Federal Register Vol. 81, No.86,
Federal Register Volume 81, Issue 86 (May 4, 2016)
Federal Register Volume 81, Issue 86 (May 4, 2016)
| Page Range | 26667-26996 | |
| FR Document |
Document Created: 2015-12-31 23:05:30
Document Modified: 2015-12-31 23:05:30
| Page and Subject | |
|---|---|
| 81 FR 26993 - Promoting Rehabilitation and Reintegration of Formerly Incarcerated Individuals | |
| 81 FR 26991 - Public Service Recognition Week, 2016 | |
| 81 FR 26989 - National Teacher Appreciation Day and National Teacher Appreciation Week, 2016 | |
| 81 FR 26987 - National Small Business Week, 2016 | |
| 81 FR 26985 - National Charter Schools Week, 2016 | |
| 81 FR 26983 - Older Americans Month, 2016 | |
| 81 FR 26981 - National Building Safety Month, 2016 | |
| 81 FR 26977 - Asian American and Pacific Islander Heritage Month, 2016 | |
| 81 FR 26774 - Meeting of the United States Manufacturing Council | |
| 81 FR 26864 - Culturally Significant Objects Imported for Exhibition Determinations: “Splendor, Myth and Vision: Nudes From the Prado” Exhibition | |
| 81 FR 26832 - Government in the Sunshine Act Meeting Notice | |
| 81 FR 26668 - Enterprise Housing Goals and Mission | |
| 81 FR 26769 - Endangered and Threatened Wildlife and Plants; Revisions to the Regulations for Candidate Conservation Agreements With Assurances | |
| 81 FR 26817 - Candidate Conservation Agreements With Assurances Policy | |
| 81 FR 26835 - National Science Board Sunshine Act Meetings | |
| 81 FR 26863 - 30-Day Notice of Proposed Information Collection: Overseas Schools-Grant Status Report | |
| 81 FR 26864 - Overseas Schools Advisory Council Notice of Meeting | |
| 81 FR 26834 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 81 FR 26863 - Main Street Mezzanine Fund, L.P., License No. 06/06-0326; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest | |
| 81 FR 26862 - Texas Disaster #TX-00468 | |
| 81 FR 26861 - Announcement of Growth Accelerator Fund Competition | |
| 81 FR 26759 - Notice of Demonstration To Test Proposed New Method of Assessing the Physical Conditions of Voucher-Assisted Housing | |
| 81 FR 26815 - Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion; Extension of Comment Period | |
| 81 FR 26767 - Safety Zone; Tall Ships Challenge Great Lakes 2016, Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Duluth, MN, Erie, PA | |
| 81 FR 26816 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports by FHA-Approved Lenders | |
| 81 FR 26777 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits | |
| 81 FR 26798 - Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB) | |
| 81 FR 26843 - New Postal Product | |
| 81 FR 26817 - 30-Day Notice of Proposed Information Collection: Screening and Eviction for Drug Abuse and Other Criminal Activity | |
| 81 FR 26776 - Fisheries of the Exclusive Economic Zone Off Alaska; Stock Assessment of Eastern Bering Sea Pollock; Peer Review Meeting | |
| 81 FR 26745 - Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska | |
| 81 FR 26668 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplane, Technical Criteria for Approving Side-Facing Seats | |
| 81 FR 26727 - Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 27 | |
| 81 FR 26844 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940 | |
| 81 FR 26851 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of a Proposed Rule Change Consisting of Proposed Amendments to Rules G-12 and G-15 To Define Regular-Way Settlement for Municipal Securities Transactions as Occurring on a Two-Day Settlement Cycle and Technical Conforming Amendments | |
| 81 FR 26857 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to FLEX Options Pilot Program | |
| 81 FR 26792 - Notice of Agreements Filed | |
| 81 FR 26813 - Notice of Kidney Interagency Coordinating Committee Meeting | |
| 81 FR 26793 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 26793 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 81 FR 26811 - Meeting of the National Preparedness and Response Science Board | |
| 81 FR 26838 - STP Nuclear Operating Company, South Texas Project, Units 1 and 2 | |
| 81 FR 26837 - Dominion Virginia Power; North Anna, Unit 3 | |
| 81 FR 26747 - Energy Conservation Program: Energy Conservation Standards for Commercial Packaged Boilers | |
| 81 FR 26776 - Endangered and Threatened Species; Take of Anadromous Fish | |
| 81 FR 26787 - H2 Refuel H-Prize Schedule Update | |
| 81 FR 26797 - Request for Nominations of Candidates To Serve on the Healthcare Infection Control Practices Advisory Committee (HICPAC) | |
| 81 FR 26794 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review | |
| 81 FR 26794 - Request for Nominations of Candidates To Serve on the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) | |
| 81 FR 26794 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) | |
| 81 FR 26773 - Submission for OMB Review; Comment Request | |
| 81 FR 26832 - Polyethylene Terephthalate Resin From Canada, China, India, and Oman | |
| 81 FR 26865 - Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler) | |
| 81 FR 26866 - Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler) | |
| 81 FR 26780 - National Advisory Committee on Institutional Quality and Integrity Meeting | |
| 81 FR 26788 - Combined Notice of Filings | |
| 81 FR 26692 - Financial Assistance and Social Services Programs; Burial Assistance | |
| 81 FR 26826 - Indian Entities Recognized and Eligible To Receive Services From the United States Bureau of Indian Affairs | |
| 81 FR 26851 - SEC Advisory Committee on Small and Emerging Companies | |
| 81 FR 26835 - Agency Information Collection Activities: Comment Request | |
| 81 FR 26779 - Notice of Intent To Prepare an Environmental Impact Statement for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland | |
| 81 FR 26832 - Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting | |
| 81 FR 26795 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 81 FR 26803 - Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01) | |
| 81 FR 26804 - Quantitative Assessment of Assumptions To Support Extrapolation of Efficacy in Pediatrics; Public Workshop | |
| 81 FR 26807 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads | |
| 81 FR 26856 - Submission for OMB Review; Comment Request | |
| 81 FR 26799 - Special Protocol Assessment; Draft Guidance for Industry; Availability | |
| 81 FR 26805 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Availability | |
| 81 FR 26722 - Mefenoxam; Pesticide Tolerances | |
| 81 FR 26802 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format | |
| 81 FR 26800 - Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 81 FR 26753 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule | |
| 81 FR 26687 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products | |
| 81 FR 26763 - Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity | |
| 81 FR 26693 - Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity | |
| 81 FR 26764 - Identification Markings Placed on Firearm Silencers and Firearm Mufflers | |
| 81 FR 26667 - Environmental Policies and Procedures; Corrections | |
| 81 FR 26775 - Endangered and Threatened Species; Take of Anadromous Fish; Reopening of Comment Period | |
| 81 FR 26826 - Agency Information Collection Activities: Request for Comments | |
| 81 FR 26774 - Notice of Public Meeting of the Illinois Advisory Committee To Discuss Approval of a Draft Advisory Memorandum Regarding Civil Rights and Environmental Justice in the State | |
| 81 FR 26667 - Environmental Policies and Procedures; Correction | |
| 81 FR 26775 - Notice of Intent To Grant Exclusive License | |
| 81 FR 26844 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Public Disclosure of Exchange Usage of Market Data | |
| 81 FR 26846 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Nasdaq Rule 7023 | |
| 81 FR 26850 - Submission for OMB Review; Comment Request | |
| 81 FR 26854 - Submission for OMB Review; Comment Request | |
| 81 FR 26853 - Proposed Collection; Comment Request | |
| 81 FR 26849 - Submission for OMB Review; Comment Request | |
| 81 FR 26857 - Submission for OMB Review; Comment Request | |
| 81 FR 26833 - Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO): Meeting | |
| 81 FR 26833 - All Items Consumer Price Index for All Urban Consumers, United States City Average | |
| 81 FR 26789 - Agency Information Collection Activities OMB Responses | |
| 81 FR 26870 - Proposed Collection of Information: FS Form 2001-Release | |
| 81 FR 26812 - Center For Scientific Review; Notice of Closed Meetings | |
| 81 FR 26738 - Fisheries of the Exclusive Economic Zone Off Alaska; Western Alaska Community Development Quota Program | |
| 81 FR 26790 - Senior Executive Service Performance Review Board | |
| 81 FR 26790 - Information Collections Being Submitted for Review and Approval to the Office of Management and Budget | |
| 81 FR 26791 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 81 FR 26815 - Agency Information Collection Activities: Submission for Review; Information Collection Request for the Department of Homeland Security Science & Technology Technology Acceptance and Evaluation Survey | |
| 81 FR 26867 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2008 Aston Martin Vantage V8 Passenger Cars Are Eligible for Importation | |
| 81 FR 26869 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2009 Mercedes-Benz G Class Long Wheelbase (463 Chassis) Multipurpose Passenger Vehicle Are Eligible for Importation | |
| 81 FR 26780 - Application for New Awards; Data Disaggregation Initiative Program | |
| 81 FR 26836 - Information Collection: Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material | |
| 81 FR 26793 - Notice of Filing of Complaint and Assignment | |
| 81 FR 26792 - Notice of Filing of Complaint and Assignment | |
| 81 FR 26814 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting | |
| 81 FR 26812 - National Institute of Environmental Health Sciences; Notice of Closed Meeting | |
| 81 FR 26814 - National Institute on Aging; Notice of Closed Meetings | |
| 81 FR 26812 - National Institute on Aging; Notice of Closed Meetings | |
| 81 FR 26814 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 26695 - Safety Zone, Cape Fear River; Southport, NC | |
| 81 FR 26903 - U.S. Citizenship and Immigration Services Fee Schedule | |
| 81 FR 26675 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
| 81 FR 26941 - Protection of Visibility: Amendments to Requirements for State Plans | |
| 81 FR 26685 - Amendment of Class D and Class E Airspace; Walla Walla, WA | |
| 81 FR 26673 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 26682 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 26871 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities | |
| 81 FR 26825 - Marianas Trench Marine National Monument, Commonwealth of the Northern Mariana Islands; Northern Islands Submerged Lands Transfer to the Commonwealth of the Northern Mariana Islands Draft Environmental Assessment | |
| 81 FR 26750 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 26747 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 26697 - Determinations of Attainment by the Attainment Date, Extensions of the Attainment Date, and Reclassification of Several Areas for the 2008 Ozone National Ambient Air Quality Standards | |
| 81 FR 26677 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 26680 - Airworthiness Directives; Airbus Airplanes |
Issue
Farm Service Agency
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
International Trade Administration
National Oceanic and Atmospheric Administration
Air Force Department
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Geological Survey
Indian Affairs Bureau
Land Management Bureau
Alcohol, Tobacco, Firearms, and Explosives Bureau
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Bureau of the Fiscal Service
Internal Revenue Service
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 LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.
Final rule; correction.
This document corrects errors in the final rule that appeared in the
This rule is effective May 4, 2016.
Kellie M. Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, Stop 1571, 1400 Independence Ave. SW., Washington, DC 20250-1571; email:
In FR Doc. 2016-03433 of March 2, 2016 (81 FR 11000), make the following correcting amendments:
Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.
Correcting amendment.
The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the
This rule is effective May 4, 2016.
Kellie M. Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, Stop 1571, 1400 Independence Ave. SW., Washington, DC 20250-1571; email:
The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the
Government acquired property, Government property management, Sale of government acquired property, Surplus government property.
For the reasons set forth in the preamble, chapter XVIII, title 7, Code of Federal Regulations is amended as follows:
5 U.S.C. 301; 7 U.S.C. 1989; 42 U.S.C. 1480.
(a) Prior to a final decision on some disposal actions, the action must comply with the environmental review requirements in accordance with each agency's environmental policies and procedures. For Farm Service Agency actions the environmental policies and procedures are found in subpart G of part 1940 of this chapter and for Rural Development programs the
In Title 12 of the Code of Federal Regulations, Part 1100 to End, revised as of January 1, 2016, on page 400, in § 1282.1, the definition of “Very low income” is reinstated to read as follows:
(b) * * *
(i) In the case of owner-occupied units, income not in excess of 50 percent of area median income; and
(ii) In the case of rental units, income not in excess of 50 percent of area median income, with adjustments for smaller and larger families in accordance with this part.
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. This airplane will have a novel or unusual design feature associated with side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
The effective date of these special conditions is May 4, 2016. We must receive your comments by June 20, 2016.
Send comments identified by docket number FAA-2016-1085 using any of the following methods:
Dan Jacquet, Airframe and Cabin Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2676; facsimile 425-227-1149.
The substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On March 29, 2012, Gulfstream Aerospace Corporation applied for a type certificate for their new Model GVII-G500 airplane. The Model GVII-G500 airplane will be a business jet capable of accommodating up to 19 passengers. It will incorporate a low, swept-wing design with winglets and a T-tail. The powerplant will consist of two aft-fuselage-mounted Pratt & Whitney turbofan engines.
Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-129.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).
The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:
Gulfstream wants the option to include side-facing seats in their new Model GVII-G500 airplane. Side-facing seats (
On June 16, 1988, 14 CFR part 25 was amended to revise the emergency-landing conditions that must be considered in the design of transport-category airplanes. Amendment 25-64 revised the static-load conditions in § 25.561, and added a new § 25.562 that required dynamic testing for all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 was to provide an improved level of safety for occupants on transport-category airplanes. However, because most seating on transport-category airplanes is forward-facing, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats.
For some time, the FAA granted exemptions for the multiple-place side-facing-seat installations because the existing test methods and acceptance criteria did not produce a level of safety equivalent to the level of safety provided for forward-and aft-facing seats. These exemptions were subject to many conditions that reflected the injury-evaluation criteria and mitigation strategies available at the time of the exemption issuance. The FAA also issued special conditions to address single-place side-facing seats because we believed that those conditions provided the same level of safety as for forward- and aft-facing seats.
Continuing concerns regarding the safety of side-facing seats prompted the FAA to conduct research to develop an acceptable method of compliance with §§ 25.562 and 25.785(b) for side-facing seat installations. That research has identified injury considerations and evaluation criteria in addition to those previously used to approve side-facing seats (see published report DOT/FAA/AR-09/41, July 2011). One particular concern that was identified during the FAA's research program, but not addressed in the previous special conditions, was the significant leg injuries that can occur to occupants of both single- and multiple-place side-facing seats. Because this type of injury does not occur on forward- and aft-facing seats, the FAA determined that, to achieve the level of safety envisioned in Amendment 25-64, additional requirements would be needed as compared to previously issued special conditions. Nonetheless, the research has now allowed the development of a single set of special conditions that is applicable to all fully side-facing seats.
On November 5, 2012, the FAA released PS-ANM-25-03-R1, “Technical Criteria for Approving Side-Facing Seats,” to update existing FAA certification policy on §§ 25.562 and 25.785(a) at Amendment 25-64 for single- and multiple-place side-facing seats. This policy addresses both the technical criteria for approving side-facing seats and the implementation of those criteria. The FAA methodology detailed in PS-ANM-25-03-R1 has been used in establishing a new set of proposed special conditions. Some of the conditions issued for previous exemptions are still relevant and are included in these new special conditions. However, others have been replaced by different criteria that reflect current research findings.
As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only a certain novel or unusual design feature on one model series of airplane. It is not a rule of general applicability.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the
The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
In addition to the airworthiness standards in §§ 25.562 and 25.785, the FAA issues the following special conditions (based on Policy Statement PS-ANM-25-03-R1) as part of the type certification basis for the Gulfstream Model GVII series airplanes. Items 1 and 2 are applicable to all side-facing seat installations, whereas items 3 through 16 represent additional requirements applicable to side-facing seats equipped with an airbag system in the shoulder belt.
1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:
a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8) and these special conditions, must have an ES-2re anthropomorphic test dummy (ATD) (49 CFR part 572 subpart U) or equivalent, or a Hybrid II ATD (49 CFR part 572, subpart B as specified in § 25.562) or equivalent, occupying each seat position and including all items (
b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572 subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re ATD at the seat place being evaluated, and a Hybrid II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).
c. If a seat is installed aft of structure (
d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.
e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:
(1) ATD positioning:
Lower the ATD vertically into the seat while simultaneously (see Figure 2 for illustration):
(a) Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.
(b) Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the torso at approximately the intersection of the midsagittal plane and the bottom rib of the ES-2re or lower sternum of the Hybrid II at the midsagittal plane, to compress the seat back cushion.
(c) Keeping the upper legs nearly horizontal by supporting them just behind the knees.
(d) After all lifting devices have been removed from the ATD:
(i) Rock it slightly to settle it into the seat.
(ii) Separate the knees by about 4 inches (100 mm).
(iii) Set the ES-2re ATD's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).
(iv) Position the ES-2re ATD's arms at the joint's mechanical detent that puts them at approximately a 40-degree angle with respect to the torso. Position the Hybrid II ATD hands on top of its upper legs.
(v) Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the airplane coordinate system).
(2) ATD clothing: Clothe each ATD in form-fitting, mid-calf-length (minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 Kg) total. The color of the clothing should be in contrast to the color of the restraint system. The ES-2re jacket is sufficient for torso clothing, although a form-fitting shirt may be used in addition if desired.
(3) ES-2re ATD lateral instrumentation: The rib-module linear slides are directional,
f. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572 subpart B as specified in § 25.562), or equivalent, occupying each seat position.
g. Restraint systems:
(1) If inflatable restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.
(2) The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands or arms of the occupant during an emergency landing.
2. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:
a. Body-to-body contact: Contact between the head, pelvis, torso, or shoulder area of one ATD with the adjacent-seated ATD's head, pelvis, torso, or shoulder area is not allowed. Contact during rebound is allowed.
b. Thoracic: The deflection of any of the ES-2re ATD upper, middle, and lower ribs must not exceed 1.73 inches (44 mm). Data must be processed as defined in Federal Motor Vehicle Safety Standards (FMVSS) 571.214.
c. Abdominal: The sum of the measured ES-2re ATD front, middle, and rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be processed as defined in FMVSS 571.214.
d. Pelvic: The pubic symphysis force measured by the ES-2re ATD must not exceed 1,350 lbs (6,000 N). Data must be processed as defined in FMVSS 571.214.
e. Leg: Axial rotation of the upper-leg (femur) must be limited to 35 degrees in either direction from the nominal seated position.
f. Neck: As measured by the ES-2re ATD and filtered at Channel Frequency Class 600 as defined in SAE J211, “Instrumentation for Impact Test—Part 1—Electronic Instrumentation.”
(1) The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lb (1,800 N).
(2) The upper-neck compression force at the O.C. location must be less than 405 lb (1,800 N).
(3) The upper-neck bending torque about the ATD x-axis at the O.C. location must be less than 1,018 in-lb (115 Nm).
(4) The upper-neck resultant shear force at the O.C. location must be less than 186 lb (825 N).
g. Occupant (ES-2re ATD) retention: The pelvic restraint must remain on the ES-2re ATD's pelvis during the impact and rebound phases of the test. The upper-torso restraint straps (if present) must remain on the ATD's shoulder during the impact.
h. Occupant (ES-2re ATD) support:
(1) Pelvis excursion: The load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of its seat's bottom seat-cushion supporting structure.
(2) Upper-torso support: The lateral flexion of the ATD torso must not exceed 40 degrees from the normal upright position during the impact.
3. For seats with an airbag system in the shoulder belts, show that the airbag system in the shoulder belt will deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th percentile male. The airbag system in the shoulder belt must provide a consistent approach to energy absorption throughout that range of occupants. When the seat system includes an airbag system, that system must be included in each of the certification tests as it would be installed in the airplane. In addition, the following situations must be considered:
a. The seat occupant is holding an infant.
b. The seat occupant is a pregnant woman.
4. The airbag system in the shoulder belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the shoulder belt.
5. The design must prevent the airbag system in the shoulder belt from being either incorrectly buckled or incorrectly installed, such that the airbag system in the shoulder belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required injury protection.
6. It must be shown that the airbag system in the shoulder belt is not susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.
7. Deployment of the airbag system in the shoulder belt must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress. This assessment should include an occupant whose belt is loosely fastened.
8. It must be shown that inadvertent deployment of the airbag system in the shoulder belt, during the most critical part of the flight, will either meet the requirement of § 25.1309(b) or not cause a hazard to the airplane or its occupants.
9. It must be shown that the airbag system in the shoulder belt will not impede rapid egress of occupants 10 seconds after airbag deployment.
10. The airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lighting, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection.
11. The airbag system in the shoulder belt must function properly after loss of normal aircraft electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the airbag system in the shoulder belt does not have to be considered.
12. It must be shown that the airbag system in the shoulder belt will not release hazardous quantities of gas or particulate matter into the cabin.
13. The airbag system in the shoulder-belt installation must be protected from the effects of fire such that no hazard to occupants will result.
14. A means must be available for a crewmember to verify the integrity of the airbag system in the shoulder-belt activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals. The FAA considers that the loss of the airbag-system deployment function alone (
15. The inflatable material may not have an average burn rate of greater than 2.5 inches/minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).
16. The airbag system in the shoulder belt, once deployed, must not adversely affect the emergency-lighting system (
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 717-200 airplanes. This AD was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. This AD requires a detailed inspection for any distress of the vertical stabilizer leading edge skin, and related investigative and corrective actions if necessary. This AD also requires, for certain airplanes, repetitive detailed inspections of the spar cap for any loose and missing fasteners, repetitive eddy current testing high frequency (ETHF) and radiographic testing (RT) inspections of the spar cap for any crack, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.
This AD is effective June 8, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet:
You may examine the AD docket on the Internet at
Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 717-200 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment. Boeing and an anonymous commenter indicated their support for the NPRM.
Boeing requested that we add a “Credit for Previous Actions” paragraph to the proposed AD that would give credit for prior accomplishment of the initial inspection in paragraph (g) of the NPRM. Boeing stated that operator structural inspection credit has been incorporated as a precedent in previous ADs.
We agree with the commenter's request. Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014, provides the same action and level of safety for the initial inspection specified in this AD. We have revised this AD by adding new paragraph (j) of this AD to give credit for the initial inspection in paragraph (g) of this AD, if that inspection was performed before the effective date of this AD using Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014. We have redesignated the remaining paragraphs accordingly.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the change described previously
• Αre 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 also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015. The service information describes procedures for a detailed inspection for any distress of the vertical stabilizer leading edge skin, a detailed inspection for any loose and missing fasteners of the spar cap, ETHF and RT inspections of the spar cap for any crack, and related investigative and corrective actions. 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
We estimate that this AD affects 106 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.
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.
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 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 June 8, 2016.
None.
This AD applies to The Boeing Company Model 717-200 airplanes, certificated in any category, as specified in Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.
Air Transport Association (ATA) of America Code 55, Stabilizers.
This AD was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (i)(1) of this AD, at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015: Do a detailed inspection for any distress of the vertical stabilizer leading edge skin and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, except as required by paragraph (i)(2) of this AD. Do all applicable related investigative and corrective actions before further flight.
For all airplanes on which no cracking was found during any related investigative action required by paragraph (g) of this AD: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin
(1) Do detailed inspections for any loose and missing fasteners of the vertical stabilizer leading edge as specified in “Part 4” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.
(2) Do eddy current testing high frequency (ETHF) and radiographic testing (RT) inspections for any crack of the vertical stabilizer spar cap as specified in “Part 2” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015; or do ETHF inspections for any crack of the vertical stabilizer spar cap as specified in “Part 3” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.
(1) Where Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015 specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) If any crack is found during any inspection required by this AD, and Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (k) of this AD.
This paragraph provides credit for the initial inspection specified in paragraph (g) of this AD, if that inspection was performed before the effective date of this AD using Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014, which is not incorporated by reference in this AD.
(1) The Manager, Los Angeles Aircraft Certification Office (ACO), 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 manager of the ACO, send it to the attention of the person identified in paragraph (l) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
For more information about this AD, contact Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email:
(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 the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.
(ii) Reserved.
(3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet:
(4) 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.
(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:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Turbomeca S.A. Astazou XIV B and H turboshaft engines. This AD requires a one-time inspection of the front surface of the 3rd stage turbine for a groove. This AD was prompted by a report of a crack on the 3rd stage turbine wheel. We are issuing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.
This AD becomes effective June 8, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.
For service information identified in this final rule, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at
You may examine the AD docket on the Internet at
Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The
During the overhaul of an ASTAZOU XIV engine, a crack was detected on the front face of the third stage turbine wheel between two balancing lugs. The cause of the crack is probably linked to a geometric singularity, likely caused by the transformation operation aimed at introducing expansion slots between the blades during embodiment of Turbomeca mod AB 173. Although there is only one known case of this type of crack, and although it was detected, the possibility exists that additional parts have the same geometric singularity.
This condition, if not detected and corrected, may lead to failure of a turbine blade and its associated piece of rim, possibly resulting in an uncommanded in-flight shut-down and/or release of high energy debris.
You may obtain further information by examining the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 5395, February 2, 2016).
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.
Turbomeca S.A. has issued Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015. The SB describes procedures for inspection of the 3rd stage turbine wheel. 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
We estimate that this AD affects 9 engines installed on helicopters of U.S. registry. We also estimate that it will take about 5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,825.
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 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 to the extent that it justifies making a regulatory distinction, 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 June 8, 2016.
None.
This AD applies to all Astazou XIV B and XIV H turboshaft engines with 3rd stage turbine wheel, part number (P/N) 0 265 25 700 0 or P/N 0 265 25 706 0, installed, if the engine incorporates Turbomeca modification AB-173 or AB-208.
This AD was prompted by a report of a crack on the 3rd stage turbine wheel. We are issuing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) At the next piece part exposure of the 3rd stage turbine wheel or within 1,000 engine hours after the effective date of this AD whichever comes first, perform a one-time inspection for a groove on the front surface of the 3rd stage turbine wheel. Use Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015 to perform the inspection.
(2) If the 3rd stage turbine wheel passes inspection required by paragraph (e)(1) of this AD, no further action is required.
(3) If the 3rd stage turbine wheel fails inspection required by paragraph (e)(1) of this AD, remove the part and replace with a part eligible for installation.
After the effective date of this AD, do not install any 3rd stage turbine wheel, P/N 0 265 25 700 0 or P/N 0 265 25 706 0, unless it was inspected per the Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. SB No. 283 72 0811, Version A, dated August 25, 2015.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0223, dated November 16, 2015, for more information. You may examine the MCAI in the AD
(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 the AD specifies otherwise.
(i) Turbomeca S.A. Service Bulletin No. 283 72 0811, Version A, dated August 25, 2015.
(ii) Reserved.
(3) For Turbomeca S.A. service information identified in this AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15.
(4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information 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), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2004-19-11 for certain Airbus Model A320 series airplanes. AD 2004-19-11 required modification of the inner rear spar web of the wing, cold expansion of the attachment holes of the forward pintle fitting and the actuating cylinder anchorage of the main landing gear (MLG), repetitive ultrasonic inspections for cracking of the rear spar of the wing, and corrective action if necessary. AD 2004-19-11 also provided optional terminating action for the repetitive inspections. This new AD retains the requirements of AD 2004-19-11, and requires the previously optional terminating action. This AD was prompted by a determination that the previously optional terminating action is necessary to address the unsafe condition. We are issuing this AD to prevent fatigue cracking of the inner rear spar, which may lead to reduced structural integrity of the wing and the MLG.
This AD becomes effective June 8, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 5, 2004 (69 FR 58828, October 1, 2004).
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of June 30, 2000 (65 FR 34069, May 26, 2000).
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 14, 1994 (59 FR 1903, January 13, 1994).
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of June 11, 1993 (58 FR 27923, May 12, 1993).
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004) (“AD 2004-19-11”). AD 2004-19-11 applied to certain Airbus Model 320 series 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 2014-0169, dated July 17, 2014, corrected July 22, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model 320 series airplanes. The MCAI states:
During centre fuselage certification full scale fatigue test, cracks were found on the inner rear spar at holes position 52 on the right hand wing due to fatigue aspects.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
To prevent such cracks, Airbus developed modifications, which were introduced in production and in service through several Airbus Service Bulletins (SB).
DGAC France issued * * * [an earlier AD], which was subsequently superseded by [DGAC] AD 2001-249 [which corresponds with FAA AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004)], to require modification of the rear spar on some
Since that [DGAC] AD [2001-249] was issued, in the framework of the A320 Extended Service Goal (ESG), it has been determined that Airbus mod 24591 is necessary to allow aeroplanes to operate up to the new ESG limit.
For the reasons described above, this [EASA] AD retains the requirements of DGAC France AD 2001-249, which is superseded, and requires modification of all pre-mod 24591 aeroplanes.
The modification includes modifying all specified fastener holes in the inner rear spar of the wing. You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We considered the comment received. United Airlines provided its support for the content of the NPRM.
We have added a new paragraph (l)(1) to this AD to provide credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1060, Revision 1, dated April 26, 1993. We have redesignated paragraphs (l)(1) and (l)(2) of the proposed AD as paragraphs (l)(2) and (l)(3) of this AD.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes 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.
Airbus has issued Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001. This service information describes procedures for modification of the airplane by accomplishing cold re-expansion of the holes in the inner rear spar for the attachment of gear rib 5, forward pintle fitting, and actuating cylinder anchorage; and the installation of interference fit fasteners in the rear spar and gear rib 5. 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
We estimate that this AD affects 84 airplanes of U.S. registry.
The actions required by AD 2004-19-11, and retained in this AD take about 684 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $13,644 per product. Based on these figures, the estimated cost of the actions that were required by AD 2004-19-11 is $71,784 per product.
We also estimate that it takes about 980 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $32,727 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $9,746,268, or $116,027 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.
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 June 8, 2016.
This AD replaces AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004) (“AD 2004-19-11”).
This AD applies to Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes, certificated in any category, all manufacturer serial numbers, except those on which Airbus modification (mod) 24591 has been embodied in production.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports of fatigue cracking of the inner rear spar of the wing and also by a determination that the modification of the inner rear spar is necessary to address the unsafe condition.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (a) of AD 2004-19-11, with a change to acceptable service information. For airplanes having manufacturer's serial numbers (MSNs) 003 through 008 inclusive, and 010 through 021 inclusive, except airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Prior to the accumulation of 12,000 total flight cycles, or within 500 flight cycles after June 11, 1993 (the effective date of AD 93-08-15, Amendment 39-8563 (58 FR 27923, May 12, 1993)), whichever occurs later, modify the inner rear spar web of the wing in accordance with Airbus Service Bulletin A320-57-1004, Revision 1, dated September 24, 1992; or Revision 2, dated June 14, 1993. As of the effective date of this AD, only Airbus Service Bulletin A320-57-1004, Revision 2, dated June 14, 1993, may be used for the actions required by this paragraph.
This paragraph restates the requirements of paragraph (b) of AD 2004-19-11, with a change to acceptable service information. For airplanes having MSNs 002 through 051 inclusive, except airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Prior to the accumulation of 12,000 total flight cycles, or within 2,000 flight cycles after February 14, 1994 (the effective date of AD 93-25-13, Amendment 39-8777 (59 FR 1903, January 13, 1994)), whichever occurs later, accomplish the requirements of paragraphs (h)(1) and (h)(2) of this AD in accordance with Airbus Service Bulletin A320-57-1060, dated December 8, 1992; Revision 1, dated April 26, 1993; or Revision 2, dated December 16, 1994. As of the effective date of this AD, only Airbus Service Bulletin A320-57-1060, Revision 2, dated December 16, 1994, may be used for the actions required by this paragraph.
(1) Perform a cold expansion of all the attachment holes for the forward pintle fitting of the main landing gear (MLG), except for the holes that are for taper-lok bolts.
(2) Perform a cold expansion of the holes at the actuating cylinder anchorage of the MLG.
This paragraph restates the requirements of paragraphs (c), (d), and (e) of AD 2004-19-11, with no changes. Except for airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Do the actions specified in paragraphs (i)(1) and (i)(2) of this AD.
(1) Do an ultrasonic inspection for cracking of the rear spar of the wing, in accordance with Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001. Inspect at the applicable time specified in paragraph 1.E. of Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001, except as required by paragraphs (i)(1)(i) and (i)(1)(ii) of this AD.
(i) For any airplane that has not been inspected but has exceeded the applicable specified compliance time in paragraph 1.E. of Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001, as of November 5, 2004 (the effective date of AD 2004-19-11): Inspect within 18 months after November 5, 2004.
(ii) For any airplane that has been inspected before November 5, 2004 (the effective date of AD 2004-19-11): Repeat the inspection within 3,600 flight cycles after the most recent inspection.
(2) Repeat the inspection required by paragraph (i)(1) of this AD at intervals not to exceed 3,600 flight cycles or 6,700 flight hours, whichever occurs first, until the requirements of paragraph (k) of this AD have been done.
This paragraph restates the requirements of paragraph (f) of AD 2004-19-11, with specific delegation approval language. If any crack is found during any inspection required by paragraph (i)(1) or (i)(2) of this AD: Before further flight, repair in accordance with a method approved by either the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate; or the Direction Générale de l'Aviation Civile (or its delegated agent); or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). Accomplishment of a repair as required by this paragraph does not constitute terminating action for the repetitive inspections required by paragraph (i)(2) of this AD.
Before exceeding 48,000 flight cycles or 96,000 flight hours, whichever occurs first since first flight of the airplane: Modify all specified fastener holes in the inner rear spar of the wing, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001; except, where Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001, specifies to contact Airbus for certain conditions, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. Modification of all specified fastener holes in the rear spar of the wing terminates the initial and repetitive inspections required by paragraphs (i)(1) and (i)(2) of this AD. If the modification is done both before the airplane accumulates 12,000 total flight cycles and before the effective date of this AD, the modification also terminates the actions required by paragraphs (g) and (h) of this AD.
(1) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1060, Revision 1, dated April 26, 1993. This service information is not incorporated by reference in this AD.
(2) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1088, Revision 02, dated July 29, 1999; or Revision 03, dated February 9, 2001. This service information is not incorporated by reference in this AD.
(3) This paragraph provides credit for actions required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1089, Revision 02, dated November 6, 1998. This service information is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.
(ii) AMOCs approved previously in accordance with AD 2004-19-11 are approved as AMOCs for the corresponding provisions of paragraphs (g) through (j) of this AD.
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0169, dated July 17, 2014, corrected July 22, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(8) and (o)(9) of this AD.
(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 June 8, 2016.
(i) Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001.
(ii) Reserved.
(4) The following service information was approved for IBR on November 5, 2004 (69 FR 58828, October 1, 2004).
(i) Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001.
(ii) Reserved.
(5) The following service information was approved for IBR on June 30, 2000 (65 FR 34069, May 26, 2000).
(i) Airbus Service Bulletin A320-57-1004, Revision 2, dated June 14, 1993. This service bulletin contains the following list of effective pages: Pages 1, 4, 12, 14, 17 through 20, 22, 23, 28, 29, Revision 2, dated June 14, 1993; page 15, Revision 1, dated September 24, 1992; and pages 2, 3, 5 through 11, 13, 16, 21, 24 through 27, 30, Original Issue, dated July 9, 1991.
(ii) Airbus Service Bulletin A320-57-1060, Revision 2, dated December 16, 1994.
(6) The following service information was approved for IBR on February 14, 1994 (59 FR 1903, January 13, 1994).
(i) Airbus Service Bulletin A320-57-1060, dated December 8, 1992.
(ii) Reserved.
(7) The following service information was approved for IBR on June 11, 1993 (58 FR 27923, May 12, 1993).
(i) Airbus Service Bulletin A320-57-1004, Revision 1, dated September 24, 1992. This service bulletin contains the following list of effective pages: Pages 1, 4, 12, 14 through 15, 17 through 18, 20, Revision 1, dated September 24, 1992; and pages 2 through 3, 5 through 11, 13, 16, 19, 21 through 30, Original Issue, dated July 9, 1991.
(ii) Reserved.
(8) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(9) 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.
(10) 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), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. This AD was prompted by reports of incorrect installation of jiffy joint connectors on cables connected to certain passenger service units (PSUs), which could cause the passenger oxygen container to malfunction if the connector becomes disengaged during flight due to vibration. This AD requires identification of the affected PSUs, and depending on findings, doing applicable related investigative and corrective actions. We are issuing this AD to prevent failure of the door of the passenger oxygen container to open in the event of airplane decompression, resulting in lack of oxygen supply and consequent injury to occupants.
This AD becomes effective June 8, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of June 8, 2016.
You may examine the AD docket on the Internet at
For Airbus service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
For Airbus Operations GmbH service information identified in this final rule, contact Airbus Operations GmbH, Cabin Electronics, Lueneburger Schanze 30, 21614 Buxtehude, Germany; telephone +49 40 7437 46 32; telefax +49 40 7437 16 80; email
You may view this referenced 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. It is also available on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 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 2014-0256, dated November 26, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus
A quality issue was reported regarding incorrect installation of jiffy joint connectors on cables connected to certain Passenger Service Units (PSU), which may lead to a malfunction of the passenger oxygen container in case of connector disengagement during flight due to vibrations. All the aeroplanes that had a potentially affected PSU installed were identified. Most of those aeroplanes were corrected during a specific quality inspection on the final assembly line prior to customer delivery. Unfortunately, a limited number of aeroplanes were delivered before the quality inspection was implemented.
This condition, if not detected and corrected, could lead to failure of the door of the passenger oxygen container and open in case of aeroplane decompression, possibly resulting in lack of oxygen supply and consequent injury to occupants.
For the reasons described above, this [EASA] AD requires identification of the affected PSU and, depending on the findings, * * * related investigative and corrective actions.
Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed, except for 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.
Airbus has issued the following service information.
• Airbus Service Bulletin A320-25-1B20, dated October 9, 2014. This service information describes procedures for inspecting for affected PSU part numbers and serial numbers, and depending on findings, doing applicable related investigative and corrective actions. Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.
• Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, including Attachment 1, “List of affected PSU PNR and S/N” (the attachment is not numbered or dated). This service information describes procedures for inspecting for the connection of the jiffy joint connectors, and depending on findings, doing rework or replacement of the jiffy joint connectors.
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
We estimate that this AD affects 7 airplanes of U.S. registry.
We also estimate that it takes about 5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,975, or $425 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, 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.
You may examine the AD docket on the Internet at
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 June 8, 2016.
None.
This AD applies to Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes, certificated in any category, having
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by reports of incorrect installation of jiffy joint connectors on cables connected to certain passenger service units (PSU), which could cause the passenger oxygen container to malfunction if the connector becomes disengaged during flight due to vibration. We are issuing this AD to prevent failure of the door of the passenger oxygen container to open in the event of airplane decompression, resulting in lack of oxygen supply and consequent injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Within 7,500 flight hours or 26 months after the effective date of this AD, whichever occurs first, do an inspection to identify the part number and serial number of each PSU, and if an affected part number or serial number is found, do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-25-1B20, dated October 9, 2014. Do all applicable related investigative and corrective actions within 7,500 flight hours or 26 months after the effective date of this AD, whichever occurs first. An affected PSU part number or serial number is one listed in Attachment 1, “List of affected PSU PNR and S/N,” of Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the PSU can be conclusively determined from that review.
On page 13 of Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, Table 4 (“List of Attachments”) under the heading “APPENDIX” identifies “Attachment 1, `List of affected PSU PNR and S/N.' ” The attachment is not numbered or dated.
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: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; 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 European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(3) Required for Compliance (RC): If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0256, dated November 26, 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.
(i) Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, including Attachment 1, “List of affected PSU PNR and S/N.” No page of the attachment to this document provides a document number, revision level, or date.
(ii) Airbus Service Bulletin A320-25-1B20, dated October 9, 2014.
(3) For Airbus service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) For Airbus Operations GmbH service information identified in this final rule, contact Airbus Operations GmbH, Cabin Electronics, Lueneburger Schanze 30, 21614 Buxtehude, Germany; telephone +49 40 7437 46 32; telefax +49 40 7437 16 80; email
(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 The Boeing Company Model 747-8 series airplanes. This AD requires a detailed inspection for correct installation of the flex hose clamp of the occupant backup air supply and a general visual inspection for damage of the flex hose, and related investigative and corrective actions if necessary. This AD was prompted by a report indicating that flex hoses of the occupant backup air supply were found disconnected from the adjacent fiberglass duct on two airplanes. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the
This AD is effective May 19, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 19, 2016.
We must receive comments on this AD by June 20, 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 Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Stanley Chen, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6585; fax: 425-917-6590; email:
We have received a report indicating that an operator, while on a maintenance visit, found a flex hose of the occupant backup air supply disconnected from the adjacent fiberglass duct on two airplanes. One of the flex hoses had a tear on the disconnected edge. A Boeing investigation found that these incidents were caused by the incorrect clamp installation on the inboard end of the flex hose, which is a quality control problem that allowed the flex hose to slowly become disconnected from the adjacent fiberglass duct. No related system faults were reported. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.
We reviewed Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015. The service information describes procedures for a detailed visual inspection of the clamp installation on the inboard end of the flex hose and general visual inspection of the flex hose for damage, and related investigative and corrective actions if necessary. 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
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires accomplishing the actions specified in the service information described previously.
The phrase “related investigative actions” is used in this AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.
The phrase “corrective actions” is used in this AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.
There are currently no domestic operators of this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written 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
Currently, there are no affected airplanes on the U.S. Register. However, if an affected airplane is imported and
We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this repair:
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.
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 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 May 19, 2016.
None.
This AD applies to The Boeing Company Model 747-8 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.
Air Transport Association (ATA) of America Code 21, Air conditioning.
This AD was prompted by a report indicating that flex hoses of the occupant backup air supply were found disconnected from the adjacent fiberglass duct on two airplanes. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (h) of this AD, at the applicable time in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015, do a detailed inspection for correct installation of the backup air supply clamp, and before further flight, do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.
Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Stanley Chen, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6585; fax: 425-917-6590; email:
(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 the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(4) 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.
(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:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA. After a review of the airspace, the FAA found it necessary to amend the airspace areas for the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport. This action also updates the geographic coordinates of Walla Walla Regional Airport in the respective Class D and E airspace areas above.
Effective 0901 UTC, July 21, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Walla Walla, WA.
On November 27, 2015, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA. Class D airspace and all Class E airspace areas are modified to correct geographic latitude and longitude (lat./long.) errors in the legal description. Class E airspace designated as an extension is modified to include that area within 2.7 miles each side of the Walla Walla Airport 215° bearing extending from the 4.3-mile radius to 7.5 miles southwest of the airport, and that airspace within 4.1 miles each side of the airport 035° bearing extending from the 4.3-mile radius to 13.4 miles northeast of the airport. Class E airspace extending upward from 700 feet above the surface is modified to include that area bounded by a line beginning at lat. 45°52′29″ N., long. 118°23′027″ W.; to lat. 45°49′51″ N., long. 118°26′02″ W.; to lat. 45°57′17″ N., long. 118°40′49″ W.; to lat. 46°10′22″ N., long. 118°27′48″ W.; to lat. 46°08′46″ N., long. 118°24′32″ W.; to lat. 46°14′38″ N., long. 118°18′44″ W.; to lat. 46°16′07″ N., long. 118°21′47″ W.; to lat. 46°29′20″ N., long. 118°08′35″ W.; to lat. 46°22′02″ N., long. 117°53′24″ W.; to lat. 46°14′25″ N., long. 118°01′11″ W.; and that airspace within a 13.4-mile radius of point in space coordinates at lat. 46°03′27″ N., long. 118°12′20″ W., from the 052° bearing from the Walla Walla Regional Airport clockwise to the 198° bearing.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 3,700 feet MSL within a 4.3-mile radius of the Walla Walla Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within a 4.3-mile radius of the Walla Walla Regional Airport.
That airspace extending upward from the surface within 2.7 miles each side of the Walla Walla 215° bearing from the airport extending from the 4.3-mile radius of Walla Walla Regional Airport to 7.5 miles southwest of the airport, and within 4.1 miles each side of the Walla Walla 35° bearing from the airport extending from the 4.3-mile radius of Walla Walla Regional Airport to 13.4 miles northeast of the airport.
That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 45°52′29″ N., long. 118°23′027″ W.; to lat. 45°49′51″ N., long. 118°26′02″ W.; to lat. 45°57′17″ N., long. 118°40′49″ W.; to lat. 46°10′22″ N., long. 118°27′48″ W.; to lat. 46°08′46″ N., long. 118°24′32″ W.; to lat. 46°14′38″ N., long. 118°18′44″ W.; to lat. 46°16′07″ N., long. 118°21′47″ W.; to lat. 46°29′20″ N., long. 118°08′35″ W.; to lat. 46°22′02″ N., long. 117°53′24″ W.; to lat. 46°14′25″ N., long. 118°01′11″ W.; and that airspace within a 13.4-mile radius of point in space coordinates at lat. 46°03′27″ N., long. 118°12′20″ W., from the 052° bearing from the Walla Walla Regional Airport clockwise to the 198° bearing.
Food and Drug Administration, HHS.
Direct final rule.
The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
This rule is effective September 16, 2016. Submit either electronic or written comments on this direct final rule or its companion proposed rule by July 18, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule 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.”
• 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
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 issuing this direct final rule because revision and removal of certain general biological products standards will update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is taking this action because the existing codified requirements are duplicative of requirements that are also specified in biologics license applications (BLAs) or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products.
This direct final rule removes the requirements contained in § 610.20 (21 CFR 610.20) from the regulations. FDA is taking this action because the standard preparations listed in the regulation are obsolete, no longer available, or described on a product specific basis in BLAs. In addition, FDA believes that it is no longer necessary to restrict the source of standard preparations to the Center for Biologics Evaluation and Research (CBER), since
FDA is taking this action under the biological products provisions of the Public Health Service Act (PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Because this direct final rule does not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.
In the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced and provided in the
We are providing a comment period on the direct final rule of 75 days after the date of publication in the
If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.
If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.
On January 18, 2011, President Barack Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011). One of the provisions in the Executive Order requires Agencies to consider how best to promote the retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned (76 FR 3821 at 3822). As one step in implementing the Executive Order, FDA published a notice in the
FDA's general biological products standards in part 610 are intended to help ensure the safety, purity, and potency of biological products administered to humans. The revision and removal of certain general biological products standards are designed to update outdated requirements and accommodate new and evolving manufacturing and control testing technology. The rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Standard preparations are generally used to perform lot release testing or other specific product characterization assays. Under the current standard preparations, § 610.20, FDA requires specific standard preparations to be used for a small number of the biological products FDA regulates unless a modification is permitted under § 610.9. Specifically, according to current § 610.20
Under the current § 610.21
In addition to sometimes being duplicative of information provided in the BLA and unnecessarily restrictive regarding the source of standard preparations, the codification by regulation of many of the standard preparations and limits of potency for certain biological products sometimes does not keep abreast of technological advances in science related to manufacturing and testing. For many years, because of the potential for impeding scientific progress, FDA has not codified additional specific standard preparations and limits of potency for licensed biological products, but instead the standards are established in the BLA. Failure to conform to applicable standards established in the license is grounds for revocation under § 601.5(b)(1)(iv) (21 CFR 601.5(b)(1)(iv)). Notwithstanding the changes in this rule, FDA will continue to require that each biological product meet standards to assure that the product is safe, pure, and potent, and will continue to require that each lot demonstrate conformance with the standards applicable to that product (see § 610.1) through appropriate testing. Therefore, we expect that standard preparations and potency limits will be established in the BLA and may be changed only in accordance with regulations for reporting post-approval changes (see § 601.12). Furthermore, no lot of any licensed product may be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product (see § 610.1).
FDA is therefore amending its regulations to remove §§ 610.20 and 610.21 because appropriate standard preparations and potency limits for any listed product are specified during the licensing process on a product specific basis. The removal of §§ 610.20 and 610.21 will also increase regulatory flexibility by allowing industry and FDA to more readily use and incorporate current scientific technology and other appropriate reference materials in the manufacture and regulation of licensed biological products.
A biological product is expected to remain stable and retain its identity, strength, quality, and purity for a period of time after manufacture when it is properly stored. The dating period limitations regulations provided at §§ 610.50 and 610.53 specify how the date of manufacture for biological products will be determined, when the dating begins, and dating periods for certain biological products. The existing § 610.50 prescribes how the date of manufacture is determined for biological products and relies in part upon §§ 610.20 and 610.21 or official standards of potency (
In addition, current § 610.50(b) does not provide FDA or applicants with flexibility to consider the variety of manufacturing situations and technologies that exist today and which may occur in the future. Since 1977, when the regulation was last amended, new methods of manufacture and testing often associated with new biological products have been developed. The revisions to § 610.50 provided in this direct final rule therefore allow additional manufacturing activities other than those currently listed to be used to determine the date of manufacture.
Under the revised regulation, the date of manufacture must be identified in the approved BLA. FDA recommends that applicants discuss a suitable date of manufacture with FDA during late clinical development and propose a date of manufacture in the BLA. We consider the underlying science and manufacturing process testing methods in determining the date of manufacture for each specific product. The approved BLA will specify how the date of manufacture is determined. A paragraph is being added, § 610.50(c), specifying how the date of manufacture for Whole Blood and blood components is determined. This will assist in complying with the dating periods prescribed for Whole Blood and blood components in the revised table in redesignated § 610.53(b).
The current table at § 610.53(c) lists dating periods, manufacturer's storage periods, and storage conditions for many biological products. The table in § 610.53(c) (which is redesignated as § 610.53(b)) is revised to remove products where storage conditions and dating periods are established to help ensure the continued safety, potency, and purity of each individual product, based upon information submitted in the relevant BLA. The dating period and storage conditions for these products will be identified in the BLA. The table in § 610.53(c) is also revised to delete those products that are no longer manufactured. We are retaining those products, specifically Whole Blood and blood components, whose dating periods are based upon data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The list is updated to include currently licensed Whole Blood and blood component products with their applicable storage temperatures and dating periods.
In listing the dating periods for Whole Blood and blood component products, we took into account existing regulations, guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. Because we understand from these materials that these dating periods are in current use, and because blood establishments can request an exception under § 640.120 (21 CFR 640.120), we do not anticipate significant objections to codifying this information. Similarly, we are removing § 610.53(d) because it is duplicative of § 640.120. In addition, we recognize that future scientific understanding and new technology, such as the implementation of pathogen reduction technology or the approval of extended storage systems, could affect what dating periods would be necessary, as a scientific matter, for Whole Blood and blood components. For this reason, the rule allows for changes to the dating periods specified in § 610.53(b) when the dating period is otherwise specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA.
In conclusion, the amendments to the regulations provided by this rule are designed to be consistent with updated practices in the biological product industry and to remove unnecessary or outdated requirements. FDA is taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations to provide flexibility without diminishing public health protection. Given the additional flexibility provided by these revised regulations, FDA does not anticipate that applicants for licensed biological products will need to revise information in BLAs in order to conform to the revised regulations.
FDA is revising the general biological products standards relating to dating periods and removing certain standard preparations and limits of potency. These changes are designed to remove unnecessary or outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is issuing these revisions directly as a final rule because the Agency believes they include only noncontroversial amendments and FDA anticipates no significant adverse comments.
FDA is removing § 610.20 because the standard preparations listed are obsolete or no longer available; standard preparations to ensure the safety, purity, and potency of a product can best be determined on a product specific basis; and standard preparations may be obtained from other sources. Applicants for biological product licenses currently identify standard preparations in the BLA, and the proposed standard preparations and their purpose are reviewed by FDA during the regulatory process. The standard preparations may include standard preparations developed by the applicant as well as appropriate standard preparations that can be obtained from other sources. Consistent with current practice, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for licensed biological products.
We are removing § 610.21 because these potency limits are best described in the BLAs on a product specific basis. Applicants for biological product licenses already identify standards for potency to help ensure the safety, purity, and potency of the product within their BLA, and the proposed standards are reviewed by FDA during the regulatory process. The use of a potency limit is suitably described in the specific product's BLA and allows for its continued and appropriate use in the absence of § 610.21.
We are revising § 610.50 by making a minor amendment to the section heading, removing the current language, redesignating § 610.53(b) as § 610.50(a) with edits, revising § 610.50(b), and adding new § 610.50(c). Current § 610.53(b), which applies to all biological products, has been moved to § 610.50(a) and edits have been made for better organization and clarification. Section 610.50(b) is being revised and § 610.50(c) is being added to clarify how the date of manufacture is set for purposes of determining the dating period for general biological products and for Whole Blood and blood components, respectively.
We are amending the section heading of § 610.53 to reflect that it only addresses dating periods for Whole Blood and blood components. We are revising § 610.53(a) since this section only applies to the dating periods for Whole Blood and blood components. We are redesignating § 610.53(c) as § 610.53(b) and revising the text to provide an explanation on using the table and to correspond with 21 CFR 606.121(c)(7). We are revising the text and table to eliminate those products for which storage periods, storage conditions, and dating periods are better established by data submitted in the BLA, and to delete those products which are no longer manufactured. The dating period and storage conditions for these products are identified in the BLA. We are including an updated list of Whole Blood and blood component products with their applicable storage temperatures and dating periods, which are based upon available information, including data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The table contains a list of storage temperatures and dating periods for Whole Blood and blood components that FDA has reviewed and determined to be necessary to help ensure the safety, potency, and purity of these products. In listing the dating periods for the Whole Blood and blood component products, we took into account existing guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. We are redesignating § 610.53(c) as § 610.53(b) and removing all products regulated by FDA's Center for Drug Evaluation and Research (CDER) from the table. Finally, we are removing § 610.53(d) because it is duplicative of § 640.120.
FDA is issuing this rule under the biological products provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the introduction, transmission, and spread of communicable disease.
We have examined the impacts of the direct final rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this direct final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the direct final rule is removing regulations and revising regulations to be consistent with updated practice, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result
We have determined under 21 CFR 25.31(h) 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.
We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
This direct final rule contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 610 have been approved under OMB control number 0910-0338. The removal of § 610.53(d) impacts OMB control number 0910-0338. We are removing § 610.53(d) because it is duplicative of § 640.120, which is also approved under the same collection of information. While there is no net change in the burden estimate, the current approved collection of information will be updated to reflect this removal. The actions taken by this direct final rule do not create a substantive or material modification to this approved collection of information. Therefore, FDA concludes that OMB has already approved this information collection and the requirements in this document are not subject to additional review by OMB.
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.
(a)
(b)
(1) Potency test or other specific test as described in a biologics license application or supplement to the application;
(2) Removal from animals or humans;
(3) Extraction;
(4) Solution;
(5) Cessation of growth;
(6) Final sterile filtration of a bulk solution;
(7) Manufacture as described in part 660 of this chapter; or
(8) Other specific manufacturing activity described in a biologics license application or supplement to the biologics license application.
(c)
(i) Collection date and/or time;
(ii) Irradiation date;
(iii) The time the red blood cell product was removed from frozen storage for deglycerolization;
(iv) The time the additive or rejuvenation solution was added;
(v) The time the product was entered for washing or removing plasma (if prepared in an open system);
(vi) As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or
(vii) As approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.
(2) For licensed Whole Blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application.
(a)
(b)
Bureau of Indian Affairs, Interior.
Final rule; confirmation.
The Bureau of Indian Affairs (BIA) is confirming the interim final rule published on March 1, 2016, extending the deadline for filing an application for burial assistance to 180 days to address hardships resulting from the current short timeframe. The Department of the Interior (Department) did not receive any significant adverse comments during the public comment period on the interim final rule, and
Effective May 4, 2016.
Elizabeth Appel, Director, Office of Regulatory Affairs and Collaborative Action, Office of the Assistant Secretary—Indian Affairs; telephone (202) 273-4680,
On March 1, 2016, the Department published an interim final rule (81 FR 10475) to extend the deadline by which a relative of a deceased Indian can apply for burial assistance for the deceased Indian from 30 days following death to 180 days following death.
The Department received three comments on the rule, all of which were supportive of the rule. None of the comments requested changes to the rule. Consequently, the Department did not make any change to the interim final rule as a result of this comment. For these reasons, the Department confirms the interim rule published March 1, 2016 (81 FR 10475), as final without change.
Internal Revenue Service (IRS), Treasury.
Final and temporary regulations.
This document contains final and temporary regulations that clarify the employment tax treatment of partners in a partnership that owns a disregarded entity. These regulations affect partners in a partnership that owns a disregarded entity. The text of these temporary regulations serves as the text of proposed regulations (REG-114307-15) published in the Proposed Rules section in this issue of the
Andrew K. Holubeck at (202) 317-4774 (not a toll-free number).
Section 301.7701-2(c)(2)(i) states that, except as otherwise provided, a business entity that has a single owner and is not a corporation under § 301.7701-2(b) is disregarded as an entity separate from its owner (a disregarded entity). However, § 301.7701-2(c)(2)(iv)(B) provides that an entity that is a disregarded entity is treated as a corporation for purposes of employment taxes imposed under subtitle C of the Internal Revenue Code (Code). Therefore, the disregarded entity, rather than the owner, is considered to be the employer of the entity's employees for purposes of employment taxes imposed by subtitle C.
While § 301.7701-2(c)(2)(iv)(B) treats a disregarded entity as a corporation for employment tax purposes, this rule does not apply for self-employment tax purposes. Specifically, § 301.7701-2(c)(2)(iv)(C)(
It has come to the attention of the Treasury Department and the IRS that even though the regulations set forth a general rule that an entity is disregarded as a separate entity from the owner for self-employment tax purposes, some taxpayers may have read the current regulations to permit the treatment of individual partners in a partnership that owns a disregarded entity as employees of the disregarded entity because the regulations did not include a specific example applying the general rule in the partnership context. Under this reading, which was not intended, some taxpayers have permitted partners to participate in certain tax-favored employee benefit plans. The Treasury Department and the IRS note that the regulations did not create a distinction between a disregarded entity owned by an individual (that is, a sole proprietorship) and a disregarded entity owned by a partnership in the application of the self-employment tax rule. Rather, § 301.7701-2(c)(2)(iv)(C)(
To address this issue, the Treasury Department and the IRS clarify in these temporary regulations that the rule that a disregarded entity is treated as a corporation for employment tax purposes does not apply to the self-employment tax treatment of any individuals who are partners in a partnership that owns a disregarded entity. The rule that the entity is disregarded for self-employment tax purposes applies to partners in the same way that it applies to a sole proprietor owner. Accordingly, the partners are subject to the same self-employment tax rules as partners in a partnership that does not own a disregarded entity.
This document contains amendments to the Procedure and Administration Regulations (26 CFR part 301) under section 7701 of the Code to clarify that a disregarded entity that is treated as a corporation for purposes of employment taxes imposed under subtitle C of the
While these temporary regulations provide that a disregarded entity owned by a partnership is not treated as a corporation for purposes of employing any partner of the partnership, these regulations do not address the application of Rev. Rul. 69-184 in tiered partnership situations. Several commenters have requested that the IRS provide additional guidance on the application of Rev. Rul. 69-184 to tiered partnership situations, and have also suggested modifying the holding of Rev. Rul. 69-184 to allow partnerships to treat partners as employees in certain circumstances, such as, for example, employees in a partnership who obtain a small ownership interest in the partnership as an employee compensatory award or incentive. However, these commenters have not provided detailed analyses and suggestions as to how the employee benefit and employment tax rules would apply in such situations. The Treasury Department and the IRS request comments on the appropriate application of the principles of Rev. Rul. 69-184 to tiered partnership situations, the circumstances in which it may be appropriate to permit partners to also be employees of the partnership, and the impact on employee benefit plans (including, but not limited to, qualified retirement plans, health and welfare plans, and fringe benefit plans) and on employment taxes if Rev. Rul. 69-184 were to be modified to permit partners to also be employees in certain circumstances.
In order to allow adequate time for partnerships to make necessary payroll and benefit plan adjustments, these temporary regulations will apply on the later of: (1) August 1, 2016, or (2) the first day of the latest-starting plan year following May 4, 2016, of an affected plan (based on the plans adopted before, and the plan years in effect as of, May 4, 2016) sponsored by an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2. For these purposes, an affected plan includes any qualified plan, health plan, or section 125 cafeteria plan if the plan benefits participants whose employment status is affected by these regulations. For rules that apply before the applicability date of these regulations, see 26 CFR part 301 revised as of April 1, 2016.
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the Special Analysis section in the preamble to the cross-referenced notice of proposed rulemaking in the Proposed Rules section of this issue of the
The principal author of these regulations is Andrew Holubeck of the Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 301 is amended as follows:
26 U.S.C. 7805 * * *
The revision and addition reads as follows:
(c) * * *
(2) * * *
(iv) * * *
(C) * * *
(
(e)(8) [Reserved]. For further guidance, see § 301.7701-2T(e)(8).
(a) through (c)(2)(iv)(C)(
(
(c)(2)(iv)(D) through (e)(7) [Reserved]. For further guidance, see § 301.7701-2(c)(2)(iv)(D) through (e)(7).
(8)(i)
(A) August 1, 2016, or
(B) The first day of the latest-starting plan year following May 4, 2016, of an affected plan (based on the plans adopted before, and the plan years in effect as of, May 4, 2016) sponsored by an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2. For rules that apply before the applicability date of these regulations, see 26 CFR part 301 revised as of April 1, 2016. For these purposes—
(
(
(3) A health plan means an arrangement described under § 1.105-5 of this chapter.
(ii)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Cape Fear River near Southport, North Carolina. This temporary safety zone is intended to restrict vessels from a portion of the Cape Fear River during the Barrier Island Challenge Stand Up Paddle Board Race. This action is necessary to protect the safety of race participants when they cross the Lower Swash Channel of the Cape Fear River. Entry into or movement within the safety zone during the enforcement period is prohibited without approval of the Captain of the Port.
This rule is effective on May 7, 2016, from 9:30 a.m. through 11:30 a.m.
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 LCDR Derek J. Burrill, Waterways Management Division Chief, Sector North Carolina, Coast Guard; telephone (910) 772-2230, 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 final details of this event were not provided until April 12, 2016, making it impracticable to publish an NPRM.
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. 1231. The Captain of the Port North Carolina (COTP) has determined that potential hazards associated with the Barrier Island Challenge Paddle Board Race on May 07, 2016 will be a safety concern when race participants cross the Lower Swash Channel on the Cape Fear River, Southport, North Carolina, a major shipping channel. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Lower Swash Channel on the Cape Fear River. The safety zone will encompass all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina. This safety zone will be established in the interest of public safety due to the participants crossing the Cape Fear River. This rule will be enforced on May 07, 2016 during the times of 9:30 a.m. through 11:30 a.m., unless otherwise cancelled earlier by the COTP.
Except for vessels authorized by the Captain of the Port or her Representative, no person or vessel may enter or remain in the safety zone during the time frame listed. The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice among the affected segments of the public. This will include publication in the Local Notice to Mariners and Marine Information Broadcasts.
We developed this rule after considering numerous statutes and Executive Orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 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. E.O. 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 E.O. 12866. Accordingly,
The primary impact of these regulations will be on limiting all vessels wishing to transit the affected waterways during enforcement of the safety zone on the Cape Fear River within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m., unless otherwise cancelled by the COTP. Although these regulations prevent traffic from transiting a portion of the Cape Fear River during this event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected 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 safety zone may be small entities, for the reasons stated in section V.A. 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. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. 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 E.O. 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 E.O. 13132.
Also, this rule does not have tribal implications under E.O. 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 an 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 the establishment of a safety zone to limit vessels within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m. to protect life and property of mariners from the hazards associated with the event. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
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 temporarily amends 33 CFR part 100 as follows:
33 U.S.C. 1233
(a)
(b)
(c)
(2) The operator of any vessel in the immediate vicinity of this safety zone shall:
(i) If on scene proceed as directed by any commissioned, warrant or petty officer on shore or on board a vessel that is displaying a U.S. Coast Guard Ensign.
(3) The Captain of the Port, North Carolina can be reached through the Sector North Carolina Command Duty Officer at Sector North Carolina in Wilmington, North Carolina at telephone number (910) 343-3882.
(4) The Coast Guard Representatives enforcing the safety zone can be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and channel 16 (156.8 Mhz).
(d)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action on three separate and independent types of determinations for each of the 36 areas that are currently classified as “Marginal” for the 2008 ozone National Ambient Air Quality Standards (NAAQS). First, the EPA is determining that 17 areas attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014. Second, the EPA is granting 1-year attainment date extensions for eight areas on the basis that the requirements for such extensions under the Clean Air Act (CAA) and the EPA's implementing regulations have been met. Third, the EPA is determining that 11 areas failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015, and thus are reclassified by operation of law as “Moderate” for the 2008 ozone NAAQS. States containing any or any portion of these new Moderate areas must submit State Implementation Plan (SIP) revisions that meet the statutory and regulatory requirements that apply to 2008 ozone nonattainment areas classified as Moderate by January 1, 2017.
This rule is effective on June 3, 2016.
The EPA has established docket number EPA-HQ-OAR-2015-0468 for this action. All documents in the docket are listed on
Mr. Cecil (Butch) Stackhouse or Mr. H. Lynn Dail, Office of Air Quality Planning and Standards, Air Quality Policy Division, Mail Code C539-01, Research Triangle Park, NC 27711. Telephone Mr. Stackhouse at (919) 541-5208 or Mr. Dail at (919) 541-2363; or both at fax number: (919) 541-5315; email addresses:
On August 27, 2015, the EPA proposed to find that 17 Marginal areas attained the 2008 NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014.
The EPA proposed two options for establishing a deadline for states to submit the SIP revisions required for Moderate areas once their areas are reclassified from Marginal. The first option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than the beginning of the ozone season in 2017 for each respective area. The second option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than January 1, 2017. After consideration of the comments received on these proposed options, the EPA is finalizing a due date of no later than January 1, 2017, for all Moderate area SIP requirements that apply to newly reclassified areas.
In the proposal, the EPA evaluated data from air quality monitors in the 36 areas classified as Marginal for the 2008 ozone NAAQS in order to determine each area's attainment status as of the applicable attainment date of July 20, 2015. Seventeen of the 36 nonattainment areas' monitoring sites with valid data had a design value
Of the 36 Marginal nonattainment areas for the 2008 ozone NAAQS, there are eight areas for which the EPA proposed to grant a 1-year attainment date extension based on determinations that these areas met the requirements for an extension under CAA section 181(a)(5), including compliance with all commitments and requirements in the applicable implementation plan and “clean” data in the year preceding the attainment year. In addition, for each of these areas, at least one state with jurisdiction over all or part of the area requested such an extension.
The EPA proposed that eight Marginal nonattainment areas for the 2008 ozone NAAQS failed to attain the NAAQS by July 20, 2015, but met the attainment date extension criteria of CAA section 181(a)(5), as interpreted in 40 CFR 51.1107. The EPA proposed to find that all implicated states were meeting the obligations and commitments of their applicable implementation plans, in accordance with CAA section 181(a)(5)(A), and that, per CAA section 181(a)(5)(B) and the implementing regulations, the 4th highest daily maximum 8-hour average concentrations for all monitors in each area were not greater than 0.075 ppm for 2014, the year preceding the attainment year (
Lastly, the EPA proposed to determine that 11 areas (listed in Table 3) failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015 and were not eligible for a 1-year attainment date extension. For each of these areas, the 4th highest daily maximum 8-hour average for at least one monitor in each area was greater than 0.075 ppm for 2014. CAA section 181(b)(2)(A) provides that a Marginal nonattainment area shall be reclassified by operation of law upon a determination by the EPA that such area failed to attain the relevant NAAQS by the applicable attainment date. The new classification proposed for each of these 11 areas would be the next higher classification of “Moderate” under the CAA statutory scheme.
The EPA also proposed to apply the Administrator's discretion, per CAA section 182(i), to adjust the statutory deadlines for submitting required SIP revisions for reclassified Moderate ozone nonattainment areas. CAA section 182(i) requires that reclassified areas meet the applicable plan submission requirements “according to the schedules prescribed in connection with such requirements, except that the Administrator may adjust any applicable deadlines (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.” Under the Moderate area plan requirements of CAA section 182(b)(1) and 40 CFR 51.1108, states with ozone nonattainment areas classified as Moderate are provided 3 years (or 36 months) from the date of designation to submit a SIP revision complying with the Moderate ozone nonattainment plan requirements. For areas designated nonattainment for the 2008 ozone NAAQS and originally classified as Moderate, that deadline was July 20, 2015, a date that has already passed. The EPA, therefore, interpreted CAA section 182(i) as providing the authority to adjust the applicable deadlines “as necessary or appropriate to assure consistency among the required submissions” for the 11 reclassified 2008 Marginal ozone nonattainment areas. The CAA neither provides authority for the EPA to adjust the deadline to provide the full 3 years from the date of reclassification nor provides that the EPA may adjust the attainment date. In determining an appropriate deadline for the states with jurisdiction for these 11 reclassified nonattainment areas to submit their Moderate area SIP revisions, the EPA proposed two options for deadlines. The first proposed option would require that states submit the required SIP revisions as expeditiously as practicable, but no later than the beginning of the ozone season in 2017 for each state. We believed that this option would provide states additional time that may be needed to accomplish planning, administrative and SIP revision processes. Of the 11 areas proposed for reclassification to Moderate, four areas have ozone seasons that begin later than January 1 (based on ozone monitoring season changes finalized with the 2015 ozone NAAQS)
On June 18, 2012, the EPA issued a clean data determination (CDD) for the NY-NJ-CT nonattainment area, suspending the three states' obligations to submit attainment-related planning requirements, including the obligation to submit attainment demonstrations, RACM and reasonable further progress (RFP) plans, and contingency measures, with respect to the 1997 8-hour ozone
In the agency's August 27, 2015, proposal regarding determinations of attainment of the 2008 Marginal ozone areas, the EPA discussed how its proposed actions affected the May 2014 proposed options for responding to a SIP Call for the 1997 8-hour ozone NAAQS. Specifically, the proposed option to permit the relevant states to respond to the final SIP Call by requesting reclassification to Moderate for the 2008 ozone standard [
The publication of the EPA's proposed rule on August 27, 2015, (80 FR 51992) started a public comment period that ended on September 28, 2015.
Pursuant to section 181(b)(2)(A) of the CAA and 40 CFR 51.1103, the EPA is making a final determination that the 17 Marginal nonattainment areas listed in Table 1 attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2105. We received no adverse comments on this proposal.
Once effective, this action satisfies the EPA's obligation pursuant to CAA section 181(b)(2)(A) to determine, based on an area's air quality as of the attainment date, whether the area attained the standard by that date. The effect of a final determination of attainment by the area's attainment date is to discharge the EPA's obligation under CAA section 181(b)(2)(A), and to establish that, in accordance with CAA section 181(b)(2)(A), the areas will not be reclassified for failure to attain by the applicable attainment date. These determinations of attainment do not constitute a redesignation to attainment. Redesignations require states to meet a number of additional statutory criteria, including the EPA approval of a state plan demonstrating maintenance of the air quality standard for 10 years after redesignation. As for all NAAQS, the EPA is committed to working with states that choose to submit redesignation requests for the 2008 ozone NAAQS.
Pursuant to CAA section 181(a)(5), the EPA is making a final determination to grant 1-year attainment date extensions of the applicable attainment date from July 20, 2015, to July 20, 2016, for the 8 Marginal nonattainment areas listed in Table 2. The EPA received a number of comments on its proposal to extend the Marginal area attainment dates for the areas listed in Table 2. We summarize and respond to some of the key comments. The docket for this action contains a more detailed Response to Comment document.
The statutory provisions governing voluntary reclassifications and requests for 1-year attainment date extensions differ in key respects regarding the question of whether all states in a nonattainment area need to request the action before the EPA may grant such requests. CAA section 181(b)(3), which governs voluntary reclassifications, states that “the Administrator shall grant the request of any State to reclassify a nonattainment area
Interpreting these two provisions to permit differing thresholds of state “unanimity” is particularly reasonable given the consequence of the EPA's action in each case. In extending an attainment date, the EPA imposes no additional obligation upon any state, but rather grants areas that are close to achieving the air quality standard 1 additional year to come into compliance, provided that the states governing that area meet certain criteria. A voluntary reclassification, on the other hand, can impose significant new attainment planning and emission reduction obligations. Had Congress intended to allow one state to request a reclassification on behalf of another state, and, therefore, to impose upon another state, without that state's consent, all of the resource-intensive consequences potentially associated with that action, it could have clearly stated so.
The EPA further disagrees with the commenter that its prior interpretation of CAA section 182(j)(1)—requiring all states in a multi-state ozone nonattainment area to agree to a voluntary reclassification—is inconsistent with
The EPA reviewed New Jersey's applicable ozone implementation plan found at 40 CFR 52.1570 and the most recent actions related to New Jersey's applicable ozone implementation plan, which include the following EPA approvals: 74 FR 22837—“Approval and Promulgation of Implementation plans, New Jersey Reasonable Further Progress Plans, Reasonable Available Control Technology, Reasonably Available Control Measures and Conformity Budgets”; 75 FR 45483—“Approval and Promulgation of Implementation Plans; Implementation Plan Revision; State of New Jersey”; and 75 FR 80340—“Approval and Promulgation of Implementation Plans; New Jersey; 8-hour Ozone Control Measure.” Since the adoption of these measures, New Jersey has also amended its SIP to adopt and implement additional emission reductions as part of its SIPs to reduce regional haze and to meet the NAAQS for fine particles. The EPA has reviewed the contents of New Jersey's applicable SIPs and notes that there are no pending enforcement actions by the EPA or outside parties alleging that New Jersey has failed to implement its applicable plan.
Similarly, the EPA reviewed Delaware's applicable ozone implementation plan found at 40 CFR 52.420. In our August 2015 proposal, we noted a recent proposal to disapprove a revision to Delaware's New Source Review (NSR) preconstruction permitting program regulation,
Moreover, the commenter has not presented any evidence or made any demonstration that suggests either New Jersey or Delaware is not in compliance with their applicable SIP and is, thus, unqualified to receive an attainment date extension. Based on its review of the states' applicable implementation plans and its knowledge and expertise of state actions with regard to those plans, the EPA is making a final determination that both New Jersey and Delaware are meeting the conditional requirement of CAA section 181(a)(5)(A).
Pursuant to CAA section 181(b)(2), the EPA is finalizing its proposed determinations that the 11 Marginal nonattainment areas listed in Table 3 have failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, upon the effective date of this rule, these 11 Marginal 2008 ozone nonattainment areas will be reclassified by operation of law to Moderate for the 2008 ozone standard. The EPA received a number of adverse comments on its proposal to find that certain Marginal nonattainment areas failed to attain and to reclassify those areas. We summarize and respond to some of the key comments later. The docket for this action contains a more detailed Response to Comments document.
The EPA received a number of comments on its two proposed options for establishing the Moderate area SIP due date that would apply to areas newly reclassified under this final action. After full consideration of those comments and pursuant to CAA section 182(i), the EPA is finalizing that SIP revisions required for the newly reclassified Moderate areas must be submitted as expeditiously as practicable, but no later than January 1, 2017. The EPA acknowledges that for some states with Moderate nonattainment areas reclassified from Marginal, meeting this SIP submittal deadline may be challenging. The EPA is committed to working closely with these states to help them prepare their SIP revisions in a timely manner.
