Federal Register Vol. 83, No.153,
Federal Register Volume 83, Issue 153 (August 8, 2018)
Federal Register Volume 83, Issue 153 (August 8, 2018)
| Page Range | 38951-39322 | |
| FR Document |
Document Created: 2017-12-29 23:37:52
Document Modified: 2017-12-29 23:37:52
| Page and Subject | |
|---|---|
| 83 FR 38964 - Interstate and Intrastate Natural Gas Pipelines; Rate Changes Relating to Federal Income Tax Rate; American Forest & Paper Association | |
| 83 FR 39087 - FIFRA Scientific Advisory Panel; Notice of Public Meeting and Request for Nomination of Ad Hoc Expert Members | |
| 83 FR 38976 - Spinetoram; Pesticide Tolerances | |
| 83 FR 39085 - Registration Review Proposed Interim Decisions for Several Pesticides; Notice of Availability | |
| 83 FR 39077 - Proposed Information Collection; Comment Request; International Fisheries Trade To Include Shrimp and Abalone | |
| 83 FR 39115 - Agency Information Collection Activities; National Land Remote Sensing Education, Outreach and Research Activity | |
| 83 FR 39102 - Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications | |
| 83 FR 39103 - Elemental Impurities in Drug Products; Guidance for Industry; Availability | |
| 83 FR 39105 - [Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices | |
| 83 FR 39103 - Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications | |
| 83 FR 39091 - Notice of Agreement Filed | |
| 83 FR 39148 - Commission Meeting | |
| 83 FR 39107 - NIH Clinical Center Research Hospital Board; Notice of Charter Renewal | |
| 83 FR 39106 - National Institute of Nursing Research; Notice of Meeting | |
| 83 FR 39108 - National Institute on Minority Health and Health Disparities; Notice of Closed Meeting | |
| 83 FR 39107 - National Institute on Minority Health and Health Disparities; Notice of Meeting | |
| 83 FR 39108 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting | |
| 83 FR 39107 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 83 FR 39148 - Notice of Release From Federal Surplus Property and Grant Assurance Obligations at Daniel K. Inouye International Airport (HNL), Honolulu, Hawaii | |
| 83 FR 39106 - Meeting of the President's Council on Sports, Fitness, and Nutrition; Correction | |
| 83 FR 39117 - Notice of Public Meeting, Boise District Resource Advisory Council, Idaho | |
| 83 FR 39131 - NASA Advisory Council; Human Exploration and Operations Committee; Meeting. | |
| 83 FR 39132 - NASA Advisory Council; Aeronautics Committee; Meeting. | |
| 83 FR 39132 - NASA Advisory Council; Science Committee; Meeting | |
| 83 FR 39132 - NASA Advisory Council; Technology, Innovation and Engineering Committee; Meeting | |
| 83 FR 39133 - NASA Advisory Council; Ad Hoc Task Force on STEM Education; Meeting | |
| 83 FR 39149 - Notice of Meetings; A Notice by the Federal Aviation Administration | |
| 83 FR 39150 - Aviation Rulemaking Advisory Committee; Meeting | |
| 83 FR 39158 - Notice of OFAC Sanctions Actions | |
| 83 FR 39135 - Solicitation of Nominations for Appointment to the Advisory Committee of the Pension Benefit Guaranty Corporation | |
| 83 FR 39116 - Notice of Intent for Potential Amendment to the Resource Management Plan for the Bakersfield Field Office, California, and To Prepare an Associated Supplemental Environmental Impact Statement | |
| 83 FR 39078 - Nominations for Advisory Committee and Species Working Group Technical Advisor Appointments to the U.S. Section to the International Commission for the Conservation of Atlantic Tunas | |
| 83 FR 39075 - Proposed Information Collection; Comment Request; Northeast Multispecies Amendment 16 | |
| 83 FR 39109 - Termination of U.S. Coast Guard Rebroadcast of HYDROLANT and HYDROPAC Information | |
| 83 FR 39155 - Drugs That Impair Safe Driving; Request for Comments; Correction | |
| 83 FR 39154 - Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB Review | |
| 83 FR 39155 - Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB Review | |
| 83 FR 39150 - Commercial Driver's License: Application for Exemption; Missouri Department of Revenue (DOR) | |
| 83 FR 39109 - Merchant Marine Personnel Advisory Committee | |
| 83 FR 39100 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 39039 - Pacific Island Fisheries; Ecosystem Component Species | |
| 83 FR 39147 - Notice of Senior Executive Service Performance Review Board Membership | |
| 83 FR 39041 - Trade and Foreign Agriculture Affairs; Codex Alimentarius Commission: International Standard-Setting Activities | |
| 83 FR 39129 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc. | |
| 83 FR 39128 - Importer of Controlled Substances Registration | |
| 83 FR 39129 - Importer of Controlled Substances Application: Chattem Chemicals, Inc. | |
| 83 FR 39127 - Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc. | |
| 83 FR 39130 - Importer of Controlled Substances Application: Myoderm | |
| 83 FR 39128 - Importer of Controlled Substances Application: AndersonBrecon Inc. | |
| 83 FR 39096 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
| 83 FR 39095 - Privacy Act of 1974; System of Records | |
| 83 FR 39079 - Submission for OMB Review; Comment Request | |
| 83 FR 39078 - Submission for OMB Review; Comment Request | |
| 83 FR 39113 - Endangered and Threatened Wildlife and Plants; Initiation of 5-Year Reviews of 19 Northeastern Species | |
| 83 FR 39130 - Agency Information Collection Activities; Comment Request; State Apprenticeship Expansion (SAE) Grants Research Study | |
| 83 FR 39147 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: Exhibition of Two Roman-Era Objects | |
| 83 FR 39148 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Animal-Shaped Vessels From the Ancient World: Feasting With Gods, Heroes, and Kings” Exhibition | |
| 83 FR 39135 - Excepted Service | |
| 83 FR 39121 - Notice of Inventory Completion: Albuquerque Museum, Albuquerque, NM | |
| 83 FR 39120 - Notice of Inventory Completion: Binghamton University, State University of New York, Binghamton, NY | |
| 83 FR 39118 - Notice of Inventory Completion: Binghamton University, State University of New York, Binghamton, NY | |
| 83 FR 39123 - Notice of Inventory Completion: Binghamton University, State University of New York, Binghamton, NY | |
| 83 FR 39117 - Notice of Inventory Completion: Binghamton University, State University of New York, Binghamton, NY | |
| 83 FR 39124 - Notice of Inventory Completion: San Diego Museum of Man, San Diego, CA | |
| 83 FR 39126 - Notice of Inventory Completion: New York University College of Dentistry, New York City, NY | |
| 83 FR 39093 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
| 83 FR 39093 - Proposed Agency Information Collection Activities; Comment Request | |
| 83 FR 39091 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
| 83 FR 39052 - Submission for OMB Review; Comment Request | |
| 83 FR 39061 - Proposed Information Collection; Comment Request; NIST SURF Program Student Applicant Information | |
| 83 FR 39133 - Records Schedules; Availability and Request for Comments | |
| 83 FR 39053 - First Responder Network Authority Combined Committee and Board Meeting | |
| 83 FR 39084 - Combined Notice of Filings #1 | |
| 83 FR 39083 - Combined Notice of Filings | |
| 83 FR 39081 - Combined Notice of Filings | |
| 83 FR 39082 - Combined Notice of Filings #1 | |
| 83 FR 39160 - Notice of OFAC Sanctions Actions; Sanctions Actions Pursuant to Directive One of Executive Order 13662 | |
| 83 FR 39157 - Notice of OFAC Sanctions Actions | |
| 83 FR 39035 - Air Plan Approval; Arkansas | |
| 83 FR 38964 - Air Plan Approval; Arkansas | |
| 83 FR 39111 - Changes in Flood Hazard Determinations | |
| 83 FR 39143 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Proposed Rule Change To Codify the Processing of Conditional Prepayment Rate Claims in the MBSD Rules and Make Other Changes | |
| 83 FR 39058 - Certain Plastic Decorative Ribbon From the People's Republic of China: Preliminary Determination of Sales at Less Than Fair Value | |
| 83 FR 39061 - Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty | |
| 83 FR 39054 - Certain Corrosion-Resistant Steel Products From the Republic of Korea: Notice of Court Decision Not in Harmony With Final Determination of Investigation and Notice of Amended Final Results | |
| 83 FR 39056 - Common Alloy Aluminum Sheet From the People's Republic of China: Amended Preliminary Affirmative Determination of Sales at Less Than Fair Value | |
| 83 FR 39090 - Information Collection Approved by the Office of the Management and Budget (OMB) | |
| 83 FR 39054 - Emerging Technology Technical Advisory Committee (ETTAC); Notice of Recruitment of Private-Sector Members | |
| 83 FR 39052 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
| 83 FR 39156 - Open Meeting: Community Development Advisory Board | |
| 83 FR 39138 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of the GraniteShares Gold MiniBAR Trust | |
| 83 FR 39143 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Withdrawal of a Proposed Rule Change To Adopt the Route QCT Cross Routing Option | |
| 83 FR 38997 - Risk-Based Capital-Supplemental Rule | |
| 83 FR 39084 - Independent Power Producers of New York, Inc. v. New York Independent System Operator, Inc.; Notice of Complaint | |
| 83 FR 39080 - Military Aviation and Installation Assurance Siting Clearinghouse; Notice and Request for Public Comment on Boardman, Oregon, and NAS Patuxent River, Maryland, Geographic Areas of Concern | |
| 83 FR 39062 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Unexploded Ordnance Investigation Survey off the Coast of Virginia | |
| 83 FR 39050 - Tongass National Forest; Ketchikan Misty Fjords Ranger District; Alaska; South Revillagigedo Integrated Resource Project Environmental Impact Statement | |
| 83 FR 39037 - Pacific Island Pelagic Fisheries; 2018 U.S. Territorial Longline Bigeye Tuna Catch Limits | |
| 83 FR 39019 - Air Plan Approval; District of Columbia, Maryland, and Virginia; Maryland and Virginia Redesignation Requests and District of Columbia, Maryland, and Virginia Maintenance Plan for the Washington, DC-MD-VA 2008 Ozone Standard Nonattainment Area | |
| 83 FR 39152 - Approved Agency Information Collection Activities | |
| 83 FR 39152 - Proposed Agency Information Collection Activities; Comment Request | |
| 83 FR 38968 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Interstate Transport Requirements for the 2012 Fine Particulate Matter Standard; Correction | |
| 83 FR 39012 - Revisions to California State Implementation Plan; South Coast Air Quality Management District; Stationary Source Permits | |
| 83 FR 38982 - Nuclear Safety Management | |
| 83 FR 39035 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Interstate Transport Requirements for the 2010 1-Hour Sulfur Dioxide Standard | |
| 83 FR 39017 - Approval of California Air Plan Revision, South Coast Air Quality Management District | |
| 83 FR 39014 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; NOX | |
| 83 FR 39009 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Amendment to Control of Emissions of Volatile Organic Compounds From Consumer Products | |
| 83 FR 38969 - Protection of Stratospheric Ozone: Revision to References for Refrigeration and Air Conditioning Sector To Incorporate Latest Edition of Certain Industry, Consensus-Based Standards | |
| 83 FR 38959 - Airworthiness Directives; Airbus Airplanes | |
| 83 FR 39292 - Additional First Year Depreciation Deduction | |
| 83 FR 38951 - Airworthiness Directives; Safran Helicopter Engines, S.A., Turboshaft Engines | |
| 83 FR 39004 - Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters | |
| 83 FR 38953 - Airworthiness Directives; Airbus SAS Airplanes | |
| 83 FR 39162 - Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program | |
| 83 FR 38957 - Airworthiness Directives; The Boeing Company Airplanes | |
| 83 FR 39007 - Airworthiness Directives; Airbus Helicopters (Previously Eurocopter France) |
Issue
Food Safety and Inspection Service
Forest Service
Economic Development Administration
First Responder Network Authority
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
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
Federal Emergency Management Agency
Fish and Wildlife Service
Geological Survey
Land Management Bureau
National Park Service
Drug Enforcement Administration
Employment and Training Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
National Highway Traffic Safety Administration
Community Development Financial Institutions Fund
Foreign Assets Control Office
Internal Revenue Service
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Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2012-03-11 for all Safran Helicopter Engines, S.A., Arriel 2B and 2B1 turboshaft engines. AD 2012-03-11 required checking the transmissible torque between the low-pressure (LP) pump impeller and the high-pressure (HP) pump shaft on the HP/LP pump and metering valve assembly, hereafter referred to as the hydro-mechanical metering unit (HMU). Since we issued AD 2012-03-11, the manufacturer determined that incorporating Modification TU 178 is a more effective method to reduce the risk of uncoupling between the LP fuel pump impeller and the HP fuel pump shaft than the prior Modification TU 147. This AD requires inspection and possible replacement of the HMU. This AD was prompted by three cases of uncoupling of the HMU LP fuel pump impeller and the HP fuel pump shaft since AD 2012-03-11 was issued. We are issuing this AD to address the unsafe condition on these products.
This AD is effective September 12, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 11, 2010 (75 FR 5689, February 4, 2010).
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 20, 2012 (77 FR 8092, February 14, 2012).
For service information identified in this final rule, contact Safran Helicopter Engines, S.A., 40220 Tarnos, France; phone: (33) 05 59 74 40 00; fax: (33) 05 59 74 45 15. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at
You may examine the AD docket on the internet at
John Frost, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7756; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2012-03-11, Amendment 39-16953 (77 FR 8092, February 14, 2012), (“AD 2012-03-11”). AD 2012-03-11 applied to all Safran Helicopter Engines, S.A., Arriel 2B and 2B1 turboshaft engines. 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 the comment.
An individual commenter questioned how the new modification in this AD is better and different from the actions required by the previous AD 2012-03-11.
AD 2012-03-11 required a check of the transmissible torque between the LP fuel pump impeller and the HP fuel pump shaft and replacement of the HMU if it does not pass the torque check. Since we issued AD 2012-03-11, Safran Service Bulletin (SB) 292 73 2178, Version A, dated April 1, 2015 introduced Modification TU 178. This AD accepts Modification TU 178 as a more robust drive link between the LP fuel pump impeller and the HP fuel pump shaft that ensures the LP impeller pump is driven even if the link with the drive shaft loosens. This AD requires installation of a Modification TU 178 HMU for any HMU that fails the torque sensor check and as a mandatory terminating action for the inspections required by this AD, as well as purging the fleet of the pre- and post-TU 147 configuration parts. We did not change this AD.
We updated paragraphs (g)(1)(i) and (ii) of this AD to clarify that only paragraph 2.A, rather than paragraph 2, in Turbomeca Alert Mandatory SB (MSB) A292 73 2830, Version B, dated July 10, 2009, and Turbomeca Alert MSB A292 73 2836, Version A, dated August 17, 2010, is used to perform the torque check.
We reviewed the relevant data, considered the comment received, 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 addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Turbomeca, S.A., Alert MSB A292 73 2830, Version B, dated July 10, 2009, and Alert MSB A292 73 2836, Version A, dated August 17, 2010. Turbomeca Alert MSB A292 73 2830, Version B, describes procedures for inspecting pre-Modification TU 147 HMUs. Turbomeca Alert MSB A292 73 2836, Version A, dated August 17, 2010, describes procedures for inspecting HMUs that have incorporated Modification TU 147
We reviewed Safran Helicopter Engines MSB 292 73 2178, Version B, dated March 23, 2017. Safran Helicopter Engines MSB 292 73 2178, Version B, describes HMU improvements that includes a reinforced drive link between the LP impeller and HP fuel pump shaft (Modification TU 178). Safran Helicopter Engines has also issued MSB A292 73 2830, Version C; and A292 73 2836, Version B, both dated April 5, 2017, which exempt HMUs incorporating Modification TU 178 from the inspections previously recommended by Safran Helicopter Engines.
We estimate that this AD affects 417 engines installed on helicopters of U.S. registry.
We estimate the following costs to comply with 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 is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
We have 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 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 September 12, 2018.
This AD replaces AD 2012-03-11, Amendment 39-16953 (77 FR 8092, February 14, 2012).
This AD applies to Safran Helicopter Engines, S.A., Arriel 2B and 2B1 turboshaft engines, except those incorporating Modification TU 178.
Joint Aircraft System Component (JASC) Code 7300, Engine Fuel and Control.
This AD was prompted by analysis that indicated the modification of an engine to incorporate Modification TU 178 provides a more effective method than Modification TU
Comply with this AD within the compliance times specified, unless already done.
(1) Check the transmissible torque between the LP fuel pump impeller and the HP fuel pump shaft as follows:
(i) For pre-Modification TU 147 HMUs, check the torque before accumulating 500 engine flight hours (FHs) since March 11, 2010 or before the next flight after the effective date of this AD, whichever occurs later. Use Paragraph 2.A. of Turbomeca Alert Mandatory Service Bulletin (MSB) A292 73 2830, Version B, dated July 10, 2009 to do the check.
(ii) For HMUs that incorporated Modification TU 147 on or before March 31, 2010, and those HMUs not listed in Figure 2 or 3 of Turbomeca Alert MSB A292 73 2836, Version A, dated August 17, 2010, check the torque before the next flight after the effective date of this AD. Use Paragraph 2.A. of Turbomeca Alert MSB A292 73 2836, Version A, dated August 17, 2010, to do the check.
(2) If the HMU does not pass the torque check, replace the HMU with a post-Modification TU 178 HMU before the next flight after the effective date of this AD.
Within 2,200 engine FHs or 72 months after the effective date of this AD, whichever occurs first, replace any pre-Modification TU 178 HMU with a post-Modification TU 178 configuration HMU.
After the effective date of this AD, do not install a pre-Modification TU 178 HMU on engines incorporating a post-Modification TU 178 HMU.
(1) The Manager, ECO Branch, 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 certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD. You may email your request 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.
(1) For more information about this AD, contact John Frost, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7756; fax: 781-238-7199; email:
(2) Refer to European Aviation Safety Agency (EASA) AD 2017-0102, dated June 13, 2017, for more information. You may examine the EASA AD 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 the AD specifies otherwise.
(3) The following service information was approved for IBR on March 11, 2010 (75 FR 5689, February 4, 2010).
(i) Turbomeca Alert Mandatory Service Bulletin (MSB) No. A292 73 2830, Version B, dated July 10, 2009.
(ii) Reserved.
(4) The following service information was approved for IBR on March 20, 2012 (77 FR 8092, February 14, 2012).
(i) Turbomeca Alert MSB No. A292 73 2836, Version A, dated August 17, 2010.
(ii) Reserved.
(5) For Safran Helicopter Engines, S.A, service information identified in this AD, contact Safran Helicopter Engines, S.A., 40220 Tarnos, France; phone: (33) 05 59 74 40 00; fax: (33) 05 59 74 45 15.
(6) You may view this service information at FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759.
(7) 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 all Airbus SAS Model A319-133 airplanes and Model A321-232 airplanes. This AD requires modification and re-identification, or replacement, of certain engine fan cowl doors (FCDs) and installation of a placard in the flight deck. This AD was prompted by reports of in-service engine FCD losses, and the development of a new FCD front latch and keeper assembly that addresses this unsafe condition. We are issuing this AD to address the unsafe condition on these products.
This AD becomes effective August 23, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 3, 2017 (82 FR 29371, June 29, 2017).
We must receive comments on this AD by September 24, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 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 Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0053, dated March 14, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A319-131, -132, and -133 airplanes, Model A320-231, -232, and -233 airplanes, and Model A321-131, -231, and -232 airplanes. The MCAI states:
Fan Cowl Door (FCD) losses during take-off were reported on aeroplanes equipped with IAE V2500 engines. Prompted by these occurrences, DGAC [Direction Générale de l'Aviation Civile] France issued AD 2000-444-156(B), mandating FCD latch improvements. This [DGAC] AD was later superseded by [DGAC] AD 2001-381(B) [which corresponds to FAA AD 2003-18-06, Amendment 39-13297 (68 FR 53501, September 11, 2003)], requiring installation of additional fan cowl latch improvement by installing a hold open device.
Since that [DGAC] AD was issued, further FCD in flight losses were experienced in service. Investigations confirmed that in all cases, the fan cowls were opened prior to the flight and were not correctly re-secured. During the pre-flight inspection, it was then not detected that the FCD were not properly latched.
This condition, if not corrected, could lead to in-flight loss of a FCD, possibly resulting in damage to the aeroplane and/or injury to persons on the ground.
Prompted by these recent events, new FCD front latch and keeper assembly were developed, having a specific key necessary to un-latch the FCD. This key cannot be removed unless the FCD front latch is safely closed. The key, after removal, must be stowed in the flight deck at a specific location, as instructed in the applicable Aircraft Maintenance Manual. Applicable Flight Crew Operating Manual has been amended accordingly. After modification, the FCD is identified with a different Part Number (P/N).
For the reasons described above, this [EASA] AD retains the requirements of DGAC AD 2001-381(B), which is superseded, and requires modification and re-identification of FCD.
You may examine the MCAI on the internet at
Airbus has issued Service Bulletin A320-71-1069, Revision 01, including Appendix 01, dated April 28, 2016. This service information describes procedures for modifying the engine FCDs, installing placards, and re-identifying the FCDs with new part numbers. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.
The MCAI applies to Airbus SAS Model A319-131 and -132 airplanes; Model A320-231, -232, and -233 airplanes; and Model A321-131 and -231 airplanes, in addition to Model A319-133 airplanes and Model A321-232 airplanes. The unsafe condition on Model A319-131 and -132 airplanes; Model A320-231, -232, and -233 airplanes; and Model A321-131 and -231 airplanes is already addressed in AD 2017-13-10, Amendment 39-18940 (82 FR 29371, June 29, 2017); therefore this AD only applies to Model A319-133 airplanes and Model A321-232 airplanes.
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 we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with 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 is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 August 23, 2018.
None.
This AD applies to Airbus SAS Model A319-133 airplanes and Model A321-232 airplanes, certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 71, Powerplant.
This AD was prompted by reports of in-service engine fan cowl door (FCD) losses, and the development of a new FCD front latch and keeper assembly that addresses this unsafe condition. We are issuing this AD to address in-flight loss of an engine FCD and possible consequent damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 36 months after the effective date of this AD, do the actions specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-71-1069, Revision 01, including Appendix 01, dated April 28, 2016.
(1) Modify the left-hand and right-hand engine FCDs on engines 1 and 2.
(2) Install a placard that specifies the FCD keys stowage location in the flight deck on the box located at the bottom of panel 120VU or at the bottom of the coat stowage, as applicable to airplane configuration.
(3) Re-identify both engine FCDs with the new part numbers, as specified in figure 1 to paragraphs (g), (j), and (k) of this AD.
Flights with one or both FCD keys missing from the stowage location in the fight deck, or with the placard (that specifies the FCD keys stowage location) missing or damaged, are permitted for a period not to exceed 10 calendar days from the date of discovery.
As an option to paragraph (g)(2) of this AD, an alternative location for the key stowage in the flight deck and installation of a placard for identification of that stowage location are permitted as specified in the operator's FAA-accepted maintenance or inspection program, provided the keys can be retrieved from that flight deck location when needed and the placard installation is done within 36 months after the effective date of this AD.
(1) Replacing an engine FCD having a part number listed as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD with an FCD having the corresponding part number listed as “New Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD is an acceptable method of compliance with the requirements of paragraphs (g)(1) and (g)(3) of this AD for that engine FCD only.
(2) An airplane on which Airbus Modification 157516 has been embodied in production is compliant with the requirements of paragraphs (g)(1) and (g)(3) of this AD, provided no engine FCD having a part number identified as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD is installed on that airplane.
(3) An airplane on which Airbus Modification 157718 has been embodied in production is compliant with the requirements of paragraph (g)(2) of this AD.
(4) Installation on an engine of a right-hand and left-hand engine FCD having a part number approved after the effective date of this AD is a method of compliance with the requirements of paragraphs (g)(1) and (g)(3) of this AD for that engine only, provided the part number is approved, and the installation is accomplished using a method approved by the Manager, International Section, Transport Standards Branch, 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.
(1) For an airplane with an engine FCD installed having a part number identified as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD: After modification of that airplane as required by paragraph (g) of this AD, do not install an engine FCD, having a part number identified as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD.
(2) For an airplane that does not have an engine FCD installed having a part number identified as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD: On or after the effective date of this AD, do not install an engine FCD having a part number identified as “Old Part Number” in figure 1 to paragraphs (g), (j), and (k) of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-71-1069, dated December 18, 2015.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016-0053, dated March 14, 2016, for related information. You may examine the MCAI on the internet at
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(4) and (o)(5) 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 August 3, 2017 (82 FR 29371, June 29, 2017).
(i) Airbus Service Bulletin A320-71-1069, Revision 01, including Appendix 01, dated April 28, 2016.
(ii) Reserved.
(4) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(5) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(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.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, 747SP, and 747SR, and 747-8 series airplanes. This AD was prompted by reports indicating that additional areas of Boeing Material Specification (BMS) 8-39 flexible urethane foam were found during an inspection required by a related AD. This AD requires inspecting for BMS 8-39 flexible urethane foam insulation in the floor panel assemblies and the power drive unit (PDU) cover assemblies, doing applicable on-condition actions, modifying certain dripshields, and replacing BMS 8-39 foam strips on certain dripshields with BMS 8-371 foam strips. We are issuing this AD to address the unsafe condition on these products.
This AD is effective September 12, 2018.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 12, 2018.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
You may examine the AD docket on the internet at
Scott Craig, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3566; 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 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, 747SP, and 747SR, and 747-8 series airplanes. The NPRM published in the
We are issuing this AD to address BMS 8-39 flexible urethane foam in certain areas, which, if exposed to an ignition source, could cause an uncontrolled fire leading to loss of control of the airplane.
We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. Boeing stated that it had no objection to the NPRM.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule 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 addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed the following Boeing service information.
• Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014, which describes procedures for performing a general visual inspection for BMS 8-39 flexible urethane foam insulation in the floor panel assemblies and the PDU cover assemblies, and applicable on-condition actions.
• Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated
• Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016, which describes procedures for modifying and replacing BMS 8-39 foam strips with BMS 8-371 foam strips on certain dripshields.
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 87 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.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all available costs in our cost estimate.
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 is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
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 September 12, 2018.
None.
This AD applies to The Boeing Company airplanes, certificated in any category, as identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, 747SP, and 747SR series airplanes, as identified in Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014.
(2) Model 747-400, -400D, and 747-8 series airplanes, as identified in Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017.
(3) Model 747-100, -100B, -100B SUD, -200B, -300, 747SP, and 747SR series airplanes, as identified in Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings; 53, Fuselage.
This AD was prompted by reports indicating that additional areas of Boeing Material Specification (BMS) 8-39 flexible urethane foam were found during an inspection required by a related AD. The degradation of the foam increases the
Comply with this AD within the compliance times specified, unless already done.
Within 72 months after the effective date of this AD, do all actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of the applicable service information identified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD.
(1) For airplanes identified in paragraph (c)(1) of this AD: Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014.
(2) For airplanes identified in paragraph (c)(2) of this AD: Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017.
(3) For airplanes identified in paragraph (c)(3) of this AD: Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016.
This paragraph provides credit for the actions specified in paragraph (g)(2) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 747-25-3646, dated June 19, 2015.
(1) The Manager, Seattle ACO Branch, 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 certification office, send it to the attention of the person identified in paragraph (j)(1) 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 Branch, 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. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. 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.
(1) For more information about this AD, contact Scott Craig, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3566; email:
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (k)(4) 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 the AD specifies otherwise.
(i) Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017.
(ii) Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016.
(iii) Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(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), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A319 and A320 series airplanes; and A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This AD was prompted by reports of battery retaining rod failures due to quality defects of the material used during parts manufacturing. This AD requires a detailed inspection of the battery support assemblies to identify the battery retaining rod manufacturer, replacement of the battery retaining rods with serviceable battery retaining rods if necessary, and the addition of the applicable service information label on each battery retaining rod if necessary. We are issuing this AD to address the unsafe condition on these products.
This AD is effective September 12, 2018.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 12, 2018.
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 2 Rond Point Emile Dewoitine, 31700 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 Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
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 A319 and A320 series airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 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 AD 2017-0161R1, dated September 19, 2017; corrected September 20, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A319 and A320 series airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:
Several occurrences have been reported of battery rod failures on certain Airbus aeroplanes. Subsequent examination of broken rod parts determined that these failures were due to quality defects of the material used during parts manufacturing. Each battery is secured on an aeroplane by two rods. Failure of one rod, in case of severe turbulence during flight or hard landing, could lead to battery displacement, or roll on the remaining rod side, up to a point where the remaining rod could be disengaged. The battery could ultimately detach from its housing and damage relays, connectors, contactor boxes, air ducts and surrounding structure.
This condition, if not detected and corrected, could lead to the loss of the normal electrical generation not followed by an automatic recovery of essential network.
To address this potential unsafe condition, Airbus issued Alert Operators Transmission (AOT) A92N001-16 (later revised) and EASA issued AD 2016-0204 [which corresponds to FAA AD 2016-25-24 (81 FR 90958, December 16, 2016) (“AD 2016-25-24”)] requiring repetitive general visual inspections (GVI) of the four battery rods (two per battery), and, in case of findings, replacement of battery rods.
Since that [EASA] AD was issued, the manufacturer of the broken battery retaining rods has been identified, which allows proper identification of the affected parts and their withdrawal from service. Consequently, Airbus issued [service bulletin] SB A320-92-1116 and SB A320-92-1118 to provide the necessary instructions to the affected operators. No rods delivered as spare parts are affected by the manufacturing issue.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2016-0204, which is superseded, and requires replacement of battery retaining rods depending on manufacturer identification. This [EASA] AD also provides a terminating action for the repetitive inspections.
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.
Air Line Pilots Association, International (ALPA) requested that we revise the compliance time. ALPA stated that the proposed AD specifies a compliance time of within 24 months after the AD effective date. ALPA commented that because the proposed AD is related to quality, it believes this compliance time is insufficient. ALPA also commented that since the issuance of the manufacturer's service information, operators have had over 12 months to comply with the required corrective actions. ALPA stated that, additionally, the time estimated to complete the inspections and replacement of the affected parts is minimal. ALPA recommended that we consider a compliance time of within 12 months after the AD effective date.
We disagree with the commenter. While some U.S. operators have had time to plan and schedule the work contained in the Airbus service information, there is no obligation for any U.S. operator to perform those actions without a regulatory requirement. Therefore, we agree with EASA's decision to allow a 24-month compliance time to plan, schedule, and accomplish the actions necessary to remove the unsafe condition. If additional data are presented that would justify a shorter compliance time, we may consider further rulemaking on this issue. We have not changed this AD in this regard.
Delta Airlines (DAL) requested that we revise the definition of a serviceable rod in paragraph (g) of the proposed AD. DAL stated to add an additional paragraph that specifies:
A battery retaining rod with an ISB [inspection service bulletin] label installed in accordance with the accomplishment instructions of Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017 (for Airbus Model A319 and A320 series airplanes; and A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes); or Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017 (for Airbus Model A320-251N and -271N airplanes).
We partially agree with revising the definition of a serviceable rod in paragraph (g) of this AD. We have determined that the installation of the ISB label does not affect the unsafe condition and have removed the requirement from this AD. We have coordinated this changed with EASA. Furthermore, we have revised paragraph (g) of this AD to clarify that the battery retaining rod used for replacement must be positively identified as a serviceable battery retaining rod.
United Airlines (UAL) requested clarification regarding manufacturer serial numbers in the proposed AD. UAL stated that the manufacturer serial numbers are not applicable to the proposed AD as identified in Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017, and Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017. UAL stated that, although the machining that caused the failure mode is identified in the service information, the same battery retaining rod part number used in pre- and post-service information remains unchanged. UAL commented that it is unclear whether a serial number, batch number, or date exists for those battery retaining rods. UAL also asked how were the battery
We agree to provide clarification for the commenter. According to EASA AD 2017-0161R1, dated September 19, 2017; corrected September 20, 2017; no spares with manufacturing defects were delivered by Airbus. Only a certain batch of defective parts were installed in production on certain manufacturer serial numbers as specified in Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017; and Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017. If an operator does not have an airplane affected as specified in the service information, then there is no concern relative to defective spare parts. We have not changed this AD in this regard.
DAL requested that we clarify the identification of the affected parts in paragraph (h) of the proposed AD. DAL stated that the detailed inspection to identify the battery retaining rod manufacturer should be of the battery support assemblies and not the battery retaining rods.
We agree with the commenter's request. We have revised paragraph (h) of this AD to require a detailed inspection of the battery support assemblies to identify the manufacturer of the battery retaining rods.
DAL requested that we add an additional method of compliance for paragraphs (h), (i), and (j) of the proposed AD. DAL stated that the language, “or using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA Design Organization Approval (DOA),” should be included as an option to using the service information. DAL also stated that this language should be considered standard wording for future ADs as applicable.
We disagree with the commenter's request. We have already provided a method of compliance (MOC) for paragraphs (h), (i), and (j) of this AD in accordance with the applicable service information. Any deviations from the required MOC would need an evaluation in form of an AMOC. DAL's proposed option is generally utilized in cases where no MOC has been established or we have known information that the MOC may not be applicable for all airplanes in the U.S fleet. We have not changed the AD in this regard.
DAL and American Airlines (AA) requested that we not mandate that a service information label be attached to each battery retaining rod as required by the Airbus service information specified in paragraphs (j) and (l) of the proposed AD. AA also requested that we not mandate attachments of a service information label as part of the replacement required by paragraph (i) of the proposed AD. DAL stated that it has 7 affected airplanes that would have a different final configuration than the current and future fleet of 348 airplanes in its A320FAM fleet.
AA stated that all battery retaining rods provided by Airbus post August 2016 are marked and stamped with manufactures part number (MPN) D8241023700000. AA commented that this marking of the new battery retaining rods can be used in lieu of the information service bulletin (ISB) label. AA also commented that it plans to replace all existing battery retaining rods with the new battery retaining rods that are marked with MPN D8241023700000.
In addition, AA stated that installing the ISB label on the battery retaining rods on 128 of its A319/A320 airplanes does not add a safety value, but will put a burden on AA to maintain two different configurations of battery retaining rod installation between 128 airplanes that are effected by the service information in the proposed AD and 265 airplanes that are not affected by the service information in the proposed AD.
We agree with the commenters' request. We agree that the ISB label is not necessary to mitigate the risk addressed in this AD. Therefore, we have determined that the installation of ISB label should be optional and not a required for compliance (RC) step.
However, 14 CFR 39.9, specifies that operators have a continuing obligation to maintain compliance with an AD, and the installation of the ISB label or an equivalent method to identify a serviceable battery retaining rod provides the operators with a simplified way to demonstrate compliance with the AD requirements. We have removed paragraph (j) of the proposed AD and revised paragraph (l) of this AD to revise the terminating action requirements. We have also added paragraph (j) of this AD to provide an exception to paragraph (i) of this AD, which specifies that installing the ISB label is not a requirement in this AD.
DAL requested that paragraph (l) of the proposed AD, “Terminating Action,” be revised to read, “Replacement of all battery retaining rods,” and not, “Replacement of all battery retaining rods marked `SA. . . .' ” DAL stated that the battery retaining rods are not marked with “SA,” only the battery support assemblies.
We agree with the commenter's request and have revised the AD accordingly.
Spirit Airlines requested that either the service information or the proposed AD be revised to provide the use of alternate materials to label part number (P/N) ASNE0248A1-4H9. Spirit Airlines stated that P/N ASNE0248A1-4H9 is no longer available, and that alternate P/N E0248A1-4H9P and P/N ASNE0248A1-4H9T may be obtained from Airbus. Spirit Airlines believes that use of these alternate part numbers would provide an equivalent level of safety as referenced in Airbus Dossier Reference 80403684/003, dated January 8, 2018, and Airbus Retrofit Information Letter SA92M16012714 R00, dated February 1, 2017.
DAL requested that a previously approved AMOC be used in the proposed AD. DAL stated that in paragraph (h) and (j) of the proposed AD, Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017, calls out a non-procurable part number for the identification label. Therefore, DAL proposed that recognition of AMOC AIR-676-18-152, issued against AD 2016-25-24, which allows an alternate label part number, be added to paragraph (m) of the proposed AD as an acceptable method of compliance to the proposed AD.
We partially agree with the commenters request. As we stated previously, we have determined that installation of an ISB label is not an RC step. Therefore, a previously issued AMOC for allowing alternate label part numbers is unnecessary. However, we would like to remind operators that 14 CFR 39.9 specifies an operator's continuing obligation to maintain compliance with an AD, and installation of an ISB label or an equivalent method provides operators with a method to demonstrate the affected battery retaining rods have been removed and replaced with serviceable retaining rods in compliance with the AD requirements.
The MCAI includes a requirement to install an ISB label. This AD does not include that requirement. We have determined that the ISB label is not necessary to mitigate the risk addressed in this AD. However, 14 CFR 39.9, specifies that operators have a continuing obligation to maintain compliance with an AD, and the installation of the ISB label or an equivalent method to identify a serviceable battery retaining rod provides the operators with a simplified way to demonstrate compliance with the AD requirements.
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.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017; and Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017. This service information describes a detailed inspection of the battery support assemblies to identify the battery retaining rod manufacturer, replacement of the battery retaining rods with serviceable battery retaining rods if necessary, and adding the applicable service information label on each battery retaining rod if necessary. These documents are distinct since they apply to different airplane models. 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 330 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacement that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacement:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
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 is effective September 12, 2018.
This AD affects AD 2016-25-24, Amendment 39-18750 (81 FR 90958, December 16, 2016) (“AD 2016-25-24”).
This AD applies to Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, -233, -251N, and -271N airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes, certificated in any category, as identified in Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017; or Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017.
Air Transport Association (ATA) of America Code 92, Electrical system installation.
This AD was prompted by reports of battery retaining rod failures due to quality defects of the material used during parts manufacturing. We are issuing this AD to detect and correct broken battery retaining rods, which, in the event of a hard landing or severe turbulence, could cause the battery to detach from its housing, resulting in damage to other electrical equipment and surrounding structure. This condition could lead to loss of normal electrical power generation and subsequent inability to restore electrical power to essential airplane systems.
Comply with this AD within the compliance times specified, unless already done.
For the purpose of this AD, a serviceable battery retaining rod is defined in paragraphs (g)(1) or (g)(2) of this AD.
(1) A battery retaining rod provided as a spare part by Airbus.
(2) A battery retaining rod previously fitted on a battery support assembly installed on an airplane manufacturer serial number that is not specified in Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017 (for Airbus Model A319 and A320 series airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes); or Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017 (for Airbus Model A320-251N and -271N airplanes), provided the battery retaining rod used for replacement can be positively identified as a serviceable battery retaining rod.
Within 24 months after the effective date of this AD: Accomplish a detailed inspection of the battery support assemblies to identify the battery retaining rod manufacturer, in accordance with the Accomplishment Instructions of the Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017 (for Airbus Model A319 and A320 series airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes); or Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017 (for Airbus Model A320-251N and -271N airplanes).
If, during the inspection specified in paragraph (h) of this AD, the quality stamp on any battery support assemblies are found marked with an “SA” manufacturer identification, before further flight, replace the battery retaining rods with serviceable battery retaining rods, in accordance with the Accomplishment Instructions of the Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017 (for Airbus Model A319 and A320 series airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes); or Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017 (for Airbus Model A320-251N and -271N airplanes); except as provided by paragraph (j) of this AD.
Although Airbus Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017; and Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017; specify to install inspection service bulletin (ISB) labels, this AD does not include that requirement.
As of the effective date of this AD, no person may install, on any airplane, a non-serviceable battery retaining rod.
Replacement of all battery retaining rods with a serviceable battery retaining rod as required by paragraph (i) of this AD constitutes terminating action for all requirements of AD 2016-25-24 for that airplane.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2017-0161R1, dated September 19, 2017; corrected September 20, 2017; for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
(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 Service Bulletin A320-92-1116, Revision 00, dated January 31, 2017.
(ii) Airbus Service Bulletin A320-92-1118, Revision 00, dated January 31, 2017.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 2 Rond Point Emile Dewoitine, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this service information that is incorporated by reference at the
In rule document 2018-15786 appearing on pages 36672-36717 in the issue of July 30, 2018, make the following correction:
Environmental Protection Agency (EPA).
Direct final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving portions of the revisions to the Arkansas State Implementation Plan (SIP) submitted by the Arkansas Department of Environmental Quality (ADEQ) on March 24, 2017. Most of the revisions are administrative in nature and make the SIP current with Federal rules. The EPA is also making ministerial changes to the Code of Federal Register (CFR) to reflect SIP actions pertaining to the Arkansas Prevention of Significant Deterioration (PSD) program.
This rule is effective on November 6, 2018 without further notice, unless the EPA receives relevant adverse comment by September 7, 2018. If the EPA receives such comment, the EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket No. EPA-R06-OAR-2017-0699, at
Carrie Paige, 214-665-6521,
Throughout this document “we,” “us,” and “our” means the EPA.
The SIP is a set of air pollution regulations, control strategies, and technical analyses developed by the state to ensure that the state meets the National Ambient Air Quality Standards (NAAQS). These ambient standards are established under section 109 of the Act and they currently address six criteria pollutants: Carbon monoxide, lead, nitrogen dioxide, ozone, particulate matter, and sulfur dioxide. The SIP is required by Section 110 of the Act and can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.
On March 24, 2017, the Governor of Arkansas submitted to the EPA revisions to the Arkansas SIP. The submittal includes revisions to the Regulations of the Arkansas Plan of Implementation for Air Pollution Control enacted at Arkansas Annotated Code (“Ark. Code Ann.”) Regulation 19 (“Reg. 19”), Chapters 1-5, 7, 9, 11, 13-15, Appendix A, and Appendix B, and the Infrastructure and NAAQS SIPs. EPA has taken separate action on the following portions of this submittal: (1) On December 21, 2017, EPA approved the revisions to Reg. 19, Chapter 2, that address the definition of “Volatile Organic Compounds” (see 82 FR 60517); (2) On February 14, 2018, EPA approved the Infrastructure portion (see 83 FR 6470); (3) On June 29, 2018, EPA approved the revisions to Reg. 19, Chapter 4, that address Minor New Source Review (see 83 FR 30553); And, (4) on June 29, 2018, EPA proposed to approve the revisions that address interstate transport requirements for the 2012 PM
Non-substantive changes were made to Regulation 19, Chapter 1, Sections
Two definitions, “NAAQS state implementation plan or NAAQS SIP” and “State implementation plan or SIP” are new—these definitions are applicable to revised provisions in this SIP submittal. Several other revisions provide current references and publication dates for the specified Federal regulations within the definition. These revisions are necessary because Arkansas does not incorporate changes to the Federal regulations by reference prospectively and thus, must update its rules as Federal regulations are revised. For example, when the EPA revises test methods to allow the use of newly approved alternative procedures, the State must revise their state rules to incorporate the date of that Federal action. We find these revisions approvable.
In addition, the revisions to the definition for “CO2 equivalent emissions” delete a sentence commonly referred to as EPA's Biomass Deferral language, which EPA disapproved as a revision to the Arkansas SIP on May 23, 2016 (see 81 FR 32239 and 40 CFR 52.172). Because of our disapproval (see 81 FR 32239), the Biomass Deferral language was never in the Arkansas approved SIP and thus, the State's removal of this language from its State rules is a non-substantive change. Because the submitted revisions delete previously disapproved language, we are removing the prior disapproval listed in 40 CFR 52.172(c) as described in paragraph
The revisions to the tables for Lead, PM
We are making ministerial changes to the CFR to reflect that (1) our March 4, 2015 approval of revisions to the Arkansas PSD regulations for the PM
Section 110(l) of the Act precludes EPA from approving a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171 of the CAA), or any other applicable requirement of the Act. The submitted revisions in this action expand the applicability of the NAAQS in Appendix B to all chapters in Reg. 19. In addition, the submitted revisions evaluated in this action do not relax or otherwise weaken existing rules in the Arkansas SIP. Therefore, these revisions would not contribute to future violations of the NAAQS or interfere with reasonable further progress or any applicable CAA requirements. The non-substantive revisions also would not contribute to future violations of the NAAQS or interfere with reasonable further progress or any applicable CAA requirements.
Pursuant to section 110 of the CAA, EPA is approving revisions to the Arkansas SIP submitted on March 24, 2017. Specifically, we are approving revisions to Regulation 19, Chapter 1, Sections 101 and 103; Chapter 2 definitions; Chapter 3, Sections 301 and 304; Chapter 5, Sections 502-504; Chapter 13, Sections 1303 and 1308; Chapter 14, Section 1401; Chapter 15, Sections 1502 and 1504; and Appendix B tables addressing Lead, Nitrogen Dioxide, Ozone, PM
The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the Arkansas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 9, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions read as follows:
(c) * * *
(e) * * *
Environmental Protection Agency (EPA).
Final rule; correction.
This document corrects an error in the amendatory language of a final rule pertaining to EPA's approval of a state implementation plan (SIP) revision submitted by Delaware to address the infrastructure requirements for interstate transport of pollution with respect to the 2012 fine particulate (PM
Effective August 13, 2018.
Joseph Schulingkamp, (215) 814-2021 or by email at
On July 12, 2018 (83 FR 32209), EPA published a final rulemaking action approving Delaware's December 14, 2015 SIP revision addressing the interstate transport requirements for the 2012 PM
EPA does not expect adverse comments on this action.
In FR Doc. 2018-14838 appearing on page 32209 in the
Environmental Protection Agency (EPA).
Final rule.
On December 11, 2017, the U.S. Environmental Protection Agency (EPA) published a direct final rule and an accompanying notice of proposed rulemaking entitled “Protection of Stratospheric Ozone: Revision to References for Refrigeration and Air Conditioning Sector To Incorporate Latest Edition of Certain Industry, Consensus-based Standards.” EPA proposed to modify the use conditions required for use of three flammable refrigerants—isobutane (R-600a), propane (R-290), and R-441A—in new household refrigerators, freezers, and combination refrigerators and freezers under the Significant New Alternatives Policy (SNAP) program to reflect an updated standard from Underwriters Laboratories. Because EPA received adverse comment, EPA withdrew the direct final rule through a separate notice. In this action, EPA is addressing relevant comments and finalizing the proposed use conditions with no changes.
This rule is effective on September 7, 2018. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of September 7, 2018.
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0472. All documents in the docket are listed on the
Chenise Farquharson, Stratospheric Protection Division, Office of Atmospheric Programs (Mail Code 6205T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-7768; email address:
On December 11, 2017, EPA published a direct final rule (82 FR 58122) to modify the use conditions for three flammable hydrocarbon refrigerants—isobutane (R-600a), propane (R-290), and R-441A—used in new household refrigerators, freezers, and combination refrigerators and freezers (hereafter “household refrigerators and freezers”) by replacing four of the five use conditions in previous hydrocarbon refrigerants rules under EPA's Significant New Alternatives Policy (SNAP) program (76 FR 78832, December 20, 2011; 80 FR 19454, April 10, 2015) with the revised Underwriters Laboratories (UL) Standard 60335-2-24, “Household and Similar Electrical Appliances—Safety—Part 2-24: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers” (2nd edition, April 28, 2017). We stated in that direct final rule that if we received adverse comment by January 25, 2018, we would publish a timely withdrawal in the
EPA also published a Notice of Proposed Rulemaking on December 11, 2017 accompanying the direct final rule, entitled “Protection of Stratospheric Ozone: Revision to References for Refrigeration and Air Conditioning Sector To Incorporate Latest Edition of Certain Industry, Consensus-based Standards” (82 FR 58154). That notice proposed to make the same changes to the relevant listing decisions as in the direct final rule. This action addresses the comments received and finalizes the revisions to the relevant listing decisions, as proposed.
This action regulates the use of three flammable hydrocarbon refrigerants—isobutane, propane, and the hydrocarbon blend R-441A—in new household refrigerators and freezers. Table 1 identifies entities potentially affected by this action. Regulated entities may include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is currently aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in 40 CFR part 82. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
Household refrigerators and freezers are intended primarily for residential use, although they may be used outside the home (
The 2014 American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Handbook of Refrigeration provides an overview of food preservation in regard to household refrigerators and freezers. Generally, a storage temperature between 32 and 39 °F (0 to 3.9 °C) is desirable for preserving fresh food. Humidity and higher or lower temperatures are more suitable for certain foods and beverages. Wine chillers, for example, are frequently used for storing wine, and have slightly higher optimal temperatures from 45 to 65 °F (7.2 to 18.3 °C). In single-door refrigerators, the optimum conditions for food preservation are also slightly higher since food storage is not intended for long-term storage. Freezers and combination refrigerators and freezers that are designed to store food for long durations are generally designed to hold temperatures near 0 to 5 °F (−17.7 to −15 °C).
American National Standards Institute (ANSI)/ASHRAE Standard 34—2016 assigns a safety group classification for each refrigerant which consists of two alphanumeric characters (
The refrigerants are also assigned a flammability classification of 1, 2, or 3. Tests are conducted in accordance with American Society for Testing and Materials (ASTM) E681 using a spark ignition source at 60 °C and 101.3 kPa.
For both toxicity and flammability classifications, refrigerant blends are designated based on the worst-case estimate of fractionation determined for the blend. Figure 1 illustrates these safety group classifications.
EPA previously found isobutane, propane, and R-441A acceptable, subject to use conditions, in new household refrigerators and freezers (76 FR 78832, December 20, 2011; 80 FR 19454, April 10, 2015). In the proposed and final rules, EPA provided information on the environmental and health properties of the three refrigerants and the various other substitutes available for use in household refrigerators and freezers. EPA's risk screens for the three refrigerants are available in the docket for these rulemakings (EPA-HQ-OAR-2009-0286 and EPA-HQ-OAR-2013-0748).
Isobutane, propane, and R-441A have an ASHRAE classification of A3, indicating that they have low toxicity and high flammability. The flammability risks are of concern because household refrigerators and freezers have traditionally used refrigerants that are not flammable. In the presence of an ignition source (
To address the flammability risk, which is not posed by other available refrigerants in this end-use, EPA listed the refrigerants as acceptable, subject to use conditions, in new household refrigerators and freezers. The use conditions ensure minimization of flammability risk by incorporating by reference Supplement SA to the 10th edition of UL Standard 250, and by including refrigerant charge size limits and requirements for markings on equipment using the refrigerants to inform consumers and technicians of potential flammability hazards. Without appropriate use conditions, the flammability risk posed by the refrigerants could be higher than non-flammable refrigerants because individuals may not be aware that their actions could potentially cause a fire, and because the refrigerants could be used in existing equipment that has not been designed specifically to minimize flammability risks. Our assessment and listing decisions (76 FR 78832; December 20, 2011 and 80 FR 19454; April 10, 2015) found that with the use conditions, the overall risk of these substitutes, including the risk due to flammability, does not present significantly greater risk in the end-use than other substitutes that are currently or potentially available for that same end-use.
The use conditions required the following:
1.
2.
3.
4.
a. On or near any evaporators that can be contacted by the consumer: `DANGER—Risk of Fire or Explosion. Flammable Refrigerant Used. Do Not Use Mechanical Devices To Defrost Refrigerator. Do Not Puncture Refrigerant Tubing.'
b. Near the machine compartment: `DANGER—Risk of Fire or Explosion. Flammable Refrigerant Used. To Be Repaired Only By Trained Service Personnel. Do Not Puncture Refrigerant Tubing.'
c. Near the machine compartment: `CAUTION—Risk of Fire or Explosion. Flammable Refrigerant Used. Consult Repair Manual/Owner's Guide Before Attempting To Service This Product. All Safety Precautions Must be Followed.'
d. On the exterior of the refrigerator: `CAUTION—Risk of Fire or Explosion. Dispose of Properly In Accordance With Federal Or Local Regulations. Flammable Refrigerant Used.'
e. Near any and all exposed refrigerant tubing: `CAUTION—Risk of Fire or Explosion Due To Puncture Of Refrigerant Tubing; Follow Handling Instructions Carefully. Flammable Refrigerant Used.'
All of these markings must be in letters no less than 6.4 mm (
5.
In 2011, UL formed a Joint Task Group (JTG) comprised of members of its Standards Technical Panel (STP) to develop recommendations for addressing the use and safety of refrigerants classified as A2, A2L, and A3 in refrigeration and air conditioning (AC) equipment. One of the outcomes is the 2017 UL Standard 60335-2-24, which is based on International Electrotechnical Commission (IEC) Standard 60335-2-24 “Household and Similar Electrical Appliances—Safety—Part 2-24: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers” (edition 7.1, May 2012). The 2017 UL Standard 60335-2-24 was developed in an open and consensus-based approach, with the assistance of experts in the refrigeration and AC industry as well as experts involved in assessing the safety of products. The revision cycle, including final recirculation, concluded on February 6, 2017, and UL published the standard on April 28, 2017. The 2017 UL Standard replaces the previously published version of this same standard as well as UL Standard 250 Supplement SA, “Requirements for Refrigerators and Freezers Employing a Flammable Refrigerant in the Refrigerating System” (Edition 10, August 25, 2000).
The 2017 UL Standard 60335-2-24 limits the charge size for each separate refrigerant circuit (
As proposed, EPA is revising the use conditions for propane, isobutane and R-441 in the household refrigerators and freezers end-use. We are finalizing the use conditions for each substitute as follows:
EPA is replacing the reference to Supplement SA to the 10th edition of UL Standard 250 in use condition “2” with “UL Standard 60335-2-24, Safety Requirements for Household and Similar Electrical Appliances, Part 2: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers (2nd Edition, April 28, 2017).” In addition, EPA is removing use conditions “3,” “4,” and “5” because the conditions specified in those use conditions are specified in 2017 UL standard 60335-2-24; the incorporation of 2017 UL standard 60335-2-24 in condition 2 includes the requirements in previous conditions 3, 4, and 5. The use conditions provide the same level of assurance that the three substitutes can be used as safely as other available alternatives. The revised use conditions apply to new household refrigerators and freezers manufactured after the effective date of this regulation. The new use conditions are as follows:
1.
2.
EPA previously required a charge size limit of 57 grams (2.01 ounces) for each separate refrigerant circuit in a refrigerator or freezer. The 2017 UL Standard 60335-2-24 specifies that the maximum charge size for each separate refrigerant circuit in a refrigerator or freezer must be no greater than 150 grams (5.29 ounces).
As discussed in the December 2017 direct final rule, EPA evaluated reasonable worst-case and more typical, yet conservative, scenarios to model the effects of the sudden release of each refrigerant from a household refrigerator or freezer containing the maximum charge size of 150 grams (5.29 ounces). This was done to determine whether the refrigerants would present flammability or toxicity concerns for consumers or workers, including those servicing or disposing of appliances. To represent a reasonable worst-case scenario, it was assumed that a catastrophic leak of each refrigerant would occur while the refrigerator or freezer unit is in a residential kitchen with a height of approximately 2.4 meters (
EPA's analysis for each of the refrigerants revealed that even if the
Concerning toxicity of the refrigerants, our risk screens found that the 30-minute acute exposure guideline level (AEGL) (
EPA is not retaining a separate charge size limit as a use condition because it would be redundant of the updated UL standard. Therefore, we are replacing the use condition in “3” with the 2017 UL Standard 60335-2-24.
The 2017 UL Standard 60335-2-24 includes requirements for red PMS #185 marked pipes, hoses, and other devices through which the refrigerant passes, and requirements for markings in letters no less than 6.4 mm (
Through this action EPA is incorporating by reference the 2017 UL Standard 60335-2-24, which establishes requirements for the evaluation of household and similar electrical appliances, and safe use of flammable refrigerants. The standard is discussed in greater detail elsewhere in this preamble. This approach is the same as that used to incorporate Supplement SA to the 10th edition of UL Standard 250 in our previous rules on flammable refrigerants (76 FR 78832, December 20, 2011; 80 FR 19454, April 10, 2015).
The 2017 UL Standard 60335-2-24 is available for purchase by mail at: COMM 2000, 151 Eastern Avenue, Bensenville, IL 60106; Email:
The use conditions in this action apply to new household refrigerators and freezers manufactured after the effective date of this regulation. This final rule does not apply to or affect equipment manufactured before the effective date of this action and manufactured in compliance with the SNAP requirements applicable at the time of manufacture.
EPA received 17 comments on the December 11, 2017, notice of proposed rulemaking. Below EPA is responding to six of those comments, which were either relevant to this rulemaking or raised issues that were addressed in related rulemakings. The other eleven comments raised issues that are outside the scope of this rulemaking or are not relevant to any related rulemaking, so EPA is not providing a specific response to those comments.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection requirements contained in the existing regulations and has assigned OMB control number 2060-0226. This rule contains no new requirements for reporting or recordkeeping.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule.
The use conditions of this rule apply to manufacturers of new household refrigerators and freezers that choose to use flammable refrigerants. Today's action allows equipment manufacturers to use flammable refrigerants at a higher charge size than previously allowed in new household refrigerators and freezers but does not mandate such use; the change to the use conditions allows more flexibility for manufacturers in the design of equipment and thus reduces the regulatory burden to the regulated community. In some cases, it may reduce costs by allowing manufacturers to design equipment with a single, larger refrigerant circuit instead of multiple, smaller refrigerant circuits for the same piece of equipment.
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. The 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. It will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in risk screens for the various substitutes.
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 action involves a technical standard. EPA is revising the use conditions for the household refrigerators and freezers end-use by incorporating by reference UL Standard 60335-2-24, “Safety Requirements for Household and Similar Electrical Appliances, Part 2: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers” (2nd edition, April 2017), which establishes requirements for the evaluation of household and similar electrical appliances, and safe use of flammable refrigerants. The 2017 UL Standard 60335-2-24 supersedes the current edition of Supplement SA the 10th edition of UL Standard 250, “Requirements for Refrigerators and Freezers Employing a Flammable Refrigerant in the Refrigerating System” (August 2000). EPA's revision to the use conditions will replace Supplement SA to the 10th edition of UL Standard 250 with the 2017 UL standard 60335-2-24. This standard is available at
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. This action's health and environmental risk assessments are contained in the risk screens for the various substitutes. The risk screens are available in the docket for this rulemaking.
This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Unless specified otherwise, all documents are available electronically through the Federal Docket Management System, Docket #EPA-HQ-OAR-2017-0472.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Recycling, Reporting and recordkeeping requirements, Stratospheric ozone layer.
For the reasons set out in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
The revisions and additions to read as follows:
The Director of the Federal Register approves the incorporation by reference of the material under “Use Conditions” in the table “SUBSTITUTES THAT ARE ACCEPTABLE SUBJECT TO USE CONDITIONS” (5 U.S.C. 552(a) and 1 CFR part 51). Copies of UL Standards 471, 484, 541, and 60335-2-24, may be purchased by mail at: COMM 2000, 151 Eastern Avenue, Bensenville, IL 60106; Email:
You may inspect a copy at U.S. EPA's Air Docket; EPA West Building, Room 3334; 1301 Constitution Ave. NW, Washington, DC or at the National Archives and Records Administration (NARA). For questions regarding access to these standards, the telephone number of EPA'S Air Docket is 202-566-1742. For information on the availability of this material at NARA, call 202-741-6030, or go to:
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of spinetoram in or on tea, dried and tea, instant. Dow AgroSciences, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective August 8, 2018. Objections and requests for hearings must be received on or before October 9, 2018, 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-2017-0352, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 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-2017-0352 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 October 9, 2018. 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-2017-0352, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
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 spinetoram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with spinetoram 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. Spinetoram and spinosad are considered by EPA to be toxicologically identical for human health risk assessment based on their very similar chemical structures and similarity of the toxicological databases for currently available studies, therefore, the Agency has assessed and summarized the toxicological profile for both together. The primary toxic effect observed from exposure to spinetoram and spinosad was histopathological changes in multiple organs (specific target organs were not identified). Vacuolization of cells and/or macrophages was the most common histopathological finding noted across the toxicological database with the dog being the most sensitive species. In addition to the numerous organs observed with histopathological changes, anemia was noted in several studies. There was no evidence of increased quantitative or qualitative susceptibility from spinetoram or spinosad exposure. In developmental studies, no maternal or developmental effects were seen in rats or rabbits. In the rat reproduction toxicity studies, offspring toxicity (decreased litter size,
Specific information on the studies received and the nature of the adverse effects caused by spinetoram 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
Spinetoram and spinosad should be considered toxicologically identical in the same manner that metabolites are generally considered toxicologically identical to the parent. As a result, studies from both toxicological databases were considered for endpoint selection.
A summary of the toxicological endpoints for spinetoram used for human risk assessment is shown in Table 1 of this unit.
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i.
ii.
iii.
iv.
2.
Based on the surface water concentration calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of spinetoram for acute exposures are estimated to be 25.9 parts per billion (ppb) for surface water and below the levels of detection for ground water. For chronic exposures for non-cancer assessments, the spinetoram EDWCs are estimated to be 19.3 ppb for surface water and well below the levels of detection for ground water. EDWCs of spinosad for acute exposures are estimated to be 30.6 ppb for surface water and below the levels of detection for ground water. For chronic exposures for noncancer assessments, the spinetoram EDWCs are estimated to be 22.8 ppb for surface water and below the levels of detection for ground water.
Modeled estimates of drinking water concentration were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 22.8 ppb was used to assess the contribution to drinking water.
3.
EPA assessed residential exposure using the following assumptions: The use on tea will not result in residential exposure; however, spinetoram and spinosad are currently registered for uses that could result in residential exposures including home lawns and pet (cats/kittens) spot-on applications; therefore, there is potential for residential handler and post-application exposures to both spinetoram and spinosad. Since spinosad and spinetoram control the same pests, EPA concludes that these products will not be used for the same uses in combination with each other and thus combining spinosad and spinetoram residential exposures would overstate exposure. EPA assessed residential exposure for both spinosad and spinetoram using the most conservative residential exposure scenarios for either chemical.
EPA assessed the following “worst-case” residential exposure scenarios as: (1) Adult residential handler (inhalation exposure from applications to lawns and turf) and (2) child (1-<2 years) (hand-to-mouth exposures from post-application exposure to turf). Because EPA's level of concern for spinetoram is a MOE below 100, the MOEs for both of these residential exposure scenarios are not of concern. In addition, the short-term assessment is protective of intermediate-term exposure as the short- and intermediate-term PODs are identical. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found spinetoram to share a common mechanism of toxicity with any other substances, and spinetoram does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spinetoram does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
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2.
3.
i. The toxicity database for spinetoram is adequate for FQPA SF consideration.
ii. There is no evidence of neurotoxicity from spinetoram exposure.
iii. There is no evidence that spinetoram results in increased pre- or post-natal susceptibility in rats or rabbits.
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in assessing exposures and these assessments will not underestimate the exposure and risks posed by spinetoram.
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.
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Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 780 for adults (handler) and 200 for children (post-application). Because EPA's level of concern for spinetoram is a MOE below 100, these MOEs are not of concern. In addition, the short-term assessment is protective of intermediate-term exposure as the short- and intermediate-term PODs are identical.
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Adequate enforcement methodology is available for both plant and livestock commodities. Method GRM 05.03 (HPLC/MS/MS) is an acceptable method for the determination of spinetoram residues in a variety of crops. Methods GRM 05.15 and GRM 06.08 (HPLC/MS) are acceptable methods for determination of spinetoram residues in bovine and poultry tissues, milk, cream, and eggs. Both methods are available to enforce the tolerance expression.
The methods 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 spinetoram.
Therefore, tolerances are established for residues of spinetoram, expressed as the combined residues of XDE-175-J: 1-
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); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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) * * *
Office of Environment, Health, Safety and Security, U.S. Department of Energy.
Notice of proposed rulemaking and notice of public meetings.
The Department of Energy (DOE or the Department) publishes a proposed rule to amend regulations concerning nuclear safety management. These regulations govern the conduct of DOE contractors, DOE personnel, and other persons conducting activities (including providing items and services) that affect, or may affect, the safety of DOE nuclear facilities. The proposed revisions reflect the experience gained in the implementation of the regulations over the past seventeen years, with specific improvements to the process for facility hazard categorization, the unreviewed safety question process, and the review and approval of safety documentation. The proposed revisions are intended to enhance operational efficiency while maintaining robust safety performance.
Public comment on this proposed rule will be accepted until October 9, 2018. For dates and more information on the public meetings for this proposed rulemaking, see
You may submit comments, identified by RIN 1992-AA57, by any of the following methods:
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Due to potential delays in DOE's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt.
Mr. Garrett Smith, U.S. Department of Energy, Office of Nuclear Safety, AU-30, 1000 Independence Avenue SW, Washington, DC 20585; (301) 903-2996 or
Public meetings for this proposed rulemaking will be held in:
1. Richland, WA at the HAMMER Federal Training Facility, Building 6091, Room 10, 2890 Horn Rapids Road, Richland, WA, on August 16th, 2018.
2. Albuquerque, NM at the Albuquerque Marriott, Sandia Room, 2101 Louisiana Blvd. NE, Albuquerque, NM, on September 6th, 2018.
3. Oak Ridge, TN at the Oak Ridge Associated Universities, Pollard Technology Conference Center Auditorium, 210 Badger Avenue, Oak Ridge, TN, on September 25th, 2018.
4. Aiken, SC at the University of South Carolina—Aiken, Business and Education Building, Room 124, 471 University Parkway, Aiken, SC, on September 27th, 2018.
All public meetings will be held from 1 p.m. to 4:30 p.m. and from 6 p.m. to 8:30 p.m. local time. Interested persons who wish to speak at the public meeting should telephone the Office of Nuclear Safety, (301) 903-2996, by 4:30 p.m. Eastern Time on August 13th, 2018 for Richland, WA, on August 31st, 2018 for Albuquerque, NM, on September 18th, 2018 for Oak Ridge, TN, and on September 20th, 2018 for Aiken, SC. Each presentation is limited to 20 minutes.
Pursuant to the Atomic Energy Act of 1954, as amended (the AEA), the Department of Energy (DOE or the Department) owns and leases nuclear and non-nuclear facilities at various locations in the United States. These facilities are operated either by DOE or by contractors with DOE oversight. Activities at these facilities include, but are not limited to: Research, testing, production, disassembly, or transporting nuclear materials. DOE regulations governing nuclear safety at these facilities are set forth in the Nuclear Safety Management rule (10 CFR part 830). The regulations were issued in response to external assessments from the National Academy of Sciences (NAS), the enactment of the Price-Anderson Amendments Act of 1988 (PAAA), and DOE efforts to improve safety at DOE nuclear facilities. Aspects of 10 CFR part 830 were finalized and issued from 1994 to 2001, covering core safety requirements for quality assurance and facility safety basis. Over the past 17 years, DOE has gained considerable experience in the implementation of 10 CFR part 830, and is proposing to modify the requirements to incorporate that experience and help ensure more effective safety performance.
On December 9, 1991, DOE published Procedural Rules for DOE Nuclear Activities (56 FR 64290) and a Notice of Proposed Rulemaking and Public Hearing (1991 Notice, 56 FR 64316) to add Parts 820 and 830 to Title 10 of the Code of Federal Regulation (CFR).
The Department issued a Notice of Limited Reopening of the Comment Periods for the remaining topics to be addressed in 10 CFR part 830 on August 31, 1995, and for a second, unrelated, rule (Reopening Notice, 60 FR 45381).
On October 10, 2000, the Department published an Interim Final Rule and Opportunity for Public Comment (65 FR 60291) which amended the nuclear safety regulations to (1) establish and maintain safety bases for Hazard Category 1, 2, and 3 DOE nuclear facilities and perform work in accordance with safety bases, and (2) clarify that the quality assurance work process requirements apply to standards and controls adopted to meet regulatory or contract requirements that may affect nuclear safety (Interim Final Rule). The Interim Final Rule was also issued to provide further opportunity for public comment on the rule.
Following the public comment period, the Department issued a Final Rule on January 10, 2001 (66 FR 1810).
1. DOE Standard 1027—Section 830.202 of the regulations requires that DOE nuclear facilities be categorized consistent with DOE-STD-1027-92 (“
DOE now proposes, after two decades of experience in facility categorization using DOE-STD-1027-92, Ch 1, to amend § 830.202(b)(3) by adding “or successor document”. This change would allow the Department to revise the standard to include up-to-date research, data, and DOE experience with implementation. This would be consistent with DOE's practice to periodically evaluate and revise DOE Technical Standards and would follow the development, review, and approval process described in DOE Order 252.1A,
DOE also proposes to amend Section C, Scope, of Appendix A to remove the reference to the specific version of DOE-STD-1027, for consistency with the revision in § 830.202. DOE would also remove Table 1 of Appendix A and replace that table with a definition for Hazard Category 1, 2, and 3 DOE nuclear facilities in § 830.3 that references DOE-STD-1027-92 or successor document. The removal of Table 1 would allow successor revisions to more clearly link the determination of Hazard Category 1, 2, 3, and below hazard category 3 to the methodology in the Standard. The concept that Hazard Category 1 will have higher potential consequences and Hazard Category 3 will have lower potential consequences will be maintained throughout all successor documents of DOE-STD-1027.
2. Unreviewed Safety Question (USQ) Process—A situation or potential situation outside the bounds of the current safety analysis for a Hazard Category 1, 2, or 3 nuclear facility (as documented in its approved safety analysis) constitutes an Unreviewed Safety Question under the current regulations. Section 830.203 allows contractors to make changes to the facility, to change site or facility procedures, and to conduct tests and/or experiments without prior DOE approval when these activities do not involve an Unreviewed Safety Question and do not require any change to Technical Safety Requirements.
The proposed change to Appendix A to Subpart B of 10 CFR part 830—General Statement of Safety Basis Policy, H, Unreviewed Safety Questions, would add the sentence, “The contractor is allowed to make editorial and format changes to its USQ procedure while maintaining DOE approval.” This proposal would focus the requirement to obtain DOE's approval on changes with the potential to impact on the safety basis of the facility.
DOE also proposes to modify § 830.3, Definitions, by changing the definition for Unreviewed Safety Question (USQ). The current definition includes four situations that define a USQ: (1) The probability of the occurrence or the consequences of an accident or the malfunction of equipment important to safety previously evaluated in the documented safety analysis (DSA) could be increased; (2) The possibility of an accident or malfunction of a different type than any evaluated previously in the documented safety analysis could be created; or (3) A margin of safety could be reduced; or (4) The documented safety analysis may not be bounding or may be otherwise inadequate. As explained in the following paragraphs, the proposed definition would remove the third situation: “A margin of safety could be reduced”.
The current set of four situations that define an USQ in 10 CFR 830.3 reflected standard nuclear industry practice and was an adaptation of 10 CFR 50.59, changes, tests and experiments, used by the United States Nuclear Regulatory Commission (NRC). The NRC, in 1968, added to § 50.59 the concept of “margin of safety as defined in the basis for any technical specification is reduced.” In issuing 10 CFR part 830, DOE modified this question to simply read “A margin of safety could be reduced”. In addition to adapting the NRC process, DOE included the situation of “(4) The documented safety analysis may not be bounding or may otherwise be inadequate.”
The NRC, after 30 years of experience implementing § 50.59, issued an October 21, 1998, Notice of Proposed Rulemaking to change the criteria associated with margin of safety, explaining that “the phrases `margin of safety' and `as defined in the basis for any technical specification' in the third criterion have been the subject of differing interpretations because the rule does not define what constitutes a margin of safety or a basis for any technical specification in the context of §§ 50.59 and 72.48. In addition, some have questioned the need for the third criterion on `margin of safety.' ” The third criterion refers to the existence of two prior questions associated with creation, consequences, and likelihood of accidents and equipment malfunction. The revision to 10 CFR part 50 removing the term “margin of safety” from 10 CFR 50.59 was issued as a final rule on October 4, 1999.
DOE's experience with the margin of safety criteria is similar to that expressed by the NRC in its rulemaking, specifically, that the other existing criteria provide sufficient guidance to identify facility and safety basis changes that warrant DOE approval. Feedback from periodic surveys considering a broad-range of USQ determinations indicated that the “margin of safety”
3. DOE Approval of Annual DSA Updates—As stated above, DOE currently requires the contractor, in § 830.203, Unreviewed Safety Question process, to obtain DOE approval prior to taking any action determined to involve a USQ. Additionally, in § 830.202 Safety basis, DOE requires the contractor to annually submit to DOE either the updated DSA for approval or a letter stating that there have been no changes in the DSA since the prior submission. This effectively requires the contractor to submit changes to the DSA for DOE approval twice. Currently, DOE provides implementation guidance for this approval process in DOE-STD-1104-2016,
Therefore, DOE is proposing to change the requirement in § 830.202, Safety basis, to require the current DSA be provided to DOE annually, but not to require DOE approval at that time. Additional guidance would also be included in Appendix A to Subpart B of 10 CFR part 830—General Statement of Safety Basis Policy, F, Documented Safety Analysis, to make clear that DOE's review and approval of the safety analysis is intended to be focused on changes submitted through the USQ process, but may require DOE approval if DOE has reason to believe a portion of the safety basis has substantially changed. DOE would continue to have the authority to review the safety basis at any time. DOE would maintain the ability to direct the contractor to incorporate in the safety basis any changes, conditions, or hazard controls.
4. Definition and Application of New Facilities, Major Modification, Preliminary Documented Safety Analysis, and Existing Facilities—The current definitions of a
DOE also proposes to change the definition of a
DOE proposes to change the definition of
The specific proposed changes to 10 CFR part 830 are summarized below in the order in which they appear:
1. In proposed § 830.3 “Definitions,” the current definition for
2. In proposed § 830.201 “Performance of Work,” current § 830.201 would be changed by adding “DOE-approved” to modify safety basis to maintain consistency with § 830.207, DOE approval of safety basis.
3. Proposed § 830.202(b)(3) would be changed to add “or successor document” to modify DOE-STD-1027-92 (“Hazard Categorization and Accident Analysis Techniques for compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,” Change Notice 1, September 1997). This proposed change would allow DOE to modify the methodology used to perform hazard categorization consistent with DOE's policy of maintaining technical standards to reflect updated knowledge and methods. Current § 830.202(c)(2) would be changed to read, “(2) Annually provide DOE the current documented safety analysis or a letter stating that
4. In proposed § 830.203 “Unreviewed safety question process,” current § 830.203(a) would be changed by adding “DOE-approved” as a modifier to USQ, and by changing the word “process” to “procedure”. These proposed changes are to clarify the connection between references to the DOE-approved procedure in proposed § 830.203(a), § 830.203(b), and § 830.203(c). Current § 830.203(b) would be deleted, since DOE no longer has existing facilities operating outside of 10 CFR part 830. In the current § 830.203(c), which is proposed to be redesignated as § 830.203(b), the word “new” has been proposed to be moved to match a proposed change in the definition of New Hazard Category 1, 2, and 3 nuclear facility, and “207(d)” would be changed to “207(a)” to reflect changes to § 830.207. Current § 830.203(d) would be redesignated as § 830.203(c). Current § 830.203(e) would be redesignated as § 830.203(d). Current § 830.203(f) would be redesignated as § 830.203(e), “submit” would be replaced by “provide”, and “submissions” would be replaced by “submittal” to better reflect that the document is being given to DOE for review, but not for approval. Current § 830.203(g) would be redesignated as § 830.203(f), and the text would be changed to read “initiated to meet paragraph (f)(1) of this section” consistent with citation changes in this section.
5. In proposed § 830.204 “Documented safety analysis,” current § 830.204(a) would be updated by changing “Table 2” to “Table 1” to reflect the deletion of Table 1 and re-numbering of subsequent tables.
6. In proposed § 830.206 “Preliminary documented safety analysis,” current § 830.206 would be changed to read “Prior to construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the design and construction of the new facility or major modification must:” To reflect changes to the definitions in § 830.3. Current § 830.206(b)(1) would be changed to add, “, or successor document” as a modifier to “DOE Order 420.1, Facility Safety” to reflect the ongoing updates to the current version of the DOE order.
7. In proposed § 830.207 “DOE approval of safety basis,” current § 830.207(a) would be deleted, as DOE no longer has existing Hazard Category 1, 2, or 3 facilities operated outside of 10 CFR part 830. Current § 830.207(b) would be changed by adding “updated or amended” to modify “safety basis”, moving the word “existing” to before the phrase “Hazard Category 1, 2, or 3 DOE nuclear facility” to better match the revised definition, and by deleting “in effect on October 10, 2000, or as approved by DOE at a later date” to reflect that all Hazard Category 1, 2, or 3 DOE nuclear facilities already operate within 10 CFR part 830. Current § 830.207(c) would be deleted, as DOE no longer has existing Hazard Category 1, 2, or 3 facilities operated outside of 10 CFR part 830. Current § 830.207(d) would be redesignated as § 830.207(a) and updated to reflect the changes in definitions in § 830.3. As a result, the proposed § 830.207(a) would now read as: “With respect to a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, a contractor may not begin operation of the facility or modification prior to the issuance of a safety evaluation report in which DOE approves the safety basis for the facility or modification.”
8. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy current “A. Introduction” would be modified by replacing a reference to an outdated DOE Policy with a specific statement that reflects current DOE policy and would now read as follows, “This Appendix does not create any new requirements and should be used consistently with DOE's policy that work be conducted safely and efficiently and in a manner that ensures protection of workers, the public, and the environment.”
9. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy current “C. Scope, 1.” would be changed by replacing the reference to “DOE-STD-1027-92 Change Notice 1, September 1997” with a general reference to DOE-STD-1027 to reflect the proposed change to allow successor versions of DOE-STD-1027 to be used, the reference to “Table 1” would be deleted to reflect the proposed deletion of Table 1. The proposed sentences now would read, “A contractor must establish and maintain a safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility because these facilities have the potential for significant radiological consequences. DOE-STD-1027 sets forth the methodology for categorizing a DOE nuclear facility based on the inventory of radioactive materials.” Current “C. Scope, 2.” Would be changed to delete the parenthetical reference to “including radiological facilities”, and by adding “DOE” to the reference to Hazard Category 1, 2, and 3 nuclear facilities to match changes to definitions within § 830.3. Current “C. Scope” Table 1 is proposed for deletion for consistency with the proposal to allow use of subsequent versions of DOE-STD-1027, since Table 1 references the specific content of DOE-STD-1027-92, Change Notice 1, September 1997.
10. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy, current “E. Enforcement of Safety Basis Requirements, 4.” would be changed by deleting the word “however” to improve clarity.
11. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy current “F. Documented Safety Analysis, 3.” would be changed by adding “as: (1) part of the initial submittal; (2) when revisions are submitted as part of a positive USQ or major modification; (3) if DOE has reason to believe a portion of the safety basis to be inadequate, or; (4) if DOE has reason to believe a portion of the safety basis has substantially changed. DOE will review the DSA” to better define when and why DOE would review a DSA. This change is proposed to be consistent with proposed changes to DOE's requirement to annually approve the DSA. Current “F. Documented Safety Analysis, 3.” would also be changed by adding “in the Safety Evaluation Report” to the end of the last sentence in that section, which currently reads, “A documented safety analysis must contain any conditions or changes required by DOE.” This change is proposed to clarify how DOE directs conditions and changes required by DOE. Additionally, Current “F. Documented Safety Analysis, 3.” would be changed by adding the following sentences, “Generally, DOE's review of the annual submittal may be limited to ensuring that the results of USQs have been adequately incorporated into the DSA. If additional changes are proposed by the contractor and included in the annual update that have not been previously approved by DOE or have not been evaluated as a part of the USQ process, DOE must review and approve these changes. DOE has the authority to review the safety basis at any time.”
12. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy current “G. Hazard Controls, 2.” would be changed to add “or successor document” as a modifier to “DOE Order 420.1, Facility Safety” to reflect the ongoing updates to the current version of the DOE order. Current “G. Hazard Controls, 4.” would be changed to update the reference to DOE Guide 423.1-1B and by adding, “or successor document” to reflect the ongoing updates to the current version of the DOE guide. Current “G. Hazard Controls, 4.” would be changed by changing the reference to “Table 4” to “Table 3” to reflect the proposed deletion of Table 1. Current “G. Hazard Controls” would be changed by changing the title of the table from “Table 4” to “Table 3” to reflect the proposed deletion of Table 1.
13. In proposed Appendix A to Subpart B to 10 CFR part 830—General Statement of Safety Basis Policy current “H. Unreviewed Safety Questions, 3.” Would be changed to update the reference to DOE Guide 424.1-1B Chg 2, to update the title of the referenced guide to “Implementation Guide for Use in Addressing Unreviewed Safety Question Requirements,” to add “or successor document” to reflect the ongoing updates to the current version of the DOE guide, and by adding the sentence, “The contractor is allowed to make editorial and format changes to its USQ procedure while maintaining DOE approval.” The additional sentence wold be provided to better delineate those aspects of the USQ process on which DOE approval focuses.
14. Throughout 10 CFR part 830, the term “Hazard Category” would be capitalized to improve consistency with the usage within the DOE regulatory structure.
Interested persons are invited to participate in this proceeding by submitting data, views, or arguments. Written comments should be submitted to the address, and in the form, indicated in the
If you submit information that you believe to be exempt by law from public disclosure, you should submit one complete copy, as well as one copy from which the information claimed to be exempt by law from public disclosure has been deleted. DOE is responsible for the final determination with regard to disclosure or nondisclosure of the information and for treating it accordingly under the DOE Freedom of Information regulations at 10 CFR 1004.11.
Public meetings will be held at the times, dates, and places indicated at the start of the
This notice of proposed rulemaking has been determined not to be a significant regulatory action under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993). Accordingly, this notice of proposed rulemaking was not subject to review by the Office of Information and Regulatory Affairs of the Office of Management and Budget.
On January 30, 2017, the President issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” That Order stated the policy of the executive branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources. The Order stated it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations. This proposed rule is expected to be an E.O. 13771 deregulatory action.
Additionally, on February 24, 2017, the President issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” The Order required the head of each agency designate an agency official as its Regulatory Reform Officer (RRO). Each RRO oversees the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms, consistent with applicable law. Further, E.O. 13777 requires the establishment of a regulatory task force at each agency. The regulatory task force is required to make recommendations to the agency head regarding the repeal, replacement, or modification of existing regulations, consistent with applicable law. At a minimum, each regulatory reform task force must attempt to identify regulations that:
(i) Eliminate jobs, or inhibit job creation;
(ii) Are outdated, unnecessary, or ineffective;
(iii) Impose costs that exceed benefits;
(iv) Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
(v) Are inconsistent with the requirements of Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not
(vi) Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
DOE concludes that this final rule is consistent with the directives set forth in these executive orders. This provisions in this proposed rule are intended, as described in section II, to enhance operational efficiency while maintaining robust safety performance at DOE nuclear facilities.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE has reviewed this proposed rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. The proposed rule would incorporate the experience of more than a decade of implementation to improve the effectiveness of the DOE nuclear safety regulatory framework while maintaining safety performance. Requirements that are considered duplicative or of little value have been proposed to be removed. DOE is proposing four key changes in this proposed rule, as described in II. Discussion of Proposed Rule, A. Discussion of Key Proposed Changes.
The changes in this proposed rule are all expected to reduce burden on affected DOE contractors. On this basis, DOE certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel for Advocacy of the Small Business Administration pursuant to 5 U.S.C. 605(b).
The information collection necessary to administer DOE's nuclear safety program under 10 CFR part 830 is subject to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a 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.
DOE has determined that this proposed rule is covered under the Categorical Exclusion in DOE's National Environmental Policy Act regulations at paragraph A.5 of Appendix A to Subpart D, 10 CFR part 1021, which applies to rulemaking that interprets or amends an existing rule or regulation without changing the environmental effect of the rule or regulation that is being amended. The proposed rule would amend DOE's regulations by removing duplicative approval requirements, updating definitions, and increasing the efficiency of internal processes. These proposed amendments are primarily procedural and would not change the environmental effect of 10 CFR part 830. Accordingly, neither an environmental assessment nor an environmental impact statement is required.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For regulatory actions likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. (This policy is also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999, 5 U.S.C. 601 note, requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family wellbeing. While this proposed rule would apply to individuals who may be members of a family, the rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this proposed rule and has determined that it would not preempt State law and
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed rule meets the relevant standards of Executive Order 12988.
The Treasury and General Government Appropriations Act, 2001, 44 U.S.C. 3516 note, provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA) a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action has been determined to not be a significant regulatory action, and it would not have an adverse effect on the supply, distribution, or use of energy. Thus, this action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.
The Secretary of Energy has approved the publication of this proposed rule.
Administrative practice and procedure, DOE contracts, Environment, Federal buildings and facilities, Government contracts, Nuclear materials, Nuclear power plants and reactors, Nuclear safety, Penalties, Public health, Reporting and recordkeeping requirements, and Safety.
For the reasons stated in the preamble, DOE proposes to revise 10 CFR part 830 to read as follows:
42 U.S.C. 2201; 42 U.S.C. 7101
This part governs the conduct of DOE contractors, DOE personnel, and other persons conducting activities (including providing items and services) that affect, or may affect, the safety of DOE nuclear facilities.
This part does not apply to:
(a) Activities that are regulated through a license by the Nuclear Regulatory Commission (NRC) or a State under an Agreement with the NRC, including activities certified by the NRC under section 1701 of the Atomic Energy Act (Act);
(b) Activities conducted under the authority of the Director, Naval Nuclear Propulsion, pursuant to Executive Order 12344, as set forth in Public Law 106-65;
(c) Transportation activities which are regulated by the Department of Transportation;
(d) Activities conducted under the Nuclear Waste Policy Act of 1982, as amended, and any facility identified under section 202(5) of the Energy Reorganization Act of 1974, as amended; and
(e) Activities related to the launch approval and actual launch of nuclear energy systems into space.
(a) The following definitions apply to this part:
(i) The relative importance to safety, safeguards, and security;
(ii) The magnitude of any hazard involved;
(iii) The life cycle stage of a facility;
(iv) The programmatic mission of a facility;
(v) The particular characteristics of a facility;
(vi) The relative importance of radiological and nonradiological hazards; and
(vii) Any other relevant factor.
(i) Physical, design, structural, and engineering features;
(ii) Safety structures, systems, and components;
(iii) Safety management programs;
(iv) Technical safety requirements; and
(v) Other controls necessary to provide adequate protection from hazards.
(i) The nuclear safety design criteria to be satisfied;
(ii) A safety analysis that derives aspects of design that are necessary to satisfy the nuclear safety design criteria; and
(iii) An initial listing of the safety management programs that must be developed to address operational safety considerations.
(i) The sufficiency of the documented safety analysis for a Hazard Category 1, 2, or 3 DOE nuclear facility;
(ii) The extent to which a contractor has satisfied the requirements of Subpart B of this part; and
(iii) The basis for approval by DOE of the safety basis for the facility, including any conditions for approval.
(i) The probability of the occurrence or the consequences of an accident or the malfunction of equipment important to safety previously evaluated in the documented safety analysis could be increased;
(ii) The possibility of an accident or malfunction of a different type than any evaluated previously in the documented safety analysis could be created; or
(iii) The documented safety analysis may not be bounding or may be otherwise inadequate.
(b) Terms defined in the Act or in 10 CFR part 820 and not defined in this section of the rule are to be used consistent with the meanings given in the Act or in 10 CFR part 820.
(a) No person may take or cause to be taken any action inconsistent with the requirements of this part.
(b) A contractor responsible for a nuclear facility must ensure implementation of, and compliance with, the requirements of this part.
(c) The requirements of this part must be implemented in a manner that provides reasonable assurance of adequate protection of workers, the public, and the environment from adverse consequences, taking into account the work to be performed and the associated hazards.
(d) If there is no contractor for a DOE nuclear facility, DOE must ensure implementation of, and compliance with, the requirements of this part.
The requirements in this part are DOE Nuclear Safety Requirements and are subject to enforcement by all appropriate means, including the imposition of civil and criminal penalties in accordance with the provisions of 10 CFR part 820.
A contractor must maintain complete and accurate records as necessary to substantiate compliance with the requirements of this part.
Where appropriate, a contractor must use a graded approach to implement the requirements of this part, document the basis of the graded approach used, and submit that documentation to DOE. The graded approach may not be used in implementing the unreviewed safety question (USQ) process or in implementing technical safety requirements.
This subpart establishes quality assurance requirements for contractors conducting activities, including providing items or services that affect, or may affect, nuclear safety of DOE nuclear facilities.
(a) Contractors conducting activities, including providing items or services, that affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with the Quality Assurance criteria in § 830.122.
(b) The contractor responsible for a DOE nuclear facility must:
(1) Submit a QAP to DOE for approval and regard the QAP as approved 90 days after submittal, unless it is approved or rejected by DOE at an earlier date.
(2) Modify the QAP as directed by DOE.
(3) Annually submit any changes to the DOE-approved QAP to DOE for approval. Justify in the submittal why the changes continue to satisfy the quality assurance requirements.
(4) Conduct work in accordance with the QAP.
(c) The QAP must:
(1) Describe how the quality assurance criteria of § 830.122 are satisfied.
(2) Integrate the quality assurance criteria with the Safety Management System, or describe how the quality assurance criteria apply to the Safety Management System.
(3) Use voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements, and identify the standards used.
(4) Describe how the contractor responsible for the nuclear facility ensures that subcontractors and suppliers satisfy the criteria of § 830.122.
The QAP must address the following management, performance, and assessment criteria:
(a)
(2) Establish management processes, including planning, scheduling, and providing resources for the work.
(b)
(2) Provide continuing training to personnel to maintain their job proficiency.
(c)
(2) Identify, control, and correct items, services, and processes that do not meet established requirements.
(3) Identify the causes of problems and work to prevent recurrence as a part of correcting the problem.
(4) Review item characteristics, process implementation, and other quality-related information to identify items, services, and processes needing improvement.
(d)
(2) Specify, prepare, review, approve, and maintain records.
(e)
(2) Identify and control items to ensure their proper use.
(3) Maintain items to prevent their damage, loss, or deterioration.
(4) Calibrate and maintain equipment used for process monitoring or data collection.
(f)
(2) Incorporate applicable requirements and design bases in design work and design changes.
(3) Identify and control design interfaces.
(4) Verify or validate the adequacy of design products using individuals or groups other than those who performed the work.
(5) Verify or validate work before approval and implementation of the design.
(g)
(2) Evaluate and select prospective suppliers on the basis of specified criteria.
(3) Establish and implement processes to ensure that approved suppliers continue to provide acceptable items and services.
(h)
(2) Calibrate and maintain equipment used for inspections and tests.
(i)
(j)
(2) Establish sufficient authority, and freedom from line management, for the group performing independent assessments.
(3) Ensure persons who perform independent assessments are technically qualified and knowledgeable in the areas to be assessed.
This Subpart establishes safety basis requirements for Hazard Category 1, 2, and 3 DOE nuclear facilities.
A contractor must perform work in accordance with the DOE-approved safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility and, in particular, with the hazard controls that ensure adequate protection of workers, the public, and the environment.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis for the facility.
(b) In establishing the safety basis for a Hazard Category 1, 2, or 3 DOE
(1) Define the scope of the work to be performed;
(2) Identify and analyze the hazards associated with the work;
(3) Categorize the facility consistent with DOE-STD-1027-92 (“Hazard Categorization and Accident Analysis Techniques for compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,” Change Notice 1, September 1997), or successor document;
(4) Prepare a documented safety analysis for the facility; and
(5) Establish the hazard controls upon which the contractor will rely to ensure adequate protection of workers, the public, and the environment.
(c) In maintaining the safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must:
(1) Update the safety basis to keep it current and to reflect changes in the facility, the work and the hazards as they are analyzed in the documented safety analysis;
(2) Annually provide DOE the current documented safety analysis or a letter stating that there have been no changes in the documented safety analysis since the prior submittal; and
(3) Incorporate in the safety basis any changes, conditions, or hazard controls directed by DOE.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish, implement, and take actions consistent with a DOE-approved USQ procedure that meets the requirements of this section.
(b) The contractor responsible for a new Hazard Category 1, 2, or 3 DOE nuclear facility must submit for DOE approval a procedure for its USQ process on a schedule that allows DOE approval in a safety evaluation report issued pursuant to section 207(a) of this Part.
(c) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must implement the DOE- approved USQ procedure in situations where there is a:
(1) Temporary or permanent change in the facility as described in the existing documented safety analysis;
(2) Temporary or permanent change in the procedures as described in the existing documented safety analysis;
(3) Test or experiment not described in the existing documented safety analysis; or
(4) Potential inadequacy of the documented safety analysis because the analysis potentially may not be bounding or may be otherwise inadequate.
(d) A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain DOE approval prior to taking any action determined to involve a USQ.
(e) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must annually provide to DOE a summary of the USQ determinations performed since the prior submittal.
(f) If a contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility discovers or is made aware of a potential inadequacy of the documented safety analysis, it must:
(1) Take action, as appropriate, to place or maintain the facility in a safe condition until an evaluation of the safety of the situation is completed;
(2) Notify DOE of the situation;
(3) Perform a USQ determination and notify DOE promptly of the results; and
(4) Submit the evaluation of the safety of the situation to DOE prior to removing any operational restrictions initiated to meet paragraph (f)(1) of this section.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain approval from DOE for the methodology used to prepare the documented safety analysis for the facility unless the contractor uses a methodology set forth in Table 1 of Appendix A to this Part.
(b) The documented safety analysis for a Hazard Category 1, 2, or 3 DOE nuclear facility must, as appropriate for the complexities and hazards associated with the facility:
(1) Describe the facility (including the design of safety structures, systems and components) and the work to be performed;
(2) Provide a systematic identification of both natural and man-made hazards associated with the facility;
(3) Evaluate normal, abnormal, and accident conditions, including consideration of natural and man-made external events, identification of energy sources or processes that might contribute to the generation or uncontrolled release of radioactive and other hazardous materials, and consideration of the need for analysis of accidents which may be beyond the design basis of the facility;
(4) Derive the hazard controls necessary to ensure adequate protection of workers, the public, and the environment, demonstrate the adequacy of these controls to eliminate, limit, or mitigate identified hazards, and define the process for maintaining the hazard controls current at all times and controlling their use;
(5) Define the characteristics of the safety management programs necessary to ensure the safe operation of the facility, including (where applicable) quality assurance, procedures, maintenance, personnel training, conduct of operations, emergency preparedness, fire protection, waste management, and radiation protection; and
(6) With respect to a nonreactor nuclear facility with fissionable material in a form and amount sufficient to pose a potential for criticality, define a criticality safety program that:
(i) Ensures that operations with fissionable material remain subcritical under all normal and credible abnormal conditions;
(ii) Identifies applicable nuclear criticality safety standards; and
(iii) Describes how the program meets applicable nuclear criticality safety standards.
(a) A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must:
(1) Develop technical safety requirements that are derived from the documented safety analysis;
(2) Prior to use, obtain DOE approval of technical safety requirements and any change to technical safety requirements; and
(3) Notify DOE of any violation of a technical safety requirement.
(b) A contractor may take emergency actions that depart from an approved technical safety requirement when no actions consistent with the technical safety requirement are immediately apparent, and when these actions are needed to protect workers, the public or the environment from imminent and significant harm. Such actions must be approved by a certified operator for a reactor or by a person in authority as designated in the technical safety requirements for nonreactor nuclear facilities. The contractor must report the emergency actions to DOE as soon as practicable.
(c) A contractor for an environmental restoration activity may follow the provisions of 29 CFR 1910.120 or 1926.65 to develop the appropriate hazard controls (rather than the provisions for technical safety requirements in paragraph (a) of this section), provided the activity involves either:
(1) Work not done within a permanent structure, or
(2) The decommissioning of a facility with only low-level residual fixed radioactivity.
Prior to construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the design and construction of the new facility or major modification must:
(a) Prepare a preliminary documented safety analysis for the facility, and
(b) Obtain DOE approval of:
(1) The nuclear safety design criteria to be used in preparing the preliminary documented safety analysis unless the contractor uses the design criteria in DOE Order 420.1, Facility Safety, or successor document; and
(2) The preliminary documented safety analysis before the contractor can procure materials or components or begin construction; provided that DOE may authorize the contractor to perform limited procurement and construction activities without approval of a preliminary documented safety analysis if DOE determines that the activities are not detrimental to public health and safety and are in the best interests of DOE.
(a) With respect to a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, a contractor may not begin operation of the facility or modification prior to the issuance of a safety evaluation report in which DOE approves the safety basis for the facility or modification.
(b) Pending issuance of a safety evaluation report in which DOE approves an updated or amended safety basis for an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must continue to perform work in accordance with the DOE-approved safety basis for the facility and maintain the existing safety basis consistent with the requirements of this Subpart.
This appendix describes DOE's expectations for the safety basis requirements of 10 CFR part 830, acceptable methods for implementing these requirements, and criteria DOE will use to evaluate compliance with these requirements. This Appendix does not create any new requirements and should be used consistently with DOE's policy that work be conducted safely and efficiently and in a manner that ensures protection of workers, the public, and the environment.
1. The safety basis requirements of part 830 require the contractor responsible for a DOE nuclear facility to analyze the facility, the work to be performed, and the associated hazards and to identify the conditions, safe boundaries, and hazard controls necessary to protect workers, the public and the environment from adverse consequences. These analyses and hazard controls constitute the safety basis upon which the contractor and DOE rely to conclude that the facility can be operated safely. Performing work consistent with the safety basis provides reasonable assurance of adequate protection of workers, the public, and the environment.
2. The safety basis requirements are intended to further the objective of making safety an integral part of how work is performed throughout the DOE complex. Developing a thorough understanding of a nuclear facility, the work to be performed, the associated hazards and the needed hazard controls is essential to integrating safety into management and work at all levels. Performing work in accordance with the safety basis for a nuclear facility is the realization of that objective.
1. A contractor must establish and maintain a safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility because these facilities have the potential for significant radiological consequences. DOE-STD-1027 sets forth the methodology for categorizing a DOE nuclear facility based on the inventory of radioactive materials.
2. Unlike the quality assurance requirements of part 830 that apply to all DOE nuclear facilities the safety basis requirements only apply to Hazard Category 1, 2, and 3 DOE nuclear facilities and do not apply to nuclear facilities below Hazard Category 3.
1. The safety basis requirements are consistent with integrated safety management. DOE expects that, if a contractor complies with the Department of Energy Acquisition Regulation (DEAR) clause on integration of environment, safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment, Safety and Health into Work Planning and Execution) and the DEAR clause on laws, regulations, and DOE directives (48 CFR 970.5204-2, Laws, Regulations and DOE Directives), the contractor will have established the foundation to meet the safety basis requirements.
2. The processes embedded in a safety management system should lead to a contractor establishing adequate safety bases and safety management programs that will meet the safety basis requirements of this Subpart. Consequently, the DOE expects if a contractor has adequately implemented integrated safety management, few additional requirements will stem from this Subpart and, in such cases, the existing safety basis prepared in accordance with integrated safety management provisions, including existing DOE safety requirements in contracts, should meet the requirements of this Subpart.
3. DOE does not expect there to be any conflict between contractual requirements and regulatory requirements. In fact, DOE expects that contract provisions will be used to provide more detail on implementation of safety basis requirements such as preparing a documented safety analysis, developing technical safety requirements, and implementing a USQ process.
1. Enforcement of the safety basis requirements will be performance oriented. That is, DOE will focus its enforcement efforts on whether a contractor operates a nuclear facility consistent with the safety basis for the facility and, in particular, whether work is performed in accordance with the safety basis.
2. As part of the approval process, DOE will review the content and quality of the safety basis documentation. DOE intends to use the approval process to assess the adequacy of a safety basis developed by a contractor to ensure that workers, the public, and the environment are provided reasonable assurance of adequate protection from identified hazards. Once approved by DOE, the safety basis documentation will not be subject to regulatory enforcement actions unless DOE determines that the information which supports the documentation is not complete and accurate in all material respects, as required by 10 CFR 820.11. This is consistent with the DOE enforcement provisions and policy in 10 CFR part 820.
3. DOE does not intend the adoption of the safety basis requirements to affect the existing quality assurance requirements or the existing obligation of contractors to comply with the quality assurance requirements. In particular, in conjunction with the adoption of the safety basis requirements, DOE revised the language in 10 CFR 830.122(e)(1) to make clear that hazard controls are part of the work processes to which a contractor and other persons must adhere when performing work. This obligation to perform work consistent with hazard controls adopted to meet regulatory or contract requirements existed prior to the adoption of the safety basis requirements and is both consistent with and independent of the safety basis requirements.
4. A documented safety analysis must address all hazards (that is, both radiological and nonradiological hazards) and the controls necessary to provide adequate protection to the public, workers, and the environment from these hazards. Section 234A of the Atomic Energy Act only authorizes DOE to issue civil penalties for violations of requirements related to nuclear safety. Therefore, DOE will impose civil penalties for violations of the safety basis requirements (including hazard controls) only if they are related to nuclear safety.
1. A documented safety analysis must demonstrate the extent to which a nuclear facility can be operated safely with respect to workers, the public, and the environment.
2. DOE expects a contractor to use a graded approach to develop a documented safety analysis and describe how the graded approach was applied. The level of detail, analysis, and documentation will reflect the complexity and hazards associated with a particular facility. Thus, the documented safety analysis for a simple, low hazard facility may be relatively short and qualitative in nature, while the documented safety analysis for a complex, high hazard facility may be quite elaborate and more quantitative. DOE will work with its contractors to ensure a documented safety analysis is appropriate for the facility for which it is being developed.
3. Because DOE has ultimate responsibility for the safety of its facilities, DOE will review each documented safety analysis as: (1) Part of the initial submittal; (2) when revisions are submitted as part of a positive USQ or major modification; (3) if DOE has reason to believe a portion of the safety basis to be inadequate, or; (4) if DOE has reason to believe a portion of the safety basis has substantially changed. DOE will review the DSA to determine whether the rigor and detail of the documented safety analysis are appropriate for the complexity and hazards expected at the nuclear facility. In particular, DOE will evaluate the documented safety analysis by considering the extent to which the documented safety analysis (1) satisfies the provisions of the methodology used to prepare the documented safety analysis and (2) adequately addresses the criteria set forth in 10 CFR 830.204(b). DOE will prepare a Safety Evaluation Report to document the results of its review of the documented safety analysis. A documented safety analysis must contain any conditions or changes required by DOE in the Safety Evaluation Report. Generally, DOE's review of the annual submittal may be limited to ensuring that the results of USQs have been adequately incorporated into the DSA. If additional changes are proposed by the contractor and included in the annual update that have not been previously approved by DOE or have not been evaluated as a part of the USQ process, DOE must review and approve these changes. DOE has the authority to review the safety basis at any time.
4. In most cases, the contract will provide the framework for specifying the methodology and schedule for developing a documented safety analysis. Table 1 sets forth acceptable methodologies for preparing a documented safety analysis.
