responsibilities, utilities, and patient clinical and support activities (CAMCAH, Standards EC.4.12 through 4.18, pp. EC-10a-EC-10g). In addition, as discussed earlier, TJC-accredited CAHs also are required to conduct an HVA (CAMCAH, Standard EC.4.11, EP 2, p. EC-10a). Therefore, we expect that the 338 TJC-accredited CAHs already have emergency preparedness plans that will satisfy our requirements. If a CAH needed to complete additional tasks to comply with the requirement, the burden will be negligible. Thus, for the 338 TJC-accredited CAHs, this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
The AOA/HFAP-accredited CAHs must work with federal, state, and local emergency preparedness authorities to identify the likely risks for their location and geographical area and develop appropriate responses to assure the safety of their patients (ARCAH, Standard 11.02.02, p. 11-5). Among the elements that AOA/HFAP-accredited CAHs must specifically consider are the special needs of their patient population, availability of medical and non-medical supplies, both internal and external communications, and the transfer of patients to home or other healthcare settings (ARCAH, Standard
The CAH CoPs require all CAHs to ensure the safety of their patients during non-medical emergencies (§ 485.623). They are also required to provide, among other things, for evacuation of patients, cooperation with disaster authorities, emergency power and lighting in their emergency rooms and for flashlights and battery lamps in other areas, an emergency water and fuel supply, and any other appropriate measures that are consistent with their particular location (§ 485.623). Thus, we believe that all CAHs have developed some type of emergency preparedness plan. However, we also expect that the 999 non-accredited CAHs will have to review their current plans and compare them to their risk assessments and revise and, in some cases, develop new sections for their current plans to ensure that their plans will satisfy our requirements.
Based on our experience with CAHs, we expect that the same individuals who were involved in conducting the risk assessment will be involved in developing the emergency preparedness plan. We expect that these individuals will attend an initial meeting, review relevant sections of the current emergency preparedness plan(s), prepare and send their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the new plan. We expect that the administrator will coordinate the meetings, perform an initial review, coordinate comments, revise the plan, and ensure that the necessary parties approve the new plan. We estimate that complying with this requirement will require 26 burden hours at a cost of $2,561. Therefore, we estimate that for all 999 non TJC-accredited CAHs to comply with this requirement will require 25,974 burden hours (26 burden hours for each non TJC-accredited CAH × 999 non TJC-accredited CAHs) at a cost of $2,558,439 ($2,561 estimated cost for each non TJC-accredited CAH × 999 non TJC-accredited CAHs).
Under this final rule, CAHs also will be required to review and update their emergency preparedness plans at least annually. The CAH CoPs already require CAHs to perform a periodic evaluation of their total program at least once a year (§ 485.641(a)(1)). Hence, all CAHs should already have an individual or team that is responsible that is for the periodic review of their total program. Therefore, we believe that this requirement will constitute a usual and customary business practice for CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA 5 CFR 1320.3(b)(2).
Under § 485.625(b), we will require CAHs to develop and maintain emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in § 485.625(a), (a)(1), and (c), respectively. We will also require CAHs to review and update these policies and procedures at least annually. These policies and procedures will have to address, at a minimum, the requirements listed at § 485.625(b)(1) through (8).
We expect that all CAHs will review their policies and procedures and compare them to their risk assessments, emergency preparedness plans, and emergency communication plans. The CAHs will need to revise, and, in some cases, develop new policies and procedures to incorporate all of the provisions previously noted and address all of our requirements.
The CAMCAH chapter entitled, “Leadership” (LD), requires TJC-accredited CAH leaders to “develop policies and procedures that guide and support patient care, treatment, and services” (CAMCAH, Standard LC.3.90, EP 1, CAMCAH Refreshed Core, January 2008, p. LD-11). Thus, we expect that TJC-accredited CAHs already have some policies and procedures for the activities and processes required for accreditation, including their EOP. As discussed later, many of the required elements we proposed have a corresponding requirement in the CAH TJC accreditation standards.
We proposed at § 485.625(b)(1) that CAHs have policies and procedures that address the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited CAHs must make plans for obtaining and replenishing medical and non-medical supplies, including food, water, and fuel for generators and transportation vehicles (CAMCAH, Standard EC.4.14, EPs 1-4, p. EC-10d). In addition, they must identify alternative means of providing electricity, water, fuel, and other essential utility needs in cases where their usual supply is disrupted or compromised (CAMCAH, Standard EC.4.17, EPs 1-5, p. EC-10f). We expect that TJC-accredited CAHs that comply with these requirements will be in compliance with our requirement concerning subsistence needs at § 485.625(b)(1).
We are proposing at § 485.625(b)(2) that CAHs have policies and procedures for a system to track the location of on-duty staff and sheltered patients in the CAH's care during an emergency. TJC-accredited CAHs must plan for communicating with their staff, as well as patients and their families, at the beginning of and during an emergency (CAMCAH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-10c). We expect that TJC-accredited CAHs that comply with these requirements will be in compliance with our requirement.
Section 485.625(b)(3) will require CAHs to have a plan for the safe evacuation from the CAH. TJC-accredited CAHs are required to make plans to evacuate patients as part of managing their clinical activities (CAMCAH, Standard EC.4.18, EP 1, p. EC-10g). They also must plan for the evacuation and transport of patients, their information, medications, supplies, and equipment to alternative care sites (ACSs) when the CAH cannot provide care, treatment, and services in its facility (CAMCAH, Standard EC.4.14, EPs 9-11, p. EC-10d). We expect that TJC-accredited CAHs that comply with these requirements will be in compliance with our requirement.
We proposed at § 485.625(b)(4) that CAHs have policies and procedures for a means to shelter in place for patients, staff, and volunteers who remain in the facility. The rationale for CAMCAH Standard EC.4.18 states, “[a] catastrophic emergency may result in the decision to keep all patients on the premises in the interest of safety” (CAMCAH, Standard EC.4.18, p. EC-10f). Therefore, we expect that TJC-accredited CAHs will be substantially in compliance with our requirement.
Section 485.625(b)(5) will require CAHs to have policies and procedures that address a system of medical documentation that preserves patient information, protects the confidentiality of patient information, and ensures that records are secure and readily available. The CAMCAH chapter entitled “Management of Information” (IM), requires TJC-accredited CAHs to have storage and retrieval systems for their clinical/service and CAH-specific information (CAMCAH, Standard IM.3.10, EP 5, CAMCAH Refreshed Core, January 2008, p. IM-11), as well as to ensure the continuity of their critical information for patient care, treatment, and services (CAMCAH, Standard IM.2.30, CAMCAH Refreshed Core, January 2008, p. IM-9). They also must ensure the privacy and confidentiality of patient information (CAMCAH, Standard IM.2.10, CAMCAH Refreshed Core, January 2008, p. IM-7). In addition, TJC-accredited CAHs must have plans for transporting patients and their clinical information, including transferring information to ACSs (CAMCAH Standard EC.4.14, EP 10 and 11, p. EC-10d and Standard EC.4.18, EP 6, pp. EC-10g, respectively). Therefore, we expect that TJC-accredited CAHs will be substantially in compliance with § 485.625(b)(5).
Section 485.625(b)(6) will require CAHs to have policies and procedures that addressed the use of volunteers in an emergency or other emergency staffing strategies. TJC-accredited CAHs must define staff roles and responsibilities in their EOP and ensure that they train their staff for their assigned roles (CAMCAH, Standard EC.4.16, EPs 1 and 2, p. EC-10e). Also, the rationale for Standard EC.4.15 indicates that the CAH “determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated” (CAMCAH, Standard EC.4.15, Rationale, p. EC-10d). In addition, in the chapter entitled “Medical Staff” (MS), CAHs “may grant disaster privileges to volunteers that are eligible to be licensed independent practitioners” (CAMCAH, Standard MS.4.110, CAMCAH Refreshed Care, January 2008, p. MS-20). Finally, in the chapter entitled “Management of Human Resources” (HR), CAHs “may assign disaster responsibilities to volunteer practitioners” (CAMCAH, Standard HR.1.25, CAMCAH Refreshed Core, January 2008, p. HR-6). Although the TJC accreditation requirements address some of our requirements, we do not believe TJC-accredited CAHs will be in compliance with all requirements in § 485.625(b)(6).
Based upon the previous discussion, we expect that the activities required for compliance by TJC-accredited CAHs with § 485.625(b)(1) through (5) constitutes usual and customary business practices for PRAs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
However, we do not believe TJC-accredited CAHs will be substantially in compliance with § 485.625(b)(6) through (8). We will discuss the burden for TJC-accredited CAHs to comply with these requirements later in this section.
The AOA/HFAP accreditation standards also contain requirements for policies and procedures related to safety and disaster preparedness. The AOA/HFAP-accredited CAHs are required to maintain plans and performance standards for disaster preparedness (ARCAH, Standard 11.00.02 Required Plans and Performance Standards, p. 11-2). They also must have “written procedures for possible situations to be followed by each department and service within the CAH and for each building used for patient treatment or housing” (ARCAH, Standard 11.07.01 Disaster Plans, Explanation, p. 11-38). AOA/HFAP-accredited CAHs also are required to have a safety team or committee that is responsible for all issues related to safety within the CAH (ARCAH, Standard 11.02.03, p. 11-7). The individuals or team will be responsible for all policies and procedures related to safety in the CAH (ARCAH, Standard 11.02.03, Explanation, p. 11-7). We expect that these performance standards and procedures are similar to some of our requirements for policies and procedures.
In regard to § 485.625(b)(1), AOA/HFAP-accredited CAHs are required to consider “pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations” and “provisions if gas, water, electricity supply is shut off to the community” when they are developing their emergency plans (ARCAH, Standard 11.02.02 Building Safety, Elements 5 and 11, pp. 11-5 and 11-6, respectively). In addition, CAHs are required “to provide emergency gas and water as needed to provide care to inpatients and other persons who may come to the CAH in need of care” (ARCAH, Standard 11.03.22 Emergency Gas and Water, p. 11-22 through 11-23). However, these standards do not specifically address all of the requirements in this section.
In regard to § 485.625(b)(2), AOA/HFAP-accredited CAHs are required to consider how they will communicate with their staff within the CAH when developing their emergency plans (ARCAH, Standard 11.02.02 Building Safety, Element 7, p. 11-6). They also are required to have a “call tree” in their external disaster plan that must be updated at least annually (ARCAH, Standard 11.07.04 Staff Call Tree, p. 11-40). However, these requirements do not sufficiently cover the requirements to track the location of staff and patients during and after an emergency.
In regard to § 485.625(b)(3), which requires policies and procedures regarding the safe evacuation from the facility, AOA/HFAP-accredited CAHs are required to consider the “transfer or discharge of patients to home, other healthcare settings, or other CAHs” and the “transfer of patients with CAH equipment to another CAH or healthcare setting” (ARCAH, Standard 11.02.02 Building Safety, Elements 12 and 13, p. 11-6). AOA/HFAP-accredited CAHs
In regard to § 485.625(b)(4), AOA/HFAP-accredited CAHs are required to consider the special needs of their patient population and the security of those patients and others that come to them for care when they develop their emergency plans (ARCAH, Standard 11.02.02 Building Safety, Elements 2 and 3, p. 11-5). In addition, as described earlier, they also must consider the food, pharmaceuticals, and other supplies and equipment they may need during an emergency in developing their emergency plan (ARCAH, Standard 11.02.02, Element 5, p. 11-5). However, these requirements do not specifically mention volunteers and CAHs are required only to consider these elements in developing their plans.
Therefore, we believe that AOA/HFAP-accredited CAHs have likely already incorporated many of the elements necessary to satisfy the requirements in § 485.625(b); however, they will need to thoroughly review their current policies and procedures and perform whatever tasks are necessary to ensure that they complied with all of our requirements for emergency policies and procedures. Because we expect that AOA/HFAP-accredited CAHs already comply with many of our requirements, we will include the AOA/HFAP-accredited CAHs with the TJC-accredited CAHs in determining the burden.
The burden for the 31 AOA/HFAP-accredited CAHs and the 338 TJC-accredited CAHs to comply with all of the requirements in § 485.625(b) will be the resources required to develop written policies and procedures that comply with all of our requirements for emergency policies and procedures. Based on our experience working with CAHs, we expect that accomplishing these activities will require the involvement of an administrator, the medical director, director of nursing, facilities director, and food services director. We expect that the administrator will review the policies and procedures and make recommendations for necessary changes or additional policies or procedures. The CAH administrator will brief other staff and assign staff to make necessary revisions or draft new policies and procedures and disseminate them to the appropriate parties. We estimate that complying with this requirement will require 10 burden hours for each TJC and AOA/HFAP-accredited CAH at a cost of $983. For all 369 TJC and AOA/HFAP-accredited CAHs to comply with these requirements will require an estimated 3,690 burden hours (10 burden hours for each TJC or AOA/HFAP-accredited CAH × 369 TJC and AOA/HFAP-accredited CAHs) at a cost of $362,727 ($983 estimated cost for each TJC or AOA/HFAP-accredited CAH × 369 TJC and AOA/HFAP-accredited CAHs).
We expect that the 892 non-accredited CAHs already have developed some emergency preparedness policies and procedures. The current CAH CoPs require CAHs to develop, maintain, and review policies to ensure quality care and a safe environment for their patients (§§ 485.627(a), 485.635(a), and 485.641(a)(1)(iii)). In addition, certain activities associated with our requirements are addressed in the current CAH CoPs. For example, all CAHs are required to have agreements or arrangements with one or more providers or suppliers, as appropriate, to provide services to their patients (§ 485.635(c)).
The burden associated with the development of emergency policies and procedures will be the resources needed to review, revise, and if needed, develop emergency preparedness policies and procedures that include our requirements. We believe the individuals and tasks will be the same as described earlier for the TJC and AOA/HFAP-accredited CAHs. However, the non-accredited CAHs will require more time to accomplish these activities. We estimate that a non-accredited CAH's compliance will require 14 burden hours at a cost of $1,357. For all 892 unaccredited CAHs to comply with this requirement will require an estimated 12,488 burden hours (14 burden hours for each non-accredited CAHs × 892 non-accredited CAHs) at a cost of $1,210,444 ($1,357 estimated cost for each non-accredited CAH × 892 non-accredited CAHs).
Section 485.625(b) will also require CAHs to review and update their emergency preparedness policies and procedures at least annually. As discussed earlier, TJC and AOA/HFAP-accredited CAHs already periodically review their policies and procedures. In addition, the existing CAH CoPs require periodic reviews of the CAH's healthcare policies (§§ 485.627(a), 485.635(a), and 485.641(a)(1)(iii)). Thus, we believe compliance with this requirement will constitute a usual and customary business practice for all CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.625(c) will require CAHs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. We proposed that CAHs review and update these plans at least annually. We proposed that these communication plans include the information listed at § 485.625(c)(1) through (7).
We expect that all CAHs will review their emergency preparedness communication plans and compare them to their risk assessments and emergency plans. We also expect that CAHs will revise and, if necessary, develop new sections that will comply with our requirements. Based on our experience with CAHs, they have some type of emergency preparedness communication plan. Furthermore, it is standard practice for healthcare facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. Thus, we believe that most, if not all, CAHs are already in compliance with § 485.625(c)(1) through (3).
However, all CAHs will need to review and, if needed, revise and update their plans to ensure compliance with § 485.625(c)(4) through (7). The TJC-accredited CAHs are required to establish strategies or plans for emergency communications (CAMCAH, Standard 4.13, p. EC-10b-10c). These plans must cover both internal and external communications and include back-up technologies and communication systems (CAMCAH, Standard 4.13, and EPs 1-14, p. EC-10b-EC-10c). However, we do not believe that these standards will ensure compliance with § 485.625(c)(4) through (7). Thus, we will include the 338 TJC-accredited CAHs in the burden of this final rule.
The AOA/HFAP-accredited CAHs must develop and implement communication plans to ensure the safety of their patients during emergencies (AOA/HFAP Standard 11.02.02). These plans must specifically include both internal and external communications (AOA/HFAP Standard 11.02.02, Elements 6, 7, and 10). Based on these standards, we do not believe they ensure compliance with § 485.625(c)(4) through (7). Thus, we will include these 31 AOA/HFAP-accredited CAHs in the burden of this final rule.
The burden associated with complying with this requirement will be the resources required to develop a communication plan that complied with the requirements of this section. Based on our experience with CAHs, we expect that accomplishing these activities will require the involvement of an administrator, director of nursing, and the facilities director. We expect that the administrator will review the communication plan and make recommendations for necessary changes or additions. The director of nursing and the facilities director will meet with the administrator to discuss and revise or draft new sections for the CAH's existing emergency communication plan. We estimate that complying with this requirement will require 9 burden hours for each CAH at a cost of $831. We estimate that for all 1,337 CAHs to comply with the requirements for an emergency preparedness communication plan will require 12,033 burden hours (9 burden hours for each CAH × 1,337 CAHs) at a cost of $1,111,047 ($831 estimated cost for each CAH × 1,337 CAHs).
Section 485.625(c) also will require CAHs to review and update their emergency preparedness communication plans at least annually. All CAHs are required to evaluate their entire program at least annually (§ 485.641(a)). Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.625(d) will require CAHs to develop and maintain emergency preparedness training and testing programs. We will also require CAHs to review and update their training and testing programs at least annually. We proposed that a CAH comply with the requirements listed at § 485.625(d)(1) and (2).
Regarding § 485.625(d)(1), CAHs will have to provide initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their
We expect that all CAHs will review their current training programs and compare them to their risk assessments and emergency preparedness plans, emergency policies and procedures, and emergency communication plans. The CAHs will need to revise and, if necessary, develop new sections or materials to ensure their training and testing programs complied with our requirements.
Current CoPs require CAHs to train their staffs on how to handle emergencies (§ 485.623(c)(1)). However, this training primarily addresses internal emergencies, such as a fire inside the facility. In addition, both TJC and AOA/HFAP require CAHs to provide their staff with training. TJC-accredited CAHs are required to provide their staff with both an initial orientation and on-going training (CAMCAH, Standards HR.2.10 and 2.30, pp. HR-8 and HR—9, respectively). On-going training must also be documented (CAMCAH, Standard HR.2.30, EP 8, p. HR-10). The AOA/HFAP-accredited CAHs are required to provide an education program for their staff and physicians for the CAH's emergency response preparedness (AOA/HFAP Standard 11.07.01). Each CAH also must provide an education program specifically for the CAH's response plan for weapons of mass destruction (AOA Standard 11.07.07).
