Food Safety and Inspection Service
Natural Resources Conservation Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Western Area Power Administration
Centers for Medicare & Medicaid Services
Children and Families Administration
Community Living Administration
Food and Drug Administration
Indian Health Service
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Indian Affairs Bureau
Ocean Energy Management Bureau
Employment and Training Administration
Copyright Royalty Board
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface for Golden Triangle Regional Airport, Columbus, MS, by updating the airport's description header and geographic coordinates, as well as the geographic coordinates of Columbus AFB, Columbus-Lowndes County Airport, Oktibbeha Airport, and McCharen Field. In addition, this action makes the editorial changes replacing the term Notice to Airmen with Notice to Air Missions and replacing the term Airport/Facility Directory with Chart Supplement. This action does not change the airspace boundaries or operating requirements.
Effective 0901 UTC, October 5, 2023. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
This final rule may be viewed online at
FAA Order JO 7400.11G, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; Telephone: (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it updates airspace descriptions. This update is an administrative change and does not change the airspace boundaries or operating requirements.
Class D and Class E airspace are published in paragraphs 5000, 6002, and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 annually. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
This amendment to 14 CFR part 71 amends the Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface for Golden Triangle Regional Airport, Columbus, MS, by updating the airport's description header's city name from Columbus Golden Triangle, MS to Columbus, MS in the Class D and Class E surface airspace descriptions, and the airport's geographic coordinates, as well as the geographic coordinates of Columbus AFB, Columbus-Lowndes County Airport, Oktibbeha Airport, and McCharen Field. In addition, this action makes the editorial changes replacing the term Notice to Airmen with Notice to Air Missions and replacing the term Airport/Facility Directory with Chart Supplement in the appropriate descriptions. This action is an administrative change and does not affect the airspace boundaries or operating requirements; therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,800 feet MSL within a 4.1-mile radius of the Golden Triangle Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within a 4.1-mile radius of the Golden Triangle Regional Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 10-mile radius of Columbus AFB, and within a 16-mile radius of Monroe County Airport, and within a 6.4-mile radius of Columbus-Lowndes County Airport, and within a 6.6-mile radius of Golden Triangle Regional Airport, and within a 6.2-mile radius of Oktibbeha Airport, and within a 6.3-mile radius of McCharen Field.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective June 30, 2023. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of June 30, 2023.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Thomas J. Nichols, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217, Oklahoma City, OK 73099. Telephone: (405) 954-1139.
This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective June 30, 2023. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of June 30, 2023.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30. 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217, Oklahoma City, OK 73099. Telephone (405) 954-1139.
This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains additional final regulations that provide guidance on the transition away from the use of interbank offer rates (“IBORs”) to other reference rates. Specifically, this regulation provides the replacement rate for the IBOR presently used in the published rate election, which may be used by taxpayers to determine the amount of interest expense attributable to their excess U.S.-connected liabilities and allocable to income that is effectively connected with the conduct of a trade or business within the United States (“ECI”). The final regulations will affect foreign banks that have income that is ECI.
D. Peter Merkel or Caleb W. Trimm, (202) 317-6938 (not a toll-free number).
This document contains final regulations that provide for the replacement of the 30-day IBOR rate presently referenced by § 1.882-5(d)(5)(ii)(B) with the Secured Overnight Financing Rate (“SOFR”) of the same tenor, plus a fixed spread adjustment.
The London Interbank Offered Rate (“LIBOR”) is an interest rate benchmark that was the dominant reference rate used in financial contracts, at one point serving as the benchmark for more than $200 trillion of contracts worldwide. On July 27, 2017, the Financial Conduct Authority, the United Kingdom regulator tasked with overseeing LIBOR, announced that publication of all currency and term variants of LIBOR, including the U.S. dollar LIBOR (“USD LIBOR”), may cease after the end of 2021. On March 5, 2021, the administrator of LIBOR, Intercontinental Exchange (ICE) Benchmark Association, announced that publication of the overnight, one-month, three-month, six-month, and 12-month USD LIBORs would cease following the LIBOR publication on June 30, 2023. The ICE Benchmark Association will continue to publish an unrepresentative synthetic USD LIBOR in one-month, three-month, and six-month tenors until September 30, 2024.
The Alternative Reference Rate Committee (“ARRC”), whose ex officio members include the Board of Governors of the Federal Reserve System, the Department of the Treasury (“Treasury Department”), the Commodity Futures Trading Commission, and the Office of Financial Research, was convened by the Board of Governors of the Federal Reserve System and the Federal Reserve Bank of New York to identify alternative reference rates that would be both more robust than USD LIBOR and that would comply with standards such as the International Organization of Securities Commissions' “Principles for Financial Benchmarks.” In 2017, the ARRC identified a SOFR-based rate as its recommended replacement for LIBOR.
In 2021, the ARRC recommended the forward-looking term SOFRs published by the Chicago Mercantile Exchange Group Benchmark Administration, Ltd. in one-month, three-month, and six-month tenors. The ARRC has also recommended static spread adjustments to each of those tenors to adjust for the fact that SOFRs are risk-free rates, while IBORs include an element of bank credit risk. The static spread adjustments are based on the historical median over a 5-year lookback period calculating the difference between USD LIBOR and compounded averages of SOFR, set on
To support the transition away from USD LIBOR, the ARRC has published recommended fallback language for inclusion in the terms of certain cash products. Contracts governed by U.S. law that reference USD LIBOR but that do not have any (or that have inadequate) fallback provisions are generally required by the Adjustable Interest Rate Act (“LIBOR Act”), Public Law 117-103, div. U, to use the SOFR of the same tenor, plus a static spread adjustment. The static spread adjustments to SOFR for each USD tenor required by the LIBOR Act are the same as those recommended by the ARRC.
The transition from IBORs to SOFRs or other reference rates may give rise to various tax issues. To minimize market disruption and facilitate an orderly transition in connection with the discontinuation of LIBOR and other IBORs, the Treasury Department and IRS published proposed regulations (REG-118784-18) in the
One issue addressed by the 2019 Proposed Regulations was the election provided by § 1.882-5(d)(5)(ii)(B). A foreign corporation that has a U.S. branch or other trade or business within the United States applies § 1.882-5 to determine its interest expense allocable under section 882(c) to its ECI. If a foreign corporation uses the method described in § 1.882-5(b) through (d), that foreign corporation could have liabilities attributable to its U.S. branch (U.S.-connected liabilities) that exceed its U.S.-booked liabilities (excess U.S.-connected liabilities). When a foreign corporation has excess U.S.-connected liabilities, § 1.882-5(d)(5)(ii)(A) entitles the foreign corporation to increase its interest expense allocable to its ECI in an amount determined by reference to the average U.S.-dollar borrowing cost on all U.S.-dollar liabilities other than its U.S.-booked liabilities. If the foreign corporation is a bank, it may elect under § 1.882-5(d)(5)(ii)(B) to use a published average 30-day LIBOR for the year rather than the actual rate computed under § 1.882-5(d)(5)(ii)(A). Because use of that election will no longer be possible when LIBOR is phased out, the 2019 Proposed Regulations included a proposal to replace 30-day USD LIBOR referenced in § 1.882-5(d)(5)(ii)(B) with a yearly average SOFR. Because SOFR is an overnight risk-free rate, the Treasury Department and the IRS acknowledged that the yearly average SOFR was likely to result in a lower rate than the 30-day LIBOR calculation previously allowed under § 1.882-5(d)(5)(ii)(B) and requested comments on whether another rate might be more appropriate.
Following publication of the 2019 Proposed Regulations, the Treasury Department and the IRS received one comment regarding the proposal to use yearly average SOFR in place of 30-day USD LIBOR for the election available under § 1.882-5(d)(5)(ii)(B). The comment noted two key differences between 30-day LIBOR and the yearly average SOFR, which the commenter stated made the yearly average SOFR an inappropriate substitute for 30-day LIBOR. First, SOFR is a risk-free rate, while LIBOR is an unsecured rate. Second, SOFR is an overnight rate, while the 30-day LIBOR is a one-month rate. The comment noted that SOFR removes the credit risk premium and term liquidity premium from the cost of borrowing as compared to 30-day LIBOR. The comment, however, did not identify a more reasonable substitute for 30-day LIBOR at that time and recommended that the Treasury Department and the IRS defer finalizing the proposed rule under § 1.882-5(d)(5)(ii)(B) because a yearly average SOFR calculation was not a reasonable replacement rate for 30-day USD LIBOR.
On January 4, 2022, the Treasury Department and the IRS published final regulations (TD 9961) in the
Following the publication of the 2022 Final Regulations, the Treasury Department and the IRS received one additional comment regarding the appropriate replacement rate for the 30-day USD LIBOR rate referenced by § 1.882-5(d)(5)(ii)(B).
This comment is available for public inspection at
In response to the request for additional comments in TD 9961, one comment was received relating to the 30-day USD LIBOR replacement in § 1.882-5(d)(5)(ii)(B). The comment made three recommendations for the final regulations under § 1.882-5(d)(5)(ii)(B).
First, the comment recommended finalizing the regulation using the one-month term SOFR plus static spread adjustment of 0.11448% as recommended by the ARRC (which endorsed Term SOFR rates in June of 2021 and spread adjustments in October of 2021) and codified in the LIBOR Act (enacted in December of 2021). The comment noted that the one-month term SOFR plus a fixed spread adjustment accounts for some of the differences between SOFR and LIBOR rates and implied that one-month term SOFR plus static spread adjustment of 0.11448% is a more appropriate replacement than yearly average SOFR. The published rate election provides eligible taxpayers with administrative relief from the burden of calculating their actual borrowing rate, which is based on data maintained outside the United States.
The final regulations adopt this recommendation. The ARRC, whose ex officio members include the Treasury Department, has generally recommended that contracts referencing USD LIBOR adopt fallback provisions that reference the term SOFR of the same tenor, plus a static spread adjustment. The Treasury Department has supported the recommendations of the ARRC in prior guidance issued in Revenue Procedure 2020-44, 2020-45 I.R.B. 991 and the 2022 Final Regulations. In addition, contracts governed by U.S. law that have not voluntarily adopted such fallback provisions are generally required by the LIBOR Act to use the SOFR of the same tenor, plus the ARRC-recommended static spread adjustment, as a matter of law. Public Law 117-103, div. U. Accordingly, both the Treasury Department and the U.S. Congress have endorsed, or required, the use of a term SOFR of the same tenor, plus the ARRC-recommended static spread adjustment, as a replacement for term USD LIBORs. Because the published rate election
The comment also recommended that the final regulations allow taxpayers to use a rate that reasonably approximates the bank's actual rate and that is consistently applied from year to year. This recommendation is based on the approach taken in regulations that were in effect from 1981 through 1996. TD 7749, 46 FR 1681 (Jan. 7, 1981) (codified at former § 1.882-5(b)(3)(i)(B)). This historical regulation provided that, if information needed to calculate the taxpayer's actual interest rate could not be reasonably obtained, then the taxpayer could determine its interest rate by applying any method that reasonably approximated its actual interest rate and that was consistently applied year over year, including, for example, approximating its interest rate by reference to 30-day LIBOR.
The final regulations do not adopt this recommendation. An approach based on a reasonable approximation of a taxpayer's actual interest would establish a different method for determining a taxpayer's borrowing rate that does not provide the certainty, accuracy, and simplicity of a published rate election. Additionally, the IRS would face significant challenges in administering such a rule. For example, the comment did not suggest any standard by which the IRS might determine whether a taxpayer's method is a reasonable approximation of its actual borrowing rate.
Finally, data from recent filing years indicates that the actual rate calculation is not a significant burden to taxpayers. For taxable years 2020 and 2021 (the most recent years for which data is available), a majority of foreign banks with excess U.S.-connected liabilities chose to calculate their actual rate rather than use the published rate election. In both years, approximately 80% of such taxpayers opted to calculate their actual rate, while less than 20% chose to use the published rate election available under § 1.882-5(d)(5)(ii)(B).
Finally, the comment recommended that the final regulations include a mechanism for identifying additional qualified alternative reference rates via Internal Revenue Bulletin, Revenue Procedure, or another similar notice. The final regulations do not adopt this recommendation. The Treasury Department and the IRS do not anticipate a need to name additional alternative reference rates, and, if the need does arise in the future, the Treasury Department and the IRS may prefer to propose any new alternative reference rate through the regulatory process.
If a taxpayer failed to file a timely return or incorrectly determined that it did not have excess U.S.-connected liabilities, § 1.882-5(d)(5)(ii)(B) allowed the Director of Field Operations to calculate the taxpayer's interest expense with respect to excess U.S.-connected liabilities using either the taxpayer's actual rate or the published rate provided by § 1.882-5(d)(5)(ii)(B). The final regulations amend this rule to require the Director of Field Operations to use the published rate in order to reduce the administrative burden of calculating the actual rate for both the IRS and taxpayers.
For a taxable year that begins before and ends after the USD LIBOR cessation date of June 30, 2023, a taxpayer that makes the published rate election available under § 1.882-5(d)(5)(ii)(B) must calculate a blended published rate average for the taxable year which uses the 30-day USD LIBOR for the portion of its taxable year ending on June 30, 2023, and the one-month Term SOFR, plus static spread adjustment, for the portion of its taxable year beginning on July 1, 2023.
These final regulations apply to taxable years ending after June 30, 2023.
Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required.
The final regulations affect any foreign bank that has ECI and that has excess U.S.-connected liabilities, but which cannot reasonably calculate its actual borrowing rate. The number of small entities potentially affected by the final regulations is unknown; however, it is unlikely to be a substantial number because the final regulations only affect foreign banks that operate in the United States. In addition, data collected from Forms 1120-F, Schedule I filed in recent taxable years indicates that fewer than 100 total taxpayers are foreign banks with both ECI and excess U.S-connected liabilities. The data from Forms 1120-F, Schedule I shows that the number of foreign banks that elected to use the 30-day USD LIBOR rate to compute the interest expense attributable to their excess U.S.-connected liabilities varied from year to year. In some years, as many as 50 foreign banks made the election on Schedule I to use the 30-day USD LIBOR rate; in other years, fewer than ten taxpayers made that election. The Secretary has determined that the economic impact on any small entities affected by the final regulations is not significant.
The final regulations provide that the annual published rate election available under § 1.882-5(d)(5)(ii)(B) will be modified by substituting the one-month term SOFR, plus a static spread adjustment, for 30-day USD LIBOR. The rule does not require taxpayers to collect additional information to determine whether the taxpayer is eligible for the election. Additionally, the rule does not impose any new costs on taxpayers because it only replaces the published rate used for the purpose of the election and does not affect a taxpayer's obligation with respect to the information to be gathered and reported.
In accordance with the Regulatory Flexibility Act (5 U.S.C. 601
Pursuant to section 7805(f), the proposed regulations (REG-118784-18) preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on the impact on small business, and no comments were received.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a state, local, or tribal government, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. This rule does not include any Federal mandate that may result in expenditures by state, local, or tribal governments, or by the private sector in excess of that threshold.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on state and local governments, and is not required by statute, or preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This regulation does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive order.
IRS Notices and other guidance cited in this preamble are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal authors of these regulations are D. Peter Merkel and Caleb W. Trimm of the Office of Associate Chief Counsel (International). However, other personnel from the IRS and Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, the Treasury Department and IRS amend 26 CFR part 1 as follows:
26 U.S.C. 7805 * * *
Section 1.882-5 also issued under 26 U.S.C. 882(c), 26 U.S.C. 864(e), 26 U.S.C. 988(d), and 26 U.S.C. 7701(l).
(a) * * *
(7) * * *
(i) * * * An elected method (other than the fair market value method under paragraph (b)(2)(ii) of this section, or the published rate election in paragraph (d)(5)(ii) of this section) must be used for a minimum period of five years before the taxpayer may elect a different method. * * *
(d) * * *
(5) * * *
(ii) * * *
(B)
(
(f)
(2) [Reserved]
(3)
Office of the Secretary of Defense, Department of Defense (DoD).
Direct final rule.
The DoD is amending its regulations to remove the exemption rules associated with 14 systems of
Elsewhere in this issue of the
The rule is effective on September 8, 2023, unless comments are received that would result in a contrary determination. Comments will be accepted on or before August 29, 2023.
You may submit comments, identified by docket number, Regulation Identifier Number (RIN), and title, by any of the following methods.
Follow the instructions for submitting comments.
Ms. Rahwa Keleta,
The DoD is amending 32 CFR part 310 to remove the exemption rules associated with the following 14 systems of records notices (SORNs) established for the DoD Components.
The Privacy Act permits Federal agencies to exempt eligible records in a system of records from certain provisions of the Act, including the provisions providing individuals with a right to request access to and amendment of their own records and accountings of disclosures of such records. If an agency intends to exempt a particular system of records, it must first go through the rulemaking process to provide public notice and an opportunity to comment on the exemption.
When a system of records is no longer required to be collected or maintained, the system of records may be discontinued. The notice for that system of record is rescinded in the
This rule is being published as a direct final rule as the Department does not expect to receive any significant adverse comments. If such comments are received, this direct final rule will be cancelled and a proposed rule for comments will be published. If no such comments are received, this direct final rule will become effective 10 days after the comment period expires.
For purposes of this rulemaking, a significant adverse comment is one that explains (1) why the rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the rule will be ineffective or unacceptable without a change. In determining whether a significant adverse comment necessitates withdrawal of this direct final rule, the Department will consider whether the comment raises an issue serious enough to warrant a substantive response had it been submitted in a standard notice-and-comment process. A comment recommending an addition to the rule will not be considered significant and adverse unless the comment explains how this direct final rule would be ineffective without the addition.
The DoD is modifying 32 CFR part 310 by rescinding the following regulation provisions (in their entirety) due to the underlying SORNs being rescinded (most of them concurrently by associated public notice):
• 32 CFR 310.14(e)(7), System identifier and name. F051 AF JA F, Courts—Martial and Article 15 Records.
• 32 CFR 310.14(f)(20), System identifier and name. F033 AF A, Information Requests—Freedom of Information Act.
• 32 CFR 310.14(f)(21), System identifier and name. F033 AF B, Privacy Act Request Files.
• 32 CFR 310.15(g)(21), System identifier and name. A0340-21 OAA, Privacy Case Files.
• 32 CFR 310.16(a)(22), System identifier and name. NM05211-1, Privacy Act Request Files and Tracking System.
• 32 CFR 310.16(a)(23), System identifier and name. NM05720-1, FOIA
• 32 CFR 310.20(b)(8), System identifier and name. LDIA 0010, Information Requests—Freedom of Information Act (FOIA) and Privacy Act.
• 32 CFR 310.21(c)(6), System identifier and name. S510.30, Freedom of Information Act/Privacy Act Requests and Administrative Appeal Records.
• 32 CFR 310.22(b)(1), System identifier and name. V1-01, Privacy and Freedom of Information Request Records.
• 32 CFR 310.23(a)(3), System identifier and name. HDTRA 021, Freedom of Information Act and Privacy Act Request Case Files.
• 32 CFR 310.25(e)(1), System identifier and name. INGB 001, Freedom of Information Act (5 U.S.C.) and Privacy Act (5 U.S.C. 552a) Case Files.
• 32 CFR 310.28(c)(5), System identifier and name. CIG 01, Privacy Act and Freedom of Information Act Case Files.
• 32 CFR 310.29(c)(12), System identifier and name. DFOISR 05, Freedom of Information Act Case Files.
• 32 CFR 310.29(c)(13), System identifier and name. DFOISR 10, Privacy Act Case Files.
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, distribute 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. It has been determined that this rule is not a significant regulatory action under these Executive orders.
The Congressional Review Act, 5 U.S.C. 801
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates may result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, in any one year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
The Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency has certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule is concerned only with the administration of Privacy Act systems of records within the DoD. Therefore, the Regulatory Flexibility Act, as amended, does not require DoD to prepare a regulatory flexibility analysis.
The Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. This rule will not have a substantial effect on State and local governments.
Executive Order 13175 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct compliance costs on one or more Indian tribes, preempts tribal law, or affects the distribution of power and responsibilities between the Federal Government and Indian tribes. This rule will not have a substantial effect on Indian tribal governments.
Privacy.
Accordingly, 32 CFR part 310 is amended as follows:
5 U.S.C. 552a.
Coast Guard, Department of Homeland Security (DHS).
Temporary final rule.
The Coast Guard is establishing 63 temporary 500-meter safety zones around the construction of 62 wind turbine generators (WTGs) and one electrical service platform (ESP) located in the Vineyard Wind 1 Wind Farm (VW1WF) project area within federal waters on the Outer Continental Shelf (OCS), specifically in the northern portion of Bureau of Ocean Energy Management (BOEM) Renewable Energy Lease Area OCS-A 0501, approximately 12 nautical miles (NM) offshore of Martha's Vineyard, Massachusetts and 12 NM offshore Nantucket, Massachusetts. This action is necessary to provide for the safety of life, property, and the environment during the planned construction of each facility's monopile type foundation and subsequent installation of the WTGs turbines and ESP platform from June 27, 2023, to May 31, 2024. When enforced, only attending vessels and those vessels specifically authorized by the First Coast Guard District Commander, or a designated representative, are permitted to enter or remain in the temporary safety zones.
This rule is effective without actual notice from June 30, 2023, through 11:59 p.m. on May 31, 2024. For the purposes of enforcement, actual notice will be used from June 27, 2023, until June 30, 2023.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Mr. Craig Lapiejko, Waterways Management, at Coast Guard First District, telephone 617-603-8592, email
On March 15, 2023, Vineyard Wind, LLC, an offshore wind farm developer, notified the Coast Guard that they plan to begin construction of facilities in the VW1WF project area within federal waters on the OCS, specifically in the northern portion of BOEM Renewable Energy Lease Area OCS-A 0501, approximately 12 NM offshore Martha's Vineyard, Massachusetts and 12 NM offshore Nantucket, Massachusetts in June 2023.
After determining that establishment of safety zones was necessary to provide for the safety of life, property, and the environment during the anticipated construction of the structures, on May 3, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; Vineyard Wind 1 Wind Farm Project Area, Outer Continental Shelf, Lease OCS-A 0501, Offshore Massachusetts, Atlantic Ocean” (88 FR 27839). There we explained the basis for the NPRM and invited comments on our proposed regulatory action related to the establishment of safety zones around the construction of 62 WTGs and one ESP located in the VW1WF project area. Five comments were received during the comment period that ended June 2, 2023.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
Based on these circumstances, the First Coast Guard District Commander has determined that establishment of 63 safety zones through rulemaking is warranted to ensure the safety of life, property, and the environment within a 500-meter radius of each of the 63 facilities during their construction.
The Coast Guard is issuing this rule under the authority provided in 14 U.S.C. 544, 43 U.S.C. 1333, and Department of Homeland Security (DHS) Delegation No. 00170.1, Revision No. 01.3. As an implementing regulation of this authority, 33 CFR part 147 permits the establishment of safety zones for non-mineral energy resource permanent or temporary structures located on the OCS for the purpose of protecting life and property on the facilities, appurtenances and attending vessels, and on the adjacent waters within the safety zone (see 33 CFR 147.10). Accordingly, a safety zone established under 33 CFR part 147 may also include provisions to restrict, prevent, or control certain activities, including access by vessels or persons to maintain safety of life, property, and the environment.
As noted above, the Coast Guard received five public comments on the NPRM published May 3, 2023. All five commenters expressed general opposition to wind farm construction.
First, the Coast Guard is issuing this rule under the authority provided in 14 U.S.C. 544, 43 U.S.C. 1333, and Department of Homeland Security (DHS) Delegation No. 00170.1, Revision No. 01.3. On January 1, 2021, Congress enacted the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (NDAA), Public Law 116-283, 134 Stat. 3388. Section 9503 of the NDAA amended Section 4(a)(1) of the Outer Continental Shelf Lands Act (43 U.S.C. 1333(a)(1)) to specifically include non-mineral energy resources. On January 11, 2023, the Coast Guard published a final rule titled “Safety Zones; Technical and Conforming Amendments” (88 FR 1511), which made non-substantive technical and conforming amendments to the Code of Federal Regulations (CFR) at part 147. That rule enabled the Coast Guard to place safety zones for non-mineral energy resource facilities on the Outer Continental Shelf in part 147 where other OCS safety zone regulations are located.
As an implementing regulation of this authority, 33 CFR part 147 permits the establishment of safety zones for non-mineral energy resource permanent or temporary structures located on the OCS for the purpose of protecting life and property on the facilities, appurtenances and attending vessels, and on the adjacent waters within the safety zone (see 33 CFR 147.10). Accordingly, a safety zone established under 33 CFR part 147 may also include provisions to restrict, prevent, or control certain activities, including access by vessels or persons to maintain safety of life, property, and the environment.
Second, while the safety zones were not analyzed by BOEM during the EIS process, the Coast Guard has analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard's compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f). The Coast Guard has determined that the action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a safety zone around an OCS facility to protect life, property, and the marine environment and categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the subject docket. For instructions on locating the docket, see the
One commenter disagreed with the finding of no significant economic impact on small entities. While this rule may affect some owners or operators of small entities, the Coast Guard believes these safety zones will have a minimal economic impact because the safety zones are temporarily enforced, allow for deviation requests, and do not significantly impact transits. Vessels will only be prohibited from the regulated zone during periods of actual construction activity. The Coast Guard anticipates the enforcement period at each location to last approximately 48 hours. Vessel traffic will be able to pass safely around each safety zone using an alternate route. Use of an alternate route will likely cause minimal delay for vessels in reaching their destination depending on other traffic in the area and vessel speeds. Vessels will be permitted to request deviations from this rule to transit through a safety zone. Such requests would be considered on a case by case basis and may be authorized by the First Coast Guard District Commander.
That same commenter expressed concerns about the effective date of the safety zones not aligning with the dates and timing of actual construction and that there is nothing preventing the Coast Guard from enacting future exclusion zones.
Although the Coast Guard has been aware of the VW1WF project area for several years, the Coast Guard was only recently granted the authority to establish safety zones for non-mineral energy resource facilities on the Outer Continental Shelf. The Coast Guard was notified of the estimated construction details on March 15, 2023, and was notified of the exact construction commencement date after the NPRM was published. The Coast Guard views public participation as essential to effective rulemaking and determined that it was in the public interest to open the comment period. The 63 safety zones established by this rule are intended to be temporary and are enforceable only through May 31, 2024. If the project is completed before May 31, 2024, enforcement of the safety zones will be suspended, and notice will be provided via Local Notice to Mariners. The implementation of additional safety zones would require additional notice and comment rulemaking.
One commenter offered two recommendations for the Coast Guard to consider when establishing temporary safety zones.
First, the commenter recommended additional means of making notice of each enforcement period. Recommendations included: directly notifying local commercial fishing organizations, creating a dedicated web page, and requiring vessel on-scene during all construction activities whose sole role is to patrol the area and ensure vessels are aware of the safety zone. As stated in the proposed rule, the Coast Guard will make notice of each enforcement period via the First Coast Guard District Local Notice to Mariners (LNM). The LNM has historically been the primary means for disseminating information concerning aids to navigation, hazards to navigation, and other marine information of interest to mariners on the waters of the United States. The First Coast Guard District LNM is available online and can be found at its dedicated website at
The proposed rule stated that the Coast Guard would issue a Broadcast Notice to Mariners (BNM) via marine channel 16 (VHF-FM) as soon as practicable in response to an emergency or hazardous condition. The Coast Guard now offers an online subscription service in addition to the standard VHF BNM broadcasts which, traditionally, was the only method to receive this vital navigational information. Mariners may now use a subscription service to plan for underway periods and can receive updates to navigational hazards in near-real-time without waiting on scheduled VHF broadcasts. Sign up to receive BNMs via email for your waterway at
The Coast Guard will also issue Safety Marine Information Broadcasts (SMIB) via marine channel 16 (VHF-FM) for each Safety Zone starting an hour before
Additionally, Vineyard Wind will provide dedicated safety and scout vessels on scene to provide advisory information.
Second, the commenter recommended the definition of a designated representative be expanded if requests to deviate from the rule to transit through a safety zone becomes time consuming. Specifically, the recommendation was to expand the definition of “designated representative” to account for need to process rule deviations in a timely manner. The Coast Guard does not anticipate delays from our designated representatives. Upon further examination, the Coast Guard believes that the current definition of “designated representative” should be maintained. Based on the particular details of this offshore construction project, including the short duration of the enforcement period (approximately 48 hours during active construction), the more distant offshore location which sees less vessel traffic, and the types of large vessels that are most likely to navigate in the vicinity of the safety zones (commercial shipping, fishing, and tugs with tows), the Coast Guard finds no compelling necessity to broaden representative designation or the authority to permit passage through and around the safety zones. Maintaining designation to Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the First Coast Guard District Commander in the enforcement of the safety zones will ensure consistent application.
The First Coast Guard District has factored applicable statutes and regulations into the subject rule. Applicable authorities are cited in section III. of this document.
After considering the comments discussed above, the Coast Guard determined that no additional changes should be made to the regulatory text. The rule ensures consistency, sufficient notice, and improved safety while minimizing impact on vessel transit.
There is one change to the regulatory text of this rule from the proposed rule in the NPRM to account for the delay in the effective date.
This rule establishes 63 temporary 500-meter safety zones around the construction of 62 WTGs and one ESP on the OCS from June 27, 2023, through 11:59 p.m. on May 31, 2024.
The construction of these facilities is expected to take place in mixed phases alternating between the installation of several monopile type foundations followed by the installation of the upper structures then repeating this process throughout the project area until all 63 facilities have been completed. The 63 temporary safety zones would be enforced individually as construction progresses from one structure location to the next throughout the entire process for a period lasting approximately 48 hours. The Coast Guard will make notice of each enforcement period via the Local Notice to Mariners and issue a Broadcast Notice to Mariners via marine channel 16 (VHF-FM) as soon as practicable in response to an emergency or hazardous condition. The Coast Guard is publishing this rulemaking to be effective, and enforceable, through May 31, 2024, to encompass any construction delays due to weather or other unforeseen circumstances. If the project is completed before May 31, 2024, enforcement of the safety zones would be suspended, and notice given via Local Notice to Mariners.
Additional information about the construction process of the VW1WF can be found at
The 63 temporary 500-meter safety zones around the construction of 62 WTGs and one ESP are in the VW1WF project area, specifically in the northern portion of BOEM Renewable Energy Lease Area OCS-A 0501, approximately 12 NM offshore of Martha's Vineyard, Massachusetts and 12 NM offshore Nantucket, Massachusetts, within federal waters on the OCS.
The positions of each individual safety zone will be referred to using a unique alpha-numeric naming convention outlined in the “Rhode Island and Massachusetts Structure Labeling Plot (West).”
Aligning with authorities under 33 CFR 147.15, the safety zones will include the area within 500-meters of the center point of the positions provided in the table below expressed in Decimal Degrees (DD) based on North American Datum 1983 (NAD 83).
When enforced, no unauthorized vessel or person would be permitted to enter the safety zone without obtaining permission from the First Coast Guard District Commander or a designated representative. Requests for entry into the safety zone would be considered and reviewed on a case-by-case basis. Persons or vessels seeking to enter the safety zone must request authorization from the First Coast Guard District Commander or designated representative via VHF-FM channel 16 or by phone at 617-603-1560 (First Coast Guard District Command Center). If permission is granted, all persons and vessels shall comply with the instructions of the First Coast Guard District Commander or designated representative.
The regulatory text appears at the end of this document.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. A summary of our analyses based on these statutes and Executive orders follows.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866 as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB).
Aligning with 33 CFR 147.15, the established safety zones will extend to a maximum distance of 500-meters around the OCS facility measured from its center point. Vessel traffic will be able to safely transit around the safety zones, which would impact a small, designated area in the Atlantic Ocean, without significant impediment to their voyage. This safety zone will provide for the safety of life, property, and the environment during the construction of each structure, in accordance with Coast Guard maritime safety missions.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant
This rule may affect owners or operators of vessels intending to transit or anchor in the VW1WF, some of which might be small entities. However, these safety zones will not have a significant economic impact on a substantial number of these entities because they are temporarily enforced, allow for deviation requests, and do not impact vessel transit significantly. Regarding the enforcement period, although these safety zones will be in effect from June 27, 2023, through May 31, 2024, vessels will only be prohibited from the regulated zone during periods of actual construction activity in correspondence to the period of enforcement. We expect the enforcement period at each location to last approximately 48 hours as construction progresses from one structure location to the next throughout the mixed phases. Additionally, vessel traffic could pass safely around each safety zone using an alternate route. Use of an alternate route likely will cause minimal delay for the vessel in reaching their destination depending on other traffic in the area and vessel speed. Vessels will also be able to request deviation from this rule to transit through a safety zone. Such requests would be considered on a case by-case basis and may be authorized by the First Coast Guard District Commander or a designated representative. For these reasons, the Coast Guard expects any impact of this rulemaking establishing a temporary safety zone around these OCS facilities to be minimal and have no significant economic impact on small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist all small entities in understanding this temporary final rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This temporary final rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this temporary final rule will not result in such an expenditure, we do discuss the potential effects of this temporary final rule elsewhere in this preamble.
We have analyzed this final rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of safety zones around an OCS facility to protect life, property, and the marine environment. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Continental shelf, Marine safety, Navigation (waters).
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 147 as follows:
14 U.S.C. 544; 43 U.S.C. 1333; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(1) An attending vessel as defined in § 147.20; and
(2) A vessel authorized by the First Coast Guard District Commander or a designated representative.
(d)
(e)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the waters surrounding the Savannah River in Savannah, Georgia, during the July 4th Fireworks event. The safety zone is necessary to ensure the safety of participant vessels, spectators, and the general public during the event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative.
This rule is effective from 9 p.m. until 11 p.m., on July 4, 2023.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Alex McConnell, Waterways Management Division, Marine Safety Unit Savannah, U.S. Coast Guard; telephone 912-652-4353, extension 240, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The Coast Guard did not receive final details of the event until June 8, 2023, and the event is scheduled to take place on July 4, 2023. The event would begin before the rulemaking process would be completed. Because of the dangers posed by the fireworks display, a safety zone is necessary without delay to ensure the safety of persons, vessels, and the marine environment. It is impracticable and contrary to the public interest to delay this rule because it is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks display.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Savannah (COTP) has determined that potential hazards with the Savannah River July 4th Fireworks event near downtown Savannah, GA. This rule is necessary to ensure the safety of the event participants, the general public, vessels and the navigable waters of Marathon, Florida, during the Savannah River July 4th Fireworks event.
This rule establishes a safety zone on all navigable waters in the Savannah River adjacent to downtown Savannah, GA, during the Savannah River, July 4th Fireworks event. The safety zone will be enforced from 9 p.m. to 11 p.m. on July 4, 2023. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by fallout from the July 4th Fireworks display. No person or vessel will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP or a designated representative. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative. The Coast Guard will provide notice of the safety zone by Broadcast Notice to Mariners, and/or by on-scene designated representatives.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the location, duration, and time-of-day of the safety zone. This rule involves a safety zone that will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within a limited area on the navigable waters of the Savannah River, Savannah, GA, during a firework display lasting thirty minutes. Although persons and vessels may not enter, transit through, anchor in, or remain within the zone without authorization from the COTP or a designated representative, they will be able to safely transit around the safety zone. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within a limited area on the navigable waters of the Savannah River, Savannah, GA during a firework display lasting thirty minutes. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the COTP by telephone at 912-247-0073, or a designated representative via VHF-FM radio on channel 16 to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Savannah or a designated representative.
(3) The Coast Guard will provide notice of the regulated area by Broadcast Notice to Mariners via VHF-FM channel 16, and/or by on-scene designated representatives.
(d)
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce a safety zone for the Madisonville Old Fashioned 4th of July fireworks display located on the navigable waters of the Tchefuncte River, in front of the Madisonville Town Hall. Our regulation for marine events within the Eighth Coast Guard District Sector New Orleans Annual and Recurring Safety Zones identifies the regulated area for this event. This action is necessary to provide for the safety of life on these navigable waterways during the event. During the enforcement period, entry into this safety zone into this zone is prohibited unless authorized by the Captain of the Port or a designated representative.
The regulations in 33 CFR 165.801, will be enforced for the location identified in Item 15 of Table 5 to § 165.801, from 8 p.m. through 9 p.m. on July 4, 2023.
If you have questions about this notification of enforcement, call or email Lieutenant Commander William Stewart, Sector New Orleans, U.S. Coast Guard; telephone 504-365-2246, email
The Coast Guard will enforce the safety zone in 33 CFR 165.801, Table 5 to § 165.801, item 15 for the Madisonville Old Fashioned 4th of July fireworks display event. This safety will be enforced from 8 p.m. through 9 p.m. on July 4, 2023. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for annual fireworks displays and other events in Sector New Orleans Annual and Recurring Safety Zones in § 165.801, Table 5 to § 165.801, Item 15, specifies the approximate location of the regulated area on the Tchefuncte River, in front of the Madisonville Town Hall. During the enforcement period, as reflected in § 165.801(a), entry into this safety zone is prohibited unless authorized by the Captain of the Port or a designated representative.
In addition to this notification of enforcement in the
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is implementing in regulation the Charles Duncan Buried with Honor Act of 2016, which expanded the casket and urn authority to apply to eligible veteran burials in State and Tribal cemeteries that received a VA cemetery grant. In addition, VA is establishing flat-rate allowances for caskets and urns, which will be adjusted annually based on the Consumer Price Index (CPI). Additionally, VA is updating the specifications for caskets based on feedback from funeral directors and other funeral industry professionals. Finally, VA is eliminating the retroactive reimbursement provisions since the relevant applicability period has passed.
This rule is effective July 31, 2023.
Daniel Catron, Supervisory Program Analyst, National Cemetery Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420;
On December 8, 2022, VA published a proposed rule in the
One comment was not relevant to this rulemaking and indicated an individual preference for memorialization. VA considers this preferential request to be beyond the scope of this rulemaking and will make no changes to the regulatory text based on this comment.
Another commenter expressed support for the proposed rule. The commenter commended VA's continued engagement and outreach to funeral homes and funeral directors regarding the casket and urn reimbursement program rates. The commenter applauded the payment of flat-rate allowances for caskets and urns, noting consistency of this programmatic approach with other VA burial benefits. The commenter agreed with VA that the flat-rate provision would provide a predictable methodology for determining casket and urn reimbursement. The commenter supported VA's approach and intent to avoid confusion regarding the “actual cost” standard that required that actual costs be shown by invoices reflecting the purchase price of the casket or urn purchased by the individual or entity requesting reimbursement. The commenter expressed support for the elimination of the outdated retroactive applicability provision and support for the programmatic expansion of the casket and urn benefit for qualifying burials in Veterans' cemeteries that received VA grant funds. VA appreciates the commenter's support for the proposed changes to implement the casket and urn benefit. VA will make no changes to the regulatory text based on this comment.
Finally, VA received a comment that expressed general support of VA programs that ensure respect for deceased veterans, regardless of whether they have a next-of-kin. VA appreciates the commenter's recognition of our commitment to ensuring veterans who die without family members to see to their last wishes still receive a dignified burial. We also acknowledge the commenter's expressed concern and opposition to the proposed flat-rate allowance for caskets and urns due to varying prices that may cause potential resource shortfalls. However, VA declines to make any changes to the regulatory text based on this comment.
To the extent the commenter had concerns that individuals and organizations would not utilize the program due to the allowance potentially not covering all costs, as stated in the proposed rule, in § 38.628(e), VA will make cost-of-living adjustments for the flat-rate allowances using the CPI, which is a methodology used in other, similar VA monetary allowances. Consistent with the Veterans Benefits Administration (VBA) cost increases for monetary allowances under 38 U.S.C. 2303, from June to June each year, under this rule the National Cemetery Administration (NCA) will apply a similar percentage increase (rounded to the nearest dollar) to the allowances for caskets and urns. Use of VBA's cost-of-living increase analysis will promote consistency across VA benefit programs and ensure the casket and urn allowances meet current costs, to the extent practicable. Also, as noted in the proposed rule, “[t]he purpose of the casket and urn reimbursement is to help offset a claimant's cost for bringing unclaimed veterans' remains to burial in a VA national or grant-funded cemetery” and to avoid a significant financial loss or gain for an individual or entity for having made the purchase, 87 FR at 75198, not necessarily to make each individual or entity completely whole for the purchase.
To the extent the commenter had concerns that the Government may not have resources to administer the program and provide caskets and urns for all eligible veterans, 38 U.S.C. 2306(f) authorizes VA to furnish a casket or urn for burial of the unclaimed remains of veterans for whom VA cannot identify the next of kin and determines that sufficient resources for the furnishing of a casket or urn for burial are not available. The implementation of flat-rate allowances will not jeopardize funding of the casket and urn reimbursement program. The program is funded through the VBA Compensation and Pension mandatory appropriation. As such, the appropriation does not constrain the payment of benefits. If a Veteran or survivor is eligible for a benefit, it is paid. As we noted in the proposed rule, we believe using flat-rate allowances will promote consistency and efficiency in the administration of this program. VA appreciates the commenter's concerns but will make no changes to the regulatory text based on this comment.
Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 (Executive Order on Modernizing Regulatory Review) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in Executive Order 12866 of September 30, 1993 (Regulatory Planning and Review), and Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review). The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866, as amended by Executive Order 14094. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612, because the number of claims and the amounts involved are expected to be small. The average cost of a burial receptacle that meets regulatory specifications under this rule is $1,199 for caskets and $138 for urns in 2023. Also, we estimate that the total number of allowances for 2023 will be 259 for caskets and 18 for urns. Because the rulemaking provides for issuance of an allowance, the individual or entity purchasing the burial receptacle is only entitled to recoup the allowance rate, regardless of the actual purchase price.
Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no
Although this action contains provisions constituting collections of information at 38 CFR 38.628, under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), no new collection of information is associated with this final rule. This rulemaking creates no change to the annual PRA costs of the program. The information collection requirements for 38 CFR 38.628 are currently approved by the Office of Management and Budget (OMB) and have been assigned OMB control number 2900-0799. VA made non-substantive text changes to an existing form (VA40-10088) to reflect programmatic updates that will not affect the information collection burden costs or create administrative costs associated with this rulemaking.
The Assistance Listing number and title for the programs affected by this document is 64.205, VA Casket or Urn Reimbursement Program.
Pursuant to Congressional Review Act) (5 U.S.C. 801
Administrative practice and procedure, Cemeteries, Claims, Veterans.
Denis McDonough, Secretary of Veterans Affairs, approved and signed this document on May 3, 2023, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 38 as set forth below:
38 U.S.C. 107, 501, 512, 2306, 2400, 2402, 2403, 2404, 2407, 2408, 2411, 7105.
(a) VA will issue a flat-rate allowance, as established in paragraph (d) of this section, to any individual or entity for a casket or urn, purchased by the individual or entity for the burial in a national cemetery or in a veterans' cemetery of a State or Tribal Organization that has received a grant under 38 U.S.C. 2408, of an eligible deceased veteran for whom VA:
(c) An individual or entity may request an allowance from VA under paragraph (a) of this section by completing and submitting VA Form 40-10088 and supporting documentation, in accordance with the instructions on the form. Prior to approving issuance of an allowance, VA must find all of the following:
(1) The veteran is eligible for burial in a VA national cemetery or in a veterans' cemetery of a State or Tribal Organization that has received a grant under 38 U.S.C. 2408;
(5) * * *
(i) Caskets must be of metal construction of at least 20-gauge thickness, designed for containing human remains, sufficient to contain the remains of the deceased veteran, and include external fixed rails or swing arm handles.
(d) The allowance for a claim received in any calendar year under paragraph (a) of this section is $1,199.00 for a metal casket and $138.00 for an urn of durable material.
(e) VA will make cost-of-living adjustments for the flat-rate casket and urn allowances using the Consumer Price Index (CPI). Each fiscal year, VA will provide a percentage increase (rounded to the nearest dollar) in the casket and urn flat-rate allowances equal to the percentage by which the CPI (all items, United States city average) for the 12-month period (June to June) preceding the beginning of the fiscal year for which the percentage increase is made exceeds the CPI for the 12-month period preceding the 12-month period described in this paragraph (e). VA will only make cost-of-living increases to the flat rate allowances when the CPI has increased.
Postal Service
Final rule.
The Postal Service is amending
Catherine Knox at (202) 268-5636 or Garry Rodriguez at (202) 268-7281.
On May 23, 2023, the Postal Service published a notice of proposed rulemaking (88 FR 33066) to discontinue Priority Mail Express postage refunds for guaranteed service for Alaska and Hawaii. The Postal Service did not receive any formal comments.
The Postal Service has determined that operationally we cannot meet the service commitments for Priority Mail Express expected by customers for Alaska and Hawaii.
As a result, the Postal Service is discontinuing postage refunds for guaranteed service for Priority Mail Express pieces destined to or originating from Alaska or Hawaii. Postage refunds for loss will still be available for pieces destined to or originating from Alaska or Hawaii.
We believe this revision will provide customers with a more efficient mailing experience.
The Postal Service adopts the described changes to
Administrative practice and procedure, Postal Service.
Accordingly, 39 CFR part 111 is amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
Postage will not be refunded if the guaranteed service was not provided due to any of the following circumstances:
i. The postage refund requested is other than for loss, and the Priority Mail Express piece was destined to or originated from Alaska or Hawaii.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to partially approve and partially disapprove a revision to the Sacramento Metropolitan Air Quality Management District (SMAQMD) portion of the California State Implementation Plan (SIP). The revision concerns the SMAQMD's demonstration regarding reasonably available control technology (RACT) requirements and negative declarations for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS or “standards”) in the portion of the Sacramento Metropolitan nonattainment area under the jurisdiction of the SMAQMD. We are also correcting sections in the Code of Federal Regulations (CFR) to reflect the current status of certain provisions of the SMAQMD portions of the California SIP related to the 1997 8-hour ozone NAAQS.
This rule is effective July 31, 2023.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2023-0036. All documents in the docket are listed on the
Eugene Chen, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 947-4304 or by email at
Throughout this document, “we,” “us” and “our” refer to the EPA.
On April 5, 2023 (88 FR 20086), the EPA proposed to partially approve and partially disapprove the California Air Resources Board's (CARB) submittals of the SMAQMD's 2017 RACT SIP for the 2008 Ozone National Ambient Air Quality Standards (NAAQS), as listed in Table 1 below.
We proposed to partially approve SMAQMD's 2017 RACT SIP and negative declarations because we determined that, except for the RACT element for non-CTG major sources of NO
The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.
No comments were submitted on the proposed action, and there is no change to our assessment of the SIP submittals as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is partially disapproving SMAQMD's 2017 RACT SIP with respect to the RACT element for the 2008 ozone NAAQS for non-CTG major sources of NO
We are also correcting an error in the CFR concerning previous disapprovals for SMAQMD's 2006 RACT SIP for the 1997 8-hour ozone NAAQS that are codified in 40 CFR 52.237(b)(1)(i). SMAQMD has since addressed these disapprovals, but in our rulemakings approving SMAQMD's submittals to address these disapprovals, we failed to remove the language in the CFR that codified the disapprovals, which could result in public confusion about the status of the California SIP.
On December 4, 2017, the EPA published two final rules entitled “Approval of California Air Plan Revisions, Sacramento Metropolitan Air Quality Management District” (82 FR 57123 and 82 FR 57130) which approved revisions to the SMAQMD portion of the California SIP. The approved revisions fixed the deficiencies identified in our partial disapproval of SMAQMD's 2006 RACT SIP for the 1997 8-hour ozone NAAQS (81 FR 53280, August 12, 2016) with respect to the requirement to establish RACT-level controls for sources covered by the pharmaceutical products manufacturing category, as well as source-specific VOC requirements for the Kiefer Landfill. However, the EPA's final rules inadvertently failed to include amendatory instructions to remove these identified elements from the regulatory text at 40 CFR 52.237(b)(1)(i), where they are listed as disapproved elements of SMAQMD's 2006 RACT SIP. This action corrects the regulatory text to reflect the current status of SMAQMD's RACT obligations for the 1997 8-hour ozone NAAQS.
The EPA has determined that this action to correct the regulatory text related to these disapprovals falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to public interest. Public notice and comment for this action to correct regulatory text is unnecessary because the underlying rules were already subject to a 30-day comment period, the final actions on these rules state that the deficiencies were cured, and this action is merely updating the regulatory text accordingly. Further, this action is consistent with the purpose and rationale of the final rules. Because this action does not change the EPA's analyses or overall actions, no purpose would be served by additional public notice and comment. Consequently, additional public notice and comment are unnecessary.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provision of the Act and applicable federal regulations. 42 U.S.C. 740(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to review state choices, and approve those choices if they meet the minimum criteria of the Act. Accordingly, this final action partially approves and partially disapproves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law.
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 does not impose an information collection burden under the PRA because this action does not
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, will result from this action.
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, because 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, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by state law.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The District did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.
This action is subject to the CRA, and the 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).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 29, 2023. 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, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(c) * * *
(599) The following plan was submitted on May 5, 2017, by the Governor's designee as an attachment to a letter dated May 5, 2017.
(i) [Reserved]
(ii)
(A) Sacramento Metropolitan Air Quality Management District.
(
(
(a) * * *
(2) * * *
(v) The following negative declarations for the 2008 ozone NAAQS were adopted by the Sacramento Metropolitan Air Quality Management District.
(b) * * *
(1) * * *
(iii) RACT determination for non-CTG major sources of Nitrogen Oxides (NO
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to partially approve and partially disapprove a revision to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California State Implementation Plan (SIP). The revision concerns the YSAQMD's demonstration regarding reasonably available control technology (RACT) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS or “standards”) in the portion of the Sacramento Metropolitan nonattainment area under the jurisdiction of the YSAQMD.
This rule is effective July 31, 2023.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2018-0160. All documents in the docket are listed on the
Eugene Chen, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 947-4304 or by email at
Throughout this document, “we,” “us” and “our” refer to the EPA.
On April 11, 2023 (88 FR 21572), the EPA proposed to partially approve and partially disapprove the California Air Resources Board's (CARB) submittal of the YSAQMD's RACT SIP for the 2008 Ozone National Ambient Air Quality Standards (NAAQS), as listed in Table 1 below.
We proposed to partially approve YSAQMD's 2017 RACT SIP because we determined that, except for the RACT elements for non-control technique guideline (CTG) major sources of nitrogen oxides (NO
The EPA's proposed action provided a 30-day public comment period, which concluded on May 11, 2023 (April 11, 2023 (88 FR 21572)). We received one comment letter regarding our proposed action, from the YSAQMD and dated May 10, 2023. We have summarized substantive adverse comments included in this comment letter and provided our responses below. In addition to the substantive comments summarized below, the District's letter includes information about recent progress it has made to address deficiencies related to SSM exemptions identified in Rule 2.43, and comments regarding the EPA's communication to the District about the identified deficiencies leading up to publication of the proposed rulemaking.
The EPA defines fugitive emissions as “those emissions which could not reasonably pass through a stack, chimney, vent, or other functionally-equivalent opening.”
The current title V operating permit (Permit No. F-01059-18, issued November 10, 2022) and statement of basis for the Recology Hay Road Landfill lists the following emission units and corresponding VOC PTE:
The YSAQMD asserts that the municipal solid waste landfill's 24.62 tpy VOC PTE (Unit ID P-85-06(a8)) consists of landfill fugitive emissions. Excluding these emissions from consideration towards major source applicability would result in a facility-wide VOC PTE of 13.04 tpy. Based upon a review of permitting information, we note that while Unit ID P-86-06(a8) includes fugitive VOC emissions from the landfill, it also includes VOC emissions from the flaring of landfill gas captured by the collection system.
The current title V operating permit (Permit No. F-01392-8, issued March 13, 2018) and statement of basis for the Yolo County Central Landfill lists the following emission units and corresponding VOC PTE:
The District asserts that the municipal solid waste landfill's 51.03 tpy VOC PTE (Unit ID P-15-05(a)) consists of landfill fugitive emissions. Excluding these emissions from consideration towards major source applicability would result in a facility-wide VOC PTE of 24.7 tpy. Based upon a review of permitting information, we agree that the 51.03 VOC PTE attributable to P-15-05(a) are fugitive landfill emissions, and note that the gas collection system and landfill flare are accounted for separately as Unit ID P-26-98(t2). With regard to the other permitted emission units, and in particular the landfill gas engines that comprise the majority of the non-fugitive VOC PTE, we note that the facility's title V permit establishes several emission and operating limits on a per-engine basis, including annual VOC tpy limits, VOC concentration limits expressed in parts per million (ppm), and landfill gas fuel usage limitations expressed in million standard cubic feet per year (MMCF/yr). The title V permit also contains requirements for annual source testing, recordkeeping of fuel usage and operating hours, and reporting requirements to ensure the practical enforceability of emission and operating limits. In addition, the title V permit establishes a landfill flare VOC emission limit and landfill gas fuel usage limit for Unit ID P-26-98(t2), and also requires an annual source test, recordkeeping of landfill gas fuel usage, and for the flare to be operated within the parameter ranges established during the most recent source test. We consider these monitoring, reporting, and recordkeeping requirements to ensure the practical enforceability of emission limits for the landfill flare. Based upon this information, we agree with the District that the VOC PTE of the Yolo County Central Landfill is 24.7 tpy, which is below the Severe nonattainment area major source threshold of 25 tpy.
As discussed in Section II of this preamble above, we received a public comment from the YSAQMD providing additional information relevant to our proposed disapproval of the RACT element for non-CTG major sources of VOC. The basis for our proposed disapproval was the lack of enforceable SIP requirements implementing VOC RACT for two municipal solid waste landfills that the 2017 RACT SIP identified as non-CTG major sources of VOC. Based upon the District's comment letter and additional information, we no longer consider these two municipal solid waste landfills to be major VOC sources, and therefore find that these sources are not
As authorized in section 110(k)(3) of the Act, the EPA is partially disapproving the 2017 RACT SIP with respect to the RACT element for non-CTG major sources of NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 740(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to review state choices, and approve those choices if they meet the minimum criteria of the Act. Accordingly, this final action partially approves and partially disapproves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law.
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 does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, will result from this action.
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, because 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, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it merely partially approves and partially disapproves state law as meeting Federal requirements. Furthermore, the EPA's Policy on Children's Health does not apply to this action.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The District did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goals of Executive Order 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
This action is subject to the CRA, and the 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).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 29, 2023. 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, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(c) * * *
(505) * * *
(ii) * * *
(A) * * *
(
(b) * * *
(6) * * *
(ii) RACT determination for non-CTG major sources of Nitrogen Oxides (NO
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing an approval and a limited approval and limited disapproval of revisions to the Mojave Desert Air Quality Management District (MDAQMD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's New Source Review (NSR) permitting program for new and modified sources of air pollution under part D of title I of the Clean Air Act (CAA or “Act”). This action updates the District's portion of the California SIP with ten revised rules. Under the authority of the CAA, this action simultaneously approves local rules that regulate emission sources and directs the District to correct rule deficiencies.
This rule is effective July 31, 2023.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2022-0338. All documents in the docket are listed on the
La Weeda Ward, Permits Office (Air-3-1), U.S. Environmental Protection Agency, Region IX, (213) 244-1812,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On November 25, 2022 (87 FR 72434), the EPA proposed approval of five rules and a limited approval and limited disapproval of five rules that were submitted for incorporation into the California SIP. Table 1 shows the rules in the California SIP that will be removed or superseded by this action, while Table 2 shows the rules that the State submitted for inclusion in the California SIP.
In our proposal, we proposed approval of Rules 206, 219, 1300, 1306, and 1402 as authorized under section 110(k)(3) of the Act. As authorized in sections 110(k)(3) and 301(a) of the Act,
1. The use of the term “contract” in the District's rules as interchangeable with the term “permit” is a deficiency because, as used in the specific contexts we identified in our proposed action, the term “contract” is not an acceptable alternative to the term “permit.”
2. The calculation procedures used in the District's rules to determine the amount of offsets required in certain situations do not comply with CAA section 173(c)(1) or 40 CFR 51.165(a)(3)(ii)(J) or (a)(1)(vi)(E). Rule 1304 uses a potential-to-potential test for calculating the quantity of “simultaneous emission reductions” (SERs) that can be used as offsets for a “Modified Major Facility.” Pursuant to Rule 1304(C)(2)(d), SERs at a Modified Major Facility are calculated using the potential to emit (PTE) in place of Historic Actual Emissions (HAE). Calculating emissions decreases using potential emissions as the baseline allows reductions “on paper” that do not represent real emissions reductions. The deficiency in Rule 1304, through cross-references, also causes related deficiencies in Rules 1301, 1302, 1303, and 1305.
3. The definitions for “Major Modification” and “Modification (Modified)” pursuant to Rule 1301(NN) and 1301(JJ), respectively, are deficient because they do not conform with Federal requirements. The definition of “Modification (Modified)” excludes modifications that do not result in a “Net Emissions Increase,” which is defined in Rule 1301(QQ) as: “An emission change as calculated pursuant to District Rule 1304(B)(2) which exceeds zero.” If there is no net emissions increase, as defined in Rule 1301(QQ) and Rule 1304(B)(2), a permit applicant can avoid NSR requirements entirely (
4. The District's use of the term “proceed” in Rule 1304 is a deficiency because the word “precede” (or a synonym of “precede”) should be used.
5. The provision in Rule 1305 allowing for interprecursor trading (IPT) for ozone precursors is a deficiency because IPT is no longer permissible.
6. The District rules do not contain the de minimis plan requirements contained in CAA section 182(c)(6) that apply to areas classified as Severe nonattainment.
As discussed in our proposal, this action is consistent with CAA sections 110(l) and 193. It will not relax any existing SIP provision, and it will not interfere with applicable attainment and reasonable further progress requirements or other applicable CAA requirements. This action will not relax any pre-November 15, 1990 requirements in the SIP, and therefore changes to the SIP resulting from this action will ensure greater or equivalent emissions reductions of ozone and its precursors and PM
Finally, we proposed to approve, under 40 CFR 51.307, the District's visibility provisions for sources subject to the District's nonattainment new source review (NNSR) requirements. Accordingly, we also proposed to revise 40 CFR 52.281(d) to add the District to the list of areas not subject to the visibility Federal Implementation Plan (FIP) at 40 CFR 52.28, to clarify that the FIP does not apply to the District.
The EPA's proposal and technical support document (TSD) for this action have more information and analysis on the District's submittal, the deficiencies, and our proposed approvals.
The public comment period on the proposed rule opened on November 25, 2022, the date of its publication in the
The EPA values its relationships with state, local, and tribal air agencies and strives to maintain open and transparent communications with them. Prior to our receipt of the District's submittal, the EPA, the District, and CARB committed significant resources to meeting, on a bi-weekly basis from approximately March 2020 to June 2021, for detailed discussions of the NSR program deficiencies we identified in a letter to the District dated December 19, 2019.
In addition, we understand the District's reference to “commitments” to suggest that the EPA could have proposed a conditional approval under CAA section 110(k)(4) rather than proposing a limited approval and limited disapproval. As authorized under CAA sections 110(k)(3) and 301(a), we are taking action to finalize a limited approval and limited disapproval of the submitted rules that contain the deficient provisions we identified in our proposed action.
As the District notes, the EPA last approved the District's Regulation XIII into the SIP in 1996. In 2002, the EPA revised its NSR regulations at 40 CFR 51.165.
The District states that “USEPA has expressed concerns in the past” that a facility could escape NSR review if it were composed entirely of exempt equipment and explains that there are several backstops that prevent facilities that consist solely of equipment that is potentially exempt under Rule 219 from escaping review, such as actions undertaken by enforcement personnel and local land use agencies pursuant to state law. The District requests that the notation regarding the nature and effect of Rule 219 as part of its NSR program be corrected or clarified in the EPA's TSD.
The District's comment refers to concerns that the EPA has expressed “in the past.” Although the EPA may have expressed concerns with a previous version of Rule 219, our review of the submitted version of Rule 219 did not identify any remaining concerns and found that the rule is approvable.
The EPA's proposed action explains that Rule 1304(C)(2)(d) is deficient because, for certain projects, it allows the amount of required offsets to be calculated using a pre-project baseline using potential emissions (generally, the emissions allowed by a permit),
Rule 1304(C)(2)(d) is not consistent with statutory and regulatory requirements that the pre-project baseline utilize actual emissions to calculate offset obligations. Instead, for emissions from units that have been “previously offset in a documented prior permitting action,” Rule 1304(C)(2)(d) allows the pre-project baseline to use the unit's potential to emit (the unit's allowable emissions) as reflected in a permit:
[Historic Actual Emissions] for a specific Emission Unit(s) may be equal to the Potential to Emit for that Emission Unit(s), [if] the particular Emissions Unit have [sic] been previously offset in a documented prior permitting action so long as: (i) The PTE for the specific Emissions Unit is specified in a Federally Enforceable Emissions Limitation; and (ii) The resulting Emissions Change from a calculation using this provision is a decrease or not an increase in emissions from the Emissions Unit(s) and (iii) Any excess SERs generated from a calculation using this provision are not eligible for banking pursuant to the provision [sic] of District Regulation XIV.
The District states that the EPA partially mischaracterizes Rule 1304(C)(2)(d) as allowing the use of the potential-to-potential test because the provision is more correctly characterized as “current fully offset allowable emissions” to “potential new emissions.” It is true that Rule 1304(C)(2)(d) allows the use of a pre-project baseline based on currently fully offset allowable emissions, because it is clear that the rule equates allowable emissions and potential to emit. However, the District's statements regarding the use of allowable emissions or potential emissions as the pre-project baseline are not relevant to the point presented in our proposed action: Rule 1304 is not consistent with Federal requirements because it does not require the use of
Allowable emissions are generally set higher than anticipated actual emissions to allow for normal fluctuations in emissions to occur without violating the permit conditions. The use of allowable emissions as the pre-project baseline means that the difference between pre-project and post-project emissions will be smaller than a calculation applying the EPA's requirement to use actual emissions as the pre-project baseline. Therefore, the District's rule, when using this provision, is likely to under-calculate the quantity of offsets required.
The District's assertion that only units that are already fully offset can use the allowable-to-potential offset quantification method does not remedy this deficiency, as fully offset units are still likely to have allowable emission limits above their actual emissions.
A real-world example that illustrates how the District's rules are less stringent than Federal requirements is a modification project reviewed by the District to upgrade three existing natural gas-fired combustion turbines at a power plant. The District's analysis of the project presents the facility's actual emissions of NO
Regarding the District's statement that “USEPA is objecting to the use of Simultaneous Emissions Reductions (SERs) which are created as part and parcel of an NSR action at a Major Facility to in effect `self-fund' the necessary offsetting emissions reductions by reducing emissions elsewhere in the Major Facility,” the EPA disagrees. This statement is inaccurate because the EPA did not categorically reject the District's use of SERs; rather, we identified the District's SERs calculation methodology as inconsistent with Federal requirements.
The District also states that SERs created from currently existing fully offset permit units at an existing major facility can only be used for changes at the same facility and cannot be banked. The fact that SERs cannot be bought and sold between facilities does not address the deficiency identified by the EPA that Rule 1304(C)(2)(d) allows the calculation of required offsets to use a baseline of allowable (
The District also states that Rule 1304(C)(2)(d) is intended to be used only to reduce the amount of offsets needed as opposed to a determination of whether offsets are required. This statement, however, appears to be a distinction without a difference. For example, any scenario in which the District's calculation of the amount of offsets required is zero (as in the real-world example described above) is tantamount to a determination that no offsets are required.
The District asserts “that it requires Best Available Control Technology (BACT) and offsets in more cases and on a greater number of Emissions Units” than the CAA requires. The District, however, provides no demonstration to support this claim, nor does the District provide any basis on which EPA could find that the District's NSR program ensures equivalency with Federal offset requirements.
The District also asserts that the EPA previously approved the provision we now find deficient and that, since 1993, when this provision came into active use, the number and extent of NAAQS exceedances has declined. The District also asserts that the decline in emissions could not have occurred if its NSR program was not achieving reductions at least as stringent as those that would occur if the District followed the requirements of the CAA. We do not agree with this comment. NSR programs primarily regulate construction and modification of stationary sources, and improvements in air quality can and do result from regulation of existing stationary sources (
We address MDAQMD's point regarding the De Minimis provisions at CAA 182(c)(6) in response to Comments 9 and 10 below.
The District admits that Rule 1304(C)(2)(d) could be interpreted incorrectly “without the procedural sequence that Rule 1302 sets forth.” The District asserts that these provisions have been in active use since 1993 with demonstrable results in overall air quality. The District states that, despite its assertion of the adequacy of the submitted provisions, it would appreciate guidance from the EPA regarding methods to clarify that SERs derived from previously fully offset activities can be used only to reduce the amount of offsets required and not for any other purpose.
We further note that Rule 1303, “New Source Review Requirements,” sets forth Best Available Control Technology (BACT) requirements
Similarly, Rule 1303(B)(2) imposes offset requirements using the term “Major Modification,” which is defined at Rule 1301(JJ). Rule 1301(JJ) defines “Major Modification” using the term “Net Emissions Increase.”
The District states, “the existence of Rule 1302 . . . very clearly sets out a flow for analysis in which one step occurs after another in sequence . . . First you determine `Emissions Change' under 1302(C)(1) on both an Emission Unit and Facility wide basis using 1304(B)(1) . . . No SERs are used in this calculation.” The EPA does not agree with these statements. Rule 1302(C)(1) does not specifically reference Rule 1304(B)(1)—it references, more generally, Rules 1304 and 1600.
The District, in its comment letter, “admits that the provisions as expressed in 1304(C)(2)(d) could, in the abstract and absent the procedural sequence set forth in 1302, potentially be interpreted incorrectly.” The EPA does not agree that Rule 1302 contains a “procedural sequence.” We also do not find any such sequence in Rule 1304. Rule 1304 identifies several different types of emissions calculations but does not specify an analytical framework for their use.
The District's comment also repeatedly refers to its Staff Report. In general, references to non-regulatory sources can be helpful to explain regulatory text; however, the District's reliance on its Staff Report in this instance is not sufficient to correct the fact that the rules fail to ensure proper analysis and implementation of Federal requirements.
Therefore, Rule 1302's broad cross reference to Rule 1304 is insufficient to establish a sequence or an “analysis flow” such as that asserted by the District. The ambiguity in the District's rules means that they do not ensure a proper analysis of emissions changes, such as, for example, correctly evaluating whether a project will result in an “Emissions Change” before evaluating whether it will result in a “Net Emissions Increase.” Such sequence is essential to correctly identifying whether a project would result in a net emissions increase under 40 CFR 51.165(a)(1)(vi), which the District currently uses as a basis for determining whether a project is a “Major Modification.”
In reviewing SIP submissions, the EPA must ensure that the plain language of the rule under review is clear and unambiguous. In a September 23, 1987 memorandum, the “Potter memo,” the EPA stated its criteria regarding the enforceability of SIPs and SIP revisions.
Additionally, the District's comment letter states that “USEPA also conveniently ignores the provisions of 1303(A)(4) which excludes the use of SERs in determining emissions increases for purpose [sic] of applying BACT.” Rule 1303(A)(4) includes an appropriately specific cross-reference to Rule 1304(B)(1), regarding “General Emissions Change Calculations.” Rule 1304(B)(1) provides for proper calculation of a project's emissions changes. However, the BACT requirement is also implemented by Rule 1303(A)(2) and (A)(3), which, as described above, use the term “Modified,” which is problematically defined by Rule 1301(NN), specifically because of its cross-reference to the term “Net Emissions Increase,” which is in turn deficient because of its cross-reference to Rule 1304's calculation
Rule 1305(C)(6) allows for the use of interprecursor trading. This fact is not changed by a footnote in the rule that acknowledges the January 2021 court decision without clearly prohibiting the use of interprecursor trading to satisfy offset obligations.
The District does not dispute the EPA's determination that the District's NSR program does not include provisions specified in CAA section 182(c)(6).
The District does not explain how the “no net increase” requirement of California Health and Safety Code section 40918(a)(1), which it references in footnote 73 of its comment letter, conflicts with the “De Minimis” requirements. The District's comment does not change the EPA's understanding that the De Minimis Rule operates independently of these requirements, and therefore the District's implementation of it would not weaken the District's current NNSR program. As the District's rules are currently written, BACT requirements apply when an emission unit has an emission increase or PTE of greater than 4.56 tpy (25 lb/day) (Rule 1303(A)(1) and (2)), or when the emission increase or PTE of all emission units exceed 25 tpy (Rule 1303(A)(3)). For example, a new facility with five emission units, each with a PTE of 4 tpy, would not be subject to BACT requirements under state or Federal NSR requirements. However, if during the next five years, the source proposed to add three additional emission units, each with a PTE of 4 tpy, BACT would still not be triggered under the current rule, since the State 4.56 tpy emission unit and the Federal 25 tpy project thresholds have not been exceeded. However, under the “De Minimis” requirements, the new project would be considered a major modification, with an aggregated emission increase of 32 tpy, and therefore, trigger both BACT and offset requirements for the current project. This is because the aggregated emissions from the two projects occurring within a five-year time frame exceed the 25 tpy threshold. The District's rules fail to ensure that such a scenario is not treated as de minimis, as CAA section 182(c)(6) requires. The Federal De Minimis Rule prevents a series of smaller projects, with emissions equivalent to the major modification threshold, from avoiding the major modification requirements of BACT and offsets. California law does not ensure conformity with the De Minimis Rule; therefore, the District's NSR program must include provisions to ensure compliance with it.
The District asserts that its submitted rules would be more stringent than implementing the De Minimis Rule and other aspects of EPA's NNSR requirements and seeks guidance from the EPA on how to make this demonstration. In general, to make a demonstration that a program is at least as stringent as Federal NNSR program requirements, the District would need to demonstrate that the requirements of its rule would trigger LAER and offsets requirements in all cases that would trigger these same requirements pursuant to the provisions of CAA section 182(c)(6). The EPA does not believe such a demonstration is possible, given the variety of project scenarios, which, depending on the facts (timing and emission rates from individual groups of emission units), would show that each set of rules is more and less stringent than the other in some cases. As we discussed in our responses to Comments 5 and 6, the District's rules are flawed in that they allow for improper calculation of net emissions increases, which affects the implementation of NSR requirements. Our responses to Comments 5 and 6 also describe the District's analysis of a permit application for a project involving a power plant and its determination that the project was not a modification because it would result in an emissions decrease, even though the project would increase actual emissions. We do not agree that the District's approach of not considering this project or other similar projects to be a modification constitutes a more stringent program.
As to the District's statement regarding the EPA not raising this issue earlier, the EPA appreciates the coordination and cooperation demonstrated over the period of joint work by our agencies to improve the rules. We remain available to discuss revisions necessary to address the deficiencies with the goal of full approval of revisions to the District's rules and a fully approved NSR program.
The District requests that the EPA “provide clear and convincing evidence that the implementation of USEPA's suggested corrections would indeed produce a benefit to air quality in the region”; however, the objective of the EPA review of the District's submitted rules is to ensure conformity with Federal requirements. Our proposed action describes the statutory and regulatory requirements that the District's NSR rules must satisfy for EPA approval.
The EPA's action to finalize a limited approval and limited disapproval of District Rules 1301, 1302, 1303, 1304, and 1305 into the SIP means that the rules, as currently submitted, will be incorporated into the SIP, but they must be revised and resubmitted to the EPA to avoid sanctions and FIP consequences. As we stated in our proposed action, we proposed limited approval and limited disapproval of these rules because although they fulfill most of the relevant CAA requirements and strengthen the SIP, they also contain certain deficiencies. Our final action incorporates into the SIP the submitted rules listed in Table 2 of this document for which we are fully approving or finalizing a limited approval/limited disapproval, including those provisions we identified as deficient.
None of the submitted comments change our assessment of the submitted rules as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is approving the submitted versions of Rules 206, 219, 1300, 1306, and 1402. Likewise, as authorized under sections 110(k)(3) and 301(a) of the Act, the EPA is finalizing a limited approval of the submitted versions of Rules 1301, 1302, 1303, 1304, and 1305. This action incorporates submitted Rules 206, 219, 1300, 1301, 1302, 1303, 1304, 1305, 1306, and 1402 into the California SIP, including those provisions identified as deficient. As authorized under section 110(k)(3) and 301(a), the EPA is simultaneously finalizing a limited disapproval of Rules 1301, 1302, 1303, 1304, and 1305.
As a result of our limited approval and limited disapproval of Rules 1301, 1302, 1303, 1304, and 1305, the EPA must promulgate a Federal implementation plan (FIP) under section 110(c) for the West Mojave Desert nonattainment area portion of the District within 24 months unless we approve subsequent SIP revisions that correct the deficiencies identified in this action. In this instance, we note that the EPA already has an existing obligation to promulgate a FIP for any NSR SIP elements that we have not taken final action to approve.
In this action we are also finalizing an approval of the District's visibility provisions for major sources subject to review under the NNSR program under 40 CFR 51.307. Therefore, we are revising 40 CFR 52.281(d) to remove the FIP for visibility protections as it applied to the District.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is incorporating by reference the District rules listed in Table 2 of this preamble which implement the District's New Source Review (NSR) permitting program for new and modified sources of air pollution under part D of title I of the CAA.
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 does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by State law.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by State law.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by State law. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, will result from this action.
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, because 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, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by State law.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
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 review state choices, and approve those choices if they meet the minimum criteria of the Act. Accordingly, this final action is finalizing the approval and the limited approval and limited disapproval of a state submittal as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law.
The State did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
This action is subject to the CRA, and the 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).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 29, 2023. 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, Administrative practice and procedure, Air pollution control, Carbon oxides, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
The additions read as follows:
(c) * * *
(31) * * *
(vi) * * *
(G) Previously approved on November 9, 1978, in paragraph (c)(31)(vi)(C) of this section and now deleted with replacement in paragraph (c)(601)(i)(A)(
(H) Previously approved on November 9, 1978, in paragraph (c)(31)(vi)(C) of this section and deleted with replacement in paragraph (c)(103)(xviii)(A) of this section: Rule 219.
(32) * * *
(iv) * * *
(G) Previously approved on November 9, 1978, in paragraph (c)(32)(iv)(C) of this section and deleted with replacement in paragraph (c)(103)(xviii)(A) of this section: Rule 219.
(39) * * *
(ii) * * *
(K) Previously approved on November 9, 1978, in paragraph (c)(39)(ii)(B) of this section and now deleted with replacement in paragraph (c)(601)(i)(A)(
(L) Previously approved on November 9, 1978, in paragraph (c)(39)(ii)(B) of this section and now deleted with replacement in paragraph (c)(600)(i)(A)(
(iv) * * *
(K) Previously approved on November 9, 1978, in paragraph (c)(39)(iv)(B) of this section and deleted without replacement for implementation in the Mojave Desert Air Quality Management District: Rules 206 and 219.
(68) * * *
(iii) Previously approved on January 21, 1981, in paragraph (c)(68)(i) of this section and deleted with replacement in paragraph (c)(239)(i)(A)(
(iv) Previously approved on January 21, 1981, in paragraph (c)(68)(i) of this section and deleted with replacement in paragraph (c)(155)(iv)(B) of this section: Rule 1305.
(70) * * *
(i) * * *
(E) Previously approved on January 21, 1981, in paragraph (c)(70)(i)(A) of this section and deleted with replacement in paragraph (c)(239)(i)(A)(
(87) * * *
(iv) * * *
(B) Previously approved on June 9, 1982, in paragraph (c)(87)(iv)(A) of this section and deleted with replacement in paragraph (c)(239)(i)(A)(
(103) * * *
(xviii) * * *
(C) Previously approved on July 6, 1982, in paragraph (c)(103)(xviii)(A) of this section and now deleted with replacement in paragraph (c)(600)(i)(A)(
(155) * * *
(iv) * * *
(C) Previously approved on January 29, 1985 in paragraph (c)(155)(iv)(B) of this section and deleted with replacement in paragraph (c)(239)(i)(A)(
(224) * * *
(i) * * *
(C) * * *
(
(239) * * *
(i) * * *
(A) * * *
(
(248) * * *
(i) * * *
(D) * * *
(
(598) [Reserved]
(599) [Reserved]
(600) The following regulations were submitted on July 23, 2021, by the Governor's designee as an attachment to a letter dated July 22, 2021.
(i)
(
(
(
(
(
(
(
(
(B) [Reserved]
(ii) [Reserved]
(601) The following regulations were submitted on October 15, 2021, by the Governor's designee as an attachment to a letter dated October 14, 2021.
(i)
(
(
(B) [Reserved]
(ii) [Reserved]
(d)
(9) Mojave Desert Air Quality Management District.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS implements management measures as described in an abbreviated framework action under the Fishery Management Plans (FMPs) for the Reef Fish Resources of the Gulf of Mexico (Reef Fish FMP) and Coastal Migratory Pelagic (CMP) Resources of the Gulf of Mexico and Atlantic Region (CMP FMP). This final rule will enable a permit holder to replace a historical captain endorsement in the reef fish and CMP fisheries in the Gulf of Mexico (Gulf) with a standard Federal charter vessel/headboat permit in the same Gulf fisheries. NMFS expects that this final rule will reduce the potential regulatory and economic burden on historical captain permit holders.
This final rule is effective on July 31, 2023.
An electronic copy of the abbreviated framework document that contains an environmental assessment and a Regulatory Flexibility Act (RFA) analysis may be obtained from the Southeast Regional Office website at
Rich Malinowski, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The Gulf of Mexico Fishery Management Council (Gulf Council) manages reef fish in Gulf Federal waters under the Reef Fish FMP. In Gulf and Atlantic Federal waters, the Gulf Council and South Atlantic Fishery Management Council (Councils) jointly manage CMP species under the CMP FMP. The Gulf Council prepared the Reef Fish FMP and the Councils jointly prepared the CMP FMP. NMFS implements the FMPs through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1801
On January 27, 2023, NMFS published a proposed rule in the
This final rule enables a permit holder with an eligible historical captain endorsement in the Gulf reef fish or Gulf CMP fishery to convert that endorsement to a standard Federal charter vessel/headboat permit (for-hire permit) in the same Gulf fishery, as applicable. This rule also extends the same rights and responsibilities of these standard for-hire permits to eligible individuals who choose to convert a historical captain endorsement to a standard for-hire permit. An eligible historical captain endorsement is hereafter referenced in this preamble as a historical captain permit. There are currently four historical captain permits, two for Gulf reef fish and two for Gulf CMP species, and are held by two individuals. Historical captain permits cannot be transferred to another person and no additional historical captain permits can be issued (50 CFR 622.20(b)(1)(i)(B); 85 FR 22043, April 21, 2020).
If an individual with an eligible historical captain permit wants to convert the permit to a standard for-hire permit, the individual must submit an application for a standard for-hire permit to NMFS along with their current, original historical captain permit (not a copy), and all supporting documents and fees, including documentation for the vessel to which NMFS will issue or associate with the standard for-hire permit. Unlike a historical captain permit, which is issued to an individual, a standard for-hire permit must be issued to a vessel with a valid U.S. Coast Guard certificate of documentation or state registration certificate (50 CFR 622.4(a)). If the permit applicant is the owner of the vessel, NMFS' Permits Office staff will
If the vessel to which the permit will be associated with is to be leased, a fully executed lease agreement of at least 7 months between the vessel owner and permit holder will need to be included with the application. Note that vessel owners and lessees cannot hold permits issued to the same vessel at the same time. NMFS' Permits Office staff will then verify the vessel does not have any other Federal permit associated with it in another permit holder's name.
After NMFS verifies that the information provided with the application allows for the conversion, the historical captain permit will then be converted to a standard for-hire permit for Gulf reef fish or Gulf CMP species, as applicable. Historical captain permit numbers are unique, and the new standard for-hire permit will keep the existing permit number (
NMFS received two public comments supporting the proposed rule for the abbreviated framework action. NMFS acknowledges the comments in favor of the action in the proposed rule. One commenter also suggested that NMFS reduce or waive the fee to convert a historical captain permit to a standard for-hire permit. However, this suggestion is beyond the scope of the action considered in the proposed rule, and we do not address it further in this final rule. NMFS made no changes to the final rule resulting from public comments.
Pursuant to section 304(b)(3) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the abbreviated framework action, the FMPs, the Magnuson-Stevens Act, and other applicable laws.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. A description of this final rule, why it is being implemented, and the purpose of this final rule are contained in the
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
Fish, Fisheries, Gulf of Mexico, Historical captain, Permit, Transfer.
For the reasons set out in the preamble, NMFS amends 50 CFR part 622 as follows:
16 U.S.C. 1801
(b) * * *
(1) * * *
(v)
(f)
National Marine Fisheries Service (NMFS), National Oceanic and
Temporary rule; retention limit adjustment.
NMFS is adjusting the General category daily retention limit from three large medium or giant (
Effective July 2, 2023, through August 31, 2023.
Erianna Hammond,
Atlantic HMS fisheries, including BFT fisheries, are managed under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). The General category baseline quota is currently 710.7 mt. This baseline quota is further subdivided into subquotas by time period. The baseline subquota for the June through August time period is 355.4 mt. The default General category daily retention limit is one large medium or giant (
Under § 635.23(a)(4), NMFS may increase or decrease the daily retention limit of large medium and giant BFT over a range of zero to five BFT per vessel after considering the regulatory determination criteria under § 635.27(a)(7).
NMFS has considered all of the relevant determination criteria and their applicability to the General category BFT retention limit for June through August 2023. As described below, after considering these criteria, NMFS has decided to decrease the daily retention limit from three to one large medium or giant BFT per vessel per day/trip (
Regardless of the duration of a fishing trip, the daily retention limit applies upon landing. For example (and specific to the June through August 2023 limit), whether a vessel fishing under the General category retention limit takes a 2-day trip or makes two trips in 1 day, the daily limit of one fish may not be exceeded upon landing. This General category retention limit is effective in all areas, except for the Gulf of Mexico, where NMFS prohibits targeting fishing for BFT, and applies to those vessels permitted in the General category, as well as to those HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT.
As described above, under § 635.23(a)(4), NMFS may adjust the daily retention limit of large medium and giant BFT after considering the regulatory determination criteria under § 635.27(a)(7). Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(7)(i)), biological samples collected from BFT landed by General category fishermen and provided by BFT dealers continue to provide NMFS with valuable parts and data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.
NMFS also considered the catches of the General category quota to date and the likelihood of closure of the General category if no adjustment is made (§ 635.27(a)(7)(ii)). Commercial-size BFT are currently readily available to vessels fishing under the General category quota. To date, the General category has landed approximately 27.4 mt, representing 8 percent of the General category June through August time period. If current catch rates continue with the three-fish daily limit, the available for the June through August time period will be reached or exceeded, and NMFS would need to close the fishery earlier than otherwise would be necessary under a lower limit. NMFS intends to provide General category participants in all areas and time periods opportunities to harvest the General category quota without exceeding it, through active inseason management such as retention limit adjustments and/or the timing and amount of quota transfers (based on consideration of the determination criteria regarding inseason adjustments), while extending the season as long as practicable. NMFS is setting the limit for the remainder of the June through August 2023 time period in such a way that NMFS believes, informed by past experience, increases the likelihood that the fishery will remain open throughout the June through August time period and year.
NMFS also took into consideration a recently published final rule that would set restricted-fishing days (RFDs) for the General category during the months of July through November 2023, with the first RFD scheduled for July 1 (88 FR 33839, June 1, 2023). On an RFD, General category permitted vessels and
NMFS also considered the effects of the adjustment on the BFT stock and the effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP (§ 635.27(a)(8)(v) and (vi)). This retention limit adjustment would be consistent with established quotas and subquotas, which are implemented consistent with ICCAT Recommendation 22-10, ATCA, and the objectives of the 2006 Consolidated HMS FMP and amendments. In establishing these quotas and subquotas and associated management measures, ICCAT and NMFS considered the best scientific information available, objectives for stock management and status, and effects on the stock. This retention limit adjustment is in line with the established management measures and stock status determinations. It is also important that NMFS be consistent with and limit landings to the subquotas both to adhere to the subquota allocations and to ensure that landings are as consistent as possible with the pattern of fishing mortality (
Another principal consideration in setting the retention limit is the objective of providing opportunities to harvest the available General category quota without exceeding the annual quota. This consideration is based on the objectives of the 2006 Consolidated HMS FMP and its amendments, and includes achieving optimum yield on a continuing basis and optimizing the ability of all permit categories to harvest available BFT quota allocations (related to § 635.27(a)(7)(x)).
Given these considerations, NMFS has determined that a one-fish General category retention limit is warranted for the remainder of the June through August 2023 time period. This retention limit would provide a reasonable opportunity to harvest the available U.S. BFT quota (including the expected increase in available 2023 quota based on 2022 underharvest), without exceeding it, while maintaining an equitable distribution of fishing opportunities; help optimize the ability of the General category to harvest its available quota; allow the collection of a broad range of data for stock monitoring purposes; and be consistent with the objectives of the 2006 Consolidated HMS FMP and amendments.
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat vessel owners are required to report their own catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act and regulations at 50 CFR part 635 and is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 533(b)(B), there is good cause to waive prior notice and opportunity to provide comment on this action, as notice and comment would be impracticable and contrary to this action for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing prior notice and an opportunity for public comment on the change in the daily retention limit from three BFT to the default level for the June through August time period would be impracticable. Based on available BFT quotas, fishery performance in recent years, and the availability of BFT on the fishing grounds, responsive adjustment to the General category BFT daily retention limit from three BFT to one fish is warranted to allow fishermen to take advantage of availability of fish and of quota. NMFS could not have proposed this action earlier, as it needed to consider and respond to updated data and information about fishery conditions and this year's landings. If NMFS was to offer a public comment period now, after having appropriately considered that data, it would preclude fishermen from harvesting BFT that are legally available consistent with all of the regulatory criteria, and/or could result in selection of a retention limit inappropriate to the amount of quota available for the period.
Adjustment of the General category retention limit needs to be effective as soon as possible to extend fishing opportunities for fishermen in all geographic areas, and to provide equitable opportunities. Fisheries under the General category daily retention limit are currently underway and thus prior notice would be contrary to the public interest. Delays in decreasing the General category retention limit would adversely affect those General category and HMS Charter/Headboat vessels that would otherwise have an opportunity to harvest BFT if the fishery were to remain open for as long as feasible throughout the remaining time periods. Limited opportunities to harvest the respective quotas may have negative social and economic impacts for U.S. fishermen that depend upon catching the available quota within the time periods designated in the 2006 Consolidated HMS FMP and amendments. NMFS provides notification of retention limit adjustments by publishing the notice in the
For all of the above reasons, the AA finds that pursuant to 5 U.S.C. 553(d), there is also good cause to waive the 30-day delay in effective date.
16 U.S.C. 971
Federal Aviation Administration (FAA) DOT.
Proposed rule; withdrawal.
The FAA is withdrawing the NPRM published in the
Effective as of 0901 UTC, June 30, 2023, the proposed rule published October 16, 2017 (82 FR 48011), is withdrawn.