We summarize and provide responses to the most significant comments on this issue later; however, all comments received on the proposed options and the EPA's responses are available in the Response to Comment document located in the docket for this final rule.
The EPA disagrees with the implication of the comment that the default assumption upon reclassification is that the EPA would not adjust the Moderate area SIP submission deadlines. The fact that Congress included CAA section 182(i) in the statute indicates that it envisioned that upon reclassification, deadlines would be adjusted by the Administrator in a reasonable fashion. This is a particularly reasonable interpretation under the facts at issue here: The attainment date for Marginal areas under the statute and regulations was July 20, 2015, and the Moderate area SIP submission date for areas initially classified as Moderate for the 2008 ozone NAAQS was also July 20, 2015. Under CAA section 181(b)(2)(A), the EPA must make determinations of attainment and necessary reclassifications within 6 months of the statutory attainment date. Therefore, under the commenter's interpretation of the CAA, upon reclassification 6 months after July 20, 2015, states would immediately be found to be in default of the obligation to submit a Moderate area plan, a deadline that had passed 6 months prior, even though that obligation did not apply until the moment of reclassification. We do not agree that Congress would have intended the draconian and absurd result of providing states initial notice of an obligation and in the same action finding them at fault for already failing to have met that obligation. Therefore, the EPA believes that it is reasonable to read CAA section 182(i) in the context of the 11 reclassified 2008 Marginal ozone areas to provide the Administrator the authority to adjust the applicable deadline for Moderate area attainment plans “as necessary or appropriate to assure consistency among the required submissions.”
Moreover, failing to establish new Moderate area SIP submission deadlines for the 11 areas that we are reclassifying in this rulemaking would lead to potential inconsistency in required submissions among those areas. Under the commenter's interpretation, these areas would all have missed their deadline to submit a Moderate area plan on July 20, 2015. The commenter would, therefore, have the EPA begin issuing findings of failure to submit under CAA section 110(k), which are required by statute 6 months following the statutory deadline to submit a SIP, simultaneously with this action, that is, the EPA's determination that the areas failed to attain and reclassification of those areas. Following the EPA's issuance of findings of failure to submit for the 11 areas, there would be no defined statutory or regulatory deadline by which to remedy the states' failures to make submittals, except the outside limit of 2 years, the deadline for EPA's obligation to implement a Federal Implementation Plan (FIP). Additionally, if the EPA had not affirmatively determined that a state had made a complete SIP submittal for an area within 18 months from the issuance of a finding of failure to submit, the offset sanction identified in CAA section 179(b)(2) would apply to the affected nonattainment area.
The EPA also disagrees with the commenter that establishing a new SIP submittal deadline for the reclassified areas is in contravention of CAA section 110(l). CAA section 110(l) requires that plan revisions must go through notice and public hearing at the state level before submission to the EPA, and that “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 . . . or any other applicable requirement of this chapter.” In order for the EPA's proposed SIP submittal date to be in contravention of CAA section 110(l), one has to assume that the states will submit deficient SIPs and that the EPA will not take any kind of corrective action on those SIPs until after the maximum possible time period permitted under the statue to take action on such submittals (18 months) has passed. Only then could a SIP submittal date of more than 18 months prior to the attainment date be interpreted as interfering with the attainment of the NAAQS. The EPA does not believe this is a reasonable reading of CAA section 110(l) or the circumstances of these reclassifications and SIP deadline adjustments. While the EPA acknowledges that the timeline for preparation and submittal of SIPs must be compressed in order for measures to be in place to ensure areas attain by their new Moderate area attainment date, in establishing the new SIP submittal deadlines for these reclassified areas, the agency is also taking into account the time required for states to identify measures, complete the public notice and hearing process at the state level, and prepare SIP submissions.
This action finalizes the EPA's determination that the NY-NJ-CT nonattainment area failed to attain the
By reclassifying the area by operation of law, this final action effectively eliminates the need for the three affected states to request reclassification under this option. However, as explained in the agency's August 27, 2015, proposal and reiterated later, the EPA believes it is appropriate for the three states involved to be able to meet their obligations under the SIP Call for the 1997 ozone NAAQS with their Moderate area SIP submittal for the 2008 ozone standard. This final action also supersedes the 18 months, which is the maximum period allowed under CAA section 110(k)(5), that EPA proposed to provide the states of New York, New Jersey and Connecticut from the effective date of a final SIP Call to develop and submit to the EPA the relevant SIPs for the 1997 or 2008 ozone NAAQS. As discussed previously, the EPA is finalizing that the required SIP revisions for these areas shall be submitted as expeditiously as practicable, but no later than January 1, 2017. We also note that this deadline meets the statutory timeframe for a SIP revision under CAA section 110(k)(5).
The EPA did not receive adverse comments on its August 27, 2015, proposal to reclassify the NY-NJ-CT nonattainment area to Moderate, nor did the EPA receive comments about its statement that submitting an attainment plan for the 2008 ozone standard would satisfy a final SIP Call on the 1997 ozone standard. We received a number of comments on the May 15, 2014, proposal (79 FR 27830) to rescind the CDD for the NY-NJ-CT 1997 8-hour ozone nonattainment area and the accompanying SIP Call for attainment plans. We summarize later some of the significant comments submitted in response to the May 15, 2014, proposal and our responses. Additionally, we have made available a more detailed summary of comments and responses in a document titled, “
For the 1997 ozone NAAQS specifically, twenty states are required under CSAPR to reduce NO
The timing of CSAPR's implementation was initially affected by litigation over the rule. On December 30, 2011, the D.C. Circuit stayed the effectiveness of CSAPR pending resolution of judicial review. On August 21, 2012, the D.C. Circuit vacated CSAPR,
The EPA disagrees with the commenter that the Supreme Court's decision in
The EPA also does not agree that it would be appropriate in this action to more broadly apply its 110(k)(5) authority to include additional states in this SIP Call to address interstate pollutant transport as described in sections 176A and 184 of the CAA. The EPA acknowledges that a number of states, including Connecticut and New York, submitted a petition under CAA section 176A requesting that the EPA add additional states to the Ozone Transport Region (OTR) that was established under section 184 of the CAA. The EPA is reviewing that petition separately and is not acting on that petition in this action. In addition, the EPA's authority to require SIP revisions under 110(k)(5) as they relate to additional control measures required by CAA section 184 applies to only states that are currently part of the OTR.
The CAA requires that states with areas designated as nonattainment submit to the Administrator the appropriate SIP revisions and implement specified control measures by certain dates applicable to the area's classification. By requiring additional planning and implementation requirements for the 11 nonattainment areas that we determined failed to attain the 2008 ozone NAAQS standard, the part of this action reclassifying those 11 areas from Marginal to Moderate will protect all those residing, working, attending school, or otherwise present in those areas regardless of minority or economic status.
This action is exempt from review by the Office of Management and Budget (OMB) because it makes determinations if designated 2008 ozone nonattainment areas are either attaining or failing to attain the 2008 ozone NAAQS by the attainment date along with resulting reclassifications or determination to grant 1-year attainment date extensions.
This rule does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0695. This action to find that the Marginal ozone nonattainment areas listed in Table 3 failed to attain the 2008 NAAQS by the applicable attainment date, to reclassify those areas as Moderate ozone nonattainment areas, and to adjust any applicable deadlines, does not establish any new information collection burden that has not already been identified in the existing 2008 ozone NAAQS Information Collection Request number 2347.01.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Determinations of nonattainment and the resulting reclassification of nonattainment areas by operation of law under section 181(b)(2) of the CAA do not in and of themselves create any new requirements. Instead, this rulemaking only makes a factual determination, and does not directly regulate any entities. This action also establishes the deadline by which states will need to submit revisions to their SIPs to address the new Moderate area requirements, and that deadline, if based on the statute, would otherwise be more stringent. In this final action, the EPA is exercising discretion under CAA section 182(i) which allows the Administrator to provide state air agencies additional time to comply with those requirements.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects 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.
This action does not have tribal implications as specified in Executive Order 13175. No tribal areas are implicated in the 11 areas that we are finding to have failed to meet their attainment date. The CAA and the Tribal Authority Rule establish the relationship of the federal government and tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because this action determines that 11 areas, identified in Table 3, did not attain the 2008 ozone standard by their applicable attainment date and to reclassify these areas as Moderate ozone nonattainment areas and to adjust applicable deadlines.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained in the section of the preamble titled “Environmental Justice Considerations.”
This rule is exempt from the CRA because it is a rule of particular applicability that names specific entities where this rule makes factual determinations and does directly regulate any entities. The determinations of attainment and failure to attain the 2008 ozone NAAQS (and resulting reclassifications), and the determination to grant 1-year attainment date extensions do not in themselves create any new requirements beyond what is mandated by the CAA.
Under section 307(b)(1) of the CAA, petitions for judicial review of final actions that are locally and regionally applicable may be filed only in the United States Court of Appeals for the appropriate circuit. However, the statute also provides that notwithstanding that general rule, “a petition for review of any action . . . may be filed only in the United States Court of Appeals for the District of Columbia if such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” 42 U.S.C. 7607(b)(1).
Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, parts 52 and 81, title 40, chapter I of the Code of Federal Regulations are amended as follows:
42 U.S.C. 7401
(a) The EPA has determined that the Crittenden County Marginal 2008 ozone NAAQS nonattainment area attained the NAAQS by the applicable attainment date of July 20, 2015.
(b) [Reserved]
(e)
(1)
(2)
(p)
(c) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Seaford, DE 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Seaford nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).
(tt)
(m)
(f) The EPA has determined that the Baton Rouge Marginal 2008 ozone NAAQS nonattainment area attained the NAAQS by the applicable attainment date of July 20, 2015.
(k)
(a)
(b) [Reserved]
(p)
(b)
(f) * * *
(2) * * *
(v) Jamestown (consisting of Chautauqua County) as of June 3, 2016.
(n)
(c)
(nn)
(k) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Allentown-Bethlehem-Easton, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Allentown-Bethlehem-Easton, PA marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).
(l) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Lancaster, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Lancaster, PA Marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).
(m) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Reading, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Reading, PA Marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).
(c)
(d)
(a)
(b) [Reserved]
42 U.S.C. 7401,
The revisions and addition read as follows:
The revisions and addition read as follows:
The revisions and addition read as follows:
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective May 4, 2016. Objections and requests for hearings must be received on or before July 5, 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-2015-0014, is available at
Susan Lewis, 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 EPA's tolerance regulations at 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-2015-0014 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 July 5, 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-2015-0014, by one of the following methods:
•
•
•
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 mefenoxam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mefenoxam follows.
EPA has evaluated the available toxicity data and considered its 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. Mefenoxam is the enriched
The Agency reassessed the toxicity databases for metalaxyl and mefenoxam in accordance with current policies and determined that many of the effects previously noted in several toxicological studies are no longer considered to be adverse (
Adverse effects were only observed from acute exposure to rats. In the rat developmental toxicity study of metalaxyl, maternal toxicity consisted of dose-related increased incidence of convulsions that occurred shortly after dosing, as well as other clinical signs. In a range-finding acute neurotoxicity study of mefenoxam, females showed abnormal functional observation battery (FOB) findings at lower doses than males. However, there was no indication of toxicity up to the HDT in the mefenoxam subchronic neurotoxicity study, which confirms the lack of adverse effects observed in all other repeated-dose studies.
There was no indication of developmental toxicity in studies of mefenoxam or metalaxyl. There was no indication of immunotoxicity in a mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have been classified as “not likely to be carcinogenic in humans” based on the results for metalaxyl in the carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats.
Specific information on the studies received and the nature of the adverse effects caused by mefenoxam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
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 degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for mefenoxam used for human risk assessment is shown in Table 1 of this unit.
1.
i.
Such effects were identified for mefenoxam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted a somewhat refined acute dietary exposure assessment for the proposed food use of mefenoxam on the rapeseed subgroup 20A and the existing uses of both metalaxyl and mefenoxam. Residues were assumed to be present at tolerance levels in plant commodities, with additional factors applied to certain plant commodities to include all residues of concern for risk assessment. Tolerance-level residues adjusted upward to account for metalaxyl/mefenoxam residues of concern in livestock commodities were used and based on data from metabolism studies on goats and hens. DEEM default and empirical processing factors were used as available. It was assumed that 100% of the crops were treated (100% CT).
ii.
iii.
iv.
2.
Based on the Surface Water Concentration Calculator (SWCC) and the Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of mefenoxam for acute exposures are estimated to be 741 parts per billion (ppb) for surface water and 3,700 ppb for ground water. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.
3.
Mefenoxam is currently registered for the following uses that could result in residential exposures: Residential turf and ornamentals, including nonbearing citrus trees. EPA assessed residential exposure using the following assumptions: Residential handler exposure is expected to be short-term in duration. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Residential post-application exposure was assessed based on short-term incidental oral risk estimates for children 1 < 2 years old. Dermal post-application risk assessments were not conducted because an adverse systemic dermal hazard was not identified for mefenoxam. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
1.
2.
3.
i. The toxicity database for metalaxyl and mefenoxam is complete.
ii. In the rat prenatal developmental toxicity with metalaxyl, maternal animals exhibited clinical signs indicative of neurobehavioral effects as previously discussed.
In the range-finding acute neurotoxicity study with mefenoxam, females exhibited abnormal functional observation battery (FOB) findings at doses lower than in males. In the subchronic neurotoxicity study with mefenoxam, there were no indications of neurotoxicity up to the HDT. In metalaxyl and mefenoxam treated adult animals, clinical signs and abnormal FOB findings were noted. However, a developmental neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam because (1) there are no indications of increased susceptibility for infants or children; (2) the convulsions observed in the rat prenatal developmental toxicity study occurred in the maternal animals with no effects being observed in the young; (3) the convulsions occurred only after a bolus dose; (4) the available developmental and range-finding acute neurotoxicity studies provided clear NOAELs and LOAELs for evaluating effects; (5) the current POD is below the level at which any effects were seen in either study, and (6) there were no other indications of neurotoxicity in the mefenoxam or metalaxyl databases, which include a subchronic (adult rat) neurotoxicity study for mefenoxam. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. In metalaxyl and mefenoxam treated animals, there was no evidence of increased susceptibility following pre-/postnatal exposure in the prenatal developmental toxicity studies or the reproduction and fertility effects study. There is no evidence that mefenoxam results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance levels or upper bound residue estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mefenoxam 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 mefenoxam.
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.
Several methods are available for enforcing tolerances: (1) A gas-liquid chromatography procedure employing an alkali flame ionization detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus detection; and (3) a multi-residue method in PAM, Vol 1.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
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 mefenoxam for the rapeseed crop subgroup 20A.
Therefore, tolerances are established for residues of mefenoxam, methyl
This action establishes tolerances 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 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 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.
(a) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS approves and implements through regulations the measures included in Framework Adjustment 27 to the Atlantic Sea Scallop Fishery Management Plan, which the New England Fishery Management Council adopted and submitted to NMFS for approval. The purpose of Framework 27 is to prevent overfishing, improve yield-per-recruit, and improve the overall management of the Atlantic sea scallop fishery. Framework 27 sets specifications for the scallop fishery for fishing year 2016, including days-at-sea allocations, individual fishing quotas, and sea scallop access area trip allocations; creates a new rotational closed area south of Closed Area 2 to protect small scallops; opens the northern portion of the Nantucket Lightship Access Area to the Limited Access General Category fleet; transfers 19 percent of the Limited Access General Category access area trips from the Mid-Atlantic Access Area to the northern portion of the Nantucket Lightship Access Area; and implements an accountability measure to the fishing year 2016 Northern Gulf of Maine Total Allowable Catch as a result of a fishing year 2015 catch overage.
Effective May 4, 2016.
The Council developed an environmental assessment (EA) for this action that describes the action and other considered alternatives and provides a thorough analysis of the impacts of these measures. Copies of the Framework, the EA, and the Initial Regulatory Flexibility Analysis (IRFA), are available upon request from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. The EA/IRFA is also accessible via the Internet at:
Copies of the small entity compliance guide are available from John K. Bullard, Regional Administrator, NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2298, or available on the internet at:
Travis Ford, Fishery Policy Analyst, 978-281-9233.
The Council adopted Framework 27 on December 3, 2015, and submitted a draft of the framework to NMFS on December 22, 2015, that presented Council recommended measures, rationale, impacts for review, and a draft EA. NMFS published a proposed rule, including a reference on how to obtain the framework and the draft final EA, for approving and implementing Framework 27 on February 24, 2016 (81 FR 9151). The proposed rule included a 30-day public comment period that closed on March 25, 2016. The Council submitted a final EA to NMFS on March 14, 2016, for approval. This annual action includes catch, effort, and quota allocations and adjustments to the rotational area management program for fishing year 2016. Framework 27 specifies measures for fishing year 2016, and includes fishing year 2017 measures that will go into place as a default should the next specifications-setting framework be delayed beyond the start of fishing year 2017. NMFS has approved all of the measures recommended by the Council and described below. The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) permits NMFS to approve, partially approve, or disapprove measures proposed by the Council based only on whether the measures are consistent with the fishery management plan, the Magnuson-Stevens Act and its National Standards, and other applicable law. We must defer to the Council's policy choices unless there is a clear inconsistency with the law or the FMP. Details concerning the development of these measures were contained in the preamble of the proposed rule and are not repeated here.
Table 1 outlines the scallop fishery catch limits derived from the ABC values.
This action deducts 1.25 million lb (567 mt) of scallops annually for 2016 and 2017 from the ABC and sets it aside
This action sets aside 1 percent of the ABC for the industry-funded observer program to help defray the cost of scallop vessels that carry an observer. The observer set-aside is 379 mt for fishing year 2016 and 379 mt for fishing year 2017. In fishing year 2016, the compensation rates for limited access vessels in open areas fishing under days-at-sea (DAS) is 0.11 DAS per DAS fished. For access area trips, the compensation rate is 175 lb (79 kg), in addition to the vessel's possession limit for the trip for each day or part of a day an observer is onboard. LAGC IFQ vessels may possess an additional 175 lb (79 kg) per trip in open areas when carrying an observer. NMFS may adjust the compensation rate throughout the fishing year, depending on how quickly the fleets are using the set aside. The Council may adjust the 2017 observer set-aside when it develops specific, non-default measures for 2017.
This action implements vessel-specific DAS allocations for each of the three limited access scallop DAS permit categories (
For fishing year 2016 and the start of 2017, Framework 27 keeps all three Georges Bank Access Areas (
Table 3 outlines the limited access allocations that can be fished from the MAAA, which each vessel can take in as many trips as needed, so long as the trip possession limits (also in Table 3) are not exceeded.
1. Delayed Harvesting of Default 2017 MAAA Allocations. Although the Framework includes default access area allocations for the 2017 fishing year (see 2017 allocations in Table 3), vessels have to wait to fish these allocations until April 1, 2017. This measure is precautionary to help to protect scallops when scallop meat weights are lower than other times of the year (generally, this change in meat-weight is a physiological change in scallops due to spawning). However, if a vessel has not fully harvested its 2016 scallop access area allocation in fishing year 2016, it may still fish the remainder of its allocation in the first 60 days of 2017 (
2. 2017 RSA Harvest Restrictions. This action prohibits vessels participating in RSA projects from harvesting RSA in access areas while default 2017 measures are in place. If default measures are in place at the start of 2017, RSA can only be harvested from open areas. The Council will re-evaluate this measure in the framework action that would set final 2017 specifications.
1.
Because Framework 27 will go into effect after the March 1 start of fishing year 2016, the default 2016 IFQ allocations went into place automatically on March 1, 2016. This action implements IFQ allocations greater than the default allocations. NMFS sent a letter to IFQ permit holders providing both March 1, 2016, IFQ allocations and Framework 27 IFQ allocations so that vessel owners know
2.
3.
Framework 27 allocates 2,068 and 602 trips in 2016 and the same default amounts for 2017, respectively, to the MAAA. Under default 2017 measures, LAGC IFQ vessels must wait to fish these trips until April 1, 2017. It also allocates 485 trips to the NLSN for fishing year 2016. The total number of trips for both areas combined (2,553) for fishing year 2016 is equivalent to the overall proportion of total catch from access areas compared to total catch. Framework 27 does not allocate any trips to either fleet category in NLSN for the 2017 fishing year.
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Despite the comments opposing the action, we find that the justification and analysis support the Council's recommendations, and that the Council process, in adopting Framework 27, followed up by the proposed and final rulemaking process, provided Council members and the public sufficient analysis to consider the proposed alternatives, including opening NLSN to LAGC vessels only, and adequate opportunity to comment on such alternatives. We have determined the Council's recommendations are consistent with law and we intend to approve all measures. Under the Magnuson-Stevens Act we can only disapprove a Council measure if it is not consistent with all applicable law. Otherwise, we give deference to the Council's policy recommendations.
This action includes several revisions to the regulatory text to address text that is unnecessary, outdated, unclear, or NMFS could otherwise improve. NMFS proposed these changes consistent with section 305(d) of the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that amendments to an FMP are carried out in accordance with the FMP and the Magnuson-Stevens Act. The first revision, at § 648.14(i)(2)(ii)(B)(
NMFS received several comments on Framework 27 after the Council voted to submit the action but prior to the publication of the proposed rule. The majority of these comments objected to the alternative to allow exclusive LAGC effort in the NLSN, but we also received comments supporting this alternative. We considered these comments when preparing the proposed rule, but they did not present sufficient legal concerns that would require us to discuss possible disapproval of the measure in the proposed rule. Because these comments were mostly mirrored in comments on the proposed rule, we have not summarized them here.
We received 17 comment letters on the proposed rule during the public comment period, including letters from 14 individuals; the Associated Fisheries of Maine (AFM); the Virginia Department of Environmental Quality; and Fisheries Survival Fund (FSF). The following summarizes the issues raised in the comments and NMFS's responses.
The Council heard public comment during the discussion of this measure both against and in support of this alternative, including comments against the measure from different representatives of FSF. The analyses included in the PDT memo, in combination with the public comment solicited at the meeting, and other analyses in Framework 27, allowed the Council to make an informed decision on this alternative. While this timing was tight, the process was consistent with the intent of the cited regulation in that it gave advance notice and analysis to the public over the course of two meetings (the November Committee meeting and the December Council meeting) before the measure was adopted. The Council frequently adjusts specific management alternatives that are logical outgrowths in the actions it is considering at or just before the final Council meeting. This provides the Council with the flexibility to consider sensible solutions or adjustments to these logical outgrowth alternatives without postponing action. Indeed, FSF was pushing for the adoption of its own sponsored proposed alternative even though it was subject to the same sequence of events and given the same analysis and consideration as the NSLN alternative. Therefore, we conclude that the Council and the public, including FSF, had more than adequate opportunity to consider and comment on the NLSN measure. Further, the adoption of this measure by the Council was consistent with the Council's procedural requirements to ensure that measures it adopts are sufficiently analyzed and the public is sufficiently aware of the analysis and propose alternatives before it adopts such a measure. Even if the Council's activity marginally infringed its established procedures because of the tight timing, courts, including those cited by FSF, have held that if there were procedural irregularities, they would not necessarily invalidate a regulation if such irregularities resulted in only “harmless error,” or there is no evidence that our decision to approve the alternative was materially affected by the Council's procedural irregularities (for which there is no evidence in this instance). Indeed, the Ninth U.S. Circuit Court of Appeals has held that “[i]if the Secretary has followed the appropriate rulemaking procedures and has established a rational basis for this action in promulgating regulations based on the submitted amendment, procedural challenges for irregularities at the Council level will not provide a justification for invalidating the regulations.”
The best available science shows that allowing access to the LAGC fleet will not harm the resource. Indeed, the analysis in the draft and final EA and the PDT memo concludes that the alternative allowing three times more access (400 mt) by limited access vessels and LAGC vessels would not jeopardize sustainability of the scallop resource.
We included changes to the regulatory text to § 648.62 to implement an AM due to the overage of the NGOM TAC.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, the ESA, and other applicable law.
The Office of Management and Budget (OMB) has determined that this rule is not significant pursuant to Executive Order (E.O.) 12866.
This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
This action does not contain any collection-of-information requirements subject the Paperwork Reduction Act (PRA).
The Assistant Administrator for Fisheries has determined that the need to implement these measures in an expedited manner in order to help achieve conservation objectives for the scallop fishery and certain fish stocks constitutes good cause, under authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness and to make the Framework 27 final measures effective upon publication in the
Because Framework 27 has not yet been approved and implemented, certain default measures, including access area designations and DAS, IFQ, research set-aside and observer set-aside allocations, are automatically put into place. These default allocations were purposely set to be more conservative than what would eventually be implemented under Framework 27. Under default measures, each full-time vessel has 26 DAS and one access area 17,000-lb (7,711-kg) trip in the MAAA. We have good cause to waive the 30-day delay in effectiveness because this action provides full-time vessels with an additional 8.55 DAS (34.55 DAS total) and 34,000 lb (15,422 kg) in access area allocation (51,000 lb (23,133 kg) total) into the MAAA. Further, LAGC IFQ vessels will receive an additional 330 mt (2,029 mt total) of allocation and 1,466 trips into the MAAA (2,068 trips total) and 485 trips in the NLSN. Framework 27 could not have been put into place sooner to allow for a 30-day delayed effectiveness because the information and data necessary for the Council to develop the framework was not available in time. We received the final submission of the EA from the Council on March 14, 2016. We published the proposed rule on February 24, 2016, and the comment period did not close until March 25, 2016. Delaying the implementation of Framework 27 for 30 days would delay positive economic benefits to the scallop fleet and could negatively impact the access area rotation program by delaying fishing in access areas that should be available. There are no new measures that implement additional burdens on the fleet, and we do not expect that any members of the scallop industry will be aggrieved by waiving this delay.
NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Framework 27 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 27 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 27 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the Regulatory Impact Review (RIR), and the EA are available upon request (see
There were no specific comments on the IRFA. The Comments and Responses section summarizes the comments that highlight concerns about the economic impacts and implications of impacts on small businesses (
The regulations affect all vessels with limited access and LAGC scallop permits. The Framework 27 EA provides extensive information on the number and size of vessels and small businesses that will be affected by the regulations, by port and state (see
Ownership data from 2014 result in 166 distinct ownership entities for the limited access fleet and 106 distinct ownership entities for the LAGC IFQ fleet. Of these, and based on the Small Business Administration (SBA) guidelines, 152 of the limited access distinct ownership entities and 102 of the LAGC IFQ entities are categorized as small. The remaining 14 of the limited access and 4 of the LAGC IFQ entities are categorized as large entities, all of which are shellfish businesses.
This action contains no new collection-of-information, reporting, or recordkeeping requirements.
During the development of Framework 27, NMFS and the Council considered ways to reduce the regulatory burden on, and provide flexibility for, the regulated entities in this action. For example, they opened the NLSN to LAGC vessels to provide vessels homeported in Massachusetts an opportunity to fish in an access area without traveling to the MAAA. This measure addresses safety and economic concerns for smaller northern LAGC vessels when fishing in an access area. Final actions and alternatives are described in detail in Framework 27, which includes an EA, RIR, and IRFA (available at
Overall, this rule minimizes adverse long-term impacts by ensuring that management measures and catch limits result in sustainable fishing mortality rates that promote stock rebuilding, and as a result, maximize yield. The measures implemented by this final rule also provide additional flexibility for fishing operations in the short-term. This final rule implements measures that enable small entities to offset some portion of the estimated economic impacts. These measures include allocating about 19 percent of LAGC IFQ access area trips (or 300,000 lb (136 mt)) to the NLSN which is open to LAGC vessels only. Because of the proximity of the LAGC vessels, which are smaller in size and homeported in Massachusetts to NLSN, this option will reduce fishing costs and have positive impacts on their profits; and allowing about 1.5 million lb (680 mt) of the total LAGC allocation of 4.4 million lb (1,996 mt) to be harvested from access areas.
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(i) * * *
(2) * * *
(ii) * * *
(B) * * *
(
(3) * * *
(v) * * *
(B) Declare into or leave port for an area specified in § 648.59(a) through (d) after the effective date of a notification published in the
(C) Fish for or land per trip, or possess in excess of 40 lb (18.1 kg) of shucked scallops at any time in or from any Sea Scallop Access Area specified at § 648.59, unless declared into the Sea Scallop Access Area Program.
(e) * * *
(2) The vessel may not use or have more than one dredge on board. However, component parts may be on board the vessel such that they do not conform with the definition of “dredge or dredge gear” in § 648.2,
(f) A limited access vessel or an LAGC vessel that is declared into the Sea Scallop Area Access Program as described in § 648.60, may not possess more than 50 bu (17.6 hL) or 75 bu (26.4 hL), respectively, of in-shell scallops outside of the Access Areas described in § 648.59(a) through (e).
(a)
(1) ABC/ACL for fishing years 2016 through 2017, excluding discards, shall be:
(i) 2016: 37,852 mt.
(ii) 2017: 37,852 mt.
(2)
(3)
(i) The limited access fishery sub-ACLs for fishing years 2016 and 2017 are:
(A) 2016: 36,884 mt.
(B) 2017: 36,884 mt.
(ii) The limited access fishery ACTs for fishing years 2016 and 2017 are:
(A) 2016: 18,290 mt.
(B) 2017: 18,290 mt.
(4)
(i) The ACLs for fishing years 2016 and 2017 for LAGC IFQ vessels without a limited access scallop permit are:
(A) 2016: 1,845 mt.
(B) 2017: 1,845 mt.
(ii) The ACLs for fishing years 2016 and 2017 for vessels issued both a LAGC and a limited access scallop permits are:
(A) 2016: 184 mt.
(B) 2017: 184 mt.
(b) * * *
(1)
(i) 2016 fishing year: 2,316 lb/DAS (1.051 kg/DAS).
(ii) 2017 fishing year: 2,690 lb/DAS (1,220 kg/DAS).
(iii) [Reserved]
(4) Each vessel qualifying for one of the three DAS categories specified in the table in this paragraph (b)(4) (full-time, part-time, or occasional) shall be allocated the maximum number of DAS for each fishing year it may participate in the open area limited access scallop fishery, according to its category, excluding carryover DAS in accordance with paragraph (d) of this section. DAS allocations shall be determined by distributing the portion of ACT specified in paragraph (a)(3)(ii) of this section, as reduced by access area allocations specified in § 648.59, and dividing that amount among vessels in the form of DAS calculated by applying estimates of open area LPUE specified in paragraph (b)(1) of this section. Allocation for part-time and occasional scallop vessels shall be 40 percent and 8.33 percent of the full-time DAS allocations, respectively. The annual open area DAS allocations for each category of vessel for the fishing years indicated are as follows:
(g) * * *
(1) To help defray the cost of carrying an observer, 1 percent of the ABC/ACL specified in paragraph (a)(1) of this section shall be set aside to be used by vessels that are assigned to take an at-sea observer on a trip. The total TAC for observer set aside is 379 mt in fishing
(b)
(2)
(c)
(e)
(a) * * *
(1) Beginning March 1, 2016, through February 28, 2018 (
(b) * * *
(1) From March 1, 2016, through February 28, 2018 (
(c) * * *
(1) From March 1, 2016, through February 28, 2018 (
(d) * * *
(1) From March 1, 2016, through February 28, 2018 (
(a) * * *
(3)
(B)
(
(C)
(
(D)
(
(5)
(c)
(e)
(i) 2016: The Mid-Atlantic Scallop Access Area, as specified in § 648.59(a).
(ii) 2017: None.
(2) [Reserved]
(g)
(2)
(3)
(ii) Scallops landed by each LAGC IFQ vessel on an access area trip shall count against the vessel's IFQ.
(iii) Upon a determination from the Regional Administrator that the total number of LAGC IFQ trips in a specified Access Area have been or are projected to be taken, the Regional Administrator shall publish notification of this determination in the
(iv)
(B) The Nantucket Lightship North Sea Scallop Access Area is defined by straight lines connecting the following points in the order stated (copies of a chart depicting this area are available from the Regional Administrator upon request):
(b) * * *
(1)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues a final rule to implement Amendment 109 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP). This final rule amends regulations governing the Western Alaska Community Development Quota (CDQ) Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 feet (ft) (14.0 meters (m)) length overall (LOA) using hook-and-line gear. Specifically, this final rule exempts operators of registered catcher vessels greater than 32 ft (9.8 m) LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry a License Limitation Program (LLP) license when groundfish CDQ fishing. This final rule also reduces observer coverage requirements for catcher vessels less than or equal to 46 ft LOA when groundfish CDQ fishing, and implements new in-season management and catch accounting requirements to properly account for the harvest of groundfish and halibut and the accrual of halibut prohibited species catch in these fisheries. In addition to the regulations necessary to implement Amendment 109, this final rule removes from the regulations a table and some explanatory text that are no longer necessary. This final rule is intended to facilitate increased participation by residents of CDQ communities in the
Effective June 3, 2016.
Electronic copies of the Regulatory Impact Review/Environmental Assessment (RIR/EA) and the Initial Regulatory Flexibility Analysis (IRFA) prepared for this action are available from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; and by email to
Sally Bibb, 907-586-7389.
This final rule implements Amendment 109 to the BSAI FMP. NMFS published a notice of availability (NOA) for Amendment 109 in the
This section summarizes background information about the CDQ Program and the regulatory constraints on the small catcher vessel hook-and-line halibut and groundfish CDQ fisheries that led the North Pacific Fishery Management Council (Council) to recommend Amendment 109 and this final rule. Additional background is included in the proposed rule (81 FR 6489; February 8, 2016) and is not repeated here.
The CDQ Program is an economic development program associated with federally managed fisheries in the BSAI. The purpose of the CDQ Program is to provide western Alaska communities with the opportunity to participate and invest in BSAI fisheries, to support economic development in western Alaska, to alleviate poverty and provide economic and social benefits for residents of western Alaska, and to achieve sustainable and diversified local economies in western Alaska. The CDQ Program also is a catch share program that allocates a portion of the BSAI total allowable catch limits for specific target crab and groundfish species, a portion of the commercial catch limits for halibut, and portions of certain prohibited species catch (PSC) limits to the CDQ Program. These amounts are then further allocated among the six CDQ groups as allocations that may be transferred among the CDQ groups. The primary focus of Amendment 109 is on the halibut CDQ allocations, the Pacific cod CDQ allocations, and the halibut PSC in the groundfish CDQ fisheries.
The successful harvest of CDQ Program allocations is integral to achieving the goals of the CDQ Program and the community development plans of each CDQ group. One of the most effective ways the CDQ groups provide benefits to residents of their CDQ communities is to use the CDQ allocations to create local small-scale commercial fisheries. For purposes of this final rule, “local small-scale” means CDQ fisheries prosecuted by catcher vessels that are less than or equal to 46 ft LOA, using hook-and-line gear, and homeported or operated from CDQ communities. These local small-scale fisheries provide opportunities for residents of the CDQ communities to earn income from the sale of the commercially harvested fish.
Certain Federal regulations have restricted the ability of fishermen in CDQ communities to harvest allocations of Pacific cod CDQ with small hook-and-line catcher vessels. In particular, requirements for full observer coverage and an LLP license limit the ability of CDQ community fishermen to retain Pacific cod CDQ when participating in the halibut CDQ fisheries or to develop separate local small-scale directed fisheries for Pacific cod CDQ. These regulatory constraints are described in more detail in the preamble to the proposed rule (81 FR 6489; February 8, 2016).
This final rule amends regulations governing the CDQ Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear as intended by Amendment 109. Specifically, this final rule:
• Exempts operators of registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry an LLP license when groundfish CDQ fishing (catcher vessels less than or equal to 32 ft LOA already are exempt from the LLP requirements in the BSAI under existing regulations);
• Implements new in-season management and catch accounting procedures to properly account for the harvest of groundfish and halibut and the accrual of halibut PSC by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when halibut or groundfish CDQ fishing;
• Allows halibut caught by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing to accrue as either halibut CDQ, halibut individual fishing quota (IFQ), or halibut PSC, on a trip-by-trip basis; and
• Places catcher vessels less than or equal to 46 ft LOA using hook-and-line gear in the partial observer coverage category when they are groundfish CDQ fishing. In addition to these changes for Amendment 109, the final rule removes a table and some explanatory text from observer program regulations at § 679.51(f) that are no longer necessary.
This final rule is intended to facilitate increased participation by residents of CDQ communities in the BSAI groundfish CDQ fisheries and to support economic development in western Alaska. This final rule benefits the six CDQ groups and the operators of the small hook-and-line catcher vessels that the CDQ groups authorize to fish on their behalf by reducing the costs of participating in the groundfish CDQ fisheries. More information about the
Regulations exempting specific vessels from LLP license requirements are codified at § 679.4(k)(2). This final rule adds a new paragraph (vi) to § 679.4(k)(2) to establish an LLP exemption for registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing. The operators of catcher vessels eligible for the LLP exemption are not required to obtain and carry an LLP license when they are groundfish CDQ fishing provided that certain vessel registration requirements are met prior to groundfish CDQ fishing.
This final rule adds a new paragraph at § 679.5(m) that includes the vessel registration requirements that must be met to receive an LLP exemption. To receive an LLP exemption, a CDQ group representative must register each eligible catcher vessel through NMFS' online CDQ vessel registration system (“the CDQ vessel registration system”). To successfully register a catcher vessel, the CDQ group representative must log into the CDQ vessel registration system using the CDQ group's existing NMFS ID and password and provide the information required on the computer screen. NMFS will add each catcher vessel successfully registered to the CDQ vessel registration list, and NMFS will post that list on the NMFS Alaska Region Web site at
With each successful registration, the CDQ vessel registration system will provide the CDQ group representative with an LLP exemption letter documenting that the vessel is eligible for the LLP exemption when groundfish CDQ fishing. The CDQ group representative must provide a copy of the LLP exemption letter to the vessel operator. NMFS will not provide the LLP exemption letter directly to vessel operators. The vessel operator must maintain a legible copy of the LLP exemption letter on board the named vessel at all times when that vessel is groundfish CDQ fishing. Because registered vessels must have a legible copy of the LLP exemption letter on board the vessel before the vessel operator starts groundfish CDQ fishing, the CDQ group representative and the vessel operator must allow sufficient time to complete the registration process prior to the start of groundfish CDQ fishing by the vessel.
The LLP exemption letter also will provide printable confirmation to the CDQ group of a successfully completed vessel registration. Once registered, a vessel will remain on the CDQ vessel registration list until removed by the CDQ group. The CDQ groups are not required to re-register vessels annually.
A CDQ group representative may remove a vessel from the CDQ vessel registration list at any time by logging into the CDQ vessel registration system and following the applicable instructions. To remove a vessel from the CDQ vessel registration list, the CDQ group representative must certify to NMFS that 1) the vessel operator has been given notice by the CDQ group that the vessel is being removed from the list, and 2) the vessel operator is not groundfish CDQ fishing at the time of removal. The CDQ vessel registration system will provide a printable confirmation that a vessel has been removed from the CDQ vessel registration list. Once a vessel is removed from the CDQ vessel registration list, that vessel is no longer exempt from the LLP requirements, even if the operator still possesses the LLP exemption letter. This final rule does not require a CDQ group representative to remove registered vessels from the CDQ vessel registration list when they are participating in a non-CDQ fishery.
To further clarify the vessel operator's responsibility, this final rule adds a new prohibition at § 679.7(d)(9) to prohibit the operator of a vessel eligible for the LLP exemption from conducting groundfish CDQ fishing without having a legible copy of the LLP exemption letter issued to a CDQ group for that vessel on board the vessel. In addition, this final rule adds a new prohibition at § 679.7(d)(10) to prohibit a CDQ group representative from removing a vessel from the CDQ vessel registration list without first providing notice to the operator of the registered vessel that the vessel is being removed from the CDQ vessel registration list, or when the vessel is groundfish CDQ fishing.
This final rule adds a new paragraph at § 679.32(c)(3)(iii) to establish the catch accounting and fishery monitoring requirements that apply to catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing and to the CDQ groups authorizing these vessels. Current regulations at § 679.32(c)(3)(i)(D) and (c)(3)(ii)(D) will continue to apply to catcher vessels greater than 46 ft LOA using hook-and-line gear when groundfish CDQ fishing.
This final rule also establishes catch accounting procedures in § 679.32(c)(3)(iii) that provide CDQ groups and vessel operators with the opportunity to retain halibut CDQ or halibut IFQ when groundfish CDQ fishing. If the vessel operator is relying on halibut CDQ from a CDQ group to support the retained catch of legal-size halibut during a fishing trip, the CDQ group must provide adequate halibut CDQ to this vessel operator to account for all the legal-size halibut caught by the vessel during the entire fishing trip. A CDQ group's halibut prohibited species quota (PSQ) will not be reduced if halibut is present in the landing. Landed halibut CDQ or halibut IFQ will accrue to the account balance of the permit holder identified by the processor in the landing report based on the permits held by the vessel operator or persons on board the vessel.
The operator of a hook-and-line catcher vessel less than or equal to 46 ft LOA who retains any halibut CDQ or halibut IFQ during the groundfish CDQ fishing trip must retain all legal-size halibut caught during that fishing trip. NMFS will continue to consider sub-legal-size halibut as wastage associated with the halibut fishery. As long as at least one halibut (IFQ or CDQ) is included in the groundfish CDQ landing, NMFS will not accrue any estimates of halibut PSC from the small catcher vessel groundfish CDQ fisheries to the CDQ group's halibut PSQ or to any component of the BSAI halibut PSC limit.
If no halibut are included in a groundfish CDQ landing, NMFS will accrue an estimate of halibut PSC to the CDQ group's small catcher vessel halibut PSC limit (described below). NMFS will estimate the halibut PSC associated with these types of groundfish CDQ fishing trips using halibut PSC rates as calculated by NMFS, and apply the halibut PSC rates when halibut fishing is closed or when halibut fishing is open but no halibut are included in a landing.
Under this final rule, NMFS will create a new quota category available to each CDQ group called the “small catcher vessel halibut PSC limit.” If a CDQ group wants to have a small hook-
With the exception of sablefish CDQ fishing, which will continue to be managed under § 679.32(c)(1), this final rule will prohibit groundfish CDQ fishing by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear unless NMFS publishes notification in the
If NMFS determines that a CDQ group's small catcher vessel halibut PSC limit has been or will be reached, NMFS will issue a notice in the
Even with conservative management, it is possible that a small catcher vessel halibut PSC limit could be exceeded due to the high degree of variability in halibut PSC rates that can occur in hook-and-line fisheries. If NMFS is unable to close a CDQ group's small catcher vessel groundfish CDQ fishery before it exceeds the amount of halibut PSC allocated to the small catcher vessel halibut PSC limit, NMFS will not consider this a violation, and NMFS will not require the CDQ group to transfer an amount of halibut PSQ needed to cover the negative balance. However, this final rule will allow a CDQ group to voluntarily choose to transfer additional halibut PSQ to bring the balance of its small catcher vessel halibut PSC limit to zero.
If a CDQ group's small catcher vessel halibut PSC limit has a negative balance at the end of the groundfish fishing year (December 31), and if the CDQ group has remaining halibut PSQ on that date, NMFS will transfer an amount of halibut PSQ into the CDQ group's small catcher vessel halibut PSC limit to bring the balance of the small catcher vessel halibut PSC limit to zero. NMFS will make this administrative transfer only after all fishing by a CDQ group is completed for the year, after data from the fishing year is finalized, and if the CDQ group has sufficient remaining halibut PSQ.
This final rule also will permit a CDQ group to transfer halibut from its small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ. In reviewing a request to transfer halibut from the small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ, NMFS will consider the status of CDQ fisheries through the end of the year and anticipated halibut PSC rates for any remaining groundfish CDQ fishing by vessels managed under the small catcher vessel halibut PSC limit for the requesting CDQ group.
This final rule adds paragraph (a)(1)(i)(D) to § 679.51 and revises § 679.51(a)(2)(i)(C)(2) to place catcher vessels less than or equal to 46 ft LOA that are using hook-and-line gear when groundfish CDQ fishing in the partial observer coverage category. Under current regulations, the owners or operators of vessels in the partial observer coverage category are placed in an observer selection pool based on the requirements of the Annual Deployment Plan (ADP). Since implementation of the ADP process in 2013, vessels less than 40 ft (12.2 m) LOA have been placed in the “no selection pool.” These vessels are not required to carry observers or register fishing trips with NMFS. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in the Observer Declare and Deploy System (ODDS). This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage. If selected for observer coverage, the catcher vessel is required to carry an observer. Operators of vessels selected for observer coverage are required to comply with all vessel responsibilities in § 679.51(e)(1). More information about logging trips in ODDS is on the NMFS Alaska Region Web site under “Frequently Asked Questions” about the Observer Program (
This final rule removes the table in § 679.51(f) that summarizes the observer coverage requirements for different management programs and industry sectors, and the introductory text about the table that is at the beginning of § 679.51. Prior to Observer Program Restructuring (77 FR 70062, November 21, 2012), this table was located at the beginning of subpart E as a table of contents or guide to observer coverage requirements. However, with the reorganization of observer coverage requirements in 2012 and the placement of this table at the end of § 679.51, it no longer serves its previous function as a table of contents for the section. Therefore, this table is removed.
During the public comment periods for the NOA for Amendment 109 and the proposed rule to implement Amendment 109, NMFS received one letter of comment on the NOA and one letter of comment on the proposed rule. Both of these letters were from one member of the public. NMFS' responses to these comments are presented below.
The paragraph numbers for two additions to prohibitions at § 679.7(d) are renumbered from paragraphs (d)(8) and (d)(9) to paragraphs (d)(9) and (d)(10), respectively, because a new paragraph (d)(8) was recently added to § 679.7 under the cost recovery program final rule (81 FR 150, January 5, 2016).
The final rule includes three revisions to § 679.51(a)(1)(i) to insert additional punctuation and make minor wording changes (moving placement of the word “or”) to the list of vessels that are in the partial observer coverage category. These minor changes are needed to reflect the addition of paragraph (a)(1)(i)(C) in § 679.51 through the final rule for Amendment 112 to the BSAI FMP and Amendment 102 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (81 FR 17403; March 29, 2016).
The Administrator, Alaska Region, NMFS, determined that Amendment 109 and this final rule are necessary for the conservation and management of the BSAI groundfish fisheries and that they are consistent with the Magnuson-Stevens Act and other applicable law.
Regulations governing the U.S. fisheries for Pacific halibut are developed by the International Pacific Halibut Commission (IPHC), the Pacific Fishery Management Council, the North Pacific Fishery Management Council (Council), and the Secretary of Commerce. Section 5 of the Northern Pacific Halibut Act of 1982 (Halibut Act, 16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The final rule is consistent with the Council's authority to allocate halibut catches among fishery participants in the waters in and off Alaska.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule (81 FR 6489; February 8, 2016) and the preamble to this final rule serve as the small entity compliance guide. This rule does not require any additional compliance from small entities that is not described in the preamble to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from NMFS at the following Web site:
Section 604 of the Regulatory Flexibility Act (RFA) requires an agency to prepare a FRFA after being required by that section or any other law to publish a general notice of proposed rulemaking and when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code. The following paragraphs constitute the FRFA for this action.
Section 604 describes the required contents of a FRFA: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.
A description of the need for, and objectives of, the rule is contained in the preamble to the proposed rule and this final rule and is not repeated here. This FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA) (see
NMFS published a proposed rule to implement Amendment 109 and the regulatory amendments on February 8, 2016 (81 FR 6489). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule ended on March 9, 2016. NMFS received one letter of comment on the proposed rule. This letter did not address the IRFA or the economic impacts of the rule more generally. The Chief Counsel for Advocacy of the Small Business Administration did not file any comments on the proposed rule.
This final rule will directly regulate two classes of small entities: (1) The six CDQ groups, which are non-profit corporations that represent the 65 western Alaska communities that are eligible to participate in the CDQ Program; and (2) the owners and operators of small hook-and-line catcher vessels who are authorized by a CDQ group to harvest groundfish or halibut CDQ allocations.
The RFA recognizes and defines three kinds of small entities: (1) Small businesses, (2) small non-profit organizations, and (3) small government jurisdictions. The CDQ groups are considered small entities due to their status as non-profit corporations. The Small Business Administration has established size standards for all major industry sectors in the United States. A business primarily involved in finfish harvesting is classified as a small business if it is independently owned
It is difficult to predict how many small hook-and-line catcher vessels may participate in the future under this final rule because no catcher vessels less than or equal to 46 ft LOA using hook-and-line gear currently are conducting directed fishing for groundfish CDQ. The best estimate of the upper bound of the number of future participants in the small catcher vessel Pacific cod CDQ fisheries is the maximum of 278 vessels less than or equal to 46 ft LOA that participated in the halibut CDQ fisheries from 2000 through 2013. NMFS assumes that all of the vessels that could be directly regulated by this action would be small entities based on estimated revenues of less than $20.5 million for all vessels and their known affiliations.
This final rule contains three new reporting and recordkeeping requirements that affect small entities. First, each CDQ group that authorizes catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear to fish for groundfish CDQ with an exemption from the LLP must register the vessel in an online CDQ vessel registration system developed and maintained by NMFS. All six CDQ groups will be subject to the vessel registration requirement if they have vessels participating.
Second, the operator of any registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear that is exempt from the LLP license requirements must maintain a legible copy of an LLP exemption letter on board the vessel at all times when groundfish CDQ fishing. The LLP exemption letter is generated through the CDQ vessel registration system when a CDQ group registers an eligible vessel. The CDQ group representative must provide this letter to the registered vessel operator. Depending on the level of participation, all six CDQ groups and all vessel operators could be subject to this requirement.
Third, small catcher vessels fishing for groundfish CDQ under this final rule will be placed in the partial observer coverage category. Vessels subject to observer coverage are determined annually through the Observer Program's ADP. Since inception of the ADP process in 2013, vessels less than 40 ft LOA have been placed in the “no selection pool” and have had no additional reporting or recordkeeping requirements. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in ODDS. This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage.
Vessels between 40 ft LOA and 46 ft LOA already log their halibut CDQ and halibut IFQ fishing trips in ODDS. Therefore, if these vessels are combining groundfish CDQ fishing with halibut CDQ or halibut IFQ fishing, they will not incur any additional reporting requirements associated with placement in the partial observer coverage category because the halibut trips already are in partial observer coverage. However, if any of these vessels start fishing for groundfish CDQ separate from their halibut CDQ or halibut IFQ fishing trips, then those additional fishing trips must be logged in ODDS. The cost of logging trips in ODDS represents an additional cost associated with the new small catcher vessel groundfish CDQ fisheries.
The RFA requires identification of any significant alternatives to the final rule that would accomplish the stated objectives of the proposed action, consistent with applicable statutes, and that would minimize any significant economic impact of the proposed rule on small entities. As noted in the IRFA, this final rule is expected to create a net benefit for the directly regulated small entities. The benefits of this action are expected to outweigh the reporting, recordkeeping, and other compliance costs described in the previous section.
The Council considered a status quo alternative (Alternative 1), and two action alternatives (Alternatives 2 and 3) in addition to this final rule (which was Alternative 4, the Council's preferred alternative). Neither Alternative 2 nor 3 would have provided more benefits to the directly regulated small entities or reduced reporting, recordkeeping, or compliance costs more than the preferred alternative that is implemented by this final rule.
Under Alternative 2, the maximum retainable amount (MRA) of Pacific cod in the halibut CDQ fisheries would have been increased so the operators of the small hook-and-line vessels could retain more Pacific cod when halibut CDQ fishing and still be considered directed fishing for halibut rather than directed fishing for Pacific cod. Alternative 2 was considered because the more costly LLP license requirements, observer coverage requirements, and vessel monitoring system (VMS) requirements do not apply to vessels halibut CDQ fishing in the BSAI (except that the VMS requirements apply to vessels halibut fishing in the Aleutian Islands). Increasing the MRAs for Pacific cod when halibut CDQ fishing would allow the small vessels to retain more Pacific cod without triggering requirements that apply to vessels directed fishing for Pacific cod. The Council did not select Alternative 2 because this final rule accomplishes a similar outcome to Alternative 2 without creating a situation where vessels with the same catch composition are defined as fishing for halibut in the CDQ fisheries and fishing for Pacific cod in the non-CDQ fisheries. Also, Alternative 2 would have increased monitoring and enforcement costs relative to this final rule.
Alternative 3 would have created a new type of LLP license specific to the small CDQ vessels in contrast to this final rule which provides an exemption to the LLP. However, Alternative 3 would not have resulted in a reduction in reporting, recordkeeping, and compliance costs in comparison to this final rule. Issuing a new CDQ LLP license would have required applications to NMFS and the issuance of a CDQ LLP license with certain conditions. Alternative 3 would have increased costs relative to this final rule.
This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) which have been approved by the Office of Management and Budget (OMB) under control numbers 0648-0269, 0648-0318, and 0648-0334. The information collections are presented by OMB control number.
Public reporting burden for CDQ Vessel Registration to add or remove vessels online that are exempt from the LLP license requirements is estimated to average five minutes per individual response and five minutes for maintenance of the LLP exemption letter on board a vessel that is groundfish CDQ fishing.
The Groundfish/Halibut CDQ and Prohibited Species Quota (PSQ) Transfer Request is mentioned in this final rule, but no changes occur in the individual response for each requirement.
The Observer Declare and Deploy System is mentioned in this final rule, but the individual response for each requirement is not changed.
The individual response for each requirement of the LLP mentioned in this final rule is not changed.
These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of these collections, including suggestions for reducing the burden, to NMFS (see
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at:
Alaska, Fisheries, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 679 is amended as follows:
16 U.S.C. 773
The addtion reads as follows:
(k) * * *
(2) * * *
(vi) The operator of a catcher vessel that is greater than 32 ft (9.8 m) LOA, that does not exceed 46 ft (14.0 m) LOA, and that is registered by a CDQ group following the procedures described in § 679.5(m) may use hook-and-line gear to conduct groundfish CDQ fishing without a groundfish license.
(m)
(2)
(3)
(4)
(d) * * *
(9) For an operator of a catcher vessel greater than 32 ft (9.8 m) LOA and less than or equal to 46 ft (14.0 m) LOA using hook-and-line gear and that is registered by a CDQ group under § 679.5(m), to conduct groundfish CDQ fishing without a legible copy of the LLP exemption letter issued to a CDQ group for that vessel on board the vessel.
(10) For a CDQ group representative, to remove a vessel from the CDQ vessel registration list under § 679.5(m)(4) without first providing notice to the operator of the registered vessel that the vessel is being removed from the CDQ vessel registration list or when the vessel operator is groundfish CDQ fishing.
(c) * * *
(3) * * *
(i) * * *
(D)
(ii) * * *
(D)
(iii)
(B)
(
(
(
(C)
(
(
(
The addition and revision read as follows:
(a) * * *
(1) * * *
(i) * * *
(D) A catcher vessel less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing under § 679.32(c)(3)(iii).
(2) * * *
(i) * * *
(C) * * *
(
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.
Effective 1200 hours, Alaska local time (A.l.t.), April 30, 2016, through 1200 hours, A.l.t., May 15, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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 second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA is 256 metric tons as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016), for the period 1200 hours, A.l.t., April
In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species fishery by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
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 closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 28, 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 § 679.21 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Extension of public comment period.
On March 24, 2016, the U.S. Department of Energy (DOE) published in the
The comment period for the proposed rule published on March 24, 2016 (81 FR 15836), is extended. DOE will accept comments, data, and information regarding this rulemaking received no later than June 22, 2016.
Interested persons may submit comments, identified by docket number EERE-2013-BT-STD-0030 and/or Regulation Identifier Number (RIN) 1904-AD01, by any of the following methods:
•
•
•
•
The rulemaking Web page can be found at:
Mr. James Raba, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-8654. Email:
In the Office of the General Counsel, contact Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9496. Email:
On March 24, 2016, DOE published in the
In view of the alternative request and oral comments presented by AHRI during the April 21 public meeting, DOE has determined that a 30-day extension of the public comment period is appropriate. The comment period would be extended to June 22, 2016.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Model 767 airplanes. This proposed AD was prompted by fuel system reviews conducted by the manufacturer. This proposed AD would require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This proposed AD would also provide optional actions for cargo airplanes. We are proposing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
We must receive comments on this proposed AD by June 20, 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 NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88”), Amendment 21-78. Subsequently, SFAR 88 was amended by: Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”).
Among other actions, SFAR 88 requires certain type design (
In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, combination of failures, and unacceptable (failure) experience. For all three failure criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.
We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.
The design of the in-tank FQIS components and wiring has the potential for latent faults that could cause arcs, sparks, or resistive heating in the event of a hot short of an FQIS tank circuit to power wiring. The wiring of the FQIS is in some areas cobundled or closely adjacent to power wiring. An ignition source combined with flammable conditions in a center fuel tank could result in ignition of flammable vapor in the fuel tank, causing a structural failure of the wing and inflight breakup of the airplane.
Under the policy contained in FAA Policy Memo PS-ANM100-2003-112-15 SFAR 88—Mandatory Action Decision Criteria, dated February 25, 2003 (
On March 21, 2016, we issued AD 2016-07-07, Amendment 39-18452 (81 FR 19472, April 5, 2016), for certain Boeing Model 757-200, -200PF, -200CB, and -300 series airplanes. AD 2016-07-07 requires similar actions to those proposed in this NPRM. AD 2016-07-07 addressed the numerous public comments that were submitted on the proposal.
We reviewed Boeing Service Bulletin 767-28-0118, dated July 15, 2014. The service information describes procedures for a BITE check (check of built-in test equipment) of the FQIS. 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
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require modifying the FQIS to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. As an alternative for cargo airplanes, this proposed AD would provide the option to modify the airplane by separating FQIS wiring routed between the FQIS processor and the center fuel tank, provided repetitive BITE checks (checks of built-in test equipment) of the FQIS are also performed. Refer to the service information identified previously for details on the procedures and compliance times.
We estimate that this proposed AD affects 133 airplanes of U.S. registry. This estimate includes 127 cargo airplanes; 4 private, business/corporate/executive, or government airplanes; and 2 experimental airplanes. We estimate the following costs to comply with this proposed AD:
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 June 20, 2016.
None.
This AD applies to The Boeing Company Model 767-200, -300, -300F, and -400ER series airplanes, certificated in any category, excluding airplanes identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Airplanes on which the center auxiliary tank consists only of the spaces between the side of body rib 0 and rib 3 of the left and right wings (
(2) Airplanes equipped with a flammability reduction means (FRM) approved by the FAA as compliant with the Fuel Tank Flammability Reduction (FTFR) rule (73 FR 42444, July 21, 2008) requirements of section 25.981(b) or section 26.33(c)(1) of the Federal Aviation Regulations (14 CFR 25.981(b) or 14 CFR 26.33(c)(1)).
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 60 months after the effective date of this AD, modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions, using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
For airplanes used exclusively for cargo operations: As an alternative to the requirements of paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD. To exercise this option, operators must perform the first inspection required under paragraph (h)(1) of this AD within 6 months after the effective date of this AD. To exercise this option for airplanes returned to service after conversion of the airplane from a passenger configuration to an all-cargo configuration more than 6 months after the effective date of this AD, operators must perform the first inspection required under paragraph (h)(1) of this AD prior to further flight after the conversion.
(1) Within 6 months after the effective date of this AD, record the existing fault codes stored in the FQIS processor and then do a BITE check (check of built-in test equipment) of the FQIS, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-28-0118, dated July 15, 2014. If any nondispatchable fault code is recorded prior to the BITE check or as a result of the BITE check, before further flight, do all applicable repairs and repeat the BITE check until a successful test is performed with no nondispatchable faults found, in accordance with Boeing Service Bulletin 767-28-0118, dated July 15, 2014. Repeat these actions thereafter at intervals not to exceed 650 flight hours. Modification as specified in paragraph (h)(2) of this AD does not terminate the repetitive BITE check requirement of this paragraph.
(2) Within 60 months after the effective date of this AD, modify the airplane by separating FQIS wiring that runs between the FQIS processor and the center tank wing spar penetrations, including any circuits that might pass through a main fuel tank, from other airplane wiring that is not intrinsically safe, using methods approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), 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 manager of the ACO, send it to the attention of the person identified in paragraph (j) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777 airplanes. This proposed AD was prompted by fuel system reviews conducted by the manufacturer. This proposed AD would require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This proposed AD would also provide alternative actions for cargo airplanes. We are proposing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a
We must receive comments on this proposed AD by June 20, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88”), Amendment 21-78. Subsequently, SFAR 88 was amended by: Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”).
Among other actions, SFAR 88 requires certain type design (
In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, combination of failures, and unacceptable (failure) experience. For all three failure criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.
We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.
The design of the in-tank FQIS components and wiring has the potential for latent faults that could cause arcs, sparks, or resistive heating in the event of a hot short of an FQIS tank circuit to power wiring. The wiring of the FQIS is in some areas cobundled or closely adjacent to power wiring. An ignition source combined with flammable conditions in a center fuel tank could result in ignition of flammable vapor in the fuel tank, causing a structural failure of the wing and inflight breakup of the airplane.
Under the policy contained in FAA Policy Memo PS-ANM100-2003-112-15 (
On March 21, 2016, we issued AD 2016-07-07, Amendment 39-18452 (81 FR 19472, April 5, 2016), for certain Boeing Model 757-200, -200PF, -200CB, and -300 series airplanes. AD 2016-07-07 requires similar actions to those proposed in this NPRM. AD 2016-07-07 addressed the numerous public comments that were submitted on the proposal.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require modifying the FQIS to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. As an alternative for cargo airplanes, this proposed AD would provide the alternative to modify the airplane by separating FQIS wiring routed between the FQIS processor and the center fuel tank, provided repetitive BITE checks (checks of built-in test equipment) of the FQIS are also performed.
We estimate that this proposed AD affects 187 airplanes of U.S. registry. This estimate includes 29 cargo airplanes. Currently, there are no experimental, private, business/corporate/executive, or government aircraft registered in the United States that would be affected by the proposed airworthiness directive. The 158 affected U.S. air-carrier passenger airplanes are already required by applicable FAA operating regulations to be modified to include flammability reduction measures (FRM), so the proposed AD would not apply to those airplanes. However, to address the potential for those airplanes to be converted to cargo airplanes before the compliance deadline for the operating rule FRM requirement, we provide the following cost estimates to comply with this proposed AD:
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 June 20, 2016.
None.
This AD applies to The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes, certificated in any category, excluding airplanes identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Airplanes on which the center tank consists only of the inboard structural box of the left and right wings (
(2) Airplanes equipped with a flammability reduction means (FRM) approved by the FAA as compliant with the Fuel Tank Flammability Reduction (FTFR) rule (73 FR 42444, July 21, 2008) requirements of section 25.981(b) or section 26.33(c)(1) of the Federal Aviation Regulations (14 CFR 25.981(b) or 14 CFR 26.33(c)(1)).
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 60 months after the effective date of this AD, modify the fuel quantity
For airplanes used exclusively for cargo operations: As an alternative to the requirements of paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD, using methods approved in accordance with the procedures specified in paragraph (i) of this AD. To exercise this alternative, operators must perform the first inspection required under paragraph (h)(1) of this AD within 6 months after the effective date of this AD. To exercise this alternative for airplanes returned to service after conversion of the airplane from a passenger configuration to an all-cargo configuration more than 6 months after the effective date of this AD, operators must perform the first inspection required under paragraph (h)(1) of this AD prior to further flight after the conversion.
(1) Within 6 months after the effective date of this AD, record the existing fault codes stored in the FQIS processor and then do a BITE check (check of built-in test equipment) of the FQIS. If any nondispatchable fault code is recorded prior to the BITE check or as a result of the BITE check, before further flight, do all applicable repairs and repeat the BITE check until a successful test is performed with no nondispatchable faults found, using a method approved in accordance with the procedures specified in paragraph (i) of this AD. Repeat these actions thereafter at intervals not to exceed 650 flight hours. Modification as specified in paragraph (h)(2) of this AD does not terminate the repetitive BITE check requirement of this paragraph.
(2) Within 60 months after the effective date of this AD, modify the airplane by separating FQIS wiring that runs between the FQIS processor and the center tank wing spar penetrations, including any circuits that might pass through a main fuel tank, from other airplane wiring that is not intrinsically safe, using methods approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), 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 manager of the ACO, send it to the attention of the person identified in paragraph (j) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
For more information about this AD, contact Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email:
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.
Submit either electronic or written comments on this proposed rule or its companion direct final rule by July 18, 2016. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. FDA will apply any significant adverse comments received on the direct final rule to the proposed rule in developing the final rule. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
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
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.
The proposed rule would revise and remove certain general biological products standards, which would update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is proposing this action because the existing codified requirements are duplicative of requirements that are also specified in biologics license applications (BLAs) or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products.
This proposed rule would remove the requirements contained in § 610.20 (21 CFR 610.20) from the regulations. FDA is proposing this action because the standard preparations listed in the regulation are obsolete, no longer available, or described on a product specific basis in BLAs. In addition, FDA believes that it would no longer be necessary to restrict the source of standard preparations to the Center for Biologics Evaluation and Research (CBER), since appropriate standard preparations can often be obtained from other sources. Furthermore, FDA is proposing to remove § 610.21 because these potency limits are either obsolete or best described on a product specific basis in the BLA. FDA is proposing to revise § 610.50 to remove references to §§ 610.20 and 610.21 and official potency tests and to reflect FDA's updated approach to establishing dates of manufacture. FDA is proposing to amend § 610.53 to remove products no longer manufactured and products for which dating information is identified in the BLA of each individual product, and to reflect updated practices for the remaining products.
FDA is proposing this action under the biological products provisions of the Public Health Service Act (PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Because this proposed rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.
This proposed rule is a companion to the direct final rule published in the rules section of this issue of the
A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to a part of the direct final rule and that part can be severed from the remainder of the rule (
If any significant adverse comments to the direct final rule are received during the comment period, FDA will publish, within 30 days after the comment period ends, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be considered comments on the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.
If no significant adverse comment is received in response to the direct final rule, no further action will be taken related to this proposed rule. Instead, we will publish a document confirming the effective date within 30 days after the comment period ends. Additional information about direct final
On January 18, 2011, President Barack Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011). One of the provisions in the Executive Order requires Agencies to consider how best to promote the retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned (76 FR 3821 at 3822). As one step in implementing the Executive Order, FDA published a notice in the
FDA's general biological products standards in part 610 (21 CFR part 610) are intended to help ensure the safety, purity, and potency of biological products administered to humans. The proposed revision and removal of certain general biological products standards are designed to update outdated requirements and accommodate new and evolving manufacturing and control testing technology. The proposed rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Standard preparations are generally used to perform lot release testing or other specific product characterization assays. Under the current standard preparations, § 610.20, FDA requires specific standard preparations to be used for a small number of the biological products FDA regulates unless a modification is permitted under § 610.9. Specifically, according to current § 610.20
Under the current § 610.21
In addition to sometimes being duplicative of information provided in the BLA and unnecessarily restrictive regarding the source of standard preparations, the codification by regulation of many of the standard preparations and limits of potency for certain biological products sometimes does not keep abreast of technological advances in science related to manufacturing and testing. For many years, because of the potential for impeding scientific progress, FDA has not codified additional specific standard preparations and limits of potency for licensed biological products, but instead the standards are established in the BLA. Failure to conform to applicable standards established in the license is grounds for revocation under § 601.5(b)(1)(iv) (21 CFR 601.5(b)(1)(iv)). If the changes proposed in this proposed rule go into effect, FDA will continue to require that each biological product meet standards to assure that the product is safe, pure, and potent, and will continue to require that each lot demonstrate conformance with the standards applicable to that product (see § 610.1) through appropriate testing. Therefore, we expect that standard preparations and potency limits will be established in the BLA and may be changed only in accordance with regulations for reporting post-approval changes (see § 601.12). Furthermore, no lot of any licensed product may be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product (see § 610.1).
FDA is therefore proposing to amend its regulations to remove §§ 610.20 and 610.21 because appropriate standard preparations and potency limits for any listed product are specified during the licensing process on a product specific basis. The removal of §§ 610.20 and 610.21 will also increase regulatory flexibility by allowing industry and FDA to more readily use and incorporate current scientific technology and other appropriate reference materials in the manufacture and regulation of licensed biological products.
A biological product is expected to remain stable and retain its identity, strength, quality, and purity for a period of time after manufacture when it is properly stored. The dating period limitations regulations provided at §§ 610.50 and 610.53 specify how the date of manufacture for biological products will be determined, when the dating begins, and dating periods for certain biological products. The existing § 610.50 prescribes how the date of manufacture is determined for biological products and relies in part upon §§ 610.20 and 610.21 or official standards of potency (
In addition, current § 610.50(b) does not provide FDA or applicants with flexibility to consider the variety of manufacturing situations and technologies that exist today and which may occur in the future. Since 1977, when the regulation was last amended,
The proposed regulatory provision would require the date of manufacture to be identified in the approved BLA. FDA recommends that applicants discuss a suitable date of manufacture with FDA during late clinical development and propose a date of manufacture in the BLA. We consider the underlying science and manufacturing process testing methods in determining the date of manufacture for each specific product. The approved BLA would specify how the date of manufacture would be determined. A proposed paragraph, § 610.50(c), would be added, specifying how the date of manufacture for Whole Blood and blood components would be determined. This provision would assist in complying with the dating periods prescribed for Whole Blood and blood components in the proposed table in redesignated § 610.53(b).
The current table at § 610.53(c) lists dating periods, manufacturer's storage periods, and storage conditions for many biological products. FDA is proposing to revise the current table in § 610.53(c) (which would be redesignated as § 610.53(b)) to remove products where storage conditions and dating periods are established to help ensure the continued safety, potency, and purity of each individual product, based upon information submitted in the relevant BLA. The dating period and storage conditions for these products would be identified in the BLA. FDA is also proposing to revise the current table in § 610.53(c) to delete those products that are no longer manufactured. We are proposing to retain those products, specifically Whole Blood and blood components, whose dating periods are based upon data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The proposed list has been updated to include currently licensed Whole Blood and blood component products with their applicable storage temperatures and dating periods.
In listing the dating periods for Whole Blood and blood component products, we took into account existing regulations, guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. Because we understand from these materials that these dating periods are in current use, and because blood establishments can request an exception under § 640.120 (21 CFR 640.120), we do not anticipate significant objections to codifying this information. Similarly, we are proposing to remove § 610.53(d) because it is duplicative of § 640.120. In addition, we recognize that future scientific understanding and new technology, such as the implementation of pathogen reduction technology or the approval of extended storage systems, could affect what dating periods would be necessary, as a scientific matter, for Whole Blood and blood components. For this reason, the proposed rule would allow for changes to the dating periods specified in proposed § 610.53(b) when the dating period is otherwise specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA.
In conclusion, the proposed amendments to the regulations are designed to be consistent with updated practices in the biological product industry and to remove unnecessary or outdated requirements. FDA is proposing this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations to provide flexibility without diminishing public health protection. If finalized, FDA does not anticipate that applicants for licensed biological products would need to revise information in BLAs in order to conform to the proposed revised regulations. Applicants must inform the Agency of any change to an approved application in accordance with § 601.12.
FDA is proposing to revise the general biological products standards relating to dating periods and proposing to remove certain standard preparations and limits of potency. These proposed changes are designed to remove unnecessary or outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health protections.
FDA is proposing to remove § 610.20 because the standard preparations listed are obsolete or no longer available; standard preparations to ensure the safety, purity, and potency of a product can best be determined on a product specific basis; and standard preparations may be obtained from other sources. Applicants for biological product licenses currently identify standard preparations for the product and purpose (
We are proposing to remove § 610.21 because these potency limits are best described in the BLAs on a product specific basis. Applicants for biological product licenses already identify standards for potency to help ensure the safety, purity, and potency of the product and purpose within their BLA, and the proposed standards are reviewed by FDA during the regulatory process. The use of a potency limit is suitably described in the specific product's BLA and allows for its continued and appropriate use in the absence of § 610.21.
We are proposing to revise § 610.50 by making a minor amendment to the section heading, removing the current language, redesignating § 610.53(b) as § 610.50(a) with edits, revising § 610.50(b), and adding new § 610.50(c). Current § 610.53(b), which applies to all biological products, would be moved to § 610.50(a) and edits will be made for better organization and clarification. Section 610.50(b) would be revised and § 610.50(c) would be added to clarify how the date of manufacture is set for purposes of determining the dating period for general biological products and for Whole Blood and blood components, respectively.
We are proposing to amend the section heading of § 610.53 to reflect that it would only address dating periods for Whole Blood and blood components. We are proposing to revise § 610.53(a) since this section would only apply to the dating periods for Whole Blood and blood components. We are proposing to redesignate current § 610.53(c) as § 610.53(b) and revise the text to provide an explanation on using the table and to correspond with 21 CFR 606.121(c)(7). We are proposing to revise the text and table to eliminate those products for which storage periods, storage conditions, and dating periods are better established by data
FDA is issuing this proposed rule under the biological products provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the introduction, transmission, and spread of communicable disease.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would remove regulations and revise regulations to be consistent with updated practice, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
We have determined under 21 CFR 25.31(h) 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.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
This proposed rule contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 610 have been approved under OMB control number 0910-0338. The proposed removal of § 610.53(d) would impact OMB control number 0910-0338. We would remove § 610.53(d) because it is duplicative of § 640.120, which is also approved under the same collection of information. While there would be no net change in the burden estimate, the current approved collection of information would be updated to reflect this removal. The actions that we propose to take in this proposed rule would not create a substantive or material modification to this approved collection of information. Therefore, FDA tentatively concludes that OMB has already approved the information collection proposed here and the proposed requirements in this document are not subject to additional review by OMB.
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.
(a) When the dating period begins. The dating period for a product must begin on the date of manufacture as described in paragraphs (b) and (c) of this section. The dating period for a combination of two or more products must be no longer than the dating period of the component with the shortest dating period.
(b) Determining the date of manufacture for biological products other than Whole Blood and blood components. The date of manufacture for biological products, other than Whole Blood and blood components, must be identified in the approved
(1) Potency test or other specific test as described in a biologics license application or supplement to the application;
(2) Removal from animals or humans
(3) Extraction;
(4) Solution;
(5) Cessation of growth;
(6) Final sterile filtration of a bulk solution;
(7) Manufacture as described in part 660 of this chapter; or
(8) Other specific manufacturing activity described in a biologics license application or supplement to the biologics license application.