Thus, we expect that all CAHs provide some emergency preparedness training for their staff. However, neither the current CoPs nor the TJC and AOA/HFAP accreditation standards ensure compliance with all our requirements. All CAHs will need to review their risk assessments, emergency preparedness plans, policies and procedures, and communication plans and then revise or, in some cases, develop new sections for their training programs to ensure compliance with our requirements. They also will need to revise, update, or, in some cases, develop new materials for the initial and ongoing training.
Based on our experience with CAHs, we expect that complying with our requirement will require the involvement of an administrator, the director of nursing, and the facilities director. We expect that the director of nursing will perform the initial review of the training program, brief the administrator and the director of facilities, and revise or develop new sections for the training program, based on the group's decisions. We estimate that each CAH will require 14 burden hours to develop an emergency preparedness training program at a cost of $1,316. Therefore, for all 1,337 CAHs to comply with this requirement will require an estimated 18,718 burden hours (14 burden hours for each CAH × 1,337 CAHs) at a cost of $1,759,492 ($1,316 estimated cost for each CAH × 1,337 CAHs).
Section 485.625(d)(1) also will require CAHs to review and update their emergency preparedness training programs at least annually. Existing regulations require all CAHs to evaluate their entire program at least annually (§ 485.641(a)). Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
The CAHs also will be required to maintain documentation of their training. Based on our experience with CAHs, it is standard practice for them to document the training they provide to staff and other individuals. If a CAH needed to make any changes to their normal business practices to comply with this requirement, the burden will be negligible. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.625(d)(2) will require CAHs to participate in a full-scale exercise and a paper-based, tabletop exercise at least annually. If a full-scale exercise was not available, the CAH will have to conduct a full-scale exercise at least annually. CAHs also will be required to analyze the CAH's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CAH's emergency plan, as needed. If a CAH experienced an actual natural or man-made emergency that required activation of the emergency plan, it will be exempt from the requirement for a full-scale exercise for 1 year following the onset of the emergency (§ 485.625(d)(2)(ii)). Thus, to meet these requirements, CAHs will need to develop scenarios for each drill and exercise and develop the required documentation.
If a CAH participated in a full-scale exercise, it will likely not need to develop the scenario for that drill. However, for the purpose of determining the burden, we will assume that CAHs need to develop scenarios for both the testing exercises annually.
The TJC-accredited CAHs are required to test their EOP twice a year, either as a planned exercise or in response to an emergency (CAMCAH, Standard EC.4.20, EP 1, p. EC-12). These tests must be monitored, documented, and analyzed (CAMCAH, Standard EC.4.20, EPs 8-19, pp. EC-12-EC-13). Thus, we believe that TJC-accredited CAHs already develop scenarios for these tests. We also expect that they also have developed the documentation necessary to record and analyze their tests and responses to actual emergency events. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for TJC-accredited CAHs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
The AOA/HFAP-accredited CAHs are required to conduct two disaster drills annually (AOA/HFAP Standard 11.07.03). In addition, AOA/HFAP-accredited CAHs are required to participate in weapons of mass destruction drills, as appropriate (AOA/HFAP Standard 11.07.09). We expect that since AOA/HFAP-accredited CAHs
Based on our experience with CAHs, we expect that the 892 non-accredited CAHs already have some type of emergency preparedness training program and conduct some type of drills or exercises to test their emergency preparedness plans. However, this does not ensure that most CAHs already perform the activities needed to comply with our requirements. Thus, we will analyze the burden for these requirements for the 892 non-accredited CAHs.
The 892 non-accredited CAHs will be required to develop scenarios for testing exercises and the documentation necessary to record and later analyze the events that occurred during these tests and actual emergency events. Based on our experience with CAHs, we believe that the same individuals who developed the emergency preparedness training program will develop the scenarios for the tests and the accompanying documentation. We expect that the director of nursing will spend more time than will the other individuals developing the scenarios and the accompanying documentation. We estimate that it will require 8 burden hours for the 892 non-accredited CAHs to comply with these requirements at a cost of $762. Therefore, for all 892 non-accredited CAHs to comply with these requirements will require an estimated 7,136 burden hours (8 burden hours for each non-accredited CAH × 892 non-accredited CAHs) at a cost of $679,704 ($762 estimated cost for each non-accredited CAH × 892 non-accredited CAHs).
Section 485.727(a) will require clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (organizations) to develop and maintain emergency preparedness plans and review and update the plan at least annually. We are proposing that the plan comply with the requirements listed at § 485.727(a)(1) through (6).
Section 485.727(a)(1) will require organizations to develop documented, facility-based and community-based risk assessment utilizing an all-hazards approach. Organizations will need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area.
The current CoPs for Organizations require these providers to have “a written plan in operation, with procedures to be followed in the event of fire, explosion, or other disaster” (§ 485.727(a)). To comply with this CoP, we expect that all of these providers have already performed some type of risk assessment during the process of developing their disaster plans and policies and procedures. However, these providers will need to review their current risk assessments and make any revisions to ensure they complied with our requirements.
We have not designated any specific process or format for these providers to use in conducting their risk assessments because we believe that they need the flexibility to determine the best way to accomplish this task. Providers of physical therapy and speech therapy services should include input from all of their major departments in the process of developing their risk assessments. Based on our experience with these providers, we expect that conducting the risk assessment will require the involvement of the organization's administrator and a therapist. The types of therapists at each Organization vary depending upon the services offered by the facility. For the purposes of determining the PRA burden, we will assume that the therapist is a physical therapist. We expect that both the administrator and the therapist will attend an initial meeting, review the current assessment, develop comments and
After conducting the risk assessment, each organization will need to develop and maintain an emergency preparedness plan and review and update it at least annually. Current CoPs require these providers to have a written disaster plan with accompanying procedures for fires, explosions, and other disasters (§ 485.727(a)). The plan must include or address the transfer of casualties and records, the location and use of alarm systems and signals, methods of containing fire, notification of appropriate persons, and evacuation routes and procedures (§ 485.727(a)). Thus, we expect that all of these organizations have some type of emergency preparedness plan and that these plans address many of our requirements. However, all organizations will need to review their current plans and compare them to their risk assessments. Each organization will need to revise, update, and, in some cases, develop new sections to complete a comprehensive emergency preparedness plan that complied with our requirements.
Based on our experience with these organizations, we expect that the administrator and physical therapist who were involved in developing the risk assessment will be involved in developing the emergency preparedness plan. However, we expect it will require more time to complete the plan and that the administrator will be the most heavily involved in reviewing and developing the organization's emergency preparedness plan. We estimate that for each organization to comply will require 12 burden hours at a cost of $1,083. We estimate that it will require 25,620 burden hours (12 burden hours for each organization × 2,135 organizations) to complete the plan at a cost of $2,312,205 ($1,083 estimated cost for each organization × 2,135 organizations).
Each organization will also be required to review and update its emergency preparedness plan at least annually. We believe that these organizations already review their plans periodically. Thus, we believe complying with this requirement will constitute a usual and customary business practice for organizations and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.727(b) will require organizations to develop and implement emergency preparedness policies and procedures based on their risk assessments, emergency plans, communication plans as set forth in § 485.727(a)(1), (a), and (c), respectively. It will also require organizations to review and update these policies and procedures at least annually. At a minimum, we will require that an organization's policies and procedures address the requirements listed at § 485.727(b)(1) through (4).
We expect that all organizations have emergency preparedness policies and procedures. As discussed earlier, the current CoPs require organizations to have procedures within their written disaster plan to be followed for fires, explosions, or other disasters (§ 485.727(a)). In addition, we expect that those procedures already address some of the specific elements required in this section. For example, the current requirements at § 485.727(a)(1) through (4) are similar to our requirements at § 485.727(a)(1) through (5). However, all organizations will need to review their policies and procedures, assess whether their policies and procedures incorporate all of the necessary elements of their emergency preparedness program, and, if necessary, take the appropriate steps to ensure that their policies and procedures are in compliance with our requirements.
We expect that the administrator and the physical therapist will be primarily involved with reviewing and revising the current policies and procedures and, if needed, developing new policies and procedures. We estimate that it will require 10 burden hours for each organization to comply at a cost of $895. We estimate that for all organizations to comply will require 21,350 burden hours (10 burden hours for each organization × 2,135 organizations) at a cost of $1,910,825 ($895 estimated cost for each organization × 2,135 organizations).
We will require organizations to review and update their emergency preparedness policies and procedures at least annually. We believe that these providers already review their emergency preparedness policies and procedures periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.727(c) will require organizations to develop and maintain emergency preparedness communication plans that complied with both federal and state law and will be reviewed and updated at least annually. The communication plan will have to include the information listed at § 485.727(c)(1) through (5).
We expect that all organizations have some type of emergency preparedness communication plan. Current CoPs for these organizations already require them to have a written disaster plan with procedures that must include, among other things, “notification of appropriate persons” (§ 485.727(a)(4)). Thus, we expect that each organization has the contact information they will need to comply with this requirement. In addition, it is standard practice for healthcare facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. However, many organizations may not have formal, written emergency preparedness communication plans or their plans may not be fully compliant with our requirements. Therefore, we expect that all organizations will need to review, update, and, in some cases, develop new sections for their plans.
Based on our experience with these organizations, we anticipate that satisfying the requirements in this section will primarily require the involvement of the organization's administrator with the assistance of a physical therapist. We estimate that for each organization to comply will require 8 burden hours at a cost of $722. We estimate that for all 2,135 organizations to comply will require 17,080 burden hours (8 burden hours for each organizations × 2,135 organizations) at a cost of $1,541,470 ($722 estimated cost for each organization × 2,135 organizations).
We are proposing that organizations must review and update their emergency preparedness communication plans at least annually. We believe that these organizations already review their emergency communication plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.727(d) will require organizations to develop and maintain emergency preparedness training and testing programs and review and update these programs at least annually. Specifically, we are proposing that organizations comply with the requirements listed at § 485.727(d)(1) and (2).
According to § 485.727(d)(1), organizations will have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the CAH will have to provide emergency preparedness training at least annually.
Current CoPs require organizations to ensure that “all employees are trained, as part of their employment orientation, in all aspects of preparedness for any disaster. The disaster program includes orientation and ongoing training and drills for all personnel in all procedures in case of a disaster (42 CFR 485.727(b)). Thus, we expect that organizations already have an emergency preparedness training program for new employees, as well as ongoing training for all staff. However, organizations will need to review their current training programs and compare them to their risk assessments and emergency preparedness plans, policies and procedures, and communication plans. Organizations will need to review, revise, and, in some cases, develop new material for their training programs so that they comply with our requirements.
We expect that complying with this requirement will require the involvement of an administrator and a physical therapist. We expect that the administrator will primarily be involved in reviewing the organization's current training program and the current emergency preparedness program; determining what tasks will need to be performed and what materials will need to be developed to comply with our requirements; and developing the materials for the training program. We expect that the physical therapist will work with the administrator to develop the revised and updated training program. We estimate that it will require 8 burden hours for each organization to develop a comprehensive emergency
In § 485.727(d)(1), we also proposed requiring that an organization must review and update its emergency preparedness training program at least annually. We believe that these providers already review their emergency preparedness training programs periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 485.727(d)(2) will require organizations to participate in a full-scale exercise at least annually. They will also be required to conduct one additional exercise of their choice at least annually. If an organization experienced an actual natural or man-made emergency that required activation of its emergency plan, it will be exempt from engaging in a drill for 1 year following the onset of the actual event. Organizations also will be required to analyze their response to and maintain documentation of all the testing exercises and emergency events, and revise their emergency plan, as needed. To comply with this requirement, an organization will need to develop scenarios for their drills and exercises. An organization also will have to develop the documentation necessary for recording and analyzing their responses to the testing exercises and actual emergency events.
The current CoPs require organizations to have a written disaster plan that is periodically rehearsed and have ongoing drills (§ 485.727(a) and (b)). Thus, we expect that all 2,135 organizations currently conduct some type of drill or exercise of their disaster plan. However, the current organizations CoPs do not specify the type of drill, how they are to conduct the drills, or whether the drills should be community-based. In addition, there is no requirement for a paper-based, tabletop exercise. Thus, these requirements do not ensure that organizations will be in compliance with our requirements. Therefore, we will analyze the burden from these requirements for all organizations.
The 2,135 organizations will be required to develop scenarios for testing exercises and the necessary documentation. Based on our experience with organizations, we expect that the same individuals who develop the emergency preparedness training program will develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator will spend more time than the physical therapist developing the scenarios and the documentation. We estimate that for each organization to comply will require 3 burden hours at a cost of $267. Based on that estimate, it will require 6,405 burden hours (3 burden hours for each organization x 2,135 organizations) at a cost of $570,045 ($267 estimated cost for each organization x 2,135 organizations).
Section 485.920(a) will require Community Mental Health Centers (CMHCs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. Specifically, we proposed that the plan must meet the requirements listed at § 485.920(a)(1) through (4).
We expect all CMHCs to identify the likely medical and non-medical emergency events they could experience within the facility and the community in which it is located and determine the likelihood of the facility experiencing an emergency due to the identified hazards. We expect that in performing the risk assessment, a CMHC will need to consider its physical location, the geographical area in which it is located and its patient population.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment. We expect that most, if not all, CMHCs have already performed at least some of the work needed for a risk assessment because it is standard practice for healthcare organizations to prepare for common emergencies, such as fires, interruptions in communication and power, and storms. However, many CMHCs may not have performed a risk assessment that complies with the requirements. Therefore, we expect that most, if not all, CMHCs will have to perform a thorough review of their current risk assessment and perform the tasks necessary to ensure that the facility's risk assessment complies with the requirements.
We have not designated any specific process or format for CMHCs to use in conducting their risk assessments because we believe CMHCs need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, healthcare organizations will include representatives from or obtain input from all major departments. Based on our experience with CMHCs, we expect that conducting the risk assessment will require the involvement of the CMHC administrator, a psychiatric registered nurse, and a clinical social worker or mental health counselor. We expect that most of these individuals will attend an initial meeting, review relevant sections of the current assessment, prepare and forward their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the risk assessment. We expect that the administrator will coordinate the meetings, do an initial review of the current risk assessment, critique the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approve the new risk assessment. It is likely that the CMHC administrator will spend more time reviewing and working on the risk assessment than the other individuals. We estimate that complying with the requirement to conduct a risk assessment will require 10 burden hours for a cost of $788. There are currently 198 CMHCs. Therefore, it will require an estimated 1,980 burden hours (10 burden hours for each CMHC x 198 CMHCs) for all CMHCs to comply with this requirement at a cost of $156,024 ($788 estimated cost for each CMHC × 198 CMHCs).
After conducting the risk assessment, CMHCs will need to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. CMHCs will need to compare their current emergency plan, if they have one, to their risk assessment. They will then need to revise and, if necessary, develop new sections of their plan to ensure it complies with the requirements.
It is standard practice for healthcare organizations to make plans for common disasters they may confront, such as fires, interruptions in communication and power, and storms. Thus, we expect that all CMHCs have some type of emergency preparedness plan. However, their plan may not address all likely medical and non-medical emergency events identified by the risk assessment. Furthermore, their plans may not include strategies for addressing likely emergency events or address their patient population, the type of services they have the ability to provide in an emergency, or continuity of operation, including delegations of authority and succession plans. We expect that CMHCs will have to review their current plan and compare it to their risk assessment, as well as to the other requirements in § 485.920(a). We expect that most CMHCs will need to update and revise their existing emergency plan and, in some cases, develop new sections to comply with our requirements.
The burden associated with this requirement will be due to the resources needed to develop an emergency preparedness plan or to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with CMHCs, we expect that the same individuals who were involved in the risk assessment will be involved in developing the emergency preparedness plan. We also expect that developing the plan will require more time to complete than the risk assessment. We expect that the administrator and a psychiatric nurse will spend more time reviewing and developing the CMHC's emergency preparedness plan. We expect that the clinical social worker or mental health counselor will review the plan and provide comments on it to the administrator. We estimate that it will require 15 burden hours for a CMHC to develop its emergency plan at a cost of $1,113. Based on this estimate, it will require 2,970 burden hours (15 burden hours for each CMHC × 198 CMHCs) for all CMHCs to complete their plans at a cost of $220,374 ($1,113 estimated cost for each CMHC × 198 CMHCs).
The CMHC will be required to review and update its emergency preparedness plan at least annually. For the purpose of determining the burden for this requirement, we expect that the CMHCs will review and update their plans annually.
We expect that all CMHCs have an administrator that is responsible for the day-to-day operation of the CMHC. This will include ensuring that all of the CMHC's plans are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. In addition, it is standard practice in the healthcare industry for facilities to have professional staff persons who periodically review their plans and procedures. However, the current CMHC CoPs do not include a requirement for an emergency preparedness plan and as such, there is no requirement for an annual review of the plan. Therefore, we will analyze the burden from this requirement for all CMHCs.
Based on our experience with CMHCs, we expect that the same individuals who develop the emergency preparedness plan will annually review and update the plan. We expect that the administrator and registered nurse will spend more time than the social worker on the review of the plan and documentation of the plan updates. We estimate that for each CMHC to comply will require 5 burden hours at a cost of $371. Based on that estimate, it will require 990 burden hours (5 burden hours for each organization × 198 organizations) at a cost of $73,458 ($371 estimated cost for each organization × 198 organizations).
Section 485.920(b) will require CMHCs to develop and maintain emergency preparedness policies and procedures based on the emergency plan, the communication plan, and the risk assessment. We also proposed requiring CMHCs to review and update these policies and procedures at least annually. The CMHC's policies and procedures will be required to address, at a minimum, the requirements listed at § 485.920(b)(1) through (7).
We expect that all CMHCs will compare their current emergency preparedness policies and procedures to their emergency preparedness plan, communication plan, and their training and testing program. They will need to review, revise and, if necessary, develop new policies and procedure to ensure they comply with the requirements. The burden associated with reviewing, revising, and updating the CMHC's emergency policies and procedures will be due to the resources needed to ensure they comply with the requirements. We expect that the administrator and the psychiatric registered nurse will be involved with reviewing, revising and, if needed, developing any new policies and procedures. We estimate that for a CMHC to comply with this requirement will require 12 burden hours at a cost of $944. Therefore, for all 198 CMHCs to comply with this requirement will require an estimated 2,376 burden hours (12 burden hours for each CMHC × 198 CMHCs) at a cost of $186,912 ($944 estimated cost for each CMHC × 198 CMHCs).