Paul Gallant, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a notice of proposed rulemaking in the
The FAA determined that the NPRM published on October 16, 2017, is unnecessary. Therefore, the FAA withdraws that NPRM.
Federal Aviation Administration (FAA) DOT.
Proposed rule; withdrawal.
The FAA is withdrawing the NPRM published in the
Effective as of 0901 UTC, June 30, 2023, the proposed rule published April 8, 2019 (84 FR 13846), is withdrawn.
Paul Gallant, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a notice of proposed rulemaking in the
The FAA determined that the NPRM published on April 8, 2019, is unnecessary. Therefore, the FAA withdraws that NPRM.
Federal Communications Commission.
Petition for reconsideration.
Petition for Reconsideration (Petition) has been filed in the Commission's proceeding The Uniendo a Puerto Rico Fund and the Connect USVI Fund.
Oppositions to the Petition must be filed on or before July 17, 2023. Replies to oppositions must be filed on or before July 10, 2023.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
For additional information on this proceeding, contact Nathan Eagan of the Wireline Competition Bureau,
This is a summary of the Commission's document, Report No. 3196, released June 21, 2023. The full text of the Petition can be accessed online via the Commission's Electronic Comment Filing System at:
Federal Communications Commission
Notice of proposed rulemaking.
In this document, The Federal Communications Commission (Commission) propose to require cable operators and direct broadcast satellite providers to clearly and prominently display the total cost of video programming service in promotional materials and on subscribers' bills. Requiring “all-in” pricing is intended to clearly and accurately reflect consumers' subscription payment obligations, eliminate unexpected fees, and allow consumers to comparison shop among competing cable operators and direct broadcast satellite providers as well as alternative programming providers like streaming services. We also seek comment on the effect of imposing such requirements on other types of multichannel video programming distributors and on our authority to do so.
Submit comments on or before July 31, 2023. Submit reply comments on or before August 29, 2023.
For additional information on this proceeding, contact Brendan Murray,
This is a summary of the Commission's
In this Notice of Proposed Rulemaking (NPRM), we propose to enhance pricing transparency by requiring cable operators and direct broadcast satellite (DBS) providers to specify the “all-in” price for service in their promotional materials and on subscribers' bills. This proposal would require cable operators and DBS providers to clearly and prominently display the total cost of video programming service. This all-in pricing proposal is intended to give consumers a transparent and accurate reflection of their subscription payment obligations and eliminate unexpected fees. It also seeks to provide consumers with the ability to comparison shop among competing cable operators and DBS providers, and to compare programming costs against alternative programming providers, including streaming services. We also seek comment on whether we should consider expanding the requirements of this proceeding to other types of multichannel video programming providers (MVPDs) and on our authority to do so.
We seek comment on our proposal. Is this proposal sufficient to ensure that subscribers and potential subscribers have accurate information about the cost for video service? To what extent are providers to already advertising an “all-in” price that is inclusive of all video programming-related costs, government-imposed taxes, and fees? Would such materials satisfy our proposal, given that it relates only to charges for video programming? If a provider attempts to attract new subscribers with a total price (which would necessarily be higher than just the price for video programming), does that benefit outweigh the benefits of requiring uniformity for comparison shopping purposes? Are there more consumer-friendly ways that cable operators and DBS providers should be required to provide this information? Is the term “prominent” specific enough to ensure that cable operators and DBS providers present consumers with an easy-to-understand “all-in” subscription price, or do we need to provide more detail about how cable operators and DBS providers must communicate the price for service? For example, should we require cable operators and DBS providers to convey the information in a consistent font size or via some other measurable metric? In cases where the cable operator or DBS provider bundles video programming with other services like broadband internet service, can the cable operator or DBS provider readily identify the amount of the bill that is attributable to video programming, and if not, how should our rulemaking account for those situations? We invite comment, particularly from consumers and local franchising authorities (LFAs), about whether consumers encounter misleading promotions or receive misleading bills, and request that commenters include documents (such as advertisements and bills with redacted personal information) to support their claims.
Subscribers are entitled to clear, concise, and understandable information about the elements that comprise their subscription fees. We also understand that cable operators and DBS providers may wish to (or in some cases are required to under 47 U.S.C. 562) provide their subscribers and potential subscribers with information about how much of their subscription payments are attributable to specific costs of the video programming service, equipment rental, or other items that contribute to the bill. Section 622(c) permits cable operators to identify franchisee fees, public, educational, and governmental access (PEG) fees, and other fees, taxes, assessments, or other charges imposed by the government “as a separate line item on each regular bill of each subscriber.” Section 642(b) states that when an MVPD provides a consumer a bill in an electronic format, that bill shall include an “itemized statement that breaks down the total amount charged for or relating to the provision of the covered service by the amount charged for the provision of the service itself and the amount of all related taxes, administrative fees, equipment fees, or other charges.” The language in our rulemaking is intended to make clear that MVPDs may itemize their bills with even more granularity than the statute requires. We are concerned, however, that some cable operators and DBS providers may currently portray retransmission consent and sports programming costs as separate lines on the bill in such a way as to lead a reasonable consumer to believe that the charge has been mandated by the government, which is a concern that is similar to the concerns that the Commission had with regard to common carriers when it adopted truth-in-billing rules that apply to them. Therefore, consistent with sections 622(c) and 642 of the Act, we propose to explicitly state in our rule that cable operators and DBS providers may complement the prominent aggregate cost line item with an itemized explanation of the elements that compose that aggregate cost, so long as the cable operator or DBS provider portrays the video programming-related costs as part of the all-in price for service. We seek comment on this proposal. Are there consumer benefits to receiving the cost line-item information, which would justify their inclusion on consumer bills? Would a prohibition on separate line items, other than those mandated by section 642 of the Act or permitted under section 622(c) of the Act, better serve the public interest, and if so, could the Commission adopt such
We tentatively conclude that section 335 of the Act provides us with authority to adopt our proposed rule as it will apply to direct broadcast satellite (DBS) providers. Section 335(a) provides us with authority to impose on DBS providers “public interest or other requirements for providing video programming.” The Commission has not relied on this authority to impose customer service obligations on DBS before, but has recognized that section 335(a) authorizes the adoption of public interest regulations. We tentatively find that the rules we propose here are public interest requirements that fall squarely within our authority under section 335(a). As the Commission recently explained, “Consumer access to clear, easy-to-understand, and accurate information is central to a well-functioning marketplace that encourages competition, innovation, low prices, and high-quality services. The same information empowers consumers to choose services that best meet their needs and match their budgets and ensure that they are not surprised by unexpected charges or service quality that falls short of their expectations.” These are some of the same goals that our proposed rule here is intended to accomplish. Although section 335(a) covers requirements for “providing video programming,” we do not read that phrase to limit our authority to cover only communications that take place after a DBS provider and consumer enter into a contract. Advertising and promotional materials are often the catalyst for locking consumers into long-term contracts for the provision of video service. Our proposed rule, as it applies to advertising and other promotional materials, will ensure consumers have accurate and understandable information from the start of their subscriber relationship with the DBS provider, prevent consumer surprise down the road from unexpected charges assessed for “providing video programming,” and allow each consumer to have accurate information about the monthly cost in order to choose an MVPD service that best suits his or her needs. Accordingly, we tentatively conclude that we have authority under section 335(a) to apply our proposed rule to DBS providers. We seek comment on this tentative conclusion.
In addition, we seek comment on whether we have authority under section 4(i) of the Act to extend our proposed rule to DBS providers. By doing so, we will ensure uniformity of regulation between and among cable operators (regulated under Title VI and by various state consumer protection laws and local franchising provisions) and DBS providers (under Title III), thereby preventing DBS providers from gaining a competitive advantage over their competitors with potentially misleading marketing materials. We seek comment on this analysis.
Further, we tentatively conclude that section 632 of the Act provides us with authority to adopt our proposed rule as it will apply to cable operators. Section 632(b) provides us authority to establish customer service standards regarding billing practices and other communications with consumers, and we have relied on that authority for decades to regulate in this area. Our mandate under section 632(b) is to adopt customer service requirements regarding, among other enumerated topics, “communications between the cable operator and the subscriber (including standards governing bills and refunds).” Although the statute identifies specific areas that the Commission's customer service standards must cover, section 632 describes these only as the “minimum” standards. Thus, by its terms, section 632(b) gives us broad authority to adopt customer service standards that go beyond those enumerated, including outside the billing context. The legislative history of section 632 provides that “[p]roblems with customer service have been at the heart of complaints about cable television,” and Congress believed that “strong mandatory requirements are necessary.” Congress expected “the FCC, in
As discussed above, section 642, as added by the TVPA, requires MVPDs to bill subscribers transparently when the MVPD sends an electronic bill, and specifically requires MVPDs to include in their bills “an itemized statement that breaks down the total amount charged for or relating to the provision of the covered service by the amount charged for the provision of the service itself and the amount of all related taxes, administrative fees, equipment fees, or other charges.” We tentatively conclude that our proposal requiring cable operators and DBS providers to provide consumers with the “all-in” price for video programming service meets this statutory directive, at least as it applies to any electronic bill the MVPD sends. Specifically, our proposal to require cable operators and DBS providers to provide consumers with the total charge for all video programming would ensure that consumers are provided complete and accurate information about the “amount charged for the provision of the service itself,” as Congress intended. We tentatively find that such costs make up the charges for the “provision of the service itself” because broadcast channels, regional sports programming, and other programming track the statutory definition of “video programming” (that is, all are programming provided by, or generally considered comparable to programming provided by, a television broadcast station), and video programming is, by definition, the service that an MVPD makes available for purchase. We tentatively conclude that listing such costs as below-the-line fees potentially results in confusion for consumers about the “amount charged for the provision of the service itself,” because the word “itself” suggests a single charge for the total service rather than one charge for one portion of the service and then a separate charge for other programming provided. This contravenes Congress's core purpose for enacting the legislation: as noted above, the legislative history of this section indicates that Congress intended to curb MVPDs' practice of charging “unexpected and confusing fees,” but recent press reports suggest that this practice continues. We observe that the statute further provides for the disclosure of a second group of costs on electronic bills—
We also tentatively conclude that our proposed rule is consistent with the First Amendment. As the Commission has explained in other contexts where it adopted truth-in-billing, advertising, and labeling rules, “[c]ommercial speech that is misleading is not protected speech and may be prohibited,” and “commercial speech that is only potentially misleading may be restricted if the restrictions directly advance a substantial governmental interest and are no more extensive than necessary to serve that interest.” To what extent is the speech at issue here—portrayal that the cost of video service is a certain amount when the actual amount for the video service is potentially much higher—misleading? Is it categorically misleading such that is not considered protected speech? Or is it only potentially misleading? Is there a credible argument that this practice is not misleading at all?
If a reviewing court were to find that the speech is misleading, the constitutional analysis would end there because the proposed rule simply prevents misleading commercial speech, which is afforded no protection under the First Amendment. However, even if our proposed rule seeks to regulate only potentially misleading speech, regulations involving commercial speech that require a disclosure of factual information (such as the disclosure of the total cost for video programming service that our proposed rule would require) are entitled to more lenient review from courts than regulations that limit speech. That is, under Supreme Court precedent, a speaker's commercial speech rights are adequately protected as long as
Assuming, for the sake of argument, that our proposed rule would be subject to the more stringent test of commercial speech regulation (
Some MVPDs charge subscribers an assortment of unexpected fees that are not identified as a cost attributable to the video programming service that they sell, even though those fees are for parts of that video programming service. This categorization can potentially be misleading and interpreted as a government-imposed tax or fee, instead of a company-imposed service fee increase. This practice can also make it difficult for consumers to compare the service prices of competing video service providers. To make sure that consumers have the information they need to budget for video programming service and compare competitive services,
In assessing the cost of compliance for small entities, at this time the Commission is not in a position to determine whether, if adopted, amending the cable operator customer service obligations will require small entities to hire professionals to comply, and cannot quantify the cost of compliance with any of the potential rule changes that may be adopted. To help the Commission more fully evaluate the cost of compliance, in the NPRM we seek comment on whether a truth-in-billing requirement would impose undue burdens on small entities. We also seek comment on ways to limit any potential compliance burdens on small entities, while still achieving the benefits to consumers of clearer, non-misleading bills and advertisements. Comments should be accompanied by specific data and analysis supporting claimed costs and benefits. In addition, we seek comment on these issues and any other issues related to the regulation of below-the-line fees and truth-in-billing requirements. We expect the comments that we receive from the parties in the proceeding, including cost and benefit analyses, to help the Commission identify and evaluate compliance costs and burdens for small entities that may result from the matters discussed in the NPRM.
The NPRM seeks comment on whether cable operators and DBS providers have changed the way they bill or promote such fees since the TVPA took effect, and if so, how. We ask whether there is a business purpose for characterizing these service rate increases as taxes, fees, or surcharges, and whether certain sectors in the MVPD marketplace more prone to charging such fees. We also ask whether any franchising authorities have regulations or franchise agreement terms about these types of billing and advertising practices, and if so, whether they would conflict with our proposal. Consistent with section 642 of the Act, the NPRM proposes to explicitly state in our rule that cable operators and DBS providers may complement the prominent aggregate cost line item with an itemized explanation of the elements that compose that aggregate cost, so long as the cable operator or DBS provider portrays the video programming-related costs as part of the all-in price for service. There may be consumer benefits to allowing cable operators and DBS providers to provide their subscribers and potential subscribers with information about how much of their subscription payments are attributable to specific elements of the video programming service, equipment rental, or other elements that contribute to the bill.
We considered alternatives to whether our proposal to provide the “all-in” price for service in their promotional materials and on subscribers' bills is sufficient to ensure that subscribers and potential subscribers have accurate information about the cost for video service. We considered whether there are more consumer-friendly ways that cable operators and DBS providers should be required to provide this information and whether the term “prominent” is specific enough to
We expect to more fully consider the economic impact and alternatives for small entities following the review of comments and costs and benefits analyses filed in response to the NPRM. Our evaluation of this information will shape the final alternatives we consider, the final conclusion we reach, and any final actions we ultimately take in this proceeding to minimize any significant economic impact that may occur on small entities.
Cable television, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 76 as follows:
47 U.S.C. 151, 152, 153, 154, 301, 302, 302a, 303, 303a, 307, 308, 309, 312, 315, 317, 325, 338, 339, 340, 341, 503, 521, 522, 531, 532, 534, 535, 536, 537, 543, 544, 544a, 545, 548, 549, 552, 554, 556, 558, 560, 561, 571, 572, 573.
Cable operators and direct broadcast satellite (DBS) providers shall aggregate the cost of video programming that they provide as a prominent single line item on subscribers' bills and in any promotional materials. Cable operators and DBS providers may complement the aggregate line item with an itemized explanation of the elements that compose that single line item.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Notice of proposed rulemaking; extension of comment period.
On May 18, 2023, PHMSA published a Notice of Proposed Rulemaking (NPRM) in the
The comment period for the proposed rule published at 88 FR 31890 on May 18, 2023, is extended from July 17, 2023 to August 16, 2023. The agency will, consistent with 49 CFR 190.323, consider late-filed comments to the extent practicable.
You may submit comments identified by the docket number PHMSA-2021-0039 by any of the following methods:
Comments are posted without changes or edits to
Sayler Palabrica, Transportation Specialist, by telephone at 202-744-0825 or by email at
On May 18, 2023, PHMSA issued a Notice of Proposed Rulemaking titled “Pipeline Safety: Gas Pipeline Leak Detection and Repair”
PHMSA will extend the comment period for the NPRM from July 17, 2023, to August 16, 2023. Consistent with 49 CFR 190.323, PHMSA will consider late-filed comments to the extent practicable.
Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to request a revision of the approved information collection for the accreditation of laboratories; transactions with official meat and poultry establishments, egg products processing plants, and other firms; and exemptions from requirements of the Federal Meat Inspection Act and the Poultry Products Inspection Act. FSIS has reduced the burden estimate for this collection by 13 hours based on updated information for the accreditation of laboratories. The approval for this information collection will expire on November 30, 2023.
Submit comments on or before August 29, 2023.
FSIS invites interested persons to submit comments on this
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Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 937-4272.
FSIS is requesting a revision of the approved information collection for the accreditation of laboratories; transactions with official meat and poultry establishments, egg products processing plants, and other firms; and exemptions from requirements of the FMIA and the PPIA. FSIS has reduced the burden estimate for this collection by 13 hours based on updated information for the accreditation of laboratories. The approval for this information collection will expire on November 30, 2023.
FSIS requires accredited non-Federal analytical laboratories to maintain certain records (9 CFR 439.20 & 590.580). The Agency uses this collected information to ensure that non-Federal laboratories act in accordance with FSIS regulations.
The FMIA (21 U.S.C. 642), the PPIA (21 U.S.C. 460(b)), and the EPIA (21 U.S.C. 1040) require establishments, brokers, wholesalers, or otherwise, to keep records that fully and correctly disclose all transactions involved in their businesses related to relevant animal carcasses and parts and egg products.
In addition, FSIS requires establishments to keep records to ensure that meat and poultry products exempted from Agency inspection are not commingled with inspected meat and poultry products (9 CFR 303.1(b)(3) and 381.175).
Finally, FSIS requires retail operations determined to have violated the requirements associated with the retail exemptions in the FMIA and PPIA to keep sales purchase and sales records to ensure future compliance (9 CFR 303.1(d)(3) and 381.10(d)(3)).
FSIS has made the following estimates based upon an information collection assessment:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 937-4272.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS will also announce and provide a link to this
In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information (
To file a program discrimination complaint, a complainant should complete a Form AD-3027,
(1)
(2)
(3)
USDA is an equal opportunity provider, employer, and lender.
Natural Resources Conservation Service, U.S. Department of Agriculture.
Notice of availability, request for comments.
The Natural Resources Conservation Service (NRCS) is revising specific conservation practice standards in the National Handbook of Conservation Practices (NHCP). This notice provides an overview of the planned changes and gives the public an opportunity to offer comments on the proposed changes to the specific conservation practice standards.
We will consider comments that we receive by July 31, 2023.
We invite you to submit comments in response to this notice. You may submit your comments through one of the following methods:
•
•
All comments received will be made publicly available on
Copies of the proposed revised standards are available through
Mr. William Reck at (202) 720-4485, or by email at
NRCS plans to revise the conservation practice standards in NHCP. This notice provides an overview of the planned changes and gives the public an opportunity to offer comments on the specific conservation practice standards and NRCS's proposed changes.
NRCS State Conservationists who choose to adopt these practices in their states will incorporate these practices into the respective electronic Field Office Technical Guide. These practices may be used in conservation systems that treat highly erodible land (HEL) or on land determined to be wetland. Section 343 of the Federal Agriculture
The extent of the proposed changes varies considerably for each of the conservation practice standards addressed in this notice. To fully understand the proposed changes, individuals are encouraged to compare these changes with each current standard, which can be found at:
NRCS is requesting comments on the following conservation practice standards:
• Fish Raceway or Tank (Code 398);
• Irrigation Pipeline (Code 430);
• Stripcropping (Code 585); and
• Woody Residue Treatment (Code 384).
The following paragraphs highlight some of the proposed changes to each standard.
In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible agency or USDA's TARGET Center at (202) 720-2600 (voice and text telephone (TTY)) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any phone). Additionally, program information may be made available in languages other than English.
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at the USDA web page on How to File a Program Discrimination Complaint and at any USDA office, or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by (1) mail to U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; or (2) email to
USDA is an equal opportunity provider, employer, and lender.
U.S. Commission on Civil Rights.
Notice of public meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Florida Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom at 2:00 p.m. ET on Monday, July 17, 2023. The purpose of the meeting is to continue discussing the draft report on voting rights in the state. Members of the public may request a copy of the draft report in advance of the meeting. To do so, please email Liliana Schiller, Support Services Specialist, at
Monday, July 17, 2023, from 2:00 p.m.-4:00 p.m. Eastern Time.
The meeting will be held via Zoom.
David Mussatt, Designated Federal Officer, at
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to David Mussatt at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Iowa Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a meeting on Friday, July 21, 2023 at 2:00 p.m.-3:00 p.m. Central time. Committee will hear from a guest speaker and continue to brainstorming potential civil rights topics for their study of the 2021-2025 term.
The meeting will take place on Friday, July 21, 2023 from 2:00 p.m.-3:00 p.m. Central time.
David Barreras, DFO, at
Members of the public can listen to these discussions. Committee meetings are available to the public through the above call in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Notice of public meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Georgia Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom. The purpose of the meeting is to discuss the post-report activities of the Committee's recent civil rights project on civil asset forfeiture in Georgia.
Tuesday, August 1, 2023, from 1 p.m.-2 p.m. Eastern Time
The meeting will be held via Zoom.
Victoria Moreno, Acting Designated
This Committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Sarah Villanueva at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Greater Maricopa Foreign Trade Zone, Inc., grantee of FTZ 277, requesting authority to expand its zone under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR 400.2(c)) to include a new magnet site in El Mirage, Arizona. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on June 26, 2023.
FTZ 277 was approved by the Board on December 22, 2010 (Board Order 1733, 76 FR 1134, January 7, 2011), reorganized under the ASF on December 16, 2011 (Board Order 1804, 76 FR 80886, December 27, 2011) and expanded on December 23, 2013 (Board Order 1924, 79 FR 2152-2153, January 13, 2014). The zone currently has a service area that includes a portion of Maricopa County and consists of two magnet sites and eight usage-driven sites.
The applicant is now requesting authority to expand its zone to include an additional magnet site: Proposed Site 19 (694 acres)—LogistiCenter at Copperwing located on property south of West Peoria Ave. and north of Northern Parkway, with North El Mirage Rd. as the eastern boundary and Litchfield Rd. as the western boundary in El Mirage, Arizona. The proposed new site is adjacent to the Phoenix Customs and Border Protection port of entry.
In accordance with the FTZ Board's regulations, Qahira El-Amin of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to:
A copy of the application will be available for public inspection in the “Online FTZ Information Section” section of the FTZ Board's website, which is accessible via
Pursuant to Section 766.24 of the Export Administration Regulations, 15 CFR parts 730-774 (2021) (“EAR” or “the Regulations”),
On June 24, 2022, I signed an order denying the export privileges of Nordwind Airlines (“Nordwind”) for a
On May 18, 2023, BIS, through OEE, submitted a written request for renewal of the Nordwind TDO that issued on December 20, 2022. The written request was made more than 20 days before the TDO's scheduled expiration. A copy of the renewal request was sent to Nordwind in accordance with sections 766.5 and 766.24(d) of the Regulations. No opposition to the renewal of the TDO was received. OEE submitted a separate written request under the Regulations that Pegas Touristik be added to the TDO. On June 15, 2023, I issued an order renewing the Nordwind TDO based upon on-going violations of the TDO and the Regulations including the reexport of aircraft subject to the EAR on flights into Russia from Bokhar, Tajikistan, Tehran, Iran, and Osh, Kyrgyzstan, respectively. The June 15 renewal order also added Pegas Touristik as a related person. OEE has since requested that Pegas Touristik be removed from the TDO to allow the opportunity for additional administrative process under part 766 of the Regulations.
Having considered OEE's request, I find that Pegas Touristik should be removed from the TDO to allow the opportunity for additional administrative process under part 766 of the Regulations. The TDO shall remain in full force and effect as to Nordwind.
A. Applying for, obtaining, or using any license (except directly related to safety of flight), license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the EAR except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations, or engaging in any other activity subject to the EAR except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the EAR, or from any other activity subject to the EAR except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations.
A. Export, reexport, or transfer (in-country) to or on behalf of Nordwind any item subject to the EAR except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by Nordwind of the ownership, possession, or control of any item subject to the EAR that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby Nordwind acquires or attempts to acquire such ownership, possession or control except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from Nordwind of any item subject to the EAR that has been exported from the United States except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations;
D. Obtain from Nordwind in the United States any item subject to the EAR with knowledge or reason to know that the item will be, or is intended to be, exported from the United States except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations; or
E. Engage in any transaction to service any item subject to the EAR that has been or will be exported from the United States and which is owned, possessed or controlled by Nordwind, or service any item, of whatever origin, that is owned, possessed or controlled by Nordwind if such service involves the use of any item subject to the EAR that has been or will be exported from the United States except directly related to safety of flight and authorized by BIS pursuant to section 764.3(a)(2) of the Regulations. For purposes of this paragraph, servicing means installation, maintenance, repair, modification, or testing.
In accordance with the provisions of sections 766.24(e) of the EAR, Nordwind may, at any time, appeal this Order by filing a full written statement in support of the appeal with the Office of the Administrative Law Judge, U.S. Coast Guard ALJ Docketing Center, 40 South Gay Street, Baltimore, Maryland 21202-4022.
In accordance with the provisions of section 766.24(d) of the EAR, BIS may seek renewal of this Order by filing a written request not later than 20 days before the expiration date. A renewal request may be opposed by Nordwind as provided in section 766.24(d), by filing a written submission with the Assistant Secretary of Commerce for Export Enforcement, which must be received not later than seven days before the expiration date of the Order.
A copy of this Order shall be provided to Nordwind and Pegas Touristik and shall be published in the
This Order is effective immediately and shall remain in effect until December 12, 2023, unless renewed in accordance with Section 766.24(d) of the Regulations.
The Sensors and Instrumentation Technical Advisory Committee (SITAC) will meet on Tuesday, July 18, 2023, at 1:00 p.m., Eastern Daylight Time, in the Herbert C. Hoover Building, Room 3884, 1401 Constitution Avenue NW, Washington, DC (enter through Main Entrance on 14th Street between Constitution and Pennsylvania Avenues). This meeting will be virtual.
The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to sensors and instrumentation equipment and technology. The purpose of the meeting is to have Committee members and U.S. Government representatives mutually review updated technical data and policy-driving information that has been gathered.
1. Welcome and Introductions.
2. Remarks from the Bureau of Industry and Security Management.
3. Industry Presentations.
4. New Business.
5. Discussion of matters determined to be exempt from the open meeting and public participation requirements found in sections 1009(a)(1) and 1009(a)(3) of the Federal Advisory Committee Act (FACA) (5 U.S.C. 1001-1014). The exemption is authorized by section 1009(d) of the FACA, which permits the closure of advisory committee meetings, or portions thereof, if the head of the agency to which the advisory committee reports determines such meetings may be closed to the public in accordance with subsection (c) of the Government in the Sunshine Act (5 U.S.C. 552b(c)). In this case, the applicable provisions of 5 U.S.C. 552b(c) are subsection 552b(c)(4), which permits closure to protect trade secrets and commercial or financial information that is privileged or confidential, and subsection 552b(c)(9)(B), which permits closure to protect information that would be likely to significantly frustrate implementation of a proposed agency action were it to be disclosed prematurely. The closed session of the meeting will involve committee discussions and guidance regarding U.S. Government strategies and policies.
The open session will be accessible via teleconference. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on January 3, 2023, pursuant to 5 U.S.C. 1009(d) of the FACA, that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. 1009(a)(1) and 1009(a)(3). The remaining portions of the meeting will be open to the public.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on January 3, 2023, pursuant to 5 U.S.C. chapter 10 of the FACA, (5 U.S.C. 1009(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. 1009(a)(1) and 1009(a)(3). The remaining portions of the meeting will be open to the public.
For more information, contact Ms. Springer via email.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this expedited sunset review, the U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on certain aluminum foil (aluminum foil) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 30, 2023.
Erin Kearney, 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) 482-0167.
On March 1, 2023, Commerce published the notice of initiation of the first sunset review of the AD order on aluminum foil from China,
On March 31, 2023, the domestic interested parties filed an adequate substantive response within the deadline specified in 19 CFR 351.218(d)(3)(i).
The product covered by this
A complete discussion of all issues raised in this sunset review is provided in the Issues and Decision Memorandum.
Pursuant to sections 751(c)(1) and 752(b) of the Act, Commerce determines that revocation of the
This notice serves as the only reminder to parties subject to an APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results and notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Zhejiang Fuerjia Wooden Co., Ltd. (Fuerjia) has not made sales of multilayered wood flooring (wood flooring) from the People's Republic of China (China) at prices below normal value during the period of review (POR) December 1, 2020, through November 30, 2021. In addition, Commerce determines that certain companies had no shipments during the POR or did not establish their eligibility for a separate rate, and that Arte Mundi Group Co., Ltd. (Arte Mundi Group) is the successor-in-interest to Arte Mundi (Shanghai) Aesthetic Home Furnishings Co., Ltd. (Arte Mundi Shanghai).
Applicable June 30, 2023.
Alexis Cherry or Max Goldman, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC, 20230; telephone: 202-482-0607 and 202-482-0224, respectively.
Commerce published the
The product covered by the
All issues raised in the parties' briefs are addressed in the Issues and Decision Memorandum. A list of these issues is attached to this notice.
Based on information received since the
In the
In the
We determine that Fuerjia and four additional companies that were not selected for individual review demonstrated their eligibility for separate rates. These companies are listed in the table in the “Final Results of Administrative Review” section below. We continue to find that Metropolitan Hardwood Floors, Inc.
The statute and our regulations do not address the establishment of a rate to be assigned to respondents not selected for individual examination when we limit our examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, we look to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero and
For the final results of this review, we continue to determine the estimated dumping margin for Fuerjia, the sole cooperative mandatory respondent in this review, to be zero percent. Thus, consistent with the
Aside from the companies for which we made a final no-shipment determination, Commerce considers all other companies for which a review was requested, and which did not demonstrate separate rate eligibility, to be part of the China-wide entity.
For the companies subject to this administrative review which established their eligibility for a separate rate, Commerce determines that the following weighted-average dumping margins exist for the period December 1, 2020, through November 30, 2021:
We intend to disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding, in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review. We intend to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these final results. If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
For Fuerjia and the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. For entries that were not reported in the U.S. sales databases submitted by Fuerjia, and for the companies that did not qualify for a separate rate in the administrative review, Commerce will instruct CBP to liquidate such entries at the China-wide rate (
Consistent with Commerce's assessment practice in non-market economy cases, for the companies which Commerce determined had no shipments of the subject merchandise, any suspended entries made under those exporters' case numbers (
The following cash deposit requirements will be effective upon publication of these final results for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) for companies which were found eligible for a separate rate in this review, the cash deposit rate will be zero; (2) for previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the China-wide entity; and (4) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that certain producers/exporters subject to this administrative review made sales of subject merchandise at less than normal value (NV) during the period of review (POR) December 1, 2020, through November 30, 2021.
Applicable June 30, 2023.
Adam Simons, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6172.
On December 29, 2022, Commerce published the
On February 6, 2023, we received case briefs from the Domestic Interested Parties,
The merchandise subject to the
All issues raised in the case and rebuttal briefs are listed in Appendix I to this notice and addressed in the Issues and Decision Memorandum. Interested parties can find a complete discussion of these issues and the corresponding recommendations in this public memorandum, which is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding our
As noted in the
Generally, Commerce looks to section 735(c)(5) of the Tariff Act of 1930, as amended (the Act), which provides instructions for calculating the all-others rate in an investigation, for guidance for calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted-average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
In this review, we calculated a weighted-average dumping margin of 2.38 percent for NEXTEEL and a weighted-average dumping margin of 4.23 percent for SeAH. With two respondents under individual examination, Commerce normally calculates: (A) a weighted-average of the estimated dumping rates calculated for the examined respondents; (B) a simple average of the estimated dumping rates calculated for the examined respondents; and (C) a weighted-average of the estimated dumping rates calculated for the examined respondents using each company's publicly-ranged U.S. sale values for the merchandise under consideration. Commerce then compares (B) and (C) to (A) and selects the rate closest to (A) as the most appropriate rate for all other producers and exporters.
Consistent with our practice, we have determined that 3.27 percent, which is the weighted average of NEXTEEL and SeAH's margins based on publicly ranged data, will be assigned to the non-examined companies under section 735(c)(5)(A) of the Act.
As a result of this review, we determine the following weighted-average dumping margins for the period
We intend to disclose the calculations performed for NEXTEEL and SeAH in connection with these final results to interested parties within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.
Pursuant to 19 CFR 351.212(b)(1), NEXTEEL reported the entered value of its U.S. sales such that we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales for which entered value was reported. SeAH did not report the actual entered value for all of its U.S. sales; in such instances, we calculated importer-specific per-unit duty assessment rates by aggregating the total amount of antidumping duties calculated for the examined sales and dividing this amount by the total quantity of those sales. Where either the respondent's weighted-average dumping margin is zero or
For the companies not selected for individual review, we used an assessment rate based on the weighted average of the cash deposit rates calculated for NEXTEEL and SeAH. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for the future deposits of estimated duties where applicable.
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by NEXTEEL or SeAH for which the reviewed companies did not know that the merchandise they sold to the intermediary (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies covered in this review will be equal to the weighted-average dumping margin that is established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that countervailable subsidies are being provided to producers and exporters of glycine from India during the period of review, January 1, 2021, through December 31, 2021. Interested parties are invited to comment on these preliminary results.
Applicable June 30, 2023.
Scarlet Jaldin or Harrison Tanchuck, 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) 482-4275 or (202) 482-7421, respectively.
On June 21, 2019, Commerce published the countervailing duty order on glycine from India.
For a complete description of the events that followed the initiation of this review,
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. Commerce received timely-filed letters withdrawing the requests from Avid, Paras, and the petitioner, pursuant to 19 CFR 351.213(d)(1).
The merchandise covered by the
Commerce is conducting this review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found to be countervailable, we preliminarily find that there is a subsidy,
There are two companies for which a review was requested and not rescinded, and which were not selected as mandatory respondents or found to be cross-owned with the mandatory respondent (Kumar): Rudraa International; and Rexisize Rasayan Industries. The Act and Commerce's regulations do not directly address the subsidy rate to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation.
Section 777A(e)(2) of the Act provides that “the individual countervailable subsidy rates determined under subparagraph (A) shall be used to determine the all-others rate under section 705(c)(5) {of the Act}.” Section 705(c)(5)(A) of the Act articulates a preference that we are not to calculate an all-others rate using rates which are zero,
For these preliminary results, Kumar is the sole mandatory respondent with a calculated rate above
For the period January 1, 2021, through December 31, 2021, we preliminarily find that the following net subsidy rates exist:
Consistent with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. For companies for which this review is rescinded, Commerce will instruct CBP to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption during period January 1, 2021, through December 31, 2021, in accordance with 19 CFR 351.212(c)(1)(i). For the companies remaining in the review, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
Pursuant to section 751(a)(1) of the Act, Commerce intends, upon publication of the final results, to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for each of the respondents listed above on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed firms, Commerce will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the all-others rate or the most recent company-specific rate applicable to the company, as appropriate. These cash deposit instructions, when imposed, shall remain in effect until further notice.
Commerce intends to disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of these preliminary results, in accordance with 19 CFR 351.224(b).
Case briefs or other written documents may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the date of publication of this
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must do so within 30 days of publication of this notice by submitting a written request to the Assistant Secretary for Enforcement and Compliance.
Parties are reminded that all briefs and hearing requests must be filed electronically using ACCESS and that electronically filed documents must be
Unless the deadline is extended, Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).
These preliminary results and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable June 30, 2023.
Dusten Hom (India), Zachary Shaykin (Israel), and Jacob Saude (the Republic of Korea), AD/CVD Operations, Offices I, IV, and VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5075, (202) 482-2638, or (202) 482-0981, respectively.
On May 17, 2023, the U.S. Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations of imports of brass rod from India, Israel, and the Republic of Korea (Korea).
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act) requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On June 22, 2023, the petitioners submitted a timely request that Commerce postpone the preliminary determinations in these investigations.
In accordance with 19 CFR 351.205(e), the petitioners have stated the reasons for requesting a postponement of the preliminary determinations, and Commerce finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations to no later than 130 days after the date on which these investigations were initiated,
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that the sole producer/exporter subject to this administrative review made sales of subject merchandise at less than normal value (NV) during the period of review (POR) August 1, 2021, through July 31, 2022. Interested parties are invited to comment on these preliminary results.
Applicable June 30, 2023.
Alice Maldonado or Andrew Hart, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4682 or (202) 482-1058, respectively.
On October 11, 2022, based on a timely request for review, in accordance with 19 CFR 351.221(c)(1)(i), we initiated an administrative review on low melt polyester staple fiber (low melt
On April 26, 2023, Commerce extended the deadline for the preliminary results of this administrative review until June 30, 2023.
The merchandise subject to the
Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act.
For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine that the following weighted-average dumping margin exists for TAK for the period August 1, 2021, through July 31, 2022:
Commerce intends to disclose the calculations performed in connection with these preliminary results to interested parties within five days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, filed electronically via ACCESS within 30 days after the date of publication of this notice.
Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless otherwise extended.
Upon completion of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by TAK for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the company listed above will be equal to the weighted-average dumping margin established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
National Institute of Standards and Technology, Department of Commerce.
Notice; request for public comment.
The National Institute of Standards and Technology seeks comments on the
Responses must be received by 11:59 p.m. Eastern Time on August 14, 2023 to be considered.
Comments may be submitted by either of the following methods:
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Please submit comments only and include your name, organization's name (if any), and cite “NIST Public Access Plan” in all correspondence. Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials.
All comments responding to this document will be a matter of public record. Relevant comments will generally be available on the Federal eRulemaking Portal at
For questions about this notice contact: Katherine Sharpless, Open Access Officer, email address
The National Institute of Standards and Technology (NIST) is one of our Nation's oldest Federal laboratories (for more information, visit
NIST publishes this notice to seek comments on the
On August 25, 2022, OSTP issued a new public access memorandum,
The
NIST invites respondents to comment on the following questions that pertain to the implementation NIST's updated public access plan:
• How can NIST ensure equity in publication opportunities?
• How can NIST ensure public access and accessibility to outputs of NIST-funded research?
• How can NIST monitor impacts on affected communities—authors and readers alike?
• How can NIST improve the plan to provide greater public access to NIST-funded research results?
Comments relating to the text of the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of a public meeting; information regarding the agenda.
The National Marine Fisheries Service, Office of Sustainable Fisheries, will host an interim session of the Council Coordination Committee (CCC), consisting of the Regional Fishery Management Council chairs, vice chairs, and executive directors, on July 17, 2023. The intent of this virtual meeting is to discuss priorities and process for distributing funds provided under the Inflation Reduction Act (IRA) to the Councils for climate-ready fisheries and to describe the agencies planned investment in various scientific data collection, processing, and analysis efforts with IRA funds.
The meeting will begin at 4 p.m. Eastern Daylight Time (EDT) on Monday, July 17, adjourning at 5:30 p.m. EDT.
The meeting will be held online via WebEx. Webinar information to join the meeting can be found at
Morgan Corey by email at
The IRA is a historic, Federal Government-wide investment that furthers efforts to build a Climate-Ready Nation. NMFS will receive an unprecedented investment to strengthen the agency's core mission to provide science-based management and conservation of the Nation's marine resources as we confront climate change.
During this interim CCC session, NMFS will outline the process for providing IRA funding to the Councils to advance climate-ready fisheries management. Actions funded under IRA for the Councils sub-component will contribute to the following goals: implementation of fishery management measures necessary to improve climate resiliency and responsiveness to climate impacts, and development and advancement of climate-related fisheries management planning and implementation efforts in support of underserved communities.
In addition, NMFS will provide an overview of how IRA funding will be used in the Data Acquisition and Management sub-component. Actions funded under this sub-component will use advanced technologies, including data management, to improve and expand observation and sampling capabilities of critical fish, protected species, ecosystem, and climate data in order to understand where climate-driven shifts in distribution of fish and other key living marine resources are occurring.
The 2007 reauthorization of the Magnuson-Stevens Fishery Conservation and Management Act established the CCC. The CCC consists of the chairs, vice chairs, and executive directors of each of the eight Regional Fishery Management Councils.
1. Data Acquisition and Management Funding Overview & Discussion
2. Regional Fishery Management Councils Funding Overview & Discussion
3. Public Comment
4. Close of Meeting
If you have particular access needs please contact Morgan Corey at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from the San Francisco Bay Area Water Emergency Transportation Authority (WETA) for authorization to take marine mammals incidental to the refurbishment of the Alameda Main Street Ferry Terminal in Alameda, California. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.
Comments and information must be received no later than July 31, 2023.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service and should be submitted via email to
Alyssa Clevenstine, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring, and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
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 (IHAs 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 preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.
We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.
On February 9, 2023, NMFS received a request from WETA for an IHA to take marine mammals incidental to pile removal and driving associated with refurbishment of the Alameda Main Street Ferry Terminal in Alameda, California. Following NMFS' review of the application, WETA submitted revised versions on March 15, April 18, May 18, and May 24, 2023. The application was deemed adequate and complete on May 25, 2023. WETA's request is for take of harbor seals (
WETA proposes to refurbish the Alameda Main Street Ferry Terminal in the Oakland Inner Harbor, Alameda, California, to update and replace ageing ferry terminal components and structural support. Water depth within the project area varies between 14-28 inches (in; 35.56-71.12 centimeter (cm)) mean lower low water (MLLW), and most construction activities will occur above or at the waterline. The only elements that would extend below the mudline are nine new steel piles that would have a maximum tip elevation of approximately 110 in MLLW. WETA intends to use vibratory extraction to remove four existing 30 in (76.2 cm) steel guide piles and vibratory installation to drive nine new steel piles: two 24 in (60.9 cm) steel pipe piles with concrete cap beams on land, one 48 in (121.9 cm) steel pipe monopile in water, four 36 in (91.4 cm) steel guide piles in water, and two 36 in (91.4 cm) donut fender piles in water. A maximum of 6 days of consecutive piling activities is proposed to occur during the course of construction (4-6 weeks) from August through November 2023. WETA proposes to use vibratory pile driving and, if necessary, impact pile driving to achieve required tip elevation for the nine new piles. No in-air impacts to marine mammals are anticipated from the installation of the two 24 in (60.9 cm) piles driven on land, as such, they were not included in the Estimated Take section and will not be discussed further.
Project construction would include replacement of the existing bridge walkway and foundation, replacement of the gangway, demolition and replacement of the float, removal and installation of guide piles, and upgrades to utilities at the project site. No take of marine mammals is anticipated to occur incidental to these portions of the project and these activities will not be discussed further.
This IHA would be effective from August 15, 2023, until August 14, 2024. Pile extraction and installation activities would occur for a total of 6 consecutive days (5 days in water, 1 day on land) from August through November 2023. WETA plans to conduct piling activities during daylight hours, with noise-generating construction activities limited to occur between the hours of 0700-1900 Monday through Friday, and 0800-1300 Saturdays. Due to in‐water work timing restrictions to protect ESA-listed fish species, all in‐water construction activities including pile extraction and installation would occur during the period from June 1 to November 30. Pile extraction is anticipated to take between 1-3 days, pile installation is anticipated to take 3 days, of which 2 days will be required for in-water pile installation.
This project will be located at the existing Alameda Main Street Ferry Terminal in Alameda, CA (Figure 1), at a water depth between 14-28 in (35.56-71.12 cm). All project activities for which take is being requested will be located in the Oakland Inner Harbor, Alameda (see Figure 2 in IHA application).
Vibratory extraction of four existing 30 in diameter steel guide piles would occur over 1 to 3 days. Vibratory installation of one 48 in diameter steel pipe monopile, four 36 in diameter steel guide piles, and two 36 in diameter donut fender piles would occur over 2 days, with the monopile requiring 1 day and the six 36 in piles requiring 1 day. Impact installation of the seven new piles would occur only if required tip elevation was not achieved through vibratory methods and a bubble curtain would be employed to attenuate noise from impact driving (assuming a 5-dB reduction).
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs;
Table 2 lists all species for which take is expected and proposed to be authorized for this activity, 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. 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' SARs). While no serious injury or mortality is anticipated or proposed to be authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks 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' 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' U.S. Pacific SARs. All values presented in Table 2 are the most recent available at the time of publication (including from the draft 2022 SARs) and are available online at:
As indicated above, both species in Table 2 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur and are also included in Table 2 of the IHA application. No other marine mammal species are expected to occur in the project area.
California sea lions occur from Vancouver Island, British Columbia, to the southern tip of Baja California,
Pupping occurs primarily on the California Channel Islands from late May until the end of June (Peterson and Bartholomew, 1967). No pupping has been recorded in the San Francisco Bay. Weaning and mating occur in late spring and summer during the peak upwelling period (Bograd
California sea lions experienced an Unusual Mortality Event (UME), not correlated to an El Niño event, from 2013-2017 (Carretta
In San Francisco Bay, sea lions haul out primarily on floating docks at Pier 39 at the Fisherman's Wharf area of the San Francisco Marina, approximately 10.5 kilometers (6.5 miles) west-northwest of the project area. Haul out numbers at Pier 39 vary seasonally. In addition to the Pier 39 haul out, California sea lions haul out on buoys, wharfs, and similar structures throughout the Bay.
Harbor seals are distributed from Baja California, Mexico, to the eastern Aleutian Islands of Alaska (Harvey and Goley, 2011). Harbor seals do not make extensive pelagic migrations but may travel hundreds of kilometers to find food or suitable breeding areas (Harvey and Goley, 2011, Carretta
Harbor seals are opportunistic, generalist foragers and are expected to forage in shallow, intertidal waters on a variety of fish, crustaceans, and other species in the San Francisco Bay and could occasionally be found foraging in the Oakland Inner Harbor (Gibble, 2011). Harbor seals haul out at approximately 20 locations in San Francisco Bay with three main locations: Mowry Slough in the south, Corte Madera Marsh and Castro Rocks in the north, and Yerba Buena Island in the central bay (Gibble, 2011, Grigg
Harbor seals are the most common marine mammal species observed in the San Francisco Bay, where they primarily haul out on exposed rocky ledges and on sloughs in the southern San Francisco Bay. Harbor seals are central-place foragers (Orians, 1979) and tend to exhibit strong site fidelity within season and across years, generally forage close to haulout sites, and repeatedly visit specific foraging areas (Grigg
Peak numbers of harbor seals haul out in central California during late May to early June, which coincides with the peak molt (May through June). During both pupping and molting seasons, the number of seals and the length of time hauled out per day increase, from an average of 7 hours per day to 10-12 hours per day (Harvey and Goley, 2011, Huber
Harbor seals tend to forage at night and haul out during the day with a peak in the afternoon between 1300 and 1600 hr (Grigg
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities (
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.
This section provides a discussion of the ways in which components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
Acoustic effects on marine mammals during the specified activities can occur from impact pile driving and vibratory pile driving and removal. The effects of underwater noise from WETA's proposed activities have the potential to result in Level A and Level B harassment of marine mammals in the project area.
The marine soundscape is comprised of both ambient and anthropogenic sounds. Ambient sound is defined as the all-encompassing sound in a given place and is usually a composite of sound from many sources both near and far (American National Standards Institute, 1995). The sound level of an area is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical (
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
In-water construction activities associated with the proposed project would include vibratory pile extraction and vibratory pile installation, with the potential for impact pile installation. The sounds produced by these activities fall into one of two general sound types: impulsive and non-impulsive. Impulsive sounds (
Two types of hammers would be used on this project, vibratory and, if necessary, impact. Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers produce non-impulsive, continuous sounds. Vibratory hammering generally produces sound pressure levels (SPLs) 10-20 dB lower than impact pile driving of the same-sized pile (Oestman
The likely or possible impacts of WETA's proposed activities on marine mammals could be generated from both non-acoustic and acoustic stressors. Potential non-acoustic stressors include the physical presence of the equipment, vessels, and personnel; however, we expect that any animals that approach the project site close enough to be harassed due to the presence of equipment or personnel would be
The introduction of anthropogenic noise into the aquatic environment from pile driving equipment is the primary means by which marine mammals may be harassed from WETA's specified activities. In general, animals exposed to natural or anthropogenic sound may experience physical and psychological effects, ranging in magnitude from none to severe (Southall
NMFS defines a noise-induced TS as a change, usually an increase, in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2018). The amount of TS is customarily expressed in dB and TS can be permanent or temporary. As described in NMFS (2018), there are numerous factors to consider when examining the consequence of TS, including, but not limited to, the signal temporal pattern (
Depending on the degree (elevation of threshold in dB), duration (
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin (
The potential for TTS from impact pile driving exists. After exposure to playbacks of impact pile driving sounds (rate 2,760 strikes/hour) in captivity, mean TTS increased from 0 dB after a 15 minute exposure to 5 dB after a 360 minute exposure; recovery occurred within 60 minutes (Kastelein
Proposed activities for this project include impact and vibratory pile driving, and vibratory pile removal. There would likely be pauses in activities producing the sound during each day. Given these pauses and the fact that many marine mammals are likely moving through the project areas and not remaining for extended periods of time, the potential for TS declines.
Disturbance may result in changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); or avoidance of areas where sound sources are located. Pinnipeds may increase their haul out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006). Behavioral responses to sound are highly variable and context-specific and any reactions depend on numerous intrinsic and extrinsic factors (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments for both laboratory and free-ranging animals (
Airborne noise would primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, there are no known haul out sites in the vicinity of the project area and, if there were, these animals would likely previously have been “taken” because of exposure to underwater sound above the behavioral harassment thresholds, which are generally larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.
WETA's proposed construction activities could have localized, temporary impacts on marine mammal habitat, including prey, by increasing in-water SPLs and slightly decreasing water quality. Increased noise levels may affect acoustic habitat (see masking discussion above) and adversely affect marine mammal prey in the vicinity of the project areas (see discussion below). During impact and vibratory pile driving or removal, elevated levels of underwater noise would ensonify the project area where both fishes and mammals occur, and could affect foraging success. Additionally, marine mammals may avoid the area during construction, however, displacement due to noise is expected to be temporary and is not expected to result in long-term effects to the individuals or populations. Construction activities are expected to be of short duration and would likely have temporary impacts on marine mammal habitat through increases in underwater and airborne sound.
A temporary and localized increase in turbidity near the seafloor would occur in the immediate area surrounding the area where piles are installed or removed. In general, turbidity associated with pile driving is localized to about a 25-ft (7.6-m) radius around the pile (Everitt
Avoidance by potential prey (
Fish utilize the soundscape and components of sound in their environment to perform important functions such as foraging, predator avoidance, mating, and spawning (Zelick
Fish react to sounds which are especially strong and/or intermittent low-frequency sounds, and behavioral responses such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to noise depends on the physiological state of the fish, past exposures, motivation (
SPLs of sufficient strength have been known to cause injury to fish and fish mortality. However, in most fish species, hair cells in the ear continuously regenerate and loss of auditory function likely is restored when damaged cells are replaced with new cells. Halvorsen
The greatest potential impact to fish during construction would occur during impact pile driving. However, the duration of impact pile driving would be limited to a contingency in the event that vibratory driving does not satisfactorily install the pile. In-water construction activities would only occur during daylight hours allowing fish to forage and transit the project area in the evening. Vibratory pile driving may elicit behavioral reactions from fish such as temporary avoidance of the area but is unlikely to cause injuries to fish or have persistent effects on local fish populations. In addition, it should be noted that the area in question is low-quality habitat since it is already highly developed and experiences a high level of anthropogenic noise from normal dock operations and other vessel traffic.
The most likely impact to fishes from pile driving and removal and construction activities at the project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution, and behavior is anticipated. In general, impacts to marine mammal prey species are expected to be minor and temporary. Further, it is anticipated that preparation activities for pile driving or removal (
In summary, given the short daily duration of sound associated with individual pile driving events and the relatively small areas being affected, pile driving activities associated with the proposed actions are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Any behavioral avoidance by fish of the disturbed area would still leave significantly large potential areas fish and marine mammal foraging habitat in the nearby vicinity. Thus, we conclude that impacts of the specified activities are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to marine mammal habitat are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.
This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers,” and the negligible impact determinations.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of 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 primarily be by Level B harassment, as use of the acoustic sources (
As described previously, no serious injury or mortality is anticipated or proposed to be authorized for this activity. Below we describe how the proposed take numbers are estimated.
Generally speaking, 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) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of 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).
WETA's proposed activity includes the use of continuous (vibratory pile removal and installation) and, potentially, impulsive (impact pile installation) sources, and therefore the RMS SPL thresholds of 120 and 160 dB re 1 μPa are applicable.
These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.
Pile driving activities, using an impact hammer as well as a vibratory hammer, would generate underwater noise that could result in disturbance to marine mammals near the project area. A review of underwater sound measurements for similar projects was conducted to estimate the near-source sound levels for impact and vibratory pile driving and vibratory extraction. Source levels for proposed removal and installation activities derived from this review are shown in Table 5.
The recommended TL coefficient for most nearshore environments is the practical spreading value of 15. This value results in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions, known as practical spreading, which is the most appropriate assumption for WETA's proposed activity in the absence of specific modeling and site-specific information. If piles are installed or removed with a vibratory hammer, the SEL
In this section we provide information about the occurrence of marine mammals, including density or other relevant information which will inform the take calculations.
The California Department of Transportation (Caltrans) conducted monitoring of marine mammals in the vicinity of the San Francisco-Oakland Bay Bridge for 16 years. From those data, Caltrans has produced at-sea density estimates for California sea lions and harbor seals (Caltrans, 2016). Using these density estimates and the estimated Level A and Level B harassment areas, take estimates were calculated for all potential construction options. Activities and potential animal exposure to Level A harassment levels are presented in the IHA application's Table 3 for phocid species and Table 4 for otariid species. Take estimates based on exposure and activity duration are provided in Tables 5 and 6 of the IHA application.
WETA ferry boat captains have reported frequently seeing both California sea lions and harbor seals in the estuary channel and within the Oakland Inner Harbor (in-water sightings, not hauled out) but did not report seeing either species or other marine mammals near the Alameda Main Street Ferry Terminal dock or platform (WETA, pers. comm.).
Here we describe how the information provided above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and proposed for authorization.
Incidental take is estimated for each species by estimating the maximum number of marine mammals potentially present within a harassment zone during active pile driving based on density estimates, harassment zone size, and length of construction activity. Animal exposure estimates for each species were calculated by multiplying the estimated density of each species by the area of each harassment zone during active each type of pile driving activity (vibratory removal, vibratory driving, impact driving) and pile size (30 in, 36 in, 48 in). The estimated density is based on Caltrans (2016) offshore at-sea density and increased to account for the likely increase of animals in a nearshore environment based on previous comments from the Marine Mammal Commission (see Tables 3, 4 in application and 82 FR 17799, April 13, 2017).
Maximum number of animals exposed per activity = Density × Level A or Level B harrassment area
Estimated take was calculated using the exposure estimate multiplied by the number of days each in-water pile driving activity will occur. An additional take of 0-2 animals per day was added to account for the potential occurrence of small groups or additional individuals. This was done because small numbers of both species are known to incidentally use the Oakland Inner Harbor but extensive surveys have not been completed in the proposed project area. Using these density estimates and the areas within the Level A and B harassment isopleths, the take estimates were calculated for all possible construction options and here we show the maximum take estimates. Maximum estimated take by Level A harassment is based on 3 days of in-water vibratory pile removal plus 2 days of in-water impact driving, as the Level A harassment isopleth is larger for impact driving than vibratory driving (Table 8). Maximum estimated take by Level B harassment is based on 3 days of in-water vibratory removal plus 2 days of in-water vibratory pile installation, as the Level B harassment isopleth for vibratory driving is larger than for impact driving (Table 9). This results in a conservative estimate of how many marine mammals might be present to ensure that take estimates will not be exceeded (Table 10).
Estimated take = Maximum number of animals exposed × number of days per activity + additional individuals
Finally, due to the probability of ENSO conditions developing throughout 2023 (
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 the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses
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, NMFS considers 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 cost, and impact on operations.
WETA must ensure that construction supervisors and crews, the monitoring team, and relevant WETA staff are trained prior to the start of all pile driving activities, so that responsibilities, communication procedures, monitoring protocols, and operational procedures are clearly understood. New personnel joining during the project must be trained prior to commencing work.
All piling activities shall be conducted between June 1 and November 30, when the likelihood of sensitive fish species being present in the work area is minimal, following U.S. Army Corps of Engineer's Proposed Additional Procedures and Criteria for Permitting Projects under a Programmatic Determination of Not Likely to Adversely Affect Select Listed Species in California (USACE, 2018). Consistent with municipal code, noise-generating construction activities would be limited to the hours between 0700 and 1900 Monday through Friday, and 0800 and 1300 on Saturdays.
The placement of PSOs during all pile driving activities (described in the Proposed Monitoring and Reporting section) would ensure that the entire shutdown zone is visible. Should environmental conditions deteriorate such that the entire shutdown zone would not be visible (
PSOs would monitor the full shutdown zones and the Level B harassment zones to the extent practicable. Monitoring zones provide utility for observing by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring zones enable observers to be aware of and communicate the presence of marine mammals in the project areas outside the shutdown zones and thus prepare for a potential cessation of activity should the animal enter the shutdown zone.
Monitoring must take place from 30 minutes prior to initiation of pile driving activities (
Soft-start procedures provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the hammer operating at full capacity. If impact pile driving is necessary to achieve required tip elevation, WETA staff and/or contractors would be required to provide an initial set of three strikes from the hammer at reduced energy, followed by a 30-second waiting period, then two subsequent reduced-energy strike sets. Soft-start would be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
A bubble curtain must be employed during all impact pile installation of piles to interrupt the acoustic pressure and reduce impact on marine mammals. The bubble curtain must distribute air bubbles around 100 percent of the piling circumference for the full depth of the water column. The lowest bubble ring must be in contact with the mudline for the full circumference of the ring. The weights attached to the bottom ring must ensure 100 percent substrate contact. No parts of the ring or other objects may prevent full substrate contact. Air flow to the bubblers must be balanced around the circumference of the pile.
WETA must establish shutdown zones for all pile driving activities. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). Shutdown zones would be based upon the Level A harassment zone for each pile size/type and driving method where applicable, as shown in Table 6. A minimum shutdown zone of 10 m would be required for all in-water construction activities to avoid physical interaction with marine mammals. For pile driving, the radii of the shutdown zones are rounded to the next largest 10 m interval in comparison to the Level A harassment zone for each activity type. If a marine mammal is observed entering or within a shutdown zone during pile driving activity, the activity must be stopped until there is visual confirmation that the animal has left the zone or the animal is not sighted for a period of 15 minutes. Proposed shutdown zones for each activity type are shown in Table 11.
All marine mammals would be monitored in the Level B harassment zones and throughout the area as far as visual monitoring can take place. If a marine mammal enters the Level B harassment zone, in-water activities would continue and PSOs would document the animal's presence within the estimated harassment zone.
Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation 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 while conducting the activities. 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.
Marine mammal monitoring must be conducted in accordance with the conditions in this section and this IHA. Marine mammal monitoring during pile driving activities would be conducted by PSOs meeting NMFS' standards and in a manner consistent with the following:
• PSOs must be independent of the activity contractor (for example, employed by a subcontractor) and have no other assigned tasks during monitoring periods;
• At least one PSO would have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Other PSOs may substitute other relevant experience, education (degree in biological science or related field), or training for prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Where a team of three or more PSOs is required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization; and
• PSOs must be approved by NMFS prior to beginning any activity subject to the IHA.
PSOs should have the following additional qualifications:
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
WETA would have 1-3 PSOs stationed at the best possible vantage points in the project area to monitor during all pile driving activities. Monitoring would occur from elevated locations along the shoreline or on vessels where the entire shutdown zones are visible. PSOs would be equipped with high quality binoculars for monitoring and radios or cells phones for maintaining contact with work crews. Monitoring would be conducted 30 minutes before, during, and 30 minutes after all in-water construction activities. In addition, PSOs would record all incidents of marine mammal occurrence, regardless of distance from activity, and would document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving activities include the time to install or
In addition to monitoring on days that pile removal and driving would occur, as proposed by the applicant, WETA would conduct pre-construction monitoring. Prior to initiation of in-water construction, a qualified NMFS-approved PSO will conduct monitoring of marine mammals to update existing information on species occurrence in and near the project area, their movement patterns, and their site use. This pre-construction monitoring will take place at least 5 days prior to the start of in-water construction and will cover a period of at least 1 week (with at least 5 days of actual observation over a period of 4 hours each day), 2 hours in the morning at the time that construction activities would begin and 2 hours at midday.
WETA will provide the following reporting as necessary during active pile driving activities:
• The applicant will report any observed injury or mortality as soon as feasible and in accordance with NMFS' standard reporting guidelines. Reports will be made by phone (866-767-6114) and by email (
○ Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
○ Species identification (if known) or description of the animal(s) involved;
○ Condition of the animal(s) (including carcass condition if the animal is dead);
○ Observed behaviors of the animal(s), if alive;
○ If available, photographs or video footage of the animal(s); and,
○ General circumstances under which the animal was discovered.
• An annual report summarizing the prior year's activities will be provided that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, estimates the number of listed marine mammals that may have been incidentally taken during project pile driving, and provides an interpretation of the results and effectiveness of all monitoring tasks. The annual draft report will be provided no later than 90 days following completion of construction activities. Any recommendations made by NMFS will be addressed in the final report, due after the IHA expires and including a summary of all monitoring activities, prior to acceptance by NMFS. Final reports will follow a standardized format for PSO reporting from activities requiring marine mammal mitigation and monitoring.
• All PSOs will use a standardized data entry format (see Appendix B of the IHA application).
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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analysis applies to both California sea lions and harbor seals, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.
Pile driving and removal activities have the potential to disturb or displace marine mammals. Specifically, the project activities may result in take, in the form of Level A and Level B harassment from underwater sounds generated from pile driving and removal. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway.
The proposed takes by Level A and Level B harassment would be due to potential behavioral disturbance, TTS, and PTS. No mortality is anticipated given the nature of the activity and measures designed to minimize the possibility of injury to marine mammals. The potential for harassment is minimized through the construction method and the implementation of the planned mitigation measures (see Proposed Mitigation section).
The Level A harassment zones identified in Table 6 are based upon an animal exposed to impact pile driving multiple piles per day. Considering duration of impact driving each pile (up to 20 minutes) and breaks between pile installations (to reset equipment and move pile into place), this means an animal would have to remain within the area estimated to be ensonified above the Level A harassment threshold for multiple hours. This is highly unlikely given marine mammal movement throughout the area. If an animal was exposed to accumulated sound energy, the resulting PTS would likely be small (
The nature of the pile driving project precludes the likelihood of serious injury or mortality. For all species and stocks, take would occur within a limited, confined area (north-central San Francisco Bay including Richardson's Bay) of the stock's range. Level A and Level B harassment will be reduced to the level of least practicable adverse impact through use of mitigation measures described herein. Further, the amount of take proposed to be authorized is extremely small when compared to stock abundance.
Behavioral responses of marine mammals to pile driving at the project site, if any, are expected to be mild and temporary. Marine mammals within the Level B harassment zone may not show any visual cues they are disturbed by activities or could become alert, avoid the area, leave the area, or display other mild responses that are not observable such as changes in vocalization patterns. Given the short duration of noise-generating activities per day and that pile driving and removal would occur across 6 consecutive days, any
In addition, it is unlikely that minor noise effects in a small, localized area of habitat would have any effect on the stocks' ability to recover. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities will have only minor, short-term effects on individuals. The specified activities are not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• The specified activities and associated ensonified areas are very small relative to the overall habitat ranges of both species;
• The project area does not overlap with known BIAs or ESA-designated critical habitat;
• The lack of anticipated significant or long-term effects to marine mammal habitat;
• The presumed efficacy of the mitigation measures in reducing the effects of the specified activity; and,
• Monitoring reports from similar work in San Francisco Bay have documented little to no effect on individuals of the same species impacted by the specified activities (AECOM, 2022; AECOM, 2023).
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 proposed monitoring and mitigation measures, NMFS preliminarily 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 previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (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. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The amount of take NMFS has authorized is below one-third of the estimated stock abundances for all seven stocks (see Table 9). For both stocks, the proposed take of individuals is less than 1 percent of the abundance of the affected stock. This is likely a conservative estimate because it assumes all takes are of different individual animals, which is likely not the case. Some individuals may return multiple times in a day, but PSOs would count them as separate takes if they cannot be individually identified.
Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals would 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.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to WETA for conducting pile removal and driving in the Oakland Inner Harbor at Alameda, California, for one year from the date of issuance, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at:
We request comment on our analyses, the proposed authorization, and any other aspect of this notice of proposed IHA for the proposed construction project. We also request comment on the potential renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent renewal IHA.
On a case-by-case basis, NMFS may issue a one-time, one-year renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical or nearly identical activities as described in the Description of Proposed Activity section of this notice is planned or (2) the activities as described in the Description of Proposed Activity section of this notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond that described in the
• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond one year from expiration of the initial IHA); and
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
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 IHA to Community Offshore Wind, LLC (COSW) to incidentally harass marine mammals during marine site characterization surveys in coastal waters off of New Jersey and New York in the New York Bight.
This authorization is effective from July 1, 2023, through June 30, 2024.
Alyssa Clevenstine, Office of Protected Resources, NMFS, (301) 427-8401.
Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
On November 17, 2022, NMFS received a request from COSW for an IHA to take marine mammals incidental to conducting marine site characterization surveys in coastal waters off of New Jersey and New York in the New York Bight, specifically within the Bureau of Ocean Energy Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Lease Area OCS-A 0539 (Lease Area) and associated Export Cable Route survey area (ECR Area). Following NMFS' review of the application, COSW submitted a revised request on February 27, 2023. NMFS deemed the application adequate and complete on March 1, 2023. COSW's request is for take of small numbers of 15 species (16 stocks) of marine mammals by Level B harassment only. Neither COSW nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
COSW plans to conduct marine site characterization surveys, including high-resolution geophysical (HRG) surveys, in coastal waters off of New Jersey and New York in the New York Bight, specifically within BOEM Lease Area OCS-A 0539 and associated ECR Area, collectively considered the Survey Area.
The planned marine site characterization surveys are designed to obtain data sufficient to meet BOEM guidelines for providing geophysical, geotechnical, and geohazard information for site assessment plan surveys and/or construction and operations plan development. The objective of the surveys is to support the site characterization, siting, and engineering design of offshore wind project facilities including wind turbine generators, offshore substations, and submarine cables within the Survey Area. Up to three vessels may conduct survey efforts concurrently. Underwater sound resulting from COSW's marine site characterization survey activities, specifically HRG surveys, have the potential to result in incidental take of marine mammals in the form of Level B harassment.
The surveys are planned to begin as soon as practicable and estimated to require 293 survey days within a single year across a maximum of three vessels operating concurrently, which includes up to two vessels operating offshore (>20 meters (m) depth) and one vessel operating nearshore (<20 m depth). The survey days will occur any month throughout the year as the exact timing of the surveys during the year is not certain. A “survey day” is defined as a 24-hour (hr) activity period in which active acoustic sound sources are used offshore and a 12-hr activity period when a vessel is operating nearshore. It is expected that each offshore vessel would cover approximately 170 kilometers (km) of trackline per day surveyed at a speed of approximately 3.8 knots (kn; 7.04 km/h), based on COSW's expectations regarding data acquisition efficiency. There is up to 30,467 km of trackline survey effort planned: a maximum trackline length of 28,290 km is planned for the Lease Area
COSW's survey activities will occur in coastal waters off of New Jersey and New York in the New York Bight, specifically within BOEM Lease Area OCS-A 0539 and associated ECR Area (Figures 1, 2). The Survey Area (14,759 km
COSW's marine site characterization surveys within the Survey Area include geotechnical and geophysical surveys, including depth sounding to determine water depth, site bathymetry, and general seafloor topography using a multibeam echosounder (MBES); and medium penetration sub-bottom profilers (SBP; sparkers) in a single (2-dimensional (2D)) or triple (3-dimensional (3D)) configuration.
Within the Lease Area and across a 500-m buffer around the Lease Area (30-51 m depth), COSW will acquire MBES data and ultra-high resolution seismic (UHRS) data in either 2D (single sparker) or 3D (triple sparker) scenario. Within the ECR Area (3-65 m depth), the survey will consist of MBES and UHRS data collection within up to 900-m wide corridors. A centerline of UHRS data will be collected with 500-m tielines. COSW would acquire MBES data at a line spacing controlled by water depth to meet coverage and resolution requirements. MBES are used to determine water depths and general bottom topography. The MBES have operating frequencies greater than 180 kilohertz (kHz) and are therefore outside the general hearing range of marine mammals. NMFS does not expect MBES survey activities to present a reasonably anticipated risk of causing incidental take of marine mammals, so these activities are not discussed further in this notice.
COSW plans two scenarios: the 2D scenario and the 3D scenario. The total survey trackline length differs between the 2D and 3D scenarios but both scenarios include a maximum of two concurrently-operating vessels in the Lease Area with the potential for a third vessel operating concurrently in the ECR Area. For the 2D scenario, a trackline length of 5,370 km (1,515 km
The only acoustic sources planned for use during COSW's HRG survey activities with the potential to cause incidental take of marine mammals are the sparkers. There are two sparker systems planned for use: Applied Acoustics Dura-Spark UHD 400+400 Seismic Sound Source (400 tip/300-1,000 joules (J)) and the Geo-Source 200-400 Marine Multi-Tip Sparker System (400 tip/300-1,000 J).
A detailed description of COSW's planned HRG surveys is provided in the
A notice of NMFS' proposal to issue an IHA to COSW was published in the
NMFS received 13 comment letters. Two of these comment letters were from non-governmental organizations: the Responsible Offshore Development Alliance (RODA) and Clean Ocean Action (COA), and one was from an elected local governmental official (Mayor of Borough of Seaside Park, New Jersey; Seaside Park). The remaining ten comments were from private citizens.
All comments from private citizens expressed general opposition to issuance of the IHA or to the underlying associated activities. We reiterate here that NMFS' action concerns only the authorization of marine mammal take incidental to the planned surveys—NMFS' authority under the MMPA does not extend to the surveys themselves, or to wind energy development more generally. Several commenters suggested, without evidence, that issuance of the proposed IHA could result in the death of whales. We reiterate here that no mortality is anticipated or authorized. Many of the comments requested that NMFS not issue any IHAs related to wind energy development and/or expressed opposition for wind energy development generally without providing information relevant to NMFS' decision. We do not specifically address comments expressing general opposition to activities related to wind energy development or respond to comments that are out of scope of the proposed IHA (88 FR 24574), such as comments on other Federal agency processes and activities not planned under this IHA.
All substantive comments and NMFS' responses are provided below, and all comment letters are available online at:
Section 101(a)(5)(D) of the MMPA requires NMFS to make a determination that the take incidental to a “specified activity” will have a negligible impact on the affected species or stocks of marine mammals. NMFS' implementing regulations 50 CFR 216.104(a)(1) require applicants to include in their request a detailed description of the specified activity or class of activities that can be expected to result in incidental taking of marine mammals. Thus, the “specified activity” for which incidental take coverage is being sought under section 101(a)(5)(D) is generally defined and described by the applicant. Here, COSW was the applicant for the IHA, and we are responding to the specified activity as described in that application and making the necessary findings on that basis.
Through the response to public comments in the 1989 implementing regulations, NMFS also indicated (1) that we would consider cumulative effects that are reasonably foreseeable when preparing a NEPA analysis, and (2) that reasonably foreseeable cumulative effects would also be considered under section 7 of the Endangered Species Act (ESA) for ESA-listed species, as appropriate. Accordingly, NMFS has written
Separately, the cumulative effects of substantially similar activities in the northwest Atlantic Ocean have been analyzed in the past under section 7 of the ESA when NMFS has engaged in formal intra-agency consultation, such as the 2013 programmatic Biological Opinion for BOEM Lease and Site Assessment Rhode Island, Massachusetts, New York, and New Jersey Wind Energy Areas (
NMFS reiterates that there is no evidence that noise resulting from offshore wind development-related site characterization surveys could potentially cause marine mammal stranding, and there is no evidence linking recent large whale mortalities and currently ongoing surveys. The commenters offer no such evidence. NMFS will continue to gather data to help us determine the cause of death for these stranded whales. We note the Marine Mammal Commission's recent statement: “There continues to be no evidence to link these large whale strandings to offshore wind energy development, including no evidence to link them to sound emitted during wind development-related site characterization surveys, known as HRG surveys. Although HRG surveys have been occurring off New England and the mid-Atlantic coast, HRG devices have never been implicated or causatively-associated with baleen whale strandings.” (Marine Mammal Commission Newsletter, Spring 2023).
There is an ongoing Unusual Mortality Event (UME) for humpback whales along the Atlantic coast from Maine to Florida, which includes animals stranded since 2016. Partial or full necropsy examinations were conducted on approximately half of the whales. Necropsies were not conducted on other carcasses because they were too decomposed, not brought to land, or stranded on protected lands (
As discussed herein, HRG sources may behaviorally disturb marine mammals (
The best available science indicates that Level B harassment, or disruption of behavioral patterns, may occur as a result of COSW's specified activities. We also refer to the Greater Atlantic Regional Fisheries Office (GARFO) 2021 Programmatic Consultation, which finds that these survey activities are in general not likely to adversely affect ESA-listed marine mammal species (
RODA's reference to vessel speed restrictions being “not fully mandated” is unclear. NMFS refers again to its required vessel strike avoidance measures (see Condition 4(m)(ii) of the issued IHA), which requires that all vessels, regardless of size, observe a 10-knot speed restriction in SMAs, DMAs, and Slow Zones. Similarly, RODA does not provide a rationale for its suggestion that vessel speed restrictions are not enforced. We note that NMFS maintains an Enforcement Hotline for members of the public to report violations of vessel speed restrictions. Further, the IHA states that the IHA may be modified, suspended, or revoked if the holder fails to abide by the conditions prescribed therein.
More information on the authorization steps and timelines can be found at
NMFS emphasizes that an IHA does not authorize the activity itself but authorizes the take of marine mammals incidental to the “specified activity” for which incidental take coverage is being sought. In this case, NMFS is responding to COSW's request to incidentally take marine mammals while engaged in marine site characterization surveys and determining whether the necessary findings can be made based on COSW's application. The authorization of COSW's survey activities is not within NMFS' jurisdiction. NMFS refers RODA to BOEM's website:
A list of all proposed and issued IHAs for renewable energy activities, such as COSW's marine site characterization surveys, including the requested, proposed, and/or authorized take is available on the agency website at:
NMFS reviews required reporting (see Monitoring and Reporting) and uses the information to evaluate the mitigation measure effectiveness. Additionally, the mitigation measures included in COSW's IHA are not unique, and data from prior IHAs support the effectiveness of these mitigation measures. NMFS finds the level of reporting currently required is sufficient for managing the issued IHA and monitoring the affected stocks of marine mammals.
One change was made from the proposed IHA as a result of consultation with GARFO: an addition to the Monitoring and Reporting section specifying requirements relating to the use of a “trained lookout” in lieu of a PSO during required breaks for the approved PSO on duty on space-limited nearshore vessels.
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, incorporated here by reference, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' SARs (
Table 1 lists all species or stocks for which take is authorized for this activity, and summarizes information related to the species or stock, including regulatory status under the MMPA and ESA, and potential biological removal (PBR), where known. 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' SARs). While no serious injury or mortality is authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks 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' 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 MMPA managed stocks in this region are assessed in NMFS' U.S. Atlantic and Gulf of Mexico SARs. All values presented in Table 1 are the most recent available at the time of publication (including from the draft 2022 SARs) and are available online at:
A detailed description of the species likely to be affected by this project, including brief introductions to the species and relevant stocks, population trends and threats, and local occurrence, were provided in the
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities (
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.
A description of the potential effects of the specified activities on marine mammals and their habitat can be found in the
This section provides an estimate of the number of incidental takes authorized through the IHA, which informs both NMFS' “small numbers” and the negligible impact determinations.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities
Authorized takes are by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to sound produced by the sparkers. Based on the characteristics of the signals produced by the acoustic sources planned for use, Level A harassment is neither anticipated (even absent mitigation) nor authorized. As described previously, no serious injury or mortality is anticipated or authorized for this activity. Below we describe how the take numbers are estimated.
For acoustic impacts, generally speaking, 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) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of 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).
Generally speaking, Level B harassment take estimates based on these behavioral harassment thresholds are expected to include any likely takes by TTS as, in most cases, the likelihood of TTS occurs at distances from the source less than those at which behavioral harassment is likely. TTS of a sufficient degree can manifest as behavioral harassment, as reduced hearing sensitivity and the potential reduced opportunities to detect important signals (conspecific communication, predators, prey) may result in changes in behavior patterns that would not otherwise occur.
COSW's marine site characterization surveys include the use of impulsive (
The references, analysis, and methodology used in the development of the thresholds are described in NMFS (2018) Technical Guidance, which may be accessed at:
COSW's marine site characterization surveys include the use of impulsive (
Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.
NMFS has developed a user-friendly methodology for estimating the extent of the Level B harassment isopleths associated with relevant HRG survey equipment (NMFS, 2020). This methodology incorporates frequency and directionality (when relevant) to refine estimated ensonified zones. For acoustic sources that operate with different beamwidths, the maximum beamwidth was used, and the lowest frequency of the source was used when calculating the frequency-dependent absorption coefficient. COSW used 180-degree beamwidth in the calculation for the planned sparker as is appropriate for an omnidirectional source.
NMFS considers the data provided by Crocker and Fratantonio (2016) to represent the best available information on source levels associated with HRG survey equipment and, therefore, recommends that source levels provided by Crocker and Fratantonio (2016) be incorporated in the method described above to estimate isopleth distances to harassment thresholds. In cases where the source level for a specific type of HRG equipment is not provided in Crocker and Fratantonio (2016), NMFS recommends either the source levels provided by the manufacturer be used, or, in instances where source levels provided by the manufacturer are unavailable or unreliable, a proxy from Crocker and Fratantonio (2016) be used instead. Table 1 in the
COSW plans to use the Applied Acoustics Dura-Spark UHD 400+400 (400 tip/300-1000 J) and the Geo-Source 200-400 Marine Multi-tip Sparker System (400 tip/300-1000 J). For all source configurations (Table 1 in the
Results of modeling using the methodology described above indicated that, of the HRG survey equipment planned for use by the applicant (Table 1 in the
In this section, we provide information about the occurrence of marine mammals, including density or other relevant information that will inform the take calculations.
Habitat-based density models produced by the Duke University Marine Geospatial Ecology Laboratory (Roberts
For the exposure analysis, density data from Roberts
There are two stocks of bottlenose dolphins that may be impacted by the surveys (Western North Atlantic Northern Migratory Coastal Stock (Coastal Stock) and Western North Atlantic Offshore Stock (Offshore Stock)); however, Roberts
Furthermore, the Roberts
Finally, the Roberts
Here we describe how the information provided above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and authorized.
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 Level B harassment thresholds were calculated, as described above. The distance (
COSW proposes to conduct HRG surveys for a maximum total of 30,467 km trackline length, of which a maximum of 28,290 km are in the Lease Area and 2,177 km are in the ECR Area. Of the ECR Area trackline, 400 km are in waters <20 m depth. COSW is requesting take based on the 3D scenario as it results in the largest estimated harassment zone based on the planned equipment configuration, trackline distance, and resulting ensonified area. The 3D scenario would use a three sparker array with 400 tips (either Geo-Source 200-400 or Applied Acoustics Dura-Spark UHD) activating
This is a conservative estimate as it assumes the scenario that results in the greatest distance to the Level B harassment threshold (3D scenario) would be operated at all times during the entire survey, which may not ultimately occur.
The number of marine mammals expected to be incidentally taken during the total survey is then calculated by estimating the number of each species predicted to occur within the ensonified area (animals/km
The resulting take of marine mammals (Level B harassment) shown in Table 3.
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 the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the 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 the 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, NMFS considers 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 cost and impact on operations.
The following mitigation measures must be implemented during COSW's planned marine site characterization surveys. Pursuant to section 7 of the ESA, COSW would also be required to adhere to relevant Project Design Criteria (PDC) of the NMFS' GARFO programmatic consultation (specifically PDCs 4, 5, and 7) regarding geophysical surveys along the U.S. Atlantic coast (
COSW must employ independent, dedicated, trained PSOs, meaning that the PSOs must (1) be employed by a third-party observer provider, (2) have
During survey operations (
Visual PSOs shall coordinate to ensure 360° visual coverage around the vessel from the most appropriate observation posts and shall conduct visual observations using binoculars and the naked eye while free from distractions and in a consistent, systematic, and diligent manner. PSOs shall establish and monitor applicable shutdown zones (see below). These zones shall be based upon the radial distance from the sparker source (rather than being based around the vessel itself).
Two shutdown zones are defined, depending on the species and context. Here, an extended shutdown zone encompassing the area at and below the sea surface out to a radius of 500 m from the sparker source (0-500 m) is defined for NARW. For all other marine mammals, the shutdown zone encompasses a standard distance of 100 m (0-100 m) during the use of the sparker. Any observations of marine mammals by crew members aboard any vessel associated with the survey shall be relayed to the PSO team.
Visual PSOs may be on watch for a maximum of 4 consecutive hours followed by a break of at least 1 hr between watches and may conduct a maximum of 12 hr of observation per 24-hr period.
A ramp-up procedure, involving a gradual increase in source level output, is required at all times as part of the activation of the sparker sources when technically feasible. Operators should ramp up sparker to half power for 5 min and then proceed to full power. A 30 min pre-start clearance observation period of the shutdown zones must occur prior to the start of ramp-up. The intent of the pre-start clearance observation period (30 min) is to ensure no marine mammals are within the shutdown zones prior to the beginning of ramp-up. The intent of the ramp-up is to warn marine mammals of pending operations and to allow sufficient time for those animals to leave the immediate vicinity. All operators must adhere to the following pre-start clearance and ramp-up requirements:
• The operator must notify a designated PSO of the planned start of ramp-up as agreed upon with the lead PSO; the notification time should not be less than 60 min prior to the planned ramp-up in order to allow the PSOs time to monitor the shutdown zones for 30 min prior to the initiation of ramp-up (pre-start clearance). During this 30 min pre-start clearance period the entire shutdown zone must be visible, except as indicated below;
• Ramp-ups shall be scheduled so as to minimize the time spent with the source activated;
• A visual PSO conducting pre-start clearance observations must be notified again immediately prior to initiating ramp-up procedures and the operator must receive confirmation from the PSO to proceed;
• Any PSO on duty has the authority to delay the start of survey operations if a marine mammal is detected within the applicable pre-start clearance zone; and
• The operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the acoustic source to ensure that mitigation commands are conveyed swiftly while allowing PSOs to maintain watch.
The pre-start clearance requirement is waived for small delphinids and pinnipeds. Detection of a small delphinid (individual belonging to the following genera of the Family Delphinidae:
If there is uncertainty regarding identification of a marine mammal species (
• Ramp-up may not be initiated if any marine mammal to which the pre-start clearance requirement applies is within the shutdown zone. If a marine mammal is observed within the shutdown zone during the 30 min pre-start clearance period, ramp-up may not begin until the animal(s) has been observed exiting the zones or until an additional time period has elapsed with no further sightings (30 min for all baleen whale species and sperm whales, 15 min for all other species).
• PSOs must monitor the shutdown zones 30 min before and during ramp-up, and ramp-up must cease and the source must be shut down upon observation of a marine mammal within the applicable shutdown zone.
• Ramp-up may occur at times of poor visibility, including nighttime, if appropriate visual monitoring has occurred with no detections of marine mammals in the 30 min prior to beginning ramp-up. Sparker activation may only occur at night where operational planning cannot reasonably avoid such circumstances.
If the acoustic source is shut down for brief periods (
All operators must adhere to the following shutdown requirements:
• Any PSO on duty has the authority to call for shutdown of the sparker source if a marine mammal is detected within the applicable shutdown zone;
• The operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the source to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch;
• When the sparker source is active and a marine mammal appears within or enters the applicable shutdown zone, the source must be shut down. When
• Two shutdown zones are defined, depending on the species and context. An extended shutdown zone encompassing the area at and below the sea surface out to a radius of 500 m from the sparker source (0-500 m) is defined for NARW. For all other marine mammals, the shutdown zone encompasses a standard distance of 100 m (0-100 m) during the use of the sparker.
The shutdown requirement is waived for small delphinids and pinnipeds. If a small delphinid (individual belonging to the following genera of the Family Delphinidae:
If there is uncertainty regarding identification of a marine mammal species (
Upon implementation of shutdown, the source may be reactivated after the marine mammal has been observed exiting the applicable shutdown zone or following a clearance period (30 min for all baleen whale species and sperm whales, 15 min for all other species) with no further detection of the marine mammal.
If a species for which authorization has not been granted, or a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within the Level B harassment zone (158 m), shutdown must occur.
Crew and supply vessel personnel must use an appropriate reference guide that includes identifying information on all marine mammals that may be encountered. Vessel operators must comply with the below measures except under extraordinary circumstances when the safety of the vessel or crew is in doubt or the safety of life at sea is in question. These requirements do not apply in any case where compliance would create an imminent and serious threat to a person or vessel or to the extent that a vessel is restricted in its ability to maneuver and, because of the restriction, cannot comply.
Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down, stop their vessel(s), or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammals. A single marine mammal at the surface may indicate the presence of submerged animals in the vicinity of the vessel; therefore, precautionary measures should always be exercised. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel (species-specific distances are detailed below). Visual observers monitoring the vessel strike avoidance zone may be third-party observers (
All survey vessels, regardless of size, must observe a 10-kn (18.52-km/h) speed restriction in specific areas designated by NMFS for the protection of NARWs from vessel strikes. These include all SMAs established under 50 CFR 224.105 (when in effect), any DMAs (when in effect), and Slow Zones. See
• All vessels must reduce speed to 10 kn (18.52 km/h) or less when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel.
• All vessels must maintain a minimum separation distance of 500 m from NARWs, baleen whales (except humpback and minke), sperm whales, and any unidentified large whales. If a NARW, baleen whale (except humpback and minke), sperm whale, and any unidentified large whale is sighted within the relevant separation distance, the vessel must steer a course away at 10 kn (18.52 km/h) or less until the 500-m separation distance has been established. If a whale is observed but cannot be confirmed as a species other than a NARW, the vessel operator must assume that it is a NARW and take appropriate action.
• All vessels must maintain a minimum separation distance of 100 m from all humpback and minke whales.
• All vessels must, to the maximum extent practicable, attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an understanding that at times this may not be possible (
• When marine mammals are sighted while a vessel is underway, the vessel must take action as necessary to avoid violating the relevant separation distance (
Members of the PSO team will consult NMFS NARW reporting system and Whale Alert, daily and as able, for the presence of NARWs throughout survey operations, and for the establishment of DMAs and/or Slow Zones. It is COSW's responsibility to maintain awareness of the establishment and location of any such areas and to abide by these requirements accordingly.
As described above, a section of the survey area partially overlaps with a portion of a NARW SMA off the port of New York/New Jersey. This SMA is active from November 1 through April 30 of each year. The survey vessel, regardless of length, would be required to adhere to vessel speed restrictions (<10 kn (18.52 km/h)) when operating within the SMA during times when the SMA is active (Table 4).