5. Table 1 refers to specific types of nuclear facilities. These references are not intended to constitute an exhaustive list of the specific types of nuclear facilities. Part 830 defines nuclear facility broadly to include reactor or a nonreactor nuclear facilities where an activity is conducted for or on behalf of DOE and includes any related area, structure, facility, or activity to the extent necessary to ensure proper implementation of the requirements established by this Part. The only exceptions are those facilities specifically excluded such as accelerators. Table 2 defines the terms referenced in Table 1 that are not defined in 10 CFR 830.3.
6. The contractor responsible for the design and construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility must prepare a preliminary documented safety analysis. A preliminary documented safety analysis can ensure that substantial costs and time are not wasted in constructing a nuclear facility that will not be acceptable to DOE. If a contractor is required to prepare a preliminary documented safety analysis, the contractor must obtain DOE approval of the preliminary documented safety analysis prior to procuring materials or components or beginning construction. DOE, however, may authorize the contractor to perform limited procurement and construction activities without approval of a preliminary documented safety analysis if DOE determines that the activities are not detrimental to public health and safety and are in the best interests of DOE. DOE Order 420.1, or successor document, sets forth acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a general matter, DOE does not expect preliminary documented safety analyses to be needed for activities that do not involve significant construction such as environmental restoration activities, decontamination and decommissioning activities, specific nuclear explosive operations, or transition surveillance and maintenance activities.
1. Hazard controls are measures to eliminate, limit, or mitigate hazards to workers, the public, or the environment. They include: (1) Physical, design, structural, and engineering features; (2) safety structures, systems, and components; (3) safety management programs; (4) technical safety requirements; and (5) other controls necessary to provide adequate protection from hazards.
2. The types and specific characteristics of the safety management programs necessary for a DOE nuclear facility will be dependent on the complexity and hazards associated with the nuclear facility and the work being performed. In most cases, however, a contractor should consider safety management programs covering topics such as quality assurance, procedures, maintenance, personnel training, conduct of operations, criticality safety, emergency preparedness, fire protection, waste management, and radiation protection. In general, DOE Orders set forth DOE's expectations concerning specific topics. For example, DOE Order 420.1, or successor document provides DOE's expectations with respect to fire protection and criticality safety.
3. Safety structures, systems, and components require formal definition of minimum acceptable performance in the documented safety analysis. This is accomplished by first defining a safety function, then describing the structure, systems, and components, placing functional requirements on those portions of the structures, systems, and components required for the safety function, and identifying performance criteria that will ensure functional requirements are met. Technical safety requirements are developed to ensure the operability of the safety structures, systems, and components and define actions to be taken if a safety structure, system, or component is not operable.
4. Technical safety requirements establish limits, controls, and related actions necessary for the safe operation of a nuclear facility. The exact form and contents of technical safety requirements will depend on the circumstances of a particular nuclear facility as defined in the documented safety analysis for the nuclear facility. As appropriate, technical safety requirements may have sections on: (1) Safety limits; (2) operating limits; (3) surveillance requirements; (4) administrative controls; (5) use and application; and (6) design features. It may also have an appendix on the bases for the limits and requirements. DOE Guide 423.1-1B, Implementation Guide for Use in Developing Technical Safety Requirements, or successor document, provides a complete description of what technical safety requirements should contain and how they should be developed and maintained.
5. DOE will examine and approve the technical safety requirements as part of preparing the safety evaluation report and reviewing updates to the safety basis. As with all hazard controls, technical safety requirements must be kept current and reflect changes in the facility, the work and the hazards as they are analyzed in the documented safety analysis. In addition, DOE expects a contractor to maintain technical safety requirements, and other hazard controls as appropriate, as controlled documents with an authorized users list.
6. Table 3 sets forth DOE's expectations concerning acceptable technical safety requirements.
1. The USQ process is an important tool to evaluate whether changes affect the safety basis. A contractor must use the USQ process to ensure that the safety basis for a DOE nuclear facility is not undermined by changes in the facility, the work performed, the associated hazards, or other factors that support the adequacy of the safety basis.
2. The USQ process permits a contractor to make physical and procedural changes to a nuclear facility and to conduct tests and experiments without prior approval, provided these changes do not cause a USQ. The USQ process provides a contractor with the flexibility needed to conduct day-to-day operations by requiring only those changes and tests with a potential to impact the safety basis (and therefore the safety of the nuclear facility) be approved by DOE. This allows DOE to focus its review on those changes significant to safety. The USQ process helps keep the safety basis current by ensuring appropriate review of and response to situations that might adversely affect the safety basis.
3. DOE Guide 424.1-1B Chg 2, Implementation Guide for Use in Addressing Unreviewed Safety Question Requirements, or successor document provides DOE's expectations for a USQ process. The contractor must obtain DOE approval of its procedure used to implement the USQ process. The contractor is allowed to make editorial and format changes to its USQ procedure while maintaining DOE approval.
1. The DOE Management Official for a DOE nuclear facility (that is, the Assistant Secretary, the Assistant Administrator, or the Office Director who is primarily responsible for the management of the facility) has primary responsibility within DOE for ensuring that the safety basis for the facility is adequate and complies with the safety basis requirements of Part 830. The DOE Management Official is responsible for ensuring the timely and proper (1) review of all safety basis documents submitted to DOE and (2) preparation of a safety evaluation report concerning the safety basis for a facility.
2. DOE will maintain a public list on the internet that provides the status of the safety basis for each Hazard Category 1, 2, or 3 DOE nuclear facility and, to the extent practicable, provides information on how to obtain a copy of the safety basis and related documents for a facility.
National Credit Union Administration (NCUA).
Proposed rule.
The NCUA Board (Board) is seeking comment on a proposed rule that would amend the NCUA's previously revised regulations regarding prompt corrective action (PCA). The proposal would delay the effective date of the NCUA's October 29, 2015 final rule regarding risk-based capital (2015 Final Rule) for one year, moving the effective date from January 1, 2019 to January 1, 2020. During the extended delay period, the NCUA's current PCA requirements would remain in effect. The proposal would also amend the definition of a “complex” credit union adopted in the 2015 Final Rule for risk-based capital purposes by increasing the threshold level for coverage from $100 million to $500 million. These proposed changes would provide covered credit unions and the NCUA with additional time to prepare for the rule's implementation, and would exempt an additional 1,026 credit unions from the rule without subjecting the National Credit Union Share Insurance Fund (NCUSIF) to undue risk.
Comments must be received by September 7, 2018.
You may submit written comments, identified by RIN 3133-AE90, by any of the following methods (Please send comments by one method only):
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You can view all public comments on the NCUA's website at
The NCUA's primary mission is to ensure the safety and soundness of federally insured credit unions. The agency performs this function by examining and supervising all federal credit unions, participating in the examination and supervision of federally insured, state-chartered credit unions in coordination with state regulators, and insuring members' accounts at federally insured credit unions.
At its October 2015 meeting, the Board issued the 2015 Final Rule to amend Part 702 of the NCUA's PCA regulations to require that credit unions taking certain risks hold capital commensurate with those risks.
The 2015 Final Rule restructures the NCUA's PCA regulations and makes various revisions, including amending the agency's current risk-based net worth requirement by replacing the risk based net worth ratio with a new risk-based capital ratio for federally insured, natural-person credit unions (credit unions). The risk-based capital requirements set forth in the 2015 Final Rule are more consistent with the NCUA's risk-based capital ratio measure for corporate credit unions and, as the law requires, are more comparable to the regulatory risk-based capital measures used by the Federal Deposit Insurance Corporation (FDIC), Board of Governors of the Federal Reserve System, and Office of the Comptroller of Currency (Other Banking Agencies). The 2015 Final Rule also eliminates several provisions in the NCUA's current PCA regulations, including provisions related to the regular reserve account, risk-mitigation credits, and alternative risk weights.
The 2015 Final Rule is currently set to become effective on January 1, 2019. The NCUA delayed the effective date until January 1, 2019 to provide credit unions and the NCUA sufficient time to make the necessary adjustments, such as systems, processes, and procedures; to reduce the burden on affected credit unions.
In 1998, Congress enacted the Credit Union Membership Access Act (CUMAA).
The purpose of section 216 of the FCUA is to “resolve the problems of [federally] insured credit unions at the least possible long-term loss to the [NCUSIF].”
Among other things, section 216(c) of the FCUA requires the NCUA to use a credit union's net worth ratio to determine its classification among five “net worth categories” set forth in the FCUA.
Section 216(d)(1) of the FCUA requires that the NCUA's system of PCA include, in addition to the statutorily defined net worth ratio requirement applicable to federally insured natural-person credit unions, “a risk-based net worth
Under § 702.103 of the NCUA's 2015 Final Rule, a credit union is defined as “complex” and the NCUA's risk-based capital ratio measure is applicable only if the credit union's quarter-end total assets exceed $100 million, as reflected in its most recent Call Report. Consistent with the spirit and intent of Executive Order 13777, the NCUA further analyzed the impact of the NCUA's risk-based capital requirements and the portfolios of assets and liabilities of credit unions to identify potential ways to reduce regulatory burden on credit unions.
Based on the NCUA's analysis, which is discussed in more detail below, the Board believes that $500 million in total assets would be a more appropriate threshold level for defining a complex credit union, and therefore subjecting it to the risk-based capital requirement. Increasing the threshold level to $500 million in assets would reduce
Under the 2015 Final Rule, the NCUA determined that credit unions exceeding the $100 million asset-size threshold had portfolios of assets and liabilities that were complex based on the products and services in which such credit unions engaged. As explained further below, the $100 million asset-size threshold was developed as a proxy measure based on a detailed analysis performed by the NCUA. The threshold set forth a clear demarcation line, above which the NCUA determined all credit unions engaged in complex activities, and where almost all such credit unions (99 percent) were involved in multiple complex activities.
The $100 million asset threshold adopted in the 2015 Final Rule for determining whether a credit union is complex was based on a complexity index (original complexity index or OCI). The OCI counted the number of complex products and services provided by credit unions based on the following indicators:
As discussed in more detail in the 2015 Final Rule, these products and services were determined by the NCUA to be good indicators of complexity.
To define “complex” credit unions for the 2015 Final Rule, the NCUA used the original complexity index to analyze June 30, 2014 and March 31, 2015 Call Report data. Based on the OCI, for credit unions with more than $100 million in assets, 100 percent engaged in offering at least one complex activity; 99 percent engaged in two or more complex activities; and 87 percent engaged in four or more complex activities. Accordingly, the Board determined it was appropriate to set the asset size threshold for “complex” credit unions at $100 million in total assets, subjecting credit unions with more than $100 million in assets to the NCUA's risk-based capital requirements.
As discussed in more detail below, the OCI did not take into account the volume of the complex activity engaged in by such credit unions.
Following a careful review of the 2015 Final Rule by the NCUA's regulatory reform task force,
• Replace the indicator for “member business loans” with an indicator for “commercial loans” to reflect changes to the NCUA's member business lending rule,
• Replace the indicator for “participation loans” (which included participation loans sold and participation loans held) with an indicator for “participation loans sold” to restrict the indicator to the most complex component of participation loans.
• Replace the indicator for “interest-only loans” to exclude first-lien mortgages. The remaining interest only loans include complex payment options. For example, only requiring monthly payments of interest during draw periods.
• Remove the indicator for “internet banking” because it has become a typical mechanism for members to transact business with most credit unions, with 78 percent of credit unions engaging in some type of internet banking. Also, it is not an asset or liability—therefore there is no suitable way to translate the volume into a financial measure for purposes of defining complex.
• Remove the indicator for “investments with maturities greater than five years (where the investments are greater than one percent of total assets)” because the indicator is adequately captured in the other index components.
• Replace the indicator for “real estate loans (where the loans are greater than five percent of assets and/or sold mortgages)” with an indicator for “sold
The NCUA believes the revised complexity index would provide a more accurate methodology, based on the assets and liabilities of credit unions, for identifying when credit unions engage in complex activities and defining credit unions as “complex.” Table 1 shows that, among credit unions with $500 million or more in total assets, 100 percent engage in at least one complex activity, and 96 percent engage in three or more complex activities.
In addition to the revised complexity index, the NCUA is also proposing to use a ratio of complex assets and liabilities to total assets (complexity ratio or CR) to evaluate the extent to which credit unions are involved in complex activities. The CR, when used in conjunction with the revised complexity index, takes into account the volume of the complex activity engaged in by complex credit unions and provides a more accurate measure of credit union complexity.
As shown in Table 2 below, credit unions with greater than $500 million in total assets hold complex assets and liabilities as a larger share of their total assets than smaller credit unions. The complexity ratio increases from 23 percent among credit unions with less than $500 million in assets to 40 percent among credit unions with more than $500 million in assets. Of the $497 billion in complex assets and liabilities in the credit union system, $423 billion (85 percent)—the majority of complex assets and liabilities in the credit union system—are held among credit unions with more than $500 million in assets.
Table 3 below shows the share of credit unions in each asset category above various complex ratio thresholds. Larger credit unions are much more likely to have a significant share of their balance sheet in complex assets and liabilities. Nearly all credit unions (95 percent) with more than $500 million in assets have complex assets and liabilities greater than 10 percent of their total assets, and 66 percent have complex assets and liabilities greater than 30 percent of their total assets.
In general, two-thirds of credit unions with more than $500 million in total assets have complex assets and liabilities ratios above 30 percent. Only 11 percent of credit unions with less than $500 million have complexity ratios above 30 percent.
Using both the revised
In addition, if the historical trends in changes to the composition of the credit union community continue, the share of total assets covered by the rule will rise in the future, potentially reaching 90 percent of total assets within the next 10 years. Also, the higher asset threshold still captures those credit unions that, if they failed, individually could present an undue risk of loss to the NCUSIF. In addition, if the historical trends in changes to the composition of the credit union community continue and historical probability of failure and loss given failure rates (excluding fraud related failures) for credit unions with total assets between $100 and $500 million and those with total assets over $500 million remain the same, total losses to the NCUSIF over the next 10 years would likely be significantly larger for credit unions with more than $500 million in assets than for those with assets between $100 million and $500 million.
Under the 2015 Final Rule, an estimated 505 credit unions would face higher required capital levels as a result of risk-based capital requirements. These 505 credit unions have total assets of $439 billion and the 2015 Final Rule would raise their required capital levels by approximately $800 million above what is required by the net worth ratio.
Exempting credit unions with assets between $100 million and $500 million represents approximately 16 percent of the total assets of credit unions with required capital levels above what is required by the net worth ratio, and about 21 percent of the incremental capital the system is required to hold under the 2015 Final Rule. However, this proposal still encompasses approximately 84 percent of the total assets of credit unions with required capital levels above what is required by the net worth ratio, and almost 80 percent of the incremental capital the system is required to hold under the 2015 Final Rule.
Under the 2015 Final Rule, a net of 20 credit unions with total assets of $11.5 billion would have a lower PCA classification with a capital shortfall of $84 million.
The Board also notes the NCUSIF is much stronger today than it was in 2015 when the agency passed the 2015 Final Rule. The equity ratio of the NCUSIF was 1.29 percent in 2015. In 2018, the NCUSIF equity ratio will be 1.39 percent even after an equity distribution of $736 million is paid to credit unions. The total funds held in the NCUSIF will be approximately $16 billion after the equity distribution this year, about $3.5 billion more than the $12.4 billion held in the fund in 2015.
The NCUA will continue to address any deficiencies in the capital levels of credit unions with $500 million or less in assets through the examination process.
Also, the Board wants to clarify for commenters that the standard under the Regulatory Flexibility Act for how the NCUA defines a “small credit union”
The Board initially established the effective date of the 2015 Final Rule as January 1, 2019 to provide credit unions and the NCUA with an extended period to make necessary adjustments to systems, processes, and procedures, and to reduce the burden on affected credit unions in meeting the new requirements. Based on feedback from the credit union community and agency staff, and that the agency is proposing to change the definition of complex credit union, the Board believes it is necessary and beneficial to delay the effective date of the 2015 Final Rule as amended by this proposal by one year. Extending the effective date would provide covered credit unions additional time to adjust systems, processes, and procedures; and would help smooth the transition for complex credit unions affected by the requirements of the 2015 Final Rule.
Until the 2015 Final Rule's effective date, the NCUA's current PCA regulation will remain in effect. The NCUA will continue to enforce the capital standards currently in place and address any supervisory concerns through existing regulatory and supervisory mechanisms. The Board believes that, given the facts above, extending the implementation period of the 2015 Final Rule for an additional year would be reasonable and would not pose undue risk to the NCUSIF. Accordingly, the Board proposes to change the effective date for the 2015 Final Rule, and any changes to that rule finalized as part of this rulemaking, from January 1, 2019 to January 1, 2020.
The proposed rule will lower the overall impact of the 2015 Final Rule by reducing the number of credit unions subject to the risk-based capital requirements of the rule. By increasing the threshold for defining a complex credit union from more than $100 million to more than $500 million in assets, an additional 1,026 credit unions would be exempt from the 2015 Final Rule's risk-based capital requirements. This represents significant burden relief for these relatively small credit unions, as half of them have assets of $190 million or less. The proposed new definition of complex credit union would exempt a total of 90 percent (5,042) of all credit unions as of December 31, 2017.
While under this proposal 9 out of 10 credit unions would be exempt, these institutions only hold 24 percent of total assets in the credit union system and 15 percent of complex assets and liabilities.
The credit unions that would be defined as complex under this proposal have estimated aggregate and average risk-based capital ratios of 16.8 and 17.2 percent, respectively. The aggregate risk-weighted assets to total assets ratio is 63 percent for complex credit unions under this proposal.
As shown in Table 5 above, most complex credit unions will have a risk-based capital ratio well in excess of the 10 percent level required to be well capitalized. Under this proposal, six complex credit unions with total assets of $8.8 billion would have a lower capital classification, with a capital shortfall of approximately $71 million.
Credit
Both measures indicate the large majority of complex credit unions hold margins well above the levels required to be well-capitalized.
The NCUA also analyzed complex credit unions to determine whether the net worth or risk-based capital requirement would require a credit union to hold more dollars of capital. Table 7 below summarizes the distribution of credit unions by the ratio of risk-weighted assets to total assets for credit unions bound by each capital requirement.
Forty-two percent of complex credit unions (221 complex credit unions with $370.3 billion in total assets) are estimated to have a higher minimum capital requirement in terms of dollars under the risk-based capital ratio than the net worth ratio.
In addition, despite holding a greater share of risk-weighted assets, the risk-based capital-bound group of 221 complex credit unions also has, on average, a net worth ratio that is 100 basis point below the net worth ratio of the other 310 complex credit unions.
The Board is requesting comment on all aspects of the changes proposed in this proposed rule. In particular, the agency requests comments on:
1. Whether the definition of a complex credit union, as defined under § 701.103 of the 2015 Final Rule, should be amended to increase the threshold level for coverage from
2. Whether the implementation date for the 2015 Final Rule should be amended to extend the effective date of the rule until January 1, 2020?
The Regulatory Flexibility Act (RFA) generally requires that, in connection with a notice of proposed rulemaking, an agency prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of a proposed rule on small entities. A regulatory flexibility analysis is not required, however, if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities (defined for purposes of the RFA to include credit unions with assets less than $100 million)
The proposed amendments to the 2015 Final Rule and part 702 would only affect complex credit unions, which are those with greater than $100 million in assets under the 2015 Final Rule and would be amended to cover only those with greater than $500 million in assets under this proposal. As a result, credit unions with $100 million or less in total assets would not be affected by this proposal. Accordingly, the NCUA certifies that this proposal will not have a significant economic impact on a substantial number of small credit unions.
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden.
The proposed changes to part 702 would increase the asset size of credit unions identified as complex from greater than $100 million to greater than $500 million. This change would reduce the number of credit unions who must comply with recordkeeping requirements prescribed by § 702.101(b). Therefore, the burden cleared under OMB number 3133-0191 will be revised to reflect the reduction in the number of respondents.
By exempting credit unions with assets between $100 million and $500 million, the NCUA estimates that the burden under this proposed rule would be 41,040 fewer hours.
The Board invites comment on (a) whether the collections of information are necessary for the proper performance of the agency's function, including practical utility; (b) the accuracy of estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information being collected, and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
All comments are a matter of public record. Comments regarding the information collection requirements of this rule should be sent to (1) Dawn Wolfgang, NCUA PRA Clearance Officer, National Credit Union Administration, 1775 Duke Street, Suite 5080, Alexandria, Virginia 22314, or Fax No. 703-519-8572, or Email at
• Evaluating whether the proposed collection of information is necessary for the proper performance of the functions of the NCUA, including whether the information will have a practical use;
• Evaluating the accuracy of the NCUA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhancing the quality, usefulness, and clarity of the information to be collected; and
• Minimizing the burden of 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;
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the principles of the executive order to adhere to fundamental federalism principles. This proposed rule reduces the number of federally insured natural-person credit unions, including federally insured, state-chartered natural-person credit unions that would be subject to the 2015 Final Rule. It may have, to some degree, a 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. It does not, however, rise to the level of material impact for purposed of Executive Order 13132.
The NCUA has determined that this proposed rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Credit unions, Reporting and recordkeeping requirements.
For the reasons discussed above, the Board proposes to further amend 12 CFR part 702, as amended in a final rule at 80 FR 66625 (Oct. 29, 2015), effective January 1, 2019, as follows:
12 U.S.C. 1766(a), 1790d.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to supersede airworthiness directive (AD) 2015-22-02 for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. AD 2015-22-02 requires inspecting the tail rotor (TR) pitch link assemblies. This proposed AD would retain the inspections of AD 2015-22-02 and would require replacing certain pitch link bearings. Since we issued AD 2015-22-02, Bell has introduced a new design bearing. The actions of this proposed AD are intended to prevent an unsafe condition on these products.
We must receive comments on this proposed AD by October 9, 2018.
You may send comments by any of the following methods:
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You may examine the AD docket on the internet at
For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at
David Hatfield, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
We issued AD 2015-22-02, Amendment 39-18306 (80 FR 65618, October 27, 2015) (AD 2015-22-02), for Bell Model 429 helicopters with a TR pitch link assembly part number (P/N) 429-112-101 or 429-112-103 installed. AD 2015-22-02 requires repetitively inspecting each inboard and outboard TR pitch link assembly for axial or radial bearing play every 50 hours time-in-service (TIS), performing a dimensional inspection of the TR pitch link if there is axial or radial bearing play, and replacing the TR pitch link before further flight if there is any wear beyond allowable limits. AD 2015-22-02 was prompted by Emergency AD No. CF-2015-16, dated July 2, 2015, and Emergency AD No. CF-2015-16R1, dated August 6, 2015, issued by Transport Canada, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advised of several occasions where the TR pitch link spherical bearings experienced early and accelerated wear.
Since we issued AD 2015-22-02, Transport Canada has issued AD No. CF-2015-16R2, dated April 17, 2017, which supersedes AD CF-2015-16R1. According to Transport Canada, Bell has reported that the TR pitch link assembly can be rotated during the 50-hour inspections to extend the serviceability life of the bearings. Transport Canada AD No. CF-2015-16R2 requires modified inspection procedures for the spherical bearings and requires replacing the TR pitch link bearings (or the TR pitch link assembly) with spherical bearings manufactured after January 12, 2015. Transport Canada AD No. CF-2015-16R2 also requires re-identifying TR pitch link assemblies with a different P/N after installing the new bearings. We propose to issue this AD to make similar changes.
These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in the Transport Canada AD. We are proposing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
Bell has issued Alert Service Bulletin No. 429-15-16, Revision B, dated June 15, 2016. This service information contains procedures for repetitively inspecting the TR pitch link assembly until it is upgraded by replacing the TR pitch link bearings.
This proposed AD would require performing a dimensional inspection of the spherical bearings for axial and radial play and inspecting the TR pitch link assembly sealant for pin holes, voids, and excessive thickness. These inspections would be required within 50 hours TIS and thereafter at intervals not exceeding 50 hours TIS.
This proposed AD would also require replacing any spherical bearing manufactured before January 13, 2015, that has exceeded 250 hours TIS or that has an unknown number of hours TIS, and re-identifying the P/N of the TR pitch link assembly.
The Transport Canada AD requires the bearing inspection within 10 hours TIS or before exceeding 60 hours TIS since new, whichever occurs later. This proposed AD would require the bearing inspection within 50 hours TIS. The Transport Canada AD also requires replacing certain bearings within 200 hours TIS after the initial bearing inspection or within 250 hours TIS since new, whichever occurs first. This proposed AD would require replacing the bearing within 200 hours of the initial inspection or at the next 50 hour TIS inspection if the hours TIS of a pitch link assembly exceed 250 hours TIS or are unknown.
We consider this proposed AD to be an interim action. If final action is later
We estimate that this proposed AD would affect 85 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this proposed AD. At an average labor rate of $85 per hour, inspecting the TR pitch link assemblies would require 2 work-hours for a cost of $170 per helicopter and $14,450 for the U.S. fleet per inspection cycle. Replacing both spherical bearings in each TR pitch link assembly would require 3 work-hours, and required parts would cost $3,088, for a cost of $3,343 per helicopter and $284,155 for the U.S. fleet.
According to Bell's service information some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Bell. Accordingly, we have included all costs in our cost estimate.
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 will not have federalism implications under Executive Order 13132. This proposed 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, I certify that this proposed regulation:
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 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.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
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.
This AD applies to Model 429 helicopters with a pitch link assembly part number (P/N) 429-012-112-101, 429-012-112-103, 429-012-112-101FM, or 429-012-112-103FM installed, certificated in any category.
This AD defines the unsafe condition as a worn pitch link. This condition, if not corrected, could result in pitch link failure and subsequent loss of control of the helicopter.
This AD replaces AD 2015-22-02, Amendment 39-18306 (80 FR 65618, October 27, 2015).
We must receive comments by October 9, 2018.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Within 50 hours time-in-service (TIS) and thereafter at intervals not to exceed 50 hours TIS:
(i) Perform a dimensional inspection of each inboard and outboard pitch link assembly for axial and radial bearing play. With a 10X or higher power magnifying glass, inspect the bearing liner for a crack, deterioration of the liner, and extrusion of the liner from the plane. If there is axial or radial play that exceeds allowable limits, or if there is a crack, deterioration of the liner, or extrusion of the liner, before further flight, replace the bearing.
(ii) Inspect the pitch link assembly sealant for pin holes and voids and to determine if the sealant thickness is 0.025 inch (0.64 mm) or less, extends over the roll staked lip by 0.030 inch (0.76 mm) or more, and is clear of the bearing ball. If there is a pin hole or void, or if the sealant exceeds 0.026 inch (0.66 mm), does not extend over the roll staked lip by 0.030 inch (0.76 mm) or more, or is not clear of the bearing ball, before further flight, replace the bearing.
(2) For pitch link assembly part number (P/N) 429-012-112-101, 429-012-112-103, 429-012-112-101FM, and 429-012-112-103FM, within 200 hours TIS following the initial inspection required by paragraph (f)(1) of this AD, or if the hours TIS of a pitch link assembly exceed 250 hours TIS or are unknown, at the next 50 hour TIS inspection required by paragraph (f)(1) of this AD:
(i) Replace each bearing P/N 429-312-107-103 with a date of manufacture before January 13, 2015, with a bearing P/N 429-312-107-103 that was manufactured on or after January 13, 2015.
(ii) Using a white permanent fine point marker or equivalent, re-identify the pitch link assembly:
(A) Re-identify P/N 429-012-112-101 and 429-012-112-101FM as 429-012-112-111FM.
(B) Re-identify P/N 429-012-112-103 and 429-012-112-103FM as 429-012-112-113FM.
(iii) Apply a coating of DEVCON 2-TON (C-298) or equivalent over the new P/N.
Special flight permits are prohibited.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: David Hatfield, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
(1) Bell Alert Service Bulletin No. 429-15-16, Revision B, dated June 15, 2016, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at
(2) The subject of this AD is addressed in Transport Canada AD No. CF-2015-16R2, dated April 17, 2017. You may view the Transport Canada AD on the internet at
Joint Aircraft Service Component (JASC) Code: 6720 Tail Rotor Control System.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2016-25-19 for Airbus Helicopters (previously Eurocopter France) Model AS350B3 and EC130B4 helicopters. AD 2016-25-19 requires inspecting the pilot's and co-pilot's throttle twist for proper operation. This proposed AD would retain the requirements of AD 2016-25-19 and add certain model helicopters to the applicability. The actions of this proposed AD are intended to address the unsafe condition on these helicopters.
We must receive comments on this proposed AD by October 9, 2018.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
George Schwab, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
We issued AD 2016-25-19, Amendment 39-18745 (81 FR 95854, December 29, 2016) (AD 2016-25-19), for Airbus Helicopters Model AS350B3 and EC130B4 helicopters with the ARRIEL 2B1 engine with the two-channel Full Authority Digital Engine Control (FADEC) and with new twist grip modification (MOD) 073254 (for the Model AS350B3 helicopter) or MOD 073773 (for the Model EC130B4 helicopter). AD 2016-25-19 requires repetitively inspecting the wiring, performing an insulation test, inspecting the pilot and copilot throttle twist grip controls, and testing the pilot and copilot throttle twist grip controls for proper functioning. AD 2016-25-19 was prompted by AD No. 2013-0191-E, dated August 22, 2013 (EASA AD 2013-0191-E), issued by EASA, which is the Technical Agent for the Member States of the European Union. EASA advised that the switches in the engine “IDLE” or “FLIGHT” control system could be affected by the corrosive effects of a salt-laden atmosphere, which could lead to engine power loss. EASA AD 2013-0191-E required repetitive inspections for corrosion, application of corrosion protection on the switches, and testing of the insulation and switches of the engine idle and flight control system. The actions required in AD 2016-25-19 are intended to prevent unintended touchdown to the ground at a flight-idle power setting during a practice autorotation, damage to the helicopter, and injury to occupants.
Since we issued AD 2016-25-19, EASA issued AD No. 2017-0052, dated March 24, 2017, which superseded EASA AD No. 2013-0191-E, dated August 22, 2013. EASA advised that Airbus Helicopters had added
EASA subsequently issued AD No. 2017-0059, dated April 6, 2017, which superseded EASA AD No. 2017-0052 to correct the applicability by including Model EC130T2 helicopters.
These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
We reviewed one document that co-publishes three Emergency Alert Service Bulletin (EASB) identification numbers: No. 05.00.61, Revision 3, dated June 15, 2015, for Model AS350B3 helicopters; No. 05.00.41, Revision 2, dated June 15, 2015, for the non-FAA type certificated Model AS550C3 helicopter; and No. 05A009, Revision 3, dated June 15, 2015, for Model EC130B4 helicopters. EASB Nos. 05.00.61 and 05A009 are incorporated by reference in AD 2016-25-19 and will be retained for the requirements of this proposed AD. EASB No. 05.00.41 is not incorporated by reference in AD 2016-25-19 and will not be incorporated by reference in this proposed AD. This service information applies to helicopters with an Arriel 2B1 engine installed and describes procedures for a functional check and installation of protection for micro-contacts (microswitches) 53Ka, 53Kb, and 65K (IDLE/FLIGHT mode).
We also reviewed one document that co-publishes three EASB identification numbers: No. 05.00.77, Revision 1, dated June 15, 2015, for Model AS350B3 helicopters; No. 05.00.52, Revision 1, dated June 15, 2015, for the non-FAA type certificated Model AS550C3 helicopter; and No. 05A014, Revision 1, dated June 15, 2015, for Model EC130T2 helicopters. EASB Nos. 05.00.77 and 05A014 will be incorporated by reference in this proposed AD. EASB No. 05.00.52 will not be incorporated by reference in this proposed AD. This service information applies to helicopters with an Arriel 2D engine installed and describes procedures for a check of the protection for micro-contacts (microswitches) 53Ka, 53Kb, and 65K (IDLE/FLIGHT mode).
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would retain the inspection requirements of AD 2016-25-19 but would add Model AS350B3 helicopters with an Arriel 2D engine installed and Model EC130T2 helicopters.
The EASA AD requires the initial inspections within 10 flight hours or 7 days; this proposed AD requires compliance before the next autorotation training flight or before 100 hours time-in-service, whichever occurs earlier, as the unsafe condition only occurs when transitioning the throttle in flight from flight to idle and back to flight, such as during a practice autorotation.
Additionally, the EASA AD requires installing Airbus Helicopters modification 074263; this proposed AD does not as it does not correct the unsafe condition.
We consider this proposed AD to be an interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this proposed AD would affect 692 helicopters of U.S. Registry.
We estimate that operators will incur the following costs in order to comply with this proposed AD. At an average labor rate of $85 per work hour, it would take about 4 work hours for the inspections and any necessary maintenance, for a total cost of $340 per helicopter and $235,280 for the U.S. fleet per inspection cycle.
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, 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 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.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
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.
This AD applies to the following helicopters, certificated in any category:
(1) Model AS350B3 helicopters with an ARRIEL 2B1 engine with the two-channel Full Authority Digital Engine Control (FADEC) and with new twist grip modification (MOD) 073254 or with an ARRIEL 2D engine installed;
(2) Model EC130B4 helicopters with an ARRIEL 2B1 engine with the two-channel FADEC and with new twist grip MOD 073773 installed; and
(3) Model EC130T2 helicopters with an ARRIEL 2D engine installed.
This AD defines the unsafe condition as failure of one of the two contactors, 53Ka or 53Kb, which can prevent switching from “IDLE” mode to “FLIGHT” mode during autorotation training making it impossible to recover from a practice autorotation and compelling the pilot to continue the autorotation to the ground. This condition could result in unintended touchdown to the ground at a flight-idle power setting during a practice autorotation, damage to the helicopter, and injury to occupants.
This AD replaces AD 2016-25-19, Amendment 39-18745 (81 FR 95854, December 29, 2016).
We must receive comments by October 9, 2018.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Before the next practice autorotation or within 100 hours time-in-service (TIS), whichever occurs first, inspect the wiring, perform an insulation test, inspect the pilot and copilot throttle twist grip controls, and test the pilot and copilot throttle twist grip controls for proper functioning by following the Accomplishment Instructions, paragraph 3.B.1 through 3.B.6, of Airbus Helicopters Emergency Alert Service Bulletin (EASB) No. 05.00.61, Revision 3, dated June 15, 2015, for Model AS350B3 helicopters with an ARRIEL 2B1 engine; EASB No. 05.00.77, Revision 1, dated June 15, 2015, for Model AS350B3 helicopters with an ARRIEL 2D engine; EASB No. 05A009, Revision 3, dated June 15, 2015, for Model EC130B4 helicopters; or EASB No. 05A014, Revision 1, dated June 15, 2015, for Model EC130T2 helicopters, as appropriate for your model helicopter.
(2) Repeat the inspections in paragraph (f)(1) of this AD at intervals not to exceed the following compliance times. For purposes of this AD, salt laden conditions exist when a helicopter performs a flight from a takeoff and landing area, heliport, or airport less than 0.5 statute mile from salt water or performs a flight within 0.5 statute mile from salt water below an altitude of 1,000 ft. above ground or sea level.
(i) For helicopters that have operated in salt laden conditions since the previous inspection required by this AD, at intervals not to exceed 330 hours TIS.
(ii) For helicopters that have not operated in salt laden conditions since the previous inspection required by this AD, at intervals not to exceed 660 hours TIS.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, 10101 Hillwood Parkway, Fort Worth, Texas 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2017-0059, dated April 6, 2017. You may view the EASA AD on the internet at
Joint Aircraft Service Component (JASC) Code: 7697 Engine Control System Wiring.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of Maryland. This revision pertains to Code of Maryland Regulations (COMAR) 26.11.32—Control of Emissions of Volatile Organic Compounds (VOCs) from Consumer Products. This action is being taken under the Clean Air Act (CAA).
Written comments must be received on or before September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0153 at
Gregory Becoat (215) 814-2036, or by email at
On November 16, 2017, the Maryland Department of Environment (MDE) submitted a revision to its SIP for COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products. The amendment is part of Maryland's strategy to achieve and maintain the 8-hour ozone national ambient air quality standards (NAAQS) throughout the State.
EPA has designated certain areas within Maryland as nonattainment for the 2008 ozone NAAQS.
In December 1999, EPA identified emission reduction shortfalls in several severe 1-hour ozone nonattainment areas, including those located in the OTR. The Ozone Transport Commission (OTC) developed model rules for a number of source categories. One of the model rules was to reduce VOC emissions from consumer products. The OTC model rules are based on existing rules developed by the California Air Resources Board (CARB) in 2001 (See “OTC Model Rule for Consumer Products,” issued March 28, 2001, revised November 29, 2001, and April 23, 2002), which were then analyzed and modified by OTC-formed workgroups to address emission reduction needs in the OTR. The 2001 OTC model rule set VOC emission limits on nearly 80 percent of the consumer product categories. Maryland adopted the 2001 OTC model rule for consumer products under COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products, on August 18, 2003. EPA approved Maryland's adopted regulation COMAR 26.11.32 as part of the SIP on December 8, 2004 (69 FR 70895). The OTC model rule for consumer products was amended on September 19, 2006, based upon changes by CARB in 2005. Maryland adopted the amended 2006 OTC model rule for consumer products under COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products, on June 8, 2007.
The amended model rule added fourteen consumer product categories with new product category definitions and VOC limits; revised one previously regulated category with a more restrictive VOC limit; and established additional requirements for two previously regulated categories. EPA approved Maryland's amended regulation into the SIP on December 10, 2007 (72 FR 69621). Maryland again amended its consumer products regulation and on October 18, 2010 (75 FR 63717), EPA approved Maryland's SIP revision to COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products. This SIP revision added and amended definitions; added VOC content limits for an additional 11 categories of consumer products; and revised the VOC content limits for one category of consumer products that was already regulated.
MDE's November 16, 2017 SIP revision asks EPA to approve into the SIP recent amendments to COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products, in order to institute the requirements of the 2010 and 2014 OTC model rules for consumer products. The 2010 and 2014 model rules were developed as part of a regional effort to attain and maintain the 8-hour ozone NAAQS, and reduce 8-hour ozone levels. The 2010 OTC model rule reflected changes made by the 2006 CARB rule. The 2014 OTC model rule reflected changes made by the 2009 CARB rule. The OTC model rules further enhance VOC standards for specific consumer products and introduces VOC standards for new products. The amendments to COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products, consists of updates to the VOC content limits and standards for a variety of consumer product categories, including personal care products, household products, automotive cleaners, and adhesives. The regulations set forth content and labeling requirements for flammable multi-purpose solvents and paint thinners. In addition, the regulations prohibit the sale, offer for sale, supply, or manufacture for use in the State of certain products manufactured on or after January 1 that contain methylene chloride, perchloroethylene, or trichloroethylene. These products include any bathroom and tile cleaner, construction panel and floor covering adhesive, electronic cleaner labeled “Energized Electronic Equipment use only,” general purpose cleaner, or oven or grill cleaner. The amendments also establish VOC standards for 11 new consumer product categories. In addition, the amendments further strengthen the VOC standards for 15 consumer product categories based on improved reformulations of these products that are capable of achieving lower VOC emissions while demonstrating an ability to maintain performance specifications for the products. The amendments also incorporate new definitions and numerous modifications to existing definitions to improve clarity. In particular, MDE amended the structure of the definition, exemptions, and VOC standard for the artist's thinner/solvent consumer product category without changing the regulatory language, which remains consistent with the 2009 CARB rule and the 2014 OTC model rule.
It is important to note that the 2006 CARB rule eliminated the “hair styling gel” category and now considers gels to fall under “hair styling product—all other forms.” Moving gels under the “hair styling product—all other forms” category reduced the VOC limit from 6 to 2 percent VOC by weight. The 2014 OTC model rule did not address this amendment as intended; however, MDE amended “hair styling gel” to be included under the “hair styling product—all other forms” category to meet the VOC limit of 2 percent VOC by weight in order to remain consistent with CARB.
The SIP revision consists of Maryland's revision to regulations .01-.06, .08, .12, .14, .16, and the addition of a new regulation .05-1, under COMAR 26.11.32—Control of Emissions of VOCs from Consumer Products. Generally, the regulations establish or amend VOC content limits and standards for a variety of consumer product categories, including personal care products, household products, automotive cleaners, and adhesives, in order to be consistent with the CARB and OTC model rules. The regulations also, among other things:
1. Set forth content and labeling requirements for flammable multi-purpose solvent and paint thinner;
2. prohibit the sale, offer for sale, supply, or manufacture for use in the State of specified products that contain methylene chloride, perchloroethylene, or trichloroethylene, which are compounds that are potential carcinogens; and
3. make various updates to the applicability provisions, documents incorporated by reference, definitions, reporting requirements, exemptions, and test methods.
Substantial amendments were made to COMAR 26.11.32.04—Standards—General, to establish that a person may not sell, supply, offer for sale, or manufacture for sale in the State a consumer product that contains VOCs in excess of limits specified in COMAR 26.11.32.04B based on the CARB and OTC model rules. The following 11
The following existing 15 consumer products categories were amended, including the VOC content limits in parentheses based on percent VOC by weight: (1) Adhesive—Construction, Panel and Floor (7); (2) Automotive Brake Cleaner (category changed to Brake Cleaner (10); (3) Bathroom and Tile Cleaner, All Other Forms (subcategory changed to Non-Aerosol (1); (4) Carburetor or Fuel-Injection Air Intake Cleaner (10); (5) Engine Degreaser, Aerosol (10); (6) Floor Polish/Wax, Resilient Flooring Material (1); (7) Floor Polish/Wax, Non-resilient Flooring Material (1); (8) Furniture Maintenance Product, All Other Forms (subcategory changed to Non-Aerosol) (3); (9) General Purpose Cleaner, Aerosol (8); (10) General Purpose Degreaser, Aerosol (10); and (11) Laundry Starch/Sizing/Fabric Finish Product (4.5); (12) Nail Polish Remover (1); (13) Oven or Grill Cleaner, Non-Aerosol (subcategory changed to Non-Aerosol) (4); (14) Oven or Grill Cleaner, Aerosol (8); and (15) Shaving Gel (4).
In addition to these revised and new standards, Maryland added a requirement for “flammable and extremely flammable multi-purpose solvent and paint thinner,” to meet the formulated California VOC limits. The revision will continue to help Maryland attain and maintain the eight-hour ozone standard for the 2008 NAAQS. The revision is expected to result in estimated statewide VOC emissions reduction potential of approximately 6.3 tons per day through the implementation of standards for new and existing forms of consumer products. This estimate is based on the proposed emissions benefit methodology of CARB and OTC model rules.
Further details of Maryland's regulation revisions and the CARB and OTC model rules for consumer products can be found in the docket of this proposed rulemaking EPA-R03-OAR-2018-0153 on
EPA is proposing to approve MDE's amendments to COMAR 26.11.32—Control of Emissions of VOCs from Consumer Products, that adopts the VOC limits established in the 2010 and 2014 OTC model rules for consumer products, based on the 2006 and 2009 CARB rules; respectively (with the exception of the previously discussed “hair styling gel” category). The OTR estimated regional VOC emission reductions of approximately 15 percent if all OTR states, including Maryland, adopts the 2010 and 2014 model rules. EPA's review of this material indicates that the revisions made to COMAR 26.11.32—Control of Emissions of VOCs from Consumer Products, meet the SIP revision requirements of the CAA. EPA is proposing to approve the State of Maryland's SIP revision for the control of emissions of VOCs from consumer products, which was submitted on November 19, 2017. EPA is soliciting public comments on the proposed adoption of these changes into the Maryland SIP.
In this proposed rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the specific provisions of the Maryland rule discussed in section II of this preamble. EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rule, to approve amendments to the State of Maryland's COMAR 26.11.32—Control of Emissions of Volatile Organic Compounds from Consumer Products, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Consumer products, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing action on a revision to the South Coast Air Quality Management District (SCAQMD or District) portion of the California State Implementation Plan (SIP). We are proposing a conditional approval of an update to provisions governing issuance of permits for stationary sources, including review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA). Specifically, the revision pertains to SCAQMD Rule 1325—
Any comments must arrive by September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2018-0413 at
Laura Yannayon, EPA Region 9, (415) 972-3534,
Throughout this document, the terms “we,” “us,” and “our” refer to EPA.
Table 1 lists the rule addressed by this proposal with the date it was adopted by SCAQMD and submitted by the California Air Resources Board (CARB), the governor's designee for California SIP submittals. Rule 1325 contains the District's New Source Review (NSR) permit program applicable to new and modified major sources emitting fine particulate matter (PM
On November 1, 2017, CARB's May 8, 2017 submittal of Rule 1325 was deemed to meet the completeness criteria in 40 CFR part 51, appendix V. Completeness criteria must be met before formal EPA review.
The current SIP contains a version of Rule 1325—
For areas designated as nonattainment for one or more National Ambient Air Quality Standards (NAAQS), the SIP must include preconstruction permit requirements for new or modified major stationary sources of such nonattainment pollutant(s), commonly referred to as “Nonattainment New Source Review” (NNSR). CAA 172(c)(5).
SCAQMD Rule 1325 addresses NNSR permit requirements for major sources of PM
Under EPA's 2016 Implementation Rule, which implements the D.C. Circuit court's January 2013 decision in
The SCAQMD is classified as a Moderate nonattainment area for the 2012 PM
In addition, EPA has reviewed the submitted rule for compliance with: (1) The requirements for SIPs as set forth in CAA section 110(a)(2); (2) the requirements related to SIP revisions in CAA sections 110(l) and 193; (3) the requirements for stationary source preconstruction permitting programs in CAA section 173(a) through (c); and (4) the requirements related to the review and modification of major sources in 40 CFR part 51.165 that pertain to a PM
In our previous May 1, 2015
Section (a)—Applicability, contains minor revisions to clarify that the rule applies to major polluting facilities that will emit PM
Section (b)—Definitions, has been revised to update: (1) The effective date of the referenced 40 CFR 51.165(a)(1) definitions; (2) the definition of Major Polluting Facility to include a 70 tpy emissions threshold, effective upon the date of the EPA's approval of the November 4, 2016 amendments to Rule 1325; (3) the definition of Precursors to include volatile organic compounds (VOC) and ammonia, effective upon the date of the EPA's approval of the November 4, 2016 amendments to Rule 1325; and (4) the definition of “Significant” to include VOC and ammonia and specify a 40 tpy threshold. EPA finds these revisions approvable, as they are consistent with current applicable requirements for a serious PM
The definition of Regulated NSR Pollutant was not revised to include VOC and ammonia as PM
Section (f)—Two Year Limit on Facility Exemption has been revised to lower the emissions threshold for this exemption provision from 100 tpy to 70 tpy, effective upon the date of the EPA's approval of the November 4, 2016 amendments to Rule 1325. The provision requires a source to aggregate its PM
Section (j)—Offset Exemptions for Regulatory Compliance has been added.
This provision allows the Executive Officer to exempt new or modified sources installed solely to comply with District, state or federal air pollution control regulations from the otherwise applicable offset requirements. EPA finds this new provision approvable.
In addition, other minor editorial or conforming edits have been made throughout the rule. EPA finds these revisions approvable.
With respect to procedural requirements, CAA sections 110(a)(2) and 110(l) require that revisions to a SIP be adopted by the state after reasonable notice and public hearing. EPA has promulgated specific procedural requirements for SIP revisions in 40 CFR part 51, subpart V. These requirements include publication of notices by prominent advertisement in the relevant geographic area, a public hearing or notice of an opportunity for a public hearing on the proposed revisions, and a public comment period of at least 30 days.
Based on our review of the public process documentation included in the May 5, 2017 submittal, we find that SCAQMD has provided sufficient evidence of public notice and opportunity for comment and a public hearing prior to adoption and submittal of these rules to EPA.
Section 193 of the Act, which was added by the Clean Air Act Amendments of 1990, includes a clause providing in pertinent part: “No control requirement in effect, or required to be adopted by an order, settlement agreement, or plan in effect before November 15, 1990, in any area which is a nonattainment area for any air pollutant may be modified after November 15, 1990, in any manner unless the modification insures equivalent or greater emission reductions of such air pollutant.” Since PM
Because the revisions to Rule 1325 do not ensure VOC and ammonia emissions are evaluated to determine if a proposed project will result in a major modification, EPA cannot grant full approval of this rule under section 110(k)(3) of the Act. However, in a letter dated June 26, 2018, the District committed to adopt and submit specific enforceable measures to address this deficiency. The District committed to submit these revisions to CARB within 11 months of the date of EPA's final action. In addition, in a letter dated July 16, 2018, CARB committed to submit the adopted rule revisions to EPA no later than 12 months from the date of EPA's final action. Accordingly, pursuant to section 110(k)(4) of the Act, EPA is proposing a conditional approval of the submitted rule. We are proposing to conditionally approve the submitted rule based on our determination that separate from the deficiency listed above, the rule satisfies the applicable requirements discussed in Section II.A of this action.
In support of this proposed action, we have concluded that our conditional approval of the submitted rule would comply with section 110(l) of the Act because the amended rule, as a whole,
If the State meets its commitment to submit the required measures within 12 months of the date of EPA's final action, Rule 1325 will remain a part of the SIP until EPA takes final action approving or disapproving any subsequently submitted SIP revision. However, if the District fails to submit a revision within the required timeframe, the conditional approval will automatically become a disapproval, and EPA will issue a finding of disapproval. EPA is not required to propose the finding of disapproval.
We will accept comments from the public on this proposal until September 7, 2018. If we take final action to approve the submitted rule, our final action will incorporate this rule into the federally enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SCAQMD rule listed in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of Maryland. This revision (Maryland SIP Revision #18-03) pertains to a new Maryland regulation that establishes ozone season nitrogen oxides (NO
Written comments must be received on or before September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0507 at
Marilyn Powers, (215) 814-2308, or by email at
On May 15, 2018, the State of Maryland, through the Maryland Department of the Environment (MDE), submitted for approval into the Maryland SIP new Code of Maryland Regulation (COMAR) 26.11.40—NO
In October 1998 (63 FR 57356), EPA finalized the “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone”—commonly called the NO
On May 12, 2005, (70 FR 25162), EPA promulgated the Clean Air Interstate Rule (CAIR) to address transported emissions that significantly contributed to downwind states' nonattainment and maintenance of the 1997 ozone and fine particulate matter (PM
In Maryland, Luke Paper Mill (formerly the Westvaco pulp and paper mill) was the only facility with non-EGUs that were affected by the NO
Subsequent to adoption of COMAR 26.11.14.07, MDE determined that additional applicable units have either started operation or were previously not subject but have become subject to the requirements for non-EGUs under the NO
On May 15, 2018, Maryland, through MDE, submitted for inclusion in the Maryland SIP new regulation COMAR 26.11.40—NO
New COMAR 26.11.40 establishes NO
Regulation .02 under COMAR 26.11.40 lists the currently affected non-EGUs meeting the definition of “non-trading large NO
Regulation .03 also establishes a 96 ton set aside for new units or modified existing units. The total, 1,013 tons of NO
To meet NO
Correspondingly, Maryland also revised a provision of COMAR 26.11.01—
EPA finds that this May 2018 SIP submittal meets Maryland's NO
The May 15, 2018 Maryland SIP submittal does not result in increased NO
EPA's review of this material indicates that Maryland's May 18, 2018 SIP revision submittal (Maryland SIP Revision #18-03) is approvable in accordance with CAA section 110. For the reasons noted previously, EPA is proposing to approve the Maryland SIP revision submitted on May 15, 2018. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.
In this proposed action, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference new Maryland regulation COMAR 26.11.40 and associated revisions to COMAR 26.11.01 and COMAR 26.11.14.07. EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this action proposing approval of Maryland regulation COMAR 26.11.40 and associated revisions to other COMAR regulations does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from architectural coatings. We are proposing to approve a local rule to regulate emissions from architectural coatings under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Any comments must arrive by September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0711 at
Arnold Lazarus, EPA Region IX, (415) 972 3024,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rule addressed by this action with the date that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB). On February 22, 2018, CARB requested the withdrawal from its earlier SIP submittal of one sentence from two definitions (“Bond Breakers” and “Form Release Compounds”), which exempted these materials from the rule, due to the adoption of a rule regulating these materials. Accordingly, our proposed approval of this rule does not include the two withdrawn sentences.
On September 27, 2016, the EPA determined that the submittal for SCAQMD Rule 1113 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
We approved an earlier version of SCAQMD Rule 1113 into the SIP on March 26, 2013 (78 FR 18244).
VOCs contribute to the production of ground-level ozone, smog, and particulate matter, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Architectural coatings are applied to stationary structures and their accessories. They include house paints, stains, industrial maintenance coatings, traffic coatings, and many other products. VOCs are emitted from the coatings during application and curing, and from the associated solvents used for thinning and clean-up. SCAQMD Rule 1113 controls VOC emissions by establishing VOC limits on architectural coatings. SCAQMD Rule 1113 was revised to increase stringency and reduce VOC emissions by updating VOC content limits, and restricting the small container exemption (less than 1 quart) for high-VOC coatings.
The EPA's technical support document (TSD) has more information about this rule.
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as Moderate or above (see CAA section 182(b)(2)). The SCAQMD has been designated as Extreme nonattainment for the 2008 8-hour ozone NAAQS (40 CFR 81.305). As addressed further in the EPA's TSD for this rule, there are no relevant EPA CTG documents and architectural coatings are considered area sources. Therefore, architectural coating sources are not subject to RACT requirements.
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation, and rule stringency include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” (57 FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).
2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations” (“the Bluebook,” U.S. EPA, May 25, 1988; revised January 11, 1990).
3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies” (“the Little Bluebook”, EPA Region 9, August 21, 2001).
4. National Volatile Organic Compound Emission Standards for Architectural Coatings, 40 CFR 59.400, Subpart D, Table 1, VOC Content Limits for Architectural Coatings.
We believe this rule is consistent with CAA requirements and relevant guidance regarding enforceability, stringency, and SIP revisions. The TSD has more information on our evaluation.
As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rule because we believe it fulfills all relevant requirements. We will accept comments from the public on this proposal until September 7, 2018. If we take final action to approve the submitted rule, our final action will incorporate this rule into the federally enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SCAQMD rule described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve the requests from the State of Maryland (Maryland) and the Commonwealth of Virginia (Virginia) to redesignate to attainment their respective portions of the Washington, DC-MD-VA nonattainment area (hereafter “the Washington Area” or “the Area”) for the 2008 8-hour ozone national ambient air quality standard (NAAQS or standard) (also referred to as the 2008 ozone NAAQS). EPA is not proposing to approve the redesignation request for the District of Columbia (the District) for its portion of the Area; EPA will address the District's redesignation request for its portion of the Area in a separate rulemaking action. EPA is also proposing to approve, as a revision to the District's, Maryland's, and Virginia's state implementation plans (SIPs), the joint maintenance plan submitted by the District, Maryland, and Virginia. The joint maintenance plan demonstrates maintenance of the 2008 ozone NAAQS through 2030 in the Washington Area. Approval of a maintenance plan is among the CAA criteria for redesignation to attainment, as discussed in more detail in this notice. The Washington Area maintenance plan includes motor vehicle emissions budgets (MVEBs) for the 2008 ozone NAAQS for nitrogen oxides (NO
Written comments must be received on or before September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0215 at
Sara Calcinore, (215) 814-2043, or by email at
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
On March 12, 2018, January 29, 2018, and January 3, 2018, the District, Maryland, and Virginia, respectively, formally submitted a request to redesignate their portions of the Washington Area from marginal nonattainment to attainment for the 2008 ozone NAAQS. Concurrently, the District, Maryland, and Virginia formally submitted, as a revision to their respective SIPs, a joint maintenance plan for the Washington Area to ensure continued attainment for at least 10 years following redesignation. The maintenance plan includes MVEBs for NO
EPA is proposing to take several related actions. EPA is proposing to determine that Maryland and Virginia have met the requirements for redesignation for their respective portions of the Washington Area pursuant to section 107(d)(3)(E) of the CAA. EPA is therefore proposing to approve Maryland's and Virginia's redesignation requests and change the designation of their respective portions of the Washington Area from marginal nonattainment to attainment for the 2008 ozone NAAQS. EPA is also proposing to approve, as revisions to the District's, Maryland's, and Virginia's SIPs, the joint Washington Area maintenance plan that was prepared by the Metropolitan Washington Council of Governments (MWCOG) and jointly submitted by the District, Maryland, and Virginia. The maintenance plan is designed to ensure continued attainment in the Washington Area for the next ten years. Additionally, EPA has found the submitted MVEBs adequate and is proposing to approve, as revisions to the District's, Maryland's, and Virginia's SIPs, the 2014, 2025, and 2030 MVEBs for NO
Under the CAA, EPA establishes NAAQS for criteria pollutants in order to protect human health and the environment. In response to scientific evidence linking ozone exposure to adverse health effects, EPA promulgated the first ozone NAAQS, the 0.12 part per million (ppm) 1-hour ozone NAAQS, in 1979.
Upon promulgation of a new or revised NAAQS, section 107(d)(1)(B) of the CAA requires EPA to designate as nonattainment any areas that are violating the NAAQS based on the most recent three years of quality-assured ozone monitoring data. On May 21, 2012 and June 11, 2012, EPA designated nonattainment areas for the 2008 ozone NAAQS. 77 FR 30088 and 77 FR 34221. Effective July 20, 2012, the Washington Area was designated as marginal nonattainment for the 2008 ozone NAAQS. The Washington Area consists of the Counties of Calvert, Charles, Frederick, Montgomery, and Prince George's in Maryland, the Counties of Arlington, Fairfax, Loudoun, and Prince William and the Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park Cities in Virginia, and the District of Columbia.
As stated previously, on March 12, 2018, January 29, 2018, and January 3, 2018, the District, Maryland, and Virginia, respectively, formally submitted requests to redesignate their respective portions of the Washington Area from marginal nonattainment to attainment for the 2008 ozone NAAQS. The District, Maryland, and Virginia concurrently submitted, as revisions to their SIPs, a maintenance plan for the Washington Area to ensure continued attainment for at least 10 years following redesignation. In this rulemaking action, EPA is proposing to approve the redesignation requests submitted by Maryland and Virginia for their respective portions of the Area. EPA is not proposing to approve the redesignation request for the District for its portion and will act on the redesignation request for the District in a separate action. EPA is also proposing to approve, as revisions to the District's, Maryland's, and Virginia's SIPs, the maintenance plan jointly submitted by the District, Maryland, and Virginia.
Section 107(d)(3)(E) of the CAA allows redesignation of an area to attainment of the NAAQS provided that: (1) The Administrator (EPA) determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the State containing the area has met all requirements applicable to the area for purposes of redesignation under section 110 and part D of the CAA.
On April 16, 1992, EPA provided guidance on redesignations in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990 (57 FR 13498) and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:
For redesignation of a nonattainment area to attainment, the CAA requires EPA to determine that the area has attained the applicable NAAQS.
As part of the final rule, “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan (SIP) Requirements,” for the 2008 ozone NAAQS (80 FR 12264, March 6, 2015) (hereinafter, SIP Requirements Rule), EPA modified the maximum attainment dates for all nonattainment areas for the 2008 ozone NAAQS to be consistent with the United States Court of Appeals for the District of Columbia Circuit's (D.C. Circuit) decision in
In a final rulemaking action published on May 4, 2016, EPA determined that the Washington Area did not attain the 2008 ozone NAAQS by its July 20, 2015 attainment date, based on ambient air quality monitoring data for the 2012-2014 monitoring period. In that same action, EPA determined that the Washington Area qualified for a 1-year extension of its attainment date, as provided in section 181(a)(5) of the CAA and interpreted by regulation at 40 CFR 51.1107. With that final rulemaking action, the new attainment date for the Washington Area was July 20, 2016.
On November 14, 2017 (82 FR 52651), in accordance with section 181(b)(2)(A) of the CAA and Provisions for Implementation of the 2008 Ozone NAAQS (40 CFR part 51, subpart AA), EPA made a determination that the Washington Area attained the 2008 ozone NAAQS by the July 20, 2016 attainment date. EPA's determination was based upon three years of complete, certified, and quality-assured data for the 2013-2015 monitoring period.
In addition, EPA has reviewed the most recent ambient air quality monitoring data for ozone in the Area, including preliminary 2017 design values, as submitted by the District, Maryland, and Virginia and recorded in EPA's AQS. The quality-assured, quality-controlled, and state-certified 2014 to 2016 ozone air quality data shows that the Washington Area continues to attain the 2008 ozone NAAQS. This data, as well as the preliminary design values for 2017, are summarized in Table 1 and are also included in the docket for this rulemaking available online at
The
EPA has determined that Maryland and Virginia have met all SIP requirements applicable for purposes of this redesignation of the Maryland and Virginia portions of the Washington Area under section 110 of the CAA (General SIP Requirements) and that they have met all applicable SIP requirements under part D of Title I of the CAA, in accordance with section 107(d)(3)(E)(v). In addition, EPA has determined that the Maryland and Virginia SIPs are fully approved with respect to all requirements applicable for purposes of redesignation in accordance with section 107(d)(3)(E)(ii). In making these determinations, EPA ascertained what requirements are applicable to the Area and determined that the portions of the Maryland and Virginia SIPs meeting these requirements are fully approved under section 110(k) of the CAA. We note that SIPs must be fully approved only with respect to applicable requirements.
The September 4, 1992 Calcagni memorandum (“Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992) describes EPA's interpretation of section 107(d)(3)(E) with respect to the timing of applicable requirements. Under this interpretation, to qualify for redesignation, states requesting redesignation to attainment must meet only the relevant CAA requirements that come due prior to the submittal of a complete redesignation request.
Section 110(a)(2) of Title I of the CAA contains the general requirements for a SIP, which include enforceable emissions limitations and other control measures, means, or techniques, provisions for the establishment and operation of appropriate devices necessary to collect data on ambient air quality, and programs to enforce the limitations. The general SIP elements and requirements set forth in section 110(a)(2) include, but are not limited to, the following: (1) Submit a SIP that has been adopted by the state after reasonable public notice and hearing; (2) include enforceable emission limitations and other control measures, means, or techniques necessary to meet the requirements of the CAA; (3) provide for establishment and operation of appropriate devices, methods, systems and procedures necessary to monitor ambient air quality; (4) provide for implementation of a source permit program to regulate the modification and construction of stationary sources within the areas covered by the plan; (5) include provisions for the implementation of part C prevention of significant deterioration (PSD) and part D new source review (NSR) permit programs; (6) include provisions for stationary source emission control measures, monitoring, and reporting; (7) include provisions for air quality modeling; and, (8) provide for public and local agency participation in planning and emission control rule development.
Section 110(a)(2)(D) of the CAA requires SIPs to contain certain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of air pollutants, in accordance with the NO
Similarly, other section 110 elements that are neither connected with attainment plan submissions nor linked with an area's ozone attainment status are not applicable requirements for purposes of redesignation. An area that is redesignated from nonattainment to attainment will remain subject to these statewide requirements after the area is redesignated to attainment of the 2008 ozone NAAQS. The section 110(a)(2) requirements, which are linked with a particular area's designation and classification, are the relevant measures to evaluate in reviewing a redesignation request. The section 110(a)(2) elements not linked to the area's nonattainment status are not applicable for purposes of redesignation. This approach is consistent with EPA's existing policy on applicability (
EPA has reviewed Maryland's and Virginia's SIPs and concludes that they meet the general SIP requirements under section 110 of the CAA, to the extent those requirements are applicable for purposes of redesignation. On November 17, 2014 (79 FR 62010) and March 27, 2014 (79 FR 17043), EPA approved elements of the SIPs submitted by Maryland and Virginia, respectively, which, with the exception of interstate transport, meet the requirements of CAA section 110(a)(2), for the 2008 ozone NAAQS. As explained previously, the general requirements of section 110(a)(2) are statewide requirements that are not linked to the 2008 8-hour ozone nonattainment status of the Washington Area and are therefore not “applicable requirements” for purpose of the review of Maryland's and Virginia's 2008 ozone NAAQS redesignation requests. Because Maryland's and Virginia's SIPs satisfy all of the general SIP elements and requirements set forth in CAA section 110(a)(2) applicable to and necessary for redesignation, EPA concludes that Maryland and Virginia have satisfied the criterion of section 107(d)(3)(E) regarding section 110 of the CAA.
Areas designated nonattainment for the ozone NAAQS are subject to the applicable nonattainment area and ozone-specific planning requirements of part D of the CAA. Sections 172-176 of the CAA, found in subpart 1 of part D, set forth the basic nonattainment requirements for all nonattainment areas. Section 172(c), under part D of the CAA, sets forth the basic requirements of air quality plans for states with nonattainment areas for all pollutants that are required to submit
Additionally, states located in the OTR, which includes Maryland and portions of Virginia,
EPA has interpreted the section 184 OTR requirements, including the NSR program, as not being applicable for purposes of redesignation. The rationale for this is based on two considerations. First, the requirement to submit SIP revisions for the section 184 requirements continues to apply to areas in the OTR even after redesignation to attainment. Therefore, states remain obligated to have NSR, as well as RACT, and I/M programs, even after redesignation. Second, the section 184 control measures are region-wide requirements and do not apply to the area by virtue of the area's designation and classification, and thus are properly considered not relevant to an action changing an area's designation.
As provided in CAA part D, subpart 2, for marginal ozone nonattainment areas such as the Washington Area, the ozone specific requirements of section 182(a) supersede (where overlapping) the attainment planning requirements that would otherwise apply under section 172(c), including the attainment demonstration and reasonably available control measures (RACM) under section 172(c)(1), reasonable further progress (RFP) under section 172(c)(2), and contingency measures under section 172(c)(9). 42 U.S.C. 7511a(a).
Section 172(c)(3) requires submission and approval of a comprehensive, accurate, and current inventory of actual emissions. This requirement is superseded by the inventory requirement in section 182(a)(1) discussed later in this notice.
Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area (NNSR). As explained previously, the Washington Area is included in the OTR established by Congress in section 184 of the CAA. Therefore, sources located in Maryland and the portions of Virginia included in the OTR will remain subject to the part D NNSR requirements even after the Washington Area is redesignated to attainment. Since the part D NNSR requirements apply to the Washington Area regardless of its attainment status, they are not considered to be relevant for purposes of redesignation. Regardless, Maryland and Virginia both have an approved NNSR program.
Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the NAAQS. Because attainment has been reached in the Area, EPA finds no additional measures are needed in the SIPs to provide for attainment.
Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted previously, Maryland's and Virginia's SIPs meet the applicable requirements of section 110(a)(2) for purposes of redesignation.
Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that federally supported or funded projects conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs, and projects that are developed, funded, or approved under title 23 of the United States Code (U.S.C.) and the Federal Transit Act (transportation conformity) as well as to all other federally supported or funded projects (general conformity). State transportation conformity SIP revisions must be consistent with federal conformity regulations relating to consultation, enforcement, and enforceability that EPA promulgated pursuant to its authority under the CAA.
EPA interprets the conformity SIP requirements
Section 182(a)(1) requires states to submit a comprehensive, accurate, and current inventory of actual emissions from sources of NO
Under section 182(a)(2)(A), states with ozone nonattainment areas that were designated prior to the enactment of the 1990 CAA amendments were required to submit, within six months of classification, all rules and corrections to existing RACT rules that were required under section 172(b)(3) prior to the 1990 CAA amendments. EPA approved Maryland's and Virginia's SIP revisions satisfying the section 182(a)(2) RACT “fix-up” requirement on March 31, 1994 (59 FR 15117) and November 29, 1994 (59 FR 60908).
Section 182(c)(3) of the CAA requires areas classified as serious and above to adopt and implement an enhanced I/M program. The Washington Area was classified as severe for the 1979 1-hour ozone NAAQS, and therefore enhanced I/M was required. In addition, section 184(b)(1)(a) of the CAA requires areas located in the OTR that are a metropolitan statistical area, or part thereof, with a population of 100,000 or more to meet the enhanced I/M program requirements of CAA section 182(c)(3). EPA approved Maryland's enhanced I/M program into Maryland's SIP on October 29, 1999 (64 FR 58340). EPA approved Virginia's enhanced I/M program on September 1, 1999 (64 FR 47670), as revised April 22, 2008 (73 FR 21540).
CAA section 182(a)(2)(C) and section 182(a)(4) contain source permitting and offset requirements (known as NNSR). As discussed previously, part D NNSR will continue to apply to the Washington Area, regardless of attainment status, due to the Washington Area being part of the OTR. Therefore, EPA concludes that Maryland and Virginia need not have a fully approved part D NSR program prior to approval of the redesignation request. As stated previously, however, Maryland and Virginia both have an approved NNSR program.
Section 182(a)(3) requires states to submit periodic emission inventories and a revision to the SIP to require the owners or operators of stationary sources to annually submit emission statements documenting actual NO
Therefore, Maryland and Virginia have satisfied all applicable SIP requirements under section 110 and part D of title I of the CAA for purposes of redesignation of their respective portions of the Washington Area. As noted previously, EPA will act on the District's redesignation request for its portion of the Washington Area in a separate rulemaking.
At various times, Maryland and Virginia have adopted and submitted, and EPA has approved, provisions addressing the various SIP elements applicable for the ozone NAAQS. As discussed previously, EPA has fully approved Maryland's and Virginia's SIPs for the Washington Area under section 110(k) for all requirements applicable for purposes of redesignation under the 2008 ozone NAAQS. EPA may rely on prior SIP approvals in approving a redesignation request (
To redesignate an area from nonattainment to attainment, section 107(d)(3)(E)(iii) of the CAA requires EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from the implementation of the SIP and applicable federal air pollution control regulations and other permanent and enforceable emission reductions. Maryland and Virginia have demonstrated that the observed ozone air quality improvement in the Washington Area is due to permanent and enforceable reductions in NO
In making this demonstration, Maryland and Virginia have calculated the change in emissions between 2011 and 2014. The change in emissions is shown in Table 2. Maryland and Virginia attribute the decrease in emissions and corresponding improvement in air quality during this time period to a number of regulatory control measures that have been implemented in the Washington Area and upwind areas in recent years. Based on the information summarized in the following sections, Maryland and Virginia have adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.
A variety of federal and state control programs have contributed to reduced on-road, point source, and nonroad emissions of NO
On February 10, 2000 (65 FR 6698), EPA promulgated Tier 2 motor vehicle emission standards and gasoline sulfur control requirements. These emission control requirements result in lower NO
On October 8, 2008 (73 FR 59034), EPA finalized emission standards for new nonroad spark-ignition engines. The exhaust emission standards applied beginning in 2010 for new marine spark-ignition engines and in 2011 and 2012 for different sizes of new land-based, spark-ignition engines at or below 19 kW (
On June 17, 1994 (59 FR 31306), EPA made an affirmative determination under section 213(a)(2) of the CAA that nonroad engines are significant contributors to ambient ozone or CO levels in more than one nonattainment area. In the same notice, EPA also made a determination under CAA section 213(a)(4) that other emissions from compression-ignition (CI) nonroad engines rated at or above 37 kilowatts (kW) cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. In the June 17, 1994 final rule, EPA set a first phase of emission standards (Tier 1 standards) for nonroad diesel engines rated 37 kW and above. These standards apply to nonroad, compression-ignition (
On November 8, 2002 (67 FR 68242), EPA established emission standards for large spark-ignition engines such as those used in forklifts and airport ground-service equipment; recreational vehicles using spark-ignition engines such as off-highway motorcycles, all-terrain vehicles, and snow mobiles; and recreational marine diesel engines. These emission standards were phased in from model year 2004 through 2012. When the emission standards are fully implemented in 2030, EPA expects a national 75 percent reduction in hydrocarbon (HC) emissions, 82 percent reduction in NO
On February 16, 1994 (59 FR 7716), EPA finalized regulations requiring that gasoline in certain areas be reformulated to reduce vehicle emissions of toxic and ozone-forming compounds, including NO
On April 16, 1998 (63 FR 18978), EPA established emission standards for NO
In addition to the measures referenced previously, a reduction of emission of ozone precursors can also be attributed to the Maryland Healthy Air Act (Annotated Code of Maryland Environment Title 2 Ambient Air Quality Control Subtitle 10 Healthy Air Act Sections 2-1001 to 2-1005, with implementing regulations at COMAR 26.11.27 Emission Limitations for Power Plants). The Maryland Health Air Act (HAA) was effective on July 16, 2007 and approved by EPA on September 4, 2008 (73 FR 51599). The HAA established limits on the amount of NO
The decrease in emissions of ozone precursors is also attributable to the closure of the GenOn Potomac River plant located in Alexandria, Virginia. This 482-megawatt electrical generating facility consisted of five coal-fired boilers and emitted 557.7 tons of NO
Maryland and Virginia calculated the change in emissions between 2011 and 2014 throughout the entire Washington Area to demonstrate that air quality has improved. The change in emissions is shown in Table 2. Maryland and Virginia used the 2011 base year emissions inventory for the Washington Area as the nonattainment year inventory because 2011 was one of the three years used to designate the area nonattainment for the 2008 ozone NAAQS. EPA approved the Washington Area 2011 base year inventory as meeting the requirements of CAA section 182(a)(1) on May 13, 2015 (80 FR 27276) for NO
Table 2 shows that emissions of NO
As one of the criteria for redesignation to attainment, section 107(d)(3)(E)(iv) of the CAA requires EPA to determine that the area has a fully approved maintenance plan pursuant to section 175A of the CAA. Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under CAA section 175A, the maintenance plan must demonstrate continued attainment of the NAAQS for at least 10 years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the state must submit a revised maintenance plan which demonstrates that attainment of the NAAQS will continue for an additional 10 years beyond the initial 10-year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures, as EPA deems necessary, to assure prompt correction of the future NAAQS violation.
The Calcagni memorandum provides further guidance on the content of a maintenance plan, explaining that a maintenance plan should address five elements: (1) An attainment emission inventory; (2) a maintenance demonstration; (3) a commitment for continued air quality monitoring; (4) a process for verification of continued attainment; and (5) a contingency plan.
In conjunction with their requests to redesignate their respective portions of the Washington Area to attainment for the 2008 ozone NAAQS, the District, Maryland, and Virginia submitted, as a revision to their SIPs, a plan to provide for maintenance of the 2008 ozone NAAQS through 2030, which is more than 10 years after the expected effective date of the redesignation to attainment. EPA anticipates redesignating the entire Washington Area, including the District's portion, by 2019. As discussed in this notice, EPA is proposing to find that the District's, Maryland's, and Virginia's maintenance plan for the 2008 ozone NAAQS includes the necessary components per the CAA, including CAA section 175A and EPA guidance, and is proposing to approve the maintenance plan as revisions to the District's, Maryland's, and Virginia's SIPs.
The Calcagni memorandum indicates that states requesting redesignation to attainment should develop an attainment emissions inventory in order to identify the level of emissions in the area which is sufficient to attain the NAAQS. The attainment inventory should be consistent with EPA's most recent guidance on emission inventories for nonattainment areas available at the time and should include the emissions during the time period associated with monitoring data showing attainment.
For the attainment inventory, the District, Maryland, and Virginia used the year 2014, which is one of the years during the three-year period associated with the monitoring data first showing attainment of the 2008 ozone NAAQS (
The District, Maryland, and Virginia have demonstrated maintenance of the 2008 ozone standard through 2030 by the use of emission inventories showing that future emissions of NO
The District, Maryland, and Virginia are using emissions inventories for the years 2025 and 2030 to demonstrate maintenance in the Washington Area. EPA anticipates redesignating the entire Washington Area, including the District's portion, in 2019. 2030 is more than 10 years after the expected effective date of the redesignation to attainment, and 2025 was selected to demonstrate that emissions are not expected to increase in the interim between the attainment year and the final maintenance year.
In order to develop the 2025 and 2030 inventories, the District, Maryland, and Virginia applied growth factors to the 2014 attainment year emissions inventory (shown in Table 3). A detailed evaluation of the methodology used to develop the maintenance inventory (and EPA's rational for approving the maintenance inventory as well as the growth factors used) is provided in EPA's EI TSD, which is included in the docket for this rulemaking available online at
The maintenance inventory, provided in Table 4, shows the projected emissions of NO
In summary, EPA finds the maintenance inventory for the Washington Area provided in Table 4 shows maintenance of the 2008 ozone NAAQS by providing emissions information and reasonable growth factors to support the demonstration that future emissions of NO
The point, nonroad, and on-road emission projections for 2025 and 2030 include a variety of control strategies that will reduce emissions of NO
COMAR 26.11.38 (also referred to as the Maryland NO
As discussed previously, a variety of federal and state control programs have contributed to reduced on-road, point source, and nonroad emissions of NO
On April 28, 2014 (79 FR 23414), EPA established more stringent vehicle emissions standards. The vehicle emissions standards will reduce both tailpipe and evaporative emissions of the ozone precursors NO
The National Capital Region Transportation Planning Board (TPB)
The District, Maryland, and Virginia operate enhanced I/M programs to ensure that motorists are driving vehicles that meet federal emission requirements. Owners of vehicles that do not meet requirements, based on tail pipe or On-Board Diagnostic (OBD) testing, must repair the vehicles or show that the total costs of repair are more than waiver limitations. As noted previously, EPA approved Maryland's and Virginia's enhanced I/M program into Maryland's and Virginia's SIPs on October 29, 1999 (64 FR 58340) and September 1, 1999 (64 FR 47670), as revised April 22, 2008 (73 FR 21540), respectively. EPA approved the District's enhanced I/M program into the District's SIP on June 11, 1999 (64 FR 31498).
The District, Maryland, and Virginia have committed, in their joint maintenance plan for the Washington Area, to continue to operate an appropriate air quality monitoring network in accordance with 40 CFR part 58. The District, Maryland, and Virginia also committed, in their redesignation requests, to continue to monitor ozone concentrations in the Washington Area in accordance with 40 CFR part 58 and EPA-approved annual monitoring plans, to quality-assure the monitoring data in accordance with 40 CFR part 58, and to enter all data into AQS in a timely fashion.
The District, Maryland, and Virginia state in their maintenance plan submittal that they have the legal authority to develop, implement, and enforce regulations regarding air pollution, including the requirements of the maintenance plan for the Washington Area. The District, Maryland, and Virginia cite the regulations and statutory provisions included in Table 5 below as providing them with the authority to develop, implement, and enforce the requirements of the maintenance plan for the Washington Area.
In their joint maintenance plan submittal, the District, Maryland, and Virginia also referenced several regulatory elements that each state will retain in order to maintain attainment of the 2008 ozone NAAQS. These regulatory elements are summarized in Table 6.
Verification of continued attainment is accomplished through operation of the ambient ozone monitoring network and the periodic update of the area's emissions inventory. As stated above, the District, Maryland, and Virginia have committed, in their joint maintenance plan for the Washington Area, to continue to operate an appropriate air quality monitoring network in accordance with 40 CFR part 58. The District, Maryland, and Virginia also committed, in their redesignation requests, to continue to monitor ozone concentrations in the Washington Area in accordance with 40 CFR part 58 and EPA-approved annual monitoring plans, to quality-assure the monitoring data in accordance with 40 CFR part 58, and to enter all data into AQS in a timely fashion. The District, Maryland, and Virginia state in their joint maintenance plan that they will track attainment and maintenance using ambient and source emission data.
In addition, to track the progress of the maintenance demonstration, the District, Maryland, and Virginia state in their joint maintenance plan submittal that they will periodically update the emissions inventory. The District, Maryland, and Virginia also commit to an annual evaluation consisting of a comparison of key emissions trend indicators, such as the annual emissions update of stationary sources and the Highway Performance Monitoring System (HPMS) vehicle miles traveled data reported to the Federal Highway Administration (FHWA), to the growth assumptions used in the plan. The District, Maryland, and Virginia also commit in their maintenance plan submittal to developing and submitting to EPA “comprehensive tracking inventories every three years or as required by federal regulation during the maintenance plan period.” EPA notes that point source facilities covered by the District's, Maryland's, and Virginia's emission statement rules are required to submit NO
Section 175A of the CAA requires that the state must adopt a maintenance plan, as a SIP revision, that includes such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after a redesignation of the area to attainment of the NAAQS. The maintenance plan must identify the contingency measures to be considered and, if needed for maintenance, adopted and implemented; a schedule and procedure for adoption and implementation; and, a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be considered, adopted, and implemented.
As required by section 175A of the CAA, the District, Maryland, and Virginia have adopted a contingency plan for the Washington Area to address possible future ozone air quality problems as described herein and in the TSD for this rulemaking available online at
The District, Maryland, and Virginia included several measures as contingency measures in their joint maintenance plan submittal that EPA found to not be appropriate for use as contingency measures as discussed in detail in the TSD for this rulemaking. However, since emission reductions from these measures were not accounted for in the maintenance inventory or the MVEBs, it is expected that these measures will provide more emission reductions than what was projected in the maintenance inventory or the MVEBs. Thus, these measures will provide additional assurance that the 2008 ozone standard will be maintained in the Washington Area. A description of the District's, Maryland's, and Virginia's submitted contingency measures as well as EPA's evaluation of these measures and the contingency plan as a whole can be found in the TSD for this rulemaking available online at
The District,
The District, Maryland, and Virginia have committed to implementing any contingency measure according to the following schedule: (1) Schedule onset: Notification received from EPA that a contingency measure must be implemented or three months after quality assured data determine that an exceedance or violation occurred within the previous year; (2) applicable regulation or program will be adopted six months following the schedule onset; (3) applicable regulation or program will be implemented six months following adoption; and, (4) compliance with regulation, or full program implementation, to be achieved within twelve months of adoption.
The District and Metropolitan Washington Air Quality Committee (MWAQC) will use their regional coordination process to determine the contingency measure to be implemented.
Based on EPA's evaluation of the District's, Maryland's, and Virginia's contingency plan for the Washington Area, which is provided in the TSD for this rulemaking available online at
EPA has concluded that the District's, Maryland's, and Virginia's joint maintenance plan adequately addresses the five basic components of a maintenance plan: Attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan. Therefore, EPA concludes that the maintenance plan SIP revisions submitted by the District, Maryland, and Virginia meet the requirements of CAA section 175A. EPA is proposing to approve the maintenance plan as a revision to the District's, Maryland's, and Virginia's SIPs.
Under section 176(c) of the CAA, new transportation plans, programs, or projects that receive federal funding or support, such as the construction of new highways, must “conform” (
Under the CAA, states are required to submit, at various times, control strategy SIPs for nonattainment areas and maintenance plans for areas seeking redesignations to attainment of the ozone standard and maintenance areas.
Under 40 CFR part 93, a MVEB for an area seeking redesignation to attainment must be established, at minimum, for the last year of the maintenance plan. A state may adopt MVEBs for other years as well. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993 Transportation Conformity Rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB, if needed, subsequent to initially establishing a MVEB in the SIP. The most recently approved MVEBs for the Washington Area originate from the attainment plan for the 1997 ozone NAAQS, which EPA found adequate on February 7, 2013 (78 FR 9044).
When reviewing submitted control strategy SIPs or maintenance plans containing MVEBs, EPA must affirmatively find that the MVEBs contained therein are adequate for use in determining transportation conformity. Once EPA affirmatively finds that the submitted MVEBs are adequate for transportation purposes, the MVEBs must be used by state and federal agencies in determining whether proposed transportation projects conform to the SIP as required by section 176(c) of the CAA.
EPA's substantive criteria for determining adequacy of a MVEB are set out in 40 CFR 93.118(e)(4). The process for determining adequacy consists of three basic steps: (1) Public notification of a SIP submission, (2) provision for a public comment period, and (3) EPA's adequacy determination. This process for determining the adequacy of submitted MVEBs for transportation conformity purposes was initially outlined in EPA's May 14, 1999 guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” EPA adopted regulations to codify the adequacy process in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM
The District's, Maryland's, and Virginia's maintenance plan includes NO
The MVEBs were calculated using the most current USEPA Motor Vehicle Emissions Simulator (MOVES) model (MOVES2014a) and regional travel demand forecasting model at the time of the submittal. These MVEBs, when considered together with all other emissions sources, are consistent with maintenance of the 2008 ozone standard. The MVEBs are shown in Table 8.
EPA's transportation conformity regulations allow for the use of a safety margin, also referred to as a “transportation buffer”, in the development of MVEBs for maintenance plans. A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. All or a portion of these transportation buffers can be allotted to mobile source inventories to develop MVEBs.
Table 4 shows the difference in total emissions for NO
These two sets of MVEBs (with and without transportation buffers) have been developed for both milestone years (2025 and 2030). As can be seen in Table 10, the MVEBs that include the transportation buffer (Table 9), remain below the emission levels of the maintenance inventory.
The District, Maryland, and Virginia will only use the MVEBs with transportation buffers, shown in Table 9, as needed in situations where the conformity analysis must be based on different data, models, or planning assumptions, including, but not limited to, updates to demographic, land use, or project-related assumptions, than were
EPA finds that the District, Maryland, and Virginia continue to demonstrate maintenance of the 2008 ozone standard with both sets of MVEBs, including the MVEBs with the transportation buffers. Therefore, EPA is proposing to approve, as revisions to the District's, Maryland's, and Virginia's SIPs, the MVEBs contained in this maintenance plan for the Washington Area.
EPA is proposing to approve the requests from Maryland and Virginia to redesignate to attainment their respective portions of the Washington Area for the 2008 ozone NAAQS. EPA is not proposing to approve the redesignation request from the District and will address the District's redesignation request in a separate rulemaking action. EPA is also proposing to approve, as a revision to the District's, Maryland's, and Virginia's SIPs, the joint maintenance plan submitted by the District, Maryland, and Virginia. The joint maintenance plan demonstrates maintenance of the 2008 ozone NAAQS through 2030 in the Washington Area and includes 2014, 2025, and 2030 MVEBs for NO
In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.
On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.”
Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”
Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.
Under the CAA, the redesignation of an area to attainment and the accompanying approval of the maintenance plan under CAA section 107(d)(3)(E) are actions that affect the status of geographical area and do not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices,
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The action approving Maryland's and Virginia's redesignation request for their respective portions of the Washington Area for the 2008 ozone NAAQS as well as the District's, Maryland's, and Virginia's maintenance plan for the Washington Area, is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve portions of the revisions to the Arkansas State Implementation Plan (SIP) submitted by the Arkansas Department of Environmental Quality (ADEQ) on March 24, 2017. Most of the revisions are administrative in nature and make the SIP current with Federal rules. The EPA is also proposing to make ministerial changes to the Code of
Written comments should be received on or before September 7, 2018.
Submit your comments, identified by EPA-R06-OAR-2017-0699, at
Ms. Carrie Paige, (214) 665-6521,
In the final rules section of this issue of the
For additional information, see the direct final rule, which is located in the rules section of this issue of the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of a state implementation plan (SIP) revision submittal from the State of Delaware. This revision addresses the infrastructure requirement for interstate transport of pollution with respect to the 2010 1-hour sulfur dioxide (SO
Written comments must be received on or before September 7, 2018.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2013-0492 at
Joseph Schulingkamp, (215) 814-2021, or by email at
On May 29, 2013, the State of Delaware, through the Delaware Department of Natural Resources and Environmental Control (DNREC) submitted a SIP revision addressing the infrastructure requirements under section 110(a)(2) of the CAA for the 2010 1-hour SO
On June 2, 2010, the EPA promulgated a revised primary SO
Current scientific evidence links short-term exposures to SO
Pursuant to section 110(a)(1) of the CAA, states are required to submit a SIP revision to address the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements to assure attainment and maintenance of the NAAQS—such as requirements for monitoring, basic program requirements, and legal authority. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances of each NAAQS and what is in each state's existing SIP. In particular, the data and analytical tools available at the time the state develops and submits the SIP revision for a new or revised NAAQS affect the content of the submission. The content of such SIP submission may also vary depending upon what provisions the state's existing SIP already contains.
Specifically, section 110(a)(1) provides the procedural and timing requirements for SIP submissions. Section 110(a)(2) lists specific elements that states must meet for infrastructure SIP requirements related to a newly established or revised NAAQS such as requirements for monitoring, basic program requirements, and legal authority that are designed to assure attainment and maintenance of the NAAQS.
Section 110(a)(2)(D)(i)(I) of the CAA requires a state's SIP to include adequate provisions prohibiting any emissions activity in one state that contributes significantly to nonattainment, or interferes with maintenance, of the NAAQS in any downwind state. The EPA sometimes refers to these requirements as prong 1 (significant contribution to nonattainment) and prong 2 (interference with maintenance), or jointly as the “good neighbor” provision of the CAA. Further information can be found in the Technical Support Document (TSD) for this rulemaking action, which is available online at
On May 29, 2013, Delaware submitted, through DNREC, a revision to its SIP to satisfy the infrastructure requirements of section 110(a)(2) of the CAA for the 2010 1-hour SO
The portions of Delaware's May 29, 2013 SIP submittal addressing interstate transport (for section 110(a)(2)(D)(i)(I)) discuss how Delaware does not significantly contribute with respect to the 2010 1-hour SO
Based on EPA's analysis, EPA agrees with Delaware's general conclusion that
EPA is proposing to approve the portions of Delaware's May 29, 2013 SIP revision addressing interstate transport for the 2010 1-hr SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rule, addressing Delaware's interstate transport requirements for the 2010 1-hour SO
Environmental protection, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed specifications; request for comments.
NMFS proposes a 2018 limit of 2,000 metric tons (t) of longline-caught bigeye tuna for each U.S. Pacific territory (American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands (CNMI)). NMFS would allow each territory to allocate up to 1,000 t each year to U.S. longline fishing vessels in a specified fishing agreement that meets established criteria. As an accountability measure, NMFS would monitor, attribute, and restrict (if necessary) catches of longline-caught bigeye tuna, including catches made under a specified fishing agreement. The proposed catch limits and accountability measures would support the long-term sustainability of fishery resources of the U.S. Pacific Islands.
NMFS must receive comments by August 23, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2018-0026, by either of the following methods:
•
•
Rebecca Walker, NMFS PIRO Sustainable Fisheries, 808-725-5184.
NMFS proposes to specify a 2018 catch limit of 2,000 t of longline-caught bigeye tuna for each U.S. Pacific territory. NMFS would also authorize each U.S. Pacific territory to allocate up to 1,000 t of its 2,000 t bigeye tuna limit to U.S. longline fishing vessels that are permitted to fish under the Fishery Ecosystem Plan for Pelagic Fisheries of the Western Pacific (FEP). Those vessels must be identified in a specified fishing agreement with
NMFS will monitor catches of longline-caught bigeye tuna by the longline fisheries of each U.S Pacific territory, including catches made by U.S. longline vessels operating under specified fishing agreements. The criteria that a specified fishing agreement must meet, and the process for attributing longline-caught bigeye tuna, will follow the procedures in 50 CFR 665.819. When NMFS projects that a territorial catch or allocation limit will be reached, NMFS would, as an accountability measure, prohibit the catch and retention of longline-caught bigeye tuna by vessels in the applicable territory (if the territorial catch limit is projected to be reached), and/or vessels in a specified fishing agreement (if the allocation limit is projected to be reached).
NMFS will consider public comments on the proposed action and will announce the final specifications in the
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator for Fisheries has determined that this proposed specification is consistent with the FEP, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.
The Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that these proposed specifications, if adopted, would not have a significant economic impact on a substantial number of small entities.
The proposed action would specify a 2018 limit of 2,000 t of longline-caught bigeye tuna for American Samoa, Guam, and the CNMI. NMFS would also allow each territory to allocate up to 1,000 t of its 2,000 t limit to U.S. longline fishing vessels in a specified fishing agreement that meets established criteria set forth in 50 CFR 665.819. As an accountability measure, NMFS would monitor, attribute, and restrict (if necessary) catches of longline-caught bigeye tuna by vessels in the applicable U.S. territory (if the territorial catch limit is projected to be reached), or by vessels operating under the applicable specified fishing agreement (if the allocation limit is projected to be reached). Payments under the specified fishing agreements support fisheries development in the U.S. Pacific territories and the long-term sustainability of fishery resources of the U.S. Pacific Islands.
This proposed action would directly apply to longline vessels federally permitted under the FEP, specifically Hawaii, American Samoa, and Western Pacific longline permit holders. As of May 2018, 145 vessels had Hawaii permits and 47 had American Samoa permits. No Western Pacific general permit has been issued since 2011.
Based on dealer data collected by the State of Hawaii, Hawaii longline vessels landed approximately 32.75 million pounds (lb) of pelagic fish valued at $101.6 million in 2017. With 145 vessels making either a deep- or shallow-set trip in 2017, the ex-vessel value of pelagic fish caught by Hawaii-based longline fisheries averaged almost $701,000 per vessel. In 2016, American Samoa-based longline vessels landed approximately 4.5 million lb of pelagic fish valued at $4.7 million, where albacore made up the largest proportion of pelagic longline commercial landings at 3.35 million lb. With 18 active longline vessels in 2016, the ex-vessel value of pelagic fish caught by American Samoa fishery averaged about $261,111 per vessel.
NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. Based on available information, NMFS has determined that all vessels permitted federally under the FEP are small entities,
In accordance with Federal regulations at 50 CFR part 300, subpart O, vessels that possess both an American Samoa and Hawaii longline permit are not subject to the U.S bigeye tuna limit. Therefore, these vessels may retain bigeye tuna and land fish in Hawaii after the date NMFS projects the fishery would reach that limit. Further, catches of bigeye tuna made by such vessels are attributed to American Samoa, provided the fish was not caught in the U.S. EEZ around Hawaii. In 2017, all dual American Samoa/Hawaii longline permitted vessels were included in the fishing agreement with the CNMI and American Samoa. Therefore, NMFS attributed bigeye catches by those vessels to the two territories.
The 2018 U.S. bigeye tuna catch limit is 3,554 t, which is the same limit in place for 2016 and higher than the limit for 2017. NMFS established this limit through a separate action (83 FR 33851, July 17, 2018). Based on preliminary logbook data, NMFS expects the fishery to reach this limit by mid-October 2018.
Through this action, Hawaii-based longline vessels could potentially enter into one or more fishing agreements with participating territories. This would enhance the ability of these vessels to extend fishing effort in the western and central Pacific Ocean after reaching the 2018 U.S. limit and provide more bigeye tuna for markets in Hawaii. Providing opportunity to land
Historical catch of bigeye tuna by the American Samoa longline fleet has been less than 2,000 t, even including the catch of vessels based in American Samoa, catch by dual permitted vessels that land their catch in Hawaii, and catch attributed to American Samoa from U.S. vessels under specified fishing agreements. With regard to Guam and the CNMI, no longline fishing has occurred since 2011.
Under the proposed action, longline fisheries managed under the FEP are not expected to expand substantially nor change the manner in which they are currently conducted, (
For the reasons above, NMFS does not expect the proposed action to have a significant economic impact on a substantial number of small entities. As such, an initial regulatory flexibility analysis is not required and none has been prepared.
This action is exempt from review under E.O. 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of fishery ecosystem plan amendments; request for comments.
NMFS announces that the Western Pacific Fishery Management Council (Council) proposes to amend the Fishery Ecosystem Plans (FEP) for American Samoa, the Mariana Archipelago, and Hawaii. Amendment 4 to the American Samoa FEP, Amendment 5 to the Marianas FEP, and Amendment 5 to the Hawaii FEP would reclassify certain management unit species as ecosystem component species. The intent of these amendments is to focus management efforts on species that are in need of conservation and management, and improve efficiency of fishery management in the region.
NMFS must receive comments on the proposed amendments by October 9, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2018-0021, by either of the following methods:
•
•
The Council prepared Amendment 4 to the American Samoa FEP, Amendment 5 to the Marianas FEP, and Amendment 5 to the Hawaii FEP. Those amendments, available as a single document, include an environmental assessment (EA). Copies of the amendments and EA, and other supporting documents are available at
Sarah Ellgen, Sustainable Fisheries, NMFS PIR, 808-725-5173.
The Council established the FEPs for American Samoa, the Mariana Archipelago, and Hawaii to conserve and manage fisheries in the US Exclusive Economic Zone (Federal waters) in the Pacific Islands. The Council developed the FEPs, and NMFS implemented the associated regulations, under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Under the National Standard guidelines (50 CFR 600.305 and 600.310) for the Magnuson-Stevens Act, the Council and NMFS manage any fish species or stock that generally is a target of a Federal fishery and caught predominantly in Federal waters. Councils develop fishery management plans for these species (known as management unit species (MUS) that describe the fisheries, essential fish habitat (EFH), the scientific data required for effective implementation of the plan, the data that should be collected from the fisheries, and other required elements. The FEPs specify maximum sustainable yield, optimum yield, and status determination criteria so that overfishing and overfished determinations can be made. The Council and NMFS are also required to set annual catch limits (ACL) and accountability measures (AM) for all MUS, and the FEPs describe the process for specifying ACLs and AMs.
The FEPs have documented that the Council would use the system for classifying certain stocks as ecosystem component species (ECS), based on the criteria outlined in National Standard 1. National Standard 1 describes ECS as stocks that are included in an FEP to achieve ecosystem management objectives, but do not require conservation and management. Once reclassified as ECS, the number of MUS would be reduced from 205 species or families to 11 species in the American Samoa FEP, from 227 species or families to 13 species in the Marianas FEP, and from 173 species or families to 20 species in the Hawaii FEP. Appendix B in the amendment document list the proposed ECS for each area.
For a detailed description of the methods that the Council and NMFS used to identify the species to reclassify from MUS to ECS, please refer to Section 2 of the EA (see
The proposed action would change the definitions of MUS and ECS in the FEPs to reflect the Council's recommendations. It would also replace the FEP definitions of Currently Harvested Coral Reef Taxa (CHCRT) and Potentially Harvested Coral Reef Taxa (PHCRT) with Coral Reef ECS. All management measures that allow for the collection of data on EC species and protect the associated role of ECS in the ecosystem, and/or address other ecosystem issues, would be retained. These include permits and fees, reporting and recordkeeping requirements, prohibitions, allowable gear and gear restrictions, notifications, at-sea observer coverage, vessel marking and gear identification, area closures, and quotas, seasons, and minimum sizes for American Samoa and Mariana precious coral ECS. The management measures unique to the CHCRT and PHCRT would be carried forward to the coral reef ECS.
Finally, the proposed action would result in revision or removal of those sections of the FEPs that are not required for ECS, including EFH designations for ECS. The effects of this change on the environment would be minor, however, because the total area designated as EFH would change only for the deep (400-700 m) benthic substrates near Guam, the CNMI, and American Samoa, and reclassification would not change any fishery activities.
NMFS must receive comments on the proposed amendments by October 9, 2018 for consideration in the decision to approve, partially approve, or disapprove the amendments.
16 U.S.C. 1801
Office of Trade and Foreign Agriculture Affairs (TFAA), USDA.
Notice.
This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts. This notice, which covers Codex activities during the time periods from June 1, 2016, to May 31, 2017, and June 1, 2017, to July 20, 2018, seeks comments on standards under consideration and recommendations for new standards.
The U.S. Codex Office invites interested persons to submit their comments on this notice. Comments may be submitted by one of the following methods:
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•
•
Please state that your comments refer to Codex and, if your comments relate to specific Codex committees, please identify the committee(s) in your comments and submit a copy of your comments to the delegate from that particular committee.
Mary Frances Lowe, United States Manager for Codex Alimentarius, U.S. Department of Agriculture, Office of Food Safety, South Agriculture Building, 1400 Independence Avenue SW, Room 4861, Washington, DC 20250-3700; Telephone: (202) 205-7760; Fax: (202) 720-3157; Email:
For information pertaining to particular committees, contact the delegate of that committee. A complete list of U.S. delegates and alternate delegates can be found in Attachment 2 of this notice. Documents pertaining to Codex and specific committee agendas are accessible via the internet at
The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). United States membership in the WTO was approved and the Uruguay Round Agreements Act (Uruguay Round Agreements) was signed into law by the President on December 8, 1994, Public Law 103-465, 108 Stat. 4809. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. The Uruguay Round Agreements amended the Trade Agreements Act of 1979. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be “responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization” (19 U.S.C. 2578). The main international standard-setting organizations are Codex, the World Organisation for Animal Health, and the International Plant Protection Convention. The President, pursuant to Proclamation No. 6780 of March 23, 1995, (60 FR 15845), designated the U.S. Department of Agriculture as the agency responsible for informing the public of the SPS standard-setting activities of each international standard-setting organization. The Secretary of Agriculture has delegated to the Office of Trade and Foreign Agricultural Affairs the responsibility to inform the public of the SPS standard-setting activities of Codex. The Office of Trade and Foreign Agricultural Affairs has, in turn, assigned the responsibility for informing the public of the SPS standard-setting activities of Codex to the U.S. Codex Office (USCO).
Codex was created in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for establishing standards for food. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of food standards work undertaken by international governmental and nongovernmental organizations. In the United States, U.S. Codex activities are managed and carried out by the United States Department of Agriculture (USDA); the Food and Drug
As the agency responsible for informing the public of the SPS standard-setting activities of Codex, the U.S. Codex Office publishes this notice in the
1. The SPS standards under consideration or planned for consideration; and
2. For each SPS standard specified:
a. A description of the consideration or planned consideration of the standard;
b. Whether the United States is participating or plans to participate in the consideration of the standard;
c. The agenda for United States participation, if any; and
d. The agency responsible for representing the United States with respect to the standard.
This notice also solicits public comment on standards that are currently under consideration or planned for consideration and recommendations for new standards. The delegate, in conjunction with the responsible agency, will take the comments received into account in participating in the consideration of the standards and in proposing matters to be considered by Codex.
The U.S. delegate will facilitate public participation in the United States Government's activities relating to Codex. The U.S. delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex Committees and will disseminate information regarding U.S. delegation activities to interested parties. This information will include the status of each agenda item; the U.S. Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following the Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its web page at
The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2016, to May 31, 2017, and June 1, 2017, to July 20, 2018. Attachment 2 provides a list of U.S. Codex Officials (including U.S. delegates and alternate delegates). A list of forthcoming Codex sessions may be found at:
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
Done at Washington, DC.
The Codex Alimentarius Commission convened for its 41st Session July 2-6, 2018, in Rome, Italy. At that time, the Commission adopted standards recommended by Committees at Step at 8 or Step 5/8 (final adoption), and it advanced the work of Committees by adopting draft standards at Step 5 (for further comment and consideration by the relevant committee). The Commission also considered proposals for new work; discontinuation of work; amendments to Codex standards and related texts; matters arising from the reports of the Commission, the Executive Committee and subsidiary bodies; committees working by correspondence and a possible pilot for a committee on standards advancement; regular review of Codex work management; Codex budgetary and financial matters for 2020-2021; FAO/WHO Scientific Support for Codex activities; matters arising from FAO and WHO; reports on side events on FAO and WHO capacity development activities, the Codex Trust Fund, and discussion panels with International Government Organizations and Non-Governmental Organizations; election of the chairperson and vice-chairpersons of Codex; and other business.