The CMHCs will be required to review and update their emergency preparedness policies and procedures at least annually. For the purpose of determining the burden for this requirement, we expect that CMHCs will review their policies and procedures annually. We expect that all CMHCs have an administrator who is responsible for the day-to-day operation of the CMHC, which includes ensuring that all of the CMHC's policies and procedures are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. We also expect that the administrator is responsible for periodically reviewing the emergency preparedness policies and procedures as part of his or her responsibilities. We expect that complying with the requirement for an
Section 485.920(c) will require CMHCs to develop and maintain an emergency preparedness communications plan that complies with both federal and state law. The CMHC also will have to review and update this plan at least annually. The communication plan must include the information listed in § 485.920(c)(1) through (7).
We expect that all CMHCs will compare their current emergency preparedness communications plan, if they have one, to the requirements. CMHCs will need to perform any tasks necessary to ensure that their communication plans were documented and in compliance with the requirements.
We expect that all CMHCs have some type of emergency preparedness communications plan. However, their emergency communications plan may not be thoroughly documented or comply with all of the elements we are requiring. It is standard practice for healthcare organizations to maintain contact information for their staff and for outside sources of assistance; alternate means of communication in case there is a disruption in phone service to the facility (for example, cell phones); and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. However, we expect that all CMHCs will need to review, update, and in some cases, develop new sections for their plans to ensure that those plans include all of the elements we are requiring for CMHC communications plans.
The burden associated with complying with this requirement will be due to the resources required to ensure that the CMHC's emergency communication plan complies with the requirements. Based upon our experience with CMHCs, we expect the involvement of the CMHC's administrator and the psychiatric registered nurse. For each CMHC, we estimate that complying with this requirement will require 8 burden hours at a cost of $637. Therefore, for all of the CMHCs to comply with this requirement will require an estimated 1,584 burden hours (8 burden hours for each CMHC × 198 CMHCs) at a cost of $126,126 ($637 estimated cost for each CMHC × 198 CMHCs).
We expect that CMHCs must also review and update their emergency preparedness communication plan at least annually. For the purpose of determining the burden for this requirement, we expect that CMHCs will review their policies and procedures annually. We expect that all CMHCs have an administrator who is responsible for the day-to-day operation of the CMHC. This includes ensuring that all of the CMHC's policies and procedures are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. We expect that the administrator is responsible for periodically reviewing the CMHC's plans, policies, and procedures as part of his or her responsibilities. In addition, we expect that an annual review of the communication plan will require only a negligible burden. Complying with the requirement for an annual review of the emergency preparedness communications plan constitutes a usual and customary business practice for CMHCs. As stated in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that will be incurred by persons in the normal course of their activities are not subject to the PRA.
Section 485.920(d) will require CMHCs to develop and maintain an emergency preparedness training program that must be reviewed and updated at least annually. We will require the CMHC to meet the requirements contained in § 485.920(d)(1) and (2).
We expect that CMHCs will develop a comprehensive emergency preparedness training program. The CMHCs will need to compare their current emergency preparedness training program and compare its contents to the risk assessment and updated emergency preparedness plan, policies and procedures, and communications plan and review, revise, and, if necessary, develop new sections for their training program to ensure it complies with the requirements.
The burden will be due to the resources the CMHC will need to comply with the requirements. We expect that complying with this requirement will include the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse will be primarily involved in reviewing the CMHC's current training program, determining what tasks need to be performed or what materials need to be developed, and developing the materials for the training program. We estimate that it will require 10 burden hours for each CMHC to develop a comprehensive emergency training program at a cost of $710. Therefore, it will require an estimated 1,980 burden hours (10 burden hours for each CMHC × 198 CMHCs) to comply with this requirement at a cost of $140,580 ($710 estimated cost for each CMHC × 198 CMHCs).
Section 485.920(d)(1) will also require the CMHCs to review and update their emergency preparedness training program at least annually. For the purpose of determining the burden for this requirement, we will expect that CMHCs will review their emergency preparedness training program annually. We expect that all CMHCs have a professional staff person, probably a psychiatric registered nurse, who is responsible for periodically reviewing their training program to ensure that it is up-to-date and complies with the relevant federal, state, and local laws, regulations, and ordinances. In addition, we expect that an annual review of the CMHC's emergency preparedness training program will require only a negligible burden. Thus, we expect that complying with the requirement for an annual review of the emergency preparedness training program constitutes a usual and customary business practice for CMHCs. As stated in the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that will be incurred by persons in the normal course of their activities are not subject to the PRA.
Section 485.920(d)(2) will require CMHCs to participate in or conduct a full-scale exercise at least annually. CMHCs are also required to participate in one additional testing exercise of their choice at least annually. CMHCs will be required to document the drills and the exercises. To comply with this requirement, a CMHC will need to develop a specific scenario for each drill and exercise. A CMHC will have to develop the documentation necessary to record what happened during the drills and exercises.
Based on our experience with CMHCs, we expect that all 198 CMHCs have some type of emergency preparedness training program and most, if not all, of these CMHCs already conduct some type of drill or exercise to test their emergency preparedness plans. However, we do not know what type of drills or exercises they typically conduct or how often they are performed. We also do not know how, or if, they are documenting and analyzing their responses to these drills and tests. For the purpose of determining a burden for these requirements, we will expect that all CMHCs need to develop two scenarios, one for the drill and one for the exercise, and develop the documentation necessary to record the facility's responses.
The associated burden will be the time and effort necessary to comply with the requirement. We expect that complying with this requirement will likely require the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse will develop the documentation necessary for both during the testing exercises and for the subsequent analysis of the CMHC's response. The psychiatric registered nurse will also develop the two scenarios for the drill and exercise. We estimate that these tasks will require 4 burden hours at a cost of $284. For all 198 CMHCs to comply with this requirement will require an estimated 792 burden hours (4 burden hours for each CMHC × 198 CMHCs) at a cost of $56,232 ($284 estimated cost for each CMHC × 198 CMHCs).
Section 486.360(a) will require Organ Procurement Organizations (OPOs) to develop and maintain emergency preparedness plans that will have to be reviewed and updated at least annually. These plans will have to comply with the requirements listed in § 486.360(a)(1) through (4).
As of June 2016, there are 58 OPOs. The current OPO Conditions for Coverage (CfCs) are located at §§ 486.301 through 486.348. These CfCs do not contain any specific emergency preparedness requirements. Thus, for the purpose of determining the burden, we have analyzed the burden for all 58 OPOs for all of the ICRs contained in this final rule.
Section 486.360(a)(1) will require OPOs to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. OPOs will need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area, including branch offices and hospitals in their donation services areas.
The burden associated with this requirement will be the time and effort necessary to perform a thorough risk assessment. Based on our experience with OPOs, we believe that all 58 OPOs have already performed at least some of the work needed for their risk assessments. However, these risk assessments may not be documented or may not address all of the elements required under § 486.360(a). Therefore, we expect that all 58 OPOs will have to perform a thorough review of their current risk assessments and perform the necessary tasks to ensure that their risk assessment complied with the requirements of this final rule. Based on our experience with OPOs, we believe that conducting a risk assessment will require the involvement of the OPO's director, medical director, quality assessment and performance improvement (QAPI) director, and an organ procurement coordinator (OPC). We expect that these individuals will attend an initial meeting; review relevant sections of the current assessment, prepare and send their comments to the QAPI director; attend a follow-up meeting; perform a final review; and approve the new risk assessment. We estimate that the QAPI director probably will coordinate the meetings, review the current risk assessment, critique the risk assessment, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved it. We estimate that it will require 10 burden hours for each OPO to conduct a risk assessment at a cost of $1,190. Therefore, for all 58 OPOs to comply with the risk assessment requirement in this section will require an estimated 580 burden hours (10 burden hours for each OPO × 58 OPOs) at a cost of $69,020 ($1,190 estimated cost for each OPO × 58 OPOs).
After conducting the risk assessment, OPOs will then have to develop emergency preparedness plans. The burden associated with this requirement will be the resources needed to develop an emergency preparedness plan that complied with the requirements in § 486.360(a)(1) through (4). We expect that all OPOs have some type of emergency preparedness plan because it is standard practice in the healthcare industry to have a plan to address common emergencies, such as fires. In addition, based on our experience with OPOs (including the performance of the Louisiana OPO during the Katrina disaster), OPOs already have plans to ensure that services will continue to be provided in their donation service areas (DSAs) during an emergency. However, we do not expect that all OPOs will have emergency preparedness plans that will satisfy the requirements of this section. Therefore, we expect that all OPOs will need to review their current emergency preparedness plans and compare their plans to their risk assessments. Most OPOs will need to revise, and in some cases develop, new sections to ensure their plan satisfied the requirements.
We expect that the same individuals who were involved in the risk assessment will be involved in developing the emergency preparedness plan. We expect that these individuals will attend an initial meeting, review relevant sections of the OPO's current emergency preparedness plan, prepare and send their comments to the QAPI director, attend a follow-up meeting, perform a final review, and approve the new plan. We expect that the QAPI Director will coordinate the meetings, perform an initial review of the current emergency preparedness plan, critique the emergency preparedness plan, coordinate comments, ensure that the appropriate individuals revise the plan, and ensure that the necessary parties approve the new plan.
Thus, we estimate that it will require 22 burden hours for each OPO to develop an emergency preparedness plan that complied with the requirements of this section at a cost of $2,568. The difference in burden between the risk assessment and the plan requirement is greater in this section because OPOs have multiple locations and personnel in various locations. Therefore, for all 58 OPOs to comply with this requirement will require an estimated 1,276 burden hours (22 burden hours for each OPO × 58 OPOs) at a cost of $148,944 ($2,568 estimated cost for each OPO × 58 OPOs).
The OPOs will also be required to review and update their emergency preparedness plans at least annually. We believe that all of the OPOs already review their emergency preparedness plans periodically. However, the current OPO CoPs do not include a requirement for an emergency preparedness plan and as such, there is no requirement for an annual review of the plan. Therefore, we will analyze the burden from this requirement for all OPOs.
Based on our experience with OPOs, we expect that the same individuals who develop the emergency preparedness plan will annually review and update the plan. We expect that the QAPI director will spend more time than the director, medical director, and organ procurement coordinator on the review of the plan and documentation of the plan updates. We estimate that for each OPO to comply will require 6 burden hours at a cost of $689. Based on that estimate, it will require 348 burden hours (6 burden hours for each organization × 58 organizations) at a cost of $39,962 ($689 estimated cost for each organization × 58 organizations).
Section 486.360(b) will require OPOs to develop and maintain emergency preparedness policies and procedures based on their risk assessments, emergency preparedness plans, emergency communication plan as set forth in § 486.360(a)(1), (a), and (c), respectively. It will also require OPOs to review and update these policies and procedures at least annually. The OPO's policies and procedures must address the requirements listed at § 486.360(b)(1) and (2).
The OPO CfCs already require the OPOs' governing body to develop and oversee implementation of policies and procedures considered necessary for the effective administration of the OPO, including the OPO's quality assessment and performance improvement (QAPI) program, and services furnished under contract or arrangement, including agreements for those services (§ 486.324(e)). Thus, we expect that OPOs already have developed and implemented policies and procedures for their effective administration. However, since the current CfCs have no specific requirement that these policies and procedures address emergency preparedness, we do not believe that the OPOs have developed or implemented all of the policies and procedures that will be needed to comply with the requirements of this section.
The burden associated with the development of the emergency preparedness policies and procedures will be the resources needed to develop emergency preparedness policies and procedures that will include, but will not be limited to, the specific elements identified in this requirement. We expect that all OPOs will need to review their current policies and procedures and compare them to their risk assessments, emergency preparedness plans, emergency communication plans, and agreements and protocols; they have developed as required by this final rule. Following their reviews, OPOs will need to develop and implement the policies and procedures necessary to ensure that they initiate and maintain their emergency preparedness plans, agreements, and protocols.
Based on our experience with OPOs, we expect that accomplishing these activities will require the involvement of the OPO's director, medical director, QAPI director, and an Organ Procurement Coordinator (OPC). We expect that all of these individuals will review the OPO's current policies and procedures; compare them to the risk assessment, emergency preparedness plan, agreements and protocols they have established with hospitals, other OPOs, and transplant programs; provide an analysis or comments; and participate in developing the final version of the policies and procedures.
We expect that the QAPI director will likely coordinate the meetings; coordinate and incorporate comments; draft the revised or new policies and procedures; and obtain the necessary signatures for final approval. We estimate that it will require 20 burden hours for each OPO to comply with the requirement to develop emergency preparedness policies and procedures at a cost of $2,154. Therefore, for all 58 OPOs to comply with this requirement will require an estimated 1,160 burden hours (20 burden hours for each OPO × 58 OPOs) at a cost of $124,932 (estimated cost for each OPO of $2,154 × 58 OPOs).
The OPOs also will be required to review and update their emergency preparedness policies and procedures at least annually. We believe that OPOs already review their emergency preparedness policies and procedures periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 486.360(c) will require OPOs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. The OPOs will have to review and update their plans at least annually. The communication plans will have to include the information listed in § 486.360(c)(1) through (3).
The OPOs must operate 24 hours a day, 7 days a week. OPOs conduct much of their work away from their office(s) at various hospitals within their DSAs. To function effectively, OPOs must ensure that they and their staff at these multiple locations can communicate with the OPO's office(s), other OPO staff members, transplant and donor hospitals, transplant programs, the Organ Procurement and Transplantation Network (OPTN), other healthcare providers, other OPOs, and potential and actual donors' next-of-kin.
Thus, we expect that the nature of their work will ensure that all OPOs have already addressed at least some of the elements that will be required by this section. For example, due to the necessity of communication with so many other entities, we expect that all OPOs will have compiled names and contact information for staff, other OPOs, and transplant programs.
We also expect that all OPOs will have alternate means of communication for their staffs. However, we do not believe that all OPOs have developed formal plans that include all of the elements contained in this requirement. The burden will be the resources needed to develop an emergency preparedness communications plan that will include, but not be limited to, the specific elements identified in this section. We expect that this will require the involvement of the OPO director, medical director, QAPI director, and OPC. We expect that all of these individuals will need to review the OPO's current plans, policies, and procedures related to communications and compare them to the OPO's risk assessment, emergency plan, and the agreements and protocols the OPO developed in accordance with § 486.360(e), and the OPO's emergency preparedness policies and procedures. We expect that these individuals will review the materials described earlier, submit comments to the QAPI director, review revisions and additions, and give a final recommendation or approval for the new emergency preparedness communication plan. We also expect that the QAPI director will coordinate the meetings; compile comments; incorporate comments into a new communications plan, as appropriate; and ensure that the necessary individuals review and approve the new plan.
We estimate that it will require 14 burden hours to develop an emergency preparedness communication plan at a cost of $1,566. Therefore, it will require an estimated 812 burden hours (14 burden hours for each OPO × 58 OPOs) at a cost of $90,828 ($1,566 estimated cost for each OPO × 58 OPOs).
We proposed that OPOs must review and update their emergency preparedness communication plans at least annually. We believe that all of the OPOs already review their emergency preparedness communication plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for OPOs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 486.360(d) will require OPOs to develop and maintain emergency preparedness training and testing programs. OPOs also will be required to review and update these programs at least annually. In addition, OPOs must meet the requirements listed in § 486.360(d)(1) and (2).
In § 486.360(d)(1), we proposed that OPOs be required to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of that training. OPOs must also ensure that their staff can demonstrate knowledge of their emergency procedures. Thereafter, OPOs will have to provide emergency preparedness training at least annually.
Under existing regulations, OPOs are required to provide their staffs with the training and education necessary for them to furnish the services the OPO is required to provide, including applicable organizational policies and procedures and QAPI activities (§ 486.326(c)). However, since there are no specific emergency preparedness requirements in the current OPO CfCs,
We expect that OPOs will develop a comprehensive emergency preparedness training program for their staffs. Based upon our experience with OPOs, we expect that complying with this requirement will require the OPO director, medical director, the QAPI director, an OPC, and the education coordinator. We expect that the QAPI director and the education coordinator will review the OPO's risk assessment, emergency preparedness plan, policies and procedures, and communication plan and make recommendations regarding revisions or new sections necessary to ensure that all appropriate information is included in the OPO's emergency preparedness training. We believe that the OPO director, medical director, and OPC will meet with the QAPI director and education coordinator and assist in the review, provide comments, and approve the new emergency preparedness training program.
We estimate that it will require 40 burden hours for each OPO to develop an emergency preparedness training program that complied with these requirements at a cost of $3,154. Therefore, we estimate that for all 58 OPOs to comply with this requirement will require 2,320burden hours (40 burden hours for each OPO × 58 OPOs) at a cost of $203,812 ($3,514 estimated cost for each OPO × 58 OPOs).
We proposed that OPOs must review and update their emergency preparedness training programs at least annually. We believe that all of the OPOs already review their emergency preparedness training programs periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for OPOs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 486.360(d)(2) will require OPOs to conduct a paper-based, tabletop exercise at least annually. OPOs also will be required to analyze their responses to and maintain documentation of all tabletop exercises and actual emergency events, and revise their emergency plans, as needed. To comply with this requirement, OPOs will have to develop scenarios for each tabletop exercise and the necessary documentation.
The OPO CfCs do not currently contain a requirement for OPOs to conduct a paper-based, tabletop exercise. However, OPOs are required to evaluate their staffs' performance and provide training to improve individual and overall staff performance and effectiveness (42 CFR 486.326(c)). Therefore, we expect that OPOs periodically conduct some type of exercise to test their plans, policies, and procedures, which will include developing a scenario for and documenting the exercise. Thus, we believe compliance with these requirements will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
We expect that the QAPI director and the education coordinator will work together to develop the scenario for the exercise and the necessary documentation. We expect that the QAPI director will likely spend more time on these activities. We estimate that these tasks will require 5 burden hours for each OPO at a cost of $408. For all 58 OPOs to comply with these requirements will require an estimated 290 burden hours (5 burden hours for each OPO × 58 OPOs) at a cost of $23,664 ($408 estimated cost for each OPO × 58 OPOs).