Based on our evaluation of the applicant's planned measures, as well as other measures considered by NMFS, NMFS has determined that the planned mitigation 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 while conducting the activities. 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.
Visual monitoring must be performed by qualified, NMFS-approved PSOs. COSW must submit PSO resumes for NMFS review and approval prior to commencement of the survey. Resumes should include dates of training and any prior NMFS approval, as well as dates and description of last experience, and must be accompanied by information documenting successful completion of an acceptable training course.
For prospective PSOs not previously approved, or for PSOs whose approval is not current, NMFS must review and approve PSO qualifications. Resumes should include information related to relevant education, experience, and training, including dates, duration, location, and description of prior PSO experience. Resumes must be accompanied by relevant documentation of successful completion of necessary training.
NMFS may approve PSOs as conditional or unconditional. A conditionally-approved PSO may be one who is trained but has not yet attained the requisite experience. An unconditionally-approved PSO is one who has attained the necessary experience. For unconditional approval, the PSO must have a minimum of 90 days at sea performing the role during a geophysical survey, with the conclusion of the most recent relevant experience not more than 18 months previous.
At least one of the visual PSOs aboard the vessel must be unconditionally-approved. One unconditionally-approved visual PSO shall be designated as the lead for the entire PSO team. This lead should typically be the PSO with the most experience, who would coordinate duty schedules and roles for the PSO team and serve as primary point of contact for the vessel operator. To the maximum extent practicable, the duty schedule shall be planned such that unconditionally-approved PSOs are on duty with conditionally-approved PSOs.
A “trained lookout” may be used on a space-limited nearshore vessel (generally operating in water less than 20 m depth for no more than 12 hr/day) during required breaks for the approved PSO on duty. Project-specific training must be conducted for all vessel crew with “lookout” responsibilities prior to the start of a survey and during any changes in crew such that all relevant survey personnel are fully aware and understand the mitigation, monitoring, and reporting requirements. All vessel crew members operating as a trained lookout must be briefed in the identification of protected species that may occur in the survey area and in relevant mitigation requirements. Reference materials must be available aboard all project vessels for identification of protected species. Should a mitigation action be taken, the Trained Lookout will immediately notify the off-watch PSO to ensure that the appropriate response was taken and sightings and mitigation measures are properly documented (
At least one PSO aboard each acoustic source vessel must have a minimum of 90 days at-sea experience working in the role, with no more than 18 months elapsed since the conclusion of the at-sea experience. One PSO with such experience must be designated as the lead for the entire PSO team and serve as the primary point of contact for the vessel operator. (Note that the responsibility of coordinating duty schedules and roles may instead be assigned to a shore-based, third-party monitoring coordinator.) To the maximum extent practicable, the lead PSO must devise the duty schedule such that experienced PSOs are on duty with those PSOs with appropriate training but who have not yet gained relevant experience.
PSOs must successfully complete relevant training, including completion of all required coursework and passing (80 percent or more) a written and/or oral examination developed for the training program.
PSOs must have successfully attained a bachelor's degree from an accredited college or university with a major in one of the natural sciences, a minimum of 30 semester hours or equivalent in the biological sciences, and at least one undergraduate course in math or statistics. The educational requirements may be waived if the PSO has acquired the relevant skills through alternate experience. Requests for such a waiver shall be submitted to NMFS and must include written justification. Alternate experience that may be considered includes, but is not limited to (1) secondary education and/or experience comparable to PSO duties; (2) previous work experience conducting academic, commercial, or government-sponsored marine mammal surveys; and (3) previous work experience as a PSO (PSO must be in good standing and demonstrate good performance of PSO duties).
COSW must work with the selected third-party PSO provider to ensure PSOs have all equipment (including backup equipment) needed to adequately perform necessary tasks, including accurate determination of distance and bearing to observed marine mammals, and to ensure that PSOs are capable of calibrating equipment as necessary for accurate distance estimates and species identification. Such equipment, at a minimum, shall include:
• At least one thermal (infrared) imagine device suited for the marine environment;
• Reticle binoculars (
• Global Positioning Units (GPSs) (at least one plus backups);
• Digital cameras with a telephoto lens that is at least 300-mm or equivalent on a full-frame single lens reflex, also known as an SLR (at least one plus backups). The camera or lens should also have an image stabilization system;
• Equipment necessary for accurate measurement of distances to marine mammal;
• Compasses (at least one plus backups);
• Means of communication among vessel crew and PSOs; and
• Any other tools deemed necessary to adequately and effectively perform PSO tasks.
The equipment specified above may be provided by an individual PSO, the third-party PSO provider, or the operator, but COSW is responsible for ensuring PSOs have the proper equipment required to perform the duties specified in the IHA.
The PSOs will be responsible for monitoring the waters surrounding the survey vessel to the farthest extent permitted by sighting conditions, including Shutdown Zones, during all HRG survey operations. PSOs will visually monitor and identify marine mammals, including those approaching or entering the established Shutdown Zones during survey activities. It will be the responsibility of the PSO(s) on duty to communicate the presence of marine mammals as well as to communicate 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 distance and bearing to detect marine mammals, particularly in proximity to Shutdown Zones. Reticulated binoculars must also be available to PSOs for use as appropriate based on conditions and visibility to support the sighting and monitoring of marine mammals. During nighttime operations, appropriate night-vision devices (
During good conditions (
COSW shall submit a draft comprehensive report to NMFS on all activities and monitoring results within 90 days of the completion of the survey or expiration of the IHA, whichever comes sooner. The report must describe all activities conducted and sightings of marine mammals, must provide full documentation of methods, results, and interpretation pertaining to all monitoring, and must summarize the dates and locations of survey operations and all marine mammals sightings (dates, times, locations, activities, associated survey activities). The draft report shall also include geo-referenced, time-stamped vessel tracklines for all time periods during which acoustic sources were operating. Tracklines should include points recording any change in acoustic source status (
PSOs must use standardized electronic data forms to record data. PSOs shall record detailed information
1. Vessel names (source vessel), vessel size and type, maximum speed capability of vessel;
2. Dates of departures and returns to port with port name;
3. PSO names and affiliations;
4. Date and participants of PSO briefings;
5. Visual monitoring equipment used;
6. PSO location on vessel and height of observation location above water surface;
7. Dates and times (Greenwich Mean Time (GMT)) of survey on/off effort and times corresponding with PSO on/off effort;
8. Vessel location (decimal degrees) when survey effort begins and ends and vessel location at beginning and end of visual PSO duty shifts;
9. Vessel location at 30-second intervals if obtainable from data collection software, otherwise at practical regular interval;
10. Vessel heading and speed at beginning and end of visual PSO duty shifts and upon any change;
11. Water depth (if obtainable from data collection software);
12. Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions change significantly), including BSS and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon;
13. Factors that may contribute to impaired observations during each PSO shift change or as needed as environmental conditions change (
14. Survey activity information (and changes thereof), such as acoustic source power output while in operation, number and volume of airguns operating in an array, tow depth of an acoustic source, and any other notes of significance (
15. Upon visual observation of any marine mammal, the following information must be recorded:
a. Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
b. Vessel/survey activity at time of sighting (
c. PSO who sighted the animal;
d. Time of sighting;
e. Initial detection method;
f. Sightings cue;
g. Vessel location at time of sighting (decimal degrees);
h. Direction of vessel's travel (compass direction);
i. Speed of the vessel(s) from which the observation was made;
j. Identification of the animal (
k. Species reliability (an indicator of confidence in identification);
l. Estimated distance to the animal and method of estimating distance;
m. Estimated number of animals (high/low/best);
n. Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition,
o. Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars, or markings, shape and size of dorsal fin, shape of head, and blow characteristics);
p. Detailed behavior observations (
q. Mitigation actions; description of any actions implemented in response to the sighting (
r. Equipment operating during sighting;
s. Animal's closest point of approach and/or closest distance from the center point of the acoustic source; and,
t. Description of any actions implemented in response to the sighting (
If a NARW is observed at any time by PSOs or personnel on the project vessel, during surveys or during vessel transit, COSW must report the sighting information to the NMFS NARW Sighting Advisory System (866-755-6622) within 2 hr of occurrence, when practicable, or no later than 24 hr after occurrence. NARW sightings in any location may also be reported to the U.S. Coast Guard via channel 16 and through the Whale Alert app (
In the event that personnel involved in the survey activities discover an injured or dead marine mammal, the incident must be reported to NMFS as soon as feasible by phone (866-755-6622) and by email (
1. Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
2. Species identification (if known) or description of the animal(s) involved;
3. Condition of the animal(s) (including carcass condition if the animal is dead);
4. Observed behaviors of the animal(s), if alive;
5. If available, photographs or video footage of the animal(s); and
6. General circumstances under which the animal was discovered.
In the event of a vessel strike of a marine mammal by any vessel involved in the activities, COSW must report the incident to NMFS by phone (866-755-6622) and by email (
1. Time, date, and location (latitude/longitude) of the incident;
2. Species identification (if known) or description of the animal(s) involved;
3. Vessel's speed during and leading up to the incident;
4. Vessel's course/heading and what operations were being conducted (if applicable);
5. Status of all sound sources in use;
6. Description of avoidance measures/requirements that were in place at the time of the strike and what additional measures were taken, if any, to avoid strike;
7. Environmental conditions (
8. Estimated size and length of animal that was struck;
9. Description of the behavior of the marine mammal immediately preceding and/or following the strike;
10. If available, description of the presence and behavior of any other marine mammals immediately preceding the strike;
11. Estimated fate of the animal (
12. To the extent practicable, photographs or video footage of the animal(s).
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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the majority of our analysis applies to all the species listed in Table 1, given that some of the anticipated effects of this project on different marine mammal stocks are expected to be relatively similar in nature. Where there are meaningful differences between species or stocks, or groups of species, in anticipated individual responses to activities, impact of expected take on the population due to differences in population status, or impacts on habitat, they are included as separate sub-sections below. Specifically, we provide additional discussion related to NARW and to other species currently experiencing UMEs.
NMFS does not anticipate that serious injury or mortality would occur as a result from HRG surveys, even in the absence of mitigation, and no serious injury or mortality is authorized. As discussed in the Potential Effects of Specified Activities on Marine Mammals and their Habitat section, non-auditory physical effects, auditory physical effects, and vessel strike are not expected to occur. NMFS expects that all potential takes would be in the form of Level B harassment in the form of temporary avoidance of the area or decreased foraging (if such activity was occurring), reactions that are considered to be of low severity and with no lasting biological consequences (
In addition to being temporary, the maximum expected harassment zone around a survey vessel is 158 m (rounded up from the 157.7 m Level B harassment isopleth). Therefore, the ensonified area surrounding each vessel is relatively small compared to the overall distribution of the animals in the area and their use of the habitat. Feeding behavior is not likely to be significantly impacted as prey species are mobile and are broadly distributed throughout the survey area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
There are no rookeries, mating or calving grounds known to be biologically important to marine mammals within the planned survey area and there are no feeding areas known to be biologically important to marine mammals within the survey area. There is no designated critical habitat for any ESA-listed marine mammals in the survey area.
The status of the NARW population is of heightened concern and, therefore, merits additional analysis. As noted previously, elevated NARW mortalities began in June 2017 and there is an active UME. Overall, preliminary findings attribute human interactions, specifically vessel strikes and entanglements, as the cause of death for the majority of NARWs. As noted previously, the survey area overlaps a migratory corridor BIA for NARWs that extends from Massachusetts to Florida and from the coast to beyond the shelf break. Due to the fact that the planned survey activities are temporary (will occur for up to 1 year) and the spatial extent of sound produced by the survey would be small relative to the spatial extent of the available migratory habitat in the BIA, NARW migration is not expected to be impacted by the survey. This important migratory area is approximately 269,488 km
Given the relatively small size of the ensonified area, it is unlikely that prey availability would be adversely affected by HRG survey operations. Required vessel strike avoidance measures will also decrease risk of vessel strike during migration; no vessel strike is expected to occur during COSW's planned activities. Additionally, only very limited take by Level B harassment of NARWs has been requested and is authorized by NMFS as HRG survey operations are required to maintain and implement a 500-m shutdown zone. The 500-m shutdown zone for NARWs is conservative, considering the Level B harassment zone for the most impactful acoustic source (
As noted previously, there are several active UMEs occurring in the vicinity of COSW's Survey Area. Elevated humpback whale mortalities have occurred along the Atlantic coast from Maine through Florida since January 2016. Of the cases examined, approximately half had evidence of human interaction (
Beginning in January 2017, elevated minke whale strandings have occurred along the Atlantic coast from Maine through South Carolina, with highest numbers in Massachusetts, Maine, and New York. This event does not provide cause for concern regarding population level impacts, as the likely population abundance is greater than 20,000 whales.
Elevated numbers of harbor seal and gray seal mortalities were first observed between 2018-2020 and, as part of a separate UME, again in 2022. These have occurred across Maine, New Hampshire, and Massachusetts. Based on tests conducted so far, the main pathogen found in the seals is phocine distemper virus (2018-2020) and avian influenza (2022), although additional testing to identify other factors that may be involved in the UMEs is underway. The UMEs do not provide cause for concern regarding population-level impacts to any of these stocks. For harbor seals, the population abundance is over 60,000 and annual M/SI (339) is well below PBR (1,729) (Hayes
The required mitigation measures are expected to reduce the number and/or severity of takes for all species listed in Table 1, including those with active UMEs, to the level of least practicable adverse impact. In particular, they would provide animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy, thus preventing them from being exposed to sound levels that have the potential to cause injury. No Level A harassment is anticipated, even in the absence of mitigation measures, or authorized.
NMFS expects that takes would be in the form of short-term Level B harassment by way of brief startling reactions and/or temporary vacating of the area, or decreased foraging (if such activity was occurring)—reactions that (at the scale and intensity anticipated here) are considered to be of low severity, with no lasting biological consequences. Since both the sources and marine mammals are mobile, animals would only be exposed briefly to a small ensonified area that might result in take. Additionally, required mitigation measures would further reduce exposure to sound that could result in more severe behavioral harassment.
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 any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• No Level A harassment (PTS) is anticipated, even in the absence of mitigation measures, or authorized;
• Foraging success is not likely to be significantly impacted as effects on species that serve as prey species for marine mammals from the survey are expected to be minimal;
• The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the ensonified areas during the planned survey to avoid exposure to sounds from the activity;
• Take is anticipated to be by Level B harassment only consisting of brief startling reactions and/or temporary avoidance of the ensonified area;
• Survey activities will occur in such a comparatively small portion of the BIA for the NARW migration that any avoidance of the area due to survey activities would not affect migration. In addition, mitigation measures require shutdown at 500 m (over three times the size of the Level B harassment zone of 158 m) to minimize the effects of any Level B harassment take of the species; and,
• The planned mitigation measures, including visual 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 planned monitoring and mitigation measures, NMFS finds that the total marine mammal take from the planned activity will have a negligible impact on all affected marine mammal species or stocks.
As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (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. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
NMFS authorizes incidental take by Level B harassment only of 15 marine mammal species with 16 managed stocks. The total amount of takes authorized relative to the best available population abundance is less than 7 percent for any of the 16 managed stocks (Table 3). The take numbers authorized are considered conservative estimates for purposes of the small numbers determination as they assume all takes represent different individual animals, which is unlikely to be the case.
Based on the analysis contained herein of the planned activity (including the planned mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals would 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.
Section 7(a)(2) of the ESA (16 U.S.C. 1531
NMFS Office of Protected Resources (OPR) has authorized take of four species of marine mammals which are listed under the ESA, including NARW,
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 (IHAs 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 this IHA qualifies to be categorically excluded from further NEPA review.
NMFS has issued an IHA to COSW for the potential harassment of small numbers of 15 marine mammal species (16 stocks) incidental to conducting marine site characterization surveys in coastal waters off of New Jersey and New York in the New York Bight for a period of 1 year that includes the previously explained mitigation, monitoring, and reporting requirements. The IHA can be found at:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the Procurement List.
This action adds service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes product(s) and service(s) from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Suite 325, Washington, DC 20024.
Michael R. Jurkowski, Telephone: (703) 785-6404, or email
On 3/31/2023, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping, or other compliance requirements for small entities other than the small organizations that will furnish the service(s) to the Government.
2. The action will result in authorizing small entities to furnish the service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) proposed for addition to the Procurement List.
Accordingly, the following service(s) are added to the Procurement List:
On 3/3/2023, 3/10/2023, 3/17/2023, 4/7/2023, 4/21/2023, and 5/5/2023, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.
After consideration of the relevant matter presented, the Committee has determined that the product(s) and service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.
Accordingly, the following product(s) and service(s) are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add and service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities and delete product(s) previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Suite 325, Washington, DC 20024.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 785-6404, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the service(s) listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following service(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following product(s) are proposed for deletion from the Procurement List:
88 FR 41085, June 23, 2023.
9:00 a.m. EDT, Friday, June 30, 2023.
The meeting has been canceled.
Christopher Kirkpatrick, Secretary of the Commission, 202-418-5964.
Corporation for National and Community Service.
Notice of a new matching program.
In accordance with the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988, OMB Final Guidance Interpreting the Provisions of the Computer Matching and Privacy Protection Act of 1988, and OMB Circular No. A-130, “Management of Federal Information Resources,” the Corporation for National and Community Service (operating as AmeriCorps) is issuing a public notice of the computer matching program with the Social Security Administration (SSA).
Comments must be received by July 31, 2023. If AmeriCorps determines that significant changes to the matching agreement are necessary, it shall publish a revised notice with an additional 30-day public comment period. AmeriCorps has filed a report of the subject computer matching agreement with the Office of Management and Budget (OMB) and Congress. The matching program will begin October 1, 2023 or 40 days after the date of AmeriCorps' submissions to OMB and Congress, whichever is later, and will continue for 18 months after the effective date. It may be extended for an additional 12 months thereafter, if the conditions specified in 5 U.S.C. 552a(o)(2)(D) have been met.
You may submit comments identified by the title of the information collection activity, by any of the following methods.
(1)
(2) By hand delivery or by courier to the AmeriCorps mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.
(3) Electronically through
Comments submitted in response to this notice may be made available to the public through
Terence King, Senior Security Engineer, 202-815-4246, or by email at
The Privacy Act of 1974 (5 U.S.C. 552a), as amended by the Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), regulates the use of computer matching agreements by Federal agencies when records in a system of records are matched with other Federal, State, or local government records. Among other things, it requires Federal agencies involved in computer matching agreements to publish a notice in the
This agreement will be in effect for a period of 18 months, with a provision for a one-time extension for a period not to exceed 12 months. To renew this agreement, both AmeriCorps and SSA must certify to their respective Data Integrity Boards that: (1) the matching program will be conducted without change; and (2) the matching program has been conducted in compliance with the original agreement.
AmeriCorps will provide SSA with a data file including each applicant's and potential education award recipient's social security number, first and last names, and date of birth. SSA will conduct a match on the identifying information. If the match does not return a result verifying the individual's citizenship status, AmeriCorps will contact the individual or the grant recipient program that selected the individual to verify the results in accordance with the requirements of 5 U.S.C. 552a(p) and applicable OMB guidelines. The affected individual will have an opportunity to contest the accuracy of the information provided by SSA. The applicant will have at least 30 days from the date of the notice to provide clear and convincing evidence of the accuracy of the social security number, proof of U.S. citizenship, or both.
Applicants will be informed at the time of application that information provided on the application is subject to verification through a computer matching program. The application package will contain a privacy certification notice that the applicant must sign, authorizing AmeriCorps to verify the information provided.
For transferees of education awards, at the time an award is transferred, AmeriCorps will provide the individual notice that the SSN is subject to verification through a computer matching program. AmeriCorps will send a privacy notice to the transferee, and in the case of a minor, to the parent or legal guardian. The transferee, parent, or legal guardian must sign the privacy certification authorizing AmeriCorps to verify the information provided.
AmeriCorps will furnish a copy of this notice to both Houses of Congress and the Office of Management and Budget.
SSA's legal authority to enter into this agreement is section 1106 of the Social Security Act (42 U.S.C. 1306) and the regulations promulgated pursuant to that section (20 CFR part 401). The authority for SSA's disclosure of record information is 5 U.S.C. 552a(b)(3).
Section 146(a)(3) of the National and Community Service Act of 1990 (NCSA; 42 U.S.C. 12602(a)) sets forth the eligibility requirements for an individual to receive an Education Award from the National Service Trust upon successful completion of a term of service in an approved national service position. Section 1711 of the Serve America Act (Pub. L. 111-13) directs AmeriCorps to enter into a data matching agreement to verify statements made by an individual declaring that such individual is in compliance with section 146(a)(3) of the NCSA by comparing information provided by the individual with information relevant to such a declaration in the possession of another Federal agency. In accordance with the study AmeriCorps completed pursuant to section 1711 of the Serve America Act, AmeriCorps determined that a data matching program with SSA is the most effective means to verify an individual's statement that they are in compliance with section 146(a)(3) of the NCSA.
Department of Defense (DoD).
Notice of rescindment of multiple System of Records Notices (SORNs).
In accordance with the Privacy Act of 1974, the DoD is providing notice to rescind 26 Privacy Act SORNs. A description of these systems can be found in the table in the
The rescindment of these SORNs is effective June 30, 2023.
Ms. Rahwa Keleta, Privacy and Civil Liberties Division, Directorate for Privacy, Civil Liberties and Freedom of Information, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Department of Defense, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-1700,
Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, and as part of its ongoing integration and management efforts, the DoD is removing 26 Privacy Act SORNs from its inventory. Upon review of its inventory, DoD determined it no longer needs or uses these system of records because the records are covered by other SORNs; therefore, DoD is retiring these SORNs (items (a) through (z) in the table) for reasons listed as follows.
Items (a) through (r) in the table are rescinded because the records are now maintained as part of the DoD-wide system of records titled DoD-0008, Freedom of Information Act and Privacy Act Records (FOIA/PA Records), published in the
Items (s) through (w) in the table are rescinded because the records are now maintained as a part of the DoD-wide system of records titled DoD 0006, Military Justice and Civilian Criminal Case Records, published in the
Items (x) through (z) in the table are rescinded because the records are now maintained as a part of the DoD-wide system of records titled DoD-0009, Defense Mass Transportation Benefits Records (DMTBR), published in the
DoD SORNs have been published in the
Under the Privacy Act, a “system of records” is a group of records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined as a U.S. citizen or lawful permanent resident.
In accordance with 5 U.S.C. 552a(r) and Office of Management and Budget (OMB) Circular No. A-108, DoD has provided a report of this SORN bulk rescindment to OMB and Congress.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Interested persons are invited to submit comments on or before July 31, 2023.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Postsecondary Education, U.S. Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda, time, and instructions to access or participate in the August 1-3, 2023, virtual meeting of NACIQI, and provides information to members of the public regarding the meeting, including requesting to make written or oral comments. Committee members will meet in-person while accrediting agency representatives and public attendees will participate virtually.
Department of Education, Barnard Auditorium, 400 Maryland Avenue SW, Washington, DC 20202. Only NACIQI members and Department of Education staff will meet at this address.
The virtual NACIQI meeting will be held on August 1-3, 2023, from 9:00 a.m. to 5:00 p.m. Eastern Time.
George Alan Smith, Executive Director/Designated Federal Official (DFO), NACIQI, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202, telephone: (202) 453-7757, or email:
NACIQI is established under section 114 of the HEA (20 U.S.C. 1011c). NACIQI advises the Secretary of Education with respect to:
• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2, part H, Title IV of the HEA, as amended;
• The recognition of specific accrediting agencies or associations;
• The preparation and publication of the list of nationally recognized accrediting agencies and associations;
• The eligibility and certification process for institutions of higher education under Title IV of the HEA, together with recommendations for improvement in such process;
• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions; and
• Any other advisory functions relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.
The notice of this meeting is required by 5 U.S.C. chapter 10 (Federal Advisory Committees) and section 114(d)(1)(B) of the Higher Education Act of 1965, as amended (HEA).
The purpose of the virtual meeting is to conduct a review of the applications for renewal of recognition and compliance reports listed below and to present and discuss policy-related matters.
1. Association of Advanced Rabbinical and Talmudic Schools, Accreditation Commission.
2. Academy of Nutrition and Dietetics, Accreditation Council for Education in Nutrition and Dietetics.
3. American Optometric Association, Accreditation Council on Optometric Education.
4. Commission on Collegiate Nursing Education.
5. Council on Accreditation of Nurse Anesthesia Educational Programs.
6. Liaison Committee on Medical Education.
7. National Association of Schools of Art and Design, Commission on Accreditation.
8. Northwest Commission on Colleges and Universities.
1. Commission on Massage Therapy Accreditation.
1. The National Defense University. Name Change of degree program from “Master of Science in Government Information Leadership” to “Master of Science in Strategic Information and Cyberspace Studies.”
To ensure sufficient time for all agency reviews, including NACIQI member questions and discussion, the Department requests that agencies limit the total time of their opening statements to 10 minutes, and that agencies avoid extended discussions about their representatives and backgrounds. Following the opening statement, the agency's presentation should focus on regulatory criteria—particularly to responses to areas where the staff has recommended a finding of noncompliance or substantial compliance, or where other concerns have been raised that the agency would like to address. Questions from NACIQI members may focus on other areas.
A representative of the Administration will discuss higher education policy priorities.
The NACIQI Regulations Subcommittee will present recommendations to the Committee for review and consideration for sharing with the Department in advance of the Department's upcoming negotiated rulemaking process.
A member of the Department staff will provide an update on recent changes to the Accreditor Dashboards.
In addition to its review of accrediting agencies for Secretarial recognition, there will be time for Committee discussions regarding any of the categories within NACIQI's statutory authority in its capacity as an advisory committee.
Accrediting agency representatives and members of the public must access or participate in the meeting virtually.
You must register online at
After you register, you will receive a confirmation email containing personalized participation links for each day of the three-day meeting.
Submission of requests to make an oral comment regarding a specific accrediting agency under review, or to make an oral comment or written statement regarding other issues within the scope of NACIQI's authority:
The opportunity to submit a written statement regarding a specific accrediting agency under review was solicited by a previous
Written statements and oral comments concerning NACIQI's work outside of a specific accrediting agency under review must be limited to matters within the scope of NACIQI's authority as outlined under Section 114 of the HEA (20 U.S.C. 1011c). Written statements of any kind submitted after the deadline will not be considered by the Department or provided to NACIQI for purposes of the current cycle of review. Requests to make oral comments that are received outside of the periods noted below will not be accepted.
To request to make oral comments of three minutes or less during the August 1-3, 2023 virtual meeting, please follow Method One or Method Two below. To submit a written statement to NACIQI concerning its work outside of a specific accrediting agency under review, please follow Method One.
Office of Science, Department of Energy.
Notice of open virtual meeting.
This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Thursday, July 27, 2023; 11:00 a.m. to 5:00 p.m.
This meeting is open to the public. This meeting will be held virtually via Zoom. Information to participate can be found on the website closer to the meeting date at
Kerry Hochberger; Office of Basic Energy Sciences; U.S. Department of Energy; Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (301) 903-7661 or Email:
Breaks taken as appropriate.
U.S. Department of Energy.
Notice of Industry Day on Developing Clean Energy Generation on DOE Lands.
The U.S. Department of Energy (DOE) is launching an initiative to increase clean energy production by making DOE land available for the potential development of new clean electricity generation through leases. To support this effort, DOE is hosting an Industry Day. At the Industry Day, Secretary Granholm will present DOE's vision for utilizing DOE land to achieve clean electricity goals and senior leaders will share information on sites potentially available for development. Participants will have the opportunity to ask questions and provide feedback.
The Industry Day will be held on Friday, July 28, 2023, from 10:00 a.m. to 2:30 p.m.
DOE Headquarters, James V. Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585.
Interested participants must register by Wednesday, July 19, 2023 at
Interested participants may also submit questions to
Craig Zamuda, Director of Sustainability Performance Office, Office of Management, U.S. Department of Energy at (202) 586-8645 or
DOE has identified land at several of its sites for potential deployment of onsite clean electricity generation or storage projects. The land is suitable for large scale clean electricity projects (
Through Executive Order (E.O.) 14057,
The E.O. also directs agencies to facilitate new clean electricity generation and energy storage by authorizing the use of their real property assets, including land, for the development of new clean electricity generation and energy storage through leases to the extent permitted by law. As the federal leader on clean-energy research and development and the steward of more than 2 million acres of land, DOE has both a unique opportunity and clear responsibility to lead and identify creative solutions to achieve the president's mandate.
DOE is acting with urgency to significantly increase onsite clean electricity generation by 2030 while ensuring robust protection for our lands, waters, and biodiversity; ensuring site security; elevating stakeholder and especially Tribal benefits where relevant; and creating good jobs.
DOE is holding the Industry Day to share additional information about this initiative and to identify parties with proven experience in implementing successful clean electricity projects generating 200 MW or larger. Such parties must have the capacity and the resources to construct, own and maintain facilities and infrastructure to generate clean electricity.
During the Industry Day, Secretary Granholm will present DOE's vision for utilizing DOE land to achieve clean electricity goals and senior leaders will share information on sites potentially available for development. In addition, policy and technical issues will be discussed including DOE leasing authorities, National Environmental Policy Act (NEPA) requirements, and transmission challenges. Participants will have the opportunity ask questions and provide feedback.
This document of the Department of Energy was signed on June 26, 2023, by Ingrid Kolb, Director, Office of Management, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
U.S. Department of Energy.
Submission for Office of Management and Budget (OMB) review; comment request.
The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension of its Financial Assistance Information Collection, OMB Control Number 1910-0400. This information collection request covers information necessary to administer and manage DOE's financial assistance programs.
Comments regarding this collection must be received on or before July 31, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period allowed by this notice, please advise the OMB Desk Officer of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 881-8585.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Richard Bonnell by email at
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
This document of the Department of Energy was signed on June 22, 2023, by John R. Bashista, Director, Office of Acquisition Management, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Office of Environmental Management, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Monday, July 24, 2023; 1:00 p.m.-4:15 p.m. EDT. Tuesday, July 25, 2023; 9:00 a.m.-4:00 p.m. EDT.
Augusta Technical College—Waynesboro, 216 Highway 24 S, Waynesboro, GA 30830.
The meeting will also be streamed on YouTube, no registration is necessary; links for the livestream can be found on the following website:
Amy Boyette, Office of External Affairs, U.S. Department of Energy (DOE), Savannah River Operations Office, P.O. Box A, Aiken, SC 29802; Phone: (803) 952-6120; or Email:
Take notice that on June 21, 2023, pursuant to sections 210 and 212 of the Federal Power Act,
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission has received the following Natural Gas & Oil Pipeline Rate and Refund Report filings:
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Western Area Power Administration, DOE.
Notice of proposed formula rates for transmission and firm electric service.
The Desert Southwest Region (DSW) of the Western Area Power Administration (WAPA) proposes new formula rates for firm and nonfirm point-to-point (P2P) and network integration (Network) transmission service. DSW also proposes to revise the existing formula rates for Parker-Davis Project (PDP) firm electric service (FES) and firm transmission service of Salt Lake City Area/Integrated Projects (SLCA/IP) power. The proposed new formula rates and revisions to existing formula rates would combine the transmission service rates of the Central Arizona Project (CAP), the southern portion of the Pacific Northwest-Pacific Southwest Intertie Project (Intertie), and PDP; and the facilities use charge for the Electrical District No. 5 to Palo Verde Hub Project (ED5-PVH). DSW's proposed formula rates will be effective January 1, 2024, through September 30, 2028. Publication of this
The consultation and comment period begins June 30, 2023 and will end September 28, 2023.
DSW will present a detailed explanation of the proposed formula rates and other modifications at a public information forum that will be held on August 7, 2023 from 10 a.m. to no later than 12 p.m. Mountain Standard Time (MST), or until the last comment is received. DSW will host a public comment forum that will be held on August 29, 2023, from 10 a.m. to no later than 12 p.m. MST, or until the last comment is received. The public information forum and the public comment forum will be conducted
DSW will accept written comments any time during the consultation and comment period.
Written comments and requests to be informed of Federal Energy Regulatory Commission (FERC) actions concerning the proposed formula rates submitted by WAPA to FERC for approval should be sent to: Jack D. Murray, Regional Manager, Desert Southwest Region, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, or email:
Tina Ramsey, Rates Manager, Desert Southwest Region, Western Area Power Administration, (602) 605-2565 or email:
FERC approved and confirmed the following Rate Schedules under the applicable Rate Orders on a final basis through the dates indicated below:
Rate Schedules
The rates for transmission service on CAP, Intertie, and PDP, and the facilities use charge for ED5-PVH, have substantially converged over the last several years. DSW proposes to combine the rates and charge into “One Transmission Rate” (OTR), which would be applicable to these projects. The OTR would provide benefits to DSW's customers by allowing more efficient scheduling and use of each project's transmission facilities, eliminating multiple charges (rate pancaking) among the transmission systems, and providing rate and financial stability by having a larger revenue requirement and more diverse customer base.
Although the transmission service rates and facilities use charge would be combined under the OTR, the projects will remain separate for financial accounting and repayment purposes. The proposed formula rates under the OTR would provide sufficient revenue to recover annual operation, maintenance, and replacement costs, interest expense, and capital repayment requirements while ensuring repayment of the projects within the cost recovery criteria set forth in Department of Energy (DOE) Order RA 6120.2.
To implement the OTR, DSW is proposing new rate schedules containing formula rates for firm and nonfirm P2P and Network transmission service. These new schedules will supersede the existing rate schedules for CAP, Intertie, and PDP transmission service and replace the contractual charge for the use of ED5-PVH facilities. DSW also proposes to make changes to the existing formula rates for PDP FES and firm transmission service of SLCA/IP power so they align with the new proposed rate schedule for firm P2P transmission service.
DSW's proposed formula rates for firm and nonfirm P2P and Network transmission service under the OTR, along with PDP FES and firm transmission service of SLCA/IP power, would go into effect on January 1, 2024, and remain in effect through September 30, 2028, or until DSW changes the formula rates through another public rate process pursuant to 10 CFR part 903, whichever occurs first. Since Rate Schedules INT-FT5, PD-FT7, INT-NFT4, PD-NFT7, PD-F7, and PD-FCT7 expire on September 30, 2023, DSW has initiated a separate rate action to extend these rate schedules to provide time to complete the public process for the OTR.
DSW proposes a new rate schedule, DSW-FT1, for long-term and short-term firm P2P transmission service on CAP, Intertie, PDP, and ED5-PVH. This new rate schedule will contain formulas to calculate the rates for firm P2P transmission service. For long-term
These long-term and short-term rates will be calculated annually using updated financial and capacity reservation information, as applicable. This new rate schedule will supersede Rate Schedules CAP-FT3, INT-FT5, and PD-FT7.
DSW proposes a new rate schedule, DSW-NFT1, for nonfirm P2P transmission service on CAP, Intertie, PDP, and ED5-PVH. This new rate schedule will contain a formula to calculate the rate for nonfirm P2P transmission service. The nonfirm rate will be calculated by dividing the annual long-term rate for firm P2P transmission service by 8,760 hours and rounding to five decimal places. The rate will be calculated annually using updated information, as applicable. This new rate schedule will supersede Rate Schedules CAP-NFT3, INT-NFT4, and PD-NFT7.
DSW proposes a new rate schedule, DSW-NTS1, for Network transmission service on CAP, Intertie, PDP, and ED5-PVH. This new rate schedule will contain a formula to calculate the monthly charge for Network transmission service. The monthly charge will be determined by multiplying the customer's load ratio share, the ratio of the customer's network load to the transmission provider's total load, times one twelfth (
DSW proposes to revise Rate Schedule PD-F7 so the transmission charge aligns with the proposed new rate schedule, DSW-FT1, for long-term and short-term firm P2P transmission service on CAP, Intertie, PDP, and ED5-PVH. No changes are being proposed to the energy or capacity charges. DSW also proposes to make other minor changes to Rate Schedule PD-F7. Specifically, the rate schedule will be modified to indicate that recently approved Rate Schedule DSW-UU1
DSW proposes to revise Rate Schedule PD-FCT7 to align with the proposed new rate schedule, DSW-FT1, for long-term and short-term firm P2P transmission service on CAP, Intertie, PDP, and ED5-PVH. DSW also proposes to make minor changes to sections of Rate Schedule PD-FCT7 addressing adjustment for losses and overrun of capacity. Specifically, the new rate schedule will be modified to reflect that recently approved Rate Schedules DSW-TL1 and DSW-UU1
The table below provides a crosswalk from the existing rate schedules to the proposed rate schedules.
DSW proposes long-term firm P2P and Network transmission service under Rate Schedules DSW-FT1 and DSW-NTS1 be prepaid one month in advance and credited in a subsequent month. The Intertie and PDP long-term firm P2P transmission customers currently prepay for service and will experience no change. As discussed below, CAP long-term firm P2P and PDP Network transmission customers and ED5-PVH facilities use customers will start prepaying for service when the rate schedules become effective.
The monthly prepayment for long-term firm P2P transmission service will be based on the capacity reserved. The monthly prepayment for Network transmission service will be based on the most recent bill. Since transmission customers that currently do not prepay for service will have two payments each month during the first two months, one for service in arrears and one for prepayment, DSW proposes an optional four-month transitional period to phase in prepayments. With a transitional period, the two additional payments that are necessary during the first two months will be evenly distributed over the first four months to help mitigate the potential financial burden on customers.
Existing DOE procedures for public participation in power and transmission rate adjustments (10 CFR part 903) were published on September 18, 1985, and February 21, 2019.
WAPA is establishing the formula rates for transmission and firm electric service in accordance with section 302 of the DOE Organization Act (42 U.S.C. 7152).
By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to WAPA's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place
All brochures, studies, comments, letters, memorandums, or other documents that DSW initiates or uses to develop the proposed formula rates are available on WAPA's website at
WAPA is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
This document of the Department of Energy was signed on June 5, 2023, by Tracey A. LeBeau, Administrator, Western Area Power Administration, pursuant to delegated authority from the Secretary of Energy. That document, with the original signature and date, is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Consolidated Pesticide Registration Submission Portal, (EPA ICR Number 2624.01 and OMB Control Number 2070-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Comments must be received on or before July 31, 2023.
Submit your comments, referencing Docket ID Number EPA-HQ-OPP-2020-0273, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Carolyn Siu, Office of Program Support (7602M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-1205; email address:
This is a request for approval of a new collection. 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.
Public comments were previously requested via the
The new ICR covers the EPA pesticide registration collection activities supporting the statutorily mandated pesticide registration program under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including the activities associated with pesticide registration; pesticide use; pesticide sale and distribution; pesticide permitting
The total combined cost burden from these eight previously approved ICRs was $170,250,338. The total cost burden requested for this ICR is $183,157,210—a increase of $12,906,872. The difference between the current cost burden request and the previously approved requests is due only to adjustments in EPA's estimates of the wage rates and material costs that were revised to reflect 2022 dollars for this ICR.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Significant New Alternatives Policy (SNAP) Program (EPA ICR Number 1596.11, OMB Control Number 2060-0226) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through August 31, 2023. Public comments were previously requested via the
Comments may be submitted on or before July 31, 2023.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2004-0077, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Christina Thompson, Stratospheric Protection Division, Office of Atmospheric Protection, (Mail Code 6205A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-0983; email address:
This is a proposed extension of the ICR, which is currently approved through August 31, 2023. 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. Public comments were previously requested via the
Responses to the collection of information are mandatory under section 612 for anyone who sells or, in certain cases, uses substitutes for an
Any substitute which is a new chemical must also be submitted to the Agency under the New Chemicals (Premanufacture Notice) program under the Toxic Substances Control Act (TSCA). Furthermore, alternatives that will be used as sterilants must be filed jointly with EPA's Office of Pesticide Programs and with SNAP.
There is an estimated 20% reduction in the number of respondents responsible for recordkeeping for substitutes acceptable subject to use conditions and narrowed use limits. This reduction is expected because the increased availability of alternatives decreases the need for industry to use alternatives previously listed as acceptable subject to narrowed use limits.
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for VOC Emissions from Petroleum Refinery Wastewater Systems (EPA ICR Number 1136.14, OMB Control Number 2060-0172) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through August 31, 2023. Public comments were previously requested via the
Comments may be submitted on or before July 31, 2023.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2022-0068, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of
This is a proposed extension of the ICR, which is currently approved through April 30, 2023. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displayed a currently valid OMB control number.
Public comments were previously requested via the
In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), “Importation of On-highway Vehicles and Motorcycles and Nonroad Engines, Vehicles, and Equipment” (EPA ICR Number 2583.03, OMB Control Number 2060-0717) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through June 30, 2023. Public comments were previously requested via the
Additional comments may be submitted on or before July 31, 2023.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2016-0094, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Holly Pugliese, Compliance Division, Office of Transportation and Air Quality, Environmental Protection Agency, 2000 Traverwood, Ann Arbor, Michigan, 48105; telephone number: 734-214-4288; fax number: 734-214-4869; email address:
This is a proposed extension of the ICR, which is currently approved through June 30, 2023. 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.
Public comments were previously requested via the
In addition, this ICR covers the burden of EPA Form 3520-8 which EPA makes available upon request and is used by Independent Commercial Importers (ICIs), who bring on-highway vehicles into compliance and provide emissions test results, to request final importation clearance for their on-highway vehicles.
Since 2016, CBP has been using the Automated Commercial Environment (ACE) to facilitate the electronic filing of imports documents rather than collecting paper. ACE has become the primary system through which the trade community and other importers report imports and exports. Through ACE as the single point of submission, manual processes have been streamlined and automated, and paper submissions (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Chemical Data Reporting under the Toxic Substances Control Act (TSCA) (EPA ICR Number 1884.15; OMB Control Number 2070-0162), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through June 30, 2023. Public comments were previously requested via the
Additional comments may be submitted on or before July 31, 2023.
Submit your comments, referencing Docket ID Number EPA-HQ-OPPT-2013-0721 to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Katherine Sleasman, Regulatory Support Branch (7602M), Office of Chemical
This is a proposed extension of the ICR which is currently approved through June 30, 2023. 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.
Public comments were previously requested via the
The CDR collection is on a four-year reporting cycle and contains detailed manufacturing, processing, and use information drawn from the principal reporting year; the rule also contains basic information on production volume, by year, for the three years prior to the principal reporting. Individual sites manufacturing (including importing) chemical substances will submit the required information. The information will be stored electronically for reference by EPA staff and others. Within the constraints of confidentiality claims, the information will be made public through the Agency's website:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Environmental Education Local Grants Progress Report Form (EPA ICR Number 2731.01, OMB Control Number 2090-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Comments may be submitted on or before July 31, 2023.
Submit your comments to EPA, referencing Docket ID No. EPA- HQ-AO-2022-0729, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Michael Band, Office of Environmental Education, (1704A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-3155; email address:
This is a request for approval of a new collection. 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.
Public comments were previously requested via the
10:00 a.m., Thursday, July 13, 2023.
You may observe the open portions of this meeting in person at 1501 Farm Credit Drive, McLean, Virginia 22102-5090, or virtually. If you would like to observe, at least 24 hours in advance, visit
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
The following matters will be considered:
If you need more information or assistance for accessibility reasons, or have questions, contact Ashley Waldron, Secretary to the Board. Telephone: 703-883-4009. TTY: 703-883-4056.
Federal Communications Commission.
Notice of a modified system of records.
The Federal Communications Commission (FCC, Commission, or Agency) has modified an existing system of records, FCC/EB-5, Enforcement Bureau Activity Tracking System (EBATS), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the
This action will become effective on June 30, 2023. The routine uses in this action will become effective on July 31, 2023 unless comments are received that require a contrary determination.
Send comments to Katherine C. Clark, Attorney-Advisor,
Katherine C. Clark, (202) 418-1773 or
This notice serves to update and modify FCC/EB-5, as a result of various necessary changes and updates. The substantive changes and modifications to the previously published version of the FCC/EB-5 system of records include:
1. Updating the language in the Security Classification to follow OMB guidance;
2. Updating the System Location to note that records are maintained primarily at FCC Headquarters in Washington, DC, and only on an
3. Updating the language in the Purposes section to be consistent with the language and phrasing currently used generally in the FCC's SORNs and to include maintaining documents and tracking the status of formal complaints, including, but not limited to those that involve market disputes as an additional purpose for the system;
4. Modifying the language in the Categories of Individuals and Categories of Records to be consistent with the language and phrasing currently used in the FCC's SORNs;
5. Updating and/or revising language in seven routine uses (listed by current routine use number): (1) Public Access; (3) FCC Enforcement Actions; (4/5) Adjudication and Litigation (now two separate routine uses); (6) Law Enforcement and Investigation; (7) Congressional Inquiries; (8) Government-wide Program Management and Oversight; and (9) Breach Notification, the revision of which is as required by OMB Memorandum No. M-17-12;
6. Deleting the following routine uses (listed by former routine use number): (2) Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by the Agency; and (3) Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by an Entity other than the Agency;
7. Adding two new routine uses (listed by current routine use number): (10) Assistance to Federal Agencies and Entities Related to Breaches, which is required by OMB Memorandum No. M-17-12; and (11) Non-Federal Personnel to allow contractors, grantees, or volunteers performing or working on a contract, grant, or cooperative agreement for the Federal Government to have access to needed information;
8. Updating the existing records retention and disposal schedule with a new records schedule, Records Disposition Authority, DAA-0173-2014-0002, which was approved by NARA in September 2015;
9. Updating the reference to the exemptions claimed under subsection (k) of the Privacy Act; and
10. Updating the notice to reflect various administrative changes related to the system managers and system addresses; policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and contesting records procedures.
FCC/EB-5, Enforcement Bureau Activity Tracking System (EBATS).
No information in the system is classified.
Enforcement Bureau (EB), FCC, 45 L Street NE, Washington, DC 20554; and FCC Field Offices that may maintain paper documents on an
Enforcement Bureau (EB), FCC, 45 L Street NE, Washington, DC 20554.
47 U.S.C. 101, 102, 104, 301, 303, 309(e), 312, 315, 318, 362, 364, 386, 501, 502, 503, 507, and 510.
The Enforcement Bureau uses the information in this system for purposes that include, but are not limited to:
1. Maintaining documents and tracking the status of enforcement investigations of entities (including individuals) that have been identified as possible violators of the Communications Act of 1934, as amended, FCC regulations, other FCC requirements or orders, other statutes and regulations subject to the FCC's jurisdiction, and/or international treaties (collectively referred to hereafter as FCC Rules and Regulations);
2. Maintaining documents and tracking the status of formal complaints, including, but not limited to those that involve market disputes;
3. Determining the levels of compliance among FCC licensees and other regulatees;
4. Documenting the Commission's monitoring, overseeing, auditing, inspecting, and investigating for compliance and enforcement purposes;
5. Providing a basis for the various administrative and civil or criminal actions against violators by EB, other appropriate Commission bureaus or offices, and/or other government agencies;
6. Gathering background information for reference materials from various external sources that include, but are not limited to, databases, documents, files, and other related resources, to ensure that the information that is being compiled is accurate and up-to-date (cross-checking) in the course of investigating consumer complaints and/or enforcement investigations;
7. Maintaining archival information (paper documents and files) for reference in enforcement investigations and other actions; and
8. Preventing duplication of FCC's enforcement actions,
The records in this system include, but are not limited to:
1. Individuals, including FCC employees, who have filed complaints alleging violations of FCC Rules and Regulations; or individuals who have filed such complaints on behalf of other entities and who may have included their personally identifiable information (PII) in the complaint;
2. Individuals who are or have been the subjects of FCC enforcement actions, including field monitoring, inspection, and investigation, for possible violations of FCC Rules and Regulations;
3. Licensees, applicants, regulatees, and unlicensed individuals about whom there are questions of compliance with FCC Rules and Regulations; and
4. FCC employees, contractors, and interns who perform work on behalf of EB.
The categories of records in this system include, but are not limited to:
1. Information that is associated with those individuals who file complaints or who are being investigated for possible enforcement actions. The information may include:
(a) An individual's name, Social Security Number (SSN) or Taxpayer Identification Number (TIN), gender,
(b) Inspection reports, audit reports, complaints, referrals, monitoring reports, inspection cases, referral memos, correspondence, audio and sound recordings, photographs, discrepancy notifications, warning notices, forfeiture actions, and other related materials.
(c) Miscellaneous materials, documents, files, and records that are used for background information and data verification concerning individuals who may have been alleged to or have violated the Commission's Rules and Regulations.
2. Information that is associated with the same or similar current enforcement investigations and historic records and other archival, background, and research data and materials that are stored for reference in enforcement actions, including inspection reports, complaints, monitoring reports, investigative cases, referral memos, correspondence, discrepancy notifications, warning notices, and forfeiture actions; and
3. Other, miscellaneous information that complainants may have included on informal consumer complaint forms, interference reports, as well as any additional FCC forms and complaint data intake systems that may be used from time to time to report possible violations of FCC Rules and Regulations to the FCC or associated with case files.
Sources of records include individuals submitting complaints, relevant law enforcement databases, publicly available electronic information and data, and individuals who have been contacted during investigations to be sources of information.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside the FCC as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows.
1. Public Access—Names and other information about individuals subject to investigations or similar actions may be disclosed to the public in Commission releases, including Notices of Apparent Liability, Forfeiture Orders, Consent Agreements, Notice Letters, or all other actions released by EB or the Commission as part of their duties to enforce FCC Rules and Regulations.
2. Due Diligence Inquiries—Where there is an indication of a violation or potential violation of FCC Rules and Regulations, records from this system may be shared with a requesting individual, or representative thereof, for purposes of obtaining such information so long as the information is relevant to a pending transaction of an FCC-issued license.
3. FCC Enforcement Actions—When a record in this system involves an informal complaint filed alleging a violation of FCC Rules and Regulations by an applicant, licensee, certified or regulated entity, or an unlicensed person or entity, the complaint may be provided to the alleged violator for a response. Where a complainant in filing his or her complaint explicitly requests confidentiality of his or her name from public disclosure, the Commission will endeavor to protect such information from public disclosure. Complaints that contain requests for confidentiality may be dismissed if the Commission determines that the request impedes the Commission's ability to investigate and/or resolve the complaint.
4. Litigation—To disclose records to the Department of Justice (DOJ) when: (a) the FCC or any component thereof; (b) any employee of the FCC in his or her official capacity; (c) any employee of the FCC in his or her individual capacity where the DOJ or the FCC has agreed to represent the employee; or (d) the United States Government is a party to litigation or has an interest in such litigation, and by careful review, the FCC determines that the records are both relevant and necessary to the litigation, and the use of such records by the Department of Justice is for a purpose that is compatible with the purpose for which the FCC collected the records.
5. Adjudication—To disclose records in a proceeding before a court or adjudicative body, when: (a) the FCC or any component thereof; or (b) any employee of the FCC in his or her official capacity; or (c) any employee of the FCC in his or her individual capacity; or (d) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the FCC determines that the records are both relevant and necessary to the litigation, and that the use of such records is for a purpose that is compatible with the purpose for which the agency collected the records.
6. Law Enforcement and Investigation—When the FCC investigates any violation or potential violation of a civil or criminal law, regulation, policy, executed consent decree, order, or any other type of compulsory obligation, to disclose pertinent information as it deems necessary to the target of an investigation, as well as with the appropriate Federal, State, local, Tribal agency, or a component of such an agency, responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order.
7. Congressional Inquiries—To provide information to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the written request of that individual.
8. Government-wide Program Management and Oversight—To the Department of Justice (DOJ) to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or the Office of Management and Budget (OMB) to obtain that office's advice regarding obligations under the Privacy Act.
9. Breach Notification—To appropriate agencies, entities, and persons when: (a) the Commission suspects or has confirmed that there has been a breach of the system of records; (b) the Commission has determined that as a result of the suspected or confirmed compromise there is a risk of harm to individuals, the Commission (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 Commission's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
10. Assistance to Federal Agencies and Entities Related to Breaches—To another Federal agency or Federal entity, when the Commission determines that information from this system is reasonably necessary to assist the recipient agency or entity in: (a) responding to a suspected or confirmed
11. Non-Federal Personnel—To disclose information to non-Federal personnel, including contractors, other vendors (
Information in this information system consists of:
1. Electronic records, files, and data are stored in the FCC's computer network databases, at headquarters; and
2. Paper records, documents, and files are stored in filing cabinets in the EB office suites at headquarters and in field offices (on an
1. Information in the electronic database information can be retrieved by the name(s) of the individual(s) who filed the complaint(s), the individual who is subject of the complaint, and by a unique file number assigned to each type of activity conducted by the Bureau,
2. Information in the central files, which includes, but is not limited to, paper documents, records, and files, includes all the other information pertaining to these internal initiative investigations, complainant investigations, and/or cases. This information may include, but is not limited to, name, address, and telephone number, and is maintained for reference and archival purposes. This information is retrieved by a unique identification file number assigned to each internal initiative investigation, complainant investigation, and/or case.
The information in this electronic system is maintained and disposed of in accordance with the National Archives and Records Administration (NARA) General Records Schedule No. DAA-0173-2014-0002-0002.
The electronic records, data, and files are maintained in the FCC computer network databases at headquarters, which are protected by the FCC's IT privacy safeguards, a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal IT privacy standards, including those required by the National Institute of Standard and Technology (NIST) and the Federal Information Security Modernization Act of 2014 (FISMA). The paper documents and files are maintained in file cabinets in “non-public” rooms in the EB office suite at headquarters and in field offices. The file cabinets are locked at the end of the business day. Access to the EB offices at both headquarters and field offices is via a key and card-coded door.
Authorized EB supervisors and staff have access to the information in both the electronic files databases and paper document files, and IT contractors, who maintain these electronic files databases, also have access to them. Other FCC employees, interns, and contractors may be granted access to the information in the electronic and paper formats only on a “need-to-know” basis.
Under the authority granted to heads of agencies by 5 U.S.C. 552a(k), the FCC has determined that this system of records is exempt from providing record access procedures for this system of records, 47 CFR 0.561.
Under the authority granted to heads of agencies by 5 U.S.C. 552a(k), the FCC has determined that this system of records is exempt from providing contesting record procedures for this system of records, 47 CFR 0.561.
Under the authority granted to heads of agencies by 5 U.S.C. 552a(k), the FCC has determined that this system of records is exempt from providing notification procedures for this system of records. 47 CFR 0.561.
This system of records is exempt from sections (c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f) of the Privacy Act of 1974, and from 47 CFR 0.554-0.557 of the Commission's rules. These provisions concern the notification, record access, and contesting procedures described above, and also the publication of record sources. The system is exempt from these provisions because it contains investigative material compiled for law enforcement purposes as defined in Section (k) of the Privacy Act.
(75 FR 77872) (December 14, 2010).
Tuesday, July 11, 2023 at 10:30 a.m. and its continuation at the conclusion of the open meeting on July 13, 2023.
1050 First Street NE, Washington, DC and Virtual.
(This meeting will be a hybrid meeting.)
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Department of Defense (DOD), General Services Administration (GSA),
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on a revision concerning Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment. DoD, GSA, and NASA invite comments on: whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through November 30, 2023. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD, GSA, and NASA will consider all comments received by August 29, 2023.
DoD, GSA, and NASA invite interested persons to submit comments on this collection through
Malissa Jones, Procurement Analyst, at telephone 571-882-4687, or
9000-0199, Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment.
DoD, GSA, and NASA are combining OMB Control Nos. for the Federal Acquisition Regulation (FAR) by FAR part. This consolidation is expected to improve industry's ability to easily and efficiently identify burdens associated with a given FAR part. The review of the information collections by FAR part allows improved oversight to ensure there is no redundant or unaccounted for burden placed on industry. Lastly, combining information collections in a given FAR part is also expected to reduce the administrative burden associated with processing multiple information collections.
This justification supports the revision of OMB Control No. 9000-0199 and combines it with the previously approved information collections under OMB Control No(s). 9000-0201, with the title “Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment”. Upon approval of this consolidated information collection, OMB Control No(s). 9000-0201 will be discontinued. The burden requirements previously approved under the discontinued number(s) will be covered under OMB Control No. 9000-0199.
This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements listed in the order in which offerors and contractors provide the information:
•
○ Review the list of excluded parties in SAM for entities excluded from receiving Federal awards for “covered telecommunications equipment or services”.
○ Represent whether it does or does not
○ Represents whether it does, or does not
•
If the offeror is required to respond to this provision, offerors are required to:
○ Review the list of excluded parties in SAM for entities excluded from receiving Federal awards for “covered telecommunications equipment or services,”
○ Represent whether it “will” or “will not”
If the offeror responded that it “will” in the representation in paragraph (d)(1) of this provision, the offeror must provide the following additional disclosure information found at 52.204-24
• For covered equipment—
○ The entity that produced the covered telecommunications equipment (including entity name, unique entity identifier, Commercial and Government Entity (CAGE) code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);
○ A description of all covered telecommunications equipment offered (including brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and
○ An explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of the provision at 52.204-24.
• For covered services—
○ If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part
○ If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and an explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of the provision at 52.204-24.
○ Represent whether it “does” or “does not”
If the offeror has responded “does” in the representation in paragraph (d)(2) of this provision, the offeror must provide the following additional disclosure information found at 52.204-24
• For covered equipment—
○ The entity that produced the covered telecommunications equipment (including entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);
○ A description of all covered telecommunications equipment offered (including brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and
○ An explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of the provision at 52.204-24.
• For covered services—
○ If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or
○ If not associated with maintenance, the PSC of the service being provided; and an explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of the provision at 52.204-24.
•
○ Report the information in paragraph 52.204-25(d)(2) to the contracting officer, unless the contract has established other procedures for reporting the information; in the case of DoD, the contractor shall report to the website at
○ For indefinite delivery contracts, the contractor shall report to the contracting officer for the indefinite delivery contract and the contracting officer(s) for any affected order or, in the case of DoD, identify both the indefinite delivery contract and any affected orders in the report provided at
○ Report the following within one business day from the date of such identification or notification:
The contract number;
The order number(s), if applicable;
Supplier name;
Supplier unique entity identifier (if known);
Supplier CAGE code (if known);
Brand;
Model number (original equipment manufacturer number, manufacturer part number, or wholesaler number);
Item description;
And any readily available information about mitigation actions undertaken or recommended.
○ Report the following within 10 business days of submitting the information in paragraph(d)(2)(i) of this clause:
Any further available information about mitigation actions undertaken or recommended.
Describe efforts undertaken to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.
The information collected is used by contracting officers to identify if an offeror
Office of Head Start; Administration for Children and Families; Department of Health and Human Services.
Request for public comments.
The Office of Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, requests public comment on an extension with changes to recordkeeping requirements for ACF Head Start grant recipients. A Final Rule published on January 6, 2023, added a recordkeeping requirement that Head Start grant recipients update their program policies and procedures to include an evidence-based COVID-19 mitigation policy. OHS requested and received emergency approval from OMB to implement the updated recordkeeping requirement as required in the Final Rule. Approval was for 6 months. Subsequently, a final rule was published on June 26, 2023, which removed all previously approved vaccination recordkeeping requirements and the requirement to maintain a testing protocol. This request is to remove these requirements from the information collection and extend approval of the remaining recordkeeping requirement under this OMB number for an additional 3 years.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Office of Child Support Services, Administration for Children and Families, Department of Health and Human Services.
Notice of an information collection; request for public comments.
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Multistate Financial Institution (MSFIDM) Data Match with Federally Assisted State Transmitted (FAST) Levy, without changes, for an additional three years. The current OMB approval (OMB No.: 0970-0169) expires January 31, 2024.
You can obtain copies of the proposed collection of information and submit comments by emailing
OCSS also operates FAST Levy, which is an automated application within the FPLS to exchange electronic lien/levy information securely and efficiently. State child support agencies and financial institutions use FAST Levy to exchange information to freeze and seize financial assets more quickly and efficiently.
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the “National SHIP-SMP Beneficiary Survey of Group Outreach and Education Events.”
Comments on the collection of information must be submitted electronically by 11:59 p.m. (EST) or postmarked by July 31, 2023.
Submit written comments and recommendations for the proposed information collection within 30 days of publication of this notice to
Shefy Simon, Administration for Community Living, Washington, DC 20201, 202-795-7572,
In compliance with the Paperwork Reduction Act, ACL has submitted the following proposed information collection to OMB for review and clearance. The SHIP-SMP Survey of Group Outreach and Education Events is a survey of individuals who attend outreach and education events provided by the State Health Insurance Assistance Program (SHIP) or Senior Medicare Patrol (SMP). These events help Medicare beneficiaries understand their Medicare benefits and options. These events also increase the ability of beneficiaries to identify fraud, waste, and abuse within health care programs generally, and Medicare/Medicaid specifically. The State Health Insurance Assistance Program (SHIP) was created under the Omnibus Budget Reconciliation Act of 1990.
This section of the law authorized the Department of Health and Human Services (HHS) to make grants to states to establish and maintain health insurance advisory service programs for Medicare beneficiaries. Grant funds were made available to support information, counseling, and assistance activities related to Medicare, Medicaid, and other health insurance options.
The Senior Medicare Patrol (SMP) program was authorized in 1997 under Titles II and IV of the Older Americans Act, the Omnibus Consolidated Appropriation Act of 1997 and the Health Insurance Portability and Accountability Act of 1996. The SMP mission is to empower and assist Medicare beneficiaries, their families, and caregivers, to prevent, detect, and report suspected healthcare fraud, errors, and abuse through outreach, counseling, and education. SMP grantees support ACL's goals of promoting increased choice and greater independence among older adults and individuals with disabilities. SMP activities enhance the financial, emotional, physical, and mental well-being of older adults, thereby increasing their capacity to maintain security in retirement and make better financial and healthcare choices. SHIP-SMP grantees provide group outreach and education through presentation events, and this collection will survey the attendees of those events.
The SHIP-SMP Survey of Group Outreach and Education Events will focus on group outreach and education events and the individuals who attend them, to determine if the target audience is satisfied with the information they are receiving. This is an extension with change to the Senior Medicare Program National Beneficiary Survey.
The Office of Healthcare Information and Counseling (OHIC) conducted an evaluation of the Medicare Improvements for Patients and Providers Act (MIPPA) in 2022-23 that invoked the need to include collecting demographic data, including sexual orientation and gender identity (SOGI) information, in all the work OHIC touches and not just MIPPA grant work. ACL is adding the collection of SOGI data to this extension of the SHIP-SMP Survey of Group Outreach and Education Events. Including sexual orientation and gender identity questions in this information collection will provide data on topics such as the accessibility and utilization of services and programs funded by ACL by lesbian, gay, bisexual, and transgender populations and the health disparities that impact this community. Understanding these disparities can and should lead to improved service delivery for ACL's programs and populations served.
An important gap in sociodemographic information on the SHIP-SMP Survey of Group Outreach and Education Events is a lack of items collecting sexual orientation and gender identity. Adding sexual orientation and gender identity items to SHIP-SMP Survey of Group Outreach and Education Events is part of ACL's strategy to address “Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity and Sexual Orientation.” Issued in January 2021, Executive Order 13988 called upon agencies to identify existing and new policies to promote equal treatment under the law and ensure that all persons are able to access healthcare and other essential services without being subjected to sex discrimination.
To support alignment with Executive Order 13988, as well as Executive Orders 13985 and 14075, three items will be added to SHIP-SMP Survey of Group Outreach and Education Events to collect sexual orientation and gender identity. The first item will ask the individual if they think of themselves as gay/lesbian, straight, bisexual, or something else.
This item has been fielded on the NHIS since 2013, where it has been closely monitored for comprehension and sensitivity. The second and third items are part of a two-step series to collect gender identity, which requires two items to accurately collect. Respondents are first asked to report
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by August 29, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection helps support implementation of FDA's Voluntary National Retail Food Regulatory Program Standards (the Retail Program Standards). Regulatory Program Standards play a critical role in an integrated food safety system and serve as the foundation for mutual reliance between FDA and other regulatory agencies that work to ensure food safety. The Retail Program Standards define what constitutes a highly effective and responsive program for the regulation of foodservice and retail food establishments. The Retail Program Standards are intended to provide a foundation upon which continuous improvements can be made with the ultimate goal to reduce the occurrence of factors that cause and contribute to foodborne illness. In support of this goal, FDA works cooperatively with our State, local, Territorial, and Tribal partners using a risk-based approach to leverage limited resources. We engage in education and outreach efforts to facilitate collaboration with our partners in food safety. The Retail Program Standards represent an important component of a comprehensive strategic approach to help ensure the safety and security of the food supply at the retail level. Respondents to the information collection are State, local, territorial, and tribal governments.
The Retail Program Standards were revised most recently in August 2022 and include the following elements: (1) regulatory foundation; (2) trained regulatory staff; (3) inspection program based on Hazard Analysis and Critical Control Point (HACCP) principles; (4) uniform inspection program, (5) foodborne illness and food defense preparedness and response; (6) compliance and enforcement; (7) industry and community relations; (8) program support and resources; and (9) program assessment. These elements are enumerated and discussed on our website at
Finally, we are revising the information collection to include additional Agency resources. We have created a dedicated emailbox at
• Proposed Form FDA 5017, “Standardized Retail Food Safety Inspection Officer Waiver of Annual Maintenance Requirement Form,” pertains to requests for waivers from maintenance requirements, referenced in section 3-403 of the “FDA Procedures for Standardization of Retail Food Safety Inspection Officers.” FDA uses the information submitted on Form FDA 5017 to determine a food safety inspection officer's eligibility for re-standardization.
• Proposed Form FDA 5018, “Standardized Retail Food Safety Inspection Officer Annual Maintenance Form,” provides verification that a food safety inspection officer has met program standardization requirements in accordance with section 3-403 of the “FDA Procedures for Standardization of Retail Food Safety Inspection Officers.”
• Proposed Form FDA 5019, “Standardized Food Safety Inspection Officer Nomination Form,” allows FDA to collect qualification information from food safety inspection officer candidates.
We estimate the burden of this collection of information as follows:
Our estimate of burden for the associated program activities as identified in table 1 is based on our experience with the information collection, along with other regulatory standards programs we administer. Upon reorganizing the collection to reflect the cumulative activities, we have accounted for burden that may be attributable recordkeeping for risk-factor studies and verification tasks that may have been previously overlooked. The burden we attribute to completing and submitting FDA Form 3958, “Voluntary National Retail Food Regulatory Program Standards FDA National Registry Report,” is exclusive of other program records, which we account for in row 4. We have also accounted for burden we assume will be attendant to the completion and submission of newly developed Agency forms. As a result of these changes and adjustments, the information collection reflects an increase of 235,776.5 hours and 1,654 responses annually.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance addresses FDA's current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP. This guidance finalizes the draft guidance of the same title issued on December 10, 2021.
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 the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Rekha Jhamnani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3395, Silver Spring, MD 20993-0002, 301-796-5636; or Diane Maloney, 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 “Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.” The guidance provides recommendations for sponsors developing products for the treatment of CRSwNP. Specifically, this guidance represents FDA's current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP. This guidance does not address the clinical development of drugs for the treatment
This guidance finalizes the draft guidance of the same title issued on December 10, 2021 (86 FR 70505). FDA considered comments received on the draft guidance in this finalized guidance. Chronic rhinosinusitis is characterized by inflammation of the nasal mucosa and paranasal sinuses and can be further divided into chronic rhinosinusitis with and without nasal polyps. Nasal polyps are inflammatory hyperplastic growths that protrude into the nasal passages. Symptoms of CRSwNP include nasal congestion, nasal discharge, facial pain or pressure, and loss of smell. Nasal polyps have associated morbidity that can have substantial impact on day-to-day functioning. Because of differences in natural history and treatment between chronic rhinosinusitis with and without nasal polyps, this guidance specifically addresses aspects of trial design, safety and efficacy assessment for CRSwNP. Changes from the draft to the final guidance include considerations for efficacy assessments for CRSwNP.
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 “Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information contained in 21 CFR part 312 relating to investigational new drug applications have been approved under OMB control number 0910-0014. The collections of information in 21 CFR part 314 relating to new drug applications have been approved under OMB control number 0910-0001. The collections of information contained in 21 CFR part 601 relating to biologics license applications have been approved under OMB control number 0910-0338.
Persons with access to the internet may obtain the guidance at
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before August 29, 2023.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference, to Sherrette A. Funn, email:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Office of the Assistant Secretary for Health (OASH), Office of the Secretary, Department of Health and Human Services (HHS).
Notice of request for information.
The Department of Health and Human Services (HHS or Department) is issuing this request for information (RFI) to receive input from the public on the Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation to guide the Department's efforts to sustain and strengthen existing programs and drive further progress toward smoking cessation, with an emphasis on serving populations and communities disproportionately impacted by smoking-related morbidity and mortality.
To be assured consideration, comments must be received at the email address provided below, no later than midnight Eastern Time (ET) on July 30, 2023. HHS will not reply individually to responders but will consider all comments submitted by the deadline. Please do not provide confidential information as comments may be published or otherwise used for agency purposes.
Please submit all comments via email to
Please submit questions for further information to Sarah Boateng, Principal Deputy Assistant Secretary for Health. Email:
The mission of HHS is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.
On February 22, 2022, President Joe Biden and First Lady Jill Biden reignited the Cancer Moonshot, setting an ambitious, achievable goal: to reduce the death rate from cancer by at least 50 percent over the next 25 years and improve the experience of people and families living with and surviving cancer, ultimately ending cancer as we know it. Additionally, on January 20, 2021, President Biden signed Executive Order 13985,
To support the executive order initiatives, and to pursue the Administration's priorities for advancing health equity and driving down cancer deaths, the Office of the Assistant Secretary for Health (OASH) is leading the development of a framework to support and accelerate smoking cessation. The Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation (the Framework) will provide direction to enhance collaboration and coordination across HHS, and with Federal and non-Federal stakeholders, drive further progress toward smoking cessation and delivering equitable outcomes for all persons in America. The draft Framework was developed with valued input from subject matter experts across HHS Operating Divisions. The Framework aims to accelerate smoking cessation and reduce smoking-related health disparities by building on current activities and collaborations across the Department, including work guided by the HHS Tobacco Control Strategic Action Plan developed in 2010.
The scope is focused on cessation of the use of commercial cigarettes, cigars, and cigarillos, for people of all ages across the lifespan. The Department also recognizes the importance of tobacco use prevention and cessation of other tobacco products. These issues as well as those related to e-cigarettes are topics that are out of scope for this phase but will be addressed in a later phase of this effort.
The purpose of this request for information (RFI) is to seek public comment on the Draft 2023 Framework to Support and Accelerate Smoking Cessation. Please see the Draft Framework below, followed by an RFI in the form of questions to the public.
Cigarette smoking is the leading cause of preventable disease, disability, and death in the United States, including about 30% of all cancer deaths. Enormous progress has been made over the last 60 years in driving down rates of cigarette smoking. In 2021, 11.5% of U.S. adults smoked cigarettes, down from an all-time high of 42%, and two-thirds (66.5%) of all adults who ever smoked cigarettes have quit. Despite this progress, cigarette smoking still claims approximately 480,000 American lives every year.
Furthermore, the gains that have been made over the past several decades have not occurred equally across the population, leaving behind many of those who have the least resources and who face the greatest barriers to quitting. Encouraging and assisting every person in America to quit smoking is critical to ensuring a healthier future for all people in America and to helping achieve the Cancer Moonshot goal of reducing cancer death rates by at least half over
The Framework vision is to ensure that every person in America has access to comprehensive, evidence-based cessation treatment and can benefit from HHS cessation supports, programs, and policies.
The Framework is organized around the six goals that serve as a foundation for long-standing HHS efforts to support and promote cessation. Moving forward, these goals will guide future HHS cessation actions, building on the work that is already underway to achieve the Framework vision.
The Framework identifies six goals.
The Framework is underpinned by cross-cutting guiding principles that apply across all six goals. These cross-cutting principles reflect the Department's commitment to leveraging the best available smoking cessation science, programs, and policies to reach diverse populations and all communities across America.
Each of the six goals are supported by broad strategies to drive progress toward smoking cessation at the population and individual levels. HHS will advance the Framework goals through coordinated strategies that leverage the full capacity and resources of the Department, including continued support for ongoing activities that serve these goals.
Addressing disparities in smoking prevalence rates and cessation outcomes is essential to achieving equitable progress in reducing smoking-related morbidity and mortality. A commitment to health equity involves understanding health disparities related to smoking and the factors that cause these disparities. Through the Framework, HHS seeks to execute broad strategies that will reach all communities and address unique barriers to cessation experienced by disparately affected groups.
Examples of broad strategies that advance this goal include:
Raising knowledge and awareness about the harmful effects of smoking and evidence-based cessation interventions drives attempts to quit and promotes treatment utilization. Through the Framework, HHS seeks to execute broad strategies that will increase awareness and knowledge related to smoking and cessation.
Examples of broad strategies that advance this goal include:
To help people quit smoking, it is important to have strong cessation supports in place with sustainable capacity and infrastructure. Through the Framework, HHS seeks to execute broad strategies that will support implementation of services that are evidence-based, optimally effective, engaging, and sustainable.
Examples of broad strategies that advance this goal include:
Ensuring that high-quality, comprehensive cessation support is accessible and affordable for all people in America is essential for advancing smoking cessation. The Framework seeks to execute broad strategies that will increase access to cessation treatment, especially in settings serving population groups that experience barriers to cessation and cessation-related disparities.
Examples of broad strategies that advance this goal include:
Expanding capacity for surveillance and evaluation is critical for measuring progress, understanding barriers to quitting success, and rewarding effective service delivery. Through the Framework, HHS seeks to execute strategies that will support the measurement, monitoring, and tracking of patterns, trends, and progress.
Examples of broad strategies that advance this goal include:
A robust evidence base exists to inform smoking cessation programs, policies, and treatments. At the same time, it is essential to identify what gaps exist in our current understanding of what works to effectively address smoking cessation. Through the Framework, HHS seeks to execute broad strategies that will support research efforts to continually build the evidence base in this area.
Examples of broad strategies that advance this goal include:
HHS is requesting information from the public regarding five questions.
1. Are the proposed goals appropriate and relevant for addressing the needs of populations disparately affected by smoking?
2. Do the broad strategies capture the key components and aspects needed to drive progress toward increasing cessation?
3. Are there additional goals or broad strategies that should be included in the Framework?
4. What targeted actions should HHS (Department-wide or within a specific HHS agency) take to advance these goals and strategies?
5. What metrics and benchmarks should be included to ensure that the Framework drives progress?
HHS invites all potentially interested parties—individuals, associations, governmental and non-governmental organizations, academic institutions, and private sector entities—to respond. HHS is interested in the questions listed above, but respondents are welcome to address as many or as few as they choose and may provide additional relevant information that is within the scope of the Framework. To facilitate review of the responses, please reference the question number in your response.
This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of HHS to provide support for any ideas in response to it. HHS will use the information submitted in response to this RFI at its discretion and will not provide comments to any respondent's submission. However, responses to this RFI may be reflected in future initiatives, solicitations, or policies. Respondents are advised that HHS is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
Indian Health Service, HHS.
Notice.
Notice is provided of the persons who will serve on the Indian Health Service Senior Executive Service Performance Review Board.
The Indian Health Service (IHS) announces the persons who will serve on the IHS Senior Executive Service Performance Review Board (PRB). This action is being taken in accordance with 5 U.S.C. 4314(c)(4), which requires that members of PRBs be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals; and requires that notice of the appointment of an individual to serve as a member be published in the
The following persons may be named to serve on the PRB from 2023-2025, which oversees the evaluation of performance appraisals and compensation for Senior Executive Service, Senior Level/Senior Technical, and Title 42 executive-equivalent members of the IHS.
For further information about the PRB, contact Nathan Anderson, Office of Human Resources, Indian Health Service, 5600 Fishers Lane, Rockville, MD 20857, or by phone at 605-681-4940.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
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
Pursuant to section 1009 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 material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 1009 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 material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 1009 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
Pursuant to section 1009 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 material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Office of the Secretary, (DHS).
Notice of rescission of determination.
On May 15, 2020, the Acting Secretary of Homeland Security published a Notice of Determination Pursuant to Section 102 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, as Amended, to waive legal requirements related to the construction of barriers and roads. (May 2020 Notice of Determination). The Secretary of Homeland Security through this notice rescinds the May 2020 Notice of Determination.
This Notice takes effect on June 30, 2023.
Section 102(c) of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, as Amended, provides the Secretary of Homeland Security with the sole discretion to waive all legal requirements related to the construction of barriers and roads. Public Law 104-208, Div. C, 110 Stat. 3009-546, 3009-554 (Sept. 30, 1996) (8 U.S.C 1103 note), as amended by the REAL ID Act of 2005, Public Law 109-13, Div. B, 119 Stat. 231, 302, 306 (May 11, 2005) (8 U.S.C. 1103 note), as amended by the Secure Fence Act of 2006, Public Law 109-367, section 3, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1103 note), as amended by the Department of Homeland Security Appropriations Act, 2008, Public Law 110-161, Div. E, Title V, section 564, 121 Stat. 2090 (Dec. 26, 2007). Any such waivers shall be effective upon being published in the
This rescission of the May 15, 2020 Notice of Determination does not rescind or supersede any other waiver determination made pursuant to section 102(c) of IIRIRA. Such waivers shall remain in full force and effect in accordance with their terms.
Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS).
30-Day notice and request for comments; new collection (request for a new OMB control number).
The
Comments are encouraged and will be accepted until July 31, 2023. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Office of Management and Budget is particularly interested in comments which:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Cameron Dixon, DHS, Cybersecurity and Infrastructure Security Agency/Cybersecurity Division, 888-282-0870,
Under the DOTGOV Act of 2020 (6 U.S.C. 665), CISA is responsible for the operation and security of the
The information will be collected on an online web portal called the “.
Only U.S.-based government organizations are eligible for
In accordance with 6 U.S.C. 665(c)(4), CISA will “limit the sharing or use of any information” obtained through this collection “with any other Department component or any other agency for any purpose other than the administration of the
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew an information collection without change.
Interested persons are invited to submit comments on or before August 29, 2023.
Send your comments on the information collection request (ICR) by one of the following methods (reference “1018-0181” in the subject line of your comment):
•
•
•
To request additional information about this ICR, contact Madonna L. Baucum, Service Information Collection
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
• The National Wildlife Refuge System Administration Act of 1966 (Administration Act, 16 U.S.C. 668dd-668ee), as amended by the National Wildlife Refuge System Improvement Act of 1997, authorizes the Secretary of the Interior to negotiate and award contracts and issue regulations to carry out the Administration Act.
• The Refuge Recreation Act of 1962 (16 U.S.C.460k-460k-3) allows the use of refuges for public recreation when such use is not inconsistent with or does not interfere with the primary purpose(s) of the refuge.
• The Refuge Revenue Sharing Act (16 U.S.C. 715s) authorizes the Secretary to grant privileges and collect revenues from leases for public accommodations or facilities established for the System.
Specifically, the Administration Act provides that, with respect to the Refuge System, it is the policy of the United States that—
a. Each refuge shall be managed to fulfill the mission of the System, as well as the specific purposes for which that refuge was established;
b. Compatible wildlife-dependent recreation is a legitimate and appropriate general public use of the System, directly related to the mission of the System and the purposes of many refuges, and which generally fosters refuge management and through which the American public can develop an appreciation for fish and wildlife;
c. Compatible wildlife-dependent recreational uses are the priority general public uses of the System and shall receive priority consideration in refuge planning and management; and
d. When the Secretary determines that a proposed wildlife-dependent recreational use is a compatible use within a refuge, that activity should be facilitated, subject to such restrictions or regulations as may be necessary, reasonable, and appropriate.
The Administration Act also provides that, in administering the Refuge System, the Secretary shall—
a. Recognize compatible wildlife-dependent recreational uses as the priority general public uses of the System, through which the American public can develop an appreciation for fish and wildlife;
b. Ensure that opportunities are provided within the System for compatible wildlife-dependent recreational uses;
c. Ensure that priority general public uses of the System receive enhanced consideration over other general public uses in planning and management within the System; and
d. Provide increased opportunities for families to experience compatible wildlife-dependent recreation, particularly opportunities for parents and their children to safely engage in traditional outdoor activities, such as fishing and hunting.
Private businesses and non-profit organizations under contract to the Service provide recreational, educational, and interpretive enjoyment of our lands and waters by managing lodging, food, transportation, and supplies and equipment for the enjoyment of the visiting public. These services gross approximately $3,000,000 every year and provide jobs for more than 100 people annually.
The regulations at 50 CFR subpart F (section 25.61) primarily implement the authorities governing public use facilities operated by concessionaires or cooperators under appropriate contact or legal agreement on national wildlife refuges where there is a demonstrated justified need for services or facilities, including but not limited to boat rentals, swimming facilities, conducted tours of special natural attractions, shelters, tables, trailer lots, food, lodging, and related services.
Service Manual chapters 630 FW 6-8 discuss the Service's current policy for concession management and provide guidance for permitting and administering concessions operations on Service lands. We use concessions contracts to assist us in providing wildlife-dependent recreation activities to the visiting public by using contracts between the Service and private entities, where each private entity is allowed to charge a fee for services provided at a field station to the visiting public.
We collect information in a narrative (non-form) format. Details concerning the specific information required are contained in 50 CFR 25.61 and the recently updated Service Manual chapters available to the public on the Service's website at
Below are examples of types of information the Service collects from a potential or current concessionaire.
• Description of how the respondent will conduct operations to minimize disturbance to wildlife; protect refuge resources; and provide visitors with a high-quality, safe, and enjoyable visitor experience.
• Proposal to protect, conserve, and preserve resources of the refuge. The proposal must respond to specific resource management objectives and issues at the refuge and regarding the contract in question.
• Proposal to provide necessary and appropriate visitor services at reasonable rates. This proposal must respond to specific visitor service questions at the refuge and regarding the contract in question.
• Experience and related background of the offeror, including past performance and expertise of the offeror in providing the same or similar visitor services as those to be provided under the draft concession contract.
• Financial capability of the offeror to carry out its proposal. In particular, we require projected financials, including initial investments, startup expenses, income statement, operating assumptions, cash flow statement, recapture of investments, and all associated assumptions.
• The amount of the proposed minimum franchise fee and other forms of financial consideration.
• Offeror's transmittal letter, including the name and contact information of the entity offering a proposal to operate a concession contract.
• Business type of the offeror, such as corporation, limited liability company, partnership, etc.
• Business history information, including adverse history that could impact future operations under a concession contract.
• Credit report, so that we can understand the offeror's credit history and any risks of contracting with the entity.
• Proposed staffing/management operation information, including organization charts and delegations of authority, to ensure adequate staffing.
• Proof of indemnification, including public liability insurance that co-names the Government as co-insured.
• Annual financial reports providing concessioner financial information, as required by each concession contract.
• Quarterly and annual progress reports to monitor performance.
• Inspections and inspection reports conducted in concert with the on-site concession manager.
• Information to assess the transferee's ability to manage the business successfully and fulfill the terms of the concession contract, in order for the Regional Director to grant approval.
• In accordance with Service Manual chapter 630 FW 8.3, a concessioner (and any subconcessioner) must keep and make available to the Service records for the term of the concession contract.
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act, we, the U.S. Fish and Wildlife Service, are proposing to renew an information collection without change.
Interested persons are invited to submit comments on or before July 31, 2023.
Written comments and recommendations for the proposed information collection should be submitted within 30 days of publication of this notice at
Madonna L. Baucum, Service Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act (PRA; 44 U.S.C. 3501
On March 20, 2023, we published in the
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, 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 especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments 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 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.
In 2017, we issued a final rule (July 24, 2017, 82 FR 34263), developed under a co-management process involving the Alaska Department of Fish and Game and Alaska Native representatives, that amended the permanent migratory bird subsistence harvest regulations at 50 CFR 92.6 to enable Alaska Native people to sell authentic native articles of handicraft or
Alaska Native artists will show eligibility with a Tribal enrollment card, Bureau of Indian Affairs card, or membership in the Silver Hand program. The State of Alaska Silver Hand program helps Alaska Native artists promote their work in the marketplace and enables consumers to identify and purchase authentic Alaska Native art. The Silver Hand insignia indicates that the artwork on which it appears is created by hand in Alaska by an individual Alaska Native artist. Only original contemporary and traditional Alaska Native artwork, not reproductions or manufactured work, may be identified and marketed with the Silver Hand insignia. To be eligible for a 2-year Silver Hand permit, an Alaska Native artist must be a full-time resident of Alaska, be at least 18 years old, and provide documentation of membership in a federally recognized Alaska Native tribe. The Silver Hand insignia may only be attached to original work that is produced in the State of Alaska.
The final rule requires that FWS Form 3-2484 (a simple certification which is not subject to the PRA) or a Silver Hand insignia accompany each Alaska Native article of handicraft or clothing that contains inedible migratory bird parts. It also requires all consignees, sellers, and purchasers to retain this documentation with each item and produce it upon the request of a law enforcement officer. The final rule also requires that artists maintain adequate records of the certification or Silver Hand insignia with each item and requires artists and sellers/consignees to provide the documentation to buyers. These recordkeeping and third-party notification requirements are subject to the PRA and require OMB approval.
The public may request copies of a Form 3-2484 contained in this information collection by sending a request to the Service Information Collection Clearance Officer (see
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Middletown Rancheria of Pomo Indians of California & State of California.
The extension takes effect on June 30, 2023.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
An extension to an existing Tribal-State Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. 25 CFR 293.5. The Middletown Rancheria of Pomo Indians of California and the State of California have reached an agreement to extend the expiration date of their existing Tribal-State Class III gaming compact to December 31st, 2024. This publication provides notice of the new expiration date of the compact.
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of intent (NOI) to prepare an environmental impact statement (EIS); request for comments.
Consistent with the regulations implementing the National Environmental Policy Act (NEPA), BOEM announces its intent to prepare an EIS for a construction and operations plan (COP) submitted by Beacon Wind LLC (Beacon Wind). This NOI initiates the public scoping and comment process under NEPA and also seeks public comments under section 106 of the National Historic Preservation Act (NHPA) and its implementing regulations. Beacon Wind proposes to construct and operate an offshore wind facility located in Renewable Energy Lease Area OCS-A 0520 (Lease Area), which is approximately 128,811 acres and 17 nautical miles (nm) south of Nantucket, Massachusetts, and 52 nm east of Montauk, New York. Beacon Wind, a joint venture owned by Equinor U.S. Holdings, Inc. and BP Wind Energy North America, Inc., proposes to develop the entire Lease Area in two
Your comments must be received by BOEM on or before July 31, 2023 for timely consideration.