Before the Commission meeting, the Executive Committee met for its 75th Session from June 26 to 29, 2018. It is composed of the chairperson and vice-chairpersons of the CAC; seven members elected by the Commission from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific; and regional coordinators from the six regional committees. The United States participated as the member elected on a geographic basis for North America. The Executive Committee conducted a critical review of the elaboration of Codex standards; reviewed the implementation status of the 2014-2019 Strategic Plan and preparation of the 2020-2025 Strategic Plan; and considered the work of committees working by correspondence and the possibility of a pilot for a committee on standards advancement, FAO/WHO Scientific Support for Codex work, other matters arising from FAO and WHO, and financial and budgetary issues.
The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. The Committee also develops codes of practice, as may be required, and considers methods of sampling and analysis for the determination of veterinary drug residues in food. A veterinary drug is defined as any substance applied or administered to any food producing animal such as meat or milk producing animals, poultry, fish, or bees, whether used for therapeutic, prophylactic or diagnostic purposes, or for modification of physiological functions or behavior.
A Codex MRL for residues of veterinary drugs is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. Residues of a veterinary drug include the parent compounds or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. An MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI) or on the basis of a temporary ADI that utilizes an additional safety factor. When establishing an MRL, consideration is also given to residues that occur in food of plant origin or the environment. Furthermore, the MRL may be reduced to be consistent with official recommended or authorized usage, approved by national authorities, of the veterinary drugs under practical conditions.
An ADI is an estimate made by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, which can be ingested daily in food over a lifetime without appreciable health risk.
The Committee convened for its 24th Session (CCRVDF24) in Chicago, Illinois, April 23-27, 2018. The relevant document is REP18/RVDF. The following items were
• Proposed draft MRLs for amoxicillin (finfish fillet, muscle); ampicillin (finfish fillet, muscle; lufenuron (salmon and trout fillet); monepantel (cattle fat, kidney, liver, muscle).
• Draft Risk Management Recommendation for gentian violet.
• Proposed draft MRL for flumethrin (honey).
The Commission also adopted the proposed amendment to the Risk Analysis Principles Applied by CCRVDF in the Codex
• Proposed draft MRLs for zilpaterol hydrochloride (cattle fat, kidney, liver, muscle);
• Draft Priority List of veterinary drugs requiring approval by CAC;
• Discussion paper on extrapolation of MRLs to one or more species (including a pilot on extrapolation of MRLs identified in Part D of the Priority List);
• Coordination with the Codex Committee on Pesticide Residues/Electronic Working Group on the revision of the Classification of Food and Feed for the development of a harmonized definition for edible offal/animal tissues for the establishment of MRLs;
• Database on countries needs for MRLs; and
• Discussion paper on advantages and disadvantages of a parallel approach to compound evaluation.
• Discussion paper on the revision of the criteria for the use of multi-residue analytical methods for the determination and identification of veterinary drugs in foods in the Guidelines for the design and implementation of national regulatory food safety assurance programs associated with the use of veterinary drugs in food producing animals; and
• Discussion paper on MRLs for groups of fish species.
The Codex Committee on Contaminants in Foods (CCCF) establishes or endorses permitted maximum levels (MLs), as necessary, revises existing guideline levels (GLs) for contaminants and naturally occurring toxicants in food and feed; prepares priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); considers and elaborates methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed; considers and elaborates on standards or codes of practice (COPs) for related subjects; and considers other matters assigned to it by the Commission in relation to contaminants and naturally occurring toxicants in food and feed.
The Committee convened for its 12th Session (CCCF12) in Utrecht, the Netherlands, March 12-16, 2018. The relevant document is REP18/CF. The following standards were forwarded to the CAC for consideration and adopted by the 41st Session of the Commission in July 2018:
• MLs for lead in selected commodities (revision of MLs and consequential revocation of corresponding MLs/amendments to MLs in the General Standard for Contaminants and Toxins in Food and Feed (GSCTFF) (CXS 193-1995));
• MLs for cadmium in chocolate containing or declaring ≥50% to <70% total cocoa solids on a dry matter basis; and chocolate containing or declaring ≥70% total cocoa solids on a dry matter basis;
• MLs for methylmercury in tuna, alfonsino, marlin and shark, and revocation of the GLs for methylmercury in predatory and non-predatory fish;
• Amendment to the note for the ML on inorganic arsenic in rice (consequential amendment); and
• COP for the prevention and reduction of dioxins, dioxin-like PCBs and non-dioxin-like polychlorinated biphenyls (PCB) contamination in food and feed.
• COP for the reduction of 3-MCPDE and GE in refined oils and products made with refined oils; and
• Guidelines for risk analysis of instances of contaminants in food where there is no regulatory level or risk management framework established.
• Establishment of MLs for cadmium in dry mixtures of cocoa and sugars sold for final consumption; and
• Establishment of MLs for methylmercury in amberjack and swordfish.
• Establishment of MLs for total aflatoxins in ready-to-eat peanuts; and
• Establishment of MLs for total aflatoxins and ochratoxin A in nutmeg, chili and paprika, ginger, pepper and turmeric.
• MLs for lead in wine and edible offals;
• MLs for cadmium in chocolate and cocoa-derived products (category of chocolate and chocolate products containing or declaring (1) <30% and (2) ≥30% to <50% total cocoa solids on a dry matter basis;
• Discussion paper on establishment of MLs for hydrocyanic acid (HCN) in cassava and cassava-based products and occurrence of mycotoxins in these products;
• Discussion paper on structured approach to prioritize commodities for which new MLs for lead could be established for inclusion in the General Standard for Contaminants and Toxins in Food and Feed;
• Discussion paper on aflatoxins in cereals (establishment of MLs for total aflatoxins in wheat, maize, sorghum and rice (specifying the categories));
• Discussion paper on development of a COP for the prevention and reduction of cadmium contamination in cocoa;
• Discussion paper on forward workplan for CCCF; and
• Priority list of contaminants and naturally occurring toxicants for evaluation by JECFA.
• Discussion paper on lead and cadmium in quinoa;
• Discussion paper on general guidance on data analysis for ML development; and
• Discussion paper, including a project document, for a proposal for new work on the revision of the COP for prevention and reduction of lead contamination in foods (CXC 56-2004).
The Codex Committee on Food Additives (CCFA) establishes or endorses acceptable maximum levels (MLs) for individual food additives; prepares a priority list of food additives for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); assigns functional classes to individual food additives; recommends specifications of identity and purity for food additives for adoption by the Codex Alimentarius Commission; considers methods of analysis for the determination of additives in food; and considers and elaborates standards or codes of practice for related subjects such as the labeling of food additives when sold as such. The 50th Session of the Committee (CCFA50) convened in Xiamen, China, March 26-30, 2018. The relevant document is REP18/FA. Immediately prior to the Plenary Session, there was a two-day physical Working Group (PWG) on the General Standard for Food Additives (GSFA) chaired by the United States.
The following items were recommended by CCFA50 and considered by the 41st Session of the Commission in July 2018:
• Proposed draft specifications for the identity and purity of food additives; and
• Proposed draft amendments to the
• Draft and proposed draft food additive provisions of the GSFA.
• Replacement of the name “sodium aluminosilicate” with “sodium aluminum silicate” in the
• Revised food additive provisions of the GSFA related to the alignment of the annexes of the Standard for Certain Canned Fruits
• Revised food additive sections of 14 standards for fish and fish products and the
• Food additive provisions of the GSFA;
• Food-additive provisions for specific malates and/or tartrates from the Standards for
• Food-additive provisions for sodium sorbate (INS 201) from the Standards for
• Draft and proposed draft food additive provisions of the GSFA, and technological justification for the use of preservatives and anticaking agents for surface treatment of mozzarella with high moisture content covered by
• Proposals for additions and changes to the
• Alignment of the food additive provisions of commodity standards and relevant provisions of the GSFA; consider revisions to the “References to Commodity Standard for GSFA Table 3 Additives” section of Table 3; proposed revisions to food-additive provisions in Food Categories 13.1.1, 13.1.2, and 13.1.3 for ascorbyl palmitate (INS 304) and ascorbyl stearate (INS 305) (EWG led by Australia, Japan and the United States);
• Revision of the Class Names and the INS for Food additives (EWG led by Iran and Belgium);
• New or revised provisions of the GSFA (PWG led by the United States);
• Clarification of the appropriate descriptors for Food Categories 14.1.4.2 and 14.1.5 for ready-to-drink coffee and tea beverages (Codex Secretariat);
• Review of all group food additives in the GSFA to determine if all food-additives in the group share a Group Acceptable Daily Intake (Codex Secretariat in consultation with JECFA Secretariat);
• Development of an inventory of data available on the use of nitrates (INS 251, 252) and nitrites (INS 249, 250) with a view to consulting with JECFA and CCFA regarding next steps (eWG led by the European Union and the Netherlands);
• Development of an alternative to Note 161 relating to the use of sweeteners and, subject to agreement on the wording of an alternative, review of recommendations in CX FA 14/47/13 in the context of pending and adopted provisions (EWG led by United States and the European Union); and
• Preparation of a discussion paper on the use of the terms “fresh”, “plain”, “unprocessed” and “untreated” in existing Codex texts (Russian Federation).
The Committee also agreed to hold a one and one-half day PWG on the GSFA immediately preceding the 51st Session of the CCFA, to be chaired by the United States. That group will discuss the recommendations of the EWG on the GSFA, new proposals and proposed revisions of food additive provisions in the GSFA.
The Committee also agreed to hold a half day PWG on the GSFA immediately preceding the 51st Session of the CCFA to be chaired by Australia. That group will discuss the recommendations of the PWG on alignment.
The Codex Committee on Pesticide Residues (CCPR) is responsible for establishing MRLs for pesticide residues in specific food items or in groups of food; establishing MRLs for pesticide residues in certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health; preparing priority lists of pesticides for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); considering methods of sampling and analysis for the determination of pesticide residues in food and feed; considering other matters in relation to the safety of food and feed containing pesticide residues; and establishing maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides in specific food items or groups of food.
The 50th Session of the Committee (CCPR50) met in Haikou, China, April 9-14, 2018. The relevant document is REP18/PR. The following items were considered at the 41st Session of the Codex Alimentarius Commission in July 2018:
• Three hundred eighty-six (386) MRLs for different pesticide residues.
• Revisions of the Classification: Class A—Primary Commodities of Plant Origin—Type 04 Nuts, Seeds, and SAPs (Step 8 and 5/8);
• Revision of the Classification: Class A-Primary Commodities of Plant Origin—Type 05 Herbs and Spices (Step 8).
• Tables with Examples of Representative Commodities for Commodity Groups in Type 04 and Type 05 (For inclusion in the Principles and Guidance for the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Pesticides for Commodity Groups).
The Commission also discontinued work, approved new work, and revoked existing MRLs as recommended by CCPR50.
• Revision of the Classification: Impact of the Revised Commodity Groups and Subgroups in Type 03, Type 04 and Type 05 on the CXLs adopted by the Codex Alimentarius Commission;
• Draft and proposed draft Revision of the Classification of Food and Feed;
• Development of a system within the classification of food and feed to provide codes for commodities not meeting the criteria for crop grouping;
• Discussion Paper on the review of the International Estimated Short-term Intake Equations (IESTI);
• Discussion paper on management of unsupported compounds;
• Discussion paper on biopesticides;
• Discussion paper on the revision of the guidelines on the use of mass spectrometry for the identification, confirmation and quantitative determination of residues;
• Discussion paper on the opportunities and challenges related to the participation of JMPR in an international joint review of a new compounds;
• National Registration Database of Pesticides; and
• Establishment of Codex Schedules and Priority Lists of Pesticides.
The Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) is responsible for developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs; developing principles and guidelines for the application of measures by the competent authorities of exporting and importing countries to provide assurance, where necessary, that foodstuffs comply with requirements, especially statutory health requirements; developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries; developing guidelines and criteria with respect to format, declarations, and language of such official certificates as countries may require with a view towards international harmonization; making recommendations for information exchange in relation to food import/export control; consulting as necessary with other international groups working on matters related to food inspection and certification systems; and considering other matters assigned to it by the Commission in relation to food inspection and certification systems. The 24th Session of the Committee will convene in Brisbane, Australia, October 22-26, 2018.
• Project document for new work on guidance on paperless use of electronic certificates (
• Project document for new work on guidance on regulatory approaches to third party assurance schemes in food safety and fair practices in the food trade;
• Discussion paper on food integrity and food authenticity;
• Discussion paper on consideration of emerging issues and future directions for the work of the Codex Committee on Food Import and Export Inspection and Certification Systems;
• Framework for the preliminary assessment and identification of priority areas for CCFICs; and
• Inter-sessional physical working groups: trial.
The Codex Committee on Methods of Analysis and Sampling (CCMAS) defines the criteria appropriate to Codex Methods of Analysis and Sampling; serves as a coordinating body for Codex with other international groups working on methods of analysis and sampling and quality assurance systems for laboratories; specifies, on the basis of final recommendations submitted to it by the bodies referred to above, reference methods of analysis and sampling appropriate to Codex standards which are generally applicable to a number of foods; considers, amends if necessary, and endorses as appropriate, methods of analysis and sampling proposed by Codex commodity committees, except for methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives; elaborates sampling plans and procedures, as may be required; considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.
The 39th Session of the Committee (CCMAS39) met in Budapest, Hungary, May 7-11, 2018. The relevant document is REP18/MAS.
At its 41st Session in July 2018, the Commission adopted, amended and revoked methods of analysis and sampling as recommended by CCMAS39. The Commission also approved new work as proposed by CCMAS:
• Revision of the Guidelines on Measurement Uncertainty (CXG 54-2004); and
• Project plan and amendment of the General Guidelines on Sampling (CXG 50-2004).
• Review/Revision of the General Standard for Methods of Analysis and Sampling (CSX 234.
At CCMAS 39, the Committee agreed to discontinue work on criteria for endorsement of biological methods to detect chemicals of concern.
The Codex Committee on Food Labelling (CCFL) drafts provisions on labeling applicable to all foods; considers, amends, and endorses draft specific provisions on labeling prepared by the Codex Committees drafting standards, codes of practice, guidelines; and studies specific labeling problems assigned by the Codex Alimentarius Commission. The Committee also studies problems associated with the advertisement of food with particular reference to claims and misleading descriptions.
The Committee convened its 44th Session (CCFL44) in Asuncion, Paraguay, October 16-20, 2017. The relevant document is REP18/FL. The following item was adopted by the Commission at its 41st Session in July 2018, as recommended by CCFL44:
• Draft Revision of the General Standard for the Labelling of Prepackaged Foods: Date marking.
The Committee will continue working on the following items:
• Proposed draft Guidance for the Labelling of Non-Retail Containers;
• Proposed draft Guidelines on Front of Pack Nutrition Labelling;
• Discussion paper on internet sales/e-commerce;
• Discussion paper on allergen labelling;
• Discussion paper on innovation—use of technology in food labelling;
• Discussion paper on labelling of alcoholic beverages;
• Discussion paper on criteria for the definition of “high in” nutritional descriptors for fats, sugars and sodium;
• Discussion paper on labelling of foods in joint presentation and multipack formats; and
• Discussion paper on future work and direction of CCFL (update).
The Codex Committee on Food Hygiene (CCFH):
• Develops basic provisions on food hygiene, applicable to all food or to specific food types;
• Considers and amends or endorses provisions on food hygiene contained in Codex commodity standards and codes of practice developed by Codex commodity committees;
• Considers specific food hygiene problems assigned to it by the Commission;
• Suggests and prioritizes areas where there is a need for microbiological risk assessment at the international level and develops questions to be addressed by the risk assessors; and
• Considers microbiological risk management matters in relation to food hygiene and in relation to the FAO/WHO risk assessments.
The Committee convened for its 49th Session (CCFH49) in Chicago, Illinois, November 13-17, 2017. The relevant document is REP 18/FH. The following item was adopted by the 41st Session of the Commission in July 2018, as recommended by CCFH49:
• Proposed draft Revision of the
The Commission also approved new work as recommended by CCFH49:
• Code of Practice on food allergen management for food business operators; and
• Guidance for the management of (micro)biological foodborne crises/outbreaks.
• Proposed draft Revision of the
• The placement for the guidance on histamine control in CXC 52-2003, the amendments of other sections of CXC 52-3002, and the revision of the section on sampling, examination and analyses in standards for fish and fishery products related to histamine food safety;
• Discussion paper on future work on Shiga toxin-producing
• New work proposals/Forward Workplan.
The Codex Committee on Fresh Fruits and Vegetables (CCFFV) is responsible for elaborating worldwide standards and codes of practice, as may be appropriate, for fresh fruits and vegetables, consulting as necessary, with other international organizations in the standards development process to avoid duplication.
The 20th Session of the Committee (CCFFV20) met in Kampala, Uganda, October 2-6, 2017. The relevant document is REP 18/FFV.
The following items were considered by the Commission at its 40th Session in July 2018, and the Commission took action as recommended by CCFFV20:
• Draft Standard for Aubergines.
• Draft Standard for Ware Potatoes.
• Standards for yam, onions and shallots, and berry fruits.
• Proposed Layout for Standards for Fresh Fruits and Vegetables;
• Draft Standard for Garlic;
• Draft Standard for Kiwifruit;
• Draft Standard for Ware Potatoes;
• Proposed Draft Standard for Fresh Dates;
• Discussion paper on glossary of terms used in the layout for Codex standards for fresh fruits and vegetables; and
• Recommendation on the inclusion of mono and di-glycerides of fatty acids and salts of myristic, palmitic and stearic acids with ammonia, calcium, potassium and sodium in the GSFA under the food categories “surface-treated fresh fruits” and “surface treated fresh vegetables.”
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is responsible for studying nutrition issues referred to it by the Codex Alimentarius Commission. The Committee also drafts general provisions, as appropriate, on nutritional aspects of all foods and develops standards, guidelines, and related texts for foods for special dietary uses, in cooperation with other committees where necessary; considers, amends if necessary, and endorses provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts.
The Committee convened for its 39th Session (CCNFSDU) in Berlin, Germany, December 4-8, 2017. The reference document is REP 18/NFSDU. The following item was adopted by the Commission at its 41st Session in July 2-6, 2018, as recommended by CCNFSDU39.
• Review of the
• Proposed draft Claim for “free of” trans fatty acids;
• Discussion of biological methods used to detect chemicals of concern;
• Review of the Standard for Follow-up Formula: Scope, product definition, labelling;
• Proposed draft definition for biofortification;
• Proposed draft Nutrient Reference Values—Noncommunicable Disease (NRV-NCD) for EPA and DHA;
• Proposed draft guideline for ready to use therapeutic foods;
• Nutrient Reference Values—Requirements (NRV-R) for older infants and young children;
• Mechanism/framework for considering the technological justification of food additives;
• Discussion paper on harmonized probiotic guidelines for use in foods and dietary supplements; and
• General guidelines to establish nutritional profiles.
The Ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) is responsible for (1) reviewing and revising, as appropriate, the
The Task Force will convene for its 6th Session (the 2nd Session since reactivation in 2016) in the Republic of Korea, December 10-14, 2018.
• The Proposed draft Revision of the Code of Practice to Minimize and Contain Antimicrobial Resistance;
• Proposed draft Guidelines on Integrated surveillance of Antimicrobial Resistance; and
• Request for Scientific Advice from Food and Agriculture Organization (FAO) and World Health Organization (WHO) in collaboration with OIE.
The Codex Committee on Fats and Oils (CCFO) is responsible for elaborating worldwide standards for fats and oils of animal, vegetable, and marine origin, including margarine and olive oil.
The Committee will convene in 2019 for its 26th Session.
• Revision of the
• Revision of the
• Revision of the
• Revision of the
• Gathering information on technical difficulties in the implementation of the fish oil standard, specifically on monitoring its application with respect to the conformity of named fish oils with the requirements (especially the fatty acid profile), and its effect on trade;
• Alignment of food additives provisions in standards for fats and oils (except fish oils) and technological justification for use of emulsifiers;
• Proposals for new substances to be added to the list of acceptable previous cargoes;
• Provision of relevant information (if available from Member countries) to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on the 23 substances on the list of acceptable previous cargoes currently on the list; and
• Discussion paper on the applicability of the fatty acid composition of all oils listed in Table 1 in relation to the fatty acid composition of corresponding crude (unrefined) forms in the
The Codex Committee on Processed Fruits and Vegetables (CCPFV) is responsible for elaborating worldwide standards and related texts for all types of processed fruits and vegetables including, but not limited to canned, dried, and frozen products, as well as fruit and vegetable juices and nectars. Proposals for new work were received by Executive Committee of the Codex Alimentarius Commission (CCEXEC) and approved by CAC40 (July 17-22, 2017) for cashew kernels, chili sauce, mango chutney, dried sweet potato, gochujang, dried fruits, and canned mixed fruits.
The Commission authorized CCPFV to work by correspondence until CAC 41 (2018) to prioritize the proposals for new work, prepare a work plan, and prepare recommendations on the establishment of electronic working groups. The Commission at its 41st Session in July 2018 endorsed the CCPFV Chairperson's proposed work plan and recommendations (1) to establish 7 EWGS to prepare proposed drafts for comments and consideration by the CCPFV, and (2) to schedule a physical meeting of the Committee at an appropriate time.
The Codex Committee on Sugars (CCS) elaborates worldwide standards for all types of sugars and sugar products.
The Committee has been re-activated to work by correspondence on a draft
The Codex Committee on Cereals, Pulses and Legumes (CCCPL) elaborates worldwide standards and/or codes of practice, as appropriate, for cereals, pulses and legumes and their products.
The Committee has been reactivated to work by correspondence to draft an international Codex Standard for quinoa. The following item was considered by the Commission at its 41st Session in July 2018:
• Standard for Quinoa
The Commission agreed to adopt, subject to the endorsement of the labelling
Several Codex Alimentarius Commodity Committees have adjourned
• Cocoa Products and Chocolate—adjourned 2001.
• Fish and Fishery Products—adjourned 2016.
• Meat Hygiene—adjourned 2003.
• Milk and Milk Products—adjourned 2017.
• Natural Mineral Waters—adjourned 2008.
• Vegetable Proteins—adjourned 1989.
The FAO/WHO Regional Coordinating Committees define the problems and needs of the regions concerning food standards and food control; promote within the Committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulate the strengthening of food control infrastructures; recommend to the Commission the development of worldwide standards for products of interest to the region, including products considered by the Committees to have an international market potential in the future; develop regional standards for food products moving exclusively or almost exclusively in intra-regional trade; draw the attention of the Commission to any aspects of the Commission's work of particular significance to the region; promote coordination of all regional food standards work undertaken by international governmental and non-governmental organizations within each region; exercise a general coordinating role for the region and such other functions as may be entrusted to them by the Commission; and promote the use of Codex standards and related texts by members.
There are six regional coordinating committees:
The Committee (CCAFRICA) will convene its 23rd Session in 2019.
• Proposed draft Regional Standard for Unrefined Shea Butter;
• Proposed draft Regional Standard for Fermented Cooked Cassava Based Products;
• Proposed draft Regional Standard for Gnetum Spp leaves;
• Priority Setting criteria for the establishment of work priorities as laid down in the Codex
• Comments on the preparation of the new global Codex Strategic Plan;
• Food quality and safety situation in countries of the Region (on-line platform, prioritization of needs in the region and comments for future consideration);
• Use of Codex Standards in the Region;
• Proposed draft Standard on Dried Meat;
• Discussion paper and project document on a Harmonized Food Law; and
• Discussion paper/project on a Regional Standard for a Fermented Non-Alcoholic Cereal Based Drink (Mahewu).
The Committee (CCASIA) will convene its 21st Session in 2019.
• Report on the status of the Implementation of the Activities of the Strategic Plan Relevant to CCASIA;
• Discussion paper and project document on the Development of a Regional Standard for Rice Based Low Alcohol Beverages (cloudy types);
• Discussion paper and project document on the Development of a Regional Standard for Soybean Products Fermented with the Bacterium Bacillus Subtilis;
• Discussion paper and project document on the Development of a Regional Standard for Quick Frozen Dumpling (Jiaozi);
• Discussion paper and the project document on the Development of a Regional Standard/Code of Practice for Zongzi;
• Emerging Issues as priorities for the CCASIA region; and
• Information sharing on the Food Safety Control Systems.
The Committee (CCEUROPE) will convene its 31st Session in 2019.
• Survey of critical and emerging issues;
• On-line Platform and information sharing on the Food Safety Control Systems;
• Survey on the use of Codex Standards;
• Relevant languages of the Codex Alimentarius Commission in the work of CCEUROPE; and
• Funding translation and interpretation services into Russian for the effective operation of CCEUROPE.
The Coordinating Committee for Latin America and the Caribbean (CCLAC) will convene its 21st in 2019.
• Monitoring of the Strategic Plan for CCLAC;
• Critical and Emerging Issues and prioritization of CCLAC issues within the framework of Codex;
• Comments on the Food Safety Control Systems Platform;
• Cross-cutting topics for the region, proposed draft standards and seeking regional support; and
• Proposal for the Development of a Standard for Yams.
The Coordinating Committee for the Near East (CCNEA) will convene its 10th Session in 2019.
The Committee (CCNASWP) will convene its 15th Session in 2019.
• New work on the development of a Regional Standard for Kava as a beverage when mixed with cold water;
• Recommendation that Vanuatu be re-appointed as Coordinator for North America and the South West Pacific;
• Proposed draft Regional Standard for Fermented Noni-Juice; and
• Development of on-line platform for information on sharing food quality and safety systems.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Forest Service will prepare an Environmental Impact Statement (EIS) for the South Revillagigedo Integrated Resource Project (South Revilla IRP) which proposes to harvest timber, restore watershed function, enhance or restore fish and wildlife habitat, and develop recreation opportunities using an integrated approach in the Shelter Cove, Shoal Cove, and Thorne Arm areas within the Ketchikan Misty Fjords Ranger District, Tongass National Forest. The Proposed Action would harvest about 60 million board feet of timber from up to 6,000 acres over the course of 15 years. In addition, transportation management activities such as road construction, reconstruction, maintenance, and decommissioning are proposed. At the same time that it would approve the proposed project, the Forest Service may approve a project-specific Forest Plan amendment to ensure the project is consistent with the Plan.
Comments concerning the scope of the analysis must be received by September 7, 2018. Designated opportunities for additional comments will be provided. The draft EIS, is expected to be published July 2019. A final EIS is expected July, 2020.
Send or hand-deliver specific written comments to the Ketchikan Misty Fjords Ranger District, Attn: South Revilla IRP, 3031 Tongass Avenue, Ketchikan, Alaska 99901; telephone (907) 225-2148. The FAX number is (907) 225-8738. Comments may be emailed to:
Susan Howle, District Ranger, Ketchikan Misty Fjords Ranger District, 3031 Tongass Avenue, Ketchikan, Alaska 99901; Daryl Bingham, Planning Staff, (907) 228-4114, or Damien Zona, Interdisciplinary Team Leader, (907) 228-4126. Individuals who use telecommunication devices for the deaf may call the Federal Information Relay Service at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
This EIS will tier to and incorporate by reference the 2016 Tongass Land and Resource Management Plan Final EIS. The project area is located on Revillagigedo Island, approximately 17 miles northeast of Ketchikan, Alaska, within the Ketchikan Misty Fjords Ranger District, Tongass National Forest and encompasses about 58,159 acres of National Forest System lands.
The purpose of the South Revilla IRP is to implement the 2016 Tongass Land and Resource Management Plan (Forest Plan) direction to move the project area toward the desired future conditions described in that plan. More specifically, the purpose is to manage the timber resource for production of sawtimber and other wood products, improve ecosystem and watershed health, and provide a range of recreation opportunities to meet public and tourism business demand through an integrated approach to meet multiple resource objectives. Maintaining existing, and expanding opportunities for the recreation and tourism sector would contribute to the local economy.
There is a need to provide a sustainable level of forest products to contribute to the economic sustainability of the region. Providing old-growth timber would preserve a viable timber industry during the transition to young-growth management and would provide jobs and opportunities for Southeast Alaska residents. Past management activities have affected watershed function in the project area. There is a need to improve and restore the natural range of habitat conditions in the project area to support viable wildlife, fish, and plant populations and to sustain diversity and production. Restoration would contribute to traditional, cultural, and subsistence uses by residents of Southeast Alaska. There is a need to provide sustainable recreation opportunities to a diverse and growing group of forest users. A sustainable recreation program in terms of operations and maintenance is needed to maintain infrastructure at an acceptable level.
The Forest Service proposes to harvest timber, construct and reconstruct roads, restore watershed function, enhance or restore fish and wildlife habitat, and develop recreation opportunities in the Shelter Cove, Shoal Cove and Thorne Arm areas within the Ketchikan Misty Fjords Ranger District, Tongass National Forest. The project area includes the following land use designations (LUDs): Wilderness, Semi-remote Recreation, Old-growth Habitat, Special Interest Area, Scenic River, Modified Landscape, and Timber Production (Forest Plan, Chapter 3). Proposed activities will be consistent with Forest Plan direction. A proposed action map and information on the 2018 Shelter Cove and Saddle Lakes Recreation Area Master Plan is provided on the project web page at:
The Forest Service proposes to harvest about 60 million board feet of old-growth timber from up to 6,000 acres of forested land in the Modified Landscape and Timber Production LUDs using one or more timber sales, with activities that would occur over the course of 15 years. The Proposed Action would construct about 30 miles of new National Forest System road and reconstruct about 104 miles of existing roads. Temporary road construction would include about 105 miles. Existing rock quarries would be used as available or new quarries would be developed as necessary to provide raw materials for road construction. Existing log transfer facilities at Shelter Cove and Shoal Cove could be used. Young-growth harvest may be considered during this planning phase if it meets the purpose and need of the Proposed Action.
Watershed enhancement and restoration activities would include instream and floodplain wood
Recreation opportunities will be developed using the 2018 Shelter Cove and Saddle Lakes Recreation Area Master Plan and ongoing public input. The Proposed Action will be refined through public involvement to meet the Purpose and Need for the project and consistency with the Forest Plan. The 2008 Access and Travel Management Plan and its associated Motor Vehicle Use map would be reviewed and updated as needed.
The 2012 Planning Rule (36 CFR 219.13(b)(2)) requires the Responsible Official to identify which substantive requirements of the Rule are likely to be directly related to a proposed land management plan amendment (36 CFR 219.13(b)(5) and 36 CFR 219.8 through 219.11) in the initial notice for the amendment (36 CFR 219.16(a)(1)). At this time, the Responsible Official believes that a modification to Scenic Integrity Objectives in the Forest Plan may be necessary for this project (see Possible Alternatives section.)
Scoping comments will be used to develop a range of alternatives to the Proposed Action in response to significant issues that are identified. A No-action Alternative will be analyzed as the baseline for comparison of action alternatives. Other alternative(s) may include a project-specific Tongass Forest Plan amendment to lower the Scenic Integrity Objectives (Forest Plan, p. 4-54 to 4-56), if needed, on portions of timber analysis areas in the project area to meet the Purpose and Need. If included in the South Revilla IRP, this plan amendment would only apply to the commercial timber sales undertaken as part of this specific project only; therefore, the notification requirements and objection procedures of 36 CFR 218, subparts A and B, apply rather than the notification requirements of 36 CFR 219. The 2012 Planning Rule (36 CFR 219.13(b)(2)) requires the Responsible Official to identify which substantive requirements of the Rule are likely to be directly related to the a proposed land management plan amendment. At this time, the Responsible Official believes the following requirements of the Rule are likely to apply to an amendment that would modify the Scenic Integrity Objectives of the Forest Plan for this project: 36 CFR 219.8(b)(2); 36 CFR 219.10(a)(1); and 36 CFR 219.10(b)(1)(i).
The Forest Service will be the lead agency for this project. Invited cooperating agencies include: Ketchikan Indian Community, Organized Village of Saxman, Metlakatla Indian Community, State of Alaska Department of Fish and Game, State of Alaska Department of Forestry, and Ketchikan Gateway Borough.
The Responsible Official for this project is M. Earl Stewart, Forest Supervisor, Tongass National Forest.
Given the Purpose and Need, the Forest Supervisor will review alternatives, and consider the environmental consequences to make decisions including: (1) Whether to select the Proposed Action or another alternative; (2) the locations, design, and scheduling of restoration activities, habitat improvements, road construction and reconstruction, and recreation development or decommissioning opportunities; (3) mitigation measures and monitoring; (4) whether there may be a significant restriction to subsistence resources; and (5) whether a project-specific Forest Plan amendment to lower Scenic Integrity Objectives (Forest Plan, p. 4-54 to 4-57) is necessary.
Preliminary concerns identified by the interdisciplinary team include: (1) Designing an economical timber sale(s) that meets market demand; (2) effects of Forest Plan scenery direction on the ability to design an economical timber sale; (3) effects of timber harvest and road construction on wildlife habitat and travel corridors; (4) effects of timber harvest and road construction on watershed condition; (5) effects of timber harvest and road construction to rare and sensitive plants; and (6) effects of herbicide use on other resources.
All necessary permits will be obtained prior to project implementation.
This Notice of Intent initiates the scoping process, which guides the development of the EIS. To help determine the location and types of activities, and how they will occur across the landscape, the Forest Service is seeking information, comments, and assistance from Tribal Governments; Federal, State, and local agencies; stakeholders, individuals and organizations interested in or affected by the proposed activities. In addition, a legal notice will be published in the
Additionally, there will be in-person opportunities for involvement including open houses and subsistence hearings held in Ketchikan, Alaska. Project information, meeting announcements, legal notices, and documents will be provided on the project web page at:
Forest Service regulations at 36 CFR part 218, subparts A and B (78 FR 18481-18504) regarding the project-level predecisional administrative review process applies to projects and activities implementing land management plans that are not authorized under the Healthy Forests Restoration Act. The South Revilla IRP is an activity implementing the Forest Plan and is subject to 36 CFR 218.
Only individuals or entities who submit timely and specific written comments concerning this project during this or another public comment period established by the Responsible Official will be eligible to file an objection. It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the EIS. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered. Anonymous commenters will not gain standing to object as defined in 36 CFR 218.2.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
To keep current with rapid changes in the marketplace caused by new businesses (a.k.a. births) the Census Bureau samples newly assigned Employer Identification Numbers (EINs) obtained from the Internal Revenue Service. Each EIN can only be selected once for the SQ-CLASS report. Companies are selected for the SQ-CLASS sample based on the presence of a newly filed application for an EIN. Companies in the sample are asked to provide data about the establishment(s) associated with the new EIN including a more reliable measure of size, consisting of sales in two recent months, company affiliation information, a new or more detailed industry classification code, and other key information needed to maintain proper coverage of the business universe on the Business Register for the current business surveys.
Based on information collected on the SQ-CLASS form, EINs meeting the criteria for inclusion in the Census Bureau's current business surveys may be eligible for a second phase of sampling. Companies with new EINs selected in this second sampling are asked to report annually on the annual retail, wholesale, and service surveys. A subsample of the wholesale and retail EINs also may be added to the monthly retail and wholesale surveys. Similarly, a subsample of companies with new EINs in the service industries are asked to report in the quarterly services surveys.
The Economic Census and the current business surveys represent the primary source of facts about the structure and function of the U.S. economy, providing essential information to government and the business community in making sound decisions. This information helps build the foundation for the calculation of Gross Domestic Product (GDP) and other economic indicators. Crucial to its success are the accuracy and reliability of the Business Register, which provides the Economic Census and current business surveys with their establishment lists. Critical to the quality of information housed in the Business Register is that each of the statistical units has an accurate industry classification, measure of size, activity status, and physical address assigned to it. The vital information obtained from the SQ-CLASS report is fed back to the Business Register to represent changes in industries and confirm coverage between the years of the Economic Census.
We are not proposing any major changes to the collection. Minimal changes are being made to the economic activity descriptions in the primary business activity question on the SQ-CLASS report. These changes include providing additional examples of activities included in a specific economic sector. Respondents will continue to choose the economic sector of their business and then select their type of business from a list of business activities based on their response to the question about their economic sector. These selections correspond to NAICS codes, which are then assigned to each business establishment. If the respondents do not see their business activity listed, then they will provide a brief description of their business activity. The response is then assigned a NAICS code by an analyst using an automated coding tool. This is the same methodology that the Census Bureau uses in the Economic Census to assign industry classification.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Economic Development Administration, U.S. Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
First Responder Network Authority (“FirstNet Authority”), U.S. Department of Commerce.
Notice of open public meetings.
The Board of the First Responder Network Authority (“FirstNet Authority Board”) will convene a meeting of the FirstNet Authority Board and the Committees of the FirstNet Authority Board (“Board Committees”) that will be open to the public via teleconference and WebEx on August 13, 2018.
A combined meeting of the Board Committees and the FirstNet Authority Board will be held on August 13, 2018, between 11:00 a.m. and 12:00 p.m., Eastern Daylight Time (EDT). The meeting of the FirstNet Authority Board and the Governance and Personnel, Technology, Public Safety Advocacy, and Finance Committees will be open to the public via teleconference and WebEx only from 11:00 a.m. to 12:00 p.m. EDT.
The combined meeting of the FirstNet Authority Board and Board Committees will be conducted via teleconference and WebEx only. Members of the public may listen to the meeting by dialing toll free 1-877-917-6910 and using passcode 3324054. To view the slide presentation, the public may visit the URL:
Karen Miller-Kuwana, Board Secretary, FirstNet Authority, 12201 Sunrise Valley Drive, M/S 243, Reston, VA 20192; telephone: (571) 665-6177; email:
This notice informs the public that the FirstNet Authority Board and Board Committees will convene a combined meeting open to the public via teleconference and WebEx only on August 13, 2018.
If you experience technical difficulty, please contact the Conferencing Center customer service at 1-866-900-1011. Public access will be limited to listen-only. Due to the limited number of ports, attendance via teleconference will be on a first-come, first-served basis.
The FirstNet Authority Board and Combined Committee Meeting is accessible to people with disabilities. Individuals requiring accommodations are asked to notify Ms. Miller-Kuwana by telephone (571) 665-6177 or email at
The Bureau of Industry and Security (BIS) is announcing a recruitment for new candidates to serve on the Emerging Technology Technical Advisory Committee (ETTAC) to advise the Department of Commerce and other agency officials on emerging technologies with potential dual-use applications. This advice will include: (a) The identification of such technologies as early as possible in their developmental stages both within the United States and abroad; (b) assessing and providing information on emerging technologies, potential “chokepoint technologies” (for example, technologies that, if developed by an adversary prior to development by the United States, could present grave threats to United States national and/or economic security) and trends in technologies of particular interest to BIS; (c) assessing the potential impact of the Export Administration Regulations (EAR) on research activities, including technical and policy issues relating to controls under the EAR, revisions of the Commerce Control List, including proposed revisions of multilateral controls in which the United States participates, and the issuance of regulations; and (d) any other matters relating to actions designed to carry out the policy set forth in Section 3(2)(A) of the Export Administration Act of 1979 as well as the directives contained in Section 1758 of H.R. 5515, the John S. McCain National Defense Authorization Act for Fiscal Year 2019. In its work, the Committee will be forward leaning—focusing both on the current state of emerging technologies and projecting their likely effects five to ten years in the future on national security, the U.S. defense industrial base, and the overall health and competitiveness of the U.S. economy.
The ETTAC will consist of experts drawn from academia, industry, federal laboratories, and pertinent U.S. Government departments and agencies who are engaged in developing and producing cutting edge technology in areas key to maintaining a U.S. forward leaning presence in the world economy. ETTAC members are appointed by the Secretary of Commerce and serve terms of two years, and may not serve more than four consecutive years. The membership term limit reflects the Department's commitment to attaining balance and diversity. As a general rule members will be highly ranked, accomplished and recognized leaders, engineers, and scientists working in their disciplines as researchers and/or program managers. All members must be able to qualify for a Secret security clearance or a security clearance at a level sufficient to perform their work for the committee. The ETTAC will also reach out to other government and non-government experts to ensure a broad and thorough review of the issues. The ETTAC meets approximately four times per year. Members of the Committee will not be compensated for their services.
To respond to this recruitment notice, please send a copy of your resume to Ms. Yvette Springer at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On June 22, 2018, the United States Court of International Trade (the CIT) entered final judgment sustaining the Department of Commerce's (Commerce) remand results pertaining to the final determination in the antidumping duty (AD) investigation on certain corrosion-resistant steel products (CORE) from the Republic of Korea (Korea) for Hyundai Steel Company (Hyundai). Commerce is notifying the public that the final judgment in this case is not in harmony with the final determination, and that
June 22, 2018.
Chloee Sagmoe or Elfi Blum, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2273 and (202) 482-0197, respectively.
On June 2, 2016, Commerce published the
On January 10, 2018, the CIT remanded for Commerce to provide Hyundai with an opportunity to remedy the deficiencies at issue for its further manufactured sales of skelp, sheet, and blanks (SSBs), and to recalculate Hyundai's overall margin.
In light of the Court's remand order, on May 3, 2018, Commerce released the
On June 22, 2018, the CIT sustained the Department's
In its decision in
Because there is now a final court decision, we are amending the
Commerce will issue revised cash deposit instructions to CBP, adjusting the cash deposit rate for Hyundai to 7.88 percent and the “all-others” cash deposit rate to 8.31 percent, effective July 2, 2018.
This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is amending the preliminary determination of the less-than-fair-value (LTFV) investigation of common alloy aluminum sheet (aluminum sheet) from the People's Republic of China (China) to correct a significant ministerial error.
Applicable August 8, 2018.
Deborah Scott or Scott Hoefke, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2657 or (202) 482-4947, respectively.
On June 22, 2018, Commerce published in the
The period of investigation is April 1, 2017 through September 30, 2017.
The product covered by this investigation is aluminum sheet from China. For a complete description of the scope of this investigation,
Commerce will analyze any comments received and, if appropriate, correct any significant ministerial error by amending the preliminary determination according to 19 CFR 351.224(e). A ministerial error is defined in 19 CFR 351.224(f) as “an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.”
Pursuant to 19 CFR 351.224(e) and (g)(1), Commerce is amending the
Mingtai is the only mandatory respondent for which Commerce calculated a weighted-average dumping margin in the
In the
The collection of cash deposits and suspension of liquidation will be revised according to the rates calculated in this amended preliminary determination. Because these amended rates result in reduced cash deposits, the amended rate for Mingtai will be effective retroactively to June 22, 2018, the date of publication of the
Commerce preliminarily determines that the following estimated weighted-average antidumping duty margins exist:
We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the amended preliminary determination, in accordance with 19 CFR 351.224.
In accordance with section 733(f) of the Act, we will notify the International Trade Commission of our amended preliminary determination.
This amended preliminary determination is issued and published pursuant to sections 733(f) and 777(i) of the Act and 19 CFR 351.224(e).
The merchandise covered by this investigation is aluminum common alloy sheet (common alloy sheet), which is a flat-rolled aluminum product having a thickness of 6.3 mm or less, but greater than 0.2 mm, in coils or cut-to-length, regardless of width. Common alloy sheet within the scope of this investigation includes both not clad aluminum sheet, as well as multi-alloy, clad aluminum sheet. With respect to not clad aluminum sheet, common alloy sheet is manufactured from a 1XXX-, 3XXX-, or 5XXX-series alloy as designated by the Aluminum Association. With respect to multi-alloy, clad aluminum sheet, common alloy sheet is produced from a 3XXX-series core, to which cladding layers are applied to either one or both sides of the core.
Common alloy sheet may be made to ASTM specification B209-14, but can also be made to other specifications. Regardless of specification, however, all common alloy sheet meeting the scope description is included in the scope. Subject merchandise includes common alloy sheet that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the common alloy sheet.
Excluded from the scope of this investigation is aluminum can stock, which is suitable for use in the manufacture of aluminum beverage cans, lids of such cans, or tabs used to open such cans. Aluminum can stock is produced to gauges that range from 0.200 mm to 0.292 mm, and has an H-19, H-41, H-48, or H-391 temper. In
Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set for the above.
Common alloy sheet is currently classifiable under HTSUS subheadings 7606.11.3060, 7606.11.6000, 7606.12.3090, 7606.12.6000, 7606.91.3090, 7606.91.6080, 7606.92.3090, and 7606.92.6080. Further, merchandise that falls within the scope of this investigation may also be entered into the United States under HTSUS subheadings 7606.11.3030, 7606.12.3030, 7606.91.3060, 7606.91.6040, 7606.92.3060, 7606.92.6040, 7607.11.9090. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that certain plastic decorative ribbon (plastic ribbon) from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less than fair value (LTFV), for the period of investigation (POI) April 1, 2017, through September 30, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable August 8, 2018.
Nancy Decker, Lauren Caserta, or Caitlin Monks, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0196, (202) 482-4737, or (202) 482-2670, respectively.
Commerce published the notice of initiation of this investigation on January 23, 2018.
The product covered by this investigation is plastic ribbon from China. For a full description of the scope of this investigation,
In accordance with the preamble to the Commerce's regulations,
Commerce is conducting this investigation in accordance with section 731 of the Act. Export prices have been calculated in accordance with section 772(a) of the Act. Because China is a non-market economy within the meaning of section 771(18) of the Act, we calculated normal value (NV) in accordance with section 773(c) of the Act. In addition, Commerce has preliminarily relied upon facts available under section 776(a)(1) of the Act, including the use of an adverse inference under section 776(b) of the Act, for determining the antidumping margin for one producer and exporter combination, as well as for the China-wide entity. For a full description of the methodology underlying our preliminary conclusions,
In the
Commerce preliminarily determines that the following weighted-average dumping margins exist:
As detailed in the Preliminary Decision Memorandum, because parties to whom we issued Q&V questionnaires did not provide timely quantity and value questionnaire responses or separate rate applications,
In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of plastic ribbon from China as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the weighted-average amount by which the NV exceeds U.S. price as follows: (1) The cash deposit rate for the exporter/producer combination listed in the table above will be the rate identified for that combination in the table; (2) for all combinations of Chinese exporters/producers of merchandise under consideration that have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate established for the China-wide entity, 370.04 percent; and (3) for all non-Chinese exporters of the merchandise under consideration which have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate applicable to the Chinese exporter/producer combination that supplied that non-Chinese exporter. These suspension of liquidation instructions will remain in effect until further notice.
We will disclose the calculations performed to parties to this proceeding within five days of the date of announcement of this preliminary determination in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs, rebuttal briefs, and hearing requests.
In accordance with section 733(f) of the Act, we will notify the United States International Trade Commission (ITC) of our affirmative preliminary determination of sales at LTFV. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for
The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.
The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.
Subject merchandise includes “pull-bows” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (
Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base which permits attachment to an object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having a diameter of less than seven-eighths (
The scope of the investigation is not intended to include shredded plastic film or shredded plastic strip, in each case where the shred does not exceed 5 mm in width and does not exceed 18 inches in length, imported in bags.
Further, excluded from the scope of the antidumping duty investigation are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China).
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable August 8, 2018.
Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230, telephone: (202) 482-3692.
On April 25, 2018, the Department of Commerce (Commerce), pursuant to section 702(h) of the Trade Agreements Act of 1979 (as amended) (the Act), published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period October 1, 2017, through December 31, 2017.
Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period January 1, 2018, through March 31, 2018. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available.
Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed. Commerce encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230.
This determination and notice are in accordance with section 702(a) of the Act.
National Institute of Standards and Technology (NIST), Commerce.
Notice.
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before October 9, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 1401 Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Dr. Brandi Toliver, NIST, 100 Bureau Drive, Stop 1090, Gaithersburg, MD 20899-1090, tel. (301) 972-2371, or
The purpose of this collection is to gather information requested on behalf of the NIST Summer Undergraduate Research Fellowship (SURF) Program for both Gaithersburg and Boulder locations. The information is submitted by the university on behalf of the student applicants. The student information is utilized by laboratory program coordinators and technical evaluators to determine student eligibility, select students to appropriate research projects which match their needs, interests, and academic preparation, and ultimately, make offers to participate in the program. The information includes: Student name, host institution, email address/contact information, permanent address, choice of SURF-specific location (Boulder and/or Gaithersburg), class standing, first-
The Student Application Information form will be available on the web. The collection is currently limited to paper form and is
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to Virginia Electric and Power Company d/b/a Dominion Energy Virginia (Dominion) for the take marine mammals, by harassment, incidental to high-resolution geophysical (HRG) surveys associated with unexploded ordnance investigation activities off the coast of Virginia in the area of the Research Lease of Submerged Lands for Renewable Energy Activities on the Outer Continental Shelf Offshore Virginia (OCS-A 0497) and coastal waters where one or more cable route corridors will be established (the Survey Area).
This Authorization is in effect for one year from the date of issuance.
Dale Youngkin, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the applications and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the internet at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On March 7, 2018, NMFS received a request from Dominion for an IHA to take marine mammals incidental to high resolution geophysical (HRG) surveys off the coast of Virginia. The purpose of these surveys are to acquire data regarding the potential presence of UXO within the proposed construction and operational footprints of the Coastal Virginia Offshore Wind (CVOW) Project Area in the Lease Area and export cable route construction corridor (Survey Area). A revised application was received on April 26, 2018. NMFS deemed that request to be adequate and complete. Dominion's request is for take of nine marine mammal species by Level B harassment. Neither Dominion nor NMFS expects injury, serious injury or mortality to result from this activity and the activity is expected to last no more than one year, therefore, an IHA is appropriate.
Dominion proposes to conduct marine site characterization surveys including HRG surveys to search for UXO in the marine environment of the approximately 2,135-acre Lease Area located offshore of Virginia (see Figure 1-1 in the IHA application). Additionally, an export cable route will be established between the Lease Area and Virginia Beach, identified as the Export Cable Route Area (see Figure 1 in the IHA application). See the IHA application for further information. The survey area consists of two 1-kilometer (km) X 1-km turbine position locations, a 2 km by 300 meter (m) Inter-array cable route connecting the two turbine position locations, and a 43-km X 300 m Export Corridor Route. For the purpose of this IHA, the survey area is designated as the Lease Area and cable route corridors. Water depths across the Lease Area are estimated to range from approximately 8 to 40 m (26 to 131 feet (ft)) while the cable route corridors will extend to shallow water areas near landfall locations. Surveys would begin no earlier than August 1, 2018 and are anticipated to last for up to three months.
The purpose of the marine site characterization surveys are to acquire data regarding the potential presence of UXO within the proposed construction and operational footprints of the CVOW Project Area (
Surveys will last for approximately three months and are anticipated to commence no earlier than August 1, 2018. This schedule is based on 24-hour operations and includes potential down time due to inclement weather. Based on 24-hour operations, the estimated duration of the HRG survey activities would be approximately 60 days for the export cable route corridor and approximately 15 days each for the inter-array cable route and wind turbine positions.
Dominion's survey activities will occur in the approximately 2,135-acre Research Lease Area located off the coast of Virginia (see Figure 1 in the IHA application). Additionally, a cable route corridor would be surveyed between the Lease Area and the coast of Virginia. The cable route corridor to be surveyed is anticipated to be 300 m wide and 43 km long. The wind turbine positions to be surveyed are twoapproximately 1 km X 1 km square areas connected by an inter-array cable route that is 300 m wide and 2 km in length.
A detailed description of the planned survey activities, including types of survey equipment planned for use, is provided in the
NMFS published a notice of proposed IHA in the
Importantly, such renewals would be limited to circumstances where: The activities are identical or nearly identical to those analyzed in the proposed IHA; monitoring does not indicate impacts that were not previously analyzed and authorized; and, the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the
Sections 3 and 4 of Dominion's IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected marine mammal species. Additional information regarding population trends and threats
Table 1 lists all species with expected potential for occurrence in the survey area and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2017). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR is included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2017 draft SARs (
All species that could potentially occur in the proposed survey areas are included in Table 1. However, the temporal and/or spatial occurrence for all but 11 of the species listed in Table 2 is such that take of these species is not expected to occur, and they are not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area, are known to occur further offshore or further north than the project area, or are considered very unlikely to occur in the project area during the proposed survey due to the species' seasonal occurrence in the area. The 11 species/stocks evaluated for incidental take in the proposed IHA included: North Atlantic right whale; humpback whale; fin whale; minke whale; Atlantic white-sided dolphin; common dolphin; bottlenose dolphin; Atlantic spotted dolphin; long-finned pilot whale; short-finned pilot whale; and harbor porpoise. However, as discussed below, takes for harbor seals and gray seals have been authorized as a result of consideration of public comment on the proposed IHA.
Five marine mammal species listed in Table 2 are listed under the ESA and are known to be present, at least seasonally, in waters of the mid-Atlantic (sperm whale, north Atlantic right whale, fin whale, blue whale, and sei whale). All of these species are highly migratory and do not spend extended periods of time in the localized survey area. The offshore waters of Virginia (including the survey area) are primarily used as a migration corridor for these species, particularly north Atlantic right whales, during seasonal movements north or south between feeding and breeding grounds (Knowlton
A detailed description of the species likely to be affected by Dominion's UXO survey activities, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the
The potential effects of Dominion's UXO survey activities have the potential to result in incidental take of marine mammals by harassment in the vicinity of the survey area. The
This section provides an estimate of the number of incidental takes authorized through this IHA, which informed both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes would be by Level B harassment only, as use of the HRG equipment has the potential to result in disruption of behavioral patterns for individual marine mammals. NMFS has determined take by Level A harassment is not an expected outcome of the proposed activity as discussed in greater detail below. As described previously, no mortality or serious injury is anticipated, nor is any authorized for this activity. Below we describe how the take is estimated for this project.
Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. Below, we describe these components in more detail and present the take estimate.
NMFS uses acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in Table 2 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that feed into estimating the area ensonified above the acoustic thresholds.
The proposed survey would entail the use of HRG survey equipment. The distance to the isopleth corresponding to the threshold for Level B harassment was calculated for all HRG survey equipment with the potential to result in harassment of marine mammals (see Table 1 of the Proposed IHA (83 FR 26968; June 11, 2018)). Of the HRG survey equipment planned for use that has the potential to result in harassment of marine mammals, acoustic modeling indicated the Innomar Medium 100 sub-bottom profiler would be expected to produce sound that would propagate the furthest in water (Table 3); therefore, for the purposes of the take calculation, it was assumed this equipment would be active during the entirety of the survey. Thus the distance to the isopleth corresponding to the threshold for Level B harassment for the Innomar Medium 100 sub-bottom profiler (100 m; Table 3) was used as the basis of the Level B take calculation for all marine mammals. However, this sound source operates at frequencies that are 50 kHz beyond the best hearing capabilities of LF cetaceans, so there is no potential for behavioral harassment of these species. The sound source with the next-largest Level B harassment threshold distance was the Geo-Source 800 sparker and this distance is 20 m, which is well within the required 100-m exclusion zone for large whales. Therefore, no take for LF cetaceans have been authorized.
Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 4), were also calculated by Dominion. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2016) were presented as dual metric acoustic thresholds using both SEL
In this case, due to the very small estimated distances to Level A harassment thresholds for all marine mammal functional hearing groups, based on both SEL
We note that because of some of the assumptions included in the methods used, isopleths produced may be overestimates to some degree. The acoustic sources proposed for use in Dominion's survey do not radiate sound equally in all directions but were designed instead to focus acoustic energy directly toward the sea floor. Therefore, the acoustic energy produced by these sources is not received equally in all directions around the source but is instead concentrated along some narrower plane depending on the beamwidth of the source. For example, in the case of the Innomar Medium 100 sub-bottom profiler, the beamwidth is only one degree. However, the calculated distances to isopleths do not account for this directionality of the sound source and are therefore conservative. For mobile sources, such as the proposed survey, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed. In addition to the conservative estimation of calculated distances to isopleths associated with the Innomar Medium 100 sub-bottom profiler, calculated takes may be conservative due to the fact that this sound source operates at frequencies beyond the best hearing capabilities of LF cetaceans, but calculated takes for all species were based on the isopleths associated with this sound source. As discussed above, the Innomar Medium 100 sub-bottom profiler operates at frequencies between 85 and 115 kHz and the best hearing range of LF cetaceans is between 7 and 35 kHz. Therefore, we would not expect that take of LF cetaceans would likely occur due to the use of this equipment because it operates beyond their hearing capabilities. The proposed IHA (83 FR 26968, June 11, 2018) noted takes were estimated based on these isopleths due to the fact that the largest distances were associated with this equipment. However, after consideration of public comments, NMFS has determined not to issue take of LF cetaceans for the following reasons: (1) the Innomar Medium 100 sub-bottom profiler operates at frequencies that are 50 kHz beyond the best hearing capabilities for these species, so there would be no potential for behavioral disturbance, and (2) the sound source with the next largest Level B harassment isopleth is the Geo-Source 800 Sparker, for which the distance to the Level B harassment threshold has been calculated to be 20 m, and this is well within the required 100-m exclusion zone (EZ) for large whales.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
The best available scientific information was considered in conducting marine mammal exposure estimates (the basis for estimating take). For cetacean species, densities calculated by Roberts
For the purposes of the take calculations, density data from Roberts
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day of the survey is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and estimated trackline distance traveled per day by the survey vessel. The estimated daily vessel track line distance was determined using the estimated average speed of the vessel (4 kn) multiplied by 24 (to account for the 24 hour operational period of the survey). Using the maximum distance to the regulatory threshold criteria (Tables 4 and 5) and estimated daily track line distance of approximately 177.8 km (110.5 mi), it was estimated that an area of 35.59 km
The number of marine mammals expected to be incidentally taken per day is then calculated by estimating the number of each species predicted to occur within the daily ensonified area, using estimated marine mammal densities as described above. In this case, estimated marine mammal density values varied between the turbine positions, inter-array cable route corridor survey areas, and export cable route corridors; therefore, the estimated number of each species taken per survey day was calculated separately for the these survey areas. Estimated numbers of each species taken per day are then multiplied by the number of survey days to generate an estimate of the total number of each species expected to be taken over the duration of the survey. In this case, as the estimated number of each species taken per day varied depending on survey area (turbine positions, inter-array cable route, and export cable route corridor), the number of each species taken per day in each respective survey area was multiplied by the number of survey days anticipated in each survey area (
As described above, due to the very small estimated distances to Level A harassment thresholds (based on both SEL
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned), and;
(2) The practicability of the measures for applicant implementation, which may consider such things as relative cost and impact on operations.
With NMFS' input during the application process, and as per the BOEM Lease, Dominion must implement the following mitigation measures during the proposed marine site characterization surveys.
Marine mammal exclusion zones (EZ) must be established around the HRG survey equipment and monitored by protected species observers (PSO) during HRG surveys as follows:
• 50 m (164.0 ft) EZ for harbor porpoises, which is the extent of the largest calculated distance to the potential for onset of PTS (Level A harassment);
• 100 m (328.1 ft) EZ for ESA-listed large whales (
• 500 m (1,640.4 ft) EZ for North Atlantic right whales. In addition, PSOs must visually monitor to the extent of the Level B zone (100 m (328.1 ft)) for all other marine mammal species not listed above.
Visual monitoring of the established exclusion and monitoring zones must be performed by qualified and NMFS-approved PSOs. It must be the responsibility of the Lead PSO on duty to communicate the presence of marine mammals as well as to communicate and enforce the action(s) that are necessary to ensure mitigation and monitoring requirements are implemented as appropriate. PSOs must be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars must also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Digital single-lens reflex camera equipment must be used to record sightings and verify species identification. During surveys conducted at night, night-vision equipment and infrared technology must be available for PSO use.
For all HRG survey activities, Dominion must implement a 30-minute pre-clearance period of the relevant EZs prior to the initiation of HRG survey equipment. During this period the EZs must be monitored by PSOs, using the appropriate visual technology for a 30-minute period. HRG survey equipment must not be initiated if marine mammals are observed within or approaching the relevant EZs during this pre-clearance period. If a marine mammal were observed within or approaching the relevant EZ during the
Where technically feasible, a ramp-up procedure must be used for HRG survey equipment capable of adjusting energy levels at the start or re-start of HRG survey activities. The ramp-up procedure must be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the survey area by allowing them to vacate the area prior to the commencement of survey equipment use at full energy. A ramp-up must begin with the power of the smallest acoustic equipment at its lowest practical power output appropriate for the survey. When technically feasible the power must then be gradually turned up and other acoustic sources added in way such that the source level would increase gradually.
If a marine mammal is observed within or approaching the relevant EZ (as described above) an immediate shutdown of the survey equipment is required. Subsequent restart of the survey equipment must only occur after the animal(s) has either been observed exiting the relevant EZ or until an additional time period has elapsed with no further sighting of the animal (15 minutes for harbor porpoises and 30 minutes for all other species).
If the HRG equipment shuts down for reasons other than mitigation (
Dominion must ensure that vessel operators and crew maintain a vigilant watch for cetaceans and pinnipeds by slowing down or stopping the vessel to avoid striking marine mammals. Survey vessel crew members responsible for navigation duties must receive site-specific training on marine mammal sighting/reporting and vessel strike avoidance measures. Vessel strike avoidance measures must include, but are not limited to, the following, except under circumstances when complying with these requirements would put the safety of the vessel or crew at risk:
• All vessel operators and crew must maintain vigilant watch for cetaceans and pinnipeds, and slow down or stop their vessel to avoid striking these protected species;
• All vessel operators must comply with 10 kn (18.5 km/hr) or less speed restrictions in any DMA. This applies to all vessels operating at any time of year. In addition (if applicable, as surveys are not anticipated to occur during this time of year), vessels over 19.8 m (65 ft) operating from November 1 through April 30 must operate at speeds of 10 kn or less;
• All vessel operators must reduce vessel speed to 10 kn (18.5 km/hr) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinoid cetaceans are observed near (within 100 m (330 ft)) an underway vessel;
• All survey vessels must maintain a separation distance of 500 m (1640 ft) or greater from any sighted North Atlantic right whale;
• If underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 kn (18.5 km/hr) or less until the 500 m (1640 ft) minimum separation distance has been established. If a North Atlantic right whale is sighted in a vessel's path, or within 500 m (1640 ft)) to an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Engines must not be engaged until the North Atlantic right whale has moved outside of the vessel's path and beyond 500 m. If stationary, the vessel must not engage engines until the North Atlantic right whale has moved beyond 100 m;
• All vessels must maintain a separation distance of 100 m (330 ft) or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel must not engage engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m;
• All vessels must maintain a separation distance of 100 m or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel must not engage the engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m.
• Any vessel underway must remain parallel to a sighted delphinoid cetacean's course whenever possible, and avoid excessive speed or abrupt changes in direction. Any vessel underway must reduce vessel speed to 10 kn (18.5 km/hr) or less when pods (including mother/calf pairs) or large assemblages of delphinoid cetaceans are observed. Vessels must not adjust course and speed until the delphinoid cetaceans have moved beyond 50 m and/or the abeam of the underway vessel;
• All vessels underway must not divert or alter course in order to approach any whale, delphinoid cetacean, or pinniped. Any vessel underway must avoid excessive speed or abrupt changes in direction to avoid injury to the sighted cetacean or pinniped; and
• All vessels must maintain a separation distance of 50 m (164 ft) or greater from any sighted pinniped.
Between watch shifts, members of the monitoring team must consult NMFS' North Atlantic right whale reporting systems for the presence of North Atlantic right whales throughout survey operations. The proposed survey activities will occur in the vicinity of the Right Whale Mid-Atlantic SMA located at the mouth of the Chesapeake Bay. The proposed survey start date in August, 2018 and would last for up to three months. Therefore, it is possible that the HRG survey activities would occur outside of the seasonal mandatory speed restriction period for this SMA (November 1 through April 30). Members of the monitoring team must monitor the NMFS North Atlantic right
These mitigation measures are designed to avoid the already low potential for injury in addition to some Level B harassment, and to minimize the potential for vessel strikes. There are no known marine mammal feeding areas, rookeries, or mating grounds in the survey area that would otherwise potentially warrant increased mitigation measures for marine mammals or their habitat (or both). The proposed survey would occur in an area that has been identified as a biologically important area for migration for North Atlantic right whales. However, given the small spatial extent of the survey area relative to the substantially larger spatial extent of the right whale migratory area, the survey is not expected to appreciably reduce migratory habitat nor to negatively impact the migration of North Atlantic right whales, thus additional mitigation to address the proposed survey's occurrence in North Atlantic right whale migratory habitat is not warranted. Further, these mitigation measures are practicable for the applicant to implement.
Based on our evaluation of the mitigation measures, NMFS has determined that the measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
As described above, visual monitoring of the EZs and monitoring zone must be performed by qualified and NMFS-approved PSOs. Observer qualifications must include direct field experience on a marine mammal observation vessel and/or aerial surveys and completion of a PSO training program, as appropriate. An observer team comprising a minimum of four NMFS-approved PSOs operating in shifts, must be employed by Dominion during the proposed surveys. PSOs must work in shifts such that no one monitor must work more than 4 consecutive hours without a 2 hour break or longer than 12 hours during any 24-hour period. During daylight hours the PSOs must rotate in shifts of one on and three off, while during nighttime operations PSOs must work in pairs. During ramp-up procedures, two PSOs must be required. Each PSO must monitor 360 degrees of the field of vision.
Also as described above, PSOs must be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars must also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Digital single-lens reflex camera equipment must be used to record sightings and verify species identification. During night operations, night-vision equipment, and infrared technology must be used to increase the ability to detect marine mammals. Position data must be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations must take place from the highest available vantage point on the survey vessel. General 360-degree scanning must occur during the monitoring periods, and target scanning by the PSO must occur when alerted of a marine mammal presence.
Data on all PSO observations must be recorded based on standard PSO collection requirements. This must include dates and locations of survey operations; time of observation, location and weather; details of the sightings (
Dominion must provide the following reports as necessary during survey activities:
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities must not resume until NMFS is able to review the circumstances of the event. NMFS shall work with Dominion to minimize reoccurrence of such an event in the future. Dominion must not resume activities until notified by NMFS.
In the event that Dominion discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that Dominion discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (
Within 90 days after completion of survey activities, a final technical report must be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, estimates the number of marine mammals estimated to have been taken during survey activities, and provides an interpretation of the results and effectiveness of all mitigation and monitoring. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival. A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, our analysis applies to all the species listed in Tables 8 and 9, given that NMFS expects the anticipated effects of the proposed survey to be similar in nature.
NMFS does not anticipate that injury, serious injury, or mortality would occur as a result of Dominion's proposed survey, even in the absence of mitigation. Thus the authorization does not authorize any serious injury or mortality. Non-auditory physical effects and vessel strike are not expected to occur.
We expect that most potential takes would be in the form of short-term Level B behavioral harassment in the form of temporary avoidance of the area or decreased foraging (if such activity were occurring), reactions that are considered to be of low severity and with no lasting biological consequences (
Potential impacts to marine mammal habitat were discussed in the notice of proposed IHA (83 FR 26968; June 11, 2018, see
The proposed survey area is within a biologically important migratory area for North Atlantic right whales (effective March-April and November-December) that extends from Massachusetts to Florida (LaBrecque,
Mitigation measures are expected to reduce the number and/or severity of takes by (1) giving animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy; (2) preventing animals from being exposed to sound levels that may otherwise result in injury. Additional vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit to and within the survey area.
NMFS concludes that exposures to marine mammal species and stocks due to Dominion's proposed survey would result in only short-term (temporary and short in duration) effects to individuals exposed. Marine mammals may temporarily avoid the immediate area, but are not expected to permanently abandon the area. Major shifts in habitat use, distribution, or foraging success are not expected. NMFS does not anticipate the authorized take estimates to impact annual rates of recruitment or survival.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No mortality or serious injury is anticipated or authorized;
• No injury is anticipated or authorized;
• The anticipated impacts of the proposed activity on marine mammals would be limited to temporary behavioral changes due to avoidance of the area around the survey vessel;
• Alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the proposed survey and avoid exposure to sounds from the activity are available;
• The proposed project area does not contain areas of significance for feeding, mating or calving;
• Effects on species that serve as prey species for marine mammals from the proposed survey are expected to be minimal;
• Mitigation measures, including visual and acoustic monitoring and shutdowns, are expected to minimize potential impacts to marine mammals.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The numbers of marine mammals that we authorized to be taken would be considered small relative to the relevant stocks or populations for all species and stocks (less than 10 percent of bottlenose dolphin stocks, and less than 1 percent of each of the other species and stocks). See Tables 6 and 7. Based on the analysis contained herein of the proposed activity (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review. We have reviewed all comments submitted in response to the proposed IHA notice prior to concluding our NEPA process and making this final decision on the IHA request.
Section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1531
The NMFS Office of Protected Resources is proposing mitigation to avoid the incidental take of the species of marine mammals which are likely to be present and are listed under the ESA: The North Atlantic right and fin whales. Therefore, consultation under section 7 of the ESA is not required.
NMFS has issued an IHA to Dominion for conducting UXO surveys offshore Virginia for a period of one year, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general
Written comments must be submitted on or before October 9, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Liz Sullivan, (978) 282-8493 or
This request is for an extension of a current information collection. Under the Magnuson-Stevens Fishery Conservation and Management Act (MSA), the Secretary of Commerce has the responsibility for the conservation and management of marine fishery resources. We, National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS), and the Regional Fishery Management Councils are delegated the majority of this responsibility. The New England Fishery Management Council (Council) develops management plans for fishery resources in New England.
In 2010, we implemented a new suite of regulations for the Northeast (NE) multispecies fishery through Amendment 16 to the NE Multispecies Fishery Management Plan (FMP). This action updated status determination criteria for all regulated NE multispecies or ocean pout stocks; adopted rebuilding programs for NE multispecies (groundfish) stocks newly classified as being overfished and subject to overfishing; revised management measures, including significant revisions to the sector management measures (established under Amendment 13) necessary to end overfishing, rebuild overfished regulated NE multispecies and ocean pout stocks, and mitigate the adverse economic impacts of increased effort controls. It also implemented new requirements under Amendment 16 for establishing acceptable biological catch (ABC), annual catch limits (ACLs), and accountability measures (AMs) for each stock managed under the FMP, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Sectors are a management tool in the NE groundfish fishery. A sector consists of three or more limited access NE multispecies vessel permits, with distinct ownership, who voluntarily enter into a contract to manage their fishing operations and to share liability. A sector is granted an annual allocation of most stocks of fish managed by the NE Multispecies FMP. In return for increased operational flexibility, such as exemptions from certain effort controls and the ability to pool and trade quota, sectors have additional reporting and monitoring requirements. The sector reporting and monitoring requirements, as established by Amendment 16 and revised by subsequent framework adjustments to the NE Multispecies FMP, are contained within this information collection.
Respondents must submit either paper forms via postal service, or electronic forms submitted via the internet or a vessels' vessel monitoring system (VMS).
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 (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before October 9, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to: Celeste Leroux at (301) 427-8372 or
The Seafood Traceability Program (
NMFS had stayed requirements for abalone and shrimp because gaps existed in the collection of traceability information for domestic aquaculture-raised shrimp and abalone, which is currently largely regulated at the state level. During development of the Seafood Traceability Program, NMFS explored the possibility of working with its state partners to establish reporting and recordkeeping requirements for aquaculture traceability information that could be shared with NMFS. However, this did not prove to be a viable approach.
On March 23, 2018, the Consolidated Appropriations Act of 2018 (Pub. L. 115-141) was signed by the President and became law. Section 539 of Division B of the Act directed the Secretary of Commerce to, within 30 days, “lift the stay on the effective date of the final rule for the Seafood Traceability Program published by the Secretary on December 9, 2016, (81 FR 88975
The Program consists of two components: (1) Reporting of harvest events at the time of entry; and (2) permitting and recordkeeping requirements with respect to both harvest events and chain of custody information.
The final rule to lift the stay on shrimp and abalone contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA).
OMB had previously approved the information collection requirements for the Seafood Traceability Program under Control Number 0648-0739, but the burden estimates did not include the requirements for shrimp and abalone given the stay. The requirements for permitting, reporting and recordkeeping for imports of shrimp and abalone will be submitted to OMB for approval.
As of the December 31, 2018 compliance date established by the final rule to lift the stay, importers of shrimp and abalone species will be required to obtain an International Fisheries Trade Permit as specified at 50 CFR 300.322, submit harvest and landing information on those products into the U.S. Customs and Border Protection International Trade Data System (ITDS) through the Automated Commercial Environment (ACE) portal prior to entry into U.S. Commerce, and maintain supply chain records from the point of harvest to the point of entry into U.S Commerce for a period of two years after entry.
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 (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of request for nominations.
NMFS is soliciting nominations to the Advisory Committee to the U.S. Section to the International Commission for the Conservation of Atlantic Tunas (ICCAT) as established by the Atlantic Tunas Convention Act (ATCA). NMFS is also soliciting nominations for Technical Advisors to the Advisory Committee's species working groups.
Nominations must be received by October 1, 2018.
Nominations, including a letter of interest and a resume or curriculum vitae, should be sent via email to Terra Lederhouse at
Grace Ferrara, Office of International Affairs and Seafood Inspection; telephone: (301) 427-8371; email:
ICCAT was established to provide an effective program of international cooperation in research and conservation in recognition of the unique problems related to the highly migratory nature of tunas and tuna-like species. The International Convention for the Conservation of Atlantic Tunas (Convention) entered into force in 1969 after receiving the required number of ratifications. The Commission holds its Annual Meeting, usually in November of each year, and convenes meetings of working groups and other ICCAT bodies between annual meetings as needed. Under Section 971a of ATCA (16 U.S.C. 971
Section 971b of ATCA (16 U.S.C. 971
Section 971b-1 of ATCA specifies that the U.S. Commissioners may establish species working groups for the purpose of providing advice and recommendations to the U.S. Commissioners and to the Advisory Committee on matters relating to the conservation and management of any highly migratory species covered by the ICCAT Convention. Any species working group shall consist of no more than seven members of the Advisory Committee and no more than four Technical Advisors, as considered necessary by the Commissioners. Currently, there are four species working groups advising the Committee and the U.S. Commissioners: A Bluefin Tuna Working Group, a Swordfish/Sharks Working Group, a Billfish Working Group, and a Bigeye, Albacore, Yellowfin, and Skipjack (BAYS) Tunas Working Group. Technical Advisors to the species working groups serve at the pleasure of the Commissioners; therefore, the Commissioners can choose to alter these appointments at any time. As with Committee Members, Technical Advisors may not be represented by a proxy during meetings of the Advisory Committee.
Nominations to the Advisory Committee or to a species working group should include a letter of interest and a resume or curriculum vitae. Self-nominations are acceptable. Letters of recommendation are useful but not required. When making a nomination, please specify which appointment (Advisory Committee member or Technical Advisor to a species working group) is being sought. Nominees may also indicate which of the species working groups is preferred, although placement on the requested group is not guaranteed.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Native Americans may conduct certain aboriginal subsistence whaling under the Whaling Convention Act in accordance with the provisions of the International Whaling Commission (IWC). In order to respond to obligations under the International Convention for the Regulation of Whaling, the IWC, and the Whaling Convention Act, whaling captains participating in these operations must submit certain information to the relevant Native American whaling organization about strikes on and catch of whales. Anyone retrieving a dead whale is also required to report. Captains must place a distinctive permanent identification mark on any harpoon, lance, or explosive dart used, and must also provide information on the mark and self-identification information. The relevant Native American whaling organization receives the reports, compiles them, and submits the information to NOAA.
The information is used to monitor the hunt and to ensure that quotas are not exceeded. The information is also provided to the IWC, which uses it to monitor compliance with its requirements.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Under the provisions of the Magnuson-Stevens Fishery and Conservation and Management Act (Magnuson-Stevens Act) [16 U.S.C. 1801
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The National Marine Fisheries Service (NMFS) operates a voluntary fee-for-service seafood inspection program (Program) under the authorities of the Agricultural Marketing Act of 1946, as amended, the Fish and Wildlife Act of 1956, and the Reorganization Plan No. 4 of 1970. The regulations for the Program are contained in 50 CFR part 260. The program offers inspection grading and certification services, including the use of official quality grade marks which indicate that specific products have been Federally inspected. Those wishing to participate in the program must request the services and submit specific compliance information. In July 1992, NMFS announced new inspection services, which were fully based on guidelines recommended by
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Under Secretary of Defense for Acquisition and Sustainment, Department of Defense.
Notice and request for public comment on the Boardman, Oregon, and NAS Patuxent River, Maryland, Geographic Areas of Concern.
The Department of Defense (DoD) is publishing this notice to announce that the Boardman, Oregon, and Naval Air Station (NAS) Patuxent River, Maryland, Geographic Areas of Concern (GAOC) maps are now available for review and to request public comment on the proposed maps. The maps are intended to support outreach efforts by DoD to the energy industry.
The public comment period will end on September 7, 2018.
You may submit comments, identified by DOD-2018-OS-0049, to the following:
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Steven J. Sample, Deputy Director of the Military Aviation and Installation Assurance Siting Clearinghouse, at 703-571-0076 during normal business hours Monday through Friday, from 9:00 a.m. to 5:00 p.m. (EDT) or by email:
Section 183a(d)(2)(B) of title 10, United States Code, provides that, solely for purposes of informing preliminary reviews under section 183a(c)(1) and early outreach efforts under section 183a(c)(5), DoD shall identify distinct geographic areas selected as proposed locations for projects filed, or for projects that are reasonably expected to be filed in the near future, with the Secretary of Transportation pursuant to section 44178 of title 49, United States Code, where the Secretary of Defense can demonstrate such projects could have an adverse impact on military operations and readiness, including military training routes, and categorize the risk of adverse impact in such areas. Section 183a defines adverse impact on military operations and readiness as any impact upon military operations and readiness, including flight operations, research, development, testing, and evaluation and training, that is demonstrable and likely to impair or degrade the ability of the armed forces to perform their warfighting missions. The identification of a GAOC does not equate to a determination that a project in the GAOC would result in an unacceptable risk to the national security of the United States. It only means that such a project would have an adverse impact and requires further review by the Military Aviation and Installation Assurance Siting Clearinghouse.
The Boardman GAOC is identified due to possible effects upon two main DoD military missions. The Naval Weapons Systems Training Facility at Boardman and its associated airspace are the U.S. Navy's primary resource for all airborne electronic attack aircraft air combat maneuver training. This training includes low level aircraft operations. Tall structures, such as wind turbines and electrical transmission lines, constructed under Restricted Airspace (R-5701) and Military Training Routes will prevent the U.S. Navy from fulfilling the training mission. Secondly, the Fossil common air route surveillance radar (CARSR) (a long range radar) in Fossil, Oregon, is a vital resource for the North American Aerospace Defense Command (NORAD). NORAD defends Canada and the United States against air threats, and an accurate “air picture” is essential for NORAD to accomplish its air defense mission. Rotating wind turbine blades can appear as unwanted false targets (clutter) and desensitize the radar, resulting in degraded target acquisition and tracking. Much of the information and data used to establish the GAOC for the Fossil CARSR is not available for public review due to security concerns.
The NAS Patuxent River GAOC is identified due to possible effects upon two DoD military missions. The missions that could be degraded or impaired due to wind turbines are the Advanced Dynamic Aircraft Measurement System (ADAMS) and the Digital Airport Surveillance Radar (DASR), both located at NAS Patuxent River. ADAMS is a national test asset and the Department of Navy's only open-air dynamic radar cross section (RCS) measurement facility supporting all military services as well as other government agencies. ADAMS is used to make precise ground-to-air radar signature measurements during aircraft maneuvers. The DASR is used to facilitate critical safety of flight control instructions for all DoD and civilian aircraft that operate within the confines of the NAS Patuxent River Air Traffic Control (ATC) Area of Responsibility (AoR). ATC services require the ability to use radar to positively identify targets that enter, work within, and depart the AoR to prevent mid-air collision and loss of life. The DASR is also utilized by ATC to monitor air traffic that might attempt to illegally enter the Washington, DC Flight Restricted Zone, thereby posing a significant threat to the national security. Rotating wind turbine blades can appear as unwanted false targets (clutter) and desensitize the radar, resulting in degraded target acquisition and tracking for both the ADAMS and DASR at NAS Patuxent River.
Comments received by the end of the comment period will be considered when making the final findings on the designation of these proposed GAOCs. Any comment, if applying to only one
Maps identifying the Boardman and NAS Patuxent River GAOCs can be viewed in the docket listed above on
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
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.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Description: Baseline eTariff Filing: Master Interconnection Services Agreement to be effective 8/16/2018.
Take notice that the Commission received the following public utility holding company filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
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.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
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.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on July 31, 2018, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Independent Power Producers of New York, Inc. (Complainant) filed a formal complaint against New York Independent System Operator, Inc. (Respondent) alleging that the Respondent is improperly applying its Market Administration and Control Area Services Tariff by allowing resources in the PJM Interconnection, L.L.C. market to deliver installed capacity (ICAP) to New York across merchant transmission facilities that are not qualified to deliver ICAP to New York, all as more fully explained in the complaint.
The Complainant certifies that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
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.
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 notice announces the availability of EPA's proposed interim registration review decisions and opens a 60-day public comment period on the proposed interim decisions for the chemicals listed in the Table in Unit IV of this Notice.
Comments must be received on or before October 9, 2018.
Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the Table in Unit IV, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.
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Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed proposed interim decisions for all pesticides listed in the Table in Unit IV. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
EPA is conducting its registration review of the chemicals listed in the Table in Unit IV pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.
Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim registration review decisions for the pesticides shown in the following table, and opens a 60-day public comment period on the proposed interim decisions.
The registration review docket for a pesticide includes earlier documents related to the registration review case. For example, the review opened with a Preliminary Work Plan, for public comment. A Final Work Plan was placed in the docket following public comment on the Preliminary Work Plan.
The documents in the dockets describe EPA's rationales for conducting additional risk assessments for the registration review of the pesticides included in the table in Unit IV, as well as the Agency's subsequent risk findings and consideration of possible risk mitigation measures. These proposed interim registration review decisions are supported by the rationales included in those documents. Following public comment, the Agency will issue interim or final registration review decisions for the pesticides listed in the table in Unit IV.
The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decision. All comments should be submitted using the methods in
The Agency will carefully consider all comments received by the closing date and may provide a “Response to Comments Memorandum” in the docket. The interim registration review decision will explain the effect that any comments had on the interim decision and provide the Agency's response to significant comments.
Background on the registration review program is provided at:
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
There will be a 4-day, in-person meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review the Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM). Preceding the in-person meeting, there will be a half-day virtual preparatory meeting, conducted via webinar using Adobe Connect, to consider and review the clarity and scope of the meeting's draft charge questions. In addition, EPA is requesting nominations of prospective candidates for service as ad hoc members of FIFRA SAP for this meeting. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates
Submit your written comments, identified by docket identification (ID) number EPA-HQ-OPP-2018-0517, by one of the following methods:
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Additional information on commenting or visiting the docket, along with more information about dockets generally, is available at
Dr. Marquea D. King, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-3626; email address:
This action is directed to the public in general. This action may be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
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You may participate in both meetings by following the instructions in this unit. To ensure proper receipt of comments, nominations or other requests by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2018-0517 in the subject line on the first page of your request.
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The selection of scientists to serve on FIFRA SAP is based on the function of the Panel and the expertise needed to address the Agency's charge to the Panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency, except EPA. Other factors considered during the selection process include availability of the potential Panel member to fully participate in the Panel's review, absence of any conflicts of interest or appearance of loss of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of loss of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on FIFRA SAP. Numerous qualified candidates are identified for each Panel; therefore, selection decisions involve carefully weighing a number of factors, including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the Panel. In order to have the collective breadth of experience needed to address the Agency's peer review charge for this meeting, the Agency anticipates selecting approximately 13 ad hoc scientists.
FIFRA SAP members are subject to the provisions of 5 CFR part 2634—Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. EPA will evaluate the candidate's financial disclosure form to assess whether there are financial conflicts of interest, appearance of a loss of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes and final report. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP website at
The FIFRA SAP serves as one of the primary scientific peer review mechanisms of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health (NIH) and the National Science Foundation (NSF). FIFRA established a Science Review Board (SRB) consisting of at least 60 scientists who are available to FIFRA SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a scientific peer review mechanism, FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.
EPA conducts human health risk assessments to evaluate the potential health effects of pesticides and toxic chemicals in residential and occupational settings based on the use pattern or conditions of use. For evaluating effects via the inhalation route, registrants and manufacturers conduct subchronic inhalation toxicity studies according to test guideline requirements (OPPTS 870.3465, 40 CFR part 798, OECD TG 412 and 413). In these studies, several groups of experimental animals are exposed daily for a defined period to graduated concentrations of test substance as a gas or aerosol/particulate. These studies are used to determine a no observed adverse effect concentration (NOAEC) for effects following repeated inhalation exposure that may be used for human health risk assessment.
The anatomy and physiology of human and animal respiratory tracts differ in several ways that can impact changes in airflow and deposition of inhaled substances and, therefore, influence the animal to human dose response extrapolation. Furthermore, traditional
New approach methodologies (NAMs) has been adopted as a broadly descriptive reference to any non-animal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. An example of a NAM for refining inhalation risk assessment has been submitted to the Agency for the pesticide chlorothalonil. Chlorothalonil is a contact irritant that has been found to be toxic via the inhalation route. Due to the irritant nature of chlorothalonil and animal welfare concerns, the registrant (Syngenta Crop Protection) indicated that a 90-day inhalation toxicity study was not feasible to fulfill the regulatory requirement of a subchronic inhalation study. Subsequently, Syngenta proposed an alternative approach using an in vitro assay (MucilAir
The Agency is soliciting advice from the FIFRA Scientific Advisory Panel (SAP) on the derivation of the POD from the in vitro assay and the integration of the in vitro POD for calculation of human equivalent concentrations for the inhalation risk assessment. Chlorothalonil will be presented as a case study to solicit advice on the proposed overall approach expected to be applied to other pesticides or industrial chemicals in the future.
The 4-day, in-person FIFRA SAP meeting may also be webcast. You may refer to the FIFRA SAP website at
Preceding the in-person meeting, there will be a half-day virtual preparatory meeting, conducted via webinar using Adobe Connect, to consider and review the clarity and scope of the meeting's draft charge questions. The virtual preparatory meeting will be webcast only, and registration is required to attend this virtual meeting. The date and registration instructions will be announced in a future
EPA's background paper, charge/questions to FIFRA SAP, and related supporting materials will be available by early September 2018. In addition, a list of candidates under consideration as prospective ad hoc panelists for this meeting will be available for a 15-day public comment period by early to mid-September 2018. You may obtain electronic copies of most meeting documents, including FIFRA SAP composition (
FIFRA SAP will prepare the meeting minutes and final report approximately 90 calendar days after the in-person meeting. The meeting minutes and final report will be posted on the FIFRA SAP website:
7 U.S.C. 136
Federal Communications Commission.
Notice.
The Federal Communications Commission has received Office of Management and Budget (OMB) approval for a revised information collection pursuant to the Paperwork Reduction Act (PRA) of 1995. An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid OMB control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the
Nicole Ongele, Office of the Managing Director, at (202) 418-2991, or via email:
This revised information collection addresses the removal of those duplicative or otherwise unnecessary
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary by email at
Board of Governors of the Federal Reserve System.
Notice.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies, and the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11 and FR Y-11S; OMB No. 7100-0244); the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations and the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314 and FR 2314S; OMB No. 7100-0073); and the Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations, Abbreviated Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations, and the Capital and Asset Report of Foreign Banking Organizations (FR Y-7N, FR Y-7NS, and FR Y-Q; OMB No. 7100-0125).
The revisions became effective for reports reflecting the June 30, 2018, report date.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC, 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Information collected in these reports generally is not considered confidential. However, because the information is collected as part of the Board's
Information collected in these reports generally is not considered confidential. However, because the information is collected as part of the Board's supervisory process, certain information may be afforded confidential treatment pursuant to exemption 8 of FOIA (5 U.S.C. 552(b)(8)). Individual respondents may request that certain data be afforded confidential treatment pursuant to exemption 4 of the FOIA if the data has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent (5 U.S.C. 552(b)(4)). Additionally, individual respondents may request that personally identifiable information be afforded confidential treatment pursuant to exemption 6 of the FOIA if the release of the information would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552(b)(6)). The applicability of FOIA exemptions 4 and 6 would be determined on a case-by-case basis.
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Senior Financial Officer Survey (FR 2023; OMB No. 7100-0223).
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
The questions asked on each survey will vary, so the ability of the Board to maintain the confidentiality of information collected must be determined on a case by case basis. It is likely that much of the information collected would constitute confidential financial information obtained from a person and would thus be protected from disclosure under exemption 4 to the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4)). Exemption 8 of the FOIA, which protects information related to examination, operating, or condition reports prepared for the use of an agency supervising financial institutions, may also occasionally apply (5 U.S.C. 552(b)(8)).
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to revise, without extension, Capital Assessments and Stress Testing (FR Y-14A/Q/M; OMB No. 7100-0341).
Comments must be submitted on or before October 9, 2018.
You may submit comments, identified by FR Y-14A, FR Y-14Q, or FR Y-14M, by any of the following methods:
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, if approved. These documents will also be made available on the Federal Reserve Board's public website at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal.
• The FR Y-14A collects quantitative projections of balance sheet, income, losses, and capital across a range of macroeconomic scenarios and qualitative information on methodologies used to develop internal projections of capital across scenarios either annually or semi-annually.
• The quarterly FR Y-14Q collects granular data on various asset classes, including loans, securities, and trading assets, and PPNR for the reporting period.
• The monthly FR Y-14M is comprised of three retail portfolio- and loan-level schedules, and one detailed address-matching schedule to supplement two of the portfolio and loan-level schedules.
The data collected through the FR Y-14A/Q/M reports provide the Board with the information and perspective needed to help ensure that large firms have strong, firm-wide risk measurement and management processes supporting their internal assessments of capital adequacy and that their capital resources are sufficient given their business focus, activities, and resulting risk exposures. The annual Comprehensive Capital Analysis and Review (CCAR) exercise complements other Board supervisory efforts aimed at enhancing the continued viability of large firms, including continuous monitoring of firms' planning and management of liquidity and funding resources, as well as regular assessments of credit, market and operational risks, and associated risk management practices. Information gathered in this data collection is also used in the supervision and regulation of these financial institutions. To fully evaluate the data submissions, the Board may conduct follow-up discussions with, or request responses to follow up questions from, respondents. Respondent firms are currently required to complete and submit up to 18 filings each year: two semi-annual FR Y-14A filings, four quarterly FR Y-14Q filings, and 12 monthly FR Y-14M filings. Compliance with the information collection is mandatory.
To rectify the unintended changes, the Board is proposing to revise sub-schedule L.5 (Derivatives and SFT Profile) on the FR Y-14Q by adding the mistakenly omitted items. This modification would allow continued operationalization of supervisory modeling, and would provide for total stressed net current exposure reporting under the two supervisory stressed scenarios.
With the addition of the total stressed net current exposure item, the instructions would be changed to modify the associated ranking methodologies for the yearly stressed/CCAR submission in sub-schedule L.5 to require the top 25 counterparties to be reported as ranked by the total stressed net current exposure. This modification would ensure that top counterparties are properly rank-ordered by the total stressed net current exposure to be added on sub-schedule L.5 in a manner that captures both derivative and securities financing transaction exposures.
The proposed revisions do not result in a change to the estimated burden for this series of reports, as the burden from the proposed revisions is already captured in the burden estimates associated with the FR Y-14Q report.
Federal Trade Commission (FTC).
Notice of modified systems of records.
The FTC is publishing in final form a modification to all FTC Privacy Act system of records notices (SORNs) by amending and bifurcating an existing global routine use relating to assistance in data breach responses, to conform with Office of Management and Budget (OMB) guidance to federal agencies, OMB Memorandum 17-12.
August 8, 2018, except that the new routine use shall be effective September 7, 2018.
G. Richard Gold and Alex Tang, Attorneys, Office of the General Counsel, FTC, 600 Pennsylvania Avenue NW, Washington, DC 20580, (202) 326-2424.
In a document previously published in the
The comment period closed on June 4, 2018, and the FTC received three comments to the proposal to modify and bifurcate an existing routine use relating to assistance in data breach responses. The commenters were Xyampza Kerz, Thomas Dickinson, and Dave Root. Xyampza Kerz's comment expressed concerns about the privacy of homeowner's personal information posted on the Web when they buy a home and about internet searches that allow a searcher to find out your age and possibly lead to discrimination. M/M. Kerz also complains about the practices of an online entity and asks that the entity be shut down. These are important privacy issues but are not
The second commenter, Thomas Dickinson, also filed a comment that is non-germane to the current public notice and comment process. Mr. Dickinson asks the FTC to apply a “monitor” to individuals' home phones that identifies violations of the Do-Not-Call Rule and allows the FTC to take appropriate punitive actions. We have also referred Mr. Dickinson's complaint to the FTC's Consumer Response Center for entry into the Consumer Sentinel Network.
The third commenter, Dave Root, commented that “due process and . . . [his] . . . privacy . . . [would] . . . be harmed by open access to sharing . . . [his] . . . personal info between all government agencies as outlined in this notice.” Mr. Root asked if there are “any safeguards against `political weaponization' without any accountability, by any federal, state or local governmental agency having access to this information.” Mr. Root asked for “`teeth' in the rule for anyone . . . that purposefully uses this information incorrectly . . . [meaning] . . . seriously enforced jail time for anyone who fails to act in the investigation and prosecution process.”
The revised routine use would not provide “open access” to “all government agencies” but would require that the FTC receive a request from another Federal agency or Federal entity that provides enough supporting information such that the FTC can determine that information from an FTC Privacy Act system or systems is reasonably necessary to assist the recipient agency or entity in (a) responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
The Privacy Act specifically provides civil remedies, 5 U.S.C. 552a(g), including damages, and criminal penalties, 5 U.S.C. 552a(i), for violations of the Act. In addition, an individual may be fined up to $5,000 for knowingly and willfully requesting or gaining access to a record about an individual under false pretenses. 5 U.S.C. 552a(i)(3).
As stated in the
The FTC provided a public comment period and notice to OMB and Congress as required by the Privacy Act and implementing OMB guidelines.
Accordingly, the FTC hereby amends Appendix I of its Privacy Act system notices, as published at 73 FR 33591, by revising item number (22), adding new item number (23), and re-designating the former item number (23) as (24) (without any other change) at the end of the existing routine uses set forth in that Appendix:
(22) To appropriate agencies, entities, and persons when (a) the FTC suspects or has confirmed that there has been a breach of the system of records; (b) the FTC has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the FTC (including its information systems, programs, and operations), the Federal Government, or national security; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the FTC's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
(23) To another Federal agency or Federal entity, when the FTC determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (a) responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
(24) May be disclosed to FTC contractors, volunteers, interns or other authorized individuals who have a need for the record in order to perform their officially assigned or designated duties for or on behalf of the FTC.
73 FR 33591-33634 (June 12, 2008).
By direction of the Commission.
Federal Trade Commission (“FTC” or “Commission”).
Notice.
The FTC intends to ask the Office of Management and Budget (“OMB”) to extend for an additional three years the current Paperwork Reduction Act (“PRA”) clearance for the information collection requirements in the FTC Red Flags, Card Issuers, and Address Discrepancies Rules
Comments must be submitted by October 9, 2018.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the
Requests for additional information should be addressed to Mark Eichorn, Assistant Director, Division of Privacy and Identity Protection, Bureau of Consumer Protection, (202) 326-3053, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
The Red Flags Rule requires financial institutions and certain creditors to develop and implement written Identity Theft Prevention Programs (“Program”). The Card Issuers Rule requires credit and debit card issuers (“card issuers”) to assess the validity of notifications of address changes under certain circumstances. The Address Discrepancy Rule provides guidance on what users of consumer reports must do when they receive a notice of address discrepancy from a nationwide consumer reporting agency (“CRA”). Collectively, these three anti-identity theft provisions are intended to prevent impostors from misusing another person's personal information for a fraudulent purpose.
The Rules implement sections 114 and 315 of the FACT Act, Public Law 108-159, which amended the Fair Credit Reporting Act (“FCRA”), 15 U.S.C. 1681
Since promulgation of the original Rule, President Obama signed the Red Flag Program Clarification Act of 2010 (“Clarification Act”), which narrowed the definition of “creditor” for purposes of the Red Flags Rule. Specifically, the Clarification Act limits application of the Red Flags Rule to creditors that regularly and in the ordinary course of business: (1) Obtain or use consumer reports, directly or indirectly, in connection with a credit transaction; (2) furnish information to consumer reporting agencies in connection with a credit transaction; or (3) advance funds to or on behalf of a person, based on an obligation of the person to repay the funds or to make repayment from specific property pledged by or on behalf of the person. This third prong does not include a creditor that advances funds on behalf of a person for expenses incidental to a service provided by the creditor to that person.
The FTC Red Flags and Card Issuers Rules implement requirements under Section 114 of the FACT Act. The Red Flags Rule requires financial institutions and covered creditors to develop and implement a written Program to detect, prevent, and mitigate identity theft in connection with existing accounts or the opening of new accounts. Under the Rule, financial institutions and certain creditors must conduct a periodic risk assessment to determine if they maintain “covered accounts.” The Rule defines the term “covered account” as either: (1) A consumer account that is designed to permit multiple payments or transactions, or (2) any other account for which there is a reasonably foreseeable risk of identity theft. Each financial institution and covered creditor that has covered accounts must create a written Program that contains reasonable policies and procedures to identify relevant indicators of the possible existence of identity theft (“red flags”); detect red flags that have been incorporated into the Program; respond appropriately to any red flags that are detected to prevent and mitigate identity theft; and update the Program periodically to ensure it reflects change in risks to customers.
The Red Flags Rule also requires financial institutions and covered creditors to: (1) Obtain approval of the initial written Program by the board of directors; a committee thereof; or, if there is no board, an appropriate senior employee; (2) ensure oversight of the development, implementation, and administration of the Program; and (3) exercise appropriate and effective oversight of service provider arrangements.
In addition, the Card Issuers Rule requires that card issuers generally must assess the validity of change of address notifications. Specifically, if the card issuer receives a notice of change of address for an existing account and, within a short period of time (during at least the first 30 days), receives a request for an additional or replacement card for the same account, the issuer must follow reasonable policies and procedures to assess the validity of the change of address.
In implementing section 315 of the FACT Act, the Address Discrepancies Rule requires each user of consumer reports to have reasonable policies and procedures in place to employ when the user receives a notice of address discrepancy from a CRA. Specifically, each user must develop reasonable policies and procedures to: (1) Enable the user to form a reasonable belief that a consumer report relates to the consumer about whom it has requested the report; and (2) in certain circumstances, provide to the CRA from which it received the notice an address for the consumer that the user has reasonably confirmed is accurate.
Under the PRA, 44 U.S.C. 3501-3521, Federal agencies must get OMB approval for each collection of information they conduct or sponsor. “Collection of information” includes agency requests or requirements to submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). The figures below reflect FTC staff's estimates of the hours burden and labor costs to complete the tasks described above that fall within reporting, disclosure, or recordkeeping requirements. FTC staff believes that the Rules impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (
Overall estimated burden hours regarding sections 114 and 315, combined, total 2,296,863 hours and the associated estimated labor costs are $92,465,982.
As noted above, the Rule requires financial institutions and certain creditors with covered accounts to develop and implement a written Program. Under the FCRA, financial institutions over which the FTC has jurisdiction include state chartered credit unions and certain insurance companies, among other entities.
Although narrowed by the Clarification Act, the definition of “creditor” still covers a broad array of entities, and application of the Rule depends upon an entity's course of conduct, not its status as a particular type of business. For these reasons, it is difficult to determine precisely the number of creditors subject to the FTC's jurisdiction. There are numerous small businesses under the FTC's jurisdiction that may qualify as “creditors,” and there is no formal way to track them. Nonetheless, FTC staff estimates that the Rule's requirement to have a written Program affects 6,278 financial institutions
To estimate burden hours for the Red Flags Rule under section 114, FTC staff divided affected entities into two categories, based on the nature of their business: (1) Entities that are subject to high risk of identity theft, and (2) entities that are subject to a low risk of identity theft, but have covered accounts that will require them to have a written Program.
FTC staff estimates that high-risk entities
Thus, estimated hours for high-risk entities are as follows:
• 94,052 high-risk entities subject to the FTC's jurisdiction at an average annual burden of 13 hours per entity [average annual burden over 3-year clearance period for creation and implementation of a Program ((25 + 1 + 1) hours/3), plus average annual burden over 3-year clearance period for staff training ((4 + 1 + 1) hours/3), plus average annual burden over 3-year clearance period for preparing an annual report ((4 + 1 + 1) hours/3)], for a total of 1,222,676 hours.
Entities that have a minimal risk of identity theft,
Thus, the estimated hours burden for low-risk entities is as follows:
• 63,533 low risk entities that have covered account subject to the FTC's jurisdiction at an average annual burden of approximately 37 minutes per entity [average annual burden over 3-year clearance period for creation and implementation of streamlined Program ((60 + 5 + 5) minutes/3), plus average annual burden over 3-year clearance period for staff training ((10 + 5 + 5) minutes/3), plus average annual burden over 3-year clearance period for preparing annual report ((10 + 5 + 5) minutes/3], for a total of 39,179 hours.
As noted above, section 114 also requires financial institutions and covered creditors that issue credit or debit cards to establish policies and procedures to assess the validity of a change of address request, including notifying the cardholder or using another means of assessing the validity of the change of address.
• FTC staff estimates that the Rule affects as many as 16,742
Thus, the total average annual estimated burden for Section 114 is 1,328,823 hours.
The FTC staff estimates labor costs by applying appropriate estimated hourly cost figures to the burden hours described above. It is difficult to calculate with precision the labor costs associated with compliance with the Rule, as they entail varying compensation levels of management (
Based on the above estimates and assumptions, the total annual labor costs for all categories of covered entities under the Red Flags and Card Issuers Rules for Section 114 is $65,112,327 (1,328,823 hours × $49).
As discussed above, the Rule's implementation of Section 315 provides guidance on reasonable policies and procedures that a user of consumer reports must employ when a user receives a notice of address discrepancy from a CRA. Given the broad scope of users of consumer reports, it is difficult to determine with precision the number of users of consumer reports that are subject to the FTC's jurisdiction. As noted above, there are numerous small businesses under the FTC's jurisdiction, and there is no formal way to track them; moreover, as a whole, the entities under the FTC's jurisdiction are so
For section 315, as detailed below, FTC staff estimates that the average annual burden during the three-year period for which OMB clearance is sought will be 919,678 hours with an associated labor cost of $17,473,882.