(c) Determining the date of manufacture for Whole Blood and blood components. (1) The date of manufacture for Whole Blood and blood components must be one of the following, whichever is applicable:
(i) Collection date and/or time;
(ii) Irradiation date;
(iii) The time the red blood cell product was removed from frozen storage for deglycerolization;
(iv) The time the additive or rejuvenation solution was added;
(v) The time the product was entered for washing or removing plasma (if prepared in an open system);
(vi) As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or
(vii) As approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.
(2) For licensed Whole Blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application.
(a)
(b)
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
Through this document, HUD solicits comment on a demonstration designed to test a new method of assessing the physical condition of housing assisted by HUD vouchers (voucher-assisted housing). In the Joint Explanatory Statement accompanying the act appropriating funds for HUD in Fiscal Year (FY 2016), Congress directed HUD to implement a single inspection protocol for public housing and voucher units. This demonstration would commence the process for implementing a single inspection protocol.
Interested persons are invited to submit comments to the Office of the General Counsel, Regulations Division, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications should refer to the above docket number and title and should contain the information specified in the “Request for Comments” section. There are two methods for submitting public comments.
To receive consideration as public comments, comments must be submitted using one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.
Daniel R. Williams, Real Estate Assessment Center, Office of Public and Indian Housing, Department of Housing and Urban Development, 550 12th Street SW., Suite 100, Washington DC 20410-4000; telephone number 202-475-8586 (this is not a toll-free number). Persons with hearing or speech impairments may contact this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.
The following four sections discuss the background through the solicitation of comments. Section II below provides background information on oversight of the Housing Choice Voucher inspection program and explains the origins of the Uniform Physical Condition Standards for Vouchers (UPCS-V), an alternative approach for ensuring safe, habitable voucher-assisted housing. In Section III, the notice explains the three main areas that will be evaluated during the demonstration, which are: The objective condition standards including a list of life threatening and emergency items that must be addressed, the revised information technology (IT) processes, and the new oversight approach. Also in Section III, HUD discusses the general public housing agency (PHA) participation criteria it will use to select a representative mix of volunteer PHAs. In Section IV, HUD describes the process by which HUD will assess the results of the demonstration. In the last section of this notice, Section V, HUD
HUD's Housing Choice Voucher (HCV) program serves approximately 2.2 million households nationwide. The HCV program is administered by PHAs at the State and local levels and allows participants the opportunity to rent from private landlords in the neighborhood of their choosing. The goal of the HCV program is to enable access to decent, safe and sanitary affordable housing for low-income families. In the 1970's HUD established housing quality standards (HQS) in accordance with the U.S. Housing Act of 1937 (1937 Act) (42 U.S.C. 1437
The HUD Office of Inspector General (OIG) has released several audit reports and evaluations that identified weakness in the HCV inspection program.
At the conclusion of the quality control review, HUD accelerated the search for a replacement to the Housing Quality Standards, leading to the eventual development of UPCS-V. In the Joint Explanatory Statement accompanying the Consolidated Appropriations Act of 2016, Public Law 114-113, approved December 18, 2015, Congress directed HUD to implement a single inspection protocol for public housing and voucher units.
In response to Congressional direction and HUD's own goal to improve the effectiveness of the inspection of public and assisted housing while minimizing burdens, HUD is developing a new inspection and oversight approach called UPCS-V. UPCS-V incorporates housing health and safety constructs, concepts from the Uniform Physical Condition Standard (UPCS), codified in HUD regulations at 24 CFR 5.703, and HQS, codified at 24 CFR 982.401. The new UPCS-V will include deficiency definitions and decision criteria, and tailored standards and protocols to better meet HCV program needs. The UPCS protocol is currently recognized by industry stakeholders as the benchmark for government-assisted and affordable housing inspections. This Demonstration is the first step in implementing an aligned inspection protocol for public housing/multi-family housing and voucher programs, and will test the UPCS-V inspection model's ability to assess the physical condition of assisted housing, improve service delivery, enhance oversight and risk management capabilities, and better identify health and safety hazards in the home.
Under this Demonstration, HUD will test, for up to three years, with up to 250 PHAs, the UPCS-V model as a new method of assessing the physical condition of voucher-assisted housing.
In addition to hands-on training and technical assistance that will be provided by HUD to participating PHAs, some additional benefits of participating in the Demonstration include the opportunity to provide input to HUD on further refining the UPCS-V standards and processes, and the ability to evaluate, test, and refine internal PHA systems and processes.
There are three components to the Demonstration, each of which may run concurrently:
For the past 17 years, HUD has used the UPCS protocol when conducting over 310,000 physical inspections of public housing (PH) and subsidized multifamily housing (MFH) developments, solidifying UPCS as the industry standard for government-assisted and affordable housing inspections. HUD leveraged its experience with UPCS and developed a product tailored to the objectives of the HCV program. The scope of the inspection, the procedural guidelines, and the individual deficiencies have been modified to emphasize those areas that present the highest risk of harm to the family living in the HCV assisted unit.
UPCS-V seeks to utilize well-defined and objective deficiency descriptions that can be used consistently within and across PHAs. The following table summarizes some of the high-level similarities and differences between UPCS-V and HQS.
Like UPCS, HUD anticipates that the new inspection model will enable a PHA inspector to more consistently identify and accurately describe those items that pose a risk to tenant health and safety in the home. The new inspection model developed by HUD has updated standards and a well-defined list of itemized deficiencies enabling inspectors to make more accurate and objective decisions on a consistent basis. The new inspection model differs from the current HQS inspection model in that it incorporates standards based on UPCS and uses a classification system that collects a more detailed level of data resulting in a better representation of the condition of the unit.
The new inspection protocol will capture levels of severity for line item deficiencies on an escalating scale of severity (L1, L2, L3). The classifications of minor (L1), major (L2) or significant (L3) would be used to determine the level of severity for each deficiency and to develop a unit condition index score. When considered in conjunction with a Pass/Fail determination, the unit condition index score would give residents, owners, PHAs, and HUD better insight into the overall condition of the unit. In addition to capturing a level of severity for all deficiencies, HUD will create a minimum, standardized list of life threatening items that PHAs participating in the demonstration must treat as “24 Hour” deficiencies.
When an inspector finds Life Threatening or Emergency (LTE) deficiencies during an inspection, the inspector is to provide a list of such deficiencies to the responsible party—either tenant or owner—for repair within 24 hours. A specific set of deficiencies that must be addressed within 24 hours is not currently defined in HQS. UPCS-V will provide a list of LTE categories to use when inspecting HCV units during the Demonstration. PHAs will be responsible for additional items to this list.
With the inclusion of a level of severity classification and a standardized list of life threatening items, the inspection report will be able to provide a more detailed description of the unit.
As part of the Demonstration, HUD will conduct extensive field tests of the standards and protocol with a representative sample of HCV units to verify that the UPCS-V model consistently, accurately, and objectively evaluates housing conditions. The feasibility of implementing the protocol will also be evaluated to identify potential barriers that would prevent PHAs from successfully implementing UPCS-V. After HUD's initial round of testing has been completed, PHAs participating in this component of the
UPCS-V is designed as an electronic inspection model. This component of the Demonstration will test the transition from a paper-based to an electronic inspection approach. Initially, the UPCS-V inspections will be performed electronically using HUD-provided software, and all inspections will include photos of the most severe deficiencies. For PHAs with their own IT systems, including PHA-produced or provided inspection software, HUD also will test the feasibility of different methods of transferring physical inspection information between PHA and HUD systems.
PHAs participating in this component will be required to document and submit to HUD all UPCS-V inspections electronically. HUD anticipates that it will then review, analyze, and where appropriate, transform the inspection data into value-added information, such as a scoring report, healthy homes report, and relative risk reports, for electronic transmission back to the PHA for its use.
PHAs participating in this component of the Demonstration and that use non-HUD provided software will be required to have and maintain the information technology resources and support necessary to interface with HUD's systems using industry standard file transfer protocols such as Simple Object Access Protocol (SOAP) and Representational State Transfer (REST) standards. Some data exchange may be via transfer of flat files.
In this component of the Demonstration, HUD seeks to ensure PHAs are consistently identifying substandard housing, remedying such cases appropriately and in a timely manner, and accurately reporting HCV unit-based inspection outcomes to HUD. Selected PHAs will be required to participate in quality assurance and internal controls reviews, technical assistance, and training activities. As part of the Demonstration, HUD will analyze PHAs' capacity, competencies, inspection processes and systems that are in place to effectively manage and evaluate HCV units as decent, safe, and sanitary. Further, HUD will test the capacity of the UPCS-V model to identify properties that are at risk of falling into non-compliance before the next regularly scheduled biennial inspection.
To develop an inspector performance baseline, HUD seeks to determine the acceptable variation between inspectors. HUD will conduct quality assurance inspections on HCV units to ensure inspector adherence to UPCS-V inspection standards and provide technical assistance where needed. HUD also will test both PHA and its own management controls to provide reasonable assurance that the process for planning, organizing, directing, and controlling the HCV unit-based inspection program will meet the requirements prescribed by UPCS-V.
To participate in this Demonstration, a PHA must administer a housing choice voucher program. PHAs participating in any aspect of the Demonstration will be required to participate in focus groups, conference calls, and training sessions on policies and procedures. HUD will train each participating PHA's inspectors, administrators, and quality control staff on the new inspection protocol, including how to use the inspection software. The PHAs will be responsible for scheduling inspections with all the participants, assigning inspectors, and conducting inspections. The PHA must conduct at least 10 inspections per week, and the geographic spread of those inspections should be such that 90 percent of inspections are accessible within a 30 mile (or 1 hour) driving range.
If selected, the PHA must participate in the Demonstration throughout the duration of the testing period for at least one (1) calendar year with the possibility of an extension, as determined by HUD, for a maximum total of three (3) years. PHAs that participate will also need to provide an internet connected, internet operating system (iOS) or Android based electronic handheld device (smart phone or tablet) for each PHA staff inspector participating with capability to download the required HUD-provided inspection software.
All PHAs must meet, at minimum, the general participation requirements described above. The strategic objectives for the Demonstration are for HUD to identify a diverse set of participants that will be representative of the different types of PHAs, properties and tenants found nationwide. HUD will use the following criteria to consider PHAs that have expressed an interest in participating in the Demonstration to ensure that participants represent the universe of PHAs that run HCV programs.
Participants will be selected based on the characteristics of the organization (PHA) and the type of properties and tenants it administers:
1.
• Is the PHA a local or state agency?
• What percentage of HQS inspections are conducted annually? Biennially?
• What percentage of the HCV housing stock is urban and what percentage is rural?
• What percentage of the PHAs inspections are HCV inspections?
• What is the number of monthly HCV inspections conducted?
2.
• What is the number of HCV voucher holders?
• What is the average rent amount?
• What is the percentage of PHA's HCV program that is Veterans Affairs Supportive Housing (VASH), Family Unification Program (FUP), and Non-Elderly Disabled (NED) participants?
• What is the average HCV family size?
• What type of housing is leased by HCV participants (single family, apartment, condo, high-rise, row house, duplex, townhouse, etc.)?
• What is the average age of the housing stock?
• What is the HCV tenant mix (by age, disability, elderly, family type, children, income level/hap amount)?
The criteria are designed to capture the variation in PHAs and market characteristics that could affect the implementation of UPCS-V. Depending on the applications for participation received and the characteristics of the PHAs applying, the criteria may be adjusted to more accurately represent the diversity of PHAs. Not all 250 participants may be selected in the first round of testing. Accordingly, as the Demonstration proceeds, HUD may expand the number of participating PHAs, revise the selection criteria, or both, to reflect HUD's experience in implementing the Demonstration.
The Demonstration will provide HUD insight into the UPCS-V model, including its ability to expand HUD's oversight and risk management capabilities through a reliable, repeatable inspection process that better identifies health and safety risks to families, before implementing such a program nationwide. The Demonstration is anticipated to begin 60 days following the date of publication of this notice, with PHAs being added on a rolling basis until a representative sample has been reached. At the conclusion of the demonstration, HUD will assess its success and determine whether to implement UPCS-V on a permanent basis throughout the country.
In the evaluation of the Demonstration, HUD will assess such factors as whether the use of the new UPCS-V protocol produces (1) more consistent and accurate results, (2) data standardization and a reliable method for information exchange, and (3) increased oversight and administration of the HCV Program. The demonstration also will review the feasibility of a PHA to implement the UPCS-V protocol, a factor HUD considers necessary for an accurate evaluation of the Demonstration's success.
In accordance with section 470 of the Housing and Urban-Rural Recovery Act of 1983 (42 U.S.C. 3542), HUD is seeking comment on the Demonstration. Section 470 provides that HUD may not begin a demonstration program not expressly authorized by statute until a description of the demonstration program is published in the
While HUD solicits comment on all aspects of the Demonstration, HUD specifically solicits comment on the following:
1. HUD is considering selecting for participation only PHAs that do not utilize contract inspectors. Are there any instances where an exception to this criterion might be useful?
2. Will utilizing commercial, off-the-shelf hardware, such as internet connected tablets or smartphones, reduce the barriers to participation for PHAs as opposed to having PHAs use more specific devices such as those required for other HUD UPCS inspections?
3. Are there other PHA characteristics that HUD should consider in selecting PHAs to participate in the demonstration?
4. Are there other revisions outside of the UPCS criteria that HUD should consider when moving toward a single inspection protocol?
HUD requests that PHAs interested in participating in the Demonstration notify HUD by the public comment deadline for this Demonstration notice by emailing HUD at
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking by cross-reference to temporary regulations.
In the Rules and Regulations section of this issue of the
Comments and requests for a public hearing must be received by August 2, 2016.
Send submissions to: CC:PA:LPD:PR (REG-114307-15), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-114307-15), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224 or sent electronically, via the Federal eRulemaking Portal at
Concerning the proposed regulations, Andrew K. Holubeck at (202) 317-4774; concerning submission of comments, or a request for a public hearing please contact Regina Johnson at (202) 317-6901 (not toll-free numbers).
Temporary regulations in the Rules and Regulations section of this issue of the
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, this notice of proposed rulemaking will be submitted
Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are submitted timely to the IRS as prescribed in this preamble under the
The principal author of these regulations is Andrew Holubeck of the Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordingkeeping requirements.
Accordingly, 26 CFR part 301 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
(c) * * *
(2) * * *
(iv) * * *
(C) * * *
(
(e) * * *
(8)(i) [ The text of the proposed amendments to § 301.7701-2(e)(8)(i) is the same as the text of § 301.7701-2T(e)(8)(i) published elsewhere in this issue of the
Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), Department of Justice.
Advance notice of proposed rulemaking.
The Department of Justice is considering amending the regulations of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to require licensed manufacturers, licensed importers, and nonlicensed makers to place identification markings on the outer tube of firearm silencers and firearm mufflers. The Department wishes to gather information and comments from the public and industry concerning whether or not the regulations should be amended.
Written comments must be postmarked and electronic comments must be submitted on or before August 2, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after Midnight Eastern Time on the last day of the comment period.
You may submit comments, identified by docket number (ATF 29P), by any of the following methods:
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•
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Shermaine Kenner, Office of Regulatory Affairs, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S. Department of Justice, 99 New York Avenue NE., Washington, DC 20226; telephone: (202) 648-7070.
Section 923(i) of the Gun Control Act of 1968 (GCA), as amended (18 U.S.C. chapter 44), requires licensed importers and licensed manufacturers to identify, by means of a serial number, each firearm imported or manufactured by such importer or manufacturer. The serial number must be engraved or cast on the receiver or frame of the weapon in such manner as the Attorney General prescribes by regulation. As defined in section 921(a)(3) of the GCA, the term “firearm” includes any firearm muffler or firearm silencer. The terms “firearm silencer” and “firearm muffler” are also defined in section 921(a)(24), as follows:
[A]ny device for silencing, muffling, or diminishing the report of a portable firearm, including any combination of parts, designed or redesigned, and intended for use in assembling or fabricating a firearm silencer or firearm muffler, and any part intended only for use in such assembly or fabrication.
With respect to certain firearms subject to the National Firearms Act (NFA) (26 U.S.C. chapter 53) (
Regulations that implement 18 U.S.C. 923(i) are set forth in 27 CFR 478.92. In general, § 478.92(a)(1)(i) requires licensed manufacturers and licensed importers of firearms to legibly identify each firearm manufactured or imported by engraving, casting, stamping (impressing), or otherwise conspicuously placing on the frame or receiver an individual serial number. The serial number must be placed in a manner not susceptible of being readily obliterated, altered, or removed and must not duplicate any serial number placed by a licensed importer or manufacturer on any other firearm. For firearms manufactured or imported on and after January 30, 2002, the engraving, casting, or stamping (impressing) of the serial number must be to a minimum depth of .003 inch and in a print size no smaller than
In addition, § 478.92(a)(1)(ii) requires licensed manufacturers and licensed importers to conspicuously place additional identification markings on the frame, receiver, or barrel of each firearm imported or manufactured in a manner not susceptible of being readily obliterated, altered, or removed. For firearms manufactured or imported on and after January 30, 2002, the engraving, casting, or stamping (impressing) of this information must be to a minimum depth of .003 inch. The additional information includes:
1. The model, if such designation has been made;
2. The caliber or gauge;
3. The name of the licensed manufacturer or licensed importer (or recognized abbreviation) and, when applicable, the name of the foreign manufacturer;
4. In the case of a domestically made firearm, the city and State (or recognized abbreviation thereof) where the licensed manufacturer maintains his place of business; and
5. In the case of an imported firearm, the name of the country in which it was manufactured and the city and State (or recognized abbreviation thereof) where the licensed importer maintains his place of business.
The same marking requirements apply to manufacturers, importers or makers of NFA firearms pursuant to 27 CFR 479.102(a).
The current regulations do not specify the placement of required identification markings on firearm silencers and firearm mufflers. However, ATF has provided the industry with some guidance on this issue. In its “Frequently Asked Questions—Silencers,” dated April 17, 2008, ATF stated the following:
The silencer must be marked in accordance with 27 CFR 478.92 and 479.102. The regulations require that the markings be conspicuous and legible, meaning that the markings may be placed on any external part, such as the outer tube or end cap. ATF strongly recommends that manufacturers place all required markings on the outer tube of the silencer, as this is the accepted industry standard. Moreover, this practice eliminates the need to remark in the event an end cap bearing the markings is damaged and requires replacement.
On April 27, 2008, ATF received a petition filed on behalf of the National Firearms Act Trade and Collectors Association (NFATCA). NFATCA is a trade group representing the firearms and import community. Some of its members primarily manufacture, transport, and possess silencers for lawful use.
Although in its April 2008 guidance ATF recommended that manufacturers place all required markings on the outer tube of the silencer, it stated that the required markings could also be placed on any external part of the silencer, including the end cap, provided the required markings are conspicuous and legible. According to the petitioner, the industry's response to ATF's guidance was not favorable:
There has been an overwhelmingly negative response from the members of our trade to this particular guidance . . . there is strong policy agreement between ATF and our trade that only the silencer [outer] tube should be marked in accordance with the marking requirements of Parts 478 and 479 of Title 27 of the Code of Federal Regulations. . . . Allowing end caps to be the possible marking location for silencers does constitute a serious public safety issue in the areas of diversion, tracing, and evasion of other NFA rules.
In addition, the petitioner stated that “[w]e have also been further advised that the Bureau does not see how they would be able to take any adverse legal action against a person or entity that should decide to mark the end caps of a silencer without promulgating a change in the regulations.”
Accordingly, the petitioner requested that the relevant regulations be amended to require that a silencer be marked on the outer tube (as opposed to other locations), unless a variance is granted by the Director on a case-by-case basis for good cause. ATF finds that the petitioner has raised valid concerns and it believes that an amendment of the regulations is warranted. Therefore, based upon the statutory language and the facts as outlined below, ATF seeks to address the marking requirements of silencers to ensure that the serial numbers are placed on the part of the silencer that is least likely to be destroyed or removed, and therefore most likely to ensure that law enforcement are able to identify and trace a particular firearm silencer or firearm muffler.
ATF is requesting information from industry members, trade associations, consumers, and all other interested parties to determine whether to require placement of identification markings on the outer tube of firearm silencers and firearm mufflers. Along with industry members, ATF considers the term “outer tube” to mean the largest external part of a silencer and is that portion of a silencer which encapsulates all components of the silencing unit and which contains and controls the expansion of the escaping gases.
As indicated, placing all required markings on the outer tube of a completed firearm silencer or firearm muffler is the accepted industry standard. In addition, requiring identification markings to be placed on a single part provides consistency of markings throughout the industry and eliminates the need to remark a device in the event an end cap bearing the markings is damaged and requires replacement. If a silencer is not aligned with the barrel, the end cap might be damaged when a projectile passes through it. Outer tubes are rarely damaged in this way. Such damage often requires replacement of the end cap. Further, end caps are often removable so that processors may access the internal components within the silencer. Permitting serialization of a removable and fungible component may facilitate trafficking or illegal transfer of silencers by permitting registrants to use the serialized end cap of a registered silencer with an otherwise unregistered silencer.
Although ATF is soliciting comments on the following specific questions, it is also requesting any relevant information on the subject.
1. What percentage of manufacturers mark the end cap? If an outer tube is present, why do manufacturers mark the end cap instead of the outer tube of the silencer?
2. If there is an additional cost (fixed or variable) between marking the end cap instead of the outer tube, how would ATF estimate such costs across the entire industry?
3. Are there other parts or locations where the markings may be placed and still meet the requirements? If so, where?
4. Are there silencer designs for a completed device for which marking the outer tube would be impossible? If so, what are those designs?
5. When there are multiple outer tubes that make up one complete device, how should they be marked?
This advance notice of proposed rulemaking (ANPRM) has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), The Principles of Regulation, and in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation.
The Department of Justice has determined that this ANPRM is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this ANPRM has been reviewed by the Office of Management and Budget. However, this action does not propose or impose any requirements. The ANPRM is being published to seek information from the public about the feasibility of marking silencer tubes.
Furthermore, the requirements of section 603 of the Regulatory Flexibility Act do not apply to this action because, at this stage, it is an ANPRM and not a “rule” as defined in section 601 of the Regulatory Flexibility Act. Following review of the comments received in response to this ANPRM, if ATF promulgates a notice or notices of proposed rulemaking regarding this matter, ATF will conduct all analyses required by the Regulatory Flexibility Act, Executive Order 12866, and any other statutes or Executive Orders relevant to those rules and in effect at the time of promulgation.
ATF requests comments on this ANPRM from all interested persons. ATF specifically requests comments on the clarity of this ANPRM and how easy it is to understand. Additional comments are sought on the costs or benefits of the proposal in this ANPRM and on the appropriate methodology and data for calculating those costs and benefits.
All comments must reference the docket number (ATF 29P), be legible, and include the commenter's complete first and last name and full mailing address. ATF will not consider, or respond to, comments that do not meet these requirements or comments containing profanity. In addition, if ATF cannot read your comment due to technical difficulties and cannot contact you for clarification, ATF may not be able to consider your comment.
ATF will carefully consider all comments, as appropriate, received on or before the closing date, and will give comments received after that date the same consideration if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before the closing date.
ATF will not acknowledge receipt of comments.
ATF will make all comments meeting the requirements of this section available for public viewing at ATF and on the Internet as part of the eRulemaking initiative, and subject to the Freedom of Information Act. ATF will not redact personal identifying information that appears within the comment and it will appear on the Internet.
The commenter should not include material that is considered confidential or inappropriate for disclosure to the public. Any person submitting a comment containing confidential material shall specifically designate that portion of the comment that contains material that is confidential under law (
Confidential information will be included in the rulemaking administrative record but will not be disclosed to the public. Any comments containing material that is not confidential under law may be disclosed to the public. In any event, a commenter's full first and last name and complete mailing address are not exempt from disclosure.
Submit comments in any of three ways (but do not submit the same comments multiple times or by more than one method).
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•
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(1) Be legible and appear in minimum 12-point font size (.17 inches);
(2) Be on 8
(3) Be signed and contain the commenter's complete first and last name and full mailing address; and
(4) Be no more than five pages long.
Any interested person who desires an opportunity to comment orally at a public hearing should submit his or her request, in writing, to the Director of ATF within the 90-day comment period. The Director, however, reserves the right to determine, in light of all circumstances, whether a public hearing is necessary.
Copies of the petition, this advance notice, and the comments received will be available at
The author of this document is Shermaine Kenner, Office of Regulatory Affairs, Enforcement Programs and Service; Bureau of Alcohol, Tobacco, Firearms, and Explosives.
Administrative practice and procedure, Arms and munitions, Customs duties and inspection, Exports, Imports, Intergovernmental relations, Law enforcement officers, Military personnel, Penalties, Reporting and recordkeeping requirements, Research, Seizures and forfeitures, Transportation.
Administrative practice and procedure, Arms and munitions, Customs duties and inspection, Excise taxes, Exports, Imports, Military
This notice is issued under the authority of 5 U.S.C. 552(a); 18 U.S.C. 847, 921-931; and 44 U.S.C. 3504(h).
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to create safety zones around each tall ship visiting the Great Lakes during the Tall Ships Challenge 2016 race series. These safety zones will provide for the regulation of vessel traffic in the vicinity of each tall ship in the navigable waters of the United States. The Coast Guard is taking this action to safeguard participants and spectators from the hazards associated with the limited maneuverability of these tall ships and to ensure public safety during tall ships events. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before June 3, 2016.
You may submit comments identified by docket number USCG-2016-0267 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Mark Bobal, Ninth District Inspections and Investigations Branch, Passenger Vessel Safety Specialist, U.S. Coast Guard; telephone 216-902-6052, email
During the Tall Ships Challenge Great Lakes 2016, tall ships will be participating in parades and then mooring in the harbors of Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Duluth, MN, and Erie, PA. This is a tri-annual event that teaches character building and leadership through sail training. The Tall Ships event seeks to educate the public about both the historical aspects of sailing ships as well as their current use as training vessels for students. Tall ships are large, traditionally-rigged sailing vessels. The event will consist of festivals at each port of call, sail training cruises, tall ship parades, and races between the ports. More information regarding the Tall Ships Challenge 2016 and the participating vessels can be found at
At 12:01 a.m. July 6, 2016, a safety zone will be established around each tall ship participating in this event. The safety zone around each ship will remain in effect as the tall ships travel throughout the Great Lakes. The safety zones will terminate at 12:01 a.m. on September 12, 2016.
These safety zones are necessary to protect the tall ships from potential harm and to protect the public from the hazards associated with the limited maneuverability of tall sailing ships. When operating under sail they require a substantial crew to manually turn the rudder and adjust the sails, therefore they cannot react as quickly as modern ships. Additionally, during parades of sail the tall ships will be following a set course through a crowded harbor, it is imperative that spectator craft stay clear since maneuvering the tall ships to avoid large crowds of spectator craft would not be possible. Due to the high profile nature and extensive publicity associated with this event, each Captain of the Port (COTP) expects a large number of spectators in confined areas adjacent to the tall ships. The combination of large numbers of recreational boaters, congested waterways, boaters crossing commercially transited waterways and low maneuverability of the tall ships could easily result in serious injuries or fatalities. Therefore, the Coast Guard will enforce a safety zone around each ship to ensure the safety of both participants and spectators in these areas. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The Coast Guard proposes to establish safety zones from 12:01 a.m. on July 6, 2016 until 12:01 a.m. on September 12, 2016. The safety zones would cover all navigable waters within 100 yards of a tall ship in the Great Lakes. The duration of the zone is intended to ensure the safety of vessels and these navigable waters during the 2016 Tall Ships Challenge. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. If the tall ships are operating in a confined area such as a small harbor and there is not adequate room for vessels to stay out of the safety zone because of a lack of navigable water, then vessels will be permitted to operate within the safety zone and shall travel at the minimum speed necessary to maintain a safe course. The navigation rules shall apply at all times within the safety zone. The regulatory text we are proposing appears at the end of this document.
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.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely
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.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
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 a safety zone lasting more than one week. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist and 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
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)
(1)
(2)
(3)
(4)
(b)
(c)
(2) Persons or vessels operating within a confined harbor or channel, where there is not sufficient navigable water outside of the safety zone to safely maneuver are allowed to operate within the safety zone and shall travel at the minimum speed necessary to maintain a safe course. Vessels operating within the safety zone shall not come within 25 yards of a tall ship unless authorized by the cognizant Captain of the Port, their designated representative, or the on-scene official patrol.
(3) When a tall ship approaches any vessel that is moored or anchored, the stationary vessel must stay moored or anchored while it remains within the tall ship's safety zone unless ordered by or given permission from the cognizant Captain of the Port, their designated representative, or the on-scene official patrol to do otherwise.
(d)
(e)
U.S. Fish and Wildlife Service (FWS), Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (FWS), propose changes to the regulations concerning enhancement of survival permits issued under the Endangered Species Act of 1973, as amended (ESA), associated with Candidate Conservation Agreements with Assurances. We propose to add the term “net conservation benefit” to the Candidate Conservation Agreements with Assurances regulations, and to eliminate references to “other necessary properties” to clarify the level of conservation effort we require each agreement to include in order for us to approve a Candidate Conservation Agreement with Assurances. We are also proposing these changes to the Candidate Conservation Agreement with Assurances policy in a separate document published in today's
We will accept comments that we receive on or before July 5, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
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We will post all comments on
Jim Serfis, Chief, Branch of Conservation and Communications, U.S. Fish and Wildlife Service Headquarters, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone 703-358-2171. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.
Through its Candidate Conservation program, one of the FWS's goals is to encourage the public to take specific conservation actions for declining species prior to them being listed under the ESA (16 U.S.C. 1531
To participate in a CCAA, non-Federal property owners agree to implement specific conservation actions on their land that reduce or eliminate threats to the species that are covered under the agreement. An ESA section 10(a)(1)(A) Enhancement of Survival permit is issued to the agreement participant providing a specific level of incidental take coverage should the property owner's agreed-upon conservation actions and routine property management actions (
Based on our experience reviewing and approving CCAAs over the past 16 years, we are proposing changes to the regulations that will clarify the level of conservation effort each agreement needs to include in order for FWS to approve an agreement and issue a permit.
We are proposing changes to the CCAA regulations at 50 CFR 17.22(d) and 17.32(d) consistent with the proposed revisions to the CCAA policy published separately in today's
Under the current policy and regulations, to approve a CCAA we must “determine that the benefits of the conservation measures implemented by a property owner under a CCAA, when combined with those benefits that would be achieved if it is assumed that conservation measures were also to be implemented on other necessary properties, would preclude or remove any need to list the covered species.” The confusion created by the hypothetical concept of conservation measures needing to be implemented on “other necessary properties” is why we are clarifying and revising the CCAA standard to require a net conservation benefit to the covered species specifically on the property to be enrolled and eliminating references to “other necessary properties.”
In concert with the proposed revisions to our CCAAs policy, published elsewhere in today's
Any final rule based on this proposal will consider information and recommendations submitted in a timely manner from all interested parties. We solicit comments, information, and recommendations from governmental agencies, Native American tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties on this proposed rule. All comments and materials we receive by the date listed in
You may submit your information concerning this proposed rule by one of the methods listed in
Information and supporting documentation that we receive in response to this proposed rule will be available for you to review at
Executive Order 12866 provides that the Office of Management and Budget's Office of Information and Regulatory Affairs will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements. This proposed rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”
Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601
The proposed rule would revise the regulations governing issuance of an enhancement of survival permit in conjunction with a CCAA to clarify but
This proposed rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(b) This proposed rule would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or tribal governments.
In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.
In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant Federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to approving enhancement of survival permits in conjunction with a CCAA under the ESA, and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.
This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify the issuance criteria for an enhancement of survival permit associated with a CCAA under the ESA.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. We have considered possible effects on federally recognized Indian tribes and have preliminarily determined that there are no potential adverse effects of issuing this proposed rule. Our intent is to provide clarity in regard to the net conservation benefit requirements for a CCAA to be approved, including any agreements in which Tribes may choose to participate. We will continue to keep our tribal obligations in mind as we finalize this proposed rule.
We analyzed the proposed regulations in accordance with the criteria of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(c)), the Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA (40 CFR 1500-1508), and the Department of the Interior's NEPA procedures (516 DM 2 and 8; 43 CFR part 46) and determined that the proposed regulations are categorically excluded from NEPA documentation requirements consistent with 40 CFR 1508.4 and 43 CFR 46.210(i). This categorical exclusion applies to policies, directives, regulations, and guidelines that are “of an administrative, financial, legal, technical, or procedural nature.” This action does not trigger an extraordinary circumstance, as outlined in 43 CFR 46.215, applicable to the categorical exclusion. Therefore, the proposed regulations do not constitute a major Federal action significantly affecting the quality of the human environment.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This proposed rule, if made final, is not expected to affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule or policy we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend part 17, subchapter A of chapter IV, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(d) * * *
(8)
(i) The benefit would be measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit.
(ii) The conservation measures and management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species populations or improve its habitat.
(iii) In the case where the species and habitat is already adequately managed to the benefit of the species, a net conservation benefit will be achieved when the property owner commits to manage the species for a specified period of time with the anticipation that the population will increase or habitat quality will improve.
(d) * * *
(8)
(i) The benefit would be measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit.
(ii) The conservation measures and management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species populations or improve its habitat.
(iii) In the case where the species and habitat is already adequately managed to the benefit of the species, a net conservation benefit will be achieved when the property owner commits to manage the species for a specified period of time with the anticipation that the population will increase or habitat quality will improve.
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (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; (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 June 3, 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.
U.S. Commission on Civil Rights.
Announcement of meeting.
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 that the Illinois Advisory Committee (Committee) will hold a meeting on Friday, May 06, 2016, at 12:00 p.m. CDT. The purpose of this meeting is to review and discuss approval of an advisory memorandum to be issued to the Commission regarding civil rights and environmental justice in the State. This memorandum is in support of the Commission's nationally focused 2016 statutory enforcement study.
This meeting is available to the public through the following toll-free call-in number: 888-427-9419, conference ID: 7143536. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan, 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. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Member of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Date: The meeting will be held on Friday, May 06, 2016, at 12:00 p.m. CDT.
Melissa Wojnaroski at
International Trade Administration, U.S. Department of Commerce.
Notice of an open meeting.
The United States Manufacturing Council (Council) will hold an open meeting via teleconference on Wednesday, May 18, 2016. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate on proposed recommendations by the Trade, Tax Policy, and Export Growth Subcommittee focused on tax policy and the Trans-Pacific Partnership and a proposed recommendation by the Workforce Subcommittee focused on career pathways to the manufacturing sector. The final agenda will be posted on the Department of Commerce Web site for the Council at
Wednesday, May 18, 12 p.m.-1 p.m. The deadline for members of the public to register, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5 p.m. EDT on May 11, 2016.
The meeting will be held by conference call. The call-in number and passcode will be provided by email to registrants. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Manufacturing Council, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC, 20230; email:
Archana Sahgal, U.S. Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email:
In addition, any member of the public may submit pertinent written comments concerning the Council's affairs at any time before or after the meeting. Comments may be submitted to Archana Sahgal at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5 p.m. EDT on May 11, 2016, to ensure transmission to the Council prior to the meeting. Comments received after that date and time will be distributed to the members but may not be considered on the call. Copies of Council meeting minutes will be available within 90 days of the meeting.
National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of intent.
Notice is hereby given that the U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), intends to grant to Picarro, Inc. of Santa Clara, California, an exclusive global license to its rights in “Methods For Rapid Gas Sampling With High Horizontal Spatial Resolution In A Manner Suitable For Subsequent Constituent Gas Analysis”.
Comments must be received on or before May 31, 2016.
Send comments to NOAA Technology Partnerships Office, SSMC4 Room 7606, 1305 East West Highway, Silver Spring, Maryland 20910.
Derek Parks, NOAA Technology Transfer Program Manager, at:
The Federal Government's rights in this invention are assigned to the United States of America, as represented by the Secretary of Commerce. It is in the public interest to so license this invention, as Picarro, Inc. of Santa Clara, California, is a co-developer and co-patent holder for this technology. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the NOAA Technology Partnerships Office receives written evidence and argument which establishes the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice; availability of hatchery plan and request for comment; reopening of public comment period.
On March 28, 2016, the National Marine Fisheries Service (NMFS) announced the availability of a Hatchery and Genetic Management Plan (HGMP) pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). The HGMP, provided by the California Department of Fish and Wildlife, specifies the operation of a hatchery program rearing steelhead in the Mad River subbasin within the State of California. The announcement opened a 30-day public comment period on the HGMP and associated draft environmental assessment (EA). In response to a request received from the public, NMFS is reopening the comment period for an additional 15 days. This action reopens the comment period for the notice that published March 28, 2016.
The comment period for the notice that published on March 28, 2016 (81 FR 17143) is reopened. Comments must be received at the appropriate address or fax number (see
Written comments on the application should be addressed to the NMFS NOAA Fisheries West Coast Region California Coastal Office, 1655 Heindon Road, Arcata, California 95521, or faxed to 707-825-4840. Comments may be submitted by email. The mailbox address for providing email comments is:
Dan Free, at phone number: (707) 825-5164, or via email:
The notice (81 FR 17143) published in the
Chinook salmon (
Coho salmon (
Steelhead (
CDFW has submitted to NMFS an HGMP describing a hatchery program that releases steelhead into the Mad
The hatchery program that is the subject of the NMFS evaluation would operate to provide steelhead for harvest in freshwater recreational fisheries in the Mad River. The program would propagate steelhead that are derived from the local steelhead population in the Mad River, ensuring that at least half of the MRH winter-run steelhead spawning pairs are hatchery spawned natural-origin and to match natural-origin steelhead with their natural counterparts whenever possible. Measures would be applied in the hatchery program to reduce the risk of incidental adverse genetic, ecological, and demographic effects on natural-origin steelhead and salmon populations.
As specified in the July 10, 2000, ESA 4(d) rule for salmon and steelhead (65 FR 42422) and updated June 28, 2005 (70 FR 37160), NMFS may approve an HGMP if it meets criteria set forth in 50 CFR 223.203(b)(5)(i)(A) through (K). Prior to final approval of an HGMP, NMFS must publish notification announcing its availability for public review and comment.
Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as she deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 5 of the updated 4(d) rule (50 CFR 223.203(b)(5)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to activities associated with artificial propagation programs provided that an HGMP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
NMFS has requested the Center for Independent Experts (CIE) to conduct a peer review of the agency's stock assessment of Eastern Bering Sea walleye pollock (
The public meeting will be held from May 16 through May 19, 2016, 9 a.m. to 5 p.m. Pacific Daylight Time.
The review will be held at the NMFS Alaska Fisheries Science Center, 7600 Sand Point Way NE., Building 4, Seattle, WA 98115. Photo identification is required to enter this facility.
James Ianelli, 206-526-6510.
The CIE panel will consist of three peer reviewers who will assess materials related to the topic, participate in a review workshop with the NMFS scientists who developed the model and the analytical approach, and produce a report. This review will be highly technical in nature and will cover mathematical details of the analytical approach. More information about the CIE is available on its Web site at
Members of the public are invited to observe, and will be provided opportunities to contribute each day from May 16 through May 19, 2016. The final report will be available prior to the September NPFMC Plan Team meetings and will consist of individual reports from each panelist and a summary report. The results of the review will be presented during the September 2016 NPFMC Plan Team meeting, which will be announced at a later time in the
These workshops will be physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ron Felthoven, 206-526-4114, at least 10 working 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 intent to prepare an Environmental Impact Statement; request for comments.
Pursuant to the National Environmental Policy Act (NEPA), this notice announces that NMFS intends to obtain information necessary to prepare an Environmental Impact Statement (EIS) for 10 Hatchery and Genetic Management Plans (HGMPs) for salmon and steelhead hatchery programs jointly submitted by the Washington Department of Fish and Wildlife (WDFW) with the Muckleshoot Indian Tribe and the Suquamish Tribe (referred to as the co-managers), for NMFS's evaluation and determination under Limit 6 of the Endangered Species Act (ESA) 4(d) Rule for threatened salmon and steelhead. The HGMPs specify the propagation of salmon and steelhead in
NMFS provides this notice to advise other agencies and the public of its plans to analyze effects related to the action, and obtain suggestions and information that may be useful to the scope of issues and alternatives to include in the EIS.
Written or electronic scoping comments must be received at the appropriate address or email mailbox (see
Written comments may be sent by any of the following methods:
•
• Mail or hand-deliver to NMFS Sustainable Fisheries Division, 510 Desmond Drive SE., Suite 103, Lacey, WA 98503.
• Fax to (360) 753-9517.
Comments received will be available for public inspection, by appointment, during normal business hours at the above address. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.
Steve Leider, NMFS, by phone at (360) 753-4650, or email to
Steelhead (
Chinook salmon (
Chum salmon (
Bull trout (
The WDFW, Muckleshoot Indian Tribe, and Suquamish Tribe have jointly submitted to NMFS HGMPs for 10 hatchery programs in the Duwamish-Green River basin in Washington State. The HGMPs were submitted to NMFS from 2013 to 2015, pursuant to limit 6 of the 4(d) Rule for salmon and steelhead. The hatchery programs include releases of ESA-listed Chinook salmon and winter-run steelhead into the Duwamish-Green River basin. The hatchery programs also release non-listed coho and fall-run chum salmon and summer-run steelhead into the Duwamish-Green River basin. One hatchery program releases coho salmon into marine waters adjacent to the Duwamish-Green River basin. Seven of the programs are currently operating, and three are new.
NEPA requires Federal agencies to conduct environmental analyses of their proposed major actions to determine if the actions may affect the human environment. NMFS's action of determining under Limit 6 of the 4(d) Rule for salmon and steelhead that implementation of the co-managers' HGMPs would not appreciably reduce the likelihood of survival and recovery of affected threatened ESUs is a major Federal action subject to environmental review under NEPA. Therefore, NMFS is seeking public input on the scope of the required NEPA analysis, including the range of reasonable alternatives, recommendations for relevant analysis methods, and information associated with impacts of the alternatives to the resources listed below or other relevant resources.
NMFS will perform an environmental review of the HGMPs and prepare an EIS that will identify potentially significant direct, indirect, and cumulative impacts on the following resources identified to have a potential for effect from the proposed action:
NMFS will rigorously explore and objectively evaluate a full range of reasonable alternatives in the EIS, including the proposed action and a no-action alternative. Other alternatives may include a decreased production alternative.
For all potentially significant impacts, the EIS will identify measures to avoid, minimize, and mitigate the impacts, where feasible.
NMFS provides this notice to: (1) Advise other agencies and the public of its plans to analyze effects related to the action, and (2) obtain suggestions and information that may be useful to the scope of issues and the full range of alternatives to include in the EIS.
NMFS invites comment from all interested parties to ensure that the full range of issues related to the 10 salmon and steelhead HGMPs is identified. Comments should be as specific as possible.
Written comments concerning the proposed action and the environmental review should be directed to NMFS as described above (see
The environmental review of the 10 salmon and steelhead HGMPs in the Duwamish-Green River basin of Washington State will be conducted in accordance with requirements of the NEPA of 1969 as amended (42 U.S.C. 4321
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow eight commercial fishing vessels to fish outside of the limited access sea scallop regulations in support of a study on seasonal bycatch distribution and optimal scallop meat yield on Georges Bank.
Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.
Comments must be received on or before May 19, 2016.
You may submit written comments by any of the following methods:
•
•
Shannah Jaburek, Fisheries Management Specialist, 978-282-8456.
Coonamesset Farm Foundation (CFF) has submitted a proposal titled “Optimizing the Georges Bank Scallop Fishery by Maximizing Meat Yield and Minimizing Bycatch,” that has been favorably reviewed and is pending final approval by NOAA's Grants Management Division under the 2016 Atlantic Sea Scallop Research Set-Aside (RSA) Program.
CFF submitted a complete application for an exempted fishing permit (EFP) on March 7, 2016. The project would look primarily at seasonal distribution of bycatch on the northern part of Georges Bank in relation to sea scallop meat weight yield while minimizing impacts to other stocks. Additional objectives include continued testing of a modified scallop dredge bag design to reduce flatfish bycatch and collecting biological samples to examine scallop meat quality and yellowtail flounder liver disease. Project investigators working on this project would also work in cooperation with New Hampshire Fish and Game (NHFG) and the Atlantic Offshore Lobstermen's Association (AOLA) to tag lobsters. CFF is requesting exemptions that would exempt eight commercial fishing vessels from the Atlantic sea scallop days-at-sea (DAS) allocations at 50 CFR 648.53(b); crew size restrictions at § 648.51(c); observer program requirements at § 648.11(g); Closed Area II (CAII) scallop gear restrictions specified at 648.81(b); and access area program requirements at § 648.60(a)(4). It would also exempt vessels from possession limits and minimum size requirements specified in 50 CFR part 648, subsections B and D through O, and 50 CFR 697.20 for sampling and tagging purposes only.
Vessels would conduct scallop dredging in a year-round seasonal study on a total of eight 7-day trips, for a total of 56 DAS. Each trip would complete approximately 70 paired tows per trip for an overall total of 520 tows for the project. Closed Area II tows would take place in the central portion situated below the Closed Area II Habitat Closure Area, including the northern portion of Atlantic Sea Scallop Closed Area II Rotational Closed Area. Open area tows would be conducted on the northern half of Georges Bank, west of the boundary of Closed Area II. Although the proposed project included tow locations inside the Closed Area II Habitat Closure Area, we will not be authorizing tows in that area, consistent with previous requests by CFF to conduct dredging in this area. We will not grant access to the Habitat Closure Area for this project until a final outcome from the Omnibus Habitat Amendment II is determined.
There is a potential for gear conflict with lobster gear in the central portion of Closed Area II. In an effort to help mitigate gear interactions, the project coordinator would distribute the time and location of stations to the lobster industry, work only during daylight hours, post an extra lookout to avoid gear, and conduct fishing operations in a way that avoids tangling in stationary gear. We do not expect the DAS, crew size, possession limits, or minimum size exemptions to generate any controversy or concern about the potential catch of egg-bearing female lobsters in this area during the months of June-October. The project would work in cooperation with NHFG and AOLA to tag lobsters with the primary goal of documenting their movement on and off Georges Bank. CFF would like to use data from the tagging project to provide data on the discard mortality of lobsters in the scallop fishery.
All tows would be conducted with two tandem 15-foot (4.6-m) turtle deflector dredges for a duration of 30 minutes using an average tow speed of 4.8 knots. One dredge would be rigged with a 7-row apron and twine top hanging ratio of 2:1, while the other dredge would be rigged with a 5-row apron and 1.5:1 twine top hanging ratio. Both dredge frames would be rigged with identical rock and tickler chain configurations, 10-inch (25.4-cm) twine top, and 4-inch (10.2-cm) ring bag.
For all tows the entire sea scallop catch would be counted into baskets and weighed. One basket from each dredge would be randomly selected and the scallops would be measured in 5-milimeter increments to determine size selectivity. All finfish catch would be sorted by species and then counted and measured. Weight, sex, and reproductive state would be determined for a random subsample (n = 10) of yellowtail, winter, and windowpane flounders. Lobsters would be measured, sexed, and evaluated for damage and shell disease. With the exception of samples retained for further processing, no catch would be retained for longer than needed to conduct sampling and no catch would be landed for sale. All catch estimates for the project are listed in the table below.
CFF needs these exemptions to allow them to conduct experimental dredge towing without being charged DAS, as well as deploy gear in areas that are currently closed to scallop fishing. Participating vessels need crew size waivers to accommodate science personnel. Possession waivers would enable researchers to sample finfish and lobster catch that exceeds possession limits or prohibitions. The project would be exempt from the sea scallop observer program requirements because activities conducted on the trip are not consistent with normal fishing operations.
If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
16 U.S.C. 1801
United States Air Force, Department of Defense.
Notice of intent.
The United States Air Force (Air Force) is issuing this notice to advise the public of its intent to prepare an Environmental Impact Statement (EIS) for the Presidential Aircraft Recapitalization (PAR) Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland (JBA). The EIS will assess the potential environmental consequences of the proposal to beddown versions of the Boeing 747-8 passenger aircraft at JBA as replacements to the two existing VC-25A aircraft currently used to transport the President of the United States (POTUS).
The Air Force plans to hold one daytime and one nighttime public scoping meeting, at the locations and times below:
1. Daytime Scoping Meeting: Veterans of Foreign Wars Post 9619, 6527 Suitland Road, Morningside, MD 20746, on Tuesday, May 24th, 2016 from 9:00- 11:00 a.m.
2. Nighttime Scoping Meeting: Veterans of Foreign Wars Post 9619, 6527 Suitland Road, Morningside, MD 20746, on Monday, May 23rd, 2016 from 6:00-8:00 p.m.
Additional information on the PAR Program and the EIS/EIAP process can be accessed at the project Web site at
The project Web site can also be used to submit scoping comments and scoping comments may also be submitted by mail to the address listed below. Comments will be accepted at any time during the Environmental Impact Analysis Process (EIAP). However, to ensure the Air Force has sufficient time to consider public input in the preparation of the Draft EIS, scoping comments should be submitted to the Web site or the address listed below by May 28th, 2016.
The aircraft replacement was requested by the White House in April 2006 and was approved by the Secretary of the Air Force in a Strategic Basing decision on June 12, 2012. The EIS will assess the potential environmental consequences of bedding down the new aircraft, including construction of a new Presidential Complex with a multi-bay hangar facility, other necessary facility improvements and relocation of select facilities displaced by PAR activities. Facilities potentially requiring relocation include the Hazardous Cargo Pad (HCP), the Explosive Ordnance Disposal (EOD) Proficiency Range, the Joint Air Defense Operations Center (JADOC) Satellite Site, areas of the existing golf course, and the Military Working Dog (MWD) Kennel. The EIS will analyze various alternatives for implementing the Proposed Action at JBA (beddown and operations of a new aircraft) including a No Action Alternative. The Air Force is preparing this EIS in accordance with National Environmental Policy Act (NEPA) of 1969; 40 Code of Federal Regulations (CFR), Parts 1500-1508, the Council on Environmental Quality (CEQ) regulations implementing NEPA; and the USAF Environmental Impact Analysis Process (EIAP) [32 CFR part 989].
National Advisory Committee on Institutional Quality and Integrity (NACIQI), Office of Postsecondary Education, U.S. Department of Education.
Announcement of the time and location of a meeting.
This meeting notice is an update to the previous notice published in the
The NACIQI meeting will be held on June 22-24, 2016, from 8:30 a.m. to 5:30 p.m., at the DoubleTree by Hilton Washington DC Crystal City, 300 Army Navy Drive, Arlington, VA 22202.
U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW., Room 6W250, Washington, DC 20202.
Jennifer Hong, Executive Director/Designated Federal Official, NACIQI, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W250, Washington, DC 20202, telephone: (202) 453-7805, or email:
• The establishment and enforcement of the criteria for recognition of accrediting agencies or associations under Subpart 2, Part H, Title IV, of the HEA, as amended.
• The recognition of specific accrediting agencies or associations or a specific State approval agency.
• The preparation and publication of the list of nationally recognized accrediting agencies and associations.
• The eligibility and certification process for institutions of higher education under Title IV, of the HEA, together with recommendations for improvement in such process.
• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.
• Any other advisory function relating to accreditation and institutional eligibility that the Secretary may prescribe.
You may also access documents of the Department published in the
20 U.S.C. 1011c.
Office of English Language Acquisition (OELA), Department of Education.
Notice.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.365D.
In addition, a number of States have found that disaggregated data on student performance is critical for identifying and developing strategies for closing
The AAPI population is one of the fastest
To better serve all ELs, this competition encourages SEAs to partner with LEAs to further disaggregate the data beyond the seven racial and ethnic categories and analyze and evaluate that data, or analyze and evaluate already-disaggregated data as a first step to inform targeted services and instructional support for underserved students, and to increase transparency in order to spotlight hidden achievement and opportunity gaps for AAPI ELs.
The Department is establishing two absolute priorities for this competition. Applicants must address one of the two absolute priorities: One for applications proposing to further disaggregate and evaluate data regarding AAPI EL students, and the other for applications proposing to identify improvements to instructional programs, initiatives, or other services for AAPI EL students based on an analysis of already disaggregated data.
The Department also has included one invitational priority for projects that will establish sustained partnerships with non-profit organizations and other private entities. An applicant may address the invitational priority regardless of which absolute priority it addresses.
To improve the quality of data available to inform the future activities of SEAs and LEAs to improve student learning outcomes, D2-funded projects must use a portion of their budgets to conduct a project evaluation. The detailed requirements for this evaluation can be found in the Program Requirements section of this notice.
These priorities are:
The purpose of this priority is to fund projects proposed by SEAs that do not currently disaggregate AAPI data on EL AAPI subpopulations beyond the existing seven racial and ethnic categories. Applicants must propose projects that will, consistent with applicable privacy requirements, improve the SEA's system of data collection by further disaggregating the AAPI subgroup and other subgroups as determined by the applicant, beyond the existing seven racial and ethnic categories and report, analyze, and evaluate the results of this effort for underserved populations including EL AAPI students.
The purpose of this priority is to fund projects proposed by SEAs whose data systems, consistent with applicable privacy requirements, currently disaggregate AAPI data on EL AAPI subpopulations beyond the existing seven racial and ethnic categories inclusive of other subgroups, if applicable. Applicants must propose projects that will analyze and evaluate the data to identify opportunity gaps, interventions, improvements to instructional programs, and other initiatives that will improve outcomes for underserved populations including EL AAPI students.
This priority is:
Projects that will establish sustained partnerships with non-profits or other private entities, including philanthropic organizations, to sustain the project beyond the life of the grant.
Applicants must provide a high-quality plan for disseminating the evaluative findings from their projects to inform educators, parents, families, and other stakeholders and to highlight lessons learned that may be used by other SEAs that undertake similar disaggregation efforts. SEA applicants must apply as part of a consortium with one or more LEAs, and also must identify the LEAs they intend to partner with for the purposes of this program.
In addition, grantees funded under Absolute Priority 1 must, by the end of the five-year award period, conduct, complete, and report the findings of an evaluation of the project that includes the elements described in paragraphs 1 through 7, below. Grantees funded under Absolute Priority 2 must address the elements described in paragraphs 1 through 9, below, even though some of the described activities may have been conducted prior to the D2 award or may have otherwise been conducted with other funds not connected to the D2 project.
This evaluation must be submitted within 90 days of the end of the project period.
Required elements for both Absolute Priority 1 and 2:
1. A description of the activities the project has undertaken.
2. A description, including documentation, of the steps the SEA or partner LEA(s) took to identify the additional disaggregations for students in the AAPI subgroup as well as any other disaggregations that were undertaken.
3. A description of how the SEA or partner LEA(s) identified the achievement and opportunity gaps between students in the AAPI subgroups and students in other racial/ethnic groups, including the source(s) of the data used for the comparison.
4. A description of how achievement and opportunity gaps between ELs and non-ELs were identified, including the source of the data. (The SEA or partner LEA(s) must use the most recent available data for all public schools in the jurisdiction.)
5. A discussion of the likely cause(s) of the identified achievement and opportunity gaps.
6. A description of how the SEA or partner LEA(s) will publicly report on the identified achievement and opportunity gaps and causes, including timelines for this reporting.
7. A plan for how the SEA or partner LEA(s) will use the information to eliminate the identified achievement and opportunity gaps, including how the SEA determined that these strategies will be effective. The plan must justify these proposed activities by tying them back to State/local needs and explain how ELs will be supported, in particular, through these activities.
8. A description of the measures that the SEA or partner LEA(s) will use to evaluate the progress toward eliminating the identified achievement and opportunity gaps including the method and timeline for the evaluation and how the continued evaluation of this progress will be built into existing strategic plans (or other guidance documents).
9. A description of how the SEA or partner LEA(s) will publicly report on its progress in eliminating the identified gaps, including timelines for this reporting.
(a) Who is aged 3 through 21;
(b) Who is enrolled or preparing to enroll in an elementary school or secondary school;
(c)(i) Who was not born in the United States or whose native language is a language other than English;
(ii)(I) Who is a Native American or Alaska Native, or a Native resident of the outlying areas; and
(II) Who comes from an environment where a language other than English has had a significant impact on the individual's level of English language proficiency; or
(iii) Who is migratory, whose native language is a language other than English, and who comes from an environment where a language other than English is dominant; and
(d) Whose difficulties in speaking, reading, writing, or understanding the English language may be sufficient to deny the individual—
(i) The ability to meet the State's challenging State academic standards;
(ii) The ability to successfully achieve in classrooms where the language of instruction is English; or
(iii) The opportunity to participate fully in society. (Section 8101 of the ESEA, as amended by the ESSA)
(a) In General. A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.
(b) Administrative Control and Direction. The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.
(c) Bureau of Indian Education Schools. The term includes an elementary school or secondary school funded by the Bureau of Indian Education but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under this Act with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency other than the Bureau of Indian Education. (Section 8101 of the ESEA, as amended by the ESSA)
(a) American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the United States Virgin Islands;
(b) The Republic of Palau, to the extent permitted under section 105(f)(1)(B)(ix) of the Compact of Free Association Amendments Act of 2003 (Pub. L. 108-188; 117 Stat. 2751) and until an agreement for the extension of United States education assistance under the Compact of Free Association becomes effective for the Republic of Palau; and
(c) The Republic of the Marshall Islands and the Federated States of Micronesia, to the extent permitted under section 105(f)(1)(B)(viii) of the Compact of Free Association Amendments Act of 2003 (Pub. L. 108-188; 117 Stat. 2751). (Section 8101 of the ESEA, as amended by the ESSA)
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 or later years from the list of unfunded applications from this competition.
1.
2.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA 84.365D.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2. a.
We will be able to develop a more efficient process for reviewing grant applications if we know the approximate number of applicants that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify us of the applicant's intent to submit an application by emailing
Applicants must use the following standards:
• A “page” is 8.5″; x 11″, on one side only, with 1” margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The page limit for the application does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the bibliography, or the letters of support of the application. However, the page limit does apply to all of the application narrative section of the application.
b.
Consistent with the process followed in the prior OELA competitions, we may post the project narrative section of funded D2 applications on the Department's Web site. Therefore, you may wish to request confidentiality of business information. Identifying proprietary information in the submitted application will help facilitate this public disclosure process.
Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).
3.
Applications for grants under this competition must be submitted electronically using the Grants.gov application site. For information
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
a.
Applications for grants under the D2 program, CFDA number 84.365D, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the D2 program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.
Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Melissa Escalante, U.S. Department of Education, 400 Maryland Avenue SW., Room 5C153, Washington, DC 20202-6510. FAX: (202) 205-1229.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.365D), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
We will not consider applications postmarked after the application deadline date.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:
U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.365D), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
(a)
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers:
(1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.
(2) The extent to which the design for implementing and evaluating the proposed project will result in information to guide possible replication of project activities or strategies including information about the effectiveness of the approach or strategies employed by the project.
(b)
The Secretary considers the quality of the personnel who will carry out the proposed project. In determining the quality of project personnel, the Secretary considers:
(1) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(2) The qualifications, including relevant training and experience, of key project personnel.
(c)
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers:
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.
(2) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.
(d)
(1) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.
(2) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.
2.
Applicants should note, however, that the Department may screen for eligibility at multiple points during the competition process, including before and after peer review; applicants that are determined to be ineligible will not receive a grant award regardless of peer reviewer scores or comments. If we determine that a D2 grant application does not meet a D2 requirement, the application will not be considered for funding.
For D2 grant applications, the Department intends to conduct a process to review and score all eligible applications. Reviewers will review and score all eligible applications on the following four selection criteria: (a) Quality of the project design; (b) Quality of project personnel; (c) Quality of the management plan; and (d) Quality of evaluation.
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) Within 90 days of the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. The elements of the report are detailed in the
If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
4.
Consistent with 34 CFR 75.591, grantees funded under this program shall comply with the requirements of any evaluation of the program conducted by the Department or an evaluator selected by the Department.
5.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
Melissa Escalante, U.S. Department of Education, 400 Maryland Avenue SW., Room 5C153, Washington, DC 20202. Telephone: (202) 401-4300. FAX: (202) 205-1229 or by email at
If you use a TDD or a TTY, call the Federal Relay Service, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).
Notice of Schedule Update to the H2 Refuel H-Prize Competition Guidelines.
In this notice, DOE is extending the completion schedule for its H2 Refuel H-Prize competition. On October 28, 2014, the Department of Energy (DOE) announced the $1 million competition in the
Key Upcoming Dates.
The H-Prize Web site is
Questions may be directed to—Technical information: Katie Randolph at 240-562-1759 or by email at
The Department of Energy (DOE) announced the $1 million H2 Refuel H-Prize competition in the
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Courtney Kerwin (202) 566-1669, or email at
EPA ICR Number 2449.02; Water Quality Standards Regulatory Clarifications (Final Rule); 40 CFR part 131; was approved without change on 12/31/2015; OMB Number 2040-0286; expires on 12/31/2018.
EPA ICR Number 1039.14; Monthly Progress Reports (Renewal); 48 CFR part 1552.211; was approved with change on 12/30/2015; OMB Number 2030-0005; expires on 12/31/2018.
EPA ICR Number 2137.07; NESHAP for Coal- and Oil-fired Electric Utility Steam Generating Units (Renewal); 40 CFR part 63, subparts A and UUUUU; was approved without change on 12/23/2015; OMB Number 2060-0567; expires on 12/31/2018.
EPA ICR Number 2268.04; NESHAP for Paint Stripping and Miscellaneous Surface Coating at Area Sources (Renewal); 40 CFR part 63, subparts HHHHHH and A; was approved without change on 12/22/2015; OMB Number 2060-0607; expires on 12/31/2018.
EPA ICR Number 1983.07; NESHAP for Carbon Black, Ethylene, Cyanide, and Spandex (Renewal); 40 CFR part 63, subparts A and YY; was approved without change on 12/22/2015; OMB Number 2060-0489; expires on 12/31/2018.
EPA ICR Number 1055.11; NSPS for Kraft Pulp Mills (Renewal); 40 CFR part 60, subparts A and BB; was approved without change on 12/22/2015; OMB Number 2060-0021; expires on 12/31/2018.
EPA ICR Number 1831.06; NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (Renewal); 40 CFR part 63, subpart XXX; was approved without change on 12/22/2015; OMB Number 2060-0391; expires on 12/31/2018.
EPA ICR Number 2237.04; NESHAP for Gasoline Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities and Gasoline Dispensing Facilities (Renewal); 40 CFR part 63, subparts A, BBBBBB and CCCCCC; was approved without change on 12/22/2015; OMB Number 2060-0620; expires on 12/31/2018.
EPA ICR Number 2152.05; Clean Air Interstate Rule to Reduce Interstate Transport of Fine Particle Matter and Ozone (Renewal); 40 CFR parts 51 and 96; was approved without change on 12/22/2015; OMB Number 2060-0570; expires on 12/31/2018.
EPA ICR Number 2385.06; Emission Guidelines for Commercial and Industrial Solid Waste Incineration (CISWI) units (Renewal); 40 CFR part 60, subpart DDDD; was approved without change on 12/22/2015; OMB Number 2060-0664; expires on 12/31/2018.
EPA ICR Number 2170.06; Revisions to the Air Emissions Reporting Requirements: Revisions to Lead (Pb) Reporting Threshold and Clarifications to Technical Reporting Details (Final Rule); 40 CFR part 51; was approved without change on 12/22/2015; OMB Number 2060-0580; expires on 12/31/2018.
EPA ICR Number 1748.10; State Small Business Stationary Source Technical and Environmental Compliance Assistance Programs (SBTCP) Annual Reporting Form (Renewal); was approved without change on 12/21/2015; OMB Number 2060-0337; expires on 12/31/2018.
EPA ICR Number 1676.06; Clean Air Act Tribal Authority (Renewal); 40 CFR parts 9, 35, 49, 50, and 81; was approved without change on 12/18/2015; OMB Number 2060-0306; expires on 12/31/2018.
EPA ICR Number 1617.08; Servicing of Motor Vehicle Air Conditioners (Renewal); 40 CFR part 82; was approved without change on 12/17/2015; OMB Number 2060-0247; expires on 12/31/2018.
EPA ICR Number 1395.09; Emergency Planning and Release Notification Requirements under Emergency Planning and Community Right-to-Know Act Sections 302, 303, and 304 (Renewal); 40 CFR part 355; was approved without change on 12/16/2015; OMB Number 2050-0092; expires on 12/31/2018.
EPA ICR Number 1352.13; Community Right-to-Know Reporting Requirements Under Sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) (Renewal); 40 CFR part 370; was approved with change on 12/16/2015; OMB Number 2050-0072; expires on 12/31/2018.
EPA ICR Number 0370.25; Underground Injection Control (UIC) Program (Renewal); 40 CFR parts 144, 145, 146, 147, 148, and 124; was approved with change on 12/8/2015; OMB Number 2040-0042; expires on 12/31/2018.
EPA ICR Number 1506.12; NSPS for Municipal Waste Combustors (Renewal); 40 CFR part 60, subparts A, Ea, and Eb; was approved with change on 12/1/2015; OMB Number 2060-0210; expires on 12/31/2018.
EPA ICR Number 1985.06; NESHAP for Leather Finishing Operations (Renewal); 40 CFR part 63, subparts A and TTTT; was approved with change on 12/1/2015; OMB Number 2060-0478; expires on 12/31/2018.
EPA ICR Number 0982.11; NSPS for Metallic Mineral Processing Plants (Renewal); 40 CFR part 60, subparts A and LL; was approved with change on 12/1/2015; OMB Number 2060-0016; expires on 12/31/2018.
EPA ICR Number 1964.06; NESHAP for Wet-Formed Fiberglass Mat Production (Renewal); 40 CFR part 63, subparts A and HHHH; was approved with change on 12/1/2015; OMB Number 2060-0496; expires on 12/31/2018.
EPA ICR Number 1807.08; NESHAP for Pesticide Active Ingredient Production (Renewal); 40 CFR part 63, subparts A and MMM; was approved without change on 12/1/2015; OMB
EPA ICR Number 2519.01; Hazardous Waste Export-Import Revisions (Proposed Rule); 40 CFR part 262, subparts E, H, F; OMB filed comment on 12/15/2015.
EPA ICR Number 1692.08; NESHAP for Petroleum Refineries (Proposed Rule); 40 CFR part 63, subpart CC; OMB filed comment on 12/15/2015.
As required by the Civil Service Reform Act of 1978 (Pub. L. 95-454), Chairman Thomas Wheeler appointed the following executive to the Senior Executive Service Performance Review Board (PRB): Jon S. Wilkins, Jr.
Federal Communications Commission.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before June 3, 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, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
Due to consolidation in the telecommunications marketplace, there is a decrease in the Commission's burden estimates. Section 69.605 requires that access revenues and cost data shall be reported by participants in association tariffs to the association for computation of monthly pool revenues distributions. The association shall submit a report on or before February 1 of each calendar year describing the associations' cost study review process for the preceding calendar year as well as the results of that process. For any revisions to the cost study results made or recommended by the association that would change the respective carrier's calculated annual common line or traffic sensitive revenue requirement by ten percent or more, the report shall include the following information:
(1) Name of the carrier;
(2) A detailed description of the revisions;
(3) The amount of the revisions;
(4) The impact of the revisions on the carrier's calculated common line and traffic sensitive revenue requirements; and
(5) The carrier's total annual common line and traffic sensitive revenue requirement. The information is used to compute charges in tariffs for access service (or origination and termination) and to compute revenue pool distributions. Neither process could be implemented without the information.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before June 3, 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, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
collection is contained in 47 U.S.C. 154 and 303 of the Communications Act of 1934.
Rush Truck Centers of Arizona, Inc., Rush Truck Centers of California, Inc., Rush Truck Centers of Colorado, Inc., Rush Truck Centers of Florida, Inc., Rush Truck Centers of Georgia, Inc., Rush Truck Centers of Idaho, Inc., Rush Truck Centers of Kansas, Inc., Rush Truck Centers of North Carolina, Inc., Rush Truck Centers of Ohio, Inc., Rush Truck Centers of Oklahoma, Inc., Rush Truck Centers of Texas, LP., Rush Truck Centers of Utah, Inc., On Behalf of Themselves and All others similarly situated V. Nippon Yusen Kabushiki Kaisha, Nyk Line (North America) Inc., Mitsui O.S.K. Lines, Ltd., Mitsui O.S.K. Bulk Shipping (USA), Inc., World Logistics Service (USA) Inc., Höegh Autoliners as, Höegh Autoliners, Inc., Nissan Motor Car Carriers Co. Ltd., Kawasaki Kisen Kaisha, Ltd., “K” Line America, Inc., Wallenius Wilhelmsen Logistics as, Wallenius Wilhelmsen Logistics Americas LLC, Eukor Car Carriers Inc., CompaÑíA Sud Americana De Vapores S.A., and CSAV Agency North America, LLC.
Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by the above named Complainants, “on behalf of themselves and all others similarly situated, hereinafter “Complainants,” against the above named “providers of Vehicle Carrier Services”, hereinafter “Respondents.” The Complaint is brought as a proposed class action. Complainants “seek to represent classes of truck and heavy equipment dealers in approximately 30 states . . . who purchased new Vehicles . . . that included in their prices Vehicle Carrier Services from any Respondent, unnamed co-conspirator, or any current or former subsidiary or affiliate thereof . . . . ” Complainants allege that Respondents “transport large numbers of cars, medium- and heavy-duty trucks, and other new, assembled motor vehicles including buses, commercial vehicles, construction equipment, mining equipment, and agricultural equipment . . . across oceans and other large bodies of water using specialized cargo ships known as Roll On-Roll Off vessels (“RoRos”).”
Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 40302(a), 41102(b)(1), 41102(c), 41103(a)(1) and (2), 41104(10), 41105(1) and (6), and the Commission's regulations at 46 CFR 535.401
Complainants request the following relief:
“(1) That Respondents be required to answer the charges herein;
(2) That after due investigation and hearing Respondents be found to have violated 46 U.S.C. 40302(a), 41102(b)(l), 41102(c), 41103(a)(l) and (2), 41104(10), 41105(1) and (6), and 46 CFR 535.401,
(3) The FMC determine that this action may be maintained as a class action under Rule 23(a), (b)(2) and (b)(3) of the Federal Rules of Civil Procedure, and direct that reasonable notice of this action, as provided by Rule 23(c)(2) of the Federal Rules of Civil Procedure, be given to each and every member of the Truck and Equipment Dealer Class;
(4) That Complainants be awarded reparations in a sum to be proven under 46 U.S.C. 41305, with interest (46 U.S.C. 41305(a)) and reasonable attorneys' fees (46 U.S.C. 41305(b));
(5) That Complainants be awarded double its proven actual injury under 46 U.S.C. 41305(c) because Respondents and their co-conspirators violated 46 U.S.C. 41102(b) and 41105(1);
(6) That Respondents be found jointly and severally liable for the conduct alleged herein, including that of their co-conspirators; and
(7) That such other and further order or orders be made as the FMC determines to be proper.
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by April 28, 2017 and the final decision of the Commission shall be issued by November 13, 2017.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by the above named Complainants, “on behalf of themselves and all others similarly situated, hereinafter “Complainants,” against the above named “providers of Vehicle Carrier Services”, hereinafter “Respondents.” The Complaint is brought as a proposed class action. Complainants “seek to represent all Automobile Dealers in the United States who purchased motor vehicles incorporating a Vehicle Carrier Service charge charged by any Respondent or any current or former subsidiary or affiliate thereof, or any co-conspirator . . . .” Complainants allege that Respondents “transport large numbers of cars, trucks, and other automotive vehicles including agriculture and construction equipment . . . across large bodies of water using specialized cargo ships known as Roll On-Roll Off vessels (“RoRos”).”
Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 40302(a), 41102(b)(1), 41102(c), 41103(a)(1) and (2), 41104(10), 41105(1) and (6), and the Commission's regulations at 46 CFR 535.401
Complainants request the following relief:
(1) That Respondents be required to answer the charges herein;
(2) That after due investigation and hearing Respondents be found to have violated 46 U.S.C. 40302(a), 41102(b)(l), 41102(c), 41103(a)(l) and (2), 41104(10), 41105(1) and (6), and 46 CFR 535.401,
(3) The FMC determine that this action may be maintained as a class action under Rule 23(a), (b)(2) and (b)(3) of the Federal Rules of Civil Procedure, and direct that reasonable notice of this action, as provided by Rule 23(c)(2) of the Federal Rules of Civil Procedure, be given to each and every member of the Class;
(4) That Complainants be awarded reparations in a sum to be proven under 46 U.S.C. 41305, with interest (46 U.S.C. 41305(a)) and reasonable attorneys' fees (46 U.S.C. 41305(b));
(5) That Complainants be awarded double its proven actual injury under 46 U.S.C. 41305(c) because Respondents and their co-conspirators violated 46 U.S.C. 41102(b) and 41105(1);
(6) That Respondents be found jointly and severally liable for the conduct alleged herein, including that of their co-conspirators; and
(7) That such other and further order or orders be made as the FMC determines to be proper.
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by April 28, 2017 and the final decision of the Commission shall be issued by November 13, 2017.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 16, 2016.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
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The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 31, 2016.
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
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In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following meeting of the aforementioned committee:
In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered on March 22, 2016 pursuant to Executive Order 13708, and will expire on September 30, 2017.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
The meeting announced below concerns Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS), DP16-006, initial review.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
The Centers for Disease Control and Prevention (CDC) is soliciting
Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. The Secretary, HHS, acting through the Director, CDC, shall appoint to the advisory committee nominees with expertise in breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Two members may be representatives of the general public with personal experience in issues related to breast or cervical cancer early detection and control. Members may be invited to serve for up to four years.
The next cycle of selection of candidates will conclude in the Summer of 2016, for selection of potential nominees to replace members whose terms will end on March 31, 2017.
Selection of members is based on candidates' qualifications to contribute to the accomplishment of BCCEDCAC objectives. The U.S. Department of Health and Human Services will give close attention to equitable geographic distribution and to minority and female representation so long as the effectiveness of the Committee is not impaired. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, HIV status, disability, and cultural, religious, or socioeconomic status. Consideration is given to a broad representation of geographic areas within the U.S., with diverse representation of both genders, ethnic and racial minorities, and persons with disabilities. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government.
Candidates should submit the following items:
Current curriculum vitae or resume, including complete contact information (name, affiliation, mailing address, telephone numbers, fax number, email address);
A 150 word biography for the nominee;
At least one letter of recommendation from a person(s) not employed by the U.S. Department of Health and Human Services. Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by HHS.
Nominations should be submitted (postmarked or received) by June 24, 2016:
Telephone and facsimile submissions cannot be accepted.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project entitled “Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients”.
Written comments must be received on or before July 5, 2016.