BOEM will hold two in-person and two virtual public scoping meetings for the Beacon Wind EIS at the following dates and times (eastern time):
• Tuesday, July 18, 2023, 6:00-9:00 p.m., UMASS-Dartmouth, The Market Place Dining Hall, 285 Old Westport Road, Dartmouth, MA 02747; and
• Thursday, July 20, 2023, 6:00-9:00 p.m., Adria Hotel and Conference Center Ballroom, 221-17 Northern Blvd., Queens, NY 11361-3600
• Thursday, July 13, 2023, 11:00 a.m.-1:00 p.m.; and
• Wednesday, July 26, 2023, 11:00 a.m.-1:00 p.m.
Registration for the virtual public meetings may be completed here:
Written comments can be submitted in any of the following ways:
• Delivered by mail or delivery service, enclosed in an envelope labeled “BEACON WIND EIS” and addressed to Jessica Stromberg, Chief, Environmental Branch for Renewable Energy, Bureau of Ocean Energy Management, 45600 Woodland Road, VAM-OREP, Sterling, Virginia 20166; or
•
Detailed information about the proposed Project, including the COP and instructions for making written comments, can be found on BOEM's website at:
Bonnie Houghton, Office of Renewable Energy Programs, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166, telephone (703) 438-5108, or email
In Executive Order 14008, “Tackling the Climate Crisis at Home and Abroad,” issued on January 27, 2021, President Biden stated that the policy of his administration is “to organize and deploy the full capacity of its agencies to combat the climate crisis to implement a Government-wide approach that reduces climate pollution in every sector of the economy; increases resilience to the impacts of climate change; protects public health; conserves our lands, waters, and biodiversity; delivers environmental justice; and spurs well-paying union jobs and economic growth, especially through innovation, commercialization, and deployment of clean energy technologies and infrastructure.”
Through a competitive leasing process conducted under 30 CFR 585.211, BOEM awarded Equinor Wind US, LLC, the commercial wind energy lease OCS-A 0520. Beacon Wind acquired 100 percent interest in the Lease Area by assignment effective January 27, 2021, and, has the exclusive right to submit a COP for activities in it.
Beacon Wind submitted a COP to BOEM proposing the construction, operation, maintenance, and conceptual decommissioning of two offshore wind energy facilities (BW1 & BW2) in Lease Area OCS-A-0520. Beacon Wind's goal is to develop two offshore wind energy facilities in the Lease Area to provide renewable energy to the State of New York and other northeastern States. Beacon Wind proposes to construct up to 155 wind turbine generators (WTG) with 2 offshore substations (OSS), for a total of up to 157 structures in a 1 nm x 1 nm grid distributed across the Lease Area (Proposed Action). The individual wind farms within the Lease Area would be electrically isolated and independent from one another. Transmission systems would connect each OSS to separate onshore points of interconnection (POIs).
BW1 has a 25-year offtake agreement with the New York State Energy Research and Development Authority (NYSERDA) and is expected to deliver 1,230 megawatts (MW) of power to the NYISO electric grid at a POI in Queens, New York. Beacon Wind is actively seeking an offtake agreement for BW2 in the New England and New York region. Beacon Wind anticipates that BW2 will deliver more than 1,200 MW of power and interconnect with either the NYISO grid in Queens or with the New England Independent System Operator (ISO-NE) grid in Waterford, Connecticut.
BW1 would supply electricity in support of renewable and offshore wind energy goals established by the State of New York under its 2019 Climate Leadership and Community Protection Act. Among other things, the law mandates that at least 70 percent of New York's electricity come from renewable energy sources by 2030 and that 9,000 MW come from offshore wind energy by 2035. If BW2 also obtains an offtake agreement with NYSERDA, it would supply additional electricity along the same cable route as BW1 in support of New York's goals.
Based on BOEM's authority under the Outer Continental Shelf Lands Act (OCSLA) (43 U.S.C. 1331
In addition, the National Oceanic and Atmospheric Administration's National Marine Fisheries Service (NMFS) anticipates one or more requests for authorization under the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361
The U.S. Army Corps of Engineers (USACE) New England District anticipates permit applications from Beacon Wind for actions undertaken through authority delegated to the district engineer under section 10 of the Rivers and Harbors Act of 1899 (RHA) (33 U.S.C. 403) and section 404 of the Clean Water Act (CWA) (33 U.S.C. 1344). In addition, Beacon Wind may need section 408 permission pursuant to 33 U.S.C. 408, for any actions it proposes to take that have the potential to alter, occupy, or use any existing federally authorized projects. USACE considers issuance of permits and permissions under these three delegated authorities a major Federal action connected to BOEM's action (40 CFR 1501.9(e)(1)).
As determined by USACE for section 404(b)(1) guidelines evaluation, the basic Project purpose is offshore wind energy generation. Beacon Wind's need, as provided in the COP and reviewed by USACE for NEPA purposes, is to generate electricity from offshore wind energy facilities located in Lease Area OCS-A 0520.
As determined by Engineer Circular 1165-2-220, the purpose of USACE section 408 action is to evaluate Beacon Wind's request and determine whether its Proposed Action would adversely impact the public interest or a USACE project. USACE section 408 permission is needed to ensure that congressionally authorized projects continue to provide their intended benefits to the public. USACE intends to adopt BOEM's EIS in accordance with 40 CFR 1506.3 if, after its independent review of the document, USACE concludes that BOEM has satisfactorily addressed its comments and recommendations. USACE intends to adopt BOEM's EIS to support its decision on any permits or permissions requested under sections 10 and 14 of the RHA and section 404 of the CWA. Based on its participation as a cooperating agency and its consideration of BOEM's EIS, USACE intends to issue a record of decision (ROD) to formally document its decision on the Proposed Action.
Beacon Wind proposes to construct and operate two offshore wind energy facilities within Lease Area OCS-A-0520, with up to 157 total foundation locations to be occupied by a combination of up to 155 WTGs and 2 OSSs. Offshore components for BW1 and BW2 include between 61 and 94 WTGs and 1 OSS each, foundations and associated scour protection for WTGs, associated inter-array cables, 1 high-voltage direct current (HVDC) submarine export cable route each, cable protection, and 1 temporary meteorological and oceanographic (metocean) buoy. Beacon Wind is considering monopile, piled jacket, or suction-bucket jacket foundation types to support the WTG. The OSS would be supported by either piled jacket or suction-bucket jacket foundations. The WTGs, OSSs, foundations, and inter-array cables would be located entirely within the Lease Area. The submarine export cables would be buried in the U.S. Outer Continental Shelf and in the seabed under the State waters of New York and potentially of Connecticut (if the export cable from BW2 makes landfall in Waterford, Connecticut).
The BW1 submarine export cable would make landfall and interconnect to the NYISO grid in Queens. The BW2 cable would make landfall in either Queens or Waterford; if landfall is in Waterford, the cables would interconnect with the ISO-NE grid in Connecticut. BW1's onshore components would be sited in Queens, and BW2's in either Queens or Waterford.
BOEM will evaluate reasonable alternatives to the Proposed Action that are identified during the scoping period and included in the draft EIS, including a no action alternative. Under the no action alternative, BOEM would disapprove the Beacon Wind COP, and the proposed wind energy facilities described in the COP would not be built within the Lease Area.
After completing the EIS and associated consultations, BOEM will decide through a ROD whether to approve, approve with modification, or disapprove the Beacon Wind COP. If BOEM approves the COP, Beacon Wind must comply with all conditions of its approval.
The draft EIS will identify and describe the potential effects of the Proposed Action and the alternatives on the human environment. Those potential effects must be reasonably foreseeable and must have a reasonably close causal relationship to the Proposed Action and the alternatives. Such effects include those that occur at the same time and place as the Proposed Action and alternatives and those that are later in time or occur in a different place. Potential effects include, but are not limited to, impacts (whether beneficial or adverse) on air quality, water quality, bats, benthic habitat, essential fish habitat, invertebrates, finfish, birds, marine mammals, terrestrial and coastal habitats and fauna, sea turtles, wetlands and other waters of the United States, commercial fisheries and for-hire recreational fishing, cultural resources, Tribal issues of concern, demographics, employment, economics, environmental justice, land use and coastal infrastructure, navigation and vessel traffic, other marine uses, recreation and tourism, and visual resources. These potential effects will be analyzed in the draft and final EIS.
Based on a preliminary evaluation of the resources listed in the preceding paragraph, BOEM expects potential impacts on sea turtles and marine mammals from underwater noise caused by construction and from collision risks with Project-related vessel traffic. Structures installed by the Project could permanently change benthic and fish habitats (
Beneficial impacts are also expected by facilitating achievement of State renewable energy goals, increasing job opportunities, improving air quality, and addressing climate change through E.O. 14008. The Project is estimated to support 5,958 to 6,491 job-years cumulatively during the development and construction phases, including indirect and induced employment opportunities. During the operations and maintenance phase, the Project is estimated to support 21,117 to 22,681 jobs-years during an estimated 40 years of operation and maintenance (including decommissioning).
In addition to the requested COP approval, various other Federal, State, and local authorizations will be required for the Project. Applicable Federal laws include the Endangered Species Act, Magnuson‐Stevens Fishery Conservation and Management Act, MMPA, RHA, CWA, Clean Air Act section 328, and the Coastal Zone Management Act. BOEM will also conduct government-to-government
BOEM has chosen to use the NEPA process to fulfill its obligations under NHPA. While BOEM's obligations under NHPA and NEPA are independent, regulations implementing section 106 of NHPA allow the NEPA process and documentation to substitute for various aspects of the NHPA review. See 36 CFR 800.8(c). This process is intended to improve efficiency, promote transparency and accountability, and support a broadened discussion of potential effects that the Project could have on the human environment. During preparation of the EIS, BOEM will ensure that the NEPA process will fully meet all NHPA obligations.
After the draft EIS is completed, BOEM will publish a notice of availability (NOA) and request public comments on the draft EIS. BOEM currently expects to issue the NOA in July 2024. After the public comment period ends, BOEM will review and respond to comments received and will develop the final EIS. BOEM currently expects to make the final EIS available to the public in March 2025. A ROD will be completed no sooner than 30 days after the final EIS is released, in accordance with 40 CFR 1506.11.
This Project is a “covered project” under section 41 of the Fixing America's Surface Transportation Act (FAST-41). FAST-41 provides increased transparency and predictability by requiring Federal agencies to publish comprehensive permitting timetables for all covered projects. FAST-41 also provides procedures for modifying permitting timetables to address the unpredictability inherent in the environmental review and permitting process for significant infrastructure projects. To view the FAST-41 Permitting Dashboard for the Project, visit:
This NOI commences the public scoping process to identify issues and potential alternatives for consideration in the Beacon Wind EIS. BOEM will hold virtual public scoping meetings at the times and dates described above under the
As noted above, BOEM will use the NEPA process to comply with NHPA. BOEM will consider all written requests from individuals and organizations to participate as consulting parties under NHPA and, as discussed below, will determine who among those parties will be a consulting party in accordance with NHPA regulations.
BOEM invites other Federal agencies and State and local governments to consider becoming cooperating agencies and invites federally recognized Tribes to become cooperating Tribal governments in the preparation of this EIS. The Council on Environmental Quality (CEQ) NEPA regulations specify that cooperating agencies and governments are those with “jurisdiction by law or special expertise.” Potential cooperating agencies should consider their authority and capacity to assume the responsibilities of a cooperating agency and should be aware that an agency's role in the environmental analysis neither enlarges nor diminishes the final decision-making authority of any other agency involved in the NEPA process.
BOEM will provide potential cooperating agencies with a written summary of expectations for cooperating agencies, including schedules, milestones, responsibilities, scope and detail of cooperating agencies' expected contributions, and availability of pre-decisional information. BOEM anticipates this summary will form the basis for a memorandum of agreement between BOEM and any non-Department of the Interior cooperating agency. Agencies should also consider the factors for determining cooperating agency status in the CEQ memorandum entitled “Cooperating Agencies in Implementing the Procedural Requirements of the National Environmental Policy Act,” dated January 30, 2002. This document is available on the internet at:
Governmental entities that are not cooperating agencies will have opportunities to provide information and comments to BOEM during the public input stages of the NEPA process.
Individuals and organizations with a demonstrated interest in the Project can request to participate as NHPA consulting parties under 36 CFR 800.2(c)(5) based on their legal or economic stake in historic properties affected by the Project.
Before issuing this NOI, BOEM compiled a list of potential consulting parties and invited them to become consulting parties. To become a consulting party, those invited must respond in writing by the requested response date.
Interested individuals and organizations that did not receive a written invitation can request to be consulting parties by writing to the staff NHPA contact at ICF International, Inc., the third-party EIS contractor supporting BOEM in its administration of this review. ICF's NHPA contact for this review is Alice Muntz at
Federal agencies, Tribes, State and local governments, and other interested parties are requested to comment on the scope of this EIS, significant issues that should be addressed, and alternatives that should be considered.
BOEM will protect privileged or confidential information that you submit when required by the Freedom of Information Act (FOIA). Exemption 4 of FOIA applies to trade secrets and commercial or financial information that is privileged or confidential. If you wish to protect the confidentiality of such information, clearly label it and request that BOEM treat it as confidential. BOEM will not disclose such information if BOEM determines under 30 CFR 585.114(b) that it qualifies for exemption from disclosure under FOIA. Please label privileged or confidential information “Contains Confidential Information” and consider submitting such information as a separate attachment.
BOEM will not treat as confidential any aggregate summaries of such information or comments not containing such privileged or confidential information. Information that is not labeled as privileged or confidential may be regarded by BOEM as suitable for public release.
BOEM discourages anonymous comments. Please include your name and address as part of your comment. You should be aware that your entire comment, including your name, address, and any other personally identifiable information included in your comment, may be made publicly available. All comments from individuals, businesses, and organizations will be available for public viewing on
For BOEM to consider withholding your PII from disclosure, you must identify any information contained in your comments that, if released, would constitute a clearly unwarranted invasion of your personal privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm. Even if BOEM withholds your information in the context of this notice, your submission is subject to FOIA. If your submission is requested under FOIA, your information will only be withheld if a determination is made that one of FOIA's exemptions to disclosure applies. Such a determination will be made in accordance with the Department's FOIA regulations and applicable law.
After consultation with the Secretary, BOEM is required to withhold the location, character, or ownership of historic resources if it determines that disclosure may, among other things, risk harm to the historic resources or impede the use of a traditional religious site by practitioners. Tribal entities should designate information that falls under section 304 of NHPA as confidential.
BOEM requests data, comments, views, information, analysis, alternatives, or suggestions relevant to the Proposed Action from the public; affected Federal, Tribal, State, and local governments, agencies, and offices; the scientific community; industry; or any other interested party. Specifically, BOEM requests information on the following topics:
1. Potential effects that the Proposed Action could have on biological resources, including bats, birds, coastal fauna, finfish, invertebrates, essential fish habitat, marine mammals, and sea turtles.
2. Potential effects that the Proposed Action could have on physical resources and conditions including air quality, water quality, wetlands, and other waters of the United States.
3. Potential effects that the Proposed Action could have on socioeconomic and cultural resources, including commercial fisheries and for-hire recreational fishing, demographics, employment, economics, environmental justice, land use and coastal infrastructure, navigation and vessel traffic, other uses (marine minerals, military use, aviation), recreation and tourism, and scenic and visual resources.
4. Other possible reasonable alternatives to the Proposed Action that BOEM should consider, including additional or alternative avoidance, minimization, and mitigation measures.
5. As part of its compliance with NHPA section 106 and its implementing regulations (36 CFR part 800), BOEM seeks comment and input from the public and consulting parties regarding the identification of historic properties within the Proposed Action's area of potential effects, the potential effects on those historic properties from the activities proposed in the COP, and any information that supports identification of historic properties under NHPA. BOEM also solicits proposed measures to avoid, minimize, or mitigate any adverse effects on historic properties. BOEM will present available information regarding known historic properties during the public scoping period at
6. Information on other current or planned activities in, or in the vicinity of, the Proposed Action, their possible impacts on the Project, and the Project's possible impacts on those activities.
7. Other information relevant to the Proposed Action and its impacts on the human environment.
To promote informed decision-making, comments should be as specific as possible and should provide as much detail as necessary to meaningfully and fully inform BOEM of the commenter's position. Comments should explain why the issues raised are important to the consideration of potential environmental impacts and possible alternatives to the Proposed Action, as well as economic, employment, and other impacts affecting the quality of the human environment.
The draft EIS will include a summary of all alternatives, information, and analyses submitted during the scoping process for consideration by BOEM and the cooperating agencies.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office on Violence Against Women (OVW), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 29, 2023.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at (202) 514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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If additional information is required contact: John R. Carlson, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office on Violence Against Women (OVW), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 29, 2023.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at (202) 514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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If additional information is required contact: John R. Carlson, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
Drug Enforcement Administration, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 29, 2023.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Courtney E. Mallon, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; telephone: (202) 598-6812.
Written comments and suggestions from the
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If additional information is required contact: John R. Carlson, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
Criminal Justice Information Services Division, Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until July 31, 2023.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact: Larry E. Cotton-Zinn, Management and Program Analyst, FBI, CJIS, Criminal History Information and Policy Unit, BTC-3, 1000 Custer Hollow Road; Clarksburg, WV 26306; phone: 304-625-5590 or email
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website
DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
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If additional information is required, contact: John R. Carlson, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.
Employment and Training Administration (ETA), Labor.
Notice.
The Acting Secretary of Labor (Secretary) has determined that the renewal of the Advisory Committee on Apprenticeship (hereinafter ACA or Committee) was necessary and in the public interest. The Department of Labor re-established the ACA Charter in 2021, and recently renewed its Charter, with revisions, on May 11, 2023. The Acting Secretary of Labor is now requesting nominations of qualified candidates to be considered for appointment to the ACA for the 2023-2025 membership term.
All ACA membership nominations must be received by midnight no later than thirty (30) days from the date of this publication.
For any questions concerning the ACA nomination process, please contact Ms. Kenya Huckaby, Executive Assistant, Office of Apprenticeship, Employment and Training Administration, at
Registered Apprenticeship is a unique public private partnership that is highly dependent on the engagement and involvement of its stakeholders and partners for its ongoing operational effectiveness. Apart from the ACA, there is no single organization or group with the broad representation of employers, labor unions, and public entities available to consider the complexities and relationship of apprenticeship activities to other training efforts or to provide advice on such matters to the Secretary. It is particularly important to have such perspectives as DOL considers the expansion of registered apprenticeship and how best to fundamentally instill a permanent culture of inclusion in our workforce. The ACA's insights and recommendations on the best ways to address critical apprenticeship issues to meet the emerging needs of industry, labor organizations, and the public are critical. To learn additional information about the ACA please visit the ACA's landing page at:
The final membership will come from a cross-section of individuals directly affected, interested, and qualified as appropriate to the nature and functions of the ACA. Each ACA member will serve at the pleasure of the Secretary for a specified term. The Secretary may also appoint members to fill any ACA vacancies for the unexpired portions of
1. A demonstrated interest in the national apprenticeship system.
2. The ability and readiness to devote time and effort to attend all public ACA meetings, actively participate in ACA deliberations, advocate for the apprenticeship system, and participate in other member activities that are planned. Appointed ACA members will meet publicly on a quarterly basis. The time commitment for these public meetings will range from two to four hours for a virtual meeting and one to two days for an in-person meeting. Meeting locations will vary and consist of a mix between in-person and virtual meetings. Attendance of these quarterly public meetings is mandatory except for limited circumstances. In such limited circumstances, an appointed ACA member will have the opportunity to send a delegate to participate in their place. Delegates should be capable of fully representing the interests of the appointed member and their constituency base. However, ACA membership is not transferable to a delegate and this opportunity should be utilized on a limited and as-needed basis to ensure the balance of perspectives of the appointed membership. Additional tasks of appointed ACA members may include participation in subcommittee meetings, site visits, and/or participation in other group engagement activities. Appointed members, or their delegate in limited circumstances, are expected to attend at least 50% of these additional tasks as scheduled.
3. The ability to analyze issues related to the apprenticeship model and to be a part of the deliberative process of advising the Secretary of Labor regarding innovative and emerging apprenticeship models and best practices.
4. The ability to remain objective and work well as a member of the Committee.
• A copy of the nominee's resume;
• A cover letter that provides the reason(s) for nominating the individual, including a description of the relevant experience and subject-matter expertise of that person concerning the development of a skilled workforce through quality apprenticeship programs, and the member category or categories (
• Contact information for the nominee (name, title, business address, business phone, and business email address. Optionally, nominees may also submit letters of support and their LinkedIn profile.
• Information related to the nominee's primary or secondary apprenticeship affiliations as well as industry representation(s).
Please do not include any information in the nomination submission that should not be publicly disclosed. In selecting ACA members, the Secretary will consider individuals nominated in response to this
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 31, 2023.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
ETA requires that staff must ensure a complainant (or his/her representative) submits a complaint on the Complaint/Apparent Violation Form or another complaint form prescribed or approved by the Department or submits complaint information. The Complaint/Apparent Violation Form must be used for all complaints, including complaints about unlawful discrimination. ETA Form 8429 is helpful because it identifies whether a complainant is a Migrant and Seasonal Farmworker which implicates additional actions that must be taken. For additional substantive information about this ICR, see the related notice published in the
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 the OMB approves it 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 OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Copyright Royalty Board, Library of Congress.
Notice of commencement; request for petitions to participate; schedule.
The Copyright Royalty Judges announce commencement of a proceeding to determine an adjustment to the administrative assessment that digital music providers and any significant nonblanket licensees must pay to fund the operations of the Mechanical Licensing Collective (MLC); set the date by which the MLC and the Digital Licensee Coordinator (DLC) must, and other eligible participants may, file a Petition to Participate and the accompanying $150 filing fee; and announce the schedule for the proceeding and deadlines for submissions.
The commencement date of the proceeding is June 30, 2023. Petitions to Participate and the filing fee are due on or before July 17, 2023. The schedule for submissions and additional proceedings is set forth in the
Participants must file petitions to participate using the
Anita Brown, CRB Program Specialist, (202) 707-7658,
On May 31, 2023, the Mechanical Licensing Collective (MLC) and Digital Licensee Coordinator (DLC) filed with the Copyright Royalty Judges (Judges) a joint petition
The Judges hereby announce commencement of the proceeding. Participation by the MLC and the DLC in the proceeding is required, and the participation of copyright owners, digital music providers, and significant nonblanket licensees in the proceeding is permitted. 17 U.S.C. 115(d)(7)(D)(iv)(II); 37 CFR 355.2(c)-(d). The Judges, therefore, direct the MLC and the DLC to file Petitions to Participate, request Petitions to Participate from any other eligible participant with a significant interest in the determination of the Administrative Assessment, and set a schedule for submissions and further proceedings.
Parties filing Petitions to Participate must comply with the requirements of 37 CFR 355.2(e).
Petitioners must submit a filing fee of $150 to the Copyright Royalty Board
Parties must file Petitions to Participate online through eCRB using the online form, including therein factual information sufficient to establish that the petitioner has a significant interest in the determination of the Administrative Assessment, pursuant to 17 U.S.C. 115(d)(7)(D)(iv)(II) and 37 CFR 355.2(e), and pay the filing fee by credit card using the payment portal on eCRB.
Any participant that is an individual may represent herself or himself. All other participants must be represented by counsel. In accordance with § 303.2 of the Judges' regulations, only attorneys who are members of the bar in one or more states or the District of Columbia and in good standing will be allowed to represent parties before the Copyright Royalty Judges. 37 CFR 303.2.
The schedule for submissions and further proceedings is as follows: the commencement date of the proceeding is June 30, 2023; the first negotiation period is June 30-August 29, 2023; written notification from the MLC and DLC regarding results of negotiations is due August 29, 2023; the opening submission from the MLC, with concurrent production of required documents and disclosures, is due September 28, 2023; the first discovery period is September 29-November 28, 2023; responsive submissions from the DLC and from other participants, with concurrent production of required documents and disclosures, are due December 28, 2023; the second discovery period is December 29, 2023-February 27, 2024; the second negotiation period is February 28-March 13, 2024; reply submissions from the MLC are due April 10, 2024; written notification from the MLC and DLC regarding results of negotiations is due March 13, 2024; the joint pre-hearing submission is due on April 15, 2024; a hearing on the record will begin on April 29, 2024.
The Judges will address further procedural matters after Petitions to Participate are filed.
The Members of the National Council on Disability (NCD) will hold a two-day in-person Council meeting on Wednesday, July 12, 2023, 9 a.m.-5:15 p.m. Eastern Daylight Time (EDT) and Thursday, July 13, 2023, 10 a.m.-12:30 p.m., EDT.
This meeting will occur at the Willard Intercontinental Hotel, 1401 Pennsylvania Avenue NW, Washington, DC 20004. Attendees can use the accessible entrance to the hotel, located to the left of the main entrance and next to Café du Parc on Pennsylvania Avenue. The event will also be streamed live via Zoom videoconference for those not able to attend in person. Registration is not required. Details are available on NCD's event page at
Day 1—Following welcome remarks and introductions, a panel will present on addressing health disparities through disability clinical care competency training; then a brief break; followed by a panel discussion regarding responding to health disparities of people with disabilities; an hour public comment session on experiences with healthcare barriers and bias; a lunch break; a presentation on NCD's project underway regarding germline editing and fetal medicine; a presentation on NCD's project underway on the inclusion of people with disabilities in clinical trials; and a presentation on NCD's 2023 progress report that is underway on income limits and asset limitations; followed by adjournment.
Day 2—Following welcome remarks and introductions, the Administration, Finance, and Operations team will provide updates to Council Members; followed by a Legislative Affairs and Outreach team update; a Policy team update; the Chairman's report; Executive Committee Report, including bylaws vote; Council Member report outs on community outreach; reminders on NCD's travel reimbursement process; and any old or new business, before adjourning.
For the July 12 Council meeting, NCD will have an extended public comment period of one hour and requests comments from the public regarding experiences with healthcare barriers and bias for people with disabilities. Additional information on specifics of the topic is available on NCD's public comment page at
The Council will prioritize in-person commenters, but as time permits, will also receive public comment by video or audio over Zoom, and always accepts advance public comments via email. Due to the hybrid nature of the event, in-person presentations will be given priority.
To provide public comment during an NCD Council Meeting in any form (in-person or by Zoom), NCD now requires advanced registration by sending send an email to
While public comment can be submitted on any topic over email, comments during the meeting should be specific to experiences with healthcare barriers and bias for people with disabilities.
Nicholas Sabula, Public Affairs Specialist, NCD, 1331 F Street NW, Suite 850, Washington, DC 20004; 202-272-2004 (V), or
If you require additional accommodations, please notify Stacey Brown by sending an email to
Due to last-minute confirmations or cancellations, NCD may substitute items without advance public notice.
Weeks of July 3, 10, 17, 24, 31, August 7, 2023. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Closed.
Members of the public may request to receive the information in these notices electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
There are no meetings scheduled for the week of July 3, 2023.
There are no meetings scheduled for the week of July 17, 2023.
There are no meetings scheduled for the week of July 24, 2023.
There are no meetings scheduled for the week of July 31, 2023.
There are no meetings scheduled for the week of August 7, 2023.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Office of Personnel Management.
Notice.
According to the provisions of section 10 of the Federal Advisory Committee Act, notice is hereby given that a virtual meeting of the Federal Prevailing Rate Advisory Committee will be held on Thursday, July 20, 2023. There will be no in-person gathering for this meeting.
The virtual meeting will be held on July 20, 2023, beginning at 10:00 a.m. (ET).
The meeting will convene virtually.
Ana Paunoiu, 202-606-2858, or email
The Federal Prevailing Rate Advisory Committee is composed of a Chair, five representatives from labor unions holding exclusive bargaining rights for Federal prevailing rate employees, and five representatives from Federal agencies. Entitlement to membership on the Committee is provided for in 5 U.S.C. 5347.
The Committee's primary responsibility is to review the Prevailing Rate System and other matters pertinent to establishing prevailing rates under subchapter IV, chapter 53, 5 U.S.C., as amended, and from time to time advise the Office of Personnel Management.
Annually, the Chair compiles a report of pay issues discussed and concluded recommendations. These reports are available to the public. Reports for calendar years 2008 to 2020 are posted at
The public is invited to submit material in writing to the Chair on Federal Wage System pay matters felt to be deserving of the Committee's attention. Additional information on these meetings may be obtained by contacting the Committee at Office of Personnel Management, Federal Prevailing Rate Advisory Committee, Room 7H31, 1900 E Street NW, Washington, DC 20415, (202) 606-2858.
This meeting is open to the public, with an audio option for listening. This notice sets forth the agenda for the meeting and the participation guidelines.
• The definition of Monroe County, PA.
• The definition of San Joaquin County, CA.
• The definition of the Salinas-Monterey, CA, wage area.
• The definition of the Puerto Rico wage area.
The following information must be provided when registering:
• Name.
• Agency and duty station.
• Email address.
• Your topic of interest.
Members of the press, in addition to registering for this event, must also RSVP to
A confirmation email will be sent upon receipt of the registration. Audio teleconference information for participation will be sent to registrants the morning of the virtual meeting.
Office of Personnel Management.
60-Day notice and request for comments.
The Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an expiring information collection request (ICR), without change, titled “Report of Medical Examination of Person Electing Survivor Benefits,” OPM 1530.
Comments are encouraged and will be accepted until August 29, 2023.
You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) and title, by the following method:
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection (OMB No. 3206-0162). The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
At the time of retirement, an employee or Member in good health may elect an insurable interest survivor annuity benefit on behalf of an eligible beneficiary. OPM Form 1530 is used to collect the information necessary to determine whether the employee or Member is in good health so that OPM can determine whether the applicant is eligible to elect an insurable interest survivor annuity benefit.
Postal Service®.
Notice of modified systems of records.
The United States Postal Service® (USPS) is proposing to revise one Customer Privacy Act System of Records (SOR). These modifications are being made to support an initiative to allow the linking of
These revisions will become effective without further notice on July 31, 2023, unless responses to comments received on or before that date result in a contrary determination.
Comments may be submitted via email to the Privacy and Records Management Office, United States Postal Service Headquarters (
Janine Castorina, Chief Privacy and Records Management Officer, Privacy and Records Management Office, via (
This notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the
The Postal Service has a long and storied history delivering for the American people. Technological advances have brought about significant changes to how people buy and sell a variety of products, allowing small businesses to reach an ever-increasing network of customers. The Postal Service is developing an initiative that supports innovation, grows revenue and meets changing marketplace needs.
One of the Postal Service's responses to this new commerce landscape is to enhance Click-n-Ship®, a Postal product that allows customers to print their own shipping labels right from their own computer. The Postal Service now seeks to upgrade Click-n-Ship's convenience, functionality and versatility by allowing
To allow for the linking of accounts, this SOR will be revised as follows:
Pursuant to 5 U.S.C. 552a(e)(11), interested persons are invited to submit written data, views, or arguments on this proposal. A report of the proposed revisions has been sent to Congress and to the Office of Management and Budget for their evaluations. The Postal Service does not expect this amended system of records to have any adverse effect on individual privacy rights. USPS SOR 810.100
USPS 810.100,
None.
Computer Operations Service Centers.
Chief Customer and Marketing Officer and Executive Vice President, United States Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260-5005, (202) 268-7536.
39 U.S.C. 401, 403, and 404.
1. To provide online registration with single sign-on services for customers.
2. To facilitate online registration, provide enrollment capability, and administer internet-based services or features.
3. To maintain current and up-to-date address information to assure accurate and reliable delivery and fulfillment of postal products, services, and other material.
4. To obtain accurate contact information in order to deliver requested products, services, and other material.
5. To authenticate customer logon information for
6. To permit customer feedback in order to improve
7. To enhance understanding and fulfillment of customer needs.
8. To verify a customer's identity when the customer establishes or attempts to access his or her account.
9. To identify, prevent, and mitigate the effects of fraudulent transactions.
10. To enhance the customer experience by improving the security of Change of Address (COA) and Hold Mail processes.
11. To protect USPS customers from becoming potential victims of mail fraud and identity theft.
12. To identify and mitigate potential fraud in the COA and Hold Mail processes.
13. To verify a customer's identity when applying for COA and Hold Mail services.
14. To provide online registration for Informed Address platform service for customers.
15. To authenticate customer logon information for Informed Address platform services.
16. To verify the name and address of the sender or the authority of the sender's representative when submitting an online International inquiry for a lost or damaged package on
17. To link
18. To facilitate the transmission of customer shipping information from third-party vendors to Click-n-Ship®.
Customers who register via the USPS website at
1.
2.
3.
4.
5.
6.
7.
8.
9.
Customers, Individual Sender and Sender's representative filing an international inquiry for lost or damaged packages.
Standard routine uses 1. through 7., 10., and 11. apply.
Automated database, computer storage media, and paper.
By customer name, customer ID(s), phone number, mail, email address, IP address, text message address, and any customer information or online user information.
By tracking number for International package shipments for which an individual sender or sender's representative is filing an online International inquiry for loss or damage.
1. ACH records are retained up to 2 years.
2. Records stored in the registration database are retained until the customer cancels the profile record, 3 years after the customer last accesses records, or until the relationship ends.
3. For small business registration, records are retained 5 years after the relationship ends.
4. Online user information may be retained for 6 months. Records existing on paper are destroyed by burning, pulping, or shredding. Records existing on computer storage media are destroyed according to the applicable USPS media sanitization practice.
Paper records, computers, and computer storage media are located in controlled-access areas under supervision of program personnel. Access to these areas is limited to authorized personnel, who must be identified with a badge.
Access to records is limited to individuals whose official duties require such access. Contractors and licensees are subject to contract controls and unannounced on-site audits and inspections. Computers are protected by mechanical locks, card key systems, or other physical access control methods. The use of computer systems is regulated with installed security software, computer logon identifications, and operating system controls including access controls, terminal and transaction logging, and file management software. Online data transmissions are protected by encryption.
For small business registration, computer storage tapes and disks are maintained in controlled-access areas or under general scrutiny of program personnel. Access is controlled by logon ID and password as authorized by the Marketing organization via secure website. Online data transmissions are protected by encryption.
Requests for access must be made in accordance with the Notification Procedure above and USPS Privacy Act regulations regarding access to records and verification of identity under 39 CFR 266.5.
See Notification Procedures and Record Access Procedures.
Customers wanting to know if information about them is maintained in this system of records must address inquiries in writing to the system manager. Inquiries must contain name, address, and other identifying information.
None.
March 8, 2023, 88 FR 14400; December 27, 2018, 83 FR 66768; August 25, 2016, 81 FR 58542; June 30, 2016, 81 FR 42760; June 20, 2014, 79 FR 35389; January 23, 2014, 79 FR 3881; July 11, 2012, 77 FR 40921; October 24, 2011, 76 FR 65756; May 08, 2008, 73 FR 26155; April 29, 2005, 70 FR 22516.
Pursuant to the requirements of the National Environmental Policy Act (NEPA) of 1969, the Council on Environmental Quality's regulations implementing NEPA (40 CFR parts 1500-1508), and the Postal Service's regulations for NEPA compliance set forth at 39 CFR part 775, the U.S. Postal Service announces availability of the Draft Supplemental Environmental Impact Statement (SEIS) which analyzes the environmental impacts of a range of alternatives for a modification to the Postal Service's February 23, 2022, Record of Decision (ROD) to purchase, over ten years, 50,000 to 165,000 purpose-built, right-hand drive vehicles—the Next Generation Delivery Vehicle (NGDV)—to replace existing delivery vehicles nationwide that are beyond the end of their service life. A minimum of 10 percent of those vehicles would be battery electric vehicles (BEVs).
As our Preferred Alternative, the Postal Service proposes in this Draft SEIS to modify the current ROD in three primary ways: (1) substantially increase the minimum BEV commitment to 62 percent, (2) reduce the total number of vehicles proposed for purchase at this time to 106,480, purchased over six years, and (3) include a mix of both NGDV and commercial-off-the-shelf (COTS) vehicles. This Draft SEIS also analyzes an NGDV-only Alternative with 62 percent BEV commitment, purchased over eight years, as well as a “No-Action” Alternative, which would proceed with the existing decision under the ROD.
The Postal Service is soliciting comments on the Draft SEIS during a 45-day public comment period. Comments should be received no later than August 14, 2023.
In addition, the Postal Service will also conduct a virtual public hearing on July 26, 2023. Registration information will be made available 15 days prior to the hearing date at the following website:
Interested parties may view the Draft SEIS and the prior NGDV ROD at
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Like most issuers of securities, when an investment company (“fund”)
Rule 482 contains certain requirements regarding the disclosure that funds are required to provide in qualifying advertisements. These requirements are intended to encourage the provision to investors of information that is balanced and informative, particularly in the area of investment performance. For example, a fund is required to include disclosure advising investors to consider the fund's investment objectives, risks, charges and expenses, and other information described in the fund's prospectus, and highlighting the availability of the fund's prospectus. In addition, rule 482 advertisements that include performance data of open-end funds or insurance company separate accounts offering variable annuity contracts are required to include certain standardized performance information, information about any sales loads or other nonrecurring fees, and a legend warning that past performance does not guarantee future results. Such funds including performance information in rule 482 advertisements are also required to make available to investors month-end performance figures via website disclosure or by a toll-free telephone number, and to disclose the availability of the month-end performance data in the advertisement. The rule also sets forth requirements regarding the prominence of certain disclosures, requirements regarding advertisements that make tax representations, requirements regarding advertisements used prior to the effectiveness of the fund's registration statement, requirements regarding the timeliness of performance data. In addition, rule 482(b) describes the information that is required to be included in an advertisement, including a cautionary statement under rule 482(b)(4) disclosing the particular risks associated with investing in a money market fund.
On October 26, 2022, the Commission adopted rule and form amendments that modernize the requirements for annual and semi-annual shareholder reports provided by open-end management investment companies.
Rule 482 advertisements must be filed with the Commission or, in the alternative, with the Financial Industry Regulatory Authority (“FINRA”).
Rule 482 contains requirements that are intended to encourage the provision to investors of information that is balanced and informative, particularly in the area of investment performance. The Commission is concerned that in the absence of such provisions fund investors may be misled by deceptive rule 482 advertisements and may rely on less-than-adequate information when determining in which funds they should invest money. As a result, the
The table below summarizes our estimates associated with the amendments to rule 482 that the Adopting Release addresses:
The table above summarizes our PRA initial and ongoing annual burden estimates associated with rule 482, as amended. In the aggregate, we estimate the total annual burden to comply with amended rule 482 to be 577,847 hours, at an average time cost of $213,133,255.
The information provided under rule 482 will not be kept confidential. The provision of information under rule 482 is necessary to obtain the benefits of the safe harbor offered by the rule.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend Section 1(b) of Schedule A to the FINRA By-Laws to exempt from the Trading Activity Fee (“TAF”) any transaction by a proprietary trading firm that occurs on an exchange of which the proprietary trading firm is a member.
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
As a general matter, the most significant sources of FINRA's funding are three core regulatory fees: the Gross Income Assessment; the TAF; and the Personnel Assessment.
Under the Exchange Act, a registered broker-dealer must become a member of a national securities association (currently, FINRA is the sole national securities association) unless the broker-dealer effects transactions in securities solely on a national securities exchange of which it is a member.
As discussed in the Proposing Release, the securities markets have evolved dramatically since the adoption of SEA Rule 15b9-1 and, today, the
The SEC estimates that the proposed amendments to SEA Rule 15b9-1 would impact approximately 65 broker dealers that are not currently FINRA members.
Proprietary trading firms that potentially could become members of FINRA have expressed concern about the TAF in particular. FINRA notes that there currently are several exemptions from the TAF, including for transactions by floor brokers and for market making transactions subject to Section 11(a) of the Act.
FINRA has filed the proposed rule change for immediate effectiveness. FINRA will announce the implementation date of the proposed rule change in a
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(5) of the Act,
FINRA believes it is reasonable to propose this amendment in view of the fact that regulatory costs for firms that do not have customers are expected to be less than the cost to oversee the activity of firms with customers. FINRA also believes that it is appropriate to proceed with an exemption for proprietary trading firms with respect to their transactions on an exchange of which they are a member because FINRA anticipates that regulatory costs largely will relate to overseeing such firms' activity over the counter or across exchanges.
Under the proposal, proprietary trading firms (as defined in the proposed rule) that are current FINRA members would experience a reduction in their TAF assessments to the extent they conduct non-market making transactions executed on exchanges of which they are members. Proprietary trading firms that become FINRA members would incur a smaller TAF assessment than they otherwise would pay absent the proposal. Finally, FINRA believes that the proposal is reasonable in that the proposed exemption is clear, simple, and cost effective for firms to implement.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
As discussed above, the SEC is proposing to amend SEA Rule 15b9-1 to narrow the scope of the exemption from FINRA membership. The proposed amendments to SEA Rule 15b9-1, if adopted, would generally require proprietary trading firms to become FINRA members if they engage in trading otherwise than on exchanges of which they are members.
The economic baseline for FINRA's proposed rule change consists of the regulatory framework under the SEC's proposed amendments to SEA Rule 15b9-1, if adopted, as well as FINRA's current TAF. In the Proposing Release, the SEC notes that, under the amended rule, a non-FINRA member firm that trades equities, options or fixed income securities off-exchange, or on exchanges of which it is not a member, can comply in four ways. One option is to join FINRA. The other options are to cease any off-exchange trading and either trade solely upon the exchanges of which the firm is already a member, or join additional exchanges, or cease trading securities altogether.
FINRA expects that some firms that are not currently FINRA members will apply for FINRA membership due to the SEC's modifications to SEA Rule 15b9-1, if adopted. These firms would maintain the ability to effect securities transactions on the same on and off exchange venues on which they currently effect such transactions. These firms would incur the one-time and ongoing costs of FINRA membership, including the TAF and other regulatory fees. The TAF would increase these firms' variable costs to trade, and the SEC notes that this may lead certain firms to reduce their trading both on-exchange and off-exchange.
Other non-FINRA member firms may choose to cease their off-exchange activity rather than join FINRA. Some of these firms may adjust their business models to trade solely upon the exchanges of which they are already a member or join additional exchanges upon which they wish to trade. However, since these firms may currently trade on exchanges of which they are not members, they may also cease trading on some of those exchanges.
The SEC also discusses how the changes non-FINRA member firms make to their business models to comply with the proposed amendments to SEA Rule 15b9-1 may affect other activities, including competition in the equity and U.S. Treasury securities markets, particularly for off-exchange liquidity provision.
Current FINRA members, including proprietary trading firms, would not be directly affected by the SEC proposal.
The SEC has estimated that there are approximately 65 broker-dealers registered with the Commission and exchange members that are not FINRA members. Each of these non-FINRA member firms will assess the costs and benefits of the options permitted by the amendments the SEC may make to SEA Rule 15b9-1. FINRA cannot determine the number of firms that may choose to become FINRA members or the likelihood or magnitude of any anticipated changes in trading behavior because of the proposed SEC rule amendments.
FINRA estimates that approximately 66 member firms derive all or most of their revenue from proprietary trading, although not all of these firms would meet the proposed definition of “proprietary trading firm” based on their current business models.
FINRA is proposing to amend the TAF to exempt all transactions by a FINRA member proprietary trading firm executed on an exchange of which it is a member.
FINRA believes that the proposed TAF exemption is clear and simple for firms to implement. In addition, the
Proprietary trading firms that are current FINRA members would experience a reduction in their TAF assessments to the extent they conduct non-market making transactions executed on exchanges of which they are members. Under the proposed TAF exemption, proprietary trading firms that become FINRA members would incur a smaller TAF assessment than they otherwise would pay absent the proposal. FINRA cannot determine the number of firms for which the proposed TAF exemption will have an impact on their determination of whether to become FINRA members and the likelihood or magnitude of any anticipated changes in trading behavior. There is significant diversity in the business models of proprietary trading firms. FINRA expects that the impacts of the exemption would depend on the level of trading activities proprietary trading firms conduct other than on the exchanges of which they are members. The impacts may also vary with the proportion of TAF to their overall FINRA membership costs. When TAF is expected to be a significant component of their membership costs, the proposed exemption is more likely to affect the firm's decision to become a FINRA member under the baseline.
As discussed above, FINRA anticipates that the proposed TAF exception may increase the number of proprietary trading firms that choose to become FINRA members relative to the baseline. The costs to these firms, like the benefits to these firms discussed above, are qualitatively the same as those incurred by proprietary trading firms that would choose to become FINRA members absent the proposed TAF exemption. These firms presumably choose to become FINRA members because the overall financial outcome is superior to that which would occur without joining FINRA and complying with the SEC proposed rule by restricting their trades to exchanges of which they are members.
Proprietary trading firms that are current FINRA members may alter their trading strategies to take advantage of the proposed TAF exemption, which may impact the amount and allocation of trading activity among exchange and off-exchange trading venues from the baseline. Likewise, the existence of the TAF exemption may impact non-FINRA member firms' decision whether to become FINRA members, and thus also may impact the amount and allocation of trading activity among exchange and off-exchange trading venues from the baseline.
These potential changes in trading activity of proprietary trading firms may affect liquidity, execution quality and trading volume on the various trading venues. However, the extent and direction of the effect is generally not determinate and depends on how other market participants, including non-proprietary trading firms, respond to proprietary firms' actions.
FINRA members that are proprietary trading firms may compete to provide liquidity with other FINRA members. Since the proposed TAF exemption is only available for proprietary trading firms, it could provide those firms with a competitive advantage over other members that engage in similar trading activity but do not qualify as proprietary trading firms by changing the relative costs of trading. However, this advantage would not be greater than what non-FINRA member proprietary trading firms currently experience (prior to the potential amendments of SEA Rule 15b9-1).
In addition, to the extent the proposed rule change leads to more proprietary trading firms joining FINRA, the proposed rule change may increase competition by having a more level playing field in terms of the costs associated with FINRA membership and regulatory requirements. As discussed in the SEC Proposal, competition in liquidity provision may be distorted by inequalities in regulatory requirements.
FINRA considered alternatives to the exemption proposed in this proposed rule change. FINRA believes that the proposed TAF exemption is preferable to an exemption from other types of fees and is directly related to the impacts on the provision of liquidity that the SEC discusses in its proposal.
FINRA also considered other alternative changes to the TAF, including adjusting the overall rate of the TAF or implementing a tiered TAF structure based on trading activity or providing caps. However, such alternatives could likely be more costly to implement for both the affected firms and FINRA, compared to the proposed TAF exemption. Accordingly, FINRA believes that the simple structure in this proposed rule change would be more cost effective to implement. FINRA will have more information about the total fees paid by proprietary trading firms, and their impact on FINRA's regulatory programs and fees once these firms become FINRA members.
Following the SEC's 2015 Proposal to amend SEA Rule 15b9-1, FINRA published
FINRA received four generally supportive comment letters in response to
The FIA PTG 2023 Letter, HRT 2023 Letter, and Group One Letter stated that the proposed TAF exemption would help address the significant increase in costs that affected firms would otherwise face in light of the SEC's proposed amendments. HRT and FIA PTG further stated that the proposed exemption from TAF appropriately recognizes the differences in the activities between proprietary trading businesses and customer businesses, and the accompanying costs related to regulating each type of business.
The FIA PTG 2015 Letter and SIFMA Letter requested that the proposed TAF exemption be broadened to include all principal trades done on an exchange of which a firm is a member, rather than just trades by proprietary trading firms.
HRT proposed that all principal trades executed on any exchange be exempt from the TAF, adding that “off-exchange trades, as well as Agency and Riskless Principal trades executed on an exchange, should continue to be charged the TAF.”
As discussed above, FINRA believes that it is appropriate to proceed with an exemption from TAF for proprietary trading firms with respect to their transactions on an exchange of which they are a member because FINRA anticipates that regulatory costs largely will relate to overseeing such firms' activity over the counter or across exchanges.
The FIA PTG 2015 Letter requested that, should the TAF exemption be limited to “proprietary trading firms” as proposed, FINRA provide guidance regarding the scope of the term “proprietary trading firm” to clarify: (i) the scope of the term “customer” for purposes of the exemption, and (ii) the requirement that traders be owners of, employees of, or contractors to the firm. Specifically, the FIA PTG 2015 Letter requested that FINRA clarify that the criteria “does not have customers” only applies to customers that are engaged in transactions in securities that are subject to the TAF, and not to “non-securities transactions, fixed-income transactions, and other businesses such as stock-lending and licensing of technology.”
In response to these comments, FINRA is clarifying that the relevant activities for purposes of the proposed definition of “proprietary trading firm” are securities activities. The term “securities activities” would include transactions in any security (including fixed income) and also would include securities lending transactions. However, the term would not include non-securities activities such as licensing of technology or non-securities transactions. In addition, FINRA is modifying the definition of “proprietary trading firm” to clarify that “customer” would include “any person, other than a broker or dealer, with whom the member engages, or within the past six
Pittsburgh University stated that proprietary trading firms engage in significant trading in the marketplace, which pose a substantial risk to the market, and that there is a related cost for FINRA to supervise and oversee proprietary trading firm activity and that, therefore, FINRA should apply a TAF rate to proprietary trading firms that is proportional to the cost of regulating such firms.
FINRA agrees that regulating proprietary trading firm trading activity will involve a cost. For this reason, FINRA is not proposing to exempt proprietary trading firms from the TAF altogether. As discussed above, FINRA believes it is appropriate to exempt proprietary trading firms from the TAF for transactions on an exchange of which they are a member because FINRA anticipates that regulatory costs largely will relate to overseeing such firms' activity over the counter or across exchanges.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Pricing Schedule at Options 7, Section 3 (Regular Order Fees and Rebates).
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the Exchange's Pricing Schedule at Options 7, Section 3 (Regular Order Fees and Rebates). The Exchange initially filed the proposed pricing changes on June 1, 2023 (SR-MRX-2023-09). On June 12, 2023, the Exchange withdrew that filing and submitted this filing.
Today, as set forth in Table 1 of Options 7, Section 3, the Exchange assesses the following maker/taker fees for regular orders in Penny and Non-Penny Symbols:
Market participants
In addition, the Exchange currently offers Market Makers a number of ways to reduce their maker/taker fees described above. First, Market Makers may qualify for reduced taker fees in Penny Symbols when trading against Priority Customer orders in Penny Symbols entered by an Affiliated
Second, Market Makers may currently qualify for reduced taker fees in Non-Penny Symbols when trading against Priority Customer orders in Non-Penny Symbols entered by an Affiliated Member or Affiliated Entity. In lieu of the $1.10 per contract Tier 1/Tier 2 Market Maker Taker Fee, a Taker Fee of $0.90 per contract applies instead when trading with Priority Customer orders in Non-Penny Symbols entered by an Affiliated Member or Affiliated Entity. A Taker Fee of $0.50 per contract applies instead when trading with Priority Customer orders in Non-Penny Symbols entered by an Affiliated Member or Affiliated Entity if the Member has a Total Affiliated Member or Affiliated Entity Priority Customer ADV of 0.20% to less than 0.75% Customer Total Consolidated Volume. A Taker Fee of $0.20 per contract applies instead when trading with Priority Customer orders in Non-Penny Symbols entered by an Affiliated Member or Affiliated Entity if the Member has a Total Affiliated Member or Affiliated Entity Priority Customer ADV of 0.75% Customer Total Consolidated Volume or more.
Third, Market Makers may qualify for a reduction in the Tier 1 and Tier 2 Maker Fees described above if the Market Maker has increased its volume which adds liquidity in Penny Symbols as a percentage of Customer Total Consolidated Volume by at least 100% over the Member's December 2022 Market Maker volume which adds liquidity in Penny Symbols as a percentage of Customer Total Consolidated Volume. Market Makers that qualify will have their Tier 1 Maker Fee reduced to $0.08 and their Tier 2 Maker Fee reduced to $0.04. Market Makers with no volume in the Penny Symbol add liquidity segment for the month of December 2022 may qualify for the reduced Tier 1 and Tier 2 Maker Fees by having any new volume considered as added volume.
The Exchange now proposes to amend the Table 3 qualifying tier thresholds in the following manner. First, the Exchange proposes to introduce new Tiers 3 and 4 and related maker/taker fees. Specifically, the Exchange proposes that Tiers 3 and 4 will have the following volume requirements:
As proposed, Market Makers that qualify for Tiers 3 and 4 will receive Penny Symbol maker rebates of $0.05 per contract (Tier 3) and $0.10 per contract (Tier 4). Additionally, Market Makers that qualify for Tiers 3 and 4 will be assessed a Penny Symbol taker fee of $0.50 per contract in both tiers, which is the same Penny Symbol taker fee they are charged today in Tiers 1 and 2. The note 2 incentive will also apply to the Market Maker Tiers 3 and 4 taker fees in Penny Symbols, like they do today for Tiers 1 and 2. Specifically, the Exchange will also offer Market Makers the reduced Penny Symbol taker fees set forth in the note 2 incentive (in lieu of the $0.50 per contract Tier 3//Tier 4 taker fee) if they trade against Priority Customer orders in Penny Symbols entered by an Affiliated Member or Affiliated Entity.
In Non-Penny Symbols, Market Makers that qualify for Tiers 3 and 4 will be charged maker fees of $0.15 per contract (Tier 3) and $0.10 per contract (Tier 4). Additionally, Market Makers that qualify for Tiers 3 and 4 will be assessed a Non-Penny Symbol taker fee of $1.10 per contract in both tiers,
For non-Priority Customers except Market Makers, the Exchange will continue to assess the same maker/taker fees in Tiers 3 and 4 for Penny and Non-Penny Symbols as the non-Priority Customer maker/taker fees in Tiers 1 and 2 today. Specifically, all non-Priority Customers other than Market Makers will be assessed the Penny Symbol maker fee of $0.47 per contract and Penny Symbol taker fee of $0.50 per contract across Tiers 1-4. Additionally, all non-Priority Customers except Market Makers will be assessed the Non-Penny Symbol maker fee of $0.90 per contract and Penny Symbol taker fee of $1.10 per contract across Tiers 1-4.
As it relates to Priority Customers, the Exchange will continue to assess no maker fees in Tiers 3 and 4 in both Penny and Non-Penny Symbols, identical to the Priority Customer Tiers 1 and 2 maker fees today. For the taker fees in both Penny and Non-Penny Symbols, the Exchange will charge Priority Customers $0.15 per contract in Tier 3 and $0.10 per contract in Tier 4.
Second, the Exchange proposes to modify the existing qualifying tier thresholds and related maker/taker pricing for Tiers 1 and 2. As it relates to the qualifying tier thresholds, the Exchange proposes to amend the Tier 2 qualifications as follows:
As described
For the related Tier 1 and Tier 2 maker/taker fees, the Exchange proposes to modify those fees for Market Makers and Priority Customers in a number of ways. For Market Makers, the Exchange proposes to decrease the Penny Symbol maker fees in Tier 1 and Tier 2 from $0.20 to $0.10 per contract (Tier 1) and from $0.10 to $0.00 per contract (Tier 2). No other changes are being proposed to the remaining Tiers 1 and 2 maker/taker fees for Market Makers.
As it relates to Priority Customers, the Exchange proposes to begin charging those market participant orders taker fees in Tiers 1 and 2. Specifically, Priority Customers will be charged taker fees of $0.15 per contract in both Tiers 1 and 2 for Penny Symbols. For Non-Penny Symbols, the Exchange proposes to charge Priority Customers taker fees of $0.35 per contract (Tier 1) and $0.25 per contract (Tier 2).
While the maker/taker fees in Table 1 of Options 7, Section 3 for the majority of market participants (
The Exchange proposes to eliminate the note 6 incentive described above. This temporary incentive was first introduced to encourage Market Makers to engage in substantial amounts of liquidity adding activity in Penny Symbols on the Exchange, as well as to grow substantially the extent to which they do so relative to a recent benchmark month.
The Exchange believes that its proposal is consistent with Section 6(b)
The Exchange's proposed changes to its schedule of credits are reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for options securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. For example, clear substitutes to the Exchange exist in the market for options security transaction services. The Exchange is only one of sixteen options exchanges to which market participants may direct their order flow.
Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules. As such, the proposal represents a reasonable attempt by the Exchange to increase its liquidity and market share relative to its competitors.
The Exchange believes that its proposal to amend the qualifying tier thresholds and related maker/taker pricing are reasonable for several reasons. The Exchange believes that the modified volume threshold in Tier 2 and the new volume thresholds in Tiers 3 and 4 are reasonably designed to encourage Market Makers and Priority Customers to increase their liquidity adding activity to qualify for lower maker fees or maker rebates (for Market Makers only) and to increase their liquidity removing activity to qualify for the lower taker fees (for Priority Customers only).
The Exchange also believes that the proposed maker/taker pricing in Table 1 of Options 7, Section 3 is reasonable for the reasons that follow. First, the Exchange believes that it is reasonable to assess qualifying Market Makers lower maker fees or maker rebates, depending on the tier achieved, in the manner described above.
The Exchange further believes that the proposed changes to the qualifying tier thresholds and related maker/taker pricing in the manner described above are equitable and not unfairly discriminatory as the proposed changes will apply uniformly to all similarly situated participants. The maker/taker fees in Table 1 of Options 7, Section 3 for the majority of market participants (
The Exchange believes that its proposal to eliminate the note 6 incentive described above is reasonable because this temporary incentive has not had its intended effect of incentivizing Market Makers to increase their liquidity adding activity in Penny Symbols on the Exchange over the stipulated time period. As such, the Exchange is eliminating the note 6 incentive in order to redirect future resources into other pricing programs intended to incentivize increased order flow.
The Exchange also believes that its proposal is equitable and not unfairly discriminatory as the note 6 incentive will be eliminated for all Market Makers. Further, the Exchange notes that the proposed changes will not adversely impact any market participant's ability to otherwise qualify for reduced fees or rebates offered under other programs in the Pricing Schedule.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of intra-market competition, the Exchange does not believe that its proposal will place any category of market participant at a competitive disadvantage. As discussed above, while parts of the Exchange's proposal provide more incentives for certain order flow and activity on the Exchange (
In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. In sum, if the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to file number SR-MRX-2023-11. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Based upon a review of the administrative records assembled in this matter, and in consultation with the Attorney General and the Secretary of the Treasury, I have concluded that there is a sufficient factual basis to find that ISIL-Libya (and other aliases) uses
Therefore, pursuant to section 1(a)(ii) of E.O. 13224, I hereby amend the designation of ISIL-Libya as a Specially Designated Global Terrorist to include the following new aliases: Islamic State of Iraq and ash-Sham in Libya, ISIS-Libya, ISIS-L; and amend the designation of Real IRA as a Specially Designated Global Terrorist to include the following new aliases: New Irish Republican Army, New IRA, NIRA, and IRA Army Council.
This notice shall be published in the
Based upon a review of the Administrative Records assembled pursuant to section 219(a)(4)(C) of the Immigration and Nationality Act, as amended (8 U.S.C. 1189(a)(4)(C)) (“INA”), and in consultation with the Attorney General and the Secretary of the Treasury, I conclude that the circumstances that were the basis for the designations of the aforementioned organizations as Foreign Terrorist Organizations have not changed in such a manner as to warrant revocation of the designations and that the national security of the United States does not warrant a revocation of the designations. I also conclude that there is a sufficient factual basis to find that ISIL-Libya (and other aliases) uses the additional alias Islamic State of Iraq and ash-Sham in Libya (also known as ISIS-Libya and ISIS-L); and that there is a sufficient factual basis to find that Real IRA (and other aliases) uses the additional alias New Irish Republican Army (also known as New IRA, NIRA, and IRA Army Council).
Therefore, I hereby determine that the designations of the aforementioned organizations as Foreign Terrorist Organizations, pursuant to section 219 of the INA (8 U.S.C. 1189), shall be maintained. Additionally, pursuant to section 219(b) of the INA, as amended (8 U.S.C. 1189(b)), I hereby amend the designation of ISIL-Libya (and other aliases) as a Foreign Terrorist Organization to include the following new aliases: Islamic State of Iraq and ash-Sham in Libya, ISIS-Libya, ISIS-L; and amend the designation of Real IRA (and other aliases) as a Foreign Terrorist Organization to include the following new aliases: New Irish Republican Army, New IRA, NIRA, and IRA Army Council.
This determination shall be published in the
Surface Transportation Board.
Notice and request for comments.
As required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an existing collection without an OMB Control Number of a Classification Index Survey Form, as described below.
Comments on this information collection should be submitted by July 31, 2023.
Written comments should be identified as “Paperwork Reduction Act Comments, Surface Transportation Board, Classification Index Survey Form.” Written comments for the proposed information collection should be submitted via
Please also direct all comments to Chris Oehrle, PRA Officer, Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001, or to
The Board previously published a notice about this collection in the
Under the PRA, a Federal agency that conducts or sponsors a collection of information must display a currently valid OMB control number. A collection of information, which is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), includes agency requirements that persons submit reports, keep records, or provide information to the agency, third parties, or the public. Section 3507(b) of the PRA requires, concurrent with an agency's submitting a collection to OMB for approval, a 30-day notice and comment period through publication in the
Naugatuck Railroad Company (NAUG), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to lease from Boston & Maine Corporation (B&M) and acquire the right to operate from Springfield Terminal Railway Company (STR) as a common carrier over approximately 1,330 feet of rail line currently owned by B&M and operated by STR between a connection to the Torrington Branch at engineering station 0+00 and engineering station 13+30, all in New Haven County, Conn. (the Line).
According to the verified notice, NAUG has entered into a land and rail assets lease agreement with CSX Transportation, Inc. (CSXT), on behalf of B&M and STR, which are both subsidiaries of CSXT. The verified notice states that, upon consummation of the agreement, NAUG will lease and operate the Line. NAUG states that it currently operates over the Torrington Branch, an approximately 19.6-mile rail line that extends between NAUG milepost 0.0 in Waterbury, Conn., and NAUG milepost 19.6 in Torrington, Conn.
NAUG certifies that its projected annual freight revenues will not result in the creation of a Class I or Class II rail carrier and will not exceed $5 million. NAUG also certifies that the agreement does not include an interchange commitment.
The transaction may be consummated on or after July 14, 2023, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than July 7, 2023 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36709, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on NAUG's representative, John R. Gamm, John R. Gamm LLC, 32 Dutton Place Way, Glastonbury, CT 06033.
According to NAUG, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Tennessee Valley Authority.
Notice of Intent; extension of comment period.
The Tennessee Valley Authority (TVA) is announcing a second extension of the public comment period on the Cheatham County Generation Site Notice of Intent to Prepare an Environmental Impact Statement. A Notice of Intent to prepare an EIS was published in the
The comment period for the Notice of Intent published May 19, 2023, at 88 FR 32267, is extended to July 7, 2023. Comments must be postmarked, emailed, or submitted online no later than July 7, 2023.
Comments can be submitted by one of the following methods:
1.
2.
3.
Before including your address, phone number, email address, or other personal identifying information in your comment, please note that any comments received, including names and addresses, will become part of the project administrative record and will be available for public inspection.
For general information about the project, please contact J. Taylor Johnson, NEPA Compliance Specialist, by mail at 1101 Market Street, BR 2C-C, Chattanooga, Tennessee 37402, by email at
The Cheatham County Generation Site (CHG) would generate approximately 900 Megawatts (MW) and replace generation capacity for a portion of the Cumberland Fossil Plant (CUF) second unit retirement planned by the end of 2028. The CHG CTs would be composed of multiple natural gas-fired frame CTs and natural gas-fired and oil-fired (
On May 19, 2023, TVA published a Notice of Intent to prepare an EIS to address the potential environmental impacts associated with the proposed construction and operation of a simple cycle Combustion Turbine (CT) plant and Battery Energy Storage System (BESS) on a parcel of TVA-owned land in Cheatham County, Tennessee. On June 20, 2023, TVA extended the public comment period to June 27, 2023 (88 FR 39903). On June 21, 2023, TVA held a public open house. Due to public interest and multiple requests, TVA is extending the public comment period until July 7, 2023. The extension will allow the public more time after the June 21st open house to provide their written comments. The TVA website listed above contains relevant information about the proposed project. TVA urges the public to review this information on the website prior to submitting comments.
Federal Aviation Administration (FAA), DOT.
Notice; correction.
The Federal Aviation Administration published a document in the
Ms. Heidi Higginbotham, Program Manager, Federal Aviation Administration, Louisiana/New Mexico Airports District Office, Telephone (817) 222-5144.
In the
The County of Dona Ana requests the release of 12.027 acres of land requested which consists of two parcels of vacant land with a combined land area. Parcel #1 contains 11.95 acres and is triangular. Parcel #2 contains 0.077-acres and is triangular. The land was acquired by Deed conveyed to the city from the United States of America Bureau of Land Management Section 23 of the Airport and Airway development Act of 1970. The land proposed for release will be swapped for 5.68 acres by Paseo Del Norte, LLC. The property to be released will ultimately be sold to Franklin Mountain for the development of a logistics park. The benefit to civil aviation has long-term impacts from the logistics park with plans to construct an air cargo handling facility.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 10 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before July 31, 2023.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2008-0355, Docket No. FMCSA-2011-0089, Docket No. FMCSA-2014-0382, Docket No. FMCSA-2015-0323, Docket No. FMCSA-2018-0057, Docket No. FMCSA-2019-0028, Docket No. FMCSA-2019-0029, or Docket No. FMCSA-2021-0025 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2008-0355, Docket No. FMCSA-2011-0089, Docket No. FMCSA-2014-0382, Docket No. FMCSA-2015-0323, Docket No. FMCSA-2018-0057, Docket No. FMCSA-2019-0028, Docket No. FMCSA-2019-0029, or Docket No. FMCSA-2021-0025), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. 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 that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
The 10 individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 10 applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The 10 drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for commercial driver's license (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of July and are discussed below.
As of July 5, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following two individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
Alan Finlayson (AL); and Stephen Harmon (WV).
The drivers were included in docket number FMCSA-2015-0323 or FMCSA-2019-0029. Their exemptions are applicable as of July 5, 2023 and will expire on July 5, 2025.
As of July 12, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2008-0355, FMCSA-2011-0089, FMCSA-2014-0382, FMCSA-2018-0057, or FMCSA-2019-0028. Their exemptions are applicable as of July 12, 2023 and will expire on July 12, 2025.
As of July 30, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), Charles Anthony (ND) has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers.
The driver was included in docket number FMCSA-2021-0025. Their exemption is applicable as of July 30, 2023 and will expire on July 30, 2025.
The exemptions are extended subject to the following conditions: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based on its evaluation of the 10 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt 17 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.
The exemptions were applicable on June 21, 2023. The exemptions expire on June 21, 2025.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to
On May 16, 2023, FMCSA published a notice announcing receipt of applications from 17 individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (88 FR 31302). The public comment period ended on June 15, 2023, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
FMCSA received no comments in this proceeding.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on the 2007 recommendations of the Agency's Medical Expert Panel. The Agency conducted an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant's driving record found in the Commercial Driver's License Information System for commercial driver's license (CDL) holders, and interstate and intrastate inspections recorded in the Motor Carrier Management Information System. For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency. A summary of each applicant's seizure history was discussed in the May 16, 2023,
These 17 applicants have been seizure-free over a range of 33 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last 2 years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially.
The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds further that in each case exempting these applicants from the epilepsy and seizure disorder prohibition in § 391.41(b)(8) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5T; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 17 exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition in § 391.41(b)(8), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a request for approval for extension with modification of a currently approved information collection.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review and approval. The ICR describes the nature of the information collection and its expected burden. The information collection described in this document is for NHTSA's Automated Vehicle Transparency and Engagement for Safe Testing (AV TEST) Initiative, which involves the collection of voluntarily-submitted information from entities involved in the testing of vehicles equipped with automated driving systems (ADS) and from States and local authorities involved in the regulation of ADS testing. The purpose of this collection is to provide information to the public about ADS testing operations in the United States and applicable State and local laws, regulations, and guidelines. A
Comments must be submitted on or before July 31, 2023.
Written comments and recommendations for the proposed information collection, including suggestions for reducing burden, should be submitted to the Office of Management and Budget at
For additional information or access to background documents, contact Chris Wiacek, Office of Data Acquisition, (NSA-100), Room W53-478, 1200 New Jersey Avenue SE, Washington, DC 20590. Mr. Wiacek's telephone number is (202) 366-4801. Please identify the relevant collection of information by referring to its OMB Control Number.
Under the PRA (44 U.S.C. 3501
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NHTSA believes that Automated Driving System (ADS) technology, including technology contemplating no human driver at all, has the potential to significantly improve roadway safety in the United States. This technology remains substantially in development phases with companies across the United States performing varying levels of development, research, and testing relating to the performance of various aspects of ADS vehicle technologies. While much of these development operations occur in private facilities and closed-course test tracks, many stakeholders have progressed to conducting ADS vehicle testing on public roads or in public demonstrations. Moreover, to regulate such operations in their jurisdictions, many local authorities, such as States and cities, have passed laws governing ADS vehicle testing on public roads. These statutes, regulations, and ordinances vary, ranging from operational requirements to mandating the submission of periodic reports detailing ADS vehicle operation.
The program supports two main objectives. The first objective is to provide the public with access to geographic visualizations of testing at the national, State, and local levels. This information is displayed on a graphic of the United States, with projects overlaid on the geographic areas in which the testing project is taking place. By clicking on a testing location, members of the public see additional information about the operation and the ADS operator. Additional information may include basic information about the ADS operator, a brief statement about the entity, specific details of the testing activity, high-level (non-confidential) descriptions of the vehicles and technology, photos of the test vehicles, the dates on which testing occurs, frequency of vehicle operations, the
The second objective is to provide members of the public with information collected from States and local authorities that regulate ADS operations. State and local authorities will be asked to provide weblinks for specific ADS-related topics, such as statutes, regulations, or guidelines for ADS operations, privacy-related issues, emergency response policies and training, or other activities that cultivate ADS testing. This program provides a central resource for the aforementioned information concerning ADS testing across the United States.
NHTSA estimates that each State or local authority respondent would spend approximately 10 hours responding to this collection. Therefore, for the estimated 35 State or local authority participants, the total burden is estimated to be 350 hours per year.
The total burden for the entire information collection request is estimated to be 2,270 hours (1,920 hours + 350 hours). The total burden hours have been reduced from the original estimate of 2,520 when the agency first sought approval for this information collection because of the lower estimated participation. However, the agency believes the annual hours per respondent has not changed.
The labor cost associated with this collection of information is derived by (1) applying the appropriate average hourly labor rate published by the Bureau of Labor Statistics, (2) dividing by either 0.705
Labor costs associated with original manufacturers of ADS Vehicles or ADS vehicle equipment and operators of ADS vehicles are estimated to be $60.48 per hour for “Project Management Specialists,” Occupation Code 13-1082, ($42.64
Labor costs associated with local and regional authorities, such as states, counties, and cities are estimated to be $66.79 per hour for “Legal Support Workers,” Occupation Code 23-2099, ($41.34
The total annual labor costs for all respondents, private industry, and regional authorities together, are estimated to be $139,499 ($116,122 + $23.377). See Table 1 below for a summary of estimated burden hours and estimated labor costs.
NHTSA's estimate for the burden hours for participants remained the same from the April 6, 2023, notice.
All commenters supported the Initiative's objective to enhance public education and engagement with public ADS vehicle testing by coalescing information regarding respondents' various testing operations or requirements into a centralized resource including information collected from States and local authorities that regulate ADS operations. Specifically, Auto Innovators commented that providing the public with access to see where testing is occurring at the national, state, and local levels helps provide additional transparency and assurances for how safety, mobility and accessibility issues are being addressed by innovators in the AV space, which is critical for building public acceptance of this burgeoning technology. OOIDA supported the objectives of the AV TEST Initiative by stating, it provides the public with direct and easy access to information about AV testing and development, along with information from states regarding activity, legislation, regulations, and local involvement in automation on our roadways. Safe Kids stated NHTSA's information and data collection under the AV TEST Initiative provides a mechanism to keep the public and safety advocates informed about automated vehicle testing activities to be conducted on public roads throughout the country.
The agency did not receive specific comments on the burden of the data collection, however OOIDA and Auto Innovators provided additional comments on how the agency may enhance the Initiative.
OOIDA stated the voluntary nature of AV TEST has not been effective in producing the necessary safety data to implement informed regulatory policies for autonomous vehicles. The AV TEST Initiative's voluntary structure prevents the program from best accomplishing its goals and NHTSA must require mandatory data transparency from manufacturers because it will help educate consumers, the industry, and regulators about the actual reliability and performance of autonomous technology.
In response, the agency's objective of the AV TEST Initiative is to provide members of the public with a centralized database of high-level information about ADS testing activities and State and local laws, recommendations, and initiatives. It is, therefore, outside of the scope of the project to make any reporting mandatory or to expand the collection to include safety information or information that NHTSA would use to evaluate the safety of ADS operations.
The Auto Innovators provided further comments specific to the AV TEST Initiative and how data is presented to the public. The Auto Innovators stated that it is important that NHTSA conduct periodic reviews to verify the accuracy of information that is made available on the AV TEST initiative portal, and that it is up to date. This may include spot check outreach to select organizations to provide updates on the status of their operations, or other updates to the data where the information is known to no longer be accurate (for example, if an AV tester were to cease operations).
In response, the agency agrees with the Auto Innovators and believes accurate data serves the intent of the Initiative to enhance public education and engagement with public ADS vehicles. However, NHTSA notes that data submitted as part of the AV TEST Initiative may become stale. For example, because the AV TEST Initiative is voluntary, an ADS operator could provide information on an ADS operation and never update NHTSA when the operation is completed. Although we provide a mechanism for participants to change the status of test sites from active to inactive or completed, participants may not update the status of an operation. NHTSA does reach out to program participants about operations that has not been updated for an extended period of time. In addition, we have provided participants the ability to remove out-of-date information and archive the data, which removes it from the AV TEST web page.
Furthermore, because the information submitted by participants is voluntary, before information is transferred to the public website the agency reviews the submissions for any obvious errors or concerns and will contact the participants accordingly prior to approval for publication if any concerns are identified. The agency also does a general periodic review for information that is out-of-data such as removing participants from the public website when we become aware the entity is no longer testing and has ceased operations.
The Auto Innovators also recommended NHTSA consider repurposing or rebranding the AV TEST initiative to emphasize not only the testing of AVs, but also to capture the transition from testing to real-world deployment. This is unlikely to create any additional burden in terms of the information provided as part of the AV TEST initiative but is likely an important distinction to make in building public acceptance and confidence in new technology. This could perhaps be achieved by using different colors and/or patterns to enable users to distinguish between testing and deployment in the online visualization tool.
In response, the agency believes the AV TEST Initiative needs to evolve over time as the technology progresses and the ADS developers transition their operations to have changing interaction with the public beyond testing and demonstration. Currently, the AV TEST Initiative provides participants the options to identify testing operations where the vehicles are providing a service to the public, however, currently specific to testing and not real-world deployment. As recently as May 10th, 2023, the agency held a workshop with
Lastly, Auto Innovators suggested, NHTSA should proactively encourage states to share information on statewide AV policies or initiatives as part of the AV TEST program, as this information is not only critical for public transparency, but also an important resource for manufacturers that need to develop systems to account for operational and policy related differences between regions.
In response, the agency has proactively reached out to states and encouraged them to participate in this voluntary program. In discussion with the states, the agency recognizes that each state has their own priorities with respect to ADS vehicles and may have limited resources or interest to participate in AV TEST. The agency continues to encourage state participation, however, as noted earlier this is a voluntary program.
NHTSA appreciates the commenters' input and will keep this input in mind when considering future approaches to ADS technologies.
Office of the Secretary (OST), DOT.
60-Day notice and request for comments.
The Department of Transportation (DOT) invites public comments on our intention to request Office of Management and Budget (OMB) approval for an information collection in accordance with the requirements of the Paperwork Reduction Act of 1995. The collection is necessary for administration of the Multimodal Project Discretionary Grants (MPDG). This includes three funding opportunities: the “National Infrastructure Project Assistance grants program (Mega),” the “Nationally Significant Multimodal Freight and Highways Projects grants program (INFRA)”, and the “Rural Surface Transportation Grant program (Rural)”. The MPDG provides Federal financial assistance for surface transportation infrastructure projects—including highway and bridge, intercity passenger rail, railway-highway grade and separation, wildlife crossing, public transportation, marine highway, and freight and multimodal projects, or groups of such projects, of national or regional significance, as well as to projects to improve and expand the surface transportation infrastructure in rural areas.
Written comments should be submitted by August 29, 2023.
To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means:
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For further information regarding this notice, please contact the Office of the Secretary via email at
New Collection. OMB number will be issued after the collection is approved.
The Nationally Significant Multimodal Freight and Highways Projects grants program (“INFRA”) (23 U.S.C. 117) was established in the Fixing American's Surface Transportation Act of 2015 (“FAST ACT”), Public Law 114-94 sec. 1105, and continued in the Infrastructure Investment and Jobs Act, Public Law 117-58 (2021). OST is referring to these grants as “FASTLANE” or “INFRA” Discretionary Grants, depending on the year of award.
The Bipartisan Infrastructure Law established two new programs along with the reauthorization of INFRA. The Mega Program, known statutorily as the National Infrastructure Project Assistance program (49 U.S.C. 6701), will support large, complex projects that are difficult to fund by other means and likely to generate national or regional economic, mobility, or safety benefits. The Rural Surface Transportation Grant Program (23 U.S.C. 173) will support projects to improve and expand the surface transportation infrastructure in rural areas to increase connectivity, improve the safety and reliability of the movement of people and freight, and generate regional economic growth and improve quality of life.
The DOT combined these three programs into single Notice of Funding Opportunity (NOFO) to provide a more efficient application process for project sponsors. While they remain separate programs for the purposes of award, the programs share many common characteristics. Because of these shared characteristics, it is possible for many projects to be eligible and considered for multiple programs using a single application.
This notice seeks comments on the proposed information collection, which will collect information necessary to support the ongoing oversight and administration of previous awards, the evaluation and selection of new applications, the funding agreement negotiation stage for new awards, and the evaluation of the programs.
The reporting requirements for the program is as follows:
To be considered to receive a MPDG grant, a project sponsor must submit an application to DOT containing a project narrative, as detailed in the NOFO. The project narrative should include the information necessary for the Department to determine that the project satisfies eligibility requirements as warranted by law.
After the award announcement the Department will send out a voluntary survey to all applicants and webinar participants to help evaluate the application process.
Following the announcement of a funding award, the recipient and DOT will negotiate and sign a funding agreement. In the agreement, the recipient must describe the project that DOT agreed to fund, which is the project that was described in the MPDG application or a reduced-scope version of that project. The agreement also includes project schedule milestones, a budget, and project-related climate change and equity planning and policies.
During the project monitoring stage, grantees will submit reports on the financial condition of the project and the project's progress. Grantees will submit progress and monitoring reports to the Government on a quarterly basis until completion of the project. The progress reports will include an SF-425, Federal Financial Report, and other information determined by the administering DOT Operating Administration. This information will be used to monitor grantees' use of Federal funds, ensuring accountability and financial transparency in the MPDG programs.
For the purposes of estimating the information collection burden below for new applicants and awardees, the Department is assuming that for each year 2023-2025, the Department will review approximately 500 applications in Year 1, negotiate 45 funding agreements in Year 2, and begin quarterly project monitoring for 45 projects in Year 3. For a new applicant in 2023, their burden will be 100 hours in 2023, 6 hours in 2024, and 20 hours in 2025. See Table 1 below:
This Notice is separately estimating the information collection burden for projects awarded from 2016-2022. Approximately 60 of these projects are in the project monitoring phase in Year 1, while 47 projects are still negotiating funding agreements. In Year 2, approximately 30 of these projects will begin project monitoring, while approximately 20 projects will cease reporting once their projects are completed. In Year 3, 10 projects will begin project monitoring while 20 projects will cease reporting. The individual burden for a project awarded from 2016-2021 will depend on when they were selected, when they completed negotiation of their funding agreement, and when their project reaches completion. See Table 2 below:
The Department's estimated burden for this information collection is the following:
The following is detailed information and instructions regarding the specific reporting requirements for each report identified above:
To be considered to receive a MPDG grant, a project sponsor must submit an application to DOT containing a project narrative, as detailed in the NOFO. The project narrative should include the information necessary for the Department to determine that the project satisfies eligibility requirements.
Applications must be submitted through
The application should include a table of contents, maps, and graphics, as appropriate, to make the information easier to review. The Department recommends that the application be prepared with standard formatting preferences (
OST estimates that it takes approximately 100 person-hours to compile an application package for a MPDG application. Since OST expects to receive 500 applications per funding round, the total hours required are estimated to be 50,00 hours (100 hours × 500 applications = 50,000 hours) on a one-time basis, per funding round.
To understand the MPDG grant process from the applicant's point of view, OST plans to send out a survey after all award decisions have been made. This survey will go to all applicants, both successful and unsuccessful, as well as webinar participants that did not apply and will take approximately .5 hours to complete.
DOT enters a funding agreement with each recipient. In the agreement, the recipient describes the project that DOT agreed to fund, which is typically the project that was described in the MPDG application or a reduced-scope version of that project. The agreement also includes a project schedule, budget, and project related climate change and equity planning and policies.
OST estimates that it takes approximately 6 person-hours to respond to provide the information necessary for funding agreements. Based on previous rounds of MPDG awards, OST estimates that there will likely be 45 agreements negotiated per additional funding round. The total hours required are estimated to be 270 (6 hours × 45 agreements = 270 hours) on a one-time basis, per funding round.
OST requires each recipient to submit quarterly reports during the project to ensure the proper and timely expenditure of Federal funds under the grant.
The requirements comply with 2 CFR part 200 and are restated in the funding agreement. During the project monitoring stage, the grantee will complete Quarterly Progress Reports to allow DOT to monitor the project budget and schedule.
OST estimates that it takes approximately 5 person-hours to develop and submit a quarterly progress report. OST expects approximately 45 projects to be awarded per funding round, while grants awarded in prior years will reach completion during the year and would no longer need to submit these reports. OST expects recipients and awardees from 2016-2021 will require 3800 hours to submit project monitoring reports while new recipients and awardees will require 900 hours from 2023-2025.
Internal Revenue Service (IRS) Treasury.
Notice of meeting; correction.
In the
The meeting will be held Monday, July 24, 2023.
Rosalind Matherne at 1-888-912-1227 or 202-317-4115.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. app. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Monday, July 24, 2023, at 3:00 p.m. Eastern Time via teleconference. This meeting was previously announced in the
The agenda will include reports from the committees, and subcommittee discussions on priorities the TAP will focus on for the 2023 year. Public input is welcomed.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice; withdrawal.
On Tuesday, June 27, 2023, the Veterans Benefits Administration (VA), published a notice in the
As of June 27, 2023, the FR notice published at 88 FR 122 on Tuesday, June 27, 2023, is withdrawn.
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
FR Doc. 2023-13529, published on Tuesday, June 27, 2023, is withdrawn by this notice.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before August 29, 2023.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2024. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also includes requests for information regarding potential changes to the low-volume payment adjustment under the ESRD PPS. In addition, this proposed rule would update requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
To be assured consideration, comments must be received at one of the addresses provided below, by August 25, 2023.
In commenting, please refer to file code CMS-1782-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
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For information on viewing public comments, see the beginning of the
Delia Houseal, (410) 786-2724, for issues related to the ESRD Quality Incentive Program (QIP).
To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents.
This proposed rule proposes updates to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), payment for renal dialysis services furnished to individuals with acute kidney injury (AKI), the ESRD Quality Incentive Program (QIP), and the ESRD Treatment Choices (ETC) Model. Additionally, this proposed rule proposes policies that reflect our commitment to achieving equity in health care for our beneficiaries by supporting our ability to assess whether, and to what extent, our programs and
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning calendar year (CY) 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This proposed rule would update the ESRD PPS for CY 2024.
On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a new subsection (r) that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017. This proposed rule would update the AKI payment rate for CY 2024.
The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is authorized by section 1881(h) of the Act. The Program establishes incentives for facilities to achieve high quality performance on measures with the goal of improving outcomes for ESRD beneficiaries. This proposed rule proposes several updates for the ESRD QIP, including: a revision to the regulatory definition of “minimum total performance score” that more accurately captures how we calculate the median of national ESRD facility performance on reporting measures; the codification of our previously finalized measure selection, retention, and removal policies; updates that would begin with Payment Year (PY) 2026, including one new measure, modifications to two current measures, and the removal of two measures; and the addition of two new measures beginning with PY 2027.
The ETC Model is a mandatory Medicare payment model tested under section 1115A of the Act. The ETC Model is operated by the Center for Medicare and Medicaid Innovation (Innovation Center), and tests the use of payment adjustments to encourage greater utilization of home dialysis and kidney transplants, to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures.
The ETC Model was finalized as part of a final rule published in the
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We are proposing to update the AKI payment rate for CY 2024. The proposed CY 2024 payment rate is $269.99, which is the same as the ESRD PPS base rate proposed for CY 2024.
We are proposing several updates for the ESRD QIP. We are proposing to codified the definition of “minimum total performance score” and to codify our previously finalized measure selection, retention, and removal policies. Beginning with PY 2026, we are proposing to add the Facility Commitment to Health Equity reporting measure to the ESRD QIP measure set, modify the COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) reporting measure to align with updated measure specifications developed by the Centers for Disease Control and Prevention (CDC), remove the Ultrafiltration Rate reporting measure and the Standardized Fistula Rate clinical measure, and update the Clinical Depression Screening and Follow-Up measure's scoring methodology and convert that measure to a clinical measure. Beginning with PY 2027, we are proposing to add the Social Drivers of Health reporting measure and the Screen Positive Rate for Social Drivers of Health reporting measure to the ESRD QIP measure set.
We are proposing to revise our regulations at § 512.390 to acknowledge the ability of the CMS Administrator to review the results of ETC Participants' targeted review requests.
In section VIII.D.5 of this proposed rule, we set forth a detailed analysis of the impacts that the proposed changes would have on affected entities and beneficiaries. The impacts include the following:
The impact table in section VIII.D.5.a of this proposed rule displays the estimated change in Medicare payments to ESRD facilities in CY 2024 compared
Section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate. Under this authority, CMS implemented § 413.234 to establish the TDAPA, a transitional drug add-on payment adjustment for certain new renal dialysis drugs and biological products and § 413.236 to establish the TPNIES, a transitional add-on payment adjustment for certain new and innovative equipment and supplies. The TDAPA and the TPNIES are not budget neutral.
As discussed in section II.D of this proposed rule, the TPNIES payment period for the Tablo® System ends on December 31, 2023. As discussed in section II.E of this proposed rule, the TDAPA payment period for KORSUVA
The impact table in section VIII.D.5.c of this proposed rule displays the estimated CY 2024 Medicare payments for renal dialysis services furnished to individuals with AKI compared to estimated Medicare payments for renal dialysis services furnished to individuals with AKI in CY 2023. The overall impact of the CY 2024 changes is projected to be a 1.6 percent increase in Medicare payments for individuals with AKI. Hospital-based ESRD facilities would have an estimated 1.8 percent increase in Medicare payments compared with freestanding ESRD facilities that would have an estimated 1.6 percent increase. The overall impact reflects the effects of the proposed Medicare payment rate update and proposed CY 2024 wage index. We estimate that the aggregate Medicare payments made to ESRD facilities for renal dialysis services furnished to patients with AKI, at the proposed CY 2024 ESRD PPS base rate, would increase by $1 million in CY 2024 compared to CY 2023.