Prior to enactment of the Address Discrepancy Rule, users of consumer reports could compare the address on a consumer report to the address provided by the consumer and discern for themselves any discrepancy. As a result, FTC staff believes that many users of consumer reports have developed methods of reconciling address discrepancies, and the following estimates represent the incremental amount of time users of consumer reports may require to develop and comply with the policies and procedures for when they receive a notice of address discrepancy.
Given the varied nature of the entities under the FTC's jurisdiction, it is difficult to determine precisely the appropriate burden estimates. Nonetheless, FTC staff estimates that it would require an infrequent user of consumer reports no more than 16 minutes to develop and comply with the policies and procedures that it will employ when it receives a notice of address discrepancy, while a frequent user might require one hour. Similarly, FTC staff estimates that, during the remaining two years of clearance, it may take an infrequent user no more than one minute to comply with the policies and procedures it will employ when it receives a notice of address discrepancy, while a frequent user might require 45 minutes. Taking into account these extremes, FTC staff estimates that, during the first year, it will take users of consumer reports under the FTC's jurisdiction an average of 38 minutes [the midrange between 16 minutes and 60 minutes] to develop and comply with the policies and procedures that they will employ when they receive a notice of address discrepancy. FTC staff also estimates that the average recurring burden for users of consumer reports to comply with the Rule will be 23 minutes [the midrange between one minute and 45 minutes].
Thus, for these 1,967,167 entities, the average annual burden for each of them to perform these collective tasks will be 28 minutes [(38 + 23 +23) ÷ 3]; cumulatively, 918,011 hours.
For the estimated 10,000 users of consumer reports that will additionally have to furnish to CRAs an address confirmation upon notice of a discrepancy, staff estimates that these entities will require, initially, 30 minutes to develop related policies and procedures. But, these 10,000 affected entities likely will have automated the process of furnishing the correct address in the first year of a three-year PRA clearance cycle. Thus, allowing for 30 minutes in the first year, with no annual recurring burden in the second and third years of clearance, yields an average annual burden of 10 minutes per entity to furnish a correct address to a CRA, for a total of 1,667 hours.
FTC staff assumes that the policies and procedures for compliance with the address discrepancy part of the Rule will be set up by administrative support personnel at an hourly rate of $19.
Cumulatively, then, estimated burden is 2,246,834 hours (1,328,823 hours for section 114 and 918,011 hours for section 315) and $82,586,209 ($65,112,327 and $17,473,882) in associated labor costs.
Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites comments on: (1) Whether the disclosure requirements are necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are useful; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of providing the required information to consumers.
You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before October 9, 2018. Write: “Red Flags Rule, PRA Comment, Project No. P095406” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Red Flags Rule PRA, Project No. P095406” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 9, 2018. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Enhanced STD surveillance Network (SSuN) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March, 15, 2018 to obtain comments from the public and affected agencies. CDC received 37 comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Enhanced STD surveillance Network (SSuN)—Reinstatement with Change—Division of STD Prevention (DSTDP), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
The Enhanced STD surveillance network project was created to provide enhanced behavioral, demographic, and clinical information on gonorrhea cases reported to state and local health departments, to provide information on patients presenting for care in STD clinical settings, and to provide an infrastructure for identifying emerging sequelae of STDs.
Enhanced SSuN continues to be a collaboration between different branches of the CDC Division of STD Prevention and selected state/local public health departments and their associated STD specialty care clinics in the US. Data from enhanced SSuN data is used to (1) provide a dataset of supplemental information on gonorrhea case reports; (2) provide geographic information on case reports of STDs of interest for investigating social determinants of STDs, (3) monitor STD screening, incidence, prevalence, epidemiologic and health care access trends in populations of interest, (4) monitor STD treatment and prevention service practices, and (5) monitor selected adverse health outcomes of STDs, including neuro/ocular syphilis,
This project will continue to utilize two distinct surveillance strategies to collect information. The first strategy employs facility-based sentinel surveillance, which will abstract routine standardized data from existing electronic medical records for all patient visits to participating STD clinics during the project period. For the facility-based component of enhanced SSuN, participating sites have developed common protocols stipulating data elements to be collected, including patient demographics, clinical, risk and sexual behaviors. The specified data elements are abstracted by clinic staff from
Under this revision, the second strategy, population-based STD surveillance is being expanded to include not only a random sample of reported gonorrhea cases but also include patients diagnosed with early syphilis that report neurologic/ocular manifestations. For the gonorrhea population component, a probability sample of gonorrhea cases (up to 10% of total gonorrhea morbidity for participating jurisdictions) will be contacted by health department staff for a standardized interview either by phone or in-person. Enhanced gonorrhea investigations will also include verification of treatment and an internal health department record review (performed on either all cases or on the sampled cases). The focus of the new population activity focuses on obtaining additional clinical information on early syphilis cases who report neurologic/ocular symptoms. The subset of patients reporting these symptoms are asked to participate in an interview to obtain additional clinical information for a more complete assessment of neurologic/ocular involvement as well as obtain additional clinical information from the diagnosing or reporting provider. Lastly, early syphilis cases reporting neurologic and/or ocular symptoms are recontacted at approximately three months following prescribed treatment to ascertain whether initial symptoms have resolved.
The population data will be directly entered into existing STD surveillance information systems at each health department. Data will be locally extracted, de-identified and recoded into standardized formats prior to being transmitted to CDC through secure file transport mechanisms on bimonthly basis. Patient participation in the interview is voluntary and refusal to participate has no impact on other STD services the health department provides to persons diagnosed with gonorrhea.
This project will not collect name, social security number, or date of birth. A Patient ID, a unique patient identifier assigned by the clinic or health department depending on the component, is requested and will be provided to CDC for purposes of enhanced surveillance. Patient IDs are not linkable across enhanced SSuN components. Sensitive information such as sex of sex partners, HIV status, sex work exposure, and injection drug use are collected. All personally identifiable information (PII) is retained by the STD clinics and/or health departments and is not recorded with data sent to CDC. The electronic enhanced SSuN database is stored on the CDC mainframe computer and only approved Division of STD Prevention (DSTDP) staff have access rights to the data. As part of the revision, we will continue to systematically identify the risks and potential effects of collecting, maintaining, and disseminating PII and to examine and evaluate alternative processes for handling that information to mitigate potential privacy risks and risks to confidentiality.
Both components of enhanced SSuN are designed to (1) Integrate traditional surveillance methods with innovative data management technologies to produce high-quality, timely surveillance and epidemiologic data, (2) provide valuable information to direct public health STD prevention and control efforts, (3) enhance understanding of the community burden of disease, (4) identify syndemic patterns and population at greatest risk, and, (5) monitor long-term health consequences of STDs. The enhanced SSuN surveillance platform allows CDC to establish and maintain common standards for data collection, transmission, and analysis, and to build and maintain STD surveillance expertise in 10 state/local health departments. Such common systems, established mechanisms of communication, and in-place expertise are all critical components for timely, flexible, and high quality surveillance. The total estimated annual burden is 3,479 hours. There are no costs to respondents other than their time.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of September 7, 2018.
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of September 7, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on September 7, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of September 7, 2018.
Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.
The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of September 7, 2018. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on September 7, 2018 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Elemental Impurities in Drug Products.” This guidance finalizes the draft guidance issued July 1, 2016, which provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with the implementation of International Council for Harmonisation (ICH) guidance for industry entitled “Q3D Elemental Impurities” (ICH Q3D). This guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Danae Christodoulou, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2602, Silver Spring, MD 20993-0002, 301-796-1342; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a guidance for industry entitled “Elemental Impurities in Drug Products.” This guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of ICH Q3D. The guidance will also assist manufacturers of compendial drug products in responding to the issuance of the USP chapters for the control of elemental impurities.
USP introduced new limits and analytical procedures for elemental impurities in General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures. Their primary goals are to (1) set limits for acceptable levels of elemental impurities in finished drug products, and (2) update the methodology used to test for elemental impurities in drug products to include modern analytical procedures. ICH Q3D contains recommendations for manufacturers of human drugs and biologics on applying a risk-based approach to control elemental impurities and permitted daily exposure. USP worked closely with ICH to align its new General Chapters with ICH Q3D.
Because elemental impurities pose toxicological concerns and do not provide any therapeutic benefit to the patient, their levels in drug products should be controlled within acceptable limits. In general, FDA recommends that the manufacturer of any U.S. marketed drug product follow ICH Q3D recommendations to establish appropriate procedures for identifying and controlling elemental impurities in the drug product based on risk assessment and product-specific considerations, unless the drug product must comply with
This guidance finalizes the draft guidance issued July 1, 2016 (81 FR 43211). Since the draft guidance was issued, USP <232> was harmonized with ICH Q3D with respect to the all elements and their limits. Originally, prior to issuance of the draft guidance, USP <232> included a fraction (15) of elemental impurities (EIs) listed in ICH Q3D. A number of stakeholder comments to the draft guidance referred to the update and harmonization of USP <232> with ICH Q3D, which is now reflected in the final guidance. In addition, a number of stakeholder comments requested clarification regarding the applicability of the guidance to biologics license applications (BLAs). The final guidance now states that “for control of EIs in approved or pending BLAs, see ICH Q3D.” This differs from the draft, where it was stated that the guidance pertained to biotechnology products covered by new drug applications (NDAs).
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Elemental Impurities in Drug Products.” It does not establish any rights for any person and is not binding on FDA or the public.
This 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 in 21 CFR part 314 for submitting NDAs and abbreviated new drug applications, including supplemental applications and annual reports, have been approved under OMB control number 0910-0001. The collections of information in 21 CFR parts 211 and 212 (current good manufacturing practices) have been approved under OMB control numbers 0910-0139 and 0910-0667.
Persons with access to the internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) 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 September 7, 2018.
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
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 513(e) and (f), 514(b), 515(b), and 520(
The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a “Supplemental Data Sheet,” Form FDA 3427, and a “General Device Classification Questionnaire,” Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type.
In the
The reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or to seek reclassification from a lower to a higher class, thereby increasing the regulatory requirements applicable to that device type. If approved, petitions requesting classification from class III to class II or class I provide an alternative route to market in lieu of premarket approval for class III devices. If approved, petitions requesting reclassification from class I or II, to a different class, may increase requirements.
In the
The comment supports continued use of Forms FDA 3427 and FDA 3429. Specifically, the commenter is addressing the issue of discontinuing the forms as previously referenced, wherein FDA issued a proposed rule (79 FR 16252) to eliminate the need for the forms. Because FDA is not discontinuing use of the forms at this time, and this comment relates to the proposed rule (79 FR 16252) and not to the information collection itself, we make no changes to this information collection based on the comment.
The Center for Devices and Radiological Health (CDRH) has continually maintained contact with industry. Informal communications concerning the importance and effect of reclassification are provided primarily through trade organizations, and via CDRH's website (
FDA estimates the burden of this collection of information as follows:
Based on reclassification petitions received in the past 3 years, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2) have consulted and advised manufacturers on these requirements, and (3) have reviewed the documentation submitted.
The burden estimate for this information collection has not changed since the past OMB approval.
Office of the Assistant Secretary for Health, President's Council on Sports, Fitness, and Nutrition, Office of the Secretary, Department of Health and Human Services.
Notice of meeting; correction.
The Department of Health and Human Services published a document in the
Ms. Holli M. Richmond, Executive Director, Office of the President's Council on Sports, Fitness, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567.
In the
The meeting will be held on September 21, 2018, from 9:00 a.m. to 12:30 p.m.
Hubert H. Humphrey Building, 200 Independence Avenue SW, Room 800, Washington, DC 20201.
Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, President's Council on Sports, Fitness, and Nutrition.
Notice of meeting; correction.
The Department of Health and Human Services published a document in the
Ms. Holli M. Richmond, Executive Director, Office of the President's Council on Sports, Fitness, and Nutrition, Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852, (240) 276-9567.
In the
The meeting will be held on September 21, 2018, from 9:00 a.m. to 12:30 p.m.
Hubert H. Humphrey Building, 200 Independence Avenue SW, Room 800, Washington, DC 20201.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Nursing Research.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public 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
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102-3.65(a), notice is hereby given that the Charter for the NIH Clinical Center Research Hospital Board was renewed for an additional two-year period on May 29, 2018.
It is determined that the NIH Clinical Center Research Hospital Board is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group.
Inquiries may be directed to Claire Harris, Acting Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail Stop Code 4875),
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, notice is hereby given of a meeting of the National Advisory Council on Minority Health and Health Disparities.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both 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 affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus.
All visitor vehicles, including taxis, hotel, and airport shuttles, will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public 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.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice of rebroadcast termination.
The United States Coast Guard is ceasing the rebroadcast of HYDROLANT and HYDROPAC (defined below) navigational warnings over HF SITOR (defined below). There is no requirement for the Coast Guard to rebroadcast this information, although the Coast Guard has been voluntarily doing so for a number of years, and doing so is duplicative of the National Geospatial-Intelligence Agency's broadcast. The information will continue to be disseminated by the National Geospatial-Intelligence Agency.
The Coast Guard will cease rebroadcasting HYDROLANT and HYDROPAC navigational warnings on August 30th, 2018.
For information about this document, please call or email Derrick Croinex, Chief, Spectrum Management and Telecommunications Policy, U.S. Coast Guard (Commandant CG-672); telephone: 202-475-3551; email:
On May 14, 2018, we published a notice in the
In the notice, we requested feedback from the public on the proposed termination. The comment period closed on July 13, 2018. We received one submission in response to our inquiry. The commenter was concerned that the information contained in the Coast Guard rebroadcast would no longer be available. In response to the comment, we would like to reiterate that the HYDROLANT and HYDROPAC products will still be available via satellite from the National Geospatial-Intelligence Agency as originally intended. The Coast Guard is only terminating the rebroadcast of these products, and only these products, via HF. All other HF Broadcast content will continue to be available.
This notice is issued under authority of 14 U.S.C. 93(a)(16) and in accordance with 5 U.S.C. 552(a).
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The Merchant Marine Personnel Advisory Committee and its Working Groups will meet to discuss various issues related to the training and fitness of merchant marine personnel. The meetings will be open to the public.
The meetings will be held at the STAR Center, 2 West Dixie Highway, Dania Beach, FL 33004,
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Alternate Designated Federal Officer as soon as possible using the contact information provided in the
Mr. Davis Breyer, Alternate Designated Federal Officer of the Merchant Marine Personnel Advisory Committee, 2703 Martin Luther King Jr. Ave SE, Stop 7509, Washington, DC 20593-7509, telephone 202-372-1445, fax 202-372-8382 or
Notice of this meeting is given pursuant to the
The Merchant Marine Personnel Advisory Committee was established under authority of U.S. Code, title 46, section 8108. The Committee acts solely in an advisory capacity to the Secretary of the Department of Homeland Security through the Commandant of the U.S. Coast Guard on matters relating to personnel in the United States merchant marine, including training, qualifications, certification, documentation, and fitness standards and other matters as assigned by the Commandant. The Committee also reviews and comments on proposed U.S. Coast Guard regulations and policies relating to personnel in the United States merchant marine, including training, qualifications, certification, documentation, and fitness standards.
The agenda for the September 11, 2018, meeting is as follows:
(1) The full Committee will meet briefly to discuss the Working Groups' business/task statements, which are listed under paragraph (3) (a)-(e) below.
(2) A job task analysis briefing will be presented to the full Committee regarding the merchant mariner credentialing program's efforts to establish or validate credentialing examinations, performance assessments, and training curriculum standards within the context of current occupational practices associated with each credentiale.
(3) Working Groups will separately address the following task statements which are available for viewing at
(a) Task Statement 87, Review of policy documents providing guidance on the implementation of the December 24, 2013, International Convention on Standards of Training, Certification and Watchkeeping for Seafarers rulemaking;
(b) Task Statement 98, To continue the progress made by the military services towards meeting the goals on the use of Military Education, Training and Assessment for STCW and National Mariner Endorsements as identified in the Howard Coble Coast Guard and Maritime Transportation Act of 2014 and subsequent legislation;
(c) Task Statement 101, Provide feedback and avenues to further enhance open communication between external stakeholders and the U.S. Coast Guard's mariner credentialing program regarding all aspects of the program;
(d) Task Statement 101a, Review of the draft medical certificate cancellation policy;
(e) Task Statement 104, National Transportation Safety Board recommendations to the U.S. Coast Guard regarding the sinking of the S.S. El Faro.
(4) Public comment period.
(5) Reports of Working Groups. At the end of the day, the Working Groups will report to the full Committee on what was accomplished in their meetings. The full Committee will not take action on these reports on this date. Any official action taken as a result of these Working Group meetings will be taken on day two of the meeting.
(6) Adjournment of meeting.
The agenda for the September 12, 2018 full Committee meeting is as follows:
(1) Introduction.
(2) Swearing in of newly appointed Committee members.
(3) Remarks from U.S. Coast Guard Leadership.
(4) Designated Federal Officer announcements.
(5) Roll call of Committee members and determination of a quorum.
(6) Reports from the following Working Groups:
(a) Task Statement 87, Review of policy documents providing guidance on the implementation of the December 24, 2013, International Convention on Standards of Training, Certification and Watchkeeping for Seafarers rulemaking;
(b) Task Statement 89, Review and update of the International Maritime Organization's Maritime Safety Committee Circular MSC/Circ.1014 Guidelines on fatigue mitigation and management;
(c) Task Statement 90, Review of International Maritime Organization's Model Courses Being Validated by the International Maritime Organization's Subcommittee on Human Element, Training and Watchkeeping;
(d) Task Statement 94, Review the MERPAC recommendations with a view to evaluating their current relevance;
(e) Task Statement 96, Review and comment on the course and program approval requirements including 46 CFR 10.402, 10.403, 10.407 and Navigation and Vessel Inspection Circular 03-14 guidelines for approval of training courses and programs;
(f) Task Statement 98, To continue the progress made by the military services towards meeting the goals on the use of Military Education, Training and Assessment for STCW and National Mariner Endorsements as identified in the Howard Coble Coast Guard and Maritime Transportation Act of 2014 and subsequent legislation;
(g) Task Statement 99, Review and comment on the “Guidelines for Issuing Endorsements for Tankerman PIC Restricted to Fuel Transfers on Towing Vessels” policy letter (CG-MMC Policy Letter No. 01-17);
(h) Task Statement 101, Provide feedback and avenues to further enhance open communication between external stakeholders and the Coast Guard's mariner credentialing program regarding all aspects of the program;
(i) Task Statement 101a, Review of the draft medical certificate cancellation policy;
(j) Task Statement 102, Consider and make recommendations regarding the current requirement for a U.S. Merchant Mariner to read and write using English; and
(k) Task Statement 104, National Safety Board recommendations to the U.S. Coast Guard regarding the sinking of the S.S. El Faro.
(7) Other items for discussion:
(a) Report on the Mariner Credentialing Program;
(b) Report on National Maritime Center activities from the National Maritime Center Commanding Officer;
(c) Report on International Maritime Organization Activities affecting merchant mariner credentialing; and
(d) Briefings about other on-going U.S. Coast Guard projects related to personnel in the U.S. merchant marine.
(8) Public comment period.
(9) Discussion of Working Group recommendations. The Committee will review the information presented on each issue, deliberate on any recommendations presented by the Working Groups, approve/formulate recommendations and close any completed tasks. Official action on these recommendations may be taken on this date.
(10) Closing remarks/plans for next meeting.
(11) Adjournment of meeting.
A public comment period will be held during each Working Group and full Committee meeting concerning matters being discussed.
A copy of all meeting documentation will be available at
Public comments will be limited to three minutes per speaker. Please note that the public comment periods will
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Fish and Wildlife Service, Interior.
Notice of initiation of reviews; request for information.
We, the U.S. Fish and Wildlife Service (Service), are initiating 5-year reviews under the Endangered Species Act, as amended (ESA), for 19 northeastern species. A 5-year review is based on the best scientific and commercial data available at the time of the review. We are requesting submission of any such information that has become available since the previous 5-year review for each species.
To ensure consideration, please submit your written information by September 7, 2018. However, we will continue to accept new information about any listed species at any time.
For instructions on how and where to submit information, see Request for Information and Table 2—Contacts under
For information regarding a particular species, contact the appropriate person or office listed in Table 2—Contacts in
We, the Service, are initiating 5-year reviews under the ESA (16 U.S.C. 1531
A 5-year review is based on the best scientific and commercial data available at the time of the review. We are requesting submission of any such information that has become available since the most recent status review for each species.
Under the ESA (16 U.S.C. 1531
We are initiating 5-year status reviews of the species in table 1.
A 5-year review considers all new information available at the time of the review. In conducting the review, we consider the best scientific and commercial data that have become available since the most recent status review. We are seeking new information specifically regarding:
(1) Species biology, including but not limited to life history and habitat requirements and impact tolerance thresholds;
(2) Historical and current population conditions, including but not limited to population abundance, trends, distribution, demographics, and genetics;
(3) Historical and current habitat conditions, including but not limited to amount, distribution, and suitability;
(4) Historical and current threats, threat trends, and threat projections in relation to the five listing factors (as defined in section 4(a)(1) of the ESA);
(5) Conservation measures for the species that have been implemented or are planned; and
(6) Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.
Any new information received will be considered during the 5-year review and will also be useful in evaluating ongoing recovery programs for the species.
To ensure that 5-year reviews are based on the best available scientific and commercial information, we request new information from all sources. If you submit information, please support it with documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.
Please submit your questions, comments, and materials to the appropriate contact in table 2. Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at 800-877-8339 for TTY assistance.
Before including your address, phone number, electronic mail address, or other personal identifying information in your submission, you should be aware that your entire submission—including your personal identifying information—may be made publicly available at any time. Although you can request that personal information be withheld from public review, we cannot guarantee that we will be able to do so.
Materials received will be available for public inspection, by appointment, during normal business hours at the offices where the information is submitted.
New information on the species covered in this notice should be submitted by mail or electronic mail to the appropriate contact person within the timeframe provided in
We publish this document under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey (USGS) is proposing to renew an information collection.
Interested persons are invited to submit comments on or before October 9, 2018.
Send your comments on the information collection request (ICR) by mail to the U.S. Geological Survey, Information Collections Clearance Officer, 12201 Sunrise Valley Drive, MS 159, Reston, VA 20192; or by email to
To request additional information about this ICR, contact Sarah Cook by email at
We, the U.S. Geological Survey, in accordance with the Paperwork Reduction Act of 1995, provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary for the proper functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This notice concerns the collection of information that is sufficient and relevant to evaluate and select proposals for funding. We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2), and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” Responses are voluntary. No questions of a “sensitive” nature are asked. We intend to release the project abstracts and primary investigators for awarded/funded projects only.
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 authorities for this action are the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
Bureau of Land Management, Interior.
Notice of intent.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, (FLPMA), the Bureau of Land Management (BLM) Bakersfield Field Office, Bakersfield, California, intends to prepare a supplemental Environmental Impact Statement (EIS) and a potential Resource Management Plan (RMP) amendment for the Bakersfield Field Office Resource Management Plan. The supplemental EIS will analyze the impacts of hydraulic fracturing technology on BLM-administered public land and mineral estate in the Bakersfield Field Office Planning Area exclusive of the California Coastal National Monument and the Carrizo Plain National Monument. This effort is in response to a settlement agreement in case No. 2:15-cv-04378-MWF/JEM, filed with, and approved by, the U.S. District Court for the Central District of California on May 3, 2017. This notice announces the beginning of the scoping process to solicit public comments and identify issues.
This notice initiates the public scoping process for the Supplemental EIS and potential RMP amendment. Comments on issues may be submitted in writing until September 7, 2018. In order to be included in the analysis, all scoping comments must be submitted in writing and received prior to the close of the 30-day scoping period. We will provide additional opportunities for public participation as appropriate.
You may submit comments on issues and planning criteria related to this Supplemental EIS and potential RMP amendment by any of the following methods:
•
•
Documents pertinent to this proposal may be examined during regular business hours at: Bureau of Land Management, Bakersfield Field Office, 3801 Pegasus Drive, Bakersfield, CA 93308.
Carly Summers, Supervisory Natural Resources Specialist, telephone 661-391-6000; address Bureau of Land Management, 3801 Pegasus Drive, Bakersfield, CA 93308; email
This document provides notice that the BLM Field Office, Bakersfield, California, intends to prepare a supplemental EIS and potential RMP amendment for the 2014 Bakersfield Field Office RMP Planning Area. Furthermore, this document announces the beginning of the scoping process and seeks public input on issues and planning criteria related to hydraulic fracturing. The planning area is located in Fresno, Kern, Kings, Madera, San Luis Obispo, Santa Barbara, Tulare, and Ventura counties in California and encompasses approximately 400,000 acres of public land and an additional 1.2 million acres of Federal mineral estate (
1. Only those portions of the existing plan that need to be updated to respond to the issues and management concerns identified in the court order and settlement agreement will be reviewed.
2. The planning process will be completed in compliance with the FLPMA and all other applicable laws.
3. The planning process will include a Supplemental EIS that will comply with NEPA standards.
4. The scope of analysis will be consistent with the level of analysis in approved plans and in accordance with Bureau-wide standards and program guidance.
5. Public comments will be addressed during the planning process.
You may submit comments on issues and planning criteria in writing to the BLM using one of the methods listed in the
The BLM will utilize and coordinate the NEPA scoping process to help fulfill the public involvement process under the National Historic Preservation Act (54 U.S.C. 306108), as provided in 36 CFR 800.2(d)(3). The information about historic and cultural resources within the area potentially affected by the proposed action will assist the BLM in identifying and evaluating impacts to such resources.
The BLM will consult with Indian tribes on a government-to-government
The BLM will evaluate identified issues to be addressed in the plan, and will place them into one of three categories:
1. Issues to be resolved in the analysis;
2. Issues to be resolved through policy or administrative action; or
3. Issues beyond the scope of the Supplemental EIS and potential RMP amendment.
The BLM will provide an explanation in the Draft Supplemental EIS as to why an issue was placed in category two or three. The public is also encouraged to help identify any management questions and concerns that should be addressed in the plan. The BLM will work collaboratively with interested parties to identify the management decisions that are best suited to local, regional, national needs, and concerns. The BLM will use an interdisciplinary approach to develop the Supplemental EIS and, if necessary, RMP amendment, in order to consider the variety of resource issues and concerns identified. Specialists with expertise in the following disciplines will be involved in the planning process: Hydrology, air, archaeology, paleontology, wildlife biology, oil and gas, geology, sociology and economics.
Before including your 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 review, we cannot guarantee that we will be able to do so.
40 CFR 1501.7 and 43 CFR 1610.2.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976, the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Boise District Resource Advisory Council (RAC) will meet as indicated below.
The Boise District RAC will meet September 13, 2018. The meeting will begin at 8:00 a.m. and end at 4:00 p.m. The public comment period will take place from 8:00 a.m. to 8:30 a.m.
The Boise District RAC will meet at the BLM Boise District Office, 3948 Development Avenue, Boise, Idaho 83705.
Michael Williamson, BLM Boise District, Idaho, 3948 Development Avenue, Boise, Idaho 83705, 208-384-3393, email
The 15-member RAC advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Idaho. During the September 13, 2018 meeting, the Boise District RAC will have a briefing on the Boise District's wild horse program, Tri-State fuel breaks project, travel management planning, and other Field Office updates. Additional topics may be added and will be included in local media announcements.
RAC meetings are open to the public. The public may present written comments to the Council at the address provided above. 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.
Before including your address, phone number, email address, or other personal identifying information in your comments, please 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.
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 above.
National Park Service, Interior.
Notice.
The Binghamton University has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Binghamton University. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary
Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-4786, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Binghamton University, Binghamton, NY. The human remains and associated funerary objects were removed from Chenango County, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Binghamton University professional staff in consultation with representatives of the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Stockbridge Munsee Community, Wisconsin; Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation.
Sometime before 1975, human remains representing, at minimum, three individuals were removed from an unknown site in Chenango County, NY, possibly the Bates Site. An unknown individual donated the human remains to the Greene Middle School in the Town of Greene, Chenango County, NY in 1975. According to the teacher interviewed, the human remains came from an area that is near (or overlaps) the previously recorded Bates site, a Late Woodland settlement. The Greene Middle School gave the human remains to Binghamton University. No known individuals were identified. There are no associated funerary objects.
A bioarchaeologist and archaeologist from Binghamton University determined that the human remains were Native American. Archeological information from the Bates site includes Canandaigua Phase (Sackett Corded) pottery and radiocarbon dates that cluster around A.D. 1190.
Haudenosaunee oral tradition states that, as The People of the Long House, they are affiliated culturally, spiritually, biologically, and personally to the ancestors located within their traditional aboriginal territories. This connection is also based upon cultural practices, language, and the philosophy of respect for those ancestors that have passed. This evidence supports a relationship of shared group identity which can reasonably be traced between the Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; and Tuscarora Nation and the human remains removed from Chenango County, as this location is within the traditional aboriginal territory of the Oneida, Onondaga, and Tuscarora Nations.
Officials of the Binghamton University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of three individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; and Tuscarora Nation.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-4786, email
The Binghamton University is responsible for notifying the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Stockbridge Munsee Community, Wisconsin; Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation that this notice has been published.
National Park Service, Interior.
Notice.
The Binghamton University has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Binghamton University at the address in this notice by September 7, 2018.
Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Binghamton University, Binghamton, NY. The human remains and associated funerary objects were removed from Thomas Lucky Site (SUBi-888), Town of Ashland, Chemung County, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Binghamton University professional staff in consultation with representatives of the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Stockbridge Munsee Community, Wisconsin; Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation.
In 1994-1995, following consultation with a chief from the Onondaga Nation, human remains representing two individuals were removed from the Thomas Lucky site in Town of Elmira, Chemung County, NY, by the Binghamton University field school. One associated funerary object, a broken white bone bead, was found with the human remains.
A bioarcheologist and archeologist from Binghamton University determined that the human remains were Native American. No known individuals were identified. Archeological information shows that two longhouses were present at the site, one with AMS dates extending from A.D. 1300 to 1450 and one with dates extending into the A.D. 1600s. Pottery at the site supports this continuous span of land use. This region was home to Delaware communities during the eighteenth century, and both the Delaware and Seneca engaged in Revolutionary War battles fought nearby as part of the Sullivan-Clinton campaign.
Haudenosaunee oral tradition states that, as The People of the Long House, they are affiliated culturally, spiritually, biologically, and personally to the ancestors located within their traditional aboriginal territories. This connection is also based upon cultural practices, language, and the philosophy of respect for those ancestors that have passed. This evidence supports a relationship of shared group identity which can reasonably be traced between the Cayuga Nation of New York; Seneca Nation of New York; Seneca-Cayuga Tribe of Oklahoma; and Tonawanda Band of Seneca Indians of New York and the human remains removed from the Thomas Luckey site, as this location is within the traditional aboriginal territory of the Cayuga Nation; Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); and Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York). Similarly, the Delaware Nation, Oklahoma and Delaware Tribe of Indians recognize that they have a territorial connection to, and cultural affiliation with, sites located in Chemung County in New York.
Officials of the Binghamton University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the one object described in this notice is reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); and Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York).
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
The Binghamton University is responsible for notifying the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga
National Park Service, Interior.
Notice.
The Binghamton University has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Binghamton University. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Binghamton University at the address in this notice by September 7, 2018.
Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Binghamton University, Binghamton, NY. The human remains and associated funerary objects were removed from Comfort Site, Town of Chenango, Broome County, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Binghamton University professional staff in consultation with representatives of the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Stockbridge Munsee Community, Wisconsin; Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation.
In 1971, human remains representing a minimum of nine individuals were removed from the Comfort site in the Town of Chenango, Broome County, NY. The site was excavated by professional and avocational archeologists during construction of a rest area associated with I-81. No known individuals were identified. The 143 associated funerary objects include: 22 pieces of shell, one cord-marked unidentified body sherd, one plain unidentified body sherd, seven pieces of shell, one chert knife, seven chert waste flakes, one retouched chert flake, one Sackett corded rim sherd, four bear teeth, 20 pieces of shell, one chert waste flake, one chert chunk, 21 shell beads, one crinoid fossil bead, three copper cones, one incised rim sherd, one piece of shell, one shell bead, one piece of wood, three chert waste flakes, one chert flake, one clay pipe bowl fragment, one bone awl, two hammerstones, one chert chunk, two chert waste flakes, one retouched/utilized flake, three eroded pottery sherds, two pieces of unworked bird bone, 22 pieces of shell, one worked animal bone, and seven pieces of animal bone.
A bioarcheologist and archeologist from Binghamton University determined that the human remains were Native American. No known individuals were identified. Archaological information includes a radiocarbon date obtained from charred plant material from one burial which produced a date of A.D. 1130, plus or minus 150 years. Additional archeological information from the pottery showed that the dates could range from A.D. 1070-1400 and recent radiometric dating of material from non-burial features indicates a date range of A.D. 1250 through A.D. 1400. Historically, the Comfort site was part of the eighteenth century string of villages known as
Haudenosaunee oral tradition states that, as The People of the Long House, they are affiliated culturally, spiritually, biologically, and personally to the ancestors located within their traditional aboriginal territories. This connection is also based upon cultural practices, language, and the philosophy of respect for those ancestors that have passed. This evidence supports a relationship of shared group identity which can reasonably be traced between the Oneida, Onondaga, and Tuscarora Nations and the human remains and associated funerary objects, removed from the Comfort site as this location is within the traditional aboriginal territory of the Oneida, Onondaga, and Tuscarora Nations. Similarly, the Delaware Nation, Oklahoma and the Delaware Tribe of Indians recognize that they have a territorial connection to, and cultural affiliation with, sites located in Broome County, New York.
Officials of the Binghamton University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of nine individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 166 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; and Tuscarora Nation.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
The Binghamton University is responsible for notifying the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk Tribe (previously listed as the St. Regis Band of Mohawk Indians of New York); Seneca Nation of Indians (previously listed as the Seneca Nation of New York); Seneca-Cayuga Nation (previously listed as the Seneca-Cayuga Tribe of Oklahoma); Stockbridge Munsee Community, Wisconsin; Tonawanda Band of Seneca (previously listed as the Tonawanda Band of Seneca Indians of New York); and Tuscarora Nation that this notice has been published.
National Park Service, Interior.
Notice.
The Albuquerque Museum has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Albuquerque Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Albuquerque Museum at the address in this notice by September 7, 2018.
Deb Slaney, History Curator, Albuquerque Museum, 2000 Mountain Road NW, Albuquerque, NM 87104 telephone (505) 243-7255, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Albuquerque Museum, Albuquerque, NM. The human remains and associated funerary objects were removed from Mesa Prieta, King Ranch, Rio Puerco Valley, Sandoval County, NM; the Deming, Luna County, NM; and Jemez Pueblo, Sandoval County, NM.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Albuquerque Museum professional staff in consultation with representatives of the Pueblo of Acoma, New Mexico; Pueblo of Cochiti, New Mexico; and Pueblo of Santa Clara, New Mexico. The Kewa Pueblo, New Mexico (previously listed as the Pueblo of Santo Domingo); Ohkay Owingeh, New Mexico (previously listed as the Pueblo of San Juan); Pueblo of Isleta, New Mexico; Pueblo of Jemez, New Mexico; Pueblo of Laguna, New Mexico; Pueblo of Nambe, New Mexico; Pueblo of Picuris, New Mexico; Pueblo of Pojoaque, New Mexico; Pueblo of San Felipe, New Mexico; Pueblo of San Ildefonso, New Mexico; Pueblo of Sandia, New Mexico; Pueblo of Santa Ana, New Mexico; Pueblo of Taos; Pueblo of Tesuque, New Mexico; Pueblo of Zia, New Mexico; Ysleta del Sur Pueblo (previously listed as the Ysleta Del Sur Pueblo of Texas); and Zuni Tribe of the Zuni Reservation, New Mexico were contacted and invited to consult, but did not participate.
In 1967-1968, human remains representing, at minimum, three individuals were removed from Prieta Vista Pueblo in Sandoval County, NM. The human remains were excavated by Eastern New Mexico University in collaboration with the Albuquerque Archaeological Society in 1967-1968, and donated by the AAS to the Albuquerque Museum in 1977. Burial #1, PC1977.34.73, belongs to a two to four year old child, who was buried (with associated lithic debris) under a
The human remains were published in Richard A. Bice and William M. Sundt,
At a date prior to 1974, human remains representing, at minimum, one individual were removed from an unknown location in the vicinity of Deming, Luna Co., NM. The human remains were donated to the Museum by a New Mexico collector in 1974. The remains, PC1974.9.29, belong to a cremation. The age and sex of the remains are unknown. The one associated funerary object, PC1974.9.29, is a small Three Circle Neck Corrugated clay jar.
The remains are dated C.E. 900 to 1000 based on the date of the jar. The cultural affiliation of the human remains and associated funerary objects is based upon geographical, kinship, biological, archeological, linguistic, folklore, oral tradition, historic evidence, other information, and expert opinion. Primary information sources include reviews of our accession and catalogue records conducted by museum staff and consultant Dena Lewis between 1991 and 2015, and consultation Indian tribe officials and traditional religious leaders. The geographical location of Deming, NM, is consistent with the historically documented territory of the Mimbres people. The cremation was identified as Mimbres by Dr. Cynthia Bettison, Director, Western New Mexico University Museum. The Pueblo of Acoma Review Committee participated in an on-site review of the human remains and associated funerary objects, but did not review or confirm the cultural affiliation of the remains and jar. The Pueblo of Cochiti Review Committee consulted the inventory while on site but did not participate in a physical review of the human remains and associated funerary objects. The Committee indicated it would consult with the Pueblos of Zuni, Acoma, Hopi, and Zia regarding cultural affiliation of the remains. The Pueblo of Santa Clara Review Committee reviewed the human remains and associated funerary objects, but declined to provide a cultural attribution for them.
At a date prior to 1974, human remains representing, at minimum, one individual was removed from an unknown location in the vicinity of the Pueblo of Jemez, Sandoval County, NM. The human remains, PC1976.83, were collected near the Pueblo of Jemez by the Albuquerque High School Archeology Club, and donated to the Albuquerque Museum in 1974. The age and sex of the human remains are unknown. No known individuals were identified. The 10 associated funerary objects, PC1976.83, are one bird bone flute, and nine samples of worked and unworked animal bone.
The human remains belong to an inhumation and include cranial bones. The date of the human remains and associated funerary objects is unknown. Cultural affiliation of the human remains and associated funerary objects is based upon geographical, kinship, biological, archeological, linguistic, folklore, oral tradition, historic evidence, other information, and expert opinion. Primary information sources include reviews of our accession and catalogue records conducted by museum staff and consultant Dena Lewis between 1991 and 2015, and consultation with Indian tribe officials and traditional religious leaders. The proximity of the collection location is geographically consistent with the historically documented territory of Jemez Pueblo. The Pueblo of Acoma Review Committee participated in an on-site review of the human remains and associated funerary objects, but did not review or confirm the cultural affiliation of the remains and associated funerary objects. The Pueblo of Cochiti Review Committee consulted the inventory while on site, but did not participate in a physical review of the human remains and associated funerary objects. The Committee indicated that it would consult with the Pueblos of Zuni, Acoma, Hopi, and Zia regarding the cultural affiliation of the remains. The Pueblo of Santa Clara Review Committee reviewed the human remains and associated funerary objects, but declined to identify a cultural affiliation for them.
At a date prior to 1974, human remains representing, at minimum, one individual were removed from an unknown location in the vicinity of Deming, Luna County, NM. The human remains, UA146.1, were likely collected by the Albuquerque High School Archeology Club and donated to the Albuquerque Museum in 1974. The age and sex of the human remains is unknown.
The human remains and associated funerary objects are believed to be collected by the AHS Archeology Club because “AHS” was written on the box in which they were contained. No known individuals were identified. The nine associated funerary objects, UA146.1, are one bone awl and eight bone beads of unknown species and date. Cultural affiliation of the human
Officials of the Albuquerque Museum have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of six individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 34 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Hopi Tribe of Arizona; Kewa Pueblo, New Mexico (previously listed as the Pueblo of Santo Domingo); Ohkay Owingeh, New Mexico (previously listed as the Pueblo of San Juan); Pueblo of Acoma, New Mexico; Pueblo of Cochiti, New Mexico; Pueblo of Isleta, New Mexico; Pueblo of Jemez, New Mexico; Pueblo of Laguna, New Mexico; Pueblo of Nambe, New Mexico; Pueblo of Pojoaque, New Mexico; Pueblo of San Felipe, New Mexico; Pueblo of San Ildefonso, New Mexico; Pueblo of Sandia, New Mexico; Pueblo of Santa Ana, New Mexico; Pueblo of Santa Clara, New Mexico; Pueblo of Tesuque, New Mexico; Pueblo of Zia, New Mexico; and Zuni Tribe of the Zuni Reservation, New Mexico (hereafter referred to as “The Tribes”).
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Deb Slaney, History Curator, Albuquerque Museum, 2000 Mountain Road NW, Albuquerque, NM 87104, telephone (505) 243-7255, email
The Albuquerque Museum is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The Binghamton University has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Binghamton University. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Binghamton University at the address in this notice by September 7, 2018.
Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Binghamton University, Binghamton, NY. The human remains and associated funerary objects were removed from the following four sites: Roundtop (SUBi-365), Village of Endicott, Broome County, NY; Steen Topsoil Removal Plant, Town of Owego, Tioga County, NY; Cottage (SUBi-220), Town of Owego, Tioga County, NY; and Owego Sewage Plant Site (SUBi-336), Town of Owego, Tioga County, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Binghamton University professional staff in consultation with representatives of the Cayuga Nation; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Oneida Nation (previously listed as the Oneida Tribe of Indians of Wisconsin); Oneida Indian Nation (previously listed as the Oneida Nation of New York); Onondaga Nation; Saint Regis Mohawk
The Roundtop site (SUBi-365): In 1965, a burial containing the human remains of two individuals was excavated at the Roundtop site in the Village of Endicott, Broome County, NY, by a Binghamton University field school. Subsequently, the human remains were transferred to the control of the New York State Museum. This site was also excavated by amateurs as well as the New York State Museum. Much has been published on the site, including data showing it was a multicomponent site dating between circa A.D. 1000 and 1600. No known individuals are associated with that burial. The human remains and some associated funerary objects (AFOs) have been under the control of the New York State Museum since their excavation; the remainder of the AFOs are under the control of the University. The 197 AFOs under the control of Binghamton University are: Six chert decortification flakes, one chert shatter, three chert blocks, 14 chert waste flakes, one large chert waste flake, three chert blocks, eight chert shatter, six chert decortification flakes, 52 chert waste flakes, seven utilized chert flakes, 18 chert waste flakes, one chert decortification flake, two chert shatter, one possible utilized flake, eight chert shatter, five chert decortification flakes, one fire-reddened jasper waste flake, six chert chunks, four utilized chert flakes, one retouched chert flake, and 49 chert waste flakes. Roundtop site is located within the traditional territories of the Delaware Nation, Oklahoma; Delaware Tribe, Oklahoma; and Onondaga Nation of New York.
Steen Topsoil Removal Plant site: During the early 1980s, human remains representing, at minimum, three individuals were removed from a back dirt pile at this mining site in the Town of Owego, Tioga County, NY. They were dropped off at Binghamton University anonymously. There were no associated funerary objects included in the donation. A bioarcheologist and archeologist from Binghamton University determined that the human remains were Native American. No known individuals are associated with that burial. The site is located within the traditional territories of the Delaware Nation, Oklahoma; Delaware Tribe, Oklahoma; and the Onondaga Nation, New York.
Cottage site (SUBi-220): In 1973, human remains representing two individuals were donated to Binghamton University by a local collector who removed items from this site located in the Town of Owego, Tioga County, NY. There were no associated funerary objects included in the donation. A bioarcheologist and archeologist from Binghamton University determined that the human remains were Native American. No known individuals are associated with that burial. The site is located within the traditional territories of the Delaware Nation, Oklahoma; Delaware Tribe, Oklahoma; and the Onondaga Nation, New York.
Owego Sewage Plant site (SUBi-336): In 1965, human remains representing, at minimum, one individual were removed from this site in the Town of Owego, Tioga County, NY. A Binghamton University faculty member and the Triple Cities Chapter of the New York State Archaeological Association conducted salvage excavations when cultural material was uncovered. A bioarcheologist and archeologist from Binghamton University determined that the human remains were Native American. No known individuals are associated with that burial. The site is located within the traditional territories of the Delaware Nation, Oklahoma; Delaware Tribe, Oklahoma; and the Onondaga Nation, New York.
Haudenosaunee oral tradition states that they are affiliated culturally, spiritually, biologically, and personally to the ancient ancestors located within their traditional aboriginal territories. This connection is based upon Haudenosaunee oral history, cultural practices, language, and the philosophy of respect for those ancestors that have passed. The Haudenosaunee assert this affiliation to all Native American ancestors located within their extended aboriginal territory based on their cultural and spiritual beliefs as The People of the Long House. Therefore, they argue that this evidence supports a relationship of shared group identity which can be reasonably traced from the Onondaga Nation to the Roundtop site, Steen Topsoil Removal site, Cottage site, and Owego Sewage Plant site. Similarly, the Delaware Nation and Delaware Tribe recognize that they have a territorial connection to, and cultural affiliation with, these sites located in Broome and Tioga Counties, NY.
Officials of the Binghamton University have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of eight individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 197 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Delaware Nation, Oklahoma; Delaware Tribe of Indians; and Onondaga Nation.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Nina M. Versaggi, Public Archaeology Facility, Binghamton University, P.O. Box 6000, Binghamton, NY 13902-6000, telephone (607) 777-478, email
The Binghamton University is responsible for The Consulted Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The San Diego Museum of Man has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the San Diego Museum of Man. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the San Diego Museum of Man at the address in this notice by September 7, 2018.
Ben Garcia, Deputy Director, San Diego Museum of Man, 1350 El Prado, San Diego, CA 92101, telephone (619) 239-2001 ext. 17, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the San Diego Museum of Man. The human remains and associated funerary objects were removed from San Diego, San Diego County, CA.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the San Diego Museum of Man professional staff in consultation with representatives of Campo Band of Diegueno Mission Indians of the Campo Indian Reservation, California; Capitan Grande Band of Diegueno Mission Indians of California (Barona Group of Capitan Grande Band of Mission Indians of the Barona Reservation, California); Viejas (Baron Long) Group of Capitan Grande Band of the Mission Indians of the Viejas Reservation, California; Ewiiaapaayp Band of Kumeyaay Indians, California; Iipay Nation of Santa Ysabel, California (previously listed as the Santa Ysabel Band of Diegueno Mission Indians of the Santa Ysabel Reservation); Inaja Band of Diegueno Mission Indians of the Inaja and Cosmit Reservation, California; Jamul Indian Village of California; La Posta Band of Diegueno Mission Indians of the La Posta Indian Reservation, California; Manzanita Band of Diegueno Mission Indians of the Manzanita Reservation, California; Mesa Grande Band of Diegueno Mission Indians of the Mesa Grande Reservation, California; San Pasqual Band of Diegueno Mission Indians of California; and Sycuan Band of the Kumeyaay Nation (hereafter referred to as “The Tribes”).
In 1929, human remains representing, at minimum, two individuals were recovered by Malcom J. Rogers from CA-SDI-694 (W-99 and W-99A), a site located on the north side of Bataquitos Lagoon. During consultation, it was determined that CA-SDI-694 is a cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects. No known individuals were identified. The 163 associated funerary objects are: One unmodified faunal bone, one chipped stone biface, one projectile point, 15 chipped stone cores, 23 chipped stone core tools, 27 chipped stone unworked flakes, 37 chipped stone utilized flakes, eight groundstone manos, five groundstone metates, 19 stone ecofacts, five lots unmodified shell, five lots of soil, and 16 battered stones.
In 1929, human remains representing, at minimum, one individual were recovered by Malcom J. Rogers from CA-SDI-691/693/6867 (W-98, W-101, W-101B, and W-102), a site complex located on the north side of Bataquitos Lagoon. During consultation, it was determined that this site complex is a cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects. No known individuals were identified. The 125 associated funerary objects are: One undecorated ceramic body sherd, 14 lots of unmodified faunal bones, six chipped stone cores, 10 chipped stone core tools, one chipped stone knife, one chipped stone unifacial tool, 11 lots of unworked flakes, 27 utilized flakes, seven manos, one metate, one groundstone fishing or netting weight, two steatite pendants, one groundstone, two pestle fragments, 10 lots of ecofacts, 10 unmodified shells, eight lots of unmodified shells, three soil samples, six battered stones, two lots of fire affected stone, and one lot of charcoal.
In 1929, human remains representing, at minimum, two individuals were recovered by Malcom J. Rogers from CA-SDI-8195, CA-SDI-4860, and CA-SDI-4847 (W-108, W-109, W-109A, W-110), a cluster of sites north of Bataquitos Lagoon. During consultation, it was determined that these sites comprise one cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from these sites are associated funerary objects. No known individuals were identified. The 233 associated funerary objects are: Four lots of unmodified faunal bones, two decorated ceramic sherds, one ceramic undecorated rim sherd, four lots of mixed ceramic sherds, one chipped stone biface, 16 chipped stone cores, 87 chipped stone core tools, three stone spear points, four chipped stones, three stone scrapers, seven projectile points, one unworked flake, three lots of unworked flakes, one stone crescentic, 54 utilized flakes, 14 manos, one metate, one groundstone, two stone pestles, one stone ecofact, three lots of ecofacts, one modified shell pendant, three lots of unmodified shell, one soil sample, and 15 battered stones.
In 1929, human remains representing, at minimum, one individual were recovered by Malcom J. Rogers from CA-SDI-4548, 4990 (W-92), a site south of Bataquitos Lagoon. Based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects. No known individuals were identified. The 241 associated funerary objects are: One chipped stone biface, 11 cores, 45 core tools, one projectile point, one scraper, four lots of unworked flakes, 162 utilized flakes, eight manos, one lot of ecofacts, one olivella shell bead, two lots of unworked shell, one soil sample, two battered stones, and one lot of unmodified faunal bone.
In 1929, human remains representing, at minimum, one individual were recovered by Malcom J. Rogers from CA-SDI-630 (W-141 and W-141B), a site east of Buena Vista Lagoon along Buena Vista Creek. Based on traditional
At an unknown date prior to 1949, human remains representing, at minimum, one individual were donated to the San Diego Museum of Man by H.E. Ellery. Other than their association to W-146, no additional information exists about the date of collection or collector. Based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects to this individual. No known individuals were identified. The 24 associated funerary objects are: One mixed lot of faunal bone and shell, two lots unmodified faunal bone, one lot of undecorated ceramics sherds, one chipped stone biface, one core tool, three scrapers, four lots of unworked flakes, two manos, one abrader, one ecofact, five unmodified shells, one soil sample, and one hammerstone.
At an unknown date prior to 1949, human remains representing, at minimum, one individual were donated to the San Diego Museum of Man by John Kelley. Mr. Kelley collected this burial following a heavy flood and landslide on his property in 1916, also known as W-148. Based on traditional Kumeyaay burial practices, all objects removed from this site are associated funerary objects to this individual. No known individuals were identified. The eight associated funerary objects are: one battered stone, one stone scraper, one unworked flake, one rim sherd, one unmodified faunal bone, one oyster shell, one lot miscellaneous shell, and one soil sample.
In 1929, human remains representing, at minimum, two individuals were recovered by Malcom J. Rogers from CA-SDI-8797, CA-SDI-10671, CA-SDI-6132, and CA-10673 (W-116, W-118, W-119, and W-129), a cluster of sites south of Agua Hedionda Lagoon. During consultation, it was determined that these site comprise one cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from these sites are associated funerary objects. No known individuals were identified. The 149 associated funerary objects are: Three lots of ceramic sherds, five lots of unmodified faunal bone, one heating stone, five stone cores, 25 chipped stone core tools, two chipped stone bifaces, eight scrappers, three unworked flakes, 11 lots of unworked flakes, 39 utilized flakes, nine manos, one metate, six groundstones, six lots of ecofacts, six lots of shell, one unmodified shell, one olivella bead, four soil samples, six battered stones, one chopper, four hammerstones, one fire-affected rock, and one stone bead.
In 1929, human remains representing, at minimum, one individual were recovered by Malcom J. Rogers from CA-SDI-6134 (W-121), a site south of Agua Hedionda Lagoon. During consultation, it was determined that this site is a cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects. No known individuals were identified. The 64 associated funerary objects are: One bone awl, seven lots unmodified faunal bone, one undecorated ceramic body sherd, one chipped stone biface fragment, one chipped stone core, 25 chipped stone scrapers, 10 lots of chipped stone unworked flakes, one chipped stone utilized flake, one mano, one hematite “charm stone”, one steatite doughnut stone fragment, one sandstone grinding slab fragment, one modified wood piece, one ecofact, six lots of unmodified shell, two soil samples, and three battered stones.
In 1929, human remains representing, at minimum, one individual were recovered by Malcom J. Rogers from W-124, a site south of Agua Hedionda Lagoon. During consultation, it was determined that this site is a cemetery and that, based on traditional Kumeyaay burial practices, all objects excavated from this site are associated funerary objects. No known individuals were identified. The 20 associated funerary objects are: One lot of undecorated ceramic body sherds, one chipped stone flaking and battering fragment, 11 chipped stone scrapers, three lots of chipped stone unworked flakes, one lot unmodified shell, and three battered stones.
The excavations at the above sites by Rogers and the other individuals were often conducted at the behest of the San Diego Museum of Man. These sites are all located within well-known and documented territories occupied by the Kumeyaay Nation. Based on archeological evidence, geographic location, ethnographic information, and oral history evidence, these remains have been identified as Native American.
Officials of the San Diego Museum of Man have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 13 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 1,071 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and The Tribes.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Ben Garcia, Deputy Director, San Diego Museum of Man, 1350 El Prado, San Diego, CA 92101, telephone (619) 239-2001 ext. 17, email
The San Diego Museum of Man is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The New York University (NYU) College of Dentistry has completed an inventory of human remains, in consultation with the
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the NYU College of Dentistry at the address in this notice by September 7, 2018.
Dr. Louis Terracio, NYU College of Dentistry, 345 East 24th Street, New York, NY 10010, telephone (212) 998-9717, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the NYU College of Dentistry, New York City, NY. The human remains were removed from Shinnecock Hills, Suffolk County, Long Island, NY.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the NYU College of Dentistry professional staff in consultation with representatives of the Delaware Nation, Oklahoma; Delaware Tribe of Indians; Shinnecock Indian Nation; and Stockbridge Munsee Community, Wisconsin.
At an unknown date, human remains representing, at minimum, one individual were removed from an unknown site in Shinnecock Hills, Suffolk County, NY. In 1926, the town of Southampton donated the human remains, which consist of the cranial fragments of one adult, to the Museum of the American Indian, Heye Foundation. They were accessioned into the collection of the Department of Physical Anthropology of the Museum of the American Indian, Heye Foundation that same year. In 1956, the human remains were transferred to Dr. Theodore Kazamiroff, NYU College of Dentistry. No known individuals were identified. No associated funerary objects are present. The age of the human remains cannot be determined from the available information. Forensic examination revealed diagnostic features of an individual with Native American ancestry. Without any information about the site or age of the remains, no identifiable earlier group can be determined.
Shinnecock Hills, which lies near the northeastern end of Long Island, is not included in any treaties, Acts of Congress, or Executive Orders that establish aboriginal land. The area is, however, within territory that was long recognized by the tribe, the town of Southampton, and the state of New York as Shinnecock land. In 1703, the Shinnecock and town of Southampton reached an agreement in which the Shinnecock held a 1,000 year lease of approximately 3,500 acres, including Shinnecock Hills. The area was subsequently referred to as the Shinnecock Reservation in various state and local documents. The Shinnecock renegotiated their lease in 1859 and relinquished the lands at Shinnecock Hills in exchange for fee title to the land at Shinnecock Neck. The current Shinnecock Reservation, which no longer includes Shinnecock Hills, was placed into trust after the tribe was federally recognized in 2010. The Department of Interior proposed finding on the Shinnecock petition for federal recognition identifies Shinnecock Hills as part of the pre-1859 Shinnecock Reservation.
Officials of the NYU College of Dentistry have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on diagnostic cranial features observed during forensic examination.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian Tribe.
• Authoritative governmental documents, including the Shinnecock Indian Nation's federal recognition decision, state agreements, and local property records indicate that the land from which the Native American human remains were removed is the aboriginal land of the Shinnecock Indian Nation.
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains may be to the Shinnecock Indian Nation.
Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Louis Terracio, NYU College of Dentistry, 345 East 24th Street, New York, NY 10010, telephone (212) 998-9717, email
The NYU College of Dentistry is responsible for notifying the Shinnecock Indian Nation that this notice has been published.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on June 29, 2018, Clinical Supplies Management Holdings, Inc., 342 42nd Street South, Fargo, North Dakota 58103-1132 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import the listed controlled substances to manufacture bulk controlled substances for use in clinical trials only.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007)
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on May 2, 2018, AndersonBrecon Inc., 5775 Logistics Parkway, Rockford, Illinois 61109 applied to be registered as an importer of the following basic class of controlled substance:
The company plans to import the listed controlled substances for clinical trial only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of registration.
Registrants listed below have applied for and been granted registration by-the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices.
The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed companies.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 9, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on June 25, 2018, Euticals, Inc., 2460 W Bennett Street, Springfield, Missouri 65807-1229 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007)
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on August 16, 2017, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import the listed controlled substances to manufacture bulk controlled substances for sale to its customers. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacture tapentadol for distribution to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007)
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on October 5, 2017, Myoderm, 48 East Main St., Norristown, Pennsylvania 19401 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import controlled substances commercially packaged in dosage form only for clinical trials purposes, research, and analytical purposes only.
Notice of information collection; request for comment.
The Department of Labor (DOL), Employment and Training Administration (ETA) is soliciting comments concerning a new request for the authority to conduct the information collection request (ICR) titled, “State Apprenticeship Expansion (SAE) Grants Research Study.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by October 9, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free by contacting Gloribel Nieves-Cartagena by telephone at (202) 693-2771, TTY 1-877-889-5627 (these are not toll free numbers), or by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Policy Development and Research, Room N-5641, 200 Constitution Avenue NW, Washington, DC 20210; by email:
Gloribel Nieves-Cartagena by telephone at (202) 693-2771, TYY 1-877-889-5627 (these are not toll-free numbers) or by email at
44 U.S.C. 3506(c)(2)(A).
The DOL, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed.
The information collection activities described in this notice will provide data for a qualitative study of Apprenticeship SAE grants and related apprenticeship expansion activities.
Through grant and contract vehicles, DOL is seeking to expand opportunities related to Registered Apprenticeships, expand programs to new industries and occupations, increase the number of apprentices, and to promote the diversity and inclusion of apprentices.
First, in September 2016, DOL awarded $20.4 million through 10 National Industry Partner contracts and four National Equity Partner contracts to increase apprenticeships in particular industries and focus on diversity and inclusion in apprenticeships, respectively. In November 2016, DOL awarded a total of $50.5 million in grants to 36 states and one territory to expand apprenticeships throughout the country. In 2017, 10 contracts were renewed for a second contract year.
This information collection covers an evaluation study, which will address six key research questions related to the SAE grants and national industry and equity partner contracts: (1) How are grantees' and contractors' implementation activities progressing around efforts to drive apprenticeship expansion and diversity, (2) What partnerships have been developed as a result of these activities, (3) What factors have affected implementation, (4) How are funds being used, (5) What state policies exist or are in development to support expansion, and (6) What promising models or lessons have emerged? In addition, through a national survey of states and U.S. territories, the study will address the question: What is the current status of states' efforts to grow apprenticeship programs and opportunities?
The National Apprenticeship Act of 1937 (29 U.S.C. 50) authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the internet without redaction. The DOL encourages commenters not to include personally identifiable information, in any comments.
The DOL is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Human Exploration and Operations Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Monday, August 27, 2018, 10:00 a.m.-5:00 p.m.; and Tuesday, August 28, 2018, 8:00 a.m.-2:45 p.m., PDT. Joint meeting with the NAC Science Committee on August 28, 2018.
NASA Ames Research Center, NASA Ames Conference Center, Building 3, 500 Severyns Road, Ballroom Meeting Room, Moffett Field, CA 94035.
Dr. Bette Siegel, Designated Federal Officer, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2245, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll free conference call number 1-888-324-9238 or toll access number 1-517-308-9132, passcode 3403297, followed by the # sign to participate in this meeting by telephone. The WebEx link is
The agenda for the meeting includes the following topics:
For NASA Ames Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Technology, Innovation and Engineering Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Tuesday, August 28, 2018, 8:00 a.m.-5:00 p.m., PDT.
NASA Ames Research Center, NASA Ames Conference Center, Building 3, 500 Severyns Road, Mezzanine Room, Moffett Field, CA 94035.
Mr. Mike Green, Designated Federal Officer, Space Technology Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-4710, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the toll free access number 1-844-467-6272, passcode 102421, followed by the # sign to participate in the meeting by telephone. The WebEx link is
For NASA Ames Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). This meeting will be held for the purpose of soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.
Tuesday, August 28, 2018, 10:00 a.m.-5:00 p.m., PDT.
NASA Ames Research Center, NASA Ames Conference Center, Building 3, 500 Severyns Road, North Wing Room, Moffett Field, CA 94035
Ms. Irma Rodriguez, Designated Federal Officer, Aeronautics Research Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0984, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and online via Adobe Connect. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll-free conference number 1-844-467-6272, passcode: 592382, followed by the # sign to participate in this meeting by telephone. The Adobe Connect link is
For NASA Ames Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning. This Committee reports to the NAC.
Monday, August 27, 2018, 8:00 a.m.-5:00 p.m.; and Tuesday, August 28, 2018, 8:00 a.m.-2:45 p.m., PDT. Joint meeting with the NAC Human Exploration and Operations Committee on August 28, 2018.
NASA Ames Research Center, NASA Ames Conference Center, Building 3, 500 Severyns Road, Moffett Field, CA 94035.
Ms. KarShelia Henderson, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2355, fax (202) 358-2779, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. For August 27, please use the following information: the Science Committee meeting will be held in the Showroom. Any interested person may dial the toll free number 1-888-324-2680 or toll access number 1-517-308-9418, passcode: 8870080, followed by the # sign to participate in the meeting by telephone. The WebEx link is
The agenda for the meeting includes the following topics:
For NASA Ames Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Ad Hoc Task Force on Science, Technology, Engineering and Mathematics (STEM) of the NASA Advisory Council (NAC). This Task Force reports to the NAC.
Tuesday, August 28, 2018, 9:30 a.m.-2:30 p.m., PDT.
Dr. Beverly Girten, Designated Federal Officer, Office of Education, NASA Headquarters, Washington, DC 20546, (202) 358-0212, or
This meeting will be virtual and will be available telephonically and by WebEx only. You must use a touch tone phone to participate in this meeting. Any interested person may dial the toll free access number 1-844-467-6272 or toll access number 1-720-259-6462, passcode: 634012, followed by the # sign to participate in the meeting by telephone. To join via WebEx, the link is
For NASA Ames Research Center visitor access, please go through the Main Gate and show a valid government-issued identification (
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when agencies no longer need them for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives of the United States and to destroy, after a specified period, records lacking administrative, legal, research, or other value. NARA publishes notice in the
NARA must receive requests for copies in writing by September 7, 2018. Once NARA finishes appraising the records, we will send you a copy of the schedule you requested. We usually prepare appraisal memoranda that contain additional information concerning the records covered by a proposed schedule. You may also
You may request a copy of any records schedule identified in this notice by contacting Records Appraisal and Agency Assistance (ACRA) using one of the following means:
You must cite the control number, which appears in parentheses after the name of the agency that submitted the schedule, and a mailing address. If you would like an appraisal report, please include that in your request.
Margaret Hawkins, Director, by mail at Records Appraisal and Agency Assistance (ACRA); National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, by phone at 301-837-1799, or by email at
NARA publishes notice in the
Each year, Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing records retention periods and submit these schedules for NARA's approval. These schedules provide for timely transfer into the National Archives of historically valuable records and authorize the agency to dispose of all other records after the agency no longer needs them to conduct its business. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
The schedules listed in this notice are media neutral unless otherwise specified. An item in a schedule is media neutral when an agency may apply the disposition instructions to records regardless of the medium in which it creates or maintains the records. Items included in schedules submitted to NARA on or after December 17, 2007, are media neutral unless the item is expressly limited to a specific medium. (See 36 CFR 1225.12(e).)
Agencies may not destroy Federal records without Archivist of the United States' approval. The Archivist approves destruction only after thoroughly considering the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value.
In addition to identifying the Federal agencies and any subdivisions requesting disposition authority, this notice lists the organizational unit(s) accumulating the records (or notes that the schedule has agency-wide applicability when schedules cover records that may be accumulated throughout an agency); provides the control number assigned to each schedule, the total number of schedule items, and the number of temporary items (the records proposed for destruction); and includes a brief description of the temporary records. The records schedule itself contains a full description of the records at the file unit level as well as their disposition. If NARA staff has prepared an appraisal memorandum for the schedule, it also includes information about the records. You may request additional information about the disposition process at the addresses above.
1. Department of Agriculture, Foreign Agricultural Service (DAA-0166-2018-0028, 2 items, 2 temporary items). Documentation and amendments to marketing plans, cooperator annual progress reports, cooperator contribution reports, and related correspondence.
2. Department of Agriculture, Forest Service (DAA-0095-2018-0007, 1 item, 1 temporary item). General correspondence, memos, and mailing lists related to cooperative fire protection programs.
3. Department of Agriculture, Forest Service (DAA-0095-2018-0008, 1 item, 1 temporary item). General correspondence, studies, and reports related to fire suppression assistance.
4. Department of Agriculture, Forest Service (DAA-0095-2018-0009, 1 item, 1 temporary item). General correspondence, studies, analysis, and reports related to cooperative wildfire programs.
5. Department of Agriculture, Forest Service (DAA-0095-2018-0010, 1 item, 1 temporary item). General correspondence, memos, and training documentation related to forestry assistance programs.
6. Department of Agriculture, Forest Service (DAA-0095-2018-0011, 1 item, 1 temporary item). Correspondence, memos, minutes, and guidance publications related to forest management assistance.
7. Department of Agriculture, Forest Service (DAA-0095-2018-0012, 1 item, 1 temporary item). General correspondence, policies, procedures, administrative studies, and testing sheets related to cooperative nursery production.
8. Department of Agriculture, Forest Service (DAA-0095-2018-0024, 1 item, 1 temporary item). General program administration and correspondence records related to the land exchange program, including unconsummated cases.
9. Department of Agriculture, Forest Service (DAA-0095-2018-0025, 1 item, 1 temporary item). General program administration and correspondence records related to the partial land interest program, including unconsummated cases.
10. Department of Agriculture, Forest Service (DAA-0095-2018-0026, 1 item, 1 temporary item). General program administration and correspondence records related to the rights-of-way acquisition program, including unconsummated cases.
11. Department of Agriculture, Forest Service (DAA-0095-2018-0027, 1 item, 1 temporary item). General program administration and correspondence records related to the sale and granting of land through special acts, including unconsummated cases.
12. Department of Agriculture, Forest Service (DAA-0095-2018-0028, 1 item, 1 temporary item). Management records of the aviation program to include aircraft policy and procedure records, oversight, and evaluation records.
13. Department of Agriculture, Forest Service (DAA-0095-2018-0034, 1 item, 1 temporary item). Reports, indexes, logs, and inventories used in tracking and control of agency records.
14. Department of Agriculture, Forest Service (DAA-0095-2018-0099, 5 items, 5 temporary items). General administrative records relating to equipment development throughout the Equipment Development Centers, including budget files, correspondence, progress reports, and administrative project files.
15. Department of Homeland Security, Bureau of Customs and Border Protection (DAA-0568-2017-0010, 3 items, 3 temporary items). Records related to human resources processes not covered in General Records Schedules.
16. Department of Transportation, National Highway Traffic Safety Administration (DAA-0416-2015-0009, 1 item, 1 temporary item). Master files of an electronic information system used to track fuel economy data for vehicles and manufacturers.
Pension Benefit Guaranty Corporation.
Notice.
The Pension Benefit Guaranty Corporation (PBGC) is soliciting nominations for appointment to the Advisory Committee of the PBGC.
Nominations must be received on or before September 24, 2018. Please allow three weeks for regular mail delivery to PBGC.
Nominations must be submitted to Judith Larsen, Office of the Director, Pension Benefit Guaranty Corporation, 1200 K Street NW, Washington, DC 20005-4026, or as email attachments to
The Pension Benefit Guaranty Corporation (PBGC or the Corporation) administers the pension plan termination insurance program under Title IV of the Employee Retirement Income Security Act of 1974 (ERISA). Section 4002(h) of ERISA provides for the establishment of an Advisory Committee to the Corporation. The Advisory Committee consists of seven members appointed by the President from among individuals recommended by the PBGC Board of Directors, which consists of the Secretaries of Labor, Treasury, and Commerce. The Advisory Committee members are as follows:
• Two representatives of employee organizations;
• Two representatives of employers who maintain pension plans; and
• Three representatives of the general public.
No more than four members of the Committee shall be members of the same political party. Anyone currently subject to federal registration requirements as a lobbyist is not eligible for appointment.
Advisory Committee members must have experience with employee organizations, employers who maintain defined benefit pension plans, the administration or advising of pension plans, or in related fields. Appointments are for three-year terms. Some of the appointments may serve unexpired terms that have less than three years remaining. Reappointments are possible but are subject to the appointment process.
The Advisory Committee's prescribed duties include advising the Corporation as to its policies and procedures relating to investment of moneys, and other issues as the Corporation may request or as the Advisory Committee determines appropriate. The Advisory Committee meets at least six times each year. At least one meeting is a joint meeting with the PBGC Board of Directors.
By February 19, 2019, the terms of all of the Advisory Committee members will have expired. Therefore, PBGC is seeking nominations for all of the seats.
PBGC is committed to equal opportunity in the workplace and seeks a broad-based and diverse Advisory Committee.
If you or your organization wants to nominate one or more people for appointment to the Advisory Committee to represent any of the interest groups specified above, you may submit nominations to PBGC. Nominations may be in the form of a letter, resolution or petition, signed by the person making the nomination or, in the case of a nomination by an organization, by an authorized representative of the organization. PBGC encourages you to include additional supporting letters of nomination. PBGC will not consider self-nominees who have no supporting letters. Please do not include any information that you do not want publicly disclosed.
Nominations, including supporting letters, should:
• State the person's qualifications to serve on the Advisory Committee (including any specialized knowledge or experience relevant to the nominee's proposed Advisory Committee position);
• State that the candidate will accept appointment to the Advisory Committee if offered;
• Include which of the positions (representing interest group) the candidate is being nominated to fill;
• Include the nominee's full name, work affiliation, mailing address, phone number, and email address;
• Include the nominator's full name, mailing address, phone number, and email address; and
• Include the nominator's signature, whether sent by email or otherwise.
PBGC will contact nominees for information on their political affiliation and their status as registered lobbyists. Nominees should be aware of the time commitment for attending meetings and actively participating in the work of the Advisory Committee. Historically, this has meant a commitment of at least 15 days per year. PBGC has a process for vetting nominees under consideration for appointment.
U.S. Office of Personnel Management (OPM).
Notice.
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from March 1, 2018 to March 31, 2018.
Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, (202) 606-2246.
In accordance with 5 CFR 213.103, Schedule A, B, and C appointing authorities available for use by all agencies are codified in the Code of Federal Regulations (CFR). Schedule A, B, and C appointing authorities applicable to a single agency are not codified in the CFR, but the U.S. Office of Personnel Management (OPM) publishes a notice of agency-specific authorities established or revoked each month in the
No schedule A Authorities to report during March 2018.
No schedule B Authorities to report during March 2018.
The following Schedule C appointing authorities were approved during March 2018.
The following Schedule C appointing authorities were revoked during March 2018.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218.
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade shares of GraniteShares Gold MiniBAR Trust under NYSE Arca Rule 8.201-E (“Commodity-Based Trust Shares”). The proposed change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade shares (“Shares”) of the GraniteShares Gold MiniBAR Trust under NYSE Arca Rule 8.201-E.
The Trust will not be registered as an investment company under the
The sponsor of the Trust is GraniteShares LLC (“Sponsor”). The “Trustee” is The Bank of New York Mellon and the “Custodian” is ICBC Standard Bank Plc.
The Commission has previously approved listing on the Exchange under NYSE Arca Rules 5.2-E(j)(5) and 8.201-E of other precious metals and gold-based commodity trusts, including the GraniteShares Gold Trust;
The Exchange represents that the Shares satisfy the requirements of NYSE Arca Rule 8.201-E and thereby qualify for listing on the Exchange.
The investment objective of the Trust will be for the Shares to reflect the performance of the price of gold, less the expenses and liabilities of the Trust. The Trust will issue Shares which represent units of fractional undivided beneficial interest in and ownership of the Trust.
The Trust will not trade in gold futures, options or swap contracts on any futures exchange or over the counter (“OTC”). The Trust will not hold or trade in commodity futures contracts, “commodity interests”, or any other instruments regulated by the Commodities Exchange Act. The Trust will take delivery of physical gold that complies with the London Bullion Markets Association (“LBMA”) gold delivery rules.
The Shares are intended to constitute a simple and cost-effective means of making an investment similar to an investment in gold. Although the Shares are not the exact equivalent of an investment in gold, they are intended to provide investors with an alternative that allows a level of participation in the gold market through the securities market.
The global trade in gold consists of OTC transactions in spot, forwards, and options and other derivatives, together with exchange-traded futures and options.
The OTC gold market includes spot, forward, and option and other derivative transactions conducted on a principal-to-principal basis. While this is a global, nearly 24-hour per day market, its main centers are London, New York, and Zurich.
According to the Registration Statement, most OTC market trades are cleared through London. The LBMA plays an important role in setting OTC gold trading industry standards. A London Good Delivery Bar (as described below), which is acceptable for settlement of any OTC transaction, will be acceptable for delivery to the Trust in connection with the issuance of Baskets.
The most significant gold futures exchange in the U.S. is COMEX, operated by Commodities Exchange, Inc., a subsidiary of New York Mercantile Exchange, Inc., and a subsidiary of the Chicago Mercantile Exchange Group (the “CME Group”). Other commodity exchanges include the Tokyo Commodity Exchange (“TOCOM”), the Multi Commodity Exchange Of India (“MCX”), the Shanghai Futures Exchange, ICE Futures US (the “ICE”), and the Dubai Gold & Commodities Exchange.
According to the Registration Statement, most trading in physical gold is conducted on the OTC market, predominantly in London. LBMA coordinates various OTC-market activities, including clearing and vaulting, acts as the principal intermediary between physical gold market participants and the relevant regulators, promotes good trading practices and develops standard market documentation. In addition, the LBMA promotes refining standards for the gold market by maintaining the “London Good Delivery List,” which identifies refiners of gold that have been approved by the LBMA. In the OTC market, gold bars that meet the specifications for weight, dimensions, fineness (or purity), identifying marks (including the assay stamp of an LBMA-acceptable refiner) and appearance described in “The Good Delivery Rules for Gold and Silver Bars” published by the LBMA are referred to
Following the enactment of the Financial Markets Act 2012, the Prudential Regulation Authority of the Bank of England is responsible for regulating most of the financial firms that are active in the bullion market, and the Financial Conduct Authority is responsible for consumer and competition issues.
According to the Registration Statement, the Trust will create and redeem Shares on a continuous basis in one or more blocks of 50,000 Shares (a block of 50,000 Shares is called a “Basket”). As described below, the Trust will issue Shares in Baskets to certain authorized participants (“Authorized Participants”) on an ongoing basis. Baskets of Shares will only be issued or redeemed in exchange for an amount of gold determined by the Trustee on each day that the Exchange is open for regular trading. No Shares will be issued unless the Custodian has allocated to the Trust's account the corresponding amount of gold. Initially, a Basket will require delivery of 500 fine ounces of gold. The amount of gold necessary for the creation of a Basket, or to be received upon redemption of a Basket, will decrease over the life of the Trust, due to the payment or accrual of fees and other expenses or liabilities payable by the Trust.
Baskets may be created or redeemed only by Authorized Participants. Orders must be placed by 3:59 p.m. Eastern Time (“E.T.”). The day on which the Trust receives a valid purchase or redemption order is the order date.
Each Authorized Participant must be a registered broker-dealer, a participant in Depository Trust Corporation, have entered into an agreement with the Trustee (the “Authorized Participant Agreement”) and be in a position to transfer gold to, and take delivery of gold from, the Custodian through one or more gold accounts. The Authorized Participant Agreement provides the procedures for the creation and redemption of Baskets and for the delivery of gold in connection with such creations or redemptions.
According to the Registration Statement, Authorized Participants may surrender Baskets of Shares in exchange for the corresponding Basket Amount announced by the Trustee. Upon surrender of such Shares and payment of the Trustee's applicable fee and of any expenses, taxes or charges (such as stamp taxes or stock transfer taxes or fees), the Trustee will deliver to the order of the redeeming Authorized Participant the amount of gold corresponding to the redeemed Baskets.
Before surrendering Baskets of Shares for redemption, an Authorized Participant must deliver to the Trustee a written request indicating the number of Baskets it intends to redeem and the location where it would like to take delivery of the gold represented by such Baskets. The date the Trustee receives that order determines the Basket Amount to be received in exchange. However, orders received by the Trustee after 3:59 p.m. Eastern Time (“E.T.”) will not be accepted.
The redemption distribution from the Trust will consist of a credit to the redeeming Authorized Participant's unallocated account representing the amount of the gold held by the Trust evidenced by the Shares being redeemed as of the date of the redemption order.
According to the Registration Statement, the net asset value of the Trust will be obtained by subtracting the Trust's expenses and liabilities on any day from the value of the gold owned by the Trust on that day; the net asset value (“NAV”) per Share will be obtained by dividing the net asset value of the Trust on a given day by the number of Shares outstanding on that day. On each day on which the Exchange is open for regular trading, the Trustee will determine the net asset value of the Trust and the NAV per Share as promptly as practicable after 4:00 p.m. (E.T.). The Trustee will value the Trust's gold on the basis of LBMA Gold Price PM. If there is no LBMA Gold Price PM on any day, the Trustee is authorized to use the LBMA Gold Price AM announced on that day. If neither price is available for that day, the Trustee will value the Trust's gold based on the most recently announced LBMA Gold Price PM or LBMA Gold Price AM. If the Sponsor determines that such price is inappropriate to use, the Sponsor will identify an alternate basis for evaluation to be employed by the Trustee. Further, the Sponsor may instruct the Trustee to use on an on-going basis a different publicly available price which the Sponsor determines to fairly represent the commercial value of the Trust's gold.
Currently, the Consolidated Tape Plan does not provide for dissemination of the spot price of a commodity such as gold over the Consolidated Tape. However, there will be disseminated over the Consolidated Tape the last sale price for the Shares. In addition, there is a considerable amount of information about gold and gold markets available on public websites and through professional and subscription services.
Investors may obtain gold pricing information on a 24-hour basis based on the spot price for an ounce of Gold from various financial information service providers, such as Reuters and Bloomberg.
Reuters and Bloomberg, for example, provide at no charge on their websites delayed information regarding the spot price of Gold and last sale prices of Gold futures, as well as information about news and developments in the gold market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on Gold prices directly from market participants. Complete real-time data for Gold futures and options prices traded on the COMEX are available by subscription from Reuters and Bloomberg. There are a variety of other public websites providing information on gold, ranging from those specializing in precious metals to sites maintained by major newspapers. In addition, the LBMA Gold Price is publicly available at no charge at
The intraday indicative value (“IIV”) per Share for the Shares will be disseminated by one or more major market data vendors. The IIV will be calculated based on the amount of gold held by the Trust and a price of gold derived from updated bids and offers indicative of the spot price of gold.
The website for the Trust (
The Trust will be subject to the criteria in NYSE Arca Rule 8.201-E(e) for initial and continued listing of the Shares.
A minimum of two Baskets or 100,000 Shares will be required to be outstanding at the start of trading, which is equivalent to 1,000 fine ounces of gold or about $1.24 million as of July 18, 2018. The Exchange believes that the anticipated minimum number of Shares outstanding at the start of trading is sufficient to provide adequate market liquidity.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Trust subject to the Exchange's existing rules governing the trading of equity securities. Trading in the Shares on the Exchange will occur in accordance with NYSE Arca Rule 7.34-E(a). The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in NYSE Arca Rule 7.6-E, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00 for which the MPV for order entry is $0.0001.
Further, NYSE Arca Rule 8.201-E sets forth certain restrictions on ETP Holders acting as registered Market Makers in the Shares to facilitate surveillance. Under NYSE Arca Rule 8.201-E(g), an ETP Holder acting as a registered Market Maker in the Shares is required to provide the Exchange with information relating to its trading in the underlying gold, related futures or options on futures, or any other related derivatives. Commentary .04 of NYSE Arca Rule 11.3-E requires an ETP Holder acting as a registered Market Maker, and its affiliates, in the Shares to establish, maintain and enforce written policies and procedures reasonably designed to prevent the misuse of any material nonpublic information with respect to such products, any components of the related products, any physical asset or commodity underlying the product, applicable currencies, underlying indexes, related futures or options on futures, and any related derivative instruments (including the Shares).
As a general matter, the Exchange has regulatory jurisdiction over its ETP Holders and their associated persons, which include any person or entity controlling an ETP Holder. A subsidiary or affiliate of an ETP Holder that does business only in commodities or futures contracts would not be subject to Exchange jurisdiction, but the Exchange could obtain information regarding the activities of such subsidiary or affiliate through surveillance sharing agreements with regulatory organizations of which such subsidiary or affiliate is a member.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading on the Exchange in the Shares may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which conditions in the underlying gold market have caused disruptions and/or lack of trading, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Shares will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”), and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading in the Shares from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
Also, pursuant to NYSE Arca Rule 8.201-E(g), the Exchange is able to obtain information regarding trading in the Shares and the underlying gold, gold futures contracts, options on gold futures, or any other gold derivative, through ETP Holders acting as registered Market Makers, in connection with such ETP Holders' proprietary or customer trades through ETP Holders which they effect on any relevant market.
In addition, the Exchange also has a general policy prohibiting the
All statements and representations made in this filing regarding (a) the description of the portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares of the Trust on the Exchange.
The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Trust to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Trust is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Rule 5.5-E(m).
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (1) The procedures for purchases and redemptions of Shares in Baskets (including noting that Shares are not individually redeemable); (2) NYSE Arca Rule 9.2-E(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (3) how information regarding the IIV is disseminated; (4) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; (5) the possibility that trading spreads and the resulting premium or discount on the Shares may widen as a result of reduced liquidity of gold trading during the Core and Late Trading Sessions after the close of the major world gold markets; and (6) trading information. For example, the Information Bulletin will advise ETP Holders, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Trust. The Exchange notes that investors purchasing Shares directly from the Trust will receive a prospectus. ETP Holders purchasing Shares from the Trust for resale to investors will deliver a prospectus to such investors.
In addition, the Information Bulletin will reference that the Trust is subject to various fees and expenses as will be described in the Registration Statement. The Information Bulletin will also reference the fact that there is no regulated source of last sale information regarding physical gold, that the Commission has no jurisdiction over the trading of gold as a physical commodity, and that the Commodity Futures Trading Commission has regulatory jurisdiction over the trading of gold futures contracts and options on gold futures contracts.
The Information Bulletin will also discuss any relief, if granted, by the Commission or the staff from any rules under the Act.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Rule 8.201-E. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange may obtain information via the ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that there is a considerable amount of gold price and gold market information available on public websites and through professional and subscription services. Investors may obtain on a 24-hour basis gold pricing information based on the spot price for an ounce of gold from various financial information service providers. Investors may obtain gold pricing information based on the spot price for an ounce of gold from various financial information service providers. Current spot prices also are generally available with bid/ask spreads from gold bullion dealers. In addition, the Trust's website will provide pricing information for gold spot prices and the Shares. Market prices for the Shares will be available from a variety of sources including brokerage firms, information websites and other information service providers. The NAV of the Trust will be published by the Sponsor on each day that the NYSE Arca is open for regular trading and will be posted on the Trust's website. The IIV relating to the Shares will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Core Trading Session. In addition, the LBMA Gold Price is publicly available at no charge at
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, as noted above, investors will have ready access to information regarding gold pricing.
The Exchange 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 the proposed rule change will enhance competition by accommodating Exchange trading of an additional exchange-traded product relating to physical gold.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On March 6, 2018, the Chicago Stock Exchange, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
On July 26, 2018, the Exchange withdrew the proposed rule change (SR-CHX-2018-001).
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to the FICC Mortgage-Backed Securities Division (“MBSD”) Clearing Rules (“MBSD Rules”) in order to (i) add terms governing MBSD's
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FICC is proposing to amend the MBSD Rules in order to (i) add terms governing MBSD's processing of CPR claims to the MBSD Rules and (ii) make certain clarifications and corrections in the MBSD Rules.
As discussed in more detail below, the submission of CPR claims is an established process that occurs today pursuant to FICC's procedures. FICC is proposing to add provisions to the MBSD Rules to formalize this process in the MBSD Rules.
Mortgage pools
CPR is the percentage of the outstanding loan balance for a pool that is expected to be repaid over a one year period.
The industry currently has a process pursuant to which a buyer may make a CPR claim against the seller as set forth in the SIFMA Guidelines.
FICC currently processes CPR claims that it receives from Clearing Members in a manner consistent with SIFMA Guidelines, except that (i) FICC currently uses a different definition of “claimable unit” as discussed below and (ii) for re-transmittals, FICC's current procedures provide a minimum threshold of $5,000 (rather than $500 as set forth in the SIFMA Guidelines). FICC is proposing to codify its existing CPR claims process in the MBSD Rules, including adding a provision providing that a Clearing Member's cash settlement obligations would include the positive or negative amount of any valid CPR claim. The proposed MBSD CPR claims process would generally follow the CPR claims process set forth in the SIFMA Guidelines and MBSD's current CPR claims process, with the following exceptions:
FICC is proposing to add to the MBSD Rules two definitions of “claimable unit,” the use of which would depend on the type of transaction. Pursuant to SIFMA Guidelines and FICC's current process, CPR claims are based on a “claimable unit” which defines the pool or group of pools that are included in a particular CPR claim.
FICC currently processes CPR claims using a different definition of claimable unit than the SIFMA definition. FICC's CPR claims process currently uses a definition of claimable unit based on characteristics of pools after MBSD Pool Netting
FICC is proposing to use the same definition of claimable unit for CPR claims as SIFMA Guidelines if the pool obligations upon which the CPR claims are based have not been through MBSD Pool Netting, as provided in subsection (1) below. FICC is proposing to use a different definition of claimable unit for CPR claims if the pool obligations upon which the CPR claims are based have been through the MBSD Pool Netting process, as described in subsection (2) below.
FICC is proposing to use the same definition of claimable unit used in the SIFMA Guidelines for CPR claims based on pool obligations that
FICC is proposing to use a different definition of a claimable unit from the SIFMA Guidelines definition for CPR claims based on pool obligations that
FICC is proposing to add to the MBSD Rules two minimum thresholds ($500 and $5,000) for re-transmittals
FICC is proposing to change its current practice and add a proposed $500 re-transmittal threshold for certain allocations described above in the MBSD Rules in order to be more consistent with SIFMA Guidelines and established industry practice. FICC is proposing to use a higher $5,000 threshold, which is consistent with its current process, for re-transmittals for certain substitutions described above to avoid having to process multiple smaller transactions, which FICC believes would likely be administratively burdensome.
To codify the CPR claims process as described above, the proposed rule change would add a description of the CPR claim process in a new Section 10 of MBSD Rule 9, including a defined term for “CPR Claim.” In addition, the proposed rule change would specify the validation process for CPR claims, which, as described above, would codify existing FICC practices relating to CPR claims and provide that the process for CPR claims is consistent with SIFMA Guidelines, in each case, with the exceptions noted above in Items II(A)1(i)(A) and (B).
Specifically, the proposed rule change would specify that CPR claims submitted would be reviewed by FICC to validate the following: (i) The claimable unit with respect to the CPR claim meets the criteria for fast paying pools as set forth in SIFMA Guidelines, (ii) the CPR claim amount is $10,000 or greater, unless the CPR claim is a re-transmittal of a CPR claim, in which case, (a) if the CPR claim relates to an allocation of a pool effected after the factor release date following the contractual settlement date and/or substitution of related pools, the amount is $500 or greater or (b) if the CPR claim relates to a substitution of a pool that was allocated prior to the factor release date following the contractual settlement date, the amount is $5,000 or greater and (iii) 90% of the Clearing Member's claimable unit has settled. Consistent with FICC's current CPR claims process, the proposed rule change would also specify that (1) FICC maintains the right to process CPR claims with no minimum denomination, (2) CPR claims may be apportioned to more than one participant, (3) CPR claims may be comprised of both debits and credits, (4) FICC would process all CPR claims on the Class “B” settlement date in the month following the transmittal month and (5) FICC would notify the Clearing Member that the CPR claim has been rejected if the CPR claim is determined to be invalid. In addition, the proposed rule change would specify that FICC shall not guaranty CPR claim payments, and any credit to be received with respect to a CPR claim would be reduced to the extent the corresponding debit in connection with a CPR claim is not paid.
To ensure that Clearing Members understand the potential credits and debits relating to CPR claims, the proposed rule change would add credits and debits relating to CPR claims in Section 7 of MBSD Rule 11 as items for end of day cash balance computations.
To further describe the CPR claims process as set forth above, a cross-reference for the defined term “CPR Claim” and new defined terms “Claimable Unit” and “Factor Release Date” would be added to MBSD Rule 1, which are consistent with existing FICC
The definitions for Fannie Mae, Freddie Mac and Ginnie Mae would be corrected in MBSD Rule 1 to be consistent with industry practice and with their usage throughout the MBSD Rules. In addition, the definition of “SIFMA Guidelines” would be clarified by adding a link identifying the location of the SIFMA Guidelines on the SIFMA website.
Section 17A(b)(3)(F) of the Act
FICC believes that the proposed changes to add the MBSD's CPR claims process to the MBSD Rules are consistent with Section 17A(b)(3)(F) of the Act.
FICC believes that the proposed changes correcting the definitions of Fannie Mae, Freddie Mac and Ginnie Mae are consistent with Section 17A(b)(3)(F) of the Act
FICC believes that the proposed change clarifying the definition of SIFMA Guidelines by adding a link identifying the location of the SIFMA Guidelines on the SIFMA website is consistent with Section 17A(b)(3)(F) of the Act
Rule 17Ad-22(e)(23)(ii) under the Act
FICC believes that the proposed rule changes to add the CPR claims process in the MBSD Rules as described above could have an impact on competition because the CPR claims process would result in CPR claim charges for Clearing Members against whom CPR claims are processed. Specifically, FICC believes this proposed rule change could burden competition by negatively affecting such Clearing Members' operating costs. While such Clearing Members may experience increases in their charges as a result of CPR claims processed through FICC, FICC does not believe such change would in and of itself mean that the burden on competition is significant. Regardless of whether the burden on competition is deemed significant, FICC believes any burden on competition that is created by the proposed rule changes to add the proposed CPR claims process would be necessary and appropriate in furtherance of the purposes of the Act, as permitted by Section 17A(b)(3)(I) of the Act.
FICC believes the proposed rule changes to include the MBSD CPR claims process in the MBSD Rules would be necessary in furtherance of the purposes of the Act.
FICC also believes any burden on competition that is created by the proposed rule changes to add the MBSD CPR claims process in the MBSD Rules would be appropriate in furtherance of the purposes of the Act.
FICC does not believe there would be an impact on competition with the proposed rule changes that would update the definitions of Fannie Mae, Freddie Mac, Ginnie Mae and SIFMA Guidelines.
FICC has not received or solicited any written comments relating to this proposal. FICC will notify the Commission of any written comments received by FICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Social Security Administration.
Notice of Senior Executive Service Performance Review Board Membership.
Title 5, U.S. Code, 4314 (c)(4), requires that the appointment of Performance Review Board members be published in the
The following persons will serve on the Performance Review Board which oversees the evaluation of performance appraisals of Senior Executive Service members of the Social Security Administration:
Notice is hereby given of the following determinations: I hereby determine that two objects to be
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made 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,
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Animal-Shaped Vessels from the Ancient World: Feasting with Gods, Heroes, and Kings,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Harvard Art Museums, Cambridge, Massachusetts, from on or about September 16, 2018, until on or about January 13, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made 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,
Susquehanna River Basin Commission.
Notice.
The Susquehanna River Basin Commission will hold its regular business meeting on September 7, 2018, in Binghamton, New York. Details concerning the matters to be addressed at the business meeting are contained in the Supplementary Information section of this notice.
The meeting will be held on Friday, September 7, 2018, at 9 a.m.
The meeting will be held at the DoubleTree by Hilton Binghamton, North Riverside Room, 225 Water Street, Binghamton, NY 13901.
Gwyn Rowland, Manager, Governmental & Public Affairs, 717-238-0423, ext. 1316.
The business meeting will include actions or presentations on the following items: (1) Informational presentation of interest to the upper Susquehanna River region; (2) release of proposed rulemaking and policies for public comment; (3) revisions to financial instruments and policies; (4) ratification/approval of contracts/grants; (5) a report on delegated settlements; (6) a proposed consumptive use mitigation project located in Conoy Township, Lancaster County, Pa.; and (7) Regulatory Program projects.
Regulatory Program projects and the consumptive use mitigation project listed for Commission action are those that were the subject of a public hearing conducted by the Commission on August 2, 2018, and identified in the notice for such hearing, which was published in 83 FR 31439, July 5, 2018.
The public is invited to attend the Commission's business meeting. Comments on the Regulatory Program projects and the consumptive use mitigation project were subject to a deadline of August 13, 2018. Written comments pertaining to other items on the agenda at the business meeting may be mailed to the Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, Pennsylvania 17110-1788, or submitted electronically through
Pub. L. 91-575, 84 Stat. 1509
Federal Aviation Administration, DOT.
Notice of request to release airport land.
The Federal Aviation Administration (FAA) proposes to rule and invites public comment on the
Comments must be received on or before September 7, 2018.
Comments on the request may be mailed or delivered to the FAA at the following address: Mr. Gordon Wong, Manager, Federal Aviation Administration, Honolulu Airports District Office,
In accordance with the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (AIR 21), Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be published in the
The following is a brief overview of the request:
The State of Hawaii requested a release from public airport purposes and grant assurance obligations for approximately 9.34 acres of airport land from the 11.34-acre site to allow for its sale and a land-use change to use for other than aeronautical purposes on the remaining approximately 2.0 acres of airport property. In 1989, Congress authorized conveying the 11.34 acres land to the State of Hawaii under Public Law 101-189, Section 2814,
The State of Hawaii will transfer the Airports Division's jurisdiction of approximately 8.37 acres parcel to the State Harbors Division and approximately 0.97 acres of property to the State Highways Division totaling approximately 9.34 acres for fair market value compensation. The Airports Division will retain and lease the remaining 2.0 acres of the land for fair market rental value for non-aeronautical revenue producing purposes.
The sales proceeds and rental income will be devoted to airport operations and capital projects. The reuse of the property will not interfere with the airport or its operation; thereby, serve the interests of civil aviation.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of meeting.
The Federal Aviation Administration (FAA) is announcing the upcoming meetings of the International Aircraft Materials Fire Test Forum (IAMFTF) and the International Aircraft Systems Fire Protection Forum (IASFPF). The IAMFTF and IASFPF were established to provide a forum for interested parties to review and provide feedback on FAA fire safety research driven by current and emerging aircraft systems fire threats and test methods. This notification provides details of where to find the date, location, and agenda for the upcoming meetings.
April Horner, Meeting Coordinator, William J. Hughes Technical Center, Building 287, Atlantic City International Airport, NJ 08405, telephone: (609) 485-4471, email:
The IAMFTF and IASFPF began in the early 1990's as forums to discuss aircraft fire safety research.
The IAMFTF began in 1991 to provide a forum for discussion of aircraft materials fire test methods, and to enable interested parties to contribute to improvement of those test methods through research. The IAMFTF also provides a setting to share research information generated by the FAA as well as other entitites. Topics include tests to assess flammability properties of thermal/acoustic insulation, composite structure, electrical wiring and non-tradtional metal alloys. The meetings typically occur 3 times per year in the spring, summer and fall, and are facilitated by the Fire Safety Branch at the FAA's William J. Hughes Technical Center.
The IASFPF began as a forum to discuss research and development (R&D) on replacements of Halon fire extguishing agents in October 1993. The IASFPF originally focused on R&D into minimum performance standards and test methodologies for non-halon aircraft fire suppression agents/systems in cargo compartments, engine nacelles, hand held extinguishers, and lavatory trash receptacles. The IASFPF's focus has expanded to include a forum for R&D for all aircraft system fire protection. The meetings occur twice per year, typically in May and October and are also facilitated by the Fire Safety Branch at the FAA's William J. Hughes Technical Center.
Topics include research into minimum performance standards for aircraft handheld extinguishers, cargo compartment fire suppression systems, and engine nacelles. Halon replacement agents for these areas are also discussed. Additionally, topics such as research on powerplants fire testing, lithium batteries, fuel cells, fuel tank explosion protection (including fuel flammability, nitrogen inerting, other methods of
The IAMFTF and IASFPF meetings follow a town hall style format. Neither has a standing membership, nor is an advisory body and do not make recommendations on regulations or policy. Any technical research issues that have future relevance to regulations or policy will be handled through the formal processes in place to include full public participation.
The meetings are open to the public, and are typically attended by the international aviation community including industry, government, and academia with an interest in aircraft fire protection systems. Due to limited capacity, advanced registration is required to attend.
An agenda will be published at least one month in advance of each meeting on the FAA Fire Safety Branch website (
Interested persons may attend the meeting. Because seating is limited, if you plan to attend please register in advance on the FAA Fire Safety Branch website (
A meeting summary for the IAMFTF and IASFPF meetings will be posted on the FAA Fire Safety Branch website (
Federal Aviation Administration (FAA), DOT.
Notice of Aviation Rulemaking Advisory Committee (ARAC) meeting.
The FAA is issuing this notice to advise the public of a meeting of the ARAC.
The meeting will be held on September 20, 2018, starting at 1:00 p.m. Eastern Standard Time. Arrange oral presentations by September 4, 2018.
The meeting will take place at the Federal Aviation Administration, Bessie Coleman Room, 800 Independence Avenue SW, Washington, DC 20591.
Lakisha Pearson, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, telephone (202) 267-4191; fax (202) 267-5075; email
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a meeting of the ARAC taking place on September 20, 2018, at the Federal Aviation Administration, Bessie Coleman Room, 800 Independence Avenue SW, Washington, DC 20591.
The Draft Agenda includes:
The Agenda will be published on the FAA Meeting web page (
Attendance is open to the interested public but limited to the space available. Please confirm your attendance with the person listed in the
For persons participating by telephone, please contact the person listed in the
The public must arrange by September 4, 2018, to present oral statements at the meeting. The public may present written statements to the Aviation Rulemaking Advisory Committee by providing 25 copies to the Designated Federal Officer, or by bringing the copies to the meeting.
If you are in need of assistance or require a reasonable accommodation for this meeting, please contact the person listed under the heading
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of application for renewal of exemption; request for comments.
FMCSA announces that it has received an application from the Missouri DOR for a renewal of its exemption from the Agency's commercial driver's license (CDL) regulations. These regulations require a driver to pass the general knowledge test before being issued a Commercial Learner's Permit (CLP). The exemption renewal would allow the Missouri DOR to continue to waive the mandatory knowledge test requirement for qualified veterans who participated in dedicated training in approved military programs. The Missouri DOR states that its goal is to continue to assist qualified veterans in obtaining employment when returning to the civilian workforce, and granting this exemption renewal will assist those veterans who have already been through extensive military training. The Missouri DOR currently holds an exemption for the period of October 27, 2016, through October 29, 2018, and is requesting a 2-year renewal. FMCSA requests public comment on the Missouri DOR's application for exemption.
Comments must be received on or before September 7, 2018.
You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2016-0130 by any of the following methods:
•
•
•
•
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 Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: (202) 366-2722. 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-2016-0130), 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
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations (FMCSRs). 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 compliance with the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
The Missouri DOR's initial exemption application from the provisions of 49 CFR 383.71(a)(2)(ii) was submitted in 2016; a copy is in the docket identified at the beginning of this notice. That 2016 application describes fully the nature of the Missouri DOR's request, and the reasons for its request. The Missouri DOR contends that those qualified veterans who participated in dedicated training in approved military programs have already received numerous hours of classroom training, practical skills training, and one-on-one road training that are essential for safe driving. The original exemption was granted on October 27, 2016 (81 FR 74861) and expires on October 29, 2018. Missouri DOR now requests a 2-year renewal of the exemption. The current exemption allows all States to waive the CDL knowledge test for qualified current or former military personnel who participated in training in military heavy-vehicle driving programs, but does not require them to do so.
The Missouri DOR provided several reasons for this renewal of the exemption request, including:
• The proposed regulatory change to 49 CFR parts 383 and 384 for Military Licensing and State Commercial Driver Licensing Reciprocity [82 FR 26894, June 12, 2017] has not yet been posted as a final rulemaking by the Agency;
• The Missouri legislature did not pass the enabling legislation to pursue full implementation during a recent legislative session; and
• Missouri, as well as other State Driver Licensing Agencies (SDLAs) that have implemented or want to pursue implementation of these provisions, must have an exemption renewal in place until such time as the proposed regulatory change is approved and posted as final.
In addition, because the issue concerning the Missouri DOR request could be applicable in each of the States, FMCSA requests public comment on whether the exemption, if granted, should cover all SDLAs.
A copy of the Missouri DOR's application for exemption renewal is available for review in the docket for this notice.
Federal Railroad Administration (FRA), U.S. Department of Transportation (DOT).
Notice of Office of Management and Budget (OMB) Approval of Revised Instructions for Form FRA F 6180.57 and Other Recent FRA Information Collection OMB Approvals.
FRA announces that OMB approved the information collection requests (ICRs) identified below for 3 years.
Mr. Robert Brogan, Information Collection Clearance Officer, Office of Railroad Safety, Regulatory Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W33-497, Washington, DC 20590 (telephone: (202) 493-6292) or Ms. Kim Toone, Information Collection Clearance Officer, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W34-212, Washington, DC 20590 (telephone: (202) 493-6132).