You may submit comments, identified by Docket No. CDC-2016-0041 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
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; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
“Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients”—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Community-Based Organizations (CBOs) play an essential role in reaching persons at high risk of transmitting and acquiring HIV infection. Through Cooperative Agreement #CDC-RFA-PS15-1502 (CBO-HPS), CDC funds 90 CBOs to provide comprehensive HIV prevention services to HIV-positive persons and high-risk HIV-negative persons. However, the CBO-HIV Prevention Services (HPS) awardees are not required to monitor or report on critical outcomes such as whether HIV-positive persons who are linked to HIV medical care were retained in care or prescribed ART, and whether high-risk HIV-negative persons who were referred to Pre-Exposure Prophylaxis (PrEP) initiated its use. Also, CBO-HPS CBOs are not required to collect and report data about clients' perceived barriers to accessing HIV prevention services.
CBO-OMP will fund a subset of CBO-HPS awardees to collect and report data to CDC about the utilization and outcomes of the HIV prevention and support services. This will increase understanding of HIV prevention and support services received by CBO-HPS clients, the outcomes of these services, and successes and challenges related to service provision and utilization.
The respondent universe will comprise clients at 15-18 CBOs funded by CBO-HPS. CBO-OPM is organized in two categories: Category 1—HIV-positive clients and Category 2—high-risk HIV-negative clients.
This information collection will evaluate HIV-prevention services over time through participant interviews, record/chart review, CBO-HPS staff interviews, and focus groups. Participant interviews will include questions for participants living with HIV-positive and high-risk HIV-negative clients at CBOs funded by CBO-HPS about demographics, HIV-related risk behaviors, HIV prevention and support services received, service outcomes, and experiences with services over time; staff interviews about strategies for and barriers to recruiting and engaging clients in HIV prevention and support services; and focus groups with clients who are receiving HIV prevention services at CBOs.
For Category 1, self-reported client interview data will be collected at baseline, 3, 6, 9 and 15 months. For Category 2, self-reported client level data will be collected at baseline, 3, 6, and 9 months. Participants will complete a 30-minute, staff-facilitated interview at baseline and 20-minute staff-facilitated interviews at each follow-up, to assess the outcomes of HIV-prevention services they receive.
This project will also collect information from CBO-HPS Staff. Two CBO-HPS staff interviews will be conducted for Category 1 and two staff interviews will be conducted for Category 2. All interviews are expected to last 2.5 hours.
This project will also collect information from participant focus groups. Respondents will also complete a short demographic questionnaire. Focus groups will occur twice during the project period and will last approximately 90 minutes.
All electronic data will be password protected and accessible only to project staff and direct supervisors. Data will be stored on network drives which are regularly backed up by staff. Participation in this project is strictly voluntary. The consent process will be implemented according to the local/state policies of the funded agencies. Consent forms are provided. The consent process for CBO-OMP involves the agency staff providing an overview of the project that includes a description of the benefits of as well as the risks and discomforts to participation as well as the protections for the respondent's privacy. Participants must sign the consent form prior to enrolling into the project.
The information collected by each funded agency may include personally identifiable information, such as name and contact information, in order to provide continuity of service, follow-up of referrals, schedule follow-up interviews and other outreach activities. Personally identifiable information will be kept in a locked file cabinet and will be accessible only to appropriate agency staff. Any individually identifiable information collected by funded agencies will not be submitted to CDC.
The category 1 information collection will occur over 33 months and will involve up to 15 CBOs. The population targeted by Category 1 are HIV-positive clients who are receiving CBO-HPS services and have been provided a CBO-HPS referral to HIV medical care. They will be screened, interviewed and CBO staff will collect their medical records related to their HIV-medical care visits, CD4 count and viral loads, and prescription to ART.
The Category 2 information collection will occur over 21 months and involve up to 3 CBOs who will target high-risk HIV-negative clients who are receiving CBO-HPS services. CBOs will screen 225 persons each year. CBO staff will collect their medical records about medical care visits, PrEP prescriptions and information about which CBO-HPS referrals. Participants will be administered a baseline interview as well as interviews at 3 months, 6 months, and 9 months. Each CBO will also conduct two focus groups over the project period, one in each year of the evaluation.
Each of the CBOs funded to participate in this project will be required to submit data they've collected each month to CDC, including the screener, medical records and CBO-HPS referrals, baseline interview, 3-month follow-up interview, 6-month follow-up interview, 9-month follow-up interview, focus groups, and staff interviews, respectively. There is no cost to respondents other than their time. Total burden hours are 1,125.
The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC).
The Committee provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC); the Deputy Director, Office of Infectious Diseases (OID), CDC; the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), CDC; and the Director, Division of Healthcare Quality Promotion (DHQP), NCEZID, CDC, regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance, and related events in settings where healthcare is provided, including hospitals, outpatient settings, long-term-care facilities, and home health agencies.
Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of HICPAC objectives.
The Secretary, HHS, acting through the Director, CDC, shall appoint to the advisory committee nominees with expertise to provide advice regarding the practice of healthcare infection control, strategies for surveillance and prevention and control of healthcare-associated infections in United States healthcare facilities. Consideration is given to professional training and background, points of view represented, and upcoming issues to be addressed by the committee. Nominees may be invited to serve for four-year terms. The next cycle of selection of candidates will begin in the spring of 2016, for selection of potential nominees to replace members whose terms will end on June 30, 2017.
Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC's objectives (
Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, HIV status, disability, and cultural, religious, or socioeconomic status. Consideration is given to a broad representation of geographic areas within the U.S., with diverse representation of both genders, ethnic and racial minorities, and persons with disabilities. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:
Current curriculum vitae or resume, including complete contact information (name, affiliation, mailing address, telephone numbers, fax number, email address) ; At least one letter of recommendation stating the
Nominations should be submitted (postmarked or received) by August 15, 2016.
Telephone and facsimile submissions cannot be accepted. Nominations may be submitted by the candidate or by the person/organization recommending the candidate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
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 an information collection concerning CMS' Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey. We are also announcing that the proposed information collection had been submitted to OMB and was approved under control number 0938-1300 through September 30, 2016. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) we requested emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the regular clearance procedures were followed.
More specifically, the regular PRA clearance process would jeopardize the timely completion of CMS' evaluation of the State's upcoming non-emergency medical transportation (NEMT) waiver and other important waivers. Most importantly, it would potentially cause significant harm by depriving Medicaid beneficiaries—especially those affected by the NEMT waiver—of appropriate medical services and needed care.
Although we have already received OMB approval to test/develop the survey instruments, we are now soliciting public comment for 30-days prior to implementing the survey in order to meet the conditions of OMB's Terms of Clearance that were issued on March 21, 2016.
Under the PRA, federal agencies are required to publish notice in the
Comments must be received by June 3, 2016.
When commenting, please reference the document identifier (CMS-10615) or OMB control number (0938-1300). To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
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, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following ICR. More detailed information can be found in the collection's supporting statement and associated materials (see
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. 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. In compliance with the requirement of section 3506(c)(2)(A) of the PRA, we submitted to OMB our request for emergency processing of this information collection. OMB approved the emergency ICR for testing/developing the survey on March 21, 2016. This iteration seeks emergency approval for fielding the survey and for conducting interviews and focus groups.
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Emergency OMB approval is being sought, as permitted under 5 CPR 1320.13(a)(2)(i), since public harm is reasonably likely to occur if the regular nonemergency PRA clearance procedures are followed. Potential harm may result due to insufficient information to adequately support decision making that is required in November 2016. The clearance is particularly important for decisions about the renewal of precedent-setting waivers of Medicaid policy that assure important beneficiary protections regarding coverage and access to care;
Written comments and recommendations will be considered from the public if received by the date and address noted above.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Special Protocol Assessment.” This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled “Special Protocol Assessment” issued May 17, 2002.
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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 5, 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 draft 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, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, 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 that office in processing your requests. See the
Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Special Protocol Assessment.” SPA is a process by which sponsors may request to meet with FDA to reach agreement on the design and size of certain trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. After completing the SPA review, FDA issues a letter including an assessment of the protocol, agreement or nonagreement with the proposed protocol, and answers to the sponsor's relevant questions. Section 119 of the Food and Drug Administration Modernization Act of 1997 amended section 505(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(b)) and directed FDA to meet with sponsors who request to meet, provided certain conditions are met, to reach agreement on the design and size of the well-controlled clinical trials intended to form the primary basis for a demonstration of effectiveness in a marketing application submitted under section 505(b) of the FD&C Act or section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). These provisions subsequently were amended in section 7002(d)(1) of the Biologics Price Competition and Innovation Act of 2009 to include any necessary clinical study or studies for biosimilar biological product applications under section 351(k) of the PHS Act. In 2013, the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) further amended the SPA provisions to provide for SPA agreements regarding animal and associated clinical trials conducted in support of applications for products developed under 21 CFR part 314 subpart I, and 21 CFR part 601 subpart H (the animal rule). Such marketing applications include new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements to approved NDAs and BLAs.
In conjunction with the Prescription Drug User Fee Amendments of 2012 (PDUFA V), enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), and with the Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of FDASIA, FDA agreed to specific performance goals (PDUFA V goals and BsUFA goals, respectively) for SPA. Per section 505(b)(5)(B) of the FD&C Act, the PDUFA V goals, and the BsUFA goals, the following protocols are eligible for SPA: (1) Animal carcinogenicity protocols; (2) drug substance and drug product stability protocols; (3) animal efficacy protocols for studies intended to provide primary evidence of effectiveness required for approval or for licensure for products developed under the animal rule; (4) protocols for clinical trials or studies intended to form the primary basis of an efficacy claim; and (5) protocols for clinical studies necessary to prove biosimilarity and/or interchangeability.
This draft guidance revises the guidance of the same name issued in May 2002. After it has been finalized, this guidance will replace the May 2002 guidance. Significant changes from the 2002 version include the following: (1) Clarifying which protocols are eligible for SPA; (2) adding animal rule efficacy protocols intended to support approval under part 314 subpart I, and part 601 subpart H, for drugs and biological products, respectively; (3) adding protocols intended to support approval of a biosimilar biological product; (4) providing greater detail about the content of an SPA submission; and (5) clarifying the process for rescinding an SPA agreement. FDA seeks comments to aid in finalizing this draft guidance.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the procedural aspects of SPA. 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 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 “Special Protocol Assessment” have been approved under OMB control number 0910-0470. The collections of information for FDA Form 1571 have been approved under OMB control number 0910-0014.
Persons with access to the Internet may obtain the document at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363,
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table in this document are no longer being marketed.
FDA has reviewed its records and, under § 314.161, and has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Submit either electronic or written comments by June 3, 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
Ana Loloei Marsal, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4552, Silver Spring, MD 20993-0002, 301-796-8774,
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the date of
On November 21, 1997, the President signed into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section, 510(m), to the FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the
Section 510(m)(2) of the FD&C Act provides that 1 day after date of publication of the list under section 510(m)(1), FDA may exempt a device on its own initiative or upon petition of an interested person if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1).
FDA has received the following petition requesting an exemption from premarket notification for a class II device: Martin O'Connor, Germaine Laboratories, Inc., 11030 Wye Dr., San Antonio, TX 78217, for its Method, Metallic Reduction, Glucose (urinary, non-quantitative) classified under 21 CFR 862.1340.
The following reference is on display in the Division of Dockets Management (see
1. “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 1998, (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OOPD) Natural History Grants Program. The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Important dates are as follows:
1. The application due dates are October 14, 2016 and October 15, 2018.
2. The anticipated start dates are March 2017 and March 2019.
3. The opening dates are August 15, 2016 and August 15, 2018.
4. The expiration date is October 16, 2018.
Submit electronic applications to:
Katherine Needleman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993-0002, 301-796-8660, email:
For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at
The OOPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. The term “rare disease or condition” is defined in section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee). FDA generally considers drugs, devices, and medical foods potentially eligible for grants under the OOPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year.
The natural history of a disease is the natural course of a disease from the time immediately prior to its inception, progressing through its pre-symptomatic phase and different clinical stages to the point where the disease has ended without external intervention. Natural history studies track the course of disease over time, identifying demographic, genetic, environmental, and other variables that correlate with its development and outcomes in the absence of treatment. Thorough understanding of disease natural history is the foundation upon which a clinical development program for drugs, biologics, medical foods or medical devices is built.
Rare diseases, as defined in the United States Orphan Drug Act (ODA) (Pub. L. 97-414), are diseases or conditions with a prevalence of fewer than 200,000 persons in the United States. Though individually rare, together there are approximately 30 million Americans affected by 7,000 known rare diseases. Unlike common diseases, there is little existing knowledge on the natural history of most rare diseases, which makes natural history studies of particular importance for rare diseases product development. In January 2014, the FDA organized a Public Workshop on Complex Issues in Developing Drugs for Rare Diseases. During the workshop, the lack of natural history studies was reconfirmed by all stakeholders (patients, industry, researchers and the FDA) as one of the most common and urgent issues that hinder treatment development for rare diseases. The need for natural history studies was also emphasized in the recently published (August 17, 2015) draft FDA Guidance for Industry, “Rare Diseases: Common Issues in Drug Development,” available at
The objective of FDA's Orphan Products Natural History Grants Program is to support studies that characterize the natural history of rare diseases/conditions, identify genotypic and phenotypic subpopulations, and develop and/or validate clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in serious rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal Agencies may not apply.
Of the estimated FY 2017 funding ($17.7 million), approximately $2 million will fund 2 to 5 new awards, subject to availability of funds. Prospective Natural History Studies are eligible for grants of up to $400,000 per year for up to 5 years. Retrospective Natural History Studies or Surveys are eligible for grants of up to $150,000 per year for up to 2 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $150,000 or $400,000 total cost limit, whichever is applicable.
The length of support will depend on the nature of the study. For those studies with an expected duration of more than 1 year, all future years of noncompetitive continuation of support will depend on the following factors: (1) Performance during the preceding year; (2) compliance with regulatory requirements as applicable; and (3) availability of Federal funds.
Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at
Steps 1 through 5, in detail, can be found at
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is announcing a public workshop entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions.
The public workshop will be held on June 1, 2016, from 8 a.m. to 5 p.m.
The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
Audrey Thomas, Office of Regulatory Science and Innovation, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, 301-796-3520,
The purpose of this public workshop is to provide an opportunity for relevant stakeholders, including clinicians, academia, industry, and FDA to discuss systematic assessment of data needed to support extrapolation of efficacy in pediatric product development. Specifically, the workshop will include: (1) Presentations on approaches for assessing disease and therapeutic response similarity between adults and pediatrics, and (2) discussion of alternative approaches to the assessment of extrapolation assumptions in pediatric product development, including the use of clinical trial simulation and Bayesian approaches. Examples in partial onset seizures, inflammatory bowel diseases, and polyarticular juvenile idiopathic arthritis will be presented and discussed.
FDA has verified the Web site addresses in this document, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This draft guidance revises the draft guidance of the same name that was issued on October 23, 2013.
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 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 5, 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
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 draft 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
Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-796-1500.
FDA is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” This draft guidance addresses nonclinical development, early phases of clinical development, and phase 3 protocol designs. Important issues addressed in this draft guidance include: Trial design options, noninferiority margin for active-controlled phase 3 trials in the evaluation of interferon (IFN)-free regimens, and trial design options and safety evaluation for specific populations, including patients with decompensated cirrhosis, patients either pre- or post-liver transplant, patients with chronic kidney disease, and clinical virology considerations.
This draft guidance revises the draft guidance of the same name that issued October 23, 2013 (78 FR 63218). Significant changes in this draft guidance compared to the previous version are:
• Modification of several sections to focus on IFN-free DAA regimens.
• Additional details on phase 2 and phase 3 trial design options for the evaluation of IFN-free regimens in treatment-naïve and treatment-experienced populations, including DAA-experienced populations. Specifically, the guidance now recommends that each marketing application contain at least one active-controlled comparative trial.
• Additional clarification on DAA drug development in specific populations, including trial design options for human immunodeficiency virus/hepatitis C virus co-infected patients, pediatric patients, patients with advanced chronic kidney disease, patients with decompensated cirrhosis, patients either pre- or post-liver transplantation, and patients who failed to respond to a prior DAA-based regimen.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing DAA drugs for treatment of chronic hepatitis C virus infection. 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 guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under 0910-0014, the collections of information in 21 CFR part 314 have been approved under 0910-0001, and the collections of information referred to in the guidance for industry “Establishment and Operation of Clinical Trial Data Monitoring Committees” have been approved under 0910-0581.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by June 3, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.
The marketing literature divides product attributes (“cues”) into intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product (
The Office of Prescription Drug Promotion (OPDP) plans to investigate, through empirical research, the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. This will be investigated in DTC print advertising for prescription drugs.
The design consists of two parts: A main study and a followup study. We will conduct two sequential pretest waves prior to the main study and one pretest prior to the followup study. The purpose of the pretests are to (1) ensure the stimuli are understandable and viewable, (2) identify and address any challenges to embedding the stimuli within the online survey, and (3) ensure the study questions are appropriate and meet the study's goals.
Participants in the main study will be randomly assigned to view one of nine versions of an ad, as depicted in table 1. The two variables of interest are type of market claim (#1 Prescribed, New) and type of efficacy information (High, Low, or None). Efficacy information will be operationalized in the form of realistic quantitative information (for example, “46 percent of patients felt their nerve pain reduced by at least half, compared to baseline”).
In the followup study, participants(n = 216) will complete a 15-minute paired choice experiment. Participants will be asked to choose between two hypothetical drugs based on print ads, one of which includes a market claim from the Main Study (#1 Prescribed or New). The ads also include different efficacy information (for example, “46 percent of patients felt their nerve pain reduced by at least half, compared to baseline” versus “51 percent of patients felt their nerve pain reduced by at least half, compared to baseline”). Figure 1 depicts an example choice. Participants are asked to indicate which drug they would prefer. They are given 48 such choice sets, which vary in efficacy information and the presence of the market claim.
In the
(Comment 1) From AbbVie: Respondents may view “benefits” and “risks” more generally versus “side effects” as a specific inquiry. For example, “side effects” could be interpreted as adverse effects or adverse events, and as such, elicit a much more specific response than “risks” which could be seen more broadly. We suggest that “side effects” be eliminated from question 4 to keep questions 3 and 4 as both general in nature.
(Response) We are interested in recall of both risks and side effects, and so we inquire about both. Inquiring about risks only may artificially reduce the quantity of recall. Moreover, we counterbalance the presentation of questions 3 and 4 in efforts to account for any influence of question ordering. It would be feasible to instead inquire about risks and side effects in separate questions; however, in our experience, we find that consumers tend to think about risks and side effects together, which makes sense given the typical presentation of risks and side effects in direct-to-consumer promotional materials.
(Comment 2) From AbbVie: The answers to questions 7 through 12 may be biased by attitudes toward advertising in general and may go well beyond the pharmaceutical ad they are shown.
(Response) By asking these questions, we hope to detect any differences in perceived effectiveness and risk between those exposed to different experimental conditions. For example, those exposed to an ad with a #1 Prescribed market claim may perceive the product to be more effective than those in the control condition. We acknowledge participants may bring their own opinions about advertising to the study. However, these opinions tend to be evenly distributed across experimental conditions based on random assignment procedures. Thus, any differences result from the experimental manipulations.
(Comment 3) From AbbVie: We acknowledge we have not seen the test ad; but, we wish to point out that questions 13 and 17 rely on the ad presenting numeric efficacy and safety information that can be interpreted by respondents.
(Response) Prior research has shown that consumers can reach numeric judgments about efficacy and risk despite no numeric information being presented (Ref. 5). As described in our study design (see table 1), we are not manipulating quantitative safety information and not all test ads contain quantitative efficacy information. We have worked with an expert reviewer in OPDP to produce efficacy claims that are realistic for this drug product class.
(Comment 4) From AbbVie: Question 18 relies on the ad presenting information about the seriousness of one or more “side effects” that the respondent could rank. We do not usually see print ads that present details about the extent of the seriousness of one or more side effects. In the absence of this presentation, how are respondents to answer this question?
(Response) We find that consumers are generally able to differentiate between the seriousness of various risks and side effects, and also that they can make judgments about the overall (gist) seriousness of the risks and side effects. We ask this question with the intention to detect whether or not exposure to market claims and efficacy information impacts risk perceptions.
(Comment 5) From AbbVie: The answers to questions 21 to 26 may reflect a patient's perception of their doctor rather than the ad. Therefore, the answers may not reflect what was communicated in the ad but rather
(Response) We are endeavoring to replicate the results of Mitra et al. (Ref. 4), who found that market leadership claims affected consumer beliefs about doctor's judgments.
(Comment 6) From AbbVie: In the table headers for questions 27 and 28, please change “claim” to “statement” so that it matches the text in the question.
(Response) We will make this change.
(Comment 7) From AbbVie: It is beneficial to rotate the order of response choices in questions 27 and 28 as is done in prior questions. Some of the features a-h are broad (b. pictures and images) while some are specific (e. percentages). It would be better to compare the very general features in a question and group the very specific features into another question to compare like features.
(Response) We will make this change.
(Comment 8) From AbbVie: For questions 35 to 38, rather than rank from Strongly Disagree to Strongly Agree, which are absolutes, it would be better to rank by frequency from Never to Always; this moves the response to how often patients perceive this and away from absolutes.
(Response) We acknowledge that it is difficult to rank agree/disagree on all drugs. However, a scale range of Always-Never is unipolar; we can't assess whether respondents think the opposite,
(Comment 9) From AbbVie: We suggest that all the features of question 43a to h be stated in the affirmative/positive. For example, question 43h should be worded as “the drug has few side effects” to be consistent with features of question 43a to g that are positively stated.
(Response) The proposed item, “the drug has few side effects,” assesses a different outcome than our current question, “the drug has serious side effects.” We have also added items assessing “drug cost and/or copay” and “doctor's recommendation.” For consistency, we will change the wording so that all features are neutral (for instance: The drug's side effects, opinions of people I know, how often the drug is prescribed).
(Comment 10) From Lilly: Given the proposed FDA research questions, Lilly believes the design is appropriate and the sample size will allow for breakouts by each cell. In advertising A/B tests, in which this is similar to, all aspects of the stimulus not being tested are held the same in order to reduce bias and isolate the feature being tested. We strongly recommend that this guideline is followed in this study.
(Response) We intend to hold all features other than the manipulations constant in the stimuli.
(Comment 11) From Lilly: One research objective for the main study suggests that the study will measure perceptions of the doctors' acceptance of the drug by respondents. Since respondents will only be seeing a print ad and not interacting with a doctor, we believe the research setting will be too artificial to gain meaningful insights into this topic. We recommend removing the section (questions 21 to 26).
(Response) Please see response to Comment 5 from AbbVie.
(Comment 12) From Lilly: The details of the followup study are less clear than the main study. What are the techniques and what are the dependent measures on which the respondent will be asked to decide?
(Response) The followup study assesses the relative weighting of a market claim and efficacy in decisionmaking. Participants are asked to choose a drug out of two options that vary in (1) the presence of a market claim and (2) efficacy. We will examine product preference as a function of efficacy using logistic regression. The difference in efficacy between the two drugs on each choice set will be a continuous predictor variable and drug choice will be a binary outcome variable. Critically, we will examine whether, and to what extent, the efficacy-choice relationship varies as a function of an added market claim; thus, market claim presence will be an interaction term. The experiment uses a discrete choice approach common in psychology and economics (Ref. 8).
(Comment 13) From Lilly: We suggest FDA stratify the sample for both studies across demographic variables to ensure it is representative of the U.S. diabetic population.
(Response) We are applying demographic quotas to achieve a representative sample.
(Comment 14) From Lilly: The questionnaire employs a number of different Likert scales that differ on the number of scale values and definition of values. Lilly suggests using a standard five-point scale with a mid-point and definitions for each value for all scalar questions.
(Response) We have changed the Likert scales to be internally consistent.
(Comment 15) From Lilly: For questions 9 and 16, by asking the respondents to perceive overall quality of the drug, the survey risks introducing perceptions outside of experimental control into the study. Overall quality is a very broad topic and might be dependent on the graphics, wording, and personal biases that are outside of the market claims and efficacy levels being tested. We suggest removing these questions, or changing the question to “overall efficacy.”
(Response) By asking these questions, we hope to detect any differences in perceived quality between those exposed to different experimental conditions. For example, those exposed to an ad with a #1 Prescribed market claim may perceive the product to be of higher quality than those in the control condition. By keeping all ad elements beyond the experimental manipulations (market claims, efficacy claims) constant, we can ensure that significant differences between conditions are a result of the manipulations rather than any extraneous factors. Random assignment to conditions should also distribute any random variance equally across all cells.
(Comment 16) From Lilly: We recommend removing questions 13 and 17 as they have the potential to be misinterpreted or simply difficult for the respondent to answer if the stimulus is not communicating prevalence of the drug's side effects or benefits using precise numbers.
(Response) Please see response to Comment 3 from AbbVie.
(Comment 17) From Lilly: For questions 27 and 28, we recommend slightly changing the wordings for the possible answer choices to “Yes/No, claim is/is not
(Response) We agree that more specific wording would be helpful and have revised the answer choices to read “Yes, statement is mentioned in the ad” and “No, statement is not mentioned in the ad.”
(Comment 18) From Lilly: Recommend removing question 31 as the question is an inverse of question 30 to avoid confounding data.
(Response) We have removed question 31 (skepticism).
(Comment 19) From Lilly: The instructions for the questions 35 through 38 section seem to have an omitted word. We recommend revising to “how much do you agree or disagree with the following statements?”
(Response) Thank you for pointing this out. We will correct this.
(Comment 20) From Lilly: We agree with placement of demographic questions (questions 39-44) at the end but recommend reevaluating them and consider removing them so as to avoid lack of response due to respondent fatigue.
(Response) The comment about respondent fatigue is well taken. However, we are adhering to good questionnaire design in putting our most important dependent measures first and are willing to accept the potential tradeoff in missing demographic data.
(Comment 21) From Lilly: We suggest providing a more complete list of choices for question 43 and placing this question earlier in the study.
(Response) We appreciate this suggestion and have added questions about cost.
(Comment 22) From Merck: Merck supports the importance of communicating information that can be understood by consumers so that they can make better decisions about prescription drugs. We believe that FDA should focus their efforts and research first on improving the health literacy of approved patient labeling and then on DTC print advertising. In addition, FDA should consider exploring the inclusion of benefit information in patient labeling, which may help improve consumer understanding and comprehension of patient labeling.
(Response) We share the goal of improving communications about prescription drugs. There are efforts underway within FDA examining ways to improve patient labeling (Ref. 9). Although this comment is outside the scope of this project, we will share this information internally.
(Comment 23) From Merck: Merck believes the current study design limits the practical utility of the information collected. The study proposes presenting efficacy information in the form of simple quantitative information. Prior OPDP research acknowledged the limitations of studying simple quantitative information. For many prescription drugs, clinical trial outcomes are often more complicated than simple frequencies, which limit the applicability of this research. Numeracy challenges are common in people with inadequate health literacy. Numeracy challenges are not well represented in online research, and hence the proposed methodology may not detect a lack of comprehension.
(Response) We are pleased Merck has read FDA's prior research in the area of communicating quantitative information. As this is the first study examining the impact of quantitative efficacy information on the perception of market share claims, we felt it was better to start with relatively straightforward, though not simplistic, quantitative efficacy information. We have worked with an expert reviewer in OPDP to product efficacy claims that are realistic for this drug product class. The efficacy claim communicates both the level of expected benefit and the likelihood of experiencing that benefit. We encourage additional research on this topic utilizing increasingly complex quantitative information.
We have included a measure of numeracy in our questionnaire. We acknowledge that online panels may underrepresent individuals with extremely low health literacy. Thus, any differences we find as a function of numeracy in our sample may be magnified in the general population.
(Comment 24) From Merck: Merck recommends a mixed-method approach to reach limited-literacy respondents. The phone or Web approach allows for a broad, diverse geographic sample. Respondents with low health literacy are not typically represented in these databases, and may need to be recruited in less traditional places, such as literacy centers, senior centers, and health clinics. Additionally, if a desktop computer is required, this may inadvertently eliminate respondents from low socioeconomic status, who are less likely to have a desktop computer and more likely to have internet only on their mobile device.
(Response) We acknowledge that internet administration is not perfect and have chosen this method to maximize our budget. We will permit the survey to be taken on a variety of devices. We are excluding phones because the stimuli cannot be fully viewed on a very small screen.
(Comment 25) From Merck: For the followup study, we recommend reducing the number of trials for respondents across health literacy levels, as respondent fatigue can occur, resulting in reduced focus and unreliably responses. Refining the methodology to present fewer choices to each respondent, and assuring the clarity of the information presented, would help to enhance comprehension.
(Response) We agree that minimizing respondent burden is a priority. We estimate that the 48 trials and instructions would require less than 8 minutes, on average. Pretest data may reveal that the experiment can be shortened without loss to validity, in which case we will reduce the number of trials.
(Comment 26) From Merck: Questions 6, 32, and 50 include percentages. According to Health Literacy Missouri, natural frequencies (1 out of 10) may be more useful than percentages. Research suggests that less literate readers may interpret numbers as more risky when in frequency form (1 out of 10) versus percentage form (10 percent).
(Response) We have worked with an expert reviewer in OPDP to product efficacy claims that are realistic for this drug product class.
(Comment 27) From Merck: We suggest adding the following screener question to increase the odds of recruiting limited-literacy respondents: “How confident are you in filling out medical forms by yourself?”
(Response) We acknowledge that internet panels underrepresent individuals with very low literacy. Thus, it is important to acknowledge that our findings may not apply to very low literacy individuals. It would be prohibitively expensive for us to screen for literacy up front in order to establish quotas. We will measure health literacy and included it in analyses.
The first two pretests and main study are expected to last no more than 30 minutes. The third pretest and followup study are expected to last no more than 15 minutes. This will be a one-time (rather than annual) collection of information. FDA estimates the burden of this collection of information as follows:
The following references are on display in the Division of Dockets Management (see
Department of Health and Human Services, Office of the Secretary.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will be holding a public teleconference.
The NPRSB will hold a public meeting on May 26, 2016, from 1:00 p.m. to 2:00 p.m. EST. The agenda is subject to change as priorities dictate.
Individuals who wish to participate should send an email to
Please submit an inquiry via the NPRSB Contact Form located at
Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), HHS established the NPRSB. The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The NPRSB may also provide advice and guidance to the Secretary and/or the Assistant Secretary for Preparedness and Response (ASPR) on other matters related to public health emergency preparedness and response.
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 meeting.
The meeting 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.
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.
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.
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on June 17, 2016, on improving access to kidney transplantation. The meeting is open to the public.
The meeting will be held on June 17, 2016, 9 a.m.to 12 p.m. Individuals wanting to present oral comments must notify the contact person at least 10 days before the meeting date.
The meeting will be held in the Natcher Conference Center on the NIH Campus at 9000 Rockville Pike, Bethesda, MD 20894.
For further information concerning this meeting, contact Dr. Andrew S. Narva, Executive Secretary of the Kidney Interagency Coordinating Committee, National Institute of Diabetes and Digestive and Kidney Diseases, 31 Center Drive, Building 31A, Room 9A27, MSC 2560, Bethesda, MD 20892-2560, telephone: 301-594-8864; FAX: 301-480-0243; email:
The KICC, chaired by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), comprises members of the Department of Health and Human Services and other federal agencies that support kidney-related activities, facilitates cooperation, communication, and collaboration on kidney disease among government entities. KICC meetings, held twice a year, provide an opportunity for Committee members to learn about and discuss current and future kidney programs in KICC member organizations and to identify opportunities for collaboration. The June 17, 2016 KICC meeting will focus on improving access to kidney transplanation.
Any member of the public interested in presenting oral comments to the Committee should notify the contact person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives or organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present; oral comments and presentations will be limited to a maximum of 5 minutes. Printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the Committee by forwarding their 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
Members of the public who would like to receive email notification about future KICC meetings should send a request to
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 meeting.
The meeting 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations.
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.
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.
Science and Technology Directorate, DHS.
30-Day notice and request for comment.
The Department of Homeland Security (DHS) invites the general public to comment on the data collection form for the DHS Science & Technology Directorate (S&T) Technology Acceptance and Evaluation (TAE) Survey. The TAE web based tool proposes to collect information from 1,200 members of an online Internet panel. All information collected will be on a voluntary basis. DHS will not receive any personally identifying information. As part of its core mission, DHS is tasked with preventing terrorism and enhancing security, securing and managing our borders, and ensuring resilience to disasters. In order to assist in those key mission spaces, the S&T managed work to create a Rapid DNA Technology that allows field testing of DNA that is inexpensive and quick while performing with high accuracy in a non-laboratory setting. To ensure the effective implementation and diffusion of this new technology, DHS S&T seeks to better understand public perceptions of Rapid DNA, its use cases, and its collection through the TAE Survey. This notice and request for comments is required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).
Comments are encouraged and will be accepted until June 3, 2016.
Interested persons are invited to submit comments, identified by docket number DHS-2016-0019, by one of the following methods:
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DHS FRCoP Contact Kathleen Deloughery (202) 254-6189 (Not a toll free number).
The Department is committed to improving its information collection and urges all interested parties to suggest how these materials can further reduce burden while seeking necessary information under the Act.
DHS is particularly interested in comments that:
(1) 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;
(2) 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;
(3) Suggest ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Suggest 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,
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Office of the Assistant Secretary for Public and Indian Housing, and Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice; extension of comment period.
HUD is extending the comment period to solicit recommendations for specific policy proposals and methods of research and evaluation to be implemented as part of the expansion of the Moving to Work (MTW) demonstration program. The original comment period will end on May 4, 2016, but HUD is extending that period for 14 days to allow interested parties to prepare and submit their comments.
Comments on the April 4, 2016 Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion are due on or before May 18, 2016.
Interested persons are invited to submit comments regarding specific policy and evaluation proposals to the Moving to Work Office, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW., Room 4130, Washington, DC 20410-0001 or email at
Questions concerning this notice should be directed to the Moving to Work Office, Office of Public and Indian Housing, Department of Housing and Urban Development at
On April 4, 2016 (81 FR 19233), HUD published an advanced notice seeking input from the general public, public housing agencies, HUD-assisted housing residents, researchers, and HUD stakeholders on two objectives, specific policy proposal recommendations, and research and evaluation proposal recommendations, as part of the expansion of the MTW demonstration. First, HUD seeks specific policy proposal recommendations related to the three MTW demonstration statutory objectives of cost effectiveness, self-sufficiency, and housing choice.
Second, HUD also seeks recommendations for research and evaluation methods to be utilized in association with specific policy proposals that will be implemented by MTW agencies in the expanded MTW demonstration. In response to several requests, HUD is extending the comment period for an additional 14 days.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 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: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
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,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 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: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
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.
U.S. Fish and Wildlife Service (FWS), Interior; National Marine Fisheries Service (NMFS), Commerce.
Announcement of draft revised policy and solicitation of public comment.
We, the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (Services when referring to both, and Service when referring to when the action is taken by
We will accept comments that we receive on or before July 5, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
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Jim Serfis, U.S. Fish and Wildlife Service, Chief, Branch of Conservation and Communications, U.S. Fish and Wildlife Service Headquarters, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803 (telephone 703-358-2171); or Angela Somma, National Marine Fisheries Service, Chief, Endangered Species Conservation Division, Office of Protected Resources, 1315 East-West Highway, Silver Spring, MD 20910 (telephone 301-427-8403, facsimile 301-713-0376). Persons who use a telecommunications device for the deaf may call the Federal Information Relay Service at 800-877-8339.
The U.S. Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) are charged with implementing the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
To participate in a CCAA, non-Federal property owners agree to implement specific conservation measures on their land that reduce or eliminate threats to the species that are covered under the agreement. An ESA section 10(a)(1)(A) enhancement of survival permit is issued to the agreement participant providing a specific level of incidental take coverage should the property owner's agreed-upon conservation measures and routine property management actions (
Under the current policy, to approve a CCAA we must “determine that the benefits of the conservation measures implemented by a property owner under a CCAA, when combined with those benefits that would be achieved if it is assumed that conservation measures were also to be implemented on other necessary properties, would preclude or remove any need to list the covered species.” The hypothetical concept of conservation measures needing to be implemented on “other necessary properties” has caused confusion, and therefore we are clarifying and revising the CCAA standard to require a net conservation benefit to the covered species specifically on the property to be enrolled and eliminating references to “other necessary properties.”
Based on our experience reviewing and approving CCAAs over the past 16 years, we are proposing changes to the policy that will clarify the level of conservation effort each agreement needs to include in order for the Service to approve an agreement. We are proposing the following changes to the policy primarily to (a) address confusion regarding the existing CCAA approval requirements (standards) and (b) make CCAAs more consistent with Safe Harbor Agreement requirements, because these agreements have similar purposes, which are to provide a conservation benefit to the covered species while providing assurances to non-Federal property owners:
(1) Add a new definition of “net conservation benefit” to
Net conservation benefit (for CCAA) is defined as the cumulative benefits of specific conservation measures designed to improve the status of a covered species by removing or minimizing threats, stabilizing populations, and increasing its numbers and improving its habitat. The benefit would be measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit. The conservation measures and property management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species'
(2) Delete the definition of “other necessary properties” under
• Revise the third sentence in the second paragraph of
• Revise the fifth paragraph under Part 1 to read as follows: The Service must determine that the benefits of the conservation measures to be implemented by a property owner under a CCAA are reasonably expected to result in a net conservation benefit to the covered species. Pursuant to section 7 of the ESA, the Service must also ensure that the conservation measures and ongoing property management activities included in a CCAA, and the incidental take allowed under the enhancement of survival section 10(a)(1)(A) permit for these measures and activities are not likely to jeopardize listed species or species proposed for listing and are not likely to destroy or adversely modify proposed or designated critical habitat.
• Revise section C of
• Revise
(3) Revise the definition of “Non-Federal property owner” in
Property owner means a person with a fee simple, leasehold, or other property interest (including owners of water rights or other natural resources), or any other entity that may have a property interest, sufficient to carry out the proposed management activities, subject to applicable State law, on non-Federal land.
(4) Add language to Part 3 to further explain the assurances provided to a property owner who is enrolled in a CCAA if there are changed circumstances or unforeseen circumstances that could require changes to or additional conservation measures. This language is already included in FWS's regulations at 50 CFR 17.22(d)(5) and 17.32(d)(5) and does not represent a change in current CCAA practice. Adding this language to the policy will make the policy and regulations consistent.
(5) Add language to Part 8 to require that a property owner notify the Services prior to termination of their CCAA. Currently, the FWS includes this requirement as part of the conditions of the section 10(a)(1)(A) permit that is issued in conjunction with a CCAA. So while this is new language the Services are adding to the policy, it is not a new practice in how the FWS administers CCAAs.
(6) Revise the first sentence of Part 10 by adding “and meets the applicable permit issuance criteria” to make it clear that any property owner who agrees to become a party to an original Agreement, through a transfer, must meet the issuance criteria for a CCAA. While most of the issuance criteria would already be met, assuming the transferred CCAA was not changing in any major way, in particular, the FWS would need to ensure the new property owner would meet issuance criteria at 50 CFR 17.22(d)(2)(vi) and 17.32(d)(2)(vi) which requires that the applicant (
(7) Revise additional language in the policy to improve clarity.
This policy is intended to facilitate the conservation of species proposed for listing under the Endangered Species Act (ESA) and candidate species, and species likely to become candidates or proposed for listing in the near future, by giving non-Federal citizens, States, local governments, Tribes, businesses, organizations, and other non-Federal property owners incentives to implement conservation measures for declining species by providing regulatory assurances with regard to land, water, or resource use restrictions that might otherwise apply should the species later become listed as endangered or threatened under the ESA. Under the policy, property owners who commit in a Candidate Conservation Agreement with Assurances (CCAA or Agreement) to implement mutually agreed-upon conservation measures for a species proposed for listing or candidate species, or a species likely to become a candidate or proposed for listing in the near future, will receive assurances from the Service that additional conservation measures above and beyond those contained in the Agreement will not be required, and that additional land, water, or resource use restrictions will not be imposed upon them should the species become listed in the future. In determining whether to enter into a CCAA, the Service will consider the
While the Services recognize that the actions of a single property owner usually will not sufficiently contribute to the conservation of the species to remove the need to list it, we also recognize that the collective result of the conservation measures of many property owners may remove the need to list the species. Accordingly, the Service will enter into an Agreement when we determine that the conservation measures to be implemented address the current and anticipated future threats that are under the property owner's control and will result in a net conservation benefit to the covered species. While some property owners are willing to manage their lands to benefit species proposed for listing, candidate species, or species likely to become candidates or proposed for listing in the near future, most desire some degree of regulatory certainty and assurances with regard to possible future land, water, or resource use restrictions that may be imposed if the species is listed in the future.
The Service will provide regulatory assurances to a non-Federal property owner who enters into a CCAA by authorizing, through issuance of an enhancement of survival permit under section 10(a)(1)(A) of the ESA, a specified level of incidental take of the covered species. Incidental take authorization and the associated agreement benefit property owners in two ways. First, in the event the species is listed, incidental take authorization enables property owners to continue current and agreed-upon land uses that have the potential to cause take, provided the take is at or reduced to a level consistent with the overall goal of providing a net conservation benefit to the species. Second, the property owner is provided the assurance that, if the species is listed, no additional conservation measures will be required and no additional land use restrictions will be imposed.
These Agreements will be developed in coordination and cooperation with appropriate State fish and wildlife agencies and other affected State agencies and Tribes. Coordination with State fish and wildlife agencies is particularly important given their primary responsibilities and authorities for the management of unlisted resident species. These Agreements must be consistent with applicable State laws and regulations governing the management of these species.
The Service must determine that the benefits of the conservation measures to be implemented by a property owner under a CCAA are reasonably expected to result in a net conservation benefit to the covered species. Pursuant to section 7 of the ESA, the Service must also ensure that the conservation measures and ongoing property management activities included in a CCAA, and the incidental take allowed under the enhancement of survival section 10(a)(1)(A) permit for these measures and activities, are not likely to jeopardize listed species or species proposed for listing and are not likely to destroy or adversely modify proposed or designated critical habitat.
Because some property owners may not have the necessary resources or expertise to develop a CCAA, the Services are committed to providing, to the maximum extent practicable given available resources, the necessary technical assistance to develop Agreements and prepare enhancement of survival permit applications. Also, based on available resources, the Service may assist or train property owners to implement conservation measures. Development of a biologically sound Agreement and enhancement of survival permit application is intricately linked. The Service will process the permit application following the procedures described in 50 CFR 17.22(d)(1) and 17.32(d)(1), and part 222, as appropriate. All terms and conditions of the permit must be consistent with the specific conservation measures included in the associated CCAA.
The following definitions apply for the purposes of this policy.
Candidate Conservation Agreement (CCA) means an agreement signed by either Service, or both Services jointly, and other Federal or State agencies, local governments, Tribes, businesses, organizations, or a citizen that identifies specific conservation measures that the participants will voluntarily undertake to conserve the covered species. There are no specific requirements for entering into a CCA and no standard has to be met; no incidental take permit or assurances are provided under these Agreements.
Candidate Conservation Agreements with Assurances means a Candidate Conservation Agreement with a non-Federal property owner that meets the standards described in this policy and provides the property owner with the assurances described in this policy.
Candidate Conservation Assurances means the associated assurances that are authorized by an enhancement of survival permit. Such assurances may apply to a whole parcel of land, or a portion, as identified in the Agreement. The assurances provided to a non-Federal property owner in a CCAA are that no additional conservation measures and no land, water, or resource use restrictions, in addition to the measures and restrictions described in the Agreement will be imposed should the covered species become listed in the future. Also the enhancement of survival permit provides a prescribed level of incidental take that may occur from agreed-upon, ongoing property management actions and the conservation measures.
Candidate species are defined differently by the Services. The Fish and Wildlife Service (FWS) defines candidate species as species for which FWS has sufficient information on file relative to status and threats to support issuance of proposed listing rules. The National Marine Fisheries Service (NMFS) defines candidate species as (1) species that are the subject of a petition to list and for which NMFS has determined that listing may be warranted, pursuant to section 4(b)(3)(A) of the ESA, and (2) species that are not the subject of a petition but for which NMFS has announced the initiation of a status review in the
Conservation measures as it applies to CCAAs are actions that a property owner voluntarily agrees to undertake when entering into a CCAA that, by addressing the threats that are occurring or have the potential to occur on their property, will result in an improvement or expansion of the species' habitat with the potential for an increase in the species' population numbers. The appropriate conservation measures designed to address the threats that are causing the species to decline will be based on the best available scientific information relative to the conservation needs of the species such as those contained in an up-to-date conservation strategy.
Covered species means those species that are the subject of a CCAA and associated enhancement of survival permit. Covered species are limited to species that are candidates or proposed for listing and species that are likely to become candidates or proposed for listing in the near future.
Enhancement of survival permit means a permit issued under section
Net conservation benefit (for CCAA) is defined as the cumulative benefits of specific conservation measures designed to improve the status of a covered species by removing or minimizing threats, stabilizing populations, and increasing its numbers and improving its habitat. The benefit is measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit. The conservation measures and property management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species' populations or improve its habitat. In the case where the species and habitat is already adequately managed to the benefit of the species, a net conservation benefit will be achieved when the property owner commits to manage the species for a specified period of time with the anticipation that the population will increase or habitat quality will improve.
Property owner means a person with a fee simple, leasehold, or other property interest (including owners of water rights or other natural resources), or any other entity that may have a property interest, sufficient to carry out the proposed management activities, subject to applicable State law, on non-Federal land.
A CCAA will identify or include:
A. The population levels (if available or determinable) of the covered species existing at the time the parties negotiate the Agreement; the existing habitat characteristics that sustain any current, permanent, or seasonal use, or potential use by the covered species on lands or waters in which the participating property owner has an interest; and consideration of the existing and anticipated condition of the landscape of the contiguous lands or waters not on the participating owner's property so that the property enrolled in a CCAA may serve as a habitat corridor or connector or as a potential source for the covered species to populate the property to be enrolled if they do not already exist on that property.
B. The conservation measures the participating property owner agrees to undertake to conserve the species included in the Agreement.
C. The benefits expected to result from the conservation measures described in B above (
D. Assurances related to take of the covered species will be authorized by the Service through a section 10(a)(1)(A) enhancement of survival permit (see Part 5). Assurances include that no additional conservation measures will be required and no additional land, water, or resource use restrictions will be imposed beyond those described in B above should the covered species be listed in the future. If conservation measures not provided for in the CCAA are necessary to respond to changed circumstances, the Service will not require any conservation measures in addition to those provided for in the CCAA without the consent of the property owner, provided the CCAA is being properly implemented. If additional conservation measures are necessary to respond to unforeseen circumstances, the Service may require additional measures of the property owner where the CCAA is being properly implemented, only if those measures maintain the original terms of the CCAA to the maximum extent possible. Additional conservation measures will not involve the commitment of additional land, water, or financial compensation, or additional restrictions on the use of land, water, or other natural resources available for development or use under the original terms of the CCAA without the consent of the property owner. The permit also allows a prescribed amount of incidental take that may result from the conservation measures or from the agreed-to ongoing property management actions.
E. A monitoring provision that requires measuring and reporting on: (1) Progress in implementing the conservation measures described in B above, and (2) changes in habitat conditions and the species' status resulting from these measures.
F. As appropriate, a notification requirement to provide the Service or appropriate State agencies with a reasonable opportunity to rescue individuals of the covered species before any authorized incidental take occurs.
Before entering into a CCAA, the Service must make a written finding that the benefits of the conservation measures to be implemented by a property owner under an Agreement would reasonably be expected to result in a net conservation benefit to the covered species. If the Service and the participating property owner cannot agree on conservation measures that satisfy this requirement, the Service will not enter into the Agreement. Expected benefits of the specific conservation measures could include, but are not limited to: removal or reduction of current and anticipated future threats for a specified period of time; restoration, enhancement, or preservation of habitat; maintenance or increase of population numbers; and reduction or elimination of impacts to the species from agreed-upon, ongoing property management actions.
Through a CCAA, the Service will provide the assurance that, if any species covered by the Agreement is listed, and the Agreement has been implemented in good faith by the participating property owner, the Service will not require additional conservation measures nor impose additional land, water, or resource use restrictions beyond those the property owner voluntarily committed to under the terms of the original Agreement. Assurances involving incidental take will be authorized through issuance of a section 10(a)(1)(A) enhancement of survival permit, which will allow the property owner to take a specific number of individuals of the covered species or quantity of habitat, should the species be listed, as long as the level of take is consistent with those levels agreed upon and identified in the Agreement. The Service will issue an enhancement of survival permit at the time of entering into the CCAA. This permit will have a delayed effective date tied to the date of any future listing of the covered species. The Service is prepared as a last resort to revoke a permit implementing a CCAA where continuation of the permitted activity would be likely to result in jeopardy to a species covered by the permit. Prior to taking such a step, however, the Service will first have to exercise all possible means to remedy such a situation.
The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Public participation in the development of a proposed CCAA will be provided only when agreed to by the participating property owner. However, the Service will make every proposed Agreement available for public review and comment as part of the public evaluation process that is statutorily required for issuance of the associated enhancement of survival permit. This comment period will generally be 30 days. The public will also be given other opportunities to review CCAAs in certain cases. For example, when the Service receives an Agreement covering a species proposed for listing, and when the Service determines, based upon a preliminary evaluation, that the Agreement could potentially justify withdrawal of the proposed rule to list the species under the ESA, the comment period for the proposed rule will be extended or reopened to allow for public comments on the CCAA's adequacy in removing or reducing threats to the species. However, the statutory deadlines in the ESA may prevent the Service from considering in their final listing determination those CCAAs that are not received within a reasonable period of time after issuance of the proposed rule.
Nothing in this policy prevents a participating property owner from implementing conservation measures not described in the Agreement, provided such measures are consistent with the conservation measures and conservation goal described in the CCAA. The Service will provide technical advice, to the maximum extent practicable, to the property owner when requested. Additionally, a participating property owner can terminate the Agreement prior to its expiration date, even if the terms and conditions of the Agreement have not been realized. However, the property owner is required to notify the Service prior to termination. The enhancement of survival permit is terminated at the same time, and the property owner would no longer have the assurances.
Nothing in this policy compels any party to enter into a CCAA at any time. Entering into an Agreement is voluntary for property owners and the Service. Unless specifically noted, a CCAA does not otherwise create or waive any legal rights of any party to the Agreement.
If a property owner who is a party to a CCAA transfers ownership of the enrolled property, the Service will regard the new property owner as having the same rights and obligations as the original property owner if the new property owner agrees to become a party to the original Agreement and meets the applicable permit issuance criteria. Actions taken by the new participating property owner that result in the incidental take of species covered by the Agreement would be authorized if the new property owner maintains the terms and conditions of the original Agreement. If the new property owner does not become a party to the Agreement, the new owner would neither incur responsibilities nor receive any assurances relative to the ESA take prohibitions resulting from listing of the covered species. An Agreement must commit the participating property owner to notify the Service of any transfer of ownership at the time of the transfer of any property subject to the CCAA. This provision allows the Service the opportunity to contact the new property owner to explain the prior CCAA and to determine whether the new property owner would like to continue the Agreement or enter a new Agreement. When a new property owner continues an existing Agreement, the Service will honor the terms and conditions of that Agreement and associated permit.
The Service will ensure that necessary monitoring provisions are included in the CCAA and associated enhancement of survival permit. Monitoring is necessary to ensure that the conservation measures specified in an Agreement and permit are being implemented and to learn about the effectiveness of the agreed-upon conservation measures. In particular, when adaptive management principles are included in an Agreement, monitoring is especially helpful for obtaining the information needed to measure the effectiveness of the conservation program and detect changes in conditions. However, the level of effort and expense required for monitoring can vary substantially among CCAAs depending on the circumstances. For many, monitoring can be conducted by the Service or a State agency and may involve only a brief site inspection and appropriate documentation. Monitoring programs must be agreed upon prior to public review and comment. The Services are committed to providing as much technical assistance as possible in the development of acceptable monitoring programs. These monitoring programs will provide valuable information that the Services can use to evaluate program implementation and success.
Coordination between the Service, the appropriate State fish and wildlife agencies, affected Tribal governments, and property owners is important to the successful development and implementation of CCAAs. When appropriate, the Service will coordinate
We solicit comments, information, and recommendations from governmental agencies, Native American tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties on this draft policy. All comments, recommendations, and materials received by the date listed in
In addition to more general comments and information, we specifically request comment on the following aspects of the policy:
(1) Is the definition of “Net conservation benefit (for CCAA)” clear as a requirement (or standard)?
(2) Will the revisions be an improvement over the current policy?
You may submit your information concerning this draft revised policy by one of the methods listed in
Information and supporting documentation that we receive in response to this draft policy will be available for you to review at
As discussed above, we intend to apply this policy, when finalized, in considering whether to approve a CCAA. Below we discuss compliance with several Executive Orders and statutes as they pertain to this draft policy.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this policy is not a significant rule.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that our regulatory system must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this policy in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601
The Services, States, local government agencies, Tribes, nongovernmental organizations, and private landowners are the entities that are affected by the draft revision to the existing policy. While the policy revision introduces and defines the term “net conservation benefit” for CCAAs and clarifies what must be achieved in order for a CCAA to be approved, the Services believe that this addition does not necessarily change the level of conservation currently required under a CCAA.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(a) On the basis of information contained in the “Regulatory Flexibility Act” section above, this draft policy would not “significantly or uniquely” affect small governments. As explained above, small governments could potentially be affected if they chose to enter into a CCAA. However, we have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this policy would not impose a cost of $100 million or more in any given year on local or State governments or private entities.
(b) This draft policy would not produce a Federal mandate on State, local, or Tribal governments or the private sector of $100 million or greater in any year; that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This policy, if finalized, does not impose any additional obligations on State, local, or tribal governments who participate in a CCAA by requiring them to take additional or different conservation measures above what they would be required to take under the current CCAA policy. As such, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630, this draft policy would not have significant takings implications. This draft policy would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this draft policy (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This draft policy would substantially advance a legitimate government interest (clarify existing policy through which non-
In accordance with Executive Order 13132 (Federalism), this draft policy does not have significant Federalism effects and a federalism summary impact statement is not required. This draft policy revision pertains only to the Service's requirement of a net conservation benefit to the covered species for approval of a CCAA and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.
In accordance with Executive Order 12988 (Civil Justice Reform), this draft policy would not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We are revising the existing policy for CCAAs specifically for the purpose of eliminating ambiguity and presenting the policy provisions in clear language.
This policy revision does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501
We have analyzed the draft policy in accordance with the criteria of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(c)), the Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA (40 CFR 1500-1508), and the Department of the Interior's NEPA procedures (516 DM 2 and 8; 43 CFR part 46) and NOAA's Administrative Order regarding NEPA compliance (NAO 216-6 (May 20, 1999)).
We have determined that the draft policy is categorically excluded from NEPA documentation requirements consistent with 40 CFR 1508.4 and 43 CFR 46.210(i). This categorical exclusion applies to policies, directives, regulations, and guidelines that are “of an administrative, financial, legal, technical, or procedural nature.” This action does not trigger an extraordinary circumstance, as outlined in 43 CFR 46.215, applicable to the categorical exclusion. Therefore, the draft policy does not constitute a major Federal action significantly affecting the quality of the human environment.
We have also determined that this action satisfies the standards for reliance upon a categorical exclusion under NOAA Administrative Order (NAO) 216-6. Specifically, the policy fits within two categorical exclusion provisions in § 6.03c.3(i)—for “preparation of regulations, Orders, manuals, or other guidance that implement, but do not substantially change these documents, or other guidance” and for “policy directives, regulations and guidelines of an administrative, financial, legal, technical or procedural nature.” NAO 216-6, § 6.03c.3(i). The policy would not trigger an exception precluding reliance on the categorical exclusions because it does not involve a geographic area with unique characteristics, is not the subject of public controversy based on potential environmental consequences, will not result in uncertain environmental impacts or unique or unknown risks, does not establish a precedent or decision in principle about future proposals, will not have significant cumulative impacts, and will not have any adverse effects upon endangered or threatened species or their habitats.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175 “Consultation and Coordination with Indian Tribal Governments,” and the Department of the Interior Manual at 512 DM 2, we have considered possible effects on federally recognized Indian tribes and have preliminarily determined that there are no potential adverse effects of issuing this draft policy. Our intent with the draft policy revision is to provide clarity in regard to the net conservation benefit requirements for a CCAA to be approved, including any agreements in which Tribes may choose to participate. We will continue to work with Tribes as we finalize this draft policy.
Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. The draft policy, if made final, is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule or policy we publish must:
a. Be logically organized;
b. Use the active voice to address readers directly;
c. Use clear language rather than jargon;
d. Be divided into short sections and sentences; and
e. Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
The primary authors of the policy are staff members of the Ecological Services Program, Branch of Communications and Candidate Conservation, U.S. Fish and Wildlife Service, 5275 Leesburg Pike, MS: ES, Falls Church, VA 22041-3803.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft environmental assessment (Draft EA) for the Marianas Trench Marine National Monument (Monument) Northern Islands Submerged Lands (submerged lands) Transfer to the Commonwealth of the Northern Mariana Islands (CNMI), for public review and comment. The Draft EA describes our proposal for the Secretary of the Interior to convey specific submerged lands within the Monument from the United States to the CNMI Government under the authority of the Territorial Submerged Lands Act (TSLA), 48 U.S.C. 1705,
To ensure consideration of your comments, please send your written comments by June 6, 2016.
You can download the Draft EA from our Web site:
Charles Houghten, (503) 231-6207 (phone).
With this notice, we are announcing the availability of our Draft EA developed in cooperation with the National Oceanic and Atmospheric Administration (NOAA) and the CNMI Government, and in compliance with the National Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4321
The subject of our EA is the Northern Islands submerged lands surrounding the islands of Farallon de Pajaros (Uracas), Maug, and Asuncion in the CNMI, which include lands permanently or periodically covered by tidal waters up to the mean low water line, and extending three miles seaward from the mean high tide line of each of these islands.
The submerged lands are among some of the most biologically diverse in the Western Pacific Ocean, with relatively pristine coral reef ecosystems that have been proclaimed objects of scientific interest and reserved for protection as part of the Monument's Islands Unit, by Presidential Proclamation 8335 of January 6, 2009.
The submerged lands and associated waters were excepted from transfer to the CNMI Government by operation of the TSLA in Presidential Proclamation 9077 of January 15, 2014. Proclamation 9077 also provided that it did not affect the authority of the Secretary of the Interior granted under the TSLA, to convey the submerged lands after an agreement has been entered for coordination of management that ensures the protection of the Monument.
The purpose of the Draft EA is to analyze alternatives for the proposed conveyance of the Northern Islands submerged lands and associated waters to the CNMI Government. We identify two alternatives in the Draft EA.
Alternative 1 is our Current Land Status Alternative (No Action); under it, the Department of the Interior (DOI) would not convey the submerged lands, including mineral rights, to CNMI. The Service and NOAA would continue to coordinate management of the submerged lands and associated waters, including fishery-related activities of the Islands Unit, in consultation with the CNMI Government. We would manage the Monument in accordance with the directives of Presidential Proclamation 8335, and implement activities to address priority management needs based on agency-specific authorities and an integrated management plan.
Under our preferred alternative, Alternative 2 (or Northern Islands Submerged Lands Conveyance alternative), DOI would convey the submerged lands, including mineral rights, to the CNMI Government through a patent with a reserved easement. Consistent with the requirements of Proclamation 9077, a Memorandum of Agreement (MOA) would also be implemented to outline the roles and responsibilities of the CNMI Government, the Service, and NOAA, for ensuring protection of the Monument, and managing and conducting activities within the submerged lands and associated waters.
Upon the conveyance of the NISL to CNMI and pursuant to the MOA, the Service and NOAA would, at no additional cost to the CNMI, continue managing the conveyed submerged lands, for the benefit of and in consultation with the CNMI Government, until such time that the CNMI Government notifies the Secretaries of Interior and Commerce of its intent to assume either all or a portion of the management responsibilities of the conveyed submerged lands.
Alternative 2 would allow the CNMI Government to assume primary responsibility for managing and protecting the Northern Islands submerged lands and associated waters consistent with the purposes and requirements of Proclamations 8335 and 9077, and in coordination with the Service and NOAA, at such time as the CNMI Government notifies the Secretaries of Interior and Commerce of its desire to do so. Consistent with the Proclamations 8335 and 9077, this management would include the benthic and living marine resources of the associated water column, and subterranean of the submerged lands, and the associated mineral rights within.
Printed copies of the Draft EA are available for review at the Commonwealth of the Northern Mariana Islands Bureau of Environmental and Coastal Quality, Gualo Rai Center, Chalan Pale Arnold-Middle Road, Saipan, MP 96950, and the following libraries.
• Joeten-Kiyu Public Library, Beach Road and Insatto St., Saipan, MP 96950.
• Tinian Public Library, San Jose Village, Tinian, MP 96952.
• Antonio Camacho Atalig Memorial Library, Tatachog Village, Rota, MP 96951.
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 can 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.
U.S. Geological Survey (USGS), Interior.
Notice of a renewal of a currently approved information collection (1028-0059).
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. This collection consists of 1 form. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on October 31, 2016.
To ensure that your comments are considered, we must receive them on or before July 5, 2016.
You may submit comments on this information collection to the Information Collection Clearance Officer, U.S. Geological Survey, 12201 Sunrise Valley Drive MS 807, Reston, VA 20192 (mail); (703) 648-7197 (fax); or
Lori E. Apodaca, National Minerals Information Center, U.S. Geological Survey, 12201 Sunrise Valley Drive, MS 989, Reston, VA 20192 (mail); 703-648-7724 (phone); or
The collection of this information is required by the Comprehensive Test Ban Treaty (CTBT), and will, upon request, provide the CTBT Technical Secretariat with geographic locations of sites where chemical explosions greater than 300 tons TNT-equivalent have occurred.
We are soliciting comments as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Please note that the comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public view, we cannot guarantee that we will be able to do so.
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the current list of 567 Tribal entities recognized and eligible for funding and services from the Bureau of Indian Affairs (BIA) by virtue of their status as Indian Tribes. The list is updated from the notice published on January 29, 2016 (81 FR 5019).
Ms. Laurel Iron Cloud, Bureau of Indian Affairs, Division of Tribal Government Services, Mail Stop 4513-MIB, 1849 C Street NW., Washington, DC 20240. Telephone number: (202) 513-7641.
This notice is published pursuant to Section 104 of the Act of November 2, 1994 (Pub. L. 103-454; 108 Stat. 4791, 4792), and in exercise of authority delegated to the Assistant Secretary—Indian Affairs under 25 U.S.C. 2 and 9 and 209 DM 8.
Published below is an updated list of federally acknowledged Indian Tribes in the contiguous 48 states and Alaska, to reflect the addition of an Indian Tribe and various name changes and corrections.
The addition to the list of Indian entities results from the January 28, 2016, Interior Board of Indian Appeals dismissal of a request for reconsideration in docket number 16-003,
To aid in identifying Tribal name changes and corrections, the Tribe's previously listed or former name is included in parentheses after the correct current Tribal name. We will continue to list the Tribe's former or previously listed name for several years before dropping the former or previously listed name from the list.
The listed Indian entities are acknowledged to have the immunities and privileges available to federally recognized Indian Tribes by virtue of their government-to-government relationship with the United States as well as the responsibilities, powers, limitations, and obligations of such Tribes. We have continued the practice of listing the Alaska Native entities separately solely for the purpose of facilitating identification of them and reference to them given the large number of complex Native names.
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
The Idaho Falls District RAC will meet in Idaho Falls, Idaho, June 6-7, 2016 for a two-day meeting. The first day will begin at 9:00 a.m. at the BLM Idaho Falls Office, 1405 Hollipark Drive, Idaho Falls, Idaho, with new member orientation. The entire RAC will convene at 1:00 p.m. A comment period will be held June 6, following introductions from 1:00-1:30. The second day will begin at same location starting at 8:30 a.m. adjourning at 1:00 p.m. Members of the public are invited to attend.
The first day will be new member orientation in the morning to explain the development of the BLM and purpose of the RAC. At 1:00 p.m. the rest of the RAC will convene to elect a secretary and continue with the full agenda. Topics include the sage-grouse implementation and discussion on bighorn/domestic sheep. On June 7, the RAC will meet at the Upper Snake Field Office at 8:30 a.m. to continue discussion on sage-grouse. The group will depart for the field at 9:30 a.m. to travel to the Medicine Lodge area to view allotments where potential conflicts exists between bighorn sheep and domestic sheep and discuss Lands with Wilderness Characteristics (LWC). The meeting will adjourn around 1:30 p.m.
The 15-member Council advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in the BLM Idaho Falls District (IFD), which covers eastern Idaho.
All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM as provided below.
Sarah Wheeler, RAC Coordinator, Idaho Falls District, 1405 Hollipark Dr., Idaho Falls, ID 83401. Telephone: (208) 524-7550. Email:
May 11, 2016 at 11 a.m.
Room 101, 500 E Street SW., Washington, DC 20436,
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. No. 731-TA-1315 (Preliminary)(Ferrovanadium from Korea). The Commission is currently scheduled to complete and file its determination on May 12, 2016; views of the Commission are currently scheduled to be completed and filed on May 19, 2016.
5. Outstanding action jackets: none.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
On the basis of the record
The Commission, pursuant to sections 705(b) and 735(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b) and 19 U.S.C. 1673d(b)), instituted these investigations effective March 10, 2015,
The Commission made these determinations pursuant to sections 705(b) and 735(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b) and 19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations by April 28, 2016. The views of the Commission are contained in USITC Publication 4604 (April 2016), entitled
By order of the Commission.
Pursuant to Section 112 of the 1976 amendments to the Federal Election Campaign Act (Pub. L. 94-283), 2 U.S.C. 441a (c)(1)-(2), the Secretary of Labor has certified to the Chairman of the Federal Election Commission and publishes this notice in the
Pursuant to Section 33105(c) of Title 49, United States Code, and the delegation of the Secretary of Transportation's responsibilities under that Act to the Administrator of the Federal Highway Administration (49 CFR 501.2(a)(9)), the Secretary of Labor has certified to the Administrator and published this notice in the
Veterans' Employment and Training Service (VETS), Department of Labor.
Notice of open meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the ACVETEO. The ACVETEO will discuss the DOL core programs and services that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for individuals or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green at 202-693-4734.
Individuals who will need accommodations for a disability in order to attend the meeting (
Thursday June 2, 2016 beginning at 9:00 a.m. and ending at approximately 4:00 p.m. (EST).
The meeting will take place at the U.S. Department of Labor, Frances Perkins Building, 200 Constitution Avenue NW., Washington, DC 20210, C-5320 Conference Room Six. Members of the public are encouraged to arrive early to allow for security clearance into the Frances Perkins Building.
1. Present a valid photo ID to receive a visitor badge.
2. Know the name of the event being attended: The meeting event is the Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO).
3. Visitor badges are issued by the security officer at the Visitor Entrance located at 3rd and C Streets NW. When receiving a visitor badge, the security officer will retain the visitor's photo ID until the visitor badge is returned to the security desk.
4. Laptops and other electronic devices may be inspected and logged for identification purposes.
5. Due to limited parking options, Metro's Judiciary Square station is the easiest way to access the Frances Perkins Building.
Mr. Gregory Green, Assistant Designated Federal Official for the ACVETEO, (202) 693-4734.
The ACVETEO is a Congressionally mandated advisory committee authorized under Title 38, U.S. Code, Section 4110 and subject to the Federal Advisory Committee Act, 5 U.S.C. App. 2, as amended. The ACVETEO is responsible for: Assessing employment and training needs of veterans; determining the extent to which the programs and activities of the U.S. Department of Labor meet these needs; assisting to conduct outreach to employers seeking to hire veterans; making recommendations to the Secretary, through the Assistant Secretary for VETS, with respect to outreach activities and employment and training needs of Veterans; and carrying out such other activities necessary to make required reports and recommendations. The ACVETEO meets at least quarterly.
National Archives and Records Administration (NARA).
Notice.
NARA gives public notice that it has submitted to OMB for approval the information collection described in this notice. We invite you to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.
OMB must receive written comments at the address below on or before June 3, 2016.
Send comments to Mr. Nicholas A. Fraser, Desk Officer for NARA by mail to Office of Management and Budget; New Executive Office Building; Washington, DC 20503; by fax to 202-395-5167; or by email to
Direct requests for additional information or copies of the proposed information collection and supporting statement to Tamee Fechhelm by phone at 301-837-1694 or by fax at 301-713-7409.
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), NARA invites the public and other Federal agencies to comment on proposed information collections. We published a notice of proposed collection for this information collection on June 9, 2015 (80 FR 32615 and 32616); we received no comments. NARA has therefore submitted the described information collection to OMB for approval.
In response to this notice, comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for NARA to properly perform its functions; (b) NARA's estimate of the burden of the proposed information collection and its accuracy; (c) ways NARA could enhance the quality, utility, and clarity of the information it collects; (d) ways NARA could minimize the burden on respondents of collecting the information, including the through information technology; and (e) whether the collection affects small businesses. In this notice, NARA solicits comments concerning the following information collection:
The National Science Board's Elections Committee, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of a meeting for the transaction of National Science Board business, as follows:
Friday, April 29, at 2 p.m. EDT.
This meeting will be held by teleconference originating at the National Science Board Office, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230.
Closed.
Election Committee Chair's opening remarks; approval of minutes of the closed February 2016 meeting; confirmation of slate of nominations; and discussion of next steps and Chair's closing remarks.
Please refer to the National Science Board Web site (
National Science Foundation.
Submission for OMB review; comment request.
The National Science Foundation (NSF) is requesting renewal of the Generic Clearance of the National Center for Science & Engineering Statistics' Survey Improvement Projects (3145-0174), and has submitted an information collection requirement to OMB for review and clearance. In accordance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), this is the second notice for public comment; the first was published in the
Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. 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
Both qualitative and quantitative methods will be used to improve
Nuclear Regulatory Commission.
Renewal of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comments on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled: “Criteria and Procedures for Determining Eligibility for Access to or Control over Special Nuclear Material.”
Submit comments by July 5, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2015-0280 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2015-0280 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
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The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Combined license application; receipt.
The U.S. Nuclear Regulatory Commission (NRC) is giving notice once each week for four consecutive weeks of the North Anna Unit 3 combined license (COL) application from Dominion Virginia Power (Dominion).
May 4, 2016.
Please refer to Docket ID NRC-2008-0066 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using the following methods:
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James Shea, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1388, email:
The Virginia Electric and Power Company, doing business as Dominion Virginia
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft environmental assessment and finding of no significant impact; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft environmental assessment (EA) prepared under the National Environmental Policy Act of 1969 (NEPA) and NRC regulations. This EA summarizes the results of the NRC staff's environmental review, which evaluates the potential environmental impacts of issuing license amendments and granting regulatory exemptions in response to a request from STP Nuclear Operating Company (STPNOC, the licensee) for Facility Operating License Nos. NPF-76 and NPF-80, for South Texas Project (STP), Units 1 and 2, respectively. The license amendments and regulatory exemptions would allow STPNOC to make changes to the STP licensing basis to incorporate the use of both a deterministic and a risk-informed approach to address safety issues discussed in Generic Safety Issue (GSI)-191 and to close Generic Letter (GL) 2004-02.
Submit comments by June 20, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lisa Regner, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001;
Please refer to Docket ID NRC-2016-0092 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2016-0092 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The NRC is considering a request to amend Facility Operating Licenses NPF-76 and NPF-80, issued to STPNOC for operation of STP, Units 1 and 2, located in Matagorda County, Texas, and to grant certain regulatory exemptions for STP, Units 1 and 2, in accordance with section 50.90, “Application for amendment of license, construction permit, or early site permit” and section 50.12, “Specific exemptions,” of title 10 of the
Pursuant to 10 CFR 51.21, “Criteria for and identification of licensing and regulatory actions requiring environmental assessments,” the NRC has prepared a draft EA summarizing the findings of its environmental NEPA review of this proposed action. The NRC concluded that the proposed action will have no significant environmental impact.
The NRC established a general safety issue (GSI-191) to determine whether the transport and accumulation of debris from a loss-of-coolant accident in the PWR containment structure would impede the operation of the emergency core cooling system or containment spray system. A loss-of-coolant accident within the containment structure is assumed to be caused by a break in the primary coolant loop piping. Water discharged from the pipe break would collect on the containment structure floor and within the containment emergency sump. During this type of accident, the emergency core cooling systems and containment spray systems would initially draw cooling water from the refueling water storage tank. However, realigning the emergency core cooling system pumps to the containment structure emergency sump would provide long-term cooling of the reactor core. Therefore, successful long-term cooling depends on the ability of the containment structure emergency sump to provide adequate flow to the residual heat removal recirculation pumps for extended periods of time.
One of the concerns addressed by the implementation of GSI-191 is that debris, such as insulation installed on piping and components, within the containment structure could be dislodged by a jet of water and steam from a loss-of-coolant accident. Water, along with debris, would accumulate at the bottom of the containment structure and would flow towards the emergency sump pumps. Insulation and other fibrous material could block the emergency sump screens and suction strainers, which in turn could prevent the ability of the containment emergency sump to provide adequate flow to the residual heat removal recirculation pumps (for more information, see NUREG-0897, “Containment Emergency Sump Performance,” Revision 1.
The NRC issued GL 2004-02 to address this safety concern by requiring licensees of PWRs to: (1) Increase the size of their containment sump strainers, (2) replace fibrous insulation inside containment, and (3) implement other compensatory measures in order to significantly reduce the risk of emergency sump strainer clogging.
Subsequent to the issuance of GL 2004-02, the NRC staff identified another related concern with the potential for debris to bypass the sump strainers (even the new strainers) and enter the reactor core. This safety issue could result in the build-up of material on fuel assemblies, inhibit heat transfer, and prevent adequate cooling of the reactor core. Since 2004, the NRC and industry have conducted tests to gain more information on this concern. In 2012, the NRC staff developed three options for resolution of all of its debris concerns, which are discussed in SECY-12-0093, “Closure Options for Generic Safety Issue 191, Assessment of Debris Accumulation on Pressurized-Water Reactor Sump Performance,” dated July 9, 2012.
The three options for demonstrating compliance with 10 CFR 50.46, “Acceptance criteria for emergency core cooling systems for light-water nuclear power reactors,” are summarized as follows.
1. Option 1 allows the use of approved models and test methods.
2. Option 2 allows the industry to implement additional mitigating measures until resolution is completed and take additional time to resolve issues through further industry testing or use of a risk-informed approach. Use of this option has two alternative methods.
• Option 2A: Industry can perform more testing and analysis and submit a topical report for NRC review and approval.
• Option 2B: Industry can develop a risk-informed approach to quantify the risk associated with this generic issue and submit a license amendment request for NRC review and approval.