We estimate that the overall economic impact of the PY 2026 ESRD QIP would be approximately $141.1 million as a result of the policies we have previously finalized and the proposals in this proposed rule. The $141.1 million estimate for PY 2026 includes $121.1 million in costs associated with the collection of information requirements and approximately $20 million in payment reductions across all facilities. We also estimate that the overall economic impact of the PY 2027 ESRD QIP would be approximately $148 million as a result of the policies we have previously finalized and the proposals in this proposed rule. The $148 million estimate for PY 2027 includes $130.7 million in costs associated with the collection of information requirements and approximately $17.3 million in payment reductions across all facilities.
The impact estimate in section VIII.D.5.d of this proposed rule describes the estimated change in anticipated Medicare program savings arising from the ETC Model over the duration of the ETC Model as a result of the changes in this proposed rule. We estimate that the ETC Model would result in $28 million in net savings over the 6.5 year duration of the ETC Model. We also estimate that the changes proposed in this proposed rule would produce no change in net savings for the ETC Model. As the ETC Model targeted review process has already been finalized in the Specialty Care Models final rule and ETC Participants are not required to seek administrative review of targeted review determinations, we believe there would be minimal additional burden associated with our proposal.
On January 1, 2011, CMS implemented the ESRD PPS, a case-mix adjusted bundled PPS for renal dialysis services furnished by ESRD facilities, as required by section 1881(b)(14) of the Act, as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act), established that beginning with CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket percentage increase reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) included several provisions that apply to the ESRD PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act, which required the Secretary, by comparing per patient utilization data from 2007 with such data from 2012, to reduce the single payment for renal dialysis services furnished on or after January 1, 2014, to reflect the Secretary's estimate of the change in the utilization of ESRD-related drugs and biologicals (excluding oral-only ESRD-related drugs). Consistent with this requirement, in the CY 2014 ESRD PPS final rule, we finalized $29.93 as the total drug utilization reduction and finalized a policy to implement the amount over a 3- to 4-year transition period (78 FR 72161 through 72170).
Section 632(b) of ATRA prohibited the Secretary from paying for oral-only ESRD-related drugs and biologicals under the ESRD PPS prior to January 1, 2016. Section 632(c) of ATRA required the Secretary, by no later than January 1, 2016, to analyze the case-mix payment adjustments under section 1881(b)(14)(D)(i) of the Act and make appropriate revisions to those adjustments.
On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted. Section 217 of PAMA included several provisions that apply to the ESRD PPS. Specifically, sections 217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced the drug utilization adjustment that was finalized in the CY 2014 ESRD
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to provide that the Secretary may not pay for oral-only ESRD-related drugs under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) of PAMA further amended section 632(b)(1) of ATRA by requiring that in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. Section 217(c) of PAMA provided that as part of the CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment.
Section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, to provide that payment for oral-only renal dialysis drugs and biological products cannot be made under the ESRD PPS bundled payment prior to January 1, 2025.
Under the ESRD PPS, a single per-treatment payment is made to an ESRD facility for all the renal dialysis services defined in section 1881(b)(14)(B) of the Act and furnished to individuals for the treatment of ESRD in the ESRD facility or in a patient's home. We have codified our definition of renal dialysis services at § 413.171, which is in 42 CFR part 413, subpart H, along with other ESRD PPS payment policies. The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients and accounts for patient case-mix variability. The adult case-mix adjusters include five categories of age, body surface area, low body mass index, onset of dialysis, and four comorbidity categories (that is, pericarditis, gastrointestinal tract bleeding, hereditary hemolytic or sickle cell anemia, myelodysplastic syndrome). A different set of case-mix adjusters are applied for the pediatric population. Pediatric patient-level adjusters include two age categories (under age 13, or age 13 to 17) and two dialysis modalities (that is, peritoneal or hemodialysis) (§ 413.235(a) and (b)).
The ESRD PPS provides for three facility-level adjustments. The first payment adjustment accounts for ESRD facilities furnishing a low volume of dialysis treatments (§ 413.232). The second payment adjustment reflects differences in area wage levels developed from core-based statistical areas (CBSAs) (§ 413.231). The third payment adjustment accounts for ESRD facilities furnishing renal dialysis services in a rural area (§ 413.233).
There are four additional payment adjustments under the ESRD PPS. The ESRD PPS provides adjustments, when applicable, for: (1) a training add-on for home and self-dialysis modalities (§ 413.235(c)); (2) an additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care (§ 413.237); (3) a TDAPA for certain new renal dialysis drugs and biological products (§ 413.234(c)); and (4) a TPNIES for certain new and innovative renal dialysis equipment and supplies (§ 413.236(d)).
Policy changes to the ESRD PPS are proposed and finalized annually in the
We published a final rule, which appeared in the November 7, 2022, issue of the
In accordance with section 1881(b)(14)(F)(i) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket percentage increase and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity adjustment may result in the increase factor being less than 0.0 for a year and may result in payment rates for a year being less than the payment rates for the preceding year. Section 1881(b)(14)(F)(i) of the Act also provides that the market basket increase factor should reflect the changes over time in the prices of an appropriate mix of goods and services included in renal dialysis services.
As required under section 1881(b)(14)(F)(i) of the Act, CMS developed an all-inclusive ESRD Bundled (ESRDB) input price index using CY 2008 as the base year (75 FR 49151 through 49162). We subsequently revised and rebased the ESRDB input price index to a base year of CY 2012 in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136). In the CY 2019 ESRD PPS final rule (83 FR 56951 through 56964), we finalized a rebased ESRDB input price index to reflect a CY 2016 base year. In the CY 2023 ESRD PPS final rule (87 FR 67141 through 67154), we finalized a revised and rebased ESRDB input price index to reflect a CY 2020 base year.
Although “market basket” technically describes the mix of goods and services used for ESRD treatment, this term is also commonly used to denote the input price index (that is, cost categories, their respective weights, and price proxies combined) derived from a market basket. Accordingly, the term “ESRDB market basket,” as used in this document, refers to the ESRDB input price index.
The ESRDB market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the
We propose to use the 2020-based ESRDB market basket as finalized in the CY 2023 ESRD PPS final rule (87 FR 67141 through 67154) to compute the proposed CY 2024 ESRDB market basket percentage increase based on the best available data. Consistent with historical practice, we propose to estimate the ESRDB market basket percentage increase based on IHS Global Inc.'s (IGI) forecast using the most recently available data at the time of rulemaking. IGI is a nationally recognized economic and financial forecasting firm with which CMS contracts to forecast the components of the market baskets. As discussed in section II.B.1.a.(2)(c), we are proposing to calculate the market basket update for CY 2024 based on the proposed market basket percentage increase and the proposed productivity adjustment, following our longstanding methodology.
Based on IGI's first quarter 2023 forecast of the 2020-based ESRDB market basket, the proposed CY 2024 market basket percentage increase is 2.0 percent. We also propose that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase), we would use such data, if appropriate, to determine the CY 2024 market basket percentage increase in the final rule.
Under section 1881(b)(14)(F)(i) of the Act, as amended by section 3401(h) of the Affordable Care Act, for CY 2012 and each subsequent year, the ESRDB market basket percentage increase shall be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the “productivity adjustment”).
The Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the U.S. economy. As we noted in the CY 2023 ESRD PPS final rule (87 FR 67155), the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act previously was published by BLS as private nonfarm business MFP. Beginning with the November 18, 2021, release of productivity data, BLS replaced the term “multifactor productivity” with “total factor productivity” (TFP). BLS noted that this is a change in terminology only and will not affect the data or methodology.
Based on IGI's first quarter 2023 forecast, the proposed productivity adjustment for CY 2024 (the 10-year moving average of TFP for the period ending CY 2024) is 0.3 percentage point. Furthermore, we propose that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the productivity adjustment), we would use such data, if appropriate, to determine the CY 2024 productivity adjustment in the final rule.
In accordance with section 1881(b)(14)(F)(i) of the Act, we propose to base the CY 2024 market basket percentage increase on IGI's first quarter 2023 forecast of the 2020-based ESRDB market basket. We propose to then reduce this percentage increase by the estimated productivity adjustment for CY 2024 based on IGI's first quarter 2023 forecast. Therefore, the proposed CY 2024 ESRDB market basket update is equal to 1.7 percent (2.0 percent market basket percentage increase reduced by a 0.3 percentage point productivity adjustment). Furthermore, as noted previously, we propose that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket and/or productivity adjustment), we would use such data, if appropriate, to determine the CY 2024 market basket percentage increase and productivity adjustment in the final rule.
We note that, as discussed in the CY 2023 ESRD PPS final rule (87 FR 67157), many commenters requested that CMS apply a forecast error payment adjustment to the ESRD PPS base rate to support ESRD facilities during the inflationary period occurring at that time, particularly accounting for what commenters stated was an error in the forecasted payment updates for CYs 2021 and 2022. In response to those comments, we reminded readers that ESRDB market basket updates are set prospectively, which means that the update relies on a mix of both historical data for part of the period for which the update is calculated, and forecasted data for the remainder. We explained that while there is no precedent to adjust for market basket forecast error in the annual ESRD PPS update, the forecast error for a market basket update is calculated as the actual market basket increase for a given year less the forecasted market basket increase.
As we discussed in the CY 2023 ESRD PPS final rule (87 FR 67156), we recognized that recent higher inflationary trends impacted the outlook for price growth over the next several
We define the labor-related share as those expenses that are labor-intensive and vary with, or are influenced by, the local labor market. The labor-related share of a market basket is determined by identifying the national average proportion of operating costs that are related to, influenced by, or vary with the local labor market. For the CY 2024 ESRD PPS payment update, we are proposing to continue using a labor-related share of 55.2 percent, which was finalized in the CY 2023 ESRD PPS final rule (87 FR 67153 through 67154).
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD PPS may include a geographic wage index payment adjustment, such as the index referred to in section 1881(b)(12)(D) of the Act, as the Secretary determines to be appropriate. In the CY 2011 ESRD PPS final rule (75 FR 49200), we finalized an adjustment for wages at § 413.231. Specifically, CMS adjusts the labor-related portion of the ESRD PPS base rate to account for geographic differences in the area wage levels using an appropriate wage index, which reflects the relative level of hospital wages and wage-related costs in the geographic area in which the ESRD facility is located. We use the Office of Management and Budget's (OMB's) CBSA-based geographic area designations to define urban and rural areas and their corresponding wage index values (75 FR 49117). OMB publishes bulletins regarding CBSA changes, including changes to CBSA numbers and titles. The bulletins are available online at
We have also adopted methodologies for calculating wage index values for ESRD facilities that are located in urban and rural areas where there is no hospital data. For a full discussion, see the CY 2011 and CY 2012 ESRD PPS final rules at 75 FR 49116 through 49117 and 76 FR 70239 through 70241, respectively. For urban areas with no hospital data, we compute the average wage index value of all urban areas within the State to serve as a reasonable proxy for the wage index of that urban CBSA, that is, we use that value as the wage index. For rural areas with no hospital data, we compute the wage index using the average wage index values from all contiguous CBSAs to represent a reasonable proxy for that rural area. We applied the statewide urban average based on the average of all urban areas within the State to Hinesville-Fort Stewart, Georgia (78 FR 72173), and we applied the wage index for Guam to American Samoa and the Northern Mariana Islands (78 FR 72172).
Under § 413.231(d), a wage index floor value of 0.6000 is applied under the ESRD PPS as a substitute wage index for areas with very low wage index values, as finalized in the CY 2023 ESRD PPS final rule (87 FR 67161). Currently, all areas with wage index values that fall below the floor are located in Puerto Rico and the US Virgin Islands. However, the wage index floor value is applicable for any area that may fall below the floor. A further description of the history of the wage index floor under the ESRD PPS can be found in the CY 2019 ESRD PPS final rule (83 FR 56964 through 56967) and the CY 2023 ESRD PPS final rule (87 FR 67161).
An ESRD facility's wage index is applied to the labor-related share of the ESRD PPS base rate. In the CY 2023 ESRD PPS final rule (87 FR 67153), we finalized a labor-related share of 55.2 percent. In the CY 2021 ESRD PPS final rule (85 FR 71436), we updated the OMB delineations as described in the September 14, 2018 OMB Bulletin No. 18-04, beginning with the CY 2021 ESRD PPS wage index. In that same rule, we finalized the application of a 5 percent cap on any decrease in an ESRD facility's wage index from the ESRD facility's wage index from the prior CY. We finalized that the transition would be phased in over 2 years, such that the reduction in an ESRD facility's wage index would be capped at 5 percent in CY 2021, and no cap would be applied to the reduction in the wage index for the second year, CY 2022. In the CY 2023 ESRD PPS final rule (87 FR 67161), we finalized a permanent policy under § 413.231(c) to apply a 5 percent cap on any decrease in an ESRD facility's wage index from the ESRD facility's wage index from the prior CY. For CY 2024, as discussed in section II.B.1.a.(2)(d) of this proposed rule, the labor-related share to which the wage index would be applied is 55.2 percent.
For CY 2024, we propose to update the wage indices to account for updated wage levels in areas in which ESRD facilities are located using our existing methodology. We propose to use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the inpatient PPS. The ESRD PPS wage index values are calculated without regard to geographic reclassifications authorized under sections 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix. For CY 2024, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2019, and before October 1, 2020 (Fiscal Year (FY) 2020 cost report data).
For CY 2024, we propose to update the ESRD PPS wage index to use the most recent hospital wage data. We propose that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the wage index), we would use such data, if appropriate, to determine the CY 2024 ESRD PPS wage index in the final rule. The proposed CY 2024 ESRD PPS wage index is set forth in Addendum A and is available on the CMS website at
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variability in the amount of erythropoiesis stimulating agents (ESAs) necessary for anemia management. Some examples of the patient conditions that may be reflective of higher facility costs when furnishing dialysis care would be frailty and obesity. A patient's specific medical condition, such as secondary hyperparathyroidism, may result in higher per treatment costs. The ESRD PPS recognizes that some patients require high cost care, and we have codified the outlier policy and our methodology for calculating outlier payments at § 413.237.
Section 413.237(a)(1) enumerates the following items and services that are eligible for outlier payments as ESRD outlier services: (i) Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (ii) renal dialysis laboratory tests that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (iii) renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (iv) renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, covered under Medicare Part D, including renal dialysis oral-only drugs effective January 1, 2025; and (v) renal dialysis equipment and supplies, except for capital-related assets that are home dialysis machines (as defined in § 413.236(a)(2)), that receive the transitional add-on payment adjustment as specified in § 413.236 after the payment period has ended.
In the CY 2011 ESRD PPS final rule (75 FR 49142), CMS stated that for purposes of determining whether an ESRD facility would be eligible for an outlier payment, it would be necessary for the ESRD facility to identify the actual ESRD outlier services furnished to the patient by line item (that is, date of service) on the monthly claim. Renal dialysis drugs, laboratory tests, and medical/surgical supplies that are recognized as ESRD outlier services were specified in Transmittal 2134, dated January 14, 2011.
Under § 413.237, an ESRD facility is eligible for an outlier payment if its imputed (that is, calculated) MAP amount per treatment for ESRD outlier services exceeds a threshold. The MAP amount represents the average estimated expenditure per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facility's predicted MAP amount per treatment plus the FDL amount. As described in the following paragraphs, the ESRD facility's predicted MAP amount is the national adjusted average ESRD outlier services MAP amount per treatment, further adjusted for case-mix and facility characteristics applicable to the claim. We use the term “national adjusted average” in this section of this proposed rule to more clearly distinguish the calculation of the average ESRD outlier services MAP amount per treatment from the calculation of the predicted MAP amount for a claim. The average ESRD outlier services MAP amount per treatment is based on utilization from all ESRD facilities, whereas the calculation of the predicted MAP amount for a claim is based on the individual ESRD facility and patient characteristics of the monthly claim. In accordance with § 413.237(c), ESRD facilities are paid 80 percent of the per treatment amount by which the imputed MAP amount for outlier services (that is, the actual incurred amount) exceeds this threshold. ESRD facilities are eligible to receive outlier payments for treating both adult and pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule and codified in § 413.220(b)(4), using 2007 data, we established the outlier percentage, which is used to reduce the per treatment ESRD PPS base rate to account for the proportion of the estimated total Medicare payments under the ESRD PPS that are outlier payments, at 1.0 percent of total payments (75 FR 49142 through 49143). We also established the FDL amounts that are added to the predicted outlier services MAP amounts. The outlier services MAP amounts and FDL amounts are different for adult and pediatric patients due to differences in the utilization of separately billable services among adult and pediatric patients (75 FR 49140). As we explained in the CY 2011 ESRD PPS final rule (75 FR 49138 through 49139), the predicted outlier services MAP amounts for a patient are determined by multiplying the adjusted average outlier services MAP amount by the product of the patient-specific case-mix adjusters applicable using the outlier services payment multipliers developed from the regression analysis used to compute the payment adjustments. In the CY 2023 ESRD PPS final rule, we finalized an update to the outlier methodology to better target 1.0 percent of total Medicare payments (87 FR 67170 through 67177). We finalized that we would continue to follow our established methodology for the calculation of the adult and pediatric MAP amounts, but we would prospectively calculate the adult FDL amounts based on the historical trend in FDL amounts that would have achieved the 1.0 percent outlier target in the 3 most recent available data years.
For CY 2024, we are proposing to update the MAP amounts for adult and pediatric patients using the latest available CY 2022 claims data. We are proposing to update the ESRD outlier services FDL amount for pediatric patients using the latest available CY 2022 claims data, and to update the ESRD outlier services FDL amount for adult patients using the latest available claims data from CY 2020, CY 2021 and CY 2022, in accordance with the methodology finalized in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67174). CY 2022 claims data showed outlier payments represented
The impact of this proposed update is shown in Table 1, which compares the outlier services MAP amounts and FDL amounts used for the outlier policy in CY 2023 with the updated proposed estimates for this proposed rule. The estimates for the proposed CY 2024 MAP amounts, which are included in Column II of Table 1, were inflation adjusted to reflect projected 2024 prices for ESRD outlier services.
As demonstrated in Table 1, the estimated FDL per treatment that determines the CY 2024 outlier threshold amount for adults (Column II; $78.21) is higher than that used for the CY 2023 outlier policy (Column I; $73.19). The higher threshold is accompanied by a decrease in the adjusted average MAP for outlier services from $39.62 to $38.58. For pediatric patients, there is a decrease in the FDL amount from $23.29 to $13.71. There is a corresponding decrease in the adjusted average MAP for outlier services among pediatric patients, from $25.59 to $24.53.
We estimate that the percentage of patient months qualifying for outlier payments in CY 2024 would be 5.10 percent for adult patients and 20.20 percent for pediatric patients, based on the 2022 claims data and methodology finalized in the CY 2023 ESRD PPS final rule. The outlier MAP and FDL amounts continue to be lower for pediatric patients than adults due to the continued lower use of outlier services (primarily reflecting lower use of ESAs and other injectable drugs).
In the CY 2011 ESRD PPS final rule (75 FR 49081) and under § 413.220(b)(4), we reduced the per treatment base rate by 1 percent to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments as described in § 413.237. In the 2023 ESRD PPS final rule, we finalized a change to the outlier methodology to better achieve this 1 percent targeted (87 FR 67170 through 67174). Based on the CY 2022 claims, outlier payments represented approximately 0.9 percent of total payments, which is below the 1 percent target due to declines in the use of outlier services. However, this is significantly closer to the 1 percent target than the outlier payments based on CY 2021 claims, which represented approximately 0.5 percent of total payments. We believe the update to the outlier MAP and FDL amounts for CY 2024 would increase payments for ESRD beneficiaries requiring higher resource utilization. This would move us even closer to meeting our 1 percent outlier policy goal, because we would be using more current data for computing the MAP and FDL amounts, which is more reflective of current outlier services utilization rates. We also note that the proposed recalibration of the FDL amounts would result in no change in payments to ESRD facilities for beneficiaries with renal dialysis items and services that are not eligible for outlier payments.
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), CMS established the methodology for calculating the ESRD PPS per-treatment base rate, that is, the ESRD PPS base rate, and calculating the per treatment payment amount, which are codified at §§ 413.220 and 413.230. The CY 2011
We are proposing an ESRD PPS base rate for CY 2024 of $269.99. This proposed update reflects several factors, described in more detail as follows:
In the CY 2021 ESRD PPS final rule (85 FR 71427), we expanded eligibility for the TPNIES under § 413.236 to include certain capital-related assets that are home dialysis machines when used in the home for a single patient. To establish the TPNIES basis of payment for these items, we finalized the additional steps that the Medicare Administrative Contractors (MACs) must follow to calculate a pre-adjusted per treatment amount, using the prices they establish under § 413.236(e) for a capital-related asset that is a home dialysis machine, as well as the methodology that CMS uses to calculate the average per treatment offset amount for home dialysis machines that is used in the MACs' calculation, to account for the cost of the home dialysis machine that is already in the ESRD PPS base rate. For purposes of this proposed rule, we will refer to this as the “TPNIES offset amount.”
The methodology for calculating the TPNIES offset amount is set forth in § 413.236(f)(3). Section 413.236(f)(3)(v) states that effective January 1, 2022, CMS annually updates the amount determined in § 413.236(f)(3)(iv) by the ESRD bundled market basket percentage increase factor minus the productivity adjustment factor. The TPNIES for capital-related assets that are home dialysis machines is based on 65 percent of the MAC-determined pre-adjusted per treatment amount, reduced by the TPNIES offset amount, and is paid for 2 calendar years.
There are currently no capital-related assets that are home dialysis machines set to receive TPNIES for CY 2024 as the TPNIES payment period for the Tablo® System ends on December 31, 2023, and the only TPNIES application for CY 2024 is not for a home dialysis machine. However, as required by § 413.236(f)(3)(v), we are proposing to update the TPNIES offset amount annually according to the methodology described above.
The proposed CY 2024 TPNIES offset amount for capital-related assets that are home dialysis machines is $9.96. As
Section 1881(b)(14)(D)(iii) of the Act provides that the ESRD PPS shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent. Therefore, the ESRD PPS provides a facility-level payment adjustment to ESRD facilities that meet the definition of a low-volume facility. In this section of the proposed rule, we discuss the low-volume payment adjustment (LVPA) under the ESRD PPS, request information from the public regarding the potential changes to LVPA methodology and potentially creating a new geographic-based payment adjustment in the future, and propose certain changes to the existing administrative process for the LVPA.
The current amount of the LVPA is 23.9 percent. In the CY 2011 ESRD PPS final rule (75 FR 49118 through 49125), we finalized the methodology used to target the appropriate population of ESRD facilities that were low-volume and to determine the treatment threshold for those ESRD facilities identified. After consideration of public comments, we established an 18.9 percent adjustment for ESRD facilities that furnish less than 4,000 treatments annually and indicated that this increase to the base rate would encourage small ESRD facilities to continue providing access to care.
In the CY 2016 ESRD PPS proposed rule (80 FR 37819), we analyzed ESRD facilities that met the definition of a low-volume facility under § 413.232(b) as part of the updated regression analysis and found that the ESRD facilities still had higher costs compared to other ESRD facilities. A regression analysis of CYs 2012 and 2013 low-volume facility claims, and cost report data indicated a multiplier of 1.239 percent; therefore, we proposed an updated LVPA adjustment factor of 23.9 percent in the CY 2016 ESRD PPS proposed rule (80 FR 37819) and finalized this policy in the CY 2016 ESRD PPS final rule (80 FR 69001). In CY 2021, 366 ESRD facilities received the LVPA. Using the most recent available data for CY 2022, the number of ESRD facilities receiving the LVPA was 353.
Under § 413.232(b), a low-volume facility is an ESRD facility that, based on the submitted documentation: (1) furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month costs reports, whichever is most recent, except as specified in paragraph (g)(4)) preceding the payment year; and (2) has not opened, closed, or received a new provider number due to a change in ownership (except where the change in ownership results in a change in facility type) in the 3 cost reporting years (based on as-filed or final settled 12-consectuive month cost reports, whichever is most recent) preceding the payment year.
In addition, under § 413.232(c), for purposes of determining the number of treatments furnished by the ESRD facility, the number of treatments considered furnished by the ESRD facility equals the aggregate number of treatments furnished by the ESRD facility and the number of treatments furnished by other ESRD facilities that are both under common ownership with, and 5 road miles or less from, the ESRD facility in question. In order to receive the LVPA, an ESRD facility must submit a written attestation statement to its Medicare Administrative Contractor (MAC) confirming that it meets all of the requirements specified in § 413.232 and qualifies as a low-volume ESRD facility. For purposes of determining eligibility for the LVPA, “treatments” mean total hemodialysis equivalent treatments (Medicare and non-Medicare). For peritoneal dialysis patients, one week of peritoneal dialysis is considered equivalent to three hemodialysis treatments (80 FR 68994). Section 413.232(e) generally imposes a yearly November 1 deadline for attestation submissions unless extraordinary circumstances justify an exception and specifies exceptions for certain years where the deadline is in December or January. The November 1st attestation timeframe provides 60 days for a MAC to verify that an ESRD facility meets the LVPA eligibility criteria (76 FR 70236). The ESRD facility would then receive the LVPA payment for all the Medicare-eligible treatments in the payment year. Once an ESRD facility is determined to be eligible for the LVPA, a 23.9 percent increase is applied to the ESRD PPS base rate for all treatments furnished by the ESRD facility (80 FR 69001).
In the CY 2021 ESRD PPS final rule (85 FR 71443), we finalized a policy to allow ESRD facilities flexibility for LVPA eligibility due to the COVID-19 Public Health Emergency (PHE). Under § 413.232(g)(4), for purposes of determining ESRD facilities' eligibility for payment years 2021, 2022, and 2023, we will only consider total dialysis treatments for any 6 months of their cost-reporting period ending in 2020. ESRD facilities that would not otherwise meet the number of treatments criterion because of the COVID-19 PHE may attest that their total dialysis treatments for those 6 months of their cost reporting period ending in 2020 are less than 2,000. The attestation must further include that although the total number of treatments furnished in the entire year otherwise exceeded the LVPA threshold, the excess treatments furnished were due to temporary patient shifting resulting from the COVID-19 PHE. MACs will annualize the total dialysis treatments for the total treatments reported in those 6 months by multiplying by 2.
Interested parties, including the Medicare Payment Advisory Commission (MedPAC) and the Government Accountability Office (GAO),
We considered several changes to the LVPA eligibility criteria to address the concerns that GAO and MedPAC raised about targeting LVPA payments to ESRD facilities that are necessary to protect access to care and are not located near other ESRD facilities. Specifically, these interested parties have requested that we take into consideration the geographic isolation of an ESRD facility within the LVPA methodology. Section 1881(b)(14)(D)(iii) of the Act requires that the LVPA must reflect the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services. Our analysis has found that isolated low-volume facilities do not face higher costs than other low-volume facilities. Therefore, we do not believe that this requested change reconciles with the central statutory requirements and limitations for the LVPA, and we are considering alternative approaches, including potentially addressing this issue through a new payment adjustment separate from the LVPA based on section 1881(b)(14)(D)(iv) of the Act. Currently, we are analyzing claims and cost data regarding dialysis treatment levels and cost to inform options for potentially tailoring our methodology to meet the requirements of the statute, while simultaneously collecting additional data on geographic isolation of ESRD facilities. The ESRD PPS has separate facility-level payment adjustments for low-volume facilities, as set forth in 42 CFR 413.232, and facilities in rural areas, as set forth in 42 CFR 413.233. To avoid overlap with these existing facility-level adjustments, we are analyzing the impact of potentially creating a new payment adjustment and considering innovative methodological options, such as the local dialysis need methodology on which we are requesting information in section II.B.1.f.(2)(b) of this proposed rule.
In addition, we have heard from interested parties that the eligibility criteria for the LVPA are very explicit and leave little room for flexibility in certain circumstances (85 FR 71442). Some also view the attestation process as burdensome to ESRD facilities and believe it may discourage participation by small ESRD facilities with limited resources that would otherwise qualify for the LVPA.
CMS's contractor has held three Technical Expert Panels (TEPs) to discuss potential refinements to the ESRD PPS.
As discussed in the previous section, we recognize the importance of revising the ESRD PPS LVPA adjustment methodology to ensure that payments accurately reflect differences in cost and adequately target low-volume facilities, and to strive for healthcare equity for ESRD beneficiaries. The LVPA and rural adjusters currently result in increased payments to some geographically isolated ESRD facilities, but these adjusters do not specifically target geographically isolated ESRD facilities. We noted several points of concern that interested parties have raised in the past, as well as certain statutory limitations that could apply to some of the methodological approaches suggested in the past. We are seeking information from the public about potential approaches to refine the ESRD PPS methodology, which we would take into consideration for any potential changes to the LVPA in the future.
This section addresses several RFIs regarding the LVPA and a potential new adjustment for geographically isolated ESRD facilities. Upon reviewing the RFIs, respondents are encouraged to provide complete, but concise responses. These RFIs are issued solely for information and planning purposes; RFIs do not constitute a Request for Proposal (RFP), application, proposal abstract, or quotation. The RFIs do not commit the United States (U.S.) Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through these RFIs and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to these RFIs will be solely at the interested party's expense. Failing to respond to either RFI will not preclude participation in any future procurement, if conducted.
Please note that we will not respond to questions about the policy issues raised in these RFIs. We may or may not choose to contact individual responders. Such communications would only serve
We are soliciting comment on potential changes to the LVPA methodology, including maintaining a single threshold, establishing LVPA tiers, and/or utilizing a continuous function. Any potential refinements to the LVPA methodology that may result from our consideration of these comments would be proposed through notice-and-comment rulemaking in the future. We request that commenters keep in mind that section 1881(b)(14)(D)(iii) of the Act requires the LVPA to reflect the extent to which costs incurred by low-volume facilities in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services.
As discussions about modifying the existing treatment threshold or payment adjustment percentage have been ongoing since the beginning of the multi-year LVPA reform efforts, we are soliciting comments on maintaining a single threshold for the LVPA. ESRD facilities that fall below the treatment threshold would continue to receive payment, and payments would not be adjusted for those ESRD facilities above the threshold. We are engaged in continuing monitoring efforts to align resource use with payment. If we were to re-compute the LVPA percentage amount using the latest available claims and cost report data and the methodology established in the CY 2011 and CY 2016 ESRD PPS final rules (75 FR 49118 through 49125 and 80 FR 69001), the current treatment threshold of 4,000 treatments per year would correspond to a 17.6 percent payment adjustment. The 4,000-treatment threshold could be maintained, or the treatment threshold could be recalibrated to maintain the 23.9 percent payment adjustment. Maintaining a single threshold would not address concerns regarding the potential for gaming or remove what commenters call the payment cliff. Potential approaches for a single LVPA threshold are outlined below in Table 2.
We are soliciting comment on creating a tiered payment adjustment that would include multiple thresholds, with separate payment adjustments calibrated so that ESRD facilities in tiers with the lowest treatment volume would receive the highest payment adjustment, and vice versa. MedPAC has previously recommended setting LVPA treatment thresholds at fewer than 4,000 treatments, between 4,000 and 4,999 treatments, and between 5,000 and 6,000 treatments, with payment adjustments calibrated so that ESRD facilities in tiers with the lowest volume would receive the highest payment adjustment, and vice versa.
We are also soliciting comments on potentially establishing a continuous function to adjust LVPA payments. Under this approach, ESRD facilities with the lowest volume would receive the highest payment adjustment, and the payment adjustment would decrease continuously as volume increases. This could include calibration of the point at which the payment adjustment becomes zero to correspond with the existing 4,000 treatment upper bound, or establishment of a new upper bound based on a regression analysis. Establishment of a continuous function has the potential to significantly reduce the potential for gaming by eliminating payment cliffs entirely. Additionally, this would increase payment for ESRD facilities with the lowest volume, therefore better aligning payment with resource use. Furthermore, a continuous function would potentially expand LVPA eligibility to the most ESRD facilities.
CMS is considering several approaches to modifying the LVPA to address concerns about its incentive structure, treatment threshold, and administrative burden, as expressed by interested parties (including the GAO, MedPAC, and industry representatives). We are issuing this RFI to seek feedback on the suggested changes to the LVPA, as described above, and to solicit further input from interested parties to inform future modifications to the methodology used to determine the LVPA.
In particular, CMS seeks input and responses to the following considerations, requests and questions:
• Regarding concerns about a payment cliff in the existing LVPA, we are considering implementing payment tiers or a continuous adjustment, based on treatment volume, in place of the current single tiered adjustment.
++ Please comment on which payment structure would be more appropriate: single threshold as currently employed, tiered structure, or continuous function, and provide the reasoning behind your recommendation.
++ Please also comment on which option would be most effective in removing gaming incentives and which option would bring greater congruency between cost of providing renal dialysis services and payment.
• Using the alternative methodology described above, under a tiered or continuous payment adjustment, the treatment threshold for eligibility would be determined based on the median treatment count among all ESRD facilities (approximately eight thousand treatments per year). The resulting tiers and incremental payment adjustments between tiers could follow several different configurations.
++ What factors should be evaluated to best determine the treatment count threshold, as well as the tiering structure? Specifically, comment on the treatment volume beneath which per-treatment costs begin to increase.
++ Please enumerate any concerns you might have should the implementation of a tiered or continuous adjustment result in an expanded set of eligible ESRD facilities, and payment redistribution.
• Interested parties have voiced concern regarding the administrative burden involved in the current LVPA attestation process. As such, we are considering potentially decreasing the number of years of attestation data needed to determine LVPA eligibility.
++ Please comment on the extent to which this change would alleviate burden, and if there are other administrative changes that could be made to simplify this process.
++ Please describe any anticipated effects of decreasing the amount of treatment volume data used to determine LVPA eligibility.
++ Please describe the ways that simplifying the attestation process could help ESRD facilities with fewer resources to promote health equity by improving their ability to serve vulnerable and underserved communities.
CMS is striving to promote health equity by ensuring that ESRD facilities, including both rural and low-volume facilities, are being paid equitably for serving populations that are currently underserved. We are therefore soliciting comments on potentially assisting geographically isolated ESRD facilities and promoting access in these areas, including labor force hiring and retention. We are considering establishing a new payment adjustment that accounts for isolation, rurality, and other geographical factors. We are also requesting information on geographic isolation to determine if ESRD facilities that are currently considered rural would benefit from a geographic isolation adjustment. The new geographically based payment adjustment may consider local dialysis
During the 2020 ESRD PPS TEP, panelists discussed the alternatives to the current LVPA set forth below.
CMS's preliminary analysis has shown that models based on this local dialysis need (LDN) methodology would often result in the ESRD facilities receiving the LDN payment adjustment (that is, ESRD facilities in geographic areas with low LDN) being the only dialysis provider for a number of miles. Additionally, our analysis shows that ESRD facilities receiving the LDN payment adjustment often would be located in a census tract that intersects with areas designated as Health Professional Shortage Areas (HPSAs). The methodology would involve dividing the U.S. into geographic areas based on a reasonable assessment of ESRD beneficiaries' ability or willingness to travel. Regarding interested parties' concerns that previous measures for travel time relied upon beneficiaries' access to a private vehicle (which many beneficiaries may lack), in collaboration with our data contractor, CMS has performed additional analysis regarding the travel time metric to include realized travel time between ESRD facilities and population centers of census tracts, instead of ESRD facilities and patient address. Sensitivity checks have shown that the exact location of patients with ESRD is not essential for accurately determining the LDN of census tracts. Latent demand is then calculated by counting the number of beneficiaries with ESRD near each ESRD facility. “Near” is defined by driving time to ESRD facilities. Latent demand is calculated by multiplying the number of beneficiaries near an ESRD facility by average number of treatments for ESRD beneficiaries. The threshold is then applied by determining the threshold of adjusted latent demand. That is, those ESRD facilities, which fall below the threshold are eligible.
We are considering approaches to implementing an additional payment adjustment for ESRD facilities operating in areas with low LDN/demand. The purpose of this RFI is to seek feedback on the approach described above and to solicit information from interested parties to inform the approach taken to implement this adjustment. Any new payment adjustment of this nature would be proposed through future notice-and-comment rulemaking.
In particular, we seek responses to the following questions.
• What factors should be considered in formulating a payment adjustment for ESRD facilities in isolated geographical areas or areas for which there is a low need for renal dialysis services?
• What are the best ways to incentivize renal dialysis service provision in isolated geographic areas?
• Our analysis of the LDN methodology has shown that low LDN census tracts intersect with areas designated as HPSAs. What impact would a payment adjustment based on geographic isolation have on the ability of ESRD facilities in isolated areas to recruit and retain health care professionals?
• Please comment on the appropriateness of maintaining the rural facility adjustment under § 413.233, if we were to establish an LDN payment adjustment in conjunction with a modified LVPA.
• Please comment on the relationship between geographic isolation and cost. Please provide any data that could further inform CMS's understanding of the relationship between geographic isolation and cost for low volume facilities.
• Please comment on the appropriateness of utilizing driving time between current beneficiary address and treatment location as the appropriate metric for travel time.
• Are there ways in which the suggested methodology for this potential payment adjustment could fail in targeting isolated ESRD facilities, or ESRD facilities in areas with low LDN?
• Are there ways in which the determination of LDN might be subject to gaming?
• Would a payment adjustment for ESRD facilities in areas with low LDN improve health equity? Are there specific recommendations to change the LDN methodology described above to promote quality access to care for all ESRD beneficiaries?
• Please comment on the favorability of CMS's implementation of a new payment adjustment for ESRD facilities in areas with low LDN as described above.
• Are there any other considerations we should keep in mind when considering proposing a new payment adjustment based on an LDN methodology?
Under our current regulations at 42 CFR 413.232(b), a low-volume facility is an ESRD facility that, based on the submitted documentation—(1) furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent, except as specified in § 413.232(g)(4)) preceding
As discussed in the CY 2021 ESRD PPS proposed rule (85 FR 42165), the COVID-19 PHE caused ESRD facilities to have to shift patients among ESRD facilities in order to provide uninterrupted care to their Medicare ESRD population. In some cases, this patient shifting increased dialysis treatments at some low-volume ESRD facilities, putting the ESRD facility temporarily over the LVPA treatment threshold. This increase in dialysis treatments, resulting from the PHE, disqualified some ESRD facilities that would have otherwise received the LVPA of 23.9 percent per treatment. In the CY 2021 ESRD PPS final rule (85 FR 71485), we established a policy that ESRD facilities would be held harmless from increases in treatment counts due to temporary patient shifting because of the PHE. To be held harmless, ESRD facilities must follow the attestation process for the exception set forth in § 413.232(g)(4) and are expected to provide supporting documentation to the MACs upon request. Interested parties have expressed support for CMS's swift response to the COVID-19 PHE's impact on ESRD facilities, with an association of dialysis providers stating that holding harmless LVPA status for these ESRD facilities will better ensure that ESRD patients can continue to access the life-sustaining dialysis treatment they need, particularly in rural and underserved areas where low-volume facilities heavily depend on the LVPA to remain open and provide treatment for patients.
We recognize there could be future circumstances, potentially similar to the circumstances of the COVID-19 PHE, in which it would be appropriate to provide flexibilities with respect to certain LVPA requirements. Commenters have previously expressed concerns about the strict attestation requirements for ESRD facilities to remain eligible for the LVPA, particularly when faced with a disaster or other emergency, such as a local or national emergency, natural disaster, catastrophic event, or public health emergency. We recognize that during disasters or other emergencies, low-volume facilities could be forced to close, or could experience increases in their treatment counts if they treat patients who are displaced from a nearby ESRD facility that is impacted by such an event. For example, in August of 2021, an ESRD facility in Louisiana sustained significant damage as a result of Hurricane Ida, which required the ESRD facility to close for repairs and temporarily stop furnishing renal dialysis services. The ESRD facility served a rural community and for over 10 years received the LVPA due to the low number of dialysis treatments it furnished each year. This ESRD facility sought recourse to maintain its eligibility for the LVPA when it resumed operations following the required repairs to the ESRD facility, however, recourse was unavailable due to the limitations set forth in 42 CFR 413.232(b). When we established the LVPA in the CY 2011 ESRD PPS final rule, we stated that we believed the LVPA should encourage small ESRD facilities to continue to provide access to care to an ESRD patient population where providing that care would otherwise be problematic (75 FR 49118). Given that these requirements for low-volume facilities were created to protect access to care for the vulnerable patient population that these ESRD facilities serve, adding certain flexibilities during disasters or other emergencies would promote our commitment to ensuring access to care for ESRD patients.
We are proposing to make two changes to the LVPA regulation at § 413.232 to allow for more administrative flexibilities during disasters or other emergencies. First, we are proposing to create a new exception to the attestation process for disasters and other emergencies. Second, we are proposing to establish a process that would allow low-volume facilities to close and reopen in response to a disaster or other emergency and still receive the LVPA. CMS would assess whether a particular situation is a disaster or other emergency based on the totality of the circumstances that could result in disruption of or inability to furnish renal dialysis services at one or more ESRD facilities, thus affecting the ESRD facility's or facilities' ability to qualify for the LVPA. For purposes of this proposal, disasters or other emergencies would include, but not be limited to, the below examples:
• A public health emergency declared by the Secretary due to a significant outbreak of infectious disease or bioterrorist attacks.
• Natural disasters including winter storms, floods, tornados, hurricanes, wildfires, earthquakes, or any combination thereof.
• Catastrophic events outside of an ESRD facility's control that disrupt operations and result in an ESRD facility's closure, for example, loss of operations or patient shifting due to a local emergency such as fire, floods, earthquakes, or tornadoes, or
• Other disaster or emergency conditions under which a waiver could be granted pursuant to section 1135 of the Act.
CMS believes these proposed policy changes could help displaced ESRD patients maintain access to renal dialysis services by preventing ESRD facilities from permanently closing due to the loss of their LVPA. It is important that ESRD facilities that are receiving the LVPA are able to maintain LVPA eligibility despite the impacts caused by a disaster or other emergency. The proposed policy could potentially protect other ESRD facilities that need to maintain the LVPA in order to remain open from potentially losing their LVPA by exceeding the treatment threshold because they accepted displaced patients. We do not want the fear of losing the LVPA due to increased treatments exceeding the threshold to disincentivize ESRD facilities from accepting patients from other ESRD facilities experiencing a disaster or other emergency. It is also important that ESRD facilities that are forced to close due to a disaster or other emergency are able to maintain their LVPA eligibility upon reopening to ensure continued access in areas that otherwise may lack sufficient ESRD facilities. The policy could also help those ESRD facilities affected by the disaster or other emergency potentially resume operations and avoid permanent closure if they would be allowed to receive the
We are proposing to create an exception to the LVPA treatment threshold requirements set forth in 42 CFR 413.232(b)(1) under a new provision in § 413.232(g)(5), which would allow an ESRD facility to receive the LVPA even if it exceeds the LVPA threshold if its treatment counts increase due to treating additional patients displaced by a disaster or other emergency. Qualification for the proposed exception would require an ESRD facility to absorb those displaced patients from an outside or adjacent ESRD facility that experienced a temporary closure or operational disruption (such as a water shut off). If an ESRD facility accepts the patients of the ESRD facility affected by the disaster or other emergency, causing that ESRD facility to meet or exceed the 4,000-treatment count for all dialysis patients, it would attest to its MAC that it furnished treatments equal to or in excess of 4,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility due to a disaster or other emergency. We are proposing to define temporary patient-shifting in the context of the LVPA in the ESRD PPS as providing renal dialysis services to one or more patient(s) at any time through the end of the calendar year following the 12-month period beginning when an ESRD facility first begins providing renal dialysis services to the displaced patient(s). The ESRD facility would be required to request this exception from CMS by writing to the ESRD Payment Mailbox
As an example: If a disaster occurs on June 1, 2024, which results in ESRD facility X's closure or operational disruption resulting in ESRD facility Y (an existing low-volume facility) treating additional patients from ESRD facility X that puts ESRD facility Y's total renal dialysis treatments for cost reporting year 2024 over the 4,000 treatment threshold, ESRD facility Y would be required to request an exception to § 413.232(b)(1) from CMS by November 1, 2024 in order to continue receiving the LVPA. Since ESRD facility Y began treating the displaced patients in CY 2024, the window for temporary patient shifting would extend until December 31, 2025. To be approved for the exception under the new provision in § 413.232(g)(5), CMS would determine that ESRD facility Y furnished treatments equal to or in excess of 4,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of ESRD facility X resulting from a disaster or other emergency. Should the exception be approved by CMS, ESRD facility Y would receive the LVPA for up to the first 4,000 treatments it furnished in 2024. Additionally, ESRD facility Y would not be disqualified from receiving the LVPA for PY 2025 and PY 2026 due to exceeding the treatment volume threshold in cost reporting year 2024, assuming the temporary patient-shifting from ESRD facility X occurred only in cost reporting year 2024. For PY 2025 and PY 2026 ESRD facility Y would have to attest that it meets all the criterion for the LVPA because it furnished treatments equal to or in excess of 4,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency and received an exception for cost reporting year 2024. This would be the same attestation process as if ESRD facility Y did not furnish any excess treatments and was attesting that it continued to meet the criteria for the LVPA for those payment years. If the closure or operational disruption of ESRD facility X causes the treatment volume for ESRD facility Y to meet or exceed the 4,000 dialysis treatment threshold in cost reporting year 2025, ESRD facility Y would have to submit another request for an exception by November 1, 2025. Should this exception be approved, ESRD facility Y would receive the LVPA for up to the first 4,000 treatments it furnished in cost reporting year 2025 and would not be disqualified from receiving the LVPA for payment year 2026 and payment year 2027 due to exceeding the treatment volume threshold in cost reporting year 2024 and cost reporting year 2025. If ESRD facility Y continued to treat displaced patients from ESRD facility X in cost reporting year CY 2026, it would only be considered temporary patient-shifting if ESRD facility Y treated those patients before January 1 2026, and if patients treated after January 1 2026 cause ESRD facility Y to exceed the 4,000-treatment volume threshold in cost reporting year 2026 then the ESRD facility would be disqualified from receiving the LVPA under § 413.232(b)(1). Under this example, ESRD facility Y would still have to meet the other eligibility requirements to receive the LVPA in any PY in which the ESRD facility would receive the LVPA.
In addition to proposing an exception to the treatment threshold requirement under § 413.232(b)(1) and (g)(5), we are proposing an exception under
Upon reopening and providing renal dialysis services, the ESRD facility would be required notify CMS and the MAC in writing within 30 days of its reopening. CMS would acknowledge receipt of the written notification within 30 days. If the exception is approved and CMS is duly informed of the ESRD facility's reopening, the ESRD facility would remain eligible for the LVPA and the MAC would process payment accordingly. In order to continue receiving the LVPA the ESRD facility would still have to meet all the other eligibility requirements for the LVPA. The exception to § 413.232(b)(2) would be applicable for a period of 2 cost reporting years following the date of closure of the ESRD facility. After the 2 cost reporting year period the ESRD facility would follow the normal attestation process for the LVPA specified in paragraphs (e) and (g) of § 413.232. The ESRD facility would be required to maintain documentation regarding its closure, and to provide such supporting documentation to CMS and/or the MAC upon request.
For example, if a disaster occurs on June 1, 2024, which results in an ESRD facility experiencing a closure, the ESRD facility would request an exception to § 413.232(b)(2) from CMS within 60 days of June 1, 2024 (that is, on or before July 31, 2024). CMS would review the request and notify the ESRD facility and the MAC within 30 days if the exception is approved or denied. If the ESRD facility then reopens on September 1, 2024, the ESRD facility would notify CMS and the MAC in writing within 30 days of reopening (that is, on or before October 1, 2024). CMS would notify the ESRD facility and the MAC of its receipt of the reopening notification within 30 days. If the exception was approved by CMS, the ESRD facility would remain eligible for the LVPA for the rest of payment year 2024 and for the entirety of payment year 2025 and payment year 2026, provided the ESRD facility continues to meet the other eligibility requirements for the LVPA.
We are proposing a technical correction at § 413.232(g) to replace “their” with “its,” to clarify the regulation language.
Section 1881(b)(14)(D)(iv)(I) of the Act provides that the ESRD PPS may include such payment adjustments as the Secretary determines appropriate, including a payment adjustment for pediatric providers of services and renal dialysis facilities. Determining such a payment adjustment has been historically difficult due to the consistent lack of data. The Medicare pediatric ESRD patient population receiving dialysis is small compared to the adult ESRD population, representing approximately 0.14 percent of the total ESRD patient population in 2022. In the past, CMS has considered various different payment adjustments for pediatric patients with ESRD, including different Medicare payments by sex or comorbidities (74 FR 49984 through 49986). However, many of these considered adjustments were not used as we were unable to get acceptable precision due to the small sample size of pediatric patients with ESRD.
Prior to the establishment of the ESRD PPS, payment for pediatric ESRD dialysis services was generally the same rate as adult ESRD dialysis, unless the ESRD facility qualified for an exception to the composite rate. Section 1881(b)(7) of the Act stated that, subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554) (BIPA), the Secretary shall provide for exceptions as may be warranted by unusual circumstances (including the special circumstances of sole facilities located in isolated, rural areas and of pediatric facilities). During this time period, CMS received many comments and concerns regarding the payment rate for renal dialysis services furnished to pediatric patients with ESRD. Section 623(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) later amended section 422(a)(2) of BIPA to provide that any pediatric ESRD facility would be eligible for an exception to the composite rate, effective October 1, 2002. This statute defined pediatric ESRD facilities as facilities with at least 50 percent patients under the age of 18. This enabled pediatric ESRD facilities to obtain payments that specifically recognized the higher cost associated with treating these patients (69 FR 47530).
We finalized a basic case-mix adjustment to the composite payment rate in the CY 2005 Physician Fee Schedule (PFS) final rule published on November 15, 2004 (69 FR 66327). This included a 62 percent pediatric payment increase (that is, an adjustment factor of 1.62) applied to the composite payment rate per treatment for any facility when furnishing outpatient dialysis services to pediatric patients with ESRD. This factor was derived from the average exception amounts for 20 ESRD facilities that had received exceptions for pediatric patients. This was intended to be a temporary measure, which would be eliminated once we developed the case-mix methodology that would apply for the ESRD PPS bundled payment. The use of this methodology allowed CMS to provide additional payment for the pediatric ESRD population under the composite rate in a data-driven manner to account for the higher costs pediatric patients faced (69 FR 66327).
Section 153(b) of MIPPA added section 1881(b)(14) of the Act, which required CMS to implement an ESRD bundled PPS beginning January 1, 2011, under which a single payment for renal dialysis services is made in lieu of any other payment. Renal dialysis services generally include items and services included in the composite rate for renal dialysis services as of December 31, 2010 and services furnished to individuals for treatment of ESRD, which were formerly separately billable, including drugs and biological products and laboratory tests. In the CY 2011 ESRD PPS proposed rule, we proposed a single composite rate modifier of 1.199 for all Pediatric ESRD Patients receiving dialysis (74 FR 49982 through 49983). A “Pediatric ESRD Patient” is defined as an individual less than 18 years of age
We codified the Pediatric ESRD Patient payment adjustment in § 413.235(b), which states that CMS adjusts the per treatment base rate for pediatric patients in accordance with section 1881(b)(14)(D)(iv)(I) of the Act, to account for patient age and treatment modality. These multipliers were updated in the CY 2016 ESRD PPS final rule using the same methodology (80 FR 69001 through 69002). The current expanded bundle case mix adjusters are presented below in Table 7.
Despite these changes intended to improve payment accuracy for renal dialysis services furnished to Pediatric ESRD Patients, we continue to receive comments and concerns from interested parties that the payment amounts for renal dialysis services furnished to Pediatric ESRD Patients are too low. In addition to comments received through the annual ESRD PPS rulemaking, we have also solicited comments from interested parties on several occasions. During the December 2020 TEP, we queried a panel of experts on how to improve payment for pediatric dialysis care under the ESRD PPS. Panelists
In the CY 2023 ESRD PPS proposed rule (87 FR 38529), we issued a request for information regarding health equity for pediatric patients with ESRD. Many commenters asserted that Medicare payments for Pediatric ESRD Patients are too low and that the ESRD PPS bundled payment does not target the unique issues facing ESRD facilities furnishing renal dialysis services to Pediatric ESRD Patients.
We are committed to improving health equity for Pediatric ESRD Patients receiving renal dialysis services by improving payment equity through more efficient Medicare payments. Ensuring Medicare payments are appropriate and reflect costs for renal dialysis services furnished to Pediatric ESRD Patients would allow more ESRD facilities to provide quality care to this vulnerable population. The main barrier to payment equity is the lack of sufficient data to determine the relative costs associated with furnishing renal dialysis services to Pediatric ESRD Patients. To improve payment rate accuracy for Pediatric ESRD Patients, CMS has issued changes to the cost reports for both freestanding ESRD facilities and hospital-based ESRD facilities effective January 1, 2023.
As noted previously, payment accuracy has been historically difficult for pediatric ESRD dialysis because of the small sample size of Pediatric ESRD Patients receiving renal dialysis services paid for under the ESRD PPS. Pediatric ESRD dialysis treatments are also furnished differently from adult ESRD dialysis treatments in several crucial ways. For example, pediatric ESRD facilities are more likely to be hospital-based and, on average, have lower treatment volume and are located in higher wage index areas. These
One can account for this bias by selecting a specific sample of ESRD facilities that have similar characteristics except for proportion of dialysis treatments furnished to Pediatric ESRD Patients. This would help to show the additional costs of furnishing dialysis to Pediatric ESRD Patients based on the variation in costs across the ESRD facilities. To achieve this, we would use propensity score matching (PSM).
PSM is a technique that uses regression analysis to account for systematic differences between two populations to isolate the effects of a single variable, in this case percentage of Pediatric ESRD Patients. The PSM regression includes a wide range of ESRD facility-level characteristics including facility type, size, geographic location, and the pediatric ESRD dialysis population nearby the ESRD facility in order to make a propensity score. This propensity score represents the probability that a given ESRD facility treats a high volume of Pediatric ESRD Patients given its facility-level characteristics.
Once the propensity score for each ESRD facility is determined, each ESRD facility with a significant percentage of Pediatric ESRD Patients (high-pediatric) is matched with the ESRD facility without a significant percentage of Pediatric ESRD Patients (low-pediatric) with the most similar propensity score. We can then compare the relative per-treatment costs of those ESRD facilities to estimate the additional costs an ESRD facility faces when it furnishes renal dialysis services to a higher proportion of Pediatric ESRD Patients, controlling for some important facility-level characteristics. The dependent variable of this regression is the log of the cost per treatment for the ESRD facility. The independent variables are the percent of dialysis treatments that are furnished to Pediatric ESRD Patients, the log of the facility size, the type of ESRD facility (hospital based, children's hospital based or freestanding), the log of the wage index for the ESRD facility and the year for the cost report data. The regression equation for cost per treatment given a certain percentage of dialysis treatments furnished to Pediatric ESRD Patients is:
This cost regression should be unbiased due to the use of PSM. However, PSM also requires a reduction in sample size, because there are relatively few ESRD facilities with a significant number of treatments furnished to Pediatric ESRD Patients that could be matched using PSM. This smaller sample size inherently results in an increase in margin of error. We believe this is a necessary tradeoff because a biased estimate cannot be relied upon, but we must be cautious while using high-error estimates. The final result of this regression is that ESRD facilities that solely serve Pediatric ESRD Patients incur costs that are 40 percent higher per patient for furnishing renal dialysis services than similar ESRD facilities that serve no Pediatric ESRD Patients. The confidence interval of this estimate is 20 percent to 60 percent. Therefore, on average, furnishing renal dialysis services to a Pediatric ESRD Patient costs 40 percent more than furnishing renal dialysis services to an adult patient with ESRD.
The ESRD PPS already accounts for some of the higher costs that ESRD facilities incur while furnishing renal dialysis services to Pediatric ESRD Patients through the case-mix adjusters. Because the analysis described above uses cost report data, it does not incorporate either the current case-mix adjusters or payment rates for Pediatric ESRD Patients receiving renal dialysis services. Our most recent estimates show that payments for dialysis treatments furnished to Pediatric ESRD Patients were approximately 10 percent higher than for adult patients with ESRD in CY 2022.
We are striving for payment accuracy, which is achieved when relative Medicare payments are proportional to relative costs. There are several ways we could adjust ESRD PPS payments to achieve payment accuracy, including calculating the unaccounted-for cost differential, which is the amount by which ESRD PPS payments for pediatric ESRD renal dialysis services must be increased to achieve payment accuracy. We could do this by reducing the cost differential estimate of 40 percent by a factor 1.1 to account for the current payment differential of 10 percent. This would yield an unaccounted-for cost differential of approximately 30 percent (1.4 divided by 1.1 is 1.27 which we are rounding to 1.3). This is a reasonable estimate of the additional labor and supply costs, which are not accounted for by the current case-mix adjusters, incurred by ESRD facilities furnishing renal dialysis services to Pediatric ESRD Patients.
Despite the high margin of error of the cost regression using PSM, we believe that 30 percent cost is the most reasonable estimate of the unaccounted-for costs incurred in treating Pediatric ESRD Patients compared to adult ESRD patients. Creating a new add-on payment adjustment using this figure would provide pediatric ESRD facilities with Medicare payments proportional to their estimated costs for a temporary period while we collect additional data. However, due to the high margin of error of the model, increasing Medicare payments to ESRD facilities such that payments are 40 percent higher for Pediatric ESRD Patients compared to all patients would risk making payments higher than appropriate. When we conduct the analysis with the more comprehensive cost report data provided by the cost report changes implemented for CY 2023, we might find that our analysis overestimated the cost of furnishing renal dialysis services to Pediatric ESRD Patients (that is, that the additional 30 percent payment adjustment was too large). If we finalize this transitional add-on payment adjustment for Pediatric ESRD Patients as proposed, pediatric ESRD facilities should be prepared for the possibility that the payment rate for Pediatric ESRD Patients could decrease in the future, should that be indicated by future data
We are proposing a new transitional add-on payment adjustment of 30 percent (adjustment factor of 1.3) for dialysis treatments furnished to Pediatric ESRD Patients for 3 calendar years, effective January 1, 2024. Based on the time lag for cost report data, 3 years should allow for enough time for CMS to get more detailed data from the changes to the cost reports described above. After that period, we would evaluate the more comprehensive cost report data from the first year of cost reporting periods beginning on or after January 1, 2023, to refine our methodology for determining the payment rate for pediatric ESRD dialysis. As proposed, this would be a separate, additional add-on payment adjustment of 30 percent of the per treatment payment amount under § 413.230, which reflects the other patient and facility level adjustments. This adjustment would not be part of the case-mix adjusters. This payment adjustment would only apply to the ESRD bundled payment and not to any outlier adjustments. Due to the multiplicative nature of the case-mix adjusters it would function similarly to a 30 percent increase to the expanded bundle case-mix adjusters. For the purpose of comparison, the effective case-mix adjusters are presented below in Table 8.
The exact magnitude of the increase in payment would vary based on the age of the patient and the wage index of a given area; we estimate approximately $80 for (hemodialysis-equivalent) peritoneal dialysis treatments and $100 for hemodialysis treatments. This would represent a substantial increase in payment for renal dialysis services furnished to Pediatric ESRD Patients, and would account for the extra costs that this population incurs temporarily until additional cost data is available. This payment adjustment would apply for all dialysis treatments furnished to ESRD patients under the age of 18, not solely treatments furnished in pediatric ESRD facilities. This is warranted because many of the additional costs related to the treatment of Pediatric ESRD Patients are not specific to treatments furnished in pediatric ESRD facilities.
We are proposing to call this the Transitional Pediatric ESRD Add-on Payment Adjustment (TPEAPA) and make this adjustment budget neutral. In general, add-on payment adjustments under section 1881(b)(14)(D)(iv) of the Act are not statutorily required to be budget neutral under the ESRD PPS, but we believe in this instance that budget neutrality is appropriate, due to the manner in which this adjustment is derived. Other non-budget neutral add-on payment adjustments that we have established under this authority generally account for costs that were not used for the construction of the ESRD PPS bundled payment, such as the TDAPA for calcimimetics (80 FR 69013 through 69027). We have also established certain non-budget neutral add-on payment adjustments for items or services that were not commonplace, and therefore not adequately represented in cost reports, such as home dialysis training (75 FR 49063). However, we have implemented other payment adjustments under this authority in a budget neutral manner; for example, the changes to the wage index in the CY 2023 ESRD PPS final rule were implemented in a budget neutral manner as they represented a shifting of cost allocations, rather than new costs not originally included in the ESRD PPS bundled payment (87 FR 67157). This proposed TPEAPA is primarily for costs that would have been included in the cost reports used in the analysis conducted when we created the ESRD PPS bundled payment in the CY 2011 ESRD PPS final rule. As explained above, the methodology used both in that analysis, and when updating the case-mix adjusters, attributed pediatric ESRD renal dialysis services costs to the general population. Therefore, we believe it would be appropriate to reduce the ESRD PPS base rate to account for the new allocation of costs. Furthermore, any changes to the case-mix adjustments are required by section 1881(b)(14)(A)(ii) of the Act to be budget neutral, which means that any future modifications to the pediatric case-mix adjusters would be budget neutral. The budget neutrality adjustment factor for this proposed TPEAPA consisting of 30 percent of the per treatment payment amount would be 0.999532. Applying this budget neutrality factor to the ESRD PPS base rate would reduce the ESRD PPS base rate by an estimated $0.12. Under the alternative proposed 10 percent TPEAPA discussed previously in this section of the proposed rule, the budget neutrality factor adjustment would be 0.999847. Applying this
To establish this new TPEAPA, we are proposing to amend § 413.235 by splitting current paragraph (b) into paragraphs (b)(1) and (2). Paragraph (b)(1) would set forth the established age and modality of treatment case mix adjustment methodology as currently stated in paragraph (b). Paragraph (b)(2) would state that beginning January 1, 2024, we would provide a per-treatment transitional add-on payment adjustment of 30 percent of the per treatment payment amount under § 413.230 for renal dialysis services furnished to Pediatric ESRD Patients during calendar years 2024, 2025, and 2026. We are also proposing to revise the current language of § 413.235(b) to use the term “Pediatric ESRD Patients,” which is defined at § 413.171, to improve clarity for this section.
We believe that CMS could better align the resource use of pediatric ESRD renal dialysis services with payment. Our analysis using the methodology outlined above has found that Pediatric ESRD Patients receiving renal dialysis services have an estimated 40 percent higher costs than adult patients and that the current payment adjusters account for 10 percent higher costs. Implementing a transitional 30 percent add-on payment adjustment for renal dialysis services furnished to Pediatric ESRD Patients would improve payment equity for these patients by increasing payments to more closely align with the estimated costs of treatment. A 30 percent increase in ESRD PPS payments for pediatric ESRD renal dialysis services would represent approximately $80 to $100 per pediatric ESRD dialysis treatment, although the exact magnitude of the increase would depend on age, modality and the wage index of the area. This payment increase would have beneficial health equity impacts on this population by improving access to care and quality of care. Some ESRD facilities may not be able to absorb the additional expense of the Pediatric ESRD Patient population. Patients may need to travel to a limited number of primarily hospital-based ESRD facilities where pediatric ESRD dialysis is performed. As a result, this population may be underserved and disadvantaged with respect to access to ESRD care. Additional payment to those ESRD facilities treating Pediatric ESRD Patients would thereby benefit this potentially underserved and disadvantaged population of Pediatric ESRD patients. Additionally, this would have a beneficial financial impact on the ESRD facilities, both pediatric and non-pediatric, that serve this pediatric population.
We are proposing that this payment adjustment be budget neutral, which would lead to an estimated decrease of $0.12 to the ESRD PPS base rate, corresponding to a budget neutrality factor of 0.99954. This relatively small adjustment would represent less than a twentieth of a percent of the total ESRD PPS base rate. However, we recognize that any decrease in the base rate would represent a monetary loss to ESRD facilities. As stated above, our analysis indicates that this proposed transfer would be reasonable given the likelihood that the methodology used in the case-mix adjusters attributed some pediatric costs to the general population. However, should future analysis of the stratified pediatric cost data indicate that pediatric ESRD renal dialysis services costs are less than 40 percent higher than adult costs, this proposed budget neutral decrease (if finalized as proposed) would mean that the treatments for adult patients with ESRD were slightly underpaid during this proposed 3-year period. In either case there would be a risk of underpayment for one group of patients. We believe that using the mean estimate of the analysis would provide us with the best approach for achieving payment accuracy while we collect additional data. Additionally, the health equity implications of potentially underpaying for Pediatric ESRD Patients receiving dialysis by 20 percent would be significantly higher than the implications of potentially underpaying for adult patients by a less than 0.1 percent. In CY 2021 there were 116 ESRD facilities that furnished more than 2 percent of their dialysis treatments to Pediatric ESRD Patients, out of 7882 total ESRD facilities. These ESRD facilities are a relatively small group, but they are critical for the care of Pediatric ESRD Patients. For these reasons, we believe that the expected benefits for the proposed TPEAPA would outweigh the costs.
We believe that providing this proposed 30 percent TPEAPA for calendar years 2024, 2025, and 2026 would be the best approach for improving payment accuracy until more precise data is available. However, we acknowledge that in any case there is a risk of making payments which are higher or lower than appropriate. We are seeking comment on this proposal for an additional 30 percent payment adjustment for renal dialysis services furnished to Pediatric ESRD Patients for 3 calendar years, effective January 1, 2024, and on any alternative add-on payment adjustment amounts, including the 10 percent payment adjustment discussed earlier in this section of the proposed rule.
As discussed in the CY 2023 PFS final rule (87 FR 69710), many drugs and biological products that are payable under Medicare Part B are dosed in a variable manner such that the entire amount identified on the vial or package is not administered to the patient. For example, many drugs are dosed based on the patient's body weight or body surface area (BSA). Often, these drugs are available only in single-dose containers. As stated in U.S. Food and Drug Administration (FDA) guidance for industry,
Beginning on January 1, 2017, CMS revised the Medicare Part B JW modifier policy to require the uniform use of the modifier for all claims for separately payable drugs with discarded drug amounts from single-dose containers or single-use packages payable under Part B, in order to more effectively identify and monitor billing and payment for
In the CY 2023 PFS final rule (87 FR 69718 through 69719), we codified our existing policy as discussed in the prior paragraph in Chapter 17 of the Medicare Claims Processing Manual, and required that billing providers report the JW modifier for all separately payable drugs with discarded drug amounts from single-dose containers or single-use packages payable under Part B, beginning January 1, 2023. These changes were promulgated in connection with the implementation of the discarded drug refund program under section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117-9, November 15, 2021). In that same CY 2023 PFS final rule (87 FR 69722), we responded to commenters who requested we exempt drugs paid for under the ESRD PPS bundled payment from the discarded drug refund policy. One commenter expressed concern regarding how implementation of the discarded drug refund might inadvertently impact ESRD products, including those used by home dialysis patients (for example, Extraneal, a peritoneal dialysis solution). In response to those comments, we clarified that units for drugs that are packaged under the Medicare ESRD PPS were not subject to the JW modifier policy or the discarded drug refund.
In the same CY 2023 PFS final rule, CMS also finalized a proposal to require billing providers to report the JZ modifier for all such drugs with no discarded drug amounts, beginning no later than July 1, 2023. Specifically, as discussed in the CY 2023 PFS proposed rule (87 FR 46058), we proposed to require the use of a separate modifier, the JZ modifier, to attest that there were no discarded amounts. We stated that to align with the JW modifier policy, the JZ modifier would be required when there are no discarded amounts from single-dose containers or single-use packages payable under Part B for which the JW modifier would be required if there were discarded amounts. Table 9 below provides additional information about these modifiers.
We explained that on all claims for single-dose containers or single-use packages payable under Part B, either the JW modifier would be used (on a separate line) to identify any discarded amounts or the JZ modifier (on the claim line with the administered amount) would be present to attest that there were no discarded amounts. We noted that we believed the JZ modifier requirement would not increase burden on the provider, because under the current JW modifier policy, the provider already needs to determine whether or not there are any discarded units from a single-dose container or single-use package, record discarded amounts in the patient medical record, and specify administered and discarded amounts on the claim form. We finalized the JZ modifier requirement in the CY 2023 PFS final rule. Lastly, we noted in the CY 2023 PFS final rule that we would begin claims edits for both the JW and JZ modifier beginning October 1, 2023 (87 FR 69179). Additional details can be found in Chapter 17 of the Medicare Claims Processing Manual and the JW/JZ modifier frequently asked questions (FAQ) document.
As discussed in the previous section, the Medicare Part B JW modifier policy generally does not apply to drugs that are not separately payable. The ESRD PPS statute generally requires a single bundled payment for renal dialysis services. Specifically, section 1881(b)(14)(A)(i) requires the Secretary to implement a payment system under which a single payment is made to a provider of services or a renal dialysis facility for renal dialysis services in lieu of any other payment. The only exception is for oral-only drugs, as defined at § 413.234(a), which are currently paid separately under Medicare Part D. Section 204 of ABLE amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, to provide that payment for oral-only renal dialysis drugs and biological products cannot be made under the ESRD PPS bundled payment prior to January 1, 2025. We note that although the ESRD PPS includes certain add-on payment adjustments such as the TDAPA and TPNIES, these are adjustments to the ESRD PPS base rate and therefore part of the single payment made under the ESRD PPS; these payment adjustments are not separate payments. For example, as described in our TDAPA implementation guidance issued August 4, 2017, and updated January 10, 2018, available on the CMS website at
Although renal dialysis drugs and biological products paid for under the ESRD PPS are not considered “separately billable” and are not subject to the general Part B JW modifier policy discussed in the prior paragraph, CMS has previously issued guidance on the use of the JW modifier on ESRD PPS claims for certain circumstances. Chapter 8, section 60.4.5.1 of the
Most recently, the March 15, 2022 Change Request
Under our current policy, we do not reduce the single payment under the ESRD PPS for any discarded amounts of renal dialysis drugs or biological products that are reported with the JW modifier. Furthermore, when calculating any adjustments to the ESRD PPS base rate for the TDAPA or outlier payments, we include all units of renal dialysis drugs and biological products billed on the claim for which an adjustment is made, including any discarded amounts of such drugs and biological products. Additionally, we have previously established in the CY 2012 ESRD PPS final rule (76 FR 70243 through 70244) that ESRD facilities may only report units and charges for drugs and biological products actually purchased and may not bill for overfill units of drugs and biological products which exceed the amount indicated on the vial or package labeling. Additionally, we explained that consistent with prior rulemaking, under our authority in section 1881(b)(14)(D)(ii) of the Act, we were adopting the average sales price (ASP) policy on overfill for purposes of calculating the outlier payment. That is, we adopted a policy to exclude overfill units of drugs and biological products which exceed the amount indicated on the vial or package labeling from consideration for the purposes of calculating outlier payments. We stated we believe the use of the ASP policy for purposes of calculating the outlier payment is appropriate because we believe overfill does not represent a cost to the ESRD facility; thus, overfill should not factor into our determination of outlier payments.
In summary, our longstanding policy for payment under the ESRD PPS, including the calculation of the TDAPA and outlier payment adjustments, includes payment for units of renal dialysis drugs and biological products billed with the JW modifier, but does not allow payment for overfill units. That is, the current ESRD PPS payment policy is consistent with the broader Medicare Part B policy to pay for the unused and discarded amount, as well as the dose administered, up to the amount of the drug indicated on the vial or package labeling.
As discussed in section II.B.1.j of this proposed rule, we are undertaking analysis of ESRD PPS claims and cost report data in order to better understand the patient-specific costs associated with furnishing renal dialysis services to Medicare beneficiaries. We believe that in order to most appropriately consider potential refinements to the ESRD PPS case-mix adjustments in the future, it is important to understand and have consistent data about the costs associated with the quantities of the renal dialysis drugs and biological products that are actually used by ESRD beneficiaries. This is consistent with our longstanding policy principles, which are reflected by our policy for billing for unused amounts of renal dialysis drugs and biological products under the ESRD PPS. In the CY 2016 ESRD PPS final rule (80 FR 69033), we discussed our existing policy since the inception of the ESRD PPS that all renal dialysis service drugs and biological products prescribed for ESRD patients, including the oral forms of renal dialysis injectable drugs, must be reported by ESRD facilities, and the units reported on the monthly claim must reflect the amount expected to be taken during that month. We stated that ESRD facilities should use the best information they have in determining the amount expected to be taken in a given month, including fill information from the pharmacy and the patient's plan of care. We noted that any billing system changes to effectuate this change needed to be made as soon as possible, as this requirement had been in effect since the ESRD PPS began in 2011. This policy is also discussed in the Medicare Benefits Policy Manual, Pub. 100-02, Chapter 11, section 20.3.C.
Consistent with our longstanding billing policies for unused amounts of drugs and biological products and consistent with the requirements for the uniform use of the JW modifier for all claims for separately payable drugs under Part B since 2017, in order to more effectively identify and monitor billing and payment for discarded amounts of drugs, we are proposing to require ESRD facilities to report accurate and consistent data about discarded amounts of single-dose renal dialysis drugs and biological products paid under the ESRD PPS. Further, section 1881(b)(2)(B) of the Act requires the Secretary to prescribe in regulations
Under our longstanding policy, payment is made under the ESRD PPS bundled payment for discarded amounts of renal dialysis drugs and biological products, and such discarded amounts are included in the calculation of the ESRD PPS base rate and any applicable adjustments, such as the TDAPA and the outlier adjustment. Therefore, consistent with the current JW and JZ reporting requirements that were finalized in the CY 2023 PFS final rule for separately payable Part B drugs, we are proposing to require that beginning no later than January 1, 2024, ESRD facilities must report information on ESRD PPS claims about the total number of billing units of any discarded amount of a renal dialysis drug or biological product from a single-dose container or single-use package that is paid for under the ESRD PPS, using the JW modifier (or any successor modifier that includes the same data). We are also proposing that ESRD facilities must document any discarded amounts in the beneficiary's medical record. Additionally, we are proposing to require ESRD facilities to report the JZ modifier for all such renal dialysis drugs and biological products with no discarded amounts, beginning no later than January 1, 2024. We are proposing to codify these reporting requirements in regulation at § 413.198(b)(5) and (6).
Under this proposal, the amount of a renal dialysis drug or biological product from a single-dose container or single-use package that is administered would be billed on one line (reflected as billing units in the unit field) and any discarded amounts would be billed on a separate line with the JW modifier (reflected as billing units in the unit field). If a renal dialysis drug or biological product from a single-dose container or single-use package is administered and there are no discarded amounts, then we are proposing that a single line would be billed on the claim form with the JZ modifier and the billing units in the unit field. Therefore, on all claims for renal dialysis drugs and biological products from single-dose containers or single-use packages payable under the ESRD PPS, we are proposing that either the JW modifier would be used (on a separate line) to identify any discarded amounts or the JZ modifier (on the claim line with the administered amount) would be present to attest that there were no discarded amounts. We are proposing that claims for renal dialysis drugs and biological products from single-dose containers or single-use packages that do not report either the JW or JZ modifier may be returned as un-processable until claims are properly resubmitted.
We are clarifying that, under our proposal, ESRD facilities would not be required to document in the beneficiary's medical record when there are no discarded amounts. Lastly, we are reiterating that, as discussed in the CY 2023 PFS final rule (87 FR 69722), units for renal dialysis drugs and biological products that are bundled under the Medicare ESRD PPS are not subject to the Medicare Part B discarded drug refund program and would continue to be exempted from the Medicare Part B discarded drug refund. We are also clarifying that for any oral-only drugs, as defined in § 413.234(a), to the extent that any such drugs are produced in single-dose containers or single-use packaging, this proposed reporting requirement would not apply until such drugs are paid for under the ESRD PPS.
We believe that this proposed reporting requirement would enable CMS to obtain more reliable information about the extent to which the costs of providing renal dialysis drugs and biological products represent amounts that beneficiaries use as well as amounts that are discarded. We believe this is particularly important because under Medicare Part B, beneficiaries are responsible for paying a 20 percent coinsurance. As noted above, nearly 40 percent of TDAPA expenditures in CY 2022 represented discarded amounts of renal dialysis drugs and biological products. Medicare beneficiaries, therefore, paid approximately $260,000 in copayments for these discarded amounts. While this currently represents a small amount of payments overall, the cost for discarded renal dialysis drugs and biological products is borne by a very small population of beneficiaries. It is important for CMS to understand the full scope of expenditures, including expenditures that may be incurred by beneficiaries, for discarded amounts of renal dialysis drugs and biological products in the future, which may be more expensive or more widely used than the current drug that is being paid for using the TDAPA under the ESRD PPS. Thus, we are not proposing in this rule to alter payments to ESRD facilities based on the amounts of discarded renal dialysis drugs and biological products reported, but data collected through adoption of the JW and JZ modifier reporting requirements discussed in this section may inform future payment policies, which would be proposed through future notice and comment rulemaking if appropriate.
Based on our analysis of ESRD PPS claims, as well as the billing guidance in sections 8 and 17 of the Medicare Claims Processing Manual, we believe the proposed JW modifier requirement reflects current practices for ESRD facilities, and would not significantly increase burden for ESRD facilities. Additionally, we believe the proposed JZ modifier requirement would not increase burden on ESRD facilities, because under the current guidance provided regarding use of the JW modifier, the ESRD facility should already have processes in place in order to determine, in the case of certain drugs and biological products, whether or not there are any discarded units from a single-dose container or single-use package, record discarded amounts in the patient medical record, and specify administered and discarded amounts on the claim form. Furthermore, we note that while renal dialysis drugs and biological products that are paid under the ESRD PPS are not considered separately payable, ESRD facilities are permitted to bill and receive separate payment using the AY modifier for drugs and biological products that are not related to the treatment of ESRD. Although we have noted that renal dialysis drugs and biological products paid under the ESRD PPS are not subject to the Medicare Part B drug refund program or the current JW or JZ reporting requirements, any separately payable drugs or biological products that ESRD facilities bill for using the AY modifier would be subject to such policies under Medicare Part B. Therefore, we believe that most ESRD facilities should already be reporting the JW and JZ modifiers in
Section 217(c) of PAMA required the Secretary to establish a process for including new injectable and intravenous (IV) products into the ESRD PPS bundled payment as part of the CY 2016 ESRD PPS rulemaking. Therefore, in the CY 2016 ESRD PPS final rule (80 FR 69013 through 69027), we finalized a process based on our longstanding drug designation process that allowed us to include new injectable and intravenous products into the ESRD PPS bundled payment and, when appropriate, modify the ESRD PPS payment amount. We codified this process in our regulations at 42 CFR 413.234. We finalized that the process is dependent upon the ESRD PPS functional categories, consistent with the drug designation process we have followed since the implementation of the ESRD PPS in 2011. As we explained in the CY 2016 ESRD PPS final rule (80 FR 69014), when we implemented the ESRD PPS, drugs and biological products were grouped into functional categories based on their action. This was done to add new drugs or biological products with the same functions to the ESRD PPS bundled payment as expeditiously as possible after the drugs are commercially available so beneficiaries have access to them. As we stated in the CY 2011 ESRD PPS final rule, we did not specify all the drugs and biological products within these categories, because we did not want to inadvertently exclude drugs that may be substitutes for drugs we identified, and we wanted the ability to reflect new drugs and biological products developed or changes in standards of practice (75 FR 49052).
In the CY 2016 ESRD PPS final rule, we finalized the definition of an ESRD PPS functional category in § 413.234(a) as a distinct grouping of drugs or biologicals, as determined by CMS, whose end action effect is the treatment or management of a condition or conditions associated with ESRD (80 FR 69077). We finalized a policy in the CY 2016 ESRD PPS final rule that if a new renal dialysis injectable or IV product falls within an existing functional category, the new injectable drug or IV product is considered included in the ESRD PPS bundled payment and no separate payment is available. The new injectable or IV product qualifies as an outlier service. We noted in that rule that the ESRD bundled market basket update is used to increase the ESRD PPS base rate annually and accounts for price changes of the drugs and biological products. We also finalized in the CY 2016 ESRD PPS final rule that, if the new renal dialysis injectable or IV product does not fall within an existing functional category, the new injectable or IV product is not considered included in the ESRD PPS bundled payment and the following steps occur. First, an existing ESRD PPS functional category is revised or a new ESRD PPS functional category is added for the condition that the new injectable or IV product is used to treat or manage. Next, the new injectable or IV product is paid for using the TDAPA codified in § 413.234(c). Finally, the new injectable or IV product is added to the ESRD PPS bundled payment following payment of the TDAPA.
In the CY 2016 ESRD PPS final rule, we finalized a policy in § 413.234(c) to pay the TDAPA until sufficient claims data for rate setting analysis for the new injectable or IV product are available, but not for less than 2 years. The new injectable or IV product is not eligible as an outlier service during the TDAPA period. We established that following the TDAPA period, the ESRD PPS base rate will be modified, if appropriate, to account for the new injectable or IV product in the ESRD PPS bundled payment.
In the CYs 2019 and 2020 ESRD PPS final rules (83 FR 56927 through 56949 and 84 FR 60653 through 60677, respectively), we made several revisions to the drug designation process regulations at § 413.234. In the CY 2019 ESRD PPS final rule, we revised the regulations at § 413.234(a), (b), and (c) to reflect that the process applies for all new renal dialysis drugs and biological products that are FDA approved regardless of the form or route of administration. In addition, we revised § 413.234(b) and (c) to expand the TDAPA to all new renal dialysis drugs and biological products, rather than just those in new ESRD PPS functional categories. In the CY 2020 ESRD PPS final rule, we revised § 413.234(b) and added paragraph (e) to exclude from TDAPA eligibility generic drugs approved by FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act and drugs for which the new drug application is classified by FDA as Type 3, 5, 7, or 8, Type 3 in combination with Type 2 or Type 4, or Type 5 in combination with Type 2, or Type 9 when the “parent NDA” is a Type 3, 5, 7, or 8, effective January 1, 2020.
Under our current TDAPA policy at § 413.234(c), a new renal dialysis drug or biological product that falls within an existing ESRD PPS functional category is considered included in the ESRD PPS base rate and is paid the TDAPA for 2 years. After the TDAPA period, the ESRD PPS base rate will not be modified. If the new renal dialysis drug or biological product does not fall within an existing ESRD PPS functional category, it is not considered included in the ESRD PPS base rate, and it will be paid the TDAPA until sufficient claims data for rate setting analysis is available, but not for less than 2 years. After the TDAPA period, the ESRD PPS base rate will be modified, if appropriate, to account for the new renal dialysis drug or biological product in the ESRD PPS bundled payment.
As discussed in the CY 2019 and CY 2020 ESRD PPS final rules, for new renal dialysis drugs and biological products that fall into an existing ESRD PPS functional category, the TDAPA helps ESRD facilities to incorporate new drugs and biological products and make appropriate changes in their businesses to adopt such products, provides additional payments for such associated costs, and promotes competition among the products within the ESRD PPS functional categories, while focusing Medicare resources on products that are innovative (83 FR 56935; 84 FR 60654). For new renal dialysis drugs and biological products that do not fall within an existing ESRD PPS functional category, the TDAPA is a potential pathway toward a potential ESRD PPS base rate modification (83 FR 56935). For the complete history of the TDAPA policy, including the pricing methodology, please see the CY 2016 ESRD PPS final rule (80 FR 69023 through 69024), CY 2019 ESRD PPS final rule (83 FR 56932 through 56948), and CY 2020 ESRD PPS final rule (84 FR 60653 through 60681).
In the CY 2023 ESRD PPS proposed rule (87 FR 38522 through 38523), we summarized the concerns of interested parties and issued a request for information about methods that could be used to develop an add-on payment adjustment for certain new renal dialysis drugs and biological products after the end of the TDAPA. We explained that since 2019, dialysis associations and pharmaceutical
We also discussed that, as mentioned in the CY 2019 (83 FR 56941) and CY 2020 (84 FR 60672 and 60693) ESRD PPS final rules, many commenters have suggested a rate-setting exercise at the end of the TDAPA period for all new renal dialysis drugs and biological products. We responded to those comments by noting that we do not believe adding dollars to the ESRD PPS base rate would be appropriate for new drugs that fall into the ESRD PPS functional categories, given that the purpose of the TDAPA for these drugs is to help ESRD facilities incorporate new drugs and biological products and make appropriate changes in their businesses to adopt such products, provide additional payments for such associated costs, and promote competition among the products within the ESRD PPS functional categories. In addition, we explained that the ESRD PPS base rate already includes money for renal dialysis drugs and biological products that fall within an existing ESRD PPS functional category. We stated that under a PPS, Medicare makes payments based on a predetermined, fixed amount that reflects the average patient, and that there would be patients whose treatment costs at an ESRD facility would be more or less than the ESRD PPS payment amount. We noted that a central objective of the ESRD PPS and of prospective payment systems in general is for ESRD facilities to be efficient in their resource use.
We also noted that price changes to the ESRD PPS bundled payment are updated annually by the ESRDB market basket update, which includes a pharmaceutical cost category weight. In addition, we explained that our analysis of renal dialysis drugs and biological products paid for under the ESRD PPS has found costs and utilization to have decreased over time for some high volume formerly separately billable renal dialysis drugs, relative to overall market basket growth. Therefore, we stated that we believe that any potential methodology for an add-on payment adjustment in these circumstances should adapt to changes in price and utilization over time.
We noted that section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate, such as a payment adjustment—(I) for pediatric providers of services and renal dialysis facilities; (II) by a geographic index, such as the index referred to in section 1881(b)(12)(D), as the Secretary determines to be appropriate; and (III) for providers of services or renal dialysis facilities located in rural areas. Regarding the patient access concerns that we discussed in the CY 2023 ESRD PPS proposed rule, we stated that we were considering whether it would be appropriate to establish an add-on payment adjustment for certain renal dialysis drugs and biological products in existing ESRD PPS functional categories after their TDAPA period ends. We noted that any add-on payment adjustment would be subject to the Medicare Part B beneficiary co-insurance payment under ESRD PPS.