On June 6, 2018, OMB approved revised instructions Form FRA F 6180.57, Highway-Rail Grade Crossing Accident/Incident Report, for 3 years under OMB No. 2130-0500 (49 CFR part 225). This latest approval authorizes FRA to capture information concerning post-accident toxicological testing for certain human-factor highway-rail grade crossing accidents and incidents in the narrative block of this form. The newly revised 49 CFR 219.201, effective on June 12, 2017, requires post-accident toxicological testing of railroad employees when at least one of five specific requirements is met for certain human factor categories of highway-rail grade crossing accidents and incidents. Additionally, under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA announces that OMB approved the renewal ICRs identified below for 3 years. These renewal ICRs pertain to 49 CFR parts 213, 217, 218, 224, 227, 228, 229, 231, 232, 234, 237, 238, 239, 241, 242, 243, and 272. Finally, FRA announces that OMB approved two study-related renewal ICRs for 3 years.
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to display OMB control numbers and inform respondents of their legal significance once OMB approval is obtained. In the past 12 months, OMB approved the following renewal information collections with the following new expiration dates: (1) OMB No. 2130-0500 (49 CFR part 225) (Form FRA F 6180.55/55a/56/57/78/81/98107/150)—June 30, 2021; (2) OMB No. 2130-0545, Passenger Train Emergency Preparedness (49 CFR part 239)—July 31, 2020; (3) OMB No. 2130-0552, Locomotive Cab Sanitation Standards (49 CFR part 229)—July 31, 2020; (4) OMB No. 2130-0564, Locomotive Crashworthiness (49 CFR part 229)—July 31, 2020; (5) OMB No. 2130-0602, Critical Incident Stress Plans (49 CFR part 272)—August 31, 2020; (6) OMB No. 2130-0005, Hours of Service Regulations (49 CFR part 228) (Form FRA F 6180.3)—January 31, 2021; (7) OMB No. 2130-0566, Reflectorization of Freight Rolling Stock (49 CFR part 224) (Form FRA F 6180.113)—November 30, 2020; (8) OMB No. 2130-0594, Railroad Safety Appliance Standards (49 CFR part 231)—October 31, 2020; (9) OMB No. 2130-0035, Railroad Operating Rules (49 CFR parts 217 & 218)—February 28, 2021; (10) OMB No. 2130-0592, Track Safety Standards; Concrete Crossties (49 CFR part 213)—February 28, 2021; (11) OMB No. 2130-0506, Identification of Cars Moved in Accordance with 49 CFR 232.3(d) (Formerly Order 13528) (49 CFR part 232)—March 31, 2021; (12) OMB No. 2130-0556, U.S. Locational Requirement for Dispatching Rail Operations in the United States (49 CFR part 241)—April 30, 2021; (13) OMB No. 2130-0595, Safety and Health Requirements Related to Camp Cars (49 CFR part 228)—April 30, 2021; (14) OMB No. 2130-0597, Training, Qualification, and Oversight for Safety-Related Railroad Employees (49 CFR parts 213 & 243)—April 30, 2021; (15) OMB No. 2130-0571, Occupational Noise Exposure for Railroad Operating Employees (49 CFR part 227)—May 31, 2021; and (16) OMB No. 2130-0596, Conductor Certification (49 CFR part 242)—May 31, 2021.
Additionally, in the last 18 months, OMB approved the following two study-related renewal information collections with the following new expiration dates: (1) OMB No. 2130-0617, Survey of Insular and Tourist Railroads (49 CFR part 237) (email survey)—November 31, 2020; and (2) OMB No. 2130-0622, Cab Technology Integration Lab (CTIL) Head-Up Display Study (Forms FRA F 6180.170a; FRA F 6180.170b)—January 31, 2021.
Persons affected by the above-referenced information collections are not required to respond to any collection of information unless it displays a currently valid OMB control number. These OMB approvals certify FRA has complied with the provisions of the PRA (44 U.S.C. 3501-3520) and with 5 CFR 1320.5(b) informing the public about OMB's approval of the information collection requirements of the above cited forms, studies, and regulations.
44 U.S.C. 3501-3520.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of Information Collection Request; request for comment.
Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collections and their expected burden. On May 10, 2018, FRA published a notice providing a 60-day period for public comment on the ICR.
Interested persons are invited to submit comments on or before September 7, 2018.
Submit written comments on the ICR to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503,
Mr. Robert Brogan, Information Collection Clearance Officer, Office of Railroad Safety, Regulatory Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W33-497, Washington, DC 20590 (telephone: (202) 493-6292); or Ms. Kim Toone, Information Collection Clearance Officer, Office of Administration, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W34-212, Washington, DC 20590 (telephone: (202) 493-6132).
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve an ICR.
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d);
The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:
Under its statutory and regulatory investigative authorities, FRA currently requires, and seeks to continue requiring, each subject railroad to submit Quarterly PTC Progress Reports (Form FRA F 6180.165) and Annual PTC Progress Reports (Form FRA F 6180.166) on its PTC system implementation progress.
Specifically, in addition to the Annual PTC Progress Report (Form FRA F 6180.166) due each March 31 under 49 U.S.C. 20157(c)(1), railroads must provide quarterly progress reports covering the preceding three-month period and submit the forms to FRA on the dates in the following table until full PTC system implementation is completed:
Each railroad must submit its Quarterly PTC Progress Reports on Form FRA F 6180.165 and its Annual PTC Progress Reports on Form FRA F 6180.166 on FRA's Secure Information Repository at
On August 15, 2017, OMB approved the Quarterly PTC Progress Report (Form FRA F 6180.165) and Annual PTC Progress Report (Form FRA F 6180.166) for a period of one year, expiring on August 31, 2018. The current Quarterly PTC Progress Report Form and Annual PTC Progress Report Form, as approved through August 31, 2018, can be accessed and downloaded in FRA's eLibrary at:
Following the above cited 60-day public comment period, FRA is now requesting OMB's re-approval of the forms, with the five changes described below. First, in Section 1 of the Quarterly PTC Progress Report Form (FRA F 6180.165), FRA proposes revising the row “Territories Where Revenue Service Demonstration Has Been Initiated” to state “Territories in Revenue Service Demonstration or in PTC Operation” for clarity, based on additional feedback from the industry following OMB's approval of the form on August 15, 2017. FRA intended this row to include any and all territories where a railroad had initiated revenue service demonstration (RSD), even if a railroad subsequently obtained PTC System Certification from FRA and is operating its PTC system in revenue service. The purpose of this row is to collect information regarding a railroad's progress toward meeting the statutory criteria under 49 U.S.C. 20157(a)(3)(B)(vi)-(vii), if applicable. Based on feedback from the industry, FRA proposes clarifying the language in this row in Section 1 so railroads understand that a railroad can include in this row the number of territories where its PTC system is in RSD or in operation. This proposed change does not result in any additional reporting burden as it is only a clarifying change.
Second, in footnotes 4 and 6 of the Quarterly PTC Progress Report Form (FRA F 6180.165), FRA proposes adding a hyperlink to Appendix A. The footnotes currently state: “If a particular category listed in this table does not apply to the railroad's technology, please indicate `N/A.' A railroad may add categories or subcategories if it wants to provide more detail.” FRA proposes adding the phrase “in Appendix A” to the second sentence with a hyperlink to that appendix to the form, as it will help direct railroads to the available section of the PDF where they can provide additional information. A hyperlink to Appendix A was in the corresponding footnotes in the prior version of the Quarterly PTC Progress Report Form that OMB approved through June 30, 2017, but the hyperlink was omitted in error from the current version of the form. This proposed change (
Third, in Section 4 (entitled “Installation/Track Segment Progress—Current Status”) of both the quarterly form and the annual form, FRA proposes replacing the “Testing” option in the drop-down menu with two more precise options—
Fourth, with respect to only the Annual PTC Progress Report Form (FRA F 6180.166), FRA proposes to delete a now inapplicable instruction from footnote 7 in Section 4, which stated,
Fifth, with respect to both the quarterly form and the annual form, FRA proposes making certain changes to Section 6 (entitled “Update on Interoperability Progress”). FRA proposes removing the portion of the instruction that states a host railroad must provide information about the status of each tenant railroad's rolling stock “if the tenant does not have a separate PTCIP on file.” FRA proposes removing this limiting instruction because FRA needs to know the PTC implementation status of any tenant railroad that operates on the host railroad's property, except any tenant railroad that is subject to an exception under 49 CFR 236.1006(b). In addition, before the final column in the table in Section 6, FRA proposes adding a column entitled, “Scheduled Completion Date for Interoperability Testing.” This information is necessary for FRA to understand the progress a host railroad and each of its required tenant railroads are jointly making toward testing and achieving PTC system interoperability, consistent with host railroad's PTC Implementation Plan and/or PTC Safety Plan. FRA estimates the additional burden for a host railroad to complete this new reporting requirement would be, on average, approximately 2.5 hours for Class I railroads and large passenger railroads; 1.25 hours for Class II and medium passenger railroads; and thirty minutes for Class III, terminal, and small passenger railroads.
The associated collection of information is summarized below.
Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice.
In compliance with the Paperwork Reduction Act of 1995, this notice announces the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. A
Comments must be received on or before September 7, 2018.
You may submit comments, within 30 days, to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington DC 20503, Attention NHTSA Desk Officer.
Dr. Kathy Sifrit, Office of Behavioral Safety Research (NPD-320), National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, W46-472, Washington, DC 20590. Dr. Sifrit's phone number is (202) 366-0868 and her email address is
Comments are invited on the following:
(i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(ii) The accuracy of the Department's estimate of the burden of the proposed information collection;
(iii) Ways to enhance the quality, utility and clarity of the information to be collected; and
(iv) Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
A comment to OMB is most effective if OMB receives it within 30 days of publication of this notice.
44 U.S.C. Section 3506(c)(2)(A).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice; correction.
NHTSA published a document in the
Richard Compton, 202-366-2699.
In the
July 19, 2018
44 U.S.C. Section 3506(c)(2)(A).
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice.
In compliance with the Paperwork Reduction Act of 1995, this notice announces the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. A
Comments must be received on or before September 7, 2018.
You may submit comments, within 30 days, to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention NHTSA Desk Officer.
Dr. Kathy Sifrit, Office of Behavioral Safety Research (NPD-320), National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, W46-472, Washington, DC 20590. Dr. Sifrit's phone number is (202) 366-0868 and her email address is
(i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(ii) The accuracy of the Department's estimate of the burden of the proposed information collection;
(iii) Ways to enhance the quality, utility and clarity of the information to be collected; and
(iv) Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
A comment to OMB is most effective if OMB receives it within 30 days of publication of this notice.
44 U.S.C. Section 3506(c)(2)(A).
Notice of open meeting.
This notice announces an open meeting of the Community Development Advisory Board (the Advisory Board), which provides advice to the Director of the Community Development Financial Institutions Fund (CDFI Fund). The meeting will be open to the public who may either attend the meeting in-person or view it as a live webcast. The meeting will be held at the U.S. Department of the Treasury in a room that will accommodate up to 50 members of the public on a first-come, first-served basis. The link to the live webcast can be found in the meeting announcement found at the top of
The meeting will be held from 9:00 a.m. to 2:00 p.m. Eastern Time on Thursday, August 23, 2018.
The Advisory Board meeting will be held in Media Rooms A & B (Rooms 4121 and 4125) at the U.S. Department of the Treasury located at 1500 Pennsylvania Avenue NW, Washington, DC 20220.
In general, the CDFI Fund will make all statements available in their original format, including any business or personal information provided such as names, addresses, email addresses, or telephone numbers, for public inspection and photocopying at the CDFI Fund. The CDFI Fund is open on official business days between the hours of 9:00 a.m. and 5:00 p.m. Eastern Time. You can make an appointment to inspect statements by emailing
Bill Luecht, Senior Advisor, Office of Legislative and External Affairs, CDFI Fund, 1500 Pennsylvania Avenue NW, Washington, DC 20220, (202) 653-0322 (this is not a toll free number) or
Section 104(d) of the Riegle Community Development and Regulatory Improvement Act of 1994 (Pub. L. 103-325), which created the CDFI Fund, established the Advisory Board. The charter for the Advisory Board has been filed in accordance with the Federal
The function of the Advisory Board is to advise the Director of the CDFI Fund (who has been delegated the authority to administer the CDFI Fund) on the policies regarding the activities of the CDFI Fund. The Advisory Board does not advise the CDFI Fund on approving or declining any particular application for monetary or non-monetary awards.
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2 and the regulations thereunder, Bill Luecht, Designated Federal Officer of the Advisory Board, has ordered publication of this notice that the Advisory Board will convene an open meeting, which will be held in Media Rooms A & B (Rooms 4121 and 4125) at the U.S. Department of the Treasury located at 1500 Pennsylvania Avenue NW, Washington, DC 20220, from 9:00 a.m. to 2:00 p.m. Eastern Time on Thursday, August 23, 2018. The room will accommodate up to 50 members of the public on a first-come, first-served basis.
Because the meeting will be held in a secure federal building, members of the public who wish to attend the meeting must register in advance. The link to the online registration system can be found in the meeting announcement found at the top of
The Advisory Board meeting will include a report from the CDFI Fund Director on the activities of the CDFI Fund since the last Advisory Board meeting and on Fiscal Year 2019 priorities, including discussion on the reexamination of CDFI Certification policies and maximizing impact in Persistent Poverty Counties.
12 U.S.C. 4703.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On July 25, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. AJAKA, Tony (a.k.a. AJAKA, Antoine); DOB 14 Mar 1968; nationality Lebanon (individual) [NPWMD] (Linked To: KATRANGI, Amir).
Designated pursuant to section 1(a)(iii) of Executive Order 13382 of June 28, 2005, “Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters” (E.O. 13382) for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, Amir KATRANGI, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. BEURKLIAN, Anni (a.k.a. AJAKA, Anni); DOB 17 May 1969; nationality Lebanon; citizen United States (individual) [NPWMD] (Linked To: KATRANGI, Amir).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, Amir KATRANGI, a person whose property and interests in property are blocked pursuant to E.O. 13382.
3. CHAHINE, Mireille; DOB 01 Mar 1983; POB Beirut, Lebanon; nationality Lebanon; Employee and Accountant at Electronic Katrangi Group (individual) [NPWMD] (Linked To: ELECTRONICS KATRANGI TRADING).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
4. KATRANGI, Amir (a.k.a. ALKANTRANJI, Amir Hachem; a.k.a. KANTRAJI, Amir Hachem; a.k.a. KATRA, Amir; a.k.a. KATRANGI, Amir Hachem; a.k.a. KATRANJI, Amir; a.k.a. KATRANJI, Amir Hachem; a.k.a. KATRANJI, Amir Hashem); DOB 24 Jun 1966; POB Hama, Syria; nationality Syria; Managing Director and Co-founder of Electronic Katrangi Group (individual) [NPWMD] (Linked To: ELECTRONICS KATRANGI TRADING).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
5. KATRANGI, Houssam Hachem (a.k.a. EL KATRANGI, Houssam Hachem; a.k.a. EL KATRANJI, Houssam Hachem; a.k.a. KATRANGI, Houssam Hachem; a.k.a. KATRANGI, Hussam; a.k.a. KATRANJI, Houssam Hachem; a.k.a. KATRANKI, Houssam Hashem; a.k.a. QATRANJI, Hussam), Khansa Jnah, Beirut, Lebanon; DOB 27 Nov 1973; POB Ramlet El Baida, Lebanon; nationality Lebanon; Co-founder and Associate of Electronic Katrangi Group (individual) [NPWMD] (Linked To: ELECTRONICS KATRANGI TRADING).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
6. KATRANGI, Maher (a.k.a. EL KATRANGI, Maher Hachem; a.k.a. EL KATRANJI, Maher Hachem; a.k.a. KATRANGI, Maher Hachem; a.k.a. KATRANGI, Maher Mohamad; a.k.a. KATRANJI, Maher Hachem; a.k.a. KATRANJI, Maher Hashem), Khansa Jnah, Beirut, Lebanon; DOB 06 Jul 1967; POB Hama, Syria; nationality Syria; Co-
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
7. KATRANGI, Mohamad (a.k.a. ALKTRANJI, Mohammed; a.k.a. KATRANJI, Mohammed); DOB 1928 (individual) [NPWMD] (Linked To: ELECTRONICS KATRANGI TRADING).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
8. ZHOU, Yishan; DOB 08 Dec 1981; POB Guangdong, China; nationality China; Director, EKT Smart Technology (individual) [NPWMD] (Linked To: EKT SMART TECHNOLOGY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, EKT SMART TECHNOLOGY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
1. EKT SMART TECHNOLOGY, 38 Dongtang Jinguang South Road, Xiashan Street, Chaonan District, Guangdong to Shantou, China; Chase Business Centre, 39-41 Chase Side, London N14 5BP, United Kingdom; Company Number 08884792 (United Kingdom) [NPWMD] (Linked To: ELECTRONICS KATRANGI TRADING).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. ELECTRONICS KATRANGI TRADING (a.k.a. AL AMIR ELECTRONICS; a.k.a. ALAMIR ELECTRONICS; a.k.a. AL-AMIR ELECTRONICS; a.k.a. AMIRCO ELECTRONICS; a.k.a. E.K.T. (KATRANGI BROS.); a.k.a. EKT (KATRANGI BROS); a.k.a. EKT ELECTRONICS; a.k.a. EKT KATRANGI BROTHERS; a.k.a. ELECTRONIC KATRANGI GROUP; a.k.a. KATRANGI ELECTRONICS; a.k.a. KATRANGI FOR ELECTRONICS INDUSTRIES; a.k.a. KATRANGI TRADING; a.k.a. KATRANJI LABS; a.k.a. LUMIERE ELYSEES (Latin: LUMIÈRE ELYSÉES); a.k.a. NKTRONICS; a.k.a. SMART GREEN POWER; a.k.a. SMART PEGASUS; a.k.a. “E.K.T.”; a.k.a. “EKT”; a.k.a. “ELECTRONIC SYSTEM GROUP”; a.k.a. “ESG”), 1st Floor, Hujij Building, Korniche Street, P.O. Box 817 No. 3, Beirut, Lebanon; P.O. Box 8173, Beirut, Lebanon; #1 fl., Grand Hills Bldg., Said Khansa St., Jnah (BHV), Beirut, Lebanon; 11/A, Abbasieh Building, Hijaz Street, Damascus, Syria; Lahlah Building, Industrial Zone, Hama, Syria; Awqaf Building, Naser Street, P.O. Box 34425, Damascus, Syria; #1 floor, 02/A, Fares Building, Rami Street, Margeh, Damascus, Syria; 46 El-Falaki Street, Facing Cook Door, BabLouk Area, Cairo, Egypt; website
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, the SCIENTIFIC STUDIES AND RESEARCH CENTER, a person whose property and interests in property are blocked pursuant to E.O. 13382.
3. GOLDEN STAR CO (a.k.a. GOLDEN STAR INTERNATIONAL FREIGHT LIMITED; a.k.a. GOLDEN STAR TRADING & INTERNATIONAL FREIGHT; a.k.a. GOLDEN STAR TRADING AND INTERNATIONAL FREIGHT; a.k.a. GOLDEN STAR TRADING INTERNATIONAL FREIGHT; a.k.a. KASSOUMA FZC; a.k.a. SHAREKAT GOLDEN STAR; a.k.a. SMART LOGISTICS F.S.S.A.L; a.k.a. SMART LOGISTICS OFFSHORE; a.k.a. SMART LOGISTICS TRADING & INTERNATIONAL FREIGHT; a.k.a. SMART LOGISTICS TRADING AND INTERNATIONAL FREIGHT), Al Awqaf building, 5th floor, Victoria Bridge, Damascus, Syria; 2 Floor, Inana Bldg, Damascus Free Zone, Damascus, Syria; Room 707, Fulijinxi Business Center, No. 05, Fuchang Road, Haizhu District, Guangzhou, China; Al Alshiah, Mar Mekheal Church, Amicho Building, 3rd Floor, Beirut, Lebanon; Office 112, First Floor, Al Manara Building, Port Street, Beirut, Lebanon; website
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, ELECTRONICS KATRANGI TRADING, a person whose property and interests in property are blocked pursuant to E.O. 13382.
4. POLO TRADING, Fakhani Building, Korniche Mazraa Street, Beirut, Lebanon; Grand Hills/GF Al Khansa St., Beirut, Lebanon; website polo-trading.com [NPWMD] (Linked To: KATRANGI, Amir).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for being owned or controlled by Amir KATRANGI, a person whose property and interests in property are blocked pursuant to E.O. 13382.
5. TOP TECHNOLOGIES SARL, Ground Floor, Dedeyan center, Dora highway, Metn, Bauchrieh, Lebanon [NPWMD] (Linked To: AJAKA, Tony).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for being owned or controlled by Antoine AJAKA, a person whose property and interests in property are blocked pursuant to E.O. 13382.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On August 3, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked pursuant to the relevant sanctions authorities listed below.
1. RI, Jong Won (a.k.a. RI, Cho'ng-Wo'n; a.k.a. RI, Jung Won), Moscow, Russia; DOB 22 Apr 1971; Passport PS654320421 expires 11 Mar 2019 (individual) [DPRK2].
Designated pursuant to Section 1(a)(ii) of Executive Order 13687 of January 2, 2015, “Imposing Additional Sanctions With Respect to North Korea” for being an official of the Government of North Korea.
3. KOREA UNGUM CORPORATION (a.k.a. KOREA UNGUM COMPANY), Pyongyang, Korea, North [DPRK3].
Designated pursuant to Section 2(a)(vii) of Executive Order 13722 of March 15, 2016, “Blocking Property of the Government of North Korea and the Workers' Party of Korea, and Prohibiting Certain Transactions With Respect to North Korea” (E.O. 13722) for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, FOREIGN TRADE BANK, an entity whose property and interest in property are blocked pursuant to E.O. 13722.
Blocked under Section 4(b)(ii) of Executive Order 13810 of September 20, 2017 “Imposing Additional Sanctions With Respect to North Korea” (E.O. 13810) pursuant to Section 4(a)(i) of E.O. 13810 for knowingly conducting or facilitating a significant transaction on behalf of HAN JANG SU, a person whose property and interests in property are blocked pursuant to E.O. 13382 in connection with North Korea-related activities.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons who are no longer subject to the prohibitions imposed pursuant to Directive One under Executive Order 13662 of March 20, 2014, “Blocking Property of Additional Persons Contributing to the Situation in Ukraine.”
OFAC's actions described in this notice were effective on July 25, 2018.
The Department of the Treasury's Office of Foreign Assets Control: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
The Sectoral Sanctions Identification List (SSI List) and additional information concerning OFAC sanctions programs are available from OFAC's website at
On July 25, 2018, OFAC removed from the SSI List the persons listed below, who were subject to prohibitions imposed pursuant to Directive One under Executive Order 13662.
EESTI KREDIIDIPANK AS (a.k.a. AS EESTI KREDIIDIPANK; a.k.a. ESTONIAN CREDIT BANK; a.k.a. JOINT-STOCK COMPANY EESTI KREDIDIPANK), Narve Road 4, Tallinn 15014, Estonia; SWIFT/BIC EKRD EE 22; website
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) beginning on October 1, 2019. The rule finalizes revisions to the regulation text that describes a beneficiary's SNF “resident” status under the consolidated billing provision and the required content of the SNF level of care certification. The rule also finalizes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program.
Penny Gershman, (410) 786-6643, for information related to SNF PPS clinical issues.
John Kane, (410) 786-0557, for information related to the development of the payment rates and case-mix indexes, and general information.
Kia Sidbury, (410) 786-7816, for information related to the wage index.
Bill Ullman, (410) 786-5667, for information related to level of care determinations, and consolidated billing.
Mary Pratt, (410) 786-6867, for information related to the skilled nursing facility quality reporting program.
Celeste Bostic, (410) 786-5603, for information related to the skilled nursing facility value-based purchasing program.
As discussed in the FY 2014 SNF PPS final rule (78 FR 47936), tables setting forth the Wage Index for Urban Areas Based on CBSA Labor Market Areas and the Wage Index Based on CBSA Labor Market Areas for Rural Areas are no longer published in the
Readers who experience any problems accessing any of these online SNF PPS wage index tables should contact Kia Sidbury at (410) 786-7816.
To assist readers in referencing sections contained in this document, we are providing the following Table of Contents.
This final rule updates the SNF prospective payment rates for FY 2019 as required under section 1888(e)(4)(E) of the Social Security Act (the Act). It will also respond to section 1888(e)(4)(H) of the Act, which requires the Secretary to provide for publication in the
In accordance with sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of the Act, the federal rates in this final rule will reflect an update to the rates that we published in the SNF PPS final
Regulatory reform and reducing regulatory burden are high priorities for us. To reduce the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care, in October 2017, we launched the Meaningful Measures Initiative.
The Meaningful Measures Framework has the following objectives:
• Address high-impact measure areas that safeguard public health;
• Patient-centered and meaningful to patients;
• Outcome-based where possible;
• Fulfill each program's statutory requirements;
• Minimize the level of burden for health care providers (for example, through a preference for EHR-based measures where possible, such as electronic clinical quality measures);
• Significant opportunity for improvement;
• Address measure needs for population based payment through alternative payment models; and
• Align across programs and/or with other payers.
In order to achieve these objectives, we have identified 19 Meaningful Measures areas and mapped them to six overarching quality priorities as shown in Table 2.
By including Meaningful Measures in our programs, we believe that we can also address the following cross-cutting measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural communities; and
• Reducing burden.
We believe that the Meaningful Measures Initiative will improve outcomes for patients, their families, and health care providers while reducing burden and costs for clinicians and providers and promoting operational efficiencies.
The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care. The Office of the National Coordinator for Health Information Technology (ONC) and CMS work collaboratively to advance interoperability across settings of care, including post-acute care.
The Improving Medicare Post-Acute Care Transformation Act of 2015 (IMPACT Act, Pub. L. 113-185) requires assessment data to be standardized and interoperable to allow for exchange of the data among post-acute providers and other providers. To further interoperability in post-acute care, CMS has developed a Data Element Library to serve as a publicly available centralized, authoritative resource for standardized data elements and their associated mappings to health IT standards. These interoperable data elements can reduce provider burden by allowing the use and reuse of healthcare data, support provider exchange of electronic health information for care coordination, person-centered care, and support real-time, data driven, clinical decision making. Standards in the Data Element Library (
Most recently, the 21st Century Cures Act (Pub. L. 114-255), enacted in late 2016, requires HHS to take new steps to enable the electronic sharing of health information ensuring interoperability for providers and settings across the care continuum. Specifically, Congress directed ONC to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” This framework (
We invite providers to learn more about these important developments and how they are likely to affect SNFs.
As amended by section 4432 of the Balanced Budget Act of 1997 (BBA 1997, Pub. L. 105-33, enacted on August 5, 1997), section 1888(e) of the Act provides for the implementation of a PPS for SNFs. This methodology uses prospective, case-mix adjusted per diem payment rates applicable to all covered SNF services defined in section 1888(e)(2)(A) of the Act. The SNF PPS is effective for cost reporting periods beginning on or after July 1, 1998, and covers all costs of furnishing covered SNF services (routine, ancillary, and capital-related costs) other than costs associated with approved educational activities and bad debts. Under section 1888(e)(2)(A)(i) of the Act, covered SNF services include post-hospital extended care services for which benefits are provided under Part A, as well as those items and services (other than a small number of excluded services, such as physicians' services) for which payment may otherwise be made under Part B and which are furnished to Medicare beneficiaries who are residents in a SNF during a covered Part A stay. A comprehensive discussion of these provisions appears in the May 12, 1998 interim final rule (63 FR 26252). In addition, a detailed discussion of the legislative history of the SNF PPS is available online at
Section 215(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added section 1888(g) to the Act requiring the Secretary to specify an all-cause all-condition hospital readmission measure and an all-condition risk-adjusted potentially preventable hospital readmission measure for the SNF setting. Additionally, section 215(b) of PAMA added section 1888(h) to the Act requiring the Secretary to implement a VBP program for SNFs. Finally, section 2(c)(4) of the IMPACT Act added section 1888(e)(6) to the Act, which requires the Secretary to implement a quality reporting program for SNFs under which SNFs report data on measures and resident assessment data.
Under sections 1888(e)(1)(A) and 1888(e)(11) of the Act, the SNF PPS included an initial, three-phase transition that blended a facility-specific rate (reflecting the individual facility's historical cost experience) with the federal case-mix adjusted rate. The transition extended through the facility's first 3 cost reporting periods under the PPS, up to and including the one that began in FY 2001. Thus, the SNF PPS is no longer operating under the transition, as all facilities have been paid at the full federal rate effective with cost reporting periods beginning in FY 2002. As we now base payments for SNFs entirely on the adjusted federal per diem rates, we no longer include adjustment factors under the transition related to facility-specific rates for the upcoming FY.
Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates to be updated annually. The most recent annual update occurred in a final rule that set forth updates to the SNF PPS payment rates for FY 2018 (82 FR 36530), as corrected in the FY 2018 SNF PPS correction notice (82 FR 46163).
Section 1888(e)(4)(H) of the Act specifies that we provide for publication annually in the
• The unadjusted federal per diem rates to be applied to days of covered SNF services furnished during the upcoming FY.
• The case-mix classification system to be applied for these services during the upcoming FY.
• The factors to be applied in making the area wage adjustment for these services.
Along with other revisions discussed later in this preamble, this final rule will provide the required annual updates to the per diem payment rates for SNFs for FY 2019.
In response to the publication of the FY 2019 SNF PPS proposed rule, we received 290 public comments from individuals, providers, corporations, government agencies, private citizens, trade associations, and major organizations. The following are brief summaries of each proposed provision, a summary of the public comments that we received related to that proposal, and our responses to the comments.
In addition to the comments we received on specific proposals contained within the proposed rule (which we address later in this final rule), commenters also submitted the following, more general, observations on the SNF PPS and SNF care generally. A discussion of these comments, along with our responses, appears below.
This policy is also discussed at § 409.34(b), where the paragraph states that a break of 1 or 2 days in the furnishing of rehabilitation services will not preclude coverage if discharge would not be practical for the 1 or 2 days during which, for instance, the physician has suspended the therapy sessions because the patient exhibited extreme fatigue.
Under section 1888(e)(4) of the Act, the SNF PPS uses per diem federal payment rates based on mean SNF costs in a base year (FY 1995) updated for inflation to the first effective period of the PPS. We developed the federal payment rates using allowable costs from hospital-based and freestanding SNF cost reports for reporting periods beginning in FY 1995. The data used in developing the federal rates also incorporated a Part B add-on, which is an estimate of the amounts that, prior to the SNF PPS, would be payable under Part B for covered SNF services furnished to individuals during the course of a covered Part A stay in a SNF.
In developing the rates for the initial period, we updated costs to the first effective year of the PPS (the 15-month period beginning July 1, 1998) using a SNF market basket index, and then standardized for geographic variations in wages and for the costs of facility differences in case mix. In compiling the database used to compute the federal payment rates, we excluded those providers that received new provider exemptions from the routine cost limits, as well as costs related to payments for exceptions to the routine cost limits. Using the formula that the BBA 1997 prescribed, we set the federal rates at a level equal to the weighted mean of freestanding costs plus 50 percent of the difference between the freestanding mean and weighted mean of all SNF costs (hospital-based and freestanding) combined. We computed and applied separately the payment rates for facilities located in urban and rural areas, and adjusted the portion of the federal rate attributable to wage-related costs by a wage index to reflect geographic variations in wages.
Section 1888(e)(5)(A) of the Act requires us to establish a SNF market basket index that reflects changes over time in the prices of an appropriate mix of goods and services included in covered SNF services. Accordingly, we have developed a SNF market basket index that encompasses the most commonly used cost categories for SNF routine services, ancillary services, and capital-related expenses. In the SNF PPS final rule for FY 2018 (82 FR 36548 through 36566), we revised and rebased the market basket index, which
The SNF market basket index is used to compute the market basket percentage change that is used to update the SNF federal rates on an annual basis, as required by section 1888(e)(4)(E)(ii)(IV) of the Act. This market basket percentage update is adjusted by a forecast error correction, if applicable, and then further adjusted by the application of a productivity adjustment as required by section 1888(e)(5)(B)(ii) of the Act and described in section III.B.2.d of this final rule. For FY 2019, the growth rate of the 2014-based SNF market basket in the proposed rule was estimated to be 2.7 percent, based on the IHS Global Insight, Inc. (IGI) first quarter 2018 forecast with historical data through fourth quarter 2017, before the multifactor productivity adjustment is applied. Using IGIs most recent forecast, the second quarter 2018 forecast with historical data through first quarter 2018, we calculate a growth rate of the 2014-based SNF market basket of 2.8 percent.
However, we note that section 53111 of the Bipartisan Budget Act of 2018 (BBA 2018) (Pub. L. 115-123, enacted on February 9, 2018) amended section 1888(e) of the Act to add section 1888(e)(5)(B)(iv) of the Act. Section 1888(e)(5)(B)(iv) of the Act establishes a special rule for FY 2019 that requires the market basket percentage, after the application of the productivity adjustment, to be 2.4 percent. In accordance with section 1888(e)(5)(B)(iv) of the Act, we will use a market basket percentage of 2.4 percent to update the federal rates set forth in this final rule. We proposed to revise § 413.337(d) to reflect this statutorily required 2.4 percent market basket percentage for FY 2019. In addition, to conform with section 1888(e)(5)(B)(iii) of the Act, we proposed to update the regulations to reflect the 1 percent market basket percentage required for FY 2018 (as discussed in the FY 2018 SNF PPS final rule, 82 FR 36533). Accordingly, we proposed to revise paragraph (d)(1) of § 413.337, which sets forth the market basket update formula, by revising paragraph (d)(1)(v), and by adding paragraphs (d)(1)(vi) and (d)(1)(vii). The revision to add paragraph (d)(1)(vi) reflects section 1888(e)(5)(B)(iii) of the Act (as added by section 411(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10)), which, as discussed above, establishes a special rule for FY 2018 that requires the market basket percentage, after the application of the productivity adjustment, to be 1.0 percent. The revision to add paragraph (d)(1)(vii) reflects section 1888(e)(5)(B)(iv) of the Act (as added by section 53111 of BBA 2018), which establishes a special rule for FY 2019 that requires the market basket percentage, after the application of the productivity adjustment, to be 2.4 percent. These statutory provisions are self-implementing and do not require the exercise of discretion by the Secretary. In section III.B.2.e. of this final rule, we discuss the specific application of the BBA 2018-specified market basket adjustment to the forthcoming annual update of the SNF PPS payment rates. In addition, we also discuss in that section the 2 percent reduction applied to the market basket update for those SNFs that fail to submit measures data as required by section 1888(e)(6)(A) of the Act.
Section 1888(e)(5)(B) of the Act defines the SNF market basket percentage as the percentage change in the SNF market basket index from the midpoint of the previous FY to the midpoint of the current FY. Absent the addition of section 1888(e)(5)(B)(iv) of the Act, added by section 53111 of BBA 2018, we would have used the percentage change in the SNF market basket index to compute the update factor for FY 2019. This factor is based on the FY 2019 percentage increase in the 2014-based SNF market basket index reflecting routine, ancillary, and capital-related expenses. In the proposed rule, the SNF market basket percentage was estimated to be 2.7 percent for FY 2019 based on IGI's first quarter 2018 forecast (with historical data through fourth quarter 2017). In this final rule, we are using IGI's more recent second quarter 2018 forecast (with historical data through first quarter 2018) and we calculate a SNF market basket percentage increase of 2.8 percent. As discussed in sections III.B.2.c and III.B.2.d of this final rule, this market basket percentage change would have been reduced by the applicable forecast error correction (as described in § 413.337(d)(2)) and by the MFP adjustment as required by section 1888(e)(5)(B)(ii) of the Act. As noted previously, section 1888(e)(5)(B)(iv) of the Act, added by section 53111 of the BBA 2018, requires us to update the SNF PPS rates for FY 2019 using a 2.4 percent SNF market basket percentage change, instead of the estimated 2.8 percent market basket percentage change adjusted by the multifactor productivity adjustment as described below. Additionally, as discussed in section II.B. of this final rule, we no longer compute update factors to adjust a facility-specific portion of the SNF PPS rates, because the initial three-phase transition period from facility-specific to full federal rates that started with cost reporting periods beginning in July 1998 has expired.
As discussed in the June 10, 2003 supplemental proposed rule (68 FR 34768) and finalized in the August 4, 2003 final rule (68 FR 46057 through 46059), § 413.337(d)(2) provides for an adjustment to account for market basket forecast error. The initial adjustment for market basket forecast error applied to the update of the FY 2003 rate for FY 2004, and took into account the cumulative forecast error for the period from FY 2000 through FY 2002, resulting in an increase of 3.26 percent to the FY 2004 update. Subsequent adjustments in succeeding FYs take into account the forecast error from the most recently available FY for which there is final data, and apply the difference between the forecasted and actual change in the market basket when the difference exceeds a specified threshold. We originally used a 0.25 percentage point threshold for this purpose; however, for the reasons specified in the FY 2008 SNF PPS final rule (72 FR 43425, August 3, 2007), we adopted a 0.5 percentage point threshold effective for FY 2008 and subsequent FYs. As we stated in the final rule for FY 2004 that first issued the market basket forecast error adjustment (68 FR 46058, August 4, 2003), the adjustment will reflect both upward and downward adjustments, as appropriate.
For FY 2017 (the most recently available FY for which there is final data), the estimated increase in the market basket index was 2.7 percentage points, while the actual increase for FY 2017 was 2.7 percentage points, resulting in the actual increase being the same as the estimated increase. Accordingly, as the difference between the estimated and actual amount of change in the market basket index does not exceed the 0.5 percentage point threshold, the FY 2019 market basket percentage change of 2.7 percent would not have been adjusted to account for the forecast error correction. Table 3 shows the forecasted and actual market basket amounts for FY 2017.
Section 1888(e)(5)(B)(ii) of the Act, as added by section 3401(b) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148, enacted on March 23, 2010) requires that, in FY 2012 and in subsequent FYs, the market basket percentage under the SNF payment system (as described in section 1888(e)(5)(B)(i) of the Act) is to be reduced annually by the multifactor productivity (MFP) adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. Section 1886(b)(3)(B)(xi)(II) of the Act, in turn, defines the MFP adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multi-factor productivity (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost-reporting period, or other annual period). The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private nonfarm business MFP. We refer readers to the BLS website at
MFP is derived by subtracting the contribution of labor and capital inputs growth from output growth. The projections of the components of MFP are currently produced by IGI, a nationally recognized economic forecasting firm with which CMS contracts to forecast the components of the market baskets and MFP. To generate a forecast of MFP, IGI replicates the MFP measure calculated by the BLS, using a series of proxy variables derived from IGI's U.S. macroeconomic models. For a discussion of the MFP projection methodology, we refer readers to the FY 2012 SNF PPS final rule (76 FR 48527 through 48529) and the FY 2016 SNF PPS final rule (80 FR 46395). A complete description of the MFP projection methodology is available on our website at
Per section 1888(e)(5)(A) of the Act, the Secretary shall establish a SNF market basket index that reflects changes over time in the prices of an appropriate mix of goods and services included in covered SNF services. Section 1888(e)(5)(B)(ii) of the Act, added by section 3401(b) of the Affordable Care Act, requires that for FY 2012 and each subsequent FY, after determining the market basket percentage described in section 1888(e)(5)(B)(i) of the Act, the Secretary shall reduce such percentage by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act (which we refer to as the MFP adjustment). Section 1888(e)(5)(B)(ii) of the Act further states that the reduction of the market basket percentage by the MFP adjustment may result in the market basket percentage being less than zero for a FY, and may result in payment rates under section 1888(e) of the Act being less than such payment rates for the preceding fiscal year.
The MFP adjustment, calculated as the 10-year moving average of changes in MFP for the period ending September 30, 2019, is estimated to be 0.8 percent based on IGI's second quarter 2018 forecast. Also, consistent with section 1888(e)(5)(B)(i) of the Act and § 413.337(d)(2), the market basket percentage for FY 2019 for the SNF PPS is based on IGI's second quarter 2018 forecast of the SNF market basket percentage, which is estimated to be 2.8 percent. The proposed rule reflected a market basket percentage for FY 2019 of 2.7 percent and an MFP adjustment of 0.8 percent based on IGI's first quarter 2018 forecast.
If not for the enactment of section 53111 of the BBA 2018, the FY 2019 update would have been calculated in accordance with section 1888(e)(5)(B)(i) and (ii) of the Act, pursuant to which the market basket percentage determined under section 1888(e)(5)(B)(i) of the Act (that is, 2.8 percent) would have been reduced by the MFP adjustment (the 10-year moving average of changes in MFP for the period ending September 30, 2019) of 0.8 percent, which would have been calculated as described above and based on IGI's second quarter 2018 forecast. Absent the enactment of section 53111 of the BBA 2018, the resulting MFP-adjusted SNF market basket update would have been equal to 2.0 percent, or 2.8 percent less 0.8 percentage point. However, as discussed above, section 1888(e)(5)(B)(iv) of the Act, added by section 53111 of the BBA 2018, requires us to apply a 2.4 percent market basket percentage increase in determining the FY 2019 SNF payment rates set forth in this final rule (without regard to the MFP adjustment described above).
Sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5)(i) of the Act require that the update factor used to establish the FY 2019 unadjusted federal rates be at a level equal to the market basket index percentage change. Accordingly, we determined the total growth from the average market basket level for the period of October 1, 2017, through September 30, 2018 to the average market basket level for the period of October 1, 2018, through September 30, 2019. This process yields a percentage change in the 2014-based SNF market basket of 2.8 percent.
As further explained in section III.B.2.c. of this final rule, as applicable, we adjust the market basket percentage change by the forecast error from the most recently available FY for which there is final data and apply this adjustment whenever the difference between the forecasted and actual percentage change in the market basket exceeds a 0.5 percentage point threshold. Since the difference between the forecasted FY 2017 SNF market basket percentage change and the actual FY 2017 SNF market basket percentage change (FY 2017 is the most recently available FY for which there is historical data) did not exceed the 0.5 percentage point threshold, the FY 2019 market basket percentage change of 2.8 percent would not be adjusted by the forecast error correction.
If not for the enactment of section 53111 of the BBA 2018, the SNF market basket for FY 2019 would have been determined in accordance with section
Historically, we have used the SNF market basket, adjusted as described above, to adjust each per diem component of the federal rates forward to reflect the change in the average prices from one year to the next. However, section 1888(e)(5)(B)(iv) of the Act, as added by section 53111 of the BBA 2018, requires us to use a market basket percentage of 2.4 percent, after application of the MFP to adjust the federal rates for FY 2019. Under section 1888(e)(5)(B)(iv) of the Act, the market basket percentage increase used to determine the federal rates set forth in Table 4 and 5 in this final rule will be 2.4 percent for FY 2019.
In addition, we note that section 1888(e)(6)(A)(i) of the Act provides that, beginning with FY 2018, SNFs that fail to submit data, as applicable, in accordance with sections 1888(e)(6)(B)(i)(II) and (III) of the Act for a fiscal year will receive a 2.0 percentage point reduction to their market basket update for the fiscal year involved, after application of section 1888(e)(5)(B)(ii) of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the Act (the 1 percent market basket increase for FY 2018). In addition, section 1888(e)(6)(A)(ii) of the Act states that application of the 2.0 percentage point reduction (after application of section 1888(e)(5)(B)(ii) and (iii) of the Act) may result in the market basket index percentage change being less than 0.0 for a fiscal year, and may result in payment rates for a fiscal year being less than such payment rates for the preceding fiscal year. Section 1888(e)(6)(A)(iii) of the Act further specifies that the 2.0 percentage point reduction is applied in a noncumulative manner, so that any reduction made under section 1888(e)(6)(A)(i) of the Act applies only with respect to the fiscal year involved, and that the reduction cannot be taken into account in computing the payment amount for a subsequent fiscal year.
Accordingly, we proposed that for SNFs that do not satisfy the reporting requirements for the FY 2019 SNF QRP, we would apply a 2.0 percentage point reduction to the SNF market basket percentage change for that fiscal year, after application of any applicable forecast error adjustment as specified in § 413.337(d)(2) and the MFP adjustment as specified in § 413.337(d)(3). In the FY 2019 SNF PPS proposed rule (83 FR 21024), we proposed that, for FY 2019, the application of this reduction to SNFs that have not met the requirements for the FY 2019 SNF QRP would result in a market basket index percentage change for FY 2019 that is less than zero (specifically, a net update of negative 0.1 percentage point, derived by subtracting 2 percent from the MFP-adjusted market basket update of 1.9 percent), and would also result in FY 2019 payment rates that are less than such payment rates for the preceding FY. However, we inadvertently applied the 2.0 percent reduction to the market basket adjustment factor that would have applied were it not for the application of the BBA 2018 stipulated market basket update factor rather than to the BBA 2018 stipulated market basket update factor of 2.4 percent. Therefore, when properly applied, the net update for providers that fail to meet the requirements for the FY 2019 SNF QRP will be 0.4 percent, rather than the negative 0.1 percent discussed in the proposed rule. We invited comments on these proposals.
Commenters submitted the following comments related to the proposed rule's discussion of the Market Basket Update Factor for FY 2019. A discussion of these comments, along with our responses, appears below.
Accordingly, for the reasons specified in this final rule and in the FY 2019 SNF PPS proposed rule (83 FR 21021 through 21024), we are applying the FY 2019 SNF market basket increase factor of 2.4 percent, as stipulated by the BBA 2018, in our determination of the FY 2019 SNF PPS unadjusted federal per diem rates. As described in this section, we are adjusting each per diem component of the federal rates forward to reflect the BBA 2018 stipulated update factor for FY 2019.
Tables 4 and 5 reflect the updated components of the unadjusted federal rates for FY 2019, prior to adjustment for case-mix.
Under section 1888(e)(4)(G)(i) of the Act, the federal rate also incorporates an adjustment to account for facility case-mix, using a classification system that accounts for the relative resource utilization of different patient types. The statute specifies that the adjustment is to reflect both a resident classification system that the Secretary establishes to account for the relative resource use of different patient types, as well as resident assessment data and other data that the Secretary considers appropriate. In the interim final rule with comment period that initially implemented the SNF PPS (63 FR 26252, May 12, 1998), we developed the RUG-III case-mix classification system, which tied the amount of payment to resident resource use in combination with resident characteristic information. Staff time measurement (STM) studies conducted in 1990, 1995, and 1997 provided information on resource use (time spent by staff members on residents) and resident characteristics that enabled us not only to establish RUG-III, but also to create case-mix indexes (CMIs). The original RUG-III grouper logic was based on clinical data collected in 1990, 1995, and 1997. As discussed in the SNF PPS proposed rule for FY 2010 (74 FR 22208), we subsequently conducted a multi-year data collection and analysis under the Staff Time and Resource Intensity Verification (STRIVE) project to update the case-mix classification system for FY 2011. The resulting Resource Utilization Groups, Version 4 (RUG-IV) case-mix classification system reflected the data collected in 2006 through 2007 during the STRIVE project, and was finalized in the FY 2010 SNF PPS final rule (74 FR 40288) to take effect in FY 2011 concurrently with an updated new resident assessment instrument, version 3.0 of the Minimum Data Set (MDS 3.0), which collects the clinical data used for case-mix classification under RUG-IV.
We note that case-mix classification is based, in part, on the beneficiary's need for skilled nursing care and therapy services. The case-mix classification system uses clinical data from the MDS to assign a case-mix group to each patient that is then used to calculate a per diem payment under the SNF PPS. As discussed in section IV.A. of this final rule, the clinical orientation of the case-mix classification system supports the SNF PPS's use of an administrative presumption that considers a beneficiary's initial case-mix classification to assist in making certain SNF level of care determinations. Further, because the MDS is used as a basis for payment, as well as a clinical assessment, we have provided extensive training on proper coding and the timeframes for MDS completion in our Resident Assessment Instrument (RAI) Manual. For an MDS to be considered valid for use in determining payment, the MDS assessment must be completed in compliance with the instructions in the RAI Manual in effect at the time the assessment is completed. For payment and quality monitoring purposes, the RAI Manual consists of both the Manual instructions and the interpretive guidance and policy clarifications posted on the appropriate MDS website at
In addition, we note that section 511 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA, Pub. L. 108-173, enacted December 8, 2003) amended section 1888(e)(12) of the Act to provide for a temporary increase of 128 percent in the PPS per diem payment for any SNF residents with Acquired Immune Deficiency Syndrome (AIDS), effective with services furnished on or after October 1, 2004. This special add-on for SNF residents with AIDS was to remain in effect only until the Secretary certifies that there is an appropriate adjustment in the case mix to compensate for the increased costs associated with such residents. The MMA add-on for SNF residents with AIDS is also discussed in Program Transmittal #160 (Change Request #3291), issued on April 30, 2004, which is available online at
For the limited number of SNF residents that qualify for the MMA add-on, there is a significant increase in payments. As explained in the FY 2016 SNF PPS final rule (80 FR 46397 through 46398), on October 1, 2015 (consistent with section 212 of PAMA), we converted from using ICD-9-CM code 042 to ICD-10-CM code B20 for identifying those residents for whom it is appropriate to apply the AIDS add-on established by section 511 of the MMA. For FY 2019, an urban facility with a resident with AIDS in RUG-IV group “HC2” would have a case-mix adjusted per diem payment of $453.52 (see Table 6) before the application of the MMA adjustment. After an increase of 128 percent, this urban facility would receive a case-mix adjusted per diem payment of approximately $1,034.03.
Under section 1888(e)(4)(H), each update of the payment rates must include the case-mix classification methodology applicable for the upcoming FY. The FY 2019 payment rates set forth in this final rule reflect the use of the RUG-IV case-mix classification system from October 1, 2018, through September 30, 2019. We list the final case-mix adjusted RUG-IV payment rates for FY 2019, provided separately for urban and rural SNFs, in
Section 1888(e)(4)(G)(ii) of the Act requires that we adjust the federal rates to account for differences in area wage levels, using a wage index that the Secretary determines appropriate. Since the inception of the SNF PPS, we have used hospital inpatient wage data in developing a wage index to be applied to SNFs. We proposed to continue this practice for FY 2019, as we continue to believe that in the absence of SNF-specific wage data, using the hospital inpatient wage index data is appropriate and reasonable for the SNF PPS. As explained in the update notice for FY 2005 (69 FR 45786), the SNF PPS does not use the hospital area wage index's occupational mix adjustment, as this adjustment serves specifically to define the occupational categories more clearly in a hospital setting; moreover, the collection of the occupational wage data also excludes any wage data related to SNFs. Therefore, we believe that using the updated wage data exclusive of the occupational mix adjustment continues to be appropriate for SNF payments. For FY 2019, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2014 and before October 1, 2015 (FY 2015 cost report data).
We note that section 315 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA, Pub. L. 106-554, enacted on December 21, 2000) authorized us to establish a geographic reclassification procedure that is specific to SNFs, but only after collecting the data necessary to establish a SNF wage index that is based on wage data from nursing homes. However, to date, this has proven to be unfeasible due to the volatility of existing SNF wage data and the significant amount of resources that would be required to improve the quality of that data. More specifically, auditing all SNF cost reports, similar to the process used to audit inpatient hospital cost reports for purposes of the Inpatient Prospective Payment System (IPPS) wage index, would place a burden on providers in terms of recordkeeping and completion of the cost report worksheet. As discussed in greater detail later in this section, adopting such an approach would require a significant commitment of resources by CMS and the Medicare Administrative Contractors, potentially far in excess of those required under the IPPS given that there are nearly five times as many SNFs as there are inpatient hospitals. Therefore, while we continue to believe that the development of such an audit process could improve SNF cost reports in such a manner as to permit us to establish a SNF-specific wage index, we do not regard an undertaking of this magnitude as being feasible within the current level of programmatic resources.
In addition, we proposed to continue to use the same methodology discussed in the SNF PPS final rule for FY 2008 (72 FR 43423) to address those geographic areas in which there are no hospitals, and thus, no hospital wage index data on which to base the calculation of the FY 2019 SNF PPS wage index. For rural geographic areas that do not have hospitals, and therefore, lack hospital wage data on which to base an area wage adjustment, we would use the average wage index from all contiguous Core-Based Statistical Areas (CBSAs) as a reasonable proxy. For FY 2019, there are no rural geographic areas that do not have hospitals, and thus, this methodology would not be applied. For rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas); instead, we would continue to use the most recent wage index previously available for that area. For urban areas without specific hospital wage index data, we would use the average wage indexes of all of the urban areas within the state to serve as a reasonable proxy for the wage index of that urban CBSA. For FY 2019, the only urban area without wage index data available is CBSA 25980, Hinesville-Fort Stewart, GA. The final wage index applicable to FY 2019 is set forth in Tables A and B available on the CMS website at
In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4, 2005), we adopted the changes discussed in OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for MSAs and the creation of micropolitan statistical areas and combined statistical areas. In adopting the CBSA geographic designations, we provided for a 1-year transition in FY 2006 with a blended wage index for all providers. For FY 2006, the wage index for each provider consisted of a blend of 50 percent of the FY 2006 MSA-based wage index and 50 percent of the FY 2006 CBSA-based wage index (both using FY 2002 hospital data). We referred to the blended wage index as the FY 2006 SNF PPS transition wage index. As discussed in the SNF PPS final rule for FY 2006 (70 FR 45041), since the expiration of this 1-year transition on September 30, 2006, we have used the full CBSA-based wage index values.
In the FY 2015 SNF PPS final rule (79 FR 45644 through 45646), we finalized changes to the SNF PPS wage index based on the newest OMB delineations, as described in OMB Bulletin No. 13-01, beginning in FY 2015, including a 1-year transition with a blended wage index for FY 2015. OMB Bulletin No. 13-01 established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas in the United States and Puerto Rico based on the 2010 Census, and provided guidance on the use of the delineations of these statistical areas using standards published on June 28, 2010 in the
On August 15, 2017, OMB announced that one Micropolitan Statistical Area now qualifies as a Metropolitan Statistical Area (OMB Bulletin No. 17-01). The new urban CBSA is as follows:
• Twin Falls, Idaho (CBSA 46300). This CBSA is comprised of the principal city of Twin Falls, Idaho in Jerome County, Idaho and Twin Falls County, Idaho.
The OMB bulletin is available on the OMB website at
In the proposed rule, we stated that in the final rule, we would incorporate this change into the final FY 2019 wage index, rate setting and tables. We did not receive any comments on this issue. Thus, in this final rule, we have incorporated this change into the final FY 2019 wage index, rate setting and tables. As we proposed, for FY 2019, we will use the OMB delineations that were adopted beginning with FY 2015 to calculate the area wage indexes, with updates as reflected in OMB Bulletin Nos. 15-01 and 17-01. As noted above, the wage index applicable to FY 2019 (with the CBSA update from OMB Bulletin No. 17-01 specified above) is set forth in Tables A and B available on the CMS website at
Once calculated, we stated in the proposed rule that we would apply the wage index adjustment to the labor-related portion of the federal rate. Each year, we calculate a revised labor-related share, based on the relative importance of labor-related cost categories (that is, those cost categories that are labor-intensive and vary with the local labor market) in the input price index. In the SNF PPS final rule for FY 2018 (82 FR 36548 through 36566), we finalized a proposal to revise the labor-related share to reflect the relative importance of the 2014-based SNF market basket cost weights for the following cost categories: Wages and Salaries; Employee Benefits; Professional Fees: Labor-Related; Administrative and Facilities Support Services; Installation, Maintenance, and Repair Services; All Other: Labor-Related Services; and a proportion of Capital-Related expenses.
We calculate the labor-related relative importance from the SNF market basket, and it approximates the labor-related portion of the total costs after taking into account historical and projected price changes between the base year and FY 2019. The price proxies that move the different cost categories in the market basket do not necessarily change at the same rate, and the relative importance captures these changes. Accordingly, the relative importance figure more closely reflects the cost share weights for FY 2019 than the base year weights from the SNF market basket.
We calculate the labor-related relative importance for FY 2019 in four steps. First, we compute the FY 2019 price index level for the total market basket and each cost category of the market basket. Second, we calculate a ratio for each cost category by dividing the FY 2019 price index level for that cost category by the total market basket price index level. Third, we determine the FY 2019 relative importance for each cost category by multiplying this ratio by the base year (2014) weight. Finally, we add the FY 2019 relative importance for each of the labor-related cost categories (Wages and Salaries, Employee Benefits, Professional Fees: Labor-Related, Administrative and Facilities Support Services, Installation, Maintenance, and Repair Services, All Other: Labor-related services, and a portion of Capital-Related expenses) to produce the FY 2019 labor-related relative importance. Table 8 summarizes the updated labor-related share for FY 2019, based on IGI's second quarter 2018 forecast with historical data through first quarter 2018, compared to the labor-related share that was used for the FY 2018 SNF PPS final rule. In the FY 2019 proposed rule, we presented the FY 2019 labor-related share based on IGI's first quarter 2018 forecast and further stated that if more recent data became available (for example, a more recent estimate of the SNF market basket and/or MFP adjustment), we would use such data, if appropriate, to determine the SNF market basket percentage change, labor-related share relative importance, forecast error adjustment, and MFP adjustment in the SNF PPS final rule.
Tables 9 and 10 show the RUG-IV case-mix adjusted federal rates for FY 2019 by labor-related and non-labor-related components. Tables 9 and 10 do not reflect the add-on for SNF residents with AIDS enacted by section 511 of the MMA, which we apply only after making all other adjustments (such as wage index and case-mix). Additionally, Tables 9 and 10 do not reflect adjustments which may be made to the SNF PPS rates as a result of either the SNF QRP, discussed in section VI.B. of this final rule, or the SNF VBP program, discussed in sections III.B.5. and VI.C. of this final rule.
Section 1888(e)(4)(G)(ii) of the Act also requires that we apply this wage index in a manner that does not result in aggregate payments under the SNF PPS that are greater or less than would otherwise be made if the wage adjustment had not been made. For FY 2019 (federal rates effective October 1, 2018), we stated in the proposed rule that we would apply an adjustment to fulfill the budget neutrality requirement. We stated we would meet this requirement by multiplying each of the components of the unadjusted federal rates by a budget neutrality factor equal to the ratio of the weighted average wage adjustment factor for FY 2018 to the weighted average wage adjustment factor for FY 2019. For this calculation, we stated we would use the same FY 2017 claims utilization data for both the numerator and denominator of this ratio. We define the wage adjustment factor used in this calculation as the labor share of the rate component multiplied by the wage index plus the non-labor share of the rate component. We did not receive any comments regarding our proposed budget neutrality factor calculation. Thus, we are finalizing the budget neutrality methodology as proposed. The final budget neutrality factor for FY 2019 is 0.9999. We note that this is different from the budget neutrality factor (1.0002) provided in the FY 2018 SNF PPS proposed rule (83 FR 21031) due to an updated wage index file and updated
As discussed above, we have historically used, and propose to continue using, pre-reclassified IPPS hospital wage data, unadjusted for occupational mix and the rural and imputed floors, as the basis for the SNF wage index. That being said, in the proposed rule, we noted that we have received recurring comments in prior rulemaking (most recently in the FY 2018 SNF PPS final rule (82 FR 36539 through 36541)) regarding the development of a SNF-specific wage index. It has been suggested that we develop a SNF-specific wage index utilizing SNF cost report wage data instead of hospital wage data. We have noted, in response that developing such a wage index would require a resource-intensive audit process similar to that used for IPPS hospital data, to improve the quality of the SNF cost report data in order for it to be used as part of this analysis. This audit process is quite extensive in the case of approximately 3,300 hospitals, and it would be significantly more so in the case of approximately 15,000 SNFs. As discussed previously in this rule, we believe auditing all SNF cost reports, similar to the process used to audit inpatient hospital cost reports for purposes of the IPPS wage index, would place a burden on providers in terms of recordkeeping and completion of the cost report worksheet. We also believe that adopting such an approach would require a significant commitment of resources by CMS and the Medicare Administrative Contractors, potentially far in excess of those required under the IPPS given that there are nearly five times as many SNFs as there are hospitals. Therefore, while we continue to review all available data and contemplate the potential methodological approaches for a SNF-specific wage index in the future, we continue to believe that in the absence of the appropriate SNF-specific wage data, using the pre-reclassified, pre-rural and imputed floor hospital inpatient wage data (without the occupational mix adjustment) is appropriate and reasonable for the SNF PPS.
As an alternative to a SNF-specific wage index, it has also been suggested that we consider adopting certain wage index policies in use under the IPPS, such as geographic reclassification or rural floor. Although we have the authority under section 315 of BIPA to establish a geographic reclassification procedure specific to SNFs under certain conditions, as discussed previously, under BIPA, we cannot adopt a reclassification policy until we have collected the data necessary to establish a SNF-specific wage index. Thus, we cannot adopt a reclassification procedure at this time. With regard to adopting a rural floor policy, as we stated in the FY 2017 SNF PPS final rule (82 FR 36540), MedPAC has recommended eliminating the rural floor policy (which actually sets a floor for urban hospitals) from the calculation of the IPPS wage index (see, for example, Chapter 3 of MedPAC's March 2013 Report to Congress on Medicare Payment Policy, available at
Given the perennial nature of these comments and responses on the SNF PPS wage index policy, in the proposed rule (89 FR 21032) we invited further comments on the issues discussed above. Specifically, we requested comment on how a SNF-specific wage index may be developed without creating significant administrative burdens for providers, CMS, or its contractors. Further, we requested comments on specific alternatives we may consider in future rulemaking which could be implemented in advance of, or in lieu of, a SNF-specific wage index. A discussion of the comments we received, along with our responses, appear below.
Further, we appreciate these commenters' suggestion that we modify the current hospital wage data used to construct the SNF PPS wage index to reflect the SNF environment more accurately by trimming hospital wage data to reflect positions staffed in nursing homes, weighing it by occupational mix data published by the BLS, and using PBJ data. While we consider whether or not such an approach may constitute an interim step in the process of developing a SNF-specific wage index, we would note that other provider types also use the hospital wage index as the basis for their associated wage index. As such, we believe that such a recommendation should be part of a broader discussion on wage index reform across Medicare payment systems. With regard to the PBJ recommendation, we will pass this comment to our colleagues managing that initiative for further consideration.
With regard to reclassification and rural floor, as discussed above, section 315 of BIPA authorized us to establish a geographic reclassification procedure that is specific to SNFs, only after collecting the data necessary to establish a SNF-specific wage index that is based on data from nursing homes. However, to date this has been infeasible due to the volatility of existing SNF wage data and the significant amount of resources that would be required to improve the quality of that data. Furthermore, we do not believe that using hospital reclassification data would be
While we continue to review all available data and contemplate the potential methodological approaches for a SNF-specific wage index in the future, we continue to believe that in the absence of the appropriate SNF-specific wage data, using the pre-reclassified, pre-rural and imputed floor hospital inpatient wage data (without the occupational mix adjustment) is appropriate and reasonable for the SNF PPS. We believe the commenters' recommendations should be part of a broader discussion of wage index reform across Medicare payment systems. In the event that a SNF-specific wage index is implemented in the future, CMS will provide education and support in a manner it deems appropriate, which may include MLN transmittals. We will continue to monitor closely research efforts surrounding the development of an alternative hospital wage index for the IPPS and the potential impact or influence of that research on the SNF PPS.
Beginning with payment for services furnished on October 1, 2018, section 1888(h) of the Act requires the Secretary to reduce the adjusted Federal per diem rate determined under section 1888(e)(4)(G) of the Act otherwise applicable to a SNF for services furnished during a fiscal year by 2 percent, and to adjust the resulting rate for a SNF by the value-based incentive payment amount earned by the SNF based on the SNF's performance score for that fiscal year under the SNF VBP Program. To implement these requirements, we proposed to add a new paragraph (f) to § 413.337. We did not receive any public comments regarding this proposal. Therefore, we are finalizing the addition of paragraph (f) to § 413.337 as proposed, without modification.
Please see section VI.C. of this final rule for further information regarding the SNF VBP Program, including a discussion of the methodology we will use to make the payment adjustments.
Using the hypothetical SNF XYZ, Table 11 shows the adjustments made to the federal per diem rates (prior to application of any adjustments under the SNF QRP and SNF VBP programs as discussed above) to compute the provider's actual per diem PPS payment for FY 2019. We derive the Labor and Non-labor columns from Table 9. The wage index used in this example is based on the FY 2019 SNF PPS wage index that appears in Table A available on the CMS website at
The establishment of the SNF PPS did not change Medicare's fundamental requirements for SNF coverage. However, because the case-mix classification is based, in part, on the beneficiary's need for skilled nursing care and therapy, we have attempted, where possible, to coordinate claims review procedures with the existing resident assessment process and case-mix classification system discussed in section III.B.3. of this final rule. This approach includes an administrative presumption that utilizes a beneficiary's initial classification in one of the upper 52 RUGs of the current 66-group RUG-IV case-mix classification system to assist in making certain SNF level of care determinations.
In accordance with the regulations at § 413.345, we include in each update of the federal payment rates in the
A beneficiary assigned to any of the lower 14 RUG-IV groups is not automatically classified as either meeting or not meeting the definition, but instead receives an individual level of care determination using the existing administrative criteria. This presumption recognizes the strong likelihood that beneficiaries assigned to one of the upper 52 RUG-IV groups during the immediate post-hospital period require a covered level of care, which would be less likely for those beneficiaries assigned to one of the lower 14 RUG-IV groups.
In the July 30, 1999 final rule (64 FR 41670), we indicated that we would announce any changes to the guidelines for Medicare level of care determinations related to modifications in the case-mix classification structure. The FY 2018 final rule (82 FR 36544) further specified that we would henceforth disseminate the standard description of the administrative presumption's designated groups via the SNF PPS website at
However, we note that this administrative presumption policy does not supersede the SNF's responsibility to ensure that its decisions relating to level of care are appropriate and timely, including a review to confirm that the services prompting the assignment of one of the designated case-mix classifiers (which, in turn, serves to trigger the administrative presumption) are themselves medically necessary. As we explained in the FY 2000 SNF PPS final rule (64 FR 41667), the administrative presumption is itself rebuttable in those individual cases in which the services actually received by the resident do not meet the basic statutory criterion of being reasonable and necessary to diagnose or treat a beneficiary's condition (according to section 1862(a)(1) of the Act). Accordingly, the presumption would not apply, for example, in those situations in which a resident's assignment to one of the upper groups is itself based on the receipt of services that are subsequently determined to be not reasonable and necessary. Moreover, we want to stress the importance of careful monitoring for changes in each patient's condition to determine the continuing need for Part A SNF benefits after the ARD of the 5-day assessment.
Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by section 4432(b) of the BBA 1997) require a SNF to submit consolidated Medicare bills to its Medicare Administrative Contractor (MAC) for almost all of the services that its residents receive during the course of a covered Part A stay. In addition, section 1862(a)(18) of the Act places the responsibility with the SNF for billing Medicare for physical therapy, occupational therapy, and speech-language pathology services that the resident receives during a noncovered stay. (Please refer to section VI.A. of this final rule for a discussion of a revision to the regulation text that describes a beneficiary's status as a SNF “resident” for consolidated billing purposes.) Section 1888(e)(2)(A) of the Act excludes a small list of services from the consolidated billing provision (primarily those services furnished by physicians and certain other types of practitioners), which remain separately billable under Part B when furnished to a SNF's Part A resident. These excluded service categories are discussed in greater detail in section V.B.2. of the May 12, 1998 interim final rule (63 FR 26295 through 26297).
A detailed discussion of the legislative history of the consolidated billing provision is available on the SNF PPS website at
As explained in the FY 2001 proposed rule (65 FR 19232), the amendments enacted in section 103 of the BBRA not only identified for exclusion from this provision a number of particular service codes within four specified categories (that is, chemotherapy items, chemotherapy administration services, radioisotope services, and customized prosthetic devices), but also gave the Secretary the authority to designate additional, individual services for exclusion within each of the specified service categories. In the proposed rule for FY 2001, we also noted that the BBRA Conference report (H.R. Rep. No. 106-479 at 854 (1999) (Conf. Rep.)) characterizes the individual services that this legislation targets for exclusion as high-cost, low probability events that could have devastating financial impacts because their costs far exceed the payment SNFs receive under the PPS. According to the conferees, section 103(a) of the BBRA is an attempt to exclude from the PPS certain services and costly items that are provided infrequently in SNFs. By contrast, the amendments enacted in section 103 of the BBRA do not designate for exclusion any of the remaining services within those four categories (thus, leaving all of those services subject to SNF consolidated billing), because they are relatively inexpensive and are furnished routinely in SNFs.
As we further explained in the final rule for FY 2001 (65 FR 46790), and as is consistent with our longstanding policy, any additional service codes that we might designate for exclusion under our discretionary authority must meet the same statutory criteria used in identifying the original codes excluded from consolidated billing under section 103(a) of the BBRA: they must fall within one of the four service categories specified in the BBRA; and they also must meet the same standards of high cost and low probability in the SNF setting, as discussed in the BBRA Conference report. Accordingly, we characterized this statutory authority to identify additional service codes for exclusion as essentially affording the flexibility to revise the list of excluded codes in response to changes of major significance that may occur over time (for example, the development of new medical technologies or other advances in the state of medical practice) (65 FR 46791). In the proposed rule (83 FR 21033), we specifically invited public comments identifying HCPCS codes in any of these four service categories (chemotherapy items, chemotherapy administration services, radioisotope services, and customized prosthetic
We note that the original BBRA amendment (as well as the implementing regulations) identified a set of excluded services by means of specifying HCPCS codes that were in effect as of a particular date (in that case, as of July 1, 1999). Identifying the excluded services in this manner made it possible for us to utilize program issuances as the vehicle for accomplishing routine updates of the excluded codes, to reflect any minor revisions that might subsequently occur in the coding system itself (for example, the assignment of a different code number to the same service). Accordingly, we stated in the proposed rule that, in the event that we identify through the current rulemaking cycle any new services that would actually represent a substantive change in the scope of the exclusions from SNF consolidated billing, we would identify these additional excluded services by means of the HCPCS codes that are in effect as of a specific date (in this case, as of October 1, 2018). By making any new exclusions in this manner, we could similarly accomplish routine future updates of these additional codes through the issuance of program instructions.
Commenters submitted the following comments related to the proposed rule's discussion of the consolidated billing aspects of the SNF PPS. A discussion of these comments, along with our responses, appears below.
Finally, regarding the comment about the complexity of this provision, in the FY 2010 SNF PPS final rule (74 FR 40355, August 11, 2009), we noted in response to a previous, similar comment that while the commenter's interest in promoting improved ease of administration is understandable, current law contains no authority to effect a comprehensive overhaul of the existing requirements administratively. However, we would also note in this context that we continue to conduct an active educational and training initiative on the consolidated billing provision that includes the following:
• A recently updated and expanded set of consolidated billing instructions in Chapter 6 of the Medicare Claims Processing Manual (available online at
• Addressing questions that arise on this topic during CMS's recurring nationwide SNF/Long-Term Care Open Door Forums (
• Development of sample model agreements between SNFs and their suppliers, which are posted online for review at our “Best Practices” website (at
• Creation of a web-based training (WBT) module accessible from the Medicare Learning Network (MLN) website at
Because the drugs at issue here would not be covered under Part B, we believe that the applicable provisions at section 1888(e)(2)(A) may not provide a basis for excluding them from consolidated billing. Accordingly, because of the need for further consideration of this
• As noted in numerous previous rules, as well as in Medicare Learning Network (MLN) Matters article SE0432 (available online at
• Ever since its inception, this exclusion was intended to be hospital-specific; as explained in the original SNF PPS interim final rule (63 FR 26298, May 12, 1998), this exclusion was created within the context of the concurrent development of a new PPS specifically for outpatient hospital services, reflecting the need to delineate the respective areas of responsibility for the SNF under the consolidated billing provision, and for the hospital under the outpatient bundling provision, with regard to these services. This point was further reinforced in the subsequent final rule for FY 2000 (64 FR 41676, July 30, 1999), in which we explained that a key concern underlying the development of the consolidated billing exclusion of certain outpatient hospital services specifically involved the need to distinguish those services that comprise the SNF bundle from those that will become part of the outpatient hospital bundle that is currently being developed in connection with the outpatient hospital PPS. Accordingly, we noted at that time that we would not be extending the outpatient hospital exclusion from consolidated billing to encompass any other, freestanding settings.
• Finally, the FY 2010 final rule (74 FR 40355, August 11, 2009), while acknowledging that advances in medical technology over time may make it feasible to perform such high-intensity outpatient services more widely in nonhospital settings, then went on to cite the FY 2006 final rule (70 FR 45049, August 4, 2005) in noting that such a development would not argue in favor of excluding the nonhospital performance of the service from consolidated billing, but rather, would call into question whether the service should continue to be excluded from consolidated billing at all, even when performed in the hospital setting.
Further, we believe the comments that cited the proration policy in this context (which involves a single portable x-ray trip that serves multiple patients) may reflect a certain amount of misunderstanding about the proration policy's actual nature and purpose. As explained in the Medicare Physician Fee Schedule (MPFS) final rule for calendar year (CY) 2016 (80 FR 70886, November 16, 2015), the reason for allocating such a trip among
Regarding the suggestion that
Section 1883 of the Act permits certain small, rural hospitals to enter into a Medicare swing-bed agreement, under which the hospital can use its beds to provide either acute- or SNF-level care, as needed. For critical access hospitals (CAHs), Part A pays on a reasonable cost basis for SNF-level services furnished under a swing-bed agreement. However, in accordance with section 1888(e)(7) of the Act, SNF-level services furnished by non-CAH rural hospitals are paid under the SNF PPS, effective with cost reporting periods beginning on or after July 1, 2002. As explained in the FY 2002 final rule (66 FR 39562), this effective date is consistent with the statutory provision to integrate swing-bed rural hospitals into the SNF PPS by the end of the transition period, June 30, 2002.
Accordingly, all non-CAH swing-bed rural hospitals have now come under the SNF PPS. Therefore, all rates and wage indexes outlined in earlier sections of this final rule for the SNF PPS also apply to all non-CAH swing-bed rural hospitals. A complete discussion of assessment schedules, the MDS, and the transmission software (RAVEN-SB for Swing Beds) appears in the FY 2002 final rule (66 FR 39562) and in the FY 2010 final rule (74 FR 40288). As finalized in the FY 2010 SNF PPS final rule (74 FR 40356 through 40357), effective October 1, 2010, non-CAH swing-bed rural hospitals are required to complete an MDS 3.0 swing-bed assessment which is limited to the required demographic, payment, and quality items. The latest changes in the MDS for swing-bed rural hospitals appear on the SNF PPS website at
In the FY 2019 SNF PPS proposed rule, we discussed our proposed changes to the SNF PPS, specifically the proposed comprehensive revisions to the SNF PPS case-mix classification system whereby we proposed to replace the current RUG-IV system with the Patient Driven Payment Model (PDPM) effective October 1, 2019. In section V.A of the FY 2019 SNF PPS proposed rule (83 FR 21034-21036), we discuss the basis for the proposed PDPM and our reasons for proposing to replace the existing case-mix classification system with the PDPM, effective October 1, 2019.
Section 1888(e)(4)(G)(i) of the Act requires the Secretary to make an adjustment to the per diem rates to account for case-mix. The statute specifies that the adjustment is to be based on both a resident classification system that the Secretary establishes that accounts for the relative resource use of different resident types, as well as resident assessment and other data that the Secretary considers appropriate.
In general, the case-mix classification system currently used under the SNF PPS classifies residents into payment classification groups, called RUGs, based on various resident characteristics and the type and intensity of therapy services provided to the resident. Under the existing SNF PPS methodology, there are two case-mix-adjusted components of payment: Nursing and therapy. Each RUG is assigned a CMI for each payment component to reflect relative differences in cost and resource intensity. The higher the CMI, the higher the expected resource utilization and cost associated with residents assigned to that RUG. The case-mix-adjusted nursing component of payment reflects relative differences in a resident's associated nursing and non-therapy ancillary (NTA) costs, based on various resident characteristics, such as resident comorbidities, and treatments. The case-mix-adjusted therapy component of payment reflects relative differences in a resident's associated therapy costs, which is based on a combination of PT, OT, and SLP services. Resident classification under the existing therapy component is based primarily on the amount of therapy the SNF chooses to provide to a SNF resident. Under the RUG-IV model, residents are classified into rehabilitation groups, where payment is determined primarily based on the intensity of therapy services received by the resident, and into nursing groups, based on the intensity of nursing services received by the resident and other aspects of the resident's care and condition. However, only the higher paying of these groups is used for payment purposes. For example, if a resident is classified into a both the RUA (Rehabilitation) and PA1 (Nursing) RUG-IV groups, where RUA has a higher per-diem payment rate than PA1, the RUA group is used for payment purposes. It should be noted that the vast majority of Part A covered SNF days (over 90 percent) are paid using a rehabilitation RUG. A variety of concerns have been raised with the current SNF PPS, specifically the RUG-IV model, which we discuss below.
When the SNF PPS was first implemented in 1998 (63 FR 26252), we developed the RUG-III case-mix classification model, which tied the amount of payment to resident resource use in combination with resident characteristic information. Staff time measurement (STM) studies conducted in 1990, 1995, and 1997 provided information on resource use (time spent by staff members on residents) and resident characteristics that enabled us not only to establish RUG-III but also to create CMIs. This initial RUG-III model was refined by changes finalized in the FY 2006 SNF PPS final rule (70 FR 45032), which included adding nine case-mix groups to the top of the original 44-group RUG-III hierarchy, which created the RUG-53 case-mix model.
In the FY 2010 SNF PPS proposed rule (74 FR 22208), we proposed the RUG-IV model based on, among other reasons, concerns that incentives in the SNF PPS had changed the relative amount of nursing resources required to treat SNF residents (74 FR 22220). These concerns led us to conduct a new
As we explained in the proposed rule (83 FR 21034), in the years since we implemented the SNF PPS, finalized RUG-IV, and made statements regarding our concerns about underutilization of services in previously considered models, we have witnessed a significant trend that has caused us to reconsider these concerns. More specifically, as discussed in section V.E. of the FY 2015 SNF PPS proposed rule (79 FR 25767), we documented and discussed trends observed in therapy utilization in a memo entitled “Observations on Therapy Utilization Trends” (which may be accessed at
In response to comments which highlighted potential explanatory factors for the observed trends, such as internal pressure within SNFs that would override clinical judgment, we stated that we found these potential explanatory factors troubling and entirely inconsistent with the intended use of the SNF benefit. Specifically, the minimum therapy minute thresholds for each therapy RUG category are certainly not intended as ceilings or targets for therapy provision. As discussed in Chapter 8, Section 30 of the Medicare Benefit Policy Manual (Pub. 100-02), to be covered, the services provided to a SNF resident must be “reasonable and necessary for the treatment of a patient's illness or injury, that is, are consistent with the nature and severity of the individual's illness or injury, the individual's particular medical needs, and accepted standards of medical practice.” Therefore, we stated that services which are not specifically tailored to meet the individualized needs and goals of the resident, based on the resident's condition and the evaluation and judgment of the resident's clinicians, may not meet this aspect of the definition for covered SNF care, and we stated we believe that internal provider rules should not seek to circumvent the Medicare statute, regulations and policies, or the professional judgment of clinicians. (79 FR 45651 through 45652).
In addition to this discussion of observed trends, we noted in the proposed rule (83 FR 21035) that others have also identified potential areas of concern within the current SNF PPS. The two most notable sources are the Office of the Inspector General (OIG) and the Medicare Payment Advisory Commission (MedPAC).
For the OIG, three recent OIG reports describe the OIG's concerns with the current SNF PPS. In December 2010, the OIG released a report entitled “Questionable Billing by Skilled Nursing Facilities” (which may be accessed at
For MedPAC's recommendations in this area, Chapter 8 of MedPAC's March 2017 Report to Congress (available at
As we discussed in the proposed rule (83 FR 21035), the combination of the observed trends in the current SNF PPS discussed above (which strongly suggest that providers may be basing service provision on financial reasons rather than resident need), the issues raised in the OIG reports discussed above, and the issues raised by MedPAC, has caused us to consider significant revisions to the existing SNF PPS, in keeping with our overall responsibility to ensure that payments under the SNF PPS accurately reflect both resident needs and resource utilization.
We explained in the proposed rule (83 FR 20135 through 21036) that under the RUG-IV system, therapy service provision determines not only therapy payments but also nursing payments. This is because, as noted above, payment is based on the highest RUG category that the resident could be assigned to, so only one of a resident's assigned RUG groups, rehabilitation or nursing, is used for payment purposes. Each rehabilitation group is assigned a nursing CMI to reflect relative differences in nursing costs for residents in those rehabilitation groups, which is less specifically tailored to the individual nursing costs for a given resident than the nursing CMIs assigned for the nursing RUGs. We explained that, as mentioned above, because most resident days are paid using a rehabilitation RUG, and since assignment into a rehabilitation RUG is based on therapy service provision, this means that therapy service provision effectively determines nursing payments for those residents who are assigned to a rehabilitation RUG. Thus, we stated that we believe any attempts to revise the SNF PPS payment methodology to better account for therapy service provision under the SNF PPS would need to be comprehensive and affect both the therapy and nursing case-mix components. Moreover, we noted that in the FY 2015 SNF PPS final rule, in response to comments regarding access for certain “specialty” populations (such as those with complex nursing needs), that we agreed with the commenter that access must be preserved for all categories of SNF residents, particularly those with complex medical and nursing needs. We stated that, as appropriate, we would examine our current monitoring efforts to identify any revisions which may be necessary to account appropriately for these populations. (79 FR 45651).
In addition, MedPAC, in its March 2017 Report to Congress, stated that it has previously recommended that we revise the current SNF PPS to “base therapy payments on patient characteristics (not service provision), remove payments for NTA services from the nursing component, [and] establish a separate component within the PPS that adjusts payments for NTA services” (March 2017 MedPAC Report to Congress, 202). Accordingly, included among the proposed revisions we discussed in the proposed rule were revisions to the SNF PPS to address longstanding concerns regarding the ability of the RUG-IV system to account for variation in nursing and NTA services.
In May 2017, CMS released an Advance Notice of Proposed Rulemaking with comment (82 FR 20980) (the ANPRM), in which we discussed the history of and analyses conducted during the SNF Payment Models Research (PMR) project, which sought to address these concerns with the RUG-IV model, and sought comments on a possible replacement to the current RUG-IV model, which we called the Resident Classification System, Version I (RCS-I). As we stated in the proposed rule (83 FR 21036), this model was intended as an improvement over the RUG-IV model because it would better account for resident characteristics and care needs, thus better aligning SNF PPS payments with resource use and eliminating therapy provision-related financial incentives inherent in the current payment model used in the SNF PPS. We received many comments from stakeholders on a wide variety of aspects of the RCS-I model. After considering these comments, we made significant revisions to the RCS-I model to account for the concerns or questions raised by stakeholders, resulting in a revised case-mix classification model which we proposed in the FY 2019 SNF PPS proposed rule (83 FR 21018). To make clear the purpose and intent of replacing the existing RUG-IV system, the model we proposed is called the Patient-Driven Payment Model (PDPM). We refer readers to the FY 2019 SNF PPS proposed rule (83 FR 21036) for a discussion of the SNF PMR project, and the resulting SNF PMR technical report which contains supporting language and documentation related to the RCS-I model (available at
As further detailed below, and as we stated in the proposed rule (83 FR 21036), we believe that the PDPM represents an improvement over the RUG-IV model and the RCS-I model because it would better account for resident characteristics and care needs while reducing both systemic and administrative complexity. To better ensure that resident care decisions appropriately reflect each resident's actual care needs, we believe it is important to remove, to the extent possible, service-based metrics from the SNF PPS and derive payment from verifiable resident characteristics. In the sections that follow, we describe the comprehensive revisions we are implementing to the SNF PPS through the PDPM. Additionally, we discuss the comments we received on each of the proposed policies, our responses to these comments and the PDPM-related policies we are finalizing in this rule.
Before moving into the specific policy areas, we first discuss general comments
With regard to the comment that PDPM does not correct the issues with the current reimbursement model and assigns too few resources to nursing and NTAs, we would refer the commenter to the impact analysis presented in Table 37, which indicates that the broadest shifts in payment are to those patients with high nursing and NTA needs.
With regard to the comment that the historical data do not sufficiently reflect current best practices or high quality care, while we are concerned about this assertion from a patient care perspective, we do not believe that this would affect the accuracy of the reported data in terms of reflecting relative differences in costs, which is all that is necessary for developing accurate case-mix groups.
With regard to the comment about tracking maintenance services, we do not believe it is necessary at this time to track maintenance services separately. Such tracking would be burdensome and it would be difficult to do so accurately, as it is possible that many patients have both maintenance and restorative goals, and allocating therapy minutes among these varied goals would be particularly complicated for providers.
With regard to the burden of the Comprehensive Person-Centered Plan, new requirements of participation, and other CMS initiatives, the burdens estimated in relation to PDPM are only those in relation to implementation of the PDPM and its related policies. As the Comprehensive Person-Centered Plan and other issues mentioned are outside of these PDPM related policies, we do not address the potential burden of such issues in this section.
With regard to the comment that states may have more of an incentive to transition to PDPM in order to reduce Medicaid spending, we believe that the primary reason that Medicaid programs may adopt PDPM is due to its focus on patient characteristics and goals, rather than on service utilization. Given the improvements in Medicare payment that this transition represents, we would expect a similar improvement in Medicaid payments in states that make this transition.
With regard to the comment that Medicaid providers will be incentivized to provide less therapy or that Medicaid beneficiaries will have lower nursing case-mix scores, we would encourage states that decide to transition to PDPM to ensure they are monitoring the impacts of such a change on their beneficiaries and the care they receive.
In terms of those states that opt not to transition to PDPM and instead use some form of legacy payment system, we would note that a number of states use systems quite distinct from the existing RUG-IV model and we are not aware of any difficulties or complexities for providers or states in managing these systems concurrently. These states still have access to MDS data for ratesetting purposes and nothing associated with PDPM implementation, in and of itself, would affect state access to MDS data. That being said, we would likely need to evaluate the costs and benefits of continued support for certain legacy payment systems, most notably any RUG-III based payment models.
Section 1888(e)(4) of the Act requires that the SNF PPS per diem federal payment rates be based on FY 1995 costs, updated for inflation to the first effective period of the PPS. These base rates are then required to be adjusted to reflect differences among facilities in patient case-mix and in average wage levels by area. In keeping with this statutory requirement, the base per diem payment rates were set in 1998 and reflect average SNF costs in a base year (FY 1995), updated for inflation to the first period of the SNF PPS, which was the 15-month period beginning on July 1, 1998. The federal base payment rates were calculated separately for urban and rural facilities and based on allowable costs from the FY 1995 cost reports of hospital-based and freestanding SNFs, where allowable costs included all routine, ancillary, and capital-related costs (excluding those related to approved educational activities) associated with SNF services provided under Part A, and all services and items for which payment could be made under Part B prior to July 1, 1998.
In general, routine costs are those included by SNFs in a daily service charge and include regular room, dietary, and nursing services, medical social services and psychiatric social services, as well as the use of certain facilities and equipment for which a separate charge is not made. Ancillary costs are directly identifiable to residents and cover specialized services, including therapy, drugs, and laboratory services. Lastly, capital-related costs include the costs of land, building, and equipment and the interest incurred in financing the acquisition of such items (63 FR 26253).
There are four federal base payment rate components which may factor into SNF PPS payment. Two of these components, “nursing case-mix” and “therapy case-mix,” are case-mix adjusted components, while the remaining two components, “therapy non-case-mix” and “non-case-mix,” are not case-mix adjusted. While we discussed the details of the proposed PDPM and justifications for certain associated policies we proposed throughout section V of the FY 2019 SNF PPS proposed rule, we note that, as part of the PDPM case-mix model, we proposed to bifurcate the “nursing case-mix” component of the federal base payment rate into two case-mix adjusted components and separate the “therapy case-mix” component of the federal base payment rate into three case-mix adjusted components, thereby creating five case-mix adjusted components of the federal base per diem rate. More specifically, we proposed to separate the “therapy case-mix” rate component into a “Physical Therapy” (PT) component, an “Occupational Therapy” (OT) component, and a “Speech-Language Pathology” (SLP) component. Our rationale for separating the therapy case-mix component in this manner is presented in section V.D.3.b. of the proposed rule. Based on the results of the SNF PMR, we also proposed to separate the “nursing case-mix” rate component into a “Nursing” component and a “Non-Therapy Ancillary” (NTA) component. Our rationale for proposing to bifurcate the nursing case-mix component in this manner is presented in section V.D.3.d. of the proposed rule. Given that all SNF residents under PDPM would be assigned to a classification group for each of the three proposed therapy-related case-mix adjusted components as further discussed below, we proposed eliminating the “therapy non-case-mix” rate component under PDPM and stated that we would distribute the dollars associated with this current rate component amongst the proposed PDPM therapy components. We also stated in the proposed rule (83 FR 21038) that the existing non-case-mix component would be maintained as it is currently constituted under the existing SNF PPS. We explained that although the case-mix components of the proposed PDPM case-mix classification system would address costs associated with individual resident care based on an individual's specific needs and characteristics, the non-case-mix component addresses consistent costs that are incurred for all residents, such as room and board and various capital-related expenses. As these costs are not likely to change, regardless of what changes we might make to the SNF PPS, we proposed to maintain the non-case-mix component as it is currently used.
In the next section, we discuss the methodology used to create the proposed PDPM case-mix adjusted components, as well as the data sources used in this calculation. As we stated in the proposed rule (83 FR 21038), the proposed methodology does not calculate new federal base payment rates but simply proposes to modify the existing base rate case-mix components for therapy and nursing. The methodology and data used in this calculation are based on the data and methodology used in the calculation of the original federal payment rates in 1998, as further discussed below.
Section II.A.2. of the interim final rule with comment period that initially implemented the SNF PPS (63 FR 26256 through 26260) provides a detailed discussion of the data sources used to calculate the original federal base payment rates in 1998. Except as discussed below, we proposed to use the same data sources (that is, cost information from FY 1995 cost reports) to determine the portion of the therapy case-mix component base rate that would be assigned to each of the proposed therapy component base rates (PT, OT, and SLP). As we stated in the proposed rule (83 FR 21038), we believe that using the same data sources, to the extent possible, that were used to calculate the original federal base
As discussed in the proposed rule (83 FR 21038), the percentage of the current therapy case-mix component of the federal base payment rates that would be assigned to the three proposed therapy components (PT, OT, and SLP) of the federal base payment rates was determined using cost information from FY 1995 cost reports, after making the following exclusions and adjustments: First, only settled and as-submitted cost reports for hospital-based and freestanding SNFs for periods beginning in FY 1995 and spanning 10 to 13 months were included. This set of restrictions replicates the restrictions used to derive the original federal base payment rates as set forth in the 1998 interim final rule with comment period (63 FR 26256). Following the methodology used to derive the SNF PPS base rates, routine and ancillary costs from as-submitted cost reports were adjusted down by 1.31 and 3.26 percent, respectively. As discussed in the 1998 interim final rule with comment period, the specific adjustment factors were chosen to reflect average adjustments resulting from cost report settlement and were based on a comparison of as-submitted and settled reports from FY 1992 to FY 1994 (63 FR 26256); these adjustments are in accordance with section 1888(e)(4)(A)(i) of the Act. We used similar data, exclusions, and adjustments as in the original base rates calculation so the resulting base rates for the components would resemble as closely as possible what they would have been had they been established in 1998. However, as we discussed in the proposed rule, there were two ways in which the PT, OT, and SLP percentage calculations deviate from the 1998 base rates calculation. First, the 1998 calculation of the base rates excluded reports for facilities exempted from cost limits in the base year. The available data do not identify which facilities were exempted from cost limits in the base year, so this restriction was not implemented. As we stated in the proposed rule, we do not believe this had a notable impact on our estimate of the PT, OT, and SLP percentages, because only a small fraction of facilities were exempted from cost limits. Consistent with the 1998 base rates calculation, we excluded facilities with per diem costs more than three standard deviations higher than the geometric mean across facilities. Therefore, facilities with unusually high costs did not influence our estimate. Second, the 1998 calculation of the base rates excluded costs related to exceptions payments and costs related to approved educational activities. The available cost report data did not identify costs related to exceptions payments nor indicate what percentage of overall therapy costs or costs by therapy discipline were related to approved educational activities, so these costs are not excluded from the PT, OT, and SLP percentage calculations. We stated in the proposed rule that because exceptions were only granted for routine costs, we believe the inability to exclude these costs should not affect our estimate of the PT, OT, and SLP percentages as exceptions would not apply to therapy costs. Additionally, the data indicate that educational costs made up less than one-hundredth of 1 percent of overall SNF costs. Therefore, we stated that we believe the inability to exclude educational costs should have a negligible impact on our estimates.
In addition to Part A costs from the cost report data, the 1998 federal base rates calculation incorporated estimates of amounts payable under Part B for covered SNF services provided to Part A SNF residents, as required by section 1888(e)(4)(A)(ii) of the Act. We stated in the proposed rule (83 FR 21038) that in calculating the PT, OT, and SLP percentages, we also estimated the amounts payable under Part B for covered SNF services provided to Part A residents. All Part B claims associated with Part A SNF claims overlapping with FY 1995 cost reports were matched to the corresponding facility's cost report. For each cost center (PT, OT, and SLP) in each cost report, a ratio was calculated to determine the amount by which Part A costs needed to be increased to account for the portion of costs payable under Part B. This ratio for each cost center was determined by dividing the total charges from the matched Part B claims by the total charges from the Part A SNF claims overlapping with the cost report. The 1998 interim final rule (63 FR 26256) states that to estimate the amounts payable under Part B for covered SNF services provided to Part A SNF residents, CMS (then known as HCFA) matched 100 percent of Part B claims associated with Part A covered SNF stays to the corresponding facility's cost report. Part B allowable charges were then incorporated at the facility level by the appropriate cost report center. Although the interim final rule does not provide further detail on how Part B allowable charges were incorporated at the facility level, we stated in the proposed rule that we believe our methodology reasonably approximates the methodology described in the interim final rule, and provides a reasonable estimate of the amounts payable under Part B for covered SNF services provided to Part A residents for purposes of calculating the PT, OT, and SLP percentages. Therefore, we stated that we believe it is reasonable to use this methodology to calculate the PT, OT, and SLP percentages of the therapy case-mix component.
Finally, the 1998 federal base rates calculation standardized the cost data for each facility to control for the effects of case-mix and geographic-related wage differences, as required by section 1888(e)(4)(C) of the Act. As we stated in the proposed rule, when calculating the PT, OT and SLP shares of the current therapy base rate, we replicated the method used in 1998 to standardize for wage differences, as described in the 1998 interim final rule with comment period (63 FR 26259 through 26260). We applied a hospital wage index to the labor-related share of costs, estimated at 75.888 percent, and used an index composed of hospital wages from FY 1994. We noted in the proposed rule that the PT, OT, and SLP percentage calculations did not include the case-mix adjustment used in the 1998 calculation because the 1998 adjustment relied on the obsolete RUG-III classification system. In the 1998 federal base rates calculation, information from SNF and inpatient claims was mapped to RUG-III clinical categories at the resident level to case-mix adjust facility per diem costs. However, the 1998 interim final rule did not document this mapping, and the data used as the basis for this adjustment are no longer available, and therefore, this step could not be replicated. We stated in the proposed rule that we believe the inability to apply the case-mix
We invited comments on the data sources used to determine the PT, OT, and SLP rate components, as discussed above.
Commenters submitted the following comments related to the proposed rule's discussion of the Data Sources Utilized for Proposed Revision of Federal Base Payment Rate Components. A discussion of these comments, along with our responses, appears below.
As discussed previously in this section, we proposed to separate the current therapy components into a PT component, an OT component, and an SLP component. To do this, we calculated the percentage of the current therapy component of the federal base rate that corresponds to each of the three proposed PDPM therapy components (PT, OT, and SLP) in accordance with the methodology set forth below and in the FY 2019 SNF PPS proposed rule (83 FR 21039).
The data described in section V.C.2. of the proposed rule (primarily, cost information from FY 1995 cost reports)
As explained in the proposed rule (83 FR 21039), the goal of this methodology is to estimate the proportion of therapy costs that corresponds to each of the three therapy disciplines. We use the facility-level per-diem costs developed from 1995 cost reports to derive average per diem amounts for both total therapy costs and for PT, OT, and SLP costs separately. To do this, we followed the methodology outlined in section II.A.3. of the 1998 interim final rule with comment period (63 FR 26260), which was used by CMS (then known as HCFA) to create the federal base payment rates:
(1) For each of the four measures of cost (PT, OT, SLP, and total therapy costs per day), we computed the mean based on data from freestanding SNFs only. This mean was weighted by the total number of Medicare days of the facility.
(2) For each of the four measures of cost (PT, OT, SLP, and total therapy costs per day), we computed the mean based on data from both hospital-based and freestanding SNFs. This mean was weighted by the total number of Medicare days of the facility.
(3) For each of the four measures of cost (PT, OT, SLP, and total therapy costs per day), we calculated the arithmetic mean of the amounts determined under steps (1) and (2) above.
In section 3.10.3. of the SNF PDPM technical report (available at
The three steps outlined above produce a measure of costs per day by therapy discipline and a measure of total therapy costs per day. We divided the discipline-specific (PT, OT, SLP) cost measure by the total therapy cost measure to obtain the percentage of the therapy component that corresponds to each therapy discipline. As we discussed in the proposed rule (83 FR 21039), we believe that following a methodology to derive the discipline-specific therapy percentages that is consistent with the methodology used to determine the base rates in the 1998 interim final rule with comment period is appropriate because a consistent methodology helps to ensure that the resulting base rates for the components resemble what they would be had they been established in 1998. We found that PT, OT, and SLP costs correspond to 43.4 percent, 40.4 percent, and 16.2 percent of the therapy component of the federal per diem rate for urban SNFs, and 42.9 percent, 39.4 percent, and 17.7 percent of the therapy component of the federal per diem rate for rural SNFs. Under the proposed PDPM, we stated that the current therapy case-mix component would be separated into a Physical Therapy component, an Occupational Therapy component, and a Speech-Language Pathology component using the percentages derived above. We stated that this process would be done separately for urban and for rural facilities. In the appendix of the SNF PDPM technical report (available at
In addition, we proposed to separate the current nursing case-mix component into a nursing case-mix component and an NTA component. Similar to the therapy component, we calculated the percentage of the current nursing component of the federal base rates that corresponds to each of the two proposed PDPM components (NTA and nursing). The 1998 reopening of the comment period for the interim final rule (63 FR 65561, November 27, 1998) states that NTA costs comprise 43.4 percent of the current nursing component of the urban federal base rate, and the remaining 56.6 percent accounts for nursing and social services salary costs. These percentages for the nursing component of the federal base rate for rural facilities are 42.7 percent and 57.3 percent, respectively (63 FR 65561). Therefore, we proposed to assign 43 percent of the current nursing component of the federal base rates to the new NTA component of the federal base rates and assign the remaining 57 percent to the new nursing component of the federal base rates to reflect what the base rates would have been for these components if they had been separately established in 1998.
As discussed in the proposed rule (83 FR 21040), we verified the 1998 calculation of the percentages of the nursing component federal base rates that correspond to NTA costs by developing a measure of NTA costs per day for urban and rural facilities. We used the same data (that is, cost information from 1995 cost reports) and followed the same methodology described above to develop measures of PT, OT, and SLP costs per day and total therapy costs per day. The measure of NTA costs per day produced by this analysis was $47.70 for urban facilities and $47.30 for rural facilities. The original 1998 federal base rates for the nursing component, which relied on a similar methodology, were $109.48 for urban facilities and $104.88 for rural facilities. Therefore, our measure of NTA costs in urban facilities was equivalent to 43.6 percent of the urban 1998 federal nursing base rate, and our measure of NTA costs in rural facilities was equivalent to 45.1 percent of the rural 1998 federal nursing base rate. These results are similar to the estimates published in the 1998 reopening of the comment period for the interim final rule (63 FR 65561, November 27, 1998), which we stated we believe supports the validity of the 43 percent figure stated above.
For illustration purposes, Tables 12 and 13 set forth what we stated the unadjusted federal per diem rates would be for each of the case-mix adjusted components if we were to apply the proposed PDPM to the FY 2019 base rates given in Tables 4 and 5. These were derived by dividing the FY 2019 SNF PPS base rates according to the percentages described above. Tables 12 and 13 also show what the unadjusted federal per diem rates for the non-case-mix component would be, which are not affected by the change in case-mix methodology from RUG-IV to PDPM. We used these unadjusted federal per diem rates in calculating the impact analysis discussed in section V.J. of the proposed rule.
We invited comments on the proposed data sources and proposed methodology for calculating the unadjusted federal per diem rates that would be used in conjunction with the proposed PDPM effective October 1, 2019.
Commenters submitted the following comments related to the proposed rule's discussion of the Methodology Used for the Calculation of Federal Base Payment Rate Components. A discussion of these comments, along with our responses, appears below.
Additionally, in setting component base rates under PDPM, we sought to replicate the methodology used to estimate the SNF PPS original base rates in 1998 as closely as possible. This is consistent with the requirements of section 1888(e)(4) of the Act, which requires that SNF PPS per diem federal payment rates be based on FY 1995 costs reports. Therefore, to ensure that the PDPM base rates resembled as closely as possible what they would have been had these components been established in 1998, we used FY 1995 cost reports to determine the share of therapy costs accounted for by PT, OT, and SLP. As described in the proposed rule (83 FR 21038 through 21039) and in section 3.10 of the SNF PDPM technical report, we then used the percentage of costs associated with each of these disciplines to calculate the corresponding base rates for the PT, OT, and SLP components under PDPM.
Finally, as further discussed in section 3.11 of the SNF PDPM technical report, we adjusted CMIs for each of the five case-mix-adjusted components of PDPM to ensure budget neutrality between RUG-IV and PDPM. In doing so, we applied a multiplier to CMIs for all five case-mix-adjusted PDPM payment components so that total estimated payments under PDPM are budget neutral relative to RUG-IV. This procedure effectively distributes resources that are currently associated with the “therapy non-case-mix” component of RUG-IV across all five case-mix components of PDPM. We acknowledge that the proposed rule inadvertently stated that the resources associated with the therapy non-case mix component were distributed across only the three PDPM case-mix therapy components. Thus, we are clarifying that, while we did eliminate the therapy non-case mix component from the model, we redistributed resources associated with this component across the five PDPM case-mix components as described in section 3.11 of the PDPM technical report.
Accordingly, after considering the comments received, for the reasons specified in the FY 2019 SNF PPS proposed rule and in this final rule, we are finalizing, effective October 1, 2019, our proposals related to the calculation of the federal base payment rate components, as described in this section, with the following clarification. As discussed above, we are clarifying that, while we did eliminate the therapy non-case mix component from the model, we redistributed resources associated with this component across the five PDPM case-mix components as described in the PDPM technical report.