Section 486.360(e) requires OPOs to develop and maintain mutually agreed upon protocols as required in § 486.344(d) that cover the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated and the OPO during an emergency. Section 486.344(d) does not currently require that emergency preparedness be addressed in those protocols. Thus, we believe that most OPOs do not currently address emergency preparedness in their protocols. OPOs will only be required to address emergency preparedness with the transplant centers and the hospitals in which they operate. Since the number of transplant hospitals varies between the DSAs and the number of transplant programs in each of those hospitals also varies, we have estimated the burden based on the average number of transplant hospitals for each DSA and the number of transplant programs in those hospitals. There are about 770 transplant programs and 234 transplant hospitals. For each OPO's DSA, there is an average of 4 transplant hospitals (234 transplant hospitals/58 OPOs) with 3 transplant programs (770 transplant programs/234 transplant hospitals). Thus, we estimate that each OPO would need to develop
The burden associated with this requirement will be the time and effort necessary to negotiate with each hospital and transplant program, and then draft the protocols that address each one's duties and responsibilities during an emergency. Based on our experience with OPOs, transplant centers, and the hospitals in which they operate, we believe that they have already had to deal with some type of emergency and have a basis for those protocols, especially the types of services that are needed by the waiting list patients and the transplant recipients and the services that each of them can provide during an emergency. Based on our experience with OPOs, we believe that conducting these negotiations would require the involvement of the OPO's director, medical director, QAPI director, and an organ procurement coordinator (OPC). We expect that these individuals would attend an initial meeting and then one individual, probably the QAPI director, would draft the protocols and ensure they are reviewed by all required parties and agreed to. This would require an hour of each individual's time, except for the QAPI director who would require 2 hours for each transplant program. Thus, for each transplant program, the OPO would need 5 burden hours at a cost of $595. As described previously, each OPO would need to develop protocols for 12 transplant programs. Thus, to comply with this requirement, each OPO would require 60 burden hours (5 burden hours × 12 transplant programs) at a cost of $7,140 ($595 for each transplant program × 12 transplant programs). For all 58 OPOs, we estimate that the total burden to develop these protocols would be 3,480 burden hours (60 burden hours for each OPO × 58 OPOs) at a cost of $414,120 ($7,140 for each OPO × 58 OPOs).
Section 486.360(e) will also require each OPO to have the capability to continue its operations from an alternate location during an emergency. The OPO can have an agreement with one or more other OPOs to provide essential organ procurement services to all or a portion of the OPO's DSA in the event that the OPO cannot provide such services due to an emergency. However, based upon comments that we received, we are also finalizing two alternate means by which an OPO can also comply with this requirement. An OPO with more than one location or office would satisfy this requirement if it had at least one other location or office from which the OPO could conduct its operations, or at least those services the OPO has deemed essential to provide, during an emergency. An OPO could also satisfy this requirement by having a plan, which has been positively tested, to locate to an alternate location during an emergency as part of its emergency plan as required by § 486.360(a). According to the commenters, some OPOs, especially those in DSAs that cover large geographical areas, already have more than one office or location. In addition, since OPOs will have to address continuity of operations in their emergency plans under § 486.360(a), we believe that virtually all of the OPOs will chose to comply with this requirement by one of the two alternate methods being finalized. We estimate that about 9 OPOs or 15 percent of all OPOs would chose to have an agreement with another OPO. Since we estimate that fewer than 10 OPOs would chose to have an agreement with another OPO, this requirement is not subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(c).
Section 491.12(a) will require Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) to develop and maintain emergency preparedness plans. The RHCs and FQHCs will also have to review and update their plans at least annually. We proposed that the plan must meet the requirements listed at § 491.12(a)(1) through (4).
Section 491.12(a)(1) will require RHCs/FQHCs to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. RHCs/FQHCs will need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area. RHCs/FQHCs will need to review any existing risk assessments and then update and revise those assessments or develop new sections for them so that those assessments complied with our requirements.
We obtained the total number of RHCs and FQHCs used in this burden analysis from the CMS CASPER data system, which the states update periodically. Due to variations in the timeliness of the data submission, all numbers in this analysis are approximate. There are currently 11,500 RHC/FQHCs (4,200 RHCs + 7,300 FQHCs). Unlike RHCs, FQHCs are grantees and look-alikes under HRSA's Health Center Program. In 2007, the Health Resources and Services Administration (HRSA) issued a Policy Information Notice (PIN) entitled “Health Center Emergency Management Program Expectations,” that detailed the expectations HRSA has for health centers related to emergency management (“Health Center Emergency Management Program Expectations,” Policy Information Notice (PIN), Document Number 2007-15, HRSA, August 22, 2007) (Emergency Management PIN). A review of the Emergency Management PIN indicates that some of its expectations are very similar to the requirements in this final rule. While the expectations set forth by HRSA in the Emergency Management PIN are not requirements for receiving a HRSA Center Program grant (and as such are not requirements for FQHCs), if HRSA finds that an FQHC is not meeting the expectations of the Emergency Management PIN, it would provide the FQHC with resources for technical assistance to assist them in meeting these expectations. This demonstrates the importance of the FQHC's compliance with the Emergency Management PIN guidance. Therefore, since the expectations in the Emergency Management PIN are a significant factor in determining the burden for FQHCs, we will analyze the burden for the 7,300 FQHCs separately from the 4,200 RHCs where the burden will be significantly different.
Based on our experience with RHCs, we expect that all 4,200 RHCs have already performed at least some of the work needed to conduct a risk assessment. It is standard practice for healthcare facilities to prepare for common emergencies, such as fires, power outages, and storms. In addition, the current Rural Health Clinic Conditions for Certification and the FQHC Conditions for Coverage (RHC/FQHC CfCs) already require each RHC and FQHC to assure the safety of patients in case of non-medical emergencies by taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic or center is located (§ 491.6(c)(3)).
Furthermore, in accordance with the Emergency Management PIN, FQHCs should have initiated their “emergency management planning by conducting a risk assessment such as a Hazard Vulnerability Analysis” (HVA) (Emergency Management PIN, p. 5). The HVA should identify potential emergencies or risks and potential direct and indirect effects on the facility's operations and demands on their services and prioritize the risks based on the likelihood of each risk occurring and the impact or severity the facility will experience if the risk occurs (Emergency Management PIN, p. 5). FQHCs are also “encouraged to participate in community level risk assessments and integrate their own risk assessment with the local community” (Emergency Management PIN, p. 5).
Despite these expectations and the existing Medicare regulations for RHCs/FQHCs, some RHC/FQHC risk assessments may not comply with all requirements. For example, the expectations for FQHCs do not specifically address our requirement to address likely medical and non-medical emergencies. In addition, participation in a community-based risk assessment is only encouraged, not required. We expect that all 4,200 RHCs and 6,502 FQHCs will need to compare their current risk assessments with our requirements and accomplish the tasks necessary to ensure their risk assessments comply with our requirements. However, we expect that FQHCs will not be subject to as many burden hours as RHCs.
We have not designated any specific process or format for RHCs or FQHCs to use in conducting their risk assessments because we believe that RHCs and FQHCs need flexibility to determine the best way to accomplish this task. However, we expect that these healthcare facilities will include input from all of their major departments. Based on our experience with RHCs/FQHCs, we expect that conducting the risk assessment will require the involvement of the RHC/FQHC's administrator, a physician, a nurse practitioner or physician assistant, and a registered nurse. We expect that these individuals will attend an initial meeting, review the current risk assessment, prepare and forward their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrator will coordinate the meetings, review the current risk assessment, provide an analysis of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We also expect that the administrator will spend more time reviewing the risk assessment than the other individuals.
We estimate that it will require 10 burden hours for each RHC to conduct a risk assessment that complied with the requirements in this section at a cost of $1,080. We estimate that for all RHCs to comply with our requirements will require 42,000 burden hours (10 burden hours for each RHC × 4,200 RHCs) at a cost of $4,536,000 ($1,080 estimated cost for each RHC × 4,200 RHCs).
We estimate that it will require 5 burden hours for each FQHC to conduct a risk assessment that complied with our requirements at a cost of $520. We estimate that for all 7,300 FQHCs to comply will require 36,500 burden hours (5 burden hours for each FQHC × 7,300 FQHCs) at a cost of $3,796,000 ($520 estimated cost for each FQHC × 7,300 FQHCs). Based on those estimates, compliance with this requirement for all RHCs and FQHCs will require 78,500 burden hours at a cost of $8,332,000.
After conducting the risk assessment, RHCs/FQHCs will have to develop and maintain emergency preparedness plans that complied with § 491.12(a)(1) through (4) and review and update them annually. It is standard practice for healthcare facilities to plan for common emergencies, such as fires, hurricanes, and snowstorms. In addition, as discussed earlier, we require all RHCs/FQHCs to take appropriate measures to ensure the safety of their patients in non-medical emergencies, based on the particular conditions present in the area in which they are located (§ 491.6(c)(3)). Thus, we expect that all RHCs/FQHCs have developed some type of emergency preparedness plan. However, under this final rule, all RHCs/FQHCs will have to review their current plans and compare them to their risk assessments. The RHCs/FQHCs will need to update, revise, and, in some cases, develop new sections to complete their emergency preparedness plans that meet our requirements.
The Emergency Management PIN contains many expectations for an FQHC's emergency management plan (EMP). For example, it states that the FQHC's EMP “is necessary to ensure the continuity of patient care” during an emergency (Emergency Management PIN, p. 6) and should contain plans for “assuring access for special populations (Emergency Management PIN, p. 7). The FQHC's EMP also should address continuity of operations, as appropriate (Emergency Management PIN, p. 6). In addition, FQHCs should use an “all-hazards approach” so that these facilities can respond to all of the risks they identified in their risk assessment (Emergency Management PIN, p. 6). Based on the expectations in the Emergency Management PIN, we expect that FQHCs likely have developed emergency preparedness plans that comply with many, if not all, of the elements with which their plans will need to comply under this final rule. However, we expect that FQHCs will need to compare their current EMP to our requirements and, if necessary, revise or develop new sections for their EMP to bring it into compliance. We expect that FQHCs will have less of a burden than RHCs.
Based on our experience with RHCs/FQHCs, we expect that the same individuals who were involved in developing the risk assessments will be involved in developing the emergency preparedness plans. However, we expect that it will require more time to complete the plans than the risk assessments. We expect that the administrator will have primary responsibility for reviewing and developing the RHC/FQHC's EMP. We expect that the physician, nurse practitioner or physician assistant, and registered nurse will review the draft plan and provide comments to the administrator. We estimate that for each RHC to comply with this requirement will require 14 burden hours at a cost of $1,379. Therefore, it will require an estimated 58,800 burden hours (14 burden hours for each RHC × 4,200 RHCs) to complete the plan at a cost of $5,791,800 ($1,379 estimated cost for each RHC × 4,200 RHCs).
We estimate that it will require 8 burden hours for each FQHC to comply with our requirements at a cost of $762. Based on that estimate, it will require 58,400 burden hours (8 burden hours for each FQHC × 7,300 FQHCs) to complete
Based on the previous estimates, for all RHCs and FQHCs to develop an emergency preparedness plan that complies with our requirements will require 117,200 burden hours at a cost of $11,354,400.
Each RHC/FQHC also will be required to review and update its emergency preparedness plan at least annually. We believe that RHCs and FQHCs already review their emergency preparedness plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for RHCs and FQHCs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 491.12(b) will require RHCs/FQHCs to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in § 491.12(a), (a)(1), and (c), respectively. We will also require RHCs/FQHCs to review and update these policies and procedures at least annually. At a minimum, we will require that the RHC/FQHC's policies and procedures address the requirements listed at § 491.12(b)(1) through (4).
We expect that all RHCs/FQHCs have some emergency preparedness policies and procedures. All RHCs and FQHCs are required to have emergency procedures related to the safety of their patients in non-medical emergencies (§ 491.6(c)). They also must set forth in writing their organization's policies (§ 491.7(a)(2)). In addition, current regulations require that a physician, in conjunction with a nurse practitioner or physician's assistant, develop the facility's written policies (§ 491.8(b)(ii) and (c)(i)). However, we expect that all RHCs/FQHCs will need to review their policies and procedures, assess whether their policies and procedures incorporate their risk assessments and emergency preparedness plans and make any changes necessary to comply with our requirements.
We expect that FQHCs already have policies and procedures that will comply with some of our requirements. Several of the expectations of the Emergency Management PIN address specific elements in § 491.12(b). For example, the PIN states that FQHCs should address, as appropriate, continuity of operations, staffing, surge patients, medical and non-medical supplies, evacuation, power supply, water and sanitation, communications, transportation, and the access to and security of medical records (Emergency Management PIN, p. 6). In addition, FQHCs should also continually evaluate their EMPs and make changes to their EMPs as necessary (Emergency Management PIN, p. 7). These expectations also indicate that FQHCs should be working with and integrating their planning with their state and local communities' plans, as well as other key organizations and other relationships (Emergency Management PIN, p. 8). Thus, we expect that burden for FQHCs from the requirement for emergency preparedness policies and procedures will be less than the burden for RHCs.
The burden associated with our requirements will be reviewing, revising, and, if needed, developing new emergency preparedness policies and procedures. We expect that a physician and a nurse practitioner will primarily be involved with these tasks and that an administrator will assist them. We estimate that for each RHC to comply with our requirements will require 12 burden hours at a cost of $1,482. Based on that estimate, for all 4,200 RHCs to comply with these requirements will require 50,400 burden hours (12 burden hours for each RHC × 4,200 RHCs) at a cost of $6,224,400 ($1,482 estimated cost for each RHC × 4,200 RHCs).
As discussed earlier, we expect that FQHCs will have less of a burden from developing their emergency preparedness policies and procedures due to the expectations set out in the Emergency Management PIN. Thus, we estimate that for each FQHC to comply with the requirements will require 8 burden hours at a cost of $932. Based on that estimate, for all 7,300 FQHCs to comply with these requirements will require 58,400 burden hours (8 burden hours for each FQHC × 7,300 FQHCs) at a cost of $6,803,600 ($932 estimated cost for each FQHC × 7,300 FQHCs).
Based on the previous estimates, for all RHCs and FQHCs to develop emergency preparedness policies and procedures that comply with our requirements will require 108,800 burden hours at a cost of $13,028,000.
We proposed that RHCs/FQHCs review and update their emergency preparedness policies and procedures at least annually. We believe that RHCs and FQHCs already review their emergency preparedness policies and procedures periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for RHCs/FQHCs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 491.12(c) will require RHCs/FQHCs to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. RHCs/FQHCs will also have to review and update these plans at least annually. We proposed that the communication plan must include the information listed in § 491.12(c)(1) through (5).
We expect that all RHCs/FQHCs have some type of emergency preparedness communication plan. It is standard practice for healthcare facilities to maintain contact information for staff and outside sources of assistance; alternate means of communication in case there is an interruption in the facility's phone services; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for patients. As discussed earlier, RHCs and FQHCs are required to take appropriate measures to ensure the safety of their patients during non-medical emergencies (§ 491.6(c)). We expect that an emergency preparedness communication plan will be an essential element in any emergency preparedness preparations. However, some RHCs/FQHCs may not have a formal, written emergency preparedness communication plan or their plan may not include all the requirements we proposed.
The Emergency Management PIN contains specific expectations for communications and information sharing (Emergency Management PIN, pp. 8-9). “A well-defined communication plan is an important component of an effective EMP” (Emergency Management PIN, p. 8). In addition, FQHCs are expected to have policies and procedures for communicating with both internal stakeholders (such as patients and staff) and external stakeholders (such as federal, tribal, state, and local agencies), and for identifying who will do the communicating and what type of information will be communicated (Emergency Management PIN, p. 8). FQHCs should also identify alternate communications systems in the event that their standard communications systems become unavailable, and the FQHC should identify these alternate systems in their EMP (Emergency Management PIN, p. 9). Thus, we expect that all FQHCs will have a formal communication plan for emergencies and that those plans will contain some of our requirements. However, we expect that all FQHCs will need to review, revise, and, if needed, develop new sections for their emergency preparedness communication plans to ensure that their plans are in compliance. We expect that these tasks will require less of a burden for FQHCs than for the RHCs.
The burden associated with complying with this requirement will be the resources required to review, revise, and, if needed, develop new sections for the RHC/FQHC's emergency preparedness communication plan. Based on our experience with RHCs/FQHCs, as well as the requirements in current regulations for a physician to work in conjunction with a nurse practitioner or a physician assistant to develop policies, we anticipate that satisfying the requirements in this section will require the involvement of the RHC/FQHC's administrator, a physician, and a nurse practitioner or physician assistant. We expect that the administrator and the nurse practitioner or physician assistant will be primarily involved in reviewing, revising, and if needed, developing new sections for the RHC/FQHC's emergency preparedness communication plan.
We estimate that for each RHC to comply with the requirements will require 10 burden hours at a cost of $1,126. Based on that estimate, for all 4,200 RHCs to comply will require 42,000 burden hours (10 burden hours for each RHC × 4,200 RHCs) at a cost of $4,729,200 ($1,126 estimated cost for each RHC × 4,200 RHCs).
We estimate that for a FQHC to comply with the requirements will require 5 burden hours at a cost of $563. Based on this estimate, for all 7,300 FQHCs to comply will require 36,500 burden hours (5 burden hours for each FQHC × 7,300 FQHCs) at a cost of $4,109,900 ($563 estimated cost for each FQHC × 7,300 FQHCs).
We proposed that RHCs/FQHCs also review and update their emergency preparedness communication plans at least annually. We believe that RHCs/FQHCs already review their emergency preparedness communication plans periodically. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for RHCs/FQHCs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 491.12(d) will require RHCs/FQHCs to develop and maintain emergency preparedness training and testing programs and review and update these programs at least annually. We proposed that an RHC/FQHC will have to comply with the requirements listed in § 491.12(d)(1) and (2).
Section 491.12(d)(1) will require each RHC and FQHC to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of that training. Each RHC and FQHC will also have to ensure that its staff could demonstrate knowledge of those emergency procedures. Thereafter, each RHC and FQHC will be required to provide emergency preparedness training annually.
Based on our experience with RHCs and FQHCs, we expect that all 11,500 RHC/FQHCs already have some type of emergency preparedness training program. The current RHC/FQHC regulations require RHCs and FQHCs to provide training to their staffs on handling emergencies (§ 491.6(c)(1)). In addition, FQHCs are expected to provide ongoing training in emergency management and their facilities' EMP to all of their employees (Emergency Management PIN, p. 7). However, neither the current regulations nor the PIN's expectations for FQHCs address initial training and ongoing training, frequency of training, or requirements that individuals providing services under arrangement and volunteers be included in the training. RHCs/FQHCs will need to review their current training programs; compare their contents to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans and then take the necessary steps to ensure that their training programs comply with our requirements.