In the CY 2023 ESRD PPS proposed rule, we presented four potential methods that we were considering, which we noted could be used to develop an add-on payment adjustment for these drugs and biological products. We noted that the methods presented differed in terms of which formerly separately billable renal dialysis drugs and biological products would be considered for a potential add-on payment adjustment. We further noted that under these potential options, we would apply a reconciliation methodology only when an add-on payment adjustment would align resource use with payment for a renal dialysis drug or biological product in an existing ESRD PPS functional category. The four options are summarized as follows:
• Reconcile the average expenditure per treatment of the renal dialysis drug or biological product that was paid for using the TDAPA with any reduction in the expenditure per treatment across all other formerly separately billable renal dialysis drugs and biological products. For example, if the reduction in the cost of all formerly separately billable renal dialysis drugs and biological products per treatment excluding the renal dialysis drug or biological product that was paid for using the TDAPA is $5 and the cost per treatment of the renal dialysis drug or biological product that was paid for using the TDAPA is $10, the add-on payment adjustment per treatment would be $10 minus $5, which is $5. The reductions in formerly separately billable renal dialysis drug and biological products expenditures per treatment would be calculated by using the difference between these expenditures in the most recent year with claims data available and these expenditures in the current base year for the ESRDB market basket, which is CY 2020. We provided the following example: If the rule year for which we are calculating the add-on payment adjustment is CY 2023 and the base year for the ESRDB market basket is CY 2020, the reduction in formerly separately billable renal dialysis drugs and biological products expenditures would be the difference between these expenditures in CY 2021 (the year with the most recent claims data) and those in CY 2020.
• Reconcile the average expenditure per treatment for the renal dialysis drug or biological product that was paid for using the TDAPA with any reduction in expenditures for other formerly separately billable renal dialysis drugs or biological products, where such reduction can be empirically attributed to the renal dialysis drug or biological product that was paid for using the TDAPA. For example, if the utilization of the renal dialysis drug or biological product that was paid for using the TDAPA was found to be statistically associated with reduction in expenditure of one drug in an ESRD PPS functional category amounting to $1 per treatment, and the cost per treatment of the renal dialysis drug or biological product that was paid for using the TDAPA is $10, the add-on payment adjustment per treatment would be $10 minus $1, which is $9.
• Reconcile the average expenditure per treatment for the renal dialysis drug or biological product that was paid for using the TDAPA with any reduction in expenditures for other formerly separately billable renal dialysis drugs that fall into one or more ESRD PPS
• Only use the average expenditure per treatment of the renal dialysis drug or biological product that was paid for using the TDAPA. For example, if the per treatment cost of the renal dialysis drug or biological product that was paid for using the TDAPA is $10, this would be the amount of the add-on payment adjustment.
Following the discussion in the CY 2023 ESRD PPS proposed rule about these potential methodologies, we issued a request for information within that proposed rule (87 FR 38523) to seek feedback from the public on the following questions.
• Is an add-on payment adjustment for certain renal dialysis drugs and biological products in existing ESRD PPS functional categories after the TDAPA period ends needed? If so, why? What criteria should CMS establish to determine which renal dialysis drugs or biological products would be included in the calculation for an add-on payment adjustment after the TDAPA period ends?
• If an add-on payment adjustment for certain renal dialysis drugs and biological products in existing ESRD PPS functional categories after the TDAPA period is needed, are the methods discussed in section II.D.4 of the CY 2023 ESRD PPS proposed rule sufficient to address the add-on payment adjustment?
++ Which method would be most appropriate?
++ Are there changes to the methodologies that CMS should consider to improve our ability to align payment for renal dialysis services with resource utilization? Please provide as much detail as possible.
++ Are there other methodologies that CMS should consider? Please provide as much detail as possible.
We noted that while we would not be responding to specific comments submitted in response to this RFI, we intended to use this input to inform future policy development. We stated that any potential payment policies related to this RFI would be proposed through a separate notice and comment rulemaking.
We provided a high-level summary of responses to this RFI in the CY 2023 ESRD PPS final rule (87 FR 67219 through 67220) and noted that we would publish more detailed information about the commenters' recommendations in a future posting on the CMS website located at the following link:
In the CY 2023 ESRD PPS final rule, we stated that most commenters expressed their belief that an add-on payment adjustment of this nature is necessary to support the adoption of new renal dialysis drugs and biological products, and that most commenters stated that they supported CMS allowing all new renal dialysis drugs and biological products to be eligible to receive an add-on payment adjustment after the TDAPA period ends. However, we noted that MedPAC opposed this type of add-on payment adjustment by stating that it would undermine competition with existing drugs in the ESRD PPS bundled payment and encourage higher launch prices. We also noted that MedPAC recommended that CMS limit the add-on payment adjustment to new renal dialysis drugs and biological products that show a substantial clinical improvement compared with existing products reflected in the ESRD PPS bundled payment.
We further noted in the CY 2023 ESRD PPS final rule that several commenters stated they supported reconciling the expenditure of the new renal dialysis drug or biological product with any reduction in expenditures for other formerly separately billable renal dialysis drugs that are clinically or statistically related to the introduction of the new renal dialysis drug in the bundle. Several commenters expressed their belief that the FDA-approved label should be used to determine the primary indication and clinical association, rather than end-action effect. MedPAC expressed opposition to calculating any add-on payment adjustment for new renal dialysis drugs and biological products in existing ESRD PPS functional categories after the TDAPA period ends, but noted that if an add-on payment adjustment were applied, it would be appropriate to use an offset, similar to the approach used with the TPNIES, to avoid duplicative payment for renal dialysis services already included in the ESRD PPS base rate.
As discussed previously, section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate. Based on the public comments received regarding the RFI in the CY 2023 ESRD PPS proposed rule,
We agree with commenters who expressed concerns that the ESRD PPS' current mechanisms may not fully account for the costs of these new drugs. Several commenters asserted that the outlier adjustment and the market basket updates cannot adequately account for these costs, and several organizations noted that if renal dialysis drugs and biological products with significant costs were adopted under the outlier policy, the threshold to qualify for outlier payments would increase dramatically, thus adversely affecting access to products traditionally eligible for the outlier payment adjustment. Commenters expressed that this increase in the outlier threshold may also raise health equity concerns because, as we noted in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67171), the outlier adjustment protects access for beneficiaries whose care is unusually costly. We recognize that if the outlier threshold were to increase significantly due to significant use of a new renal dialysis drug or biological product after the end of the
We do not agree with MedPAC's statement that a post-TDAPA add-on payment adjustment would undermine competition with existing drugs in the ESRD PPS bundled payment and encourage higher launch prices. As discussed in the following section, we are proposing to apply the post-TDAPA add-on payment adjustment to all ESRD PPS payments following the end of the TDAPA period and would not limit the adjustment to claims that include the new renal dialysis drug or biological product. We believe that this proposed methodology would appropriately align incentives for ESRD facilities and would support competition with existing drugs, because payment for an individual claim would not be dependent on individual utilization of the new renal dialysis drug or biological product. Thus, we anticipate that the proposed methodology would create incentives for ESRD facilities to efficiently allocate resources in a way that would be consistent with the principles of prospective payment. We note that when Erythropoietin (EPO) switched from being separately payable to being paid for under the ESRD PPS beginning in CY 2011, these incentives to efficiently allocate resources resulted in decreases in expenditures for these drugs while also providing increased payment to ESRD facilities that supported beneficiaries' access to the new renal dialysis drugs and biological products. Because of these incentives, which would encourage ESRD facilities to efficiently allocate resources, we anticipate that the proposed methodology would not encourage higher launch prices for new renal dialysis drugs and biological products, as manufacturers would need to price such drugs and biological products appropriately to compete with existing drugs and biological products included in the ESRD PPS bundled payment.
We also do not agree with MedPAC's recommendation that CMS limit the post-TDAPA add-on payment adjustment to new renal dialysis drugs and biological products that show a substantial clinical improvement compared with existing products reflected in the ESRD PPS bundled payment. As stated previously, we recognize that continuity and predictability is integral to ESRD facilities' operations, and we do not believe that this principle applies only to drugs and biological products that show a substantial clinical improvement. As we explained in the CY 2023 ESRD PPS final rule (87 FR 67189), the intent of the ESRD PPS functional category framework is to be broad and to facilitate adding new drugs to the therapeutic armamentarium of the treating physician. As we further explained in the CY 2023 ESRD PPS final rule, the functional category structure helps to ensure the ESRD
We are proposing to calculate the post-TDAPA add-on payment adjustment following the methodology described in the following subsections for any new renal dialysis drug or biological product that is paid for using the TDAPA under § 413.234(c)(1). We are proposing that the post-TDAPA add-on payment adjustment would be applied for a period of 3 years following the end of the TDAPA period for those products. We believe that a 3-year payment period would provide sufficient time for CMS to analyze cost reports that include costs for the new renal dialysis drug or biological product paid for using the TDAPA under the ESRD PPS, in order to incorporate changes as appropriate to the ESRD PPS market basket price proxies. The ESRDB market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. The proposed 3-year payment period for the post-TDAPA add-on payment adjustment would allow CMS to evaluate how the new drug or biological product affects the overall mix of renal dialysis drugs and biological products in the ESRDB market basket and to determine the appropriate price proxies for such new drug or biological product. We note that for new renal dialysis drugs and biological products that are not considered included in the ESRD PPS base rate, the TDAPA is paid until sufficient claims data for rate setting analysis for the new renal dialysis drug or biological product is available, but not for less than 2 years. Similarly, as described earlier in this paragraph, we are proposing a 3-year payment period for the post-TDAPA add-on payment adjustment, which would enable the collection and analysis of sufficient cost report information and would address the concerns that commenters raised about the effectiveness of the ESRD PPS market basket price proxies to account for the costs of new renal dialysis drugs and biological products going forward by allowing CMS to incorporate data showing trends in use over an adequate period of time. Additionally, we believe that a 3-year period for the post-TDAPA add-on payment adjustment would be appropriate and consistent with the transition period that we finalized at the beginning of the ESRD PPS, when ESRD facilities were transitioned from receiving payments under the composite rate payment system to receiving payments under the ESRD PPS (79 FR 49162). We finalized the transition period for CY 2011 through CY 2013 in order to comply with the requirement of section 1881(b)(14)(E)(i) of the Act to provide a 4-year phase-in of the payment amount under the ESRD PPS, where full implementation of the ESRD PPS payment would occur beginning in the fourth year, CY 2014. We are proposing a similar timeline to provide an appropriate transition for new renal dialysis drugs and biological products in existing ESRD PPS functional categories, which are not eligible for a modification to the ESRD PPS base rate. Based on the experience of ESRD facilities during the 4-year phase-in from CY 2011 to CY 2014, ESRD facilities would be familiar with this timeline for phasing in major changes that impact their long-term planning and budgeting. Lastly, in the interest of transparency, we note that this 3-year period would provide time for analysis of utilization data for public awareness about the potential need for refinements to the ESRD PPS. Therefore, we are proposing to calculate and apply the post-TDAPA add-on payment adjustment for a period of 3 years following the end of the TDAPA period, with no post-TDAPA add-on payment adjustment calculated beginning in the 4th year.
We are proposing that this post-TDAPA add-on payment adjustment would not be budget neutral, as discussed later in this proposed rule. We note that this proposed post-TDAPA add-on payment adjustment, if finalized, would be calculated for
As discussed earlier in this section of the proposed rule, we are proposing to establish a new add-on payment adjustment for certain new renal dialysis drugs and biological products in existing ESRD PPS functional categories after the end of the TDAPA period. We are proposing to apply the post-TDAPA add-on payment adjustment to all ESRD PPS payments beginning at the end of a new renal dialysis drug or biological product's TDAPA period. Specifically, we are proposing that the post-TDAPA add-on payment adjustment would begin 8 calendar quarters after the beginning of the first calendar quarter in which TDAPA payment is made for the new renal dialysis drug or biological product in an existing ESRD PPS functional category, and would end no later than the 12th calendar quarter after the last calendar quarter in which TDAPA payment is made. As discussed in the following paragraphs, we believe our proposed calculation of the post-TDAPA add-on payment adjustment would be the most appropriate to address the patient access concerns we discussed in the CY 2023 ESRD PPS proposed rule and in this section of the proposed rule, and the most consistent with the
In determining the proposed calculation of the proposed post-TDAPA add-on payment adjustment, we considered the comments that we received regarding the RFI in the CY 2023 ESRD PPS proposed rule. Some commenters expressed that new and innovative drugs may only be used by a small percentage of the dialysis population and suggested that an add-on payment adjustment should address patient-specific needs in order to support access.
First, we considered calculating the post-TDAPA add-on payment adjustment as the average cost for patients that used the new renal dialysis drug or biological product that was previously paid for using the TDAPA under the ESRD PPS, and applying the post-TDAPA add-on payment adjustment only to claims that include the new renal dialysis drug or biological product. However, we are concerned that such an approach would not align with the principles of prospective payment under the ESRD PPS. As we noted earlier in this proposed rule, a central objective of the ESRD PPS (and of prospective payment systems in general) is for ESRD facilities to be efficient in their resource use. Under a PPS, Medicare makes payments based on a predetermined, fixed amount that reflects the average patient, and CMS acknowledges there will be patients whose treatment costs at an ESRD facility would be more or less than the ESRD PPS payment amount. Additionally, we are concerned that such an approach would result in a substantial cost burden for beneficiaries who use the new renal dialysis drug or biological product, because they incur a 20 percent coinsurance under Part B for renal dialysis services. We do not believe this approach would align with our priorities to reduce drug costs for Medicare beneficiaries. In contrast, our proposed methodology would apply the post-TDAPA add-on payment adjustment to all ESRD PPS payments, which would result in a minimal increase in per-treatment coinsurance amounts for all beneficiaries. As discussed later in this section, we are proposing to apply the ESRD PPS patient-level adjustments to the post-TDAPA add-on payment adjustment for each treatment.
Next, we considered applying the post-TDAPA add-on payment adjustment based only on claims from ESRD facilities that used the new renal dialysis drug or biological product during the TDAPA period. However, like the previous option, we believe that limiting application of this add-on payment adjustment to claims from ESRD facilities that include the new renal dialysis drug or biological product would be inconsistent with the principles of prospective payment. As we discussed in the CY 2011 ESRD PPS final rule, there are patients whose medical treatment results in more costly care as well as those with less costly care, and the ESRD PPS bundled base rate reflects Medicare payment for the average ESRD patient (75 FR 49045). Further, we are concerned that limiting the post-TDAPA add-on payment adjustment to claims from ESRD facilities that use the new renal dialysis drug or biological product could result in substantial overestimation of the post-TDAPA add-on payment adjustment, if more ESRD facilities begin using the new renal dialysis drug or biological product. As we discuss later in this proposed rule, we are proposing to apply this post-TDAPA add-on payment adjustment in a non-budget neutral manner. Therefore, we are concerned that an overestimation of the post-TDAPA add-on payment adjustment could result in an inappropriate increase in Medicare expenditures. As we discussed in the CY 2019 and CY 2020 ESRD PPS final rules (83 FR 56935; 84 FR 60654), for new renal dialysis drugs and biological products that fall into an existing ESRD PPS functional category, the TDAPA helps ESRD facilities to incorporate the new drugs and biological products and make appropriate changes in their businesses to adopt such products, provides additional payments for such associated costs, and promotes competition among the products within the ESRD PPS functional categories, while focusing Medicare resources on products that are innovative. We believe that after the end of the TDAPA period, ESRD facilities will have made appropriate changes in their business models to adopt such products, and therefore any approach to a post-TDAPA add-on payment adjustment should apply equally to all ESRD PPS treatments, in order to apply the appropriate incentive structures for ESRD facilities' utilization of renal dialysis drugs and biological products and to continue to promote competition among the products within the ESRD PPS functional categories, including the new renal dialysis drug or biological product that was previously paid for using the TDAPA under the ESRD PPS. Furthermore, we believe that such an approach would help to support access to new renal dialysis drugs and biological products to the widest scope of beneficiaries. This is in line with CMS's commitment to advance health equity by supporting access to renal dialysis services.
Accordingly, we are proposing to apply the post-TDAPA add-on payment adjustment to each ESRD PPS treatment, and to adjust it for patient characteristics. In other words, the post-TDAPA add-on payment adjustment would be multiplied by the ESRD PPS patient-level adjustments under § 413.235. We believe this approach would appropriately adjust aggregate ESRD PPS payment to account for the new renal dialysis drugs and biological products in a way that is consistent with the principles of prospective payment, and would support beneficiary access to new renal dialysis drugs and biological products by recognizing the additional patient-specific needs associated with the existing ESRD PPS case-mix adjusters. We note that in order to calculate an appropriate post-TDAPA add-on payment adjustment, we would apply a case-mix standardization factor to the post-TDAPA add-on payment adjustment amount as discussed in the following paragraphs.
In addition, we considered the public comments regarding the need to reconcile estimated expenditures for a new renal dialysis drug or biological product with the declines in expenditures for related drugs. As we noted earlier in this proposed rule, commenters expressed support for establishing a methodology that would consider the decline in estimated expenditures for drugs that are clinically or empirically related to the new renal dialysis drug or biological product. Such a methodology would be highly complex and less transparent than other potential options that commenters suggested. Commenters noted various ideas that CMS would
We are proposing to calculate the post-TDAPA add-on payment adjustment annually, based on the latest available full calendar quarter of average sales price (ASP) data, which would be consistent with the current policy for determining the basis of payment for the TDAPA. Under current policy, finalized in the CY 2020 ESRD PPS final rule (84 FR 60679), we pay the TDAPA based on 100 percent of ASP. If ASP is not available, we base the TDAPA payment adjustment on wholesale acquisition cost (WAC), and if WAC is not available, then we base payment on invoice pricing. As we stated in the CY 2020 ESRD PPS final rule, we continue to believe that after the TDAPA period, calculating the proposed post-TDAPA add-on payment adjustment for new renal dialysis drugs based on ASP, as compared to WAC or invoice pricing, would be the most appropriate choice for the ESRD PPS, and would strike the right balance in supporting ESRD facilities in their uptake of innovative, new renal dialysis drugs and biological products and limiting increases to Medicare expenditures. We propose to address the annual calculation of the post-TDAPA add-on payment adjustment in the annual proposed and final ESRD PPS rules for future years.
As discussed in section II.B.1.k, under current TDAPA policy, if CMS stops receiving ASP during the TDAPA period, then CMS will stop paying the TDAPA after 2 calendar quarters. Similarly, we believe that if drug manufacturers were to stop submitting ASP data for products that are included in the calculation of the proposed post-TDAPA add-on payment adjustment, and we had to revert to basing calculation of the post-TDAPA add-on payment adjustment on WAC or invoice pricing, we would be overpaying for the proposed add-on payment adjustment. Therefore, we are proposing to make payment of the post-TDAPA add-on payment adjustment conditional on receiving ASP data. Because the post-TDAPA add-on payment adjustment would be calculated annually rather than quarterly, we are proposing that if CMS does not receive the latest full calendar quarter of ASP data for a drug that would be included in the calculation of the post-TDAPA add-on payment adjustment, then CMS would not include that drug in the calculation of the post-TDAPA add-on payment
Finally, we are proposing that for each of the 3 years for which this proposed post-TDAPA add-on payment adjustment would be paid, we would update the amount of the post-TDAPA add-on payment adjustment by the ESRD PPS market basket update to account for estimated future input price changes faced by ESRD facilities. We are soliciting comment on whether it would be more appropriate to consider using the growth in the market basket price proxy for the Pharmaceuticals cost category in the ESRDB market basket, rather than the market basket update.
Therefore, we are proposing to use the following calculation to determine the amount of the post-TDAPA add-on payment adjustment to be applied to each ESRD PPS treatment.
• Step 1, using the most recent available 12 months of claims data, calculate the total expenditure of the new renal dialysis drug or biological product being paid for using the TDAPA under the ESRD PPS. Total expenditure would be calculated by multiplying the latest available full calendar quarter of ASP data for the new renal dialysis drug or biological product by the quantity of units billed. If CMS does not receive the latest available calendar quarter of ASP data for a drug or biological product, then CMS would not apply the post-TDAPA add-on payment adjustment for that drug or biological product. As we noted earlier, if the latest available full calendar quarter of ASP data reflects zero or negative sales, CMS would calculate the post-TDAPA add-on payment adjustment based on WAC, or if WAC is not available, invoice pricing.
• Step 2, divide the total expenditure of the new renal dialysis drug or biological product from Step 1 by the total number of ESRD PPS treatments furnished during the same 12-month period as used in Step 1. The resulting quotient from Step 2 would be the post-TDAPA add-on payment adjustment amount for each treatment, before applying the reduction factor to account for case-mix standardization, as described in Step 4.
• Step 3, calculate the dollar amount of the total aggregate case-mix adjusted post-TDAPA add-on payment adjustment amount by multiplying the post-TDAPA add-on payment adjustment amount from Step 2 by the applicable patient-level adjustments for each ESRD PPS treatment furnished during the 12-month period.
• Step 4, divide the aggregate case-mix adjusted add-on payment adjustment amount from Step 3 by total expenditure from Step 1. The resulting quotient would be the reduction factor applied to the post-TDAPA add-on payment adjustment amount to account for case-mix standardization.
• Step 5, apply the reduction factor from Step 4 to the post-TDAPA add-on payment adjustment amount from Step 2.
• Step 6, apply the 65 percent risk-sharing factor to the amount from Step 5 to calculate the case-mix adjusted post-TDAPA add-on payment adjustment amount.
• Step 7, multiply the case-mix adjusted post-TDAPA add-on payment adjustment amount by the ESRD PPS market basket update percentage.
We propose to amend 42 CFR 413.234 by revising § 413.234(c)(1)(i) and adding regulations at § 413.234(b)(1)(iii), (c)(1)(ii), (c)(3), and (g) that would describe the post-TDAPA payment adjustment and the calculation we would use to determine the post-TDAPA payment adjustment amount, as described above. In addition, we propose to amend § 413.230 by adding reference to the proposed post-TDAPA add-on payment adjustment in the calculation of the ESRD PPS per treatment payment amount.
In the section below, we provide an example of the proposed calculation for CY 2024 for
We are proposing to follow these steps to calculate the case-mix adjusted post-TDAPA add-on payment adjustment amount for CY 2024 and future years, when appropriate. We are proposing to include in the calculation of the case-mix adjusted post-TDAPA add-on payment adjustment amount any new renal dialysis drugs and biological products in existing ESRD PPS functional categories that are eligible for payment using the TDAPA described in § 413.234(c). We are proposing to begin making payment under this new post-TDAPA add-on payment adjustment 8-calendar quarters after the beginning of the TDAPA payment period for the new renal dialysis drug or biological product. We are proposing that payment of the post-TDAPA add-on payment adjustment would end no later than 12 calendar quarters after the end of the TDAPA payment period for the new renal dialysis drug or biological product. We are soliciting comments on this proposed methodology for a post-TDAPA add-on payment adjustment and its appropriateness for CY 2024 and future years.
Following the proposed methodology in the previous section, we are proposing to apply a post-TDAPA add-on payment adjustment to all ESRD PPS treatments beginning April 1, 2024, when the TDAPA payment period for
Based on the latest available data, which includes utilization of
As discussed earlier in this proposed rule, the ESRD PPS includes other add-on payment adjustments based on the authority in section 1881(b)(14)(D)(iv) of the Act, which are not statutorily required to be budget neutral. In the case of existing add-on payment adjustments under the ESRD PPS, these generally account for costs that were not included in cost reports used for the construction of the ESRD PPS bundled payment. These include items that either did not exist at the time of the construction of the ESRD PPS bundled payment, like new drugs and equipment, or services that were not commonplace that the add-on payment adjustment is meant to encourage, like home dialysis training. We expect this increased payment would support ESRD facilities in providing the new renal dialysis drug or biological product to all beneficiaries for whom it is reasonable and medically necessary. We believe it is also important to support access to new renal dialysis drugs and biological products while minimizing the financial impact to beneficiaries, who incur a 20 percent coinsurance for renal dialysis services under the ESRD PPS.
As discussed above, we considered and are proposing this new post-TDAPA add-on payment adjustment in response to concerns that a sudden decrease in payment for certain new renal dialysis drugs and biological products after the end of the TDAPA period could negatively affect Medicare beneficiaries' access to such new renal dialysis drugs and biological products. Although we have noted that the ESRD PPS base rate already includes money for renal dialysis drugs and biological products that fall within an existing ESRD PPS functional category, we do not believe that proposing a budget neutral payment adjustment would be appropriate for the post-TDAPA add-on payment adjustment. Because we are proposing to apply the post-TDAPA add-on payment adjustment to every ESRD PPS treatment, budget neutralizing this proposed add-on payment adjustment would effectively undo the adjustment and leave aggregate payments at the same level they would have been without an adjustment, which as we previously noted could negatively affect beneficiaries' access to such drugs and biological products. In contrast, applying this proposed add-on payment adjustment in a non-budget neutral manner would increase aggregate ESRD PPS expenditures to a level that reflects the most recent 12 months' utilization of the new renal dialysis drug or biological product, which we believe would support beneficiary access. By applying the proposed post-TDAPA add-on payment adjustment in a non-budget neutral way, we would effectively maintain expenditures for these new renal dialysis drugs and biological products at 65 percent of the level of expenditures paid during the TDAPA period. We believe this approach would provide consistency and predictability in a way that would support beneficiaries' continued access to new renal dialysis drugs and biological products, while appropriately reducing expenditures for such drugs after the TDAPA period ends both for the Medicare program and for individual beneficiaries, as discussed earlier in this section. Accordingly, we are proposing that this post-TDAPA add-on payment adjustment would not be budget neutral. We welcome comments on the budget neutrality aspect of this proposal.
We are proposing certain new recordkeeping and cost reporting requirements for outpatient maintenance dialysis at proposed 42 CFR 413.198(b)(5). CMS proposes to require patient-level reporting on resource use involved in furnishing hemodialysis treatment in-center in ESRD facilities that would serve to apportion composite rate costs for use in the case-mix adjustment. Importantly, this new data would be used to disaggregate facility-level composite rate costs (as obtained from the cost reports) and assign them to the patient-month level, which would enable a refined single-equation estimation methodology. The integrity of the ESRD PPS is dependent on our ability to monitor payment accuracy and make refinements to the payment system, as needed. Under this proposal, CMS would require ESRD facilities to report information on ESRD PPS claims for renal dialysis services about the duration of time in minutes that ESRD beneficiaries spend in center receiving hemodialysis treatment, also known as “time on machine” (hereafter referred to in this section as “time on machine”). We would use time on machine data to help us evaluate and monitor the accuracy of our payments for patient-level adjustment factors. CMS would also evaluate whether the data could be used to inform future refinements to the existing patient-level adjustment factors set forth at § 413.235(a), which include patient age, body mass index (BMI), BSA, and co-morbidities such as sickle cell anemia. Finally, CMS would review the data for its potential to identify any disparities from a health equity perspective that may support proposing in future rulemaking new patient-level adjustment factors, including potential social determinants of health (SDOH) factors.
Section 1881(b)(2)(B) of the Act generally directs the Secretary to prescribe in regulations any methods and procedures to determine the costs incurred by providers of services and renal dialysis facilities in furnishing covered services to individuals with ESRD, and to determine, on a cost-related or other economical and equitable basis, payment amounts for Medicare part B services furnished by such providers and facilities to individuals with ESRD. To that end, CMS promulgated 42 CFR 413.198,
Section 1881(b)(14)(D)(i) of the Act requires that the ESRD PPS include a payment adjustment based on case-mix that may take into account patient weight, body mass index, comorbidities, length of time on dialysis, age, race, ethnicity, and other appropriate factors. We implemented this statutory requirement in § 413.235, which sets forth certain patient characteristics for which the per treatment ESRD PPS base rate may be adjusted, specifically where those patient characteristics result in higher costs for ESRD facilities. The patient characteristics at § 413.235(a) include: patient age, body surface area, low body mass index, onset of renal
Finally, the proposal to collect and evaluate time on machine data would provide additional information concerning resource use to enable CMS to identify, assess, and address potential health disparities. This proposal therefore may support the Secretary's efforts to evaluate race and ethnicity data and provide recommendations for improving the quality of the data, as required under section 1809 of the Act, previously discussed in the CY 2011 ESRD PPS final rule (75 FR 49030 at 49108 through 49113).
We note that, if the proposed requirement to collect time on machine data were to be finalized as proposed, we would issue corresponding guidelines. Such guidance would provide instructions regarding the applicable administrative requirements for reporting a value code on an electronic claim, here value code D6, connected to the number of minutes of hemodialysis treatment provided in center in an ESRD facility. We further note that the National Uniform Billing Committee (NUBC) has approved and is prepared for ESRD facilities' use of value code D6 on claim form CMS-1450 (UB-04) (OMB-0938-0997), to report the total number of minutes of hemodialysis provided during the billing period.
The ESRD PPS includes patient-level adjustments that adjust the ESRD PPS base rate for certain patient characteristics. The current ESRD PPS case-mix adjustments are derived from a case-mix adjustment model involving two equations. In the CY 2011 ESRD PPS final rule (75 FR 49083), we discussed the two-equation methodology used to develop the adjustment factors that would be applied to the ESRD PPS base rate to calculate each patient's case-mix adjusted payment per treatment. The two-equation approach used to develop the ESRD PPS included a facility-based regression model for services historically paid for under the composite rate as indicated in ESRD facility cost reports, and a patient-month-level regression model for services historically billed separately. One significant limitation, which in large part drove the development of the two-equation model, was that there was no way to reliably identify, using claims data, the costs for composite rate services—that is, items and services such as staff labor, dialysate, capital-related assets such as renal dialysis machines, and certain drugs and laboratory tests, that are used in the provision of outpatient maintenance dialysis for the treatment of ESRD and that were included in the composite payment system established under section 1881(b)(7) of the Act and the basic case-mix adjusted composite payment system established under section 1881(b)(12) of the Act.
In the CY 2016 ESRD PPS final rule, we updated the payment multipliers for the ESRD PPS patient-level adjustment factors for age, BSA, low BMI, sex, four co-morbidity categories (that is, pericarditis; gastrointestinal tract bleeding with hemorrhage; hereditary hemolytic or sickle cell anemias; and myelodysplastic syndrome), and the onset of renal dialysis; we also established payment adjustments for pediatric patients and for ESRD facilities treating a low-volume of ESRD patients (80 FR 68968 at 68973 through 68984). In that CY 2016 ESRD PPS final rule, we discussed and responded to a number of public comments in which commenters expressed concerns about the continued use of the two-equation model (80 FR 68974 through 68976). One comment from MedPAC suggested that CMS develop a one-equation model for the ESRD PPS. In response, we noted that the ESRD PPS is not currently able to utilize a one-equation method because ESRD facilities do not report charges associated with the components of renal dialysis treatment costs that vary across patients, such as time on machine. In other words, patient-level claims provide line item detail on the use of the formerly separately billable services, but do not provide any information regarding variation across patients in the use of the formerly composite rate services. In addition, we stated that we believed that capturing the resource cost for furnishing renal dialysis services is complex since Medicare has historically paid an ESRD PPS base rate (that is, composite rate payment) to account for those costs that were never itemized on a claim but were reported through the cost report (80 FR 68975 through 68976).
Interested parties, including MedPAC, have long expressed concerns about the complexity of the two-equation model underpinning the ESRD PPS and have questioned the validity of assuming that the composite rate costs for all patients at an ESRD facility are the same. Interested parties have encouraged CMS to develop a patient cost model that is based on a single patient-level cost variable that accounts for all composite rate and formerly separately billable services. Additionally, interested parties have expressed concerns that the existing case-mix adjustors might not correlate well with the current cost of renal dialysis treatment and have encouraged CMS to explore a refinement.
In response, CMS has explored the feasibility of collecting time on machine data on patient claims from ESRD facilities and the potential for using such data. These efforts include: a Technical Expert Panel (TEP) held on December 6, 2018, a Request for Information (RFI) published in the ESRD PPS CY 2020 ESRD PPS proposed rule (84 FR 38399), and more recently an RFI published in the ESRD PPS CY 2022 proposed rule (86 FR 36322, 36399 through 36400). In addition, CMS issued sub-regulatory guidance in Transmittal 10368, from September 24, 2020, in an effort to begin collecting time on machine data, but it later rescinded that guidance.
As we discussed in the CY 2020 ESRD PPS proposed rule (84 FR 38396 through 38400), a TEP was held on
In the CY 2020 ESRD PPS proposed rule, we noted that CMS's data contractor's pre-TEP analysis of CY 2016 cost report data showed that composite rate costs comprise nearly 90 percent of average total treatment costs, with capital, direct patient care labor, and administrative costs representing approximately 88 percent of total average composite rate cost per treatment. The data contractor provided examples of ways that longer duration of renal dialysis time might be associated with increased treatment costs, including utility costs, accelerated depreciation on equipment, and lower daily census counts, which, among other things, would result in increased per-treatment capital costs. The analysis suggested that additional labor hours for a patient with longer treatments on average could increase per-treatment labor costs, and that patients with increased use of dialysate and water treatment supplies or equipment likely have higher average per-treatment supply costs. We noted that, under current reporting practices, there are no data on the patient-and treatment-level variation in the cost of composite rate items and services. We explained that these findings underscore the importance of identifying variation in these costs to inform the development of a refined case-mix adjustment model.
CMS published the findings from the December 2018 TEP in a report dated June 2019.
CMS presented further discussion into collection of time on machine data for each dialysis session in the CY 2020 ESRD PPS proposed rule (84 FR 38396 through 38400), where we further identified this potential data set as a singular option that would provide sufficient data to develop a refined case-mix adjustment model. If renal dialysis session time were reported for each renal dialysis treatment, cost report and treatment-level data could be integrated to infer differences in composite rate costs across patients. In this paradigm, patient-level differences in composite rate costs could be attributed to two discrete categories: differences due to renal dialysis treatment duration (measured in units of time); and, differences unrelated to treatment duration. To alleviate concerns from interested parties, we noted that time on machine data would not be used to directly adjust ESRD PPS payment, rather, it would be used to apportion composite rate costs (currently only observable at the facility level to the patient or treatment level) for use in the case-mix adjustment. Time on machine data would allow for a higher proportion of composite rate costs to be allocated to patients with longer renal dialysis treatment times, and ultimately inform CMS refinements to existing patient-level adjusters, including age and comorbidities.
We further explained that, in the December 2018 TEP, the data contractor proposed two approaches to collect time on machine data: (1) Use existing data from Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb) (now EQRS) on delivered renal dialysis minutes during the monthly session when a laboratory specimen is drawn to measure blood urea nitrogen (BUN); or (2) have ESRD facilities report time on machine data on Medicare claims. For the latter, we suggested that time on machine data could be reported by using a new HCPCS or revenue center code to indicate units of treatment time for each renal dialysis treatment or by updating the definition of the existing revenue center code for renal dialysis treatments so that the units correspond to treatment time instead of the number of treatments. We noted that ESRD facilities already reported to CMS a single monthly treatment time in CROWNWeb for in-facility treatments, indicating that ESRD facilities currently collect time on machine data.
The December 2018 TEP participants preferred that the data be collected on Medicare claims (84 FR 38398). They did not support using the then-existing CROWNWeb data for time on machine data, as there were too many questions about its completeness and timeliness. They agreed that if time on machine data is collected on claims that it should be reported in actual minutes dialyzed and not, for example, in 15-minute increments. We explained that the TEP participants cautioned that reporting time on renal dialysis on the claims would place additional burden on ESRD facilities. However, we stated that we believed that, for ESRD facilities with EHRs, the burden associated with the collection of renal dialysis treatment time is expected to be small and temporary, because the information is already being collected. We noted that collecting time on machine data could be difficult to accomplish for ESRD facilities that do not use EHRs. Lastly, we stated that some participants maintained that certain factors related to patient complexity—such as comorbidities and mental health status—that are associated with treatment costs are unrelated to treatment duration.
In addition to presenting the findings from the December 2018 TEP, we solicited comments in the CY 2020 ESRD PPS proposed rule (84 FR 38399) on the option of collecting time on machine data. As discussed in the CY 2020 ESRD PPS final rule (84 FR 60648, 60782), commenters responding to the RFI opposed the use of time on machine data, maintaining that other factors were more directly related to cost of treatment. Commenters claimed that many subgroups of patients are challenged to stay on renal dialysis for the prescribed treatment time because of their physical status or other limitations, leading to more frequent treatment and/or higher costs related to patients' special circumstances and comorbidities and not to treatment duration. With regard to patient-level factors contributing to high costs of care, commenters expressed that patient-level adjusters should be based on sound, empirical evidence of their contribution to cost of care and opposed the use of time on machine data as a single, patient-level factor to estimate variation in composite rate costs. Some commenters expressed the objection that use of this measure would not be productive because there was great homogeneity in treatment times across patients.
In Transmittal 10368, published September 24, 2020, CMS instructed its Medicare Administrative Contractors (“MACs”) to implement a new value code D6, which reflects the total number of minutes of dialysis provided during the billing period. See Transmittal 10368, CR 11871 (
CMS revisited the topic of time on machine in the 2020 TEP and discussed the case-mix adjusters.
We received similar comments on this RFI to those expressed in response to the CY 2020 ESRD PPS proposed rule. As discussed in the CY 2022 ESRD PPS final rule, commenters cited concerns that apportioned composite rate costs (such as labor and capital related costs) from the cost reports, used in the case-mix adjustments, were currently only observable at the facility-level and did not include patient or treatment level variations.
Similar to previously mentioned concerns regarding the collection of time on machine data, commenters suggested this data element would be burdensome and complex (especially for those dialyzing at home), and would not identify high-cost patients. They stated that what little variation might be identified would not be worth the burden of collecting the information. In addition, these commenters stated that ESRD facilities' staffing is based on prescribed time, not on the actual time a patient is on the machine. They stated that the prescription approach is the most rational way to determine staffing levels, because ESRD facilities do not have time on machine in advance. According to these commenters, ESRD facilities thus would only have the prescribing physician's prescription to use.
A provider advocacy organization opposed the use of time on machine data for purposes of ESRD PPS primarily because certain patients benefit from shorter, more frequent dialysis, such as patients with catheter-related access issues, non-compliant patients, patients with chronic pain or diarrhea, and patients suffering from certain comorbidities. They expressed significant concern that use of time on machine data for differentiating treatment cost variability creates inappropriate incentives for certain ESRD facilities to “game the system” by: (1) putting patients on renal dialysis longer than necessary; or (2) placing patients on the cheapest dialyzer and keeping them on it for all five possible hours of dialysis. Another small renal dialysis organization agreed, pointing out that most renal dialysis treatments, regardless of time, will have similar composite rate costs. In other words, they asserted that if a treatment is 3.5 hours compared to 5 hours, the composite rate costs for those treatments will be very similar. The only difference in cost between those two treatments would be 1.5 hours more use of utilities, dialysate and bicarbonate solution, machine depreciation, and a small amount of labor to check on the patient. The vast majority of labor for renal dialysis treatments is putting the patient on and taking the patient off of dialysis. Therefore, in both of the above scenarios, the commenter asserted that cost will remain the same. Further, they pointed out that some patients will not remain for their full renal dialysis treatment, and they generally cannot force a patient to remain for their full prescribed treatment time. Therefore, in
A small renal dialysis organization within a large non-profit health system commented that reporting treatment times would be difficult and confusing and identified many factors that would need to be outlined by CMS including: When does renal dialysis time start; what happens when a patient chooses to discontinue their treatment early, or has complications resulting in reduced treatment time; what happens when an ESRD facility inadvertently does not track time for a treatment; how does this information get included on a claim; and how ESRD facilities would need to train staff on how to count and track time. They also expressed concern about the reporting of time on machine creating opportunities for ESRD facilities to game the system by having the renal dialysis run a few extra minutes to move into the next highest level.
Several commenters recommended changes or removal of the case-mix adjusters, including refinement of the age and weight (BSA and BMI) adjustments and removal of the comorbidity adjustments, based on declining frequency of claims containing comorbidities. Moreover, some comments recommended removal of the comorbidity adjustments, because they report the adjustments are not utilized. They recommended CMS refine the age and weight (BSA and BMI) adjusters to better capture and designate higher cost patients. Many commenters expressed the belief that the comorbidity categories no longer protect beneficiary access and no longer correlate with increased costs. A non-profit renal dialysis association recommended that CMS minimize resources devoted to adjusters, providing only the minimum needed to deliver quality patient care, restore significant funding to the ESRD PPS base rate for the benefit and care of all beneficiaries, and focus retained adjusters only on those that are clearly linked to patient cost of care or clear barriers to access. Specifically, they recommended that: CMS retire the remaining comorbid case mix adjusters; revise the weight adjusters to maintain a low-BMI adjuster; create a high-BMI adjuster; eliminate the BSA adjuster; retire the age adjuster (which they believe is not methodologically sound and does not resonate with clinician or renal dialysis facility experience of care); maintain the adjuster for low volume facilities; consider expanding the adjuster to a second tier of facilities providing fewer than 6,000 treatments per year; eliminate the rural adjuster; and maintain the onset of renal dialysis adjuster to support the resource intensive needs of patients starting dialysis. Other commenters stated it would be too preliminary to eliminate the case-mix adjusters wholesale; they recommended that CMS initiate a discussion of the adjusters that are true drivers of high costs and how the use of adjusters can be operationalized for practical purposes. One payment adjustment that was universally supported by commenters was the onset adjustment.
MedPAC recommended that CMS develop a one-equation regression model in place of the current two-equation model currently used as the basis for the ESRD PPS. MedPAC also recommended that CMS consider removing the comorbidity adjustments and revise the body size adjustment. MedPAC further recommended that CMS address the inherent correlation between BSA and BMI by jointly estimating the association of BSA and BMI with treatment cost. Both BSA and BMI are calculated based on patient height and weight. MedPAC's analyses found that BSA and BMI values are correlated such that patients with low BMI also tend to have low BSA, and that these variables have a joint effect on treatment costs that is different from the sum of independent effects as currently implemented. We reiterated our current inability to implement such a model given the absence of data on the charges associated with the components of renal dialysis treatment costs that vary across patients in the use of the formerly composite rate services. A non-profit renal dialysis association agreed with MedPAC.
CMS prioritizes expansion of the collection, reporting, and analysis of standardized data as a key means to advance health equity.
As noted earlier, as part of CMS's December 2018 TEP and in the ESRD PPS CY 2020 final rule, CMS's EQRS data (formerly collected under CROWNWeb) is reported once per patient-month. Thus, CMS's proposal to collect time on machine data, which would require duration of treatment data reported for every renal dialysis treatment, would provide a more granular set of standardized data for analyzing (and, potentially, apportioning) composite rate costs for use in the case-mix adjustment. CMS would also look to time on machine data as a source to monitor claims data and identify disparities in care that could be mitigated by potential future adjustments that would incentivize equitable care within the framework of the ESRD PPS.
We note that ESRD PPS reform is an on-going multi-year effort to refine payment adjustments and methodologies under the ESRD PPS. Section 1881(b)(2)(B) of the Act provides that the Secretary shall prescribe in regulations any methods and procedures to determine the amounts of payments to be made for part B services (which include renal dialysis services), on a cost-related basis or other economical and equitable basis. Furthermore, section 1881(b)(14)(D) of the Act requires the ESRD PPS to include a payment adjustment based on case mix that may take into account various patient characteristics and other appropriate factors.
Since the establishment of the ESRD PPS in the CY 2011 ESRD PPS final rule (75 FR 49030), CMS has been engaged in ongoing monitoring and analysis of the ESRD PPS. CMS publishes these monitoring results regularly.
Presently, CMS adjusts the per-treatment ESRD PPS base rates to account for variation in the case mix, as set forth in 42 CFR 413.235. These adjustments account for patient age, BSA, low BMI, onset of renal dialysis (new patient), and comorbidities (for example, sickle cell anemia), as specified by CMS. The data and information that inform these adjustments are derived from cost reports, which are submitted to CMS on the facility level. However, we note that time on machine data would be provided to CMS at the patient level, on patient claims. This change would shift CMS's focus to a more patient-centered paradigm. We believe time on machine data would provide the insights we need to develop (and propose) potential amendments to the payment multipliers for the current, and potential future, patient-level adjustments, including new SDOH factors or health conditions (such as profound post-dialytic exhaustion) as patient-level adjustments. More immediately, however, time on machine data would significantly enhance CMS's insight into whether our current payment adjusters are appropriately aligning with actual resource use for individuals and communities who are underserved or disadvantaged and who may have multiple patient-level characteristics that necessitate longer renal dialysis times.
For example, CMS is aware of anecdotal evidence and published studies showing that patients with the comorbidity of sickle cell anemia may need a longer renal dialysis treatment time as well as additional resources from medical staff to attend to the manifestations of sickle cell that occur during dialysis. In fact, renal dialysis patients with sickle cell anemia may have frequent pain attacks during the actual renal dialysis treatment.
In addition to re-evaluating and potentially updating the payment multiplier for the patient-level adjuster for the co-morbidity of sickle cell anemia, CMS anticipates that there could be other instances where patients need more time on renal dialysis to avoid uncomfortable post-dialytic sequela, such as profound post-dialytic exhaustion. In instances of profound post-dialytic exhaustion, for example, CMS would evaluate the forthcoming time on machine data for the potential correlations between additional hemodialysis treatment time and decreased incidence of profound post-dialytic exhaustions, which may have cost implications. We are aware that there may be a need for a future patient-level payment adjuster associated with post-dialysis fatigue.
We propose to require patient-level reporting on resource use involved (time on machine) in furnishing hemodialysis treatment in-center in ESRD facilities, which would serve as a proxy to apportion composite rate costs (capital, labor, and administrative costs, as well as drugs, laboratory tests, and supplies necessary to administer the dialysis treatment) for use in the case-mix adjustment. This would allow us to more precisely estimate the average costs of the various above-mentioned components of a renal dialysis treatment that cannot currently be captured because payment for these items is bundled, and claims data do not contain detail on the use of these items and services. CMS would review the patient-level resource use data, including time on machine data, to evaluate and monitor the accuracy of the methods and procedures, including the patient-level adjustment factors, enhancing the integrity of the ESRD PPS. In addition, CMS would evaluate whether the data could be used to inform future refinements to the existing patient-level adjustment factors set forth at § 413.235(a), which may include age, BMI, BSA, and co-morbidities such as sickle cell anemia. Finally, CMS would review the data for its potential to identify any disparities from a health equity perspective and to support the future proposal of any new patient-level adjustment factors, including potential SDOH factors. We note that such data may also be used to inform potential future refinements to the facility-level adjustment factors, if appropriate. Per 42 CFR 413.196, we would publish notice of any proposed changes to payment adjustments, including adjustments to the composite rate, in the
We propose to amend 42 CFR 413.198 by adding language at § 413.198(b)(5) that would require each ESRD facility to submit data and information, under existing paragraph § 413.198(b)(3) describing allowable costs, of the types and in the formats established by CMS, for the purpose of estimating patient-level and facility-level variation in resource use, such as data and information on the duration of hemodialysis treatment (that is, time on machine data) involved in furnishing hemodialysis treatment in center in an ESRD facility. For additional context, we note that, under § 413.198(b)(3), allowable cost is the reasonable cost related to renal dialysis treatments. Reasonable cost includes all necessary and proper expenses incurred by the ESRD facility in furnishing the renal dialysis treatments, such as administrative costs, maintenance costs, and premium payments for employee health and pension plans. Reasonable cost includes both direct and indirect costs and normal standby costs.
We also propose to update § 413.198(a) by adding a reference to section 1881(b)(14) of the Act to acknowledge the statutory provisions for the ESRD PPS.
(b) Additional Considerations for the Proposed Reporting of Time on Machine Data CMS reviewed past comments from its TEPs and RFIs and gave additional consideration to the approach of our now-rescinded sub-regulatory guidance in Transmittal 10368 and to the complexities of reporting the number of minutes of hemodialysis treatment on patient claims. With this background in mind, we further refined our proposed requirements at proposed § 413.198(b)(5) in a way that would result in the reporting of the most useful, high value data.
In light of past comments questioning the feasibility and accuracy of time on machine reporting for home dialysis patients, we are proposing a reporting requirement that would only apply to patients receiving an in-center hemodialysis treatment. We believe this approach would ensure greater uniformity to the recording process and thus greater consistency in the data reported. We note that Chapter 11 of the Medicare Benefit Policy Manual at
CMS also considered past comments responding to its RFI in the CY 2020 ESRD PPS final rule (84 FR 60648, 60782) regarding patient-level factors that contribute to high costs of care. CMS agrees with commenters that expressed that patient-level adjusters should be based on sound, empirical evidence of their contribution to cost of care.
We also considered comments from a provider advocacy organization that opposed the use of time on machine data for purposes of ESRD PPS primarily because, they stated, certain patients benefit from shorter, more frequent dialysis, such as patients with catheter-related access issues, non-compliant patients, patients with chronic pain or diarrhea, and patients suffering from certain comorbidities. Still other commenters claimed that many subgroups of patients are challenged to stay on renal dialysis for the prescribed treatment time because of their physical status or other limitations, leading to more frequent treatment and/or higher costs related to patients' special circumstances and comorbidities and not to treatment duration. The commenters noted that, in both of the above scenarios, costs would remain the same. Further, they pointed out that some patients will not remain for their full renal dialysis treatment, and short of using restraints, there is nothing that can be done to force a patient to remain for their full prescribed treatment time. Therefore, in their view, using actual treatment time for cost allocation is not realistic.
CMS agrees that the payment multipliers for patient-level adjusters should be grounded in strong evidence, and we recognize that each patient will have unique needs, with some being more costly to treat and others with fewer costs, given their medical backgrounds. We emphasize and again clarify that, under this proposal, time on machine data would not be directly used to determine payment for renal dialysis services, nor would higher payments be made for longer treatments.
CMS also considered comments suggesting that a “time on machine” data element would not identify high-cost patients and comments suggesting such a data element would not be productive given the commenter's assertion that there was great homogeneity in treatment times across patients. One commenter noted that the vast majority of labor for renal dialysis treatments is putting the patient on and taking the patient off of dialysis, and another commenter pointed out that most renal dialysis treatments, regardless of time, will have similar composite rate costs. (In other words, they asserted that if a treatment is 3.5 hours compared to 5 hours, the composite rate costs for those treatments will be very similar. The only difference in cost between those two treatments would be 1.5 hours more use of utilities, dialysate and bicarbonate solution, machine depreciation, and a small amount of labor to check on the patient.) We agree with commenters that treatment times and costs may be similar across most patients based on our analysis and the comments of TEP participants. However, we would not expect to find that ESRD facilities are treating ESRD patients in a homogeneous fashion, but on a case-by-case basis determined by patient-centered plans of care. We note that a review of CY 2016 cost report data, conducted as part of the December 2018 TEP,
We anticipate that the data that would become available under the proposed requirement, if finalized, for reporting time on machine data would provide insight into meaningful, measurable variabilities in certain costs associated with patient-level characteristics.
The significance of the proposed time on machine data is dependent upon the collection of data from a preponderance of patient claims for in-facility hemodialysis. While the majority of patient claims may come from patients with similar profiles and treatment plans, the needs of the more complex and resource-intensive patients can only be identified by CMS through the collection of patient-level data from across the ESRD PPS patient population. Complex and resource-intensive patients are frequently encountered in the ESRD dialysis treatment setting, but it is not possible to obtain precise estimates of the higher costs of these patients' hemodialysis treatments from currently reported data. Cost reports and claims are the two data sources from which per treatment costs can be estimated. Since cost reports aggregate data at the facility level, patient-level differences in resource use are not detectable as higher medical needs, and related costs are masked by averages. Further, analysis of claims data from 2016 found that roughly 99 percent of ESRD facilities reported 10 or fewer distinct charge values across all patients and treatment modalities.
We also considered comments that the costs to ESRD facilities for providing dialysis treatment could be better measured by looking at costs based on prescribed time, and not on the actual time a patient is on the dialysis machine. The commenters stated their view that looking to prescribed time(s) would be the most rational way to determine staffing levels (and costs), because ESRD facilities plan for dialysis session length based on the prescribed time. Although CMS recognizes ESRD facilities' labor practices to align staffing with the stated prescription times, CMS is concerned that, for some patients, their prescription times are not aligning with actual usage and thus may not be the best predictor of ESRD facilities' costs. For example, we are aware that patients who experience severe itching
We anticipate that our proposed requirement would generate the data we would need to evaluate a potential adjustment of the payment multipliers for patient level adjustments, thereby allowing us to counteract possible financial disincentives to serving those patients. We would expect that such adjustments may thereby enhance access to renal dialysis services for such resource-intensive patients. We also believe that collecting time on machine data is preferable to collecting prescribed times, since we recognize that patients' actual experiences do not always align with their doctors' orders.
Finally, we considered the comments by a small renal dialysis organization within a large non-profit health system that reporting treatment times would be difficult and confusing and that identified many factors that would need to be outlined by CMS including: When does renal dialysis time start; what happens when a patient chooses to discontinue their treatment early, or has complications resulting in reduced treatment time; what happens when an ESRD facility inadvertently does not track time for a treatment; how does this information get included on a claim. We recognize that a new reporting requirement will require uniformity in its implementation across ESRD facilities. We note that the proposed “time on machine” requirement is for the reporting of the number of minutes of hemodialysis treatment a beneficiary receives, and it refers to only the minutes (reported in whole minutes) spent dialyzing, while the patient is connected to the dialysis machine. If the proposed requirement were to be finalized, we would address such details in operational guidance.
We propose that ESRD facilities report the number of minutes of hemodialysis treatment received in center in an ESRD facility using the D6 value code on the Medicare 72X type of bill (TOB) that is part of the CMS claim form CMS-1450 (UB-04) (OMB-0938-0997).
CMS further notes that the proposed time on machine data requirement would be collected on Medicare 72X claims. This approach would address long-standing concerns, including such concerns raised by MedPAC and other interested parties, that CMS should move to a one-equation model. CMS agrees with interested parties that a single-equation model, to be constructed at the patient level, would reduce the complexity of the current model and would better align payment with costs. The current two-equation model's payment adjusters are derived using weighted averages of the coefficients from the facility-level and patient-level equations. Because the composite rate items currently compose roughly 90 percent of the payment, we are seeking a more detailed understanding of patients' utilization of such treatment resources. We anticipate that the time on machine data would provide a useful proxy for these composite rate items.
Furthermore, CMS notes that its proposal to collect time on machine data on patient claims would address past comments on whether such a reporting requirement could create perverse incentives for ESRD facilities to amend actual reported time on machine. Another past commenter expressed concern about whether an ESRD facility might have the renal dialysis run a few extra minutes to increase the payment. However, we note that requiring the reporting of time on machine data on a claim, by definition, would involve an attestation that the information submitted is correct and that the items presented represent medically necessary expenses. The False Claims Act (31 U.S.C. 3729 to 3733) establishes civil liability for knowingly presenting a false or fraudulent claim to the government for payment.
We note that, if the proposed requirement to collect duration of treatment data were to be finalized, we would then issue operational guidance in support of the requirement. Such guidance would describe the applicable instructions for reporting a value code (in this case, the D6
We emphasize and again clarify that, under this proposal, time on machine data would not be directly used to determine payment for renal dialysis services, nor would higher payments be made for longer treatments. Rather, time on machine data would allow for patient-specific calculation of costs for composite rate services, including labor costs, costs for the use of renal dialysis machines and related equipment, and costs for such items as dialysate and other essential supplies. In this way, time on machine data would be used to disaggregate facility-level composite rate costs (as obtained from the cost reports) and assign them to the patient-month
We are proposing a January 1, 2025, effective date for this new reporting requirement. We are aware that all ESRD facilities record the time a patient has received hemodialysis treatment into a patient's medical record, and that, for most ESRD facilities, this time is automatically recorded into the patient's electronic health record (EHR). We further understand that ESRD facilities are able to transfer data from EHRs into the patient-specific claims that are submitted to Medicare for payment. However, we recognize that some ESRD facilities with limited resources may need to make modifications to their record keeping and reporting systems to facilitate the transfer of a patient's recorded hemodialysis treatment time in the patient's medical record to the Medicare claim. Although we did receive a past comment indicating that a facility's implementation time would involve training staff on how to count and track time, we do not expect that the manual recording of a patient's hemodialysis treatment time into their health record is widespread. Finally, we note that ESRD facilities are already reporting extensive information from patient EHRs into Medicare institutional claim form CMS-1450 (UB-04) (OMB-0938-0997), and we would not expect implementation to be overly burdensome to ESRD facilities. We recognize that some ESRD facilities would need to establish a new pathway from patient EHRs to the Medicare claim form, in addition to making simpler programming updates to add a field for the total number of minutes of dialysis provided during the billing period. Based on our findings in the TEP from December 2018, we anticipate that the implementation challenges that ESRD facilities might experience would be small and temporary, as a patient's time receiving dialysis treatment is already collected for the patient's medical record. We are seeking comment on whether an earlier effective date, such as January 1, 2024, is feasible and would provide ESRD facilities with adequate time to implement this new reporting requirement.
We are proposing to fix a typographical error in 42 CFR 413.198(b)(3)(iii), which currently refers to “luxury items or servicess”. We are proposing to change this to “luxury items or services”.
In the CY 2020 ESRD PPS final rule, we finalized a conditional policy for TDAPA payment based on the availability of ASP data (84 FR 60679). In that final rule, we explained that if drug manufacturers were to stop submitting full quarters of ASP data for products that are eligible for the TDAPA, and we had to revert to basing the TDAPA on WAC or invoice pricing, we believed we would be overpaying for the TDAPA for those products. We stated that we would no longer apply the TDAPA for a new renal dialysis drug or biological product if a drug manufacturer submits a full calendar quarter of ASP data into CMS within 30 days after the last day of the 3rd calendar quarter after the TDAPA is initiated for the product, but at a later point during the applicable TDAPA period specified in § 413.234(c)(1) or (2), stops submitting a full calendar quarter of ASP data into CMS. We explained that once we determine that the latest full calendar quarter of ASP is not available, we would stop applying the TDAPA for the new renal dialysis drug or biological product within the next 2-calendar quarters. For example, we stated that if we begin paying the TDAPA on January 1, 2021 for an eligible new renal dialysis drug or biological product, and a full calendar quarter of ASP data is made available to CMS by October 30, 2021 (30 days after the close of the 3rd quarter of paying the TDAPA), but a full calendar quarter of ASP data is not made available to CMS as of January 30, 2022 (30 days after the close of the 4th quarter of paying the TDAPA), we would stop applying the TDAPA for the product no later than June 30, 2022 (2 quarters after the 4th quarter of paying the TDAPA).
We adopted this conditional policy in order to avoid overpaying for the TDAPA on an ongoing basis and in order to ensure that TDAPA payment is based on the most appropriate data, that is, ASP. Specifically, we explained in the CY 2020 ESRD PPS proposed rule (84 FR 38349) and final rule (84 FR 60680) that we were concerned about (1) increases to Medicare expenditures due to the TDAPA for calcimimetics; (2) drug manufacturers not reporting ASP data for products eligible for TDAPA; and (3) our TDAPA policy potentially incentivizing drug manufacturers to withhold ASP data from CMS.
Our existing regulation at § 413.234(c) does not specifically address the application of the TDAPA conditional policy in situations in which the manufacturer of the new renal dialysis drug or biological product submitted ASP data to CMS and reported zero or negative sales. Zero or negative sales may occur for a variety of reasons, including no sales, recalls of a product, or repurchases of sold products. In the CY 2012 PFS final rule (76 FR 73296), CMS clarified that zero or negative values are valid for ASP, ASP units, and WAC. Therefore, when such a scenario occurs for separately payable Part B drugs, we consider the submission of zero or negative sales to fulfill the reporting requirements of manufacturer ASP data to CMS as set forth in sections 1927(b)(3)(A)(iii) and 1847A(f) of the Act. We note that in situations when zero sales are submitted, CMS guidance
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), CMS established the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) under the ESRD PPS, under the authority of section 1881(b)(14)(D)(iv) of the Act, to support ESRD facility use and beneficiary access to these new technologies. We established this add-on payment adjustment to help address the unique circumstances experienced by ESRD facilities when incorporating new and innovative equipment and supplies into their businesses and to support ESRD facilities transitioning or testing these products during the period when they are new to market. We added § 413.236 to establish the eligibility criteria and payment policies for the TPNIES.
In the CY 2020 ESRD PPS final rule (84 FR 60650), we established in § 413.236(b) that for dates of service occurring on or after January 1, 2020, we would provide the TPNIES to an ESRD facility for furnishing a covered equipment or supply only if the item: (1) has been designated by CMS as a renal dialysis service under § 413.171; (2) is new, meaning granted marketing authorization by the FDA on or after January 1, 2020; (3) is commercially available by January 1 of the particular CY, meaning the year in which the payment adjustment would take effect; (4) has a Healthcare Common Procedure Coding System (HCPCS) application submitted in accordance with the official Level II HCPCS coding procedures by September 1 of the particular CY; (5) is innovative, meaning it meets the substantial clinical improvement criteria specified in the Inpatient Prospective Payment System (IPPS) regulations at § 412.87(b)(1) and related guidance; and (6) is not a capital-related asset that an ESRD facility has an economic interest in through ownership (regardless of the manner in which it was acquired).
Regarding the innovation requirement in § 413.236(b)(5), in the CY 2020 ESRD PPS final rule (84 FR 60690), we stated that we would use the following criteria to evaluate substantial clinical improvement for purposes of the TPNIES under the ESRD PPS based on the IPPS substantial clinical improvement criteria in § 412.87(b)(1) and related guidance:
A new technology represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries. First, CMS considers the totality of the circumstances when making a determination that a new renal dialysis equipment or supply represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries. Second, a determination that a new renal dialysis equipment or supply represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries means one of the following:
• The new renal dialysis equipment or supply offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments; or
• The new renal dialysis equipment or supply offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable, or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods, and there must also be evidence that use of the new renal dialysis service to make a diagnosis affects the management of the patient; or
• The use of the new renal dialysis equipment or supply significantly improves clinical outcomes relative to renal dialysis services previously available as demonstrated by one or more of the following: (1) a reduction in at least one clinically significant adverse event, including a reduction in mortality or a clinically significant complication; (2) a decreased rate of at least one subsequent diagnostic or therapeutic intervention; (3) a decreased number of future hospitalizations or physician visits; (4) a more rapid beneficial resolution of the disease process treatment including, but not limited to, a reduced length of stay or recovery time; (5) an improvement in one or more activities of daily living; an improved quality of life; or (6) a demonstrated greater medication adherence or compliance; or,
• The totality of the circumstances otherwise demonstrates that the new renal dialysis equipment or supply substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries.
Third, evidence from the following published or unpublished information sources from within the United States or elsewhere may be sufficient to establish that a new renal dialysis equipment or supply represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries: Clinical trials, peer reviewed journal articles; study results; meta-analyses; consensus statements; white papers; patient surveys; case studies; reports; systematic literature reviews; letters from major healthcare associations; editorials and letters to the editor; and public comments. Other appropriate information sources may be considered.
Fourth, the medical condition diagnosed or treated by the new renal dialysis equipment or supply may have a low prevalence among Medicare beneficiaries.
Fifth, the new renal dialysis equipment or supply may represent an advance that substantially improves, relative to services or technologies previously available, the diagnosis or treatment of a subpopulation of patients with the medical condition diagnosed or treated by the new renal dialysis equipment or supply.
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), we also established a process modeled after IPPS's process of determining if a new medical service or technology meets the substantial clinical improvement criteria specified in § 412.87(b)(1). As we discussed in the CY 2020 ESRD PPS final rule (84 FR 60682), we believe it is appropriate to facilitate access to new and innovative equipment and supplies through add-on payment adjustments similar to the IPPS New Technology Add-On Payment and to provide stakeholders with standard criteria for both inpatient and ESRD facility settings. In § 413.236(c), we established a process for our announcement of TPNIES determinations and a deadline for consideration of new renal dialysis equipment or supply applications under the ESRD PPS. We would consider whether a new renal dialysis equipment or supply meets the eligibility criteria specified in § 413.236(b) and summarize the applications received in the annual
In the CY 2020 ESRD PPS final rule, we established § 413.236(d) to provide a payment adjustment for certain new and innovative renal dialysis equipment or supplies. We stated that the TPNIES is paid for two calendar years. Following payment of the TPNIES, the ESRD PPS base rate will not be modified and the new and innovative renal dialysis equipment or supply will become an eligible outlier service as provided in § 413.237.
Regarding the basis of payment for the TPNIES, in the CY 2020 ESRD PPS final rule, we finalized at § 413.236(e) that the TPNIES is based on 65 percent of the price established by the MACs, using the information from the invoice and other specified sources of information.
In the CY 2021 ESRD PPS final rule (85 FR 71410 through 71464), we made several changes to the TPNIES eligibility criteria at § 413.236. First, we revised the definition of new at § 413.236(b)(2) as within 3 years beginning on the date of the FDA marketing authorization. Second, we changed the deadline for TPNIES applicants' HCPCS Level II code application submission from September 1 of the particular CY to the HCPCS Level II code application deadline for biannual Coding Cycle 2 for durable medical equipment, orthotics, prosthetics, and supplies (DMEPOS) items and services as specified in the HCPCS Level II coding guidance on the CMS website prior to the CY. In addition, a copy of the applicable FDA marketing authorization must be submitted to CMS by the HCPCS Level II code application deadline for biannual Coding Cycle 2 for DMEPOS items and services as specified in the HCPCS Level II coding guidance on the CMS website in order for the equipment or supply to be eligible for the TPNIES the following year. Third, we revised § 413.236(b)(5) to remove a reference to related guidance on the substantial clinical improvement criteria, as the guidance had already been codified.
Finally, in the CY 2021 ESRD PPS final rule, we expanded the TPNIES policy to include certain capital-related assets that are home dialysis machines when used in the home for a single patient. We explained that capital-related assets are defined in the Provider Reimbursement Manual (chapter 1, section 104.1) as assets that a provider has an economic interest in through ownership (regardless of the manner in which they were acquired). We noted that examples of capital-related assets for ESRD facilities are dialysis machines and water purification systems. We explained that, although we stated in the CY 2020 ESRD PPS proposed rule (84 FR 38354) that we did not believe capital-related assets should be eligible for additional payment through the TPNIES because the cost of these items is captured in cost reports, they depreciate over time, and are generally used for multiple patients, there were a number of other factors we considered that led us to consider expanding eligibility for these technologies in the CY 2021 ESRD PPS rulemaking. We explained that, following publication of the CY 2020 ESRD PPS final rule, we continued to study the issue of payment for capital-related assets under the ESRD PPS, taking into account information from a wide variety of stakeholders and recent developments and initiatives regarding kidney care. For example, we considered various HHS home dialysis initiatives, Executive Orders to transform kidney care, and how the risk of COVID-19 for particularly vulnerable ESRD beneficiaries could be mitigated by encouraging home dialysis.
After closely considering these issues, we proposed a revision to § 413.236(b)(6) in the CY 2021 ESRD PPS proposed rule to provide an exception to the general exclusion for capital-related assets from eligibility for the TPNIES for capital-related assets that are home dialysis machines when used in the home for a single patient and that meet the other eligibility criteria in § 413.235(b), and finalized the exception as proposed in the CY 2021 ESRD PPS final rule. We finalized the same determination process for TPNIES applications for capital-related assets that are home dialysis machines as for all other TPNIES applications; that we will consider whether the new home dialysis machine meets the eligibility criteria specified in § 413.236(b) and announce the results in the
In the CY 2021 ESRD PPS final rule, at § 413.236(f), we finalized a pricing methodology for capital-related assets that are home dialysis machines when used in the home for a single patient, which requires the MACs to calculate the annual allowance and the preadjusted per treatment amount. The pre-adjusted per treatment amount is reduced by an estimated average per treatment offset amount to account for the costs already paid through the ESRD PPS base rate.
We revised § 413.236(d) to reflect that we would pay 65 percent of the pre-adjusted per treatment amount minus the offset for capital-related assets that are home dialysis machines when used in the home for a single patient.
We revised § 413.236(d)(2) to reflect that following payment of the TPNIES, the ESRD PPS base rate will not be modified and the new and innovative renal dialysis equipment or supply will be an eligible outlier service as provided in § 413.237, except a capital-related asset that is a home dialysis machine will not be an eligible outlier service as provided in § 413.237.
In summary, under the current eligibility requirements in § 413.236(b), CMS provides for a TPNIES to an ESRD facility for furnishing a covered equipment or supply only if the item: (1) has been designated by CMS as a renal dialysis service under § 413.171; (2) is new, meaning within 3 years beginning on the date of the FDA marketing authorization; (3) is commercially available by January 1 of the particular CY, meaning the year in
This section of the proposed rule discusses proposed clarifications to our policies for evaluating the TPNIES eligibility criteria under § 413.236(b).
As stated previously, we consider whether a new renal dialysis supply or equipment meets the TPNIES eligibility criteria as part of the annual ESRD PPS rulemaking and announce the results in ESRD PPS final rule. To qualify for the TPNIES, an applicant must meet each of the TPNIES eligibility criteria set forth in § 413.236(b)(1) through (6). An applicant that fails to demonstrate that it meets each of the six eligibility criteria is not eligible for the TPNIES.
In the CY 2021 ESRD PPS final rule, we focused our analysis of the TPNIES eligibility criteria on those that were not met. That is, for the Theranova Dialyzer, we included our analysis of how the applicant did not meet the innovation criterion under § 413.236(b)(5), and for the Tablo® cartridge, we included our analysis of how the applicant did not meet the newness criterion under § 413.236(b)(2) and innovation criterion under § 413.236(b)(5) (85 FR 71444 through 71464). In the CY 2022 and CY 2023 ESRD PPS final rules, we expanded our analysis to include our determination as to whether the applicants met each of the six criteria. In doing so, we analyzed the TPNIES eligibility criteria in the sequence that is provided in § 413.236(b)(1) through (6) (86 FR 61889 through 61906 and 87 FR 67193 through 67216).
We clarify that our analysis of the TPNIES eligibility criteria would continue to proceed in sequential order. Specifically, in the annual ESRD PPS proposed rule, we would continue to summarize the information from the application regarding each of the six eligibility criteria and include any questions or concerns that we identify during our analysis of the application.
Based on information provided by the applicant and from public comments during the annual ESRD PPS rulemaking cycle, we would continue to analyze the TPNIES eligibility criteria in sequential order in the annual ESRD PPS final rule. However, the change that we are proposing is that once it has been established that one criterion has not been met, we would not discuss or make specific determinations on the subsequent criteria for that item in the annual ESRD PPS final rule. We note that the criteria set forth in § 413.236(b) are intentionally listed in the order in which they appear. The first criterion is foundational in that an equipment or supply that is not a renal dialysis service would not be paid for under the ESRD PPS and therefore would not fit within the TPNIES payment pathway. As such, it would not be pertinent to evaluate the remaining TPNIES criteria for that item. TPNIES criteria two through four are objective and not subject to interpretation in that they each require date evidence to demonstrate newness, commercial availability, and the submission of a HCPCS application, respectively. The TPNIES innovation criterion under § 413.236(b)(5) requires the most significant CMS evaluation. Under our TPNIES policy and § 412.87(b)(1)(i), CMS is required to consider the totality of the circumstances when making a determination that a new renal dialysis equipment or supply represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries. In doing so, we consider various non-objective circumstances in our review of the TPNIES applications, including the state of the ESRD landscape and the particular challenges and vulnerabilities of patients with ESRD (86 FR 61905). We believe that it is prudent to reserve our in-depth analysis of the TPNIES innovation criterion only for applications that provide the necessary evidence to demonstrate that they meet the earlier foundational and objective TPNIES criteria.
As described previously in the background section of this proposed rule, the TPNIES innovation criterion in § 413.236(b)(5) incorporates the substantial clinical improvement criteria in the IPPS regulations at § 412.87(b)(1) for the new technology add-on payment (NTAP). This sequential approach for reviewing eligibility criteria is also in place for the NTAP pathway. The FY 2009 IPPS final rule (73 FR 48561 through 48563) discussed the way in which CMS evaluates the NTAP eligibility criteria for new medical service or technology add-on payment applications. That is, we first determine whether a medical service or technology meets the newness criterion, and only if so, do we then make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. The NTAP cost criterion is not applicable in analyzing TPNIES eligibility. However, consistent with our approach under NTAP, we believe that the most prudent use of CMS resources would be to reserve our analysis and determination regarding whether a new equipment or supply meets the TPNIES innovation criterion by representing a substantial clinical improvement over existing technologies until after we determine the new equipment or supply meets the earlier criteria.
Under this proposal, we would first determine whether an equipment or supply meets the renal dialysis service criterion in § 413.236(b)(1) and present our analysis of this first criterion in the final rule. In instances where CMS determines that § 413.236(b)(1) has been met, we would proceed in assessing the newness criterion in § 413.236(b)(2) and present our analysis of this second criterion in the final rule. In instances where CMS determines that § 413.236(b)(2) has been met, we would proceed in assessing whether the commercial availability criterion in § 413.236(b)(3) has either been met or the applicant expects that it will be met by January 1 of the particular calendar year deadline and present our analysis of this third criterion in the final rule. In instances where CMS determines that § 413.236(b)(3) has been met or the applicant expects that it will be met by January 1 of the particular calendar year deadline, we would proceed in assessing the HCPCS Level II code application criterion in § 413.236(b)(4) and present our analysis of this fourth criterion in the final rule. In instances where CMS determines that § 413.236(b)(4) has been met, we would proceed in assessing the innovation criteria in §§ 413.236(b)(5) and 412.87(b)(1) and present our analysis of this fifth criterion in the final rule. In instances where CMS determines that § 413.236(b)(5) has been met, we would proceed in assessing the non-capital-related asset (except home dialysis machines) criterion in § 413.236(b)(6) and present our analysis of this sixth criterion in the final rule. In instances where CMS determines that
In summary, we are proposing to clarify that as CMS proceeds through the sequential analysis of the six TPNIES eligibility criteria in the ESRD PPS final rule for a particular equipment or supply, once we determine that the item has failed to demonstrate having met one of the eligibility criteria, the item would be ineligible for the TPNIES. We would limit our analysis in the final rule to the TPNIES criterion that is not met and any preceding criteria that have been determined to have been met. We would not include the analysis of the remaining criteria in the final rule. If finalized, this policy would be effective January 1, 2024, and would apply to our analysis of TPNIES applications for CY 2025 payment.
As stated previously, applicants must meet the newness criterion in § 413.236(b)(2) to qualify for the TPNIES. CMS defines the TPNIES newness criterion at § 413.236(b)(2) as within 3 years beginning on the date of the FDA marketing authorization. In this proposed rule, we wish to clarify two distinct aspects of the criterion that are consistent with our current TPNIES policies and would not represent any changes to the eligibility criteria: (1) the 3-year newness period and (2) FDA marketing authorization.
First, with respect to the 3-year newness period, we stated in the CY 2021 ESRD PPS final rule that by defining new as within 3 years beginning on the date of the FDA marketing authorization, we limit eligibility for the TPNIES to new technologies but allow prospective TPNIES applicants 3 years beginning on the date of FDA marketing authorization in which to submit their applications (85 FR 71410 through 71464).
To ensure that the timeframe during which a prospective TPNIES applicant is eligible to apply is clear, we are proposing to modify our regulation to specify that the applicant would have 3 years from the date of FDA marketing authorization to apply for the TPNIES, based on the date the application is submitted. This proposed modification is consistent with current policy, and while it is not a change in policy, we believe that clarifying the regulation text would help to eliminate any confusion about the 3-year newness period. As indicated in § 413.236(c), February 1 prior to the particular calendar year is the annual TPNIES application submission deadline. We are proposing to clarify that the 3-year newness period is only for submission of the complete application. An applicant does not have to ensure that the application is submitted and that CMS renders its determination through notice and comment rulemaking within the 3-year newness period. Specifically, we are proposing to revise § 413.236(b)(2) to clarify that the equipment or supply is new if a complete application has been submitted to CMS under § 413.236(c) within 3 years of the date of the FDA marketing authorization.
Second, with respect to the requirement in § 413.236(b)(2) that the equipment or supply must have FDA marketing authorization, we clarify that an equipment or supply with FDA Exempt status would not meet the newness criterion and therefore would not be eligible for the TPNIES. As described on the FDA website, the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act established three regulatory classes for medical devices: Class I, Class II, and Class III. The three classes are based on the degree of control necessary to assure the various types of devices are safe and effective.
We received one application for the TPNIES for CY 2024. A discussion of the application is presented below.
Pain Care Labs
The applicant described the steps for using Buzzy® Pro during dialysis: (1) thread the hands free strap or regular tourniquet through the ice pack and the device so that the ice pack is on the concave side of the device; (2) attach the device and the ice directly over the site; (3) activate the vibration toggle switch and leave in place 30 to 120 seconds; (4) during cannulation, move the device proximally so the dot on the side opposite the switch is 2 to 3 cm proximal to the cannulation site; (5) clean the site per cannulation protocol; and (6) remove the device after the painful part of procedure is completed.
Regarding the first TPNIES eligibility criterion in § 413.236(b)(1), that the item
With respect to the second TPNIES eligibility criterion in § 413.236(b)(2), that the item is new, meaning within 3 years beginning on the date of the FDA marketing authorization, the applicant stated that it is seeking 510(k) marketing authorization from the FDA for a new utility and design of Buzzy® created for dialysis fistulae sites, patented in 2022 under the name Buzzy® Pro. To be eligible for the TPNIES, the applicant must apply within 3 years of the FDA marketing authorization date and receive FDA marketing authorization by the HCPCS Level II deadline of July 3, 2023.
The applicant submitted the indications for use portion of its FDA 510(k) application that identifies Buzzy® as all Buzzy® models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal and Pro to control pain associated with needle procedures including dialysis and the temporary relief of minor injuries. The applicant provided supplemental information in a document titled “510(k) Summary” that included a comparison table of the Predicate Device (K130631) to the Subject Device (K202993). The document indicated that only the Buzzy® Pro model is recommended for dialysis. The document also indicated that Buzzy® Pro is identical to the predicate device in terms of materials, vibration motor, circuitry, functionality, and intended use; differs only in shape but is comparable in size to the predicate device; and Buzzy® Pro is distinguished by its rectangular shape to offer users a more professional looking alternative to the bee-shape of the other device. We would be interested in better understanding the way in which the Buzzy® Pro, that is the subject of this TPNIES application, differs from the other Buzzy® models and whether Buzzy® Pro is indicated for adult versus pediatric patients, or both. We note that to satisfy the newness criterion, the FDA 510(k) marketing authorization must have been issued within 3 years covering the specific device and model that is the subject of the TPNIES application. We welcome public comment on this issue.
Regarding the third TPNIES eligibility criterion in § 413.236(b)(3), that the item is commercially available by January 1 of the particular calendar year, meaning the year in which the payment adjustment would take effect, the applicant stated that it expects Buzzy® Pro would be commercially available immediately after receiving FDA marketing authorization.
Regarding the fourth TPNIES eligibility criterion in § 413.236(b)(4) requiring that the applicant submit a complete HCPCS Level II code application by the HCPCS Level II application deadline of July 3, 2023, the applicant stated that it intends to apply by the deadline.
With regard to the fifth TPNIES eligibility criterion under § 413.236(b)(5), that the item is innovative, meaning it meets the substantial clinical improvement criteria specified in § 412.87(b)(1), the applicant presented two substantial clinical improvement claims. First, the applicant stated that Buzzy® Pro controls needle pain for dialysis. Specifically, per the applicant, Buzzy® Pro makes cannulation pain relief available to dialysis patients, which significantly improves clinical outcomes related to depression and discontinuation of dialysis due to needle pain. Second, the applicant stated that Buzzy® Pro reduces needle fear.
With respect to the claim that Buzzy® Pro controls needle pain for dialysis, the applicant stated that currently, the most effective options for dialysis cannulation pain are the topical anesthetic, EMLA® and vapocoolant spray.
With respect to the claim that Buzzy® Pro reduces needle fear, the applicant stated that 25 to 47 percent of chronic kidney patients have needle fear.
The applicant submitted 33 unique sources of evidence with its application in support of its claims of substantial clinical improvement. Thirty of the sources that were submitted examined the effect of external cold and vibration devices, including the Buzzy® device, though not Buzzy® Pro, during needle procedures other than dialysis cannulation. One article examined the effect of cryotherapy on pediatric pain management at the arteriovenous fistula site during hemodialysis.
The applicant also submitted a list of references, referred to as a literature review, that pertained to the applicant's products, among which, the Buzzy® device was listed as relieving or reducing needle pain and fear and for needle procedures and for musculoskeletal pain.
In a document titled “Summary of Clinical Evidence—relief of needle pain and fear,” the applicant presented the study objectives and key features of 29
As stated previously, the applicant must demonstrate that the equipment or supply meets at least one of the following three substantial clinical improvement criteria in order to be eligible for the TPNIES: (1) the item offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatment; (2) the item offers the ability to diagnose a medical condition in the patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods; or (3) the item significantly improves clinical outcomes relative to services or technologies previously available. The applicant stated that
With respect to the submitted evidence, it does not appear that the studies reflect the use of (1) Buzzy® Pro, the device that is the subject of the TPNIES application, nor (2) Buzzy® Pro in the context of dialysis cannulation. Specifically, the applicant submitted an application for Buzzy® Pro, indicating that Buzzy® Pro is a new design created for dialysis fistulae sites, patented in 2022. However, the sources submitted were dated prior to the 2022 new design patent date for dialysis fistulae sites. As such, it appears that the sources submitted reflect the use of a predecessor Buzzy® device. In addition, while the applicant's “Summary of Clinical Evidence” document presented sources as evaluating Buzzy® Pro's efficacy in managing vascular access pain or fear, we note that none of these sources appear to evaluate vascular access in the context of dialysis cannulation. The studies evaluated pain and fear in the context of other types of needle procedures, including vaccine or medication injections, blood specimen collection, and intravenous catheter insertion.
It is unclear whether findings of pain or fear reduction from the use of the Buzzy® device in non-dialysis needle procedures could be extrapolated to dialysis cannulation pain or fear. There are several unique features to dialysis cannulation that may limit generalizability. These include the need for regular punctures several times per week, the maintenance of cannulation for several hours during dialysis treatments, the use of substantially larger needle sizes in dialysis, and complications that are associated with frequent vascular access cannulation, such as infections and thrombosis. As such, we question whether outcomes could reasonably be extrapolated as applicable to patients undergoing dialysis cannulation.
As identified in the table, the majority of the studies provided in support of the applicant's claims reflect pediatric patient experiences. We note that pediatric patients comprise a small proportion, just 0.14 percent, of the total Medicare ESRD patient population (87 FR 67222). As such, the data that is heavily weighted towards the pediatric population may have limited generalizability to the non-pediatric majority of the ESRD patient population.
While the applicant stated that the Buzzy® devices are less expensive than topical anesthetic, we note that cost is not an eligibility criterion for the TPNIES.
It is also unclear whether a single Buzzy® Pro device and its components (for example, tourniquet and ice pack) are intended for single versus multiple patient use in the ESRD facility setting. To the extent that the device or its components are intended for use among multiple patients, we would be interested in data that examines the risk of infection associated with the use of Buzzy® Pro in the dialysis patient population. Additionally, we are not aware of any data that examines the risk of harm to the dialysis access site or any other adverse events associated with use of the Buzzy® Pro in the dialysis patient population, including access and bloodstream infections and thromboses but would be interested in the results of such data.
In addition, the applicant stated that currently, the most effective options for dialysis cannulation pain are topical anesthetics and vapocoolant spray. We would be interested in studies comparing the use of Buzzy® Pro to topical anesthetics or vapocoolant and that demonstrate that Buzzy® Pro significantly improves clinical outcomes of dialysis patients relative to existing available treatments.
We are inviting public comments on whether the Buzzy® Pro meets the substantial clinical improvement criteria for the TPNIES.
With respect to the sixth TPNIES eligibility criterion under § 413.236(b)(6), limiting capital-related assets from being eligible for the TPNIES, except those that are home dialysis machines, we note that Buzzy® Pro does not meet the definition of a capital-related asset under § 413.236(a)(2), because it is not an asset that the ESRD facility has an economic interest in through ownership that is subject to depreciation.
In this section of the proposed rule, we identify any items previously approved for the TPNIES and for which payment is continuing for CY 2024. As described in the CY 2023 ESRD PPS final rule, payment for the one item approved for TPNIES, the Tablo® Hemodialysis System, as described by HCPCS code E1629, expires on December, 31, 2023 (87 FR 67216). As such there are no items previously approved for TPNIES for which payment is continuing in CY 2024.
Under § 413.234(c)(1), a new renal dialysis drug or biological product that is considered included in the ESRD PPS base rate is paid the TDAPA for 2 years. In December 2021, CMS approved
The Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27) was enacted on June 29, 2015, and amended the Act to provide coverage and payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a subsection (r) to provide payment, beginning January 1, 2017, for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate, as adjusted by any applicable geographic adjustment applied under section 1881(b)(14)(D)(iv)(II) of the Act and adjusted (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under section 1881(b)(14)(D) of the Act that the Secretary elects.
In the CY 2017 ESRD PPS final rule, we finalized several coverage and payment policies to implement subsection (r) of section 1834 of the Act and the amendments to section 1861(s)(2)(F) of the Act, including the payment rate for AKI dialysis (81 FR 77866 through 77872 and 77965). We interpret section 1834(r)(1) of the Act as requiring the amount of payment for AKI dialysis services to be the base rate for renal dialysis services determined for a year under the ESRD PPS base rate as set forth in § 413.220, updated by the ESRD bundled market basket percentage increase factor minus a productivity adjustment as set forth in § 413.196(d)(1), adjusted for wages as set forth in § 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under § 413.373. We codified this policy in § 413.372 (81 FR 77965).
The payment rate for AKI dialysis is the ESRD PPS base rate determined for a year under section 1881(b)(14) of the Act, which is the finalized ESRD PPS base rate, including the applicable annual market basket update, geographic wage adjustments, and any other discretionary adjustments, for such year. We note that ESRD facilities have the ability to bill Medicare for non-renal dialysis items and services and receive separate payment in addition to the payment rate for AKI dialysis.
As discussed in section II.B.1.d of this proposed rule, the proposed ESRD PPS base rate is $269.99, which reflects the application of the proposed CY 2024 wage index budget-neutrality adjustment factor of 0.999652 and the proposed CY 2024 ESRDB market basket percentage increase of 2.0 percent reduced by the proposed productivity adjustment of 0.3 percentage point, that is, 1.7 percent. Accordingly, we are proposing a CY 2024 per treatment payment rate of $269.99 (($265.57 × 0.999652) × 1.017 = $269.99) for renal dialysis services furnished by ESRD facilities to individuals with AKI. This proposed payment rate is further adjusted by the wage index, as discussed in the next section of this proposed rule.