In section III.B. of the proposed rule, we described the process used to update the federal per diem rates each year. Additionally, as discussed in section III.B.4 of the proposed rule, SNF PPS rates are adjusted for geographic differences in wages using the most recent hospital wage index data. Under PDPM, we proposed to continue to update the federal base payment rates and adjust for geographic differences in wages following the current methodology used for such updates and wage index adjustments under the SNF PPS (83 FR 21040). Specifically, we proposed to continue the practice of using the SNF market basket, adjusted as described in section III.B. of the proposed rule to update the federal base payment rates and to adjust for geographic differences in wages as described in section III.B.4. of the proposed rule.
We received comments on the proposed methodology for updating the federal base payment rates and adjusting the per diem rates for geographic differences in wages under the PDPM. Those comments, and our responses, appear below.
Accordingly, after considering the comments received, for the reasons specified in the FY 2019 SNF PPS proposed rule (83 FR 21040) and discussed in this section, we are finalizing our proposal, without modification, for updating the federal base payment rates and for adjusting the per diem rates for geographic differences in wages under the PDPM, effective October 1, 2019.
Section 1888(e)(4)(G)(i) of the Act requires that the Secretary provide an appropriate adjustment to account for case mix and that such an adjustment shall be based on a resident classification system that accounts for the relative resource utilization of different patient types. The current case-mix classification system uses a combination of resident characteristics and service intensity metrics (for example, therapy minutes) to assign residents to one of 66 RUGs, each of which corresponds to a therapy CMI and a nursing CMI, which are indicative of the relative cost to a SNF of treating residents within that classification category. However, as noted in section V.A. of the proposed rule, incorporating service-based metrics into the payment system can incentivize the provision of services based on a facility's financial considerations rather than resident needs. To better ensure that resident care decisions appropriately reflect each resident's actual care needs, we stated in the proposed rule (83 FR 21040) that we believe it is important to remove, to the extent possible, service-based metrics from the SNF PPS and derive payment from verifiable resident characteristics that are patient, and not facility, centered. To that end, as we stated in the proposed rule, the proposed PDPM was developed to be a payment model which derives payment classifications almost exclusively from verifiable resident characteristics.
Additionally, the current RUG-IV case-mix classification system reduces the varied needs and characteristics of a resident into a single RUG-IV group that is used for payment. As of FY 2017, of the 66 possible RUG classifications, over 90 percent of covered SNF PPS days are billed using one of the 23 Rehabilitation RUGs, with over 60 percent of covered SNF PPS days billed using one of the three Ultra-High Rehabilitation RUGs. As we stated in the proposed rule (83 FR 21040), the implication of this pattern is that more than half of the days billed under the SNF PPS effectively utilize only a resident's therapy minutes and Activities of Daily Living (ADL) score to determine the appropriate payment for all aspects of a resident's care. Both of these metrics, more notably a resident's therapy minutes, may not derive so much from the resident's own characteristics, but rather, from the type and amount of care the SNF decides to provide to the resident. We stated that even assuming that the facility takes the resident's needs and unique characteristics into account in making these service decisions, the focus of payment remains centered, to a potentially great extent, on the facility's own decision making and not on the resident's needs.
We explained in the proposed rule (83 FR 21041) that while the RUG-IV model
To understand, research, and analyze the costs of providing Part A services to SNF residents, we utilized a variety of data sources in the course of research. In the proposed rule (83 FR 21041) and in this section, we discuss these sources and how they were used in the SNF PMR in developing the proposed PDPM. A more thorough discussion of the data sources used during the SNF PMR is available in section 3.1. of the SNF PDPM technical report (available at
Beneficiary enrollment and demographic information was extracted from the CMS enrollment database (EDB) and Common Medicare Environment (CME). Beneficiaries' Medicare enrollment was used to apply restrictions to create a study population for analysis. For example, beneficiaries were required to have continuous Medicare Part A enrollment during a SNF stay. Demographic characteristics (for example, age) were incorporated as being predictive of resource use. Furthermore, enrollment and demographic information from these data sources were used to assess the impact of the proposed PDPM on subpopulations of interest. In particular, the EDB and CME include indicators for potentially vulnerable subpopulations, such as those dually-enrolled in Medicaid and Medicare.
Medicare Parts A and B claims from the CMS Common Working File (CWF) were used to conduct claims analyses as part of the SNF PMR. SNF claims (CMS-1450 form, OMB control number 0938-0997), including type of bill (TOB) 21x (SNF Inpatient Part A) and 18x (hospital swing bed), were used to identify Medicare Part A stays paid under the SNF PPS. Part A stays were constructed by linking claims that share the same beneficiary, facility CMS Certification Number (CCN), and admission date. Stays created from SNF claims were linked to other claims data and assessment data via beneficiary identifiers.
Acute care hospital stays that qualified the beneficiary for the SNF benefit were identified using Medicare inpatient hospital claims. The dates of the qualifying hospital stay listed in the span codes of the SNF claim were used to connect inpatient claims with those dates listed as the admission and discharge dates. Although there are exceptions, the claims from the preceding inpatient hospitalization commonly contain clinical and service information relevant to the care administered during a SNF stay. Components of this information were used in the regression models predicting therapy and NTA costs and to better understand patterns of post-acute care (PAC) referrals for patients requiring SNF services. Additionally, the most recent hospital stay was matched to the SNF stay, which often (though not always) was the same as the preceding inpatient hospitalization, and used in the regression models.
Other Medicare claims, including outpatient hospital, physician, home health, hospice, durable medical equipment, and drug prescriptions, were incorporated, as necessary, into the analysis in one of three ways: (1) To verify information found on assessments or on SNF or inpatient claims; (2) to provide additional resident characteristics to test outside of those found in assessment and SNF and inpatient claims data; and (3) to stratify modeling results to identify effects of the system on beneficiary subpopulations. These claims were linked to SNF claims using beneficiary identifiers.
Minimum Data Set (MDS) assessments were the primary source of resident characteristic information used to explain resource utilization in the SNF setting. The data repositories include MDS assessments submitted by SNFs and swing-bed hospitals. MDS version 2.0 assessments were submitted until October 2010, at which point MDS version 3.0 assessments began. MDS data were extracted from the Quality Improvement Evaluation System (QIES). MDS assessments were then matched to SNF claims data using the beneficiary identifier, assessment indicator, assessment date, and Resource Utilization Group (RUG).
Facility characteristics, while not considered as explanatory variables when modeling service use, were used for impact analyses. By incorporating this facility-level information, we could identify any disproportionate effects of the proposed case-mix classification system on different types of facilities.
Facility-level characteristics were taken from the Certification and Survey Provider Enhanced Reports (CASPER). From CASPER, we draw facility-level characteristics such as ownership, location, facility size, and facility type. CASPER data were supplemented with information from publicly available data sources. The principal data sources that are publicly available include the Medicare Cost Reports (Form 2540-10, 2540-96, and 2540-92) extracted from the Healthcare Cost Report Information System (HCRIS) files, Provider-Specific Files (PSF), Provider of Service files (POS), and Nursing Home Compare (NHC). These data sources have information on facility costs, payment, and characteristics that directly affect PPS calculations.
We received comments from stakeholders regarding the data used to develop PDPM, though we address these comments later in this section in relation to the specific PDPM component to which the comments were addressed.
As noted above, section 1888(e)(4)(G)(i) of the Act requires that the Secretary provide for an appropriate adjustment to account for case mix and that such an adjustment shall be based on a resident classification system that accounts for the relative resource utilization of different patient types. As we stated in the proposed rule (83 FR 21040), the proposed PDPM was developed to be a payment model which derives almost exclusively from resident characteristics. We stated that the proposed PDPM would separately identify and adjust five different case-mix components for the varied needs and characteristics of a resident's care
We stated in the proposed rule (83 FR 21041 through 21042) that, as with any case-mix classification system based on resident characteristics, the proposed predictors that would be part of case-mix classification under PDPM are those which our analysis identified as associated with variation in costs for the given case-mix component. We explained that the proposed federal per diem rates discussed above serve as “base rates” specifically because they set the basic average cost of treating a typical SNF resident. Based on the presence of certain needs or characteristics, caring for certain residents may cost more or less than that average cost. We explained that a case-mix system identifies certain aspects of a resident or of a resident's care which, when present, lead to average costs for that group being higher or lower than the average cost of treating a typical SNF resident. For example, if we found that therapy costs were the same for two residents regardless of having a particular condition, then that condition will not be relevant in predicting increases in therapy costs. If, however, we found that, holding all else constant, the presence of a given condition was correlated with an increase in therapy costs for residents with that condition over those without that condition, then this could mean that this condition is indicative, or predictive, of increased costs relative to the average cost of treating SNF residents generally.
In the subsections that follow, we describe each of the five case-mix adjusted components under the proposed PDPM and the basis for each of the predictors that we stated would be used within the PDPM to classify residents for payment purposes.
As we stated in the proposed rule (83 FR 21042), a fundamental aspect of the proposed PDPM is to use resident characteristics to predict the costs of furnishing similarly situated residents with SNF care. Costs derived from the charges on claims and cost-to-charge ratios (CCRs) on facility cost reports were used as the measure of resource use to develop the proposed PDPM. We explained that costs better reflect differences in the relative resource use of residents as opposed to charges, which partly reflect decisions made by providers about how much to charge payers for certain services. We further explained that costs derived from charges are reflective of therapy utilization as they are correlated to the therapy minutes recorded for each therapy discipline. Under the current RUG-IV case-mix model, therapy minutes for all three therapy disciplines (PT, OT, SLP) are added together to determine the appropriate case-mix classification for the resident. However, as shown in section 3.3.1. of the SNF PDPM technical report (available at
In contrast, we stated in the proposed rule (83 FR 21042) that the correlation coefficient between PT and OT costs per day was high (0.62). Additionally, regression analyses found that predictors of high PT costs per day were also predictive of high OT costs per day. For example, the analyses found that late-loss ADLs are strong predictors of both PT and OT costs per day. We then used a range of resident characteristics to predict PT and OT costs per day separately and we found that the coefficients in both models followed similar patterns. Finally, we noted that resident characteristics were found to be better predictors of the sum of PT and OT costs per day than for either PT or OT costs separately. These analyses used a variety of items from the MDS as independent variables and used PT, OT, and SLP costs per day as dependent variables. In the proposed rule, we referred readers to section 3.3.1. of the SNF PMR technical report that accompanied the ANPRM available at
Given the results of this analytic work, as well as feedback from multiple stakeholders, we proposed three separate case-mix adjusted components, one corresponding to each therapy discipline: PT, OT, and SLP. In the original RCS-I model presented in the ANPRM, we stated that we were considering addressing PT and OT services through a single component, given the strong correlation between PT and OT costs and our finding that very similar predictors explained variation in the utilization of both therapy disciplines. However, as we explained in the proposed rule (83 FR 21042), commenters on the ANPRM stated that having a single combined PT and OT component could encourage providers to inappropriately substitute PT for OT and vice versa. We stated that this belief comports with feedback received from professional organizations and other stakeholders during technical expert panels (TEPs). The TEP commenters stated that PT and OT services should be addressed via separate components given the different aims of the two therapy disciplines and differences in the clinical characteristics of the resident subpopulations for which PT or OT services are warranted. For example, clinicians consulted during development of PDPM advised that personal hygiene, dressing, and upper extremity motion may bear a closer clinical relationship to OT utilization, while lower extremity motion may be more closely related to PT utilization. We stated in the proposed rule that while we do not believe that RCS-I, which included two separate components for PT/OT and SLP, contained stronger incentives for substitution across therapy disciplines compared to RUG-IV, which reimburses all three therapy disciplines through a single therapy component, we concur with the TEP commenters that PT and OT have different aims and that there are clinically relevant differences between residents who could benefit from PT, residents who could benefit from OT, and residents who could benefit from both disciplines. For the foregoing reasons, we decided to separate the combined PT/OT component presented in the ANPRM into two separate case-mix adjusted components in the proposed PDPM. As we stated in the proposed rule, because of the strong correlation between the dependent variables used for both components and the similarity in predictors, we decided to maintain the same case-mix classification model for
After delineating the three separate case-mix adjusted therapy components, we continued our analysis, as described in the proposed rule (83 FR 21043), by identifying resident characteristics that were best predictive of PT and OT costs per day. To accomplish this, we conducted cost regressions with a host of variables from the MDS assessment, the prior inpatient claims, and the SNF claims that were believed to be potentially predictive of relative increases in PT and OT costs. As we stated in the proposed rule, the variables were selected with the goal of being as inclusive as possible with respect to characteristics related to the SNF stay and the prior inpatient stay. The selection also incorporated clinical input. We explained that these initial costs regressions were exploratory and meant to identify a broad set of resident characteristics that are predictive of PT and OT resource utilization. The results were used to inform which variables should be investigated further and ultimately included in the payment system. A table of all of the variables considered as part of this analysis appears in the appendix of the SNF PMR technical report that accompanied the ANPRM available at
Under the RUG-IV case-mix model, residents are first categorized based on being a rehabilitation resident or a non-rehabilitation resident, then categorized further based on additional aspects of the resident's care. As explained in the proposed rule (83 FR 21043), under the proposed PDPM, for the purposes of determining the resident's PT and OT groups and, as will be discussed below, the resident's SLP group, the resident would first be categorized based on the clinical reasons for the resident's SNF stay. We stated that empirical analyses demonstrated that the clinical basis for the resident's stay (that is, the primary reason the resident is in the SNF) is a strong predictor of therapy costs. For example, we explained that all of the clinical categories (described below) developed to characterize the primary reason for a SNF stay (except the clinical category used as the reference group) were found to be statistically significant predictors of therapy costs per day. More detail on these analyses can be found in section 3.4.1. of the SNF PMR technical report that accompanied the ANPRM (available at
We proposed to categorize a resident into a PDPM clinical category using item I8000 on the MDS 3.0. We stated in the proposed rule (83 FR 21043) that providers would use the first line in item I8000 to report the ICD-10-CM code that represents the primary reason for the resident's Part A SNF stay. We further stated that this code would be mapped to one of the ten clinical categories provided in Table 14 of the proposed rule (set forth at Table 14 of this final rule). The mapping between ICD-10-CM codes and the ten clinical categories is available at
As discussed above, we proposed to categorize a resident into a PDPM clinical category for purposes of PT, OT, and SLP classification using the ICD-10-CM code in the first line of item I8000, and if applicable, the ICD-10 PCS code in the second line of item I8000. As an alternative to using item I8000 to classify a resident into a clinical category, we stated in the proposed rule (83 FR 21044) that we were considering using a resident's primary diagnosis as reflected in MDS item I0020 as the basis for assigning the resident to a clinical category, and were evaluating the categories provided in item I0020 to determine if there is sufficient overlap between the categories used in item I0020 and the proposed PDPM clinical categories provided in Table 14 that this item could serve as the basis for a resident's initial classification into a clinical category under PDPM. We stated that the MDS item I0020 would require facilities to select a primary diagnosis from a pre-populated list of primary diagnoses representing the most common types of beneficiaries treated in a SNF, while item I8000, if used to assign residents to clinical categories, would require facilities to code a specific ICD-10-CM code that corresponds to the primary reason for the resident's Part A SNF stay. As indicated above, we also proposed that providers would code a specific ICD-10-PCS code in the second line of item I8000 when surgical information from the prior inpatient stay is necessary to assign a resident to a clinical category. We explained that if we were to use item I0020 to categorize residents under PDPM, we would not require providers to record additional information on inpatient surgical procedures as we expect the primary diagnosis information provided through item I0020 to be adequate to appropriately assign a resident to a clinical category.
We invited comments on our proposal to categorize a resident into a PDPM clinical category using the ICD-10-CM code recorded in the first line of item I8000 on the MDS 3.0, and the ICD-10-PCS code recorded on the second line of item I8000 on the MDS 3.0. In addition, we solicited comments on the alternative of using item I0020 on the MDS 3.0, as discussed above, as the basis for resident classification into one of the ten clinical categories in Table 14.
Commenters submitted the following comments related to the proposed rule's discussion of the clinical category assignments under PDPM. A discussion of these comments, along with our responses, appears below.
With regard to the comment that CMS offer ICD-10 coding training for clinicians and other personnel, we do not believe it is the role of CMS to offer this type of professional training, as it is the responsibility of the provider to ensure that their staff is properly trained to perform these types of more general tasks that are not specific to a given payer or requirement. With regard to the comment that CMS provide case studies and other resources as part of an educational strategy, we appreciate this comment and will take it into consideration as we develop the educational materials for PDPM. In terms of the explicit instructions for how providers record diagnosis and procedure information, we do intend to provide such information in the MDS RAI manual.
With regard to the comment that we should require that providers employ credentialed medical record staff to ensure accurate coding, we agree that the emphasis on ICD-10 could cause changes in staffing at some providers. However, we do not believe it would be appropriate for CMS, in this instance, to specifically identify the type of staff that providers must employ to ensure accurate coding, as this is a decision best left to the provider. With regard to the potential consequences of ICD-10 coding errors on RAC audits, as under the current payment system, the information reported to CMS must be accurate. Inaccuracies in the data reported to CMS, or a failure to document the basis for such data, will necessitate the same types of administrative actions as occur today.
Finally, with regard to the question of whether the reporting of ICD-10 coding information constitutes a HIPAA transaction, we note that while some HIPAA Administrative Simplification requirements at 45 CFR part 162 require the use of ICD-10 codes, reporting ICD-10 codes does not in and of itself constitute a HIPAA transaction.
With regard to suggestions of using a checkbox for recording diagnosis information, we believe that the use of such checkboxes for recording diagnosis information may not provide sufficient granularity for CMS to monitor properly the effects of PDPM implementation or to accurately classify patients for payment purposes, nor provide enough information for the SNF in terms of care planning. Given the use of ICD-10 diagnosis coding in other Medicare payment systems and given efforts to align payment across multiple post-acute care payment systems, we believe that using the actual diagnosis code, rather than a checkbox for a category, will provide greater consistency between payment systems and would provide a smoother transition to the extent such payment systems are aligned further in the future.
With regard to the comment that CMS consider using item J2000 to report procedural information, we believe that while the actual ICD-10 code is important in the case of diagnosis coding, we agree with the commenter that the procedural information may be coded at a more aggregated level, as this information is only being used to augment the patient's classification rather than as the primary basis for the classification. However, we believe that item J2000 (which requires providers to report if the patient experienced a surgical procedure in the preceding 100 days) would not adequately link to the care being delivered in the SNF, potentially close to 100 days after the surgical event. To address this, consistent with this commenter's suggestion, and in response to other concerns about the complexity of the proposed methodology, we believe that it would be appropriate and sufficient to develop subitems for item J2000 that would allow providers to report, through a checkbox-style mechanism, if a surgical procedure occurred during the preceding hospital stay (as opposed to the previous 100 days, as is used for J2000), and then provide a series of procedural categories, related to the PDPM clinical categories, that providers could select using a checkbox style mechanism, that would allow the provider to report on the relevant procedural information (rather than recording the specific ICD-10-PCS code). We believe this is a substantial improvement to the procedure we proposed for recording surgical procedure information, as it reduces the burden and complexity of provider reporting on procedural information while maintaining payment accuracy and integrity. Moreover, similar to how PDPM utilizes the procedural information to augment the patient's clinical category classification, we believe that using a checkbox mechanism also augments care-planning by helping ensure that the procedural history information from the hospital is properly taken into account in determining the resident's care needs and care plan. Therefore, we are developing sub-items for item J2000, which will allow providers to report the patient's procedural information in a way that uses a checkbox mechanism, and this procedural information will be used in concert with the patient's diagnosis information, as was discussed above and in the FY 2019 SNF PPS proposed rule, to classify the patient into a clinical category. We will provide both the subitems under item J2000, and the instructions regarding their use, for this purpose in the RAI manual.
With regard to the comment related to multiple inpatient surgical procedures, we expect that the checkbox mechanism discussed above, which would include more aggregated procedural groupings, should address much of this possibility, as often times multiple procedures may be done of the same type. In the case of different types of procedures, providers should code or check-off all information supportable by the patient's medical record.
With regard to the comment that Z codes are not appropriate for traumatic fractures, as detailed in the ICD-10-CM Official Guidelines for Coding and Reporting, the aftercare codes cover situations when the initial treatment of a disease has been performed and the patient requires continued care during the healing or recovery phase, or for the long-term consequences of the disease. The aftercare Z codes should not be used if treatment is directed at a current, acute disease. Therefore, the aftercare Z codes should not be used for aftercare for traumatic fractures. For aftercare of a traumatic fracture, providers are instructed to assign the acute fracture code with the appropriate 7th character. We agree with the commenter and will update the PDPM mapping accordingly.
Accordingly, after considering the comments received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals discussed above relating to PT and OT case-mix classification under the PDPM, with the modification discussed below. As discussed above, rather than requiring providers to record the type of inpatient surgical procedure performed during the prior inpatient hospital stay by coding an ICD-10-PCS code in the second line of item I8000 as we proposed, we will instead require providers to select, as necessary, a surgical procedure category in a sub-item within Item J2000 which would identify the relevant surgical procedure that occurred during the patient's preceding hospital stay and which would augment the patient's PDPM clinical category.
Once we identified these clinical categories as being generally predictive of resource utilization in a SNF, we then undertook the necessary work to identify those categories predictive of PT and OT costs specifically. As we discussed in the proposed rule (83 FR 21044), we conducted additional regression analyses to determine if any of these categories predicted similar levels of PT and OT as other categories, which may provide a basis for combining categories. As a result of this analysis, for the RCS-I model presented in the ANPRM, we found that the ten inpatient clinical categories could be collapsed into five clinical categories, which predict varying degrees of PT and OT costs. However, as explained in the proposed rule, we received comments on the ANPRM regarding the number of possible case-mix group combinations under RCS-I, so we sought to try and reduce this number of possible case-mix group combinations by further simplifying the model. As part of that effort, we observed similar PT and OT resource utilization patterns in the clinical categories of Non-Orthopedic Surgery and Acute Neurologic and, therefore, proposed to collapse these categories for the purpose of PT and OT classification. Additionally, as reflected in the RCS-I model presented in the ANPRM, we proposed that under PDPM, the remaining clinical categories would be collapsed as follows: Acute infections, cancer, pulmonary, cardiovascular and coagulations, and medical management would be collapsed into one clinical category entitled “Medical Management” because their residents had similar PT and OT costs. Similarly, we proposed that orthopedic surgery (except major joint replacement or spinal surgery) and non-surgical orthopedic/musculoskeletal would be collapsed into a new “Other Orthopedic” category for equivalent reasons. Finally, the remaining category, Major Joint Replacement, showed a distinct PT and OT cost profile and, thus, we proposed to retain it as an independent category. More information on this analysis can be found in section 3.4.2. of the SNF PMR technical report that accompanied the ANPRM and in section 3.4.2. of the SNF PDPM technical report, both available at
We received several comments regarding the collapsed PT and OT clinical categories. These comments, along with our responses, appear below.
Accordingly, after considering the comments received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals without modification relating to the collapsed clinical categories for the PT and OT components.
As discussed previously in this section and in the proposed rule (83 FR 21044), regression analyses demonstrated that the resident's functional status is also predictive of PT and OT costs in addition to the resident's initial clinical categorization. In the RCS-I model discussed in the ANPRM, we presented a function score similar to the existing ADL score to measure functional abilities for the purposes of PT and OT payment. In response to the ANPRM, we received comments requesting that we consider replacing the functional items used to build the RCS-I function score with newer, IMPACT Act-compliant items from section GG. Therefore, we constructed, and proposed as discussed below, a new function score for PT and OT payment based on section GG functional items.
Under the RUG-IV case-mix system, a resident's ADL or function score is calculated based on a combination of self-performance and support items coded by SNFs in section G of the MDS 3.0 for four ADL areas: Transfers, eating, toileting, and bed mobility. These four areas are referred to as late-loss ADLs because they are typically the last functional abilities to be lost as a resident's function declines. Each ADL is assigned a score of up to four points, with a potential total score as high as 16 points. Under the proposed PDPM, we proposed that section G items would be replaced with functional items from section GG of the MDS 3.0 (Functional Abilities and Goals) as the basis for calculating the function score for resident classification used under PDPM. We explained that section GG offers standardized and more comprehensive measures of functional status and therapy needs. Additionally, we stated that the use of section GG items better aligns the payment model with other quality initiatives. SNFs have been collecting section GG data since October 2016 as part of the requirements for the IMPACT Act. We stated that given the advantages of section GG and of using a more comprehensive measure of functional abilities, we received numerous comments in response to the ANPRM requesting the incorporation of section GG items and of early ADLs items into the function score.
As explained in the proposed rule (83 FR 21045), multiple stakeholders commented on the ANPRM that late-loss items do not adequately reflect functional abilities on their own. These commenters stated that early-loss ADL items also capture essential clinical information on functional status. Therefore, we stated in the proposed rule that in building a new function score based on section GG items, we also investigated the incorporation of early-loss items. To explore the incorporation of section GG items, we evaluated each item's relationship with PT and OT costs. We ran individual regressions using each of the 12 section GG items assessed at admission to separately predict PT and OT costs per day. As explained in the proposed rule, the regression results showed that early-loss items are indeed strong predictors of PT and OT costs, with the exception of two wheeling items. Both wheeling items were excluded from the functional measure due to their weak predictive relationship with PT and OT costs. We observed high predictive ability among the remaining items. In total, we selected ten items for inclusion in the functional measure for the PT and OT components based on the results of the analysis. Thus, under the proposed functional measure for the PT and OT components, a resident's function would be measured using four late-loss ADL activities (bed mobility, transfer, eating, and toileting) and two early-loss ADL activities (oral hygiene and walking). Specifically, the proposed measure includes: Two bed mobility items, three transfer items, one eating item, one toileting item, one oral hygiene item, and two walking items that were all found to be highly predictive of PT and OT costs per day. A list of proposed section GG items that would be included in the functional measure for the PT and OT components was included in Table 18 of the proposed rule (and is shown in Table 18 of this final rule). Section 3.4.1. in the SNF PDPM technical report (available at
We explained in the proposed rule (83 FR 21045) that, similar to the RUG-IV ADL score, each of these ADL areas would be assigned a score of up to 4 points. However, in contrast to the RUG-IV ADL score, we stated that points were assigned to each response level to track functional independence rather than functional dependence. In other words, higher points are assigned to higher levels of independence. We stated that this approach is consistent with functional measures in other care settings, such as the IRF PPS. Further, under the RUG-IV model, if the SNF codes that the “activity did not occur” or “occurred only once,” these items are assigned the same point value as “independent.” However, as explained in the proposed rule, we observed that residents who were unable to complete an activity had similar PT and OT costs as dependent residents. Therefore, we stated that when the activity cannot be completed, the equivalent section GG responses (“Resident refused,” “Not applicable,” “Not attempted due to medical condition or safety concerns”) are grouped with “dependent” for the purpose of point assignment. For the two walking items, we proposed an additional response level to reflect residents who skip the walking assessment due to their inability to walk. We stated that we believe this is appropriate because this allows us to assess the functional abilities of residents who cannot walk and assign them a function score. We explained that without this modification, we could not calculate a function score for residents who cannot walk because they would not be assessed on the two walking items included in the function score. We further stated that residents who are coded as unable to walk receive the same score as dependent residents to match with clinical expectations. In Tables 16 and 17 of the proposed rule (set forth at Tables 16 and 17 in this final rule), we provided the proposed scoring algorithm for the PT and OT functional measure.
We explained in the proposed rule (83 FR 21046) that, unlike section G, section GG measures functional areas with more than one item. We noted that this results in substantial overlap between the two bed mobility items, the three transfer items, and the two walking items. Because of this overlap, we stated that a simple sum of all scores for each item may inappropriately overweight functional areas measured by multiple items. Therefore, to adjust for this overlap, we proposed to calculate an average score for these related items. That is, we would average the scores for the two bed mobility items, the three transfer items, and the two walking items. We stated that the average bed mobility, transfer, and walking scores would then be summed with the scores for eating, oral hygiene, and toileting hygiene, resulting in equal weighting of the six activities. This proposed scoring algorithm produces a function score that ranges from 0 to 24. In section 3.4.1. of the SNF PDPM technical report (available at
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposals relating to the use of the section GG items as the basis for determining the patient's PDPM functional score and for classifying the patient under PDPM PT and OT components, with modifications. As discussed above, in response to comments, all missing values for section GG assessment items will receive zero points as a function score. Similarly, the function score will incorporate a new response “10. Not attempted due to environmental limitations” and we will assign it a point value of zero. Furthermore, consistent with a commenter's suggestion, we will adopt MDS item GG0170I1 (Walk 10 feet) as a substitute for retired item GG0170H1 (Does the resident walk), and we will use responses 07: “resident refused,” 09: “not applicable,” 10: “not attempted due to environmental limitations,” or 88: “not attempted due to medical condition or safety concerns” from MDS item GG0170I1 to identify residents who cannot walk.
Under the RCS-I case-mix model presented in the ANPRM, we used cognitive status to classify residents under the PT and OT components in addition to the primary reason for SNF care and functional ability. As explained in the proposed rule (83 FR 21046) and in greater detail below, after publication of the ANPRM, we removed cognitive status as a determinant of resident classification for the PT and OT components. Still, although cognitive status was not ultimately selected as a determinant of PT and OT classification, it was considered as a possible element in developing the proposed resident groups for these components via the Classification and Regression Trees (CART) algorithm described in greater detail in the proposed rule and below. Because we included cognitive status as an independent variable in the CART analysis used to develop case-mix groups for PT and OT, we stated that we believed it was appropriate to discuss construction of the proposed new cognitive measure here even though it was not ultimately selected as a determinant of payment for PT and OT. Thus, we discussed construction of the instrument used to measure cognitive status under the proposed PDPM in the section addressing case-mix classification under the PT and OT components, rather than introducing it when discussing SLP classification, in which we proposed cognitive status as a determinant of resident classification. Under the current SNF PPS, cognitive status is used to classify a small portion of residents that fall into the Behavioral Symptoms and Cognitive Performance RUG-IV category. For all other residents, cognitive status is not used in determining the appropriate payment for a resident's care. However, as we explained in the proposed rule, industry representatives and clinicians at multiple TEPs suggested that a resident's cognitive status can have a significant impact on a resident's PT and OT costs. Based on this feedback, we explored a resident's cognitive status as a predictor of PT and OT costs.
Under the RUG-IV model, cognitive status is assessed using the Brief Interview for Mental Status (BIMS) on the MDS 3.0. The BIMS is based on three items: “repetition of three words,” “temporal orientation,” and “recall.” These items are summed to produce the BIMS summary score. The BIMS score ranges from 0 to 15, with 0 assigned to residents with the worst cognitive performance and 15 assigned to residents with the highest performance. Residents with a BIMS score less than or equal to 9 classify for the Behavioral Symptoms and Cognitive Performance category. Residents with a summary score greater than 9 but not 99 (resident interview was not successful) are considered cognitively intact for the purpose of classification under RUG-IV.
As we explained in the proposed rule (83 FR 21046), in approximately 15 percent of 5-day MDS assessments, the BIMS is not completed: in 12 percent of cases the interview is not attempted, and for 3 percent of cases the interview is attempted but cannot be completed. The MDS directs assessors to skip the BIMS if the resident is rarely or never understood (this is scored as “skipped”). In these cases, the MDS requires assessors to complete the Staff Assessment for Mental Status (items C0700 through C1000). The Cognitive Performance Scale (CPS) is then used to assess cognitive function based on the Staff Assessment for Mental Status and other MDS items (“Comatose” (B0100), “Makes Self Understood” (B0700), and the self-performance items of the four late-loss ADLs). The Staff Assessment for Mental Status consists of four items: “Short-term Memory OK,” “Long-term Memory OK,” “Memory/Recall Ability,” and “Cognitive Skills for Daily Decision Making.” Only “Short-term Memory OK” and “Cognitive Skills for Daily Decision Making” are currently used for payment. In MDS 2.0, the CPS was used as the sole measure of cognitive status. A resident was assigned a CPS score from 0 to 6 based on the Staff Assessment for Mental Status and other MDS items, with 0 indicating the resident was cognitively intact and 6 indicating the highest level of cognitive impairment. In addition to the items on the Staff Assessment for Mental Status, MDS items “Comatose” (B0100), “Makes Self Understood” (B0700), and the self-performance items of the four late-loss ADLs factored into the CPS score. Any score of 3 or above was considered cognitively impaired. The CPS on the current version of the MDS (3.0) functions very similarly. Instead of assigning a score to each resident, a resident is determined to be cognitively impaired if he or she meets the criteria to receive a score of 3 or above on the CPS, based on the MDS items mentioned above. In other words, whereas the MDS 2.0 assigned a CPS
We stated in the proposed rule (83 FR 21047) that given that the 15 percent of residents who are not assessed on the BIMS must be assessed using a different scale that relies on a different set of MDS items, there is currently no single measure of cognitive status that allows comparison across all residents. To address this issue, Thomas et al., in a 2015 paper, proposed use of a new cognitive measure, the Cognitive Function Scale (CFS), which combines scores from the BIMS and CPS into one scale that can be used to compare cognitive function across all residents (Thomas KS, Dosa D, Wysocki A, Mor V;
As explained in the proposed rule (83 FR 21047), once each of these variables—clinical reasons for the SNF stay, the resident's functional status, and the presence of a cognitive impairment—was identified, we then used a statistical regression technique called Classification and Regression Trees (CART) to explore the most appropriate splits in PT and OT case-mix groups using these three variables. In other words, CART was used to investigate how many PT and OT case-mix groups should exist under the proposed PDPM and what types of residents or score ranges should be combined to form each of those PT and OT case-mix groups. CART is a non-parametric decision tree learning technique that produces either classification or regression trees, depending on whether the dependent variable is categorical or numeric, respectively. We stated that using the CART technique to create payment groups is advantageous because it is resistant to both outliers and irrelevant parameters. The CART algorithm has been used to create payment groups in other Medicare settings. For example, it was used to determine Case Mix Groups (CMGs) splits within rehabilitation impairment groups (RICs) when the inpatient rehabilitation facility (IRF) PPS was developed. This methodology is more thoroughly explained in section 3.4.2. of the SNF PDPM technical report (available at
As explained in the proposed rule (83 FR 21047), we used CART to develop splits within the four collapsed clinical categories shown in Table 15 of the proposed rule (set forth in Table 15 of
Based on the CART results and the administrative decisions described above, we proposed 16 case-mix groups to classify residents for PT and OT payment. We noted in the proposed rule (83 FR 21048) that this represents a marked reduction in the number of case-mix groups for PT and OT classification under the RCS-I model discussed in the ANPRM. As discussed in the proposed rule and throughout the sections above, after publication of the ANPRM, we received feedback from stakeholders that the RCS-I payment model was overly complex. In particular, commenters expressed concern about the relatively large number of possible combinations of case-mix groups. Based on this feedback, we sought to reduce the number of resident groups in the PT and OT components. First, as discussed in the proposed rule and in this final rule, because we observed similar PT and OT resource utilization patterns in the clinical categories of Non-Orthopedic Surgery and Acute Neurologic, we decided to collapse these categories for the purpose of PT and OT classification. In addition, as discussed in the proposed rule and in this final rule, we replaced the section G-based functional measure from RCS-I with a new functional measure based on section GG items. We found that the inclusion of the section GG-based functional measure in the CART algorithm resulted in case-mix groups in which cognitive function played a less important role in classification. Based on these results, we determined that we could remove cognitive function as a determinant of PT and OT classification without a notable loss in the predictive ability of the payment model, as discussed above. We also consulted with clinicians who advised CMS during development of PDPM, who confirmed the appropriateness of this decision. We stated in the proposed rule that the decisions to collapse Non-Orthopedic Surgery and Acute Neurologic into one clinical category and remove cognitive status resulted in a large reduction in the number of PT and OT case-mix groups, from the 30 in RCS-I to the 16 in the proposed PDPM provided in Table 21 of the proposed rule (and set forth in Table 21 of this final rule). We provided the criteria for each of these groups along with its CMI for both the PT and OT components in Table 21. As shown in Table 21, two factors would be used to classify each resident for PT and OT payment: Clinical category and function score. Each case-mix group corresponds to one clinical category and one function score range. We proposed classifying each SNF resident into one of the 16 groups shown in Table 21 based on these two factors.
To help ensure that payment reflects the average relative resource use at the per diem level, we stated in the proposed rule (83 FR 21048) that CMIs would be set to reflect relative case-mix related differences in costs across groups. We stated that this method helps ensure that the share of payment for each case-mix group would be equal to its share of total costs of the component. We further explained that CMIs for the PT and OT components were calculated based on two factors. One factor was the average per diem costs of a case-mix group relative to the population average. The other factor was the average variable per diem adjustment factor of the group relative to the population average. In this calculation, average per diem costs equaled total PT or OT costs in the group divided by number of utilization days in the group. Similarly, the average variable per diem adjustment factor equaled the sum of variable per diem adjustment factors corresponding to a given component (PT or OT) for all utilization days in the group divided by the number of utilization days in the group. We calculated CMIs such that they equal the ratio of relative average per diem costs for a group to the relative average variable per diem adjustment factor for the group. In this calculation, relative average per diem costs and the relative average variable per diem adjustment factor were weighted by length of stay to account for the different length of stay distributions across case-mix groups (as further discussed in section 3.11.1. of the SNF PDPM technical report, available at
After adjusting the CMIs to align the distribution of resources across payment components with the statutory base rates, a parity adjustment was then applied by multiplying the CMIs by the ratio of case-mix-related payments in RUG-IV over estimated case-mix-related payments in PDPM, as further discussed in section V.J. of the proposed rule. More information on the variable per diem adjustment factors is discussed in section V.D.4. of the proposed rule. The full methodology used to develop CMIs is presented in section 3.11. of the SNF PDPM technical report (available at
We stated in the proposed rule that, under the proposed PDPM, all residents would be classified into one and only one of these 16 PT and OT case-mix groups for each of the two components. We explained that as opposed to the RUG-IV system that determines therapy payments based only on the amount of therapy provided, these groups classify residents based on the two resident characteristics shown to be most predictive of PT and OT utilization: Clinical category and function score. Thus, we believe that the PT and OT case-mix groups better reflect relative resource use of clinically relevant resident subpopulations, and therefore, provide for more appropriate payment under the SNF PPS.
Commenters submitted the following additional comments related to the proposed rule's discussion of the Physical and Occupational Therapy Case-Mix Classification. A discussion of these comments, along with our responses, appears below.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in the final rule, we are finalizing the proposed PT and OT components under the PDPM and our proposals relating to the methodology for classifying residents under the PT and OT components, effective October 1, 2019, with the modifications discussed in this section. As discussed above, in response to comments, rather than requiring providers to record the type of inpatient surgical procedure performed during the prior inpatient hospital stay by coding an ICD-10-PCS code in the second line of item I8000 as we proposed, we will instead require providers to select, as necessary, a surgical procedure category in a sub-item within Item J2000 which would identify the relevant surgical procedure that occurred during the patient's preceding hospital stay and which would augment the patient's PDPM clinical category. For purposes of calculating the function score, all missing values for section GG assessment items will receive zero points. Similarly, the function score will incorporate a new response “10. Not attempted due to environmental limitations” and we will assign it a point value of zero. Furthermore, consistent with a commenter's suggestion, we will adopt MDS item GG0170I1 (Walk 10 feet) as a substitute for retired item GG0170H1 (Does the resident walk), and we will use responses 07: “resident refused,” 09: “not applicable,” 10: “not attempted due to environmental limitations,” or 88: “not attempted due to medical condition or safety concerns” from MDS item GG0170I1 to identify residents who cannot walk.
As discussed above and in the proposed rule (83 FR 21049), many of the resident characteristics that we found to be predictive of increased PT and OT costs were predictive of lower SLP costs. We stated that as a result of this inverse relationship, using the same set of predictors to case-mix adjust all three therapy components would obscure important differences in variables predicting variation in costs across therapy disciplines and make any model that attempts to predict total therapy costs inherently less accurate. Therefore, we stated that we believe it is appropriate to have a separately adjusted case-mix SLP component that is specifically designed to predict relative differences in SLP costs. As discussed in the proposed rule and in the prior section of this final rule, costs derived from the charges on claims and CCRs on facility cost reports were used as the measure of resource use to develop an alternative payment model. Costs are reflective of therapy utilization as they are correlated to therapy minutes recorded for each therapy discipline.
Following the same methodology we used to identify predictors of PT and OT costs, we explained in the proposed rule that our project team conducted cost regressions with a host of variables from the MDS assessment, prior inpatient claims, and SNF claims that were identified as likely to be predictive of relative increases in SLP costs. The variables were selected with the goal of being as inclusive of the measures recorded on the MDS assessment as possible and also included diagnostic information from the prior inpatient stay. The selection process also incorporated clinical input from TEP panelists, the contractor's clinical staff, and CMS clinical staff. We stated that
As we stated in the proposed rule (83 FR 21049), based on these cost regressions, we identified a set of three categories of predictors relevant in predicting relative differences in SLP costs: Clinical reasons for the SNF stay, presence of a swallowing disorder or mechanically-altered diet, and the presence of an SLP-related comorbidity or cognitive impairment. We explained that a model using these predictors to predict SLP costs per day accounted for 14.5 percent of the variation in SLP costs per day, while a very extensive model using 1,016 resident characteristics only predicted 19.3 percent of the variation. We stated that this shows that these predictors alone explain a large share of the variation in SLP costs per day that can be explained with resident characteristics.
As with the proposed PT and OT components, we began with the set of clinical categories identified in Table 14 of the proposed rule (set forth in Table 14 of this final rule) meant to capture general differences in resident resource utilization and ran cost regressions to determine which categories may be predictive of generally higher relative SLP costs. Through this analysis, we found that one clinical category, the Acute Neurologic group, was particularly predictive of increased SLP costs. More detail on this investigation can be found in section 3.5.2. of the SNF PMR technical report that accompanied the ANPRM, available at
In addition to the clinical reason for the SNF stay, based on cost regressions and feedback from TEP panelists, we stated in the proposed rule (83 FR 21050) that we also identified the presence of a swallowing disorder or a mechanically-altered diet (which refers to food that has been altered to make it easier for the resident to chew and swallow to address a specific resident need) as a predictor of relative increases in SLP costs. First, we stated that residents who exhibited the signs and symptoms of a swallowing disorder, as identified using K0100Z on the MDS 3.0, demonstrated significantly higher SLP costs than those who did not exhibit such signs and symptoms. Therefore, we considered including the presence of a swallowing disorder as a component in predicting SLP costs. However, when this information was presented during the October 2016 TEP, stakeholders indicated that the signs and symptoms of a swallowing disorder may not be as readily observed when a resident is on a mechanically-altered diet and requested that we also consider evaluating the presence of a mechanically-altered diet, as determined by item K0510C2 on the MDS 3.0, as an additional predictor of increased SLP costs. As we further explained in the proposed rule, our project team conducted this analysis and found that there was an associated increase in SLP costs when a mechanically-altered diet was present. Moreover, we stated that this analysis revealed that while SLP costs may increase when either a swallowing disorder or mechanically-altered diet is present, resident SLP costs increased even more when both of these items were present. More detail on this investigation and these analyses can be found in section 3.5.3. of the SNF PDPM technical report, available at
As a final aspect of the proposed SLP component case-mix adjustment, we explored how SLP costs vary according to cognitive status and the presence of an SLP-related comorbidity. As we explained in the proposed rule, we observed that SLP costs were notably higher for residents who had a mild to severe cognitive impairment as defined by the PDPM cognitive measure methodology described in Table 20 of the proposed rule (set forth in Table 20 of this final rule) or who had an SLP-related comorbidity present. We stated that for each condition or service included as an SLP-related comorbidity, the presence of the condition or service was associated with at least a 43 percent increase in average SLP costs per day. The presence of a mild to severe cognitive impairment was associated with at least a 100 percent increase in average SLP costs per day. Similar to the analysis conducted in relation to the PT and OT components, the project team ran cost regressions on a broad list of possible conditions. As we stated in the proposed rule (83 FR 21050), based on that analysis, and in consultation with stakeholders during our TEPs and clinicians, we identified the conditions listed in Table 22 of the proposed rule (set forth in Table 22 of this final rule) as SLP-related comorbidities which we believe best predict relative differences in SLP costs. As discussed in the proposed rule, we used diagnosis codes on the most recent inpatient claim and the first SNF claim, as well as MDS items on the 5-day assessment for each SNF stay to identify these diagnoses and found that residents with these conditions had much higher SLP costs per day. Further, we stated that rather than accounting for each SLP-related comorbidity separately, all conditions were combined into a single flag. If the resident has at least one SLP-related comorbidity, the combined flag is turned on. We explained in the proposed rule that we combined all SLP-related comorbidities into a single flag because we found that the predictive ability of including a combined SLP comorbidity flag is comparable to the predictive ability of including each SLP-related comorbidity as an individual predictor. Additionally, we stated that using a combined SLP-
Under the original RCS-I SLP component, a resident could be classified into one of 18 possible case-mix groups. Comments received in response to the ANPRM expressed concern over the complexity of the payment model due to the high number of possible combinations of case-mix groups. We stated in the proposed rule (83 FR 21051) that, to reduce the number of possible SLP case-mix groups, we simplified the consistent splits model selected for RCS-I. To accomplish this, we combined clinical category (Acute Neurologic or Non-Neurologic), cognitive impairment, and the presence of an SLP-related comorbidity into a single predictor due to the clinical relationship between acute neurologic conditions, cognition, and SLP comorbidities. We explained in the proposed rule that these three predictors are highly interrelated as acute neurologic conditions may often result in cognitive impairment or SLP-related comorbidities such as speech and language deficits. As we discussed in the proposed rule, using this combined variable along with presence of a swallowing disorder or mechanically-altered diet results in 12 groups. We compared the predictive ability of the simplified model with more complex classification options, including the original RCS-I SLP model. We explained that regression results showed that the reduction in case-mix groups by collapsing independent variables had little to no effect on payment accuracy. Specifically, we noted that the proposed PDPM SLP model has an R-squared value almost identical to that of the original RCS-I SLP model, while reducing the number of resident groups from 18 to 12. Therefore, we determined that 12 case-mix groups would be necessary to classify residents adequately in terms of their SLP costs in a manner that captures sufficient variation in SLP costs without creating unnecessarily granular separations. More information on this analysis can be found in section 3.5.2. of the SNF PDPM technical report (available at
To help ensure that payment reflects the average relative resource use at the per diem level, we stated in the proposed rule (83 FR 21051) that CMIs would be set to reflect relative case-mix related differences in costs across groups. We stated that this method helps ensure that the share of payment for each case-mix group would be equal to its share of total costs of the component. We further explained that CMIs for the SLP component were calculated based on the average per diem costs of a case-mix group relative to the population average. Relative average differences in costs were weighted by length of stay to account for the different length of stay distributions across case-mix groups (as further discussed in section 3.11.1. of the SNF PDPM technical report, available at
As with the PT and OT components, we stated that all residents would be classified into one and only one of these 12 SLP case-mix groups under the PDPM. We explained that, as opposed to the RUG-IV system that determines therapy payments based only on the amount of therapy provided, under the PDPM, residents would be classified into SLP case-mix groups based on resident characteristics shown to be predictive of SLP utilization. Thus, we stated that believe the SLP case-mix groups will provide a better measure of resource use and will provide for more appropriate payment under the SNF PPS.
We invited comments on the approach we proposed above to classify residents for SLP payment under the proposed PDPM.
Commenters submitted the following comments related to the proposed rule's discussion of the classification of residents for SLP payment under the PDPM. A discussion of these comments, along with our responses, appears below.
With regard to the possibility of some providers prescribing mechanically altered diets inappropriately or the possibility of overutilization, we do plan to monitor the use of these diets as part of our general PDPM monitoring strategy.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing, without modification, the proposed SLP component of PDPM and our proposals relating to the classification of residents under the SLP component.
As we explained in the proposed rule (83 FR 21051 through 21052), the RUG-IV classification system first divides residents into “rehabilitation residents” and “non-rehabilitation residents” based on the amount of therapy a resident receives. We stated that differences in nursing needs can be obscured for rehabilitation residents, where the primary driver of payment classification is the intensity of therapy services that a resident receives. For example, for two residents classified into the RUB RUG-IV category, which would occur on the basis of therapy intensity and ADL score alone, the nursing component for each of these residents would be multiplied by a CMI of 1.56. We stated that this reflects that residents in that group were found, during our previous Staff time measurement (STM) work, to have nursing costs 56 percent higher than residents with a 1.00 index. We noted that while this CMI also includes adjustments made in FY 2010 and FY 2012 for budget-neutrality purposes, what is clear is that two residents, who may have significantly different nursing needs, are nevertheless deemed to have the very same nursing costs, and SNFs would receive the same nursing payment for each. Given the discussion above and in the proposed rule, which noted that approximately 60 percent of resident days are billed using one of three Ultra-High Rehabilitation RUGs (two of which have the same nursing index), we stated that the current case-mix model effectively classifies a significant portion of SNF therapy residents as having exactly the same degree of nursing needs and requiring exactly the same amount of nursing resources. As such, we stated we believed that further refinement of the case-mix model would be appropriate to better differentiate among patients, particularly those who receive therapy services with different nursing needs.
We further explained in the proposed rule (83 FR 21052) that an additional concern in the RUG-IV system is the use of therapy minutes to determine not only therapy payments but also nursing payments. For example, residents classified into the RUB RUG fall in the same ADL score range as residents classified into the RVB RUG. The only difference between those residents is the number of therapy minutes that they received. However, as we stated in the proposed rule, the difference in payment that results from this difference in therapy minutes impacts not only the RUG-IV therapy component but also the nursing component: Nursing payments for RUB residents are 40 percent higher than nursing payments for RVB residents. We stated that as a result of this feature of the RUG-IV system, the amount of therapy minutes provided to a resident is one of the main sources of variation in nursing payments, while other resident characteristics that may better reflect nursing needs play a more limited role in determining payment.
As discussed in the proposed rule (83 FR 21052), the more nuanced and resident-centered classifications in current RUG-IV non-rehabilitation categories are obscured under the current payment model, which utilizes only a single RUG-IV category for payment purposes and has over 90 percent of resident days billed using a rehabilitation RUG. The RUG-IV non-rehabilitation groups classify residents based on their ADL score, the use of extensive services, the presence of specific clinical conditions such as depression, pneumonia, or septicemia, and the use of restorative nursing services, among other characteristics. These characteristics are associated with nursing utilization, and the STRIVE study accounted for relative differences in nursing staff time across groups. Therefore, we proposed to use the existing RUG-IV methodology for classifying residents into non-rehabilitation RUGs to develop a proposed nursing classification that helps ensure nursing payment reflects expected nursing utilization rather than therapy utilization.
For example, in the proposed rule (83 FR 21052), we considered two residents. The first patient classifies into the RUB rehabilitation RUG (on the basis of the
While resident classification in the proposed PDPM nursing component is guided by RUG-IV methodology, we proposed to make several modifications to the RUG-IV nursing RUGs and classification methodology under the proposed PDPM. First, we proposed under the PDPM to reduce the number of nursing RUGs by decreasing distinctions based on function. We stated that under RUG-IV, residents with a serious medical condition/service such as septicemia or respiratory therapy are classified into one of eight nursing RUGs in the Special Care High category. The specific RUG into which a resident is placed depends on the resident's ADL score and whether the resident is depressed. RUG-IV groups ADL score into bins for simplicity (for example, 2-5 and 6-10). For example, under RUG-IV, a resident in the Special Care High category who has depression and an ADL score of 3 would fall into the 2-5 ADL score bin, and therefore, be classified into the HB2 RUG, which corresponds to Special Care High residents with depression and an ADL score between 2 and 5 (a mapping of clinical traits and ADL score to RUG-IV nursing groups is shown in the appendix of the SNF PDPM technical report, available at
In the Special Care High, Special Care Low, Clinically Complex, and Reduced Physical Function classification groups (RUGs beginning with H, L, C, or P), for nursing groups that were otherwise defined with the same clinical traits (for example, extensive services, medical conditions, depression, restorative nursing services received), we proposed to combine the following pairs of second characters due to their contiguous ADL score bins: (E, D) and (C, B). These characters correspond to ADL score bins (15 to 16, 11 to 14) and (6 to 10, 2 to 5), respectively. We observed that nursing utilization did not vary notably across these contiguous ADL score bins; therefore, we stated that we believe it is appropriate to collapse pairs of RUGs in these classification groups that correspond to contiguous ADL score bins but are otherwise defined by the same clinical traits. For example, HE2 and HD2, which are both in the Special Care High group and both indicate the presence of depression, would be collapsed into a single nursing case-mix group. Similarly, we stated that PC1 and PB1 (Reduced Physical Function and 0 to 1 restorative nursing services) also would be combined into a single nursing case-mix group. Section 3.6.1. of the SNF PDPM technical report (available at
As explained in the proposed rule (83 FR 21053), the second modification to the RUG-IV nursing classification methodology would update the nursing ADL score to incorporate section GG items. Currently, the RUG-IV ADL score is based on four late-loss items from section G of MDS 3.0: eating, toileting, transfer, and bed mobility. We stated that under the proposed PDPM, these section G items would be replaced with an eating item, a toileting item, three transfer items, and two bed mobility items from the admission performance assessment of section GG. In contrast to the RUG-IV ADL score, the proposed PDPM score assigns higher points to higher levels of independence. Therefore, an ADL score of 0 (independent) corresponds to a section GG-based function score of 16, while an ADL score of 16 (dependent) corresponds to a section GG-based function score of 0. We explained that this scoring methodology is consistent with the proposed PDPM PT and OT function score, as well as functional scores in other care settings, such as the IRF PPS. The proposed nursing scoring methodology also assigns 0 points when an activity cannot be completed (“Resident refused,” “Not applicable,” “Not attempted due to medical condition or safety concerns”). As described in section V.D.3.c. (PT and OT Case-Mix Classification) of the proposed rule, grouping these responses with “dependent” aligns with clinical expectations of resource utilization for residents who cannot complete an ADL activity. The proposed scoring methodology is shown in Table 24 of the proposed rule (set forth in Table 24 of this final rule). As discussed in section V.D.3.c. of the proposed rule, section GG measures functional areas with more than one item, which results in substantial overlap between the two bed mobility items and the three transfer items. To address overlap, we proposed to calculate an average score for each of these related items. That is, we stated we would average the scores for the two bed mobility items and for the three transfer items. This averaging approach was also used in the proposed PT and OT function scores and is illustrated in Table 25 of the proposed rule (set forth in Table 25 of this final rule). We stated that the final score sums the average bed mobility and transfer scores with eating and toileting scores, resulting in a nursing function score that ranges from 0 to 16.
In addition to proposing to replace the nursing ADL score with a function score based on section GG items and to collapse certain nursing RUGs, we also proposed (83 FR 21054) to update the existing nursing CMIs using the STRIVE staff time measurement data that were originally used to create these indexes. We explained that under the current payment system, non-rehabilitation nursing indexes were calculated to capture variation in nursing utilization by using only the staff time collected for the non-rehabilitation population. We stated we believe that, to provide a more accurate reflection of the relative nursing resource needs of the SNF population, the nursing indexes should reflect nursing utilization for all residents. To accomplish this, we stated in the proposed rule that we replicated the methodology described in the FY 2010 SNF PPS rule (74 FR 22236 through 22238) but classified the full STRIVE study population under non-rehabilitation RUGs using the RUG-IV classification rules. The methodology set forth in the proposed rule for updating resource use estimates for each nursing RUG proceeded according to the following steps:
(1) Calculate average wage-weighted staff time (WWST) for each STRIVE study resident using FY 2015 SNF wages.
(2) Assign the full STRIVE population to the appropriate non-rehabilitation RUG.
(3) Apply sample weights to WWST estimates to allow for unbiased population estimates. The reason for this weighting is that the STRIVE study was not a random sample of residents. Certain key subpopulations, such as residents with HIV/AIDS, were over-sampled to ensure that there were enough residents to draw conclusions on the subpopulations' resource use. As a result, STRIVE researchers also developed sample weights, equal to the inverse of each resident's probability of selection, to permit calculation of unbiased population estimates.
(4) Smooth WWST estimates that do not match RUG hierarchy in the same manner as the STRIVE study. RUG-IV, from which the nursing RUGs are derived, is a hierarchical classification in which payment should track clinical acuity. It is intended that residents who are more clinically complex or who have other indicators of acuity, including a higher ADL score, depression, or restorative nursing services, would receive higher payment. When STRIVE researchers estimated WWST for each RUG, several inversions occurred because of imprecision in the means. These are defined as WWST estimates that are not in line with clinical expectations. The methodology used to smooth WWST estimates is explained in Phase II of the STRIVE study. A link to the STRIVE study is available at
(5) Calculate nursing indexes, which reflect the average WWST for each of the 25 nursing case-mix groups divided by the average WWST for the study population used throughout our research. To impute WWST for each stay in the population, we assigned each resident the average WWST of the collapsed nursing RUG into which they are categorized. To derive the average WWST of each collapsed RUG, we first estimate the average WWST of the original 43 nursing RUGs based on steps 1 through 4 above, then calculate a weighted mean of the average WWST of the two RUGs that form the collapsed RUG. More details on this analysis can be found in section 3.6.3. of the SNF PDPM technical report (available at
Through this refinement, we stated that we believe the nursing indexes under the proposed PDPM better reflect the varied nursing resource needs of the full SNF population. In Table 26 of the proposed rule (set forth in Table 26 of this final rule), we provided the nursing indexes under the proposed PDPM.
To help ensure that payment reflects the average relative resource use at the per diem level, we stated that the nursing CMIs would be set to reflect case-mix related relative differences in WWST across groups. We further stated that Nursing CMIs would be calculated based on the average per diem nursing WWST of a case-mix group relative to the population average. In this calculation, average per diem WWST equaled total WWST in the group divided by number of utilization days in the group. We further explained that because the nursing component does not have a variable per diem schedule (as further discussed in section 3.9.1. of the SNF PDPM technical report, available at
As with the previously discussed components, we stated that all residents would be classified into one and only one of these 25 nursing case-mix groups under the proposed PDPM. As explained in the proposed rule (83 FR 21055), we also used the STRIVE data to quantify the effects of an HIV/AIDS diagnosis on nursing resource use. We controlled for case mix by including the proposed PDPM resident groups (in this case, the nursing RUGs) as independent variables. The results showed that even after controlling for nursing RUG, HIV/AIDS status is associated with a positive and significant increase in nursing utilization. Based on the results of regression analyses, we found that wage-weighted nursing staff time is 18 percent higher for residents with HIV/AIDS. (The estimate of average wage-weighted nursing staff time for the SNF population was adjusted to account for the deliberate over-sampling of certain sub-populations in the STRIVE study. Specifically, we applied sample weights from the STRIVE dataset equal to the inverse of each resident's probability of selection to permit calculation of an unbiased estimate.) Based on these findings, as discussed in the proposed rule, we concluded that the proposed PDPM nursing groups may not fully capture the additional nursing costs associated with HIV/AIDS residents. More information on this analysis can be found in section 3.8.2. of the SNF PDPM technical report (available at
We invited comments on the approach we proposed to classify residents for nursing payment under the proposed PDPM.
Commenters submitted the following comments related to the proposed rule's discussion of the classification of residents for nursing payment under the PDPM. A discussion of these comments, along with our responses, appears below.
In response to the concern about the methodology in collecting therapy minutes, we note that we only used nursing time to estimate CMIs for the nursing component under PDPM. Because therapy minutes were not included in the nursing staff time measure, concerns about how the STRIVE study collected therapy utilization data are not relevant to our use of STRIVE data to estimate nursing CMIs under PDPM.
As for the comments on the small sample sizes of certain resident groups in the STRIVE study, as detailed in section 4.1.2 of the STRIVE Phase II Report available at
With regard to the comment stating concerns about how the STRIVE study measured nursing time, it is unclear what the commenter means by “usual nursing time” and “nursing time needed to assure resident safety and maintain resident well-being.” As discussed in the STRIVE Phase I and Phase II reports available at
In response to the alternative data source proposed by commenters, the Schnelle et al. simulation model estimates resource use for nurse aides only; therefore, it is not a comprehensive or appropriate measure of nursing utilization.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposals, without modification, relating to the methodology, as described in this section, for classifying patients under the nursing component of PDPM.
Under the current SNF PPS, payments for NTA costs incurred by SNFs are incorporated into the nursing component. This means that the CMIs used to adjust the nursing component of the SNF PPS are intended to reflect not only differences in nursing resource use but also NTA costs. However, as we explained in the proposed rule (83 FR 21055), there have been concerns that the current nursing CMIs do not accurately reflect the basis for or the magnitude of relative differences in resident NTA costs. In its March 2016 Report to Congress, MedPAC wrote: “Almost since its inception, the SNF PPS has been criticized for encouraging the provision of unnecessary rehabilitation therapy services and not accurately targeting payments for nontherapy ancillary (NTA) services such as drugs (Government Accountability Office 2002, Government Accountability Office 1999, White et al. 2002)” (available at
As noted in the quotation from MedPAC above, MedPAC is not the only group to offer this critique of the SNF PPS. We stated in the proposed rule that just as the aforementioned criticisms that MedPAC cited have existed almost since the inception of the SNF PPS itself, ideas for addressing this concern have a similarly long history. In
In response to those comments, we stated in the 1998 interim final rule that “we are funding substantial research to examine the potential for refinements to the case-mix methodology, including an examination of medication therapy, medically complex patients, and other nontherapy ancillary services” (64 FR 41648). In the FY 2019 SNF PPS proposed rule (83 FR 21055 through 21056), we proposed a methodology that we believe would case-mix adjust SNF PPS payments more appropriately to reflect differences in NTA costs.
Following the same methodology we used for the proposed PT, OT, and SLP components, the project team ran cost regression models to determine which resident characteristics may be predictive of relative increases in NTA costs. As explained in the proposed rule, the three categories of cost-related resident characteristics identified through this analysis were resident comorbidities, the use of extensive services (services provided to residents that are particularly expensive and/or invasive), and resident age. However, as discussed in the proposed rule, we removed age from further consideration as part of the NTA component based on concerns shared by TEP panelists during the June 2016 TEP. Particularly, some panelists expressed concern that including age as a determinant of NTA payment could create access issues for older populations. Additionally, we state that the CART algorithm used to explore potential resident groups for the NTA component only selected age as a determinant of classification for 2 of the 7 groups created. We noted that we also tested a classification option that used age as a determinant of classification for every NTA group. This only led to a 5 percent increase in the R-squared value of the NTA classification. More information on these analyses can be found in section 3.7.1. of the SNF PMR technical report available at
As we explained in the proposed rule (83 FR 21056), with regard to capturing comorbidities and extensive services associated with high NTA utilization, we used multiple years of data (FY 2014 to FY 2017) to estimate the impact of comorbidities and extensive services on NTA costs. This was in response to comments on the ANPRM that the design of the NTA component should be more robust and remain applicable in light of potential changes in the SNF population and care practices over time. We explained in the proposed rule that conditions and services were defined in three ways. First, clinicians identified MDS items that correspond to conditions/extensive services likely related to NTA utilization. However, we stated that since many conditions/extensive services related to NTA utilization are not included on the MDS assessment, we then mapped ICD-10 diagnosis codes from the prior inpatient claim, the first SNF claim, and section I8000 of the 5-day MDS assessment to condition categories from the Part C risk adjustment model (CCs) and the Part D risk adjustment model (RxCCs). The CCs and RxCCs define conditions by aggregating related diagnosis codes into a single condition flag. We use the condition flags defined by the CCs and RxCCs to predict Part A and B expenditures or Part D expenditures, respectively for Medicare beneficiaries. The predicted relationship between the conditions defined in the respective models and Medicare expenditures is then used to risk-adjust capitated payments to Part C and Part D sponsors. Similarly, we explained that our comorbidities investigation aimed to use a comprehensive list of conditions and services to predict resource utilization for beneficiaries in Part A-covered SNF stays. As we stated in the proposed rule, ultimately, the predicted relationship between these conditions/services and utilization of NTA services would be used to case-mix adjust payments to SNF providers, in a process similar to risk adjustment of capitated payments. Given these similarities, we decided to use the diagnosis-defined conditions from the Part C and Part D risk adjustment models to define conditions and services that were not defined on the MDS. Because the CCs were developed to predict utilization of Part A and B services, while the RxCCs were developed to predict Part D drug costs, the largest component of NTA costs, we stated that believe using both sources allows us to define the conditions and services potentially associated with NTA utilization more comprehensively. Lastly, we used ICD-10 diagnosis codes to define additional conditions that clinicians who advised CMS during PDPM development identified as being potentially associated with increased NTA service utilization but are not fully reflected in either the MDS or the CCs/RxCCs. The resulting list was meant to encompass as many diverse and expensive conditions and extensive services as possible from the MDS assessment, the CCs, the RxCCs, and diagnoses. As discussed in the proposed rule, using cost regressions, we found that certain comorbidity conditions and extensive services were highly predictive of relative differences in resident NTA costs. These conditions and services were identified in Table 27 of the proposed rule (set forth in Table 27 in this final rule). More information on this analysis can be found in section 3.7.1. of the SNF PDPM technical report available at
Having identified the list of relevant conditions and services for adjusting NTA payments, in the proposed rule (83 FR 21056 through 21057), we considered different options for how to capture the variation in NTA costs explained by these identified conditions and services. We stated that one such method would be merely to count the number of comorbidities and services a resident receives and assign a score to that resident based on this count. We found that this option accounts for the additive effect of having multiple comorbidities and extensive services but
We stated in the proposed rule (83 FR 21057) that a resident's total comorbidity score, which would be the sum of the points associated with all of a resident's comorbidities and services, would be used to classify the resident into an NTA case-mix group. For conditions and services where the source is indicated as MDS item I8000, SNF PDPM NTA Comorbidity Mapping (which accompanied the FY 2019 SNF PPS proposed rule) (available at
We also noted that the source of the HIV/AIDS diagnosis is listed as the SNF claim. We explained in the proposed rule that this is because 16 states have state laws that prevent the reporting of HIV/AIDS diagnosis information to CMS through the current assessment system and/or prevent CMS from seeing such diagnosis information within that system, should that information be mistakenly reported. We noted that the states are Alabama, Alaska, California, Colorado, Connecticut, Idaho, Illinois, Massachusetts, Nevada, New Hampshire, New Jersey, New Mexico, South Carolina, Texas, Washington, and West Virginia. Given this restriction, it would not be possible to have SNFs utilize the MDS 3.0 as the vehicle to report HIV/AIDS diagnosis information for purposes of determining a resident's NTA classification. We noted that the current SNF PPS uses a claims reporting mechanism as the basis for the temporary AIDS add-on payment which exists under RUG-IV. To address the issue discussed above with respect to reporting of HIV/AIDS diagnosis information under the proposed PDPM, we proposed to utilize this existing claims reporting mechanism to determine a resident's HIV/AIDS status for the purpose of NTA classification. More specifically, we explained that HIV/AIDS diagnosis information reported on the MDS would be ignored by the GROUPER software used to classify a resident into an NTA case-mix group. Instead, we stated that providers would be instructed to locate the HIPPS code provided to the SNF on the validation report associated with that assessment and report it to CMS on the associated SNF claim. Following current protocol, the provider would then enter ICD-10-CM code B20 on the associated SNF claim as if it were being coded to receive payment through the current AIDS add-on payment. The PRICER software, which we use to determine the appropriate per diem payment for a provider based on their wage index and other factors, would make the adjustment to the resident's NTA case-mix group based on the presence of the B20 code on the claim, as well as adjust the associated per diem payment based on the adjusted resident HIPPS code. Again, we noted that this methodology follows the same logic that the SNF PPS currently uses to pay the temporary AIDS add-on adjustment but merely changes the target and type of adjustment from the SNF PPS per diem to the NTA component of the proposed PDPM. We explained that the difference is that while under the current system, the presence of the B20 code would lead to a 128 percent increase in the per diem rate, under the proposed PDPM, the presence of the B20 code would mean the addition of 8 points (as determined by the OLS regression described above) to the resident's NTA score, the categorization of the resident into the appropriate NTA group, and an adjustment to the nursing component, as described in section V.D.3.d. of the proposed rule. Section 1888(e)(12) of the Act enacted a temporary 128 percent increase in the PPS per diem payment for SNF residents with HIV/AIDS and stipulated that the temporary adjustment was to be applied only until the Secretary certifies that there is an appropriate case-mix adjustment to compensate for the increased costs associated with this population. As we explained in the proposed rule, based on this language, we conducted an analysis similar to that used to determine the HIV/AIDS add-on for the nursing component to examine the adequacy of payment for ancillary services (all non-nursing services: PT, OT, SLP, and NTA) for residents with HIV/AIDS under the proposed PDPM. This analysis determined that after accounting for the 8 points assigned for HIV/AIDS in the NTA component and controlling for case-mix classification across the three therapy components and NTA component, HIV/AIDS was not associated with an increase in ancillary costs. We noted that nursing costs were not included in this regression because we separately
Table 27 provides the proposed list of conditions and extensive services that would be used for NTA classification, the source of that information, and the associated number of points for that condition.
Given the NTA scoring methodology described in the proposed rule (83 FR 21058 through 21059) and above, and following the same methodology used for the PT, OT, and SLP components, we used the CART algorithm to determine the most appropriate splits in resident NTA case-mix groups. This methodology is more thoroughly explained in sections 3.4.2. and 3.7.2. of the SNF PDPM technical report available at
We stated in the proposed rule (83 FR 21059) that to help ensure payment reflects the average relative resource use at the per diem level, CMIs would be set to reflect relative case-mix related differences in costs across groups. We further stated that this method helps ensure that the share of payment for each case-mix group would be equal to its share of total costs of the component. CMIs for the NTA component were calculated based on two factors. One factor was the average per diem costs of a case-mix group relative to the population average. The other factor was the average variable per diem adjustment factor of the group relative to the population average. In this calculation, average per diem costs equaled total NTA costs in the group divided by number of utilization days in the group. Similarly, the average variable per diem adjustment factor equaled the sum of NTA variable per diem adjustment factors for all utilization days in the group divided by the number of utilization days in the group. We calculated CMIs such that they equaled the ratio of relative average per diem costs for a group to the relative average variable per diem adjustment factor for the group. In this calculation, relative average per diem costs and the relative average variable per diem adjustment factor were weighted by length of stay to account for the different length of stay distributions across case-mix groups (as further discussed in section 3.11.1. of the SNF PDPM technical report, available at
We stated in the proposed rule (83 FR 21059) that as with the previously discussed components, all residents would be classified into one and only one of these 6 NTA case-mix groups under the proposed PDPM. We explained that the proposed PDPM would create a separate payment component for NTA services, as opposed to combining NTA and nursing into one component as in the RUG-IV system. This separation would allow payment for NTA services to be based on resident characteristics that predict NTA resource utilization rather than nursing staff time. Thus, we stated that we believe the proposed NTA case-mix groups would provide a better measure of resource utilization and lead to more accurate payments under the SNF PPS.
We invited comments on the approach proposed above to classify residents for NTA payment under the proposed PDPM.
Commenters submitted the following comments related to the proposed rule's discussion of the classification of residents for NTA payment under the PDPM. A discussion of these comments, along with our responses, appears below.
Regarding the concern that current administrative data may not fully capture NTA utilization for the SNF population, first, as described in Section 3.2.2. of the SNF PDPM technical report, we checked the quality of self-reported NTA utilization data by comparing charges from cost reports and charges from claims and verifying that these were generally consistent. Second, we used four years of data (FYs 2014-2017) to identify the conditions and services associated with high NTA utilization and assign points to these comorbidities
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing the proposed NTA component of the PDPM and the proposed classification methodology for the NTA component, without modification.
RUG-IV classifies each resident into a single RUG, with a single payment for all services. By contrast, the PDPM classifies each resident into five components (PT, OT, SLP, NTA, and nursing) and provide a single payment based on the sum of these individual classifications. The payment for each component would be calculated by multiplying the CMI for the resident's group first by the component federal base payment rate, then by the specific day in the variable per diem adjustment schedule (as discussed in section V.D.4 of the proposed rule and in section V.D.4 of this final rule). Additionally, for residents with HIV/AIDS indicated on their claim, the nursing portion of payment would be multiplied by 1.18 (as discussed in section V.D.3.d. of the proposed rule and section V.H of this final rule). These payments would then be added together along with the non-case-mix component payment rate to create a resident's total SNF PPS per diem rate under the PDPM. This section describes how two hypothetical residents would be classified into payment groups under the current RUG-IV model and PDPM. To begin, consider two residents, Resident A and Resident B, with the resident characteristics identified in Table 29.
Currently under the SNF PPS, Resident A and Resident B would be classified into the same RUG-IV group. They both received rehabilitation, did not receive extensive services, received 730 minutes of therapy, and have an
Under the PDPM, however, these two residents would be classified very differently. With regard to the PT and OT components, Resident A would fall into group TO, as a result of his categorization in the Acute Neurologic group and a function score within the 10 to 23 range. Resident B, however, would fall into group TC for the PT and OT components, as a result of his categorization in the Major Joint Replacement group and a function score within the 10 to 23 range. For the SLP component, Resident A would be classified into group SH, based on his categorization in the Acute Neurologic group, the presence of moderate cognitive impairment, and the presence of Mechanically-Altered Diet, while Resident B would be classified into group SA, based on his categorization in the Non-Neurologic group, the absence of cognitive impairment or any SLP-related comorbidity, and the lack of any swallowing disorder or mechanically-altered diet. For the Nursing component, following the existing nursing case-mix methodology, Resident A would fall into group LBC1, based on his use of dialysis services and a nursing function score of 7, while Resident B would fall into group HBC2, due to the diagnosis of septicemia, presence of depression, and a nursing function score of 7. Finally, with regard to NTA classification, Resident A would be classified in group NC, with an NTA score of 7, while Resident B would be classified in group NE, with an NTA score of 1. This demonstrates that, under the PDPM, more aspects of a resident's unique characteristics and needs factor into determining the resident's payment classification, which makes for a more resident-centered case-mix model while also eliminating, or greatly reducing, the number of service-based factors which are used to determine the resident's payment classification. Because this system is based on specific resident characteristics predictive of resource utilization for each component, we expect that payments will be better aligned with resident need.
Section 1888(e)(4)(G)(i) of the Act provides that payments must be adjusted for case mix, based on a resident classification system which accounts for the relative resource utilization of different types of residents. Additionally, section 1888(e)(1)(B) of the Act specifies that payments to SNFs through the SNF PPS must be made on a per-diem basis. Currently under the SNF PPS, each RUG is paid at a constant per diem rate, regardless of how many days a resident is classified in that particular RUG. However, we explained in the proposed rule (83 FR 21060) that during the course of the SNF PMR project, analyses on cost over the stay for each of the case-mix adjusted components revealed different trends in resource utilization over the course of the SNF stay. These analyses utilized costs derived from claim charges as a measure of resource utilization. Costs were derived by multiplying charges from claims by the CCRs on facility-level costs reports. As described in section V.B.3.b. of the proposed rule, costs better reflect differences in the relative resource use of residents as opposed to charges, which partly reflect decisions made by providers about how much to charge payers for certain services. In examining costs over a stay, we stated we found that for certain categories of SNF services, notably PT, OT and NTA services, costs declined over the course of a stay. Based on the claim submission schedule and variation in the point during the month when a stay began, we were able to estimate resource use for a specific day in a stay. Facilities are required to submit monthly claims. Each claim covers the period from the first day during the month a resident is in the facility to the end of the month. If a resident was admitted on the first day of the month, remains in the facility, and continues to have Part A SNF coverage until the end of the month, the claim for that month will include all days in the month. However, if a resident is admitted after the first day of the month, the first claim associated with the resident's stay will be shorter than a month. We stated in the proposed rule that to estimate resource utilization for each day in the stay, we used the marginal estimated cost from claims of varying length based on random variation in the day of a month when a stay began. Using this methodology, we observed a decline in the marginal estimated cost of each additional day of SNF care over the course of the stay. We further stated that to supplement this analysis, we also looked at changes in the number of therapy minutes reported in different assessments throughout the stay. Because therapy minutes are recorded on the MDS, the presence of multiple assessments throughout the stay provided information on changes in resource use. For example, it was clear whether the number of therapy minutes a resident received changed from the 5-day assessment to the 14-day assessment. We explained that the results from this analysis were consistent with the cost from claims analysis and showed that, on average, the number of therapy minutes is lower for assessments conducted later in the stay. This finding was consistent across different lengths of stay. More information on these analyses can be found in section 3.9. of the SNF PDPM technical report and section 3.9. of the SNF PMR technical report that accompanied the ANPRM, both available at
As discussed in the proposed rule (83 FR 21060 through 21061), analyses of the SLP component revealed that the per diem costs remain relatively constant over time, while the PT, OT, and NTA component cost analyses indicate that the per diem cost for these three components decline over the course of the stay. We stated in the proposed rule that in the case of the PT and OT components, costs start higher at the beginning of the stay and decline slowly over the course of the stay. By comparison, the NTA component cost analyses indicated significantly increased NTA costs at the beginning of a stay that then drop to a much lower level that holds relatively constant over the remainder of the SNF stay. This is consistent with how most SNF drug costs are typically incurred at the outset of a SNF stay. We stated that these results indicate that resource utilization for PT, OT, and NTA services changes over the course of the stay. More information on these analyses can be found in section 3.9.1. of the SNF PMR technical report that accompanied the ANPRM available at
We explained in the proposed rule that constant per diem rates, by
As noted above and in the proposed rule (83 FR 21061), and discussed more thoroughly in section 3.9. of the SNF PMR technical report that accompanied the ANPRM (available at
In Table 30 of the proposed rule, the adjustment factor for the PT and OT components was 1.00 for days 1 to 20. We explained that this was because the analyses described above indicated that PT and OT costs remain relatively high for the first 20 days and then decline. The estimated daily rates of decline for PT and OT costs relative to the initial 20 days were both 0.3 percent. Thus, we stated that a convenient and appropriate way to reflect this was to bin days in the PT and OT variable per diem adjustment schedules such that payment declines at less frequent intervals, while still reflecting a 0.3 percent daily rate of decline in PT and OT costs. Therefore, we proposed to set the adjustment factors such that payment would decline 2 percent every 7 days after day 20 (0.3 * 7 = 2.1). We explained that the 0.3 percent rate of decline was derived from a regression model that estimates the level of resource use for each day in the stay relative to the beginning of the stay. The regression methodology and results are presented in section 3.9. of the SNF PDPM technical report, available at
As described previously in this section and in the proposed rule (83 FR 21061), NTA resource utilization exhibits a somewhat different pattern. The analyses described above indicate that NTA costs are very high at the beginning of the stay, drop rapidly after the first 3 days, and remain relatively stable from the fourth day of the stay. We stated that starting on day 4 of a stay, the per diem costs drop to roughly one-third of the per diem costs in the initial 3 days. We explained that this suggests that many NTA services are provided in the first few days of a SNF stay. Therefore, we proposed setting the NTA adjustment factor to 3.00 for days 1 to 3 to reflect the extremely high initial costs, then setting it at 1.00 (two-thirds lower than the initial level) for subsequent days. We explained that the value of the adjustment factor was set at 3.00 for the first 3 days and 1.00 after (rather than, for example, 1.00 and 0.33, respectively) for simplicity. The results are presented in section 3.9. of the SNF PDPM technical report, available at
As we described in the proposed rule (83 FR 21061), case-mix adjusted federal per diem payment for a given component and a given day would be equal to the base rate for the relevant component (either urban or rural), multiplied by the CMI for that resident, multiplied by the variable per diem adjustment factor for that specific day, as applicable. Additionally, as described in further detail in section V.D.3.d. of the proposed rule, we stated that an additional 18 percent would be added to the nursing per-diem payment to account for the additional nursing costs associated with residents who have HIV/AIDS. We further explained that these payments would then be added together along with the non-case-mix component payment rate to create a resident's total SNF PPS per diem rate under the proposed PDPM. We invited comments on the proposed variable per diem adjustment factors and payment schedules discussed in this section.
Commenters submitted the following comments related to the proposed rule's discussion of the variable per diem adjustment factors and payment schedules. A discussion of these comments, along with our responses, appears below.
Regarding the concern about resource utilization patterns of residents with chronic conditions, we would note that as discussed above, we estimated that PDPM would actually increase overall per-stay payment for many resident subpopulations with chronic conditions. Further, while payment would be highest during the early part of a stay, facilities would have flexibility to allocate this payment to cover costs later in a stay, as they do now. Our research, discussed in the proposed rule (83 FR 21061) and section 3.9 of the SNF PDPM technical report, revealed that for the average SNF stay, NTA utilization declines dramatically after the first 3 days of a stay. Of course, we acknowledge that there are cases that may not match this resource utilization pattern exactly. However, we believe that PDPM, because it is based on the observed relationship between patient characteristics and resource utilization, represents an improvement over the current payment model in terms of payment accuracy. Further, as stated, our investigations show that for many of the specific cases cited by commenters as potential concerns, we expect PDPM actually to increase associated payment compared to RUG-IV. While the variable per diem schedule decreases pay throughout the stay, the overall increase in payment accounts for the treatment cost of chronic conditions, which is costly due to the sustained level of care needed to manage chronic conditions.
As discussed in the proposed rule (83 FR 21060 through 21061) and section 3.9 of the SNF PDPM technical report, we developed a methodology to estimate per-diem resource use over a stay for PT, OT, and NTA. Based on this methodology, we observed that estimated per-diem PT and OT costs remain high for the first 20 days of a stay and decline thereafter. Therefore, we established a variable per diem payment adjustment schedule for the PT and OT components that begins to adjust payment downward beginning on day 21.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposal without modification to apply a variable per diem adjustment as part of the PDPM effective October 1, 2019. Table 30 sets forth the final PDPM Variable Per Diem Payment Adjustment Factors and Schedule for the PT and OT components, and Table 31 sets for the final PDPM Variable Per Diem Payment Adjustment Factors and Schedule for the NTA component.
Consistent with section 1888(e)(6)(B) of the Act, to classify residents under the SNF PPS, we use the MDS 3.0 Resident Assessment Instrument. Within the SNF PPS, there are two categories of assessments, scheduled and unscheduled. In terms of scheduled assessments, SNFs are currently required to complete assessments on or around days 5, 14, 30, 60, and 90 of a resident's Part A SNF stay, including certain grace days. Payments based on these assessments depend upon standard Medicare payment windows associated with each scheduled assessment. More specifically, each of the Medicare-required scheduled assessments has defined days within which the Assessment Reference Date (ARD) must be set. The ARD is the last day of the observation (or “look-back”) period that the assessment covers for the resident. The facility is required to set the ARD on the MDS form itself or in the facility software within the appropriate timeframe of the assessment type being completed. The clinical data collected from the look-back period is used to determine the payment associated with each assessment. For example, the ARD for the 5-day PPS Assessment is any day between days 1 to 8 (including Grace Days). The clinical data collected during the look-back period for that assessment is used to determine the SNF payment for days 1 to 14. Unscheduled assessments, such as the Start of Therapy (SOT) Other Medicare Required Assessment (OMRA), the End of Therapy OMRA (EOT OMRA), the Change of Therapy (COT) OMRA, and the Significant Change in Status Assessment (SCSA or Significant Change), may be required during the resident's Part A SNF stay when triggered by certain defined events.
For example, if a resident is being discharged from therapy services, but remaining within the facility to continue the Part A stay, then the facility may be required to complete an EOT OMRA. Each of the unscheduled assessments affects payment in different and defined manners. A description of the SNF PPS scheduled and unscheduled assessments, including the criteria for using each assessment, the assessment schedule, payment days covered by each assessment, and other related policies, are set forth in the MDS 3.0 RAI manual on the CMS website (available at
Table 32 outlines when each of the current SNF PPS assessments is required to be completed and its effect on SNF PPS payment.
As we explained in the proposed rule (83 FR 21062), an issue which has been raised in the past with regard to the existing SNF PPS assessment schedule is that the sheer number of assessments, as well as the complex interplay of the assessment rules, significantly increases the administrative burden associated with the SNF PPS. We stated that case-mix classification under the proposed SNF PDPM relies to a much lesser extent on characteristics that may change very frequently over the course of a resident's stay (for example, therapy minutes may change due to resident refusal or unexpected changes in resident status), but instead relies on more stable predictors of resource utilization by tying case-mix classification, to a much greater extent, to resident characteristics such as diagnosis information. We explained that in view of the greater reliance of the proposed SNF PDPM (as compared to the RUG-IV model) on resident characteristics that are relatively stable over a stay and our general focus on reducing administrative burden for providers across the Medicare program, we are making an effort to reduce the administrative burden on providers by concurrently proposing to revise the assessments that would be required under the proposed SNF PDPM. Specifically, we proposed to use the 5-day SNF PPS scheduled assessment to classify a resident under the proposed SNF PDPM for the entirety of his or her Part A SNF stay effective beginning FY
We also stated in the proposed rule (83 FR 21062) that we understand Medicare beneficiaries are each unique and can experience clinical changes which may require a SNF to reassess the resident to capture changes in the resident's condition. Therefore, to allow SNFs to capture these types of changes, effective October 1, 2019 in conjunction with the proposed implementation of the PDPM, we proposed to require providers to reclassify residents as appropriate from the initial 5-day classification using a new assessment called an Interim Payment Assessment (IPA), which would be comprised of the 5-day SNF PPS MDS Item Set (Item Set NP). We stated that providers would be required to complete an IPA in cases where the following two criteria are met:
(1) There is a change in the resident's classification in at least one of the first tier classification criteria for any of the components under the proposed PDPM (which are those clinical or nursing payment criteria identified in the first column in Tables 21, 23, 26, and 27 of the proposed rule), such that the resident would be classified into a classification group for that component that differs from that provided by the 5-day scheduled PPS assessment, and the change in classification group results in a change in payment either in one particular payment component or in the overall payment for the resident; and
(2) The change(s) are such that the resident would not be expected to return to his or her original clinical status within a 14-day period.
In addition, we proposed that the Assessment Reference Date (ARD) for the IPA would be no later than 14 days after a change in a resident's first tier classification criteria is identified. We stated that the IPA is meant to capture substantial changes to a resident's clinical condition and not everyday, frequent changes. We believe 14 days gives the facility an adequate amount of time to determine whether the changes identified are in fact routine or substantial. To clarify, we explained that the change in classification group described above refers not only to a change in one of the first tier classification criteria in any of the proposed payment components, but also to one that would be sufficient to change payment in either one component or in the overall payment for the resident. For example, we stated that given the collapsed categories under the PT and OT components, this would mean that a change from the medical management group to the cancer group would not necessitate an IPA, as they are both collapsed under the medical management group for purposes of the PT and OT components. However, we stated a change from the major joint replacement group to the medical management group would necessitate an IPA, as this would change the resident's clinical category group for purposes of categorization under the PT and OT components and would result in a change in payment.
We stated that we believe the proposed requirement to complete an IPA balances the need to ensure accurate payment and monitor for changes in the resident's condition with the importance of ensuring a more streamlined assessment approach under the proposed PDPM.
In cases where the IPA is required and a facility fails to complete one, we proposed that the facility would follow the guidelines for late and missed unscheduled MDS assessments which are explained in Chapters 2.13 and 6.8 of the MDS RAI Manual (
In addition to proposing to require completion of the IPA as described above, we also considered the implications of a SNF completing an IPA on the variable per diem adjustment schedule described in section V.D.4. the proposed rule. More specifically, in the proposed rule, we considered whether an SNF completing an IPA should cause a reset in the variable per diem adjustment schedule for the associated resident. In examining costs over a stay, we found that for certain categories of SNF services, notably PT, OT, and NTA services, costs declined over the course of a stay. Our analyses showed that, on average, the number of therapy minutes is lower for assessments conducted later in the stay. Additionally, we stated that we were concerned that by providing for the variable per diem adjustment schedule to be reset after an IPA is completed, providers may be incentivized to conduct multiple IPAs during the course of a resident's stay to reset the variable per diem adjustment schedule each time the adjustment is reduced. Therefore, in cases where an IPA is completed, we proposed that this assessment would reclassify the resident for payment purposes as outlined in Table 33 of the proposed rule, but that the resident's variable per diem adjustment schedule would continue rather than being reset on the basis of completing the IPA.
Finally, we stated that believe, regardless of the payment system or case-mix classification model used, residents should continue to receive therapy that is appropriate to their care needs, and this includes both the
In addition to these proposed changes, we also examined in the proposed rule (83 FR 21064) the current use of grace days in the MDS assessment schedule. Grace days have been a longstanding part of the SNF PPS. They were created in order to allow clinical flexibility when setting ARD dates of scheduled PPS assessments. In the FY 2012 final rule (76 FR 48519), we discussed that in practice, there is no difference between regular ARD windows and grace days and we encouraged the use of grace days if their use would allow a facility more clinical flexibility or would more accurately capture therapy and other treatments. Thus, we do not intend to penalize any facility that chooses to use the grace days for assessment scheduling or to audit facilities based solely on their regular use of grace days. We may explore the option of incorporating the grace days into the regular ARD window in the future; nevertheless, we will retain them as part of the assessment schedule at the present time consistent with the current policy and the new assessment schedule proposed in the proposed rule.
We proposed, effective beginning October 1, 2019, in conjunction with the proposed implementation of the PDPM, to incorporate the grace days into the existing assessment window. We explained that this proposal would eliminate grace days as such from the SNF PPS assessment calendar and provide for only a standard assessment window. We stated that, as discussed, there is no practical difference between the regular assessment window and grace days and there is no penalty for using grace days. Accordingly, we stated that we believe it would be appropriate to eliminate the use of grace days in PPS assessments.
Table 33 of the proposed rule, set forth at Table 33 of this final rule, sets forth the proposed SNF PPS assessment schedule, incorporating the proposed revisions discussed above, which we stated would be effective October 1, 2019 concurrently with the proposed PDPM.
We noted in the proposed rule (83 FR 21064) that, as in previous years, we intend to continue to work with providers and software developers to assist them in understanding changes we proposed to the MDS. Further, we noted that none of the proposals related to changes to the MDS assessment schedule should be understood to change any assessment requirements which derive from the Omnibus Budget Reconciliation Act of 1987 (OBRA 87), which establishes assessment requirements for all nursing home residents, regardless of payer. We invited comments on our proposals to revise the SNF PPS assessment schedule and related policies as discussed above.
We also solicited comment on the extent to which implementing these proposals would reduce provider burden.
Commenters submitted the following comments related to the proposed changes to the MDS assessment schedule and related assessment policies as discussed above. A discussion of these comments, along with our responses, appears below.
We appreciate the recommendation to revise the assessment period and ARD to align more closely with other PAC providers in order to implement standardized patient data elements required by the IMPACT Act. We believe that many of the policies being finalized as part of PDPM serve to improve alignment with other PAC settings such as the utilization of functional measures similar to those in IRFs, and the interrupted stay policy which is similar to the IRF and IPF policies, and we hope to continue to improve this alignment in future refinements. As such, we may consider these recommendations in the future.
Most commenters were concerned about the complexity of the proposed IPA. They believed it would create more burden for providers to have to monitor the clinical changes and subsequent payment changes that would trigger the IPA on a daily basis. Several commenters doubted whether the proposed changes would support CMS' Patients over Paperwork initiative and related Medicare Simplifying Document Requirements. One commenter stated that monitoring the first tier changes in each of the case-mix adjusted components would be just as burdensome as the current assessment schedule and is too high a bar, particularly for NTAs. Furthermore, some commenters communicated that the complexities and uncertainties of the IPA would cause providers not to do them and the aim of CMS to provide SNFs with satisfactory reimbursement would not come to fruition. Similarly, some commenters expressed that because of the confusion and burden related to the IPA, this would unnecessarily increase the risk of provider error and potential medical review. This, in turn, would cause facilities to complete fewer IPAs and consequently this could lead to less quality care provided to patients who otherwise would have needed it had it
We disagree with the commenter that stated that even though the number of assessments have been reduced, the MDS itself has become more complex with new reporting requirements and items, leaving administrative burden unchanged. Section VII. of this final rule discusses burden associated with the changes we are making and our calculations show that there is a significant reduction in administrative burden to providers under PDPM.
We thank the commenters for calling our attention to their questions and confusion about the IPA. We continue to believe that it is necessary for SNFs to continually monitor the clinical status of each and every patient in the facility regularly regardless of payment or assessment requirements and we believe that there should be a mechanism in place that would allow facilities to do this. However, we also believe that providers may be best situated, as in the case of the Significant Change in Status Assessment, to determine when a change has occurred that should be reported through the IPA. Therefore, to further ease the administrative burden associated with PDPM and improve clarity on when an IPA should be completed, we have decided to make the IPA an optional assessment. Facilities will be able to determine when IPAs will be completed for their patients to address potential changes is clinical status and what criteria should be used to decide when an IPA would be necessary. We are not finalizing the proposed criteria for the triggering of the IPA, but rather we will seek additional stakeholder input on this issue. We note that we are finalizing the proposal surrounding IPA completions and the variable per diem adjustment schedule (including the NTA variable per diem, that is, the completion of an IPA will not reset the variable per diem adjustment schedule)) even though the IPA will now be optional. However, because the IPA will be optional and providers can determine their own criteria for when an IPA is completed, we are revising the ARD criteria we proposed. The ARD for the IPA will be the date the facility chooses to complete the assessment relative to the triggering event that causes a facility to choose to complete the IPA. Payment based on the IPA will begin the same day as the ARD. The IPA will not be susceptible to assessment penalties, given the optional nature of the assessment. We reiterate that we expect facilities to complete IPAs as they deem necessary to address clinical changes throughout a SNF stay and that the removal of the requirement to complete these assessments does not in any way negate the need to provide excellent skilled nursing and rehabilitative care and continually monitor and document patient status.
We believe that the ability to reset the variable per diem would incentivize providers to complete IPAs every time the variable per diem was reduced. We also believe it is possible that providers may refrain from coding certain conditions on an initial assessment and then code other conditions on later assessments to justify the variable per diem adjustment reset.
With regard to the ideas presented by commenters for when the variable per diem should be reset, we do not believe that the variable per diem should be reset except in cases of an entirely new SNF stay (we also refer readers to section V.F. of this final rule for a discussion of our interrupted stay policy). We understand that some commenters are concerned that unless the variable per diem adjustment schedule is reset, a patient's per diem rate may not reflect changes in NTA use identified in an IPA that is completed during a patient's stay. However, we note that if a new condition is coded on an IPA during a SNF stay, the SNF PPS per diem payment for the patient may in fact increase to reflect changes in the patient's clinical condition if the new condition results in a change to the patient's case-mix group. Thus, a patient's case-mix group and associated payment could change within a stay to reflect a change in NTA use on the IPA. However, we do not think that resetting the variable per diem adjustment would be appropriate each time such a change occurs. As we explained above, we found that for PT, OT, and NTA services, costs generally decline over the course of a stay and we believe the variable per diem adjustment appropriately accounts for this decline in costs. Furthermore, as the SNF PPS is a prospective payment system, it is not intended to reimburse for each additional condition or service separately, but rather provides a predictive payment based on a snapshot of the patient's condition. Resetting the variable per diem adjustment in each case of a change in the patient's condition would be more akin to a traditional fee-for-service model, providing additional payment for each additional service or condition, which is precisely the opposite of the goals of implementing PDPM.
Commenters were also concerned that there might be financial implications to not re-setting the variable per diem for NTAs and that this might result in facilities not providing the drugs that patients require because of financial reasons. However, we do not believe that the variable per diem adjustment creates new financial implications that would affect patient care, as this incentive also exists under the current payment system that utilizes a constant per diem rate and we have no evidence that SNF patients are being denied necessary medications or services. Further, we would note that there are quality safeguards in place such as readmission penalties and quality metrics such as the SNF QRP quality measures that should provide a disincentive against providers engaging in this type of stinting behavior.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposed changes to the MDS assessment schedule and related assessment policies as discussed in the proposed rule, with the following modifications. As discussed above, rather than making the IPA a required assessment as we proposed, this assessment will be optional, and providers may determine whether and when an IPA is completed. In addition, because the IPA is an optional assessment and providers can determine their own criteria for when an IPA is completed, we are revising the ARD criteria such that the ARD will be the date the facility chooses to complete the IPA relative to the triggering event that causes the facility to choose to complete the IPA. Payment based on the IPA would begin the same day as the ARD. These changes will be effective October 1, 2019 in conjunction with the implementation of the PDPM.
As noted previously in section IV.C of this final rule, section 1883 of the Act permits certain small, rural hospitals to enter into a Medicare swing-bed agreement, under which the hospital can use its beds to provide either acute or SNF care, as needed. For critical access hospitals (CAHs), Part A pays on a reasonable cost basis for SNF services furnished under a swing-bed agreement. However, in accordance with section 1888(e)(7) of the Act, such services furnished by non-CAH rural hospitals are paid under the SNF PPS, effective
For purposes of the proposed PDPM, we proposed to add three items to the Swing Bed PPS Assessment. Until now, these additional items have not been part of the Swing Bed PPS Assessment form because they have not been used for payment. However, we stated in the proposed rule (83 FR 21064) that presence of each of these items would be used to classify swing bed residents under the proposed SNF PDPM as explained in section V.D. of the proposed rule. Thus, we stated that believed it was necessary and appropriate to include these items in the Swing Bed PPS Assessment beginning October 1, 2019, in conjunction with the proposed implementation of the PDPM. The items we proposed to add to the Swing Bed PPS assessment are provided in Table 34 of the proposed rule (also set forth in Table 34).
Commenters submitted the following comments related to the proposed addition of three items to the Swing Bed PPS assessment. A discussion of these comments, along with our responses, appears below.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing the addition of the items in Table 34 to the Swing Bed PPS Assessment as proposed without modification, effective October 1, 2019 in conjunction with the implementation of the PDPM.
Under the MDS 3.0, the Part A PPS Discharge assessment is completed when a resident's Medicare Part A stay ends, but the resident remains in the facility (MDS 3.0 RAI Manual Chapter 2.5). The PPS Discharge Assessment uses the Item Set NPE and does not currently contain section O of the MDS 3.0. The therapy items in section O of the MDS allow CMS to collect data from providers on the volume, type (physical therapy, occupational therapy and speech-language pathology), and mode (individual, concurrent, or group therapy) of the therapy provided to SNF residents. As noted in comments received on the ANPRM in relation to therapy provision, this data would be particularly important to monitor. Specifically, a significant number of commenters expressed concerns that the amount of therapy provided to SNF residents, were RCS-I to have been implemented, would drop considerably as compared to the amount currently delivered under RUG-IV. Commenters noted that this is because the incentive to provide a high volume of therapy services to SNF residents (to achieve the highest resident therapy group classification) would no longer exist under RCS-I, potentially leading providers to reduce significantly the amount of therapy provided to SNF residents.
We stated in the proposed rule (83 FR 21065) that, given that the RCS-I model and PDPM both present the potential for providers to reduce significantly the amount of therapy provided to SNF residents as compared to RUG-IV, we believe that the same potential result may occur under the proposed PDPM as commenters identified with RCS-I. To better track therapy utilization under PDPM, and to better ensure that residents continue to receive an appropriate amount of therapy commensurate with their needs, given the reduction in the frequency of resident assessments required under the proposed PDPM, we proposed to add therapy collection items to the PPS Discharge assessment and to require providers to complete these items beginning October 1, 2019, in conjunction with the proposed implementation of the PDPM.
Specifically, we proposed to add the items listed in Table 35 of the proposed rule (as set forth in Table 35 of this final rule) to the PPS Discharge Assessment.
We stated that for the proposed items, which refer to the total number of minutes for each therapy discipline and each therapy mode, this would allow CMS both to conduct reviews of changes in the volume and intensity of therapy services provided to SNF residents under the proposed PDPM compared to that provided under RUG-IV, as well as to assess compliance with the proposed group and concurrent therapy limit discussed in section V.F of the FY 2019 SNF PPS proposed rule. We further stated that the proposed “total days” items for each discipline and mode of therapy would further support our monitoring efforts for therapy, as requested by commenters on the ANPRM, by allowing us to monitor not just the total minutes of therapy provided to SNF residents under the proposed PDPM, but also assess the daily intensity of therapy provided to SNF residents under the proposed PDPM, as compared to that provided under RUG-IV. As we explained in the proposed rule, ultimately, these proposed items would allow facilities to easily report therapy minutes provided to SNF residents and allow us to monitor the volume and intensity of therapy services provided to SNF residents under the proposed PDPM, as suggested by commenters on the ANPRM. We stated that if we discovered that the amount of therapy provided to SNF residents did change significantly under the proposed PDPM, if implemented, then we would assess the need for additional policies to ensure that SNF residents continued to receive sufficient and appropriate therapy services consistent with their unique needs and goals.
Commenters submitted the following comments related to the proposed rule's discussion of the SNF PPS Discharge Assessment. A discussion of these comments, along with our responses, appears below.
We appreciate the commenters' suggestion of using claims information as the basis for therapy reporting, but would note that this mechanism would be more complicated and not provide the same level of detail in the data as is currently reported in section O of the MDS. Further, as providers are already familiar with the section O items, we believe that this method will provide the simplest transition for providers.
We appreciate the suggestion to deny claims if the threshold is exceeded and we may consider this option further in the future. As stated in the FY 2019 SNF PPS proposed rule (83 FR 21068), services furnished to SNF residents may be considered reasonable and necessary insomuch as the services are consistent with the individual's particular medical needs and that excessive levels of group and/or concurrent therapy could constitute a reason to deny SNF coverage for such stays. We appreciate the suggestion to monitor patient outcomes in addition to collecting therapy provision data, as well as the recommendation to specifically use the four new SNF QRP section GG outcome measures and current readmission measures to measure the effectiveness of therapy provided in SNFs. We may consider these suggestions in future policy making decisions.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing the addition of the items in Table 35 to the PPS Discharge Assessment as proposed, without modification, effective October 1, 2019 in conjunction with the implementation of the PDPM.
Currently, almost 90 percent of residents in a Medicare Part A SNF stay receive therapy services. Under the current RUG-IV model, therapy services are case mix-adjusted primarily based on the therapy minutes reported on the MDS. As discussed in the proposed rule (83 FR 21065), when the original SNF PPS model was developed, most therapy services were furnished on an individual basis, and the minutes reported on the MDS served as a proxy for the staff resource time needed to provide the therapy care. Over the years, we have monitored provider behavior and have made policy changes as it became apparent that, absent safeguards like quality measurement to ensure that the amount of therapy provided did not exceed the resident's actual needs, there were certain inherent incentives for providers to furnish as much therapy as possible. Thus, for example, in the SNF PPS FY 2010 final rule (74 FR 40315 through 40319), we decided to allocate concurrent therapy minutes for purposes of establishing the RUG-IV group to which the patient belongs, and to limit concurrent therapy to two patients at a time who were performing different activities.