We expect that each RHC and FQHC has a professional staff person who is responsible for ensuring that the facility's training program is up-to-date and complies with all federal, state, and local laws and regulations. This individual will likely be an administrator. We expect that the administrator will be primarily involved in reviewing the RHC/FQHC's emergency preparedness program; determining what tasks need to be performed and what materials need to be developed to bring the training program into compliance with our requirements; and making changes to current training materials and developing new training materials. We expect that the administrator will work with a registered nurse to develop the revised and updated training program. We estimate that it will require 10 burden hours for each RHC or FQHC to develop a comprehensive emergency training program at a cost of $602. Therefore, it will require an estimated 115,500 burden hours (10 burden hours for each RHC/FQHC × 11,500 RHCs/FQHCs) to comply with this requirement at a cost of $6,923,000 ($602 estimated cost for each RHC/FQHC × 11,500 RHCs/FQHCs).
Section 491.12(d) will also require that RHCs/FQHCs develop and maintain emergency preparedness training and testing programs that will be reviewed and updated at least annually. We believe that RHCs/FQHCs already review their emergency preparedness programs periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice for RHCs/FQHCs and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 491.12(d)(2) will require RHCs/FQHCs to participate in a full-scale exercise at least annually. They will also be required to participate in an additional testing exercise of their choice at least annually. RHCs/FQHCs will also be required to analyze their responses to and maintain documentation of drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. If an RHC or FQHC experienced an actual natural or man-made emergency that required activation of its emergency plan, it will be exempt from the requirement for a community or individual, facility-based full-scale exercise for 1 year following the onset of the actual event. However, for purposes of determining the burden for these requirements, we will assume that all RHCs/FQHCs will have to comply with all of these requirements.
The burden associated with complying with these requirements will be the resources the RHC or FQHC will
Based on our experience with RHCs/FQHCs, we expect that most of the 11,500 RHCs/FQHCs already conduct some type of testing of their emergency preparedness plans and develop scenarios and documentation for their testing and emergency events. For example, FQHCs are expected to conduct some type of testing of their EMP at least annually (Emergency Management PIN, p. 7). However, we do not believe that all RHCs/FQHCs have the appropriate documentation for the testing exercises and emergency events or that they conduct both two testing exercises annually. Thus, we will analyze the burden associated with these requirements for all 11,500 RHCs/FQHCs.
Based on our experience with RHCs/FQHCs, we expect that the same individuals who are responsible for developing the RHC/FQHC's training and testing program will develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator and a registered nurse will be primarily involved in accomplishing these tasks. We estimate that for each RHC/FQHC to comply with the requirements in this section will require 5 burden hours at a cost of $347. Based on this estimate, for all 11,500 RHCs/FQHCs to comply with the requirements in this section will require 57,500 burden hours (5 burden hours for each RHC/FQHC × 11,500 RHCs/FQHCs) at a cost of $3,990,500 ($347 estimated cost for each RHC/FQHC × 11,500 RHC/FQHCs).
Section 494.62(a) will require dialysis facilities to develop and maintain emergency preparedness plans that will have to reviewed and updated at least annually. Section 494.62 will require that the plan include the elements set out at § 494.62(a)(1) through (4).
Section 494.62(a)(1) will require dialysis facilities to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. The risk assessment should address the medical and non-medical emergency events the facility could experience both within the facility and within the surrounding area. The dialysis facility will have to consider its location and geographical area; patient population, including, but not limited to, persons-at-risk; and the types of services the dialysis facility has the ability to provide in an emergency. The dialysis facility also will need to identify the measures it will need to take to ensure the continuity of its operations, including delegations of authority and succession plans.
The burden associated with this requirement will be the resources needed to perform a thorough risk assessment. The current CfCs already require dialysis facilities to implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failure, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area (§ 494.60(d)). Thus, to be in compliance with this CfC, we believe that all dialysis facilities will have already performed some type of risk assessment during the process of developing their emergency preparedness processes and procedures. However, these risk assessments may not be as thorough or address all of the elements required in § 494.62(a). For example, the current CfCs do not require dialysis facilities to plan for man-made disasters. Therefore, we believe that all dialysis facilities will have to conduct a thorough review of their current risk assessments and then perform the necessary tasks to ensure that their facilities' risk assessments complied with the requirements of this section.
Based on our experience with dialysis facilities, we expect that conducting the
After conducting the risk assessment, each dialysis facility will then have to develop and maintain an emergency preparedness plan that the facility must evaluate and update at least annually. This emergency plan will have to comply with the requirements at § 494.62(a)(1) through (4).
Current CfCs already require dialysis facilities to have a plan to obtain emergency medical system assistance when needed and to evaluate at least annually the effectiveness of emergency and disaster plans and update them as necessary (§ 494.60(d)(4)). Thus, we expect that all dialysis facilities have some type of emergency preparedness or disaster plan. In addition, dialysis facilities must implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area (§ 494.60(d)). We expect that the facility will incorporate many, if not all, of these processes and procedures into its emergency preparedness plan. We expect that each dialysis facility has some type of emergency preparedness plan and that plan should already address many of these requirements. However, all of the dialysis facilities will have to review their current plans and compare them to the risk assessment they performed according to § 494.62(a)(1). The dialysis facility will then need to update, revise, and, in some cases, develop new sections to complete an emergency preparedness plan that addressed the risks identified in their risk assessment and the specific requirements contained in this section. The plan will also address how the dialysis facility will continue providing its essential services, which are the services that the dialysis facility will continue to provide despite an emergency. The dialysis facility will also need to review, revise, and, in some cases, develop delegations of authority or succession plans that the dialysis facility determined were necessary for the appropriate initiation and management of their emergency preparedness plan.
The burden associated with this requirement will be the time and effort necessary to develop the emergency preparedness plan. Based upon our experience with dialysis facilities, we expect that developing the emergency preparedness plan will require the involvement of the dialysis facility's chief executive officer or administrator, medical director, nurse manager, social worker, and a PCT. We believe that all of these individuals will probably have to attend an initial meeting, review relevant sections of the facility's current emergency preparedness or disaster plan(s), develop comments and recommendations for changes to the assessment, attend a follow-up meeting, and then perform a final review and approve the risk assessment. We believe that the administrator will probably coordinate the meetings, do an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved the new risk assessment. We also believe that the administrator, medical director, and nurse manager will probably spend more time reviewing and working on the risk assessment than the other individuals involved in developing the plan. The social worker and PCT will likely just review the plan or relevant sections of it. In addition, since the medical director's responsibilities include participation in the development of patient care policies and procedures (42 CFR 494.150(c)), we expect that the medical director will be involved in the development of the emergency preparedness plan. This is less time than we estimate it will take for the risk assessment because dialysis facilities are currently required to have an emergency plan (§ 494.60(d)(4)). Based on this final rule, the dialysis facility will need to update, revise, and, in some cases, develop new sections to complete an emergency preparedness plan that addresses the risks identified in their risk assessment and the specific requirements contained in this regulation.
We estimate that complying with this requirement will require 10 burden hours at a cost of $1,116 for each dialysis facility. There are 6,648 dialysis facilities. Therefore, it will require an estimated 66,480 burden hours (10 burden hours for each dialysis facility × 6,648 dialysis facilities) to complete the plan at a cost of $7,419,168 ($1,116
Each dialysis facility will also be required to review and update its emergency preparedness plan at least annually. We believe that dialysis facilities already review their emergency preparedness plans periodically. The current CfCs already requires dialysis facilities to evaluate the effectiveness of their emergency and disaster plans and update them as necessary (42 CFR 494.60(d)(4)(ii)). Thus, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 494.62(b) will require dialysis facilities to develop and implement emergency preparedness policies and procedures based on the emergency plan, the risk assessment, and communication plan as set forth in § 494.62(a), (a)(1), and (c), respectively. These emergencies will include, but will not be limited to, fire, equipment or power failures, care-related emergencies, water supply interruptions, and natural and man-made disasters that are likely to occur in the facility's geographical area. Dialysis facilities will also have to review and update these policies and procedures at least annually. The policies and procedures will be required to address, at a minimum, the requirements listed at § 494.62(b)(1) through (9).
We expect that all dialysis facilities have some emergency preparedness policies and procedures. The current CfCs at § 494.60(d) already require dialysis facilities to implement processes and procedures to manage medical and nonmedical emergencies that include, but not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. In addition, we expect that dialysis facilities already have procedures that will satisfy some of the requirements in this section. For example, each dialysis facility is already required at § 494.60(d)(4)(iii) to contact its local disaster management agency at least annually to ensure that such agency is aware of dialysis facility needs in the event of an emergency. However, all dialysis facilities will need to review their policies and procedures, assess whether their policies and procedures incorporated all of the necessary elements of their emergency preparedness program, and then, if necessary, take the appropriate steps to ensure that their policies and procedures encompassed these requirements.
The burden associated with the development of these emergency policies and procedures will be the time and effort necessary to comply with these requirements. We expect the administrator, medical director, and the nurse manager will be primarily involved with reviewing, revising, and if needed, developing any new policies and procedures that were needed. The remaining individuals will likely review the sections of the policies and procedures that directly affect their areas of expertise. Therefore, we estimate that complying with this requirement will require 10 burden hours at a cost of $1,116 for each dialysis facility. There are 6,648 dialysis facilities. Therefore, it will require an estimated 66,480 burden hours (10 burden hours for each dialysis facility × 6,648 dialysis facilities) to complete the plan at a cost of $7,419,168 ($1,116 estimated cost for each dialysis facility × 6,648 dialysis facilities).
The dialysis facility must also review and update its emergency preparedness policies and procedures at least annually. We believe that dialysis facilities already review their emergency preparedness policies and procedures periodically. In addition, the current CfCs already require (at 42 CFR 494.150(c)(1)) the medical director to participate in a periodic review of patient care policies and procedures. Thus, we believe compliance with this requirement will constitute a usual and customary business practice for dialysis facilities and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 494.62(c) will require dialysis facilities to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The dialysis facility must also review and update
We expect that all dialysis facilities have some type of emergency preparedness communication plan. A communication plan will be an integral part of any emergency preparedness plan. Current CfCs already require dialysis facilities to have a written disaster plan (42 CFR 494.60(d)(4)). Thus, each dialysis facility should already have some of the contact information they will need to have in order to comply with this section. In addition, we expect that it is standard practice in the healthcare industry to have and maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility, such as cell phones or text-messaging devices; and a method for sharing information and medical documentation with other healthcare providers to ensure continuity of care for their patients. However, many dialysis facilities may not have formal, written emergency preparedness communication plans. Therefore, we expect that all dialysis facilities will need to review, update, and in some cases, develop new sections for their plans to ensure that those plans included all of the previously-described required elements in their emergency preparedness communication plan.
The burden associated with complying with this requirement will be the resources required to review and revise the dialysis facility's emergency preparedness communication plan to ensure that it complied with these requirements. Based upon our experience with dialysis facilities, we anticipate that satisfying these requirements will primarily require the involvement of the dialysis facility's administrator, medical director, and nurse manager. For each dialysis facility, we estimate that complying with this requirement will require 4 burden hours at a cost of $513. Therefore, for all of the dialysis facilities to comply with this requirement will require an estimated 26,592 burden hours (4 burden hours for each dialysis facility × 6,648 dialysis facilities) at a cost of $3,410,424 ($513 estimated cost for each dialysis facility × 6,648 dialysis facilities).
Each dialysis facility will also have to review and update its emergency preparedness communication plan at least annually. For the purpose of determining the burden for this requirement, we will expect that dialysis facilities will review their emergency preparedness communication plans annually. We believe that all dialysis facilities have an administrator that will be primarily responsible for the day-to-day operation of the dialysis facility. This will include ensuring that all of the dialysis facility's policies, procedures, and plans were up-to-date and complied with the relevant federal, state, and local laws, regulations, and ordinances. We expect that the administrator will be responsible for periodically reviewing the dialysis facility's plans, policies, and procedures as part of his or her work responsibilities. Therefore, we expect that complying with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 494.62(d) will require dialysis facilities to develop and maintain emergency preparedness training, testing and patient orientation programs that will have to be evaluated and updated at least annually. The dialysis facility will have to comply with the requirements located at § 494.62(d)(1) through (3).
Section 494.62(d)(1) will require that dialysis facilities provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the dialysis facility will have to provide emergency preparedness training at least annually.
Current CfCs already require dialysis facilities to provide training and orientation in emergency preparedness to the staff (§ 494.60(d)(1)) and provide appropriate orientation and training to patients in emergency preparedness (§ 494.60(d)(2)). In addition, the dialysis facility's patient instruction will have to include the same matters that are specified in the current CfCs (42 CFR 494.60(d)(2)). Thus, dialysis facilities should already have an emergency preparedness training program for new employees, as well as ongoing training for all their staff and patients. However, all dialysis facilities will need to review their current training programs and compare their contents to their updated emergency preparedness programs, that is, the risk assessment, emergency preparedness plan, policies and procedures, and communications plans that they developed in accordance with § 494.62(a) through (c). Dialysis facilities will then need to review, revise, and in some cases, develop new material for their training programs so that they complied with these requirements.
The burden associated with complying with this requirement will be the time and effort necessary to develop the required training program. We expect that complying with this requirement will require the involvement of the administrator, medical director, and the nurse manager. In fact, the medical director's responsibilities include, among other things, staff education and training (§ 494.150(b)). We estimate that it will require 7 burden hours for each dialysis facility to develop an emergency training program at a cost of $807. Therefore, it will require an estimated 46,536 burden hours (7 burden hours for each dialysis facility × 6,648 dialysis facilities) to comply with this requirement at a cost of $5,364,936 ($807 estimated cost for each dialysis facility × 6,648 dialysis facilities).
The dialysis facility must also review and update its emergency preparedness training program at least annually. We believe that dialysis facilities already review their emergency preparedness training programs periodically. Therefore, we believe compliance with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 494.62(d)(2) requires dialysis facilities to participate in a full scale exercise at least annually. They will also be required to conduct one additional exercise of their choice at least annually. If the dialysis facility experienced an actual natural or man-made emergency that required activation of their emergency plan, the dialysis facility will be exempt from engaging in a full-scale exercise for 1 year following the onset of the actual event. Dialysis facilities will also be required to analyze their responses to and maintain document of all drills, tabletop exercises, and emergency events. To comply with this requirement, a dialysis facility will need to develop scenarios for each drill and exercise. A dialysis facility will also have to develop the documentation necessary for recording and analyzing the drills, tabletop exercises, and emergency events.
The current CfCs already require dialysis facilities to evaluate their emergency preparedness plan at least annually (42 CFR 494.60(d)(4)(ii)). Thus, we expect that all dialysis facilities are already conducting some type of tests to evaluate their emergency plans. Although the current CfCs do not specify the type of drill or test, dialysis facilities should have already been developing scenarios for testing their plans. Thus, we believe complying with this requirement will constitute a usual and customary business practice and will not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
Section 494.62(d)(3) will require dialysis facilities to provide appropriate orientation and training to patients, including the areas specified in § 494.62(d)(1). Section 494.62(d)(1) specifically will require that staff demonstrate knowledge of emergency procedures including the emergency information they must give to their patients. Thus, the burden associated with this section will already be included in the burden estimate for § 494.62(d)(1).
Based on the previous analysis, the burden for complying with all of the requirements in this final rule will be 3,089,505 burden hours at a cost of $279,680,069. Table 127 provides a summary of the ICR burden, for the hours and the costs, for each element of the requirements in this final rule for each provider and supplier type.
If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Attn.: William Parham, (CMS-3178-F), Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: CMS Desk Officer, CMS-3178-F, Fax (202) 395-6974.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).
In response to past terrorist attacks, natural disasters, and the subsequent national need to refine the nation's strategy to handle emergency situations, there continues to be a coordinated effort across federal agencies to establish a foundation for development and expansion of emergency preparedness systems. There are two Presidential Directives, HSPD-5 and HSPD-21, instructing agencies to coordinate their emergency preparedness activities with each other. Although these directives do not specifically require Medicare providers and suppliers to adopt measures, they have set the stage for what we expect from our providers and suppliers in regard to their roles in a more unified emergency preparedness system.
Homeland Security Presidential Directive (HSPD-21) addresses public health and medical preparedness. The directive establishes a National Strategy for Public Health and Medical Preparedness (Strategy), which builds upon principles set forth in “Biodefense for the 21st Century” (April 2004), “National Strategy for Homeland Security” (October 2007), and the “National Strategy to Combat Weapons of Mass Destruction” (December 2002). The directive aims to transform our national approach to protecting the health of the American people against all disasters.
We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995 Pub. L. 104-4), and Executive—Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more annually). The total projected cost of this rule will be $373 million in the first year, and the subsequent projected annual cost will be approximately $25 million. We solicited and received comments on the proposed RIA. As such, we have presented our best estimate of the impact, including both costs and benefits, of this rule.
Published reports after Hurricane Katrina reported that the Louisiana Attorney General investigated approximately 215 deaths that occurred in hospitals and nursing homes following Katrina. (Fink, Sheri (September 10, 2013). Five Days at Memorial: Life and Death in a Storm-Ravaged Hospital. New York: Crown Publishers. p. 360. ISBN 978-0-307-71896-9.) Since nearly all hospitals and nursing homes are certified to participate in the Medicare program, we estimate that at least a small percentage of these lives could be saved as a result of emergency preparedness measures in a single disaster of equal magnitude. Katrina is an extreme example of a natural disaster, so we also considered other more common disasters. The United States experiences numerous natural disasters annually, including, in particular, tornadoes and flooding. Based on data from the National Oceanic and Atmospheric Administration, the United States experiences an annual average of 56 fatalities as a result of tornadoes (
It is commonly understood that healthcare facilities that do not have an emergency plan, develop policies and procedures, and train and exercise their staff are at a heightened risk for healthcare delivery and service disruptions. For instance, patients with ESRD have experienced problems accessing care and adverse outcomes during disasters. These patients are particularly at risk for having increased morbidity and mortality following disasters due to their dependence on regular life-maintaining dialysis treatments. Hurricane Katrina was particularly devastating for the dialysis-dependent population and led to the dialysis community, including facilities, recommending more integrated and better emergency planning, training and exercises in addition to other preparedness recommendations. One example was for dialysis facilities to implement early dialysis (an early treatment in advance of the storm's landfall) for notice weather events, such as hurricanes, snow storms, or other severe weather (Kenney, Robert J. “Emergency preparedness concepts for dialysis facilities: Reawakened after Hurricane Katrina.” Clinical Journal of the American Society of Nephrology 2.4 (2007): 809-813 DOI: 10.2215/CJN.03971106). In order to implement early dialysis, particularly in moderate to large scale emergencies, facilities need to have an integrated emergency plan, policies and procedures, training and exercises. All of which are needed to better ensure that staff are able to rapidly activate and operate the facility emergency plan, prioritize and contact patients and transportation, and coordinate a surge in patient care coordination for both early and their regularly scheduled dialysis treatments.