Under section 1834(r)(1) of the Act and regulations at § 413.372, the amount of payment for AKI dialysis services is the base rate for renal dialysis services determined for a year under section 1881(b)(14) of the Act (updated by the ESRDB market basket percentage increase and reduced by the productivity adjustment), as adjusted by any applicable geographic adjustment factor applied under section 1881(b)(14)(D)(iv)(II) of the Act. Accordingly, we apply the same wage index under § 413.231 that is used under the ESRD PPS and discussed in section II.B.1.b of this proposed rule. The AKI dialysis payment rate is adjusted by the wage index for a particular ESRD facility in the same way that the ESRD PPS base rate is adjusted by the wage index for that ESRD facility (81 FR 77868). Specifically, we apply the wage index to the labor-related share of the ESRD PPS base rate that we utilize for AKI dialysis to compute the wage adjusted per-treatment AKI dialysis payment rate. We also apply the wage index policies regarding the 0.600 wage index floor (87 FR 67161 through 67166) and the 5 percent cap on wage index decreases (87 FR 67159 through 67161) to AKI dialysis payments to ESRD facilities. As stated previously, we are proposing a CY 2024 AKI dialysis payment rate of $269.99, adjusted by the ESRD facility's wage index.
For a detailed discussion of the End-Stage Renal Disease Quality Incentive Program's (ESRD QIP's) background and history, including a description of the Program's authorizing statute and the policies that we have adopted in previous final rules, we refer readers to previous ESRD QIP rules at: 75 FR 49030; 76 FR 628; 76 FR 70228; 77 FR 67450; 78 FR 72156; 79 FR 66120; 80 FR 68968; 81 FR 77834; 82 FR 50738; 83 FR 56922; 84 FR 60648; 85 FR 71398; 86 FR 61874; and 87 FR 67136.
We have also codified many of our policies for the ESRD QIP at 42 CFR 413.177 and 413.178.
In the CY 2019 ESRD PPS final rule, we codified a number of key terms used in the ESRD QIP at § 413.178(a) of our regulations (83 FR 56980 through 56982). One of these terms is “minimum total performance score” (mTPS), which we defined at § 413.178(a)(8) “with respect to a payment year”
We have recently reevaluated this definition and determined that it should be revised to more accurately capture how we calculate the median of national ESRD facility performance on reporting measures. Although we use data prior to the performance period to calculate these medians, the data may not be from the same time period, or “baseline period” (see § 413.178(a)(2)) used to calculate the 50th percentile of national ESRD facility performance on the clinical measures. Instead, our policy has been to calculate the median of national ESRD facility performance on the ESRD QIP reporting measures using the most recently available data prior to the applicable performance period for the payment year. If there were no data available prior to the first performance period of a new reporting measure, as was the case for the Clinical Depression Screening and Follow-Up reporting measure, we would use a proxy median for purposes of including the reporting measure in our calculation of the mTPS. We selected the values for these proxy medians based on the availability of previous measure data, a facility's familiarity with similar measures or requirements, and considerations regarding a facility's ability to comply with new reporting measure requirements during the initial performance periods for a new reporting measure.
We are proposing to update the definition of “minimum total performance score” at § 413.178(a)(8) so that it accurately captures these policies. We are also proposing that, with respect to the adoption of future reporting measures, including the reporting measures proposed in this proposed rule, if there are an insufficient quantity of data available prior to the first performance period of a new reporting measure, we will set a proxy median of zero for the reporting measure until we have sufficient data to calculate the median. We believe that this proposal will provide facilities with additional predictability and transparency regarding our calculation of the mTPS for a payment year. Although many facilities score much higher than zero during the initial performance periods of a new reporting measure, we believe that setting the proxy median at zero where we do not have sufficient data available will account for the possibility that new reporting measures may have different reporting requirements. For example, a new reporting measure may require a facility to report new or additional data in EQRS in order to be eligible for scoring on the reporting measure. Additionally, a new reporting measure may require that a facility reconsider its internal processes to comply with the reporting requirements and be eligible for scoring. We believe that using a median of 0 for new reporting measures would ensure that the mTPS is calculated based on the worst-case scenario, rather than assuming a median higher than what may be observed once data are available. Setting the proxy median at zero until we have sufficient data available to calculate the median would allow the timely inclusion of a new reporting measure in the ESRD QIP measure set, as well as our calculation of the mTPS, while also encouraging facilities to report the new or additional data that may be specified by that reporting measure so that they are able to receive credit for reporting.
We welcome public comment on this proposal.
In the CY 2013 ESRD PPS final rule (77 FR 67475), we finalized a policy to retain measures from prior program years for each successive program year, unless otherwise proposed and finalized. In the CY 2019 ESRD PPS final rule (83 FR 56983 through 56985), we finalized eight measure removal factors for the ESRD QIP, and we refer readers to that final rule for details. We also finalized a policy to retain a measure for certain specified reasons, such as when a particular measure addresses a gap in quality so significant that removing the measure could result in poor quality or when a measure addresses a statutorily-required topic, even if one or more of the measure removal factors applies. In the CY 2013 ESRD PPS final rule (77 FR 67475), we also finalized that we would generally remove an ESRD QIP measure using notice and comment rulemaking unless we determined that the continued collection of data on the measure raised patient safety concerns. In that case, we stated that we would promptly remove the measure, immediately notify ESRD facilities and the public through the usual communication channels (including listening sessions, memos, email notification, and website postings), and publish the justification for the removal in the
We are proposing to revise 42 CFR 413.178(c) to incorporate these measure adoption, retention, and removal policies. Existing § 413.178(c)(1) through (5) would be consolidated and renumbered as § 413.178(c)(1)(i) through (v), and we would add a new § 413.178(c)(1)(vi), which would codify our policy to adopt measures for the ESRD QIP beyond those that address the topics described at § 413.178(c)(1)(i) through (v). We are also proposing to codify at § 413.178(c)(2) our policies regarding the use of endorsed measures. We are proposing to codify at § 413.178(c)(3) our policy regarding the updating of measure specifications. Additionally, we are proposing to codify at § 413.178(c)(4) our policy regarding measure retention. Finally, we are proposing to codify at § 413.178(c)(5) our policies regarding measure removal. We believe these proposals will make it easier for interested parties to find these policies and will further align the ESRD QIP regulations with the regulations we have codified for other quality reporting programs.
We welcome public comment on these proposals.
Under our current policy, we retain all ESRD QIP measures from year to year unless we propose through rulemaking to remove them or otherwise provide notification of immediate removal if a measure raises potential safety issues (77 FR 67475). In this proposed rule, we are proposing to remove the Ultrafiltration Rate reporting measure and the Standardized Fistula Rate clinical measure beginning with PY 2026. We are also proposing to add the Facility Commitment to Health Equity reporting measure to the ESRD QIP measure set beginning with PY 2026. Table 12 below summarizes the previously finalized and proposed new measures that we would include in the PY 2026 ESRD QIP measure set. The technical specifications for each of these measures that would apply for PY 2026 can be found in the CMS ESRD Measures Manual for the 2023 Performance Period.
Significant
In the CY 2022 ESRD PPS proposed rule (86 FR 36362 through 36369), we requested information on our Equity Plan for Improving Quality in Medicare (also referred to as the CMS Framework for Health Equity),
The Agency for Healthcare Research and Quality (AHRQ) and The Joint Commission have independently concluded that facility leadership plays an important role in promoting a culture of quality and safety.
We believe that strong and committed leadership from dialysis facility executives and board members is essential and can play a role in shifting organizational culture and advancing equity goals for dialysis facilities. Studies demonstrate that hospital leadership can positively influence culture for better quality, patient outcomes, and experience of care.
Our belief that a leadership commitment to health equity can lead to a reduction of health disparities is also supported by research conducted by the Institute for Healthcare Improvement (IHI), which studied 23 health systems throughout the U.S. and Canada. The IHI's research showed that health equity must be a priority championed by leadership teams to improve both patient access to needed healthcare services and outcomes among populations that have been disadvantaged by the healthcare system.
The first pillar of our strategic priorities
We are proposing to adopt the measure under section 1881(h)(2)(A)(iv) of the Act, which gives the Secretary broad authority to specify measures for the ESRD QIP. Disparities in health equity are tied to worse patient outcomes in the ESRD community. For example, individuals from racial and ethnic minority groups and with lower incomes are less likely to receive recommended care for CKD risk factors and are also less likely to reduce CKD risk through recommended treatment goals.
The five questions of the proposed structural measure are adapted from the CMS Office of Minority Health's Building an Organizational Response to Health Disparities framework, which focuses on data collection, data analysis, culture of equity, and quality improvement.
The proposed Facility Commitment to Health Equity reporting measure would assess dialysis facility commitment to health equity using a suite of equity-focused organizational competencies aimed at achieving health equity for all populations, including those that have been disadvantaged, marginalized, and underserved by the healthcare system. As previously noted, this includes, but is not limited to: racial and ethnic minority groups, people with disabilities, members of the LGBTQ+ community, individuals with limited English proficiency, rural populations, religious minorities, and people facing socioeconomic challenges. Table 13 includes the five attestation domains and the elements within each of those domains to which a facility would report an affirmative attestation for the facility to receive points for that domain.
The proposed Facility Commitment to Health Equity measure consists of five attestation-based questions, each representing a separate domain of commitment. For a facility to affirmatively attest “yes” to a domain, and receive points for that domain, the facility would need to determine that it engages in all of the activities that are included as elements under the domain. A facility that engages in all of the activities for a domain would report an affirmative attestation by answering “yes” to the attestation-based question for that domain. There is no option for a facility to answer “yes” in response to an attestation-based question for a domain if the facility engages in some, but not all, of the activities included as domain elements, and there is also no option for a facility to answer “no” in response to any attestation-based question for a domain. The measure would be expressed as a fraction, and a facility can score either 0, 2, 4, 6, 8, or 10 for the performance period, depending on the number of domains to which a facility positively attests. We are proposing that the measure denominator would be “ten,” with each domain being represented as two points out of that total ten points, and that the numerator would be calculated as two points for each “yes” answer the facility reports which are then summed together. We chose to award facilities two points for each affirmative response to an attestation-based question so that the maximum number of points a facility could receive for the measure is ten, which is the same maximum number of points that a facility can receive on other ESRD QIP measures.
For example, for Domain 1 (“Facility commitment to reducing healthcare disparities is strengthened when equity is a key organizational priority”), a facility would evaluate and determine whether its strategic plan satisfies all of the elements described in (A) through (D) (see Table 13). If the facility's plan satisfies all four of these elements, the facility would respond “yes” to the attestation-based question for Domain 1 and receive two (2) points for that response. If the facility determined that its strategic plan satisfies elements (A) and (B) but not (C) and (D), the facility would not be able to respond “yes” to Domain 1 and would not receive any points for that domain.
The numerator would be calculated as the sum of the points the facility earns for responding “yes” to the attestation-based questions. For example, a facility that responds “yes” to all five attestation-based questions would receive the maximum 10 points (two points for each of the five “yes” responses). A facility that responds “yes” to three of the attestation-based questions would receive six points.
We are proposing that the Facility Commitment to Health Equity reporting measure would be added to the Reporting Measure Domain, as discussed further in section IV.C.6 of this proposed rule. Technical specifications for the proposed measure can be found in the ESRD QIP CY 2024 Technical Measure Specifications, which are available at:
We are proposing that facilities would be required to submit data needed to calculate the Facility Commitment to Health Equity measure once on an annual basis using EQRS beginning with PY 2026. We are proposing that the deadline for submission would be the end of the EQRS December data reporting month for the applicable performance period, which is consistent with current reporting deadlines for other ESRD QIP measures. For example, for the PY 2026 ESRD QIP, facilities would need to report data on the measure by the end of the December data reporting month in CY 2024. As described in Table 17 of this proposed rule, we are proposing performance standards for the Facility Commitment to Health Equity reporting measure. We are proposing a 12-month performance period for the measure. We are also proposing that facilities would be required to follow the submission and reporting requirements for web-based measures for the ESRD QIP posted on the QualityNet website:
We included the Facility Commitment to Health Equity measure as a measure under consideration for the ESRD QIP on the publicly available “List of Measures Under Consideration for December 1, 2022” (MUC List), a list of measures under consideration for use in various Medicare quality programs.
Although section 1881(h)(2)(B)(i) of the Act generally requires that measures specified by the Secretary for the ESRD QIP be endorsed by the entity with a contract under section 1890(a) of the Act, section 1881(h)(2)(B)(ii) of the Act states that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. We reviewed CBE-endorsed measures and were unable to identify any other CBE-endorsed measures on this topic, and therefore we believe the exception in section 1881(h)(2)(B)(ii) of the Act applies.
We are proposing to publicly display the facility-specific results for the Facility Commitment to Health Equity reporting measure on an annual basis through our
We invite public comment on this proposal.
On January 31, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency (PHE) for the United States in response to the global outbreak of SARS-COV-2, a novel (new) coronavirus that causes a disease named “coronavirus disease 2019” (COVID-19).
As we stated in the CY 2023 ESRD PPS final rule (87 FR 67244) and in our Revised Guidance for Staff Vaccination Requirements,
We stated in the CY 2023 ESRD PPS final rule that HCP are at risk of carrying COVID-19 infection to patients, experiencing illness or death themselves as a result of contracting COVID-19, and transmitting COVID-19 to their families, friends, and the general public (87 FR 67244). While the impact of COVID-19 vaccines on asymptomatic infection and transmission is not yet fully known, there is now robust data available on COVID-19 vaccine effectiveness across multiple populations against symptomatic infection, hospitalization, and death. Two-dose COVID-19 vaccines from Pfizer-BioNTech and Moderna were found to be 88 percent and 93 percent effective against hospitalization for COVID-19, respectively, over 6 months for adults over age 18 without immunocompromising conditions.
As SARS-COV-2 persists and evolves, our COVID-19 vaccination strategy must remain responsive. When we finalized adoption of the COVID-19 Vaccination Coverage Among HCP measure in the CY 2023 ESRD PPS final rule, we stated that HCP should be counted as vaccinated if they received COVID-19 vaccination any time from when it first became available in December 2020 (87 FR 67247). We noted that a completed vaccination course, defined for purposes of the measure as the primary vaccination series, may require one or more doses depending on the specific vaccine used, and that the NHSN application automatically calculates the total value for “Any completed COVID-19 vaccine series.” We also stated that, as vaccination protocols continue to evolve, we will continue to work with the CDC to update relevant measure specifications as necessary. Since we finalized the COVID-19 Vaccination Coverage Among HCP measure in the CY 2023 ESRD PPS final rule, new variants of SARS-COV-2 have emerged around the world and within the United States. Specifically, the Omicron variant (and its related subvariants) is listed as a variant of concern by the CDC because it spreads more easily than earlier variants.
We believe that vaccination remains the most effective means to prevent the worst consequences of COVID-19, including severe illness, hospitalization, and death. Given the availability of vaccine efficacy data, EUAs issued by the FDA for bivalent boosters, the continued presence of SARS-COV-2 in the United States, and variance among rates of booster dose vaccination, it is important to modify the COVID-19 Vaccination Coverage Among HCP measure to reflect recent updates that explicitly specify for HCP to receive primary series and booster vaccine doses in a timely manner. As the COVID-19 pandemic persists, we continue to believe that monitoring and surveillance is important and provides patients, beneficiaries, and their caregivers with information to support informed decision making. We propose to modify the COVID-19 Vaccination Coverage Among HCP measure to replace the term “complete vaccination course” with the term “up to date” in the HCP vaccination definition. We also propose to update the numerator to specify the time frames within which an HCP is considered up to date with recommended COVID-19 vaccines, including booster doses, beginning with PY 2026. As we stated in the CY 2023 ESRD PPS final rule (87 FR 67245), the COVID-19 Vaccination Coverage Among HCP measure is a process measure that assesses HCP vaccination coverage rates. Unlike outcome measures, process measures do not assess a particular outcome.
The COVID-19 Vaccination Coverage Among HCP measure is a process measure developed by the CDC to track COVID-19 vaccination coverage among HCP in settings such as dialysis facilities, and the measure is reported via the CDC's National Healthcare Safety Network (NHSN).
We refer readers to the CY 2023 ESRD PPS final rule (87 FR 67245 through 67246) for more information on the initial review of the measure by the Measure Applications Partnership (MAP). We included an updated version of the measure on the Measures Under Consideration (MUC) list for the 2022-2023 pre-rulemaking cycle for consideration by the MAP. In December 2022, the MAP's Hospital Workgroup discussed the modified measure. The Hospital Workgroup stated that the revision of the current measure captures up-to-date vaccination information in accordance with CDC recommendations
This reporting measure includes at least one week of data collection a month for each of the three months in a quarter. The denominator would be the number of HCP eligible to work in the facility for at least one day during the reporting period, excluding persons with contraindications to COVID-19 vaccination that are described by the CDC. Facilities report the following four categories of HCP to NHSN:
1.
2.
3.
4.
The denominator excludes denominator-eligible individuals with contraindications as defined by the CDC.
The numerator is the cumulative number of HCP in the denominator population who are considered up to date with recommended COVID-19 vaccines. Facilities should refer to the definition of up to date as of the first day of the applicable reporting quarter, which can be found at
1. Individuals who received an updated bivalent
2a. Individuals who received their last booster dose less than 2 months ago, or
2b. Individuals who completed their primary series
We note that for purposes of NHSN surveillance, the CDC began using this definition of up to date during the quarter 4 2022 surveillance period (September 26, 2022-December 25, 2022).
We refer readers to
The current version of the measure in the ESRD QIP received CBE endorsement (CBE #3636, “Quarterly Reporting of COVID-19 Vaccination Coverage among Healthcare Personnel”) on July 26, 2022. Although section 1881(h)(2)(B)(i) of the Act generally requires that measures specified by the Secretary for the ESRD QIP be endorsed by the entity with a contract under section 1890(a) of the Act, section 1881(h)(2)(B)(ii) of the Act states that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is
We refer readers to the CY 2023 ESRD PPS final rule (87 FR 67246) for information on data submission and reporting for the measure. We are not proposing any changes to the existing data submission requirements.
We invite public comment on this proposal.
In the CY 2015 ESRD PPS final rule, we finalized the adoption of the Clinical Depression Screening and Follow-Up reporting measure, beginning in PY 2018 (79 FR 66200 through 66203). As we noted in the CY 2015 ESRD PPS final rule, depression is a highly prevalent condition in patients with ESRD, which impacts many aspects of a patient's life and is associated with higher rates of mortality in the ESRD population. Adoption of a measure that assesses whether facilities screen patients for depression, and develop follow-up plans when appropriate, was and still is an opportunity to improve the health of patients with ESRD.
In this proposed rule, we are proposing to convert the Clinical Depression Screening and Follow-Up reporting measure to a clinical measure and to adopt a new methodology for scoring that measure as a clinical measure. We believe this proposal would help to ensure that the measure is scored in a manner that more closely aligns with current clinical guidelines for depression screening and follow-up because it narrows the number of conditions on which a facility can earn points.
Clinical guidelines indicate that providers should both screen for depression and develop a follow-up plan for patients who test positive for depression.
• Screening for clinical depression is documented as being positive, and a follow-up plan is documented.
• Screening for clinical depression is documented as positive, and a follow-up plan is not documented, and the facility possesses documentation stating the patient is not eligible.
• Screening for clinical depression is documented as positive, the facility possesses no documentation of a follow-up plan, and no reason is given.
• Screening for clinical depression is documented as negative, and a follow-up plan is not required.
• Screening for clinical depression is not documented, but the facility possesses documentation stating the patient is not eligible.
• Screening for clinical depression is not documented, and no reason is given.
We are not proposing to revise any of these conditions. However, we are proposing that we would convert the measure to a clinical measure and award credit to facilities only if they report one of the following four of those six conditions:
• Screening for clinical depression is documented as being positive, and a follow-up plan is documented.
• Screening for clinical depression is documented as positive, and a follow-up plan is not documented, and the facility possesses documentation stating the patient is not eligible.
• Screening for clinical depression is documented as negative, and a follow-up plan is not required.
• Screening for clinical depression is not documented, but the facility possesses documentation stating the patient is not eligible.
If a facility selects one of the other two conditions (that is, “Screening for clinical depression is documented as positive, the facility possesses no documentation of a follow-up plan, and no reason is given” and “Screening for clinical depression is not documented, and no reason is given”), the facility would not receive credit in the numerator. We believe this proposed update is important because it would assess facility performance on both the clinical depression screening and the follow-up plan, to the extent that one is needed, and would also incentivize facilities to report the reason for either not documenting that they screened for clinical depression, or why they do not possess documentation of a follow-up plan. We believe that the performance score calculation methodology changes we are proposing to the Clinical Depression Screening and Follow-Up reporting measure would have a greater impact on fostering care coordination among providers and improving patient outcomes by incentivizing the documentation of depression screenings and follow-up plans, or alternatively requiring facilities to provide a reason why no screening or follow-up plan was documented. This proposed measure update would also align with our efforts under the Meaningful Measures Framework, which identifies high-priority areas for quality measurement and improvement to assess core issues most critical to high-quality healthcare and improving patient outcomes.
We are also proposing to convert the proposed updated version of the Clinical Depression Screening and Follow-Up measure to a clinical measure beginning with PY 2026, and to move that measure to the Care Coordination Measure Domain beginning with that payment year. We are proposing to convert the Clinical Depression Screening and Follow-Up measure from a reporting measure to a clinical measure because we believe that our proposed update to the performance score calculation aligns with that of a clinical measure. We are proposing to move the Clinical Depression Screening and Follow-Up measure from the Reporting Measure Domain to the Care Coordination Measure Domain because the updated clinical measure would no longer be appropriate for inclusion under the Reporting Measure Domain. We note that we are not proposing to change eligibility requirements for the measure. We discuss our proposed updates to measure domains and weights for PY 2026 in section IV.C.6 of this proposed rule.
We welcome public comment on our proposal to update the Clinical Depression Screening and Follow-Up measure and our proposal to convert it to a clinical measure beginning with PY 2026.
We have undertaken efforts to review the existing ESRD QIP measure set to ensure continued clinical impact and effectiveness of the measures on facility performance. Based on that analysis and our evaluation of the Program's measures, we are proposing to remove the Ultrafiltration Rate reporting measure and the Standardized Fistula Ratio clinical measure beginning with PY 2026.
In the CY 2017 ESRD PPS final rule, we adopted the Ultrafiltration Rate reporting measure (81 FR 77912 through 77915). The measure assesses the number of months for which a facility reports all data elements required to calculate ultrafiltration rates (UFR) for each qualifying patient. The Ultrafiltration Rate reporting measure is intended to guard against risks associated with high ultrafiltration (that is, rapid fluid removal) rates for adult dialysis patients undergoing hemodialysis (HD), because of indications that high ultrafiltration is an independent predictor of mortality. Faster ultrafiltration may lead to a number of health risks resulting from large volumes of fluid removed rapidly during each dialysis session, with deleterious consequences for the patient both in the short and longer term. When we added this measure to the ESRD QIP, we believed the documentation of the ultrafiltration measurements would ultimately contribute to the quality of the patient's ESRD treatment (81 FR 77912 through 77915).
More recent studies have indicated that the Ultrafiltration Rate reporting measure may not result in the intended patient outcomes. For example, a patient's body size may be a confounding, possibly explanatory factor for the relationship between higher UFR and increased mortality.
We welcome public comment on our proposal.
In the CY 2018 ESRD PPS final rule, we adopted the Standardized Fistula Rate clinical measure (82 FR 50774 through 50777). Along with the Long-Term Catheter Rate clinical measure, we stated that the two vascular access measures, when used together, consider arteriovenous (AV) fistula use as a positive outcome and prolonged use of a tunneled catheter as a negative outcome. With the growing recognition that some patients may exhaust their options for an AV fistula, or have comorbidities that may limit the success of AV fistula creation, pairing the measures accounts for all vascular access options. The Standardized Fistula Rate measure adjusts for patient
Since the CY 2018 ESRD PPS final rule, there have been several changes to what many experts consider to be best practices with respect to vascular access in ESRD patients due to improvements in the care of ESRD patients overall, changes in patient demographics, and increasing patient longevity. Guidance published in 2019 by the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) reflects updated best practices.
After considering these evolving best practices and the KDOQI's 2019 guidance, we have determined that the Standardized Fistula Rate Clinical Measure does not provide patients and their healthcare providers the necessary level of flexibility to choose the most suitable dialysis access. We believe that patients and their healthcare providers should have the flexibility to choose vascular access (either AV fistula or AV graft) where appropriate to their specific patient characteristics and treatment plans. This determination should be based on the healthcare provider's best clinical judgment that considers the vessel characteristics, patient comorbidities, health circumstances, and patient preference. Accordingly, we are proposing to remove the Standardized Fistula Rate clinical measure from the ESRD QIP measure set beginning with PY 2026 under measure removal factor 3 (a measure no longer aligns with current clinical guidelines or practice).
We continue to consider both AV fistula and AV graft as preferable forms of vascular access to a long-term catheter, and evidence shows that long-term catheters should only be used when all other AV access options have been exhausted.
We are also proposing to remove the reference to the Vascular Access Type Measure Topic and to assign the total weight of that topic (12 percent) solely to the Long-Term Catheter Rate clinical measure, as described in Table 15 of this proposed rule. We are proposing to assign the total weight to the Long-Term Catheter Rate clinical measure because we believe this continues to be an important measure of facility performance tied to improved patient outcomes. We believe that our proposal to assign the total 12 percent weight to the Long-Term Catheter Rate clinical measure will reflect our view that long-term catheter use is the least-favored vascular access treatment option, and should be avoided where more clinically preferable vascular access treatment options would be appropriate.
We welcome public comment on our proposal.
In the CY 2023 ESRD PPS final rule (87 FR 67251 through 67254), we finalized revisions to the ESRD QIP measure domains beginning with PY 2025. Specifically, we added the Reporting Domain and updated measure domains and measure weights across five measure domains: Patient & Family Engagement, Care Coordination, Clinical Care, Safety, and Reporting. The measure domains and weights we finalized in the CY 2023 ESRD PPS final rule are depicted in Table 14 below.
As discussed above, we are proposing that beginning with PY 2026, the Clinical Depression Screening and Follow-Up reporting measure would be converted to a clinical measure and included in the Care Coordination Domain, the Standardized Fistula Rate clinical measure would be removed from the Clinical Care Domain, the Ultrafiltration Rate reporting measure would be removed from the Reporting Domain, and the Facility Commitment to Health Equity reporting measure would be added to the Reporting Domain. To accommodate the new numbers of measures in the Care Coordination Domain, Clinical Care Domain, and Reporting Domain, we are proposing to update the individual measure weights in each of these domains. We believe that these proposed updates to the individual measure weights would help to ensure that a facility's individual measure performance has an appropriately proportionate impact on a facility's TPS, while also further incentivizing improvement on clinical measures. For example, for the Care Coordination Domain, we are proposing to update the measure weights for the SHR clinical measure and the SRR clinical measure to accommodate the inclusion of the proposed Clinical Depression Screening and Follow-Up clinical measure. We believe these newly proposed measure weights would strike an appropriate balance between the importance of facility performance on the SHR clinical measure and the SRR clinical measure on measuring patient outcomes, while also reflecting the impact of the proposed Clinical Depression Screening and Follow-Up clinical measure on patient quality of care. Additionally, the Vascular Access Type Measure Topic is currently weighted at 12 percent and includes both the Standardized Fistula Rate clinical measure and the Long-Term Catheter Rate clinical measure. We are proposing to remove the Standardized Fistula Rate clinical measure and the Vascular Access Type Measure Topic, and we are also proposing to weight the Long-Term Catheter Rate clinical measure at 12 percent. We believe this proposal would incentivize improvement and reflect the impact of facility performance on the Long-Term Catheter Rate clinical measure (as the sole vascular access type measure) on patient outcomes. We continue to believe that patient outcomes improve when they receive the most clinically appropriate vascular access treatment option, and that long-term catheters should only be used when other vascular access treatment options are not feasible. Consistent with our approach in the CY 2023 ESRD PPS final rule, we are proposing to assign individual measure weights to reflect the proposed updated number of measures in the Reporting Measure Domain so that each measure is weighted equally (87 FR 67251 through 67253). In light of these proposed updates to measures within the Reporting Measure Domain, we would weight each measure equally at 2 percent, which is consistent with our previously finalized approach to weight each measure in the Reporting Measure Domain equally. We note that although we are proposing to change the number of measures in three of the domains and the weights of certain individual measures in those domains, we are not proposing to change the weights of the five domains themselves because we believe the proposed updates to individual measures and measure weights do not significantly impact the measure domains themselves such that updating the weights of the measure domains would be required to accommodate the updated individual measure weights. The previously finalized and newly proposed measures that would be included in each domain, along with the proposed new measure weights, for PY 2026 are depicted in Table 15.
We welcome public comment on these proposals.
Section 1881(h)(4)(A) of the Act requires the Secretary to establish performance standards with respect to the measures selected for the ESRD QIP for a performance period with respect to a year. The performance standards must include levels of achievement and improvement, as determined appropriate by the Secretary, and must be established prior to the beginning of the performance period for the year involved, as required by section 1881(h)(4)(C) of the Act. We refer readers to the CY 2013 ESRD PPS final rule (76 FR 70277) for a discussion of the achievement and improvement standards that we have established for clinical measures used in the ESRD QIP. We define the terms “achievement threshold,” “benchmark,” “improvement threshold,” and “performance standard” in our regulations at 42 CFR 413.178(a)(1), (3), (7), and (12), respectively. For reporting measures, performance standards are the levels of data submission and completion of other actions specified by CMS that are used to award points to an ESRD facility on the measure (42 CFR 413.178(a)(12)).
In the CY 2023 ESRD PPS final rule (87 FR 67259 through 67260), we set the performance period for the PY 2026 ESRD QIP as CY 2024 and the baseline period as CY 2022. In this proposed rule, we are estimating the performance standards for the PY 2026 clinical measures in Table 5 using data from CY 2021, which was the most recent data available (87 FR 67260). For certain measures previously suppressed for the PY 2023 performance period due to significant impacts on the measure related to the COVID-19 public health emergency (87 FR 67225 through 67237), we used CY 2019 data. We intend to update these performance standards for all measures, using CY 2022 data, in the CY 2024 ESRD PPS final rule.
In addition, we summarize in Table 17 requirements for successful reporting on previously finalized and newly proposed reporting measures for the PY 2026 ESRD QIP.
Our current minimum eligibility requirements for scoring the ESRD QIP measures are described in Table 18a.
We are proposing to add eligibility requirements for the new measures we are proposing beginning with the PY 2026 ESRD QIP. Our previously finalized and proposed new minimum eligibility requirements for scoring the
Under our current policy, a facility does not receive a payment reduction for a payment year in connection with its performance under the ESRD QIP if it achieves a TPS that is at or above the minimum TPS (mTPS) that we establish for the payment year. We have defined the mTPS in our regulations at 42 CFR 413.178(a)(8) as, with respect to a payment year, the TPS that an ESRD facility would receive if, during the baseline period, it performed at the 50th percentile of national performance on all clinical measures and the median of national ESRD facility performance on all reporting measures.
Under our current policy, which is codified at 42 CFR 413.177 of our regulations, we implement the payment reductions on a sliding scale using ranges that reflect payment reduction differentials of 0.5 percent for each 10 points that the facility's TPS falls below the mTPS (76 FR 634 through 635).
For PY 2026, we estimate using available data that a facility must meet or exceed a mTPS of 52 to avoid a payment reduction. We note that the mTPS estimated in this proposed rule is based on data from CY 2021 and CY 2019 instead of the PY 2026 baseline period (CY 2022) because CY 2022 data are not yet available. We will update and finalize the mTPS and associated payment reduction ranges using CY 2022 data in the CY 2024 ESRD PPS final rule.
Under our current policy, we generally retain all measures once adopted for a payment year for subsequent payment years. In this proposed rule, we are proposing to add the Screening for Social Drivers of Health reporting measure and the Screen Positive Rate for Social Drivers of Health reporting measure to the ESRD QIP measure set beginning with PY 2027.
Our commitment to supporting facilities in building equity into their health care delivery practices is, in part, focused on empowering their workforce to recognize and eliminate health disparities that disproportionately impact their patients who have health-related social needs (HRSNs). HRSNs are significant risk factors associated with worse health outcomes as well as increased health care utilization.
In the FY 2023 IPPS/LTCH PPS final rule (87 FR 49191 through 49220), we finalized the adoption of two evidence-based measures in the Hospital Inpatient Quality Reporting Program, the Screening for Social Drivers of Health and the Screen Positive Rate for Social Drivers of Health measures. These two Social Drivers of Health measures support identification of specific risk factors for inadequate healthcare access and adverse health outcomes among patients. These measures also encourage hospitals to systematically collect HRSN data. We have also finalized a policy requiring that all Special Needs Plans (SNPs) include one or more questions on housing stability, food security, and access to transportation in their Health Risk Assessment (HRA) using questions from a list of screening instruments specified in sub-regulatory guidance (87 FR 27726 through 27740), as well as adopted the Screening for Social Drivers of Health Measure in the Merit-based Incentive Payment System Program (87 FR 70054 and 70055).
Advancing health equity by addressing the health disparities that underlie the country's health system is one of our strategic pillars and a Biden-Harris Administration priority.
Health disparities manifest primarily as worse health outcomes in population groups where access to care is inequitable.
Significant and persistent health disparities in the United States result in adverse health outcomes for people with ESRD.
We believe that improvement in care coordination between ESRD facilities, hospitals, and community-based organizations would yield better health outcomes for people with ESRD, and subsequently lead to improvements in quality performance for dialysis and other health care providers. We believe that the proposed Screening for Social Drivers of Health reporting measure would help inform facilities of the impact of HRSNs in people with ESRD by assessing the proportion of adult patients who are screened for social drivers of health in five core domains: food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
In the CY 2023 ESRD PPS proposed rule, we sought public comment on the potential future inclusion of the Screening for Social Drivers of Health measure (87 FR 38554 through 38556) in the ESRD QIP. For a summary of the comments we received, as well as our responses, we refer readers to the CY 2023 ESRD PPS final rule (87 FR 67265 through 67268). In the CY 2023 ESRD PPS final rule, we stated that we were considering whether to incorporate measures that assess screening for health-related social needs into the ESRD QIP measure set (87 FR 67264).
We are proposing to adopt the Screening for Social Drivers of Health reporting measure under section 1881(h)(2)(A)(iv) of the Act, which gives the Secretary broad authority to specify measures for the ESRD QIP. As discussed above, disparities in health equity are tied to worse patient outcomes in the ESRD community. While widespread interest in addressing HRSNs exists, action is inconsistent, specifically in ESRD facilities. Therefore, we believe it is appropriate to require facilities to report data on this measure because the intent of the proposed measure is to incentivize facilities to collect and utilize their data to identify the impact of HRSNs in their ESRD patient population, including whether there is a relationship between those HRSNs and the outcomes experienced by their patients with those HRSNs. Screening data collected by the facility could inform their provision of care such that they improve the outcomes experienced by patients with HRSNs. Facilities could analyze their screening data to understand whether there are any HRSNs that may be affecting their patients' access to care or contributing to poor outcomes in their patient populations and, in turn, develop appropriate solutions to improve access and outcomes. While the measure does not require facilities to take specific actions following an HRSN screening, we expect that any solution a facility might develop to address a gap it identifies would comply with all applicable Federal non-discrimination laws. We also note that the proposed measure is intended to promote health equity for all patients and is not intended to create a conflict between a CMS requirement and a state's civil rights laws.
Under our Meaningful Measures Framework,
Growing evidence demonstrates that specific social risk factors are directly associated with patient health outcomes as well as healthcare utilization, costs, and performance in quality reporting and payment programs.
While social risk factors may have a significant impact on health outcomes, the mechanisms by which this connection emerges are complex and multifaceted.
The following five core domains were selected to screen for HRSNs among Medicare and Medicaid beneficiaries under the AHC Model: (1) food insecurity; (2) housing instability; (3) transportation needs; (4) utility difficulties; and (5) interpersonal safety. These domains were chosen based upon literature review and expert consensus utilizing the following criteria: (1) availability of high-quality scientific evidence linking a given HRSN to adverse health outcomes and increased healthcare utilization, including hospitalizations and associated costs; (2) ability for a given HRSN to be screened and identified in the inpatient setting prior to hospital discharge, addressed by community-based services, and potentially improve healthcare outcomes, including reduced hospital re-admissions; and (3) evidence that a given HRSN is not systematically addressed by healthcare providers.
These five evidence-based HRSN domains informed our development of the proposed Screening for Social Drivers of Health reporting measure, as well as a second measure, Screen Positive Rate for Social Drivers of Health reporting measure, that we are also proposing to adopt for the ESRD QIP. These domains are described in Table 21.
The
We are proposing that facilities would be able to choose a screening tool for purposes of this measure or otherwise screen their patients using a method of their choosing in order to give facilities the flexibility to accommodate the population they serve and their individual needs.
The Screening for Social Drivers of Health measure would assess the percentage of patients age 18 and older that a dialysis facility screens for food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety. To report on this measure, facilities would provide: (1) the number of patients admitted to the facility who are 18 years or older during the applicable performance period who are screened for all of the following five HRSNs: Food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety; and (2) the total number of patients at the facility who are 18 years or older during the applicable performance period and who are not excluded from the measure. We are proposing to add this measure to the Reporting Measure Domain beginning with PY 2027. We discuss our proposed updates to measure domains and weights for PY 2027 in section IV.D.7 of this proposed rule.
Measure specifications for this proposed measure are currently available on the QualityNet website at:
The cohort for the proposed Screening for Social Drivers of Health reporting measure is all patients, aged 18 years and older, who are treated at the facility during the applicable performance period and not eligible to be excluded from the measure.
The numerator is calculated as the number of patients who are 18 years or older who are treated at the facility during the applicable performance period and are not eligible to be excluded from the measure, and are screened during the performance period for all of the following five HRSNs: Food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
The denominator is calculated as the number of patients at the dialysis facility and who are 18 years or older on the first day of the performance period. The following patients would be excluded from the denominator: (1) Patients who opt-out of screening; and (2) patients who are unable to complete the screening and have no legal guardian or caregiver who is able to complete the screening on their behalf.
The Screening for Social Drivers of Health measure would be calculated as the number of patients at a dialysis facility who are 18 years or older who are treated at the facility during the applicable performance period and are not eligible to be excluded from the measure, and are screened by the facility for all five HRSNs (food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety) divided by the total number of patients 18 years or older on the 1st day of the performance period (January 1st) at that dialysis facility. We are proposing a 12-month period of performance for the measure, and facilities would be required to report annually. We are proposing that a facility would be scored according to the following equation:
We believe that this scoring policy would encourage facilities to report the measure data appropriately without penalizing facilities for the results of such data, which may be based on circumstances beyond a facility's control.
We are proposing that facilities would report this measure on an annual basis beginning with PY 2027. In alignment with the policy we finalized for the Hospital IQR Program, we are proposing that facilities would be able to select their own screening tool or method to screen patients for food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety. Potential sources of these data for incorporation in a tool could include, for example, administrative claims data, electronic clinical data, standardized patient assessments, or patient-reported data and surveys. Additionally, multiple screening tools exist and are publicly available. Facilities could refer to the Social Interventions Research and Evaluation Network (SIREN) website, for example, for comprehensive information about the most widely used HRSN screening tools.
We are proposing that the deadline for submission would be the end of the EQRS December data reporting month for the applicable performance period, which is consistent with current reporting deadlines for other ESRD QIP measures. For example, the deadline for submission in PY 2027 would be the end of the December data reporting month in CY 2025.
We included the Screening for Social Drivers of Health reporting measure as a measure under consideration for the
Although section 1881(h)(2)(B)(i) of the Act generally requires that measures specified by the Secretary for the ESRD QIP be endorsed by the entity with a contract under section 1890(a) of the Act, section 1881(h)(2)(B)(ii) of the Act states that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. We reviewed CBE-endorsed measures and were unable to identify any other CBE-endorsed measures on this topic, and, therefore, we believe the exception in section 1881(h)(2)(B)(ii) of the Act applies.
We are proposing to publicly display the facility-specific results for the Screening for Social Drivers of Health measure on an annual basis through our
We invite public comment on this proposal.
The impact of social risk factors on health outcomes has been well-established in the literature.
While the proposed Screening for Social Drivers of Health reporting measure (discussed in section IV.D.2 of this proposed rule) enables facilities to identify patients with HRSNs, the Screen Positive Rate for Social Drivers of Health measure would allow facilities to capture the magnitude of these needs by reporting the rate of those patients who screen positive for HRSNs and even potentially estimate the impact of individual-level HRSNs on healthcare utilization when evaluating quality of care.
We are proposing to adopt this proposed measure under section 1881(h)(2)(A)(iv) of the Act, which gives the Secretary broad authority to specify measures for the ESRD QIP. The Screen Positive Rate for Social Drivers of Health reporting measure would require facilities to screen all patients who are 18 years or older for food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety and then report the resulting screen positive rates for each of those domains to CMS. These are the same five core HRSN domains that facilities would be required to screen for under the proposed Screening for Social Drivers of Health reporting measure, and facilities could use the same screening tool for purposes of both measures. Reporting the screen positive rate for social drivers of health for each domain could inform actionable planning by facilities by helping to enable the development of individual patient action plans for those patients who screen positive (including navigation and referral). Following a positive HRSN screening, facilities could analyze data to understand, for example, whether there are any HRSNs that may be affecting their patients' access to care or contributing to poor outcomes in their patient populations and, in turn, develop appropriate solutions to improve access and outcomes. Thus, this measure has the potential to improve patient outcomes by acknowledging patients' non-clinical needs that nevertheless greatly contribute to adverse clinical outcomes and providing the opportunity for additional support by linking providers with community-based organizations to enhance patient-centered treatment and discharge planning, although such reach out is not required.
The Screen Positive Rate for Social Drivers of Health measure would identify the proportion of patients at the facility who screened positive for each of the following five HRSNs: Food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety. We would require facilities to report these data as five separate rates.
Measure specifications for this measure are currently available on the QualityNet website at:
The cohort for the Screen Positive Rate for Social Drivers of Health is a process measure that would provide information on the percentage of patients, aged 18 years or older who are treated at the facility during the applicable performance period and are not eligible to be excluded from the measure, who were screened by the facility for an HRSN, and who screened positive for one or more of the following five HRSNs: Food insecurity, housing instability, transportation needs, utility difficulties, or interpersonal safety.
The numerator would consist of the number of patients at a dialysis facility who are 18 years or older who are treated at the facility during the applicable performance period and are not eligible to be excluded from the measure, who were screened for an HRSN, and for whom the facility reports the results of a screen asking whether they have a need in one or more of the following five HRSNs (calculated separately): Food insecurity, housing instability, transportation needs, utility difficulties or interpersonal safety.
The denominator would consist of the number of patients at a dialysis facility who are 18 years or older who are treated at the facility during the applicable performance period and are not eligible to be excluded from the measure, and are screened for an HRSN (food insecurity, housing instability, transportation needs, utility difficulties and interpersonal safety). The following patients would be excluded from the denominator: (1) Patients who opt-out of screening; and (2) patients who are themselves unable to complete the screening and have no caregiver able to do so on the patient's behalf.
The facility's measure rate for this measure would be calculated for a payment year as the number of eligible patients for whom the facility reports the screening results for all five HRSNs during the performance period over the total number of eligible patients who the facility screened for all five HRSNs during that performance period. To calculate the facility's score on the measure, we would multiply the results of that fraction by ten. The full equation is set forth here:
However, for purposes of public reporting only, we are proposing to display the facility's screen positive rate for each HRSN separately, for a total of five separate rates. Although we will not score facilities on the results of those five separate rates, we believe that making such data public may help to better inform patients and their caregivers about a facility. We are proposing a 12-month period of performance for the measure, and facilities would be required to report annually.
We believe that these policies would encourage facilities to report the measure data appropriately without scoring facilities based on the results of such data, which may be based on circumstances beyond a facility's control. Although we believe that it is important to encourage facilities to screen their patients for HSRNs and to report data for screen positive rates, we want to avoid potential unintended consequences that may result from scoring facilities on the outcomes of the screen positive rates themselves. That is, we do not want to score a facility based on its patients' given socioeconomic factors, which may be based on circumstances beyond a facility's control.
We are proposing that facilities would be required to submit data necessary to calculate the numerator and the denominator for this measure once annually within the ESRD Quality Reporting System (EQRS), beginning with PY 2027. We are proposing that facilities would be required to submit data on this proposed measure using the same process we have finalized for the submission of data on other measures in the ESRD QIP within EQRS.
We included the Screen Positive Rate for Social Drivers of Health reporting measure for consideration in the ESRD QIP on the publicly available 2022 MUC List, a list of measures under consideration for use in various Medicare programs.
Although section 1881(h)(2)(B)(i) of the Act generally requires that measures specified by the Secretary for the ESRD QIP be endorsed by the entity with a contract under section 1890(a) of the Act, section 1881(h)(2)(B)(ii) of the Act states that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. We reviewed CBE-endorsed measures and were unable to identify any other CBE-endorsed measures on this topic, and, therefore, we believe the exception in section 1881(h)(2)(B)(ii) of the Act applies.
We are proposing to publicly display the ESRD QIP score and facility-specific rates for the Screen Positive Rate for Social Drivers of Health measure on an annual basis beginning in PY 2027 through our
We invite public comment on this proposal.
We continue to believe that our current policy of 12-month performance and baseline periods provide us sufficiently reliable quality measure data for the ESRD QIP. Under this policy, we would adopt CY 2025 as the performance period and CY 2023 as the baseline period for the PY 2027 ESRD QIP.
We are not proposing any changes to this policy.
Section 1881(h)(4)(A) of the Act requires the Secretary to establish performance standards with respect to the measures selected for the ESRD QIP for a performance period with respect to a year. The performance standards must include levels of achievement and improvement, as determined appropriate by the Secretary, and must be established prior to the beginning of the performance period for the year involved, as required by section 1881(h)(4)(C) of the Act. We refer readers to the CY 2012 ESRD PPS final rule (76 FR 70277) for a discussion of the achievement and improvement standards that we have established for clinical measures used in the ESRD QIP. We define the terms “achievement threshold,” “benchmark,” “improvement threshold,” and “performance standard” in our regulations at 42 CFR 413.178(a)(1), (3), (7), and (12), respectively. For reporting measures, performance standards are the levels of data submission and completion of other actions specified by CMS that are used to award points to an ESRD facility on the measure (42 CFR 413.178(a)(12)).
At this time, we do not have the necessary data to assign numerical values to the achievement thresholds, benchmarks, and 50th percentiles of national performance for the clinical measures because we do not have CY 2022 data. We intend to publish these numerical values, using CY 2022 data, in the CY 2024 ESRD PPS final rule.
We are proposing to add the Screening for Social Drivers of Health reporting measure and the Screen Positive Rate for Social Drivers of Health reporting measure beginning with the PY 2027 ESRD QIP, which we discuss in IV.D.2 and IV.D.3 of this proposed rule. We are proposing a 12-month period of performance for both the Screening for Social Drivers of Health reporting measure and the Screen Positive Rate for Social Drivers of Health reporting measure, and facilities would be required to report annually for both measures beginning with the PY 2027 ESRD QIP.
In the CY 2014 ESRD PPS final rule, we finalized policies for scoring performance on clinical measures based on achievement and improvement (78 FR 72215 through 72216). In the CY 2019 ESRD PPS final rule, we finalized a policy to continue use of this
Our policy for scoring performance on reporting measures is codified at 42 CFR 413.178(e). In section IV.D.2 of this proposed rule, we are proposing to adopt the Screening for Social Drivers of Health reporting measure beginning with PY 2027. We are also proposing to adopt the Screen Positive Rate for Social Drivers of Health reporting measure, as discussed in section IV.D.3 of this proposed rule. We are proposing that a facility would be scored based on the equations proposed in sections IV.D.2.c and IV.D.3.c of this proposed rule. We are proposing a 12-month period of performance for the measures, and facilities would be required to report annually. We believe that these scoring policies would encourage facilities to report the measure data appropriately without penalizing facilities for the results of such data, which may be impacted by circumstances beyond a facility's control.
Beginning with PY 2027, we are proposing to add the Screening for Social Drivers of Health reporting measure and the Screen Positive for Social Drivers of Health reporting measure to the Reporting Measure Domain. To accommodate the new number of measures in the Reporting Measure Domain, we are proposing to update the individual measure weights in this domain. We believe that these proposed updates would help to ensure that a facility's individual measure performance has an appropriately proportionate impact on a facility's TPS, while also continuing to further incentivize improvement on clinical measures through those individual measure weights. Consistent with our approach in the CY 2023 ESRD PPS final rule, we are proposing to assign individual measure weights to reflect the proposed updated number of measures in the Reporting Measure Domain so that each measure is weighted equally (87 FR 67251 through 67253). Since we are adding two new measures to the Reporting Measure Domain beginning with PY 2027, we would weight each measure within that domain equally at approximately 1.43, which is consistent with our previously finalized approach to weight each measure in the Reporting Measure Domain equally. We note that although we are proposing to change the number of measures in the Reporting Measure Domain and weights of certain individual measures in that domain, we are not proposing to change the weights of the five domains themselves, because we believe the proposed updates to individual measures and measure weights do not significantly impact the measure domains themselves such that updating the weights of the measure domains would be required to accommodate the updated individual measure weights. The previously finalized and newly proposed measures that would be included in each domain, along with the proposed new measure weights, beginning with PY 2027 are depicted in Table 22.
We welcome public comment on these proposals.
Section 1115A of the Act authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and Children's Health Insurance Program (CHIP) expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of these programs. The purpose of the ETC Model is to test the effectiveness of adjusting certain Medicare payments to ESRD facilities and Managing Clinicians to encourage greater utilization of home dialysis and kidney transplantation, support Beneficiary modality choice, reduce Medicare expenditures, and preserve or enhance the quality of care. As described in the Specialty Care Models final rule (85 FR 61114), beneficiaries with ESRD are among the most medically fragile and high-cost populations served by the Medicare program. ESRD Beneficiaries require dialysis or kidney transplantation to survive, and the majority of ESRD Beneficiaries receiving dialysis receive hemodialysis in an ESRD facility. However, as described in the Specialty Care Models final rule, alternative renal replacement modalities to in-center hemodialysis, including home dialysis and kidney transplantation, are associated with improved clinical outcomes, better quality of life, and lower costs than in-center hemodialysis (85 FR 61264).
The ETC Model is a mandatory payment model. ESRD facilities and Managing Clinicians are selected as ETC Participants based on their location in Selected Geographic Areas—a set of 30 percent of Hospital Referral Regions (HRRs) that have been randomly selected to be included in the ETC Model, as well as HRRs with at least 20 percent of ZIP codes
Under the ETC Model, ETC Participants are subject to two payment adjustments. The first is the Home Dialysis Payment Adjustment (HDPA), which is an upward adjustment on certain payments made to participating ESRD facilities under the ESRD Prospective Payment System (PPS) on home dialysis claims, and an upward adjustment to the Monthly Capitation Payment (MCP) paid to participating Managing Clinicians on home dialysis-related claims. The HDPA applies to claims with claim service dates beginning January 1, 2021 and ending December 31, 2023.
The second payment adjustment under the ETC Model is the Performance Payment Adjustment (PPA). For the PPA, we assess ETC Participants' home dialysis rates and transplant rates during a Measurement Year (MY), which includes 12 months of performance data. Each MY has a corresponding PPA Period—a 6-month period that begins 6 months after the conclusion of the MY. We adjust certain payments for ETC Participants during the PPA Period based on the ETC Participant's home dialysis rate and transplant rate, calculated as the sum of the transplant waitlist rate and the living donor transplant rate, during the corresponding MY.
Based on an ETC Participant's achievement in relation to benchmarks based on the home dialysis rate and transplant rate observed in Comparison Geographic Areas during the Benchmark Year, and the ETC Participant's improvement in relation to their own home dialysis rate and transplant rate during the Benchmark Year, we would make an upward or downward adjustment to certain payments to the ETC Participant. The magnitude of the positive and negative PPAs for ETC Participants increases over the course of the Model. These PPAs apply to claims with claim service dates beginning July 1, 2022 and ending June 30, 2027.
In the CY 2022 ESRD PPS final rule, we finalized a number of changes to the ETC Model. We made adjustments to the calculation of the home dialysis rate (86 FR 61951 through 61955) and the transplant rate (86 FR 61955 through 61959) and updated the methodology for attributing Pre-emptive Living Donor Transplant (LDT) Beneficiaries (86 FR 61950 through 61951). We modified the achievement benchmarking and scoring methodology (86 FR 61959 through 61968), as well as the improvement benchmarking and scoring methodology (86 FR 61968 through 61971). We specified the method and requirements for sharing performance data with ETC Participants (86 FR 61971 through 61984). We also made a number of updates and clarifications to the kidney disease patient education services waivers and made certain related flexibilities available to ETC Participants (86 FR 61984 through 61994). In the CY 2023 ESRD PPS final rule (87 FR 67136) we finalized further changes to the ETC Model. We updated the PPA achievement scoring methodology beginning in the fifth Measurement Year (MY) of the ETC Model, which began on January 1, 2023 (87 FR 67277 through 67278). We also clarified requirements for qualified staff to furnish and bill kidney disease patient education services under the ETC Model's Medicare program waivers (87 FR 67278 through 67280), and finalized our intent to publish participant-level model performance information to the public (87 FR 67280).
In the Specialty Care Models final rule (85 FR 61114), we established our policies for targeted reviews of the calculation of an ETC Participant's Modality Performance Score (MPS). As described in § 512.390(c), targeted reviews are limited to the calculation of the MPS and may not pertain to the methodologies used to calculate the MPS, home dialysis rate, transplant rates, achievement and improvement benchmarks, or the PPA amounts. ETC Participants have 90 days following the availability of the MPS to submit a targeted review request. CMS responds to each targeted review request that is received within the 90-day time period. CMS may solicit additional information from the ETC Participant in support of the request after which a determination is made as to whether there was an error in the calculation of the ETC Participant's MPS that results in an incorrect PPA being applied during the PPA period. In such a scenario, CMS notifies the ETC Participant and resolves any resulting discrepancy in payment that arises from the application of an incorrect PPA.
We are proposing revisions to our regulations at § 512.390 to clarify the ability of the CMS Administrator to review targeted review determinations. In particular, we are proposing to add § 512.390(d) to specify that the CMS Administrator may review targeted review requests when administrative review is requested by ETC Participants within 15-calendar days of a targeted review request determination made by CMS.
We are proposing that within 45 days of the date of the ETC Participant's request for administrative review, the CMS Administrator may act as follows: (i) decline to review the targeted review request determination made by CMS, (ii) render a final decision based on the CMS Administrator's review of the targeted review request determination, or (iii) choose to take no action on the request for administrative review. We are proposing that targeted review request determinations made by the CMS Administrator are considered final if the CMS Administrator declines an ETC Participant's request for administrative review or if the CMS Administrator does not take any action on the ETC Participant's request for administrative review by the end of the 45-day period described.
We are also proposing a conforming change to delete the existing provision in § 512.390(c)(5), which states that decisions based on targeted review are final, and there is no further review or appeal.
These proposed changes would ensure that accountability for the decisions of CMS is vested in a principal officer and would bring the targeted review process to a more similar posture as other CMS appeals entities that provide for CMS Administrator review. These proposed revisions would also ensure that ETC Participants are aware that administrative review is available to ETC Participants who wish to seek additional review of the results of a targeted review request.
We seek comment on this proposal.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain
As discussed in section II.B.1.h of this proposed rule, we are proposing to require that beginning January 1, 2024, ESRD facilities must report information on claims about the total number of billing units of any discarded amount of a renal dialysis drug or biological product from a single-dose container or single-use package that is paid for under the ESRD PPS, using the JW modifier (or any successor modifier that includes the same data). Additionally, we are proposing to require ESRD facilities to report the JZ modifier for all such drugs and biological products with no discarded amounts beginning no later than January 1, 2024. Based on our analysis of ESRD PPS claims as well as the billing guidance in sections 8 and 17 of the Medicare Claims Processing Manual, we have determined that the proposed JW modifier requirement reflects current practices for ESRD facilities, and would not significantly increase burden for ESRD facilities. Additionally, the proposed JZ modifier requirement is not expected to increase burden on ESRD facilities because under the guidance provided regarding use of the JW modifier, the ESRD facility should already have processes in place in order to determine, in the case of certain drugs and biological products, whether or not there are any discarded units from a single use container or package, record discarded amounts in the patient medical record, and specify administered and discarded amounts on the claim form. Additionally, as discussed in section II.B.1.h of this proposed rule, any separately payable drugs or biological products that ESRD facilities bill for using the AY modifier would already be subject to the JW and JZ modifier policies under Medicare Part B. Therefore, most ESRD facilities should already be set up to report the JW and JZ modifiers in such circumstances, and would reasonably be able to report these modifiers for renal dialysis drugs and biological products as well.
We are proposing to require ESRD facilities to submit data and information on ESRD PPS claims regarding the number of minutes of hemodialysis treatment received by a beneficiary in center in an ESRD facility. This patient-level reporting on resource use involved (that is, reporting on ESRD PPS patient claims the minutes of time on machine for each hemodialysis treatment) in furnishing renal dialysis services at ESRD facilities. We have developed monetary estimates of the amount of ESRD facility staff time required to report this information on claims in order to estimate the costs associated with the proposal to require the reporting of time on machine data. We have included those estimates in the Regulatory Impact Analysis section of this proposed rule. We acknowledge the burden associated with this proposed requirement, but we note that the burden associated with the CMS-1450 institutional claim form already accounts for the variability in the number and type of codes submitted for each claim.
To derive wages estimates, we used data from the U.S. Bureau of Labor Statistics' May 2021 National Occupational Employment and Wage Estimates. In the CY 2016 ESRD PPS final rule (80 FR 69069), we stated that it was reasonable to assume that Medical Records and Health Information Technicians, who are responsible for organizing and managing health information data, are the individuals tasked with submitting measure data to the ESRD Quality Reporting System (EQRS) (formerly, CROWNWeb) and the CDC's National Healthcare Safety Network (NHSN), as well as compiling and submitting patient records for the purpose of data validation studies. The most recently available median hourly wage of a Medical Records Specialist is $22.43 per hour.
We used this updated wage estimate, along with updated facility and patient counts, to update our estimate for the total information collection burden in the ESRD QIP for PY 2026 that we discussed in the CY 2023 ESRD PPS final rule (87 FR 67281) and to estimate the total information collection burden in the ESRD QIP for PY 2027, which we discuss further in section VIII.C.3 of this proposed rule.
In the CY 2020 ESRD PPS final rule, we finalized a policy to adopt the EQRS (formerly, CROWNWeb) data validation methodology that we previously adopted for the PY 2016 ESRD QIP as the methodology we would use to validate EQRS data for all payment years, beginning with PY 2021 (83 FR 57001 through 57002). Under this methodology, 300 facilities are selected each year to submit 10 records to CMS, and we reimburse these facilities for the costs associated with copying and mailing the requested records. The burden associated with these validation requirements is the time and effort necessary to submit the requested records to a CMS contractor. In this proposed rule, we are updating these burden estimates using a newly available wage estimate of a Medical Records Specialist. In the CY 2020 ESRD PPS final rule, we estimated that it would take each facility approximately 2.5 hours to comply with this requirement (84 FR 60787). If 300 facilities are requested to submit records, we estimated that the total combined annual burden for these facilities would be 750 hours (300 facilities × 2.5 hours). Since we anticipate that Medical Records Specialists or similar administrative staff would submit these data, we estimate that the aggregate cost of the EQRS data validation each year would
In the CY 2021 ESRD PPS final rule, we finalized our policy to reduce the number of records that a facility selected to participate in the NHSN data validation must submit to a CMS contractor, beginning with PY 2023 (85 FR 71471 through 71472). Under this finalized policy, a facility is required to submit records for 20 patients across any two quarters of the year, instead of 20 records for each of the first two quarters of the year. The burden associated with this policy is the time and effort necessary to submit the requested records to a CMS contractor. Applying this policy for NHSN validation, we estimated that it would take each facility approximately 5 hours to comply with this requirement. If 300 facilities are requested to submit records each year, we estimated that the total combined annual burden hours for these facilities per year would be 1,500 hours (300 facilities × 5 hours). Since we anticipate that Medical Records Specialists or similar staff would submit these data, using the newly available wage estimate of a Medical Records Specialist, we estimate that the aggregate cost of the NHSN data validation each year would be approximately $67,290 (1,500 hours × $44.86), or a total of approximately $224.30 ($67,290/300 facilities) per facility in the sample. While the burden hours estimate would not change, the burden cost updates associated with these requirements will be submitted to OMB in the revised information collection request (OMB control number 0938-1340; Expiration date: November 30, 2025).
To estimate the burden associated with the EQRS reporting requirements (previously known as the CROWNWeb reporting requirements), we look at the total number of patients nationally, the number of data elements per patient-year that the facility would be required to submit to EQRS for each measure, the amount of time required for data entry, the estimated wage plus benefits applicable to the individuals within facilities who are most likely to be entering data into EQRS, and the number of facilities submitting data to EQRS. In the CY 2023 ESRD PPS final rule, we estimated that the burden associated with EQRS reporting requirements for the PY 2026 ESRD QIP was approximately $220 million for approximately 4,908,291 total burden hours (87 FR 67282).
We are proposing several changes to the ESRD QIP measure set in this proposed rule that would affect the burden associated with EQRS reporting requirements for PY 2026 or PY 2027. Beginning with PY 2026, we are proposing to remove two measures from the ESRD QIP measure set and to add one measure to the ESRD QIP measure set. For PY 2027 and for subsequent years, we are proposing to add two measures to the ESRD QIP measure set. We have re-calculated the burden estimate for PY 2026 to reflect the impact of these proposals if finalized, using updated estimates of the total number of ESRD facilities, the total number of patients nationally, and wages for Medical Records Specialists or similar staff, as well as a refined estimate of the number of hours needed to complete data entry for EQRS reporting. In this proposed rule, we estimate that the amount of time required to submit measure data to EQRS would be 2.5 minutes per element and did not use a rounded estimate of the time needed to complete data entry for EQRS reporting. We are further updating these estimates in this proposed rule. There are 126 data elements proposed for 514,406 patients across 7,847 facilities, for a total of 64,815,156 elements (126 data elements × 514,406 patients). At 2.5 minutes per element, this would yield approximately 344 hours per facility. Therefore, the PY 2026 burden would be 2,700,632 hours (344 hours × 7,847 facilities). Using the wage estimate of a Medical Records Specialist, we estimate that the PY 2026 total burden cost is approximately $121.1 million (2,700,632 hours × $44.86).
There would also be an incremental burden change from PY 2026 to PY 2027 because we are proposing to add two new measures beginning with PY 2027. For PY 2027, there are 136 data elements proposed for 514,406 patients across 7,847 facilities. At 2.5 minutes per element, this would yield approximately 371 hours per facility. Therefore, the PY 2027 burden would be 2,914,967 hours (371 hours × 7,847 facilities). Using the wage estimate of a Medical Records Specialist, we estimate that the PY 2027 total burden cost would be approximately $130.7 million (2,914,967 hours × $44.86).
If you comment on these information collection requirements, please submit your comments electronically as specified in the
Comments must be received on/by August 25, 2023.
Because of the large number of public comments we normally receive on
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning calendar year (CY) 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This proposed rule proposes updates and policy changes to the CY 2024 ESRD wage index values, the proposed combined wage index and TPEAPA budget-neutrality adjustment factor, the outlier payment threshold amounts, and the TPNIES offset amount. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2024 for renal dialysis services furnished to ESRD beneficiaries.
This rule also has a number of proposed policy changes to improve payment stability and adequacy under the ESRD PPS. These include a proposed transitional add-on payment adjustment for pediatric patients and a proposed add-on payment adjustment for certain new renal dialysis drugs and biological products in existing ESRD
This proposed rule proposes updates to the payment for renal dialysis services furnished by ESRD facilities to individuals with AKI. As discussed in section III.B of this proposed rule, we are also proposing to apply to all AKI dialysis payments the updates to the ESRD PPS base rate and wage index. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2024 for renal dialysis services furnished to patients with AKI in accordance with section 1834(r) of the Act.
Section 1881(h)(1) of the Act requires CMS to reduce the payments otherwise made to a facility under the ESRD PPS by up to two percent if the facility does not satisfy the requirements of the ESRD QIP for that year. This proposed rule proposes updates for the ESRD QIP, including removing the Ultrafiltration Rate reporting measure from the ESRD QIP measure set beginning with PY 2026, removing the Standardized Fistula Rate clinical measure from the ESRD QIP measure set beginning with PY 2026, updating the COVID-19 Vaccination Coverage Among HCP beginning with PY 2026, converting the Clinical Depression Screening and Follow-Up reporting measure to a clinical measure beginning with PY 2026, and adding the Facility Commitment to Health Equity reporting measure to the ESRD QIP measure set beginning with PY 2026. This proposed rule also proposes to add the Screening for Social Drivers of Health reporting measure and the Screen Positive Rate for Social Drivers of Health reporting measure to the ESRD QIP measure set beginning with PY 2027.
We believe it is necessary to propose certain changes to the ETC Model to acknowledge the availability of administrative review of targeted review requests. This proposed revision is necessary to provide transparency to ETC Participants regarding the avenue available to them should they wish to seek additional review of the results of a targeted review request determination.
We have examined the impacts of this proposed 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), Executive Order 14094 on Modernizing Regulatory Review (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999).
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 14094 (Modernizing Regulatory Review) amends section 3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more in any 1 year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.
A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with significant effects as per section 3(f)(1) of Executive Order 12866 ($200 million or more in any 1 year). Based on our estimates of the combined impact of the ESRD PPS, ESRD QIP, and ETC provisions in this proposed rule, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) economic effect. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking. Therefore, OMB has reviewed this proposed rule, and the Department have provided the following assessment of its impact. We solicit comments on the regulatory impact analysis provided.
We estimate that the proposed revisions to the ESRD PPS would result in an increase of approximately $130 million in Medicare payments to ESRD facilities in CY 2024, which includes the amount associated with updates to the outlier thresholds, payment rate update, updates to the wage index, the budget-neutral transitional pediatric ESRD add-on payment adjustment, the beginning of the proposed post-TDAPA add-on payment adjustment, and continuation of the approved TDAPA from CY 2023 until March 31, 2024.
We estimate that the proposed updates to the AKI payment rate would result in an increase of approximately $1 million in Medicare payments to ESRD facilities in CY 2024.
We estimate that the proposed updates to the ESRD QIP will result in $20 million in estimated payment reductions across all facilities for PY 2026.
We estimate that the proposed changes to the ETC Model would not impact the Model's projected direct savings from payment adjustments alone. As described in the CY 2023 ESRD PPS final rule, we estimate that the Model would generate $28 million in direct savings related to payment adjustments over 6.5 years (87 FR 67297 through 67299).
We estimate that the combined impact of the proposals in this rule on payments for CY 2024 is $131 million based on the estimates of the updates to the ESRD PPS and the AKI payment rates. We estimate an additional $4 million in costs associated with the
In this section, we discuss the anticipated benefits, costs, and transfers associated with the changes in this proposed rule. Additionally, we estimate the total regulatory review costs associated with reading and interpreting this proposed rule.
Under the CY 2024 ESRD PPS and AKI payment, ESRD facilities would continue to receive payment for renal dialysis services furnished to Medicare beneficiaries under a case-mix adjusted PPS. We continue to expect that making prospective Medicare payments to ESRD facilities would enhance the efficiency of the Medicare program. Additionally, we expect that updating the Medicare ESRD PPS base rate and rate for AKI treatments furnished at ESRD facilities by 1.7 percent based on the proposed CY 2024 ESRD PPS market basket percentage increase less the proposed CY 2024 productivity adjustment would improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in delivering renal dialysis services. We estimate that the overall payment rate for the ESRD PPS would increase by 1.6 percent.
As discussed in section II.B.1.j of this proposed rule, we are proposing to require ESRD facilities to submit data and information on ESRD PPS claims for renal dialysis services regarding the number of minutes of hemodialysis treatment received by a beneficiary in center in an ESRD facility. This patient-level reporting on resource use would be used to apportion composite rate costs for use in the case-mix adjustment under the ESRD PPS. We estimate that there would be an increase in costs for ESRD facilities associated with this proposed reporting requirement; however, as we previously noted in the CY 2020 ESRD PPS proposed rule (84 FR 38396 through 38400), we are aware that many ESRD facilities' electronic health records (EHR) systems automatically collect this information for every dialysis treatment, minimizing the additional burden of reporting this metric on claims. For those ESRD facilities that use EHRs, we estimate that there would be only very minimal additional staff time required to report such time on machine data on ESRD PPS claims for renal dialysis services. For those ESRD facilities that do not use EHRs, we estimate that additional staff time would be required to take note of the time at which hemodialysis began and the time at which hemodialysis ended, and subtract the start time from the end time to determine the total number of minutes of hemodialysis. Conservatively, we estimate this would require no more than 1 minute per treatment.
To calculate the annual additional ESRD facility staff time that would be associated with reporting time on machine data on ESRD PPS claims for renal dialysis services, we multiply the estimated time per treatment by the number of dialysis treatments. Based on the most recent available CY 2022 ESRD PPS claims for this proposed rule, we estimate there were approximately 29.8 million treatments. However, as discussed in section II.B.1.j, we are proposing to limit this reporting requirement to in-center claims. We estimate that approximately 14.6 percent of claims are for home dialysis, and therefore we reduce our estimate of the total number of treatments by 14.6 percent. Additionally, we believe it is reasonable to assume that LDOs would utilize existing systems and processes to document treatment duration in the EHR and send that information to the claim. Based on the latest available data as shown in Table 23, approximately 77.9 percent of treatments were furnished by LDOs. Therefore, we estimate that the additional costs associated with this proposed time on machine reporting requirement would be associated with approximately 5.6 million in-center, non-LDO dialysis treatments per year.
Additionally, ESRD facilities already report time on machine data on a monthly basis in the EQRS for a single dialysis session. This means that for a patient who receives 156 dialysis treatments per year, the duration of twelve of those sessions would already be reported in the EQRS. We do not believe there would be any additional staff time required to report time on machine data on ESRD PPS claims for the treatments already reported in EQRS. Therefore, we estimate that the additional staff time would be needed for reporting time on machine for 144 out of 156 treatments per year for the typical patient. For our cost estimate, we multiplied our estimate of 5.6 million in-center dialysis treatments by a factor of (144/156), which equals approximately 5.2 million treatments per year.
To derive wages estimates, we used data from the U.S. Bureau of Labor Statistics' May 2021 National Occupational Employment and Wage Estimates. We believe it is reasonable to assume that Medical Records and Health Information Technicians, who are responsible for organizing and managing health information data, are the individuals reporting time on machine data. As discussed in the CY 2016 ESRD PPS final rule (80 FR 69069), this is consistent with our assumptions about the types of employees tasked with submitting measure data to CROWNWeb (now EQRS) and NHSN, as well as compiling and submitting patient records for the purpose of data validation studies. The most recently available median hourly wage of a Medical Records and Health Information Technician is $23.67 per hour.
Based on the figures discussed in the preceding paragraphs, we estimate that total additional staff time each year for ESRD facilities associated with the proposed requirement to report time on machine data is equal to 5.2 million × 1 minute = 5.2 million minutes = 86,667 hours. We estimate the total annual cost associated with this proposed
We recognize that some non-LDO ESRD facilities may also choose to adopt an automated process, rather than a manual process. Therefore, the estimate of $4,102,815.78, calculated based on 5.2 million treatments, represents the upper limit of our burden estimate. For ESRD facilities that choose to utilize existing systems and processes to document treatment duration in the EHR and send that data to the claim, we estimate the burden associated with our proposed requirement to report time on machine data would be minimal.
For PY 2026 and PY 2027, we have updated the estimated costs associated with the information collection requirements under the ESRD QIP with updated estimates of the total number of ESRD facilities, the total number of patients nationally, wages for Medical Records Specialists or similar staff, and a refined estimate of the number of hours needed to complete data entry for EQRS reporting. We have made no changes to our methodology for calculating the annual burden associated with the information collection requirements for the EQRS validation study (previously known as the CROWNWeb validation study) or the NHSN validation study. We have updated our methodology for calculating the annual burden associated with the information collection requirements for EQRS reporting based on our proposed measure updates for PY 2026 and PY 2027.
We also updated the payment reduction estimates based on our proposals in this proposed rule, using more recent data for the measures in the ESRD QIP measure set. We estimate that as a result of our proposed and previously finalized policies for PY 2026, there would be approximately $121.1 million in information collection burden and an additional $20 million in estimated payment reductions across all facilities, for a total estimated impact of $141.1 million.
For PY 2027, we estimate that as a result of our proposed and previously finalized policies for PY 2027, there would be approximately $130.7 million in information collection burden and $17.3 million in estimated payment reductions across all facilities, for a total estimated impact of $148 million.
We estimate that the updates to the ESRD PPS and AKI payment rate would result in a total in increase of approximately $130 million in Medicare payments to ESRD facilities in CY 2024, which includes the amount associated with updates to the outlier thresholds, and updates to the wage index. This estimate includes an increase of approximately $1 million in Medicare payments to ESRD facilities in CY 2024 due to the updates to the AKI payment rate, of which approximately 20 percent is increased beneficiary co-insurance payments. We estimate approximately $100 million in transfers from the Federal Government to ESRD facilities due to increased Medicare program payments and approximately $30 million in transfers from beneficiaries to ESRD facilities due to increased beneficiary co-insurance payments as a result of this proposed rule.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed 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 proposed rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed 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 would be a fair estimate of the number of reviewers of this proposed rule. We welcome any comments on the approach in estimating the number of entities which will review this proposed rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We seek comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this proposed rule is $115.22 per hour, including overhead and fringe benefits (
To understand the impact of the changes affecting Medicare payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2023 to estimated payments in CY 2024. To estimate the impact among various types of ESRD facilities, it is imperative that the estimates of Medicare payments in CY 2023 and CY 2024 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we are able to calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we used CY 2022 data from the Medicare Part A and Part B Common Working Files as of 2/17/2023, as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2022 claims to 2023 and 2024 using various updates. The updates to the ESRD PPS base rate are described in section II.B.1.d of this proposed rule. Table 23 shows the impact of the estimated CY 2024 ESRD PPS payments compared to estimated Medicare payments to ESRD facilities in CY 2023.
Column A of the impact table indicates the number of ESRD facilities for each impact category and column B indicates the number of dialysis treatments (in millions). The overall effect of the proposed changes to the outlier payment policy described in section II.B.1.c of this proposed rule is shown in column C. For CY 2024, the impact on all ESRD facilities as a result of the proposed changes to the outlier payment policy would be a 0.1 percent decrease in estimated Medicare payments.
Column D shows the effect of the proposed TPEAPA as described in section II.B.1.g of this proposed rule. This adjustment would be implemented in a budget neutral manner, so the total impact of this change would be 0.0 percent. However, there would be distributional impacts of this proposed change, primarily a 25.2 percent increase to payments to Pediatric ESRD facilities (with more than 50 percent of patients under age 18). This proposed policy change also corresponds to a 0.8 percent increase to hospital-based ESRD facilities. Because the budget neutrality factor for this proposed policy is so small, the impact analysis found no significant decrease to any ESRD facility as the total decrease in payments for ESRD facilities that predominantly serve adults would still be less than 0.05 percent.
Column E shows the effect of year-over-year payment changes related to the proposed post-TDAPA add-on payment adjustment as described in section II.B.1.i of this proposed rule and current TDAPA payments. The post-TDAPA add-on payment adjustment would not be budget neutral; however, we estimate the difference between total payments in CY 2023 during which time payment is made using the TDAPA under the ESRD PPS, and estimated total payments in CY 2024 under the proposed post-TDAPA add-on payment adjustment would be less than 0.1 percent. Therefore, the total impact of this change as compared to current TDAPA payments is 0.0 percent.
Column F reflects the effect of the proposed update to the ESRD PPS wage index as described in section II.B.1.c of this proposed rule. This update would be budget neutral, so the total impact of this policy change is 0.0 percent. However, there would be distributional impacts of this change. The largest increase would be to mid-Atlantic ESRD facilities that would receive 0.8 percent higher payments as a result of the proposed updated ESRD PPS wage
Column G reflects the overall impact, that is, the effects of the proposed outlier policy changes, the TPEAPA, the post-TDAPA payment adjustment, the updated wage index, and the payment rate update as proposed in section II.B.1.d of this proposed rule. The proposed ESRD PPS payment rate update for CY 2024 is 1.7 percent, which reflects the proposed ESRDB market basket percentage increase for CY 2024 of 2.0 percent and the proposed productivity adjustment of 0.3 percent. We expect that overall ESRD facilities would experience a 1.6 percent increase in estimated Medicare payments in CY 2024. The categories of types of ESRD facilities in the impact table show impacts ranging from a 1.1 percent increase to a 27.6 percent increase in their CY 2024 estimated Medicare payments.
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers (for example, laboratories, durable medical equipment suppliers, and pharmacies) by Medicare prior to the implementation of the ESRD PPS. Therefore, in CY 2024, we estimate that the ESRD PPS would have zero impact on these other providers.
We estimate that Medicare spending (total Medicare program payments) for ESRD facilities in CY 2024 would be approximately $6.4 billion. This estimate considers a projected decrease in fee-for-service Medicare ESRD beneficiary enrollment of 4.2 percent in CY 2024.
Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 1.6 percent overall increase in the CY 2024 ESRD PPS payment amounts, we estimate that there would be an increase in beneficiary co-insurance payments of 1.6 percent in CY 2024, which translates to approximately $30 million.
As discussed in section II.B.1.g.(4) of this proposed rule, we are proposing to implement a transitional add-on payment adjustment of 30 percent for Pediatric ESRD Patients, which we would call the TPEAPA. We also considered, but did not propose, an alternative payment structure which would phase in the adjustment over 3 years starting at 10 percent for the first year and 20 percent for the second year.
As discussed in section II.B.1.i.(3) of this proposed rule, we are proposing an add-on payment adjustment for new renal dialysis drugs and biological products in existing ESRD PPS functional categories after the end of the TDAPA period. We also considered, but did not propose, an alternative methodology for calculating this payment adjustment which would incorporate a reconciliation of all the formerly separately billable drugs against the calculated post-TDAPA payment adjustment. Additionally, we considered but did not propose alternative approaches to applying and calculating this add-on payment adjustment for specific patient populations.
As discussed in section II.B.1.j.(5) of this proposed rule, we are proposing to require ESRD facilities to submit data and information on ESRD PPS claims for renal dialysis services regarding the number of minutes of hemodialysis treatment received by a beneficiary in center in an ESRD facility. This patient-level reporting on resource use would be used to apportion composite rate costs for use in the case-mix adjustment. We also considered, but did not propose, to use dialysis duration data from EQRS to apportion composite rate costs for this purpose. We discuss why we did not propose this alternative in further detail in section II.B.1.j.(5) of this proposed rule.
One renal dialysis drug for which the TDAPA was paid in CY 2022 and CY 2023 would continue to be eligible for the TDAPA in CY 2024. CMS Transmittal 11295,
We based the CY 2024 impacts on the most current 72x claims data from May 2022, when utilization first appeared on the claims, through February 2023. During that timeframe, the average monthly TDAPA payment amount for KORSUVA
To understand the impact of the proposed changes affecting Medicare payments to different categories of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is necessary to compare estimated Medicare payments in CY 2023 to estimated Medicare payments in CY 2024. To estimate the impact among various types of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is imperative that the Medicare payment estimates in CY 2023 and CY 2024 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we are able to calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we used CY 2022 data from the Medicare Part A and Part B Common Working Files as of 2/17/2023, as a basis for Medicare for renal dialysis services furnished to individuals with AKI. We updated the 2022 claims to 2023 and 2024 using various updates. The proposed updates to the AKI payment amount are described in section III.B of this proposed rule. Table 24 shows the impact of the estimated CY 2024 Medicare payments for renal dialysis services furnished to individuals with AKI compared to estimated Medicare payments for renal dialysis services furnished to individuals with AKI in CY 2023.
Column A of the impact table indicates the number of ESRD facilities for each impact category and column B indicates the number of AKI dialysis treatments (in thousands). Column C shows the effect of the CY 2024 wage indices.
Column D shows the overall impact, that is, the effects of proposed combined wage index and TPEAPA budget-neutrality adjustment factor, wage index updates, and the payment rate update of 1.7 percent, which reflects the proposed ESRDB market basket percentage increase for CY 2024 of 2.0 percent and the proposed productivity adjustment of 0.3 percentage point. We expect that overall ESRD facilities would experience a 1.6 percent increase in estimated Medicare payments in CY 2024. The categories of types of ESRD facilities in the impact table show impacts ranging from an increase of −0.4 percent to 2.4 percent in their CY 2024 estimated Medicare payments.
Under section 1834(r) of the Act, as added by section 808(b) of TPEA, we are proposing to update the payment rate for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. The only two Medicare providers and suppliers authorized to provide these outpatient renal dialysis services are hospital outpatient departments and ESRD facilities. The patient and his or her physician make the decision about where the renal dialysis services are furnished. Therefore, this change would have zero impact on other Medicare providers.
We estimate approximately $70 million would be paid to ESRD facilities in CY 2024 as a result of patients with AKI receiving renal dialysis services in an ESRD facility at the lower ESRD PPS base rate versus receiving those services only in the hospital outpatient setting and paid under the outpatient prospective payment system, where services were required to be administered prior to the TPEA.
Currently, beneficiaries have a 20 percent co-insurance obligation when they receive AKI dialysis in the hospital outpatient setting. When these services are furnished in an ESRD facility, the patients would continue to be responsible for a 20 percent coinsurance. Because the AKI dialysis payment rate paid to ESRD facilities is lower than the outpatient hospital PPS's payment amount, we expect beneficiaries to pay less co-insurance when AKI dialysis is furnished by ESRD facilities.
As we discussed in the CY 2017 ESRD PPS proposed rule (81 FR 42870), we considered adjusting the AKI payment rate by including the ESRD PPS case-mix adjustments, and other adjustments at section 1881(b)(14)(D) of the Act, as well as not paying separately for AKI specific drugs and laboratory tests. We ultimately determined that treatment for AKI is substantially different from treatment for ESRD and the case-mix adjustments applied to ESRD patients may not be applicable to AKI patients, and as such, including those policies and adjustments is inappropriate. We continue to monitor utilization and trends of items and services furnished to individuals with AKI for purposes of refining the payment rate in the future. This monitoring would assist us in developing knowledgeable, data-driven proposals.
The ESRD QIP is intended to prevent reductions in the quality of ESRD dialysis facility services provided to beneficiaries. The general methodology that we use to calculate a facility's TPS is described in our regulations at 42 CFR 413.178(e).
Any reductions in the ESRD PPS payments as a result of a facility's performance under the PY 2026 ESRD QIP will apply to the ESRD PPS payments made to the facility for services furnished in CY 2026, as codified in our regulations at 42 CFR 413.177.
For the PY 2026 ESRD QIP, we estimate that, of the 7,847 facilities (including those not receiving a TPS) enrolled in Medicare, approximately 31.56 percent or 2,477 of the facilities
Table 25 shows the overall estimated distribution of payment reductions resulting from the PY 2026 ESRD QIP.
To estimate whether a facility would receive a payment reduction for PY 2026, we scored each facility on achievement and improvement on several clinical measures we have previously finalized and for which there were available data from EQRS and Medicare claims. Payment reduction estimates are calculated using the most recent data available (specified in Table 19) in accordance with the policies proposed in this proposed rule. Measures used for the simulation are shown in Table 26.
For all measures except the SHR clinical measure, the SRR clinical measure, and the STrR measure, measures with less than 11 patients for a facility were not included in that facility's TPS. For the SHR clinical measure and the SRR clinical measure, facilities were required to have at least 5 patient-years at risk and 11 index discharges, respectively, to be included in the facility's TPS. For the STrR clinical measure, facilities were required to have at least 10 patient-years at risk to be included in the facility's TPS. Each facility's TPS was compared to an estimated mTPS and an estimated payment reduction table that were consistent with the proposed policies outlined in section IV.C of this proposed rule. Facility reporting measure scores were estimated using available data from CY 2021. Facilities were required to have at least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2026 for each facility resulting from this proposed rule, we multiplied the total Medicare payments to the facility during the 1-year period between January 2021 and December
Table 27 shows the estimated impact of the finalized ESRD QIP payment reductions to all ESRD facilities for PY 2026. The table also details the distribution of ESRD facilities by size (both among facilities considered to be small entities and by number of treatments per facility), geography (both rural and urban and by region), and facility type (hospital based and freestanding facilities). Given that the performance period used for these calculations differs from the performance period we are using for the PY 2026 ESRD QIP, the actual impact of the PY 2026 ESRD QIP may vary significantly from the values provided here.
For the PY 2027 ESRD QIP, we estimate that, of the 7,847 facilities (including those not receiving a TPS) enrolled in Medicare, approximately 29.29 percent or 2,299 of the facilities that have sufficient data to calculate a TPS would receive a payment reduction for PY 2027. Among an estimated 2,299 facilities that would receive a payment reduction, approximately 68.3 percent or 1,571 facilities would receive the smallest payment reduction of 0.5 percent. The total payment reductions for all the 2,299 facilities expected to receive a payment reduction is approximately $17,388,145. Facilities
Table 28 shows the overall estimated distribution of payment reductions resulting from the PY 2027 ESRD QIP.
To estimate whether a facility would receive a payment reduction in PY 2027, we scored each facility on achievement and improvement on several clinical measures we have previously finalized and for which there were available data from EQRS and Medicare claims. Payment reduction estimates were calculated using the most recent data available (specified in Table 26) in accordance with the policies proposed in this proposed rule. Measures used for the simulation are shown in Table 29.
For all measures except the SHR clinical measure, the SRR clinical measure, and the STrR measure, measures with less than 11 patients for a facility were not included in that facility's TPS. For the SHR and SRR measures, facilities were required to have at least 5 patient-years at risk and 11 index discharges, respectively, to be included in the facility's TPS. For the STrR clinical measure, facilities were required to have at least 10 patient-years at risk to be included in the facility's TPS. Each facility's TPS was compared to an estimated mTPS and an estimated payment reduction table that incorporates the proposed and previously finalized policies outlined in section IV.D of this proposed rule. Facility reporting measure scores were estimated using available data from CY 2021. Facilities were required to have at least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2027 for each facility resulting from this proposed rule, we multiplied the total Medicare payments to the facility during the 1-year period between January 2021 and December 2021 by the facility's estimated payment reduction percentage expected under the ESRD QIP, yielding a total payment reduction amount for each facility.
Table 30 shows the estimated impact of the finalized ESRD QIP payment reductions to all ESRD facilities for PY 2027. The table details the distribution of ESRD facilities by size (both among facilities considered to be small entities and by number of treatments per facility), geography (both rural and urban and by region), and facility type (hospital based and freestanding facilities). Given that the performance period used for these calculations differs from the performance period we are using for the PY 2027 ESRD QIP, the actual impact of the PY 2027 ESRD QIP may vary significantly from the values provided here.