3. Option 3 allows industry to separate the regulatory treatment of the sump strainer and in-vessel effects. The emergency core cooling system strainers will be evaluated using currently approved models, while in-vessel effects will be addressed using a risk-informed approach.
STPNOC proposes to use Option 2B to demonstrate compliance with 10 CFR 50.46 through both plant-specific testing and a risk-informed approach (described in more detail in the following paragraphs). Since the use of a risk-informed approach is not recognized in the regulations, STPNOC requested an exemption to 10 CFR 50.46(a)(1) for certain conditions associated with the treatment of debris. Additionally, STPNOC requested exemptions to appendix A to 10 CFR part 50, General Design Criteria (GDC) 35, “Emergency Core Cooling,” GDC 38, “Containment Heat Removal,” and GDC 41, “Containment Atmosphere Cleanup,” to allow its use of a risk-informed approach for certain conditions in the containment debris analysis. If approved, the proposed action would not result in modifications within the containment structure or changes to the emergency core cooling system.
The proposed action is to issue certain license amendments and to grant certain regulatory exemptions requested by STPNOC. The license amendments and regulatory exemptions would allow STPNOC to make changes to the STP licensing basis to incorporate the use of both a deterministic and a risk-informed approach to address safety issues discussed in GSI-191 and close GL 2004-02. If approved, no physical modifications to the nuclear plant or changes to reactor operations involving the emergency core cooling system would be required. The proposed action is in response to the licensee's application dated June 19, 2013, and supplemented by letters dated October 3, October 31, November 13, November 21, and December 23, 2013 (two letters); January 9, February 13, February 27, March 17, March 18, May 15 (two letters), May 22, June 25, and July 15, 2014; and March 10, March 25, and August 20, 2015.
As the holder of Facility Operating License Nos. NPF-76 and NPF-80, STPNOC is expected to address the safety issues discussed in GSI-191 and to close GL 2004-02 with respect to STP, Units 1 and 2. Consistent with SECY-12-0093, STPNOC chose an approach which requires, in part, that STPNOC request that the NRC amend the operating licenses and grant certain regulatory exemptions for each unit.
The STP is located on approximately 12,220 acres (4,945 hectares) in rural and sparsely populated Matagorda County, Texas, approximately 70 miles (mi) [110 kilometers (km)] south-southwest of Houston. Nearby communities include Matagorda, approximately 8 mi (13 km) south of the site; the City of Palacios, 11 mi (18 km)
The STP power plant consists of two four-loop Westinghouse PWR units. The reactor core of each unit heats water, which is pumped to four steam generators, where the heated water is converted to steam. The steam is then used to turn turbines, which are connected to electrical generators that produce electricity. A simplified drawing of a PWR can be viewed at
The reactor, steam generators, and other components are housed in a concrete and steel containment structure (building). The containment structure is a reinforced concrete cylinder with a concrete slab base and hemispherical dome. A welded steel liner is attached to the inside face of the concrete shell to ensure a high degree of leak tightness. In addition, the 4-foot (1.2-meter)-thick concrete walls of the containment structure serve as a radiation shield. Additional information on the plant structures and systems, as well as the environmental impact statement for license renewal, can be found in NUREG-1437, Supplement 48, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants: Supplement 48 Regarding South Texas Project, Units 1 and 2.”
Radiological and non-radiological impacts on the environment that may result from issuing the license amendments and granting the regulatory exemptions are summarized in the following sections.
No physical modifications to the nuclear plant or changes to reactor operations involving the emergency core cooling system would be required if the NRC were to issue the requested license amendments and grant the regulatory exemptions. Also, no physical changes would be made to other structures or land use within the STP site. Non-radiological liquid effluents or gaseous emissions would not change and therefore environmental conditions at the STP site also would not change. In addition, issuing the license amendments and granting the regulatory exemptions would not result in changes to the use of resources or cause any new environmental impacts.
Therefore, there would be no non-radiological environmental impacts to any resource or any irreversible and irretrievable commitments of resources.
Since issuing the license amendments and granting the regulatory exemptions would not result in environmental effects, there would be no cumulative impact.
The STP uses waste treatment systems to collect, process, recycle, and dispose of gaseous, liquid, and solid wastes that contain radioactive material in a safe and controlled manner within NRC and Environmental Protection Agency radiation safety standards. Issuing the license amendments and granting the regulatory exemptions will not result in any physical changes to the nuclear plant or reactor operations that would affect the types and quantities of radioactive material generated during plant operations; therefore, there will be no changes to the plant radioactive waste treatment systems. A detailed description of the STP radioactive waste handling and disposal activities is contained in Chapter 2.1.2 of Supplement 48 to NUREG-1437.
The objectives of the STP gaseous waste management system (GWMS) are to process and control the release of radioactive gaseous effluents into the environment to be within the requirements of 10 CFR 20.1301, “Dose limits for individual members of the public,” and to be consistent with the as low as is reasonably achievable (ALARA) dose objectives set forth in appendix I to 10 CFR part 50. The GWMS is designed so that radiation exposure to plant workers is within the dose limits in 10 CFR 20.1201, “Occupational dose limits for adults.”
Issuing the license amendments and granting the regulatory exemptions will not result in any physical changes to the nuclear plant or reactor operations; therefore, there will be no changes to the GWMS. The existing equipment and plant procedures that control radioactive releases to the environment will continue to be used to maintain radioactive gaseous releases within the dose limits of 10 CFR 20.1301 and the ALARA dose objectives in appendix I to 10 CFR part 50.
The function of the STP liquid waste processing system (LWPS) is to collect and process radioactive liquid wastes to reduce radioactivity and chemical concentrations to levels acceptable for discharge to the environment or to recycle the liquids for use in plant systems. The principal objectives of the LWPS are to collect liquid wastes that may contain radioactive material and to maintain sufficient processing capability so that liquid waste may be discharged to the environment below the regulatory limits of 10 CFR 20.1301 and consistent with the ALARA dose objectives in appendix I to 10 CFR part 50. The waste is routed through a monitor that measures the radioactivity and can automatically terminate the release in the event radioactivity exceeds predetermined levels. The liquid waste is discharged into the main cooling reservoir. The entire main cooling reservoir is within the STP site boundary and the public is prohibited from access to the area.
Issuing the license amendments and granting the regulatory exemptions will not result in any physical changes to the nuclear plant or reactor operations; therefore, there will be no changes to the LWPS. The existing equipment and plant procedures that control radioactive releases to the environment will continue to be used to maintain radioactive liquid releases within the dose limits of 10 CFR 20.1301 and the ALARA dose objectives in appendix I to 10 CFR part 50.
The function of the STP solid waste processing system (SWPS) is to process, package, and store the solid radioactive wastes generated by nuclear plant operations until they are shipped off site to a vendor for further processing or for permanent disposal at a licensed burial facility, or both. The storage areas have restricted access and shielding to reduce radiation rates to plant workers. The principal objectives of the SWPS are to package and transport the waste in compliance with NRC regulations in 10 CFR part 61, “Licensing Requirements for Land Disposal of Radioactive Waste,” and 10 CFR part 71, “Packaging and Transportation of Radioactive Material,” and the U.S. Department of Transportation regulations in 49 CFR parts 170 through 179; and to maintain the dose limits of 10 CFR 20.1201, 10 CFR 20.1301, and appendix I to 10 CFR part 50.
Issuing the license amendments and granting the regulatory exemptions will not result in any physical changes to the nuclear plant or reactor operations; therefore, the waste can be handled by the SWPS without modification. The existing equipment and plant procedures that control radioactive solid waste handling will continue to be used to maintain exposures within the dose limits of 10 CFR 20.1201, 10 CFR
The proposed action of issuing the license amendments and granting the regulatory exemptions will not result in any physical changes being made to the nuclear plant or reactor operations; therefore, there will be no change to any in-plant radiation sources. The licensee's radiation protection program monitors radiation levels throughout the nuclear plant to establish appropriate work controls, training, temporary shielding, and protective equipment requirements so that worker doses will remain within the dose limits of 10 CFR part 20, subpart C, “Occupational Dose Limits.” Issuing the license amendments and granting the regulatory exemptions will not change radiation levels within the nuclear plant and, therefore, will have no increased radiological impact to the workers.
The primary sources of offsite dose to members of the public from the STP are radioactive gaseous and liquid effluents. As discussed previously, there will be no change to the operation of the STP radioactive gaseous and liquid waste management systems or the ability to perform their intended functions. Also, there will be no change to the STP radiation monitoring system and procedures used to control the release of radioactive effluents in accordance with radiation protection standards in 10 CFR 20.1301, 40 CFR 190, “Environmental Radiation Protection Standards for Nuclear Power Operations,” and the ALARA dose objectives in appendix I to 10 CFR part 50.
Based on the previous statements, the offsite radiation dose to members of the public would not change and would continue to be within regulatory limits, and, therefore, issuing the license amendments and granting the regulatory exemptions will not change offsite dose levels and, consequently, the health effects of the proposed action will not be significant.
Design-basis accidents at STP, Units 1 and 2, are evaluated by both the licensee and the NRC to ensure that the units can withstand the spectrum of postulated accidents without undue hazard to the public health and safety and the protection of the environment.
Separate from its environmental review in this EA, the NRC staff is evaluating the licensee's technical and safety analyses provided in support of the proposed action of issuing the license amendments and granting the exemption requests to ensure that, following the proposed action, the licensee will continue to meet the NRC regulatory requirements for safe operation. The results and conclusion of the NRC staff's safety review will be documented in a publicly available safety evaluation. If the NRC staff concludes in this safety evaluation that taking the proposed action will (1) provide reasonable assurance that the health and safety of the public will not be endangered by operation in the proposed manner, (2) provide reasonable assurance that such activities will be conducted in compliance with the Commission's regulations, and (3) not be inimical to the common defense and security or to the health and safety of the public, then the proposed action will also not have a significant environmental impact. The NRC will not take the proposed action absent such a safety conclusion.
The radiological dose limits for protection of the public and plant workers have been developed by the NRC and the Environmental Protection Agency to address the cumulative impact of acute and long-term exposure to radiation and radioactive material. These dose limits are codified in 10 CFR part 20, “Standards for Protection Against Radiation,” and 40 CFR part 190.
Cumulative radiation doses are required to be within the limits set forth in the regulations cited in the previous paragraph. Issuing the license amendments and granting the exemptions will not require any physical changes to the plant or plant activities, there will not be changes to in-plant radiation sources, and offsite radiation dose to members of the public will not change. Therefore, the NRC staff concludes that there would not be a significant cumulative radiological impact from the proposed action.
Based on these radiological evaluations, the proposed action of issuing the license amendments and granting the exemptions would not result in any significant radiological impacts. Therefore, if the NRC staff concludes in its separate safety evaluation that taking the proposed action will (1) provide reasonable assurance that the health and safety of the public will not be endangered by operation in the proposed manner, (2) provide reasonable assurance that such activities will be conducted in compliance with the Commission's regulations, and (3) not be inimical to the common defense and security or to the health and safety of the public, then the proposed action will not have a significant radiological impact.
As discussed earlier, licensees have options in responding to GL 2004-02 and demonstrating compliance with 10 CFR 50.46 to consider the impacts of debris on emergency core cooling system. Consistent with these options, as an alternative to the proposed action, the licensee could choose to remove and replace insulation within the reactor containment building. This would require the physical removal and disposal of significant amounts of insulation from a radiation area within the reactor containment building and the installation of new insulation less likely to impact sump performance.
Removal of the existing insulation from the containment building would generate radiologically contaminated waste. STPNOC estimated that 4,620 cubic feet of insulation would be removed and stored onsite until disposal. The old insulation would require special handling and packaging so that it could be safely transported from the STP site. The licensee's existing low-level radioactive and hazardous waste handling and disposal activities would likely be used to process and store this waste material. The old insulation would then be transported to a low-level radioactive or hazardous waste disposal site. Energy (fuel) would be expended to transport the insulation and land would be expended at the disposal site.
The removal of the old insulation and installation of the new insulation would expose workers to radiation. In its application, STPNOC estimates that this would result in an additional collective radiation exposure of 158-176 person-roentgen equivalent man (rem) over its baseline collective radiation exposure. The NRC staff reviewed NUREG-0713, Volume 34, “Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other Facilities 2012: Forty-Fifth Annual Report,” and determined that STPNOC's average baseline collective radiation exposure is approximately 90 person-rem. This additional 158-176 person-rem collective exposure would be shared across the entire work force involved with removing and reinstalling insulation.
In SECY-12-0093, the NRC staff attempted to develop a total occupational dose estimate for the work
As stated in the “Occupational Radiation Doses” section of this document, STPNOC's radiation protection program monitors radiation levels throughout the nuclear plant to establish appropriate work controls, training, temporary shielding, and protective equipment requirements so that worker doses are expected to remain within the dose limits of 10 CFR 20.1201.
In addition, as stated in the “Offsite Radiation Dose” section of this document, STPNOC also has a radiation monitoring system and procedures in place to control the release of radioactive effluents in accordance with radiation protection standards in 10 CFR 20.1301, 40 CFR part 190, and the ALARA dose objectives in appendix I to 10 CFR part 50. Therefore, radiation exposure to members of the public would be maintained within the NRC dose criteria in 10 CFR 20.1301, 40 CFR part 190, and the ALARA dose objectives of appendix I to 10 CFR part 50.
Based on this information, impacts to members of the public from removing and replacing insulation within the reactor containment building would not be significant. However, impacts to plant workers and the environment from implementing this alternative would be greater than implementing the proposed action.
The proposed action would not involve the use of any different resources (
In accordance with its stated policy, on April 7, 2016, the NRC staff consulted with the Texas State official, Mr. Robert Free, regarding the environmental impact of the proposed action. The state official concurred with the EA and finding of no significant impact.
The NRC is considering STPNOC's requests to amend Facility Operating License Nos. NPF-76 and NPF-80 for STP, Units 1 and 2, and to grant exemptions for STP, Units 1 and 2, from certain requirements of 10 CFR 50.46(a)(1), and 10 CFR part 50, appendix A, GDCs 35, 38, and 41. This proposed action would not result in changes to radioactive effluents or emissions to nuclear plant workers and members of the public or any changes to radiological and non-radiological impacts to the environment. Therefore, the NRC has concluded that implementing the proposed action would result in no significant environmental effects, and that a draft Finding of No Significant Impact is appropriate. The NRC's draft EA, included in section III, “Draft Environmental Assessment,” of this document, is incorporated by reference into this finding.
On the basis of the EA, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an environmental impact statement for the proposed action.
The documents identified in the following table are available for public inspection through the NRC's Agencywide Documents Access and Management System (ADAMS) or by using one of the methods discussed in Section I.A, “Obtaining Information,” of this document.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning notice to enter into an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On April 28, 2016, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-157 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than May 6, 2016. The public
The Commission appoints Katalin K. Clendenin to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-157 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than May 6, 2016.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of April 2016. A copy of each application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
The Commission: Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Hae-Sung Lee, Attorney-Adviser, at (202) 551-7345 or Chief Counsel's Office at (202) 551-6821; SEC, Division of Investment Management, Chief Counsel's Office, 100 F Street NE., Washington, DC 20549-8010.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to update Exchange Rule 4759 and to amend the public disclosure of the sources of data that the Exchange utilizes when performing (1) order handling and execution; (2) order routing; and (3) related compliance processes.
The text of the proposed rule change is below. Proposed new language is
The NASDAQ System utilizes the below proprietary and network processor feeds for the handling, routing, and execution of orders, as well as for the regulatory compliance processes related to those functions. The Secondary Source of data is, where applicable, utilized only in emergency market conditions and only until those emergency conditions are resolved.
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.
The Exchange proposes to update and amend the table in Exchange Rule 4759 that sets forth on a market-by-market basis the specific network processor and proprietary data feeds that the Exchange utilizes for the handling, routing, and execution of orders, and for performing the regulatory compliance checks related to each of those functions.
Specifically, the table will be amended to update the symbol for the Chicago Stock Exchange, Inc. from “CSX” to “CHX”, as well as to update the primary and secondary sources in the table for CHX. The primary source will be CHX Book Feed and the former primary source, CQS/UQDF, will become the secondary source. The change to the primary source reflects the Exchange's effort to increase the amount of data it gathers.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes that its proposal to amend the table in Exchange Rule 4759 to update the symbol for the Chicago Stock Exchange, Inc. and to amend the primary and secondary sources of data for CHX that the Exchange utilizes when performing (1) order handling and execution; (2) order routing; and (3) related compliance processes will ensure that Exchange Rule 4759 correctly identifies and publicly states on a market-by-market basis all of the specific network processor and proprietary data feeds that the Exchange utilizes for the handling, routing, and execution of orders, and for performing the regulatory compliance checks related to each of those functions. The Exchange also believes that the proposed rule change removes impediments to and perfects the mechanism of a free and open market and protects investors and the public interest because it provides additional specificity, clarity and transparency.
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, as amended. To the contrary, the Exchange believes the proposal will enhance competition because including all of the correct information for the exchanges enhances transparency and enables investors to better assess the quality of the Exchange's execution and routing services.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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.
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”),
Nasdaq is proposing to amend Nasdaq Rule 7023 (NASDAQ Depth-of-Book Data) to remove free top-of-file (“Top-of-File”) data from Nasdaq OpenView.
The text of the proposed rule change is available at
In its filing with the Commission, Nasdaq 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.
The Exchange proposes to amend Nasdaq Rule 7023 (NASDAQ Depth-of-Book Data). Currently, Nasdaq does not charge a fee for use of Nasdaq OpenView Top-of-File data that is created using Nasdaq OpenView. Top-of-File data consists of Nasdaq's aggregate best bid and offer quotation for each security listed on an exchange other than Nasdaq. Vendors can create Top-of-File data from Nasdaq OpenView and offer it to both professionals and non-professionals either for display or non-display.
The Exchange proposes to keep Top-of-File data as part of Nasdaq OpenView, but to no longer provide for free the use of this data (
Since no firms currently are utilizing Nasdaq OpenView Top-of-File data, there will be no immediate impact on any subscribers due to the proposed rule change. However, the proposed rule change makes clear going forward that any subscribers creating this data will not be able to use it for free.
To effectuate this proposed rule change, the Exchange will eliminate Nasdaq Rule 7023(b)(3)(C) and renumber Nasdaq Rule 7023(b)(3)(D) as Nasdaq Rule 7023(b)(3)(C).
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Likewise, in
Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . .”
Vendors can create Top-of-File data from Nasdaq OpenView and offer it to both professionals and non-professionals either for display or non-display. The Exchange believes that the proposed rule change to charge all market participants that opt to receive Nasdaq OpenView and create a Top-of-File data product the Nasdaq OpenView fee rate applicable to Non-Professional Subscribers or Professional Subscribers, as appropriate, is reasonable because the Exchange is entitled to receive a fee from each subscriber that receives such data to help offset costs associated with providing Nasdaq OpenView data to subscribers. Also, the proposed rule change is reasonable because a market participant must use Nasdaq OpenView data in order to create a Top-of-File data product and since Nasdaq OpenView is fee liable, the same should be true of the resulting Top-of-File data product.
The Exchange also believes that the proposed rule change is an equitable allocation of fees and is not unfairly discriminatory because market participants cannot be charged for both Top-of-File data and OpenView and the proposed rule change applies uniformly to all market participants since it treats all similarly situated market participants the same.
The renumbering of Nasdaq Rule 7023(b)(3)(D) as Nasdaq Rule 7023(b)(3)(C) is reasonable because it is a technical and clarifying change that is intended to maintain the coherency and consistency within the Nasdaq rule book.
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, as amended. Notwithstanding its determination that the Commission may rely upon competition to establish fair and equitably allocated fees for market data, the
There is intense competition between trading platforms that provide transaction execution and routing services and proprietary data products. Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. Data products are valuable to many end Subscribers only insofar as they provide information that end Subscribers expect will assist them or their customers in making trading decisions.
The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs.
Moreover, an exchange's customers view the costs of transaction executions and of data as a unified cost of doing business with the exchange. A broker-dealer (“BD”) will direct orders to a particular exchange only if the expected revenues from executing trades on the exchange exceed net transaction execution costs and the cost of data that the BD chooses to buy to support its trading decisions (or those of its customers). The choice of data products is, in turn, a product of the value of the products in making profitable trading decisions. If the cost of the product exceeds its expected value, the BD will choose not to buy it. Moreover, as a BD chooses to direct fewer orders to a particular exchange, the value of the product to that BD decreases, for two
Thus, an increase in the fees charged for either transactions or data has the potential to impair revenues from both products. “No one disputes that competition for order flow is `fierce'.”
Analyzing the cost of market data distribution in isolation from the cost of all of the inputs supporting the creation of market data will inevitably underestimate the cost of the data. Thus, because it is impossible to create data without a fast, technologically robust, and well-regulated execution system, system costs and regulatory costs affect the price of market data. It would be equally misleading, however, to attribute all of the exchange's costs to the market data portion of an exchange's joint product. Rather, all of the exchange's costs are incurred for the unified purposes of attracting order flow, executing and/or routing orders, and generating and selling data about market activity. The total return that an exchange earns reflects the revenues it receives from the joint products and the total costs of the joint products.
Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products, but different platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of recovering total costs. Nasdaq pays rebates to attract orders, charges relatively low prices for market information and charges relatively high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower liquidity rebates to attract orders, setting relatively low prices for accessing posted liquidity, and setting relatively high prices for market information. Still others may provide most data free of charge and rely exclusively on transaction fees to recover their costs. Finally, some platforms may incentivize use by providing opportunities for equity ownership, which may allow them to charge lower direct fees for executions and data.
In this environment, there is no economic basis for regulating maximum prices for one of the joint products in an industry in which suppliers face competitive constraints with regard to the joint offering. Such regulation is unnecessary because an “excessive” price for one of the joint products will ultimately have to be reflected in lower prices for other products sold by the firm, or otherwise the firm will experience a loss in the volume of its sales that will be adverse to its overall profitability. In other words, an increase in the price of data will ultimately have to be accompanied by a decrease in the cost of executions, or the volume of both data and executions will fall.
The level of competition and contestability in the market is evident in the numerous alternative venues that compete for order flow, including eleven SRO markets, as well as internalizing BDs and various forms of alternative trading systems (“ATSs”), including dark pools and electronic communication networks (“ECNs”). Each SRO market competes to produce transaction reports via trade executions, and two FINRA-regulated TRFs compete to attract internalized transaction reports. It is common for BDs to further and exploit this competition by sending their order flow and transaction reports to multiple markets, rather than providing them all to a single market. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products.
The large number of SROs, TRFs, BDs, and ATSs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO, TRF, ATS, and BD is currently permitted to produce proprietary data products, and many currently do or have announced plans to do so, including NASDAQ, NYSE, NYSE MKT, NYSE Arca, and BATS/Direct Edge.
Any ATS or BD can combine with any other ATS, BD, or multiple ATSs or BDs to produce joint proprietary data products. Additionally, order routers and market data vendors can facilitate single or multiple BDs' production of proprietary data products. The potential sources of proprietary products are virtually limitless. Notably, the potential sources of data include the BDs that submit trade reports to TRFs and that have the ability to consolidate and distribute their data without the involvement of FINRA or an exchange-operated TRF.
The fact that proprietary data from ATSs, BDs, and vendors can by-pass SROs is significant in two respects. First, non-SROs can compete directly with SROs for the production and sale of proprietary data products, as BATS and NYSE Arca did before registering as exchanges by publishing proprietary book data on the internet. Second, because a single order or transaction report can appear in a core data product, an SRO proprietary product, and/or a non-SRO proprietary product, the data available in proprietary products is exponentially greater than the actual number of orders and transaction reports that exist in the marketplace.
In addition to the competition and price discipline described above, the market for proprietary data products is also highly contestable because market entry is rapid, inexpensive, and profitable. The history of electronic trading is replete with examples of entrants that swiftly grew into some of the largest electronic trading platforms and proprietary data producers: Archipelago, Bloomberg Tradebook, Island, RediBook, Attain, TracECN, BATS Trading and BATS/Direct Edge. A proliferation of dark pools and other ATSs operate profitably with fragmentary shares of consolidated market volume.
Regulation NMS, by deregulating the market for proprietary data, has increased the contestability of that market. While BDs have previously published their proprietary data individually, Regulation NMS encourages market data vendors and BDs to produce proprietary products cooperatively in a manner never before possible. Multiple market data vendors already have the capability to aggregate data and disseminate it on a profitable scale, including Bloomberg and Thomson Reuters. In Europe, Cinnober aggregates and disseminates data from
In the case of TRFs, the rapid entry of several exchanges into this space in 2006-2007 following the development and Commission approval of the TRF structure demonstrates the contestability of this aspect of the market.
Moreover, consolidated data provides two additional measures of pricing discipline for proprietary data products that are a subset of the consolidated data stream. First, the consolidated data is widely available in real-time at $1 per month for non-professional users. Second, consolidated data is also available at no cost with a 15- or 20- minute delay. Because consolidated data contains marketwide information, it effectively places a cap on the fees assessed for proprietary data (such as last sale data) that is simply a subset of the consolidated data. The mere availability of low-cost or free consolidated data provides a powerful form of pricing discipline for proprietary data products that contain data elements that are a subset of the consolidated data, by highlighting the optional nature of proprietary products.
In this instance, the proposed rule change to charge all market participants that create a Top-of-File product using Nasdaq OpenView data the fee rate applicable to Non-Professional Subscribers or Professional Subscribers, as appropriate, by eliminating current rule text in Nasdaq Rule 7023(b)(3)(C), does not impose a burden on competition because no firms currently are utilizing this data so there will be no immediate impact on any subscribers.
In sum, if the rule change proposed herein is unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that the proposed change will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
Written comments were neither solicited nor received.
The foregoing change has become effective pursuant to Section 19(b)(3)(A)(ii) 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 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.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Section 6(h) of the Act (15 U.S.C. 78f(h)) requires national securities
It is estimated that approximately 1 respondent, consisting of a designated contract market not already registered as a national securities exchange under Section 6(g) of the Exchange Act that seeks to list or trade security futures products, will incur an average burden of 10 hours per year to comply with this rule, for a total burden of 10 hours. At an average cost per hour of approximately $387, the resultant total cost of compliance for the respondents is $3,870 per year (1 respondent × 10 hours/respondent × $387/hour).
Compliance with Rule 6h-1 is mandatory. Any listing standards established pursuant to Rule 6h-1 would be filed with the Commission as proposed rule changes pursuant to Section 19(b) of the Act and would be published in the
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Rule 20a-1 (17 CFR 270.20a-1) was adopted under Section 20(a) of the Investment Company Act of 1940 (“1940 Act”) (15 U.S.C. 80a-20(a)) and concerns the solicitation of proxies, consents, and authorizations with respect to securities issued by registered investment companies (“Funds”). More specifically, rule 20a-1 under the 1940 Act (15 U.S.C. 80a-1
The types of proposals voted upon by Fund shareholders include not only the typical matters considered in proxy solicitations made by operating companies, such as the election of directors, but also include issues that are unique to Funds, such as the approval of an investment advisory contract and the approval of changes in fundamental investment policies of the Fund. Through rule 20a-1, any person making a solicitation with respect to a security issued by a Fund must, similar to operating company solicitations, comply with the rules and regulations adopted pursuant to Section 14(a) of the 1934 Act. Some of those Section 14(a) rules and regulations, however, include provisions specifically related to Funds, including certain particularized disclosure requirements set forth in Item 22 of Schedule 14A under the 1934 Act.
Rule 20a-1 is intended to ensure that investors in Fund securities are provided with appropriate information upon which to base informed decisions regarding the actions for which Funds solicit proxies. Without rule 20a-1, Fund issuers would not be required to comply with the rules and regulations adopted under Section 14(a) of the 1934 Act, which are applicable to non-Fund issuers, including the provisions relating to the form of proxy and disclosure in proxy statements.
The staff currently estimates that approximately 1,196 proxy statements are filed by Funds annually. Based on staff estimates and information from the industry, the staff estimates that the average annual burden associated with the preparation and submission of proxy statements is 85 hours per response, for a total annual burden of 101,660 hours (1,196 responses × 85 hours per response = 101,660). In addition, the staff estimates the costs for purchased services, such as outside legal counsel, proxy statement mailing, and proxy tabulation services, to be approximately $30,000 per proxy solicitation.
Rule 20a-1 does not involve any recordkeeping requirements. Providing the information required by the rule is mandatory and information provided under the rule will not be kept confidential.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Securities and Exchange Commission.
Notice of meeting.
The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing notice that it will hold a public meeting on Wednesday, May 18, 2016, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (EDT) and will be open to the public. The meeting will be webcast on the Commission's Web site at
The public meeting will be held on Wednesday, May 18, 2016. Written statements should be received on or before May 16, 2016.
The meeting will be held at the Commission's headquarters, 100 F Street NE., Washington, DC. Written statements may be submitted by any of the following methods:
• Use the Commission's Internet submission form (
• Send an email message to
• Send paper statements to Brent J. Fields, Federal Advisory Committee Management Officer, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Statements also will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All statements received will be posted without change; we do not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
Julie Z. Davis, Senior Special Counsel, at (202) 551-3460, Office of Small Business Policy, Division of Corporation Finance, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-3628.
In accordance with Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C.—App. 1, and the regulations thereunder, Keith Higgins, Designated Federal Officer of the Committee, has ordered publication of this notice.
On March 1, 2016, the Municipal Securities Rulemaking Board (the “MSRB” or “Board”) filed with the Securities and Exchange Commission (the “SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change was published for comment in the
The MSRB's proposed rule change consists of proposed amendments to Rule G-12, on uniform practice, and Rule G-15, on confirmation, clearance, settlement and other uniform practice requirements with respect to transactions with customers, to define
The MSRB has identified two MSRB rules—G-12(b)(ii)(B)-(D) and Rule G-15(b)(ii)(B)-(C)—essential to facilitate the move to T+2.
According to the MSRB, the migration to T+2 will provide significant benefits to the financial industry broadly.
According to the MSRB, Rule G-12 establishes uniform industry practices for processing, clearance and settlement of transactions in municipal securities between a broker, dealer or municipal securities dealer and any other broker, dealer or municipal securities dealer.
According to the MSRB, Rule G-15 requires municipal securities brokers and municipal securities dealers to provide customers with written confirmations of transactions, containing specified information; and prescribes certain uniform practice procedures for dealers that transact municipal securities business with customers.
The MSRB has proposed technical conforming amendments to Rules G-12(b)(i)(B), G-15(b)(i)(B) and G-15(g)(ii)(B).
The MSRB has stated that the compliance date of the proposed rule change will be announced by the MSRB in a notice published on the MSRB Web site, which date would correspond with the industry's transition to a T+2 regular-way settlement, which would include amendments by the SEC to Exchange Act Rule 15c6-1(a).
As noted previously, the Commission received four comment letters on the proposed rule change.
The BDA Letter and the SIFMA Letter each addressed the impact of the proposed rule change on MSRB Rule G-32.
The FSI Letter also expressed general support and agreement with the
The Commission has carefully considered the proposed rule change as well as the comments received. The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to the MSRB.
In particular, the Commission finds that the proposed rule change is consistent with Section 15B(b)(2)(C) of the Act,
In approving the proposed rule change, the Commission has also considered the proposed rule change's impact on efficiency, competition, and capital formation.
For the reasons noted above, the Commission believes that the proposed rule change is consistent with the Act.
IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the Act,
For the Commission, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Several sections of the Investment Company Act of 1940 (“Act” or “Investment Company Act”)
Rule 0-2 under the Investment Company Act,
Applicants for orders can include registered investment companies, affiliated persons of registered investment companies, and issuers seeking to avoid investment company status, among other entities. Commission staff estimates that it receives approximately 184 applications per year under the Act. Although each application typically is submitted on behalf of multiple entities, the entities in the vast majority of cases are related companies and are treated as a single respondent for purposes of this analysis.
The time to prepare an application depends on the complexity and/or novelty of the issues covered by the application. We estimate that the Commission receives 25 of the most time-consuming applications annually, 125 applications of medium difficulty, and 34 of the least difficult applications. Based on conversations with applicants, we estimate that in-house counsel would spend from ten to fifty hours helping to draft and review an application. We estimate a total annual hour burden to all respondents of 5,340 hours [(50 hours × 25 applications) + (30 hours × 125 applications) + (10 hours × 34 applications)].
Much of the work of preparing an application is performed by outside counsel. The cost outside counsel charges applicants depends on the complexity of the issues covered by the application and the time required for preparation. Based on conversations with attorneys who serve as outside counsel, the cost ranges from approximately $10,000 for preparing a well-precedented, routine application to approximately $150,000 to prepare a complex and/or novel application. This distribution gives a total estimated
These estimates of average costs are made solely for the purposes of the Paperwork Reduction Act. The estimate is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
This collection of information is necessary to obtain a benefit and will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Section 7(d) of the Investment Company Act of 1940 (15 U.S.C. 80a-7(d)) (the “Act” or “Investment Company Act”) requires an investment company (“fund”) organized outside the United States (“foreign fund”) to obtain an order from the Commission allowing the fund to register under the Act before making a public offering of its securities through the United States mail or any means of interstate commerce. The Commission may issue an order only if it finds that it is both legally and practically feasible effectively to enforce the provisions of the Act against the foreign fund, and that the registration of the fund is consistent with the public interest and protection of investors.
Rule 7d-1 (17 CFR 270.7d-1) under the Act, which was adopted in 1954, specifies the conditions under which a Canadian management investment company (“Canadian fund”) may request an order from the Commission permitting it to register under the Act. Although rule 7d-1 by its terms applies only to Canadian funds, other foreign funds generally have agreed to comply with the requirements of rule 7d-1 as a prerequisite to receiving an order permitting the foreign fund's registration under the Act.
The rule requires a Canadian fund proposing to register under the Act to file an application with the Commission that contains various undertakings and agreements of the fund. The requirement for the Canadian fund to file an application is a collection of information under the Paperwork Reduction Act. Certain of the undertakings and agreements, in turn, impose the following additional information collection requirements:
(1) The fund must file with the Commission agreements between the fund and its directors, officers, and service providers requiring them to comply with the fund's charter and bylaws, the Act, and certain other obligations relating to the undertakings and agreements in the application;
(2) the fund and each of its directors, officers, and investment advisers that is not a U.S. resident, must file with the Commission an irrevocable designation of the fund's custodian in the United States as agent for service of process;
(3) the fund's charter and bylaws must provide that (a) the fund will comply with certain provisions of the Act applicable to all funds, (b) the fund will maintain originals or copies of its books and records in the United States, and (c) the fund's contracts with its custodian, investment adviser, and principal underwriter, will contain certain terms, including a requirement that the adviser maintain originals or copies of pertinent records in the United States;
(4) the fund's contracts with service providers will require that the provider perform the contract in accordance with the Act, the Securities Act of 1933 (15 U.S.C. 77a), and the Securities Exchange Act of 1934 (15 U.S.C. 78a), as applicable; and
(5) the fund must file, and periodically revise, a list of persons affiliated with the fund or its adviser or underwriter.
As noted above, under section 7(d) of the Act the Commission may issue an order permitting a foreign fund's registration only if the Commission finds that “by reason of special circumstances or arrangements, it is both legally and practically feasible effectively to enforce the provisions of the (Act).” The information collection requirements are necessary to assure that the substantive provisions of the Act may be enforced as a matter of contract right in the United States or Canada by the fund's shareholders or by the Commission.
Rule 7d-1 also contains certain information collection requirements that are associated with other provisions of the Act. These requirements are applicable to all registered funds and are outside the scope of this request.
The Commission believes that one foreign fund is registered under rule 7d-1 and currently active. Apart from requirements under the Act applicable to all registered funds, rule 7d-1 imposes ongoing burdens to maintain records in the United States, and to update, as necessary, certain fund agreements, designations of the fund's custodian as service agent, and the fund's list of affiliated persons. The Commission staff estimates that each year under the rule, the active registrant and its directors, officers, and service providers engage in the following collections of information and associated burden hours:
• For the fund and its investment adviser to maintain records in the United States:
0 hours: 0 minutes of compliance clerk time.
• For the fund to update its list of affiliated persons:
2 hours: 2 hours of support staff time.
• For new officers, directors, and service providers to enter into and file agreements requiring them to comply with the fund's charter and bylaws, the Act, and certain other obligations:
0.5 hours: 7.5 minutes of director time; 2.5 minutes of officer time; 20 minutes of support staff time.
• For new officers, directors, and investment advisers who are not residents of the United States to file irrevocable designation of the fund's custodian as agent for process of service:
0.25 hours: 5 minutes of director time; 10 minutes of support staff time.
Based on the estimates above, the Commission estimates that the total annual burden of the rule's paperwork requirements is 2.75 hours.
If a fund were to file an application under rule 7d-1 to register under the Act, the Commission estimates that the rule would impose initial information collection burdens (for filing an application, preparing the specified charter, bylaw, and contract provisions, designations of agents for service of process, and an initial list of affiliated persons, and establishing a means of keeping records in the United States) of approximately 90 hours for the fund and its associated persons. The Commission is not including these hours in its calculation of the annual burden because no fund has applied to register under the Act pursuant to rule 7d-1 in the last three years.
After registration, a Canadian fund may file a supplemental application seeking special relief designed for the fund's particular circumstances. Rule 7d-1 does not mandate these applications. The active registrant last filed a substantive supplemental application in 2013. The Commission staff estimates that the rule would impose an additional information collection burden of 5 hours on a fund to comply with the Commission's application process at a cost of $5,928.
Therefore, the Commission estimates the aggregate annual burden hours of the collection of information associated with rule 7d-1 is 7.75 hours, at a cost of $7,013.90.
If a Canadian or other foreign fund in the future applied to register under the Act under rule 7d-1, the fund initially might have capital and start-up costs (not including hourly burdens) of an estimated $20,000 to comply with the rule's initial information collection requirements. These costs include legal and processing-related fees for preparing the required documentation (such as the application, charter, bylaw, and contract provisions, designations for service of process, and the list of affiliated persons). Other related costs would include fees for establishing arrangements with a custodian or other agent for maintaining records in the United States, copying and transportation costs for records, and the costs of purchasing or leasing computer equipment, software, or other record storage equipment for records maintained in electronic or photographic form.
The Commission expects that a foreign fund and its sponsors would incur these costs immediately, and that the annualized cost of the expenditures would be $20,000 in the first year. Some expenditures might involve capital improvements, such as computer equipment, having expected useful lives for which annualized figures beyond the first year would be meaningful. These annualized figures are not provided, however, because, in most cases, the expenses would be incurred immediately rather than on an annual basis. The Commission is not including these costs in its calculation of the annualized capital/start-up costs because no fund has applied under rule 7d-1 to register under the Act pursuant to rule 7d-1 in the last three years.
As indicated above, a Canadian fund may file a supplemental application seeking special relief designed for the fund's particular circumstances. Rule 7d-1 does not mandate these applications. The active registrant filed a substantive application in the past three years. The staff understands that funds generally use outside counsel to prepare the application. The staff estimates that outside counsel spends 10 hours preparing the application, including 8 hours by an associate and 2 hours by a partner. Outside counsel billing arrangements vary based on numerous factors, but the staff has estimated the average cost of outside counsel at $400 per hour, based on information received from funds, intermediaries and their counsel. The Commission therefore estimates that the fund would obtain assistance from outside counsel at a cost of $4000.
These estimates of average costs are made solely for the purposes of the Paperwork Reduction Act. The estimate is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Rule 204-3 (17 CFR 275.204-3) under the Investment Advisers Act of 1940.” (15 U.S.C. 80b). Rule 204-3, the “brochure rule,” requires advisers to deliver their brochures and brochure supplements at the start of an advisory relationship and to deliver annually thereafter the full updated brochures or a summary of material changes to their brochures. The rule also requires that advisers deliver amended brochures or brochure supplements (or just a statement describing the amendments) to clients only when disciplinary information in the brochures or supplements becomes materially inaccurate.
The brochure assists the client in determining whether to retain, or continue employing, the adviser. The information that Rule 204-3 requires to be contained in the brochure is also used by the Commission and staff in its enforcement, regulatory, and examination programs. This collection of information is found at 17 CFR 275.204-3 and is mandatory.
The respondents to this information collection are investment advisers registered with the Commission. The Commission has estimated that compliance with rule 204-3 imposes a burden of approximately 39 hours annually based on an average adviser having 1,494 clients. Our latest data indicate that there were 11,956 advisers registered with the Commission as of January 4, 2016. Based on this figure, the Commission estimates a total annual burden of 466,145 for this collection of information.
Rule 204-3 does not require recordkeeping or record retention. The collection of information requirements under the rule are mandatory. The information collected pursuant to the rule is not filed with the Commission, but rather takes the form of disclosures to clients and prospective clients. Accordingly, these disclosures are not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form F-8 (17 CFR 239.38) may be used to register securities of certain Canadian issuers under the Securities Act of 1933 (15 U.S.C. 77a
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 19d-1 prescribes the form and content of notices to be filed with the Commission by self-regulatory organizations (“SROs”) for which the Commission is the appropriate regulatory agency concerning the following final SRO actions: (1) Disciplinary actions with respect to any person; (2) denial, bar, prohibition, or limitation of membership, participation or association with a member or of access to services offered by an SRO or member thereof; (3) summarily suspending a member, participant, or person associated with a member, or summarily limiting or prohibiting any persons with respect to access to or services offered by the SRO or a member thereof; and (4) delisting a security.
The Rule enables the Commission to obtain reports from the SROs containing information regarding SRO determinations to delist a security, discipline members or associated persons of members, deny membership or participation or association with a member, and similar adjudicated findings. The Rule requires that such actions be promptly reported to the Commission. The Rule also requires that the reports and notices supply sufficient information regarding the background, factual basis and issues involved in the proceeding to enable the Commission: (1) To determine whether the matter should be called up for review on the Commission's own motion; and (2) to ascertain generally whether the SRO has adequately carried out its responsibilities under the Exchange Act.
It is estimated that approximately eighteen respondents will utilize this application procedure annually, with a total burden of approximately 2,250 hours, based upon past submissions. This figure is based on eighteen respondents, spending approximately 125 hours each per year. It is estimated that each respondent will submit approximately 250 responses. Commission staff estimates that the average number of hours necessary to comply with the requirements of Rule 19d-1 for each submission is 0.5 hours. The average cost per hour, per each submission is approximately $101. Therefore, it is estimated that the internal labor cost of compliance for all respondents is approximately $227,250 (18 respondents × 250 responses per respondent × 0.5 hours per response × $101 per hour).
The filing of notices pursuant to Rule 19d-1 is mandatory for the SROs, but does not involve the collection of confidential information. Rule 19d-1 does not have a record retention requirement.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to extend the operation of its Flexible Exchange Options (“FLEX Options”) pilot program through May 3, 2017.
The text of the proposed rule change is also available on the Exchange's Web site (
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 January 28, 2010, the Exchange received approval of a rule change that, among other things, established a pilot program regarding permissible exercise settlement values for FLEX Index Options.
Under Rules 24A.4,
Under the exercise settlement values pilot, this restriction on p.m. and specified average price settlements in FLEX Index Options was eliminated.
CBOE is proposing to extend the pilot program through the earlier of May 3, 2017 or the date on which the pilot program is approved on a permanent basis. CBOE believes the pilot program has been successful and well received by its Trading Permit Holders and the investing public for the period that it has been in operation as a pilot. In support of the proposed extension of the pilot program, and as required by the pilot program's Approval Order, the Exchange has submitted to the Securities and Exchange Commission (the “Commission”) pilot program reports regarding the pilot, which detail the Exchange's experience with the program. Specifically, the Exchange provided the Commission with annual reports analyzing volume and open interest for each broad-based FLEX Index Options class overlying an Expiration Friday, p.m.-settled FLEX Index Options series.
The Exchange believes there is sufficient investor interest and demand in the pilot program to warrant its extension. The Exchange believes that, for the period that the pilot has been in operation, the program has provided investors with additional means of managing their risk exposures and carrying out their investment objectives. Furthermore, the Exchange believes that it has not experienced any adverse market effects with respect to the pilot program, including any adverse market volatility effects that might occur as a result of large FLEX exercises in FLEX Option series that expire near Non-FLEX expirations and use a p.m. settlement (as discussed below).
In that regard, based on the Exchange's experience in trading FLEX Options to date and over the pilot period, CBOE continues to believe that the restrictions on exercise settlement values are no longer necessary to insulate Non-FLEX expirations from the potential adverse market impacts of FLEX expirations.
The Exchange also notes that certain position limit, aggregation and exercise limit requirements continue to apply to FLEX Index Options in accordance with Rules 24A.7,
CBOE is also cognizant of the OTC market, in which similar restrictions on exercise settlement values do not apply. CBOE continues to believe that the pilot program is appropriate and reasonable and provides market participants with additional flexibility in determining whether to execute their customized options in an exchange environment or in the OTC market. CBOE continues to believe that market participants benefit from being able to trade these customized options in an exchange environment in several ways, including, but not limited to, enhanced efficiency in initiating and closing out positions, increased market transparency, and heightened contra-party creditworthiness due to the role of the Options Clearing Corporation as issuer and guarantor of FLEX Options.
If, in the future, the Exchange proposes an additional extension of the pilot program, or should the Exchange propose to make the pilot program permanent, the Exchange will submit, along with any filing proposing such amendments to the pilot program, an annual report (addressing the same areas referenced above and consistent with the pilot program's Approval Order) to the Commission at least two months prior to the expiration date of the program. The Exchange will also continue, on a periodic basis, to submit interim reports of volume and open interest consistent with the terms of the exercise settlement values pilot program as described in the pilot program's Approval Order. All such pilot reports would continue to be provided by the Exchange along with a request for confidential treatment under FOIA.
The Exchange believes the proposed rule change is consistent with the Act
In particular, the Exchange believes that the proposed extension of the pilot program, which permits additional exercise settlement values, would provide greater opportunities for investors to manage risk through the use of FLEX Options. Further, the Exchange believes that it has not experienced any adverse effects from the operation of the pilot program, including any adverse market volatility effects that might occur as a result of large FLEX exercises in FLEX Option series that expire near Non-FLEX expirations and use a p.m. settlement. The Exchange also believes that the extension of the exercise settlement values pilot does not raise any unique regulatory concerns. In particular, although p.m. settlements may raise questions with the Commission, the Exchange believes that, based on the Exchange's experience in trading FLEX Options to date and over the pilot period, market impact and investor protection concerns will not be raised by this rule change. The Exchange also believes that the proposed rule change would continue to provide Trading Permit Holders and investors with additional opportunities to trade customized options in an exchange environment (which offers the added benefits of transparency, price discovery, liquidity, and financial stability as compared to the over-the-counter market) and subject to exchange-based rules, and investors would benefit as a result.
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes there is sufficient investor interest and demand in the pilot program to warrant its extension. The Exchange believes that, for the period that the pilot has been in operation, the program has provided investors with additional means of managing their risk exposures and carrying out their investment objectives. Furthermore, the Exchange believes that it has not experienced any adverse market effects with respect to the pilot program, including any adverse market volatility effects that might occur as a result of large FLEX exercises in FLEX Option series that expire near Non-Flex expirations and use a p.m. settlement. CBOE believes that the restriction actually places the Exchange at a competitive disadvantage to its OTC counterparts in the market for customized options, and unnecessarily limits market participants' ability to trade in an exchange environment that offers the added benefits of transparency, price discovery, liquidity, and financial stability. Therefore, the Exchange does not believe that the proposed rule change will impose any burden on competition.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed 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. Waiver of the operative delay will allow the Exchange to extend the pilot program prior to its expiration on May 3, 2016, which will ensure that the program continues to operate uninterrupted. 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. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
The U.S. Small Business Administration (SBA) announces the 2016 Growth Accelerator Fund Competition, pursuant to the America Competes Act, to identify the nation's most innovative accelerators and similar organizations and award them cash prizes they may use to fund their operations costs and allow them to bring startup companies to scale and new ideas to life.
The submission period for entries begins 12:00 p.m. EDT, May 2, 2016 and ends June 3, 2016 at 11:59 p.m. EDT. Winners will be announced no later than August 24, 2016.
Nareg Sagherian, Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW., 6th Floor Washington, DC 20416, (202) 205-7576,
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• Selective process to choose participating startups.
• Regular networking opportunities offered to startups.
• Introductions to customers, partners, suppliers, advisory boards and other players.
• High-growth and tech-driven startup mentorship and commercialization assistance.
• Shared working environments focused on building a strong startup community.
• Resource sharing and co-working arrangements for startups.
• Opportunities to pitch ideas and startups to investors along with other capital formation avenues to startups.
• Small amounts of angel money, seed capital or structured loans to startups.
• Service to underserved communities, such as women, veterans, and economically disadvantaged individuals.
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• What is your accelerator's mission in one sentence?
• What specific elements make your accelerator model stand out?
• What experiences prepare your team for this?
• What gaps does or will your accelerator fill?
• What are the specifics of your model and how it will accomplish the above?
• For existing accelerators, what has been your success/metrics so far?
• For existing accelerators, please explain your overall statistics of the start-up life cycle?
• What is your plan for the prize money if you win?
• If you are an existing accelerator using the funds to scale up, provide
• If you are creating a new accelerator, provide basics of business plan and phases for implementation.
• Aside from the founding team members, what do you look for in staff?
• What are the largest risk factors you see?
• What are your fundraising goals or metrics? (aside from the 4-to-1 match)
• Is there a plan in place to secure/work to secure funds (cash, in-kind donations, or sponsorships) in a 4-to-1 proportion to the prize dollars received?
• Aside from metrics required by SBA, what are 5 key metrics you will use to self-evaluate?
• What does success look like?
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Pub. L. 111-358 (2011).
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Texas (FEMA-4269-DR), dated 04/25/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and
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 President's major disaster declaration on 04/25/2016, 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:
The Interest Rates are:
The number assigned to this disaster for physical damage is 147086 and for economic injury is 147090.
Notice is hereby given that Main Street Mezzanine Fund, L.P., 1300 Post Oak Blvd., Suite 800, Houston, TX 77056, 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 part 107). Main Street Mezzanine Fund, L.P. proposes to provide loan financing to PCI Holding Company, Inc., 1007 Church Street, Suite 420, Evanston, IL 60201.
The financing is brought within the purview of § 107.730(a) of the Regulations because Main Street Capital II, L.P., an Associate of Main Street Mezzanine Fund, L.P., holds a direct ownership interest in PCI Holding Company, Inc., of greater than 10 percent. Therefore, PCI Holding Company Inc. is an Associate of Main Street Mezzanine Fund, L.P. Therefore this transaction requires a prior SBA exemption.
Notice is hereby given that any interested person may submit written comments on the transaction, within fifteen days of the date of this publication, to the Associate Administrator for Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW., Washington, DC 20416.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. 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 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to June 3, 2016.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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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 Keith D. Miller, Office of Overseas Schools, U.S. Department of State, 2201 C Street NW., Washington, DC 20520 and can be reached on 202-261-8200 or at
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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 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.
The Department of State Overseas Schools Advisory Council will hold its next Executive Committee Meeting on Thursday, June 16, 2016, at 9:30 a.m. in Conference Room 1482, Marshall Center, Department of State Building, 2201 C Street NW., Washington, DC. The meeting is open to the public and will last until approximately 12:00 p.m.
The Overseas Schools Advisory Council works closely with the U.S. business community to improve American-sponsored schools overseas that are assisted by the Department of State and attended by dependents of U.S. government employees, and children of employees of U.S. corporations and foundations abroad.
This meeting will deal with issues related to the work and support provided by the Overseas Schools Advisory Council to American-sponsored overseas schools. There will be a report and discussion about the status of the Council-sponsored projects such as The World Virtual School and The Child Protection Project. The Regional Education Officers in the Office of Overseas Schools will make presentations on the activities and initiatives in American-sponsored overseas schools.
Members of the public may attend the meeting and join in the discussion, subject to the instructions of the Chair. Admittance of public members will be limited to the seating available. Access to the State Department is controlled, and individual building passes are required for all attendees. Persons who plan to attend should advise the office of Dr. Keith D. Miller, Department of State, Office of Overseas Schools, telephone 202-261-8200, prior to June 9, 2016. Each visitor will be asked to provide his/her date of birth and either a driver's license or passport number at the time of registration and attendance, and must bring a valid photo ID to the meeting.
Personal data is requested pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and E.O. 13356. The purpose of the collection is to validate the identity of individuals who enter Department facilities. The data will be entered into the Visitor Access Control System (VACS-D) database. Please see the Security Records System of Records Notice (State-36) at
Any requests for reasonable accommodation should be made at the time of registration. All such requests will be considered, however, it might not be possible to accommodate requests made after June 9, 2016. All attendees must use the C Street entrance to the building.
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 (
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Henning Oeltjenbruns, general manager of the Daimler Truck Plant in Cleveland, NC, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in “real world” environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
Comments must be received on or before June 3, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2012-0032 using any of the following methods:
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Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 202-366-4325. Email:
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2012-0032), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews the safety analyses and the public comments, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
Section 5206(a)(3) of the “Fixing America's Surface Transportation Act,” (FAST Act) amended 49 U.S.C. 31315 by adding a new paragraph (b)(2) to permit exemptions for no longer than five years from their dates of inception, instead of the previous two years. This statutory provision will be codified in 49 CFR part 381 in a forthcoming rulemaking.
On behalf of Henning Oeltjenbruns, Daimler has applied for a 5-year exemption from 49 CFR 383.23, which prescribes licensing requirements for drivers operating CMVs in interstate or intrastate commerce. Mr. Oeltjenbruns is unable to obtain a CDL in any of the States due to his lack of residency in the United States. A copy of the application is in Docket No. FMCSA-2012-0032.
The exemption would allow Mr. Oeltjenbruns to operate CMVs in interstate or intrastate commerce to support Daimler field tests designed to meet future vehicle safety and
Mr. Oeltjenbruns would be required to comply with all applicable Federal Motor Carrier Safety Regulations (49 CFR parts 350-399) except the CDL provisions described in this notice.
Mr. Oeltjenbruns holds a valid German commercial license, and as explained by Daimler in its exemption request, the requirements for that license ensure that the same level of safety is met or exceeded as if this driver had a U.S. CDL. Furthermore, according to Daimler, Mr. Oeltjenbruns is familiar with the operation of CMVs worldwide.
FMCSA has previously determined that the process for obtaining a German commercial license is comparable to, or as effective as, the requirements of part 383, and adequately assesses the driver's ability to operate CMVs in the U.S. Since 2012, FMCSA has granted Daimler drivers similar exemptions [May 25, 2012 (77 FR 31422); July 22, 2014 (79 FR 42626); March 27, 2015 (80 FR 16511); October 5, 2015 (80 FR 60220); December 7, 2015 (80 FR 76059); December 21, 2015 (80 FR 79410)].
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for exemption; request for comments.
FMCSA announces that Daimler Trucks North America (Daimler) has requested a five-year exemption for one of its employees from the Federal requirement to hold a U.S. commercial driver's license (CDL). Mr. Sebastian Boehm, a project engineer, holds a valid German commercial license and wants to test drive Daimler vehicles on U.S. roads to better understand product requirements in “real world” environments, and verify results. Daimler believes the requirements for a German commercial license ensure that operation under the exemption will likely achieve a level of safety equivalent to or greater than the level that would be obtained in the absence of the exemption.
Comments must be received on or before June 3, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2012-0032 using any of the following methods:
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Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
For information concerning this notice, contact Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards;
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2012-0032), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews the safety analyses and the public comments, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
Section 5206(a)(3) of the “Fixing America's Surface Transportation Act,” (FAST Act) amended 49 U.S.C 31315 by adding a new paragraph (b)(2) to permit exemptions for no longer than five years from their dates of inception, instead of the previous two years. This statutory provision will be codified in 49 CFR part 381 in a forthcoming rulemaking.
On behalf of Sebastian Boehm, Daimler has applied for a 5-year exemption from 49 CFR 383.23, which prescribes licensing requirements for drivers operating CMVs in interstate or intrastate commerce. Mr. Boehm is unable to obtain a CDL in any of the States due to his lack of residency in the United States. A copy of the application is in Docket No. FMCSA-2012-0032.
The exemption would allow Mr. Boehm to operate CMVs in interstate or intrastate commerce to support Daimler field tests designed to meet future vehicle safety and environmental requirements and to promote technological advancements in vehicle safety systems and emissions reductions. Mr. Boehm needs to drive Daimler vehicles on public roads to better understand “real world” environments in the U.S. market. According to Daimler, Mr. Boehm will typically drive for no more than 6 hours per day, and that 10 percent of the test driving will be on two-lane state highways, while 90 percent will be on interstate highways. The driving will consist of no more than 200 miles per day, for one to two weeks on a quarterly basis. He will in all cases be accompanied by a holder of a U.S. CDL who is familiar with the routes to be traveled.
Mr. Boehm would be required to comply with all applicable Federal Motor Carrier Safety Regulations (49 CFR parts 350-399) except the CDL provisions described in this notice.
Mr. Boehm holds a valid German commercial license, and as explained by Daimler in its exemption request, the requirements for that license ensure that the same level of safety is met or exceeded as if this driver had a U.S. CDL. Furthermore, according to Daimler, Mr. Boehm is familiar with the operation of CMVs worldwide.
FMCSA has previously determined that the process for obtaining a German commercial license is comparable to, or as effective as, the requirements of part 383, and adequately assesses the driver's ability to operate CMVs in the U.S. Since 2012, FMCSA has granted Daimler drivers similar exemptions [May 25, 2012 (77 FR 31422); July 22, 2014 (79 FR 42626); March 27, 2015 (80 FR 16511); October 5, 2015 (80 FR 60220); December 7, 2015 (80 FR 76059); December 21, 2015 (80 FR 79410)].
National Highway Traffic Safety Administration, DOT.
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2008 Aston Martin Vantage V8 passenger cars (PC) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2008 Aston Martin Vantage V8 PC) and they are capable of being readily altered to conform to the standards.
The closing date for comments on the petition is June 3, 2016.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
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George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
U.S. Specs of Harve de Grace, Maryland (Registered Importer R-03-321) has petitioned NHTSA to decide whether nonconforming 2008 Aston Martin Vantage V8 PCs are eligible for importation into the United States. The vehicles which U.S. Specs believes are substantially similar are MY 2008 Aston Martin Vantage V8 PCs sold in the United States and certified by their manufacturer as conforming to all applicable FMVSS.
The petitioner claims that it compared non-U.S. certified MY 2008 Aston Martin Vantage V8 PCs to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.
U.S. Specs submitted information with its petition intended to demonstrate that non-U.S. certified MY 2008 Aston Martin Vantage V8 PCs, as originally manufactured, conform to many applicable FMVSS in the same manner as their U.S.-certified counterparts, or are capable of being readily altered to conform to those standards.
Specifically, the petitioner claims that the non U.S.-certified MY 2008 Aston Martin Vantage V8 PCs, as originally manufactured, conform to: Standard Nos. 102
The petitioner also contends that the subject non-U.S certified vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
Standard No. 118
Standard No. 138
Standard No. 208
In response to NHTSA's letter dated August 7, 2014, requesting additional information, the petitioner provided supplemental information in the form of an email from Aston Martin Lagonda Limited stating that the passenger side seat weight sensor and passenger side seat module (which may need to be individually identified for each vehicle), and fixed height cushion frame are required for the vehicle. In addition, Aston Martin Langonda Limited stated that two air bag [warning] labels will need to be installed to conform the vehicle to the standard.
Standard No. 225
Standard No. 301
The petitioner also provided a copy of a letter from Aston Martin Lagonda Limited stating, “Aston Martin will provide the software configuration file to a United States Aston Martin Dealership for U.S. Specs. U.S. Specs will be required to take the vehicle to the dealership for programming. Once the vehicle has been re-programmed and diagnosed that all systems are functioning properly, the dealership will provide U.S. Specs with documentation confirming that all vehicle systems are functioning as a 2008 Aston Martin Vantage V8, United States model.”
The petitioner additionally states that a vehicle identification plate must be affixed to the vehicle near the left windshield pillar to meet the requirements of 49 CFR part 565.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2009 Mercedes-Benz G Class Long Wheelbase (LWB) (463 Chassis) multipurpose vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2009 Mercedes-Benz G Class LWB MPV) and they are capable of being readily altered to conform to the standards.
The closing date for comments on the petition is June 3, 2016.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
•
•
•
•
George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
J.K. Technologies LLC (JK) of Baltimore, Maryland (Registered Importer R-90-006) has petitioned NHTSA to decide whether nonconforming 2009 Mercedes-Benz G Class LWB MPVs are eligible for importation into the United States. The vehicles which JK believes are substantially similar are MY 2009 Mercedes-Benz G Class LWB MPVs sold in the United States and certified by their manufacturer as conforming to all applicable FMVSS.
The petitioner claims that it compared non-U.S. certified MY 2009 Mercedes-Benz G Class LWB MPVs to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.
JK submitted information with its petition intended to demonstrate that non-U.S. certified MY 2009 Mercedes-Benz G Class LWB MPVs, as originally manufactured, conform to many applicable FMVSS in the same manner as their U.S.-certified counterparts, or are capable of being readily altered to conform to those standards.
Specifically, the petitioner claims that the non U.S.-certified MY 2009 Mercedes-Benz G Class LWB MPVs, as originally manufactured, conform to: Standard Nos. 102
The petitioner also contends that the subject non-U.S certified vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
No. 114
Standard No. 208
Standard No. 225
Standard No. 301
The petitioner also states that a vehicle identification plate must be affixed to the vehicle near the left windshield pillar to meet the requirements of 49 CFR part 565.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Release.
Written comments should be received on or before July 5, 2016 to be assured of consideration.
Direct all written comments and requests for further information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street A4-A, Parkersburg, WV 26106-1328, or
Requests for additional information or copies of the form(s) and instructions should be directed to Ron Lewis; 200 Third Street Room 515, Parkersburg, WV 26106-1328, or
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions of the Life Safety Code. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
This regulation is effective July 5, 2016.
The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 5, 2016.
Kristin Shifflett, (410) 786-4133. Danielle Shearer, (410) 786-6617.
The word “space” takes its meaning from the context in which it is used as it is a definable area, such as a room, toilet room, storage room, assembly room, corridor, or lobby.
For a sprinkler system to be considered supervised as required by NFPA 101, the supervision must be electrical as contrasted with supervision via chaining and locking of valves in the open position as permitted for supervision by NFPA 13. Supervision in accordance with NFPA 101 involves more than valve monitoring as any condition that would impair satisfactory operation of the sprinkler system must provide a supervisory signal.
The Life Safety Code (LSC) is a compilation of fire safety requirements for new and existing buildings, and is updated and published every 3 years by the National Fire Protection Association (NFPA), a private, nonprofit organization dedicated to reducing loss of life due to fire. The LSC regulations adopted by Centers for Medicare & Medicaid Services (CMS) apply to hospitals, long-term care facilities (LTC), critical access hospitals (CAHs), ambulatory surgical centers (ASC), intermediate care facilities for individuals with intellectual disabilities (ICF-IIDs), hospice inpatient care facilities, programs for all inclusive care for the elderly (PACE), and religious non-medical health care institutions (RNHCIs). The Medicare and Medicaid regulations have historically incorporated these requirements by reference, along with Secretarial waiver authority. The statutory basis for incorporating NFPA's LSC into the regulations we apply to Medicare and, as applicable, Medicaid providers and suppliers is the Secretary of the Department of Health and Human Services (the Secretary's) authority to stipulate health and safety regulations for each type of Medicare and (if applicable) Medicaid-participating facility, as well as the Secretary's general rulemaking authority, set out at sections 1102 and 1871 of the Social Security Act (the Act).
In our regulations, issued pursuant to the Act, we have stated that we believe CMS has the authority to grant waivers of some provisions of the LSC when necessary; for instance, to hospitals under section 1861(e)(9) of the Act, and to LTC facilities at sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Act. Under our current regulations, the Secretary may waive specific provisions of the LSC for any type of facility, if application of our rules would result in unreasonable hardship for the facility, and if the health and safety of its patients would not be compromised by such waiver.
We do not consider it always necessary for a facility to be cited for a
In addition, the Secretary may accept a state's fire and safety code instead of the LSC if CMS determines that the protections of the state's fire and safety code are equivalent to, or more stringent than, the protections offered by the LSC. Further, the NFPA's Fire Safety Evaluation System (FSES), an equivalency system, provides alternatives to meeting various provisions of the LSC, thereby achieving the same level of fire protection as the LSC. These flexibilities mitigate the potential unnecessary burdens of applying the requirements of the LSC to all affected health care facilities.
On January 10, 2003, we published a final rule in the
In 2002, the Centers for Disease Control and Prevention (CDC) published on its Web site (
The September 2006 final rule also required that LTC facilities, at a minimum, install battery-powered single station smoke alarms in resident rooms and common areas if their buildings were not fully sprinklered, or if the building did not have system-based smoke detectors. A Government Accountability Office (GAO) report entitled “Nursing Home Fire Safety: Recent Fires Highlight Weaknesses in Federal Standards and Oversights” GAO-04-660, July 16, 2004 (
On August 13, 2008, we published a final rule (73 FR 47075) to require all LTC facilities to install automatic sprinkler systems throughout their buildings in accordance with the technical provisions of the 1999 edition of NFPA 13,
On May 12, 2014 CMS also published a final rule, “Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction” (79 FR 27106) that allows CMS to grant very limited extensions of the due date for a facility that is building a replacement facility or undergoing major modifications to unsprinklered living areas.
On October 24, 2011, we published a proposed rule (76 FR 65891), to reform hospital and critical access hospital conditions of participation. Many of the public comments received during the comment period strongly encouraged CMS to adopt the 2012 edition of the LSC. The commenters stated that the 2012 edition of the LSC would clarify several issues and would be beneficial to facilities.
On April 16, 2014, we published a proposed rule (79 FR 21552), “Fire Safety Requirements for Certain Health Care Facilities” that would amend the fire safety standards. We proposed the adoption of the 2012 edition of the NFPA LSC and the elimination of references to earlier editions of the LSC.
CMS must emphasize that the LSC is not an accessibility code, and compliance with the LSC does not ensure compliance with the requirements of the Americans with Disabilities Act (ADA). State and local government programs and services, including health care facilities, are required to comply with Title II of the ADA. Private entities that operate public accommodations such as nursing homes, hospitals, and social service center establishments are required to comply with Title III of the ADA. The same accessibility standards apply regardless of whether health care facilities are covered under Title II or
The 2012 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible. The term “Patient(s)” will be globally used throughout this document, and refers to patient, clients, residents and all other terms used to describe the type of individuals cared for in each provider type.
The use of earlier editions of the code can become problematic due to advances in safety and technology, and changes made to each edition of the code. Newer buildings are typically built to comply with the newer versions of the LSC because state and local jurisdictions, as well as non-CMS-approved accreditation programs, often adopt and enforce newer versions of the code as they become available. Therefore, a health care facility that is constructed or renovated in 2015 would likely be required by its state and local authorities to comply with a more recent edition of the LSC, while also being required to comply with the 2000 edition of the LSC in order to meet the Medicare and applicable Medicaid regulatory requirements. Requiring compliance with two different editions of the LSC at the same time can create unnecessary conflicts, duplications, and inconsistencies that increase construction and compliance costs without any fire safety or patient care benefits. For example, the 2000 edition of the LSC limits ABHRs to gel form, whereas the 2012 edition of the LSC expands to allow aerosol and gel ABHRs. Limiting the choice of ABHRs creates barriers to improved hand hygiene, which has been shown to reduce the number of health care associated infections. We believe that adopting the 2012 LSC would simplify and modernize the construction and renovation process for affected health care providers and suppliers, reduce compliance-related burdens, and allow for more resources to be used for patient care.
The 2012 edition of the LSC contains a new chapter,—“Building Rehabilitation.” This new chapter allows for the application of the requirements for new construction versus the requirements for existing construction to vary based on the type and extent of rehabilitation work being done to a given building. This chapter sets out different types of building rehabilitation work (that is, repair, renovation, modification, reconstruction, change of use, change of occupancy and addition) to which different standards apply.
Buildings that have not received, all pre-construction governmental approvals before the rule's effective date, or those buildings that begin construction after the effective date of this regulation, will be required to meet the New Occupancy chapters of the 2012 edition of the LSC. Buildings constructed before the effective date of this regulation will be required to meet the Existing Occupancy chapters of the 2012 edition of the LSC. Any changes made to buildings will be required to comply with Chapter 43—Building Rehabilitation, which depending on the changes being made, could require compliance with the new or existing occupancy chapters. In any instances where mandatory LSC references do not include existing chapters, such as Chapter 43—Building Rehabilitation, existing occupancies must ensure buildings and equipment are in compliance with provisions previously adopted by CMS at the time they were constructed or installed.
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; and 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.
(1) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011;
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(i) TIA 12-2 to NFPA 99, issued August 11, 2011.
(ii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(iv) TIA 12-5 to NFPA 99, issued August 1, 2013.
(v) TIA 12-6 to NFPA 99, issued March 3, 2014.
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 following are key provisions that appear in the 2012 edition of the LSC for Chapter 18, “New Health Care Occupancies,” and Chapter 19, “Existing Health Care Occupancies.” We have provided the LSC citation and a description of the 2012 requirement at the beginning of each section discussed.
The 2012 edition of the LSC classifies a “Health Care Occupancy” as a facility having 4 or more patients on an inpatient basis. We proposed that the LSC exception for health care occupancy facilities with fewer than four occupants/patients would be inapplicable to the Medicare and Medicaid facilities; all health care occupancies that provide care to one or more patients would be required to comply with the relevant requirements of the 2012 edition of the LSC.
This provision requires noncontinuous projections to be no more than 6 inches from the corridor wall. In addition to following the requirements of the LSC, health care facilities must comply with the requirements of the ADA, including the requirements for protruding objects. The 2010 Standards for Accessible Design (2010 Standards) generally limit the protrusion of wall-mounted objects into corridors to no more than 4 inches from the wall when the object's leading edge is located more than 27 inches, but not more than 80 inches, above the floor. See Sections 204.1 and 307 of the 2010 Standards, available at
Although the LSC allows 6-inch projections, under the ADA, objects mounted above 27 inches and no more than 80 inches high can only protrude a maximum of 4 inches into the corridor beyond a detectable surface mounted less than 27 inches above the floor (except for certain handrails which may protrude up to 4
This new provision requires that containers used solely for recycling clean waste be limited to a maximum capacity of 96 gallons. If the recycling containers are located in a protected hazardous area, container size will not be limited.
A roller latch is a type of door latching mechanism to keep a door closed. The 2012 edition of the LSC requires corridor doors to be provided with a means for keeping the door closed that is acceptable to the authority having jurisdiction. The LSC permits roller latches capable of keeping the door fully closed if a force of 5 pounds is applied at the latch edge or roller latches in fully sprinklered buildings. However, we proposed not to adopt these standards from the 2012 LSC. Through fire investigations, roller latches have proven to be an unreliable door latching mechanism requiring extensive maintenance to operate properly. Many roller latches in fire situations failed to provide adequate protection to residents in their rooms during an emergency. Roller latches will be prohibited in existing and new Health Care Occupancies for corridor doors and doors to rooms containing flammable or combustible materials. These doors will be required to have positive latching devices instead.
This provision requires buildings over 75′ (generally greater than 7 or 8 stories) in height to have automatic sprinkler systems installed throughout the building. The 2012 LSC allows 12 years from when the authority having jurisdiction (which in this case is CMS) officially adopts the 2012 edition of the LSC for existing facilities to comply with the sprinkler system installation requirement. Therefore, those facilities that are not already required to do so will have 12 years following publication of this final rule, which adopts the 2012 LSC, to install sprinklers in high-rise buildings.
Where the needs of patients require specialized protective measures for their safety, door-locking arrangements are permitted by this section. For example, locked psychiatric facilities are designed such that the entire facility is secure and obstructs patients and others from improperly entering and exiting. This provision allows interior doors to be locked, subject to the following requirements: (1) All staff must have keys; (2) smoke detection systems must be in place; (3) the facility must be fully sprinklered; (4) the locks are electrical locks that will release upon loss of power to the device; and (5) the locks release by independent activation of the smoke detection system and the water flow in the automatic sprinkler system.
This provision explicitly allows aerosol dispensers, in addition to gel hand rub dispensers. The aerosol dispensers are subject to limitations on size, quantity, and location, just as gel dispensers are limited. Automatic dispensers are also now permitted in health care facilities, provided that the following requirements are met: (1) They do not release contents unless they are activated; (2) the activation occurs only when an object is within 4 inches of the sensing device; (3) any object placed in the activation zone and left in place must not cause more than one activation; (4) the dispenser must not dispense more than the amount required for hand hygiene consistent with the label instructions; (5) the dispenser is designed, constructed and operated in a way to minimize accidental or malicious dispensing; and (6) all dispensers are tested in accordance with the manufacturer's care and use instructions each time a new refill is installed. The provision further defines prior language regarding “above or adjacent to an ignition source” as being “within 1 inch” of the ignition source.
This provision is related to sprinkler system requirements and requires the evacuation of a building or the instituting of an approved fire watch when a sprinkler system is out of service for more than 10 hours in a 24-hour period until the system has been returned to service. We proposed not to adopt this requirement. In its place, we proposed that a health care occupancy must evacuate a building or institute an approved fire watch when a sprinkler system is out of service for more than 4 hours. Based on comments received from the industry, we are withdrawing our proposal and adopting the requirement as specified by NFPA for an evacuation of a building or the instituting of an approved fire watch when a sprinkler system is out of service for more than 10 hours in a 24-hour period until the system has been returned to service.
This provision requires that anesthetizing locations be protected in accordance with the 2012 edition of NFPA 99, Health Care Facilities Code. Separate from the requirements of the NFPA 99, we proposed that dedicated supply and exhaust systems for windowless anesthetizing locations must be arranged to automatically vent smoke and products of combustion to prevent the circulation of smoke originating from within and outside the operating rooms.
This provision allows for wheeled equipment that is in use, medical emergency equipment not in use, and patient lift and transportation equipment be permitted to be kept in the corridors for more timely patient care. This provision also allows facilities to place fixed furniture in the corridors, although the placement of furniture or equipment must not obstruct accessible routes required by the ADA. See section 403.5 of the 2010 Standards.
Cooking facilities are allowed in a smoke compartment where food is prepared for 30 individuals or fewer (by bed count). The cooking facility is permitted to be open to the corridor, provided that the following conditions are met:
• The area being served is limited to 30 beds or less.
• The area is separated from other portions of the facility by a smoke barrier.
• The range hood and stovetop meet certain standards—
++ A switch must be located in the area that is used to deactivate the cook top or range whenever the kitchen is not under staff supervision.