As we explained in the proposed rule (83 FR 21066), following the decision to allocate concurrent therapy, using STRIVE data as a baseline, we found two significant provider behavior changes with regard to therapy provision under the RUG-IV payment system. First, there was a significant decrease in the amount of concurrent therapy that was provided in SNFs. Simultaneously, we observed a significant increase in the provision of group therapy, which was not subject to allocation at that time. We concluded that the manner in which group therapy minutes were counted in determining a patient's RUG-IV group created a payment incentive to provide group therapy rather than individual therapy or concurrent therapy, even in cases where individual therapy (or concurrent therapy) was more appropriate for the resident. Thus, we stated that we made two policy changes regarding group therapy in the FY 2012 SNF PPS final rule (76 FR 48511 through 48517). We defined group therapy as exactly four residents who are performing the same or similar therapy activities. Additionally, we allocated group therapy among the four patients participating in group therapy—meaning that the total amount of time that a therapist spent with a group will be divided by 4 (the number of patients that comprise a group) to establish the RUG-IV group to which the patient belongs.
We stated in the proposed rule (83 FR 21066) that since we began allocating group therapy and concurrent therapy, these modes of therapy (group and concurrent) represent less than one percent of total therapy provided to SNF residents. Table 36, which appeared in the FY 2014 SNF PPS Proposed Rule (78 FR 26464) (and was also presented in the FY 2019 SNF PPS proposed rule) and sets forth our findings with respect to the effect of policies finalized in the FY 2012 SNF PPS Final Rule, demonstrates the change in therapy provision between the STRIVE study and the implementation of the therapy policy changes in FY 2012. As we noted in the proposed rule, the distribution of therapy modes presented in Table 36 reflecting therapy provision in FY 2012 is also an accurate reflection of current therapy provision based on resident data collected in the QIES Database and continued monitoring of therapy utilization.
As we explained in the proposed rule (83 FR 21066), based on our prior experience with the provision of concurrent and group therapy in SNFs, we again were concerned that if we were to implement the proposed SNF PDPM, providers may base decisions regarding the particular mode of therapy to use for a given resident on financial considerations rather than on the clinical needs of SNF residents. We stated that because the proposed SNF PDPM would not use the minutes of therapy provided to a resident to classify the resident for payment purposes, we were concerned that SNFs may once again become incentivized to emphasize group and concurrent therapy, over the kind of individualized therapy which is tailored to address each beneficiary's specific care needs which we believe is generally the most appropriate mode of therapy for SNF residents. As we stated in the FY 2012 proposed rule (76 FR 26387), while group therapy can play an important role in SNF patient care, group therapy is not appropriate for either all patients or for all conditions, and is primarily effective as a supplement to individual therapy, which we maintain should be considered the primary therapy mode and standard of care in therapy services provided to SNF residents. We stated in the FY 2012 proposed rule that, as evidenced by the application of a cap on the amount of group therapy services that may be provided to SNF residents, we do not believe that a SNF providing the preponderance of therapy in the form of group therapy would be demonstrating the intensity of therapy appropriate to this most frail and vulnerable nursing home population.
We stated in the FY 2019 SNF PPS proposed rule (83 FR 21066) that since the inception of the SNF PPS, we have limited the amount of group therapy provided to each SNF Part A resident to 25 percent of the therapy provided to them by discipline. We referred to the FY 2000 final rule (64 FR 41662), where we stated that although we recognize that receiving PT, OT, or ST as part of a group has clinical merit in select situations, we do not believe that services received within a group setting should account for more than 25 percent of the Medicare resident's therapy regimen during the SNF stay.
We explained that although we recognize that group and concurrent therapy may have clinical merit in specific situations, we also continue to believe that individual therapy is generally the best way of providing therapy to a resident because it is most tailored to that specific resident's care needs. As such, we stated that individual therapy should represent the majority of the therapy services received by SNF residents both from a clinical and payment perspective. As we stated in the FY 2012 proposed rule (76 CFR 26372), even under the previous RUG-53 model, it was clear that the predominant mode of therapy that the payment rates were designed to address was individual therapy rather than concurrent or group therapy.
We stated in the proposed rule (83 FR 21066) that to help ensure that SNF residents would receive the majority of therapy services on an individual basis, if we were to implement the proposed PDPM, we believed concurrent and group therapy combined should be limited to no more than 25 percent of a SNF resident's therapy minutes by discipline. In combination, this limit would ensure that at least 75 percent of a resident's therapy minutes are provided on an individual basis. We stated that because the change in how therapy services would be used to classify residents under the proposed PDPM gives rise to the concern that providers may begin to utilize more group and concurrent therapy due to financial considerations, we proposed to set a combined 25 percent limit on concurrent therapy and group therapy for each discipline of therapy provided. For example, if a resident received 800 minutes of physical therapy, no more than 200 minutes of this therapy could be provided on a concurrent or group basis. Finally, we noted that under RUG-IV, we currently allocate minutes of therapy because we pay for therapy based on therapy minutes and not resident characteristics. We stated that given that therapy minutes would no longer be a factor in determining payment classifications for residents under the proposed PDPM, we would utilize the total, unallocated number of minutes by therapy mode reported on the MDS, to determine compliance with the proposed limit. We explained that utilizing unallocated therapy minutes also serves to underscore the patient-driven nature of the PDPM, as it focuses the proposed limit on concurrent and group therapy on the way in which the therapy is received by the beneficiary, rather than furnished by the therapist, and would better ensure that individual therapy represents at least a vast majority of the therapy services received by a resident.
In the proposed rule (83 FR 21067), we considered other possible limits, and even no limit, on group and concurrent therapy. For example, we considered placing no limit on group or concurrent therapy, in order to afford providers the greatest degree of flexibility in designing a therapy program for each SNF resident. However, even in response to this option to have no limit on concurrent and group therapy, many commenters on the ANPRM expressed concerns regarding the lack of appropriate safeguards for ensuring that SNF residents continue to receive an appropriate level of therapy under the revised case-mix model. We stated in the proposed rule that we agree with these commenters and believe that there should be some limit on the amount of group and concurrent therapy that is provided to residents in order to ensure that residents receive an appropriate amount of individual therapy that is tailored to their specific needs. Also, in the ANPRM, we discussed the possibility of proposing a 25 percent limit on each of concurrent and group therapy, allowing for up to 50 percent of therapy services provided in the SNF to be provided in a non-individual modality. We stated in the proposed rule that this option sought to balance the flexibility afforded to therapists in designing an appropriate therapy plan that meets the needs and goals of the specific resident with the importance of ensuring that SNF residents receive an appropriate level of individual therapy. However, we were concerned that a separate 25 percent limit for group and concurrent therapy would not provide sufficient assurance that at least a majority of a resident's therapy would be provided on an individual basis.
As discussed in the proposed rule (83 FR 21067), we believe that individual therapy is usually the best mode of therapy provision as it permits the greatest degree of interaction between the resident and therapist, and should therefore represent, at a minimum, the majority of therapy provided to an SNF resident. However, we recognized that, in very specific clinical situations, group or concurrent therapy may be the more appropriate mode of therapy provision, and therefore, we stated we would want to allow providers the flexibility to be able to utilize these modes. We continued to stress that group and concurrent therapy should not be utilized to satisfy therapist or resident schedules, and that all group and concurrent therapy should be well documented in a specific way to demonstrate why they are the most appropriate mode for the resident and reasonable and necessary for his or her individual condition.
Currently the RUG-IV grouper calculates the percentage of group therapy each resident receives in the SNF based on the algorithms described in section 6.6 of the MDS RAI Manual (found at
Therefore, we proposed that at a component level (PT, OT, SLP), when the amount of group and concurrent therapy exceeds 25 percent within a given therapy discipline, that providers would receive a non-fatal warning edit on the validation report that the provider receives when submitting an assessment which would alert the provider that the therapy provided to that resident exceeded the threshold. To explain, a fatal error in the QIES ASAP system occurs when one or more items in the submitted record fail to pass the requirements identified in the MDS data submission specifications. A warning error occurs when an item or combination of items in the submitted record trigger a non-fatal edit in the QIES ASAP system. We stated that the non-fatal warning would serve as a reminder to the facility that they are out of compliance with the proposed limit for group and concurrent therapy. We also stated that, as part of our regular monitoring efforts on SNF Part A services, we would monitor group and concurrent therapy utilization under the proposed PDPM and consider making future proposals to address abuses of this proposed policy or flag providers for additional review should an individual provider consistently be found to exceed the proposed threshold after the implementation of the proposed PDPM. We noted that as the proportion of group and/or concurrent therapy (which are, by definition, non-individual modes of therapy provision) increases, the chances that the provider is still meeting the individualized needs of each resident would diminish. We stated that given that meeting the individualized needs of the resident is a component of meeting the coverage requirements for SNF Part A services, as described in section 1814(a)(2)(B) of the Act and further described in section 30 of Chapter 8 of the Medicare Benefit Policy Manual (accessible at
Commenters submitted the following comments related to the proposed revisions to the therapy policies under the PDPM. A discussion of these comments, along with our responses, appears below.
We also do not agree that setting a limit on group and concurrent therapy may restrict some patients from receiving the most appropriate mode of therapy for their individual needs. We currently have a 25 percent limit in place for group therapy and, based on our data, this limit has not restricted patients from receiving what we assume is the most appropriate amount of therapy for their individual needs. Given the stakeholders' comments that individual therapy is the most costly form of therapy along with the evidence of therapy being furnished to SNF patients on the basis of financial considerations rather than patient need, the extremely high prevalence of individual therapy would indicate that the amount of individual therapy, despite being the most costly, is the most effective for beneficiaries, which would comport with our reasons for supporting either the limit we proposed or a lower such limit. To hold otherwise would indicate that the minutes currently being reported are an inaccurate representation of the way in which therapy is currently being delivered, which could potentially constitute fraud on the part of some SNF providers. Based on the MDS assessment data mentioned above that demonstrate that almost no group or concurrent therapy is being reported on the MDS currently, the commenters' characterization of the proposed limit (which is far above the current level of furnishing such services) as insufficiently flexible would actually beg the question of why commenters would appear to believe that group and concurrent therapy would be better suited to address patient needs under PDPM rather than under RUG-IV.
Given the historical precedent of 25 percent as a therapy threshold and the very limited amount that group and concurrent therapy that has actually been reported in SNFs, we believe it is an appropriate threshold. That being said, using the new items in section O of the PPS Discharge Assessment, we will monitor therapy provision as discussed in section V.D of this final rule and we will consider policy changes as we receive data and see how therapy is being furnished under PDPM.
With regard to the “rigid” documentation requirements, we would like to remind the commenter that we did not impose new documentation requirements on SNFs with regard to concurrent and group therapy. Rather, in the FY 2012 proposed rule, we simply clarified certain already-established documentation standards (76 FR 26387 through 26388). As we wrote in the FY 2012 final rule in response to comments, since we simply clarified existing expectations, we did not agree that these documentation guidelines would increase or create undue burden on therapists, or that these guidelines create a disincentive for clinicians to perform group therapy due to increased paperwork. We stated that there should be no additional burden to provide this documentation, as it should be a standard part of any documentation. We agreed with those commenters who stated that rehabilitation professionals need to support the work they do through documentation, and that the documentation should reflect the need for skilled care and the mode of therapy provided, as well as demonstrate how the therapy provision will support patients' needs and goals. (76 FR 48516).
We continue to believe that it is vital for SNFs to document services appropriately in order to demonstrate the skilled nature and the fact that the services are reasonable and necessary. This will be especially important when the 25 percent cap on concurrent and group therapy is in place after the implementation of PDPM. We will monitor the mode of therapy given and we will be interested to see how facilities document the therapy used so we can determine whether we will increase, decrease or maintain the limit following extensive monitoring.
Regarding the request to provide additional guidance related to documentation of group and concurrent therapy, we remind commenters of the guidance provided in the FY2012 proposed rule (76 FR 26388) regarding group therapy: Because group therapy is not appropriate for either all patients or all conditions, and in order to verify that group therapy is medically necessary and appropriate to the needs of each beneficiary, SNFs should include in the patient's plan of care an explicit justification for the use of group, rather than individual or concurrent, therapy. This description should include, but need not be limited to, the specific benefits to that particular patient of including the documented type and amount of group therapy; that is, how the prescribed type and amount of group therapy will meet the patient's needs and assist the patient in reaching the documented goals. In addition, we believe that the above documentation is necessary to demonstrate that the SNF is providing services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident in accordance with section 1819(b)(2) of the Act.
While the above guidance was provided in relation to group therapy, we believe that it applies to concurrent therapy as well.
Our latest (FY 2017) data indicate that individual therapy was provided 99.77 percent of the time, meaning that group and concurrent therapy combined was reported as having been provided 0.23 percent of the time. If therapy continues to be provided in the same way, there is no reason to believe that a combined 25 percent limit on group and concurrent therapy is not a generous limit given the amount of group and concurrent therapy that has been provided under RUG IV. Therefore, we do not agree with the request to implement the separate 25 percent caps for group and concurrent therapy discussed in the ANPRM. We further disagree that CMS put restrictions on the “ability to furnish concurrent and group therapy.” We did not change any restrictions in FY 2011 and FY 2012 on the amount or type of therapy provided. The 25 percent cap on group therapy was in place since the inception of the SNF PPS. Rather, we allocated first concurrent therapy in FY 2011 (74 FR 40315-40319) and then group therapy in FY 2012 (76 FR 48511-48517) as a way to equalize payment across therapy modes and remove any financial
We appreciate the suggestion to implement a combined 25 percent group and concurrent therapy limit at the facility level rather than the patient level; however, given that a significant part of the reason we proposed a limit on group and concurrent therapy is so that patients receive therapy that reflects their individualized needs, we believe that implementing a facility based limit on concurrent and group therapy would defeat the purpose. With regard to a facility level limit, as opposed to the patient-level limit, we believe that therapy decisions should be driven by clinical standards and judgment related to an individual patient and not in relation to all patients within a facility. Utilizing a facility-level cap may allow for certain patients to receive excessive levels of group or concurrent therapy, which we do not believe would be advisable for any patient.
With regard to the comment that providers not be required to report group and concurrent therapy separately, while we have a combined cap, we believe that it is important to understand which of the two modes of therapy, concurrent or group therapy, is actually occurring in relation to this cap. Given that some commenters requested separate caps on group and concurrent therapy, we would not be in a position to assess the need for this separation in the future if group and concurrent therapy were reported under a single heading.
When a therapy student is involved with the treatment, and one of the following occurs, the minutes may be coded as concurrent therapy: The therapy student is treating one resident and the supervising therapist/assistant is treating another resident, and both residents are in line of sight of the therapist/assistant or student providing their therapy.
This instruction is describing one possible scenario. We would like to reiterate that CMS does not require students to do concurrent therapy. As stated in the FY 2012 final rule (76 FR 48511), as the therapy student is under the direction of the supervising therapist (even if no longer required to be under line-of-sight supervision), the time the student spends with a patient will continue to be billed as if it were the supervising therapist alone providing the therapy. In other words, the therapy student, for the purpose of billing, is treated as simply an extension of the supervising therapist rather than being counted as an additional practitioner.
We suspect that, as noted in the FY 2012 final rule referenced above, because we do not allow facilities to count therapy students' independent time on the MDS, many facilities rely on the MDS instructions above (allowing a therapist or assistant and a student to treat one patient each while both residents are in line of sight of the therapist/assistant or student providing their therapy) to permit them to count student concurrent therapy time. However, this should in no way be considered mandatory practice and like all concurrent therapy, should be used sparingly.
Further, as mentioned above, our most recent (FY 2017) data show that individual therapy was provided 99.77 percent of the time, meaning that group and concurrent therapy combined was reported as having been provided 0.23 percent of the time. It concerns us that commenters have stated that they are providing so much concurrent therapy with students that the 25 percent cap would be too low for them, because this would suggest that either the comments were provided mistakenly or that facilities are falsely reporting concurrent therapy as individual therapy. While we agree with commenters that the opportunity to supervise student therapists in SNFs is valuable to the education of future therapists and assistants, our data indicate that a 25 percent combined cap on group and concurrent therapy should not deter facilities from taking more therapy students. We believe the recommendation to monitor student therapy minutes along with just therapist/assistant minutes has merit and it is something we will consider for future policy making.
• 51 percent of all RV assessments showed therapy provided between 500 and 510 minutes.
• 65 percent of all RU assessments showed therapy provided between 720 and 730 minutes.
• For 88 providers, all of their RV assessments showed therapy provided between 500 and 510 minutes.
• For 215 providers, all of their RU assessments showed therapy provided between 720 and 730 minutes.
• More than one in five providers had more than 75 percent of both RU and RV assessments that showed therapy provided within 10 minutes of the minimum threshold.
This clear evidence of thresholding behavior supports our assertion regarding SNFs that are driven by payment considerations rather than therapy needs of patients. Furthermore, we received a significant number of comments from stakeholders on the proposed rule who believe that the quality and volume of therapy services are likely to diminish under PDPM. This belief is, itself, predicated on the notion that SNFs will continue to utilize financial considerations as the basis for care planning decisions. However, with better and more reliable patient diagnosis and characteristic data and given the removal of therapy service volume as a component of the payment system, we expect that we will be better positioned under PDPM to exercise our authority to make case-mix creep adjustments under section 1888(e)(4)(F) of the Act, as may be appropriate, to address any changes in payment which are merely the result of changes in the coding or classification of SNF patients that do not reflect actual changes in case mix. This type of analysis will also be a part of CMS monitoring efforts under PDPM.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposal, without modification, to set a combined 25 percent limit on group and concurrent therapy per discipline. Additionally, we are finalizing our proposal, without modification, to implement a non-fatal warning edit on the validation report upon submission when the amount of group and concurrent therapy exceeds 25 percent within a given therapy discipline, which would alert the provider to the fact that the therapy provided to that resident exceeded the threshold.
Under section 1812(a)(2)(A) of the Act, Medicare Part A covers a maximum of 100 days of SNF services per spell of illness, or “benefit period.” A benefit period starts on the day the beneficiary begins receiving inpatient hospital or SNF benefits under Medicare Part A. (See section 1861(a) of the Act; § 409.60). SNF coverage also requires a prior qualifying, inpatient hospital stay of at least 3 consecutive days' duration (counting the day of inpatient admission but not the day of discharge). (See section 1861(i) of the Act; § 409.30(a)(1)). Once the 100 available days of SNF benefits are used, the current benefit period must end before a beneficiary can renew SNF benefits under a new benefit period. For the current benefit period to end so a new benefit period can begin, a period of 60 consecutive days must elapse throughout which the beneficiary is neither an inpatient of a hospital nor receiving skilled care in a SNF. (See section 1861(a) of the Act; § 409.60). Once a benefit period ends, the beneficiary must have another qualifying 3-day inpatient hospital stay and meet the other applicable requirements before Medicare Part A coverage of SNF care can resume. (See section 1861(i); § 409.30)
While the majority of SNF benefit periods, approximately 77 percent, involve a single SNF stay, it is possible for a beneficiary to be readmitted multiple times to a SNF within a single benefit period, and such cases represent the remaining 23 percent of SNF benefit periods. For instance, a resident can be readmitted to a SNF within 30 days after a SNF discharge without requiring a new qualifying 3-day inpatient hospital stay or beginning a new benefit period. SNF admissions that occur between 31 and 60 days after a SNF discharge require a new qualifying 3-day inpatient hospital stay, but fall within the same benefit period. (See sections 1861(a) and (i) of the Act; §§ 409.30, 409.60)
Other Medicare post-acute care (PAC) benefits have “interrupted stay” policies that provide for a payment adjustment when the beneficiary temporarily goes to another setting, such as an acute care hospital, and then returns within a specific timeframe. In the inpatient rehabilitation facility (IRF) and inpatient psychiatric facility (IPF) settings, for instance, an interrupted stay occurs when a patient returns to the same facility (or in the case of an IPF, the same or another IPF) within 3 days of discharge. The interrupted stay policy for long-term care hospitals (LTCHs) is more complex, consisting of several policies depending on the length of the interruption and, at times, the discharge destination: An interruption of 3 or fewer days is always treated as an interrupted stay, which is similar to the IRF PPS and IPF PPS policies; if there is an interruption of more than 3 days, the length of the gap required to trigger a new stay varies depending on the discharge setting. In these three settings, when a beneficiary is discharged and returns to the facility within the interrupted stay window, Medicare treats the two segments as a single stay.
As we explained in the proposed rule (83 FR 21068), while other Medicare PAC benefit categories have interrupted stay policies, the SNF benefit under the RUG-IV case-mix model had no need for such a policy because, given a resident's case-mix group, payment did not change over the course of a stay. In other words, assuming no change in a
However, as described in section V.D of the proposed rule (83 FR 21068) and section V.C.4 of this final rule, we stated that the PDPM would adjust the per diem rate across the length of a stay (the variable per diem adjustment) to better reflect how and when costs are incurred and resources used over the course of the stay, such that earlier days in a given stay receive higher payments, with payments trending lower as the stay continues. In other words, the adjusted payment rate on Day 1 and Day 7 of a SNF stay may not be the same. Although we stated that we believe this variable per diem adjustment schedule more accurately reflects the increased resource utilization in the early portion of a stay for
We stated in the proposed rule (83 FR 21068) that, given the potential harm which may be caused to the resident if discharged inappropriately, and other concerns outlined previously in this section and in the proposed rule, we discussed in last year's FY 2018 ANPRM the possibility of adopting an interrupted stay policy under the SNF PPS in conjunction with the implementation of the RCS-I case-mix model. Several commenters expressed support for this interrupted stay policy in responding to the ANPRM, saying that the interrupted stay policy is in alignment with similar policies in other post-acute settings, and that a similar policy would likely be implemented under any cross-setting PAC payment system.
Thus, we proposed to implement an interrupted stay policy as part of the SNF PPS, effective beginning FY 2020 in conjunction with the proposed implementation of the SNF PDPM. Specifically, in cases where a resident is discharged from a SNF and returns to the same SNF by 12:00 a.m. at the end of the third day of the interruption window (as defined below), we proposed treating the resident's stay as a continuation of the previous stay for purposes of both resident classification and the variable per diem adjustment schedule. In cases where the resident's absence from the SNF exceeds this 3-day interruption window (as defined below), or in any case where the resident is readmitted to a different SNF, we proposed treating the readmission as a new stay, in which the resident would receive a new 5-day assessment upon admission and the variable per diem adjustment schedule for that resident would reset to Day 1. We stated in the proposed rule (83 FR 21068 through 21069) that, consistent with the existing interrupted stay policies for the IRF and IPF settings, we would define the interruption window as the 3-day period starting with the calendar day of discharge and additionally including the 2 immediately following calendar days. We stated that for the purposes of the interrupted stay policy, the source of the readmission would not be relevant. That is, the beneficiary may be readmitted from the community, from an intervening hospital stay, or from a different kind of facility, and the interrupted stay policy would operate in the same manner. We explained that the only relevant factors in determining if the interrupted stay policy would apply are the number of days between the resident's discharge from a SNF and subsequent readmission to a SNF, and whether the resident is readmitted to the same or a different SNF.
In the proposed rule (83 FR 21069), we presented the following examples, which we believed aided in clarifying how this policy would be implemented:
We note two clarifications to the preceding examples. In each of the above examples, when the beneficiary is discharged from the SNF stay, the SNF would complete the required PPS Discharge Assessment (see Table 33: PPS Assessment Schedule under PDPM). Additionally, in Example B, we inadvertently indicated in the proposed rule that the first day of the second stay would be paid at the Day 8 per diem rates. However, the first day of the second stay would actually be paid at the rate for the day of discharge, Day 7. These points are further addressed in our responses to comments below.
We also stated in the proposed rule (83 FR 21069) that we considered alternative ways of structuring the interrupted stay policy. For example, we considered possible ranges for the interrupted stay window other than the 3 calendar day window proposed. For example, we considered windows of fewer than 3 days (for example, 1 or 2 day windows for readmission), as well as windows of more than 3 days (for example, 4 or 5 day windows for readmission). However, we stated we believe that 3 days represents a reasonable window after which it is more likely that a resident's condition and resource needs will have changed. We also stated that we believe
In addition, we explained that, to determine how best to operationalize an interrupted stay policy within the SNF setting, we considered three broad categories of benefit periods consisting of multiple stays. The first type of scenario, SNF-to-SNF transfers, is one in which a resident is transferred directly from one SNF to a different SNF. The second case we considered, and the most common of all three multiple-stay benefit period scenarios, is a benefit period that includes a readmission following a new hospitalization between the two stays—for instance, a resident who was discharged from a SNF back to the community, re-hospitalized at a later date, and readmitted to a SNF (the same SNF or a different SNF) following the new hospital stay. The last case we considered was a readmission to the same SNF or a different SNF following a discharge to the community, with no intervening re-hospitalization.
We further explained that, to simplify the analysis, we primarily examined benefit periods with two stays. We stated that benefit periods with exactly two stays account for a large majority (70 percent) of all benefit periods with multiple stays, and benefit periods with more than two stays represent a very small portion (less than 7 percent) of all benefit periods overall. We therefore assume the data for cases where there are exactly two stays in a benefit period are representative of all benefit periods with multiple stays. We noted that, of cases where there are exactly two stays in a benefit period, over three quarters (76.4 percent) consist of re-hospitalization and readmission (to the same SNF or a different SNF). Discharge to the community and readmission without re-hospitalization cases represent approximately 14 percent of cases, while direct SNF-to-SNF transfers represent approximately 10 percent.
For each of these case types, in which a resident was readmitted to a SNF after discharge, we explained that we examined whether (1) the variable per diem adjustment schedule should be “reset” back to the Day 1 rates at the outset of the second stay versus “continuing” the variable per diem adjustment schedule at the point at which the previous stay ended, and (2) a new 5-day assessment and resident classification should be required at the start of the subsequent SNF stay.
With regard to the first question above, specifically whether or not a readmission to a SNF within the proposed 3-day interruption window would reset the resident's variable per diem adjustment schedule, we stated that in each of the cases described above, we were concerned generally that an interrupted stay policy that “restarts” the variable per diem adjustment schedule to Day 1 after readmissions could incentivize unnecessary discharges with quick readmissions. We explained that this concern is particularly notable in the second and third cases described above, as the beneficiary may return to the same facility. As we discussed in the proposed rule (83 FR 21069), to investigate this question, we conducted linear regression analyses to examine changes in costs in terms of both PT/OT and NTA costs per day from the first to second admission for the three scenarios described above (SNF-to-SNF direct transfers, readmissions following re-hospitalization, and readmissions following community discharge). As discussed in section V.D.4. of the proposed rule (83 FR 21060 through 21061) and in section V.C.4 of this final rule, investigations revealed that utilization of PT, OT, and NTA services changes over the course of a stay. Based on both empirical analysis and feedback from multiple technical expert panels, we determined that SLP and nursing utilization remained fairly constant over a stay. Therefore, we proposed variable per diem adjustment schedules for the PT, OT, and NTA components but not for the SLP or nursing components. We stated in the proposed rule that, because the analysis of changes in costs across two stays in a single benefit period is relevant to determining how the variable per diem payment adjustments should apply to benefit periods with multiple stays, we restricted our analysis to the three payment components for which we are proposing variable per diem adjustments (PT, OT, and NTA). For this analysis, both the re-hospitalization and community discharge cases were separated into two sub-cases: When the resident returns to the same SNF, and when the resident is admitted to a different SNF. By definition, SNF-to-SNF transfer cases always have different providers for the first and second stays. We stated in the proposed rule that the regression results showed that PT/OT costs from the first to second admission were very similar for SNF-to-SNF transfers and for readmissions to a different provider following re-hospitalization or discharge to community, suggesting that the second admission is comparable to a new stay. NTA costs from the first to second admission also were very similar for SNF-to-SNF transfers. We stated that, for readmissions following re-hospitalization or discharge to community, NTA costs for readmissions to the same provider were notably less than NTA costs for readmissions to a different provider. We explained that, overall, these results suggest that a readmission to a
We explained in the proposed rule (83 FR 21070) that with regard to the question of whether or not SNFs would be required to complete a new 5-day assessment and reclassify the resident after returning to the SNF within the proposed 3-day interruption window, we investigated changes in resident characteristics from the first to the second stay within a benefit period. First, we looked at changes in clinical categories from the first to second stay for residents with an intervening re-hospitalization. We explained that this analysis could only be conducted for residents with a re-hospitalization because, as described in section 3.10.2. of the SNF PMR technical report, for research purposes, classification into clinical categories was based on the diagnosis from the prior inpatient stay. We stated that for those residents who had a re-hospitalization and were readmitted to a SNF (either the same or a different SNF), and therefore, could be reclassified into a new clinical category (because of new diagnostic information as a result of the intervening re-hospitalization), we found that a majority had the same clinical category for both the first and second admission. We further explained that because we could not conduct this investigation for SNF-to-SNF transfers or community discharge cases (as they lack a new hospitalization), we separately investigated changes in function from the first to second stay for SNF-to-SNF transfers and for readmissions following community discharge. We found that in a large majority of cases, there was no change in function from the first to second stay, regardless of whether the second provider was the same or different as the first provider. Thus, we stated we believe it would be appropriate to maintain the classification from the first stay for those residents returning to the same SNF no more than 3 calendar days after discharge from the same facility. However, we stated that because we proposed to exclude from the interrupted stay policy readmissions to a different SNF (regardless of the number of days between admissions) and readmissions to the same SNF when the gap between admissions is longer than 3 days, and to treat these readmissions as new stays for purpose of the variable per diem adjustment schedule, we believe it would be appropriate and consistent to treat these cases as new stays for purposes of clinical classification and to require a new 5-day PPS assessment. More information on these analyses can be found in section 3.10.2. of the SNF PMR technical report available at
We also noted that we believe that frequent SNF readmissions may be indicative of poor quality care being provided by the SNF. Given this belief, we stated we plan to monitor the use of this policy closely to identify those facilities whose beneficiaries experience frequent readmission, particularly facilities where the readmissions occur just outside the 3-day window used as part of the proposed interrupted stay policy. We stated that should we discover such behavior, we would flag these facilities for additional scrutiny and review and consider potential policy changes in future rulemaking.
We invited comments on the proposals outlined above. Commenters submitted the following comments related to the proposed rule's discussion of the proposed interrupted stay policy under the PDPM. A discussion of these comments, along with our responses, appears below.
We do not believe that facilities have cause for reluctance to admit patients who are at high risk of changes in care needs. The optional IPA allows for patients to be reclassified in cases of significant changes in care needs.
With regard to the question of the IPA resetting the variable per diem adjustment, this issue is addressed in our responses to comments in section V.D. of this final rule.
With regard to the question of interruptions of 3 or less days resetting the variable per diem adjustment, as we stated in the proposed rule, our analyses found that some costs, specifically NTA costs, are notably higher for cases where the gap is longer than 3 days, compared to cases where the interruption is 3 or less days, where costs are more similar to uninterrupted stays. We believe this supports the use of a 3-day gap as the metric for when to reset the variable per diem adjustment.
Regarding any current alignment of quality measures and the monitoring of unnecessary discharges, we interpret the commenter to be suggesting that CMS does not currently have in place quality measures that address unnecessary discharges to the hospital during the SNF Stay. We disagree with this assertion in that CMS has developed and implemented a hospital readmission measure for SNF.
With regard to whether providers would be required to report on the claim form when a patient is readmitted or an evaluation is completed for such a patient, we do not anticipate such changes in claims reporting, though we would have providers report on the claim when an interrupted stay occurred.
With regard to managing the assessment schedule and payment schedule, we would refer commenters to the assessment schedule discussed in section V.D of this final rule, which outlines both the assessment calendar and payment timeline for each assessment under PDPM.
We disagree that not performing an assessment for all returning patients creates unneeded risk. We believe that the new assessment schedule we proposed achieves efficiencies in terms of provider burden while still providing enough data to accurately monitor provider behavior, changes in patient condition, and outcomes via the 5-day assessment, IPA assessments, and discharge assessments. While a 5-day assessment would not be required upon readmission in the case of an interrupted stay, the provider has the option of completing an IPA as it determines appropriate to assess whether the patient's condition and care needs have changed.
While we appreciate the commenter's concern, we believe the use of the number of days between discharge and readmission to determine whether there is an interrupted stay is appropriate. As described in the proposed rule, our analyses found that some types of costs, notably NTA costs, tend to be higher for cases where the gap is longer than 3 days, suggesting that such stays are more like new stays than continuing stays and thus supporting the 3-day metric for resetting the variable per diem schedule. The length of the interruption is also used in determining whether there is an interrupted stay in other Medicare post-acute payment systems and we expect that its use here will be just as effective.
With regard to the commenters' recommendation that a 5-day assessment be completed upon readmission after an interrupted stay, we believe that this would constitute an unnecessary burden on providers, particularly given the provider's option to complete an IPA upon readmission to the SNF. We also do not believe a 5-day assessment is necessary upon readmission after an interrupted stay of 3 days or less. While we found that PT and OT costs for cases where the gap is longer than 3 days are similar to PT and OT costs for cases where the gap is shorter than 3 days, NTA costs are notably higher for cases where the gap is longer than 3 days. We explained that this provides further support for resetting the variable per diem schedule for cases where the gap is longer than 3 days (as costs tend to be higher, similar to a new stay). As discussed in section 3.10 of the SNF PMR technical report, our analyses also showed that clinical category (in cases with an intervening re-hospitalization) and functional status (in cases involving SNF-to-SNF transfers and readmissions following community discharge) tended not to change between the first stay and the second stay in an interrupted stay of 3 days or less. Thus, we believe our research suggests that stays with interruptions of 3 days or less are more similar in cost to uninterrupted stays and are less likely to involve significant changes in patient condition or function. Therefore, we do not agree that a 5-day assessment should be required upon readmission after an interrupted stay, or that it is appropriate to reset the variable per diem adjustment schedule to day 1 after an interrupted stay.
We agree with the commenter that the patient's condition should be the most relevant factor in determining the need for a new assessment, and CMS has given providers the option of performing an IPA at their discretion based on changing conditions. As we explained previously, if a new condition is coded on an IPA, the SNF PPS per diem payment for the patient could increase to reflect changes in the patient's clinical condition if there is a change in the patient's case-mix group.
The commenter described a sequence of assessments and events that the commenter stated would occur under the current payment system if Example B on page 21069 were to occur: 5-day assessment, NPE, discharge of less than 3 days, 5-day assessment, and final NPE. This would be counted as two Medicare stays for SNF QRP.
The commenter then described how this sequence might differ under the new system, depending on whether the NPE is required or not. In Example B, if the NPE was required on day 7 when the resident was discharged, but a new 5-day assessment was not required when the resident returned within the interruption window, then the sequence of assessments and events would be: 5-day assessment, NPE, interrupted stay, NPE. This would result in one unmatched stay (between the return from the interrupted stay to the final NPE) and one matched stay.
In Example B, if the NPE is not required on day 7 when the resident discharges for less than 3 days, the sequence would be: 5-day assessment, interrupted stay, NPE. This would result in only one Medicare stay.
The commenter requested clarification on how the Medicare stays will be calculated with the interrupted stay policy, presumably for the purposes of the QRP, and recommended evaluation by the SNF QRP CMS team to evaluate any further risks, errors, or concerns that may arise from this proposed policy.
The day of discharge in an interrupted stay would not be counted against the beneficiary's count of 100 days of covered Part A care in a benefit period. SNFs are not currently paid for the day of discharge, even with an anticipated leave of absence, unless the patient returns to the SNF before midnight of the same day. We do not believe there is anything about the interrupted stay policy that warrants changing this.
Accordingly, after considering the comments received, for the reasons discussed in the proposed rule and in this final rule, we are finalizing our proposed interrupted stay policy without modification, to be effective October 1, 2019 in conjunction with the implementation of the PDPM.
As discussed in the proposed rule (83 FR 21070), the establishment of the SNF PPS did not change Medicare's fundamental requirements for SNF coverage. However, because the case-
As further discussed below, in the proposed rule (83 FR 21070-72), we proposed to adopt a similar approach under the PDPM effective October 1, 2019, by retaining an administrative presumption mechanism that would utilize the initial assignment of one of the case-mix classifiers that we designate for this purpose to assist in making certain SNF level of care determinations. This designation would reflect an administrative presumption under the PDPM that beneficiaries who are correctly assigned one of the designated case-mix classifiers on the initial 5-day, Medicare-required assessment are automatically classified as meeting the SNF level of care definition up to and including the assessment reference date on the 5-day Medicare required assessment.
We stated that, as under the existing RUG-IV administrative presumption, a beneficiary who is not assigned one of the designated classifiers would not automatically be classified as either meeting or not meeting the level of care definition, but instead would receive an individual level of care determination using the existing administrative criteria. We stated that the use of the administrative presumption reflects the strong likelihood that those beneficiaries who are assigned one of the designated classifiers during the immediate post-hospital period require a covered level of care, which would be less likely for other beneficiaries.
In the ANPRM (82 FR 21007), we discussed some potential adaptations of the RUG-IV model's administrative presumption to accommodate specific features of the RCS-I model, including the possible designation of the following case-mix classifiers for purposes of the administrative presumption:
• Continued designation of the same nursing (non-rehabilitation) groups that currently comprise the Extensive Services, Special Care High, Special Care Low, and Clinically Complex categories under RUG-IV, as those groups would crosswalk directly from RUG-IV to the RCS-I model we were considering;
• In addition, designation of the most intensive functional score (14 to 18) under the RCS-I model's combined PT/OT component, as well as the uppermost comorbidity score (11+) under its NTA component.
In response, a number of comments expressed concern that the possible adaptations of the presumption could adversely affect access to care for some beneficiaries. Others questioned whether using the PT/OT component's highest functional score bin (14 to 18) as a trigger for the presumption would be appropriate, inasmuch as the residents that typically require the most therapy are those with only moderate functional impairments. In addition, commenters questioned the discussion's inclusion of the RCS-I model's NTA component as a possible classifier under the presumption, as well as its omission of RCS-I's SLP component.
Regarding the commenters' concerns about access to care, we noted in the proposed rule that we have indicated in the ANPRM and in previous rulemaking that the actual purpose of the level of care presumption has always been to afford a streamlined and simplified administrative procedure for readily identifying those beneficiaries with the
As for concerns about the appropriateness of certain classifiers, including the possible use of the PT/OT component's highest functional score bin (14 to 18) for this purpose under RCS-I, we noted in the proposed rule that the case-mix classification model for PT and OT that we were proposing in connection with the PDPM would essentially reconfigure the PT/OT component from the RCS-I model. As discussed in section V.D.3.b. of the proposed rule, the proposed PDPM would divide the RCS-I model's combined PT/OT component into two separate case-mix adjusted components, under which each resident would be assigned separate case-mix groups for PT and OT payment. Those groups would classify residents based on clinical category and function score, the two resident characteristics shown to be most predictive of PT and OT utilization.
The proposed rule's discussion also cited section III.B.4. of the ANPRM (“Variable Per Diem Adjustment Factors and Payment Schedule”), as well as section V.D.4. of the proposed rule itself, which indicated that our initial analyses revealed that in contrast to the SLP component—where per diem costs remain relatively constant over time—costs for the PT, OT, and NTA components typically are highest at the outset and then decline over the course of the stay. The proposed rule noted that our research to date continues to show a strong correlation between the dependent variables used for the proposed separate PT and OT components and a similarity in predictors, in that the associated costs for both therapy disciplines remain highest in the initial (and typically most intensive) portion of the SNF stay. We stated that this heightened resource intensity during the initial part of the SNF stay under the PT, OT, and NTA components, in turn, more closely reflects the distinctive utilization patterns that served as the original foundation for the level of care presumption itself—that is, the tendency as noted in the FY 2000 SNF PPS final rule for SNF stays to be at their most intensive and unstable immediately following admission as justifying a presumption of coverage at the very outset of the SNF stay (64 FR 41667, July 30, 1999). We also stated that we believe this would make the most intensive classifiers within each of these three proposed components well-suited to serve as clinical proxies for identifying those beneficiaries with the most intensive care needs and greatest likelihood of requiring an SNF level of care.
Accordingly, for purposes of the administrative presumption under the proposed PDPM, we proposed to continue utilizing the same designated nursing (non-rehabilitation) categories under the PDPM as had been used to
• Extensive Services;
• Special Care High;
• Special Care Low; and,
• Clinically Complex.
In addition, along with the continued use of the RUG-IV nursing categories above, we also proposed to apply the administrative presumption using those other classifiers under the proposed PDPM that we identified as relating the most directly to identifying a patient's need for skilled care at the outset of the SNF stay. We proposed to designate such classifiers for this purpose based on their ability to fulfill the administrative presumption's role as described in the FY 2000 SNF PPS final rule (64 FR 41668 through 41669, July 30, 1999)—that is, to identify those situations that involve a high probability of the need for skilled care when taken in combination with the characteristic tendency for an SNF resident's condition to be at its most unstable and intensive state at the outset of the SNF stay.
Specifically, we additionally proposed to designate for this purpose proposed PT and OT case-mix groups TB, TC, TD, TF, and TG, the groups displayed in Table 21 of the proposed rule that collectively accounted for the five highest case-mix indexes for PT, as well as for OT and, thus, would consistently be associated with the most resource-intensive care across both of these therapy disciplines. We also proposed to designate the uppermost comorbidity group under the NTA component, in the belief that this particular classifier would serve to identify those cases that are the most likely to involve the kind of complex medication regimen (for example, a highly intensive drug requiring specialized expertise to administer, or an exceptionally large and diverse assortment of medications posing an increased risk of adverse drug interactions) that would require skilled oversight to manage safely and effectively. As discussed in section V.D.3.e of this final rule, the specific value assigned to the NTA component's uppermost comorbidity score (which was 11+ under the RCS-I model and is 12+ under PDPM) might change once again in the future if the NTA score bins are reconfigured to reflect changes in the resident population and care practices over time.
We further explained that under this proposed approach, those residents not classifying into a case-mix group in one of the designated nursing RUG categories under the proposed PDPM on the initial, 5-day Medicare-required assessment could nonetheless still qualify for the administrative presumption on that assessment by being placed in one of the designated case-mix groups for either the PT or OT components, or by receiving the uppermost comorbidity score under the NTA component. We indicated that these particular case-mix classifiers would appropriately serve to fulfill the administrative presumption's role of identifying those cases with the highest probability of requiring an SNF level of care throughout the initial portion of the SNF stay. We additionally noted that in order to help improve the accuracy of these newly-designated groups in serving this function, we would continue to review the new designations going forward and may make further adjustments to the proposed designations over time as we gain actual operating experience under the new classification model. As discussed above, this proposed administrative presumption mechanism would take effect October 1, 2019 in conjunction with the proposed PDPM itself. We invited comments on our proposed administrative presumption mechanism under the proposed PDPM.
Commenters submitted the following comments related to the proposed rule's discussion on our proposed administrative presumption mechanism under the proposed PDPM. A discussion of these comments, along with our responses, appears below.
However, we would also note in this context that we do not share and cannot support the view that would essentially equate a given case-mix classifier's non-designation under the administrative presumption with a restriction on access or a denial of SNF coverage, or an increase in administrative burden. SNF coverage ultimately is based not on whether a beneficiary is assigned one of the designated classifiers, but on whether the SNF level of care criteria are met. As further explained in the proposed rule (83 FR 21071), the purpose of the administrative presumption is solely to afford a streamlined and simplified administrative procedure for readily identifying those beneficiaries with the
Accordingly, for the reasons set forth in the proposed rule and in this final rule, we are finalizing our proposed classifiers for purposes of applying the administrative presumption under the PDPM with the following modifications. As discussed above, we are adding the following PT and OT classifiers to those we proposed: TA, TE, TJ, TK, TN and TO. We are also adding the following 8 SLP classifiers: SC, SE, SF, SH, SI, SJ, SK, and SL. Thus, effective October 1, 2019, we are designating the classifiers shown below for purposes of the administrative presumption under the PDPM:
• The case-mix classifiers in the following nursing categories: Extensive Services, Special Care High, Special Care Low, and Clinically Complex;
• The following PT and OT groups: TA, TB, TC, TD, TE, TF, TG, TJ, TK, TN, and TO;
• The following SLP groups: SC, SE, SF, SH, SI, SJ, SK, and SL; and
• The NTA component's uppermost comorbidity group (which, as finalized in this final rule, is 12+).
As discussed in section V.I. of the proposed rule (83 FR 21072) and also in section III.E. of the ANPRM (82 FR 21007), section 511(a) of the MMA amended section 1888(e)(12) of the Act to provide for a temporary increase of 128 percent in the PPS per diem payment for any SNF residents with Acquired Immune Deficiency Syndrome (AIDS), effective with services furnished on or after October 1, 2004. This special add-on for SNF residents with AIDS was intended to be of limited duration, as the MMA legislation specified that it was to remain in effect only until the Secretary certifies that there is an appropriate adjustment in the case mix to compensate for the increased costs associated with such residents.
The temporary add-on for SNF residents with AIDS is also discussed in Program Transmittal #160 (Change Request #3291), issued on April 30, 2004, which is available online at
In the House Ways and Means Committee Report that accompanied the MMA, the explanation of the MMA's temporary AIDS adjustment notes the following under
As we noted in the ANPRM and in the proposed rule, at that point over a decade and a half had elapsed since the Urban Institute conducted its study on AIDS patients in SNFs, a period that has seen major advances in the state of medical practice in treating this condition. We stated that these advances have notably included the introduction of powerful new drugs and innovative prescription regimens that have dramatically improved the ability to manage the viral load (the amount of human immunodeficiency virus (HIV) in the blood). We noted that the decrease in viral load secondary to medications has contributed to a shift from intensive nursing services for AIDS-related illnesses to an increase in antiretroviral therapy. We further stated that this phenomenon, in turn, is reflected in our recent analysis of differences in SNF resource utilization, which indicates that while the overall historical disparity in costs between AIDS and non-AIDS patients has not entirely disappeared, that disparity is now far greater with regard to drugs than it is for nursing. Specifically, as explained in the proposed rule, NTA costs per day for residents with AIDS were 151 percent higher than those for other residents while the difference in wage-weighted nursing staff time between the two groups was only 19 percent, as discussed in section 3.8.3. of the SNF PMR technical report (available at
As discussed in the proposed rule, in response to the ANPRM, we received comments expressing concerns that a projected 40 percent drop in overall payments for SNF residents with AIDS under the RCS-I model could adversely affect access to care for this patient population. Regarding those concerns, we noted in the proposed rule that the special add-on for SNF residents with AIDS itself was never meant to be permanent, and does not serve as a specific benchmark for use in establishing either the appropriate methodology or level of payment for this patient population. Rather, we stated that, as discussed in the ANPRM, it was designed to be only a temporary measure, representing a general approximation that reflected the current state of research and clinical practice at the time (82 FR 21007 through 21008). As such, we stated that the special add-on would not account for the significant changes in the care and treatment of this condition that have occurred over the intervening years. We further noted that as a simple across-the-board multiplier, the MMA adjustment by its very nature is not accurately targeted at those particular rate components that actually account for the disparity in cost between AIDS patients and others.
As discussed in section V.D.3.e. of the proposed rule (83 FR 21058), our updated investigations into the adequacy of payments under the proposed PDPM for residents with HIV/AIDS indicated that the four proposed ancillary payment components (PT, OT, SLP, and NTA) would adequately reimburse ancillary costs associated with HIV/AIDS residents (see section 3.8.2. of the SNF PDPM technical report, available at
In the proposed rule, we expressed the belief that when taken collectively, these adjustments under the proposed PDPM would appropriately serve to justify issuing the certification prescribed under section 511(a) of the MMA effective with the proposed conversion to the PDPM on October 1, 2019, thus permitting the MMA's existing, temporary AIDS add-on to be replaced by a permanent adjustment in the case mix (as proposed under the PDPM) that appropriately compensates for the increased costs associated with these residents, and we invited comments on this proposal. At the same time, we acknowledged that even with an accurately targeted model that compensates for the increased costs of SNF residents with AIDS, an abrupt conversion to an altogether different payment methodology might nevertheless be potentially disruptive for facilities, particularly those that serve a significant number of patients with AIDS and may have become accustomed to operating under the
Commenters submitted the following comments related to the proposed rule's discussion on the Effect of the Proposed PDPM on Temporary AIDS Add-on Payment. A discussion of these comments, along with our responses, appears below.
Regarding that final point about the imprecision of applying an across-the-board multiplier in this context, we further noted in the proposed rule (83 FR 20180) that our research found that HIV/AIDS was associated with a negative and statistically significant decrease in PT, OT and SLP costs per day. This means inherently that, to the extent that the existing add-on is applied against the full SNF PPS per diem payment, the magnitude of the add-on payment increases with increases in therapy payment, which conflicts with the data described above regarding the relationship between therapy costs and the presence of an AIDS diagnosis. As a result, maintaining the current add-on would create an inconsistency between how SNF payments would be made and the data regarding AIDS diagnoses and resident therapy costs.
Furthermore, to the extent that the RUG-IV model's case-mix classification system may have included inherent incentives toward the overprovision of therapy services, the MMA adjustment's operation as an across-the-board multiplier would actually serve to magnify the effects of any such incentives, by inflating the resulting payment levels even further beyond the patient's actual therapy care needs. In this context, we note that the specific standard prescribed for the Secretary's required certification under section 511(a) of the MMA is that “. . . there is an appropriate adjustment in the case mix . . . to compensate for the increased costs” associated with SNF residents with AIDS. As set forth in the proposed rule, we believe that the PDPM's payment methodology for patients with AIDS clearly meets this statutory standard of appropriately accounting for the actual costs incurred in caring for such patients. In fact, we believe it provides a far more accurate and current accounting of those costs than the temporary MMA adjustment that it would replace, which represents only a very broad approximation that was developed at a time when the treatment regimens for this condition differed dramatically from what they are currently. Finally, it is worth noting that the cited 2017 MedPAC report, which characterized the SNF PPS's NTA payments as poorly targeted, reflected that the SNF PPS has always included NTA costs within its nursing component rather than accounting for them separately, and the longstanding concerns about that approach were, in fact, the very impetus behind our development of a separate component for NTA costs under the PDPM.
Accordingly, for the reasons discussed in the proposed rule and in this final rule, the Secretary is certifying that there is an appropriate adjustment in the PDPM to compensate for the increased costs associated with residents with AIDS, and thus we are finalizing our proposal without modification to replace the temporary MMA add-on with the PDPM's permanent adjustment in the case mix that appropriately accounts for the increased costs of patients with AIDS, effective with the conversion to the PDPM on October 1, 2019.
This section outlines the projected impacts of implementing the PDPM effective October 1, 2019 under the SNF PPS and the related policies finalized in sections V of this final rule that would be effective in conjunction with the PDPM. This impact analysis makes a series of assumptions, as described below (as were discussed in the proposed rule (83 FR 21073 through 21080)). First, the impacts presented here assume consistent provider behavior in terms of how care is provided under RUG-IV and how care might be provided under the PDPM, as we do not make any attempt to anticipate or predict provider reactions to the implementation of the PDPM. That being said, we acknowledge the possibility that implementing the PDPM could substantially affect resident care and coding behaviors. Most notably, based on the concerns raised during a number of TEPs, we acknowledge the possibility that, as therapy payments under the PDPM would not have the same connection to service provision as they do under RUG-IV, it is possible that some providers may choose to reduce their provision of therapy services to increase margins under the PDPM. However, we do not have any basis on which to assume the approximate nature or magnitude of these behavioral responses, nor have we received any sufficiently specific guidance on the likely nature or magnitude of behavioral responses from ANPRM commenters, TEP panelists, or other sources of feedback. As a result, lacking an appropriate basis to forecast behavioral responses, we do not adjust our analyses of resident and provider impacts discussed in this section for projected changes in provider behavior. However, we do intend to monitor behavior which may occur in response to the implementation of PDPM, and may consider proposing policies in the future to address such behaviors to the extent determined appropriate.
As with prior system transitions, we proposed to implement the PDPM case-mix system, along with the other policy changes discussed throughout this section, in a budget neutral manner through application of a parity adjustment to the case-mix weights under the proposed PDPM, as further discussed below. We proposed to implement the PDPM in a budget neutral manner because, as with prior system transitions, in proposing changes to the case-mix methodology, we do not intend to change the aggregate amount of Medicare payments to SNFs. Rather, we aim to utilize a case-mix methodology to classify residents in such a manner as to best ensure that payments made for specific residents are an accurate reflection of resource utilization without introducing potential incentives which could encourage inappropriate care delivery, as we believe may exist under the current case-mix methodology. Therefore, the impact analysis presented here assumes implementation of these proposed changes in a budget neutral manner. We invited comments on the proposal, as further discussed below, to implement the PDPM in a budget neutral manner. In addition, we solicited comment on whether it would be appropriate to implement the proposed PDPM in a manner that is not budget neutral.
As discussed above, the impact analysis presented here assumes implementation of these changes in a budget neutral manner without a behavioral change. The prior sections describe how case-mix weights are set to reflect relative resource use for each case-mix group. We stated in the proposed rule that the proposed PDPM payment before application of a parity adjustment would be calculated using the unadjusted CMI for each component, the variable per diem payment adjustment schedule, the unadjusted urban and rural federal per diem rates shown in Tables 12 and 13, the labor-related share, and the geographic wage indexes. In applying a parity adjustment to the case-mix weights, we stated in the proposed rule that we would maintain the relative value of each CMI but would multiply every CMI by a ratio to achieve parity in overall SNF PPS payments under the PDPM and under the RUG-IV case-mix model. The parity adjustment multiplier was calculated through the following steps, as described in the proposed rule (83 FR 21074). First, we calculated RUG-IV total payment. Total RUG-IV payments were calculated by adding total allowed amounts across all FY 2017 SNF claims. The total allowed amount in the study population was the summation of Medicare and non-Medicare payments for Medicare-covered days. More specifically, it was the sum of Medicare claim payment amount, National Claim History (NCH) primary payer claim paid amount, NCH beneficiary inpatient deductible amount, NCH beneficiary Part A coinsurance liability amount, and NCH beneficiary blood deductible liability amount. Second, we calculated what total payment would have been under the proposed PDPM in FY 2017 before application of the parity adjustment. Total estimated payments under PDPM were calculated by summing the predicted payment for each case-mix component together for all FY 2017 SNF stays. This represented the total allowed amount if PDPM had been in place in FY 2017. Total estimated FY 2017 payments under the PDPM were calculated using resident information from FY 2017 SNF claims, the MDS assessment, and other Medicare claims, as well as the unadjusted CMI for each component, the variable per diem payment adjustment schedule, the unadjusted urban and rural federal per diem rates shown in Tables 12 and 13, the labor-related share, and the geographic wage indexes. After calculating total actual RUG-IV payments and total estimated case-mix-related PDPM payments, we subtracted non-case-mix component payments from total RUG-IV payments, as this component does not change across systems. This subtraction did not include the temporary add-on for residents with HIV/AIDS in the RUG-IV system, which PDPM replaces with additional payments for residents with HIV/AIDS through the NTA and nursing components (as discussed in section V.I. of the proposed rule and section V.H. of this final rule). By retaining the portion of non-case-mix component payments associated with the temporary HIV/AIDS add-on in total RUG-IV payments, all payments associated with the add-on under RUG-IV were re-allocated to the case-mix-adjusted components in PDPM. This was appropriate because, as discussed, under the PDPM, additional payments for residents with HIV/AIDS are made exclusively through the case-mix-adjusted components (that is, the nursing and NTA components). Lastly, in calculating budget neutrality, we set total estimated case-mix-related payment under PDPM such that it equals total allowable Medicare payments under RUG-IV. To do this, we divided the remaining total RUG-IV payments over the remaining total estimated PDPM payments prior to the parity adjustment. This division yielded a ratio (parity adjustment) of 1.46 by which the PDPM CMIs were multiplied so that total estimated payments under the PDPM would be equal to total actual payments under RUG-IV, assuming no changes in the population, provider behavior, and coding. We stated in the proposed rule that, if this parity adjustment had not been applied, total estimated payments under the PDPM would be 46 percent lower than total actual payments under RUG-IV, therefore the implementation of the PDPM would not be budget neutral. More details regarding this calculation and analysis are described in section 3.11.2. of the SNF PDPM technical report (available at
The projected resident-level impacts are presented in Table 37. The first column identifies different resident subpopulations and the second column
The projected provider-level impacts are presented in Table 38. The first column identifies different facility subpopulations and the second column shows what percentage of SNFs in FY 2017 are represented by the given subpopulation. The third column shows the projected change in total payments for facilities in a given subpopulation, represented as a percentage change in actual FY 2017 payments made for that subpopulation under RUG-IV versus estimated payments which would have been made to that subpopulation in FY 2017 had the PDPM been in place. Total RUG-IV payments are calculated by adding total allowed amounts across all FY 2017 SNF claims associated with a facility subpopulation. The total allowed amount in the study population is the summation of Medicare and non-Medicare payments for Medicare-covered days. More specifically, it is the summation of Medicare claim payment amount, NCH primary payer claim paid amount, NCH beneficiary inpatient deductible amount, NCH beneficiary Part A coinsurance liability amount, and NCH beneficiary blood deductible liability amount. Payments corresponding to the non-case-mix component are subtracted from the RUG-IV total payments, not including the portion of non-case-mix payments corresponding to the temporary add-on for residents with HIV/AIDS. Total estimated payments under PDPM are calculated by summing the predicted payment for each case-mix component together for all FY 2017 SNF stays associated with a facility subpopulation. Positive changes in this column represent a projected positive shift in payments for that subpopulation under the PDPM, while negative changes in this column represent projected negative shifts in payment for that subpopulation. More information on the construction of current payments under RUG-IV and payments under the PDPM for purposes of this impact analysis can be found in section 3.12. of the SNF PDPM technical report (available at
We proposed to implement the PDPM effective beginning in FY 2020 (that is, October 1, 2019). This effective date would incorporate a 1-year period to allow time for provider education and training, internal system transitions, and to allow states to make any Medicaid program changes which may be necessary based on the changes related to PDPM.
With regard to the changes finalized in this rule, we provide our reasons for each change throughout the subsections above. Below in this section, we discuss alternatives we considered which relate generally to implementation of the PDPM.
When making major system changes, CMS often considers possible transition options for providers and other stakeholders between the former system and the new system. For example, when we updated OMB delineations used to establish a provider's wage index under the SNF PPS in FY 2015, we utilized a blended rate in the first year of implementation, whereby 50 percent of the provider's payment was derived from their former OMB delineation and 50 percent from their new OMB delineation (79 FR 45644-45646).
However, due to the fundamental nature of the change from the current RUG-IV case-mix model to the PDPM, which includes differences in resident assessment, payment algorithms, and other policies, as we stated in the proposed rule (83 FR 21079), we believe that proposing a blended rate for the whole system (that would require two full case-mix systems—RUG-IV and the PDPM—to run concurrently) is not advisable as part of any transition strategy for implementing the PDPM, due to the significant administrative and logistical issues that would be associated with such a transition strategy. Specifically, CMS and providers would be required to manage both the RUG-IV payment model and PDPM simultaneously, creating significant burden and undue complexity for all involved parties. Furthermore, providers would be required to follow both sets of MDS assessment rules, each of which carries with it its own level of complexity. CMS would also be required to process assessments and claims under each system, which would entail a significant amount of resources and burden for CMS, MACs, and providers. Finally, a blended rate option would also mitigate some of the burden reduction associated with implementing PDPM, estimated to save SNFs close to $200 million per year as compared to estimated burden under RUG-IV, given that the current assessment schedule would need to continue until full implementation of PDPM was achieved. As we stated in the proposed rule, we believe these issues also would be implicated in any alternative transition strategy which would require both case-mix systems to exist concurrently, such as giving providers a choice in the first year of implementation of operating under either the RUG-IV or PDPM. Therefore, we did not pursue any alternatives which required concurrent operation of both the RUG-IV and PDPM.
As discussed in the proposed rule (83 FR 21079), we then considered alternative effective dates for implementing the PDPM, and other associated policy changes. We considered implementing the new case-mix model effective beginning in FY 2019, but we believe that this would not permit sufficient time for providers and other stakeholders, including CMS, to make the necessary preparations for a change of this magnitude in the SNF PPS. We also believe that such a quick transition would not be in keeping with how similar types of SNF PPS changes have been implemented in the past. We also considered implementing PDPM more than one year after being finalized, such as implementing the PDPM effective beginning October 1, 2020 (FY 2021). However, we believe that setting the effective date of PDPM this far out is not necessary, based on our prior experience with similar SNF PPS changes. As is customary, we plan to continue to provide free software to providers which can be used to group residents under the PDPM, as well as providing data specifications for this grouper software as soon as is practicable, thereby mitigating potential concerns around software vendors having sufficient time to develop products for PDPM. Moreover, given the issues identified throughout the proposed rule and this final rule with the current RUG-IV model, notably the issues surrounding the burden and complexity of the current SNF PPS assessment schedule and concerns around the incentives for therapy overprovision under the RUG-IV system, we believe it appropriate to implement the PDPM as soon as is practicable.
Finally, we considered alternatives related to the proposal discussed in section V.I. of this final rule, specifically the proposed certification that we have met the requirements set forth in section 511(a) of the MMA, which would permit us to use the PDPM's permanent case-mix adjustments for SNF residents with AIDS to replace the temporary special add-on in the PPS per diem payment for such residents. As noted in section V.I. of this final rule, this special add-on for SNF residents with AIDS was intended to be of limited duration, as the MMA legislation specified that it was to remain in effect only until the Secretary certifies that there is an appropriate adjustment in the case mix to compensate for the increased costs associated with such residents. We considered maintaining this adjustment under the PDPM. However, given the adjustment incorporated into the NTA and nursing components under the PDPM to account for the increased costs of treating residents with AIDS, this would result in a substantial increase in payment for such residents beyond even the current add-on payment. Moreover, as discussed in section V.I. of this final rule, we believe that the PDPM provides a tailored case-mix adjustment that more accurately accounts for the additional costs and resource use of residents with AIDS, as compared to an undifferentiated add-on which simply applies an across-the-board multiplier to the full SNF PPS per diem. Finally, as stated in section 3.8.2. of the SNF PDPM technical report (available at
We invited comments on the projected impacts and on the proposals and alternatives discussed throughout this section.
Commenters submitted the following comments related to the proposed rule's discussion of the Potential Impacts of Implementing the Proposed PDPM and Proposed Parity Adjustment. A discussion of these comments, along with our responses, appears below.
Finally, while we did not analyze the impact of PDPM on individual providers and beneficiaries across multiple years, we note that we also examined the impact of the RCS-I payment model, which has substantially similar classification criteria as PDPM, on various resident and provider subpopulations using FY 2014 data. The results of this analysis, shown in section 3.13 of the SNF PMR technical report and the 2017 ANPRM (82 FR 21008 through 21012), were consistent with the resident and provider subpopulation impact analysis conducted for PDPM (section 3.12 of the SNF PDPM technical report) in showing that a payment model based on the set of resident characteristics used to construct PDPM would be expected to increase payment associated with resident subpopulations with complex clinical needs, such as extensive services, high NTA utilization, IV medications, ESRD, diabetes, wound infections, amputation/prosthesis care, and longer inpatient stays. For all of the foregoing reasons, we expect PDPM to be robust and to have similar impacts on residents and providers across multiple years.
(1) The use of hospital MS-DRGs in developing clinical categories will likely result in an inaccurate estimation of payment. Payment rates were set and impacts predicted based on using the MS-DRG assignment of the patient, whereas PDPM when implemented will rely on MDS responses. If SNFs report patients at a net lower acuity level in MDS data than the predicted clinical categorization, then the budget neutrality assumptions made by PDPM will be invalid.
(2) The conversion of charges to costs will likely result in an underestimation of payment. Because SNF charges have not driven payments under the SNF PPS before, it is possible SNFs will systematically re-evaluate their charges practices to bring them more in line with the cost information within their accounting systems. As a result, the use of SNF charges may need to be rapidly reevaluated once PDPM is implemented.
(3) The quality of FY 2017 section GG data is questionable due to the likely inaccuracies in newly implemented items. Thus, PDPM impacts may need to be re-run once more stable section GG data are available to ensure PDPM accurately accounts for patient functional characteristics.
Second, the two provider-level files provide impacts for two different payment models: The first displays impacts for RCS-I, while the second displays impacts for PDPM. While the two payment models are similar, differences between the two models also contribute to changes in estimated provider-level impacts. For the foregoing reasons, we should not expect the estimated payment impact for each provider be the same across the two payment models and data years. We further note that at the population level, the estimated impact on specific types of providers and residents was similar under RCS-I and PDPM, reflecting the similarity of the payment models. Specifically, for both models we estimate that payment would shift from stays receiving high amounts of therapy and providers that provide high amounts of therapy to stays associated with medically complex beneficiaries and providers that serve these beneficiaries.
Regarding providers that were included in the RCS-I provider-specific file but not in the PDPM provider-specific file, this occurs for three reasons: (1) The provider had no stays in FY 2017, the year of analysis for the PDPM file, (2) after applying matching and validity restrictions, the provider had no stays remaining in the dataset, or had fewer than 11 stays (and therefore could not be included for confidentiality reasons), or (3) after excluding stays that did not have sufficient information to be classified into a case-mix group for each PDPM component, the provider had fewer than 11 stays. Of the roughly 1,100 providers that were included in the RCS-I file but not included in the PDPM file, about 60 percent were excluded for reason (3); of the remaining excluded providers, about half were excluded for reason (1) and half were excluded for reason (2). It should also be noted that in total, there are about 700 fewer providers in the PDPM file than there are in the RCS-I file. Because this number is less than the number of providers included in the RCS-I file but not included in the PDPM file, this indicates that there are also a number of providers that are included in the PDPM file but not in the RCS-I file. To confirm the representativeness of our PDPM study population, we compared resident characteristics for the study population and the Medicare Part A SNF population, as shown in section 3.1.5 of the SNF PDPM technical report. As noted in the technical report, the two populations are similar in most respects, although the study population contains a higher proportion of stays from for-profit and freestanding facilities and a lower proportion of stays from non-profit, government, hospital-based, and swing bed facilities. Given the similarity of the two populations, we do not believe our population restrictions compromised the representativeness of our study population or the reliability of our results.
With regard to the comment about a patient that begins a stay under RUG-IV but ends under PDPM, given that there will be no transition period between RUG-IV and PDPM, providers would bill under RUG-IV for all days up to and including September 30, 2019 and then bill under PDPM for all days beginning October 1, 2019. Further, RUG-IV assessment scheduling and other RUG-IV payment-related policies would be in effect until September 30, 2019. Beginning on October 1, 2019, all PDPM related assessment scheduling and other PDPM payment-related policies would take effect.
Accordingly, after considering the comments received, for the reasons discussed throughout section V of the FY 2019 SNF PPS proposed rule and for the reasons presented in this final rule, we are finalizing our proposals to implement the PDPM, as well as the other PDPM related changes discussed in this final rule, with the modifications previously discussed in this final rule, effective beginning October 1, 2019. Specifically, in section V.B of this final rule, we finalized our proposal, without modification, for updating the federal base payment rates and for adjusting the per diem rates for geographic differences under the PDPM. In section V.C.3.b of this final rule, we finalized the proposed PT and OT components under the PDPM and our proposals relating to the methodology for classifying residents under the PT and OT components, effective October 1, 2019, with the modifications discussed in that section. More specifically, in response to comments, rather than requiring providers to record the type of inpatient surgical procedure performed during the prior inpatient hospital stay by coding an ICD-10-PCS code in the second line of item I8000 as we proposed, we will instead require providers to select, as necessary, a surgical procedure category in a sub-item within Item J2000 which would identify the relevant surgical procedure that occurred during the patient's preceding hospital stay and which would augment the patient's PDPM clinical category. For purposes of calculating the function score, all missing values for section GG assessment items will receive zero points. Similarly, the function score will incorporate a new response “10. Not attempted due to environmental limitations” and we will assign it a point value of zero. Furthermore, consistent with a commenter's suggestion, we will adopt MDS item GG0170I1 (Walk 10 feet) as a substitute for retired item GG0170H1 (Does the resident walk), and we will use responses 07: “resident refused,” 09: “not applicable,” 10: “not attempted due to environmental limitations,” or 88: “not attempted due to medical condition or safety concerns” from MDS item GG0170I1 to identify residents who cannot walk. In section V.C.3.b of this final rule, we finalized, without modification, the proposed SLP component of PDPM and our proposals relating to the classification of residents under the SLP component. In section V.C.3.d of this final rule, we finalized,
As we proposed and as discussed in section V.I of this final rule, we will implement the PDPM and the other PDPM-related changes finalized in this rule in a budget neutral manner.
Along with our revisions to the regulations as discussed elsewhere in this final rule, we also proposed (83 FR 21080) to make two other revisions in the regulation text. The first involves § 411.15(p)(3)(iv), which specifies that whenever a beneficiary is formally discharged (or otherwise departs) from the SNF, this event serves to end that beneficiary's status as a “resident” of the SNF for purposes of consolidated billing (the SNF “bundling” requirement), unless he or she is readmitted (or returns) to that or another SNF “by midnight of the day of departure.” In initially establishing this so-called “midnight rule,” the FY 2001 SNF PPS final rule (65 FR 46770, July 31, 2000) noted in this particular context that, as we explained in the proposed rule, a patient “day” begins at 12:01 a.m. and ends the following midnight, so that the phrase “midnight of the day of departure” refers to the midnight that immediately follows the actual moment of departure, rather than to the midnight that immediately precedes it (65 FR 46792).
However, the Medicare program's standard practice for counting inpatient days is actually one in which an inpatient day would begin at midnight (see, for example, § 20.1 in the Medicare Benefit Policy Manual, Chapter 3, which specifies that in counting inpatient days, “. . .
We also proposed a technical correction to § 424.20(a)(1)(i) (which describes the required content of the SNF level of care certification) in order to conform it more closely to that of the corresponding statutory requirements at section 1814(a)(2)(B) of the Act. This statutory provision defines the SNF level of care in terms of skilled services furnished on a daily basis which, as a practical matter, can only be provided on an inpatient basis in a SNF. In addition, it provides that the SNF-level care must be for either:
• An ongoing condition that was one of the conditions that the beneficiary had during the qualifying hospital stay; or
• A new condition that arose while the beneficiary was in the SNF for treatment of that ongoing condition.
In setting forth the SNF level of care definition itself, the implementing regulations at § 409.31 reflect both of the above two criteria (at paragraphs (b)(2)(i) and (b)(2)(ii), respectively); however, as we stated in the proposed rule (83 FR 21080), the regulations describing the content of the initial level of care certification at § 424.20(a)(1)(i) have inadvertently omitted the second criterion. Further, while that criterion admittedly might not be relevant in those instances where the initial certification is obtained promptly “at the time of admission” in accordance with the regulations at 42 CFR 424.20(b)(1), that same provision alternatively allows this requirement to be met “as soon thereafter as is reasonable and practicable.” Accordingly, in order to rectify this omission, we proposed to revise § 424.20(a)(1)(i) so that it more accurately tracks the language in the corresponding statutory authority at section 1814(a)(2)(B) of the Act.
We invited comments on our proposed revisions to § 411.15(p)(3)(iv) and § 424.20(a)(1)(i), but received no comments on either revision. Accordingly, in this final rule, we are finalizing both revisions as proposed, without further modification.
The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is authorized by section 1888(e)(6) of the Act and it applies to freestanding SNFs, SNFs affiliated with acute care facilities,
Although we have historically used the preamble to the SNF PPS proposed and final rules each year to remind stakeholders of all previously finalized program requirements, we have concluded that repeating the same discussion each year is not necessary for every requirement, especially if we have codified it in our regulations. Accordingly, the following discussion is limited as much as possible to a discussion of our proposals, responses to comments submitted on those proposals, and policies we are finalizing for future years of the SNF QRP after consideration of the comments, and it represents the approach we intend to use in our rulemakings for this program going forward.
For a detailed discussion of the considerations we historically used for the selection of SNF QRP quality, resource use, and other measures, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46429 through 46431).
We received several comments generally related to the SNF QRP. The comments and our responses are discussed below.
In the FY 2018 SNF PPS final rule (82 FR 36567 through 36568), we discussed the importance of improving beneficiary outcomes including reducing health disparities. We also discussed our commitment to ensuring that medically complex residents, as well as those with social risk factors, receive excellent care. We discussed how studies show that social risk factors, such as being near or below the poverty level as determined by HHS, belonging to a racial or ethnic minority group, or living with a disability, can be associated with poor health outcomes and how some of this disparity is related to the quality of health care.
In the FY 2018/CY 2018 proposed rules for our quality reporting and value-based purchasing programs, we solicited feedback on which social risk factors provide the most valuable information to stakeholders and the methodology for illuminating differences in outcomes rates among patient groups within a provider that would also allow for a comparison of those differences, or disparities, across providers. Feedback we received across our quality reporting programs included encouraging us to explore whether factors that could be used to stratify or risk adjust the measures (beyond dual eligibility); to consider the full range of differences in resident backgrounds that might affect outcomes; to explore risk adjustment approaches; and to offer careful consideration of what type of information display would be most useful to the public.
We also sought public comment on confidential reporting and future public reporting of some of our measures stratified by resident dual eligibility. In general, commenters noted that stratified measures could serve as tools for SNFs to identify gaps in outcomes for different groups of residents, improve the quality of health care for all residents, and empower consumers to make informed decisions about health care. Commenters encouraged us to stratify measures by other social risk factors such as age, income, and educational attainment. With regard to value-based purchasing programs, commenters also cautioned CMS to balance fair and equitable payment while avoiding payment penalties that mask health disparities or discouraging the provision of care to more medically complex patients. Commenters also noted that value-based payment program measure selection, domain weighting, performance scoring, and payment methodology must account for social risk.
As a next step, we are considering options to improve health disparities among patient-groups within and across hospitals by increasing the transparency of disparities as shown by quality measures. We also are considering how this work applies to other CMS quality programs in the future. We refer readers to the FY 2018 IPPS/LTCH PPS final rule (82 FR 38403 through 38409) for more details, where we discuss the potential stratification of certain Hospital Inpatient Quality Reporting (IQR) Program outcome measures. Furthermore, we continue to consider options to address equity and disparities in our value-based purchasing programs.
We plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all beneficiaries and minimizing unintended consequences.
As a part of our Meaningful Measures Initiative discussed in section I.D. of this final rule, we strive to put patients first, ensuring that they, along with their clinicians, are empowered to make decisions about their own healthcare using data-driven information that is increasingly aligned with a parsimonious set of meaningful quality measures. We began reviewing the SNF QRP's measures in accordance with the Meaningful Measures Initiative, and we are working to identify how to move the SNF QRP forward in the least burdensome manner possible while continuing to incentivize improvement in the quality of care provided to patients.
Specifically, we believe the goals of the SNF QRP and the measures used in the program cover most of the Meaningful Measures Initiative priorities, including making care safer, strengthening person and family engagement, promoting coordination of care, promoting effective prevention and treatment, and making care affordable.
We also evaluated the appropriateness and completeness of the SNF QRP's current measure removal factors. We have previously finalized that we would use notice and comment rulemaking to remove measures from the SNF QRP based on the following factors
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We continue to believe that these measure removal factors are appropriate for use in the SNF QRP. However, even if one or more of the measure removal factors applies, we may nonetheless choose to retain the measure for certain specified reasons. Examples of such instances could include when a particular measure addresses a gap in quality that is so significant that removing the measure could in turn
In the FY 2019 SNF PPS proposed rule (83 FR 21082), we proposed to adopt an additional factor to consider when evaluating potential measures for removal from the SNF QRP measure set:
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As we discussed in section I.D. of this final rule, with respect to our new Meaningful Measures Initiative, we are engaging in efforts to ensure that the SNF QRP measure set continues to promote improved health outcomes for beneficiaries while minimizing the overall costs associated with the program. We believe these costs are multifaceted and include not only the burden associated with reporting, but also the costs associated with implementing and maintaining the program. We have identified several different types of costs, including, but not limited to: (1) The provider and clinician information collection burden and burden associated with the submission/reporting of quality measures to CMS; (2) the provider and clinician cost associated with complying with other programmatic requirements; (3) the provider and clinician cost associated with participating in multiple quality programs, and tracking multiple similar or duplicative measures within or across those programs; (4) the cost to CMS associated with the program oversight of the measure including measure maintenance and public display; and (5) the provider and clinician cost associated with compliance with other federal and/or state regulations (if applicable).
For example, it may be needlessly costly and/or of limited benefit to retain or maintain a measure which our analyses show no longer meaningfully supports program objectives (for example, informing beneficiary choice). It may also be costly for health care providers to track the confidential feedback, preview reports, and publicly reported information on a measure where we use the measure in more than one program. CMS may also have to expend unnecessary resources to maintain the specifications for the measure, as well as the tools we need to collect, validate, analyze, and publicly report the measure data. Furthermore, beneficiaries may find it confusing to see public reporting on the same measure in different programs.
When these costs outweigh the evidence supporting the continued use of a measure in the SNF QRP, we believe it may be appropriate to remove the measure from the program. Although we recognize that one of the main goals of the SNF QRP is to improve beneficiary outcomes by incentivizing health care providers to focus on specific care issues and making data public related to those issues, we also recognize that those goals can have limited utility where, for example, the publicly reported data is of limited use because it cannot be easily interpreted by beneficiaries and used to influence their choice of providers. In these cases, removing the measure from the SNF QRP may better accommodate the costs of program administration and compliance without sacrificing improved health outcomes and beneficiary choice.
We proposed that we would remove measures based on this factor on a case-by-case basis. We might, for example, decide to retain a measure that is burdensome for health care providers to report if we conclude that the benefit to beneficiaries justifies the reporting burden. Our goal is to move the program forward in the least burdensome manner possible, while maintaining a parsimonious set of meaningful quality measures and continuing to incentivize improvement in the quality of care provided to patients.
We invited public comment on our proposal to adopt an additional measure removal Factor 8. The costs associated with a measure outweigh the benefit of its continued use in the program.
We also proposed to add a new § 413.360(b)(3) that would codify the removal factors we have previously finalized for the SNF QRP, as well as the new measure removal factor that we proposed to adopt in the proposed rule.
We sought comments on these proposals. A discussion of these comments, along with our responses, appears below.
Regarding concern over the subjectivity of the new measure removal factor and the suggestion for clearer guidelines and criteria for determining the costs and benefits of a measure before it is removed, we intend to be transparent in our assessment of measures under this measure removal factor. As described above, there are various considerations of costs and
After considering the comments, we are finalizing our proposal to add an additional measure removal factor: Factor 8. The costs associated with a measure outweigh the benefit of its continued use in the program. We are also finalizing our proposal to the updates to the regulatory text and to codify the seven removal factors we have previously finalized for the SNF QRP, as well as the new measure removal factor, Factor 8 at new § 413.360(b)(3). We are also making minor grammatical edits to the SNF QRP measure removal factor language to align with the language of other CMS quality programs.
The SNF QRP currently has 12 measures for the FY 2020 program year, which are outlined in Table 39.
In the FY 2018 SNF PPS final rule (82 FR 36596 through 36597), we stated that we intended to specify two measures that would satisfy the domain of
As stated in the FY 2019 SNF PPS proposed rule (83 FR 21083), as a result of the input provided during a public comment period between November 10, 2016 and December 11, 2016, input provided by a technical expert panel (TEP), and pilot measure testing conducted in 2017, we are engaging in continued development work on these two measures, including supplementary measure testing and providing the public with an opportunity for comment in 2018. We stated that we would reconvene a TEP for these measures in mid-2018 which occurred in April 2018. We stated that we now intend to specify the measures under section 1899B(c)(1)(E) of the Act no later than October 1, 2019 and intend to propose to adopt the measures for the FY 2022 SNF QRP, with data collection beginning with residents admitted as well as discharged on or after October 1, 2020. For more information on the pilot testing, we refer readers to
Under our current policy, SNFs report data on SNF QRP assessment-based measures and standardized resident assessment data by reporting the designated data elements for each applicable resident on the Minimum Data Set (MDS) resident assessment instrument and then submitting completed instruments to CMS using the Quality Improvement Evaluation System Assessment Submission and Processing (QIES ASAP) system. We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601 through 36603) for the data collection and submission time frames for assessment-based measures and standardized resident assessment data that we finalized for the SNF QRP.
Section 413.360(d)(1) of our regulations states, in part, that SNFs that do not meet the SNF QRP requirements for a program year will receive a letter of non-compliance through the QIES ASAP system, as well as through the United States Postal Service.
In the FY 2019 SNF PPS proposed rule (83 FR 21083), we proposed to revise § 413.360(d)(1) to expand the methods by which we would notify a SNF of non-compliance with the SNF QRP requirements for a program year. Revised § 413.360(d)(1) would state that we would notify SNFs of non-compliance with the SNF QRP requirements via a letter sent through at least one of the following notification methods: The QIES ASAP system; the United States Postal Service; or via an email from the Medicare Administrative Contractor (MAC). We believe that this change will address feedback from providers who requested additional methods for notification.
In addition, § 413.360(d)(4) currently states that we will make a decision on the request for reconsideration and provide notice of the decision to the SNF through the QIES ASAP system and via letter sent through the United States Postal Service.
We proposed to revise § 413.360(d)(4) to state that we will notify SNFs, in writing, of our final decision regarding any reconsideration request via a letter sent through at least one of the following notification methods: The QIES ASAP system, the United States Postal Service, or via an email from the Medicare Administrative Contractor (MAC).
We invited public comments on these proposals.
With regard to the comment about specifying the recipient of notification for a facility, our notifications are sent to the point of contact on file in the QIES database. This information is populated via ASPEN. It is the responsibility of the facility to ensure that this information is up-to-date. For information regarding how to update provider information in QIES, we refer providers to contact their Medicare Administrative Contractor or CMS Regional Office at
We disagree with the recommendation that CMS notify all
We are finalizing our proposal to revise § 413.360(d)(1) to state that we will notify a SNF of non-compliance with the SNF QRP requirements for a program year via a letter sent through at least one of the following notification methods: The QIES ASAP system; the United States Postal Service; or via an email from the Medicare Administrative Contractor (MAC).
We are also finalizing our proposal, to revise § 413.360(d)(4) to state that we will notify SNFs, in writing, of our final decision regarding any reconsideration request via a letter sent through at least one of the following notification methods: The QIES ASAP system, the United States Postal Service, or via an email from the Medicare Administrative Contractor (MAC).
Section 1899B(g) of the Act requires the Secretary to establish procedures for the public reporting of SNFs' performance on measures under sections 1899B(c)(1) and 1899B(d)(1) of the Act. SNF QRP measure data will be displayed on the Nursing Home Compare website, an interactive web tool that assists individuals by providing information on SNF quality of care to those who need to select a SNF.
In the FY 2018 SNF PPS final rule (82 FR 36606 through 36607), we finalized that we would publicly display the Medicare Spending Per Beneficiary-PAC SNF QRP and Discharge to Community-PAC SNF QRP measures in calendar year 2018 based on discharges from October 1, 2016 through September 30, 2017. In the FY 2019 SNF PPS proposed rule (83 FR 21084), we proposed to increase the number of years of data used to calculate the Medicare Spending Per Beneficiary-PAC SNF QRP and Discharge to Community-PAC SNF QRP measures for purposes of display from 1 year to 2 years. Under this proposal, data on these measures would be publicly reported in CY 2019, or as soon thereafter as operationally feasible, based on discharges from October 1, 2016 through September 30, 2018.
Increasing the measure calculation and public display periods from 1 to 2 years of data increases the number of SNFs with enough data adequate for public reporting for the Medicare Spending Per Beneficiary-PAC SNF QRP measure from 86 percent (based on 2016 Medicare FFS claims data) to 95 percent (based on 2015 through 2016 Medicare FFS claims data), and for the Discharge to Community-PAC SNF QRP measure from 83 percent (based on 2016 Medicare FFS claims data) to 94 percent (based on 2015 through 2016 Medicare FFS claims data). Increasing measure public display periods to 2 years also aligns with the public display periods of these measures in the IRF QRP and LTCH QRP.
We also proposed to begin publicly displaying data in CY 2020, or as soon thereafter as is operationally feasible, on the following four assessment-based measures: (1) Application of IRF Functional Outcome Measure: Change in Self-Care Score for Medical Rehabilitation Patients (NQF #2633) (Change in Self-Care Score); (2) Application of IRF Functional Outcome Measure: Change in Mobility Score for Medical Rehabilitation Patients (NQF #2634) (Change in Mobility Score); (3) Application of IRF Functional Outcome Measure: Discharge Self-Care Score for Medical Rehabilitation Patients (NQF #2635) (Discharge Self-Care Score); and (4) Application of IRF Functional Outcome Measure: Discharge Mobility Score for Medical Rehabilitation Patients (NQF #2636) (Discharge Mobility Score). SNFs are required to submit data on these four assessment-based measures with respect to admissions as well as discharges occurring on or after October 1, 2018. We proposed to display data for these assessment-based measures based on 4 rolling quarters of data, initially using 4 quarters of discharges from January 1, 2019 through December 31, 2019. To ensure the statistical reliability of the measure rates for these four assessment-based measures, we also proposed that if a SNF has fewer than 20 eligible cases during any 4 consecutive rolling quarters of data that we are displaying for any of these measures, then we would note in our public display of that measure that with respect to that SNF, the number of cases/resident stays is too small to publicly report.
After consideration of public comments we received, we are finalizing our proposal, to increase the number of years of data used to calculate the Medicare Spending per Beneficiary-PAC SNF QRP measure and Discharge to Community-PAC SNF QRP measure for purposes of public display from 1 to 2 years, starting in CY 2019 or as soon thereafter as operationally feasible. We are also finalizing our proposal to begin publicly displaying data in CY 2020, or as soon thereafter as is operationally feasible, on the following four assessment-based measures: (1) Application of IRF Functional Outcome Measure: Change in Self-Care Score for Medical Rehabilitation Patients (NQF #2633); (2) Application of IRF Functional Outcome Measure: Change in Mobility Score for Medical Rehabilitation Patients (NQF #2634); (3) Application of IRF Functional Outcome Measure: Discharge Self-Care Score for Medical Rehabilitation Patients (NQF #2635); and (4) Application of IRF Functional Outcome Measure: Discharge Mobility Score for Medical Rehabilitation Patients (NQF #2636).
Section 215(b) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) authorized the SNF VBP Program (the “Program”) by adding section 1888(h) to the Act. As a prerequisite to implementing the SNF VBP Program, in the FY 2016 SNF PPS final rule (80 FR 46409 through 46426), we adopted an all-cause, all-condition hospital readmission measure, as required by section 1888(g)(1) of the Act. In the FY 2017 SNF PPS final rule (81 FR 51986 through 52009), we adopted an all-condition, risk-adjusted potentially preventable hospital readmission measure for SNFs, as required by section 1888(g)(2) of the Act. In the FY 2018 SNF PPS final rule (82 FR 36608 through 36623), we adopted additional policies for the Program, including an exchange function methodology for disbursing value-based incentive payments.
Section 1888(h)(1)(B) of the Act requires that the SNF VBP Program apply to payments for services furnished on or after October 1, 2018. The SNF VBP Program applies to freestanding SNFs, SNFs affiliated with acute care facilities, and all non-CAH swing-bed rural hospitals. We believe the implementation of the SNF VBP Program is an important step towards transforming how care is paid for, moving increasingly towards rewarding better value, outcomes, and innovations instead of merely rewarding volume.
For additional background information on the SNF VBP Program, including an overview of the SNF VBP Report to Congress and a summary of the Program's statutory requirements, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46409 through 46410). We also refer readers to the FY 2017 SNF PPS final rule (81 FR 51986 through 52009) for discussion of the policies that we adopted related to the potentially preventable hospital readmission measure, scoring, and other topics. Finally, we refer readers to the FY 2018 SNF PPS final rule (82 FR 36608 through 36623) for discussions of the policies that we adopted related to value-based incentive payments, the exchange function, and other topics.
We proposed additional requirements for the FY 2021 SNF VBP Program in the FY 2019 SNF PPS proposed rule (83 FR 21084 through 21089). We received several general comments on the SNF VBP Program.
For background on the measures we have adopted for the SNF VBP Program, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46419), where we finalized the Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM) (NQF #2510) that we are currently using for the SNF VBP Program. We also refer readers to the FY 2017 SNF PPS final rule (81 FR 51987 through 51995), where we finalized the Skilled Nursing Facility 30-Day Potentially Preventable Readmission Measure (SNFPPR) that we will use for the SNF VBP Program instead of the SNFRM as soon as practicable, as required by statute.
We did not propose any changes to the Program's measures. However, we received several comments on the Program's measures.
We also acknowledge the commenter's concern about the number of hospitalization measures in Medicare and in other quality programs, including those used by the states. We will consider how we might further streamline our quality programs, particularly under the Meaningful Measures Initiative. However, we note that all rehospitalization measures share the same underlying care focus—that is, avoiding rehospitalizations—even if they vary somewhat in the specifics of which hospitalizations they measure. We continue to believe that SNFs working to improve care quality and minimize rehospitalizations for their patients will perform well on hospitalization measures.
We continue to determine when it is practicable to transition the Program to the measure of potentially preventable readmissions, and we will propose that transition in future rulemaking, which we believe will provide sufficient notice to SNFs about the quality measure that will form the basis for the SNF VBP Program. We intend to take all of the views expressed by public commenters into account when we make that decision, as well as the operational necessities of the Program (such as the time needed to calculate measure rates on the SNFPPR and how that time interacts with the Program's performance and baseline periods). However, we would like to clarify that the SNFRM currently excludes certain planned readmissions.
We thank the commenters for their feedback on SNF VBP measures.
In the FY 2018 SNF PPS final rule (82 FR 36611 through 36613), we discussed the importance of improving beneficiary outcomes including reducing health disparities. We also discussed our commitment to ensuring that medically complex patients, as well as those with social risk factors, receive excellent care. We discussed how studies show that social risk factors, such as being near or below the poverty level as determined by HHS, belonging to a racial or ethnic minority group, or living with a disability, can be associated with poor health outcomes and how some of this disparity is related to the quality of health care.
In the FY 2018/CY 2018 proposed rules for our quality reporting and value-based purchasing programs, we solicited feedback on which social risk factors provide the most valuable information to stakeholders and the methodology for illuminating differences in outcomes rates among patient groups within a provider that would also allow for a comparison of those differences, or disparities, across providers. Feedback we received across our quality reporting programs included encouraging CMS to explore whether factors could be used to stratify or risk adjust the measures (beyond dual eligibility); to consider the full range of differences in patient backgrounds that might affect outcomes; to explore risk adjustment approaches; and to offer careful consideration of what type of information display would be most useful to the public.
We also sought public comment on confidential reporting and future public reporting of some of our measures stratified by patient dual eligibility. In general, commenters noted that stratified measures could serve as tools for hospitals to identify gaps in outcomes for different groups of patients, improve the quality of health care for all patients, and empower consumers to make informed decisions about health care. Commenters encouraged us to stratify measures by other social risk factors such as age, income, and educational attainment. With regard to value-based purchasing programs, commenters also cautioned CMS to balance fair and equitable payment while avoiding payment penalties that mask health disparities, or discouraging the provision of care to more medically complex patients. Commenters also noted that value-based payment program measure selection, domain weighting, performance scoring, and payment methodology must account for social risk.
We stated in the FY 2019 SNF VBP PPS proposed rule that as a next step, we are considering options to improve health disparities among patient groups within and across hospitals, SNFs, and other health care providers by increasing the transparency of disparities as shown by quality measures. We also stated that we are considering how this work applies to other CMS quality programs in the future. We refer readers to the FY 2018
We plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all beneficiaries and minimizing unintended consequences.
We received several comments on our discussion of social risk factors.
We agree with the commenters that studying health care disparities is critically important for the health care system, and we will continue to do so. We will also take that point under consideration as we consider social risk factors adjustment policies for the SNF VBP Program in the future. We will continue monitoring the SNF VBP Program to ensure that Medicare beneficiaries maintain access to needed SNF care.
We thank the commenters for this feedback, and will take it account as we consider the appropriateness of accounting for social risk factors in the SNF VBP Program.
We refer readers to the FY 2017 SNF PPS final rule (81 FR 51995 through
We published the final numerical values for the FY 2020 performance standards in the FY 2018 SNF PPS final rule (82 FR 36613), and for reference, we are displaying those values again in Table 40.
We will continue to use the achievement threshold and benchmark as previously finalized in the FY 2018 SNF PPS final rule. However, due to timing constraints associated with the compilation of the FY 2017 MedPAR file to include 3 months of data following the last discharge date, we were unable to provide estimated numerical values for the FY 2021 Program year's performance standards in the proposed rule. As discussed further below, we proposed to adopt FY 2017 as the baseline period for the FY 2021 program year. While we did not expect either the achievement threshold or benchmark to change significantly from what was finalized for the FY 2020 Program year, we stated our intent to publish the final numerical values for the performance standards based on the FY 2017 baseline period in the FY 2019 SNF PPS final rule.
We welcomed public comment on this approach.
After consideration of the public comments, we are finalizing the numerical values for the FY 2021 SNF VBP Program based on the FY 2017 baseline period. Those values follow below in Table 41.
As noted previously, section 1888(h)(3)(C) of the Act requires that we establish and announce the performance standards for a fiscal year not later than 60 days prior to the performance period for the fiscal year involved. However, we currently do not have a policy that would address the situation where, subsequent to publishing the numerical values for the finalized performance standards for a program year, we discover an error that affects those numerical values. Examples of the types of errors that we could subsequently discover are inaccurate variables on Medicare claims, programming errors, excluding data should have been included in the performance standards calculations, and other technical errors that resulted in inaccurate achievement threshold and benchmark calculations. While we do not have reason to believe that the SNF VBP Program has previously published inaccurate numerical values for performance standards, in the FY 2019 SNF PPS proposed rule (83 FR 21086), we stated our concern about the possibility that we would discover an error in the future and have no ability to correct the numerical values.
We are aware that SNFs rely on the performance standards that we publicly display in order to target quality improvement efforts, and we do not believe that it would be fair to SNFs to repeatedly update our finalized performance standards if we were to identify multiple errors. In order to balance the need of SNFs to know what performance standards they will be held accountable to for a SNF VBP program year with our obligation to provide SNFs with the most accurate performance standards that we can based on the data available at the time, we proposed that if we discover an error in the calculations subsequent to having published the numerical values for the performance standards for a program year, we would update the numerical values to correct the error. We also
We welcomed public comments on this proposal.
After consideration of the public comments we have received, we are finalizing our policy to correct performance standard numerical values in cases of errors as proposed.
We refer readers to the FY 2016 SNF PPS final rule (80 FR 46422) for a discussion of our considerations for determining performance periods under the SNF VBP Program. Based on those considerations, as well as public comment, we adopted CY 2017 as the performance period for the FY 2019 SNF VBP Program, with a corresponding baseline period of CY 2015.
Additionally, in the FY 2018 SNF PPS final rule (82 FR 36613 through 36614), we adopted FY 2018 as the performance period for the FY 2020 SNF VBP Program, with a corresponding baseline period of FY 2016. We refer readers to that rule for a discussion of the need to shift the Program's measurement periods from the calendar year to the fiscal year.
As we discussed with respect to the FY 2019 and FY 2020 SNF VBP Program years, we continue to believe that a 12-month duration for the performance and baseline period is the most appropriate for the SNF VBP Program. Therefore, we proposed to adopt FY 2019 (October 1, 2018 through September 30, 2019) as the performance period for the FY 2021 SNF VBP Program year. We also proposed to adopt FY 2017 (October 1, 2016 through September 30, 2017) hospital discharges as the baseline period for the FY 2021 SNF VBP Program year.
We welcomed public comment on these proposals.
After consideration of the public comments that we received, we are finalizing the performance period and baseline period for FY 2021 as proposed.
As we have described in previous rules (see, for example, the FY 2016 SNF PPS final rule, 80 FR 46422), we strive to link performance furnished by SNFs as closely as possible to the program year to ensure clear connections between quality measurement and value-based payment. We also strive to measure performance using a sufficiently reliable population of patients that broadly represent the total care provided by SNFs.
Therefore, we proposed that beginning with the FY 2022 program year and for subsequent program years, we would adopt for each program year, a performance period that is the 1-year period following the performance period for the previous program year. We also proposed that beginning with the FY 2022 program year and for subsequent program years, we would adopt for each program year a baseline period that is the 1-year period following the baseline period for the previous year. Under this policy, the performance period for the FY 2022 program year would be FY 2020 (the 1-year period following the proposed FY 2021 performance period of FY 2019), and the baseline period for the FY 2022 program year would be FY 2018 (the 1-year period following the proposed FY 2021 baseline period of FY 2017). We believe adopting this policy will provide SNFs with certainty about the performance and baseline periods during which their performance will be assessed for future program years.
We welcomed public comments on this proposal.
After consideration of the public comments that we have received, we are finalizing our policy to adopt performance periods and baseline
We refer readers to the FY 2017 SNF PPS final rule (81 FR 52000 through 52005) for a detailed discussion of the scoring methodology that we have finalized for the Program, along with responses to public comments on our policies and examples of scoring calculations. We also refer readers to the FY 2018 SNF PPS final rule (82 FR 36614 through 36616) for discussion of the rounding policy we adopted, our request for comments on SNFs with zero readmissions, and our request for comments on a potential extraordinary circumstances exception policy.
In some cases, a SNF will not have sufficient baseline period data available for scoring for a Program year, whether due to the SNF not being open during the baseline period, only being open for a small portion of the baseline period, or other reasons (such as receiving an extraordinary circumstance exception, which we finalize below). The availability of baseline data for each SNF is an integral component of our scoring methodology, and we are concerned that the absence of sufficient baseline data for a SNF will preclude us from being able to score that SNF on improvement for a program year. As discussed further below, with respect to the proposed scoring adjustment for a SNF without sufficient data in the performance period to create a reliable SNF performance score, we are concerned that measuring SNFs with fewer than 25 eligible stays (or index SNF stays that would be included in the calculation of the SNF readmission measure) during the baseline period may result in unreliable improvement scores, and as a result, unreliable SNF performance scores. We considered policy options to address this issue.
We continue to believe it is important to compare SNF performance during the same periods to control for factors that may not be attributable to the SNF, such as increased patient case-mix acuity during colder weather periods when influenza, pneumonia, and other seasonal conditions and illnesses are historically more prevalent in the beneficiary population. Using a 12-month performance and baseline period for all SNFs ensures that, to the greatest extent possible, differences in performance can be attributed to the SNF's care quality rather than to exogenous factors.
Additionally, because we have proposed that for FY 2021 and future Program years, the start of the performance period for a Program year would begin exactly 12-months after the end of the baseline period for that Program year and there would not be sufficient time to compute risk-standardized readmission rates from another 12-month baseline period before the performance period if a SNF had insufficient data during the baseline period. For the FY 2021 Program, for example, the proposed baseline period would conclude at the end of FY 2017 (September 30, 2017) and the proposed performance period would begin on the first day of FY 2019 (October 1, 2018). We also do not believe it would be equitable to score SNFs without sufficient baseline period data using data from a different period. Doing so would, in our view, impede our ability to compare SNFs' performance on the Program's quality measure fairly, as additional factors that may affect SNFs' care could arise when comparing performance during different time periods. Therefore, we have concluded that it is not operationally feasible or equitable to use different baseline periods for purposes of awarding improvement scores to SNFs for a Program year.
We believe that SNFs without sufficient data from a single baseline period, which we would define for this purpose as SNFs with fewer than 25 eligible stays during the baseline period for a fiscal year based on an analysis of Pearson correlation coefficients at various denominator counts, should not be measured on improvement for that Program year. Accordingly, we are proposing to score these SNFs based only on their achievement during the performance period for any Program year for which they do not have sufficient baseline period data. The analysis of Pearson correlation coefficients at various denominator counts used in developing this proposal is available on our website at
We proposed to codify this proposal by adding § 413.338(d)(1)(iv). We welcomed public comment on this proposal.
After consideration of the public comments that we received, we are finalizing our scoring policy for SNFs without sufficient baseline period data as proposed. We are also finalizing our regulation text on this policy as proposed.
In previous rules, we have discussed and sought comment on policies related to SNFs with zero readmissions during the performance period. For example, in the FY 2018 SNF PPS rule (82 FR 36615 through 36616), we sought comment on policies we should consider for SNFs with zero readmissions during the performance period because under the risk adjustment and the statistical approach used to calculate the SNFRM, outlier values are shifted towards the
Therefore, we considered whether we should make changes to our methodology for assessing the total performance of SNFs for a Program year that better accounts for SNFs with zero or low numbers of eligible stays during the performance period. Because the number of eligible SNF stays makes up the denominator of the SNFRM, we have concluded that the reliability of a SNF's measure rate and resulting performance score is adversely impacted if the SNF has less than 25 eligible stays during the performance period, as the Pearson correlation coefficient is lower at denominator counts of 5, 10, 15, and 20 eligible stays in comparison to 25 eligible stays. The analysis of Pearson correlation coefficients at various denominator counts used in developing this proposal is available on our website at
We believe that the most appropriate way to ensure that low-volume SNFs (which we define for purposes of the SNF VBP Program as SNFs with fewer than 25 eligible stays during the performance period) receive sufficiently reliable SNF performance scores is to adopt an adjustment to the scoring methodology we use for the SNF VBP Program. We proposed that if a SNF has less than 25 eligible stays during a performance period for a Program year, we would assign a performance score to the SNF for that Program year. That assigned performance score would, when used to calculate the value-based incentive payment amount for the SNF, result in a value-based incentive payment amount that is equal to the adjusted Federal per diem rate that the SNF would have received for the fiscal year in the absence of the Program. The actual performance score that we would assign to an individual low-volume SNF for a Program year would be identified based on the distribution of all SNFs' performance scores for that Program year after calculating the exchange function. We would then assign that score to an individual low-volume SNF, and we would notify the low-volume SNF that it would be receiving an assigned performance score for the Program year in the SNF Performance Score Report that we provide not later than 60 days prior to the fiscal year involved.
We believe this scoring adjustment policy would appropriately ensure that our SNF performance score methodology is fair and reliable for SNFs with fewer than 25 eligible stays during the performance period for a Program year.