The ESRD QIP is applicable to ESRD facilities. We are aware that several of our measures impact other providers. For example, with the introduction of the SRR clinical measure in PY 2017 and the SHR clinical measure in PY 2020, we anticipate that hospitals may experience financial savings as facilities work to reduce the number of unplanned readmissions and hospitalizations. We are exploring various methods to assess the impact these measures have on hospitals and other facilities, such as through the impacts of the Hospital Readmissions Reduction Program and the Hospital-Acquired Condition Reduction Program, and we intend to continue examining the interactions between our quality programs to the greatest extent feasible.
For PY 2027, we estimate that the ESRD QIP would contribute approximately $17,388,145.07 in Medicare savings. For comparison, Table 31 shows the payment reductions that we estimate will be applied by the ESRD QIP from PY 2018 through PY 2027.
The ESRD QIP is applicable to ESRD facilities. Since the Program's inception, there is evidence of improved performance on ESRD QIP measures. As we stated in the CY 2018 ESRD PPS final rule, one objective measure we can examine to demonstrate the improved quality of care over time is the improvement of performance standards (82 FR 50795). As the ESRD QIP has refined its measure set and as facilities have gained experience with the measures included in the Program, performance standards have generally continued to rise. We view this as evidence that facility performance (and therefore the quality of care provided to Medicare beneficiaries) is objectively improving. We are in the process of monitoring and evaluating trends in the quality and cost of care for patients under the ESRD QIP, incorporating both existing measures and new measures as they are implemented in the Program. We will provide additional information about the impact of the ESRD QIP on beneficiaries as we learn more. However, in future years we are interested in examining these impacts through the analysis of available data from our existing measures.
In section IV.C.5 of this proposed rule, we are proposing to remove the Ultrafiltration Rate reporting measure and the Standardized Fistula Rate clinical measure, beginning with PY 2026. We considered not proposing to remove these measures. However, we concluded that proposing to remove these two measures was appropriate under our previously finalized measure removal factors. This approach would help to ensure that a facility's performance is assessed based on measures that continue to be meaningful parts of the ESRD QIP measure set.
The ETC Model is a mandatory payment model designed to test payment adjustments to certain dialysis and dialysis-related payments, as discussed in the Specialty Care Models final rule (85 FR 61114), the CY 2022 ESRD PPS final rule (86 FR 61874), and the CY 2023 ESRD PPS final rule (87 FR 67136) for ESRD facilities and for Managing Clinicians for claims with dates of service from January 1, 2021, to June 30, 2027. The requirements for the ETC Model are set forth in 42 CFR part 512, subpart C. We are proposing to revise our regulations at § 512.390 to acknowledge the ability of the CMS Administrator to review the results of ETC Participants' targeted review requests. For the results of the detailed economic analysis of the ETC Model and a description of the methodology used to perform the analysis, please see the Specialty Care Models final rule (85 FR 61114).
A stochastic simulation was created to estimate the financial impacts of the ETC Model relative to baseline expenditures, where baseline expenditures were defined as data from CYs 2018 and 2019 without the changes applied. The simulation relied upon statistical assumptions derived from retrospectively constructed ESRD facilities' and Managing Clinicians' Medicare dialysis claims, transplant claims, and transplant waitlist data reported during 2018 and 2019, the most recent years of complete data available before the start of the ETC Model. Both datasets and the risk-adjustment methodologies for the ETC Model were developed by the CMS Office of the Actuary (OACT).
Table 32 summarizes the estimated impact of the ETC Model when the achievement benchmarks for each year are set using the average of the home dialysis rates for year
In Table 32, negative spending reflects a reduction in Medicare spending, while positive spending reflects an increase. The results for this table were generated from an average of 400 simulations under the assumption that benchmarks are rolled forward with a 1.5-year lag. For a detailed description of the key assumptions underlying the impact estimate, see the Specialty Care Models final rule (85 FR 61353) and the CY 2022 ESRD PPS final rule (86 FR 60214 through 60216).
The changes in this proposed rule would not impact the findings reported for the effects of the ETC Model on the home dialysis rate or the transplant rate described in the Specialty Care Models final rule (85 FR 61355) and the CY 2022 ESRD PPS final rule (86 FR 62017).
The changes in this proposed rule will not impact the findings reported for the effects of the ETC Model on kidney disease patient education services and HD training add-ons described in the Specialty Care Models final rule (85 FR 61355) and the CY 2023 ESRD PPS final rule (87 FR 67136).
Our proposal to provide the option for ETC Participants to seek administrative review of targeted review determinations will not impact the findings reported for the effects of ETC Model on Medicare beneficiaries in lieu of the ETC Model's likelihood of incentivizing ESRD facilities and Managing Clinicians to improve access to home dialysis and transplantation for Medicare beneficiaries. Further details on the impact of the ETC Model on ESRD Beneficiaries may be found in the Specialty Care Models final rule (85 FR 61357), the CY 2022 ESRD PPS final rule (86 FR 61874), or the CY 2023 ESRD PPS final rule (87 FR 67136).
In this proposed rule, we are proposing to revise our regulations at 42 CFR 512.390 to acknowledge the availability of administrative review of targeted review requests. We considered retaining our current process, in which targeted review determinations are final with no further review or appeal; however, we believe that providing for administrative review of targeted review determinations is important to provide ETC Participants with transparency regarding the avenue that is available should they wish to seek review of their targeted review determination, to vest accountability for the decisions of CMS in a principal officer, and to bring the
As required by OMB Circular A-4 (available at
The Regulatory Flexibility Act (RFA) requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. We do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis. Individuals and states are not included in the definition of a small entity. Therefore, the number of small entities estimated in this RFA analysis includes the number of ESRD facilities that are either considered small businesses or nonprofit organizations.
According to the Small Business Administration's (SBA) size standards, an ESRD facility is classified as a small business if it has total revenues of less than $41.5 million in any 1 year. For the purposes of this analysis, we exclude the ESRD facilities that are owned and operated by LDOs and regional chains, which would have total revenues of more than $8.1 billion in any year when the total revenues for all locations are combined for each business (LDO or regional chain), and are not, therefore, considered small businesses. Because we lack data on individual ESRD facilities' receipts, we cannot determine the number of small proprietary ESRD facilities or the proportion of ESRD facilities' revenue derived from Medicare payments. Therefore, we assume that all ESRD facilities that are not owned by LDOs or regional chains are considered small businesses. Accordingly, we consider the 451 facilities that are independent and 352 facilities that are hospital-based, as shown in the ownership category in Table 23, to be small businesses. These facilities represent approximately 10 percent of all ESRD facilities in our data set.
Additionally, we identified in our analytic file that there are 806 facilities that are considered nonprofit organizations, which is approximately 10 percent of all ESRD facilities in our data set. In total, accounting for the 364 nonprofit ESRD facilities that are also considered small businesses, there are 1,245 ESRD facilities that are either small businesses or nonprofit organizations, which is approximately 16 percent of all ESRD facilities in our data set.
For the ESRD PPS updates in this proposed rule, a hospital-based ESRD facility (as defined by type of ownership, not by type of ESRD facility) is estimated to receive a 2.6 percent increase in Medicare payments for CY 2024. An independent facility (as defined by ownership type) is likewise estimated to receive a 2.2 percent increase in Medicare payments for CY
For AKI dialysis, we are unable to estimate whether patients would go to ESRD facilities, however, we have estimated there is a potential for $70 million in payment for AKI dialysis treatments that could potentially be furnished in ESRD facilities.
For the ESRD QIP, we estimate that of the 2,477 ESRD facilities expected to receive a payment reduction as a result of their performance on the PY 2026 ESRD QIP, 393 are ESRD small entity facilities. We present these findings in Table 25 (“Estimated Distribution of PY 2026 ESRD QIP Payment Reductions”) and Table 27 (“Estimated Impact of ESRD QIP Payment Reductions to ESRD Facilities for PY 2026”).
Regarding the ETC Model, in the Specialty Care Models final rule, we described our assumption, for the purposes of the regulatory impact analysis, that the great majority of Managing Clinicians are small entities by nature of meeting the SBA definition of a small business, but that the greater majority of ESRD facilities are not, as they are owned, either partially or entirely, by organizations that do not meet the SBA definition of a small entity. We described the low volume threshold exclusions and aggregation policies used in the ETC Model and our assessment that, in conjunction with the fact that the ETC Model affects Medicare payment only for select services furnished to Medicare FFS beneficiaries; the ETC Model will not have a significant impact on spending for a substantial number of small entities. For the purposes of this proposed rule, we have determined that our proposal to clarify the ability of the CMS Administrator to review targeted review determinations will not change the assessment that the ETC Model will not have a significant impact on spending for a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe this proposed rule would have a significant impact on operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding. While there are 121 rural hospital-based ESRD facilities, we do not know how many of them are based at hospitals with fewer than 100 beds. However, overall, the 121 rural hospital-based ESRD facilities would experience an estimated 2.2 percent increase in payments. Therefore, the Secretary has certified that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals. Our proposal to clarify the ability of the CMS Administrator to review ETC Model targeted review determinations is not expected to change the Secretary's assessment.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2023, that threshold is approximately $177 million. This proposed rule would not impose a mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of more than $177 million in any 1 year. Moreover, HHS interprets UMRA as applying only to unfunded mandates. We do not interpret Medicare payment rules as being unfunded mandates but simply as conditions for the receipt of payments from the Federal Government for providing services that meet Federal standards. This interpretation applies whether the facilities or providers are private, State, local, or Tribal.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of State, local, or Tribal governments.
The Addenda for the annual ESRD PPS proposed and final rule will no longer appear in the
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on June 15, 2023.
Diseases, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health facilities, Health insurance, Medicare, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395m, 1395x(v), 1395x(kkk), 1395hh, 1395rr, 1395tt, and 1395ww.
(a) * * *
(8)
(c)
(i) Measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management;
(ii) Measures on dialysis adequacy;
(iii) To the extent feasible, a measure (or measures) of patient satisfaction;
(iv) To the extent feasible, measures on iron management, bone mineral metabolism, and vascular access (including for maximizing the placement of arterial venous fistula);
(v) Beginning with the 2016 payment year, measures specific to the conditions treated with oral-only drugs and that are, to the extent feasible, outcomes-based; and
(vi) Other measures that CMS specifies.
(2)
(ii)
(A) CMS has determined that a specified area or medical topic is appropriate for inclusion in the ESRD QIP;
(B) CMS has not identified a feasible and practical measure with respect to that specified area or medical topic that has been endorsed by the entity with a contract under section 1890(a) of the Social Security Act; and
(C) CMS has given due consideration to measures that have been endorsed or adopted by a consensus organization.
(3)
(4)
(5)
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)
(ii)
(iii)
(A) Provide notice to facilities and the public at the time CMS removes the measure, along with a statement of the specific patient safety concerns that would be raised if facilities continued to submit data on the measure; and
(B) Provide notice of the removal in the
(a)
(b) * * *
(3) * * *
(iii) Flow from the provision of luxury items or services (items or services substantially in excess of or more expensive than those generally considered necessary for the provision of needed health services); or
(5) Each ESRD facility must submit data and information of the types and in the formats established by CMS for the purpose of estimating patient-level and facility-level variation in resource use involved in furnishing renal dialysis services. The data and information must include, but is not limited to:
(i) Beginning January 1, 2025, information reported on ESRD prospective payment system (PPS) claims for renal dialysis services regarding the number of minutes of hemodialysis treatment received by a beneficiary in center in an ESRD facility;
(ii) Information reported on ESRD PPS claims about the total number of billing units of any discarded amount of a renal dialysis drug or biological product from a single-dose container or single-use package that is paid for under the ESRD PPS, using the JW modifier (or any successor modifier that includes the same data); and
(iii) Information reported on ESRD PPS claims about any renal dialysis drug or biological product from a single-dose container or single-use package that is paid for under the ESRD PPS for which there is no discarded amount, using the JZ modifier (or any successor modifier that includes the same data).
(6) Each ESRD facility must document in the beneficiary's medical record any discarded amounts of a renal dialysis drug or biological product from a single-dose container or single-use package that is paid for under the ESRD PPS.
(d) Any transitional drug add-on payment adjustment under § 413.234(c);
(e) Any transitional add-on payment adjustment for new and innovative equipment and supplies under § 413.236(d); and
(f) Any add-on payment adjustment for new renal dialysis drugs or biological products in existing ESRD PPS functional categories after the payment period for the transitional drug add-on payment adjustment has ended, as described in § 413.234(c)(3) and (g).
(b) * * *
(1) Furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent, except as specified in paragraphs (g)(4) and (5) of this section) preceding the payment year; and
(2) Has not opened, closed, or received a new provider number due to a change in ownership (except where the change in ownership results in a change in facility type) in the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent) preceding the payment year, except as specified in paragraph (g)(6) of this section.
(g) To receive the low-volume adjustment, an ESRD facility must include in its attestation provided pursuant to paragraph (e) of this section a statement that the ESRD facility meets the definition of a low-volume facility in paragraph (b) of this section. To determine eligibility for the low-volume adjustment, the MAC on behalf of CMS relies upon as filed or final settled 12-consecutive month cost reports, except as specified in paragraphs (g)(4) and (5) of this section, for the 3 cost reporting years preceding the payment year to verify the number of treatments, except that:
(5) For payment year 2024 and subsequent payment years, an ESRD facility may attest in the attestation specified in paragraph (e) of this section that it would have met the requirements of paragraph (b)(1) of this section, except that for one or more of the most recent 3 cost reporting years the facility furnished 4,000 or more treatments because of temporary patient-shifting as a result of the closure or operational disruption of another ESRD facility due to a disaster or other emergency. For the purposes of the exception in this paragraph (g)(5), temporary patient-shifting is defined as providing renal dialysis services to one or more displaced patient(s) at any time through the end of the calendar year following the 12-month period beginning when an ESRD facility first begins providing renal dialysis services to one or more displaced patients. For any facility that so attests—
(i) The facility must also attest that it furnished treatments equal to or in excess of 4,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency;
(ii) The facility must request an exception under this paragraph (g)(5) from CMS, in the form and manner specified by CMS, no later than the attestation deadline specified in paragraph (e) of this section for each cost reporting year that the facility furnishes treatments equal to or in excess of 4,000 due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency;
(iii) Within 30 days of CMS's receipt of the facility's request, CMS will review the request and either approve the request based on a determination that the ESRD facility furnished treatments equal to or in excess of 4,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency, or deny the request, and will notify the facility and the MAC of its decision;
(iv) If CMS approves the request, the ESRD facility is paid the low-volume adjustment on claims for Medicare beneficiaries for up to the first 4,000 dialysis treatments, on the basis of the exception in this paragraph (g)(5), during the payment year in which the temporary patient-shifting occurred, so long as all other requirements for the low-volume adjustment are met. For any future payment year, the ESRD facility would not be prevented from receiving the low-volume adjustment if the ESRD facility meets or exceeds the 4,000 treatment threshold in a cost reporting year due to temporary patient-shifting as a result of the disaster or other emergency that resulted in another ESRD facility's closure or operational disruption, so long as all other requirements for the low-volume adjustment are met; and
(v) The facility must maintain documentation of the number of displaced patients treated and information about the ESRD facility or facilities that closed or experienced operational disruptions due to a disaster or other emergency and previously treated those patients, and must provide such supporting documentation to CMS and the MAC upon request.
(6) In the case of an ESRD facility that closes due to a disaster or other emergency and later reopens, the ESRD facility may attest in the attestation specified in paragraph (e) of this section that CMS has granted an exception to the requirements specified in paragraph (b)(2) of this section because it closed due to a disaster or other emergency. For any facility that so attests—
(i) The ESRD facility would need to request such an exception from CMS, in the form and manner specified by CMS, within 60 days of the facility's closure, and the ESRD facility must inform the MAC of this request in writing;
(ii) With 30 days of CMS's receipt of the facility's request, CMS will review the request and either approve the request based on a determination that the ESRD facility closed due to a disaster or other emergency, or deny the request, and will inform both the facility and the MAC of its decision; and
(iii) If CMS approves the request, the exception under this paragraph (g)(6) will be applicable for a period consisting of the remainder of the cost reporting year (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent, except as specified in paragraph (g)(4) of this section) in which the closure occurred and the following full 2 cost reporting years. After this period the ESRD facility would follow the general attestation process for the low-volume adjustment specified in paragraphs (e) and (g) of this section.
(iv) The ESRD facility that attests under this paragraph (g)(6) to have closed due to a disaster or other emergency would need to notify CMS and the MAC, in the form and manner specified by CMS, within 30 days reopening and providing renal dialysis services. Within 30 days of CMS's receipt of the facility's notification, CMS will confirm receipt to the facility and the MAC of the facility's notification and the ESRD facility will be able to receive the low-volume adjustment as of the date of reopening, so long as all
(v) The ESRD facility must maintain documentation regarding its closure, and must provide such supporting documentation to CMS and/or the MAC upon request.
The additions and revision read as follows:
(b) * * *
(1) * * *
(iii) The new renal dialysis drug or biological product is paid for using the add-on payment adjustment described in paragraphs (c)(3) and (g) of this section, referred to as the post- transitional drug add-on payment adjustment (TDAPA) add-on payment adjustment.
(c) * * *
(1) * * *
(i) Following payment of the transitional drug add-on payment adjustment, the new renal dialysis drug or biological product is paid the post-TDAPA add-on payment adjustment as set forth in paragraphs (c)(3) and (g) of this section.
(ii) Following payment of the transitional drug add-on payment adjustment the ESRD PPS base rate will not be modified.
(3) For any new renal dialysis drug or biological product that is eligible for payment using the transitional drug add-on payment adjustment described in paragraphs (b)(1)(iii) and (c)(1) of this section, CMS applies a post-TDAPA add-on payment adjustment to all ESRD PPS claims that is calculated using the methodology set forth in paragraph (g) of this section. CMS will apply the post-TDAPA add-on payment adjustment beginning 8 calendar quarters after the first calendar quarter in which the transitional drug add-on payment adjustment is paid for the applicable product, and ending 12 calendar quarters after the end of the last calendar quarter in which the transitional drug add-on payment adjustment is paid for the applicable product. If CMS stops receiving the latest full calendar quarter of ASP data for the applicable renal dialysis drug or biological product during the applicable time period specified in paragraph (c)(1) of this section or during the 3-year period following such applicable time period, CMS will not pay any post-TDAPA add-on payment adjustment for such product in any future year.
(g)
(1) CMS bases the calculation on the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of ASP data. If the most recent full calendar quarter of ASP data reflects zero or negative sales, then the calculation is based on 100 percent of WAC and, when WAC is not available, the payment is based on the drug manufacturer's invoice.
(2) CMS calculates the post-TDAPA add-on payment adjustment annually as the expenditure for the new renal dialysis drug or biological product divided by the total number of ESRD PPS treatments during the same period.
(3) CMS applies a reduction factor to the post-TDAPA add-on payment adjustment for case mix standardization to reflect estimated increases resulting from the application of the patient-level adjustments as described in paragraph (g)(5) of this section. This reduction factor is calculated based on the patient-level adjustments (as described in § 413.235) applicable to the most recent 12-month period of utilization of ESRD PPS claims.
(4) The amount of the post-TDAPA add-on payment adjustment is equal to 65 percent of the amount calculated in paragraph (g)(2) of this section, multiplied by the reduction factor specified in paragraph (g)(3) of this section, and multiplied by the market basket increase factor under § 413.220(a)(5).
(5) The post-TDAPA add-on payment adjustment that is applied to an ESRD PPS claim is adjusted by any applicable patient-level case-mix adjustments under § 413.235.
(b) CMS adjusts the per treatment base rate for Pediatric ESRD Patients in accordance with section 1881(b)(14) (D)(iv)(I) of the Act as follows:
(1) To account for patient age and treatment modality; and
(2) Beginning January 1, 2024, to provide a per-treatment transitional add-on payment adjustment of 30 percent of the per treatment payment amount under § 413.230 for renal dialysis services furnished to Pediatric ESRD Patients during calendar years 2024, 2025, and 2026.
(b) * * *
(2) Is new, meaning a complete application has been submitted to CMS under paragraph (c) of this section within 3 years of the date of the Food and Drug Administration (FDA) marketing authorization;
42 U.S.C. 1302, 1315a, and 1395hh.
(d)
(1)
(i) Decline to review a targeted review request determination made by CMS;
(ii) Render a final decision based on the CMS Administrator's review of the targeted review request determination; or
(iii) Choose to take no action on the request for administrative review.
(2)
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission (“SEC” or “Commission”) is adopting a final rule, under the Securities Exchange Act of 1934 (“Exchange Act”), that is designed to prevent fraud, manipulation, and deception in connection with effecting any transaction in, or attempting to effect any transaction in, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap. The rule takes into account the features fundamental to a security-based swap and the broad definitions of purchase and sale under the Exchange Act as they relate to security-based swaps. In addition, the Commission is adopting a final rule, under the Exchange Act, that makes it unlawful for any officer, director, supervised person, or employee of a security-based swap dealer (“SBSD”) or major security-based swap participant (“MSBSP”) (each SBSD and each MSBSP also referred to as an “SBS Entity” and together referred to as “SBS Entities”), or any person acting under such person's direction, to directly or indirectly take any action to coerce, manipulate, mislead, or fraudulently influence the SBS Entity's chief compliance officer (“CCO”) in the performance of their duties under the Federal securities laws or the rules and regulations thereunder.
Pamela Carmody, Special Counsel, Rajal B. Patel, Senior Special Counsel, or Carol M. McGee, Associate Director, at (202) 551-5870, Office of Derivatives Policy, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-8010.
First, the Commission is adopting 17 CFR 240.9j-1 (“Rule 9j-1”) under the Exchange Act, which is a new rule designed to prevent fraud, manipulation, and deception in connection with effecting transactions in, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap. The Commission is also adopting 17 CFR 240.15fh-4(c) (“Rule 15fh-4(c)”) under the Exchange Act, which is a new rule making it unlawful for any officer, director, supervised person, or employee of an SBS Entity, or any person acting under such person's direction, to directly or indirectly take any action to coerce, manipulate, mislead, or fraudulently influence the SBS Entity's CCO in the performance of their duties under the Federal securities laws or the rules and regulations thereunder.
Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)
The Dodd-Frank Act also amended the Exchange Act in a number of important ways to prohibit fraud, manipulation, and deception in connection with security-based swaps. In particular, section 763(g) of the Dodd-Frank Act expanded the anti-manipulation provisions of section 9 of the Exchange Act to encompass purchases or sales of security-based swaps and requires the Commission to adopt rules to prevent fraud, manipulation, and deception in connection with security-based swaps.
Additionally, section 761 of the Dodd-Frank Act modified several definitions in both the Exchange Act and the Securities Act of 1933 (“Securities Act”) to account for security-based swaps.
Moreover, the Dodd-Frank Act amended the definitions of “purchase” and “sale” in section 2(a)(18) of the Securities Act,
On December 15, 2021, the Commission re-proposed antifraud and anti-manipulation rules,
The Commission also proposed for comment a new Rule 10B-1,
Although the definition of security-based swap is detailed and comprehensive,
Parties may enter into a security-based swap for a multitude of reasons, but often, the parties to the contract seek to gain exposure to an asset without owning it or to manage or transfer risks in their asset and liability portfolios (
Two common examples of security-based swaps—credit default swaps (“CDS”) and total return swaps (“TRS”)—are described in more detail below.
Generally, a CDS is a contract in which a party (the “protection buyer”), such as a lender, agrees to make periodic payments (the “premium”) over an agreed upon time period to another party (the “protection seller”) in exchange for a payment from the protection seller in the event of default by an issuer (or group of issuers) of securities (the “reference entity”).
In contrast, a TRS may obligate one of the parties (
In 2010, following the 2008 financial crisis, Congress enacted the Dodd-Frank Act “to promote the financial stability of the United States by improving accountability and transparency in the financial system.”
The security-based swap market remains large. Based on information reported pursuant to 17 CFR 242.900 to 242.909 (“Regulation SBSR”), as of November 25, 2022, the gross notional amount outstanding in the security-based swap market is approximately $8.5 trillion across the credit, equity, and interest rate asset classes.
In general, the ongoing payments of a security-based swap depend, in part, on
• A CDS buyer working with a reference entity to create an artificial, technical, or temporary failure-to-pay credit event in order to trigger a payment on a CDS to the buyer (and to the detriment of the CDS seller).
• Alone or in combination with the above or other strategies, causing the reference entity to issue a below-market debt instrument in order to artificially increase the auction settlement price for the CDS (
• CDS buyers endeavoring to influence the timing of a credit event in order to ensure a payment (upon the triggering of the CDS) before expiration of a CDS, or a CDS seller taking similar actions to
• CDS sellers offering financing to restructure a reference entity in such a way that “orphans” the CDS—eliminating or reducing the likelihood of a credit event by moving the debts off the balance sheets of the reference entity and onto the balance sheets of a subsidiary or an affiliate that is not referenced by the CDS.
• Taking actions, including as part of a larger restructuring, to increase (or decrease) the supply of deliverable obligations by, for example, adding (or removing) a co-borrower to existing debt of a reference entity, thereby increasing (or decreasing) the likelihood of a credit event and the cost of CDS.
The 2021 Proposing Release also discussed the fact that in 2019, the former SEC Chairman issued a joint public statement with the principals of the CFTC and the U.K. Financial Conduct Authority at the time stating that the “continued pursuit of various opportunistic strategies in the credit derivatives markets . . . may adversely affect the integrity, confidence and reputation of the credit derivatives markets, as well as markets more generally.”
Taking into consideration all of the above, Rule 9j-1 will be an important additional tool to augment the Commission's oversight of the security-based swap markets including, but not limited to, the markets for CDS and TRS.
As described in detail below, final Rule 9j-1 includes prohibitions on categories of misconduct prohibited by section 10(b) of the Exchange Act, and Rule 10b-5 thereunder, and section 17(a) of the Securities Act, when effecting any transaction in, or attempting to effect any transaction in, any security-based swap, or when purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap (including but not limited to, in whole or in part, the execution, termination (prior to its scheduled maturity date), assignment, exchange, or similar transfer or conveyance of, or extinguishing of any rights or obligations under, any security based-swap).
The Commission also is adopting a rule aimed at protecting the independence and objectivity of an SBS Entity's CCO by preventing the personnel of an SBS Entity from taking actions to coerce, mislead, or otherwise interfere with the CCO. The Commission recognizes that SBS Entities dominate the security-based swap market and also recognizes the important role that CCOs of SBS Entities play in ensuring compliance by SBS Entities and their personnel with the Federal securities laws. As a result, the Commission is adopting Rule 15fh-4©, which makes it unlawful for any officer, director, supervised person, or employee of an SBS Entity, or any person acting under such person's direction, to directly or indirectly take any action to coerce, manipulate, mislead, or fraudulently influence the SBS Entity's CCO in the performance of their duties under the Federal securities laws or the rules and regulations thereunder.
Final Rule 9j-1 will aid the Commission in its pursuit of actions that directly target misconduct that reaches security-based swaps. The rule takes into account the features of a security-based swap and the broad definitions of “purchase” and “sale” in the Securities Act,
In general, fraudulent, deceptive, or manipulative conduct, such as providing false or incomplete information to a counterparty to secure better terms or pricing or to alter the performance of ongoing rights and obligations, has the potential to harm counterparties to all forms of security-based swaps, including CDS, equity security-based swaps, and non-CDS debt security-based swaps. Manipulation of the reference underlying security can affect the pricing of an equity or debt security-based swap, as well as the ongoing payments and obligations that are based on the value of that reference security. Further, in some cases, particularly in instances involving security-based swap transactions that are effected over the internet, there is a potential for trading software to distort pricing and payouts on security-based swaps.
As proposed, Rule 9j-1 would have prohibited the same categories of misconduct addressed by section 10(b) of the Exchange Act,
The Commission is adopting final Rule 9j-1(a), but has revised the rule to more closely follow the language used in the definitions of “purchase” and “sale,” and “buy” and “sell” in the Exchange Act, as amended by the Dodd-Frank Act, and to respond to commenter concerns.
Several commenters supported the application of Rule 9j-1(a) to the exercise of rights and performance of obligations under a security-based swap.
Two commenters argued that the Commission exceeded its statutory authority by applying proposed Rule 9j-1(a) “to every interim performance obligation” and every exercise of a right under a security-based swap.
The same two commenters also raised practical concerns about applying Rule 9j-1(a) to every exercise of a right or performance of an obligation under a security-based swap. One commenter stated that “if the proposed antifraud rule can be applied to any action or omission `
The Commission has carefully considered the comments and, as discussed below in sections II.A.2.a through II.A.2.c, is revising Rule 9j-1 to specify that it applies to misconduct that occurs in connection with effecting any transaction in, or attempting to effect any transaction in, any security-based swap, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap (including but not limited to, in whole or in part, the execution, termination (prior to its scheduled maturity date), assignment, exchange, or similar transfer or conveyance of, or extinguishing of any rights or obligations under, a security based-swap). The language in final Rule 9j-1(a) is based on section 9(j) of the
Depending on the facts and circumstances of a particular situation, as discussed in sections II.A.2.a through II.A.2.c below, final Rule 9j-1 may reach misconduct that affects the payments and deliveries that typically occur throughout the life of a security-based swap, if that misconduct occurs in connection with effecting or attempting to effect any transaction in, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap. Consistent with the operation of other antifraud provisions in the securities laws, whether that connection exists will be determined on a case-by-case basis.
Final Rule 9j-1 prohibits misconduct “in connection with” effecting any transaction in, or attempting to effect any transaction in, any security-based swap, or when purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap. Even if taking an action related to payments and deliveries under any security-based swap would not itself constitute a purchase or sale, or effecting a transaction, conduct that affects payments and deliveries may occur “in connection with” purchases or sales, or effecting a transaction. The Supreme Court has “espoused a broad interpretation” of “in connection with,”
Moreover, the Supreme Court has held that the requirement that “deception occur `in connection with the purchase or sale of any security'” does not require “deception of an identifiable purchaser or seller” because “[t]he Exchange Act was enacted in part `to insure the maintenance of fair and honest markets'” generally.
Not only is “in connection with” construed broadly, Congress also has broadly defined what constitutes a “purchase” and “sale.” Generally, purchases and sales of securities include “contracts to buy, purchase or otherwise acquire” or “contracts to sell or otherwise dispose of” the security, respectively.
Those definitions are not limited to executions, terminations, assignments, exchanges, or similar transfer or conveyance of, or extinguishing of
It also is reasonable to include partial executions, terminations, assignments, exchanges, or similar transfers or conveyances of, or extinguishing of rights or obligations under, a security-based swap within the scope of the rule because those actions could result in amendments to the material terms of the security-based swap and, therefore, result in a new security-based swap (that is, a “purchase” or “sale”).
Relatedly, the Commission reiterates that “[i]f the material terms of a” security-based swap “are amended or modified during its life based on an exercise of discretion and not through predetermined criteria or a predetermined self-executing formula,” then “the amended or modified” security-based swap is a “new” security-based swap.
Two commenters agreed that “Rule 9j-1 should be applicable . . . if the parties to a security-based swap transaction make changes to material terms that result in the creation of a new transaction.”
Exchange Act section 9(j), and accordingly final Rule 9j-1(a), also is not limited to prohibitions on fraud, manipulation, or deception in connection with the purchase or sale of a security-based swap, but also encompasses misconduct in connection with effecting a transaction in any security-based swap. While the term “transaction” “is not defined in the Act, its broad meaning in everyday usage” and “the context in which it is used in the various sections of the Act” demonstrate that “it has a broader meaning than purchases or sales.”
Final Rule 9j-1(a) therefore prohibits fraudulent, manipulative, or deceptive conduct related to the exercise of rights or performance of obligations—including ongoing payments and deliveries—under a security-based swap if that misconduct occurs in connection with a broad range of activities “beyond the actual consummation of purchases or sales.”
In addition, the Commission is extending the application of final Rule 9j-1(a) to fraudulent, deceptive, or manipulative misconduct that occurs in connection with an “attempt” to effect a transaction in any security-based swap. This application is consistent with section 9(j)'s prohibition of fraud, deception, and manipulation in connection with an “attempt to induce the purchase or sale of” any security-based swap and is supported by case law that recognizes that fraudulent, deceptive, or manipulative conduct need not be successful to violate the securities laws.
Proposed Rules 9j-1(a)(1) through (4), describing the prohibited fraudulent, manipulative, or deceptive conduct, was structured to include the antifraud and anti-manipulation provisions—in section 10(b) of the Exchange Act, and Rule 10b-5 thereunder, and section 17(a) of the Securities Act—that apply to
Proposed Rules 9j-1(a)(1) and (2), consistent with section 10(b) of the Exchange Act, and Rule 10b-5 thereunder, and section 17(a)(1) of the Securities Act, would have required scienter. In contrast, proposed Rules 9j-1(a)(3) and (4) would not have required scienter and would have extended to conduct that is at least negligent, consistent with sections 17(a)(2) and (3) of the Securities Act.
After considering the comments, the Commission is revising proposed Rule 9j-1(a) as discussed below in sections II.B.2.a and II.B.2.b.
Final Rule 9j-1(a)(1) is being adopted as proposed, and will prohibit employing or attempting to employ any device, scheme, or artifice to defraud or manipulate. Although most of that language is derived from section 10(b) of the Exchange Act,
Final Rule 9j-1(a)(2), which is based on section 9(j) and Rule 10b-5, will prohibit making or attempting to make any untrue statement of a material fact, or omitting to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading.
Proposed paragraphs (a)(3) and (4) are revised to separate attempted conduct into a new paragraph (a)(5) (to which a scienter standard is applicable, as discussed in section II.B.2.b below). Paragraph (a)(3) will prohibit obtaining money or property by means of any untrue statement of a material fact or any omission to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading. Paragraph (a)(4) will prohibit engaging in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person. Paragraphs (a)(3) and (4) are based on sections 17(a)(2) and (3) of the Securities Act, as well as Exchange Act section 9(j), which similarly prohibits “engag[ing] in any transaction, practice, or course of business which operates as a fraud or deceit upon any person.”
Paragraph (a)(5) will prohibit attempting to obtain money or property by means of any untrue statement of a material fact or any omission to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading or attempts to engage in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person. As discussed in section II.B.2.b below, the prohibition on attempted conduct in paragraphs (a)(1), (a)(2), and (a)(5) is premised on the text of section 9(j), including the Commission's prophylactic authority to “prescribe means reasonably designed to prevent, such transactions, acts, practices, and courses of business as are fraudulent, deceptive, or manipulative, and such quotations as are fictitious.”
The provisions described above generally prohibit a range of fraudulent, manipulative, and deceptive conduct in the security-based swap market.
Findings of misconduct under final Rules 9j-1(a)(1) and (2) require scienter while final Rules 9j-1(a)(3) and (4) do not require scienter and extend to conduct that is at least negligent.
Several commenters argued for a scienter standard, rather than the proposed negligence standard, with respect to paragraphs (3) and (4) of Rule 9j-1(a).
Although the Commission has considered the concerns raised by these commenters, it is adopting Rules 9j-1(a)(1) through (4) using the same standards as proposed, with the exception of the attempted misconduct addressed in paragraph (a)(5), as discussed below. Each of these four provisions is based on an existing statutory and regulatory provision that is supported by a large body of case law. Final Rules 9j-1(a)(1) and (2), consistent with section 10(b) of the Exchange Act, and Rule 10b-5 thereunder,
Although, as noted above, certain commenters argued that a negligence standard would be inconsistent with a fraud rule,
In addition, the Commission disagrees with commenters who argued that scienter must apply because of the ongoing and “fluid nature” of security-based swap transactions.
Similarly, the Commission does not agree with the commenters who suggested that the sophistication of, or the extent of the relationship between, counterparties to a security-based swap negates the need to prohibit certain misconduct, such as the acquisition of money or property by means of an untrue statement or acts that operate as a fraud, absent a showing of scienter, as provided in Rules 9j-1(a)(3) and (4).
To the extent that there is overlap between Rules 9j-1(a)(3) and (4) and sections 17(a)(2) and (3) of the Securities Act, introducing a different standard would be counter to the position the Supreme Court took with regard to identical language used in section 17(a) of the Securities Act.
Commenters also argued that the negligence standard of Rules 9j-1(a)(3) and (4) would chill or disrupt the security-based swap market and would capture actions, including errors, taken in connection with normal and legitimate business activity due to the nature of security-based swap transactions.
Finally, as proposed, the Rule 9j-1(a) prohibitions would have extended to the attempted fraudulent, manipulative or deceptive conduct described in paragraphs (a)(1) through (4) of the rule. The Commission largely adopts Rule 9j-1(a) as proposed as it relates to attempted conduct, except to address the mental state applicable to attempted conduct by placing the attempted conduct described in paragraphs (3) and (4) of proposed Rule 9j-1 into a standalone paragraph (5) in the final rule.
The inclusion of attempted conduct in Rules 9j-1(a)(1), (2), and (5) is premised on the text of section 9(j). First, the statute expressly prohibits “engag[ing] in any fraudulent, deceptive, or manipulative act or practice, mak[ing] any fictitious quotation, or engag[ing] in any transaction, practice, or course of business which operates as a fraud or deceit upon any person” in an “attempt to induce the purchase or sale of, any security-based swap.”
Second, section 9(j) authorizes the Commission to “prescribe means reasonably designed to prevent” the fraudulent, deceptive, or manipulative conduct that the statute expressly prohibits. The Supreme Court has held that this language allows the Commission to “prohibit acts not themselves fraudulent . . . if the prohibition is `reasonably designed to prevent . . . acts and practices [that] are fraudulent.' ”
Rule 9j-1(a)'s prohibition on such attempted misconduct recognizes that fraud, deception, and manipulation in the security-based swaps market can involve complex strategies implemented over multiple stages, as discussed above in section I.B.2. The prohibition is consistent with other provisions of the securities laws that recognize the importance of Commission intervention before the completion of a fraudulent, deceptive, or manipulative act, practice, transaction, or course of business. The Commission has the authority to seek an injunction whenever “any person is engaged or
One commenter argued against applying the negligence standard applicable to the misconduct prohibited by Rules 9j-1(a)(3) and (4) to attempts to engage in that misconduct because it “may capture conduct that is not itself fraudulent or manipulative” but rather “legitimate business activities” and would have a “chilling effect on the market for security-based swaps.”
Although, as discussed above, the Commission disagrees with assertions that a different standard would capture legitimate business decisions,
Partly in response to manufactured credit events and other opportunistic CDS strategies observed over the last decade,
Proposed Rule 9j-1(b) was designed to capture misconduct such as situations in which a payment under the security-based swap is intentionally or recklessly distorted for the benefit of one of the security-based swap counterparties or situations in which a person intentionally or recklessly causes or avoids the purchase or sale of a security-based swap for the benefit of one counterparty. The proposed rule was not designed to capture affirmative actions taken in the ordinary course of a security-based swap transaction or the reference underlying security.
The Commission is adopting a price manipulation rule as proposed in Rule 9j-1(b), but as a new paragraph (6) to Rule 9j-1(a). Consistent with the revisions to Rule 9j-1(a) discussed above in section II.A, the placement of the price manipulation rule in a new paragraph to Rule 9j-1(a), rather than in standalone paragraph 9j-1(b) as proposed, clarifies that the prohibited manipulative conduct must occur in connection with effecting, or attempting to effect a transaction in any security-based swap or in connection with purchasing or selling, or inducing or attempting to induce the purchase or sale, of any security-based swap.
The Commission received multiple comment letters specifically addressing paragraph (b) of proposed Rule 9j-1. One commenter was supportive of proposed Rule 9j-1(b) and the application of a “facts and circumstances” analysis to determine whether conduct in connection with a security-based swap is manipulative.
However, most of the comments addressing paragraph (b) of proposed Rule 9j-1 argued against the new provision or asked for added clarity.
The Commission has carefully considered the comments. The Commission is adopting final Rule 9j-1(a)(6) to prohibit manipulation and attempted manipulation of the price or valuation of any security-based swap, including any payment or delivery related thereto, in connection with effecting or attempting to effect a transaction in, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap. The Commission will apply a scienter standard—which includes intentional or reckless misconduct—to determine whether conduct is in violation of final Rule 9j-1(a)(6).
Many of the commenters critical of proposed Rule 9j-1(b) believed that it was too broad and would lack clarity in application, thereby leading to a chilling effect on the security-based swap market and the credit market.
Similarly, one commenter believed that proposed Rule 9j-1(b) included a “manipulation standard that is new to securities markets” and requested further guidance or definition to avoid “the chilling effect that a poorly-understood standard could have on legitimate conduct.”
The Commission is revising the price manipulation provision, originally proposed as Rule 9j-1(b) and adopted as final Rule 9j-1(a)(6), in response to the comments above. Consistent with the revisions to final Rule 9j-1(a) discussed above in section II.A, Rule 9j-1(a)(6) will apply to conduct undertaken in connection with effecting or attempting to effect a transaction in any security-based swap, and to purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap (including but not limited to, in whole or in part, the execution, termination (prior to its scheduled maturity date), assignment, exchange, or similar transfer or conveyance of, or extinguishing of any rights or obligations under, a security based-swap).
A determination as to whether a person has violated final Rule 9j-1(a)(6) will depend on the facts and circumstances of each particular situation. The assessment of facts and circumstances is an objective evaluation that considers all relevant information surrounding the alleged misconduct, including both quantitative and qualitative factors, to determine whether prohibited manipulation is present. A “facts and circumstances” analysis will provide the Commission with the flexibility it needs to address an evolving security-based swap market, including the ever-changing CDS market, and potential misconduct in those markets. Bright line rules or tests, on the other hand, may artificially exclude manipulative and attempted manipulative conduct and could create a roadmap for market participants to avoid liability for manipulative actions. A substantial body of case law regarding manipulative behavior exists with regard to other antifraud and anti-manipulation provisions in the Securities Act and Exchange Act to which the Commission will look to assess whether a violation of Rule 9j-1(a)(6) has occurred.
Also, as noted, commenters encouraged the Commission to explicitly recognize certain market activities as legitimate.
However, to further address commenter concerns, the Commission reiterates that Rule 9j-1(a)(6) prohibits, among other things, a situation where a person (or group of persons) intentionally or recklessly causes or
The Commission also recognizes that reference entities often rely on financing and other forms of relief to avoid defaulting on their debt. We understand that CDS transactions are an important means by which debt holders hedge their underlying debt instruments, and that the absence of such hedging opportunities could impact prospective investors' willingness and ability to invest in that underlying market. The final rule is not intended to discourage lenders and prospective lenders from discussing or providing such financing or relief, even when those persons also hold CDS positions. Rather, the Commission is adopting Rule 9j-1(a)(6) to account for actions taken outside the ordinary course of a typical lender-borrower relationship (or a prospective lender-borrower relationship). Although, as discussed, any such determination would need to be based on the facts and circumstances of a particular situation, as a general matter an action that appears to be designed almost exclusively to harm one or more CDS counterparties would likely fall within the prohibition in Rule 9j-1(a)(6). Security-based swap market participants should and can take care that their legitimate market activities remain within the scope of the typical lender-borrower relationship and do not cross the line into prohibited manipulation. Using a “facts and circumstances” analysis to identify conduct that is prohibited by Rule 9j-1(a)(6), the Commission will consider all relevant facts in any attempt to determine whether prohibited manipulation or attempted manipulation has occurred. Further, the Commission will apply a scienter standard, which will work to eliminate legitimate conduct from the scope of Rule 9j-1(a)(6). As discussed above, the adoption of a “facts and circumstances” analysis is appropriate given the complex fact patterns in many security-based swap transactions.
Proposed Rule 9j-1(b) was intended to address, among other things, a number of the manufactured credit events or other opportunistic strategies in the CDS market observed over the last decade.
One commenter requested that the “valuation” prong of proposed Rule 9j-1(b) be removed because “a prohibition on manipulation of the `valuation' of an asset does not exist in any U.S. regulatory context and would require a new body of case law to be formed to determine how any such new prohibition should be interpreted.”
Rule 9j-1(a)(6) prohibits manipulation in connection with effecting or attempting to effect a transaction in, any security-based swap, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap, which may include intentionally or recklessly distorting payments related to a security-based swap to benefit, or harm, one of the security-based swap counterparties, or actions that serve little to no economic purpose other than to artificially influence the composition of the deliverable obligations in a CDS auction and affect the security-based swap's valuation and price. To remove the valuation prong from final Rule 9j-1(a)(6) would create a gap in the prohibition against the manipulation or attempted manipulation of prices in the security-based swap market.
The Commission included paragraphs (c) and (d) of re-proposed Rule 9j-1 to make it clear that market participants could not avoid liability under the rule by effecting a fraudulent scheme through the purchase or sale of an underlying security, rather than the purchase or sale of the security-based swap on which it is based, and vice versa. The first of those two provisions would have provided that a person could not escape liability for trading based on possession of material nonpublic information about a security by purchasing or selling a security-based swap based on that security (as opposed to trading in the security itself). The second provision would have provided that a person could not escape liability under section 9(j) or Rule 9j-1 by purchasing or selling the underlying security (as opposed to purchasing or selling a security-based swap that is based on that security).
One commenter specifically addressed these provisions and was supportive, noting that the antifraud and anti-manipulation provisions in proposed Rules 9j-1(a) and (b) would be enhanced by the addition of proposed Rules 9j-1(c) and (d).
The Commission is adopting Rule 9j-1(b), as proposed in paragraph (c). Final Rule 9j-1(b) provides that wherever communicating, or purchasing or selling a security (other than a security-based swap) while in possession of, material nonpublic information would violate, or result in liability to any purchaser or seller of the security under either the Exchange Act or the Securities Act, or any rule or regulation thereunder, such conduct in connection with a purchase or sale of a security-based swap with respect to such security or with respect to a group or index of securities including such security shall also violate, and result in comparable liability to any purchaser or seller of that security under such provision, rule, or regulation.
Although generally a situation where a person uses material nonpublic information about a security in connection with the purchase or sale of a security-based swap would be subject to the existing antifraud authority under the Federal securities laws, particularly section 10(b) of the Exchange Act, and Rule 10b-5 thereunder, market participants also would benefit from a clarified interpretation of that statutory provision in this rulemaking.
The Commission also is adopting Rule 9j-1(c) largely as it was proposed as paragraph (d), with a clarifying edit as discussed below.
This provision prevents a person from escaping liability under section 9(j) or Rule 9j-1(a) with respect to a security-based swap by limiting all of its actions to purchases or sales of the security, loan, or narrow-based security index underlying that security-based swap. For example, if a person with an existing total return swap on equity securities issued by XYZ Corporation subsequently engages in a number of wash trades to artificially inflate the price of the equity securities in order to benefit from the manipulated price by way of their existing security-based swap position, such person would be liable for violations of Exchange Act section 9(j) and Rule 9j-1 regardless of the fact the manipulation was conducted through purchases or sales of the equity securities.
In response to the commenter who questioned the Commission's authority to extend the prohibitions of Rule 9j-1 to the purchase or sale of underlying securities,
Moreover, this provision does not impose liability on a person for violations of section 9(j) of the Exchange Act and Rule 9j-1 based solely on the impact of that person's purchases or sales on the equity, debt, or loan markets. The rule states that the person engaged in prohibited activities in the equity, debt, or loan markets must be a counterparty to a security-based swap that references such equity or debt securities or loan, or be an affiliate of, or a person acting in concert with, such security-based swap counterparty in furtherance of such prohibited activity. Accordingly, the Commission would analyze whether transactions in the underlying equity or debt securities or loan have been used as the mechanism to violate section 9(j) and Rule 9j-1. The Commission would also analyze the same transactions to determine whether they independently violate other antifraud and anti-manipulation provisions of the securities laws—including sections 9 and 10(b) of the Exchange Act, and Rule 10b-5 thereunder, as well as section 17(a) of the Securities Act.
In response to operational concerns raised by commenters with regard to the 2010 Proposed Rule, the Commission proposed two limited safe harbors from re-proposed Rule 9j-1(a) to address situations when a counterparty to a security-based swap was required to take certain actions while in possession of material nonpublic information.
Second, recognizing the important operational benefits and market efficiencies related to security-based swap portfolio compression, proposed Rule 9j-1(f)(2) would have provided a safe harbor for transactions effected in connection with certain types of bilateral or multilateral portfolio compression exercises.
As discussed above, in response to operational concerns raised in response to the 2010 Proposed Rule, the Commission included two limited safe harbors from re-proposed Rule 9j-1(a).
Consistent with the analogous provisions of Rule 10b5-1, final Rule 9j-1 does not provide for an affirmative defense for violations of the anti-manipulation provision in Rule 9j-1(a)(6). Paragraph (a)(6) of Rule 9j-1 does not apply to actions that the affirmative defenses address: those taken in the ordinary course of a security-based swap transaction (including actions related to the reference underlying security) while aware of material nonpublic information.
Several commenters urged the Commission to make the affirmative defenses under Rule 10b5-1 available under Rule 9j-1, to address situations in which a counterparty comes into possession of material nonpublic information during the life of a security-based swap.
Several commenters noted that most security-based swap market participants are global financial firms that have spent considerable resources to meet the requirements of current Rule 10b5-1(c)(2), by separating their organizations so that individuals on the public side can engage in dealing and market-making activity, while individuals on the private side are allowed to possess material nonpublic information.
In addition, certain commenters expressed concern with the operational impacts of Rule 9j-1(a) on the capital and loan markets. One commenter argued that the application of proposed Rule 9j-1 to the ongoing, “non-volitional” rights and obligations that occur throughout the life of a security-based swap could “cast uncertainty on a wide range of bona fide conduct necessary to the operation of the capital markets.”
The Commission agrees with commenters that an affirmative defense similar to those available under Rule 10b5-1 (when the investment decision is not based on material nonpublic information) is important given the similarity in the antifraud provisions. The Commission also agrees that the affirmative defenses would address concerns regarding market disruption. As a result, the Commission is adopting two affirmative defenses similar in concept to the affirmative defenses in Rule 10b5-1(c).
Accordingly, the Commission is adopting two affirmative defenses to liability under paragraphs (a)(1) through (a)(5) of final Rule 9j-1.
First, the Commission is adopting an affirmative defense that maintains the substance of the safe harbor provision in re-proposed Rule 9j-1(f)(1), which would have applied to actions taken pursuant to binding rights and obligations in written documentation governing a security-based swap that was entered into prior to the person coming into possession of material nonpublic information. As adopted, the provision in Rule 9j-1(e)(1) (renumbered from proposed paragraph (f)) is an affirmative defense, rather than a safe harbor, to be consistent with the structure of current Rule 10b5-1(c)(1). The affirmative defense in final Rule 9j-1(e)(1) provides that actions that would otherwise violate the prohibitions of Rule 9j-1(a)(1) through (5) are not a violation “solely for reason of being aware of material nonpublic information” if such actions are “taken by a person in accordance with binding contractual rights and obligations under a security-based swap (as reflected in the written security-based swap documentation governing such transaction or any amendment thereto).”
Framing this relief as an affirmative defense rather than as a safe harbor, and restricting its use to circumstances in which the security-based swap was entered into in good faith and not as part of a plan or scheme to evade the prohibitions of the rule, is consistent with Rule 10b5-1(c)(1) treatment of the defense. As discussed above, multiple commenters requested the Commission adopt affirmative defenses based on the Rule 10b5-1(c) defenses.
If the security-based swap was entered into in good faith and not as part of a plan or scheme to evade the prohibitions of the rule, the new Rule 9j-1(e)(1) affirmative defense will allow counterparties to take actions that are required by, and in accordance with, the written agreements governing the security-based swap (
A person relying on the affirmative defense in adopted final Rule 9j-1(e)(1) must demonstrate that they entered into the security-based swap, or amendment, before becoming “aware of” the material nonpublic information rather than before they “came into possession” of the information, as required in re-proposed Rule 9j-1.
Second, Rule 9j-1(e)(2) provides a defense from liability under Rules 9j-1(a)(1) through (5) for actions taken by a person, other than a natural person, who demonstrates that: (1) the individual making the investment decision on behalf of the person was not aware of the material nonpublic information; and (2) the person had implemented reasonable policies and procedures, taking into consideration the nature of the person's business, to ensure that individuals making investment decisions would not be in violation of Rule 9j-1(a)(1) through (5).
Because the Commission is adopting final Rule 9j-1(e)(2), the Commission is not adopting proposed Rule 9j-1(f)(2), which would have provided a safe harbor for transactions made in connection with certain portfolio compression exercises. The proposed safe harbor would have conflicted with Rules 10b-5 and 10b5-1 by providing the same action with protection from liability under Rule 9j-1, but not Rule 10b-5. In proposing the portfolio compression safe harbor, the Commission recognized the benefits provided by portfolio compression along with the “largely administrative nature of the portfolio compression process.”
Certain commenters were supportive of the proposed safe harbors
In response to the proposed safe harbors, one commenter urged for the elimination of all safe harbors from proposed Rule 9j-1(a) liability because the Commission had “not demonstrated that a safe harbor from the prohibition on fraud and manipulation is necessary or appropriate.”
In addition to the request for the inclusion of additional safe harbors and affirmative defenses, commenters also addressed the scope of Rule 9j-1 as it applies to different types of security-based swap instruments. One commenter argued for carving out sovereign debt from the scope of Rule 9j-1 due to the unlikelihood that holders of security-based swaps on sovereign debt would be able to manufacture credit events or otherwise engage in opportunistic trading, especially life insurers which are prohibited by state law from entering into speculative or abusive trading.
The Commission also proposed a rule aimed at protecting the independence and objectivity of an SBS Entity's CCO by preventing the personnel of an SBS Entity from taking actions to coerce, mislead, or otherwise interfere with the CCO. Specifically, proposed Rule 15Fh-4(c) (“proposed Rule 15Fh-4(c)”) would have made it unlawful for any officer, director, supervised person, or employee of an SBS Entity, or any person acting under such person's direction, to directly or indirectly take any action to coerce, manipulate, mislead, or fraudulently influence the SBS Entity's CCO in the performance of their duties under the Federal securities laws or the rules and regulations thereunder.
After review of the comments, the Commission is adopting Rule 15fh-4(c) as proposed. The final rule will protect the independence and objectivity of an SBS Entity's CCO by preventing the personnel of an SBS Entity from taking actions to coerce, mislead, or otherwise interfere with the CCO.
The Commission agrees with the two commenters who supported the adoption of Rule 15fh-4(c) to further protect SBS Entities' CCOs from undue influence.
One commenter suggested that the proposed rule was unnecessary because the existing requirements of 17 CFR 240.15Fk-1 (“Rule 15Fk-1”) are sufficient to address the risks of undue influence on a CCO.
Moreover, existing 17 CFR 240.15Fh-3(h) (“Rule 15Fh-3(h)”) requires an SBS Entity to establish and maintain a system to supervise its business and the activities of its associated persons, which must be reasonably designed to prevent violations of the provisions of applicable Federal securities laws and the rules and regulations thereunder.
One commenter argued that the scope of proposed Rule 15Fh-4(c) was “unclear and could lead to confusion and uncertainty in the market as to which activities are prohibited.”
After considering the comments, the Commission declines to revise Rule 15fh-4(c) and adopts the rule as proposed. Rule 15fh-4(c) protects the independence and objectivity of an SBS Entity's CCO by prohibiting undue influence by other personnel. The concerns regarding the rule having a chilling effect on communications are misplaced since the rule prohibits actions to coerce, manipulate, mislead, or fraudulently influence CCOs—not good faith disagreements or legitimate discussions. However, such influence could take many forms and is not limited to material misstatements or omissions. As noted, the Commission has adopted the majority of its Title VII rules related to security-based swaps,
A commenter also argued for more clarity with regard to the intent and conduct required to be liable under Rule 15fh-4(c).
One commenter suggested expanding the scope of the rule to actions taken to coerce, manipulate, mislead, or fraudulently influence all officers and other decision-makers, and not limit the rule to actions taken with respect to the SBS Entity's CCO.
The Paperwork Reduction Act of 1995 (“PRA”)
The Commission is mindful of the economic effects, including the costs and benefits, of Rule 9j-1 and Rule 15fh-4(c). Section 3(f) of the Exchange Act
The analysis below addresses the likely economic effects of Rule 9j-1 and Rule 15fh-4(c), including the anticipated benefits and costs of the rules and their likely effects on efficiency, competition, and capital formation. Many of the benefits and costs discussed below are difficult to quantify. For example, the Commission cannot quantify the impact of litigation and litigation risk on counterparties and underlying entities or the overall impact on the credibility and reputation of the security-based swap market. The extent of some of these impacts will depend, in part, on events difficult to predict that might affect security-based swaps, such as changes in counterparty or reference underlying entity behavior. Reputational and credibility effects also are difficult to measure. Therefore, while the Commission attempted to quantify economic effects where possible, much of the discussion of the anticipated economic effects below is qualitative and descriptive in nature.
The Commission received a number of comments related to various aspects of the economic analysis of re-proposed Rule 9j-1 and proposed Rule 15Fh-4(c). The Commission has considered and responded to these comments in the sections that follow.
This section discusses certain aspects of the security-based swap market that may raise concerns or may be associated with concerns that would be addressed by final Rule 9j-1. The discussion is illustrative and is not intended to exhaust all types of conduct that may implicate final Rule 9j-1.
Opportunistic strategies often involve CDS buyers or sellers taking steps, either with or without the participation of the underlying entity, to avoid, trigger, delay, accelerate, decrease, and/or increase payouts on CDS.
To the extent that market participants anticipate opportunistic strategies, the CDS spread or price becomes a reflection of the likelihood of an opportunistic strategy being announced (or, if already announced, of succeeding) and decouples from the credit fundamentals of the reference entity.
As discussed in section I.A, because security-based swaps are included in the Exchange Act's definition of “security,” participants in the security-based swap market are currently subject to the general antifraud and anti-manipulation provisions of the Federal securities laws, including sections 9(a) and 10(b) of the Exchange Act, and Rule 10b-5 thereunder, and section 17(a) of the Securities Act. In particular, Rule 10b5-1 provides that a person trades “on the basis of” material nonpublic information when the person purchases or sells securities while aware of the information. However, the rule also sets forth several affirmative defenses to permit persons to trade in certain circumstances where it is clear that the information was not a factor in the decision to trade.
In addition, the Dodd-Frank Act expanded the anti-manipulation provisions of section 9 of the Exchange Act to encompass security-based swap transactions and required the Commission to adopt rules to prevent fraud, manipulation, and deception in connection with security-based swaps.
Finally, Rule 15Fk-1 requires an SBS Entity to designate a CCO and imposes certain duties and responsibilities on that CCO.
As of January 4, 2023, there were 50 entities registered with the Commission as SBSDs, and no entities registered as MSBSPs.
The Commission uses information reported pursuant to Regulation SBSR to two registered SBSDRs—Depository Trust & Clearing Corporation Data Repository (“DDR”) and the ICE Trade Vault (“ITV”)—to describe the baseline.
Table 1 also shows that U.S. security-based swap market participants trade a variety of security-based swaps in each of the three asset classes. Based on information reported to DDR, as of November 25, 2022, active credit security-based swaps fall into five product types. Single-name corporate CDS constitute the largest product type, with approximately 364,000 active CDS and $1.6 trillion gross notional amount outstanding. The second largest active credit security-based swaps product type consists of single-name sovereign CDS, with approximately 94,000 active CDS and $0.9 trillion gross notional amount outstanding. For active equity security-based swaps, equity portfolio swaps constitute the largest product type, with approximately 2.3 million active equity portfolio swaps and $1.7 trillion gross notional amount outstanding. The second largest active equity security-based swaps product type consists of equity swaps, with approximately 492,000 active equity swaps and $1.2 trillion gross notional amount outstanding. Equity portfolio swaps and equity swaps can be further divided into sub-products that include, among other things, equity TRS.
Table 2 shows that both SBS Entities and non-SBS Entities participate in all three asset classes in the U.S. security-based swap market. Based on information reported to DDR, as of November 25, 2022, SBS Entities and non-SBS Entities had, respectively, entered into approximately 813,000 and 234,000 active credit security-based swaps.
In addition to information reported to registered SBSDRs, the Commission also uses data from the DTCC Derivatives Repository Limited Trade Information Warehouse (“DTCC-TIW”) to describe the baseline. DTCC-TIW provides data regarding the activity of market participants in the single-name CDS market during the period from 2006 to the end of 2021.
Data from the DTCC-TIW show that activity in the single-name CDS market is concentrated among a relatively small number of entities, predominantly registered SBSDs.
Non-dealer single-name CDS market participants include, but are not limited to, investment companies, pension funds, private funds, sovereign entities, and industrial companies. We observe that most non-dealer market participants of single-name CDS do not engage directly in the trading of security-based swaps, but trade through banks, investment advisers or funds, or other types of firms, which we refer to as transacting agents, consistent with DTCC-TIW terminology.
Figure 1 describes the percentage of global, notional transaction volume in North American corporate single-name CDS reported to the DTCC-TIW from January 2011 through December 2021, separated by whether transactions are between two ISDA-recognized dealers (interdealer transactions) or whether a transaction has at least one non-dealer counterparty. Figure 1 also depicts the notional trading volume of all North American corporate single-name CDS. As Figure 1 shows, all types of exposures have declined approximately proportionally since 2011.
Rule 9j-1 would decrease fraudulent activity and litigation costs, and could decrease compliance costs. In addition, Rule 9j-1 may indirectly increase price efficiency and decrease capital costs of underlying entities. The Commission discusses each of these individual benefits in more detail below.
Rule 9j-1 would reduce the risk of fraud in the security-based swap market, including the risk of opportunistic trading strategies to the extent that such strategies occur in connection with effecting or attempting to effect any transaction in any security-based swap, or purchasing or selling, or inducing or attempting to induce the purchase or sale of, any security-based swap (including but not limited to, in whole or in part, the execution, termination (prior to its scheduled maturity date), assignment, exchange, or similar transfer or conveyance of, or extinguishing of any rights or obligations under, a security based-swap). The additional specificity offered by Rule 9j-1 may enhance Commission oversight of the security-based swap market, which may ultimately benefit market participants through reducing the risk of fraud. Any reduction in the risk of fraud as a result of Rule 9j-1 would be limited to the extent that the fraudulent, manipulative, and deceptive conduct by security-based swap market participants is currently subject to the general antifraud and anti-manipulation provisions of the Federal securities laws, including but not limited to sections 9(a) and 10(b) of the Exchange Act, and Rule 10b-5 thereunder, and section 17(a) of the Securities Act. To the extent that Rule 9j-1 reduces the risk of fraud, the rule could encourage participation in the security-based market, which may result in increased competition.
Rule 9j-1 may provide additional precision and specificity regarding the application of existing antifraud and anti-manipulation laws to misconduct in the security-based swap market, which could prompt some market participants to devote greater resources to ensure that they are compliant with their obligations under antifraud and anti-manipulation laws, which could also decrease the risk of fraud in the security-based swap market. Because of this decreased risk of fraud, market participants may have fewer disputes
Decreased risk of fraud in the security-based swap market may also lead to increased price efficiency, as more trading could lead to a greater exchange of market expectations from buyers and sellers transacting in the market. Further, by providing specificity, Rule 9j-1 would help prevent prohibited conduct from distorting the market and artificially increasing or decreasing security-based swap prices, which also would help to ensure more efficient pricing. Increased price efficiency would consequently lead to greater security-based swap market efficiency, as security-based swap prices would provide greater confidence that their prices more likely reflect fundamental values and risk in more liquid markets. For example, the prices of single-name CDS contracts would more likely reflect the fundamental credit risk of the underlying entity, as opposed to counterparty credit risk, or the probability that fraudulent activity prohibited by Rule 9j-1 is being perpetrated in connection with the CDS contracts.
Increased participation and price efficiency in the security-based swap market as a result of Rule 9j-1 could encourage lenders to make greater use of security-based swaps for hedging their loans, which in turn could increase lending activity and capital formation.
In addition, improvements in the security-based swap market as a result of Rule 9j-1 may in turn have a positive impact on capital formation and the cost of capital for the underlying entities. The market participation increases in security-based swaps may enhance liquidity in the underlying market and related swap indices, and, in general, lower the cost of capital for entities referenced by security-based swaps.
In the 2021 Proposing Release, the Commission solicited feedback on, among other things, the benefits of the proposed rules, including re-proposed Rule 9j-1.
Three commenters believed that re-proposed Rule 9j-1's anticipated benefit of reduced fraudulent and manipulative activity in the security-based swap market would not materialize.
The Commission has considered feedback from the commenters who argued that the proposed rule would not have the benefit of reducing fraudulent and manipulative activity in the security-based swap market. The provisions in Rule 9j-1 are designed generally to prohibit a range of fraudulent, manipulative, and deceptive conduct in the security-based swap market. The rule is not solely intended to address opportunistic strategies in the CDS market.
In response to the comment that opportunistic strategies have been, on the whole, extremely infrequent so that re-proposed Rule 9j-1 will not result in any market-wide benefit, the Commission reiterates that the provisions in Rule 9j-1 are designed generally to prohibit a range of fraudulent, manipulative, and deceptive conduct in the security-based swap market. The rule is not solely intended to address opportunistic strategies in the CDS market.
The Commission is not persuaded that the CDS-cash basis data provided by one of the commenters necessarily indicate that CDS protection buyers perceived the risk of certain opportunistic strategies to be low.
One commenter asserted that proposed Rule 9j-1(b) (adopted as Rule 9j-1(a)(6)) would introduce substantial uncertainty in the application of the antifraud and anti-manipulation provisions of the Federal securities laws, and therefore questioned whether the benefits of “additional precision and specificity” that the Commission identified would materialize.
Some security-based swap market participants may incur costs associated with taking actions to update existing compliance systems for compliance with Rule 9j-1. The Commission estimates that security-based swap market participants may incur one-time aggregate costs ranging between $1,225,360 and $2,450,720 to update their existing compliance systems.
In addition, the rule could discourage some legitimate market activities, including some hedging activity, because of concerns that such activities might be viewed as rule violations. As a result, compliance costs related to evaluating whether or not certain activities are permissible may increase for some market participants.
Market participants might incur costs associated with the affirmative defenses in Rule 9j-1(e). However, such costs likely would be very limited. As a general matter, the affirmative defenses in Rule 9j-1(e) are voluntary and do not impose requirements on market participants. Market participants choose to incur costs related to the affirmative defenses if they anticipate the associated benefits to exceed the associated costs. Market participants for whom the anticipated benefits of the affirmative defenses do not exceed the associated costs likely would not incur those costs. However, market participants that choose not to rely on the affirmative defenses may incur other costs (
Market participants that seek to rely on the affirmative defense in paragraph (e)(1) of Rule 9j-1 likely would do so by creating and retaining the written security-based swap documentation governing such transaction or any amendment thereto. As discussed in the 2021 Proposing Release, such documentation is already created and retained as a result of SBS Entities' compliance with existing 17 CFR 240.15Fi-5 and the Commission's recordkeeping requirements in 17 CFR 240.17a-4 or 17 CFR 240.18a-6, as applicable.
Market participants that seek to rely on the affirmative defense in paragraph (e)(2) of Rule 9j-1 would be required to comply with the specific provisions of that paragraph, including implementing reasonable policies and procedures to prevent insider trading. For most market participants to whom this affirmative defense would be relevant, the costs associated with policies and procedures likely would be very limited. As discussed above, most security-based swap market participants have spent considerable resources to avail themselves of the affirmative defense of Rule 10b5-1(c)(2).
One commenter believed that the proposed rules would help to reduce costs for all investors by removing fraud and manipulation from the security-based swap market and the market for underlying securities.
One commenter believed that re-proposed Rule 9j-1 would require market participants to incur costs to design and implement extensive compliance programs to adhere to the rule's broad prohibitions; and that such costs are only marginally alleviated by the narrow proposed safe harbors, since ensuring that each activity falls within a designated safe harbor presents resource challenges of its own. The commenter stated that such compliance costs would be unreasonably burdensome to lenders and would have a significant, negative impact on the loan markets. The commenter also stated that, absent an affirmative defense similar to Rule 10b5-1(c)(2), market participants may have to incur cost and effort to identify all security-based swaps and related reference underlying entities held by the organization and to track and coordinate all activity that could affect the purchase, sale, payments, deliveries, and other ongoing obligations or rights with respect to the security-based swaps and the related reference underlying entities.
The Commission has considered the above comments in finalizing Rule 9j-1. As discussed above and in the 2021 Proposing Release, some security-based swap market participants may incur costs associated with taking actions to update existing compliance systems for compliance with Rule 9j-1. These additional costs could be limited to the extent that many of these practices and systems are already in place to ensure compliance with section 9(j) and the other general antifraud and anti-manipulation statutory and regulatory provisions. To the extent that market participants incur compliance costs as a result of Rule 9j-1, these costs represent a reasonable trade-off in light of the benefits discussed in section V.D.1. With respect to the identification, tracking, and coordination activities that might be necessary absent an information barrier safe harbor, final Rule 9j-1(e)(2) provides an affirmative defense modeled on the affirmative defense in Rule 10b5-1(c)(2). Final Rule 9j-1(e)(2) will help mitigate the cost and effort that market participants may incur to identify, track, and coordinate activities involving security-based swaps and related reference underlying entities held by the organization.
Several commenters were concerned that re-proposed Rule 9j-1's liability standards are vague and that such vagueness would foster significant uncertainty among security-based swap market participants, resulting in reduced market participation, liquidity, capital formation, and investor choice.
Where commenters noted a discrepancy in the Commission's proposed rule and the legal standard for certain attempted offenses, the Commission revised the rule to conform to the legal standard in new Rule 9j-1(a)(5). These revisions should address any uncertainty that security-based swap market participants may have regarding the rule's liability standards. In addition, the Commission is adopting Rule 9j-1(e), which includes two affirmative defenses for violations of the provisions in paragraphs (a)(1) through (a)(5) of Rule 9j-1.
One commenter was concerned that the inclusion of interim actions in the performance of contractual obligations within the scope of re-proposed Rule 9j-1 will discourage market participants from transacting in security-based swaps, reduce liquidity in the security-based swap markets, increase the cost of capital, and reduce the availability of capital.
Some commenters were concerned that the Commission's choice of a negligence standard for re-proposed Rules 9j-1(a)(3) and (4), coupled with the omission of Rule 10b5-1(c)(2) affirmative defenses, would discourage market participants from entering into security-based swaps and would, as a result, reduce liquidity in security-based swap markets, exacerbate risks for market participants, and increase issuers' cost of capital. These commenters were concerned that lenders may also reduce their lending activities, which would reduce financing to private companies.
Some commenters stated that proposed Rule 9j-1(b) would create uncertainty and implicate a wide range of innocuous and ordinary course activities that are essential to markets in both security-based swaps and underlying cash instruments. The commenters stated that this would materially increase compliance costs for security-based swap market participants, reduce participation in security-based swap and securities markets, reduce lending activity and capital formation, and raise issuers' cost of capital.
A determination as to whether a person has violated final Rule 9j-1(a)(6) will depend on the facts and circumstances of each particular situation. Further, a scienter standard will be used to determine whether conduct is in violation of the rule. With respect to the loan market, final Rule 9j-1(a)(6) applies to actions taken outside the ordinary course of a typical lender-borrower relationship, such as an action taken for the purposes of avoiding or causing, or increasing or decreasing, a payment under a security-based swap in a manner that would not have occurred but for such actions, or when an action appears to be designed almost exclusively to harm counterparties, and is not intended to discourage lenders from discussing or providing financing or relief to avoid default. To be clear, Rule 9j-1(a)(6) will require that security-based swap market participants take care that their legitimate market activities remain within the scope of the typical lender-borrower relationship and do not cross the line into prohibited manipulation. The foregoing discussion should help address concerns related to uncertainty that the rule may create and the proposed rule's scope.
However, to the extent that market participants continue to have such concerns, final Rule 9j-1(a)(6) could increase compliance costs, reduce market participation, reduce lending activity and capital formation, and raise issuers' cost of capital. That said, by reducing the risk of fraudulent and manipulative activity in the security-based swap market, Rule 9j-1 would increase market participation, increase lending activity and capital formation, and lower issuers' cost of capital thereby mitigating the potential adverse effects that commenters identified. Further, to the degree that Rule 9j-1 provides additional precision and specificity regarding the application of existing antifraud and anti-manipulation laws to misconduct in the security-based swap market, some market participants may need to spend fewer resources determining appropriate compliance under section 9(j) of the Exchange Act and reduce their compliance costs.
Rule 15fh-4(c) makes it unlawful for any officer, director, supervised person, or employee of an SBS Entity, or any person acting under such person's direction, to take, directly or indirectly, any action to coerce, mislead, or otherwise interfere with the SBS Entity's CCO. This prohibition would support the ability of the CCO to meet the CCO's important obligations to foster compliance in its role of overseeing compliance within the SBS Entity. Rule 15fh-4(c) will make it more likely that a CCO is able to more efficiently and effectively execute the CCO's responsibilities to foster compliance, including for example, by ensuring that the SBS Entity maintains and reviews written policies and procedures reasonably designed to achieve compliance with the rules and regulations relating to the business of the SBS Entity. Ultimately, these effects will likely also reduce the risk of fraud, market manipulation, or other fraudulent activities in the security-based swap market, providing additional protection for both counterparties in the security-based swap transaction and the underlying entity.
Rule 15fh-4(c) will encourage officers, directors, supervised persons, and employees of SBS Entities to exercise reasonable attention and care in their dealings with CCOs, as discussed in section III.B. To the extent that such exercise of reasonable attention and care increases the quantity and quality of information exchanged between CCOs, officers, directors, supervised persons, and employees of SBS Entities, CCOs may more efficiently and effectively foster compliance in SBS Entities. Any resulting improvement in compliance in turn could reduce the risk of fraud, market manipulation, or other fraudulent activities in the security-based swap market. More broadly, improved communication between CCOs, officers, directors, supervised persons, and employees of SBS Entities also could facilitate decision making within the SBS Entities.
Rule 15fh-4(c) would likely have minor indirect positive impacts on competition, price efficiency, and capital formation, as discussed in section V.F.
Two commenters believed that proposed Rule 15Fh-4(c) would deter the types of actions that prevent CCOs from performing their duties and that deterring such actions would in turn help protect the CCOs' independence and objectivity in the fulfillment of their duties.
Rule 15fh-4(c)'s prohibition on taking actions to coerce, mislead, or otherwise interfere with the SBS Entity's CCO, may create additional costs for SBS Entities. For example, to the extent that any current practices of an SBS Entity include activities that are explicitly prohibited under Rule 15fh-4(c), applicable policies and procedures will need to be updated. In addition, it is possible that the rule could cause officers, directors, supervised persons, or employees of an SBS Entity to be overly cautious when consulting with a CCO. The Commission does not, however, believe that any such effects will be significant, given the specificity of the rule's prohibition on certain interferences with the SBS Entity's CCO.
One commenter was concerned that the scope of the proposed rule is unclear and could lead to confusion and uncertainty as to what communications between the CCO and the officers, directors, supervised persons, and employees of the SBS Entity might violate the rule. The commenter states that such confusion and uncertainty could have a chilling effect on dialog about compliance, budget, and resource matters, which, by implication, could impede decision making within the SBS Entity.
The final rules would likely affect capital formation, competition, and efficiency in various ways, as discussed below.
As discussed earlier, by reducing the risk of fraud, Rule 9j-1 could encourage participation in the market, which may result in increased competition in the security-based swap market.
Rule 15fh-4(c) would likely have a minor indirect positive impact on competition in the security-based swap market. Because Rule 15fh-4(c) would support the ability of the CCO to oversee compliance with the Federal securities laws within the SBS Entity and likely reduce the risk of fraud, security-based swaps would more likely reflect the fundamental credit risk of the underlying entity. This in turn could encourage greater participation in the security-based swap market and therefore, increase competition among the market participants.
By decreasing the risk of fraud and preventing price manipulation in the security-based swap market, Rule 9j-1 may increase price efficiency. This would consequently lead to greater security-based swap market efficiency, as security-based swap prices would provide greater confidence that their prices more likely reflect fundamental values and risk in more liquid markets.
Rule 15fh-4(c) would likely have a minor indirect positive impact on price efficiency. To the extent that the rule increases participation in the security-based swap market as discussed in section V.F.1, price efficiency may increase because increased trading by market participants could incorporate more information into security-based swap prices.
Final Rule 9j-1 likely would have a positive impact on capital formation. As discussed earlier, greater activity in the underlying security market due to increased price efficiency and greater availability to hedge these securities in the security-based swap market could lead to lower capital costs and increase capital formation for the underlying entities. Increased participation and price efficiency in the security-based swap market as a result of Rule 9j-1 could encourage lenders to make greater use of security-based swaps for hedging their loans, which in turn could increase lending activity and capital formation.
As discussed in section V.D.2, a number of commenters were concerned that re-proposed Rule 9j-1's compliance costs, scope, and liability standards would reduce capital formation (including financing to private companies) and increase the cost of capital, among other potential effects. As discussed in that section, compliance costs could be limited by existing practices and systems that are in place to comply with section 9(j) and the other antifraud and anti-manipulation provisions; that the rule's use of clear, consistent, and familiar liability standards reduces uncertainty; and that the rule's beneficial effects on capital formation and the cost of capital
Rule 15fh-4(c) would likely have a minor indirect positive impact on capital formation. To the extent that the rule increases price efficiency and competition in the security-based swap market, as discussed in sections V.F.1 and V.F.2, capital formation could, as a result, further indirectly increase, as greater price efficiency and competition among market participants could lead to a decrease in security-based swaps prices, and in turn, lower costs of borrowing (as a result of lowering the cost of CDS).
The Commission considered a number of alternatives when finalizing Rules 9j-1 and 15fh-4(c).
Commenters recommended narrowing the scope of re-proposed Rule 9j-1 in various ways: (1) exclude valuation, payment, and delivery from the scope of proposed Rule 9j-1(b);
The Commission has considered these alternatives but determined that the adopted approach is preferable to them. With respect to the exclusion of valuation, payment, and delivery from the scope of proposed Rule 9j-1(b), the Commission declines to adopt this alternative. The Commission is concerned that the alternative would create a gap in the prohibition against the manipulation and attempted manipulation of prices in the security-based swap market and reduce the benefits of final Rule 9j-1(a)(6), as revised from proposed Rule 9j-1(b). The exclusion of valuation, payment, and delivery from the scope of final Rule 9j-1(a)(6) could increase the occurrence of manipulation and attempted manipulation of security-based swap prices in connection with such activities.
With respect to the exclusion of certain credit market conduct, the Commission believes it cannot specify all possible types of misconduct that may prevail in the future. Hence, provisions designed to exclude certain legitimate credit market conduct could unintentionally apply to activities that final Rule 9j-1(a)(6), as revised from proposed Rule 9j-1(b), is designed to prohibit, reducing the benefits of the rule. Further, an exclusion of certain credit market conduct would need to be balanced against the risk that market participants undertake transactions for which their counterparties should have the protections of final Rule 9j-1(a)(6). In addition, as discussed in section II.C.2, the fact that the Commission intends to apply a scienter standard in connection with final Rule 9j-1(a)(6), and that the rule does not impose liability for actions taken in the ordinary course of a typical lender-borrower relationship (or a prospective lender-borrower relationship), should help mitigate concerns regarding any “chilling effects” of the rule.
With respect to the exclusion of sovereign debt security-based swaps, as a general matter, the Commission does not see a compelling reason to treat security-based swaps referencing sovereign underliers differently than security-based swaps referencing other underliers. As discussed in section II.E.2.d, while security-based swaps related to sovereign debt may have lesser opportunity for manufactured credit events or opportunistic strategies by regulated and non-regulated market participants alike, such instruments are not without risk of fraudulent and manipulative conduct and should remain within the scope of Rule 9j-1.
Commenters suggested that the Commission add various safe harbors to Rule 9j-1. The Commission discusses these alternatives below.
One commenter urged the Commission to consider creating a safe harbor to re-proposed Rule 9j-1 for entering into security-based swap transactions for purposes of hedging some or all exposure arising out of lending activities with a reference entity or the syndication of such lending activities.
One commenter urged the Commission to consider allowing the lender to avoid liability under re-proposed Rule 9j-1 by disclosing to the counterparty that it is a lender to the borrower and may have material nonpublic information from the borrower.
One commenter requested a safe harbor from liability under proposed Rule 9j-1(b) for publicly executed strategies, where multiple parties or an independent body (such as a court or regulator) are involved. The commenter distinguished publicly executed strategies from privately executed strategies, such as a single market participant entering into an agreement with a reference entity. The commenter argued that publicly executed strategies are more difficult for a single participant to manipulate than privately executed strategies because publicly executed strategies are driven by the incentives of a broader group of participants than privately executed strategies.
Four commenters urged for the elimination of all safe harbors and affirmative defenses from proposed Rule 9j-1(a) liability.
One commenter urged the Commission to consider the alternative approach of identifying and prohibiting within Rule 9j-1 specific types of events (for example, market behavior around certain events and fact patterns) and opportunistic trading behavior that have been observed. According to the commenter, this alternative approach could provide even more certainty and precision with respect to the particular types of activities that are prohibited in the security-based swap market. The commenter believed that the greater certainty of outcome with respect to Rule 9j-1 would benefit lenders when they need to exercise rights or remedies under a loan or credit agreement.
The Commission acknowledges the commenter's concern that not adopting the more prescriptive alternative approach could prevent lenders or security-based swap participants from exercising legitimate rights and remedies and impose costs that would be greater than those discussed in the 2021 Proposing Release in connection with re-proposed Rule 9j-1.
One commenter asserted that opportunistic strategies work best with CDS and that equity SBS are less susceptible to such strategies. The commenter suggested that the Commission propose separate rules for each type of instrument.
One commenter urged the Commission to modify re-proposed Rule 9j-1 by providing that its prohibitions do not extend to the purchase or sale of underlying securities.
One commenter suggested that final Rule 15fh-4(c) should limit the prohibited interference to knowingly making untrue statements or omitting material facts.
The Regulatory Flexibility Act (“RFA”)
For purposes of Commission rulemaking in connection with the RFA, a small entity includes: (1) when used with reference to an “issuer” or a “person,” other than an investment company, an “issuer” or “person” that, on the last day of its most recent fiscal year, had total assets of $5 million or less;
Based on available information about the security-based swap market, the market, while broad in scope, is largely dominated by entities such as those that will be covered by the SBSD and MSBSP definitions. Based on feedback from industry participants about the security-based swap market, the Commission continues to believe that: (1) the types of entities that are and will continue to register with the Commission as SBSDs (
Although Rule 15fh-4(c) applies only to SBS Entities, Rule 9j-1 is not on its face limited to SBS Entities. However, while it is possible that other parties may engage in security-based swap transactions, the Commission does not believe that any such entities would be “small entities” as defined in Exchange Act Rule 0-10.
For the foregoing reasons, the Commission certifies that Rules 9j-1 and 15fh-4(c) will not have a significant
Pursuant to the Congressional Review Act,
If any of the provisions of these final rules, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of such provisions to other persons or circumstances that can be given effect without the invalid provision or application.
The Commission is adopting the new rules and rule amendment contained in this release under the authority set forth in the Exchange Act, 15 U.S.C. 78a
Administrative practice and procedure, Brokers, Confidential business information, Fraud, Reporting and recordkeeping requirements, Securities, Swaps.
For the reasons set forth in the preamble, title 17, chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78j-4, 78k, 78k-1, 78
Sections 240.15fh-1 through 240.15Fh-6 and 240.15Fk-1 are also issued under sec. 943, Pub. L. 111-203, 124 Stat. 1376.
(a) It shall be unlawful for any person, directly or indirectly, to effect any transaction in, or attempt to effect any transaction in, any security-based swap, or to purchase or sell, or induce or attempt to induce the purchase or sale of, any security-based swap (including but not limited to, in whole or in part, the execution, termination (prior to its scheduled maturity date), assignment, exchange, or similar transfer or conveyance of, or extinguishing of any rights or obligations under, a security based-swap, as the context may require), in connection with which such person:
(1) Employs or attempts to employ any device, scheme, or artifice to defraud or manipulate;
(2) Makes or attempts to make any untrue statement of a material fact, or omits to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading;
(3) Obtains money or property by means of any untrue statement of a material fact or any omission to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading;
(4) Engages in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person;
(5) Attempts to obtain money or property by means of any untrue statement of a material fact or any omission to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading, or attempts to engage in any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person; or
(6) Manipulates or attempts to manipulate the price or valuation of any security-based swap, or any payment or delivery related thereto.
(b) Wherever communicating, or purchasing or selling a security (other than a security-based swap) while in possession of material nonpublic information would violate, or result in liability to any purchaser or seller of the security under, either the Act or the Securities Act of 1933, or any rule or regulation thereunder, such conduct in connection with a purchase or sale of a security-based swap with respect to such security or with respect to a group or index of securities including such security shall also violate, and result in comparable liability to any purchaser or seller of that security under, such provision, rule, or regulation.
(c) Wherever taking any of the actions set forth in paragraph (a) of this section involving a security-based swap would violate, or result in liability under, Section 9(j) of the Act or this section, such conduct, when taken by a counterparty to such security-based swap (or any affiliate of, or a person acting in concert with, such security-based swap counterparty in furtherance of such prohibited activity), in connection with a purchase or sale of a security, loan, or group or index of securities on which such security-based swap is based, shall also violate, and shall be deemed a violation of, section 9(j) of the Act or paragraph (a) of this section.
(d) For purposes of this section, the terms “purchase” and “sale” shall have the same meanings as set forth in Sections 3(a)(13) (15 U.S.C. 78c(a)(13)) and 3(a)(14) (15 U.S.C. 78c(a)(14)) of the Act.
(e) A person shall not be liable under paragraphs (a)(1) through (a)(5) of this section solely for being aware of material nonpublic information while taking the following actions:
(1) Actions taken by a person in accordance with binding contractual rights and obligations under a security-based swap (as reflected in the written documentation governing such security-based swap or any amendment thereto) so long as the person demonstrates that:
(i) The security-based swap was entered into, or the amendment was made, before the person became aware of such material nonpublic information, and
(ii) The security-based swap was entered into in good faith and not as part of a plan or scheme to evade the prohibitions of this section.
(2) Actions taken by a person other than a natural person if the person demonstrates that:
(i) The individual making the investment decision on behalf of the person taking the action was not aware of the material nonpublic information, and
(ii) The person had implemented reasonable policies and procedures, taking into consideration the nature of the person's business, to ensure that individuals making investment decisions would not be in violation of paragraphs (a)(1) through (a)(5) of this section. These policies and procedures may include those that restrict effecting a transaction in, or purchasing or selling, any security, including any security-based swap, as to which the person has material nonpublic information, or those that prevent such individuals from becoming aware of such information.
The revisions read as follows:
(c)
By the Commission.