Hurricane Sandy was predicted to be a severe storm many days in advance of its actual landfall. State health officials, in anticipation of its severity, encouraged dialysis facilities to dialyze patients ahead of schedule and rapidly activated the Kidney Community
Although we are unable to specifically quantify the number of lives saved as a result of this final rule, all of the data we have reviewed regarding emergency preparedness indicate that implementing the requirements in this final rule could have a significant impact on protecting the health and safety of individuals served by providers and suppliers that participate in the Medicare and Medicaid programs. The following cost analysis is based on “Guidelines for Regulatory Impact Analysis” (Robinson, L.A. and J.K. Hammitt. 2015, “Valuing Reductions in Risks of Fatal Illness: Implications of Recent Research.” Health Economics. 25(8): 1039-1052) developed by Harvard University for the Assistant Secretary for Planning and Evaluation (ASPE). The Guidelines are not yet public, however based on the research that was published in Health Economics, we have provided the following cost analysis. In order to “break even” on the cost of this rule, that is, in order for the total costs of implementing this rule to equal the total benefits of doing so- this rule would need to save 11.5 lives per year for 5 years at a 7 percent discount rate and a value of $9 million per statistical life saved. It would take about 11 statistical lives saved per year for 5 years at a 3 percent discount rate for this final rule to break even. Therefore, we believe it is crucial for all providers and suppliers to have an emergency disaster plan that is integrated with other local, state and federal agencies to effectively address both natural and manmade disasters.
We believe that this final rule will be an economically significant regulatory action under section 3(f)(1) of Executive Order 12866, since it may lead to impacts of greater than $100 million in the first year following the rule's effective date.
This final rule will establish a regulatory framework with which Medicare- and Medicaid-participating providers and suppliers will have to comply to ensure that the varied providers and suppliers of healthcare are adequately prepared to respond to natural and man-made disasters.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $11 million to $38.5 million in any 1 year. For purposes of the RFA, a majority of hospitals are considered small entities due to their non-profit status. Individuals and states are not included in the definition of a small entity. Since the cost associated with this final rule is less than $46,000 for hospitals and $4,000 for other entities, the Secretary has determined that this proposed will not have a significant economic impact on a substantial number of small entities.”
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Since the cost associated with this final rule is less than $46,000 for hospitals, this this proposed will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule that includes a federal mandate that could result in expenditure in any 1 year by state, local or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold level is approximately $146 million. This omnibus final rule contains mandates that will impose a one-time cost of approximately $373 million. Thus, we have assessed the various costs and benefits of this final rule. It is clear that a number of providers and suppliers will be affected by the implementation of this final rule and that a substantial number of those entities will be required to make changes in their operations. This final rule will not mandate any new requirements for state, local or tribal governments. For the private sector facilities, this regulatory impact section constitutes the analysis required under UMRA.
Executive Order 13132 establishes certain requirements that an agency must meet when it develops a final rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This final rule will not impose substantial direct requirement costs on state or local governments,
This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
This final rule will require each of the Medicare- and Medicaid-participating providers and suppliers discussed in previous sections to perform a risk analysis; establish an emergency preparedness plan, emergency preparedness policies and procedures, and an emergency preparedness communication plan; train staff in emergency preparedness, and test the emergency plan. The economic impact will differ between hospitals and the various other providers and suppliers, depending upon a variety of factors, including existing regulatory requirements and accreditation standards.
We discuss the economic impact for each provider and supplier type included in this final rule in the order in which they appear in the CFR. Most of the economic impact of this final rule will be due to the cost for providers and suppliers to comply with the information collection requirements. Thus, we discuss most of the economic impact under the Collection of Information Requirements section of this final rule. We provide a chart at the end of the RIA section of the total regulatory impact for each provider or supplier.
As stated in the ICR section of this final rule, we obtained all salary information from the May 2014 National Occupational Employment and Wage Estimates, United States by the Bureau of Labor Statistics (BLS) at
This final rule will require all inpatient providers to meet the subsistence needs of staff and patients, whether they evacuate or shelter in place, including, but not limited to, food, water, and supplies, alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of such provisions.
Based on our experience, we expect inpatient providers to currently have food, water, and supplies, alternate sources of energy to provide electrical power, and the maintenance of temperatures for the safe and sanitary storage of such provisions as a routine measure to ensure against weather related and non-disaster power failures. Thus, we believe that this requirement is a usual and customary business practice for inpatient providers and we have not assigned any impact for this requirement.
Furthermore, we expect that most providers have agreements with their vendors to receive supplies within 24 to 48 hours in the event of an emergency, as well as arrangements with back-up vendors in the event that the disaster affects the primary vendor. We considered proposing a requirement that providers must keep a larger quantity of food and water on hand in the event of a disaster. However, we believe that a provider should have the flexibility to determine what is adequate based on the location and individual characteristics of the facility. While some providers may have the storage capacity to stockpile supplies that will last for a longer duration, other may not. Thus, we believe that to require such stockpiling will create an unnecessary economic impact on some healthcare providers.
We expect that when inpatient providers determine their supply needs, they will consider the possibility that volunteers, visitors, and individuals from the community may arrive at the facility to offer assistance or seek shelter.
Based on the previous factors, we have not estimated a cost for a stockpile of food and water.
We proposed to require hospitals, CAHs, and LTC facilities to test and maintain their emergency and standby power systems in such a way to ensure proper operation in the event they are needed. The 2012 edition of the Life Safety Code (LSC) of the NFPA® states that the alternate source of power (for example, generator) must be located in an appropriate area to minimize the possible damage resulting from disasters such as storms, floods, earthquakes, tornadoes, hurricanes, vandalism, sabotage and other material and equipment failures. Since hospitals, CAHs and LTC facilities are currently required to comply with the referenced LSC; we have not assigned any additional burden for this requirement.
In addition to the emergency power system inspection and testing requirements found in NFPA® 99 and NFPA® 110 and NFPA® 101, we proposed that hospitals test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the hospital anticipates it will require during an emergency. We received the following public comment(s) on this requirement:
We are finalizing our proposal to require providers and suppliers to develop and maintain a communication plan that includes the contact information for and a means for communicating with staff, federal, state,
We anticipate that most providers and suppliers maintain updated information for staff as well as state and local officials as part of their typical business operations. We also expect that as a best practice, many providers and suppliers already utilize some type of communication system or device for purposes of communicating with their staff, physicians, volunteers, and other providers and suppliers during emergency situations. We want to reiterate that in addition to cellular phones, alternate communication devices may also include but are not limited to pagers, radio transceivers, various radio devices such as the National Oceanic and Atmospheric Administration's Weather Radio All Hazards, and Portable interconnected Voice over Internet Protocol (VoIP) services.
For purposes of the RIA, we assume that, at a minimum, those providers and suppliers without existing emergency preparedness requirements are mostly likely to be presented with the need to purchase communication devices to comply with the requirements of the communication plan in this final rule. Those provider and supplier types without any existing emergency preparedness requirements are CMHCs, OPOs, PRTFs, and outpatient hospices. As stated previously, this final rule will impact 17 different provider and supplier types. When taking into consideration all 17 provider and supplier types, this rule will have a combined impact on 72,315 entities (sum of the total number of provider and supplier entities). Those providers and supplier types without emergency preparedness requirements represent 6 percent of this total (4,622 total entities without existing emergency preparedness related requirements (198 CMHCs + 58 OPOs + 377 PRTFs + 3,989 outpatient hospices)/72,315 (sum of the total number of entities impacted by this regulation)). Therefore, we anticipate that, at a minimum 6 percent of the providers and suppliers impacted by this final rule will have the potential need to purchase communication devices to comply with the requirements of the final rule.
We recognize that some of the provider and supplier types impacted by this final rule have more experience in the area of emergency preparedness than others. In particular, those provider and supplier types without existing emergency preparedness related requirements may find it useful to seek resources and guidance from outside consultants for purposes of complying with the requirements of this final rule. We note that we have not required providers and suppliers to hire outside consultants to develop their emergency preparedness programs, and we do not believe it will be necessary in most cases based on the free resources and information available to providers. Furthermore, in advance of hiring outside consultants, we encourage providers and suppliers to look to their local public health, emergency management agencies and local healthcare coalitions for assistance and guidance. Therefore, for purposes of the RIA we have not included a cost associated with the activity of hiring outside consultants, as we are unable to quantify with any degree of certainty the number of providers that may choose to use outside resources or the cost of such resources.
There are nearly 500 healthcare coalitions nationwide that providers and suppliers may seek to participate in, which currently include more than 24,000 healthcare facilities and community partners. In addition, providers and suppliers should leverage resources through their memberships with professional associations and non-government agencies, such as the Red Cross. Many non-government organizations and both national and local professional associations provide vetted emergency preparedness resources, materials and trainings. These organizations and healthcare coalitions also commonly conduct and support community-based exercises and encourage participation from other providers in their localities.
In addition, we note that there are several readily accessible, free, and expert-vetted, emergency preparedness resources that are available to providers and suppliers from government entities. First, providers and suppliers may access HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources Assistance Center Information Exchange (TRACIE) found at
Providers and suppliers may also access the Centers for Disease Control and Prevention (CDC) Web site found at
Lastly, while we recognize that some providers may choose to seek some outside consulting assistance, we note that it is important that providers and suppliers develop their own plans to ensure that they truly understand their capabilities and can readily activate and implement their emergency and communication plans in the event of an emergency. Additional resources that can support provider and supplier preparedness are below:
•
•
•
We discuss the majority of the economic impact for this requirement in the ICR section, which is estimated at $30,240.
Section 403.748(d)(2) will require RNHCIs to conduct a paper-based, tabletop exercise at least annually. RNHCIs must analyze their response and maintain documentation of all tabletop exercises, and emergency events, and revise their emergency plan as needed.
We expect that the cost associated with this requirement will be limited to the staff time needed to participate in the tabletop exercises. We estimate that approximately 4 hours of staff time will be required of the administrator and director of nursing, and 2 hours of staff time for the head of maintenance to coordinate facility evacuations and protocols for transporting residents to alternate sites. We believe that other staff members will be required to spend a minimal amount of time during these exercises and such staff time will be considered a part of regular on-going training for RNHCI staff. We estimate that it will require 10 hours of staff time for each of the 18 RNHCIs to conduct exercises at a cost of $476. Therefore, it will require an estimated total impact of $8,568 each year after the initial year for all RNHCIs to comply with § 403.748(d)(2). For the initial year, we estimate $38,808 as the total economic impact and cost estimates for all 18 RNHCIs to comply with the requirements in this final rule.
Section 416.54(d)(2) will require ASCs to participate in a full-scale exercise at least annually. ASCs also will be required to conduct one additional testing exercise of their choice at least annually. ASCs also will be required to maintain documentation of the exercise.
State, Tribal, Territorial, and local public health and medical systems comprise a critical infrastructure that is integral to providing the early recognition and response necessary for minimizing the effects of catastrophic public health and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal Government. There are currently three programs at HHS addressing education and training in the area of public health emergency preparedness and response: The Centers for Public Health Preparedness (CPHP), the Bioterrorism Training and Curriculum Development Program (BTCDP), and National Laboratory Training Network (NLTN).
As discussed earlier in this preamble, ASCs can use these and other resources, such as tools offered by the Department of Homeland Security, to assist them in complying with this proposed requirement. Thus, we believe that the cost associated with this requirement will be limited to the staff time to participate in the community-wide and facility-wide trainings, and testing exercises. We believe that appreciable staff time will be required of the administrator and a registered nurse. We believe that other staff members will be required to spend a minimal amount of time during these exercises and the training will be considered as part of regular on-going training for ASC staff. We estimate that the administrator and a registered nurse will spend about 4 hours each on an annual basis to participate in the testing exercises. Thus, we anticipate that complying with this requirement will require 8 hours for an estimated cost of $724 for each of the 5,485 ASCs and a total cost estimate of $3,971,140 for all ASCs ($724 × 5,485 ASCs) each year after the first year. We estimate total costs for ASCs of $22,366,315 ($3,971,140 impact cost + $18,395,175ICR burden) in the first year of compliance, and $3,971,140, per year in subsequent years.
Section 418.113(d)(2)(i) through (iii) will require hospices to participate in testing exercises at least annually. We believe that the administrator will be responsible for participating in community-wide disaster drills and will be the primary person to organize any testing exercises with the assistance of one member of the IDG. We believe that the registered nurse will most likely represent the IDG during the testing exercises. While we expect that all staff will be involved in the testing exercises, we will consider their involvement as part of their regular staff training. However, for the purpose of this analysis we assume that the administrator will spend approximately 4 hours annually to participate in a full-scale exercise and one additional testing exercise of the facility's choice outside of their regular and ongoing training. We also assume that the registered nurse will spend 4 hours to participate in the testing exercises. Thus, we estimate that each hospice will spend $560. The total estimate for all hospices to comply with this requirement after the initial year will total $2,464,560 ($560 × 4,401 hospices). We estimate the total economic impact and cost estimates for all 4,401 hospices to comply with the requirements in this final rule for the initial year will be $22,428,668 ($2,464,560 impact cost + $19,964,108 ICR burden).
Section 441.184(d)(2)(i) through (iii) will require PRTFs to participate in a full-scale exercise and one additional exercise of their choice annually. We estimate that the cost associated with this requirement is the time that it will take key personnel to participate in the testing exercises. Furthermore, we estimate that the testing exercises will involve the administrator and registered nurse to spend about 4 hours each on an annual basis to participate. Thus, we anticipate that complying with this requirement will require 4 hours for the administrator (at a salary of $93 an hour) and 4 hours for the registered nurse (salary $64 an hour) at a combined estimated cost of $628 per facility. The total annual cost for all 377 PRTFs will be $236,756. The total cost for the first year to comply with the requirement will be $1,471,431 ($236,756 impact cost + $1,234,675 ICR burden).
Section 460.84(d)(2)(i) through (iii) will require PACE organizations to conduct a full-scale exercise and one additional testing exercise of their choice annually. Since PACE organizations are currently required to conduct a facility-wide drill annually, we are only estimating economic impact
We proposed that hospitals must maintain medical supplies. This regulation does not require sufficient supplies for a certain time frame, but other organizations do suggest standards. The American Hospital Association (AHA) recommends that individual hospitals have a 24-hour supply of pharmaceuticals and that they develop a list of required medical and surgical equipment and supplies. TJC standards require a hospital to have a 48 to 72 hour stockpile of medication and supplies.
The Department of Homeland Security (DHS) Act of 2002 established the Strategic National Stockpile (SNS) Program to work with governmental and non-governmental partners to upgrade the nation's public health capacity to respond to a national emergency. The SNS is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications and medical supplies.
The SNS, and other federal agencies,
However, prudent emergency planning requires that some supplies be maintained in-hospital for immediate needs. The Federal Metropolitan Medical Response System (MMRS) guidelines call for MMRS communities to be self-sufficient for 48 hours. We encourage hospitals to work with stakeholders (state boards of pharmacy, pharmacy organizations, and public health organizations) for guidance and assistance in identifying medications they may need. Based on our experience with hospitals, we believe that they will have on hand a 2 to 3 day supply of medical supplies at the onset of a disaster. In the event of a prolonged emergency response, additional resources may be requested from state and federal agencies. CDC's Strategic National Stockpile (SNS), for example, has large quantities of medicine and medical supplies for a public health emergency that is severe enough to cause local supplies to run out and can deliver them to any state in the U.S. in time for them to be effective. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. (
Additional information regarding HHS' core capabilities to support public health and medical responses can be found in 2015 FEMA National Response Framework (see:
Section 482.15(d)(1) will require hospitals to develop and maintain an emergency preparedness training program and review and update it at least annually. Based on our experience with healthcare facilities, we expect that all healthcare facilities provide some type of training to all personnel, including those providing services under contract or arrangement and volunteers. Since such training is required for the TJC-accredited hospitals, the proposed requirements for developing an emergency preparedness-training program and the materials they plan to use in providing initial and on-going annual training will constitute a usual and customary business practice for TJC-accredited hospitals.
However, under this final rule, non TJC-accredited hospitals will need to review their existing training program and appropriately revise, update, or develop new sections and new material for their training program. The economic impact associated with this requirement is the staff time required for non-TJC accredited hospitals to review, update or develop a training program. We discuss the economic impact for this requirement in the ICR section.
Section 482.15(d)(2)(i) through (iii) will require hospitals to participate in or conduct a full-scale exercise and one additional testing exercise of their choice at least annually. State, tribal, territorial, and local public health and medical systems comprise a critical infrastructure that is integral in providing early recognition and response necessary for minimizing the effects of catastrophic public health and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal government. There are currently three programs at HHS addressing education and training in the area of public health emergency preparedness and response. The programs are the Centers for Public Health Preparedness (CPHP), The Bioterrorism Training and Curriculum Development Program (BTCDP), and National Laboratory Training Network (NLTN). Hospitals can use these and other resources, such as tools offered by the DHS, to assist them in complying with this requirement. Thus, for non-TJC accredited hospitals, the costs associated with this requirement will be primarily due to the staff time needed to participate in the testing exercises. We believe that appreciable staff time will be required of the risk management director, facilities director, safety director, and security manager. We expect that other staff members will be required to spend a minimal amount of time during these exercises, which will be considered a part of regular on-going training for hospital staff. We estimate that the risk management director, facilities director, safety director and security manager will spend about 12 hours each on an annual basis to meet the proposed requirement.
Thus, we have estimated the economic impact for the 1,345 non-TJC accredited hospitals. We anticipate that complying with this requirement will require 48 hours for an estimate of $4,992 for each non TJC-accredited hospital. Therefore, it will cost all non TJC-accredited hospitals an estimated total cost of $6,714,240 ($4,992 per non
Based on TJC's standards, the TJC-accredited hospitals are currently required to test their emergency operations plan twice a year. Therefore, for TJC-accredited hospitals to conduct testing exercises will constitute a usual and customary business practice and we will not include this activity in the economic impact analysis. We have estimated that the total economic impact of this final rule on hospitals will be $46,140,139 ($6,714,240 testing exercises impact cost + $39,425,899 ICR burden).
There is no additional economic impact to discuss in this section for transplant centers. All transplant centers are located within a hospital and, thus, will not have to stockpile supplies in an emergency or conduct testing exercises.
Section 483.73(b)(1) will require LTC facilities to provide subsistence needs for staff and residents, whether they evacuate or shelter in place, including, but not limited to, food, water, and medical supplies alternate sources of energy for the provision of electrical power, and maintenance of temperatures for the safe and sanitary storage of such provisions.