++ The switch also has a timer, not exceeding 120-minute capacity that automatically shuts off after time runs out.
• Two smoke detectors must be located no closer than 20 feet and not further than 25 feet from the cooktop or range.
This provision allows combustible decor in any health care occupancy as long as the décor is flame-retardant or treated with approved fire-retardant coating that is listed and labeled, and meet fire test standards. Additionally, decor may not exceed—(1) 20 percent of the wall, ceiling and doors, in any room that is not protected by an approved automatic sprinkler system; (2) 30 percent of the wall, ceiling and doors, in any room (no maximum capacity) that is not protected by an approved, supervised automatic sprinkler system; and (3) 50 percent of the wall, ceiling and doors, in any room with a capacity of 4 people (the actual number of occupants in the room may be less than its capacity) that is not protected by an approved, supervised automatic sprinkler system.
This provision allows direct-vent gas fireplaces in smoke compartments without the 1 hour fire wall rating. Fireplaces must not be located inside of any patient sleeping room. Solid fuel-burning fireplaces are permitted and can be used only in areas other than patient sleeping rooms, and must be separated from sleeping rooms by construction of no less than a 1 hour fire resistance wall rating.
Separate from the requirements of the LSC, we proposed that every health care occupancy patient sleeping room must have an outside window or outside door with an allowable sill height not to exceed 36 inches above the floor with certain exceptions, as follows:
• Newborn nurseries and rooms intended for occupancy for less than 24 hours have no sill height requirements.
• Windows in atrium walls shall be considered outside windows for the purposes of this requirement.
• The window sill height in special nursing care areas shall not exceed 60 inches above the floor.
The following are key provisions in the 2012 edition of the LSC from Chapter 20, “New Ambulatory Health Care Occupancies” and Chapter 21, “Existing Ambulatory Health Care Occupancies.” We have provided the LSC citation and a description of the requirement at the beginning of each section discussed.
The 2012 edition of the LSC defines an “Ambulatory Health Care Occupancy” as a facility capable of treating 4 or more patients simultaneously on an outpatient basis. CMS regulations at 42 CFR 416.44 require that all ASCs meet the provisions applicable to Ambulatory Health Care Occupancy, regardless of the number of patients served. We believe that hospital outpatient surgical departments are comparable to ASCs and thus should also be required to meet the provisions applicable to Ambulatory Health Care Occupancy Chapters, regardless of the number of patients served.
This provision requires all doors to hazardous areas be self-closing or close automatically.
This provision explicitly allows aerosol dispensers, in addition to gel hand rub dispensers. The aerosol dispensers are subject to limitations on size, quantity, and location, just as gel dispensers are limited. Automatic dispensers are also now permitted in ambulatory care facilities, provided, among other things, that—(1) they do not release contents unless they are activated; (2) the activation occurs only when an object is within 4 inches of the sensing device; (3) any object placed in the activation zone and left in place must not cause more than one activation; (4) the dispenser must not dispense more than the amount required for hand hygiene consistent with the label instructions; (5) the dispenser is designed, constructed and operated in a way to minimize accidental or malicious dispensing; (6) all dispensers are tested in accordance with the manufacturer's care and use instructions each time a new refill is installed. The provision further defines prior language regarding “above or adjacent to an ignition source” as being “within 1 inch” of the ignition source.
This provision is related to sprinkler system requirements and requires the evacuation of a building or the instituting of an approved fire watch when a sprinkler system is out of service for more than 10 hours in a 24-hour period until the system has been returned to service. We proposed to replace this requirement with a separate requirement for evacuation or a fire watch when a sprinkler system is out of service for more than 4 hours. Based on comments received from the industry, we are withdrawing our proposal and adopting the requirement as specified by NFPA for an evacuation of a building or the instituting of an approved fire watch when a sprinkler system is out of service for more than 10 hours in a 24-hour period until the system has been returned to service.
This provision requires that anesthetizing locations be protected in accordance with the 2012 edition of NFPA 99, Health Care Facilities Code. The 2012 edition of NFPA 99 does not require a smoke control ventilation system in anesthetizing locations. We proposed a requirement, separate from the LSC and NFPA 99, to require air supply and exhaust systems for windowless anesthetizing locations that is arranged to automatically vent smoke and products of combustion to prevent the circulation of smoke originating from within and outside the operating room.
Both the 2000 and 2012 editions of the LSC classify “board and care” as a facility “used for lodging or boarding of 4 or more patients not related to the owners or operators by blood or marriage, for the purpose of providing personal care services.” We proposed that the LSC requirements would apply to a facility regardless of the number of patients served. We note that the only CMS-regulated facilities that would be subject to these provisions would be intermediate care facilities for individuals with intellectual disabilities (ICF-IIDs), which are regulated under 42 CFR part 483, subpart I.
The following are key provisions that appear in the 2012 edition of the LSC for Chapter 32, “New Residential Board and Care Occupancies” and Chapter 33, “Existing Residential Board and Care Occupancies.” We are providing the LSC citation and a description of the requirement at the beginning of each section discussed.
This revised provision has been expanded to require that sprinkler systems be installed in all habitable areas, closets, roofed porches, balconies and decks of new occupancies.
This new provision requires attics of new and existing facilities to be sprinklered. For both new and existing board and care facilities, if the attic is used for living purposes, storage, or housing of fuel fired equipment, it must be protected with an automatic approved sprinkler system. If the attic is used for other purposes or is not used, then it must meet one of the following requirements: (1) Have a heat detection system that activates the building fire alarm system; (2) have automatic sprinklers; (3) be of noncombustible or limited-combustible construction; or (4) be constructed of fire-retardant-treated-wood.
This provision will only affect newly constructed facilities. Approved smoke alarms are required to be installed inside every sleeping room, outside every sleeping area, in the immediate vicinity of the bedrooms, and on all levels within a resident unit.
This provision is for existing facilities with impractical evacuation capabilities. All hazardous areas must be separated from other parts of the building by smoke partitions.
We proposed to retain our existing authority to waive provisions of the LSC under certain circumstances, further reducing the exposure to additional cost and burden for facilities with unique situations. A waiver may be granted for a specific LSC requirement if we determine that—(1) the waiver would not adversely affect patient/staff health and safety; and (2) it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. In cases where a provider or supplier has been cited for a LSC deficiency, the provider or supplier may request a waiver recommendation from its State Survey Agency or Accrediting Organization (AO) with a CMS-approved Medicare and applicable Medicaid accreditation program. The State Survey Agency or AO reviews the request and makes a recommendation to the appropriate CMS Regional Office. The CMS Regional Office will review the waiver request and the recommendation and make a final decision. CMS will not grant a waiver if patient health and safety is compromised.
The LSC recognizes alternative systems, methods, or devices approved as equivalent by the authority having jurisdiction (AHJ) as being in compliance with the LSC. CMS, as the AHJ for certification, will determine equivalency through the waiver approval process.
In addition to the proposed waiver option, a state may request that its state fire safety requirements, imposed by state law, be used in lieu of the 2012 edition of the LSC. The state must submit the request to the appropriate CMS Regional Office, and the Regional Office will forward the request to CMS central office for final determination.
We retain our authority to apply the Fire Safety Evaluation System (FSES) option within the LSC as an alternative approach to meeting the requirements of the LSC. This includes the determination of how the FSES will be applied to each occupancy and which edition of the FSES is most appropriate to use.
The 2012 edition of the NFPA 99, “Health Care Facilities Code,” addresses requirements for both health care occupancies and ambulatory care occupancies, and serves as a resource for those who are responsible for protecting health care facilities from fire and associated hazards. The purpose of this Code is to provide minimum requirements for the installation, inspection, testing, maintenance, performance, and safe practices for health care facility materials, equipment and appliances. This Code is a compilation of documents that have been developed over a 40-year period by NFPA, and is intended to be used by those persons involved in the design, construction, inspection, and operation of health care facilities, and in the design, manufacture, and testing of appliances and equipment used in patient care areas of health care facilities. It provides information on subjects, for example, medical gas and vacuum systems, electrical systems, electrical equipment, and gas equipment. The NFPA 99 applies specific requirements in accordance with the results of a risk-based assessment methodology. A risk-based approach allows for the application of requirements based upon the types of treatment and services being provided to patients or residents rather than the type of facility in which they are being performed. In order to ensure the minimum level of protection afforded by NFPA 99 is applicable to all patient and resident care areas within a health care facility, CMS proposed the adoption of the 2012 edition of NFPA 99, with the exception of chapters 7—Information Technology and Communications Systems for Health Care Facilities; 8—Plumbing; 12—Emergency Management; and 13—Security Management. In the following section, we describe the key provisions within the NFPA 99.
The first three chapters of the NFPA 99 address the administration of the NFPA 99, the referenced publications and definitions.
Chapter 4 provides guidance on how to apply NFPA 99 requirements to health care facilities based upon “categories” determined when using a risk-based methodology.
There are four categories utilized in the risk assessment methodology, depending on the types of treatment and services being provided to patients or residents. Section 4.1.1 of NFPA 99
Section 4.2 requires that each facility that is a health care or ambulatory occupancy define its risk assessment methodology, implement the methodology, and document the results. CMS does not require the submission of risk assessment methods to CMS. However, CMS, will confirm that facilities are using risk assessment methodologies when conducting onsite surveys. We did not propose to require the use of any particular risk assessment procedure. However, if future situations indicate the need to define a particular risk assessment procedure, we would pursue that through a separate notice and comment rulemaking.
The hazards addressed in Chapter 5 include the ability of oxygen and nitrous oxide to exacerbate fires, safety concerns from the storage and use of pressurized gas, and the reliance upon medical gas and vacuum systems for patient care. Chapter 5 does not mandate the installation of any systems; rather, if they are installed or are required to be installed, the systems will be required to comply with NFPA 99. Chapter 5 covers the performance, maintenance, installation, and testing of the following:
• Nonflammable medical gas systems with operating pressure below a gauge pressure of 300 psi;
• Vacuum systems in health care facilities;
• Waste anesthetic gas disposal systems (WAGD); and
• Manufactured assemblies that are intended for connection to the medical gas, vacuum, or WAGD systems.
The hazards addressed in Chapter 6 are related to the electrical power distribution systems in health care facilities, and address issues such as electrical shock, power continuity, fire, electrocution, and explosions that might be caused by faults in the electrical system.
Chapter 6 covers the performance, maintenance, and testing of the electrical systems in health care facilities.
Chapter 9 requires HVAC systems serving spaces- a portion of the health care facility designated by the governing body that serves a specific purpose or providing health care functions to be in accordance with the American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 170- Ventilation of Health Care Facilities (2008 edition) (
Chapter 9 does not apply to existing HVAC systems, but applies to the construction of new health care facilities, and the altered, renovated, or modernized portions of existing systems or individual components. Chapter 9 ensures minimum levels of heating, ventilation, and air conditioning performance in patient and resident care areas. Some of the issues discussed in Chapter 9 are:
• HVAC system energy conservation.
• Commissioning.
• Piping.
• Ductwork.
• Acoustics.
• Requirements for the ventilation of medical gas storage and trans-filling areas.
• Waste anesthetic gases.
• Plumes from medical procedures.
• Emergency power system rooms.
• Ventilation during construction.
Chapter 10 covers the performance, maintenance, and testing of electrical equipment in health care facilities. Much of this chapter applies to requirements for portable electrical equipment in health care facilities, but there are also requirements for fixed-equipment and information on administrative issues.
The hazards addressed in Chapter 11 relate to general fire, explosions, and mechanical issues associated with gas equipment, including compressed gas cylinders.
Chapter 14 addresses the hazards associated with hyperbaric facilities in health care facilities, including electrical, explosive, implosive, and fire hazards. Chapter 14 sets forth minimum safeguards for the protection of patients and personnel administering hyperbaric therapy and procedures. Chapter 14 contains requirements for hyperbaric chamber manufacturers, hyperbaric facility designers, and personnel operating hyperbaric facilities. It also contains requirements related to construction of the hyperbaric chamber itself and the equipment used for supporting the hyperbaric chamber, as well as administration and maintenance. Many requirements in this chapter are applicable only to new construction and new facilities.
Chapter 15 covers the performance, maintenance, and testing of fire protection equipment in health care facilities. Issues addressed in this chapter range from the use of flammable liquids in an operating room to special sprinkler protection. These fire protection requirements are independent of the risk-based approach, as they are applicable to all patient care areas in both new and existing facilities.
Chapter 15 has several sections taken directly from the NFPA 101, including requirements for the following:
• Construction and compartmentalization of health care facilities.
• Laboratories.
• Utilities.
• Heating, ventilation and air conditioning systems.
• Elevators.
• Escalators.
• Conveyors.
• Rubbish Chutes.
• Incinerators.
• Laundry Chutes.
• Fire detection, alarm and communication systems.
• Automatic sprinklers and other extinguishing equipment.
• Compact storage including mobile storage and maintenance.
• Testing of water based fire protection systems.
These sections have requirements for inspection, testing and maintenance which apply to all facilities, as well as specific requirements for existing systems and equipment that also apply to all facilities.
This section details the specific regulatory changes for each affected
In § 403.744, we proposed to maintain most of the current provisions for Religious Nonmedical Health Care Institutions (RNHCI) published in the
In addition, we proposed to—
• Retain the requirements at § 403.744(a)(1)(ii) related to the prohibition of roller latches in health care facilities. We also proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2”.
• Modify the requirements specific to ABHRs, since most of the requirements in our regulation are now included in the 2012 edition of the LSC. Therefore, we proposed to remove the requirements at § 403.744(a)(4)(i), (ii), (iv) and (v).
• Retain the requirements at § 403.744(a)(4)(iii) related to protection against inappropriate access, and redesignate it at § 403.744(a)(4).
• Add a new requirement at § 403.744(a)(5) that required facilities with sprinkler systems that were out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the LSC.
• Add a new requirement at § 403.744(a)(6) to require window sills must not exceed 36 inches above the floor.
• Retain the requirement at § 403.744(b) related to the Secretary's waiver authority and state imposed codes. We did not propose to make any changes to this section.
• Remove the requirements at § 403.744(c) related to the phase-in period for compliance with emergency lighting. In the 2003 final rule, we allowed facilities until March 13, 2006, to upgrade their emergency lighting equipment. This phase-in period has now expired and is no longer a necessary regulatory provision.
• Add a new Condition of Participation at § 403.745 requiring RNHCIs to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to RNHCIs.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 416.44, we proposed that all ASCs meet the provisions applicable to Ambulatory Health Care Centers in the 2012 edition of the LSC, except as detailed in section I of this preamble, regardless of the number of patients the facility serves. We also proposed to retain the provision at § 416.44(b)(2) and (b)(3) related to the Secretary's waiver authority and state imposed codes. We did not propose to make any changes to these provisions.
In addition, we proposed to—
• Remove the requirements at § 416.44(b)(4) related to the phase-in period for compliance with emergency lighting. This phase-in period has now expired and this phase-in provision is no longer a necessary regulatory provision.
• Modify the requirements specific to ABHRs since most of the requirements are now included in the 2012 edition of the LSC. Specifically, we proposed to remove the requirements at § 416.44(b)(5)(i), (ii), (iv), (A) through (G), and (v).
• Retain the requirements at § 416.44(b)(5)(iii) related to protection against inappropriate access and redesignate it at § 416.44(b)(4).
• Add a new requirement at § 416.44(b)(5) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new requirement at § 416.44(b)(6) to require facilities with windowless anesthetizing locations to have an air supply and exhaust system that automatically vents smoke and products of combustion, prevents recirculation of smoke originating within the operating room, and prevents the circulation of smoke entering the system intake.
• Add a new paragraph at § 416.44(c) requiring ASCs to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to ASCs.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 418.110, we proposed that all inpatient hospice facilities meet the provisions applicable to health care occupancies in the 2012 edition of the LSC, with the exceptions discussed in section I of this preamble, regardless of the number of patients they serve. We note that this is not a change in requirements, but merely a clarification that, for LSC purposes, an inpatient hospice facility is considered a health care occupancy. The LSC does not apply to hospice care that is provided in a patient's home.
In addition, we proposed to—
• Retain the requirements at § 418.110(d)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the provision at § 418.110(d)(2) and (3) related to the Secretary's waiver authority and state imposed codes. We did not propose any changes to these provisions.
• Modify the requirements specific to ABHRs because most of the requirements are now included in the 2012 edition of the LSC. We proposed to remove the requirements at § 418.110(d)(4)(i), (ii) and (iv). We proposed to retain the requirements at § 418.110(d)(4)(iii) related to protection against inappropriate access and redesignate this requirement at § 418.110(d)(4).
• Add a new requirement at § 418.110(d)(5) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new requirement at § 418.110(d)(6) to require that window sills must not exceed 36 inches.
• Add a new paragraph at § 418.110(e) requiring hospices to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 not would apply to hospices.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 460.72, we proposed to retain most of the provisions of the existing final regulation for Programs of All-Inclusive Care for the Elderly (PACE) published in the
In addition, we proposed to—
• Retain the requirements at § 460.72(b)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the provision at § 460.72(b)(2)(i) and (ii) related to the Secretary's waiver authority and state imposed codes. We did not propose to make any changes to these provisions.
• Remove the requirement at § 460.72(b)(3) related to the phase-in period for compliance with emergency lighting. This phase-in period has now expired and is no longer a necessary regulatory provision.
• Remove the requirements at § 460.72(b)(4) related to the phase-in period for the prohibition of roller latches in health care facilities. This phase-in period has now ended and is no longer a necessary regulatory provision.
• Modify the requirements specific to ABHRs because most of the requirements are now located in the 2012 edition of the LSC. We proposed to remove the requirements at § 460.72(b)(5)(i), (ii), (iv) and (v). We proposed to retain the requirements at § 460.72(b)(5)(iii) related to protection against inappropriate access, and redesignate it to § 460.72(b)(3). We proposed to add a new requirement at § 460.72(b)(4) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new paragraph at § 460.72(d) to require PACE centers to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to PACEs.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 482.41, we proposed that the hospitals meet the health care occupancy provisions of the 2012 edition of the LSC, regardless of the number of patients the hospital serves. There can be multiple occupancy classifications within a single hospital. Therefore, multiple chapters of the code may be applied to a single hospital in accordance with the Multiple Occupancies provisions in 18.1.3 and 19.1.3. We also proposed that hospital outpatient surgical departments are comparable to ASCs and thus should be required to meet the provisions applicable to Ambulatory Health Care Occupancy chapters, regardless of the number of patients served.
In addition, we proposed to—
• Retain most of the provisions from the existing final regulation for hospitals published in the
• Retain the requirements at § 482.41(b)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the provision at § 482.41(b)(2) and (3) related to the Secretary's waiver authority and state imposed codes. We did not propose to make any changes to these provisions.
• Remove the requirements at § 482.41(b)(4) related to the phase-in period for compliance with emergency lighting. This phase-in period has now ended, and is no longer a necessary regulatory provision.
• Remove the requirements at § 482.41(b)(5) related to the phase-in period of the prohibition on roller latches in health care facilities. This phase-in period has now expired and is no longer a necessary regulatory provision.
• Retain the requirements at § 482.41(b)(6) through (b)(8), and redesignate them at § 482.41(b)(4) through (b)(6), without changes.
• Modify the requirements specific to ABHRs since most of the requirements are now located in the 2012 edition of the LSC. We proposed to remove the requirements at § 482.41(b)(9)(i), (ii), (iv) and (v). We proposed to retain the requirement at § 482.41(b)(9)(iii) related to protection against inappropriate access and redesignate it at § 482.41(b)(7).
• Add a new requirement at § 482.41(b)(8) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new requirement at § 482.41(b)(9) that to require facilities with windowless anesthetizing locations to have an air supply and exhaust system that automatically vents smoke and products of combustion, prevents recirculation of smoke originating within the surgical suite, and prevents the circulation of smoke entering the system intake.
• Add a new requirement at § 482.41(b)(10) to require a minimum 36 inch window sill, with certain exceptions for newborn nurseries, rooms intended for occupancy for less than 24 hours, and special nursing care areas.
• Add a new paragraph at § 482.41(c) requiring hospitals to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to hospitals.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 483.70, we proposed to retain most of the provisions of the existing final regulation for LTC facilities published in the
In addition, we proposed to—
• Retain the requirements at § 483.70(a)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the provision at § 483.70(a)(2) and (3) related to the Secretary's waiver authority and state imposed codes. We did not propose to make any changes to these provisions.
• Remove the requirements at § 483.70(a)(4) related to the phase-in period for compliance with emergency lighting. This phase-in period has now expired and is no longer a necessary regulatory provision.
• Remove the requirements at § 483.70(a)(5) related to the phase-in period for the prohibition of roller latches in health care facilities. This phase-in period has now ended and is no longer a necessary regulatory provision.
• Modify the requirements specific to ABHRs since most of the requirements are now included in the 2012 edition of the LSC. Specifically, we proposed to remove the requirements at § 483.70(a)(6)(i), (ii), (iv) and (v). We proposed to retain the requirement at § 483.70(a)(6)(iii) related to protection against inappropriate access, and redesignate it at § 483.70(a)(4).
• Retain the requirements at § 483.70(a)(7)(i), (ii), (iii), (A) and (B) related to installation, inspection, testing and maintenance of battery operated single station smoke alarms, without changes. We proposed to redesignate these requirements at § 483.70(a)(5) (i), (ii), (iii) (A) and (B).
• Retain the requirements at § 483.70(a)(8)(i) and (ii) related to the installation of supervised automatic sprinklers and the testing, inspection and maintenance of the sprinkler system. We proposed to redesignate these requirements as § 483.70(a)(6)(i) and (ii), without changes.
• Add a new requirement at § 483.70(a)(7) to require a minimum 36 inch window sill.
• Add a new paragraph at § 483.70(b) to require LTC facilities to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to LTC facilities.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 483.470, we proposed to retain most of the provisions of the existing regulation for ICFs/IID. In accordance with the regulatory requirements at § 483.470 (j)(2), ICFs/IID will continue to be permitted to meet either the Residential Board and Care Occupancies chapter or the Health Care Occupancy chapter of the LSC, as appropriate, in accordance with the determination of the State survey agency, regardless of the number of patients the facility serves.
In addition, we proposed to—
• Not adopt the provisions at Chapters 32.3.2.11.2 and 33.3.2.11.2, related to “lockups.” Lock-ups, as described in the LSC, are not appropriate under any circumstances for board and care facilities.
• Retain the requirements at § 483.470(j)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the requirements at § 483.470(j)(2), (3), and (4).
• Remove the requirements at § 483.470(j)(5) related to the phase-in period for compliance with emergency lighting. This phase-in period has expired and is no longer a necessary regulatory provision.
• Remove § 483.470(j)(6) related to the phase-in period for the prohibition of roller latches in health care facilities. This phase-in period has now ended and is no longer a necessary regulatory provision.
• Retain the provision at § 483.470(j)(7)(A) and (B) related to the Secretary's waiver authority and state imposed codes. We proposed to redesignate these provisions at § 483.470(j)(5)(A) and (B) without change.
• Modify the requirements specific to ABHRs since most of the requirements are now included in the 2012 edition of the LSC. Specifically, we proposed to remove the requirements at § 483.470(j)(7)(ii)(A), (B), (D) and (E). We proposed to retain the requirements at § 483.470(j)(7)(ii)(C) related to protection against inappropriate access, and redesignate it at § 483.470(j)(5)(ii).
• Add a new requirement at § 483.470(j)(5)(iii) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new paragraph at § 483.470(j)(5)(iv) to require ICF-IIDs to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to ICF-IIDs.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
In § 485.623, we proposed to retain most of the provisions of the existing final regulation for Critical Access Hospitals (CAHs) published in the
In addition, we proposed to—
• Retain the requirements at § 485.623(d)(1)(ii) related to the prohibition of roller latches in health care facilities. We proposed to update the LSC chapter reference from “19.3.6.3.2 exception number 2” to “19.3.6.3.5 numbers 1 and 2 and 19.3.6.3.6 number 2.”
• Retain the requirements at § 485.623(d)(2) through (d)(4), without any changes.
• Remove the requirement at § 485.623(d)(5) related to the phase-in period for compliance with emergency lighting. This phase-in period has now expired and is no longer a necessary regulatory provision.
• Remove the requirement at § 485.623(d)(6) related to the phase-in period of the prohibition on roller latches in health care facilities. This phase-in period has also expired and is no longer a necessary regulatory provision.
• Modify the requirements specific to ABHRs since most of the requirements are now incorporated in the 2012 edition of the LSC. Specifically, we proposed to remove the requirements at § 485.623(d)(7)(i), (ii), (iv) and (v). We proposed to retain the requirement at § 485.623(d)(7)(iii) related to protection against inappropriate access and redesignate it at § 485.623(d)(5).
• Add a new requirement at § 485.623(d)(6) to require a facility with a sprinkler system that is out of service for more than 4 hours in a 24-hour period to evacuate the building or portion of the building affected by the system outage, or establish a fire watch until the system is back in service, notwithstanding the lower standard of the 2012 LSC.
• Add a new requirement at § 485.623(d)(7) to require facilities with windowless anesthetizing locations to have an air supply and exhaust system that automatically vents smoke and products of combustion, prevents recirculation of smoke originating within the surgical suite, and prevents the circulation of smoke entering the system intake.
• Add a new requirement at § 485.623(d)(8) to require a minimum 36 inch window sill, with the exception of
• Add a new paragraph at § 485.623(e) requiring CAHs to comply with the 2012 edition of the NFPA 99.
• Chapters 7, 8, 12, and 13 of the NFPA 99 would not apply to CAHs.
• Allow for waivers of these provisions under the same conditions and procedures that we currently use for waivers of applicable provisions of the LSC.
We received over 362 public comments concerning the LSC proposed rule, “Fire Safety Requirements for Certain Health Care Facilities” (79 FR 21552), which this rule is finalizing. The majority of the comments were from medical societies, hospital associations, hospitals, medical centers, LTC facilities, and advocate groups for different provider types. The remaining comments were from individual physicians, nurses, facility engineers, and private citizens. A summary of the major issues and our responses follow:
We note that only the following CMS-regulated facilities would be subject to these comments, unless otherwise specified: Hospitals, CAHs, LTC facilities, hospices, RNHCIs, and PACE facilities.
• Requiring that an operational exhaust hood for the cooking facility should not contribute to nor create an egress corridor return air plenum (an air pressure differential between different parts of a building);
• Requiring that the activate/deactivate switch be hidden from view;
• Requiring that staff must be present when a range hood or stovetop is in use; and
• Requiring that cooking facilities be screened off when not in use to prevent resident access.
We note that the only CMS-regulated facilities that would be subject to these comments would be ambulatory surgical centers, which are regulated under 42 CFR part 416.
We note that the only CMS-regulated facilities that would be subject to these comments would be intermediate care facilities for individuals with intellectual disabilities (ICF-IIDs), which are regulated under 42 CFR part 483, subpart I.
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• Of the millions of surgical procedures performed each year, 0.00092 percent per year results in surgical fires;
• Surgical fires are largely preventable, and training on prevention of and prompt response to fires is much more likely to be effective for patient safety than installing and maintaining ventilation systems;
• While anesthetics used to be flammable, they are not flammable anymore, which significantly reduces the risk of fires in anesthetizing locations;
• Most anesthetizing locations have quick response sprinklers present to extinguish any fire that may occur, eliminating the need for a smoke ventilation system. Healthcare occupancies required to install sprinklers to fulfill new construction or renovation requirements would need to install quick response sprinklers through smoke compartments containing patient rooms. If an anesthetizing location is located in the same compartment as the patient sleeping rooms, then the anesthetizing location would require quick response sprinklers;
• The types of fires that occur in anesthetizing locations produce such a small amount of smoke that the smoke would not compromise the ability of staff to implement emergency interventions to extinguish a fire;
• Staff in anesthetizing locations have training in updated techniques to quickly extinguish any fire that may occur;
• Some facilities have smoke purge systems that are just as capable of smoke control as the proposed ventilation system; and
• The proposed smoke ventilation system may, under certain circumstances, create an increased risk for surgical infections in the affected anesthetizing locations.
We are adopting the provisions of this rule as proposed, except for the following changes and clarifications:
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vi) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors to corridors and to rooms containing flammable or combustible materials.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are revising the window sill requirement for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014, regardless of the number of patients served:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are removing the requirements for the installation of a dedicated air supply and exhaust system in windowless anesthetizing locations.
• We are revising the requirements for door locking mechanisms on hazardous areas.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are revising the window sill requirements for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors to corridors and to rooms containing flammable or combustible materials.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are revising the window sill requirement for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors to corridors and to rooms containing flammable or combustible materials.
• We are clarifying that all outpatient surgical departments must meet applicable provisions in Ambulatory Health Care occupancy chapter, regardless of the number of patients served.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are removing the requirement for installation of a dedicated air supply and exhaust system in windowless anesthetizing locations.
• We are revising the window sill requirement for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors leading into corridors and leading into rooms containing flammable or combustible materials.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-3 to NFPA 99, issued August 9, 2012.
(vii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(viii) TIA 12-5 to NFPA 99, issued August 1, 2013.
(ix) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors to corridors and to rooms containing flammable or combustible materials.
• We are revising the exclusion of provisions related to “Lockups.”
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are revising the window sill requirement for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
We are clarifying that our adoption of the 2012 edition of the NFPA 101 and NFPA 99, includes the following TIAs issued prior to April 16, 2014:
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(v) TIA 12-1 to NFPA 99, issued August 11, 2011.
(vi) TIA 12-2 to NFPA 99, issued August 11, 2011.
(vii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(viii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(ix) TIA 12-5 to NFPA 99, issued August 1, 2013.
(x) TIA 12-6 to NFPA 99, issued March 3, 2014.
• We are clarifying that the prohibition on roller latches applies only to doors to corridors and to rooms containing flammable or combustible materials.
• We are revising the requirements for the shutdown of a sprinkler system for an extended period of time.
• We are removing the requirement for installation of a dedicated air supply and exhaust system in windowless anesthetizing locations.
• We are revising the window sill requirement for new construction only to indicate that such sills must not be higher than 36 inches above the floor.
This final rule does not impose any new reporting, recordkeeping or third-party disclosure requirements. However, this final rule does reference the NFPA 99 that has several non-reported recordkeeping requirements for medical gas and vacuum systems, and electrical equipment. We believe that documenting maintenance and testing is a usual and customary business practice in accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) at 5 CFR 1320.3(b)(2), and it would not impose any additional information collection burden beyond that associated with the normal course of business. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
We have examined the impacts of this 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), Executive Order 13132 on Federalism
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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The overall economic impact for this rule is estimated to be $18 million in the first year of implementation, $12 million, annually, for years 2 and 3 of implementation, and $6 million, annually, for years 4-12 of implementation. We estimate that this rulemaking is not “economically significant” as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis (RIA) that, to the best of our ability, presents the costs and benefits of rulemaking.
The 2012 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible. The use of earlier editions of the code can become problematic due to advances in safety and technology and changes made to each edition of the code. Newer buildings are typically built to comply with the newer versions of the LSC because state and local jurisdictions, as well as non-CMS-approved accreditation programs, often adopt and enforce newer versions of the code as they become available. We believe that adopting the 2012 LSC would simplify and modernize the construction and renovation process for affected health care providers and suppliers, reduce compliance-related burdens, and allow for more resources to be used for patient care. Many health care facilities complete unnecessary work and incur unnecessary expense without any gain in fire safety by continuing to comply with the 2000 edition of the LSC.
The 2012 edition of the NFPA 99, “Health Care Facilities Code,” addresses requirements for both health care occupancies and ambulatory care occupancies, and serves as a resource for those who are responsible for protecting health care facilities from fire and associated hazards. The purpose of this Code is to provide minimum requirements for the installation, inspection, testing, maintenance, performance, and safe practices for health care facility materials, equipment and appliances. This Code is a compilation of documents that have been developed over a 40-year period by NFPA, and is intended to be used by those persons involved in the design, construction, inspection, and operation of health care facilities, and in the design, manufacture, and testing of appliances and equipment used in patient care areas of health care facilities. Many requirements of the LSC already cross reference the NFPA 99, and it addresses additional building safety topics that are related to important fire safety issues specific to health care facilities.
We believe that it is in the best interest of CMS to adopt the more recent 2012 edition of the NFPA 101 and the 2012 edition of the NFPA 99, in order to be up to date with all of the latest upgrades to health care facilities and safety requirements.
Section 19.4.2 of the LSC requires that all existing high-rise buildings containing health care occupancies be protected throughout by an approved, supervised automatic sprinkler system. We feel that this requirement will only affect hospitals and any other provider type located in the same building as a hospital (for example, an ASC that is located in a hospital building). This provision was added to the LSC in 2012 and we anticipate that there would be a cost associated with installing the sprinklers. Since this is a new provision for the 2012 edition of the LSC, 14 states have adopted this requirement, accounting for an estimated 142 high-rise facilities.
To develop the most accurate estimate possible for this provision, we requested data from all 50 states regarding the sprinkler status of high-rise buildings containing health care occupancies, and the average square footage needing to be sprinklered. Of the 50 states, we received some data from 30 states.
Next, we applied these percentages to the states that did not respond to our data request or that provided a limited amount of data. For example, Alabama has a total of 125 hospitals. Based on the data from states that submitted information, we know that, on average, 15.64 percent of hospitals have high-rise buildings, for an estimated 20 high-rise hospitals in Alabama. We used this same methodology to estimate the average number of high-rise hospitals in all of the states that did not respond to our data request or that provided only a limited amount of data, for a total of 179 high-rise hospitals. Of the 179 estimated high-rise hospitals in states that did not respond, we estimate there are 151 fully sprinklered, 26 partially sprinklered, and 2 non-sprinklered. We note that these numbers do not directly match because there was limited actual data available for the state of Massachusetts. The number of high-rise hospitals in Massachusetts is included in the count of states for which we have reported data. However, because we did not receive a breakdown of those high-rise hospitals by their current sprinkler status, we used the methodology described to estimate the distribution of fully sprinklered, partially sprinklered, and non-sprinklered high-rise hospitals in that state.
We combined this information with the information from the states that submitted data to develop an estimate of 515 high-rise facilities with health care occupancies throughout all 37 states and the District of Columbia that have not adopted the 2012 NFPA 101 (336 high-rise facilities in states that submitted data + 179 estimated high-rise facilities in states that did not submit data). We estimate that 376 of those high-rise facilities are fully sprinklered, 130 are partially sprinklered, and 9 are not sprinklered.
We also requested that the 50 states and the District of Columbia submit information regarding the area (measured in square feet) per partially sprinklered and non-sprinklered facility that does not currently have sprinklers. Only 8 states supplied data regarding the area to be sprinklered in partially sprinklered facilities.
We estimated that there are 9 non-sprinklered facilities nationwide, and that an average non-sprinklered facility would install sprinklers for, 127,667 square feet, for a total of 1,149,003 square feet (9 facilities × 127,667 square feet per facility). At an estimated cost of $11 per square foot to install sprinklers, we estimate that it would cost $12,639,033 for all non-sprinklered facilities to install sprinklers in their facilities. We estimate that an average non-sprinklered facility would spend $1,404,337 per facility (127,667 square feet × $11 per square foot).
Therefore, we estimate the total cost associated with the installation of sprinklers in partially sprinklered and non-sprinklered facilities to be $65,796,423 ($53,157,390 for all partially sprinklered facilities + $12,639,033 for all non-sprinklered facilities). This cost would be distributed over a phase-in period of 12 years, per the phase-in period established within the LSC, or an average yearly cost of $5.5 million.
We have removed the requirement for a fire watch or building evacuation if the sprinkler system is out of service for more than 4 hours, and have adopted the LSC requirements of a fire watch or building evacuation if the sprinkler system is out for more than 10 hours in a 24-hour period. Based on comments received from stakeholders, associations and the public, sprinkler systems are generally only out of service for 8 hours in a 24-hour period. Therefore, we do not anticipate additional costs associated with this requirement. If there is an event where the sprinkler system would be out of service for more than 10 hours in a 24-hour period, we feel that it would be considered a standard business practice to implement a fire watch or building evacuation, as the previous requirement was more stringent and required a fire watch or building evacuation after the sprinkler system is out of service for more than 4 hours.
Sections 20.3.2.1 and 21.3.2.1 of the LSC requires all doors to hazardous areas to be self-closing or automatic-closing. This requirement is only located in sections 20.3.2.1 and 21.3.2.1, which applies to Ambulatory health care. This provision was added to the LSC in 2003, and we anticipate that there would be a cost associated with installing the self-closing or automatic closing doors. Since 2003, 35 states have adopted this requirement, accounting for an estimated 3,684 ASCs. As of December 2013, there were 5,368 total Medicare and applicable Medicaid participating ASCs. The 1,684 remaining facilities would be required to upgrade their door closing mechanisms to meet this requirement. The estimated cost per door is $349, and we would assume the average facility has 3 hazardous areas that would require a replacement door closing mechanism for a total cost of $1,047 per facility. The anticipated cost is $1,763,148.
Sections 32.2.3.5.7 and 33.2.3.5.7 of the LSC requires attics of new and existing residential board and care occupancies, which, for our purposes, are ICF-IIDs to be sprinklered if the attic space is used for living purposes, including storage and fuel fired equipment. Facilities that do not use their attics for living purposes may choose to install a heat detection system in place of the sprinklers. This provision was added to the LSC in 2012. Since this is a new provision for the 2012 edition of the LSC, only 14 states have adopted this requirement, accounting for an estimated 1,750 ICF-IIDs. We are not including those 1,750 facilities in our analysis. For purposes of this analysis only, we assume that about 10 percent (637) of facilities will install a heat detection system because they do not use the attic for living purposes. As of December 2013, there were 6,374 total Medicare participating ICF-IIDs. After excluding those facilities located in states that have already adopted this requirement and those that would install a heat detection system instead of sprinklers, the 3,987 remaining facilities would be required to install sprinklers in their attics to meet this requirement. Installing sprinklers into an unfinished attic is less complicated than installing sprinklers in a finished hospital, therefore the cost per square foot would be less to install in attics than hospitals. The estimated cost per square foot to install sprinklers in an attic is $3.00, and the average estimated square footage per attic per facility is 1500 square feet, for a total of $4,500 per ICF-IID. We estimate that all ICF-IIDs would spend $17,941,500 to install sprinklers in their attic spaces. After soliciting public comment, we have decided to finalize a 3 year phase-in period, which would make the cost $5,980,500 per year over 3 years.
Facilities that do not use their attics for living purposes may choose to install a heat detection system in the attic instead of sprinklers. As stated, for the purposes of this analysis only, we assume that about 10 percent (637) of facilities will install a heat detection system because they do not use the attic for living purposes. We estimate the cost to install a heat detection system to be $1,000 per facility. The anticipated cost would be $637,000 for all affected facilities to install heat detection systems. After soliciting public comment, we have decided to finalize a 3 year phase-in period, which would make the cost $212,333 per year over 3 years.
Section 33.3.3.2.3 of the LSC requires all hazardous areas in existing residential board and care occupancies (which, under our regulations, are ICF-IIDs) with impractical evacuation capabilities to be separated from other parts of the building by a smoke partition. This provision was added to the LSC in 2012 and we anticipate there being a cost associated with installing the smoke partition. Since this is a new provision for 2012, only 14 states have adopted this requirement, accounting for 1,750 ICF-IIDs. As of December 2013, there were 6,374 total Medicare and applicable Medicaid participating
Section 33.3.3.4.6.2 of the LSC requires that, when an existing residential board and care occupancy (that is, ICF-IIDs) installs a new fire alarm system, or the existing fire alarm system is replaced, notification of emergency forces should be handled in accordance with section 9.6.4. Section 9.6.4states that notification of emergency forces should alert the municipal fire department and fire brigade (if provided) of fire or other emergency. This provision was added to the LSC in 2012, and we anticipate there being a cost associated with upgrading a new or existing fire alarm system. Since this is a new provision for 2012, only 14 states have adopted this requirement, accounting for 1,750 ICF-IIDs. As of December 2013, there were 6,374 total Medicare participating ICF-IIDs. The 4,624 remaining facilities would be required to add emergency notifications capabilities when they choose to update or install a new fire alarm system. The estimated cost per upgrade is $1,000. For purposes of this analysis only, we assume that about 8.3 percent (384) of facilities will do this in any given year, for an annual cost of $384,000 over a 12-year period.
As a result of this rule, we believe that there would be a decreased risk of premature death. A decreased risk of premature death is valuable to people and that value is symbolized by their willingness to pay for such benefits. The Department of Transportation found in a recent literature review that willingness to pay for reductions in the risk of premature death equivalent to saving one life in expectation is typically over $9 million (
As a regulatory alternative, we could have chosen not to update our fire safety provisions. We believe that this is not an acceptable alternative because many health care facilities complete unnecessary work and incur unnecessary expense without any gain in fire safety by continuing to comply with the 2000 edition of the LSC. Many states have adopted subsequent editions of the LSC. This has caused confusion for, and imposed additional burdens on, health care facilities, that must request waivers or modify designs to meet the requirements of both the state- and federally-adopted editions of the LSC. Updating the LSC would not only relieve the regulatory burden on health care providers, but also assist in ensuring the health and safety of patients and staff.
We considered an alternative phase-in period for the requirement to install sprinklers in high rise health care occupancies. The LSC allows for a 12-year phase-in period, which would begin on the day a final rule is published. We considered shortening this period in order to accelerate compliance. However, based on our recent experience with requiring LTC facilities to install sprinklers within 5 years, and the difficulties that several facilities have faced in meeting this deadline, we have learned that a shorter phase-in period is not always feasible for facilities. We also considered a longer phase-in period, but believe that extending beyond 12 years set out in the LSC may not sufficiently convey the importance of this requirement to improving patient and staff safety in these buildings.
We considered not including separate requirements for window sill heights. Although the NFPA has removed these requirements from the LSC, because the total concept approach of all health care facilities should be designed, constructed, maintained and operated to minimize the possibility of a fire emergency requiring the evacuation of occupants can be achieved without reliance on such window sill requirements, we felt that this was an important issues that still needed to be required for the safety of patients, visitors, and staff. Window sill height requirements were eliminated from the 2012 edition of the LSC. We believe that this requirement is essential to allow easier access for emergency personnel in the event of a fire or other emergency situation and it is important to quality of life and the healing process. This will, however, only be required in new facilities.
We considered not including the adoption of the NFPA 99 Health care Facilities code. However, many requirements of the LSC already cross-reference the NFPA 99, therefore we decided to adopt the NFPA 99 because it addresses additional building safety topics that are related to important fire safety issues specific to health care facilities. The requirements of NFPA 99, like those in NFPA 101, will be legally enforceable to the extent specified in this rule.
We also considered adoption of chapters 7, 8, 12, and 13 of the NFPA 99, related to information technology, plumbing, emergency management, and security management. We believe that information technology, plumbing and security management are not within the scope of the conditions of participation and conditions for coverage. In addition, emergency management topics are addressed in our December 27, 2013 proposed rule, “Medicare and Medicaid Programs: Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” (78 FR 79081).
As required by OMB Circular A-4 (available at
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, small entities include small businesses, nonprofit organizations, and government agencies. Individuals and states are not included in the definition of a small entity. For purposes of the RFA, most of the providers and suppliers that would be affected by this rule (hospitals, ASCs, and ICF-IIDs) are considered to be small entities, either by virtue of their nonprofit or government status or by having yearly revenues below industry threshold established by the Small Business Administration (for details, see the Small Business Administration's Web site at
• We estimate that the following affected facilities are expected to spend less than $3,500 in any given year on a per average facility basis; all LTC facilities, all hospices with inpatient care facilities, all PACE facilities, all RNHCIs, all existing ASCs, all existing CAHs, and all existing fully sprinklered hospitals.
• We estimate that the average affected ICF-IID will spend $5,400-$8,900 in the first year, which requires the most significant investment and, by year four, that amount drops to $3,400 per year.
• We estimate that the average affected partially sprinklered high-rise hospital and the average affected non-sprinklered high-rise hospitals will spend $36,475-$119,428 each year during the 12 year phase-in period to install sprinklers. After the installation of sprinklers, we estimate that the annual cost decreases to $2,400 per year.
• We estimate that newly constructed hospitals will spend $2,400, newly constructed CAHs will spend $2,400 and newly constructed ASCs will spend $2,400, respectively, in any given year.
The Department of Health and Human Services uses as its measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3 to 5 percent. Therefore, the Secretary proposes to certify that this rule will not have a significant impact on a substantial number of small entities, since the impact will be less than 3 percent of the revenue. The preceding economic analysis, together with the remainder of this preamble, constitutes that analysis.
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. We believe that this rule 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) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that threshold is approximately $144 million. This rule will not have an impact on the expenditures of state, local, or tribal governments in the aggregate, or on the private sector of $144 million in any one year.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed 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 rule has no Federalism implications.
This regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget.
Health insurance, Hospitals, Intergovernmental relations, Incorporation by reference, Medicare, Reporting and recordkeeping requirements.
Health facilities, Kidney diseases, Incorporation by reference, Medicare, Reporting and recordkeeping requirements.
Health facilities, Hospice care, Incorporation by reference, Medicare, Reporting and recordkeeping requirements.
Aged, Health, Incorporation by reference, Medicare, Medicaid, Reporting and recordkeeping requirements.
Grant programs—health, Hospitals, Incorporation by reference, Medicaid, 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.
Grant programs—health, Health facilities, Incorporation by reference,
For the reasons set forth in the preamble, the Centers for Medicare & 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 revisions and additions read as follows:
(a)
(1) * * *
(i) The RNHCI must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).
(ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(4) The RNHCI may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.
(5) When a sprinkler system is shut down for more than 10 hours the RHNCI must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(6) Building must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.
(b) * * *
(1) In consideration of a recommendation by the State survey agency or Accrediting Organization, or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a RNHCI facility, but only if the waiver will not adversely affect the health and safety of the patients.
(c) 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 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 101, Life Safety Code, 2012 edition, issued August 11, 2011;
(ii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(iii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iv) TIA 12-3 to NFPA 101, issued October 22, 2013.
(v) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
(a)
(c)
(d)
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The revisions and additions read as follows:
(b) * * *
(1) Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory
(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients.
* * *
(4) An ASC may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.
(5) When a sprinkler system is shut down for more than 10 hours, the ASC must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(6) Beginning July 5, 2017, an ASC must be in compliance with Chapter 21.3.2.1, Doors to hazardous areas.
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to an ASC.
(2) If application of the Health Care Facilities Code required under paragraph (c) of this section would result in unreasonable hardship for the ASC, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.
(f) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The revisions and additions read as follows:
(d) * * *
(1) * * *
(i) The hospice must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a hospice facility, but only if the waiver will not adversely affect the health and safety of the patients.
(4) A hospice may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against access by vulnerable populations.
(5) When a sprinkler system is shut down for more than 10 hours, the hospice must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(6) Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a hospice.
(2) If application of the Health Care Facilities Code required under paragraph (e) of this section would result in unreasonable hardship for the hospice, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.
(q) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302 and 1395, 1395eee(f), and 1396u-4(f)).
The revisions and addition read as follows:
(b) * * *
(1) * * *
(i) A PACE center must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(2) * * *
(ii) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a PACE facility, but only if the waiver will not adversely affect the health and safety of the patients.
(3) A PACE center may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.
(4) When a sprinkler system is shut down for more than 10 hours in a 24-hour period, the PACE must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a PACE center.
(2) If application of the Health Care Facilities Code required under paragraph (d) of this section would result in unreasonable hardship for the PACE center, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.
(e) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102, 1871, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
The revisions and additions read as follows:
(b) * * *
(1) * * *
(i) The hospital must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a hospital, but only if the waiver will not adversely affect the health and safety of the patients.
(7) A hospital may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access;
(8) When a sprinkler system is shut down for more than 10 hours, the hospital must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(9) Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.
(i) The sill height requirement does not apply to newborn nurseries and rooms intended for occupancy for less than 24 hours.
(ii) The sill height in special nursing care areas of new occupancies must not exceed 60 inches.
(c)
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a hospital.
(2) If application of the Health Care Facilities Code required under paragraph (c) of this section would result in unreasonable hardship for the hospital, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.
(e) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
The revisions read as follows:
(a) * * *
(1) * * *
(i) The LTC facility must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a long-term care facility, but only if the waiver will not adversely affect the health and safety of the patients.
(4) A long-term care facility may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.
(7) Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.
(8) When a sprinkler system is shut down for more than 10 hours, the ASC must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(b)
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a LTC facility.
(2) If application of the Health Care Facilities Code required under paragraph (b) of this section would result in unreasonable hardship for the LTC facility, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of residents.
(j) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
The revisions and additions read as follows:
(j) * * *
(1) * * *
(i) The facility must meet the applicable provisions of either the Health Care Occupancies Chapters or the Residential Board and Care Occupancies Chapter and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (j)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 of the adopted 2012 Life Safety Code do not apply to a facility.
(iv) Beginning July 5, 2019, an ICF-IID must be in compliance with Chapter 33.2.3.5.7.1, Sprinklers in attics, or Chapter 33.2.3.5.7.2, Heat detection systems in attics of the Life Safety Code.
(5)
(ii) A facility may install alcohol-based hand rub dispensers if the dispensers are installed in a manner that adequately protects against inappropriate access.
(iii) When a sprinkler system is shut down for more than 10 hours, the ICF-IID must:
(A) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(B) Establish a fire watch until the system is back in service.
(iv) Beginning July 5, 2019, an ICF-IID must be in compliance with Chapter 33.2.3.5.7.1, sprinklers in attics, or Chapter 33.2.3.5.7.2, heat detection systems in attics of the Life Safety Code.
(v) Except as otherwise provided in this section, ICF-IIDs must meet the applicable provisions and must proceed in accordance with the Health Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).
(A) Chapter 7,8,12 and 13 of the adopted Health Care Facilities Code does not apply to an ICF-IID.
(B) If application of the Health Care Facilities Code required under paragraph
(j)(5)(iv) of this section would result in unreasonable hardship for the ICF-IID, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of clients.
(m) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
The revisions and additions read as follows:
(d) * * *
(1) * * *
(i) The CAH must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.)
(ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.
(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a CAH, but only if the waiver will not adversely affect the health and safety of the patients.
(5) A CAH may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.
(6) When a sprinkler system is shut down for more than 10 hours, the CAH must:
(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or
(ii) Establish a fire watch until the system is back in service.
(7) Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.
(i) The sill height requirement does not apply to newborn nurseries and rooms intended for occupancy for less than 24 hours.
(ii) Special nursing care areas of new occupancies shall not exceed 60 inches.
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to a CAH.
(2) If application of the Health Care Facilities Code required under paragraph (e) of this section would result in unreasonable hardship for the CAH, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.
(f) 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 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, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) 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.
(2) [Reserved]
U.S. Citizenship and Immigration Services, DHS.
Proposed rule.
The Department of Homeland Security (DHS) proposes to adjust certain immigration and naturalization benefit request fees charged by U.S. Citizenship and Immigration Services (USCIS). USCIS conducted a comprehensive fee review, after refining its cost accounting process, and determined that current fees do not recover the full costs of the services it provides. Adjustment to the fee schedule is necessary to fully recover costs for USCIS services and to maintain adequate service. DHS proposes to increase USCIS fees by a weighted average of 21 percent and add one new fee. In addition, DHS proposes to clarify that persons filing a benefit request may be required to appear for biometrics services or an interview and pay the biometrics services fee, and make a number of other changes.
Written comments must be submitted on or before July 5, 2016.
You may submit comments, identified by DHS Docket No. USCIS-2016-0001, by one of the following methods:
•
•
•
•
Joseph D. Moore, Chief Financial Officer, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Washington, DC 20529-2130, telephone (202) 272-1969.
DHS invites you to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this proposed rule. Comments providing
• Fiscal Year (FY) 2016/2017 Immigration Examinations Fee Account Fee Review Supporting Documentation; and
• Small Entity Analysis for Adjustment of the U.S. Citizenship and Immigration Services Fee Schedule notice of proposed rulemaking (NPRM).
You may review these documents on the electronic docket. The software
DHS proposes to adjust its fee schedule, which specifies the amount of the fee charged for each immigration and naturalization benefit request. The fee schedule was last adjusted on November 23, 2010.
U.S. Citizenship and Immigration Services (USCIS) is primarily funded by immigration and naturalization benefit request fees charged to applicants and petitioners. Fees collected from individuals and entities filing immigration benefit requests are deposited into the Immigration Examinations Fee Account (IEFA) and used to fund the cost of processing immigration benefit requests.
In accordance with the requirements and principles of the Chief Financial Officers Act of 1990, 31 U.S.C. 901-03, (CFO Act), and Office of Management and Budget (OMB) Circular A-25, USCIS reviews the fees deposited into the IEFA biennially and, if necessary, proposes adjustments to ensure recovery of costs necessary to meet national security, customer service, and adjudicative processing goals. USCIS completed a biennial fee review for FY 2016/2017 in 2015. The results indicate that current fee levels are insufficient to recover the full cost of activities funded by the IEFA.
USCIS calculates its fees to recover the full cost of USCIS operations, which do not include the limited appropriated funds provided by Congress. USCIS anticipates if it continues to operate at current fee levels, it will experience an average annual shortfall of $560 million between IEFA revenues and costs. This projected shortfall poses a risk of degrading USCIS operations funded by IEFA revenue. The proposed rule would eliminate this risk by ensuring full cost recovery. DHS proposes to adjust fees by a weighted average increase of 21 percent. The weighted average increase is the percentage difference between the current and proposed fees by immigration benefit type.
In addition to ensuring that fees for each specific benefit type are adequate to cover the USCIS costs associated with administering the benefit, the weighted average increase of 21 percent also accounts for USCIS costs for services that are not directly fee funded. For instance, DHS proposes certain changes to how USCIS funds the costs for fee-exempt benefit types through IEFA fee collections received from other fee-paying individuals seeking immigration benefits.
In addition to the overall increase to existing fees, DHS proposes to establish a new fee of $3,035 to recover the full cost of processing the Employment Based Immigrant Visa, Fifth Preference
DHS also proposes to establish a three-level fee for the Application for Naturalization (Form N-400). First, DHS would increase the standard fee for Form N-400 from $595 to $640. Second, DHS would continue to charge no fee to an applicant who meets the requirements of sections 328 or 329 of the Immigration and Nationality Act of 1952 (INA) with respect to military service and applicants with approved fee waivers. Third, DHS would charge a reduced fee of $320 for naturalization applicants with family income greater than 150 percent and not more than 200 percent of the Federal Poverty Guidelines. DHS is proposing this change to increase access to United States citizenship.
DHS also proposes to remove regulatory provisions that prevent USCIS from rejecting an immigration or naturalization benefit request paid with a dishonored check or lacking the required biometric services fee until the remitter has been provided an opportunity to correct the deficient payment. Finally, DHS proposes to clarify that persons filing any benefit request may be required to appear for biometrics services or an interview and may be required to pay the biometrics services fee.
DHS issues this proposed rule consistent with INA section 286(m), 8 U.S.C. 1356(m) (authorizing DHS to charge fees for adjudication and naturalization services at a level to “ensure recovery of the full costs of providing all such services, including the costs of similar services provided without charge to asylum applicants or other immigrants”
This proposed rule is also consistent with non-statutory guidance on fees, the budget process, and federal accounting principles.
Finally, this rule accounts for and is consistent with congressional appropriations for specific USCIS programs. Appropriated funding for USCIS for FY 2016 provided funding only for the E-Verify employment eligibility verification program in the amount of $119.7 million.
Consistent with the aforementioned authorities and sources, this proposed rule would ensure that USCIS recovers the full costs for its services and maintains an adequate level of service. The proposed rule would do this in two ways. First, where possible, the proposed rule would set fees at levels sufficient to cover the full cost of the corresponding services.
• Direct and indirect personnel costs, including salaries and fringe benefits such as medical insurance and retirement;
• Physical overhead, consulting, and other indirect costs, including material and supply costs, utilities, insurance, travel, and rents or imputed rents on land, buildings, and equipment;
• Management and supervisory costs; and
• The costs of enforcement, collection, research, establishment of standards, and regulation.
Second, this proposed rule would set fees at a level sufficient to fund overall requirements and general operations when no annual appropriations are received, fees are statutorily set at a level that does not recover costs, or DHS determines that a type of immigration benefit request should be exempt, in whole or in part, from payment of fees. As noted, Congress has provided that USCIS may set fees for providing
Consistent with this historical position, this proposed rule would set fees at a level that will ensure recovery of the full operating costs of USCIS, the entity within DHS that provides almost all immigration adjudication and naturalization services.
Thus, for example, certain functions (such as SAVE
In short, the full costs of USCIS operations cannot be as directly correlated or connected to a specific fee as OMB Circular A-25 advises. Nonetheless, DHS follows OMB Circular A-25 to the extent appropriate, including its direction that fees should be set to recover the costs of an agency's services in their entirety and that full costs are determined based upon the best available records of the agency.
By approving the DHS annual appropriations that provide very limited funds to USCIS, Congress has consistently recognized that the “full” cost of operating USCIS, including SAVE and the Office of Citizenship, less any appropriated funding, is the appropriate cost basis for establishing IEFA fees. Nevertheless, in each biennial review, DHS adds refinements to its determination of immigration benefit fees, including the level by which fees match directly assignable, associated, and indirect costs.
The James Zadroga 9/11 Victim Compensation Fund Reauthorization Act increased Fees For Certain H-1B
The additional fees apply to petitioners who employ 50 or more employees in the United States, with more than 50 percent of those employees in H-1B or L-1 (including L-1A and L-1B) nonimmigrant status.
• Initially to grant status to a nonimmigrant described in subparagraph (H)(i)(b) or (L) of section 101(a)(15) of the Immigration and Nationality Act; or
• To obtain authorization for a nonimmigrant in such status to change employers.
USCIS began rejecting petitions after February 11, 2016 that do not include the additional Public Law 114-113 fee, if applicable. This fee is in addition to the Petition for a Nonimmigrant Worker (Form I-129) fee, the Fraud Prevention and Detection Fee, and the American Competitiveness and Workforce Improvement Act of 1998 fee (when required), as well as the premium processing fee (if applicable). These fees, when applicable, may not be waived. Public Law 114-113 fees will remain effective through September 30, 2025.
USCIS collects this revenue, but does not spend it. One half of the revenue collected from such fees goes to the General Fund of the Treasury. The other half is deposited by DHS into the 9-11 Response and Biometric Exit Account to fund a biometric entry-exit data system to track the lawful entrance and departure of all noncitizens at U.S. airports and land border crossings. After a total of $1,000,000,000 is deposited into the 9-11 Response and Biometric Exit Account, further revenue will be deposited in the general fund of the Treasury. The funds in the 9-11 Response and Biometric Exit Account will remain available until expended to U.S. Customs and Border Protection and/or other DHS components to implement the biometric entry-exit data system.
USCIS is already collecting these new statutory fees and is in the process of revising the instructions for the Petition for a Nonimmigrant Worker, Form I-129, and the Nonimmigrant Petition Based on Blanket L Petition, Form I-129S, to include them. DHS is required to charge these fees and has no authority to change them. DHS is proposing to publish these new statutory fees in the interest of transparency, information and clarity.
In 1988, Congress established the IEFA in the Treasury of the United States.
Most recently, DHS published a revised USCIS fee schedule in its 2010/2011 Fee Rule that amended many USCIS fees to more accurately reflect the costs of services provided by USCIS. 75 FR 58962 (Sept. 24, 2010).
USCIS reviews the IEFA every 2 years as required by the CFO Act and consistent with guidance in OMB Circular A-25. 31 U.S.C. 902(a)(8); OMB Circular A-25, section 8e. The CFO Act and OMB Circular A-25 require that fees be reviewed biennially so that fee-funded agencies monitor and adjust their fees in light of actual and projected expenses.
Table 1 sets out the IEFA and biometric services fee schedule that took effect on November 23, 2010. DHS is proposing to change the fee schedule as a result of the 2016/2017 Fee Review. The table excludes statutory fees that DHS cannot adjust.
In
•
•
•
USCIS acknowledges that since it last adjusted fees in FY 2010, the agency has experienced elevated processing times compared to the goals established in FY 2007. These processing delays have contributed to case processing backlogs. This can partially be attributed to having removed the surcharge previously applied to the IEFA fee schedule to recover costs related to the USCIS Refugee, Asylum, and International Operations Directorate (RAIO), SAVE, and the Office of Citizenship. This was done in anticipation of Congress granting the request for annual discretionary appropriations to fund these programs that was in the President's Budget. Those resources did not fully materialize and since FY 2012 USCIS has used other fee revenue to support these programs. DHS is proposing to adjust fees by a total weighted average increase of 21 percent; the total 21 percent weighted average increase would be allocated as follows:
• Reinstate a surcharge in the fee schedule to fully fund RAIO, SAVE, and the Office of Citizenship (approximately 8 percent);
• Account for reduced revenue stemming from an increase in fee waivers granted since FY 2010 (approximately 9 percent); and
• Recover the costs needed to sustain current operating levels while allowing for limited, strategic investments necessary to ensure the agency's information technology infrastructure is strengthened to protect against potential cyber intrusions, and to build the necessary disaster recovery and back-up capabilities required to effectively deliver the USCIS mission (approximately 4 percent).
Through this rule, USCIS expects to collect sufficient fee revenue to fully support RAIO, SAVE and the Office of Citizenship. This would allow USCIS to discontinue diverting fee revenue to fund these programs, thereby increasing resources to fund the personnel needed to improve case processing, reduce backlogs, and achieve processing times that are in line with the commitments in the FY 2007 Fee Rule, which USCIS is still committed to achieving.
In addition, to make current published processing time information more transparent and easier for customers to interpret, USCIS is evaluating the feasibility of calculating processing times using data generated directly from case management systems, rather than with self-reported performance data provided by Service Centers and Field Offices. Preliminary findings suggest that USCIS will be able to publish processing times sooner and with greater transparency by showing different processing times for each office and form type. USCIS is also considering publishing processing times using a range rather than using one number or date. This approach would show that, for example, half of cases are decided in between X and Y number of months.
USCIS also expects to improve the customer experience as we continue to transition to online filing and electronic processing of immigration applications and petitions. With the new person-centric electronic case processing environment, USCIS will possess the data needed to provide near-real-time processing updates to the customer that will identify the case status and time period lapsed between actions for each individual case. This will allow greater transparency to the public on how long it will take to process each case as it moves from stage to stage (
USCIS is committed to giving stakeholders and customers the information they need, when they need it. To that end, it is transforming how it calculates and posts processing time information to improve the timeliness of such postings, but more importantly, to achieve greater transparency of USCIS case processing.
USCIS manages three fee accounts:
1. The IEFA (which includes premium processing revenues),
2. The Fraud Prevention and Detection Account,
3. The H-1B Nonimmigrant Petitioner Account.
The Fraud Prevention and Detection Account and the H-1B Nonimmigrant Petitioner Account are both funded by statutorily set fees. The proceeds of these fees are divided among USCIS to use for fraud detection and prevention activities and for the National Science Foundation and the Department of Labor. DHS has no authority to adjust fees for these accounts.
The IEFA comprised approximately 94 percent of total funding for USCIS in FY 2015 and is the focus of this proposed rule. The FY 2016/2017 Fee Review encompasses three core elements:
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The primary objective of this fee review was to ensure that fee revenue provides sufficient funding to meet ongoing operating costs, including national security, customer service, and adjudicative processing needs.
When conducting the comprehensive fee review, USCIS reviewed its recent cost history, operating environment, and current service levels to determine the appropriate method to assign costs to particular form types. Overall, USCIS kept costs as low as possible and minimized non-critical program changes that would have increased costs.
The cost baseline is comprised of the resources (including both personnel and non-personnel expenses) necessary for each USCIS office to sustain operations. The baseline excludes new or expanded programs and significant policy changes. A detailed annual operating plan is the starting point for baseline estimates.
In developing estimates for program needs in FY 2016/2017, USCIS used the FY 2015 annual operating plan as the starting point and made necessary adjustments, including:
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Table 2 summarizes adjustments to the FY 2015 cost baseline to reach the FY 2016 and FY 2017 cost baselines. After accounting for reductions, additional staff, and additional resource requirements, FY 2016 costs are 5 percent higher than the FY 2015 adjusted IEFA budget. FY 2017 costs are 2 percent higher than FY 2016 costs.
The projected annual budget for the FY 2016/2017 biennial fee review period is $3.038 billion. This is a $767 million, or 34 percent, increase over the FY 2010/2011 adjusted annual budget of $2.271 billion. The main drivers of this increase are described in detail throughout this rule and the supporting documentation.
The FY 2016/2017 Fee Review assumes that baseline revenue under the current fee schedule will increase from the FY 2010/2011 Fee Rule projection of $2.056 billion to $2.478 billion, an increase of approximately 9 percent. This results from a fee-paying volume increase of 13 percent despite a workload volume increase of 23 percent.
Historically, and for the purpose of the fee review, USCIS has reported costs and revenue using an average over the biennial time period. In Table 3, FY 2016 and 2017 costs and revenue are averaged to determine the projected Fee Rule amounts. Based on current immigration benefit and biometric services fees and projected volumes, fees are expected to generate $2.478 billion in average annual revenue in FY 2016 and FY 2017. For the same period, the average cost of processing those benefit requests is $3.038 billion. This calculation results in an average annual deficit of $560 million.
The current fee schedule is inadequate partly because it was established assuming that funds requested in the President's FY 2010 and FY 2011 budgets would be appropriated from Congress, yet those requests were not fulfilled. The FY 2010 and FY 2011 budgets requested $55 million and $259 million, respectively, to enable USCIS to remove the surcharge associated with refugee and asylum workload and military naturalization processing from immigration benefit request fees and to fund the cost of the SAVE program and the Office of Citizenship.
Therefore, DHS proposes to fund the USCIS costs for RAIO, SAVE, and the Office of Citizenship through IEFA fee collections received from other fee-paying individuals seeking immigration benefits. DHS proposes to set the fees at a level sufficient to recover full costs.
USCIS is, however, requesting reimbursement from DOD for costs related to military naturalizations. DOD has reimbursed USCIS for the cost of naturalization processing for eligible military service members since FY 2012.
DHS proposes to establish a new fee in this rule for Annual Certification of Regional Center, Form I-924A, to recover the full cost of processing this EB-5 benefit type. See proposed 8 CFR 103.7(b)(1)(i)(WW). Form I-924A is used by regional centers to demonstrate continued eligibility for their designation. See 8 CFR 204.6(m)(6). Regional centers must submit the form to USCIS annually or upon request.
USCIS is proposing to establish a fee for the Form I-924A because USCIS incurs significant costs to review the Form I-924A and to administer the regional center program. In addition, the regional center program is continuing to grow rapidly.
DHS proposes to establish the fee for the Form I-924A at $3,035. Proposed 8 CFR 103.7(b)(1)(i)(WW)(
In addition to establishing the fee, DHS is clarifying the related regulations that provide for the annual regional center review related to the Form I-924A. In addition, a change is proposed to accommodate regional centers that seek to withdraw their designation. Proposed 8 CFR 204.6(m)(6)(vi). USCIS has received requests recently from regional centers seeking to withdraw their designation and discontinue their participation in the program. We currently have no procedure for this request and instead must proceed with the formal termination process of issuing a Notice of Intent to Terminate followed by a termination notice. Providing a withdrawal procedure will simplify the ability to terminate a regional center when the entity seeks to withdraw its designation. In conjunction with the fee, DHS wants to ensure that the requirements for continued participation for regional centers and the procedures to follow to meet the requirements are clear. Proposed 8 CFR 204.6(m)(6).
USCIS' projected FY 2016/2017 total operating costs are expected to exceed projected total revenue; this differential would be addressed with increased revenue. Under this proposed rule, increased revenue would be derived from a weighted average fee increase on existing immigration benefits and a new fee for Annual Certification of Regional Center, Form I-924A. The level of fee increase necessary to align costs and revenue is a weighted average of 21 percent. As noted earlier in this preamble, of the 21 percent weighted average increase, approximately four percent is directly attributable to cost increases for services included in the FY 2010/2011 Fee Rule. The remaining 17
When conducting a fee review, USCIS reviews its recent cost history, operating environment, and current service levels to determine the appropriate method to assign costs to particular benefit requests. The methodology used in the review reflects a robust capability to calculate, analyze, and project costs and revenues.
USCIS uses commercially available ABC software to create financial models to calculate the costs for processing immigration benefit requests, including the costs for biometric services. Following the FY 2010/2011 Fee Rule, USCIS identified several key methodology changes to improve the accuracy of its ABC model, as discussed in the “Methodology for the 2016/2017 Fee Review” section in the Supporting Documentation. USCIS continues to update the ABC model with the most current information for fee review and cost management purposes.
ABC is a business management tool that assigns resource costs to operational activities and then to products and services. These assignments provide an accurate cost assessment of each work stream involved in producing the individual outputs of an agency or organization. The Federal Accounting Standards Advisory Board (FASAB) notes that ABC helps improve product costing by avoiding arbitrary indirect cost allocation and enables USCIS to conform to Managerial Cost Accounting Concepts and Standards for the Federal Government.
DHS has included FY 2016/2017 Fee Review Supporting Documentation, including a detailed report on how it calculated the fee schedule proposed in the docket for this rulemaking. Comments are welcome on the supporting documentation and all aspects of this proposal. A summary of the fee study, calculations, methodology and conclusions follows.
Resources equal the projected FY 2016/2017 annual cost baseline of $3.0 billion. USCIS designed the ABC model structure for FY 2016/2017 to resemble the structure of the FY 2015 annual operating plan. That plan is the detailed budget execution plan USCIS establishes at the beginning of the fiscal year consistent with the approved fiscal year spending authority and forecasted fee revenue.
ABC uses resource drivers to assign resources to activities. (See Section VI.A.1.c. of this preamble for more information.) All resource costs are assigned to activities, so the total resources in the model equal the total cost of activities.
A common resource driver in ABC is the number of employees in an organization and the percentage of time they spend performing various activities. The FY 2016/2017 ABC model uses employee counts and activity information to assign resources to activities. USCIS refers to this process as the payroll title analysis. The payroll title analysis determines how employees contribute to the eleven activities in the fee review. When an office engages in more than one activity, USCIS uses operational information to prorate that office's time to multiple activities. Historical activity information is applied to projected staffing levels in FY 2016/2017. The ABC model assigns resources to activities using anticipated staffing levels and historical activity information from the payroll title analysis for each office.
USCIS assigns some costs directly to activities. For example, the contract awarded to support USCIS Application Support Center operations only pertains to the “Perform Biometric Services” activity. Therefore, the costs of this contract are assigned directly to this activity. Other overhead costs, including costs for the Office of Information Technology, service-level agreements, and USCIS contributions to the DHS working capital fund are prorated to each office based on the number of authorized positions in those offices, so that each office pays a proportionate share.
The allocation methods in the FY 2016/2017 review are in line with FASAB's Standard 4 on managerial cost accounting concepts. This fulfills the guideline for agencies to directly trace costs when feasible and to either assign costs on a cause-and-effect basis or allocate them in a reasonable and consistent way. Statement of Federal Financial Accounting Standards (SFFAS) 4, No. 126.
In ABC, activities are the critical link between resources and cost objects. Activities represent work performed by an organization. USCIS allocates projected FY 2016/2017 operating costs (resources) to the following eleven activities:
• Inform the Public involves receiving and responding to customer inquiries through telephone calls, written correspondence, and walk-in inquiries. It also involves public engagement and stakeholder outreach activities.
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• Intake involves mailroom operations, data entry and collection, file assembly, fee receipting, adjudication of fee waiver requests, and file room operations.
• Conduct TECS
• Records Management involves searching for and requesting files; creating temporary and/or permanent individual files; consolidating files; appending evidence submitted by applicants, petitioners, and requestors to existing immigration files; retrieving, storing, and moving files upon request; auditing and updating systems that track the location of files; and archiving inactive files.
• Make Determination involves adjudicating immigration benefit requests; making and recording adjudicative decisions; requesting and reviewing additional evidence; interviewing applicants, petitioners, or requestors; consulting with supervisors or legal counsel; and researching applicable laws and decisions on non-routine adjudications.
• Fraud Detection and Prevention involves activities performed by the Fraud Detection and National Security Directorate in detecting, combating, and deterring immigration benefit fraud and addressing national security and intelligence concerns.
• Issue Document involves producing and distributing secure cards that identify the holder as a foreign national and also identifies his or her immigration status and/or employment authorization.
• Management and Oversight involves activities in all offices that provide broad, high-level operational support and leadership necessary to deliver on the USCIS mission and achieve its strategic goals.
Since the 2010 Fee Rule, USCIS added two activities to the fee review.
• Direct Costs directly support a specific immigration benefit type. For instance, USCIS applies costs specific to naturalization, including conducting naturalization ceremonies and naturalization benefit requests.
• Systematic Alien Verification for Entitlements (SAVE) represents the cost of this program.
The fourth stage in the ABC process assigns activity costs to specific immigration benefit requests (cost objects) using activity drivers. For most activities, USCIS assigns activity costs to cost objects based on the percentage of total projected volume because, for these activities, similar time and effort are involved for each benefit request. Unique activity drivers are used for two activities: Make Determination and Perform Biometric Services.
USCIS allocates the Make Determination activity across immigration benefit requests by projected adjudication hours. USCIS calculates projected adjudication hours by multiplying projected volumes by completion rates for most benefit types. Completion rates are the average amount of time that employees take to adjudicate immigration benefit requests.
The Perform Biometric Services activity uses a direct activity driver. All costs associated with this activity are assigned directly to the biometric services fee.
Activity costs are allocated to immigration benefit requests by the locations (service centers, field offices, etc.) that process them. USCIS uses data from the USCIS Performance Reporting Tool that, among other data points, include workload volumes, adjudication hours, and the number of completed requests by field office location and immigration benefit type. The Performance Reporting Tool also captures and records information on biometrics, records management, and customer service. For the FY 2016/2017 Fee Review, USCIS aligned its fee review metrics with the Performance Reporting Tool metrics used in the FY 2015 Staffing Allocation Model to ensure organizational alignment and consistency.
Cost objects are the immigration benefit requests that USCIS processes. USCIS calculates a separate fee for biometric services. The costs for the biometric services fee are derived from the costs of the Perform Biometric Services activity and a small amount of direct costs.
USCIS excludes from the fee calculation model the costs and revenue associated with programs that are temporary by definition or where the program may diminish or cease to exist because the program is predicated on guidance only (and not preserved in regulations or statute). This exclusion applies to: The Application for TPS, Form I-821, proposed 8 CFR 103.7(b)(1)(i)(NN); Consideration of Deferred Action for Childhood Arrivals, (DACA), Form I-821D; and Application for Suspension of Deportation or Special Rule Cancellation of Removal (Pursuant to Section 203 of Pub. L. 105-100) (Nicaraguan Adjustment and Central American Relief Act (NACARA)), Form I-881, proposed 8 CFR 103.7(b)(1)(i)(QQ). These programs are excluded from the FY 2016/2017 Fee Rule Supporting Documentation and this rule.