In section X.A.6. of the proposed rule, we estimated that $527.4 million would be withheld from SNFs' payments for the FY 2019 Program year based on the most recently available data. Additionally, the 60 percent payback percentage would result in an estimated $316.4 million being paid to SNFs in the form of value-based incentive payments with respect to FY 2019 services. Of the $316.4 amount, we estimated that $8.6 million will be paid to low-volume SNFs. However, if our proposal to adopt a scoring adjustment for low-volume SNFs were finalized, we estimated that we would redistribute an additional $6.7 million in value-based incentive payments to low-volume SNFs with respect to FY 2019 services, for a total of $15.3 million of the estimated $527.4 million available for value-based incentive payments for that Program year. The additional $6.7 million in value-based incentive payments that would result from finalizing this proposal would increase the 60 percent payback percentage for FY 2019 by approximately 1.28 percent, which would result in a payback percentage 61.28 percent of withheld funds. The payback percentage would similarly increase for all other Program years, however the actual amount of the increase for a particular Program year would vary based on the number of low-volume SNFs that we identify for that Program year and the distribution of all SNFs' performance scores for that Program year.
As an alternative, we considered assigning a performance score to SNFs with fewer than 25 eligible stays during the performance period that would result in a value-based incentive payment percentage of 1.2 percent, or 60 percent of the 2 percent withhold. This amount would match low-volume SNFs' incentive payment percentages with the finalized SNF VBP Program payback percentage of 60 percent, and would represent a smaller adjustment to low-volume SNFs' incentive payment percentages than the proposed policy described above. We estimated that this alternative would redistribute an additional $1 million with respect to FY 2019 services to low-volume SNFs. We also estimated that this alternative would increase the 60 percent payback percentage for FY 2019 by approximately 0.18 percent of the approximately $527.4 million of the total withheld from SNFs' payments, which would result in a payback percentage of 60.18 percent of the estimated $527.4 million in withheld funds for that Program year. However, as with the proposal above, we stated that the specific amount by which the payback percentage would increase for each Program year would vary based on the number of low-volume SNFs that we identify for each Program year and the distribution of all SNFs' performance scores for that Program year.
We welcomed public comments on this proposal and on the alternative that we considered. We also proposed to codify the definition of low-volume SNF at § 413.338(a)(16), and the definition of eligible stay at § 413.338(a)(17). We proposed to codify the low-volume scoring adjustment proposal at § 413.338(d)(3). We also proposed a conforming edit to the payback percentage policy at § 413.338(c)(2)(i).
After consideration of the public comments that we have received, we are finalizing our scoring adjustment for low-volume SNFs as proposed. We are also finalizing our regulation text on this policy as proposed.
In the FY 2018 SNF PPS final rule (82 FR 36616), we summarized public comments that we received on the topic of a possible extraordinary circumstances exception policy for the SNF VBP Program. As we stated in that rule, in other value-based purchasing and quality reporting programs, we have adopted Extraordinary Circumstances Exceptions (ECE) policies intended to allow facilities to receive relief from program requirements due to natural disasters or other circumstances beyond the facility's control that may affect the facility's ability to provide high-quality health care.
In other programs, we have defined a “disaster” as any natural or man-made catastrophe which causes damages of sufficient severity and magnitude to partially or completely destroy or delay access to medical records and associated documentation or otherwise affect the facility's ability to continue normal operations. Natural disasters could include events such as hurricanes, tornadoes, earthquakes, volcanic eruptions, fires, mudslides, snowstorms, and tsunamis. Man-made disasters could include such events as terrorist attacks, bombings, flood caused by man-made actions, civil disorders, and explosions. A disaster may be widespread and impact multiple structures or be isolated and affect a single site only. As a result of either a natural or man-made disaster, we are concerned that SNFs' care quality and subsequent impact on measure performance in the SNF VBP Program may suffer, and as a result, SNFs might be penalized under the Program's quality measurement and scoring methodology. However, we do not wish to penalize SNFs in these circumstances. For example, we recognize that SNFs might receive patients involuntarily discharged from hospitals facing mandatory evacuation due to probable flooding, and these patients might be readmitted to inpatient acute care hospitals and result in poorer readmission measure performance in the SNF VBP Program. We therefore proposed to adopt an ECE policy for the SNF VBP Program to provide relief to SNFs affected by natural disasters or other circumstances beyond the facility's control that affect the care provided to the facility's patients. We proposed that if a SNF can demonstrate that an extraordinary circumstance affected the care that it provided to its patients and subsequent measure performance, we would exclude from the calculation of the measure rate for the applicable baseline and performance periods the calendar months during which the SNF was affected by the extraordinary circumstance. Under this proposal, a SNF requesting an ECE would indicate the dates and duration of the extraordinary circumstance in its request, along with any available evidence of the extraordinary circumstance, and if approved, we would exclude the corresponding calendar months from that SNF's measure rate for the applicable measurement period and by extension, its SNF performance score.
We further proposed that SNFs must submit this ECE request to CMS by filling out the ECE request form that we will place on the QualityNet website to the
To accompany an ECE request, SNFs must provide any available evidence showing the effects of the extraordinary circumstance on the care they provided to their patients, including, but not limited to, photographs, newspaper and other media articles, and any other
We stated our intent for this policy to offer relief to SNFs whose care provided to patients suffered as a result of the disaster or other extraordinary circumstance, and we believe that excluding calendar months affected by extraordinary circumstances from SNFs' measure performance under the Program appropriately ensures that such circumstances do not unduly affect SNFs' performance rates or performance scores. We developed this process to align with the ECE process adopted by the SNF Quality Reporting Program to the greatest extent possible and to minimize burden on SNFs. This policy is not intended to preclude us from granting exceptions to SNFs that have not requested them when we determine that an extraordinary circumstance, such as an act of nature, affects an entire region or locale. If we made the determination to grant an exception to all SNFs in a region or locale, we proposed to communicate this decision through routine communication channels to SNFs and vendors, including but not limited to, issuing memos, emails, and notices on our SNF VBP website at
We noted that if we finalize this policy, we would score any SNFs receiving ECEs on achievement and improvement for any remaining months during the performance period, provided the SNF had at least 25 eligible stays during both of those periods. If a SNF should receive an approved ECE for 6 months of the performance period, for example, we would score the SNF on its achievement during the remaining 6 months on the Program's measure as long as the SNF met the proposed 25 eligible stay threshold during the performance period. We would also score the SNF on improvement as long as it met the proposed 25 eligible stay threshold during the applicable baseline period.
We welcomed public comments on this proposal. We also proposed to codify this proposal at § 413.338(d)(4).
After consideration of the public comments that we received, we are finalizing our Extraordinary Circumstances Exception policy as proposed. We are also finalizing our regulation text on this policy as proposed.
We refer readers to the FY 2018 SNF PPS final rule (82 FR 36616 through 36621) for discussion of the exchange function methodology that we have adopted for the Program, as well as the specific form of the exchange function (logistic, or S-shaped curve) that we finalized, and the payback percentage of 60 percent. We adopted these policies for FY 2019 and subsequent fiscal years.
As required by section 1888(h)(7) of the Act, we will inform each SNF of the adjustments to its Medicare payments as a result of the SNF VBP Program that we will make not later than 60 days prior to the fiscal year involved. We will fulfill that requirement via SNF Performance Score Reports that we will circulate to SNFs using the QIES-CASPER system, which is also how we distribute the quarterly confidential feedback reports that we are required to provide to SNFs under section 1888(g)(5) of the Act. The SNF Performance Score Reports will contain the SNF's performance score, ranking, and value-based incentive payment adjustment factor that will be applied to claims submitted for the applicable fiscal year. Additionally, as we finalized in the FY 2018 SNF PPS final rule (82 FR 36622 through 36623), the provision of the SNF Performance Score Report will trigger the Phase Two Review and Corrections Process, and SNFs will have 30 days from the date we post the report on the QIES-CASPER system to submit corrections to their SNF performance score and ranking to the
Finally, as we discussed in the FY 2018 SNF PPS final rule (82 FR 36618), beginning with FY 2019 (October 1, 2018) payments, we intend to make the 2 percent reduction and the SNF-specific value-based incentive payment adjustment to SNF claims simultaneously. Beginning with FY 2019, we will identify the adjusted federal per diem rate for each SNF for claims under the SNF PPS. We will then reduce that amount by 2 percent by multiplying the per diem amount by 0.98, in accordance with the requirements in section 1888(h)(6) of the Act. We will then multiply the result of that calculation by each SNF's specific value-based incentive payment adjustment factor, which will be based on each SNF's performance score for the program year and will be calculated by the exchange function, to generate the value-based incentive payment amount that applies to the SNF for the fiscal year. Finally, we will add the value-based incentive payment amount to the reduced rate, resulting in a new adjusted federal per diem rate that applies to the SNF for the fiscal year.
At the time of the publication of the proposed rule, we had not completed SNF performance score calculations for the FY 2019 program year. However, we stated our intent to provide the range of value-based incentive payment adjustment factors applicable to the FY 2019 program year in this final rule. For the FY 2019 SNF VBP Program Year, and incorporating the 2 percent reduction to SNFs' payments, we estimate the value-based incentive payment adjustment factors that we will award to SNFs range from 0.9802915381 to 1.02326809. That is, we estimate that SNFs may receive incentive payment percentages ranging from approximately −1.97 percent to approximately +2.33 percent, on a net basis.
We proposed to codify the SNF VBP Program's payment adjustments at § 413.337(f).
Further, we do not believe it is appropriate to revisit the payback percentage policy at this time, with the exception of the low-volume policy, which we view as a narrow exception to the 60 percent payback percentage that would have no effect on the majority of facilities. At the time of the publication of this final rule, the SNF VBP Program will not yet have delivered its first incentive payments based on measured performance, and we do not believe we should consider whether to change the payback percentage further until we are able to more fully assess the effects that it has on the quality of care provided in SNFs. We refer readers to the FY 2018 SNF PPS final rule (82 FR 36619 through 36621) for our full discussion of the payback percentage policy that we have adopted for the SNF VBP Program.
We thank the commenters for their feedback. As noted in section III.B.5. of this final rule, we are finalizing the codification of the SNF VBP program payment adjustment as proposed.
In the FY 2019 SNF PPS proposed rule, we included a Request for Information (RFI) related to promoting interoperability and electronic healthcare information exchange (83 FR 21089). We received 22 comments on this RFI, and appreciate the input provided by commenters.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit comment on the following issues:
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
In our May 8, 2018 proposed rule (83 FR 21018), we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs).We did not receive any comments on the ICR section of the proposed rule.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2017 National Occupational Employment and Wage Estimates for all salary estimates (as compared to the FY 2019 SNF PPS proposed rule when we used May 2016 estimates) (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. We believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
The following sets out the requirements and burden associated with the MDS assessment schedule that will be effective October 1, 2019 under the SNF PPS in conjunction with implementation of the PDPM. The requirements and burden will be submitted to OMB for approval under control number 0938-1140 (CMS-10387).
Section V.D. of this final rule finalizes revisions to the current SNF PPS assessment schedule to require only two scheduled assessments (as opposed to the current requirement for five scheduled assessments) for each SNF stay: A 5-day scheduled PPS assessment and a discharge assessment.
The current 5-day scheduled PPS assessment will be used as the admission assessment under this rule's finalized PDPM and set the resident's case-mix classification for the resident's SNF stay. The PPS discharge assessment (which is already required for all SNF Part A residents) will serve as the discharge assessment and be used for monitoring purposes. In section V.D. of this final rule, we discuss that while we proposed to require SNFs to reclassify residents under the PDPM using the Interim Payment Assessment (IPA) if certain criteria are met, we have decided in this final rule to make this assessment optional, thereby leaving completion of this assessment at the discretion of the individual provider. Thus, the 5-day SNF PPS scheduled assessment will be the only PPS assessment required to classify a resident under the PDPM for payment purposes, while the IPA may also be completed, as discussed in section V.D. of this final rule. This eliminates the requirement for the following assessments under the SNF PPS: 14-day scheduled PPS assessment, 30-day scheduled PPS assessment, 60-day scheduled PPS assessment, 90-day scheduled PPS assessment, Start of Therapy Other Medicare Required
In estimating the amount of time to complete a PPS assessment, we utilize the OMRA assessment, or the NO/SO item set (this is consistent with the current information collection request as approved by OMB on July 28, 2017; see
When calculating the burden for each assessment, we estimated that it will take 40 minutes (0.6667 hours) at $70.72/hr for an RN to collect the information necessary for preparing the assessment, 10 minutes (0.1667 hours) at $55.95/hr (the average hourly wage for RN ($70.72/hr) and health information technician ($41.18/hr)) for staff to code the responses, and 1 minute (0.0167 hours) at $41.18/hr for a health information technician to transmit the results. In total, we estimate that it would take 51 minutes (0.85 hours) to complete a single PPS assessment. Based on the adjusted hourly wages for the noted staff, we estimate that it would cost $57.17 [($70.72/hr × 0.6667 hr) + ($55.95/hr × 0.1667 hr) + ($41.18/hr × 0.0167 hr)] to prepare, code, and transmit each PPS assessment.
The ongoing burden associated with the revisions to the SNF PPS assessment schedule is the time and effort it would take each Medicare Part A SNF to complete the 5-day PPS and discharge assessments. Based on our most current data, there are 15,471 Medicare Part A SNFs (as opposed to the 15,455 discussed in the proposed rule). Based on FY 2017 data, we estimate that 2,406,401 5-day PPS assessments will be completed and submitted by Part A SNFs each year under the PDPM. We used the same number of assessments (2,406,401) as a proxy for the number of PPS discharge assessments that would be completed and submitted each year, since all residents who require a 5-day PPS assessment will also require a discharge assessment under the SNF PDPM.
As compared to the FY 2019 SNF PPS proposed rule, in which we used the Significant Change in Status Assessment (SCSA) as a proxy to estimate the number of IPAs (83 FR 21093), we have eliminated this portion of our burden estimate as this assessment would not be required, per the discussion in section V.D. of this final rule. Therefore, we estimate that the total number of 5-day scheduled PPS assessments, and PPS discharge assessments that would be completed across all facilities is 4,812,802 assessments (2,406,401 + 2,406,401, respectively) instead of 4,905,042 assessments (2,406,401 + 92,240 + 2,406,401) that was set out in the proposed rule. For all assessments under the PDPM, we estimated a burden of 4,090,882 hours (4,812,802 assessments × 0.85 hr/assessment) at a cost of $275,147,890 (4,812,802 assessments × $57.17/assessment).
Based on the same FY 2017 data, there were 5,833,476 non-discharge related assessments (scheduled and unscheduled PPS assessments) completed under the RUG- IV payment system. To this number we add the same proxy as above for the number of discharge assessments (2,406,401), since every resident under RUG-IV who required a 5-day scheduled PPS assessment would also require a discharge assessment. This brings the total number of estimated assessments under RUG-IV to 8,239,877. Using the same wage and time figures (per assessment), we estimated a burden of 7,003,895 hours (8,239,877 assessments × 0.85 hr/assessment) at a cost of $471,073,768 (8,239,877 assessments × $57.17/assessment).
When comparing the currently approved RUG-IV burden with the PDPM burden, we estimate a savings of 2,913,013 administrative hours (7,003,895 RUG-IV hours − 4,090,882 PDPM hours) or approximately 188 hours per provider per year (2,913,013 hours/15,471 providers). As depicted in Table 43, we also estimate a cost savings of $195,925,878 ($471,073,768 RUG-IV costs − $275,147,890 PDPM costs) or $12,664 per provider per year ($195,925,878/15,471 providers). This represents a significant decrease in administrative burden to providers under PDPM.
Finally, in section V.D. of this final rule, we finalized the addition of 3 items, as listed in Table 34 of this final rule), to the MDS 3.0 for Nursing Homes and Swing Bed Providers. Based on the small number of items being added and the small percentage of assessments that Swing Bed providers make up, we do not believe this action will cause any measurable adjustments to our currently approved burden estimates. Consequently, we are not revising any of those estimates.
In section VI.C.5.d. of this final rule, we are adopting an Extraordinary Circumstances Exception (ECE) process for the SNF VBP. Because the same CMS Extraordinary Circumstances Exceptions (ECE) Request Form would be used across ten quality programs: Hospital IQR Program, Hospital Outpatient Reporting Program, Inpatient Psychiatric Facility Quality Reporting Program, PPS-Exempt Cancer Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Hospital VBP Program, Hospital-Acquired Condition Reduction Program, Hospital Readmissions Reduction Program, End Stage Renal Disease Quality Incentive Program, and
We are not removing or adding any new or revised SNF QRP measure-related requirements or burden in this rule. Consequently, this final rule does not set out any new QRP-related collections of information that would be subject to OMB approval under the authority of the PRA.
This final rule will update the FY 2018 SNF prospective payment rates as required under section 1888(e)(4)(E) of the Act. It also responds to section 1888(e)(4)(H) of the Act, which requires the Secretary to provide for publication in the
We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA, September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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. This rule has been designated an economically significant rule, under section 3(f)(1) of Executive Order 12866. Accordingly, we have prepared a regulatory impact analysis (RIA) as further discussed below. Also, the rule has been reviewed by OMB.
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. OMB's implementation guidance, issued on April 5, 2017, explains that “Federal spending regulatory actions that cause only income transfers between taxpayers and program beneficiaries (for example, regulations associated with . . . Medicare spending) are considered `transfer rules' and are not covered by E.O. 13771. . . . However . . . such regulatory actions may impose requirements apart from transfers . . . In those cases, the actions would need to be offset to the extent they impose more than de minimis costs. Examples of ancillary requirements that may require offsets include new reporting or recordkeeping requirements.” As discussed in section VII. of this final rule, we estimate that this final rule will lead to paperwork cost savings of approximately $196 million per year, or $171 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon. This final rule is considered an E.O. 13771 deregulatory action.
This final rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2018 (82 FR 36530). We estimate that the aggregate impact will be an increase of approximately $820 million in payments to SNFs in FY 2019, resulting from the SNF market basket update to the payment rates, as required by section 53111 of the BBA 2018. Absent the application of section 53111 of the BBA 2018, as discussed in section III.A.2. of this final rule, the aggregate impact from the 2.0 percentage point market basket increase factor would have been approximately $680 million. We note that these impact numbers do not incorporate the SNF VBP reductions that we estimate will total $527.4 million for FY 2019.
We would note that events may occur to limit the scope or accuracy of our impact analysis, as this analysis is future-oriented, and thus, very susceptible to forecasting errors due to events that may occur within the assessed impact time period. In accordance with sections 1888(e)(4)(E) and 1888(e)(5) of the Act, we update the FY 2018 payment rates by a factor equal to the market basket index percentage change adjusted by the MFP adjustment to determine the payment rates for FY 2019. As discussed previously, section 53111 of the BBA 2018 stipulates a market basket increase factor of 2.4 percent. The impact to Medicare is included in the total column of Table 45. In updating the SNF PPS rates for FY 2019, we made a number of standard annual revisions and clarifications
The annual update set forth in this final rule applies to SNF PPS payments in FY 2019. Accordingly, the analysis of the impact of the annual update that follows only describes the impact of this single year. Furthermore, in accordance with the requirements of the Act, we will publish a rule or notice for each subsequent FY that will provide for an update to the payment rates and include an associated impact analysis.
The FY 2019 SNF PPS payment impacts appear in Table 45. Using the most recently available data, in this case FY 2017, we apply the current FY 2018 wage index and labor-related share value to the number of payment days to simulate FY 2018 payments. Then, using the same FY 2017 data, we apply the proposed FY 2019 wage index and labor-related share value to simulate FY 2019 payments. We tabulate the resulting payments according to the classifications in Table 45 (for example, facility type, geographic region, facility ownership), and compare the simulated FY 2018 payments to the simulated FY 2019 payments to determine the overall impact. The breakdown of the various categories of data Table 45 follows:
• The first column shows the breakdown of all SNFs by urban or rural status, hospital-based or freestanding status, census region, and ownership.
• The first row of figures describes the estimated effects of the various changes on all facilities. The next six rows show the effects on facilities split by hospital-based, freestanding, urban, and rural categories. The next nineteen rows show the effects on facilities by urban versus rural status by census region. The last three rows show the effects on facilities by ownership (that is, government, profit, and non-profit status).
• The second column shows the number of facilities in the impact database.
• The third column shows the effect of the annual update to the wage index. This represents the effect of using the most recent wage data available. The total impact of this change is 0 percent; however, there are distributional effects of the change.
• The fourth column shows the effect of all of the changes on the FY 2019 payments. The update of 2.4 percent is constant for all providers and, though not shown individually, is included in the total column. It is projected that aggregate payments will increase by 2.4 percent, assuming facilities do not change their care delivery and billing practices in response.
As illustrated in Table 45, the combined effects of all of the changes vary by specific types of providers and by location. For example, due to changes in this rule, providers in the urban Pacific region will experience a 3.4 percent increase in FY 2019 total payments.
We did not propose to add, remove, or revise any measures in the SNF QRP. Consequently, this final rule does not set out any new QRP-related impacts associated with the SNF QRP.
In Table 44 of the FY 2019 SNF PPS proposed rule (83 FR 21096 through 20197), we estimated the impacts of the FY 2019 SNF VBP Program without taking into account our low-volume scoring adjustment proposal. We modeled SNFs' performance in the Program using SNFRM data from CY 2014 as the baseline period and FY 2016 as the performance period. Additionally, we modeled a logistic exchange function with a payback percentage of 60 percent, as we finalized in the FY 2018 SNF PPS final rule (82 FR 36619 through 36621), and based the following analyses on payments to SNFs in FY 2016. We estimated the total reductions to payments required by section 1888(h)(6) of the Act, to be $527.4 million for FY 2019. Based on the 60 percent payback percentage, we estimated that we would disburse approximately $316.4 million in value-based incentive payments to SNFs in FY 2019, which we estimated would result in approximately $211 million in savings to the Medicare program in FY 2019.
In Table 45 of the FY 2019 SNF PPS proposed rule (83 FR 21097), we also modeled the estimated impacts of the FY 2019 SNF VBP Program and included in that model the impacts of our proposed scoring adjustment for low-volume SNFs. We estimated that the scoring adjustment policy proposal would redistribute an additional $6.7 million to the group of low volume SNFs. As we discuss further in section II.E.3.e. of this final rule, we are finalizing our low-volume scoring adjustment policy, and our estimated FY 2019 SNF VBP impacts, which we described in Table 45 of the proposed rule, are reproduced as Table 46 below.
We continue to estimate that this policy will result in increasing low-volume SNFs' value-based incentive payment percentages by approximately 0.99 percent, on average, from the value-based incentive payment percentage that they would receive in the absence of the low-volume adjustment. An increase in value-based incentive payment percentages by 0.99 percent is needed to bring low-volume SNFs back to the 2.0 percent that was withheld from their payments. We also continue to estimate that we will pay an additional $6.7 million in incentive payments to low-volume SNFs, which would increase the 60 percent payback percentage for FY 2019 by approximately 1.28 percent, making the new payback percentage for FY 2019 equal to 61.28 percent of the estimated $527.4 million in withheld funds for that fiscal year.
Our detailed analysis of the impacts of the FY 2019 SNF VBP Program, including the finalized low-volume scoring adjustment policy, follows in Table 46.
As described in this section, we estimated that the aggregate impact for FY 2019 under the SNF PPS will be an increase of approximately $820 million in payments to SNFs, resulting from the SNF market basket update to the payment rates, as required by section 53111 of the BBA 2018. Absent application of section 53111 of the BBA 2018, as discussed in section III.A.2. of this final rule, the market basket increase factor of 2.0 percent would have resulted in an aggregate increase in payments to SNFs of approximately $680 million.
Section 1888(e) of the Act establishes the SNF PPS for the payment of Medicare SNF services for cost reporting periods beginning on or after July 1, 1998. This section of the statute prescribes a detailed formula for calculating base payment rates under the SNF PPS, and does not provide for the use of any alternative methodology. It specifies that the base year cost data to be used for computing the SNF PPS payment rates must be from FY 1995 (October 1, 1994, through September 30, 1995). In accordance with the statute, we also incorporated a number of elements into the SNF PPS (for example, case-mix classification methodology, a market basket index, a wage index, and the urban and rural distinction used in the development or adjustment of the federal rates). Further, section 1888(e)(4)(H) of the Act specifically requires us to disseminate the payment rates for each new FY through the
As discussed in section VI.C. of this final rule, we also considered an alternative SNF VBP low-volume scoring policy. This alternative scoring assignment would result in a value-based incentive payment percentage of 1.2 percent, or 60 percent of the 2 percent withhold. This amount would match low-volume SNFs' incentive payment percentages with the finalized SNF VBP Program payback percentage of 60 percent, and would represent a smaller adjustment to low-volume SNFs' incentive payment percentages than the proposed policy described above. We estimated that this alternative would redistribute an additional $1 million with respect to FY 2019 services to low-volume SNFs. We also estimated that this alternative would increase the 60 percent payback percentage for FY 2019 by approximately 0.18 percent of the approximately $527.4 million of the total withheld from SNFs' payments, which would result in a payback percentage of 60.18 percent of the estimated $527.4 million in withheld funds for that Program year. We estimated that this alternative would pay back SNFs about $5.7 million less than the proposed low-volume scoring methodology adjustment in total estimated payments on an annual basis. However, under this alternative, like the policy we are finalizing, the specific amount by which the payback percentage would increase for each Program year would vary based on the number of low-volume SNFs that we identify for each Program year and the distribution of all SNFs' performance scores for that Program year.
We discussed the comments that we received on this alternative and our responses to those comments in section II.E.3.e. of this final rule in our discussion of the low-volume scoring adjustment policy.
As required by OMB Circular A-4 (available online at
This final rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2018 (82 FR 36530). Based on the above, we estimate the overall estimated payments for SNFs in FY 2019 are projected to increase by approximately $820 million, or 2.4 percent, compared with those in FY 2018. We estimate that in FY 2019 under RUG-IV, SNFs in urban and rural areas will experience, on average, a 2.4 percent increase and 2.5 percent increase, respectively, in estimated payments compared with FY 2018. Providers in the urban rural West South Central region will experience the largest estimated increase in payments of approximately 3.5 percent. Providers in the urban Mountain and rural New England regions will experience the smallest estimated increase in payments of 1.6 percent.
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, non-
This final rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2018 (82 FR 36530). Based on the above, we estimate that the aggregate impact for FY 2019 will be an increase of $820 million in payments to SNFs, resulting from the SNF market basket update to the payment rates. While it is projected in Table 45 that providers will experience a net increase in payments, we note that some individual providers within the same region or group may experience different impacts on payments than others due to the distributional impact of the FY 2019 wage indexes and the degree of Medicare utilization.
Guidance issued by the Department of Health and Human Services on the proper assessment of the impact on small entities in rulemakings, utilizes a cost or revenue impact of 3 to 5 percent as a significance threshold under the RFA. In their March 2017 Report to Congress (available at
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 an MSA and has fewer than 100 beds. This final rule will affect small rural hospitals that (1) furnish SNF services under a swing-bed agreement or (2) have a hospital-based SNF. We anticipate that the impact on small rural hospitals will be similar to the impact on SNF providers overall. Moreover, as noted in previous SNF PPS final rules (most recently, the one for FY 2018 (82 FR 36530)), the category of small rural hospitals is included within the analysis of the impact of this final rule on small entities in general. As indicated in Table 45, the effect on facilities for FY 2019 is projected to be an aggregate positive impact of 2.4 percent. As the overall impact on the industry as a whole is less than the 3 to 5 percent threshold discussed above, the Secretary has determined that this final rule will not have a significant impact on a substantial number of small rural hospitals for FY 2019.
Section 202 of the Unfunded Mandates Reform Act of 1995 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 2018, that threshold is approximately $150 million. This final rule will impose no mandates on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This final rule will have no substantial direct effect on state and local governments, preempt state law, or otherwise have federalism implications.
This final regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this year's proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons, we thought that the number of past commenters is a fair estimate of the number of reviewers of this rule. In the FY 2019 SNF PPS proposed rule (83 FR 21099), we welcomed any comments on the approach in estimating the number of entities which will review the proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule, and therefore, for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We sought comments on this assumption in the FY 2019 SNF PPS proposed rule (83 FR 21099).
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits
In accordance with the provisions of Executive Order 12866, this final rule
Diseases, Medicare, Reporting and recordkeeping requirements.
Health facilities, Diseases, Medicare, Reporting and recordkeeping requirements.
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
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. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn.
42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww; and sec. 124 of Public Law 106-113, 113 Stat. 1501A-332; sec. 3201 of Public Law 112-96, 126 Stat. 156; sec. 632 of Public Law 112-240, 126 Stat. 2354; sec. 217 of Public Law 113-93, 129 Stat. 1040; and sec. 204 of Public Law 113-295, 128 Stat. 4010; and sec. 808 of Public Law 114-27, 129 Stat. 362.
(d) * * *
(1) * * *
(v) For each subsequent fiscal year, the unadjusted Federal payment rate is equal to the rate computed for the previous fiscal year increased by a factor equal to the SNF market basket index percentage change for the fiscal year involved, except as provided in paragraphs (d)(1)(vi) and (vii) of this section.
(vi) For fiscal year 2018, the unadjusted Federal payment rate is equal to the rate computed for the previous fiscal year increased by a SNF market basket index percentage change of 1 percent (after application of paragraphs (d)(2) and (3) of this section).
(vii) For fiscal year 2019, the unadjusted Federal payment rate is equal to the rate computed for the previous fiscal year increased by a SNF market basket index percentage change of 2.4 percent (after application of paragraphs (d)(2) and (3) of this section).
(f)
The additions and revision read as follows:
(a) * * *
(16)
(17)
(c) * * *
(2) * * *
(i)
(d) * * *
(1) * * *
(iv) CMS will not award points for improvement to a SNF that has fewer than 25 eligible stays during the baseline period.
(3) If CMS determines that a SNF is a low-volume SNF with respect to a fiscal year, CMS will assign a performance score to the SNF for the fiscal year that, when used to calculate the value-based incentive payment amount (as defined in paragraph (a)(14) of this section), results in a value-based incentive payment amount that is equal to the adjusted Federal per diem rate (as defined in paragraph (a)(2) of this section) that would apply to the SNF for the fiscal year without application of § 413.337(f).
(4)(i) A SNF may request and CMS may grant exceptions to the SNF Value-Based Purchasing Program's requirements under this section for one or more calendar months when there are certain extraordinary circumstances beyond the control of the SNF.
(ii) A SNF may request an exception within 90 days of the date that the extraordinary circumstances occurred by sending an email to
(iii) Except as provided in paragraph (d)(4)(iv) of this section, CMS will not consider an exception request unless the SNF requesting such exception has complied fully with the requirements in this paragraph (d).
(iv) CMS may grant exceptions to SNFs without a request if it determines that an extraordinary circumstance affects an entire region or locale.
(v) CMS will calculate a SNF performance score for a fiscal year for a SNF for which it has granted an exception request that does not include its performance on the SNF readmission
(b) * * *
(3) CMS may remove a quality measure from the SNF QRP based on one or more of the following factors:
(i) Measure performance among SNFs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
(ii) Performance or improvement on a measure does not result in better resident outcomes.
(iii) A measure does not align with current clinical guidelines or practice.
(iv) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic.
(v) The availability of a measure that is more proximal in time to desired resident outcomes for the particular topic.
(vi) The availability of a measure that is more strongly associated with desired resident outcomes for the particular topic.
(vii) Collection or public reporting of a measure leads to negative unintended consequences other than resident harm.
(viii) The costs associated with a measure outweigh the benefit of its continued use in the program.
(d) * * *
(1) SNFs that do not meet the requirements in paragraph (b) of this section for a program year will receive a written notification of non-compliance through at least one of the following methods: Quality Improvement Evaluation System (QIES) Assessment Submission and Processing (ASAP) system, the United States Postal Service, or via an email from the Medicare Administrative Contractor (MAC). A SNF may request reconsideration no later than 30 calendar days after the date identified on the letter of non-compliance.
(4) CMS will notify SNFs, in writing, of its final decision regarding any reconsideration request through at least one of the following notification methods: QIES ASAP system, the United States Postal Service, or via email from the Medicare Administrative Contractor (MAC).
42 U.S.C. 1302 and 1395hh.
(a) * * *
(1) * * *
(i) The individual needs or needed on a daily basis skilled nursing care (furnished directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in an SNF or a swing-bed hospital on an inpatient basis, and the SNF care is or was needed for a condition for which the individual received inpatient care in a participating hospital or a qualified hospital, as defined in § 409.3 of this chapter, or for a new condition that arose while the individual was receiving care in the SNF or swing-bed hospital for a condition for which he or she received inpatient care in a participating or qualified hospital; or.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations that provide guidance regarding the additional first year depreciation deduction under section 168(k) of the Internal Revenue Code (Code). These proposed regulations reflect changes made by the Tax Cuts and Jobs Act. These proposed regulations affect taxpayers who deduct depreciation for qualified property acquired and placed in service after September 27, 2017.
Written or electronic comments and requests for a public hearing must be received by October 9, 2018.
Send submissions to: CC:PA:LPD:PR (REG-104397-18), 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-104397-18), 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, Elizabeth R. Binder, (202) 317-7005; concerning submissions of comments or requests for a public hearing, Regina L. Johnson, (202) 317-6901 (not toll-free numbers).
This document contains proposed amendments to 26 CFR part 1 under section 168(k). Section 168(k) was added to the Code by section 101 of the Job Creation and Worker Assistance Act of 2002, Public Law 107-147 (116 Stat. 21). Section 168(k) allows an additional first year depreciation deduction in the placed-in-service year of qualified property. Subsequent amendments to section 168(k) increased the percentage of the additional first year depreciation deduction from 30 percent to 50 percent (to 100 percent for property acquired and placed in service after September 8, 2010, and generally before January 1, 2012), extended the placed-in-service date generally through December 31, 2019, and made other changes. See section 201 of the Jobs and Growth Tax Relief Reconciliation Act of 2003, Public Law 108-27 (117 Stat. 752), sections 403 and 408 of the Working Families Tax Relief Act of 2004, Public Law 108-311 (118 Stat. 1166), sections 336 and 337 of the American Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418), sections 403 and 405 of the Gulf Opportunity Zone Act of 2005, Public Law 109-135 (119 Stat. 2577), section 103 of the Economic Stimulus Act of 2008, Public Law 110-185 (122 Stat. 613), section 3081 of the Housing Assistance Tax Act of 2008, Public Law 110-289 (122 Stat. 2654), section 1201 of the American Recovery and Reinvestment Tax Act of 2009, Public Law 111-5 (123 Stat. 115), section 2022 of the Small Business Jobs Act of 2010, Public Law 111-240 (124 Stat. 2504), section 401 of the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312 (124 Stat. 3296), section 331 of the American Taxpayer Relief Act of 2012, Public Law 112-240 (126 Stat. 2313), sections 125, 202, 210, 212, and 214 of the Tax Increase Prevention Act of 2014, Public Law 113-295 (128 Stat. 4010), and section 143 of the Protecting Americans from Tax Hikes Act of 2015, enacted as Division Q of the Consolidated Appropriations Act, 2016, Public Law 114-113 (129 Stat. 2242).
On December 22, 2017, section 168(k) and related provisions were amended by sections 12001(b)(13), 13201, and 13204 of the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054) (the “Act”) to provide further changes to the additional first year depreciation deduction. Unless otherwise indicated, all references to section 168(k) hereinafter are references to section 168(k) as amended.
Section 167(a) allows as a depreciation deduction a reasonable allowance for the exhaustion, wear and tear, and obsolescence of property used in a trade or business or of property held for the production of income. The depreciation deduction allowable for tangible depreciable property placed in service after 1986 generally is determined under the Modified Accelerated Cost Recovery System provided by section 168 (MACRS property). The depreciation deduction allowable for computer software that is placed in service after August 10, 1993, and is not an amortizable section 197 intangible, is determined under section 167(f)(1).
Section 168(k), prior to amendment by the Act, allowed an additional first year depreciation deduction for the placed-in-service year equal to 50 percent of the adjusted basis of qualified property. Qualified property was defined in part as property the original use of which begins with the taxpayer.
Section 13201 of the Act made several amendments to the allowance for additional first year depreciation deduction in section 168(k). For example, the additional first year depreciation deduction percentage is increased from 50 to 100 percent; the property eligible for the additional first year depreciation deduction is expanded to include certain used depreciable property and certain film, television, or live theatrical productions; the placed-in-service date is extended from before January 1, 2020, to before January 1, 2027 (from before January 1, 2021, to before January 1, 2028, for longer production period property or certain aircraft property described in section 168(k)(2)(B) or (C)); and the date on which a specified plant is planted or grafted by the taxpayer is extended from before January 1, 2020, to before January 1, 2027.
Section 168(k) allows a 100-percent additional first year depreciation deduction for qualified property acquired and placed in service after September 27, 2017, and placed in service before January 1, 2023 (before January 1, 2024, for longer production period property or certain aircraft property described in section 168(k)(2)(B) or (C)). If a taxpayer elects to apply section 168(k)(5), the 100-percent additional first year depreciation deduction also is allowed for a specified plant planted or grafted after September 27, 2017, and before January 1, 2023. The 100-percent additional first year depreciation deduction is decreased by 20 percent annually for qualified property placed in service, or a specified plant planted or grafted, after December 31, 2022 (after December 31, 2023, for longer production period property or certain aircraft property described in section 168(k)(2)(B) or (C)).
Section 168(k)(2)(A), as amended by the Act, defines “qualified property” as meaning, in general, property (1) to which section 168 applies that has a recovery period of 20 years or less, which is computer software as defined in section 167(f)(1)(B) for which a deduction is allowable under section 167(a) without regard to section 168(k), which is water utility property, which is
However, section 168(k)(2)(D) provides that qualified property does not include any property to which the alternative depreciation system under section 168(g) applies, determined without regard to section 168(g)(7) (relating to election to have the alternative depreciation system apply), and after application of section 280F(b) (relating to listed property with limited business use).
Section 13201(h) of the Act provides the effective dates of the amendments to section 168(k) made by section 13201 of the Act. Except as provided in section 13201(h)(2) of the Act, section 13201(h)(1) of the Act provides that these amendments apply to property acquired and placed in service after September 27, 2017. However, property is not treated as acquired after the date on which a written binding contract is entered into for such acquisition. Section 13201(h)(2) provides that the amendments apply to specified plants planted or grafted after September 27, 2017.
Additionally, section 12001(b)(13) of the Act repealed section 168(k)(4) (relating to the election to accelerate alternative minimum tax credits in lieu of the additional first year depreciation deduction) for taxable years beginning after December 31, 2017. Further, section 13204(a)(4)(B)(ii) repealed section 168(k)(3) (relating to qualified improvement property) for property placed in service after December 31, 2017.
The proposed regulations describe and clarify the statutory requirements that must be met for depreciable property to qualify for the additional first year depreciation deduction provided by section 168(k). Further, the proposed regulations instruct taxpayers how to determine the additional first year depreciation deduction and the amount of depreciation otherwise allowable for this property. Because the Act made substantial amendments to section 168(k), the proposed regulations update existing regulations in § 1.168(k)-1 by providing a new section at § 1.168(k)-2 for property acquired and placed in service after September 27, 2017, and make conforming amendments to the existing regulations.
The proposed regulations follow section 168(k)(2), as amended by the Act, and section 13201(h) of the Act to provide that depreciable property must meet four requirements to be qualified property. These requirements are (1) the depreciable property must be of a specified type; (2) the original use of the depreciable property must commence with the taxpayer or used depreciable property must meet the acquisition requirements of section 168(k)(2)(E)(ii); (3) the depreciable property must be placed in service by the taxpayer within a specified time period or must be planted or grafted by the taxpayer before a specified date; and (4) the depreciable property must be acquired by the taxpayer after September 27, 2017.
The proposed regulations follow the definition of qualified property in section 168(k)(2)(A)(i) and (k)(5) and provide that qualified property must be one of the following: (1) MACRS property that has a recovery period of 20 years or less; (2) computer software as defined in, and depreciated under, section 167(f)(1); (3) water utility property as defined in section 168(e)(5) and depreciated under section 168; (4) a qualified film or television production as defined in section 181(d) and for which a deduction would have been allowable under section 181 without regard to section 181(a)(2) and (g) or section 168(k); (5) a qualified live theatrical production as defined in section 181(e) and for which a deduction would have been allowable under section 181 without regard to section 181(a)(2) and (g) or section 168(k); or (6) a specified plant as defined in section 168(k)(5)(B) and for which the taxpayer has made an election to apply section 168(k)(5). Qualified improvement property acquired after September 27, 2017, and placed in service after September 27, 2017, and before January 1, 2018, also is qualified property.
For property placed in service after December 31, 2017, section 13204 of the Act amended section 168(e) to eliminate the 15-year MACRS property classification for qualified leasehold improvement property, qualified restaurant property, and qualified retail improvement property, and amended section 168(k) to eliminate qualified improvement property as a specific category of qualified property. Because of the effective date of section 13204 of the Act (property placed in service after December 31, 2017), the proposed regulations provide that MACRS property with a recovery period of 20 years or less includes the following MACRS property that is acquired by the taxpayer after September 27, 2017, and placed in service by the taxpayer after September 27, 2017, and before January 1, 2018: (1) Qualified leasehold improvement property; (2) qualified restaurant property that is qualified improvement property; and (3) qualified retail improvement property. For the same reason, the proposed regulations provide that qualified property includes qualified improvement property that is acquired by the taxpayer after September 27, 2017, and placed in service by the taxpayer after September 27, 2017, and before January 1, 2018. Further, to account for the statutory amendments to the definition of qualified improvement property made by the Act, the proposed regulations define qualified improvement property for purposes of section 168(k)(3) (before amendment by section 13204 of the Act) and section 168(e)(6) (as amended by section 13204 of the Act).
For purposes of determining the eligibility of MACRS property as qualified property, the proposed regulations retain the rule in § 1.168(k)-1(b)(2)(i)(A) that the recovery period applicable for the MACRS property under section 168(c) of the general depreciation system (GDS) is used, regardless of any election made by the taxpayer to depreciate the class of property under the alternative depreciation system of section 168(g) (ADS).
The proposed regulations provide that qualified property does not include (1) property excluded from the application of section 168 as a result of section 168(f); (2) property that is required to be depreciated under the ADS (as described below); (3) any class of
Property is required to be depreciated under the ADS if the property is described under section 168(g)(1)(A), (B), (C), (D), (F), or (G) or if other provisions of the Code require depreciation for the property to be determined under the ADS. Accordingly, MACRS property that is nonresidential real property, residential rental property, and qualified improvement property held by an electing real property trade or business (as defined in section 163(j)(7)(B)), and property with a recovery period of 10 years or more that is held by an electing farming business (as defined in section 163(j)(7)(C)), are not eligible for the additional first year depreciation deduction for taxable years beginning after December 31, 2017. Pursuant to section 168(k)(2)(D), MACRS property for which the taxpayer makes an election under section 168(g)(7) to depreciate the property under the ADS is eligible for the additional first year depreciation deduction (assuming all other requirements are met).
The proposed regulations provide rules for making the election out of the additional first year depreciation deduction pursuant to section 168(k)(7) and for making the election to apply section 168(k)(5) to a specified plant. Additionally, the proposed regulations provide rules for making the election under section 168(k)(10) to deduct 50 percent, instead of 100 percent, additional first year depreciation for qualified property acquired after September 27, 2017, by the taxpayer and placed in service or planted or grafted, as applicable, by the taxpayer during its taxable year that includes September 28, 2017. Because section 168(k)(10) does not state that the election may be made “with respect to any class of property” as stated in section 168(k)(7) for making the election out of the additional first year depreciation deduction, the proposed regulations provide that the election under section 168(k)(10) applies to all qualified property.
The proposed regulations generally retain the original use rules in § 1.168(k)-1(b)(3). Pursuant to section 168(k)(2)(A)(ii), the proposed regulations do not provide any date by which the original use of the property must commence with the taxpayer. Because section 13201 of the Act removed the rules regarding sale-leaseback transactions, the proposed regulations also do not retain the original use rules in § 1.168(k)-1(b)(3)(iii)(A) and (C) regarding such transactions, including a sale-leaseback transaction followed by a syndication transaction. The rule in the proposed regulations for syndication transactions involving new or used property is explained later in the preamble.
Pursuant to section 168(k)(2)(A)(ii) and (k)(2)(E)(ii), the proposed regulations provide that the acquisition of used property is eligible for the additional first year depreciation deduction if such acquisition meets the following requirements: (1) The property was not used by the taxpayer or a predecessor at any time prior to the acquisition; (2) the acquisition of the property meets the related party and carryover basis requirements of section 179(d)(2)(A), (B), and (C) and § 1.179-4(c)(1)(ii), (iii), and (iv), or (c)(2); and (3) the acquisition of the property meets the cost requirements of section 179(d)(3) and § 1.179-4(d).
A section 338 election and a section 336(e) election share many of the same characteristics. Therefore, the proposed regulations modify § 1.179-4(c)(2), which addresses the treatment of a section 338 election, to include property deemed to have been acquired by a new target corporation as a result of a section 336(e) election. Section 1.336-1(a)(1) provides that to the extent not inconsistent with section 336(e) or the regulations under section 336(e), the principles of section 338 and the regulations under section 338 apply for purposes of the regulations under section 336. To the extent that property is deemed to have been acquired by a “new target corporation,” the Treasury Department and the IRS read § 1.179-4(c)(2), without modification, as applying to the deemed acquisition of property by a new target corporation as a result of a section 336(e) election, just as it applies as the result of a section 338 election. However, to remove any doubt, the proposed regulations modify § 1.179-4(c)(2) to provide that property deemed to have been acquired by a new target corporation as a result of a section 338 or a section 336(e) election will be considered acquired by purchase for purposes of section 179.
The proposed regulations provide that the property is treated as used by the taxpayer or a predecessor at any time before its acquisition of the property only if the taxpayer or the predecessor had a depreciable interest in the property at any time before the acquisition, whether or not the taxpayer or the predecessor claimed depreciation deductions for the property. If a lessee has a depreciable interest in the improvements made to leased property and subsequently the lessee acquires the leased property of which the improvements are a part, the proposed regulations provide that the unadjusted depreciable basis, as defined in § 1.168(b)-1(a)(3), of the acquired property that is eligible for the additional first year depreciation deduction, assuming all other requirements are met, does not include the unadjusted depreciable basis attributable to the improvements.
Further, if a taxpayer initially acquires a depreciable interest in a portion of the property and subsequently acquires an additional depreciable interest in the same property, the proposed regulations also provide that such additional depreciable interest is not treated as being previously used by the taxpayer. However, if a taxpayer holds a depreciable interest in a portion of the property, sells that portion or a part of that portion, and subsequently acquires a depreciable interest in another portion
The Treasury Department and the IRS request comments on whether a safe harbor should be provided on how many taxable years a taxpayer or a predecessor should look back to determine if the taxpayer or the predecessor previously had a depreciable interest in the property. Such comments should provide the number of taxable years recommended for the look-back period and the reasoning for such number.
Members of a consolidated group generally are treated as separate taxpayers. See
The Treasury Department and the IRS also believe that the additional first year depreciation deduction should not be allowed when, as part of a series of related transactions, one or more members of a consolidated group acquire both the stock of a corporation that previously had a depreciable interest in the property and the property itself. Assume a corporation (the selling corporation) has a depreciable interest in property and sells it to an unrelated party. Subsequently, as part of a series of related transactions, a member of a consolidated group, unrelated to the selling corporation, acquires the property and either that member or a different member of the group acquires the stock of the selling corporation. In substance, the series of transactions is the same as if the selling corporation reacquired the property and then transferred it to another member of the group, in which case the additional first year depreciation deduction would not be allowed. Accordingly, these proposed regulations deny the deduction in such circumstances.
Additionally, if the acquisition of property is part of a series of related transactions that also includes one or more transactions in which the transferee of the property ceases to be a member of a consolidated group, then whether the taxpayer is a member of a consolidated group is tested immediately after the last transaction in the series.
In determining whether property meets the requirements of section 168(k)(2)(E)(ii), the Treasury Department and the IRS believe that the ordering of steps, or the use of an unrelated intermediary, in a series of related transactions should not control. For example, if a father buys and places equipment in service for use in the father's trade or business and subsequently the father sells the equipment to his daughter for use in her trade or business, the father and daughter are related parties under section 179(d)(2)(A) and § 1.179-4(c)(1)(ii) and therefore, the daughter's acquisition of the equipment is not eligible for the additional first year depreciation deduction. However, if in a series of related transactions, the father sells the equipment to an unrelated party and then the unrelated party sells the equipment to the father's daughter, the daughter's acquisition of the equipment from the unrelated party, absent the rule in the proposed regulations, is eligible for the additional first year depreciation deduction (assuming all other requirements are met). Thus, the proposed regulations provide that in the case of a series of related transactions, the transfer of the property will be treated as directly transferred from the original transferor to the ultimate transferee, and the relation between the original transferor and the ultimate transferee is tested immediately after the last transaction in the series.
On September 8, 2003, the Treasury Department and the IRS published temporary regulations (T.D. 9091, 2003-2 C.B. 939) in the
Section 1.704-3(d)(2) provides, in part, that under the remedial allocation method, the portion of a partnership's book basis in contributed property that exceeds its adjusted tax basis is recovered using any recovery period and depreciation (or other cost recovery) method available to the partnership for newly purchased property (of the same type as the contributed property) that is placed in service at the time of contribution. The proposed regulations provide that remedial allocations under section 704(c) do not qualify for the additional first year depreciation deduction under section 168(k).
Notwithstanding the language of § 1.704-3(d)(2) that any method available to the partnership for newly purchased property may be used to recover the portion of the partnership's book basis in contributed property that exceeds its adjusted tax basis, remedial allocations do not meet the requirements of section 168(k)(2)(E)(ii).
The same rule applies in the case of revaluations of partnership property (reverse section 704(c) allocations).
Section 1.704-1(b)(2)(iv)(
Section 732(a)(1) provides that the basis of property (other than money) distributed by a partnership to a partner other than in liquidation of the partner's interest is its adjusted basis to the partnership immediately before the distribution. Section 732(a)(2) provides that the basis determined under section 732(a)(1) shall not exceed the adjusted basis of the partner's interest in the partnership reduced by any money distributed in the same transaction. Section 732(b) provides that the basis of property (other than money) distributed by a partnership to a partner in liquidation of the partner's interest is equal to the adjusted basis of the partner's interest in the partnership reduced by any money distributed in the same transaction.
Property distributed by a partnership to a partner fails to satisfy the original use requirement because the partnership used the property prior to the distribution. Distributed property also fails to satisfy the acquisition requirements of section 168(k)(2)(E)(ii)(II). Any portion of basis determined by section 732(a)(1) fails to satisfy section 179(d)(2)(C) because it is determined by reference to the partnership's basis in the distributed property. Similarly, any portion of basis determined by section 732(a)(2) or (b) fails to satisfy section 179(d)(3) because it is determined by reference to the distributee partner's basis in its partnership interest (reduced by any money distributed in the same transaction).
Section 734(b)(1) provides that, in the case of a distribution of property to a partner with respect to which a section 754 election is in effect (or when there is a substantial basis reduction under section 734(d)), the partnership will increase the adjusted basis of partnership property by the sum of (A) the amount of any gain recognized to the distributee partner under section 731(a)(1), and (B) in the case of distributed property to which section 732(a)(2) or (b) applies, the excess of the adjusted basis of the distributed property to the partnership immediately before the distribution (as adjusted by section 732(d)) over the basis of the distributed property to the distributee, as determined under section 732.
Because a section 734(b) basis adjustment is made to the basis of partnership property (
Section 743(b)(1) provides that, in the case of a transfer of a partnership interest, either by sale or exchange or as a result of the death of a partner, a partnership that has a section 754 election in effect (or if there is a substantial built-in loss immediately after such partnership interest transfer under section 743(d)), will increase the adjusted basis of partnership property by the excess of the transferee's basis in the transferred partnership interest over the transferee's share of the adjusted basis of partnership's property. This increase is an adjustment to the basis of partnership property with respect to the transferee partner only and, therefore, is a partner specific basis adjustment to partnership property. The section 743(b) basis adjustment is allocated among partnership properties under section 755. As stated above, prior to the Act, a section 743(b) basis adjustment would always fail the original use requirement in section 168(k)(2)(A)(ii) because partnership property to which a section 743(b) basis adjustment relates would have been previously used by the partnership and its partners prior to the transfer that gave rise to the section 743(b) adjustment. After the Act, while a section 743(b) basis adjustment still fails the original use clause in section 168(k)(2)(A)(ii), a transaction giving rise to a section 743(b) basis adjustment may satisfy the used property clause in section 168(k)(2)(A)(ii) because of the used property acquisition requirements of section 168(k)(2)(E)(ii), depending on the facts and circumstances.
Because a section 743(b) basis adjustment is a partner specific basis adjustment to partnership property, the proposed regulations take an aggregate view and provide that, in determining whether a section 743(b) basis adjustment meets the used property acquisition requirements of section 168(k)(2)(E)(ii), each partner is treated as having owned and used the partner's proportionate share of partnership property. In the case of a transfer of a partnership interest, section 168(k)(2)(E)(ii)(I) will be satisfied if the partner acquiring the interest, or a predecessor of such partner, has not used the portion of the partnership property to which the section 743(b) basis adjustment relates at any time prior to the acquisition (that is, the transferee has not used the transferor's portion of partnership property prior to the acquisition), notwithstanding the fact that the partnership itself has previously used the property. Similarly, for purposes of applying section 179(d)(2)(A), (B), and (C), the partner acquiring a partnership interest is treated as acquiring a portion of partnership property, and the partner who is transferring a partnership interest is treated as the person from whom the property is acquired.
For example, the relationship between the transferor partner and the transferee partner must not be a prohibited relationship under section 179(d)(2)(A). Also, the transferor partner and transferee partner may not be part of the same controlled group under section 179(d)(2)(B). Finally, the transferee partner's basis in the transferred partnership interest may not be determined in whole or in part by reference to the transferor's adjusted basis, or under section 1014.
The same result will apply regardless of whether the transferee partner is a new partner or an existing partner purchasing an additional partnership interest from another partner. Assuming that the transferor partner's specific
Finally, the proposed regulations provide that a section 743(b) basis adjustment in a class of property (not including the property class for section 743(b) basis adjustments) may be recovered using the additional first year depreciation deduction under section 168(k) without regard to whether the partnership elects out of the additional first year depreciation deduction under section 168(k)(7) for all other qualified property in the same class of property and placed in service in the same taxable year. Similarly, a partnership may make the election out of the additional first year depreciation deduction under section 168(k)(7) for a section 743(b) basis adjustment in a class of property (not including the property class for section 743(b) basis adjustments), and this election will not bind the partnership to such election for all other qualified property of the partnership in the same class of property and placed in service in the same taxable year.
The syndication transaction rule in the proposed regulations is based on the rules in section 168(k)(2)(E)(iii) for syndication transactions. For new or used property, the proposed regulations provide that if (1) a lessor has a depreciable interest in the property and the lessor and any predecessor did not previously have a depreciable interest in the property, (2) the property is sold by the lessor or any subsequent purchaser within three months after the date the property was originally placed in service by the lessor (or, in the case of multiple units of property subject to the same lease, within three months after the date the final unit is placed in service, so long as the period between the time the first unit is placed in service and the time the last unit is placed in service does not exceed 12 months), and (3) the user (lessee) of the property after the last sale during the three-month period remains the same as when the property was originally placed in service by the lessor, then the purchaser of the property in the last sale during the three-month period is considered the taxpayer that acquired the property and the taxpayer that originally placed the property in service, but not earlier than the date of the last sale. Thus, if a transaction is within the rules described above, the purchaser of the property in the last sale during the three-month period is eligible to claim the additional first year depreciation for the property (assuming all requirements are met), and the earlier purchasers of the property are not.
The proposed regulations generally retain the placed-in-service date rules in § 1.168(k)-1(b)(5). Pursuant to the effective date in section 13201(h) of the Act and section 168(k)(2)(A)(iii) and (k)(2)(B)(i)(II), the proposed regulations provide that qualified property must be placed in service by the taxpayer after September 27, 2017, and before January 1, 2027, or, in the case of property described in section 168(k)(2)(B) or (C), before January 1, 2028. Because section 13201 of the Act removed the rules regarding sale-leaseback transactions, the proposed regulations do not retain the placed-in-service date rules in § 1.168(k)-1(b)(5)(ii)(A) and (C) regarding such transactions, including a sale-leaseback transaction followed by a syndication transaction.
Further, the proposed regulations provide rules for specified plants. Pursuant to section 168(k)(5)(A), if the taxpayer has made an election to apply section 168(k)(5) for a specified plant, the proposed regulations provide that the specified plant must be planted before January 1, 2027, or grafted before January 1, 2027, to a plant that has already been planted, by the taxpayer in the ordinary course of the taxpayer's farming business, as defined in section 263A(e)(4).
Pursuant to section 168(k)(2)(H), the proposed regulations also provide that a qualified film or television production is treated as placed in service at the time of initial release or broadcast as defined under § 1.181-1(a)(7), and a qualified live theatrical production is treated as placed in service at the time of the initial live staged performance. The proposed regulations also provide that the initial live staged performance of a qualified live theatrical production is the first commercial exhibition of a production to an audience. An initial live staged performance does not include limited exhibition, prior to commercial exhibition to general audiences, if the limited exhibition is primarily for purposes of publicity, determining the need for further production activity, or raising funds for the completion of production. For example, the initial live staged performance does not include a preview of the production if the preview is primarily to determine the need for further production activity.
The proposed regulations provide rules applicable to the acquisition requirements of the effective date under section 13201(h) of the Act. The proposed regulations provide that these rules apply to all property, including self-constructed property or property described in section 168(k)(2)(B) or (C).
Pursuant to section 13201(h)(1)(A) of the Act, the proposed regulations provide that the property must be acquired by the taxpayer after September 27, 2017, or, acquired by the taxpayer pursuant to a written binding contract entered into by the taxpayer after September 27, 2017. Because of the clear language of section 13201(h)(1) of the Act regarding written binding contracts, the proposed regulations also provide that property that is manufactured, constructed, or produced for the taxpayer by another person under a written binding contract that is entered into prior to the manufacture, construction, or production of the property for use by the taxpayer in its trade or business or for its production of income is acquired pursuant to a written binding contract. Further, if the written binding contract states the date on which the contract was entered into and a closing date, delivery date, or other similar date, the date on which the contract was entered into is the date the taxpayer acquired the property. The proposed regulations retain the rules in § 1.168(k)-1(b)(4)(ii) defining a binding contract. Additionally, the proposed regulations provide that a letter of intent for an acquisition is not a binding contract.
If a taxpayer manufactures, constructs, or produces property for its own use, the Treasury Department and the IRS recognize that the written binding contract rule in section 13201(h)(1) of the Act does not apply. In such case, the proposed regulations provide that the acquisition rules in section 13201(h)(1) of the Act are treated as met if the taxpayer begins
The proposed regulations also provide rules for qualified film, television, or live theatrical productions. For purposes of section 13201(h)(1)(A) of the Act, the proposed regulations provide that a qualified film or television production is treated as acquired on the date principal photography commences, and a qualified live theatrical production is treated as acquired on the date when all of the necessary elements for producing the live theatrical production are secured. These elements may include a script, financing, actors, set, scenic and costume designs, advertising agents, music, and lighting.
Pursuant to section 13201(h)(2) of the Act, if the taxpayer makes an election to apply section 168(k)(5) for a specified plant, the proposed regulations provide that the specified plant must be planted after September 27, 2017, or grafted after September 27, 2017, to a plant that has already been planted, by the taxpayer in the ordinary course of the taxpayer's farming business, as defined in section 263A(e)(4).
The proposed regulations provide rules for determining when longer production period property or certain aircraft property described in section 168(k)(2)(B) or (C) meets the acquisition requirements of section 168(k)(2)(B)(i)(III) or (k)(2)(C)(i), as applicable. Pursuant to section 168(k)(2)(B)(i)(III) and (k)(2)(C)(i), the proposed regulations provide that property described in section 168(k)(2)(B) or (C) must be acquired by the taxpayer before January 1, 2027, or acquired by the taxpayer pursuant to a written binding contract that is entered into before January 1, 2027. These acquisition requirements are in addition to those in section 13201(h)(1) of the Act, which require acquisition to occur after September 27, 2017.
The proposed regulations provide that the written binding contract rules for longer production period property and certain aircraft property are the same rules that apply for purposes of determining whether the acquisition requirements of section 13201(h)(1) of the Act are met.
With respect to self-constructed property described in section 168(k)(2)(B) or (C), the proposed regulations follow the acquisition rule in section 168(k)(2)(E)(i) for self-constructed property and provide that the acquisition requirements of section 168(k)(2)(B)(i)(III) or (k)(2)(C)(i), as applicable, are met if a taxpayer manufactures, constructs, or produces the property for its own use and such manufacturing, construction, or productions begins before January 1, 2027. Further, only for purposes of section 168(k)(2)(B)(i)(III) and (k)(2)(C)(i), the proposed regulations provide that property that is manufactured, constructed, or produced for the taxpayer by another person under a written binding contract that is entered into prior to the manufacture, construction, or production of the property for use by the taxpayer in its trade or business or for its production of income is considered to be manufactured, constructed, or produced by the taxpayer. The proposed regulations also provide rules similar to those in § 1.168(k)-1(b)(4)(iii)(B) for defining when manufacturing, construction, or production begins, including the same safe harbor, and in § 1.168(k)-1(b)(4)(iii)(C) for a contract to acquire, or for the manufacture, construction, or production of, a component of the larger self-constructed property.
Pursuant to section 168(k)(1)(A), the proposed regulations provide that the allowable additional first year depreciation deduction for qualified property is equal to the applicable percentage (as defined in section 168(k)(6)) of the unadjusted depreciable basis (as defined in § 1.168(b)-1(a)(3)) of the property. For qualified property described in section 168(k)(2)(B), the unadjusted depreciable basis (as defined in § 1.168(b)-1(a)(3)) of the property is limited to the property's basis attributable to manufacture, construction, or production of the property before January 1, 2027, as provided in section 168(k)(2)(B)(ii).
Pursuant to section 168(k)(2)(G), the proposed regulations also provide that the additional first year depreciation deduction is allowed for both regular tax and alternative minimum tax (AMT) purposes. However, for AMT purposes, the amount of the additional first year depreciation deduction is based on the unadjusted depreciable basis of the property for AMT purposes. The amount of the additional first year depreciation deduction is not affected by a taxable year of less than 12 months for either regular or AMT purposes.
The proposed regulations provide rules similar to those in § 1.168(k)-1(d)(2) for determining the amount of depreciation otherwise allowable for qualified property. That is, before determining the amount of depreciation otherwise allowable for qualified property, the proposed regulations require the taxpayer to first reduce the unadjusted depreciable basis (as defined in § 1.168(b)-1(a)(3)) of the property by the amount of the additional first year depreciation deduction allowed or allowable, whichever is greater (the remaining adjusted depreciable basis), as provided in section 168(k)(1)(B). Then, the remaining adjusted depreciable basis is depreciated using the applicable depreciation provisions of the Code for the property (for example, section 168 for MACRS property, section 167(f)(1) for computer software, and section 167 for film, television, or theatrical productions). This amount of depreciation is allowed for both regular tax and AMT purposes, and is affected by a taxable year of less than 12 months. However, for AMT purposes, the amount of depreciation allowed is determined by calculating the remaining adjusted depreciable basis of the property for AMT purposes and using the same depreciation method, recovery period, and convention that applies to the property for regular tax purposes. If a taxpayer uses the optional depreciation tables in Rev. Proc. 87-57 (1987-2 C.B. 687) to compute depreciation for qualified property that is MACRS property, the proposed regulations also provide that the remaining adjusted depreciable basis of the property is the basis to which the annual depreciation rates in those tables apply.
The proposed regulations also provide rules similar to those in § 1.168(k)-1(f) for certain situations. However, the
The proposed regulations provide rules for the following situations: (1) Qualified property placed in service or planted or grafted, as applicable, and disposed of in the same taxable year; (2) redetermination of basis of qualified property; (3) recapture of additional first year depreciation for purposes of section 1245 and section 1250; (4) a certified pollution control facility that is qualified property; (5) like-kind exchanges and involuntary conversions of qualified property; (6) a change in use of qualified property; (7) the computation of earnings and profits; (8) the increase in the limitation of the amount of depreciation for passenger automobiles; (9) the rehabilitation credit under section 47; and (10) computation of depreciation for purposes of section 514(a)(3).
The proposed regulations provide a special rule for qualified property that is placed in service in a taxable year and then contributed to a partnership under section 721(a) in the same taxable year when one of the other partners previously had a depreciable interest in the property. Situation 1 of Rev. Rul. 99-5 (1999-1 C.B. 434) is an example of such a fact pattern. Under § 1.168(k)-1(f)(1)(iii) and its cross-reference to § 1.168(d)-1(b)(7)(ii), the additional first year depreciation deduction associated with the contributed property would be allocated between the contributing partner and the partnership based on the proportionate time the contributing partner and the partnership held the property throughout the taxable year. The partnership could then allocate a portion of the deduction to the partner with a previous depreciable interest in the property. The Treasury Department and the IRS believe that allocating any portion of the deduction to a partner who previously had a depreciable interest in the property would be inconsistent with section 168(k)(2)(E)(ii)(I). Therefore, the proposed regulations provide that, in this situation, the additional first year depreciation deduction with respect to the contributed property is not allocated under the general rules of § 1.168(d)-1(b)(7)(ii). Instead, the additional first year depreciation deduction is allocated entirely to the contributing partner prior to the section 721(a) transaction and not to the partnership.
With respect to like-kind exchanges and involuntary conversions, § 1.168(k)-1(f)(5) provides that the exchanged basis and excess basis, if any, of the replacement property is eligible for the additional first year depreciation deduction if the replacement property is qualified property. The proposed regulations retain this rule if the replacement property also meets the original use requirement. Pursuant to section 168(k)(2)(E)(ii)(II) and its cross-reference to section 179(d)(3), the proposed regulations also provide that only the excess basis, if any, of the replacement property is eligible for the additional first year depreciation deduction if the replacement property is qualified property and also meets the used property acquisition requirements. These rules also apply when a taxpayer makes the election under § 1.168(i)-6(i)(1) to treat, for depreciation purposes only, the total of the exchanged basis and excess basis, if any, in the replacement MACRS property as property placed in service by the taxpayer at the time of replacement and the adjusted depreciable basis of the relinquished MACRS property as disposed of by the taxpayer at the time of disposition. The proposed regulations also retain the other rules in § 1.168(k)-1(f)(5) for like-kind exchanges and involuntary conversions, but update the definitions to be consistent with the definitions in § 1.168(i)-6, which addresses how to compute depreciation of property involved in like-kind exchanges or involuntary conversions.
These regulations are proposed to apply to qualified property placed in service or planted or grafted, as applicable, by the taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
The Administrator of the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, has waived review of this proposed rule in accordance with section 6(a)(3)(A) of Executive Order 12866. OIRA will subsequently make a significance determination of the final rule, pursuant to section 3(f) of Executive Order (E.O.) 12866 and the April 11, 2018, Memorandum of Agreement between the Department of Treasury and the Office of Management and Budget (OMB).
The proposed regulations do not impose a collection of information on small entities and provide clarifying rules for taxpayers to enjoy the tax benefit of 100-percent additional first year depreciation as provided by the amendments to section 168 by the Act. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act (5 U.S.C. chapter 6). Pursuant to section 7805(f) of the Code, this notice of proposed rulemaking will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
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 authors of these proposed regulations are Kathleen Reed and Elizabeth R. Binder of the Office of Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the Treasury Department and the IRS participated in their development.
The IRS Revenue Procedures and Revenue Rulings cited in this document are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
Section 1.168(k)-2 also issued under 26 U.S.C. 1502.
The additions read as follows:
(a) * * *
(2) * * *
(i) * * * The last sentence of paragraph (c)(8)(i) of this section applies to qualified rehabilitation expenditures that are qualified property under section 168(k)(2) and placed in service by a taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(c) * * *
(8) * * *
(i) * * * Further, see § 1.168(k)-2(f)(9) if the qualified rehabilitation expenditures are qualified property under section 168(k), as amended by the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)).
The addition reads as follows:
(e) * * *
(3) * * * The language “or § 1.168(k)-2, as applicable,” in the third sentence in paragraph (b)(1) of this section applies to computer software that is qualified property under section 168(k)(2) and placed in service by a taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(a) * * *
(5)
(A) For purposes of section 168(e)(6), the improvement is placed in service by the taxpayer after December 31, 2017;
(B) For purposes of section 168(k)(3) as in effect on the day before amendment by section 13204(a)(4)(B) of the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)) (“Act”), the improvement is acquired by the taxpayer before September 28, 2017, the improvement is placed in service by the taxpayer before January 1, 2018, and the improvement meets the original use requirement in section 168(k)(2)(A)(ii) as in effect on the day before amendment by section 13201(c)(1) of the Act; or
(C) For purposes of section 168(k)(3) as in effect on the day before amendment by section 13204(a)(4)(B) of the Act, the improvement is acquired by the taxpayer after September 27, 2017; the improvement is placed in service by the taxpayer after September 27, 2017, and before January 1, 2018; and the improvement meets the requirements in section 168(k)(2)(A)(ii) as amended by section 13201(c)(1) of the Act; and
(ii) Does not include any qualified improvement for which an expenditure is attributable to—
(A) The enlargement, as defined in § 1.48-12(c)(10), of the building;
(B) Any elevator or escalator, as defined in § 1.48-1(m)(2); or
(C) The internal structural framework, as defined in § 1.48-12(b)(3)(iii), of the building.
(b)
(2)
(ii)
The additions read as follows:
(b) * * *
(3) * * *
(ii) * * * Further, see § 1.168(k)-2(f)(1) for rules relating to qualified property under section 168(k), as amended by the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)), that is placed in service by the taxpayer in the same taxable year in which either a partnership is terminated as a result of a technical termination under section 708(b)(1)(B) or the property is transferred in a transaction described in section 168(i)(7).
(7) * * *
(ii) * * * However, see § 1.168(k)-2(f)(1)(iii) for a special rule regarding the allocation of the additional first year depreciation deduction in the case of certain contributions of property to a partnership under section 721.
(d) * * *
(2) * * * The last sentences in paragraphs (b)(3)(ii) and (b)(7)(ii) of this section apply to qualified property under section 168(k)(2) placed in service by a taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
The addition and revision read as follows:
(g) * * *
(1) * * * Except as provided in paragraph (g)(2) of this section, this section applies to any change in the use of MACRS property in a taxable year ending on or after June 17, 2004. * * *
(2)
The additions read as follows:
(d) * * *
(4) * * * Further, see § 1.168(k)-2(f)(5)(iv) for replacement MACRS property that is qualified property under section 168(k), as amended by the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)).
(h) * * * Further, see § 1.168(k)-2(f)(5) for qualified property under section 168(k), as amended by the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)).
(k) * * *
(4)
This section lists the major paragraphs contained in §§ 1.168(k)-1 and 1.168(k)-2.
(a) Scope and definitions.
(1) Scope.
(2) Definitions.
(b) Qualified property.
(1) In general.
(2) Description of qualified property.
(i) In general.
(ii) Property not eligible for additional first year depreciation deduction.
(3) Original use or used property acquisition requirements.
(i) In general.
(ii) Original use.
(A) In general.
(B) Conversion to business or income-producing use.
(C) Fractional interests in property.
(iii) Used property acquisition requirements.
(A) In general.
(B) Property was not used by the taxpayer at any time prior to acquisition.
(C) Special rules for a series of related transactions.
(iv) Application to partnerships.
(A) Section 704(c) remedial allocations.
(B) Basis determined under section 732.
(C) Section 734(b) adjustments.
(D) Section 743(b) adjustments.
(v) Syndication transaction.
(vi) Examples.
(4) Placed-in-service date.
(i) In general.
(ii) Specified plant.
(iii) Qualified film, television, or live theatrical production.
(iv) Syndication transaction.
(v) Technical termination of a partnership.
(vi) Section 168(i)(7) transactions.
(5) Acquisition of property.
(i) In general.
(ii) Acquisition date.
(iii) Definition of binding contract.
(A) In general.
(B) Conditions.
(C) Options.
(D) Letter of intent.
(E) Supply agreements.
(F) Components.
(iv) Self-constructed property.
(A) In general.
(B) When does manufacture, construction, or production begin.
(C) Components of self-constructed property.
(v) Qualified film, television, or live theatrical production.
(vi) Specified plant.
(vii) Examples.
(c) Property described in section 168(k)(2)(B) or (C).
(1) In general.
(2) Definition of binding contract.
(3) Self-constructed property.
(i) In general.
(ii) When does manufacture, construction, or production begin.
(A) In general.
(B) Safe harbor.
(iii) Components of self-constructed property.
(A) Acquired components.
(B) Self-constructed components.
(iv) Examples.
(d) Computation of depreciation deduction for qualified property.
(1) Additional first year depreciation deduction.
(i) Allowable taxable year.
(ii) Computation.
(iii) Property described in section 168(k)(2)(B).
(iv) Alternative minimum tax.
(A) In general.
(B) Special rules.
(2) Otherwise allowable depreciation deduction.
(i) In general.
(ii) Alternative minimum tax.
(3) Examples.
(e) Elections under section 168(k).
(1) Election not to deduct additional first year depreciation.
(i) In general.
(ii) Definition of class of property.
(iii) Time and manner for making election.
(A) Time for making election.
(B) Manner of making election.
(iv) Failure to make election.
(2) Election to apply section 168(k)(5) for specified plants.
(i) In general.
(ii) Time and manner for making election.
(A) Time for making election.
(B) Manner of making election.
(iii) Failure to make election.
(3) Election for qualified property placed in service during the 2017 taxable year.
(i) In general.
(ii) Time and manner for making election.
(A) Time for making election.
(B) Manner of making election.
(iii) Failure to make election.
(4) Alternative minimum tax.
(5) Revocation of election.
(i) In general.
(ii) Automatic 6-month extension.
(f) Special rules.
(1) Property placed in service and disposed of in the same taxable year.
(i) In general.
(ii) Technical termination of a partnership.
(iii) Section 168(i)(7) transactions.
(iv) Examples.
(2) Redetermination of basis.
(i) Increase in basis.
(ii) Decrease in basis.
(iii) Definitions.
(iv) Examples.
(3) Sections 1245 and 1250 depreciation recapture.
(4) Coordination with section 169.
(5) Like-kind exchanges and involuntary conversions.
(i) Scope.
(ii) Definitions.
(iii) Computation.
(A) In general.
(B) Year of disposition and year of replacement.
(C) Property described in section 168(k)(2)(B).
(D) Effect of § 1.168(i)-6(i)(1) election.
(E) Alternative minimum tax.
(iv) Replacement MACRS property or replacement computer software that is acquired and placed in service before disposition of relinquished MACRS property or relinquished computer software.
(v) Examples.
(6) Change in use.
(i) Change in use of depreciable property.
(ii) Conversion to personal use.
(iii) Conversion to business or income-producing use.
(A) During the same taxable year.
(B) Subsequent to the acquisition year.
(iv) Depreciable property changes use subsequent to the placed-in-service year.
(v) Examples.
(7) Earnings and profits.
(8) Limitation of amount of depreciation for certain passenger automobiles.
(9) Coordination with section 47.
(i) In general.
(ii) Example.
(10) Coordination with section 514(a)(3).
(g) Applicability dates.
(1) In general.
(2) Early application.
(a)
(2)
(i)
(ii)
(b)
(i) The requirements in § 1.168(k)-2(b)(2) (description of qualified property);
(ii) The requirements in § 1.168(k)-2(b)(3) (original use or used property acquisition requirements);
(iii) The requirements in § 1.168(k)-2(b)(4) (placed-in-service date); and
(iv) The requirements in § 1.168(k)-2(b)(5) (acquisition of property).
(2)
(A) MACRS property, as defined in § 1.168(b)-1(a)(2), that has a recovery period of 20 years or less. For purposes of this paragraph (b)(2)(i)(A) and section 168(k)(2)(A)(i)(I), the recovery period is determined in accordance with section 168(c) regardless of any election made by the taxpayer under section 168(g)(7). This paragraph (b)(2)(i)(A) includes the following MACRS property that is acquired by the taxpayer after September 27, 2017, and placed in service by the taxpayer after September 27, 2017, and before January 1, 2018:
(
(
(
(B) Computer software as defined in, and depreciated under, section 167(f)(1) and the regulations under section 167(f)(1);
(C) Water utility property as defined in section 168(e)(5) and depreciated under section 168;
(D) Qualified improvement property as defined in § 1.168(b)-1(a)(5)(i)(C) and (a)(5)(ii) and depreciated under section 168;
(E) Qualified film or television production, as defined in section 181(d) and § 1.181-3, for which a deduction would have been allowable under section 181 without regard to section 181(a)(2) and (g), or section 168(k);
(F) Qualified live theatrical production, as defined in section 181(e), for which a deduction would have been allowable under section 181 without regard to section 181(a)(2) and (g), or section 168(k); or
(G) A specified plant, as defined in section 168(k)(5)(B), for which the taxpayer has properly made an election to apply section 168(k)(5) for the taxable year in which the specified plant is planted, or grafted to a plant that has already been planted, by the taxpayer in the ordinary course of the taxpayer's farming business, as defined in section 263A(e)(4) (for further guidance, see paragraph (e) of this section).
(ii)
(A) Described in section 168(f) (for example, automobiles for which the taxpayer uses the optional business standard mileage rate);
(B) Required to be depreciated under the alternative depreciation system of section 168(g) pursuant to section 168(g)(1)(A), (B), (C), (D), (F), or (G), or other provisions of the Internal Revenue Code (for example, property described in section 263A(e)(2)(A) if the taxpayer or any related person, as defined in section 263A(e)(2)(B), has made an election under section 263A(d)(3), or property described in section 280F(b)(1));
(C) Included in any class of property for which the taxpayer elects not to deduct the additional first year depreciation (for further guidance, see paragraph (e) of this section);
(D) A specified plant that is placed in service by the taxpayer during the taxable year and for which the taxpayer made an election to apply section 168(k)(5) for a prior taxable year;
(E) Included in any class of property for which the taxpayer elects to apply section 168(k)(4). This paragraph (b)(2)(ii)(E) applies to property placed in service in any taxable year beginning before January 1, 2018;
(F) Described in section 168(k)(9)(A) and placed in service in any taxable year beginning after December 31, 2017; or
(G) Described in section 168(k)(9)(B) and placed in service in any taxable year beginning after December 31, 2017.
(3)
(ii)
(B)
(
(C)
(iii)
(
(
(
(B)
(
(
(
(
(C)
(
(
(iv)
(B)
(C)
(D)
(
(
(
(v)
(vi)
(i) On August 1, 2018,
(ii)
(iii)
On April 1, 2015,
In the ordinary course of its business,
On September 1, 2017,
The facts are the same as in
The facts are the same as in
During 2016,
The facts are the same as in
The facts are the same as in
The facts are the same as in
The facts are the same as in
The facts are the same as in
In November 2017, AA Corporation purchases a used drill press costing $10,000 and is granted a trade-in allowance of $2,000 on its old drill press. The used drill press is qualified property under section 168(k)(2)(A)(i). The old drill press had a basis of $1,200. Under sections 1012 and 1031(d), the basis of the used drill press is $9,200 ($1,200 basis of old drill press plus cash expended of $8,000). Only $8,000 of the basis of the used drill press satisfies the requirements of section 179(d)(3) and § 1.179-4(d) and, thus, satisfies the used property acquisition requirement of paragraph (b)(3)(iii) of this section. The remaining $1,200 of the basis of the used drill press does not satisfy the requirements of section 179(d)(3) and § 1.179-4(d) because it is determined by reference to the old drill press. Accordingly, assuming all other requirements are met, only $8,000 of the basis of the used drill press is eligible for the additional first year depreciation deduction.
In a series of related transactions, a father sells a machine to an unrelated party who sells the machine to the father's daughter for use in the daughter's trade or business. Pursuant to paragraph (b)(3)(iii)(C) of this section, the transfers of the machine are treated as a direct transfer from the father to his daughter and the time to test whether the parties are related is immediately after the last transaction in the series. Because the father and the daughter are related parties within the meaning of section 179(d)(2)(A) and § 1.179-4(c)(ii), the daughter's acquisition of the machine does not satisfy the used property acquisition requirements of paragraph (b)(3)(iii) of this section. Further, because the transfers of the machine are treated as a direct transfer from the father to his daughter, the unrelated party's acquisition of the machine is not eligible for the additional first year depreciation deduction.
Parent owns all of the stock of B Corporation and C Corporation. Parent, B Corporation, and C Corporation are all members of the Parent consolidated group. C Corporation has a depreciable interest in Equipment #1. During 2018, C Corporation sells Equipment #1 to B Corporation. Prior to this acquisition, B Corporation never had a depreciable interest in Equipment #1. B Corporation's acquisition of Equipment #1 does not satisfy the used property acquisition requirements of paragraph (b)(3)(iii) of this section for two reasons. First, B Corporation and C Corporation are related parties within the meaning of section 179(d)(2)(B) and § 1.179-4(c)(2)(iii). Second, pursuant to paragraph (b)(3)(iii)(B)(
(i) Parent owns all of the stock of D Corporation and E Corporation. Parent, D Corporation, and E Corporation are all members of the Parent consolidated group. D Corporation has a depreciable interest in Equipment #2. No other members of the Parent consolidated group ever had a depreciable interest in Equipment #2. During 2018, D Corporation sells Equipment #2 to
(ii) Pursuant to paragraph (b)(3)(iii)(B)(
(i) Parent owns all of the stock of F Corporation and G Corporation. Parent, F Corporation, and G Corporation are all members of the Parent consolidated group. G Corporation has a depreciable interest in Equipment #3. No other members of the Parent consolidated group ever had a depreciable interest in Equipment #3. X Corporation is the common parent of a consolidated group and is not related, within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c), to any member of the Parent consolidated group. No member of the X consolidated group ever had a depreciable interest in Equipment #3. In a series of related transactions, G Corporation sells Equipment #3 to F Corporation, and Parent sells all of the stock of F Corporation to X Corporation.
(ii) F Corporation was a member of the Parent consolidated group at the time it acquired Equipment #3 from G Corporation, another member of the group. Paragraph (b)(3)(iii)(B)(
(iii) After the sale of the F Corporation stock to X Corporation, F Corporation is a member of the X consolidated group. Because no member of the X consolidated group previously had a depreciable interest in Equipment #3, F Corporation is not treated as previously having a depreciable interest in Equipment #3 under paragraph (b)(3)(iii)(B)(
(iv) Because relatedness is tested after F Corporation leaves the Parent consolidated group, F Corporation and G Corporation are not related within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c). Accordingly, F Corporation's acquisition of Equipment #3 satisfies the used property acquisition requirements of paragraph (b)(3)(iii)(A)(
(i) H Corporation, which is not a member of a consolidated group, has a depreciable interest in Equipment #4. Parent owns all the stock of I Corporation, and Parent and I Corporation are members of the Parent consolidated group. No member of the Parent consolidated group ever had a depreciable interest in Equipment #4. Neither Parent nor I Corporation is related to H Corporation within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c). During 2018, H Corporation sells Equipment #4 to a person not related to H Corporation, Parent, or I Corporation within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c). In a series of related transactions, during 2019, Parent acquires all of the stock of H Corporation, and I Corporation purchases Equipment #4 from an unrelated person.
(ii) In a series of related transactions, H Corporation became a member of the Parent consolidated group, and I Corporation, also a member of the Parent consolidated group, acquired Equipment #4. Because H Corporation previously had a depreciable interest in Equipment #4, pursuant to paragraph (b)(3)(iii)(B)(
(i) J Corporation, K Corporation, and L Corporation are unrelated parties within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c). None of J Corporation, K Corporation, and L Corporation is a member of a consolidated group. J Corporation has a depreciable interest in Equipment #5. During 2018, J Corporation sells Equipment #5 to K Corporation. During 2020, J Corporation merges into L Corporation in a transaction described in section 368(a)(1)(A). In 2021, L Corporation acquires Equipment #5 from K Corporation.
(ii) Because J Corporation is the predecessor of L Corporation and J Corporation previously had a depreciable interest in Equipment #5, L Corporation's acquisition of Equipment #5 does not satisfy paragraphs (b)(3)(iii)(A)(
(i) M Corporation acquires and places in service a used airplane on March 26, 2018. Prior to this acquisition, M Corporation never had a depreciable interest in this airplane. On March 26, 2018, M Corporation also leases the used airplane to N Corporation, an airline company. On May 27, 2018, M Corporation sells to O Corporation the used airplane subject to the lease with N Corporation. M Corporation and O Corporation are related parties within the meaning of section 179(d)(2)(A) or (B) and § 1.179-4(c). As of May 27, 2018, N Corporation is still the lessee of the used airplane. Prior to this acquisition, O Corporation never had a depreciable interest in the used airplane. O Corporation is a calendar-year taxpayer.
(ii) The sale transaction of May 27, 2018, satisfies the requirements of paragraph (b)(3)(v) of this section. As a result, O Corporation is considered the taxpayer that acquired the used airplane for purposes of applying the used property acquisition requirements in paragraph (b)(3)(iii) of this section. In applying these rules, the fact that M Corporation and O Corporation are related parties is not taken into account because O Corporation, not M Corporation, is treated as acquiring the used airplane. Further, pursuant to paragraph (b)(4)(iv) of this section, the used airplane is treated as originally placed in service by O Corporation on May 27, 2018. Because O Corporation never had a depreciable interest in the used airplane and assuming all other requirements are met, O Corporation's purchase price of the used airplane qualifies for the 100-percent additional first year depreciation deduction for O Corporation.
(i) The facts are the same as in
(ii) Because O Corporation, a calendar-year taxpayer, placed in service and disposed of the used airplane during 2018, the used airplane is not eligible for the additional first year depreciation deduction for O Corporation pursuant to paragraph (f)(1)(i) of this section.
(iii) Because P Corporation never had a depreciable interest in the used airplane and assuming all other requirements are met, P Corporation's purchase price of the used airplane qualifies for the 100-percent additional first year depreciation deduction for P Corporation.
(4)
(ii)
(iii)
(B) For purposes of this paragraph (b)(4), a qualified live theatrical production is treated as placed in service at the time of the initial live staged performance. Solely for purposes of this paragraph, the term
(iv)
(v)
(vi)
(5)
(ii)
(iii)
(B)
(C)
(D)
(E)
(F)
(iv)
(B)
(
(C)
(
(v)
(B) For purposes of section 13201(h)(1)(A) of the Act, a qualified live theatrical production is treated as acquired on the date when all of the necessary elements for producing the live theatrical production are secured. These elements may include a script, financing, actors, set, scenic and costume designs, advertising agents, music, and lighting.
(vi)
(vii)
On September 1, 2017,
The facts are the same as in
The facts are the same as in
On September 1, 2017,
The facts are the same as in
On August 15, 2017,
On June 1, 2017,
The facts are the same as in
On September 1, 2017,
On July 1, 2017,
(c)
(2)
(3)
(ii)
(B)
(iii)
(B)
(iv)
On June 1, 2017,
On June 1, 2026,
On December 1, 2026,
(d)
(A) Except as provided in paragraph (d)(1)(i)(B) or (f) of this section, in the taxable year in which the qualified property is placed in service by the taxpayer for use in its trade or business or for the production of income; or
(B) In the taxable year in which the specified plant is planted, or grafted to a plant that has already been planted, by the taxpayer in the ordinary course of the taxpayer's farming business, as defined in section 263A(e)(4), if the taxpayer properly made the election to apply section 168(k)(5) (for further guidance, see paragraph (e) of this section).
(ii)
(iii)
(iv)
(
(
(B)
(2)
(ii)
(3)
On March 1, 2023,
On June 1, 2023,
(e)
(ii)
(A) Except for the property described in paragraphs (e)(1)(ii)(B) and (D), and (e)(2) of this section, each class of property described in section 168(e) (for example, 5-year property);
(B) Water utility property as defined in section 168(e)(5) and depreciated under section 168;
(C) Computer software as defined in, and depreciated under, section 167(f)(1) and the regulations under section 167(f)(1);
(D) Qualified improvement property as defined in § 1.168(b)-1(a)(5)(i)(C) and (a)(5)(ii), and depreciated under section 168;
(E) Each separate production, as defined in § 1.181-3(b), of a qualified film or television production;
(F) Each separate production, as defined in section 181(e)(2), of a qualified live theatrical production; or
(G) A partner's basis adjustment in partnership assets under section 743(b) for each class of property described in paragraphs (e)(1)(ii)(A) through (F), and (e)(2) of this section (for further guidance, see § 1.743-1(j)(4)(i)(B)(
(iii)
(B)
(iv)
(2)
(ii)
(B)
(iii)
(3)
(ii)
(B)
(iii)
(4)
(5)
(ii)
(f)
(ii)
(iii)
(iv)
On January 5, 2018, XX purchased and placed in service qualified property for a total amount of $9,000. On August 20, 2018, XX transferred this qualified property to Partnership BC in a transaction described in section 721(a). No other partner of Partnership BC has ever had a depreciable interest in the qualified property. XX and Partnership BC are calendar-year taxpayers. Because the transaction between XX and Partnership BC is a transaction described in section 168(i)(7), pursuant to paragraph (f)(1)(iii) of this section, the 100-percent additional first year
(2)
(i)
(A) Qualified property, except for computer software described in paragraph (b)(2)(i)(B) of this section, is depreciated over the recovery period of the qualified property remaining as of the beginning of the taxable year in which the increase in basis occurs, and using the same depreciation method and convention applicable to the qualified property that applies for the taxable year in which the increase in basis occurs; and
(B) Computer software, as defined in paragraph (b)(2)(i)(B) of this section, that is qualified property is depreciated ratably over the remainder of the 36-month period, the useful life under section 167(f)(1), as of the beginning of the first day of the month in which the increase in basis occurs.
(ii)
(A) Qualified property, except for computer software described in paragraph (b)(2)(i)(B) of this section, reduces the amount otherwise allowable as a depreciation deduction over the recovery period of the qualified property remaining as of the beginning of the taxable year in which the decrease in basis occurs, and using the same depreciation method and convention of the qualified property that applies in the taxable year in which the decrease in basis occurs. If, for any taxable year, the reduction to the amount otherwise allowable as a depreciation deduction, as determined under this paragraph (f)(2)(ii)(A), exceeds the total amount otherwise allowable as a depreciation deduction for all of the taxpayer's depreciable property, the taxpayer shall take into account a negative depreciation deduction in computing taxable income; and
(B) Computer software, as defined in paragraph (b)(2)(i)(B) of this section, that is qualified property reduces the amount otherwise allowable as a depreciation deduction over the remainder of the 36-month period, the useful life under section 167(f)(1), as of the beginning of the first day of the month in which the decrease in basis occurs. If, for any taxable year, the reduction to the amount otherwise allowable as a depreciation deduction, as determined under this paragraph (f)(2)(ii)(B), exceeds the total amount otherwise allowable as a depreciation deduction for all of the taxpayer's depreciable property, the taxpayer shall take into account a negative depreciation deduction in computing taxable income.
(iii)
(A) An increase in basis occurs in the taxable year an amount is taken into account under section 461; and
(B) A decrease in basis occurs in the taxable year an amount would be taken into account under section 451.
(iv)
(i) On May 15, 2023, YY, a cash-basis taxpayer, purchased and placed in
(ii) For 2023, YY is allowed an 80-percent additional first year depreciation deduction of $160,000 (the unadjusted depreciable basis of $200,000 multiplied by 0.80). In addition, YY's depreciation deduction for 2023 for the remaining adjusted depreciable basis of $40,000 (the unadjusted depreciable basis of $200,000 reduced by the additional first year depreciation deduction of $160,000) is $8,000 (the remaining adjusted depreciable basis of $40,000 multiplied by the annual depreciation rate of 0.20 for recovery year 1).
(iii) For 2024,
(i) On May 15, 2023,
(ii) For 2023,
(iii) For 2024,
(iv) For 2025,
(3)
(4)
(5)
(ii)
(A)
(B)
(C)
(D)
(E)
(F) Except as provided in paragraph (f)(5)(iv) of this section, the
(
(
(G)
(
(
(H)
(I)
(
(
(J)
(
(
(
(K)
(L)
(M)
(N)
(iii)
(B)
(C)
(D)
(
(
(E)
(iv)
(A) The time of replacement for purposes of this paragraph (f)(5) is when the replacement MACRS property or replacement computer software, as applicable, is placed in service by the taxpayer, provided the threat or imminence of requisition or condemnation of the involuntarily converted MACRS property or involuntarily converted computer software, as applicable, existed before January 1, 2027, or, in the case of property described in section 168(k)(2)(B) or (C), existed before January 1, 2028; and
(B) The taxpayer depreciates the replacement MACRS property or replacement computer software, as applicable, in accordance with paragraph (d) of this section. However, at the time of disposition of the involuntarily converted MACRS property, the taxpayer determines the exchanged basis, as defined in § 1.168(i)-6(b)(7), and the excess basis, as defined in § 1.168(i)-6(b)(8), of the replacement MACRS property and begins to depreciate the depreciable exchanged basis, as defined in § 1.168(i)-6(b)(9), of the replacement MACRS property in accordance with § 1.168(i)-6(c). The depreciable excess basis, as defined in § 1.168(i)-6(b)(10), of the replacement MACRS property continues to be depreciated by the taxpayer in accordance with the first sentence of this paragraph (f)(5)(iv)(B). Further, in the year of disposition of the involuntarily converted MACRS property, the taxpayer must include in taxable income the excess of the depreciation deductions allowable, including the additional first year depreciation deduction allowable, on the unadjusted depreciable basis of the replacement MACRS property over the additional first year depreciation deduction that would have been allowable to the taxpayer on the remaining exchanged basis of the replacement MACRS property at the time of replacement, as defined in paragraph (f)(5)(v)(A) of this section, plus the depreciation deductions that would have been allowable, including the additional first year depreciation deduction allowable, to the taxpayer on the depreciable excess basis of the replacement MACRS property from the date the replacement MACRS property was placed in service by the taxpayer, taking into account the applicable convention, to the time of disposition of the involuntarily converted MACRS property. Similar rules apply to replacement computer software.
(v)
(i) In April 2016,
(ii) For 2016,
(iii) For 2017,
(iv) Pursuant to paragraph (f)(5)(iii)(A) of this section, the additional first year depreciation deduction allowable for Canopy W1 for 2017 equals $64,000 (100 percent of Canopy W1's remaining exchanged basis at the time of replacement of $64,000 (Canopy V1's remaining adjusted depreciable basis of $100,000 minus 2016 regular MACRS depreciation deduction of $20,000 minus 2017 regular MACRS depreciation deduction of $16,000)).
(i) The facts are the same as in
(ii) For 2016,
(iii) For 2017,
(iv) Pursuant to paragraph (f)(5)(iii)(A) of this section, the additional first year depreciation deduction allowable for Canopy W1 for 2017 equals $128,000 (100 percent of Canopy W1's remaining exchanged basis at the time of replacement of $128,000 (Canopy V1's unadjusted depreciable basis of $200,000 minus 2016 regular MACRS depreciation deduction of $40,000 minus 2017 regular MACRS depreciation deduction of $32,000)).
The facts are the same as in
(i) In December 2016,
(ii) For 2016,
(iii) For 2017,
(iv) Pursuant to paragraph (f)(5)(iii)(A) of this section, the 100-percent additional first year depreciation deduction for Computer Y2 for 2017 is allowable for the remaining exchanged basis at the time of replacement of $3,200 (Computer X2's unadjusted depreciable basis of $10,000 minus additional first year depreciation deduction allowable of $5,000 minus the 2016 regular MACRS depreciation deduction of $1,000 minus the 2017 regular MACRS depreciation deduction of $800) and for the remaining excess basis at the time of replacement of $1,000 (cash paid for Computer Y2). Thus, the 100-percent additional first year depreciation deduction allowable for Computer Y2 totals $4,200 for 2017.
(i) In July 2017,
(ii) Pursuant to § 1.168(k)-1(f)(5)(iii)(B), no additional first year depreciation deduction is allowable for Equipment X3 and, pursuant to § 1.168(d)-1(b)(3)(ii), no regular depreciation deduction is allowable for Equipment X3, for 2017.
(iii) Pursuant to paragraph (f)(5)(iii)(A) of this section, no additional first year depreciation deduction is allowable for Equipment Y3's remaining exchanged basis at the time of replacement of $20,000 (Equipment X3's unadjusted depreciable basis of $20,000). However, pursuant to paragraph (f)(5)(iii)(A) of this section, the 100-percent additional first year depreciation deduction is allowable for Equipment Y3's remaining excess basis at the time of replacement of $5,000 (cash paid for Equipment Y3). Thus, the 100-percent additional first year depreciation deduction allowable for Equipment Y3 is $5,000 for 2017.
(i) The facts are the same as in
(ii) Pursuant to § 1.168(k)-1(f)(5)(iii)(B), no additional first year depreciation deduction is allowable for Equipment X3 and, pursuant to § 1.168(d)-1(b)(3)(ii), no regular depreciation deduction is allowable for Equipment X3, for 2017.
(iii) Pursuant to § 1.168(i)-6(i)(1),
(6)
(ii)
(iii)
(B)
(iv)
(B) If depreciable property is not qualified property in the taxable year the property is placed in service by the taxpayer, the additional first year depreciation deduction is not allowable for the property even if a change in the use of the property subsequent to the taxable year the property is placed in service results in the property being qualified property in the taxable year of the change in use.
(v)
(i) On January 1, 2019,
(ii) For 2019, the computers are considered as used predominantly outside the United States in 2019 pursuant to § 1.48-1(g)(1)(i). As a result, the computers are required to be depreciated under the alternative depreciation system of section 168(g). Pursuant to paragraph (b)(2)(ii)(B) of this section, the computers are not qualified property in 2019, the placed-in-service year. Thus, pursuant to paragraph (f)(6)(iv)(B) of this section, no additional first year depreciation deduction is allowed for these computers, regardless of the fact that the computers are permanently returned to the United States in 2020.
(i) On February 8, 2023,
(ii) For 2023,
(iii) For 2024, the equipment is considered as used predominantly outside the United States pursuant to § 1.48-1(g)(1)(i). As a result of this change in use, the adjusted depreciable basis of $160,000 for the equipment is required to be depreciated under the alternative depreciation system of section 168(g) beginning in 2024. However, the additional first year depreciation deduction of $800,000 allowed for the equipment in 2023 is not redetermined.
(7)
(8)
(9)
(A) With respect to the portion of the basis of the qualified rehabilitated building that is attributable to the qualified rehabilitation expenditures if the taxpayer makes the applicable election under paragraph (e)(1)(i) of this section not to deduct any additional first year depreciation for the class of property that includes the qualified rehabilitation expenditures; or
(B) With respect to the portion of the remaining rehabilitated basis of the qualified rehabilitated building that is attributable to the qualified rehabilitation expenditures if the taxpayer claims the additional first year depreciation deduction on the unadjusted depreciable basis, as defined in § 1.168(b)-1(a)(3) but before the reduction in basis for the amount of the rehabilitation credit, of the qualified rehabilitation expenditures; and the taxpayer depreciates the remaining adjusted depreciable basis, as defined in paragraph (d)(2)(i) of this section, of such expenditures using straight line cost recovery in accordance with section 47(c)(2)(B)(i) and § 1.48-12(c)(7)(i). For purposes of this paragraph (f)(9)(i)(B), the remaining rehabilitated basis is equal to the unadjusted depreciable basis, as defined in § 1.168(b)-1(a)(3) but before the reduction in basis for the amount of the rehabilitation credit, of the qualified rehabilitation expenditures that are qualified property reduced by the additional first year depreciation allowed or allowable, whichever is greater.
(ii)
(i) Between February 8, 2023, and June 4, 2023,
(ii) Because
(10)
(g)
(i) Qualified property under section 168(k)(2) that is placed in service by the taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(ii) A specified plant for which the taxpayer properly made an election to apply section 168(k)(5) and that is planted, or grafted to a plant that was previously planted, by the taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(2)
(i) Qualified property under section 168(k)(2) acquired and placed in service after September 27, 2017, by the taxpayer during taxable years ending on or after September 28, 2017, and ending before the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(ii) A specified plant for which the taxpayer properly made an election to apply section 168(k)(5) and that is planted, or grafted to a plant that was previously planted, after September 27, 2017, by the taxpayer during taxable years ending on or after September 28, 2017, and ending before the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(a) * * * Further, before computing the amortization deduction allowable
(g) * * * The last sentence of paragraph (a) of this section applies to a certified pollution control facility that is qualified property under section 168(k)(2) and placed in service by a taxpayer during or after the taxpayer's taxable year that includes the date of publication of a Treasury decision adopting these rules as final regulations in the
(c) * * *
(2) Property deemed to have been acquired by a new target corporation as a result of a section 338 election (relating to certain stock purchases treated as asset acquisitions) or a section 336(e) election (relating to certain stock dispositions treated as asset transfers) will be considered acquired by purchase.
(a) * * * Except as provided in paragraphs (b), (c), (d), and (e) of this section, the provisions of §§ 1.179-1 through 1.179-5 apply for property placed in service by the taxpayer in taxable years ending after January 25, 1993. * * *
(e)
(2)
(a) * * *
(1) * * * Further, see § 1.168(k)-2(f)(7) with respect to the treatment of the additional first year depreciation deduction allowable under section 168(k), as amended by the Tax Cuts and Jobs Act, Public Law 115-97 (131 Stat. 2054 (December 22, 2017)), for purposes of computing the earnings and profits of a corporation.
(e)
(b) * * *
(1) * * *
(ii) * * *
(
(2) * * *
(iv) * * *
(
(
The additions and revision read as follows:
(d) * * *
(2) * * * However, the additional first year depreciation deduction under section 168(k) is not a permissible method for purposes of the preceding sentence and, if a partnership has acquired property in a taxable year for which the additional first year depreciation deduction under section 168(k) has been used of the same type as the contributed property, the portion of the contributed property's book basis that exceeds its adjusted tax basis must be recovered under a reasonable method. See § 1.168(k)-2(b)(3)(iv)(B).
(f) * * * With the exception of paragraphs (a)(1), (a)(8)(ii) and (iii), and (a)(10) and (11) of this section, and of the last sentence in paragraph (d)(2) of this section, this section applies to properties contributed to a partnership and to restatements pursuant to § 1.704-1(b)(2)(iv)(
(
(4) * * *
(i) * * *
(B) * * *
(
(l) * * * The last three sentences of paragraph (j)(4)(i)(B)(
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