As stated earlier in this section, each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. The federal responsibility ceases at the delivery of the push-packs to state-designated airports. It is then the responsibility of the state to break down and transport the components of the push-pack to the affected community. It is also at the state's discretion where to deliver push-pack material in the event of multiple events.
We expect that a 1- to 2-day supply will be sufficient because various national agencies with stockpiles of medicine, medical supplies, food and water can be mobilized within 12 hours and supplies can be replenished or provided within 48 hours. Thus, for the sake of this impact analysis, we assume that, at a minimum, a LTC facility will have a 2-day supply of food and potable water for the patients and staff at the onset of a disaster and will not assign a cost to this requirement.
We encourage LTC facilities to work with stakeholders (State Boards of Pharmacy, pharmacy organizations, and public health organizations) for guidance and assistance in identifying medications that may be needed and plan to provide access to all healthcare partners during an event.
Section 483.73(d)(2)(i) through (iii) will require LTC facilities to participate in or conduct a full-scale exercise and one additional testing exercise of their choice at least annually. The current requirements for LTC facilities already mandate that these facilities periodically review their procedures with existing staff, and carry out unannounced staff drills (§ 483.75(m)(2)). Thus, we expect that complying with the requirement for annual testing of their emergency plan will constitute a minimal economic impact, if any.
Therefore, the cost of this final rule for all LTC Facilities will be limited to the ICR burden of $68,808,717 as discussed in the COI section.
Section 483.475(d)(2)(i) through (iii) will require ICFs/IID to participate in or conduct a full scale exercise and one additional testing exercise of their choice at least annually. The current ICF/IID CoPs require them to conduct evacuation drills at least quarterly for each shift and under varied conditions to evaluate the effectiveness of emergency and disaster plans and procedures (§ 483.470(i) and (i)(iii)). In addition, ICFs/IID must evacuate clients during at least one drill each year on each shift, file a report and evaluation on each evacuation drill and investigate all problems with evacuation drills, including accidents, and take corrective action (§ 483.470(i)(2)). Since all 6,237 ICFs/IID already conduct quarterly drills, we estimate a small additional burden to cover the added complexities of the rule. Specifically, the rule would require the administrator and the registered nurse each to spend an additional hour to participate in testing programs for their facility. Thus, we estimate that the additional cost for each ICF/IID to comply with this requirement would be $157 for each facility. The total estimate for all facilities to comply with this requirement is $979,209 ($157 × 6,237 facilities = $979,209). We estimate the total cost will be $22,303,512 ($21,324,303 ICR burden + $979,209 impact cost).
We discuss the majority of the economic impact for this requirement in the COI section which is estimated to be $72,678,600.
Section 484.22(d)(2)(i) through (iii) will require HHAs to participate in a full-scale exercise and one additional testing exercise of their choice at least annually. We also require the HHA to maintain documentation of the testing exercises.
There are currently three programs at HHS addressing education and training in the area of public health emergency preparedness and response: The Centers for Public Health Preparedness (CPHP), the Bioterrorism Training and Curriculum Development Program (BTCDP), and National Laboratory Training Network (NLTN). HHAs can use these and other resources, such as tools offered by the Department of Homeland Security, to assist them in complying with this requirement. HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR) and HHS's Centers for Disease Control and Prevention (CDC) also provides numerous tools and resources on their Web site (see
Section 485.68(d)(2)(i) through (iii) will require CORFs to participate in or conduct a full-scale exercise and one additional exercise of their choice at least annually and document the testing exercises. To comply with this requirement, a CORF will need to develop a specific scenario for each exercise.
The current CoPs require CORFs to provide ongoing drills for all personnel associated with the facility in all aspects of disaster preparedness (§ 485.64(b)(1)). Thus, for the purpose of this analysis, we believe that CORFs will incur minimal or no additional cost to comply with this requirement. Thus, we estimate the cost for all 205 CORFs to comply with this requirement will be limited to the ICR burden of $931,520 discussed in the COI section.
Section 485.625(d)(2)(i) through (iii) will require CAHs to conduct two annual testing exercises. Accredited CAHs are currently required to conduct such drills and exercises (See COI section for detailed discussion regarding our review of accrediting organizations). Although we believe that non-accredited CAHs are currently participating in such drills and exercises, we are not convinced that it is at the level that will be required under this final rule. Thus, we will analyze the economic impact for these requirements for the 892 non-accredited CAHs. As discussed earlier in the preamble, CAHs will have access to various training resources and emergency preparedness initiatives to use in complying with this requirement. Thus, we believe that the cost associated with this requirement will be limited to staff time to participate in the community-wide and facility-wide trainings, and testing exercises. We believe that appreciable staff time will be required of the administrator, facilities director, director of nursing and nursing education coordinator. We believe that other staff members will be required to spend a minimal amount of time during these exercises that will be considered as part of regular on-going training for hospital staff. We estimate that the administrator (for 7 hours), facilities director (for 6 hours), and the director of nursing (for 7 hours) will spend approximately a total of 20 hours on an annual basis to participate in the testing exercises. Thus, we anticipate that complying with this requirement will require 20 hours for an estimated cost of $1,856 for each of the 892 non-accredited CAHs. Therefore, for all non-accredited CAHs to comply with this requirement, it will require 17,800 total economic impact hours (20 economic impact hours per non-accredited CAH × 892 non-accredited CAH) at an estimated total cost of $1,655,552 ($1,856 × 892). Therefore, the total economic impact of this rule on CAHs will be $10,830,910 ($1,655,552 testing exercises impact cost + $9,175,358 ICR burden).
Current CoPs require these organizations to ensure that employees are trained in all aspects of preparedness for any disaster. They are also required to have ongoing drills and exercises to test their disaster plan. Rehabilitation Agencies will need to review their current activities and make minor adjustment to ensure that they comply with the new requirement. Therefore, we expect that the economic impact to comply with this requirement will be minimal, if any. Therefore, the total economic impact of this rule on these organizations will be limited to the estimated ICR burden of $9,586,150.
Section 485.920(d)(2) will require CMHCs to participate in or conduct a full-scale exercise and one additional testing exercise of their choice at least annually. We estimate that to comply with the requirement to participate in these testing exercises annually will primarily require the involvement of the administrator and a registered nurse. We estimate that the administrator will spend approximately 5 hours to participate in these testing exercises. We also estimate that a nurse will spend about 3 hours on an annual basis to participate in the testing exercises. Thus, we anticipate that complying with this requirement will require 8 hours for each CMHC at an estimated cost of $683 for each facility. The economic impact for all 198 CMHCs will be 135,234 ($683 × 198 CMHCs). Therefore, the total economic impact of this final rule on CMHCs will be $1,094,940 ($135,234 impact cost + $959,706 ICR burden).
The OPO CfCs do not currently contain a requirement for OPOs to conduct testing exercises. We estimate that these tasks will require the quality assessment and performance improvement (QAPI) director and the education coordinator to each spend 1 hour to participate in the testing exercises. Thus, the total annual economic impact hours for each OPO will be 2 hours. The total cost will be $188 for a (QAPI coordinator hourly salary and the Education Coordinator to participate). The economic impact for all OPOs will be 188 (2 impact hours × 58 OPOs) total economic impact hours at an estimated cost of $10,904 (188 × 58 OPOs). Therefore, the total economic impact of this rule on OPOs will be $1,126,186 ($10,904 impact cost + $1,115,282 ICR burden).
We expect RHCs and FQHCs to participate in their local and state emergency plans and training drills to identify local and regional disaster centers that could provide shelter during an emergency.
We proposed that an RHC/FQHC must review and update its emergency preparedness policies and procedures at least annually. For purposes of determining the economic impact for this requirement, we expect that RHCs/FQHCs will review their emergency preparedness policies and procedures annually. Based on our experience with Medicare providers and suppliers, healthcare facilities have a compliance officer or other staff member who reviews the facility's program periodically to ensure that it complies with all relevant federal, state, and local laws, regulations, and ordinances. We believe that complying with the requirement for an annual review of the emergency preparedness policies and
Section 491.12(d)(2)(i) through (iii) will require RHCs/FQHCs to participate in a full-scale exercise and one additional testing exercise of their choice at least annually. We have stated previously that FQHCs are currently required to conduct annual drills. We believe that for FQHCs to comply with these requirements will constitute a minimal economic impact, if any. Thus, we are estimating the economic impact for RHCs to comply with these requirements to conduct testing exercises. We estimate that a RHCs administrator will spend 4 hours annually to participate in the exercises. Also, we estimate that a nurse coordinator (registered nurse) will each spend 4 hours on an annual basis to participate in the testing exercises. Thus, we anticipate that complying with this requirement will require 8 hours for each RHC for an estimated cost of $672 per facility. The total annual cost for 4,200 RHCs will be $4,905,600. Therefore, the total economic impact of this rule on RHCs/FQHCs will be $57,372,600 ($4,905,600 impact cost + $52,467,000 ICR burden).
Section 494.62(d)(2) will require dialysis facilities to participate in or conduct a full-scale exercise and one additional testing exercise of their choice at least annually. The current CfCs already require dialysis facilities to evaluate their emergency preparedness plan at least annually (§ 494.60(d)(4)(ii)). Thus, we expect that all dialysis facilities are already conducting some type of tests to evaluate their emergency plans. Although the current CfCs do not specify the type of drill or test, we believe that dialysis facilities are currently participating in community or facility-wide drills. Therefore, for the purpose of this impact analysis, we estimate that dialysis facilities will need to add the additional testing exercise of their choice to their emergency preparedness activities. We estimate that it will require 1 hour each for the administrator (hourly wage of $106.00) and the nurse manager (hourly wage of $94.00) to conduct the additional exercise. We estimate the total cost to be $200 for each facility, with a total economic impact of $1,329,600 ($200 × 6,648 facilities). Therefore, the total economic impact of this rule on ESRD facilities will be $32,960,784 ($1,329,600 impact cost + $31,631,184 ICR burden).
The following is a summary of the total providers and the annual cost estimates for all providers to comply with the requirements in this rule.
Based upon the ICR and RIA analyses, it will require 62,968 providers and suppliers covered by this emergency preparedness final rule to comply with all of its requirements with an estimated total first-year cost of $373 million. After the initial cost of $373 million associated with conducting a risk assessment and developing an EP plan, the annual cost for the total providers and suppliers to test their plans and train staff will be $25 million.
The previous summaries include only the upfront and routine costs associated with emergency risk assessment, development and updating of policies and procedures, development and maintenance of communication plans, disaster training and testing, and generator testing (as specified). If these preparations are effective, they will lead to increased amounts of life-saving and morbidity-reducing activities during emergency events. These activities impose cost on society; for example, if complying with this final rule's requirements allows an ESRD facility to remain open during and immediately after a natural disaster, there will be associated increases in provision of dialysis services, thus entailing labor, material and other costs. As discussed in the next section (“Benefits of the Final Rule”), it is difficult to predict how disaster responses will be different in the presence of this final rule than in its absence, so we have been unable to quantify the portion of costs that will be incurred during emergencies.
The Presidential Policy Directive/PPD-8 is aimed at strengthening the security and resilience of the United States through systematic preparation for the threats that pose the greatest risk to the security of the nation, including acts of terrorism, cyber-attacks, pandemics, and catastrophic natural disasters. (
This final rule serves to help ensure continuity of care and service delivery for those that depend on the healthcare system both daily and in the event of a disaster by requiring providers and suppliers to adequately plan for and respond to both natural and man-made disasters. The devastation of the Gulf Coast by Hurricane Katrina is one of the most horrific disasters in our nation's history. In those chaotic early days following the disaster in the greater New Orleans area, hundreds of thousands of people were adversely impacted, and healthcare services were not available for many who needed them. Rudowitz, Robin, Diane Rowland, and Adele Shartzer. “Health care in New Orleans before and after Hurricane Katrina.” Health Affairs 25.5(2006): w393-w406. . There is no reason to believe that future disasters might not be as large or larger. In the event of such disasters, vulnerable populations are at greatest risk for negative consequences from healthcare disruptions. Individuals requiring mental health treatments are another at-risk population that can be adversely impacted by healthcare disruptions following an emergency or disaster. A 2008 study concluded that many Hurricane Katrina survivors with mental disorders experienced unmet treatment needs, including frequent disruptions of existing care and widespread failure to initiate treatment for new-onset disorders (Wang, P.S., et al. “Disruption of Existing Mental Health Treatments and Failure to Initiate New Treatment After Hurricane Katrina. American Journal of Psychiatry, 165(1), 34-41)” (2006).
Hospital closures during Sandy resulted in up to a 25 percent increase in emergency department visits at numerous centers in New York and a 70 percent increase in ambulance traffic. Not only do vulnerable populations experience disruptions in care, they may also incur increased costs for care, especially when those who require ongoing medical treatment during disasters are required to visit emergency departments for treatment and or hospitalization. (Absorbing citywide patient surge during Hurricane Sandy: a case study in accommodating multiple hospital evacuations.) (Ann Emerg Med. 2014 Jul ;64(1):66-73.e1. doi: 10.1016/j.annemergmed.2013.12.010. Epub 2014 Jan 10.); (Howard D, Zhang R, Huang Y, Kutner N. Hospitalization rates among dialysis patients during Hurricane Katrina. Prehosp Disaster Med. 2012;27(4):1-5.).)
Emergency department visits incur a copay for most beneficiaries. Similar costs are also incurred by patients for hospitalizations. The literature shows that natural catastrophes disproportionately affect ill and socioeconomically disadvantaged populations that are most at risk (Abdel-Kader K, Unrah ML. Disaster and end-stage renal disease: targeting vulnerable patients for improved outcomes. Kidney Int. 2009;75:1131-1133; Zoraster R,
We know that advance planning improves disaster response. In 2007,
Therefore, we believe that it is essential to require providers and suppliers to conduct a risk assessment, to develop an emergency preparedness plan based on the assessment, and to comply with the other requirements we propose to minimize the disruption of services for the community and ensure continuity of care in the event of a disaster. As noted previously, we have varied our requirements by provider type and understand that the degree of vulnerability of patients in a disaster will vary according to provider type. For example, patients with scheduled outpatient appointments such as someone coming in for speech therapy or routine clinic services is likely more self-reliant in a disaster than someone in a hospital ICU or someone who is homebound and receiving services from an HHA.
Overall, we believe that this final rule will reduce the risk of mortality and morbidity associated with disasters. While New Orleans has a unique location, below sea level, everywhere in the United States is vulnerable to weather emergencies and other potential natural or manmade disasters. A recent report, “In the path of the Storm” (
The White House, in July 2014, also released a report titled “The Health Impacts of Climate Change on Americans” (
According to the CDC, changing climate is linked to increases in a wide range of non-communicable and infectious diseases. There are complex ways in which climatic factors (like temperature, humidity, precipitation, extreme weather events, and sea-level rise) can directly or indirectly affect the prevalence of disease. Identification of communities and places vulnerable to these changes can help healthcare providers prepare to work with health departments as they assess such health vulnerabilities associated with climate change and prevent associated adverse health impacts. CDC has developed the Building Resilience Against Climate Effects (BRACE) framework to help health departments prepare for and respond to climate change. Additional information can be found at:
While we are unable to quantify the number of lives that could be saved by emergency planning and execution, Table 131 provides the number of Medicare FFS beneficiaries receiving services from some of the provider types affected by this final rule during the month of May 2016. We are unable to provide volume data for those patients in Medicare Advantage plans or the Medicaid population. However, one could assume the May 2016 summary is representative of an average month during the year. In the event of a disaster, a portion of the fee-for-service patients represented in Table 131 could be at risk; therefore, we could assume that they could benefit from the additional emergency preparedness measures in this final rule.
Benefits from effective disaster planning will not only accrue to individuals requiring healthcare services. Healthcare facilities themselves may benefit from improved ability to maintain or resume delivering services. After Hurricane Katrina, 94 dialysis facilities closed for at least 1 week. More than a month after super storm Sandy devastated flood-prone communities in New Jersey and New York, five hospitals were unable to admit patients because of damage that destroyed electrical systems, flooded emergency and exam rooms and crippled elevators. Following Hurricane Sandy, $180 million of the $810 million damages reported by the New York City Health and Hospitals Corporation was due to lost revenue. Lost revenue from Long Beach Medical Center hospital and nursing home was estimated at $1.85 million a week after closing due to damage from Hurricane Sandy.
Finally, taxpayers and insurance companies may benefit from effective emergency preparedness. After Hurricane Ike, it was estimated that the cost to Medicare for ESRD patients presenting to the ED for dialysis instead of their usual facility was, on average, $6,997 per visit. Those ESRD patients who did not require dialysis were billed $482 on average (McGinley et al, 2012). The usual cost for these patients as reimbursed through Medicare is in the order of $250 to 300 per visit. Many of these costs or lost revenues may be mitigated by effective emergency preparedness planning. For a non-ESRD individual who cannot receive care from his or her office-based physician but must instead go to an emergency room, not only are the individual's costs increased, but reimbursement through Medicare, Medicaid or private insurance is also increased. AHRQ's Medical Expenditure Panel Survey from 2008 notes that the average expense for an office based visit was $199 versus $922 for an emergency room visit (Machlin, S., and Chowdhury, S. “Expenses and Characteristics of Physician Visits in Different Ambulatory Care Settings, 2008.” Statistical Brief #318. March 2011. Agency for Healthcare Research and Quality, Rockville, MD.
With the annualized costs of the rule's emergency preparedness requirements estimated to be approximately $100 million depending on the discount rate used (see the accounting statement table that follows) and the rule generating additional, unquantified costs associated with the life-saving activities that become implementable as a result of the preparedness requirements, this final rule will have to result in at least $100 million in average yearly benefits, principally derived from reductions in morbidity and mortality, for the benefits to equal or exceed costs. ASPR and CMS, using Medicare claims data, conducted an analysis of the impact of Hurricane Sandy on dialysis-dependent ESRD patients. The study found a significant increase in emergency department visits, hospitalizations, and 30-day mortality for ESRD patients living in the areas most affected by the storm (Kelman, et al.). Approximately 23 percent of the study patients who had an emergency visit also received dialysis in the ED during their visits (Kelman, et al.). (Kelman, Jeffrey, et al. “Dialysis care and death following Hurricane Sandy.” American Journal of Kidney Diseases 65.1 (2015): 109-115.) Adoption of the following requirements in this final rule will better enable individual facilities to—
• Anticipate threats;
• Rapidly activate plans, processes and protocols;
• Quickly communicate with their patients, other facilities and state or local officials to ensure continuity of care for these life maintaining services; and
• Reduce healthcare system stress by remaining open or re-opening quickly following closure. This will decrease the rate of interrupted dialysis, thereby reducing preventable ED visits, hospitalizations, and mortality during and following disasters.