DHS excludes projected revenue from expiring or temporary programs in setting the fees required to support baseline operations due to the uncertainty associated with such programs. For example, the Secretary may designate a foreign country for TPS due to conditions in the country that temporarily prevent the country's nationals from returning safely, or in certain circumstances, where the country is unable to handle the return of its nationals adequately. TPS, however, is a temporary benefit, and
DHS excludes the costs and revenue associated with these programs because program eligibility is subject to the discretion of the Department. Given this discretion, USCIS has excluded the cost and workload of these programs from the fee review and does not propose to allocate overhead and other fixed costs to these workload volumes. This mitigates an unnecessary revenue risk,
DHS uses its fee setting discretion to adjust certain immigration request fees that would be overly burdensome on applicants, petitioners, and requestors if set at recommended ABC model levels. Historically, as a matter of policy, DHS has chosen to limit USCIS fee adjustments for certain benefit requests to the weighted average fee increase represented by the model output costs for fee-paying benefit types.
In the fee review for this proposed rule, the model output costs identified a weighted average 8 percent cost increase across all fee-paying benefit types. Accordingly, consistent with prior practice, DHS proposes to limit the fee adjustments for certain benefit types to this 8 percent weighted average increase. These immigration benefit requests do not receive any additional cost reallocation for fee waivers, refugee, asylum or other programs. DHS does not believe that using the calculated 8 percent weighted average increase figure as a basis for fee increases for these benefit types would result in fees for other benefit types that would be overly burdensome to the applicants, petitioners or requestors.
DHS proposes to subject specific benefit types to the 8 percent weighted average increase because the combined effect of cost, fee-paying volume, and methodology changes since the last Fee Rule would otherwise place an inordinate fee burden on individuals requesting these types of benefits. For example, without Low Volume Reallocation, the Petition to Classify Orphan as an Immediate Relative, Form I-600, would have a fee of at least $2,258. DHS believes it would be contrary to the public interest to impose a fee of this amount on an estimated 15,000 potential adoptive parents each year. Similar reasoning led to the other forms chosen to be adjusted using Low Volume Reallocation. For this reason, DHS proposes to subject these benefit types to the calculated 8 percent weighted average increase. In other words,
DHS recognizes that charging less than the full cost of adjudicating an immigration benefit request requires USCIS to increase fees for other immigration benefit requests to ensure full cost recovery. This complies with INA section 286(m), which permits fees to cover those costs of providing applicants, petitioners, or requestors a service or part of a service “without charge.”
DHS proposes to apply the Low Volume Reallocation methodology to the following USCIS forms:
As described below, DHS also proposes to limit fee increases for additional benefit types at the calculated 8 percent weighted average increase, even though the potential fee increases for these benefit types would not have imposed the same level of burden on affected requestors as the benefit types described in the preceding section.
First, DHS proposes to increase the Application for Naturalization, Form N-400, fee by the 8 percent weighted average increase described above.
DHS also proposes to limit the adjustment of the fee for Application for Provisional Unlawful Presence Waiver, Form I-601A, and the Application for Employment Authorization, Form I-765. The current Form I-601A fee was not established by the 2010/2011 Fee Rule because it did not exist at that time. USCIS unfortunately has insufficient data on Form I-601A volumes and completion rates with which to use its fee calculation model to identify an appropriate fee with a sufficient level of confidence. Therefore, DHS has decided that proposing a weighted average increase at 8 percent of the current fee amount is appropriate until sufficient data becomes available. DHS will consider setting the fee for Form I-601A at the amount the model calculates if sufficient data are collected before the final rule is published.
DHS also proposes to apply the same 8 percent weighted average increase to the Form I-765 for humanitarian and practical reasons. Many individuals seeking immigration benefits face financial obstacles and cannot earn money through lawful employment in the United States until they receive an Employment Authorization Document (EAD).
Finally, as noted above, in the 2010 fee rule, DHS held fee increases for a number of benefit requests to the weighted average fee increase for all fee-paying immigration benefits. 75 FR 33461. In this rule, DHS proposes to not apply the 8 percent weighted average increase to a subset of those benefit requests, both because DHS has better data upon which to base proposed fees for those benefit requests, and because DHS believes the calculated fee is appropriate. Therefore, DHS no longer believes it is necessary to limit fee increases to the weighted average for the following USCIS forms:
Accordingly, the fees for these USCIS forms are proposed to be set at the level calculated in the ABC model, with adjustments.
DHS proposes to establish a three-level fee for the Application for Naturalization, Form N-400.
DHS proposes the new reduced fee option to limit potential economic disincentives some eligible applicants may face when deciding whether or not to apply for naturalization. The proposed reduced fee option for low-income applicants supports the Administration's immigration integration policies
USCIS is uncertain exactly how many new N-400 applicants would be eligible and apply for naturalization as a result of the reduced fee. In addition, DHS has no reliable data indicating how demand for filing an N-400 may change due to adjustments in the fee amount. Nonetheless, research on barriers to naturalization indicates a correlation between the N-400 filing fee and the number of applications submitted to USCIS. As the Center for the Study of Immigrant Integration stated:
Some evidence of price sensitivity was shown when USCIS increased the cost to naturalize from $400 to $595 (plus the costs of biometrics) in the middle of 2007: the result was a surge of applications just prior to the fee increase. As a result, there were nearly 1.4 million naturalization applications filed in 2007 but just over 500,000 in 2008.
DHS proposes to hold the biometric services fee at its current level of $85. Proposed and current 8 CFR 103.7(b)(1)(i)(C). While the model calculated a biometric services fee of $75, DHS believes that the importance of and uncertainty in the biometric services area justifies holding that fee at $85.
DHS has broad statutory authority to collect biometric information when such information is “necessary,” or “material and relevant” to the administration and enforcement of the INA.
In addition, DHS proposes to use its discretion in setting this fee to hedge against potential rising programmatic costs which USCIS cannot foresee or control. For example, new regulatory or statutory background check requirements may be borne out of increased national security concerns dictated by events or changing circumstances. For the same reasons, DHS is also proposing to clarify regulations pertaining to biometrics and the biometric services fee.
Current regulations provide both general authority for the collection of biometrics in connection with immigration and naturalization benefits as well as requirements specific to certain benefit types.
Consistent with U.S. obligations under Article 28 of the 1951 Convention Relating to the Status of Refugees,
DHS proposes to hold the fee for the Petition by Entrepreneur to Remove Conditions, Form I-829, at its current level of $3,750. While the fee model calculated a fee of $2,353, DHS proposes to maintain the current fee for such petitions. Because of the recent and continued growth and maturation of the EB-5 Program, the costs over the next few fiscal years are uncertain because the final parameters of the program are still evolving, such as the number of employees and facilities necessary to carry out the enhanced review of EB-5 filings and site visits. This makes it uncertain whether EB-5 related fees will fully fund EB-5 program activities.
The EB-5 program was created by Congress in 1990 to stimulate the U.S. economy through job creation and capital investment by foreign investors. The EB-5 “regional center program” was later added in 1992 by the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1993. Public Law 102-395, sec. 610, 106 Stat 1828 (Oct. 6, 1992). The EB-5 immigrant classification allows qualifying individuals, and any accompanying or following to join spouses and children, to obtain lawful permanent resident (LPR) status if the qualifying individuals have invested, or are actively in the process of investing, $1 million in a new commercial enterprise.
To increase its support of Congress's objective in establishing the program, USCIS has recently implemented several changes to refine and improve the delivery, security and integrity of the EB-5 Program.
The FY 2016/2017 Fee Review isolates the workload volume and fee-paying percentage of Applications for Employment Authorization, Forms I-765, and Applications for Travel Document, Forms I-131, that are not associated with Applications to Register Permanent Residence or Adjust Status, Forms I-485. This change helps DHS to more accurately calculate the fees necessary for cost recovery for all three benefit types.
Usually, the favorable adjudication of an immigration benefit request is necessary before the beneficiary will receive ancillary benefits such as work and travel authorization. That is, USCIS only grants those ancillary benefits after, or at the same time as, it grants the underlying immigration status or benefit. In some situations, however, an individual may become entitled to a benefit because a case is pending adjudication. For example, a person who applies for adjustment of status would, in certain instances, be able to obtain work and/or travel authorization based on the pending immigration benefit request. 8 CFR 274a.12(c)(9). When this occurs, these ancillary benefits are referred to generally as “interim benefits.”
DHS currently permits applicants who file and pay the required fee for an Application to Register Permanent Residence or Adjust Status, Form I-485, to submit an Application for Employment Authorization, Form I-765, and/or an Application for Travel Document, Form I-131, without paying an additional fee.
In the FY 2016/2017 Fee Review, USCIS determined the workload volume and fee-paying percentage of Forms I-765 and Forms I-131 that are not associated with Forms I-485. This methodology change enables USCIS to derive a fee-paying percentage for standalone Forms I-765 and Forms I-131, meaning those forms not filed concurrently with a Form I-485. By isolating stand-alone interim benefit customers from those concurrently filing Form I-485, USCIS can more accurately assess fee-paying percentages, fee-paying volumes, and fees for all three benefit types. As a result, DHS is confident that the fees for these three benefit types proposed in this rule are consistent with the ABC methodology for full cost recovery.
USCIS proposes a fee of $750 for a child under the age of 14 years when filing Form I-485 concurrently with the application of a parent seeking classification as an immediate relative of a U.S. citizen, a family-sponsored preference immigrant, or a family member accompanying or following to join a spouse or parent under sections 201(b)(2)(A)(i), 203(a)(2)(A), or 203(d) of the INA, 8 U.S.C. 1151(b)(2)(A)(i), 1153(a)(2)(A), or 1153(d). Proposed 8 CFR 103.7(b)(1)(i)(U)(
Currently, the fee is $985 for an adult and $635 for a child under the age of 14 filing with a parent ($350 less than the fee for adults). 8 CFR 103.7(b)(1)(i)(U). In the 2010 Fee Rule, USCIS calculated the $635 fee outside of the model due to a lack of available data. The FY 2016/2017 Fee Review calculated the proposed $750 fee using actual data for each of the elements of the model. Therefore, the proposed fee for Form I-485 for a child under the age of 14 filing with a parent complies more closely with the ABC methodology for full cost recovery at a level that tracks its relative burden.
USCIS proposes to remove the provision at 8 CFR 103.7(b)(1)(i)(U)(iii) that states, “The child's application is based on a relationship to the same individual who is the basis for the child's parent's adjustment of status, or under the same legal authority as the parent.”
USCIS has included the genealogy fees in the FY 2016/2017 IEFA fee review. The USCIS genealogy program processes requests for historical records of deceased individuals.
The current genealogy program fees were not established based on the projected full cost of operating the genealogy research and information services of USCIS, although that was permitted by the authorizing law.
Current regulations state that the Form G-1041A fee is $20 for each file copy from microfilm and $35 for each hard copy. In some cases, the requestor may be unable to determine the fee, because the requestor will have a file number obtained from a source other than USCIS and therefore not know whether the format of the file is microfilm or paper. In such cases, individuals may provide the lesser $20 amount and if USCIS discovers the relevant file is a paper file, USCIS will notify the requestor to remit an additional $15. In addition, USCIS will refund the records request fee only when the agency is unable to locate the file previously identified in response to the index search request.
DHS proposes to charge a single $65 fee for Form G-1041A.
DHS proposes to amend the regulations regarding how USCIS will treat a benefit request accompanied by fee payment (in the form of check or other financial instrument) that is subsequently returned as not payable. Proposed 8 CFR 103.2(a)(7)(ii). DHS also proposes changes to provisions governing non-payment of the biometric service fee. Proposed 8 CFR 103.17(b).
Current regulations provide that when a check or other financial instrument used to pay a filing fee is subsequently returned as not payable, the remitter will be notified and requested to pay the filing fee and associated service charge within 14 calendar days, without extension. If the benefit request is pending and these charges are not paid within 14 days, the benefit request will be rejected as improperly filed.
DHS proposes to eliminate the three rules requiring that cases be held while deficient payments are corrected.
This proposal further recognizes that a fee is a fundamental aspect of the benefit request filing. For example, under current 8 CFR 103.2(a)(7)(ii), an H-1B cap-subject petition
DHS is also proposing minor changes to this same provision to clarify when USCIS would consider a benefit request received and when USCIS would reject a benefit request. Proposed 8 CFR 103.2(a)(7)(i)-(ii). Currently, numerous regulations address filing requirements for different benefits, including rejection criteria.
DHS proposes a minor change in the provision regarding USCIS fee refunds.
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DHS is proposing that 8 CFR 103.2(a)(1) be revised to provide that fees are “generally” not refunded.
DHS has identified a number of issues that do not affect the 2016/2017 Fee Review but which, for a variety of reasons, merit some discussion. No changes are proposed related to the issues discussed in this section. USCIS may discuss these issues in future biennial fee reviews or in conjunction with other USCIS Fee Rules. DHS welcomes comments on all facets of the 2016/2017 Fee Review, this proposed rule, and USCIS fees in general, regardless of whether changes have been proposed here.
USCIS is proposing no change to premium processing fees or regulations but notes it here for consideration due to stakeholder interest, past comments, and correspondence on the subject. Section 286(u) of the INA, 8 U.S.C. 1356(u), authorizes DHS to establish and collect a fee for a premium processing service for employment-based petitions and applications. Revenue from premium processing fees fund the costs associated with providing the premium processing service, as well as infrastructure improvements in the adjudications and customer service processes.
Congress set the premium processing fee at $1,000 and authorized USCIS to adjust the fee for inflation, as determined by the Consumer Price Index (CPI). USCIS adjusted the premium processing fee by using the CPI in the 2010 Fee Rule to $1,225.
DHS also notes that commenters regularly request that DHS: Extend premium processing beyond the limits of section 286(u) to other immigration benefit requests.
USCIS currently offers premium processing to business customers filing: A Petition for Nonimmigrant Worker, Form I-129, and an Immigrant Petition for Alien Worker, Form I-140, in certain visa classifications. In the 2007 and 2010 Fee Rules, USCIS indicated that it would dedicate premium processing fee revenue for transformation activities.
In the FY 2016/2017 Fee Review, USCIS identified $79.3 million in additional costs to be funded through premium processing fee revenue, thereby reducing the costs that USCIS must recover through its standard (non-premium) immigration benefit request fees. Consistent with INA section 286(u), 8 U.S.C. 1186(u), DHS intends to use premium processing revenue to pay for the salaries of immigration services officers that process this workload, associated supervisory and support staff, and associated non-personnel costs. Premium processing revenue will also be used to fund the salaries and benefits costs for Office of Transformation Coordination staff that manage USCIS' electronic immigration system and transformation investment.
DHS has endeavored, as it did in the 2010 fee rule, to propose fees based on form titles instead of form numbers to avoid prescribing fees in a manner that could undermine the transformation process.
Likewise, if USCIS determines that efficiency and customer service would be improved by breaking paper Form I-131 into separate paper forms (for instance, USCIS could institute a separate form and form number for advance parole, humanitarian parole, parole in place, refugee travel documents, reentry permits, or boarding documents), USCIS could do so and continue to charge the Form I-131 fee that is included in this rule. This structure permits USCIS to change forms more easily without having to perform a new fee study each time the agency chooses to do so.
USCIS may waive the fee for certain immigration benefit requests when the individual requesting the benefit is unable to pay the fee.
Following the 2010 Fee Rule, USCIS also issued guidance to the field to streamline fee waiver adjudications and make them more consistent among offices and form types nationwide.
• Are currently receiving a means-tested benefit;
• Have household income at or below 150 percent of the Federal poverty level; or
• Are experiencing extreme financial hardship such as unexpected medical bills or emergencies.
As noted in the Fiscal Year (FY) 2016/2017 Immigration Examinations Fee Account Fee Review Supporting Documentation, the projected annual impact of fee waivers and exemptions has increased markedly since the 2010 Fee Rule from $191 million to $613 million. Applicants, petitioners, and requestors that pay a fee cover the cost of processing requests that are fee-waived or fee-exempt. Although DHS does not currently plan to do so, it may in the future revisit the USCIS fee waiver guidance with respect to what constitutes inability to pay under 8 CFR 103.7(c). DHS welcomes comment on this issue.
USCIS uses two types of volume data in the fee review. Workload volume is a projection of the total number of immigration benefit requests that will be received in a fiscal year. Fee-paying volume is a projection of the number of applicants, petitioners, and requestors that will pay a fee when filing requests for immigration benefits. Not all applicants, petitioners, or requestors pay a fee. Those applicants, petitioners, and requestors for whom USCIS grants a fee waiver or to whom an exemption applies are represented in the workload volume but not the fee-paying volume. Applicants, petitioners, and requestors that pay a fee fund the cost of processing requests for fee-waived or fee-exempt immigration benefit requests.
USCIS uses statistical time series modeling and immigration receipt data from the last 15 years, as well as the best available internal assessment of future developments (such as annualized data prepared by the USCIS Office of Performance and Quality) to develop workload volume projections. All relevant USCIS directorates and program offices are represented on the USCIS Volume Projection Committee
USCIS uses historical revenue and receipt data to determine the number of individuals that paid the fee for each immigration benefit type. Total revenue for an immigration benefit request is divided by its fee to determine the number of fee-paying immigration benefit requests. Fee-paying receipts are compared to the total number of receipts (workload volume) to determine a fee-paying percentage for each immigration benefit request. When appropriate, projected fee-paying volumes are adjusted to reflect filing trends and anticipated changes.
USCIS completion rates are the average hours per adjudication of an immigration benefit request. They identify the adjudicative time required to complete (render a decision on) specific immigration benefit request types. The completion rate for each benefit type represents an average. Completion rates reflect what is termed “touch time” or the time an employee with adjudicative responsibilities actually handles the case. It does not reflect “queue time” or time spent waiting, for example, for additional evidence or supervisory approval. It does not reflect the total processing time customers can expect to wait for a decision on their case after USCIS accepts it.
USCIS requires the employees who adjudicate immigration benefit requests to report adjudication hours and case completions by benefit type. Adjudication hours are divided by the number of completions for the same time period to determine an average completion rate. In addition to using this data to determine fees, completion rates help determine staffing allocations appropriate to handle the projected workload. The Office of Performance and Quality, field offices, and regional management scrutinize the data to ensure accuracy. When the data is inconsistent and anomalies are identified, the Office of Performance and Quality contacts the reporting office and makes necessary adjustments. USCIS has confidence in the data, given the consistency of reporting over the last several years. The continual availability of the information makes it easier for USCIS to update cost information more frequently for fee review and cost management purposes.
USCIS does not calculate completion rates for the following immigration benefit requests, forms, or other services, due to the special nature of their processing as explained below:
• Biometric Services. Application Support Centers and the Biometrics Division incur certain costs, which are assigned to this fee. Completion rates are not necessary to assign processing activity costs to this product.
• USCIS Immigrant Fees. USCIS does not adjudicate immigrant visa benefit requests. Rather, individuals located outside of the United States apply with a Department of State overseas consular officer for an immigrant visa. If DOS issues the immigrant visa, the individual may apply with a U.S. Customs and Border Protection officer for admission to the United States as an immigrant at a port of entry. This fee represents USCIS costs to create and maintain files and to issue permanent resident cards to individuals who go through this process.
• Refugee and Asylee Processing. Refugee Division and Asylum Division costs are not directly assigned to any fee and are covered by immigration benefit requests that pay fees. USCIS does not charge a fee for the following:
○ Application for Asylum and Withholding of Removal, Form I-589;
○ Registration for Classification as a Refugee, Form I-590;
○ Application By Refugee For Waiver of Grounds of Excludability, Form I-602; and
○ Refugee/Asylee Relative Petition, Form I-730.
• Other Forms Exempt from Fees. The following forms are also not discussed in this rule as applicants for these form types are exempt from paying a fee:
○ Application for Posthumous Citizenship, Form N-644;
○ Application for T Nonimmigrant Status, Form I-914; and
○ Petition for U Nonimmigrant Status, Form I-918.
• Forms with Uncertain Fee Revenue. These form types may be terminated under current law, or may cease due to a reduction in the eligible population, and DHS proposes to not rely on their uncertain fee revenue streams for recovering USCIS operational expenses. The following forms are excluded from discussion in this rule because, as discussed earlier in this preamble, this proposed rule does not propose to change or establish a special fee for those programs:
○ Application for Temporary Protected Status, Form I-821;
○ Consideration of Deferred Action for Childhood Arrivals, Form I-821D; and
○ Application for Suspension of Deportation or Special Rule Cancellation of Removal, Form I-881.
Because projected USCIS costs for FY 2016 and 2017 exceed projected revenue by an average of $569 million each year, USCIS must adjust the fee schedule to recover the full cost of processing immigration benefits, and to continue to
After resource costs are identified, they are distributed to USCIS' primary processing activities in the ABC model. Table 7 outlines total IEFA costs by activity.
The activity costs are then distributed to the immigration benefit requests. Table 8 summarizes total revenue by immigration benefit request based on the proposed fee schedule.
Table 9 depicts the current and proposed USCIS fees for immigration benefits and biometric services. For a more detailed description of the basis for the changes described in this table, see Appendix Table 4 in the FY 2016/2017 Fee Review Supporting Documentation accompanying this proposed rule.
In accordance with the RFA, 5 U.S.C. 601(6), USCIS examined the impact of this rule on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act, 15 U.S.C. 632), a small not-for-profit organization, or a small governmental jurisdiction (locality with fewer than 50,000 people). Below is a summary of the small entity analysis. A more detailed analysis is available in the rulemaking docket at
Individuals rather than entities submit the majority of immigration and naturalization benefit applications and petitions. Entities that would be affected by this rule are those that file and pay the fees for certain immigration benefit applications and petitions. There are four categories of USCIS benefits that are subject to a RFA analysis for this rule: Petition for a Nonimmigrant Worker, Form I-129; Immigrant Petition for an Alien Worker, Form I-140; Application for Civil Surgeon Designation, Form I-910; and the Application for Regional Center Designation Under the Immigrant Investor Program, Form I-924.
DHS does not believe that the increase in fees proposed in this rule will have a significant economic impact on a substantial number of small entities that are filing Form I-129, Form I-140, or Form I-910. However, DHS does not have sufficient data on the revenue collected through administrative fees by regional centers to definitively determine the economic impact on small entities that may file Form I-924.
DHS proposes to adjust certain immigration and naturalization benefit request fees charged by USCIS. USCIS has determined that current fees do not recover the full costs of services provided. As USCIS is nearly fully funded by fees, adjustment to the fee schedule is necessary to recover costs and maintain adequate service.
DHS's objectives and legal authority for this proposed rule are discussed in Section III of this preamble.
Entities affected by this rule are those that file and pay fees for certain immigration benefit applications and petitions on behalf of a foreign national. These applications include Petition for Nonimmigrant Worker, Form I-129; Immigrant Petition for Alien Worker, Form I-140; Civil Surgeon Designation, Form I-910; and Application for Regional Center Designation Under the Immigrant Investor Program, Form I-924. Annual numeric estimates of small entities affected by this fee increase total (in parentheses): Form I-129 (70,211), Form I-140 (17,812), Form I-910 (589), and Form I-924 (412).
This rule applies to small entities including businesses, non-profit organizations, and governmental jurisdictions filing for the above benefits. Form I-129 and Form I-140 will see a number of industry clusters affected by this rule (see Appendix A of the Small Entity Analysis for a list of industry codes). The fee for civil surgeon designation will apply to physicians requesting such designation. Finally, the Form I-924 will apply to any entity requesting approval and designation as a regional center under the Immigrant Investor Program or filing an amendment to an approved regional center application. Also captured in the dataset for Form I-924 is the Supplement Form I-924A, which regional centers must file annually to certify their continued eligibility for regional center designation.
USCIS proposes to increase the fee for the Petition for a Nonimmigrant Worker, Form I-129, from $325 to $460, a $135 (42 percent) increase. Using a 12-month period of data on filings of Form I-129 from September 1, 2014 to August 31, 2015, USCIS collected internal data for each filing organization including the name, Employer Identification Number, city, state, ZIP code, and number/type of filings. Each entity may make multiple filings; for instance, there were 482,190 Form I-129 petitions, but only 84,490 unique entities that filed those petitions. Since the filing statistics do not contain information such as the revenue of the business, USCIS looked for this information by researching databases from third-party sources. USCIS used the subscription-based online database from Hoover's, as well as three open-access databases from Manta, Cortera, and Guidestar, to help determine an organization's small entity status and apply Small Business Administration size standards.
USCIS devised a methodology to conduct the small entity analysis based on a representative sample of the affected population for each form. To achieve a 95 percent confidence level and a 5 percent confidence interval on a population of 84,490 unique entities for Form I-129, USCIS used the standard statistical formula to determine a minimum sample size of 382 entities was necessary. Based on past experience, USCIS expected to find about 40 to 50 percent of the filing organizations in the online subscription and public databases. Accordingly, USCIS selected a sample size approximately 40 percent larger than the minimum necessary in order to allow for non-matches (filing organizations that could not be found in any of the four databases). Therefore, USCIS conducted searches on 534 randomly selected entities from the population of 84,490 unique entities for Form I-129.
The 534 searches for Form I-129 resulted in 404 instances where the name of the filing organization was successfully matched in the databases and 130 instances where the name of the filing organization was not found in the databases. Based on previous experience conducting regulatory flexibility analyses, USCIS assumes filing organizations not found in the online database are likely to be small entities. Thus, in order not to underestimate the number of small entities affected by this rule, USCIS makes the conservative assumption to consider all of the non-matched entities as small entities for the purpose of this analysis. Among the 404 matches for Form I-129, 287 were determined to be small entities based on their reported revenue or employee count and their North American Industry Classification System (NAICS) code. Combining non-matches (130), matches missing data (27), and small entity matches (287), enables us to classify 444 of the 534 entities as small for Form I-129.
With an aggregated total of 444 out of a sample size of 534, DHS inferred that a majority, or 83.1 percent, of the entities filing Form I-129 petitions during the period were small entities. Furthermore, 284 of the 534 searched were small entities with the sales revenue data needed to estimate the economic impact of the proposed rule. Because these 284 small entities were a subset of the random sample of 534 searches, they were statistically significant in the context of this research. In order to calculate the economic impact of this rule, USCIS estimated the total costs associated with the proposed fee increase for each entity, divided by the sales revenue of that entity.
In terms of range, among the 284 small entities with reported revenue data, all experienced an economic impact of considerably less than 1.0 percent in the analysis, with the exception of one entity. Using the above methodology, the greatest economic impact imposed by this fee change totaled 2.55 percent on that one entity and the smallest totaled 0.0001 percent.
The evidence suggests that the additional fee imposed by this rule does not represent a significant economic impact on these entities.
USCIS proposes to increase the fee for the Immigrant Petition for an Alien Worker, Form I-140, from $580 to $700, a $120 (21 percent) increase. Using a 12-month period of data on filings of Form I-140 petitions from September 1, 2014 to August 31, 2015, USCIS collected internal data similar to that of Form I-129. There were 101,245 Form I-140 petitions, but only 23,284 unique entities that filed those petitions. Again, USCIS used the third party sources of
USCIS used the same methodology as with Form I-129 to conduct the small entity analysis based on a representative sample of the affected population. To achieve a 95 percent confidence level and a 5 percent confidence interval on a population of 23,284 unique entities for Form I-140, USCIS used the standard statistical formula to determine that a minimum sample size of 378 entities was necessary. Again, based on past experience, USCIS expected to find about 40 to 50 percent of the filing organizations in the online subscription and public databases. Accordingly, USCIS oversampled in order to allow for non-matches (filing organizations that could not be found in any of the four databases).
USCIS conducted searches on 514 randomly selected entities from the population of 23,284 unique entities for Form I-140. The 514 searches resulted in 430 instances where the name of the filing organization was successfully matched in the databases and 84 instances where the name of the filing organization was not found in the databases. Based on previous experience conducting regulatory flexibility analyses, USCIS assumes filing organizations not found in the online databases are likely to be small entities. In order not to underestimate the number of small entities affected by this rule, USCIS makes the conservative assumption to consider all of the non-matched entities as small entities for the purpose of this analysis. Among the 430 matches for Form I-140, 290 were determined to be small entities based on their reported revenue or employee count and their NAICS code. Combining non-matches (84), matches missing data (19), and small entity matches (290), enables us to classify 393 of 514 entities as small for Form I-140.
With an aggregated total of 393 out of a sample size of 514, USCIS inferred that a majority, or 76.5 percent, of the entities filing Form I-140 petitions during the period were small entities. Furthermore, 287 of the 514 searched were small entities with the sales revenue data needed in order to estimate the economic impact of the proposed rule. Because these 287 small entities were a subset of the random sample of 514 searches, they were statistically significant in the context of this research. Similar to Form I-129, DHS estimated the total costs associated with the proposed fee increase for each entity, divided by the sales revenue of that entity in order to calculate the economic impact of this rule.
Among the 287 small entities with reported revenue data, all experienced an economic impact considerably less than 1.0 percent in the analysis. Using the above methodology, the greatest economic impact imposed by this fee change totaled 0.68 percent and the smallest totaled 0.000002 percent. The average impact on all 287 small entities with revenue data was 0.04 percent.
The evidence suggests that the additional fee imposed by this rule does not represent a significant economic impact on these entities.
Additionally, USCIS analyzed any cumulative impacts to Form I-129 and Form I-140, as well the individual analyses. USCIS wanted to determine if there were cumulative impacts when the forms were analyzed together. USCIS isolated those entities that overlapped in both samples of Forms I-129 and I-140 by EIN. Only 3 entities had EINs that overlapped in both samples. Of these 3 entities, 2 of them were small entities and 1 was not a small entity. Only 1 entity submitted multiple Form I-129 petitions, while all 3 entities submitted multiple Form I-140 petitions. Due to little overlap in entities in the samples and the relatively minor impacts on revenue of fee increases of Forms I-129 and I-140, USCIS does not expect the combined impact of these two forms to be an economically significant burden on a substantial number of small entities.
USCIS proposes to increase the fee for the Application for Civil Surgeon Designations, Form I-910, from $615 to $785, a $170 (28 percent) increase. Using a 12-month period of August 1, 2014 to July 31, 2015, USCIS collected internal data on the applicants. There were 719 Form I-910 applications, but only 602 unique entities that filed such applications. Again, USCIS used third party sources of data mentioned previously to search for revenue and employee count information.
Using the same methodology as with Form I-129 and Form I-140, USCIS conducted the small entity analysis based on a representative sample, with a 95 percent confidence level and a 5 percent confidence interval, of the population of 602 unique entities for Form I-910. USCIS determined that a minimum sample size of 235 entities was necessary. USCIS oversampled and conducted searches on 329 randomly selected entities for Form I-910.
The 329 searches for Form I-910 resulted in 252 instances where the name of the filing organization was successfully matched in the databases and 77 instances where the name of the filing organization was not found in the databases. USCIS assumed again that filing organizations not found in the online databases are likely to be small entities, so USCIS considered all of the non-matched entities as small entities for the purpose of this analysis. Among the 252 matches for Form I-910, 240 were determined to be small entities based on their reported revenue or employee count and their NAICS code. Combining non-matches (77), matches missing data (5), and small entity matches (240), USCIS classified 322 of 329 entities as small for Form I-910.
With an aggregated total of 322 out of a sample size of 329, USCIS inferred that a majority, or 97.9 percent, of the entities filing Form I-910 applications were small entities. Furthermore, 238 of the 329 entities searched were small entities with the sales revenue data needed in order to estimate the economic impact of the proposed rule. Because these 238 small entities were a subset of the random sample of 329 searches, they were statistically significant in the context of this research.
Similar to Form I-129 and Form I-140, USCIS estimated the total costs associated with the proposed fee increase for each entity. Among the 238 small entities with reported revenue data, all experienced an economic impact considerably less than 1.0 percent in the analysis. The greatest economic impact imposed by this fee change totaled 0.61 percent and the smallest totaled 0.00002 percent. The average impact on all 238 small entities with revenue data was 0.09 percent.
The evidence suggests that the additional fee imposed by this rule does not represent a significant economic impact on these entities.
Congress created the EB-5 Program in 1990 under section 203(b)(5) of the INA to stimulate the U.S. economy through job creation and capital investment by foreign investors. Foreign investors have the opportunity to obtain lawful permanent residence in the United States for themselves, their spouses, and their minor unmarried children through a certain level of capital investment and associated job creation or preservation. There are two distinct EB-5 pathways for a foreign investor to gain lawful permanent residence: the Basic Program and the Regional Center Program. Both options require a capital investment from the foreign investor in a new commercial enterprise located within
A regional center is an economic entity, public or private, that promotes economic growth, regional productivity, job creation, and increased domestic capital investment. Regional centers pool funds into development loans or equity for commercial space and real estate development projects. As of January 4, 2016, there were 790 USCIS-approved regional centers.
DHS proposes to increase the fee for the Application for Regional Center Designation Under the Immigrant Investor Program, Form I-924, from $6,230 to $17,795, an $11,565 (186 percent) increase. Additionally, DHS proposes to introduce a filing fee of $3,035 for Form I-924A. In proposing to establish this fee, DHS would also clarify the related regulations that provide for the annual regional center review related to Form I-924A. Currently, there is no procedure for regional centers seeking to withdraw their designation and discontinue their participation in the program. Formal termination is currently processed by USCIS issuing a Notice of Intent to Terminate and a subsequent termination notice. The proposed withdrawal procedure would allow a regional center to proactively request withdrawal without the need for the more formal notices sent out by USCIS. This proposed procedure would reduce administrative costs and time for the Department, while timely clarifying status to the requesting regional center. Over a 13-month period of August 1, 2014 through August 31, 2015, USCIS received a total of 412 Form I-924 applications.
DHS was not able to determine the numbers of regional centers that would be considered small entities. Regional centers are difficult to assess because there is a lack of official data on employment, income, and industry classification for these entities. Regional centers also pose a challenge for analysis as their structure is often complex and can involve many related business and financial activities not directly involved with EB-5 activities. Regional centers can be made up of several layers of business and financial activities that focus on matching foreign investor funds to development projects to capture above market return differentials. While USCIS attempted to treat the regional centers similar to the other entities in this analysis, we were not able to identify most of the entities in any of the online databases. Furthermore, while regional centers are an integral component of the EB-5 program, DHS does not collect data on the administrative fees the regional centers charge to the foreign investors who are investing in one of their projects. DHS did not focus on the bundled capital investment amounts (either $1 million or $500,000 per investor) that the regional center invests into a new commercial enterprise. Such investment amounts are not necessarily indicative of whether the regional center is appropriately characterized as a small entity for purposes of the RFA.
Due to the lack of regional center revenue data, DHS assumes regional centers collect revenue through the administrative fees charged to investors. Searching through several public Web sites, DHS gathers that administrative fees charged to investors could range between $30,000 and $100,000 per investor.
The proposed rule does not directly impose any new or additional “reporting” or “recordkeeping” requirements on filers of Forms I-129, I-140, I-910, or I-924 other than the fee adjustments. The proposed rule does not require any new professional skills for reporting.
DHS is unaware of any duplicative, overlapping, or conflicting federal rules, but invites any comment and information regarding any such rules.
(1) Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(2) Clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;
(3) Use of performance rather than design standards; and
(4) Any exemption from coverage of the rule, or any part thereof, for such small entities.
The INA provides for the collection of fees at a level that will ensure recovery of the full costs of providing adjudication and naturalization services, including services provided without charge to those eligible for fee waivers and exemptions. DHS funds the costs of providing services without charge by using a portion of the filing fees that are collected for other immigration benefits. Without an increase in fees, USCIS will be unable to maintain the level of service for immigration and naturalization benefits as it now provides. DHS considered the alternative of maintaining fees at the current level but with reduced services and increased processing times, but has decided that this would not be in the interest of applicants and petitioners. While most immigration benefit fees are paid by individuals, as described above, some also apply to small entities. USCIS seeks to minimize the impact on all parties, but in particular small entities. Another alternative would be to maintain fees at their current level for small entities. This alternative would avoid additional fee-burdens on small entities; however, small entities would experience negative effects due to the service reductions that would result in the absence of the fee adjustments proposed in this rule.
Without the fee adjustments proposed in this rule, significant operational changes would be necessary. Given current filing volume and other economic considerations, USCIS requires additional revenue to prevent immediate and significant cuts in planned spending. These spending cuts would include reductions in areas such as federal and contract staff, infrastructure spending on information technology and facilities, and training. Depending on the actual level of workload received, these operational changes would result in longer processing times, a degradation in customer service, and reduced efficiency over time. These cuts would ultimately represent an increased cost to small entities by causing delays in benefit processing and reductions in customer service.
• Please provide comment on the numbers of small entities that may be affected by this rulemaking.
• Please provide comment on any or all of the provisions in the proposed rule with regard to the economic impact of this rule, paying specific attention to the effect of the rule on small entities in light of the above analysis, as well as the full analysis on regulations.gov.
• Please provide comment on any significant alternatives DHS should consider instead of the changes proposed by this rule.
• Please describe ways in which the rule could be modified to reduce burdens for small entities consistent with the INA and the CFO Act of 1990 requirements.
• Please identify all relevant federal, state or local rules that may duplicate, overlap or conflict with the proposed rule.
The Unfunded Mandates Reform Act of 1995 (UMRA) requires certain actions to be taken before an agency promulgates any proposed or final rule “that is likely to result in promulgation of any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.
This rulemaking is a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rulemaking will result in an annual effect on the economy of more than $100,000,000 in order to generate the revenue necessary to fully fund the increased cost associated with the processing of immigration benefit applications and petitions and associated support benefits; the full cost of providing similar benefits to asylum and refugee applicants at no charge; and the full cost of providing similar benefits to other immigrants, as specified in the proposed regulation, at no charge. The increased costs would be recovered through the fees charged for various immigration benefit requests.
The Congressional Review Act (5 U.S.C. 801
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated an “economically significant regulatory action” under section 3(f)(1) of Executive Order 12866. Accordingly, OMB has reviewed the proposed rule.
USCIS projects an annual budget of $3.038 billion in FY 2016/FY 2017, a $767 million (34 percent) increase over the FY 2010/FY2011 Fee Review-adjusted annual budget of $2.271 billion. The implementation of this proposed rule would provide USCIS with an average of $546 million in FY 2016 and FY 2017 annual fee revenue above the FY 2010/FY 2011 levels, based on a projected annual fee-paying volume of 4.9 million immigrant benefit requests and 2.6 million requests for
If USCIS does not adjust the current fees to recover the full costs of processing immigration benefit requests, it would be forced to make reductions in services provided to applicants and petitioners. These would reverse the considerable progress USCIS has made over the last several years to reduce the backlogs of immigration benefit filings, to increase the integrity of the immigration benefit system, and to protect national security and public safety. The proposed revenue increase is based on USCIS costs and volume projections available at the time the rule was drafted. USCIS has placed in the rulemaking docket a detailed analysis that explains the basis for the annual fee increase. USCIS has included an accounting statement detailing the annualized costs of the proposed rule in Table 10 below.
This proposed rule is intended to adjust current fees to ensure that USCIS is able to recover the full costs of the immigration services it provides and maintain adequate service. In addition to increasing fees, USCIS proposes the following amendments: provisions that USCIS will reject an immigration benefit request paid with a dishonored check; provisions that USCIS will reject an application that does not include the required biometric services fee; the institution of a reduced fee for the Application for Naturalization, Form N-400; and provisions that fee refunds will be provided at USCIS discretion.
Earlier in this preamble USCIS explains its proposal to change how it will treat a benefit request accompanied by fee payment (in the form of check or other financial instrument) that is subsequently returned as not payable.
DHS proposes to eliminate provisions requiring that applications or petitions be held while deficient payments are corrected. Under the proposed amendment, if a check or other financial instrument used to pay a filing fee is subsequently returned as not payable, the benefit request will be rejected as improperly filed.
In order to get an estimate of the numbers of applicants who make a payment with a dishonored check or failed payment, USCIS analyzed the count of all returned and subsequently corrected payments of a credit card or check from fiscal years 2012 to 2015.
The proposed provisions would require USCIS to reject these returned payments and associated benefit requests for nonpayment. The existing $30 service charge would continue to be imposed for benefit requests rejected when a financial institution does not honor a payment. USCIS anticipates that the prospect of rejection would encourage applicants to provide the correct filing fees at the time they submit an application or petition. However, USCIS recognizes that there would continue to be applicants who file an application with an incorrect fee and would be required to pay the $30 service fee. While USCIS knows currently this additional service fee averages to $293,430 for all applicants and anticipates it would be lower in the future, we do not have enough information at this time to estimate the degree of this decrease.
For applicants, filing fees are a required and fundamental aspect of the benefit being requested. By providing a 14-day window to correct for dishonored checks, the regulation currently permits a benefit request paid with a dishonored payment instrument to secure a place in line ahead of a benefit request that was accompanied by a proper payment, for what may be a time sensitive or numerically limited program. In all cases, rejected filings may be refiled immediately with the proper payment but there are some slight differences depending upon if the submission is paper-based or electronically filed. The USCIS online filing system will permit the rejected applications to remain accessible for the applicant to print and view. The original rejected electronic submission would not be available for resubmission with a new payment; however, the rejected submission may be used as a reference when a new application is being completed. In cases where the rejected submission is paper-based, the entire application/petition/request and supporting documentation are returned and can generally be refiled with the proper payment instrument.
The proposed amendments will provide several benefits to USCIS. First, USCIS currently clears payment checks via the ACH by converting checks to electronic payments. Because USCIS converts checks into ACH payments, there is currently little or no delay before USCIS knows whether the check is valueless. Thus, unlike in the past, USCIS would not begin adjudication until the check has cleared. USCIS benefits by streamlining the process for adjudicators to only begin work on those applications with properly filed fees, eliminating the need to hold applications. USCIS anticipates this streamlined process would help adjudicators to more efficiently process cases without the need to wait on payments. This change in process also provides parity to those applicants who file an application with the correct fees. In addition, the proposed amendments would lower USCIS administrative costs for holding and tracking applications and payments. The holding and tracking of applications requires physical storage space that would no longer be required with the proposed revisions. USCIS currently incurs administrative costs through tracking payments in postage costs and adjudicator time among other costs. USCIS recognizes the unique situation that these proposed changes may have on H-1B lottery regulations, which allow numbers available to petitions in the order in which the petitions are filed.
DHS also proposes amendments to eliminate provisions governing non-payment of the biometric service fee. Currently, if a benefit request is received by DHS without the correct biometric service fee, USCIS will notify the applicant of the deficiency and take no further action on the benefit request until payment is received.
USCIS proposes to eliminate the provisions requiring that applications be held while deficient payments are corrected. USCIS is proposing that if a benefit request is received by USCIS without the correct biometric service fee, as specified in the form instructions, USCIS would reject the benefit request.
In order to analyze the number of people who do not pay the biometric fee, USCIS gathered 6 months of data from USCIS lockbox facilities.
This change would streamline USCIS' process for handling applications and petitions when biometrics fees are not submitted when required. USCIS costs are reduced by eliminating the administrative handling costs associated with holding cases while biometric fees are collected.
The current fee for the Application for Naturalization, Form N-400, is $595. In most cases, applicants must also pay an $85 biometrics fee, so the total cost for most applicants is $680. If an applicant cannot pay the fee, he or she can file a Request for Fee Waiver, Form I-912, along with their Form N-400. USCIS considers anyone with a household income below 150 percent of the Federal Poverty Guidelines to be eligible for a fee waiver. If USCIS approves an applicant's fee waiver, both the $595 Form N-400 fee and the $85 biometrics fee, where applicable, are waived.
DHS proposes to increase the Form N-400 fee from $595 to $640, a $45 (8 percent) increase. The biometrics fee would remain unchanged at $85. Therefore, if the proposed fees are implemented, the new costs of Form N-400 plus the biometric fee would total $725. DHS also proposes an additional fee option for those non-military naturalization applicants with family incomes greater than 150 percent and not more than 200 percent of the Federal Poverty Guidelines. Specifically, DHS proposes that such applicants would receive a 50 percent discount and only be require to pay a filing fee of $320 for the N-400, plus an additional $85 for biometrics (for a total of $405). DHS proposes this reduced fee option to limit any potential economic disincentives that some eligible naturalization applicants may face when deciding whether or not to seek citizenship. The lower fee would help ensure that those who have worked hard to become eligible for naturalization are not limited by their economic means. In order to qualify for this fee, the eligible applicant will have to submit a newly proposed Request for Reduced Fee, Form I-942, along with their Form N-400. Form I-942 will require the names of everyone in the household and documentation of the household income to determine if the applicant's household income is greater than 150 and not more than 200 percent of the Federal Poverty Guidelines.
As described earlier in the preamble, USCIS estimates that approximately 11 percent of all Form N-400 applicants, excluding military applicants, could qualify for the reduced fee. Given the non-military Form N-400 volume projection estimate of 821,500 annually, over the biennial period, USCIS expects that 90,365 filers would be included in the population eligible for the fee reduction.
USCIS has factored the estimated revenue loss from this product line into its fee model, so those costs are reallocated over other fee paying benefit requests. While the costs of the reduced fee are being reallocated to other fee-paying customers, DHS believes the benefits of providing a means to promote citizenship among those with limited economic means outweighs the cost reallocation impacts.
As previously mentioned, an eligible applicant would have to submit a Form I-942 along with their N-400 application to qualify for this reduced fee. While USCIS is not imposing an additional fee for Form I-942, we have estimated the opportunity cost of time to applicants to complete the form. The total opportunity cost of time for applicants would be $717,724, if all 90,365 eligible applicants apply for the reduced fee.
DHS is also proposing to amend regulations for fee refunds. In general, and except for a premium processing fee under 8 CFR 103.7(e)(2)(i), USCIS does not refund a fee regardless of the decision on the immigration benefit request. USCIS makes very rare exceptions when USCIS determines that an administrative error occurred resulting in the inadvertent collection of a fee. USCIS errors may include:
• Unnecessary filings. Cases in which USCIS (or DOS in the case of an immigration benefit request filed overseas) erroneously requests that an individual file an unnecessary form along with the associated fee; and
• Accidental Payments. Cases in which an individual pays a required fee more than once or otherwise pays a fee in excess of the amount due and USCIS (or the DOS in the case of an immigration benefit request filed overseas) erroneously accepts the erroneous fee.
DHS is proposing to codify into regulation the continuance of providing these refunds under circumstances where refunds are necessary due to obvious USCIS error. Under this proposal, individuals would continue to request a refund by the current process. The current process requires that an individual call the customer service line or submit a written request for a refund to the office having jurisdiction over the relevant immigration benefit request.
Any USCIS refunds provided are generally due to obvious USCIS errors resulting from system behavior issues or human error. The anticipation of future electronic filings also spurs the need for this provision. Currently, DHS provides fee refunds and amounts to applicants as shown in Table 12. Over the past 3 fiscal years, an annual average of 5,363 refunds were provided by USCIS, resulting in an average of $2.1 million refunded. This is approximately $396 per refund. These numbers and amounts of refunds do not include premium processing refunds regulated under 8 CFR 103.7(e)(2)(i). In the context of the number of fees collected by USCIS, this average amount of refunds is still less than 1 percent of the total fees collected.
These proposed amendments would benefit applicants that might accidently submit payments twice. USCIS anticipates this to be a bigger issue as more forms and associated fees begin to be collected through electronic means. Applicants would recoup any fees that were submitted due to these electronic systems issues. USCIS would benefit by having clear regulatory authority to justify the few cases in which refunds are provided.
There may be some administrative costs associated with the issuance of refunds to USCIS, as well as some time burden costs to USCIS adjudicators who process these refund requests. It may be possible to see a potential increase initially in requests for refunds due to the visibility of this rule; however, USCIS does not anticipate a sustained increase as the parameters of the refunds issued are not proposed to be changed from current policy. There may also be a potential increase in the time burden costs for USCIS adjudicators due to potential initial increases in refund requests. USCIS does not have cost estimates at this time indicating the number of hours required to process and issue these refunds. There may also be some opportunity costs of time to applicants who submit a refund request; however, USCIS anticipates this cost is offset by the benefit gained in receiving a refund.
This proposed rule will not have substantial direct effects 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this proposed rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This proposed rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
Under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163 (1995) (PRA), DHS is required to submit to OMB, for review and approval, any reporting or recordkeeping requirements inherent in a rule. USCIS is revising two information collections, adding a new information collection in association with this rulemaking action, and requesting public comments on the proposed information collection changes as follows: Application for Naturalization, Form N-400, to collect information necessary to document the applicant's eligibility for the reduced fee proposed in this rule at 8 CFR 103.7(b)(1)(i)(AAA)(
(1) Evaluate 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) Evaluate the accuracy of the agency's estimate of the burden of the 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, such as permitting electronic submission of responses.
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• Form I-924—400 respondents.
• Form I-924A—882 respondents.
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Comments concerning these collections and forms can be submitted to the Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2020. Please include the OMB control number in the comment letter.
Please also submit comments on the forms to OMB by:
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•
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The changes to the proposed fees will require minor amendments to USCIS forms to reflect the new fees. The necessary changes to the annual cost burden and to the forms will be submitted to OMB when a final rule is submitted to OMB.
Administrative practice and procedures, Authority delegations (government agencies), Freedom of Information, Privacy, Reporting and recordkeeping requirements, and Surety bonds.
Administrative practice and procedure, Immigration, Reporting and recordkeeping requirements.
Accordingly, DHS proposes to amend chapter I of title 8 of the Code of Federal Regulations as follows:
5 U.S.C. 301, 552, 552(a); 8 U.S.C. 1101, 1103, 1304, 1356; 31 U.S.C. 9701; Pub. L. 107-296, 116 Stat. 2135 (6 U.S.C. 1
The revisions read as follows:
(a) * * *
(1)
(7)
(ii) A benefit request which is rejected will not retain a filing date. A benefit request will be rejected if it is not:
(A) Signed with valid signature;
(B) Executed;
(C) Filed in compliance with the regulations governing the filing of the specific application, petition, form, or request; and
(D) Submitted with the correct fee(s). If a financial instrument used to pay a fee is returned as unpayable, the filing will be rejected and a charge will be imposed in accordance with 8 CFR 103.7(a)(2).
(iii) A rejection of a filing with USCIS may not be appealed.
(b) * * *
(9)
(i) Appear before the scheduled date and time;
(ii) For good cause, request that the biometric services appointment be rescheduled; or
(iii) Withdraw the benefit request.
(a) * * *
(2) Remittances must be drawn on a bank or other institution located in the United States and be payable in United States currency. Remittances must be made payable in accordance with the guidance specific to the applicable U.S. Government office when submitting to a Department of Homeland Security office located outside of the United States. Remittances to the Board of Immigration Appeals must be made payable to the “United States Department of Justice,” in accordance with 8 CFR 1003.8. A charge of $30.00 will be imposed if a remittance in payment of a fee or any other matter is not honored by the bank or financial institution on which it is drawn. If the remittance is found uncollectible the provisions of 8 CFR 103.2(a)(7)(ii) apply, no receipt will be issued, and if a receipt was issued, it is void and the benefit request loses its receipt date.
(b)
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8 U.S.C. 1101, 1103, 1151, 1153, 1154, 1182, 1184, 1186a, 1255, 1641; 8 CFR part 2.
(m) * * *
(6)
(A) Continue to meet the requirements of section 610(a) of the Appropriations Act.
(B) Provide USCIS with updated information annually, and/or as otherwise requested by USCIS, to demonstrate that the regional center is continuing to promote economic growth, including increased export sales, improved regional productivity, job creation, and increased domestic capital investment in the approved geographic area, using a form designated for this purpose; and
(C) Pay the fee provided by 8 CFR 103.7(b)(1)(i)(WW).
(ii) USCIS will issue a notice of intent to terminate the designation of a regional center in the program if:
(A) A regional center fails to submit the information required in paragraph (m)(6)(i)(B) of this section, or pay the associated fee; or
(B) USCIS determines that the regional center no longer serves the purpose of promoting economic growth, including increased export sales, improved regional productivity, job creation, and increased domestic capital investment.
(iii) A notice of intent to terminate the designation of a regional center will be sent to the regional center and set forth the reasons for termination.
(iv) The regional center will be provided 30 days from receipt of the notice of intent to terminate to rebut the ground or grounds stated in the notice of intent to terminate.
(v) USCIS will notify the regional center of the final decision. If USCIS determines that the regional center's participation in the program should be terminated, USCIS will state the reasons for termination. The regional center may appeal the final termination decision in accordance with 8 CFR 103.3.
(vi) A regional center may elect to withdraw from the program and request a termination of the regional center designation. The regional center must notify USCIS of such election in the form of a letter or as otherwise requested by USCIS. USCIS will notify the regional center of its decision regarding the withdrawal request in writing.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing amendments to requirements under the Clean Air Act (CAA) for state plans for protection of visibility in mandatory Class I federal areas (Class I areas) in order to continue steady environmental progress while addressing administrative aspects of the program. The EPA amendments would clarify the relationship between long-term strategies and reasonable progress goals in state plans, and the long-term strategy obligation of all states. The amendments would also change the way in which some days during each year are to be selected for purposes of tracking progress towards natural visibility conditions to account for events such as wildfires; change aspects of the requirements for the content of progress reports; update, simplify and extend to all states the provisions for reasonably attributable visibility impairment and revoke existing federal implementation plans (FIPs) that require the EPA to assess and address any existing reasonably attributable visibility impairment situations in some states; and add a requirement for states to consult with Federal Land Managers (FLMs) earlier in the development of state plans. The EPA also proposes to address administrative aspects of the program by making a one-time adjustment to the due date for the next state implementation plans (SIPs), revising the due dates for progress reports and removing the requirement for progress reports to be SIP revisions.
For general information on this proposed rule and Information Collection Request (ICR), contact Mr. Christopher Werner, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-5133 or by email at
The following are abbreviations of terms used in this document.
Entities potentially affected directly by this proposed rule include state, local and tribal
When submitting comments, remember to:
• Identify the rulemaking docket by docket number and other identifying information (subject heading,
• Follow directions. The proposed rule may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used to support your comment.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns wherever possible, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
Please note that this is a narrow proposed rulemaking. Please focus your comments on only those sections of the CFR affected by our proposed changes.
The May 19, 2016, public hearing will be held to accept oral comments on this proposed rulemaking. The hearing will be held at the U.S. Environmental Protection Agency, William Jefferson Clinton East Building (WJC East), Room 1117A, 1201 Constitution Avenue NW., Washington, DC. It will convene at 9:00 a.m. and continue until the earlier of 5:00 p.m. or 1 hour after the last registered speaker has spoken. We have scheduled a lunch break from 12:00 to 1:00 p.m. People interested in presenting oral testimony should contact Ms. Pamela Long, Air Quality Planning Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711, telephone (919) 541-0641, fax number (919) 541-5509, email address
Oral testimony will be limited to 5 minutes for each commenter. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) before the hearing and in hard copy form at the hearing.
The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the rulemaking.
Because this hearing is being held at United States (U.S.) government facilities, individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. Please note that the REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. If your driver's license is issued by American Samoa, Illinois or Missouri, you must present an additional form of identification to enter the federal building. Enhanced driver's licenses from Minnesota and Washington are acceptable. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses, and military identification cards. For additional information for the status of your state regarding REAL ID, go to
Attendees may be asked to go through metal detectors. To help facilitate this process, please be advised that you will be asked to remove all items from all pockets and place them in provided bins for screening; remove laptops, phones, or other electronic devices from their carrying case and place in provided bins for screening; avoid shoes with metal shanks, toe guards, or supports as a part of their construction; remove any metal belts, metal belt buckles, large jewelry, watches, and follow the instructions of the guard if identified for secondary screening. Additionally, no weapons or drugs or drug paraphernalia will be allowed in the building. We recommend that you arrive 20 minutes in advance of your speaking time to allow time to go through security and to check in with the registration desk.
In addition to being available in the docket, an electronic copy of this
The information presented in this document is organized as follows:
The EPA is proposing changes to the requirements that states (and, if applicable, tribes) would have to meet as they implement programs for the protection of visibility in mandatory Class I areas.
The EPA is proposing these changes for several reasons, as described more fully in the descriptions of each change detailed later in this proposed action. The proposed clarifications regarding the relationship between reasonable progress goals, long-term strategies and the long-term strategy obligation of all states reflect long-standing EPA interpretation of the Regional Haze Rule and are intended to ensure consistent (and appropriate) understanding of these requirements as states prepare their plans for the second implementation period. Changes to FLM consultation requirements would help ensure that the expertise and perspective of these officials are brought into the state plan development process earlier, so that they contribute meaningfully during the state's technical analysis and deliberations. The proposals related to how days are selected for visibility progress tracking would provide the public and state officials more meaningful information on how existing and potential new emission reduction measures are contributing or could contribute to reasonable progress in reducing man-made visibility impairment, by greatly reducing the trend-distorting effect of wildfires and natural dust storms. Collectively, these changes would serve to strengthen the regional haze program based upon lessons learned during the decade and a half since the program's inception.
With regard to the proposed extension of the current deadline of July 31, 2018, to July 31, 2021, for states' comprehensive SIP revisions for the second implementation period, the EPA believes this one-time change would benefit states by allowing them to obtain and take into account information on the effects of a number of other regulatory programs that will be affecting sources over the next several years. The change would also allow states to develop SIP revisions for the second implementation period that are more integrated with state planning for these other programs, an advantage that was widely confirmed in discussions with states and that is anticipated to result in greater environmental progress than if planning for these multiple programs were not as well integrated. The end date for the second implementation period remains 2028, meaning state plans will still focus on emission reduction measures designed to achieve reasonable progress by 2028,
The proposed changes related to progress reports are intended to make the timing of progress reports more useful as mid-course reviews, to clarify the required content of progress reports for aspects on which there has been some ambiguity, and to allow states to conserve their administrative resources and make progress reports more timely by removing the requirement that they be submitted as formal SIP revisions. We are proposing to retain a requirement that states consult with FLMs on their progress reports, and that states offer the public an opportunity to comment on progress reports before they are finalized, which are two of the steps that apply now to progress reports that are SIP revisions and which will help ensure ongoing accountability for progress reports.
Finally, the current provisions related to reasonably attributable visibility impairment require a recurring process of assessment and planning by the states. Experience since the current provisions were promulgated suggests that situations involving reasonably attributable visibility impairment occur infrequently and therefore that an “as needed” approach for initiating a state planning obligation would be more efficient in the use of resources. The EPA is proposing to replace the recurring process of assessment of reasonably attributable visibility impairment with an as-needed approach, and given our increased understanding of the interstate nature of visibility impairment, to expand the applicability for reasonably attributable visibility impairment from only states with Class I areas to all states. The proposed change to an as-needed approach only applies to reasonably attributable visibility impairment; periodic planning for purposes of regional haze will continue. This would improve visibility protection, if a situation exists or arises in which a source in a state without any Class I area causes reasonably attributable visibility impairment at a Class I area in another state.
The EPA also intends to provide states with updated guidance on the development of regional haze SIPs, in consultation with the states and FLMs, separately from this rulemaking. The guidance will assist states as they refocus on reasonable progress analyses for the next regional haze implementation period ending in 2028. We expect to invite public comment on a draft of this new guidance, and we expect to receive and be able to consider those comments before we finalize the Regional Haze Rule revisions.
In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks, wilderness areas and other Class I areas due to their “great scenic importance.”
In 1980, the EPA promulgated regulations to address visibility impairment in Class I areas, including but not limited to impairment that is “reasonably attributable” to a single source or small group of sources,
It is important to note that not all states were subject to the 1980 reasonably attributable visibility impairment requirements. Under the 1980 rules, the 35 states and one territory (Virgin Islands) containing Class I areas were required to submit SIPs addressing reasonably attributable visibility impairment. The 1980 rules required states to (1) develop, adopt, implement and evaluate long-term strategies for making reasonable progress toward remedying existing and preventing future impairment in the mandatory Class I areas through their SIP revisions; (2) adopt certain measures to assess potential visibility impacts due to new or modified major stationary sources, including measures to notify FLMs of proposed new source permit applications, and to consider visibility analyses conducted by FLMs in their new source permitting decisions; (3) conduct visibility monitoring in mandatory Class I areas, and (4) revise their SIPs at 3-year intervals to assure reasonable progress toward the national visibility goal. In addition, the 1980 regulations provide that an FLM may certify to a state at any time that visibility impairment at a Class I area is reasonably attributable to a single source or small group of sources. Following such a certification by an FLM, a state is required to address the requirements for best available retrofit technology (BART) for BART-eligible sources considered to be contributing to reasonably attributable visibility impairment. Also, the appropriate control of any source certified by an FLM, whether BART-eligible or not, would be specifically addressed in the long-term strategy for making reasonable progress toward the national goal of natural visibility conditions.
In practice, the 1980 rules resulted in few SIPs being submitted by states and approved by the EPA, requiring the EPA to develop and apply FIPs to those states that failed to submit an approvable reasonably attributable visibility impairment SIP. 52 FR 45132 (November 24, 1987). Most of these FIPs contain planning requirements only,
We are proposing extensive changes to the existing provisions regarding reasonably attributable visibility impairment to improve coordination with the regional haze program
Regional haze is visibility impairment that is produced by a multitude of sources and activities that are located across a broad geographic area and emit PM
Data from the existing visibility monitoring network, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) monitoring network, show that at the time the Regional Haze Rule was finalized in 1999, visibility impairment caused by air pollution occurred virtually all the time at most national park and wilderness areas. The average visual range
Based on visibility data through 2014, considerable visibility improvements (4 to 7 deciviews)
Congress added section 169B to the CAA in 1990 to address regional haze issues. Among other things, this section included provisions for the EPA to conduct visibility research on regional regulatory tools with the National Park Service and other federal agencies, and to provide periodic reports to Congress on visibility improvements due to implementation of other air pollution protection programs. Section 169B also generally allowed the Administrator to establish visibility transport commissions and specifically required the Administrator to establish a commission for the Grand Canyon area. The EPA promulgated a rule to address regional haze in 1999. 64 FR 35714 (July 1, 1999). The 1999 Regional Haze Rule established a more comprehensive visibility protection program for Class I areas. The requirements for regional haze are found at 40 CFR 51.308 and 51.309.
The requirement to submit a regional haze SIP applies to all 50 states, the District of Columbia and the Virgin Islands.
Further, 40 CFR 51.308(f) currently requires states to submit periodic comprehensive revisions of implementation plans (referred to in this document as periodic comprehensive SIP revisions) addressing regional haze visibility impairment by no later than July 31, 2018, and every 10 years thereafter. These periodic comprehensive SIP revisions must address a number of elements, including current visibility conditions and actual progress made toward natural conditions during the previous implementation period; a reassessment of the effectiveness of the long-term strategy in achieving the reasonable progress goals over the prior implementation period; and affirmation of or revision to the reasonable progress goals. Further information on these periodic comprehensive SIP revisions can be found in section III.B.3 of this document. In addition, 40 CFR 51.308(g) requires each state to submit progress reports, in the form of SIP revisions, every 5 years after the date of the state's initial SIP submission. The progress reports are required to evaluate the progress made towards the reasonable progress goals for mandatory Class I areas located within the state, as well as those mandatory Class I areas located outside the state that may be affected by emissions from within the state. Further information on progress reports can be found in Section III.B.4 of this document.
The 1999 Regional Haze Rule sought to improve efficiency and transparency by requiring states to coordinate planning under the 1980 reasonably attributable visibility impairment provisions with planning under the provisions added by the 1999 Regional Haze Rule. The states were directed to submit reasonably attributable visibility impairment SIPs every 10 years rather than every 3 years, and to do so as part of the newly required regional haze SIPs. Many, but not all, states submitted initial regional haze SIPs that committed to this coordinated planning process. Coordination of reasonably attributable visibility impairment and regional haze planning is described in more detail later.
Successful implementation of the regional haze program requires long-
Because the pollutants that lead to regional haze can originate from sources located across broad geographic areas, and because these sources may be numerous and emit amounts of pollutants that, even though small, contribute to the collective whole, the EPA has encouraged states to address visibility impairment from a regional perspective. Five regional planning organizations (RPOs) were formed after the promulgation of the Regional Haze Rule in 1999 to address regional haze and related issues. The RPOs first evaluated technical information to better understand how their states and tribes impact Class I areas across the country, and then supported the development (by states) of regional strategies to reduce emissions of pollutants that lead to regional haze.
The Regional Haze Rule required the implementation plans due in 2007, which covered what we refer to as the first implementation period, to give specific attention to certain stationary sources that were in existence on August 7, 1977, but were not in operation before August 7, 1962, by requiring these sources, where appropriate, to install BART controls for the purpose of eliminating or reducing visibility impairment.
States undertook the BART determination process during the first implementation period. The BART requirement was a one-time requirement, but BART-eligible sources may need to be re-assessed for additional controls in future implementation periods under the CAA's reasonable progress provisions. Specifically, we anticipate that BART-eligible sources that installed minor controls (or no controls at all) will need to be reassessed. States should treat BART-eligible sources the same as other reasonable progress sources going forward. Consequently, we are not proposing any changes to the BART provisions in this rulemaking.
States must also develop an estimate of natural visibility conditions for the purpose of estimating progress toward the national goal. Natural visibility is determined by estimating the natural concentrations of pollutants that cause visibility impairment and then calculating total light extinction based on those estimates. The EPA has provided guidance to states regarding how to calculate baseline, natural and current visibility conditions at each Class I area.
Baseline visibility conditions reflect the degree of visibility impairment for the 20 percent least impaired days and 20 percent most impaired days for each calendar year from 2000 to 2004. Using monitoring data for 2000 through 2004, states are required to calculate the average degree of visibility impairment for each Class I area, based on the average of annual values over the 5-year period. The comparison of initial baseline visibility conditions to natural visibility conditions indicates the amount of improvement that would be necessary to attain natural visibility. Over time, the comparison of current conditions
The rule text adopted in 1999 defined “visibility impairment” as a humanly perceptible change (
In establishing reasonable progress goals, states are required to consider the following factors set out in the definition of “reasonable progress” in section 169A of the CAA and incorporated into the Regional Haze Rule at 40 CFR 51.308(d)(1)(i)(A): (1) The costs of compliance; (2) the time necessary for compliance; (3) the energy and non-air quality environmental impacts of compliance; and (4) the remaining useful life of any potentially affected sources. States must demonstrate in their SIPs how these factors have been considered when selecting the reasonable progress goals for the least impaired and most impaired days for each applicable Class I area. It is important to understand that a state's long-term strategy is inextricably linked to the reasonable progress goals because the long-term strategy “must include enforceable emission limitations, compliance schedules, and other measures as necessary to achieve the reasonable progress goals established by states having mandatory Class I Federal areas.” 40 CFR 51.308(d)(3). As intended by the EPA and as understood by all states in the first implementation period, the four reasonable progress factors are considered by a state in setting the reasonable progress goal by virtue of the state having first considered them, and certain other factors listed in § 51.308(d)(3) of the Regional Haze Rule, when deciding what controls are to be included in the long-term strategy. Then, the numerical levels of the reasonable progress goals are the predicted visibility outcome of implementing the long-term strategy in addition to ongoing pollution control programs stemming from other CAA requirements. To ensure consistent understanding about the relationship between reasonable progress goals and the long-term strategy, we are proposing rule text changes to clarify this
In deciding on the long-term strategy and in setting the reasonable progress goals, states must also consider the rate of progress for the most impaired days that would be needed to reach natural visibility conditions by 2064 and the emission reduction measures that would be needed to achieve that rate of progress over the approximately 10-year period of the SIP. Uniform progress towards achievement of natural conditions by the year 2064 represents a rate of progress that states are to use for analytical comparison to the amount of progress they expect to achieve on average. The CAA has the goal of reaching natural conditions,
In setting reasonable progress goals, each state with one or more Class I areas must also consult with potentially “contributing states,”
In accordance with the Regional Haze Rule, states should consider all types of anthropogenic sources of visibility impairment in developing their long-term strategy, including major and minor stationary sources, mobile sources and area sources. At a minimum, states must describe how each of the following seven factors are taken into account in developing their long-term strategy: (1) Emission reductions due to ongoing air pollution control programs, including measures to address reasonably attributable visibility impairment; (2) measures to mitigate the impacts of construction activities; (3) emissions limitations and schedules for compliance to achieve the reasonable progress goal; (4) source retirement and replacement schedules; (5) smoke management techniques for agricultural and forestry management purposes including plans as currently exist within the state for these purposes; (6) enforceability of emissions limitations and control measures; and (7) the anticipated net effect on visibility due to projected changes in point, area and mobile source emissions over the period addressed by the long-term strategy. 40 CFR 51.308(d)(3)(v). We are proposing to update the terminology in the fifth of these factors. We are not proposing any changes to the current requirements regarding the other six factors.
As discussed earlier, the current version of the Regional Haze Rule requires control strategies to cover an initial implementation period extending to the year 2018, with a comprehensive reassessment and revision of those strategies, as appropriate, every 10 years thereafter. The reasonable progress goals are specific to the end date of a given implementation period. New reasonable progress goals for the end of the next period are established in the next periodic comprehensive SIP revision. We are proposing to extend, to July 31, 2021, the due date for the SIP revision that under the existing Regional Haze Rule is due July 31, 2018. This proposed change is discussed in the “Proposed Rule Changes” section of this document (Section IV.J).
The current version of the Regional Haze Rule includes provisions for progress reports to be submitted at 5-year intervals, counting from the submission of the first required SIP revision by the particular state. The requirements for these reports are included for most states in 40 CFR 51.308 (g) and (h). Three western states (New Mexico, Utah and Wyoming) exercised an option provided in the Regional Haze Rule to meet alternative requirements contained in 40 CFR 51.309 for their SIPs. For these three states, the requirements for the content of the 5-year progress reports are identical to those for the other states, but for these states the requirements for the reports are codified in 40 CFR 51.309(d)(10). This section specifies fixed due dates in 2013 and 2018 for these progress reports. Regardless, the current Regional Haze Rule provides that these three states will revert to the progress report requirements in 40 CFR 51.308 after the report currently due in 2018.
An explanation of the 5-year progress reports is provided in the preamble to the 1999 Regional Haze Rule. 64 FR 35747 (July 1, 1999). This 5-year review is intended to provide an interim report on the implementation of, and, if necessary, mid-course corrections to, the regional haze SIP, which, as noted earlier, is prepared in 10-year increments. The progress report provides an opportunity for public input on the state's (and the EPA's) assessment of whether the approved regional haze SIP is being implemented appropriately and whether reasonable visibility progress is being achieved consistent with the projected visibility improvement in the SIP.
Required elements of the progress report include: The status of implementation of all measures included in the regional haze SIP; a summary of the emissions reductions achieved throughout the state; an assessment of current visibility conditions and the change in visibility impairment over the past 5 years; an analysis tracking the change over the past 5 years in emissions of pollutants contributing to visibility impairment from all sources and activities within the state; an assessment of any significant changes in anthropogenic emissions within or outside the state that have occurred over the past 5 years that have limited or impeded progress in reducing pollutant emissions and improving visibility; an assessment of whether the current SIP elements and strategies are sufficient to enable the state (or other states with mandatory Class I areas affected by emissions from the state) to meet all established reasonable progress goals; a review of the state's visibility monitoring strategy and any modifications to the strategy as necessary; and a determination of the adequacy of the existing SIP (including
In accordance with 40 CFR 51.308(g) and 51.309(d)(10), progress reports must currently take the form of SIP revisions, so states must follow formal administrative procedures (including public review and opportunity for a public hearing) before formally submitting the 5-year progress report to the EPA.
In addition, as with SIPs, states are required to provide FLMs with an opportunity for in-person consultation at least 60 days prior to any public hearing on an implementation plan or plan revision, which must include an opportunity for FLMs to discuss their assessment of impairment of visibility in any mandatory Class I area, and discuss their recommendations on the development of reasonable progress goals and the development of implementation strategies to address visibility impairment.
The first progress reports are currently due 5 years from the initial SIP submittal (with the next progress reports for New Mexico, Utah, and Wyoming due in 2018). Most of these deadlines have already passed although some are due in 2016 and in 2017. We are proposing a set of common due dates for future progress reports from all states, as described in Section IV.K of this document.
Tribes have a distinct interest in regional haze due to the effects of visibility impairment on tribal lands as well as on other lands of high value to tribal members, such as landmarks considered sacred. Tribes, therefore, have a strong interest in emission control measures that states and the EPA incorporate into SIPs and FIPs with regard to regional haze, and also have an interest in the state response to any reasonably attributable visibility impairment certification made by an FLM.
The EPA takes seriously our government-to-government relationship with tribes.
In the first implementation period for regional haze SIPs, the partnerships within the RPOs included strong relationships between the states and the tribes, and the EPA encourages states to continue to invest in those relationships (including consulting with tribes), particularly with respect to tribes located near Class I areas. States should continue working directly with tribes on their SIPs and their response to any reasonably attributable visibility impairment certification made by an FLM. The EPA believes that it is preferable for states to address tribal concerns during their planning process rather than the EPA addressing such concerns in its subsequent rulemaking process. During the development of this rulemaking, the EPA was asked by the National Tribal Air Association to adopt a requirement that states formally consult with tribes during the development of their regional haze SIPs. While we recognize the value of dialog between state and tribal representatives, we are not proposing to require it. We note that the CAA does not explicitly authorize the EPA to impose such a requirement on the states.
One part of the visibility protection program, 40 CFR 51.307, New Source Review, was created in 1980 with the rationale that while most new sources that may impair visibility were already subject to review under the Prevention of Significant Deterioration (PSD) provisions (Part C of Title I of the CAA), additional regulations would “ensure that certain sources exempt from the PSD regulations because of geographic criteria will be adequately reviewed for their potential impact on visibility in the mandatory Class I Federal area.” 45 FR 80084 (December 2, 1980). The EPA explained at proposal that this was necessary because the PSD regulations did not call for the review of major emitting facilities (or major modifications) located in nonattainment areas,
The changes being proposed by the EPA will continue steady environmental progress in the regional haze program while streamlining its administrative aspects that do not add to environmental protection. The EPA has gained a substantial amount of knowledge through the process of approving SIPs for the first regional haze implementation period and has learned what aspects of the program work well and what aspects should be modified going forward. Feedback
The EPA is proposing to amend § 51.308(f) of the Regional Haze Rule, which contains the requirements for comprehensive periodic revisions to regional haze SIPs, by adding new provisions that will govern the development of long-term strategies and reasonable progress goals in future implementation periods. We are proposing these changes to make clear the connections between the existing long-strategy and reasonable progress goal requirements. Although the regional haze SIPs submitted by the states during the first planning period generally demonstrated a clear understanding of the connections between these two program elements, recent comments by some owners of industrial sources and states have indicated confusion as to the meaning of these provisions. The EPA's proposed revisions to § 51.308(f) are consistent with the EPA's long-standing interpretation
Section 51.308(d) of the existing Regional Haze Rule is organized into four subsections: (d)(1), concerning the calculation of reasonable progress goals; (d)(2), concerning the calculation of baseline and natural visibility conditions; (d)(3), concerning the development of long-term strategies; and (d)(4), concerning the development of monitoring strategies. This organizational structure does not reflect the actual sequence of steps in the regional haze planning process. For example, § 51.308(d) lists the requirements for reasonable progress goals before the requirements for long-term strategies. In practice, states must evaluate the four statutory factors to select emission control measures for their long-term strategies before they can calculate their reasonable progress goals by modeling the visibility improvement that will result from the implementation of those controls.
To address this issue and provide clarity to states and other stakeholders, the EPA is proposing to organize the requirements in § 51.308(f) in a more logical fashion. First, proposed subsection (f)(1) provides the requirements governing the calculation of baseline and natural visibility conditions, which are necessary to calculate the URP. A state should calculate current visibility conditions, the URP and the URP line first. In doing so, the contributions of PM species to current anthropogenic light extinction (referred to as the anthropogenic light extinction budget) will become evident, which will inform the state's thinking as to which sources or source categories should be evaluated for potential reasonable progress control measures. Second, proposed subsection (f)(2) provides the requirements governing the development of long-term strategies. In this step, states must, among other things, evaluate sources that impact visibility at one or more Class I areas for potential control measures by considering the four statutory factors. Third, proposed subsection (f)(3) provides the requirements governing the calculation of reasonable progress goals. Once a state has established emission limitations and other control measures as part of its long-term strategy, the state will have the information necessary to model the visibility improvement that will result at each Class I area on the 20 percent most impaired days and 20 percent clearest days after the long-term strategy has been implemented. The projected visibility conditions at the end of the applicable implementation period constitute the reasonable progress goals. States must then compare the goals for the Class I area to the URP. If the goal for the 20 percent most impaired days is above the URP line, the state must demonstrate that there are no additional control measures for sources reasonably anticipated to contribute to visibility impairment in the Class I area that are reasonable to include in the long-term strategy. Finally, proposed subsection (f)(6) provides the requirements governing monitoring strategies, which must be sufficient to allow states to assess the adequacy of their long-term strategies going forward.
In addition to these organizational changes, the EPA is proposing new language in § 51.308(f)(2) that differs from the existing language in § 51.308(d)(3), but is intended to achieve the same result. First, the EPA is proposing language in § 51.308(f)(2)(i) and (iv) to clarify that all states, not just those with Class I areas, must consider the four statutory factors and properly document all cost, visibility and other technical analyses when developing their long-term strategies. Second, the EPA is proposing language in § 51.308(f)(2)(ii) that requires states to consider the URP and the measures that contributing states are including in their long-term strategies when determining whether the state's own long-term strategy is sufficient to ensure reasonable progress.
The following clarifications and changes are also proposed to be included in the revised § 51.308(f).
To ensure consistent understanding, the EPA is proposing rule revisions to state explicitly that in every implementation period, the glidepath or URP line for each Class I area is drawn starting on December 31, 2004, at the value of the 2000-2004 baseline visibility conditions for the 20 percent most impaired days, and ending at the value of natural visibility conditions on December 31, 2064. In this way, it is clear that for a Class I area that has achieved more than the URP in the first implementation period, the state can take that into account in its URP analysis for the second implementation period. Specifying that the 5-year average baseline visibility conditions are associated with the date of December 31, 2004 and that natural visibility conditions are associated with the date of December 31, 2064 also clarifies that the period of time between the baseline period and natural visibility conditions, which is needed for determining the URP (deciviews/year) is 60 years.
Note that because of updates to the IMPROVE program, some data values from 2000-2004 may be revised over time.
Along with the clarification that the baseline period remains 2000-2004 for subsequent implementation periods, the EPA also proposes to include clarifications on how states treat Class I areas without available monitoring data or Class I areas with incomplete monitoring data. If Class I areas do not have monitoring data for the baseline period, data from representative sites should be used. If baseline monitoring data are incomplete, states should use the 5 complete years closest to the baseline period (
As part of this clarification and to maintain consistency in the reasonable progress goal framework, the proposed language in § 51.308(f)(3)(i) (and an accompanying definition of “end of the applicable implementation period” added to § 51.301) would make clear that reasonable progress goals are to address the period extending to the end of the year of the due date of the next periodic comprehensive SIP revision. Also, proposed § 51.308(f)(1)(iv) specifies the end day of 2064 as the ending point of the glidepath or URP line.
The current text of § 51.308(d)(1)(ii) discusses required actions of the state containing the Class I area should it set a reasonable progress goal that provides for a slower rate of visibility improvement than that needed to attain natural conditions by 2064 (
In existing sections 51.308(d)(2)(iv) and 51.308(d)(3)(i) and (ii), sentences addressing obligations of the state with the Class I area and obligations of the contributing state(s) are juxtaposed in such a way that it can be confusing for a reader to understand which of the two states is being referred each time the word “state” appears. The proposed § 51.308(f)(2)(iii) more clearly spells out the respective consultation responsibilities of states containing Class I areas as well as states with sources that may reasonably be anticipated to cause or contribute to visibility impairment in those areas.
To clarify and solidify the obligations of what we are referring to as contributing states, § 51.308(f)(3)(ii)(B) is proposed to specify that in situations where reasonable progress goals are set above the glidepath, a contributing state must make the same demonstration with respect to its own long-term strategy that is required of the state containing the Class I area, namely that there are no other measures needed to provide for reasonable progress. This provision will ensure that states perform rigorous analyses, and adopt measures necessary for reasonable progress, with respect to Class I areas that their sources contribute to, regardless of whether such areas are physically located within their borders.
Section 51.308(d) of the existing Regional Haze Rule requires states to determine the visibility conditions (in deciviews) for the average of the 20 percent least impaired and 20 percent most impaired visibility days over a specified time period at each of their Class I areas. Section 51.301 of the Regional Haze Rule defines visibility impairment as the humanly perceptible change in visibility from that which would have existed under natural conditions. This definition of visibility impairment suggests that only visibility impacts from anthropogenic sources should be included when considering the degree of visibility impairment. However, the preamble to the 1999 final rule stated that the least and most impaired days were to be selected as the monitored days with the lowest and highest actual deciview levels, respectively. 64 FR 35728 (July 1, 1999). The interpretation in the preamble was subsequently reflected in the EPA guidance on setting reasonable progress goals and tracking progress. In practice, in their SIPs for the first implementation period states followed the approach described in the 1999 preamble and the subsequent guidance, and the EPA approved the SIPs with respect to that aspect. However, as described later, experience now indicates that for the most impaired days an approach focusing on anthropogenic impairment in particular is more appropriate going forward. We are not proposing to change the approach of using the 20 percent of days with the best visibility to represent good visibility conditions for reasonable progress goal and tracking purposes, but we are proposing text changes to accurately describe how those days are to be selected. These days would be referred to as the 20 percent clearest days.
Natural contributions to the total actual deciview levels vary from year to year. In order to minimize interannual variability, the Regional Haze Rule uses 5-year averages for determining the baseline and current visibility conditions. Also, under the EPA's modeling guidance for regional haze SIPs, reasonable progress goals are projected starting from the average of visibility conditions in a 5-year period that is centered around (or at least includes) the year of the base emission inventory used in the air quality modeling process. Now that many visibility monitoring sites have at least 15 years of data, it is clear that in some locations 5-year averages are not long enough to dampen the visibility impacts of occasional extreme fire years. In their SIPs and SIP revisions for the first implementation period, some states explained that the 20 percent most impaired days in certain Class I areas can be dominated by uncontrollable visibility impacts. Many states, particularly western states, have urged
To help states minimize the impacts of uncontrollable emissions on visibility tracking, the EPA proposes to more explicitly (and consistently) address this issue for future implementation periods. In general, the proposed changes related to the selection of days for visibility tracking are intended to accomplish the following for future implementation periods: (1) Clarify that “visibility impairment” means the deviation from natural visibility and therefore is due to anthropogenic impacts, (2) revise definitions in § 51.301 to make clear that the 20 percent most impaired days should be selected based on anthropogenic visibility impairment rather than based on the days with highest deciview values due to impacts from all types of sources, and (3) continue to use the 20 percent of days with the lowest total deciviews (
The definitions in § 51.301 for several terms and phrases related to the selection of days for visibility tracking have been clarified in the proposed revisions of the rule text. Definitions that are proposed to be changed slightly to provide more clear explanations of their meanings include the following:
Additionally, we propose definitions for the following previously undefined terms be included in § 51.301:
Given the current Regional Haze Rule's definitions of
The EPA seeks comment also on a second, alternative proposal under which the final rule would allow each state with a Class I area to choose between using the revised approach described earlier (using the 20 percent most anthropogenically impaired days) and using the 20 percent haziest days (whether dominated by natural or anthropogenic impacts) to track visibility as all states with Class I areas did in the first regional haze SIPs. (This alternative approach is not laid out in proposed rule text revisions, but only minor edits would be required to implement it in the final rule.) If the final rule takes this approach, states would still have the option to also present the visibility data using the other approach.
In summary, the EPA seeks comment on two approaches for selecting the 20 percent “worst” days from the IMPROVE monitoring data. In the first approach, states would be required to select the 20 percent most impaired days,
If the 20 percent most anthropogenically impaired days are used to estimate natural visibility conditions, current visibility conditions and the URP, they must also be used in setting reasonable progress goals and in progress reports. Conforming edits are being proposed to the provisions related to each of these, for that purpose. If the final rule requires the revised approach described earlier in the first proposal, it would apply starting with the second and subsequent periodic comprehensive SIP revisions and then to progress reports submitted after the second SIP revision. There would be no change with respect to the EPA action on SIP revisions for the first implementation period.
In order to select the 20 percent most impaired days based on the days with the most anthropogenic impairment, natural contributions to daily deciview values must be estimated by some method. This in turn requires measured concentration values for PM components to be allocated to natural versus anthropogenic sources. The EPA is not proposing that any particular method for determining natural contributions to daily haze and thus the degree of visibility impairment for each monitored day be codified in the rule
The EPA acknowledges that emissions (natural and anthropogenic) from other countries (and from marine vessel activity in non-U.S. waters) may impact Class I areas, especially those areas near borders and coastlines. We have had requests from states with such Class I areas that given these emissions are beyond states' control, the states should be allowed to account for international impacts when preparing SIPs and progress reports. For example, states have requested that they be allowed to consider impacts from international emissions when comparing their reasonable progress goals to the URP line. This comparison matters because (as described in Section IV.C of this document) it may trigger an additional analytical requirement by the state. Impacts from international emissions can also affect whether a progress report will conclude that actual visibility conditions are approaching the reasonable progress goals for the end of the implementation period. It has been suggested to the EPA that estimated impacts from international emissions might be added to the 2064 end point of the URP line. It has also been suggested that estimated impacts from international emissions be subtracted from baseline and current visibility conditions.
On this issue, we first wish to clarify that it has never been the intention of the EPA that states be obligated to in any way compensate for haze impacts from anthropogenic international emissions by adopting more stringent emission controls on their own sources. We also wish to note that impacts from natural sources in other countries should be considered part of natural visibility conditions. States have the flexibility under the Regional Haze Rule to justify and use values for natural visibility conditions that include such effects. We believe the proposed changes regarding which days in a year are used for tracking progress (
The EPA has further considered possible approaches regarding the impacts from anthropogenic sources in other countries, including border countries as well as more distant countries such as China. It is the role of the federal government, much more than of the states, to work with other countries to make such reasonable progress. The EPA is, in fact, actively engaged with other countries to help them reduce their anthropogenic emissions, particularly emissions in Mexico from sources near the U.S.-Mexico border.
We believe that it may be appropriate to allow states to adjust the reasonable progress goal framework, including their progress reports, to explicitly take into account international impacts from anthropogenic sources, but only when and if these impacts can be estimated with sufficient accuracy. We do not believe that explicit consideration of impacts from anthropogenic sources outside the U.S. would actually affect the conclusions that states should make about what emission controls for their own sources are needed for reasonable progress. Even so, explicit quantification of international impacts, if accurate, could improve public understanding and effective participation in the development of regional haze SIPs. Also, taking international impacts into account in some cases may affect whether a state (and contributing states) are subject to the requirement of proposed § 51.308(f)(3)(ii) regarding a demonstration that there are not additional emission reduction measures needed for reasonable progress. However, we are not convinced that such impacts can be estimated with sufficient accuracy at this time, in part due to great uncertainty about past, present and future emissions from sources in most other countries. However, it may be that by the time some future periodic comprehensive SIP revisions are to be prepared, for some states possibly as early as when they are preparing their second SIP, methods and data for estimating international impacts will be substantially more robust.
Therefore, the EPA is requesting comment on a proposed provision that would allow states with Class I areas significantly impacted by international emissions to make an adjustment to the URP with specific approval by the Administrator. The adjustment would consist of adding to the value of natural visibility conditions an estimate of international impacts, only for the purpose of calculating the URP.
Fires on wildlands within the U.S. can significantly impact visibility in some Class I areas on some days and have lesser impacts on a greater number of days. Accordingly, we discuss here whether measures to reduce emissions from wildland wildfire and wildland
An extensive discussion of the background on wildland fire concepts, including actions that the manager of a prescribed fire can take to reduce the amount of smoke generated by a prescribed fire and/or to reduce public exposure to the smoke that is generated (
We do not consider the term smoke management program for the purposes of § 51.308(f)(2)(v)(E) to mean programs that include only seasonal restrictions on burning because of fire safety concerns, voluntary educational programs designed to raise air quality awareness of potential prescribed fire users, voluntary programs in which land managers agree to coordinate their prescribed fire activities but are free to withdraw from the program at any time or some combination of the above. The EPA supports these latter types of programs, but we do not believe it is appropriate to have the obligation in § 51.308(f)(2)(v)(E) triggered by the existence of these types of programs.
The recently proposed revisions to the Exceptional Events Rule would clarify that in the context of the regulatory programs for the protection of the NAAQS, (i) wildland wildfires are natural events and prescribed fires are anthropogenic events; (ii) a wildland wildfire is not controllable or preventable (in the sense that generally it would not be reasonable to expect efforts at prevention of occurrence and/or control of emissions to have gone beyond the efforts actually made for a given wildfire by responsible land managers and fire safety officials); (iii) a prescribed fire is not reasonably controllable (in the sense that it would not have been reasonable to do more to control its emissions) if it was conducted in accordance with a state-certified smoke management plan or if the burn manager has employed appropriate basic smoke management practices; and (iv) a prescribed fire is presumptively not reasonably preventable (in the sense that it not would have been reasonable to not conduct it, because of the multiple important benefits that would have been foregone) if a multi-year land or resource management plan
As natural events, two issues are associated with wildfires on wildland. The first is whether and how a state is obligated to consider measures which could reduce emissions from these wildfires as part of a regional haze program. The second issue is the one identified at the start of this section, namely the possible impact of wildland wildfires on whether the RPG is above the URP line and thus whether a state is subject to the additional analytical requirement described Section IV.B of this document.
As anthropogenic events, two issues are associated with prescribed fires on wildland. The first is whether and how a state is obligated to consider measures that could reduce emissions from these prescribed fires as part of a regional required haze program. The second issue is the possible impact of wildland prescribed fires on whether the RPG is above the URP line.
Taken together, we interpret these provisions to mean that every state must consider whether wildland prescribed fires contribute to impairment at their own Class I areas or Class I areas in other states. If they do not contribute to any meaningful degree, the SIP may take note of this and thereby satisfy both provisions. If prescribed fires in a state contribute meaningfully to impairment at a Class I area, the state is required to consider basic smoke management practices for prescribed fires in the development of its long-term strategy, regardless of whether or not those practices are currently being implemented, required by state law or mandated by an EPA-approved SIP. The state would be required to consider only smoke management programs as currently exist within the state.
We would like to make clear that taken together, these two provisions do not necessarily require any state to “select” wildland prescribed fire (under § 51.308(f)(2)(v)) as an anthropogenic source of visibility impairment for which it must consider and analyze emission reduction measures (such as a smoke management program or basic smoke management practices) based on the four reasonable progress factors listed in § 51.308(f)(2)(i). Thus, a state is not necessarily required to develop cost estimates for smoke management programs or basic smoke management practices. However, if a state does not “select” wildland prescribed fire as a source for four-factor analysis, it must explain why it has not. As previously stated, the explanation may be as simple as taking note that prescribed fires do not make a meaningful contribution to visibility impairment at in-state and nearby Class I areas. Where prescribed fires are more important, it may be sufficient for the SIP revision to explain the role of properly planned and managed wildland prescribed fire as described in this section, the state's ongoing smoke management programs, if any, and the current and possibly increased future use of basic smoke management practices by federal, state, local and private land managers, but not to “select” wildland prescribed fire as a source category for four-factor analysis.
If a state does “select” wildland prescribed fire as a source for four-factor analysis, the state must conclude this analysis by determining whether additional measures to reduce emissions from wildland prescribed fire are necessary for reasonable progress. Any such measures must be included in the long-term strategy. Because some of the basic smoke management practices are difficult to describe with the specificity needed to make them practically enforceable, it may not be appropriate to conclude that a SIP requirement for the use of each practice is necessary for reasonable progress. For example, one basic smoke management practice is to monitor the effects on air quality due to the smoke plume from a prescribed fire. “Monitoring” could include ground-based visual observations, aircraft observations, meteorology-based modeling, fixed or portable air quality monitoring stations, hand-held monitors, etc. Because the most appropriate monitoring approach is often situation- and resource-specific, mandating a specific approach is inadvisable. Therefore, a SIP commitment for a state or local agency to include the use of basic smoke management practices could be more desirable than a SIP requirement for land managers to use each basic smoke management practice.
Given the benefits of prescribed fires including the reduction they can achieve in visibility-obscuring smoke from wildfires that affect visitor's experiences even though not intended to be reflected in the metrics for tracking progress towards natural visibility conditions, a state may determine that reasonable progress does not require implementation of a new or revised smoke management program that includes an authorization to burn component,
While the Regional Haze Rule thus does not require regional haze SIPs to include measures to limit emissions from prescribed fire, it is not our intention to in any way discourage federal, state, local or tribal agencies or private land owners from taking situation-appropriate steps to minimize emissions from prescribed fires on wildland, or other types of land. The EPA encourages all land owners and managers to apply appropriate basic smoke management practices to reduce emissions from prescribed fires. The EPA understands that the FLMs apply these measures routinely and will be available to consult with other agencies and private parties interested in doing the same.
Generally, as discussed earlier in this section, we do not expect the total acreage subject to prescribed fires on wildlands to decrease in the future because prescribed fire is needed for ecosystem health and to reduce the risk of catastrophic wildfires.
If the projected RPG for a Class I area is above the URP line due only to the anticipated use of wildland prescribed fire needed for ecosystem health and to reduce the risk of catastrophic wildfires, we do not believe that states should expend valuable analytical and decision making resources on additional analysis of measures necessary for reasonable progress if basic smoke management practices have been applied to prescribed fires and the states have otherwise satisfied the terms of the Regional Haze Rule. Therefore, we are requesting comment on a proposed provision in § 51.308(f)(1)(vi) that would allow states with Class I areas significantly impacted by emissions from wildland prescribed fires to make an adjustment to the URP with specific approval by the Administrator. The adjustment would consist of adding to the value of natural visibility conditions an estimate of wildland prescribed fire impacts, only for the purpose of calculating the URP and only for prescribed fires that were conducted with the objective to establish, restore and/or maintain sustainable and resilient wildland ecosystems, to reduce the risk of catastrophic wildfires and/or to preserve endangered or threatened species during which appropriate basic smoke management practices were applied. We would consider a plan for prescribed fire use on federal, state, tribal or private lands with this objective that has been reviewed and certified by the appropriate fire and/or resource management professionals and agreed to and followed by the land owner/manager to be sufficient to meet this restriction on the scope of the adjustment to the URP.
We are also proposing changes to fire-related definitions in § 51.301. One of the proposed changes is to remove the term “prescribed natural fire” from the definition of “fire” because we consider prescribed fires to be anthropogenic, although we recognize that some prescribed fires are intended to emulate and/or mitigate natural wildfires that would otherwise occur at some point in time. In addition, we are adding definitions for wildland, wildfire and prescribed fire. The proposed definitions are consistent with the definitions we recently proposed for inclusion in the Exceptional Events Rule.
The EPA believes that additional amendments to § 51.308(g) are appropriate at this time in order to clarify the substance of the regional haze progress reports. In its current form, there is ambiguity in this section with respect to the period to be used for calculating current visibility conditions, as well as ambiguity with respect to whether forward-looking, quantitative modeling is required in the progress reports to assess whether reasonable progress goals will be met. The EPA wishes to clarify both of these and other issues, and so proposes to amend § 51.308(g) in the following ways. The EPA seeks comment on these proposed amendments as well as alternative approaches.
Section 51.308(g)(3)(ii) is proposed to be amended by adding a number of explanatory sentences to better indicate what “current visibility conditions” are and how to calculate them. Under the current version of the rule, it is not clear what “current visibility conditions” are, in part because the term is not defined in § 51.301. Although § 51.308(g)(3) makes reference to 5-year averages of
Section 51.308(g)(3)(iii), as currently written, requires a progress report to contain the value of the change in visibility impairment for the most and least impaired days over the past 5 years. This text fails to make clear what the “past 5 years” are for assessing the change in visibility impairment. Because of data reporting delays, the period covered by available monitoring data will not line up with the periods defined by the submission dates for progress reports. Moreover, it is important to ensure that each year of visibility information is included either in a periodic comprehensive SIP revision or the progress report that follows it. Therefore, the “past 5 years” text is proposed to be deleted and replaced with text indicating the change in visibility impairment is to be assessed over the period since the period addressed in the most recent periodic comprehensive SIP revision.
The same change to existing “past 5 years” text is proposed to be made to the first sentence of § 51.308(g)(4) for the purposes of reporting changes in emissions of pollutants contributing to visibility impairment, for similar reasons. Like monitoring trend summaries, available emissions trend summaries will not line up with the periods defined by the submission dates of progress reports. Therefore, the proposed language removes the “past 5 years” text and replaces it with text indicating the change in emissions of pollutants contributing to visibility impairment is to be assessed over the period since the period addressed in the most recent periodic comprehensive SIP revision.
The final sentence of § 51.308(g)(4) is proposed to be modified to revise and clarify the obligation of states regarding emissions inventories. The current rule text directs the analysis be based on the “most recent updated emissions inventory,” with emissions estimates “projected forward as necessary and appropriate to account for emissions changes during the applicable 5-year period.” States are otherwise required by 40 CFR part 51, subpart A (Air Emissions Reporting Requirements) to prepare complete emission inventories only for every third calendar year (2011, 2014, etc.) and to submit these inventories to the EPA's National Emissions Inventory (NEI). (After aggregating and quality assuring these submissions, the EPA then publicly provides summaries of the inventories that have been submitted.) The current text of § 51.308(g)(4) seemingly requires a state to “project” the most recent of these inventories to the end of the “applicable 5-year period” whenever that end is not the year of a triennial inventory required by subpart A. Emissions projection is not a simple or low-resource task even if limited to a projection date that is in the recent past, as would be the case here. We do not think the informational value of such projections is in balance with the effort and time that would be required. At the same time, we believe that progress reports should present for each significant source sector the most recently available information, which may be newer for some sectors than for others. For most sectors, this will be the information for the triennial year of the most recent NEI submission. However, the EPA operates a data system that provides information on emissions from electric generating units (EGUs), which account for a significant percentage of visibility impairing pollution in many states, with only a few months lag time. This information comes from reports submitted by the EGU operators based on continuous emissions monitoring systems. Therefore, we are proposing text changes that explain clearly the most recent year through which the emissions analysis must be extended, by sector. States would be required to include in their progress reports emissions with respect to all sources and activities up to the triennial year for which information has already been submitted to the NEI. With regard to EGUs, states would need to include data up to the most recent year for which the EPA has provided a state-level summary of such EGU-reported data. Finally, the last sentence of the proposed text for this section makes clear that if emission estimation methods have changed from one reporting year to the next, states need not backcast,
Section 51.308(g)(5) involves assessments of any significant changes in anthropogenic emissions that have occurred, and is proposed to be changed in a similar fashion to other sections, deleting the reference to the “past 5 years” and instead directing that the period to be assessed involves that since the last periodic comprehensive SIP revision. Text is also proposed to be added that would require states to report whether these changes were anticipated in the most recent SIP. Having this explanation within the progress report should not be a significant burden on the state and will
The existing § 51.308(g)(6) is proposed to be renumbered as § 51.308(g)(7). Proposed changes to its provisions regarding assessment of progress toward meeting reasonable progress goals would clarify that the reasonable progress goals to be assessed are those established for the period covered by the most recent periodic comprehensive SIP revision. This does not change the intended meaning of this section, and only clarifies that in a progress report, a state is not required to look forward to visibility conditions beyond the end of the current implementation period.
The new § 51.308(g)(6) is proposed to include a provision requiring a state whose long-term strategy includes a smoke management program for prescribed fires on wildland to include a summary of the most recent periodic assessment of the smoke management program including conclusions that were reached in the assessment as to whether the program is meeting its goals regarding improving ecosystem health and reducing the damaging effects of catastrophic wildfires.
A final proposed change to § 51.308(g) is to remove the provisions of the existing § 51.308(g)(7) entirely, relieving the state of the need to review its visibility monitoring strategy within the context of the progress report. This change was requested by many states during our pre-proposal consultations, and is appropriate in our view. Because all states currently rely on their participation in the IMPROVE monitoring program and expect to continue to do so, continuing the requirement for every state to submit a distinct monitoring strategy element in each progress report would consume state and EPA resources with little or no practical value for visibility protection. As needed, the EPA will work with involved states and the IMPROVE Steering Committee to address any needed changes in the visibility monitoring program.
It should be noted that minor changes are proposed to § 51.308(h) regarding actions the state is required to take based on the progress report. These changes merely remove the implication that all progress reports are to be submitted at 5-year intervals, and improve public understanding of the declaration that a state must make when it determines that no SIP revisions are required by removing the word “negative.” Minor changes are also proposed to § 51.308(i) in order to create a stand-alone requirement that states must consult with FLMs regarding progress reports. This stand-alone requirement is needed if progress reports are not SIP revisions, because at present the FLM consultation requirements are applicable only to SIP revisions.
The EPA is proposing extensive changes to 40 CFR 51.300 through 51.308 in regard to reasonably attributable visibility impairment. As discussed in Section III of this document, the reasonably attributable visibility impairment provisions were originally promulgated in 1980, when technology for evaluating visibility impairment and its causes was in its infancy and visual observation of “plume blight” was the main method of determining whether a source was affecting a mandatory Class I area. Since that time, there have been many advances in ambient monitoring, emissions quantification, emission control technology and meteorological and air quality modeling. These advances have been built into the regional haze program, such that state compliance with the Regional Haze Rule's requirements will largely ensure that progress is made towards the goal of natural visibility conditions. Therefore, it is likely that some aspects of the reasonably attributable visibility impairment provisions of the visibility regulations have less potential benefit than they did when they originally took effect over 3 decades ago. In addition, the reasonably attributable visibility impairment provisions have received few amendments over the years, including during amendments made by the Regional Haze Rule in 1999 where the changes to integrate the reasonably attributable visibility impairment assessment and mitigation provisions with the new regional haze program requirements were limited to putting the two separately designed programs on the same recurring schedule. This has left a substantial amount of confusing and outdated language within the current visibility regulations including seemingly overlapping and redundant requirements, particularly between §§ 51.302 and 51.306. Also, as noted in Section III.A of this document, in actual practice the portion of the reasonably attributable visibility impairment provisions mandating periodic assessment of reasonably attributable visibility impairment by states (or by the EPA in the case of states that do not have an approved reasonably attributable visibility impairment SIP) has not resulted in any additional emission control requirements being placed on emission sources. While there have historically been very few certifications of existing reasonably attributable visibility impairment by an FLM, in several situations a certification by an FLM has ultimately resulted in new controls or changes in source operation.
The EPA therefore believes it is time to bring clarity to the reasonably attributable visibility impairment provisions of the rule and enhance the potential for environmental protection. In brief, our proposed changes would (1) eliminate recurring requirements on states that we believe have no significant benefit for visibility protection;
The EPA is proposing to amend § 51.300, Purpose and applicability, to expand the reasonably attributable visibility impairment requirements to all states and territories, with the exceptions of Guam, Puerto Rico, American Samoa and the Northern Mariana Islands. These territories have no mandatory Class I areas and are sufficiently far from other Class I areas to have no anticipated impact on visibility in such areas. Under our proposal, the geographic coverage of the reasonably attributable visibility impairment provisions and the regional haze provisions would be the same. The EPA believes these changes would strengthen the visibility program and are appropriate in light of the evolved understanding that pollutants emitted
The EPA is proposing to amend § 51.301, Definitions, to change the definition of
Due to the confusing, and in large part outdated, content of § 51.302, the EPA is proposing to delete the entire text of this section and replace it with new language. The new text clearly describes a state's responsibilities upon receiving a FLM certification of reasonably attributable visibility impairment.
The proposed § 51.302(a) involves FLM certification of reasonably attributable visibility impairment and reads much like the existing § 51.302(c), with the added language that FLMs would identify in the certification which single source or small number of sources is responsible for the reasonably attributable visibility impairment being certified.
The proposed § 51.302(b) describes the required state action in response to any FLM reasonably attributable visibility impairment certification,
The proposed § 51.302(c) addresses those situations where an FLM certifies as a reasonably attributable visibility impairment source a BART-eligible source where there is at that time no SIP or FIP in place setting BART emission limits for that source or addressing BART requirements via a better-than-BART alternative program.
Regarding the time schedule for state response to an FLM certification of reasonably attributable visibility impairment, we are considering a number of possible approaches for the final rule, with proposed rule text provided for three alternative approaches referred to as options one, two and three.
The first alternative proposed rule text at, option one, § 51.302(d) would retain the existing requirement for a state to respond to a reasonably attributable visibility impairment certification with a SIP revision within 3 years regardless of when the certification is made in the cycle of periodic comprehensive SIP revisions.
The second alternative proposed rule text, option two, at § 51.302(d) would require the state's responsive SIP revision to be submitted on the due date of the next progress report (but not as part of the progress report, if the final rule does not require progress reports themselves to be submitted as SIP revisions) or the next periodic comprehensive SIP revision, whichever is earlier, provided the earlier date is at least 2 years after the RAVI certification.
The third alternative proposed rule text, option three, at § 51.302(d) provides for different deadlines for the state response to the certification depending on when in the cycle of periodic comprehensive SIP revisions the reasonably attributable visibility impairment certification is made. Table 1 provides specific examples of how application of the third alternative approach in the proposed rule text would determine due dates for the state response to a certification.
• If the certification is made more than 2 years prior to the due date for any periodic comprehensive regional haze SIP revision required under § 51.308(f) (but, with respect to the SIP due for the just-prior period, not so early as to be within the 6-month window described next), then a state must respond to the certification in that upcoming SIP revision. Failure to respond adequately would prevent full approval of that SIP revision. If the certification is made more than 2 years before the SIP due date, the state would have more than 2 years to respond, except as provided in the next bullet.
• If the certification is made less than 2 years prior to the due date for any periodic comprehensive SIP revision (but no more than 6 months subsequent to the submission date of that periodic comprehensive regional haze SIP revision or a SIP revision that amends a previous submission in a way that affects the emission limits applicable to the reasonably attributable visibility impairment-certified source),
The final rule may incorporate any one of these three proposals, or may combine features of these proposals.
It is important to note that regardless how the final rule sets the deadline for the state's responsive SIP revision, if the reasonable progress goals in the periodic comprehensive regional haze SIP for a state with a Class I area (and thus required to have reasonable progress goals in its SIP for that area) have been approved prior to the approval of its own or a contributing state's separate reasonably attributable visibility impairment-response SIP, the state would not be required to revisit and revise its reasonable progress goals to take into account any additional emission reductions from the certified source until the next due date for a periodic comprehensive SIP revision.
Proposed changes to § 51.303, Exemptions from control, are minor edits to paragraph (a) designed to
Proposed changes to § 51.304, Identification of integral vistas, are more extensive. An integral vista is defined in § 51.301 as a view perceived from within the Class I area of a specific landmark or panorama located outside the boundary of the Class I area. The current version of § 51.304 was written at a time when FLMs were still in the process of identifying integral vistas. We are proposing to remove antiquated language in § 51.304 in light of the fact that FLMs were required to identify any such integral vistas on or before December 31, 1985. The proposed language would explain this fact as well as list those few integral vistas that were properly identified during the applicable time period. States would continue to be subject to the requirement that these integral vistas be listed in their SIPs. The EPA notes that the current version of 40 CFR part 51, subpart P is not perfectly clear on how the existence of an identified integral vista affects obligations on states and sources, but we are not proposing any clarification as part of this rulemaking.
Proposed changes to § 51.305, Monitoring for reasonably attributable visibility impairment, involve adding language stating that the requirement for a state to include in a periodic comprehensive SIP revision a monitoring strategy specifically for evaluating reasonably attributable visibility impairment in Class I area(s) only applies in situations where the Administrator, Regional Administrator or FLM has advised the state of a need for it. In concept, special monitoring for reasonably attributable visibility impairment purposes might be appropriate for a Class I area without an IMPROVE monitoring station or when the impairment is from a relatively narrow plume such that the existing IMPROVE monitoring site is not affected. The nature of the special monitoring might be situation-specific, and might be the same as or different than the IMPROVE monitoring protocols. These proposed changes would reduce the paperwork that states are required to submit to the EPA on a recurring schedule, since under the proposed language a state containing one or more Class I areas and participating in the IMPROVE monitoring program would be relieved of the need to include information in its SIP regarding monitoring to specifically assess reasonably attributable visibility impairment absent being advised to do so. A strategy for monitoring for regional haze visibility impairment under § 51.308(d)(4) is still required and any monitoring for reasonably attributable visibility impairment under § 51.305 would be in addition to that requirement.
Section 51.306, on long-term strategy requirements for reasonably attributable visibility impairment, is proposed to be completely removed and reserved. Like the current version of § 51.302, the language of this section is outdated. In this case, the EPA believes it makes sense to delete the entire text of this section and instead refer to long-term strategy requirements for reasonably attributable visibility impairment within the text of § 51.308, specifically in § 51.308(f)(2). In this way, long-term strategy requirements for reasonably attributable visibility impairment would be retained in clearer form, and the visibility program would be more understandable to states and the public by listing the long-term strategy requirements for both regional haze and reasonably attributable visibility impairment in one place. Such a change would also reduce the planning burden on states by making clear in § 51.308(f)(2) that a long-term strategy for reasonably attributable visibility impairment is not required without an FLM having made a reasonably attributable visibility impairment certification under § 51.302(a).
Several proposed changes in § 51.308 were discussed in Sections IV.A, B, C, D, E and F of this document. We are also proposing changes in § 51.308 related to reasonably attributable visibility impairment. The proposed addition of § 51.308(c) (currently a reserved section) explains the relationship between regional haze and reasonably attributable visibility impairment and the state requirements for each, including that a state would not be required to address reasonably attributable visibility impairment unless triggered to do so by an FLM certification under § 51.302(a), and that a state would not be required to re-address its monitoring strategy for reasonably attributable visibility impairment unless advised to perform monitoring as described in the proposed § 51.305.
The EPA is also proposing changes to the language of § 51.308(f)(2) to describe when reasonably attributable visibility impairment must be addressed in the long-term strategy required for regional haze. Finally, proposed changes to § 51.308(f)(6) regarding the monitoring strategy requirements for SIPs would remove references to § 51.305 that exist in the corresponding subsection in § 51.308(d), namely, subsection (4) (again, regarding monitoring for reasonably attributable visibility impairment).
Proposed changes to § 51.308(e), BART, relate to a state's option to enact an emissions trading program or other alternative measure in lieu of source-specific BART. Under the proposed approach, if a source is already covered for BART by an approved emissions trading program or other alternative measure (or the program codified in § 51.309), certification of that source by an FLM would not trigger a new BART determination. However, certification would still trigger the requirement for a reasonable progress analysis. Proposed changes to § 51.308(e)(4) are similar in nature and motivated by the same concerns.
Consistent with our proposal to remove the requirement for states to periodically assess reasonably attributable visibility impairment, we are also proposing to amend many sections of 40 CFR part 52, to remove provisions that establish FIPs that require the EPA to periodically assess whether reasonably attributable visibility impairment exists at Class I areas in certain states and to address it if it does, and to respond to any reasonably attributable visibility impairment certification that may be directed to a state that does not have an approved reasonably attributable visibility impairment SIP. These changes include the removal of §§ 52.26 and 52.29, which now contain the statement of the EPA's obligations, and specific provisions for 30 states to establish that §§ 52.26 and 52.29 are applicable to those states.
Proposed changes to § 51.307, New Source Review, involve a few proposed
The EPA believes that state consultation with FLMs is a critical part of the creation of quality SIPs. As mentioned earlier, the EPA is proposing to extend the FLM consultation requirements of § 51.308(i)(2) to progress reports that are not SIP revisions. In addition, the EPA believes further edits to § 51.308(i)(2) are necessary because the current requirement for consultation at least 60 days prior to a public hearing may not occur sufficiently early in the state's planning process to meaningfully inform the state's development of the long-term strategy. This proposed rule change would add a requirement that such consultation occur early enough to allow the state time for full consideration of FLM input, but no fewer than 60 days prior to a public hearing or other public comment opportunity. A consultation opportunity that takes place no less than 120 days prior to a public hearing or other public comment opportunity would be deemed to have been “early enough.”
Finally, the EPA notes that pursuant to the existing provisions of § 51.307(a), the SIP for every state must require the new source permitting authority to consult with FLMs regarding new source review of any new major stationary source or major modification that would be constructed in an area that is designated attainment or unclassified that may affect visibility in any Class I Federal area. As required by the regulations, that consultation must include sharing with the FLMs a copy of all information relevant to the permit application for the proposed new stationary source or major modification. The regulations also specify that this material must be provided within particular time frames. Also, under § 51.307(b)(2), a proposed new major source or major modification locating in a nonattainment area is subject to review if it may have an impact on visibility in any mandatory Class I area. Two EPA guidance documents interpret the consultation requirement, particularly with regard to evaluating whether a proposed new major source or major modification may affect visibility in a Class I area and thus consultation is required.
The EPA is proposing to amend § 51.308(f) to move the compliance deadline for the submission of the next periodic comprehensive SIP revisions from July 31, 2018, to July 31, 2021. Under this proposal, states would retain the option of submitting their SIP revisions before July 31, 2021. Regardless of the date on which a state chooses to submit its periodic comprehensive SIP revision, the EPA would evaluate that SIP using the same criteria. The EPA is proposing to leave the end date for the second implementation period at 2028, regardless of when SIP revisions are submitted. We are proposing this change as a one-time schedule adjustment. Periodic comprehensive SIP revisions for the third planning will be due on July 31, 2028, with future periodic comprehensive SIP revisions due every 10 years thereafter.
We are proposing this extension of the due date for periodic comprehensive SIP revisions to allow states to coordinate regional haze planning with other regulatory programs, including but not limited to the Mercury and Air Toxics Standards,
The EPA is proposing to amend the requirements in 40 CFR 51.308(g) and (h) regarding the timing of submission of reports evaluating progress towards the natural visibility goal. Under the current rule, regional haze progress reports are required to be submitted 5 years after submission of periodic comprehensive SIP revisions. Because states submitted these first SIP revisions on dates spread across about a 3-year period, many of the due dates for progress reports currently do not fall mid-way between the due dates for periodic comprehensive SIP revisions, as the EPA initially envisioned that they would. Looking forward, the current Regional Haze Rule would in many cases require a progress report shortly before or shortly after a periodic comprehensive SIP revision, at which time it could not be expected to have much utility as a mid-course review of environmental progress or much incremental informational value for the public compared to the data contained in that SIP revision.
Complementing the proposed amendments to 40 CFR 51.308(f) regarding the deadlines for submittal of periodic comprehensive revisions, we propose to amend 40 CFR 51.308 (g) and (h) such that second and subsequent progress reports would be due by January 31, 2025, July 31, 2033, and every 10 years thereafter, placing one progress report mid-way between the due dates for periodic comprehensive SIP revisions. The EPA believes that this timing provides a good balance between allowing the implementation of the most recent SIP revision to have proceeded far enough since its adoption for a review to be possible and worthwhile and having enough time
Regarding the concept of a progress report also being useful at or near the time of submission of a periodic comprehensive SIP revision, as the EPA envisioned in the 1999 Regional Haze Rule, we note that although they are expressed with somewhat different terminology, in practical terms a progress report would provide little additional information beyond that required to be addressed in a periodic comprehensive SIP revision. The only significant additional information required in a progress report but not explicitly required in a periodic comprehensive SIP revision is the requirement to report on the trend in visibility over the whole period since the baseline period of 2000-2004. While the EPA believes that a state should be aware of, and share with the public, information on the trend in visibility over the whole period since the baseline period of 2000-2004, we believe it would be inefficient to require the preparation of a separate progress report for this purpose. Therefore, we are proposing to limit the requirement for separate progress reports to the one due mid-way between periodic comprehensive SIP revisions, and to add to the requirement for periodic comprehensive SIP revisions a requirement to include this trend information. The EPA believes this approach would substantially reduce administrative burdens and make progress reports of more informational use to the public, with no attendant reduction in environmental protection. The EPA solicits comment on this and any alternative approaches to progress report scheduling.
The EPA is proposing to amend 40 CFR 51.308(g) regarding the requirements for the form of progress reports. Under the current regulations, progress reports must take the form of SIP revisions that comply with the procedural requirements of 40 CFR 51.102, 40 CFR 51.103 and Appendix V to Part 51—Criteria for Determining the Completeness of Plan Submissions. The EPA included the requirements for progress reports in the Regional Haze Rule primarily with an emphasis toward ensuring that the states remain on track during the 10 years between periodic comprehensive SIP revisions. By requiring progress reports to be in the form of SIP revisions, the 1999 Regional Haze Rule ensured an opportunity for public input on the progress reports, while specifically pointing out that the EPA “intends for progress reports to involve significantly less effort than a comprehensive SIP revision.” 64 FR 35747 (July 1, 1999). For all SIP revisions, however, the state must provide public notice and a public hearing if requested, and it must conform to certain administrative procedural requirements and provide various administrative material. Also, the submission must be made by an official who is authorized by state law to submit a SIP revision. As a required SIP revision, a finding by the EPA that a state has not submitted a complete progress report by the deadline would start a “clock” for the EPA to prepare, take public comment on, and issue a progress report like the state was required to submit.
We are proposing that progress reports need not be in the form of SIP revisions, but that states must consult with FLMs and obtain public comment on their progress reports before submission to the EPA. We are also proposing that the SIP revision that would be due in 2021 must include a commitment to prepare and submit these progress reports to the EPA according to the proposed revised schedule (
The EPA is proposing these changes because it believes these reports are not the kind of state submissions for which the formality of a SIP revision, and the accompanying requirement for the EPA to have to prepare the report within 2 years of finding that a state has failed to do so, are warranted. It is important to note that as part of the EPA's review of the report, we will follow up with the state on any appropriate next steps. There are also additional remedies, such as undertaking a less formal assessment of the results of the implementation of the previously submitted SIP, that are available to the EPA in the event a state fails to properly submit a progress report. These changes have been widely supported by state air agencies in our pre-proposal consultations because they would allow more efficient use of state resources. This option would relieve states of the obligation to follow the procedural requirements of 40 CFR 51.102 and 51.103. States have expressed concern that these procedural requirements are resource-intensive, and increase the burden on states by requiring formal procedures be followed when submitting progress reports. By avoiding the specific formal steps required for a SIP revision, including requirements imposed by state law that may involve time-consuming steps beyond those required by the EPA, this proposal may also reduce the time between the completion of the technical analysis in the progress report and when the final report becomes available to the EPA and the public. Thus, progress reports could contain fresher information on the environmental progress being made by a state. Removing the requirement that progress reports be submitted as SIP revisions is consistent with regulatory requirements for similar reports from states for progress reporting or planning purposes where control requirements are not imposed, such as annual monitoring plans required for planning and maintenance of state monitoring networks.
The EPA invites comment on whether it should finalize this proposed change. Also, the EPA invites comment on changing the progress report scheduling as described in the previous section without making any change to the requirement that progress reports take the form of SIP revisions, and vice versa.
It is important to note that under this option, states would still be required to include the required progress report elements listed in 40 CFR 51.308(g)(1) through (g)(6). Also, § 51.308(h) would continue to require that at the same time the state is required to submit a progress report, it must also take one of four listed actions concerning whether the SIP is adequate to achieve established goals for visibility improvement. Where a state determines that its own SIP is or may be inadequate to ensure reasonable progress due to emissions from sources within the state, the state will continue to have an obligation to revise its SIP to address the plan's deficiencies within 1 year of its submission of such a determination.
Upon receipt of such progress reports, the EPA would review the reports. In addition, the EPA intends to create a system of logging progress reports as they are received, and making them available to the public. In addition to putting the public on notice that a progress report was received by the EPA, this system would provide the public an opportunity to view the contents of the progress report. Although the EPA would not formally approve or disapprove a progress report,
We are proposing that the next periodic comprehensive SIP revisions (currently due in 2018 but proposed to be due in 2021) would need to include a commitment for states to provide progress reports. The 1999 Regional Haze Rule does not require such a commitment because the current requirement for progress reports to be submitted in the form of SIP revisions makes such a commitment superfluous. The EPA solicits comment on this or alternative approaches to ensuring that states continue to provide progress reports.
Section 51.309 has limited applicability going forward because its provisions apply only to 16 Class I areas covered by the Grand Canyon Visibility Transport Commission Report, and only to the first regional haze implementation period (
A final change in section 51.309 appears in § 51.309(g)(2)(iii). This change is purely to correct a typographical error and the EPA will therefore not consider comments on this subsection.
The EPA believes this action would not have disproportionately high and adverse human health, well-being or environmental effects on minority, low-income or indigenous populations because it would not negatively affect the level of protection provided to human health, well-being or the environment under the CAA's visibility protection program. When promulgated, these proposed regulations will revise procedural and timing aspects of the SIP requirements for visibility protection but will not substantively change the requirement that SIPs provide for reasonable progress towards the goal of natural visibility conditions. These SIP requirements are designed to protect all segments of the general population.
The EPA acknowledges that the proposed delay in submitting SIP revisions from 2018 to 2021 might cause delays in when sources must comply with any new requirements. However, because neither the CAA nor the existing Regional Haze Rule set specific deadlines for when sources must comply with any new requirements in a state's next periodic comprehensive SIP revision, states have substantial discretion in establishing reasonable compliance deadlines for measures in their SIPs. Given this, we expect to see a range of compliance deadlines in the next round of regional haze SIPs from early in the second implementation period to 2028, depending on the types of measures adopted, whether or not these proposed rule changes are finalized. Thus, the EPA believes the delay in the periodic comprehensive SIP revision submission deadline from 2018 to 2021 will not meaningfully reduce the overall progress towards better visibility made by the end of 2028 and will not meaningfully adversely affect environmental protection for all general segments of the population.
This action is a significant regulatory action that was submitted to the OMB for review because it raises novel policy issues. Any changes made in response to OMB recommendations have been documented in the docket.
The information collection activities in this proposed rule have been submitted for approval to the OMB under the PRA. The ICR document that the EPA prepared has been assigned the EPA ICR number 2540.01. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0421. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
The EPA is proposing these amendments to requirements for state regional haze planning to change the requirements that must be met by states in developing regional haze SIPs, periodic comprehensive SIP revisions, and progress reports for regional haze. The main intended effects of this rulemaking are to provide states with additional time to submit regional haze plans for the second implementation period and to provide states with an improved schedule and process for progress report submission. Further reductions in burden on states include this proposal's removal of the requirement for progress reports to be SIP revisions, clarifying that states are not required to project emissions inventories as part of preparing a progress report, and relieving the state of the need to review its visibility monitoring strategy within the context of the progress report. With all of these proposed changes considered, the overall burden on states would represent a reduction compared to what would otherwise occur if the provisions of the current rule were to stay in place. Total estimated burden is estimated to be reduced from 10,307 hours (per year) to 5,974 hours (per year), and total estimated cost is expected to be reduced from $510,498 (per year) to $295,876 (per year). All states are required to submit regional haze SIPs and progress reports under this rule.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Entities potentially affected directly by this proposal include state governments, and for the purposes of the RFA, state governments are not considered small government. Tribes may choose to follow the provisions of the Regional Haze Rule but are not required to do so. Other types of small entities are not directly subject to the requirements of this rule. The EPA continues to be interested in the potential impacts of the proposed rule on small entities and welcomes comments on issues related to such impacts.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector. The CAA imposes the obligation for states to submit regional haze SIPs. In this rule, the EPA is proposing to revise those requirements in a manner that would not increase the obligation of any state, local or tribal governments or the private sector. In this rule, the EPA is also proposing to extend the reasonably attributable visibility impairment certification provisions to some additional states, but these states are not small governments and any mandate on the private sector would be indirect since this rule does not mandate how an affected state should address such a certification. Therefore, this action is not subject to the requirements of sections 202, 203 and 205 of the UMRA.
This action does not have federalism implications. It will not have substantial direct effects 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. The requirement to submit regional haze SIPs is mandated by the CAA. Thus, Executive Order 13132 does not apply to these proposed regulations.
In the spirit of Executive Order 13132 and consistent with the EPA policy to promote communications between the EPA and state and local governments, the EPA has already consulted extensively with state air agency officials prior to this proposal. The EPA specifically solicits comments on this proposed action from state and local officials. In addition, the EPA intends to meet with organizations representing state and local officials during the comment period for this action.
This proposed action does not have tribal implications as specified in Executive Order 13175. It would not have a substantial direct effect on one or more Indian tribes. Furthermore, these proposed regulation revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes. The CAA and the TAR establish the relationship of the federal government and tribes in characterizing air quality and developing plans to protect visibility in Class I areas. Thus, Executive Order 13175 does not apply to this action.
Although Executive Order 13175 does not apply to this action, the EPA solicits comment on this proposed action from tribal officials. The EPA also intends to offer to consult with any tribal government to discuss this proposal.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of our evaluation are contained in Section V of this document.
The statutory authority for this action is provided by 42 U.S.C. 7403, 7407, 7410 and 7601.
Environmental protection, Administrative practice and procedure, Air pollution control, Nitrogen dioxide, Particulate matter, Sulfur oxides, Transportation, Volatile organic compounds.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Nitrogen dioxide, Particulate matter, Sulfur oxides, Transportation, Volatile organic compounds.
For the reasons stated in the preamble, Title 40, Chapter I of the Code of Federal Regulations is proposed to be amended as follows:
23 U.S.C. 101; 42 U.S.C. 7401-7671q.
(b)
The revisions and additions read as follows:
Deciview index=10 ln (b
b
(a) The affected Federal Land Manager may certify, at any time, that there exists reasonably attributable impairment of visibility in any mandatory Class I Federal area and identify which single source or small number of sources is responsible for such impairment. The affected Federal Land Manager will provide the certification to the State in which the impairment occurs and the State(s) in which the source(s) is located.
(b) The State(s) in which the source(s) is located shall revise its regional haze implementation plan, in accordance with the schedules set forth in paragraphs (d)(1) and (2) of this section, to include for each source or small number of sources that the Federal Land Manager has identified in whole or in part for reasonably attributable visibility impairment as part of a certification under paragraph (a) of this section:
(1) A determination, based on the factors set forth in § 51.308(d)(1)(i)(A), of the control measures, if any, that are necessary with respect to the source or sources in order for the plan to make reasonable progress toward natural visibility conditions in the affected Class I Federal area;
(2) Emission limitations that reflect the degree of emission reduction achievable by such control measures and schedules for compliance as expeditiously as practicable; and
(3) Monitoring, recordkeeping, and reporting requirements sufficient to ensure the enforceability of the emission limitations.
(c) If a source that the Federal Land Manager has identified as responsible in whole or in part for reasonably attributable visibility impairment as part of a certification under paragraph (a) of this section is a BART-eligible source, and if there is not in effect as of the date of the certification a fully or conditionally approved implementation plan addressing the BART requirement for that source (which existing plan may incorporate either source-specific emission limitations reflecting the emission control performance of BART, an alternative program to address the BART requirement under § 51.308(e)(2), (3), and (4), or for sources of SO
(d) For any existing reasonably attributable visibility impairment the Federal Land Manager certifies to the State(s) under paragraph (a) of this section, the State(s) shall submit a revision to its regional haze implementation plan that includes the elements described in paragraph (b) and
(c) no later than 3 years after the date of the certification. The State(s) is not required at that time to also revise its reasonable progress goals to reflect the additional emission reductions required from the source or sources.]
(d) For any existing reasonably attributable visibility impairment the Federal Land Manager certifies to the State(s) under paragraph (a) of this section more than 2 years prior to the due date for a regional haze implementation plan revision required under § 51.308(f) or the due date for a regional haze progress report required under § 51.308(g), the State(s) shall include the elements described in paragraphs (b) and (c) in a plan revision by the due date for that implementation plan revision as part of such revision or by the due date for the progress report, whichever is due first, provided that the earlier date is at least 2 years after the certification. For plan revisions submitted by the due date for the progress report, the State(s) is not required at that time to also revise its reasonable progress goals to reflect the additional emission reductions required from the source or sources.]
(d)(1) For any existing reasonably attributable visibility impairment the Federal Land Manager certifies to the State(s) under paragraph (a) of this section more than 2 years prior to the due date for a regional haze implementation plan revision required under § 51.308(f), the State(s) shall include the elements described in paragraphs (b) and (c) in such revision and such elements shall be considered a required part of such revision.
(2) For any existing reasonably attributable visibility impairment the Federal Land Manager certifies to the State(s) under paragraph (a) of this section less than 2 years prior to the due date for a regional haze implementation plan revision required under § 51.308(f), but no more than 6 months subsequent to the submission date of that implementation plan revision or no more than 6 months subsequent to a further plan revision that changes the emission limitation for the subject source, the State(s) shall submit a revision to its regional haze implementation plan that includes the elements described in paragraph (b) and (c) no later than 2 years after the date of the certification. The State(s) is not required at that time to also revise its reasonable progress goals to reflect the additional emission reductions required from the source or sources.]
(a) Federal Land Managers were required to identify any integral vistas on or before December 31, 1985, according to criteria the Federal Land Managers developed. These criteria must have included, but were not limited to, whether the integral vista was important to the visitor's visual experience of the mandatory Class I Federal area.
(b) The following integral vistas were identified by Federal Land Managers: at Roosevelt Campobello International Park, from the observation point of Roosevelt cottage and beach area, the viewing angle from 244 to 256 degrees; and at Roosevelt Campobello International Park, from the observation point of Friar's Head, the viewing angle from 154 to 194 degrees.
(c) The State must list in its implementation plan any integral vista listed in paragraph (b) of this section.
(d) [Reserved]
For the purposes of addressing reasonably attributable visibility impairment, if the Administrator, Regional Administrator, or the affected Federal Land Manager has advised a State containing a mandatory Class I Federal area of a need for monitoring to assess reasonably attributable visibility impairment at a mandatory Class I Federal area in addition to the monitoring currently being conducted to meet the requirements of § 51.308(d)(4), the State must include in the next implementation plan revision to meet the requirement of § 51.308(f) an appropriate strategy for evaluating reasonably attributable visibility impairment in the mandatory Class I Federal area by visual observation or other appropriate monitoring techniques. Such strategy must take into account current and anticipated visibility monitoring research, the availability of appropriate monitoring techniques, and such guidance as is provided by the Agency.
(a) For purposes of new source review of any new major stationary source or major modification that would be constructed in an area that is designated attainment or unclassified under section 107(d) of the CAA, the State plan must, in any review under § 51.166 with respect to visibility protection and analyses, provide for:
(b) * * *
(1) That may have an impact on any integral vista of a mandatory Class I Federal area listed in § 51.304(b), or
(2) That proposes to locate in an area classified as nonattainment under section 107(d)(1) of the Clean Air Act that may have an impact on visibility in any mandatory Class I Federal area.
The revisions and additions read as follows:
(b)
(c)
(d)
(2)
(iv) For the first implementation plan addressing the requirements of paragraphs (d) and (e) of this section, the number of deciviews by which baseline conditions exceed natural visibility conditions for the most impaired and least impaired days.
(3)
(e)
(2)
(v) At the State's option, a provision that the emissions trading program or other alternative measure may include a geographic enhancement to the program to address the requirement under § 51.302(b) related to reasonably attributable impairment from the pollutants covered under the emissions trading program or other alternative measure.
(4) A State subject to a trading program established in accordance with § 52.38 or § 52.39 under a Transport Rule Federal Implementation Plan need not require BART-eligible fossil fuel-fired steam electric plants in the State to install, operate, and maintain BART for the pollutant covered by such trading program in the State. A State that chooses to meet the emission reduction requirements of the Transport Rule by submitting a SIP revision that establishes a trading program and is approved as meeting the requirements of § 52.38 or § 52.39 also need not require BART-eligible fossil fuel-fired steam electric plants in the State to install, operate, and maintain BART for the pollutant covered by such trading program in the State. A State may adopt provisions, consistent with the requirements applicable to the State for a trading program established in accordance with § 52.38 or § 52.39 under the Transport Rule Federal Implementation Plan or established under a SIP revision that is approved as meeting the requirements of § 52.38 or § 52.39, for a geographic enhancement to the program to address any requirement under § 51.302(b) related to reasonably attributable impairment from the pollutant covered by such trading program in that State.
(5) After a State has met the requirements for BART or implemented emissions trading program or other alternative measure that achieves more reasonable progress than the installation and operation of BART, BART-eligible sources will be subject to the requirements of paragraphs (d) and (f) of this section, as applicable, in the same manner as other sources.
(f)
(1)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(B) The State may submit a request to the Administrator seeking an adjustment to the uniform rate of progress for a mandatory Class I Federal area to account for impacts from (1) anthropogenic sources outside the United States and/or (2) wildland prescribed fires that were conducted with the objective to establish, restore, and/or maintain sustainable and resilient wildland ecosystems, to reduce the risk of catastrophic wildfires, and/or to preserve endangered or threatened species during which appropriate basic smoke management practices were applied. To calculate the proposed adjustment, the State must add the estimated impacts to natural visibility conditions and compare the resulting value to baseline visibility conditions. If the Administrator determines that the State has estimated the impacts from anthropogenic sources outside the United States or wildland prescribed fires using scientifically valid data and methods, the Administrator may approve the proposed adjustment to the uniform rate of progress for use in the State's implementation plan.
(2)
(i) The State must consider and analyze emission reduction measures based on the costs of compliance, the time necessary for compliance, the energy and non-air quality environmental impacts of compliance, and the remaining useful life of any potentially affected major or minor stationary source or group of sources. The State must document the criteria used to determine which sources or groups of sources were evaluated, and how these four factors were taken into consideration in selecting the measures for inclusion in its long-term strategy.
(ii) The State must consider the uniform rate of improvement in visibility, the emission reduction measures identified in (f)(2)(i), and additional measures being adopted by other contributing states in (f)(2)(iii) as needed to make reasonable progress towards natural visibility conditions for the period covered by the implementation plan.
(iii) The State must consult with those States which may reasonably be anticipated to cause or contribute to visibility impairment in the mandatory Class I Federal area.
(A)
(B)
(C) In any situation in which a State cannot agree with another State or group of States on the emission reductions needed for reasonable progress towards natural visibility conditions in any mandatory Class I Federal area, each involved State must describe in its submittal the actions taken to resolve the disagreement. In reviewing the State's implementation plan submittal, the Administrator will take this information into account in determining whether the State's implementation plan provides for reasonable progress towards natural visibility conditions at each mandatory Class I Federal area that is located in the State or that may be affected by emissions from the State. All substantive interstate consultations must be documented.
(iv) As part of the demonstration required by (f)(2)(i), the State must document the technical basis, including information on the factors listed in (f)(2)(i) and modeling, monitoring, and emissions information, on which the State is relying to determine the emission reductions from anthropogenic sources in the State that are necessary for achieving reasonable progress towards natural visibility conditions in each mandatory Class I Federal area it affects. The State may meet this requirement by relying on technical analyses developed by a regional planning process and approved by all State participants. The State must identify the baseline emissions inventory on which its strategies are based. The baseline emissions inventory year shall be the most recent year for which the State has submitted emission inventory information to the Administrator in compliance with the triennial reporting requirements of subpart A of this part unless the State adequately justifies the use of another inventory year.
(v) The State must identify all anthropogenic sources of visibility impairment considered by the State in developing its long-term strategy and the criteria used to select the sources considered. The State should consider major and minor stationary sources, mobile sources, and area sources.
(vi) The State must consider, at a minimum, the following factors in developing its long-term strategy:
(A) Emission reductions due to ongoing air pollution control programs, including measures to address
(B) Measures to mitigate the impacts of construction activities;
(C) Emissions limitations and schedules for compliance to achieve the reasonable progress goal;
(D) Source retirement and replacement schedules;
(E) Basic smoke management practices for prescribed fire used for agricultural and wildland vegetation management purposes and smoke management programs as currently exist within the State for these purposes;
(F) Enforceability of emissions limitations and control measures; and
(G) The anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the long-term strategy.
(3)
(ii)(A) If a State in which a mandatory Class I Federal area is located establishes a reasonable progress goal for the most impaired days that provides for a slower rate of improvement in visibility than the uniform rate of progress calculated under paragraph (f)(1)(vi) of this section, the State must demonstrate, based on the analysis required by paragraph (f)(2)(i) of this section, that there are no additional emission reduction measures for anthropogenic sources or groups of sources in the State that may reasonably be anticipated to contribute to visibility impairment in the Class I area that would be reasonable to include in the long-term strategy. The State must provide a robust demonstration, including documenting the criteria used to determine which sources or groups of sources were evaluated and how the four factors required by paragraph (f)(2)(i) were taken into consideration in selecting the measures for inclusion in its long-term strategy. The State must provide to the public for review as part of its implementation plan an assessment of the number of years it would take to attain natural visibility conditions if visibility improvement were to continue at the rate of progress selected by the State as reasonable for the implementation period.
(B) If a State contains sources which are reasonably anticipated to contribute to visibility impairment in a mandatory Class I Federal area in another State for which a demonstration by the other State is required under (f)(3)(ii)(A), the State must demonstrate that there are no additional emission reduction measures for anthropogenic sources or groups of sources in the State that may reasonably be anticipated to contribute to visibility impairment in the Class I area that would be reasonable to include in its own long-term strategy.
(iii) The reasonable progress goals established by the State are not directly enforceable but will be considered by the Administrator in evaluating the adequacy of the measures in the implementation plan in providing for reasonable progress towards achieving natural visibility conditions at that area.
(iv) In determining whether the State's goal for visibility improvement provides for reasonable progress towards natural visibility conditions, the Administrator will also evaluate the demonstrations developed by the State pursuant to paragraphs (f)(2) and (f)(3)(ii)(A) of this section and the demonstrations provided by other States pursuant to paragraphs (f)(2) and (f)(3)(ii)(B) of this section.
(4) If the Administrator, Regional Administrator, or the affected Federal Land Manager has advised a State of a need for additional monitoring to assess reasonably attributable visibility impairment at a mandatory Class I Federal area in addition to the monitoring currently being conducted, the State must include in the plan revision an appropriate strategy for evaluating reasonably attributable visibility impairment in the mandatory Class I Federal area by visual observation or other appropriate monitoring techniques.
(5) So that the plan revision will serve also as a progress report, the State must address in the plan revision the requirements of paragraphs (g)(1) through (5) of this section. However, the period to be addressed for these elements shall be the period since the past progress report.
(6)
(i) The establishment of any additional monitoring sites or equipment needed to assess whether reasonable progress goals to address regional haze for all mandatory Class I Federal areas within the State are being achieved.
(ii) Procedures by which monitoring data and other information are used in determining the contribution of emissions from within the State to regional haze visibility impairment at mandatory Class I Federal areas both within and outside the State.
(iii) For a State with no mandatory Class I Federal areas, procedures by which monitoring data and other information are used in determining the contribution of emissions from within the State to regional haze visibility impairment at mandatory Class I Federal areas in other States.
(iv) The implementation plan must provide for the reporting of all visibility monitoring data to the Administrator at least annually for each mandatory Class I Federal area in the State. To the extent possible, the State should report visibility monitoring data electronically.
(v) A statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any mandatory Class I Federal area. The inventory must include emissions for a baseline year, emissions for the most recent year for which data are available, and estimates of future projected emissions. The State must also include a commitment to update the inventory periodically.
(vi) Other elements, including reporting, recordkeeping, and other measures, necessary to assess and report on visibility.
(g)
(3) For each mandatory Class I Federal area within the State, the State must assess the following visibility conditions and changes, with values for most impaired, least impaired and/or clearest days as applicable expressed in terms of 5-year averages of these annual values. The period for calculating current visibility conditions is the most recent 5-year period preceding the required date of the progress report for which data are available as of a date 6 months preceding the required date of the progress report.
(i)(A) Progress reports due before January 31, 2025. The current visibility conditions for the most impaired and least impaired days.
(B) Progress reports due on and after January 31, 2025. The current visibility conditions for the most impaired and clearest days;
(ii)(A) Progress reports due before January 31, 2025. The difference between current visibility conditions for the most impaired and least impaired days and baseline visibility conditions.
(B) Progress reports due on and after January 31, 2025. The difference between current visibility conditions for the most impaired and clearest days and baseline visibility conditions.
(iii)(A) Progress reports due before January 31, 2025. The change in visibility impairment for the most impaired and least impaired days over the period since the period addressed in the most recent plan required under paragraph (f) of this section.
(B) Progress reports due on and after January 31, 2025. The change in visibility impairment for the most impaired and clearest days over the period since the period addressed in the most recent plan required under paragraph (f) of this section.
(4) An analysis tracking the change over the period since the period addressed in the most recent plan required under paragraph (f) of this section in emissions of pollutants contributing to visibility impairment from all sources and activities within the State. Emissions changes should be identified by type of source or activity. With respect to all sources and activities, the analysis must extend at least through the most recent year for which the state has submitted emission inventory information to the Administrator in compliance with the triennial reporting requirements of subpart A of this part. With respect to sources that report directly to a centralized emissions data system operated by the Administrator, the analysis must extend through the most recent year for which the Administrator has provided a State-level summary of such reported data or an internet-based tool by which the State may obtain such a summary. The State is not required to backcast previously reported emissions to be consistent with more recent emissions estimation procedures, and may draw attention to actual or possible inconsistencies created by changes in estimation procedures.
(5) An assessment of any significant changes in anthropogenic emissions within or outside the State that have occurred since the period addressed in the most recent plan required under paragraph (f) of this section including whether or not these changes in anthropogenic emissions were anticipated in that most recent plan and whether they have limited or impeded progress in reducing pollutant emissions and improving visibility.
(6) For a state with a long-term strategy that includes a smoke management program for prescribed fires on wildland, a summary of the most recent periodic assessment of the smoke management program including conclusions that were reached in the assessment as to whether the program is meeting its goals regarding improving ecosystem health and reducing the damaging effects of catastrophic wildfires.
(7) An assessment of whether the current implementation plan elements and strategies are sufficient to enable the State, or other States with mandatory Class I Federal areas affected by emissions from the State, to meet all established reasonable progress goals for the period covered by the most recent plan required under paragraph (f) of this section.
(h)
(1) If the State determines that the existing implementation plan requires no further substantive revision at this time in order to achieve established goals for visibility improvement and emissions reductions, the State must provide to the Administrator a declaration that revision of the existing implementation plan is not needed at this time.
(i) * * *
(2) The State must provide the Federal Land Manager with an opportunity for consultation, in person at a point early enough in the State's technical and policy analyses of its long-term strategy emission reduction obligation and prior to development of reasonable progress goals so that information and recommendations provided by the Federal Land Manager can meaningfully inform the State's development of the long-term strategy. The opportunity for consultation will be deemed to have been early enough if the consultation has taken place at least 120 days prior to holding any public hearing or other public comment opportunity on an implementation plan (or plan revision) or progress report for regional haze required by this subpart. The opportunity for consultation must be provided no less than 60 days prior to said public hearing or public comment opportunity. This consultation must include the opportunity for the affected Federal Land Managers to discuss their:
(3) In developing any implementation plan (or plan revision) or progress report, the State must include a description of how it addressed any comments provided by the Federal Land Managers.
(4) The plan (or plan revision) must provide procedures for continuing consultation between the State and Federal Land Manager on the implementation of the visibility protection program required by this subpart, including development and review of implementation plan revisions and progress reports, and on the implementation of other programs having the potential to contribute to impairment of visibility in mandatory Class I Federal areas.
(d) * * *
(4) * * *
(v) Market Trading Program. The implementation plan must include requirements for a market trading program to be implemented in the event that a milestone is not achieved. The plan shall require that the market trading program be activated beginning no later than 15 months after the end of the first year in which the milestone is not achieved. The plan shall also require that sources comply, as soon as practicable, with the requirement to hold allowances covering their emissions. Such market trading program must be sufficient to achieve the milestones in paragraph (d)(4)(i) of this section, and must be consistent with the elements for such programs outlined in § 51.308(e)(2)(vi). Such a program may include a geographic enhancement to the program to address the requirement under § 51.302(b) related to reasonably attributable impairment from the pollutants covered under the program.
(10)
(i) The report due in 2013 will assess the area for reasonable progress as provided in this section for mandatory Class I Federal area(s) located within the State and for mandatory Class I Federal area(s) located outside the State that may be affected by emissions from within the State. This demonstration may be based on assessments conducted by the States and/or a regional planning body. The progress report due in 2013 must contain at a minimum the following elements:
(ii) At the same time the State is required to submit the 5-year progress report due in 2013 to EPA in accordance with paragraph (d)(10)(i) of this section, the State must also take one of the following actions based upon the information presented in the progress report:
(iii) The requirements of § 51.308(g) regarding requirements for periodic reports describing progress towards the reasonable progress goals apply to States submitting plans under this section, with respect to subsequent progress reports due after 2013.
(iv) The requirements of § 51.308(h) regarding determinations of the adequacy of existing implementation plans apply to States submitting plans under this section, with respect to subsequent progress reports due after 2013.
(g) * * *
(2) * * *
(iii) The Transport Region State may consider whether any strategies necessary to achieve the reasonable progress goals required by paragraph (g)(2) of this section are incompatible with the strategies implemented under paragraph (d) of this section to the extent the State adequately demonstrates that the incompatibility is related to the costs of the compliance, the time necessary for compliance, the energy and non air quality environmental impacts of compliance, or the remaining useful life of any existing source subject to such requirements.
42 U.S.C. 7401
The revision reads as follows:
(b) Regulations for visibility monitoring and new source review. The provisions of §§ 52.27 and 52.28 are hereby incorporated and made part of the applicable plan for the State of Arizona.
(b) The Visibility NSR regulations are approved for industrial source categories regulated by the NSR and PSD regulations which have previously been approved by EPA. However, Colorado's NSR and PSD regulations have been disapproved for certain sources as listed in 40 CFR 52.343(a)(1). The provisions of 40 CFR 52.28 are hereby incorporated and made a part of the applicable plan for the State of Colorado for these sources.
The revision reads as follows:
(b) Regulations for visibility monitoring and new source review. The provisions of §§ 52.27 and 52.28 are hereby incorporated and made part of the applicable plan for the State of Hawaii.
The revision reads as follows:
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of Michigan.
The revision reads as follows:
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of Minnesota.
The revision reads as follows:
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of Nevada except for that portion applicable to the Clark County Department of Air Quality and Environmental Management.
The revision reads as follows:
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of New Hampshire.
The revision reads as follows:
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of South Dakota.
(b) Regulations for visibility monitoring and new source review. The provisions of § 52.27 are hereby incorporated and made part of the applicable plan for the State of Vermont.
The revision reads as follows:
(a) Reasonably Attributable Visibility Impairment. The requirements of section 169A of the Clean Air Act are not met because the plan does not include approvable measures for meeting the requirements of 40 CFR 51.305 for protection of visibility in mandatory Class I Federal areas.
The revisions read as follows:
(a) Reasonably Attributable Visibility Impairment. The requirements of section 169A of the Clean Air Act are not met because the plan does not include approvable measures for meeting the requirements of 40 CFR 51.305 and 51.307 for protection of visibility in mandatory Class I Federal areas.
(b) Regulation for visibility monitoring and new source review. The provisions of § 52.28 are hereby incorporated and made a part of the applicable plan for the State of West Virginia.
(b) The Co-Chairs may also invite representatives of the Consumer Financial Protection Bureau, the Court Services and Offender Supervision Agency, the Equal Employment Opportunity Commission, the Federal Communications Commission, the Federal Deposit Insurance Corporation, the Federal Trade Commission, the Internal Revenue Service, and the Social Security Administration to participate in the activities of the Reentry Council to the extent that such activities are relevant to their respective statutory authorities and legal obligations.
(c) As appropriate, the Co-Chairs may invite relevant representatives of the judicial branch, including representatives of the United States Probation and Pretrial Services System and Federal Public Defender Organizations, to attend and participate in meetings of the Reentry Council.
(d) The Reentry Council shall work across executive departments, agencies, and offices (agencies) to:
(e) The Reentry Council shall engage with Federal, State, local, and tribal officials, including corrections officials, as necessary to carry out its objectives. The Reentry Council shall engage with nongovernmental organizations, including those representing or composed of formerly incarcerated individuals, exonerees, victims, and criminal justice agencies, to ensure that these stakeholders have the opportunity to offer recommendations and information to the Reentry Council.
(f) The Attorney General shall designate an Executive Director, who is a full-time officer or employee of the Federal Government, to coordinate the day-to-day functions of the Reentry Council.
(g) The Co-Chairs shall convene a meeting of the Reentry Council at least once per year.
(b) Consistent with applicable law and the need to protect public safety, agencies with statutory authority to grant or deny occupational licenses and the discretion to define the criteria by which such licensing decisions are made shall undertake to revise their procedures to provide that such licenses are not denied presumptively by reason of an applicant's criminal record in the absence of a specific determination that denial of the license is warranted in light of all relevant facts and circumstances known to the agency, including:
(c) Independent agencies are encouraged to comply with the requirements of this section.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
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