As previously discussed, the status quo is not a desirable alternative because the current regulatory requirements for Medicare and Medicaid providers and suppliers addressing emergency and disaster preparedness are insufficient to protect beneficiaries and other patients during a disaster.
Another alternative we considered was to propose a regulation that would require Medicare providers and suppliers to comply with local, state and federal laws regarding emergency and disaster planning. Various federal, state and local entities (FEMA, the National Response Plan (NRP), CDC, the Assistant Secretary for Preparedness and Response (ASPR), et al) have disaster management plans that provide an integrated process that involves all local and regional emergency responders. We also considered allowing healthcare providers to voluntarily implement a comprehensive emergency preparedness program utilizing grant funding from the Office of the Assistant Secretary for Preparedness and Response, (ASPR). Based on a 2010 survey of the American College of Healthcare Executives (ACHE), less than 1 percent of hospital CEOs identified “disaster preparedness” as a top priority. Also, a 2012 survey of 1,202 community hospital CEOs (found at:
We currently have regulations for Medicare and Medicaid providers and suppliers to protect the health and safety of Medicare beneficiaries and others. We revise these regulations on an as-needed basis to address changes in clinical practice, patient needs, and public health issues. The responses to the various past disasters demonstrated that our current regulations are in need of improvement in order to protect patients, residents, and clients during an emergency and that emergency preparedness for healthcare providers and suppliers is an urgent public health issue. Therefore, we are finalizing emergency preparedness requirements that are consistent and enforceable for all Medicare and Medicaid providers and suppliers. This final rule addresses the three key elements needed to ensure that healthcare is available during emergencies: Safeguarding human resources, ensuring business continuity, and protecting physical resources. Current regulations for Medicare and Medicaid providers and suppliers do not adequately address these key elements.
Surveyors will be trained and interpretive guidelines will be developed. If these requirements are finalized, we will update the interpretive guidance, update the survey process, and make IT systems changes. In order to implement these new standards, we anticipate initial federal start-up costs to be $700,000. Once implemented, surveys will begin in FY17 and we anticipate initial costs for these surveys to carry into FY18 due to the survey cycle. Therefore, we anticipate approximately $4,411,286 for FY18 with a decrease in subsequent years to an estimated $3,749,593 annually in federal costs.
As required by OMB Circular A-4 (available at
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.
As previously discussed, we will remove the burden and cost for hospitals, CAHs and LTC facilities to conduct an additional testing of their generators. We have also provided flexibility under the training and testing requirements and we have increased the salary cost for the staff that will participate in complying with this rule.
We ordinarily publish a notice of proposed rulemaking in the
In various sections of the December 2013 proposed rule (78 FR 79101), we referenced the latest version of the Life Safety Code (NFPA® 101), the Health Care Facilities Code (NFPA® 99) and the Standard for Standby Power Generators (NFPA® 110). In the May 4, 2016
Grant programs-health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
Aged, Family planning, Grant programs-health, Infants and children, Medicaid, Penalties, Reporting and recordkeeping requirements.
Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Hospitals, Medicaid, Incorporation by reference, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Health facilities, Health professions, Health records, Incorporation by Reference, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Health facilities, Incorporation by Reference, Medicaid, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.
Grant programs-health, Health facilities, Medicaid, Medicare, Reporting and recordkeeping requirements, Rural areas.
Health facilities, Incorporation by reference, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare and Medicaid Services amends 42 CFR chapter IV as set forth below:
42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The Religious Nonmedical Health Care Institution (RNHCI) must comply with all applicable Federal, State, and local emergency preparedness requirements. The RNHCI must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, persons at-risk; the type of services the RNHCI has the ability to provide in an emergency; and, continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the RNHCI's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, and supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered patients in the RNHCI's care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the RNCHI must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the RNHCI, which includes the following:
(i) Consideration of care needs of evacuees.
(ii) Staff responsibilities.
(iii) Transportation.
(iv) Identification of evacuation location(s).
(v) Primary and alternate means of communication with external sources of assistance.
(4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(5) A system of care documentation that does the following:
(i) Preserves patient information.
(ii) Protects confidentiality of patient information.
(iii) Secures and maintains the availability of records.
(6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency.
(7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of nonmedical services to RNHCI patients.
(8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Next of kin, guardian or custodian.
(iv) Other RNHCIs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) RNHCI's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the RNHCI's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The Ambulatory Surgical Center (ASC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The ASC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the ASC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency
(b)
(1) A system to track the location of on-duty staff and sheltered patients in the ASC's care during an emergency. If on-duty staff or sheltered patients are relocated during the emergency, the ASC must document the specific name and location of the receiving facility or other location.
(2) Safe evacuation from the ASC, which includes the following:
(i) Consideration of care and treatment needs of evacuees.
(ii) Staff responsibilities.
(iii) Transportation.
(iv) Identification of evacuation location(s).
(v) Primary and alternate means of communication with external sources of assistance.
(3) A means to shelter in place for patients, staff, and volunteers who remain in the ASC.
(4) A system of medical documentation that does the following:
(i) Preserves patient information.
(ii) Protects confidentiality of patient information.
(iii) Secures and maintains the availability of records.
(5) The use of volunteers in an emergency and other staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(6) The role of the ASC under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) ASC's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the ASC's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, individual, facility-based. If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in an community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ASC's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the ASC's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The hospice must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospice must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.
(3) Address patient population, including, but not limited to, the type of services the hospice has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the hospice's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) Procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The hospice must inform State and local officials of any on-duty staff or patients that they are unable to contact.
(2) Procedures to inform State and local officials about hospice patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.
(3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(5) The development of arrangements with other hospices and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to hospice patients.
(6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following:
(i) A means to shelter in place for patients, hospice employees who remain in the hospice.
(ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance.
(iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
(A) Food, water, medical, and pharmaceutical supplies.
(B) Alternate sources of energy to maintain the following:
(
(
(
(C) Sewage and waste disposal.
(iv) The role of the hospice under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(v) A system to track the location of hospice employees' on-duty and sheltered patients in the hospice's care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location.
(c)
(1) Names and contact information for the following:
(i) Hospice employees.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other hospices.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) Hospice's employees.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the hospice's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles.
(ii) Demonstrate staff knowledge of emergency procedures.
(iii) Provide emergency preparedness training at least annually.
(iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others.
(v) Maintain documentation of all emergency preparedness training.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospice's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs. 1102, 1902, and 1928 of the Social Security Act (42 U.S.C. 1302).
The Psychiatric Residential Treatment Facility (PRTF) must comply with all applicable Federal, State, and local emergency preparedness requirements. The PRTF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address resident population, including, but not limited to, persons at-risk; the type of services the PRTF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the PRTF's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered residents in the PRTF's care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the PRTF must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the PRTF, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s);
(4) A means to shelter in place for residents, staff, and volunteers who remain in the facility.
(5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(7) The development of arrangements with other PRTFs and other providers to receive residents in the event of limitations or cessation of operations to maintain the continuity of services to PRTF residents.
(8) The role of the PRTF under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Residents' physicians.
(iv) Other PRTFs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the PRTF's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for residents under the PRTF's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release resident information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of residents under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the PRTF's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) After initial training, provide emergency preparedness training at least annually.
(iii) Demonstrate staff knowledge of emergency procedures.
(iv) Maintain documentation of all emergency preparedness training.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the PRTF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PRTF is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PRTF's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PRTF's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs: 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).
The Program for the All-Inclusive Care for the Elderly (PACE) organization must comply with all applicable Federal, State, and local emergency preparedness requirements. The PACE organization must establish and maintain an emergency preparedness
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address participant population, including, but not limited to, the type of services the PACE organization has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the PACE's efforts to contact such officials and, when applicable, of its participation in organization's collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and participants, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, and medical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect participant health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered participants under the PACE center(s) care during and after an emergency. If on-duty staff and sheltered participants are relocated during the emergency, the PACE must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the PACE center, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(4) The procedures to inform State and local emergency preparedness officials about PACE participants in need of evacuation from their residences at any time due to an emergency situation based on the participant's medical and psychiatric conditions and home environment.
(5) A means to shelter in place for participants, staff, and volunteers who remain in the facility.
(6) A system of medical documentation that preserves participant information, protects confidentiality of participant information, and secures and maintains the availability of records.
(7) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(8) The development of arrangements with other PACE organizations, PACE centers, or other providers to receive participants in the event of limitations or cessation of operations to maintain the continuity of services to PACE participants.
(9) The role of the PACE organization under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(10)(i) Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs.
(ii) Staff who know how to use the equipment must be on the premises of every center at all times and be immediately available.
(iii) A documented plan to obtain emergency medical assistance from outside sources when needed.
(c)
(1) Names and contact information for staff; entities providing services under arrangement; participants' physicians; other PACE organizations; and volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) PACE organization's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for participants under the organization's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release participant information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of participants under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the PACE organization's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Demonstrate staff knowledge of emergency procedures, including
(iv) Maintain documentation of all training.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, participant populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs. 1102, 1871, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, persons at-risk; the type of services the hospital has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the hospital's efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered patients in the hospital's care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the hospital must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(5) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(6) The use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(7) The development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to
(8) The role of the hospital under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other hospitals and CAHs
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) Hospital's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the hospital's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the hospital's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the hospital experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospital's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed.
(e)
(1)
(2)
(3)
(f)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
(g)
(1) A representative from each transplant center must be included in the development and maintenance of the hospital's emergency preparedness program; and
(2) The hospital must develop and maintain mutually agreed upon protocols that address the duties and responsibilities of the hospital, each
(h) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
A transplant center located within a hospital that has a Medicare provider agreement must meet the conditions of participation specified in §§ 482.72 through 482.104 in order to be granted approval from CMS to provide transplant services.
(a) Unless specified otherwise, the conditions of participation at §§ 482.72 through 482.104 apply to heart, heart-lung, intestine, kidney, liver, lung, and pancreas centers.
(b) In addition to meeting the conditions of participation specified in §§ 482.72 through 482.104, a transplant center must also meet the conditions of participation in §§ 482.1 through 482.57, except for § 482.15.
A transplant center must be included in the emergency preparedness planning and the emergency preparedness program as set forth in § 482.15 for the hospital in which it is located. However, a transplant center is not individually responsible for the emergency preparedness requirements set forth in § 482.15.
(a)
(b)
Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
The LTC facility must comply with all applicable Federal, State and local emergency preparedness requirements. The LTC facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the LTC facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain—
(A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions;
(B) Emergency lighting;
(C) Fire detection, extinguishing, and alarm systems; and
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered residents in the LTC facility's care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the LTC facility must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the LTC facility, which includes consideration of
(4) A means to shelter in place for residents, staff, and volunteers who remain in the LTC facility.
(5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(7) The development of arrangements with other LTC facilities and other providers to receive residents in the event of limitations or cessation of operations to maintain the continuity of services to LTC residents.
(8) The role of the LTC facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Residents' physicians.
(iv) Other LTC facilities.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency preparedness staff.
(ii) The State Licensing and Certification Agency.
(iii) The Office of the State Long-Term Care Ombudsman.
(iv) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) LTC facility's staff.
(ii) Federal, State, tribal, regional, or local emergency management agencies.
(4) A method for sharing information and medical documentation for residents under the LTC facility's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release resident information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of residents under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the LTC facility's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(8) A method for sharing information from the emergency plan that the facility has determined is appropriate with residents and their families or representatives.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the LTC facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the LTC facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the LTC facility's emergency plan, as needed.
(e)
(1)
(2)
(3)
(f)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include—
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
(g) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Health Care Facilities Code 2012 edition, issued August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
The Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) must comply with all applicable Federal, State, and local emergency preparedness requirements. The ICF/IID must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address the special needs of its client population, including, but not limited to, persons at-risk; the type of services the ICF/IID has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the ICF/IID efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and clients, whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, medical, and pharmaceutical supplies.
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect client health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered clients in the ICF/IID's care during and after an emergency. If on-duty staff and sheltered clients are relocated during the emergency, the ICF/IID must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the ICF/IID, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(4) A means to shelter in place for clients, staff, and volunteers who remain in the facility.
(5) A system of medical documentation that preserves client information, protects confidentiality of client information, and secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(7) The development of arrangements with other ICF/IIDs or other providers to receive clients in the event of limitations or cessation of operations to maintain the continuity of services to ICF/IID clients.
(8) The role of the ICF/IID under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Clients' physicians.
(iv) Other ICF/IIDs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(iii) The State Licensing and Certification Agency.
(iv) The State Protection and Advocacy Agency.
(3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for clients under the ICF/IID's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release client information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of clients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the ICF/IID's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(8) A method for sharing information from the emergency plan that the facility has determined is appropriate with clients and their families or representatives.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
The Home Health Agency (HHA) must comply with all applicable Federal, State, and local emergency preparedness requirements. The HHA must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the HHA's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at § 484.55.
(2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.
(3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact.
(4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the HHA's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(6) A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(ii) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
The Comprehensive Outpatient Rehabilitation Facility (CORF) must comply with all applicable Federal, State, and local emergency preparedness requirements. The CORF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the CORF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the CORF's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts;
(5) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
(b)
(1) Safe evacuation from the CORF, which includes staff responsibilities, and needs of the patients.
(2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(4) The use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other CORFs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the CORF's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the CORF's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the CORF's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d)
(1)
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the CORF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CORF is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CORF's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CORF's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness plan must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, persons at-risk; the type of services the CAH has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the CAH's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to—
(i) Food, water, medical, and pharmaceutical supplies;
(ii) Alternate sources of energy to maintain:
(A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions;
(B) Emergency lighting;
(C) Fire detection, extinguishing, and alarm systems; and
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered patients in the CAH's care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the CAH must document the specific name and location of the receiving facility or other location.
(3) Safe evacuation from the CAH, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(5) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(7) The development of arrangements with other CAHs or other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to CAH patients.
(8) The role of the CAH under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other CAHs and hospitals.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) CAH's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the CAH's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the CAH's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based exercise. If the CAH experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CAH is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CAH's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CAH's emergency plan, as needed.
(e)
(1)
(2)
(3)
(f)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include—
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
(g) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.
(ii) Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(xiii) NFPA 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 2009.
(2) [Reserved]
The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”) must comply with all applicable Federal, State, and local
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the Organizations have the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Address the location and use of alarm systems and signals; and methods of containing fire.
(5) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(6) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
(b)
(1) Safe evacuation from the Organizations, which includes staff responsibilities, and needs of the patients.
(2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(4) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other Organizations.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, state, tribal, regional and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) Organizations' staff.
(ii) Federal, state, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the Organizations' care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the Organizations' needs, and their ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the Organizations experience an actual natural or man-made emergency that requires activation of the emergency plan, the organization is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the Organization's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
The Community Mental Health Center (CMHC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The CMHC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address client population, including, but not limited to, the type of services the CMHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the CMHC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) A system to track the location of on-duty staff and sheltered clients in the CMHC's care during and after an emergency. If on-duty staff and sheltered clients are relocated during the emergency, the CMHC must document the specific name and location of the receiving facility or other location.
(2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
(3) A means to shelter in place for clients, staff, and volunteers who remain in the facility.
(4) A system of medical documentation that preserves client information, protects confidentiality of client information, and secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state or Federally designated health care professionals to address surge needs during an emergency.
(6) The development of arrangements with other CMHCs or other providers to receive clients in the event of limitations or cessation of operations to maintain the continuity of services to CMHC clients.
(7) The role of the CMHC under a waiver declared by the Secretary of Health and Human Services, in accordance with section 1135 of the Social Security Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Clients' physicians.
(iv) Other CMHCs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) CMHC's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for clients under the CMHC's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release client information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of clients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the CMHC's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d)
(1)
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the CMHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CMHC is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator,
(iii) Analyze the CMHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CMHC's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C 273).
The Organ Procurement Organization (OPO) must comply with all applicable Federal, State, and local emergency preparedness requirements. The OPO must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the OPO's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) A system to track the location of on-duty staff during and after an emergency. If on-duty staff is relocated during the emergency, the OPO must document the specific name and location of the receiving facility or other location.
(2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Volunteers.
(iv) Other OPOs.
(v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA).
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) OPO's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the OPO's response to and maintain documentation of all
(e)
(1) The OPO must develop and maintain in the protocols with transplant programs required under § 486.344(d), mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the OPO during an emergency.
(2) The OPO must have the capability to continue its operation from an alternate location during an emergency. The OPO could either have:
(i) An agreement with one or more other OPOs to provide essential organ procurement services to all or a portion of its DSA in the event the OPO cannot provide those services during an emergency;
(ii) If the OPO has more than one location, an alternate location from which the OPO could conduct its operation; or
(iii) A plan to relocate to another location as part of its emergency plan as required by paragraph (a) of this section.
(f)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
The Rural Health Clinic/Federally Qualified Health Center (RHC/FQHC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The RHC/FQHC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the RHC/FQHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the RHC/FQHC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients.
(2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(4) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other RHCs/FQHCs.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) RHC/FQHC's staff.
(ii) Federal, State, tribal, regional, and local emergency management agencies.
(4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(5) A means of providing information about the RHC/FQHC's needs, and its
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles,
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the RHC/FQHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC/FQHC is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the RHC/FQHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC/FQHC's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan, and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. l302 and l395hh).
The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the dialysis facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the dialysis facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency.
(b)
(1) A system to track the location of on-duty staff and sheltered patients in the dialysis facility's care during and after an emergency. If on-duty staff and
(2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients.
(3) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
(4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(6) The development of arrangements with other dialysis facilities or other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to dialysis facility patients.
(7) The role of the dialysis facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
(8) How emergency medical system assistance can be obtained when needed.
(9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Other dialysis facilities.
(v) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional or local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the following:
(i) Dialysis facility's staff.
(ii) Federal, State, tribal, regional, or local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the dialysis facility's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(7) A means of providing information about the dialysis facility's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d)
(1)
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually. Staff training must:
(iii) Demonstrate staff knowledge of emergency procedures, including informing patients of—
(A) What to do;
(B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an emergency occurs.
(iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and
(v) Properly train its nursing staff in the use of emergency equipment and emergency drugs.
(vi) Maintain documentation of the training.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the dialysis facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ESRD is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event.
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the dialysis facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the dialysis facility's emergency plan, as needed.
(3)
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
This document was received by the Office of the Federal Register for publication on September 1, 2016.
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |