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Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce safety zones for five fireworks displays as described in the table to 33 CFR 165.506 on multiple dates on and around July 4, 2022. Our regulation for marine events within the Fifth Coast Guard District identifies the regulated areas for these fireworks displays. During the enforcement periods, vessels may not enter, remain in, or transit through the safety zones unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.
The regulations in table 1 to paragraph (h)(1) to 33 CFR 165.506, will be enforced for the safety zones identified in the
If you have questions about this notice of enforcement, you may call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division, telephone 215-271-4814, email
The Coast Guard will enforce the safety zones established in table 1 to paragraph (h)(1) to 33 CFR 165.506, for the following five fireworks displays during the dates, times, and at the locations listed in the following table:
During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.
In addition to this notice of enforcement in the
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement an Executive order regarding maximizing the use of American-made goods, products, and materials.
Effective June 23, 2022.
Ms. Kimberly Bass, telephone 571-372-6174.
DoD is issuing a final rule amending the DFARS to implement Executive Order (E.O.) 13881, Maximizing Use of American-made Goods, Products, and Materials, which calls for more aggressive implementation of the Buy American statute (41 U.S.C. chapter 83) to maximize the Government's procurement of American-made goods, products, and materials. The Buy American statute requires the purchase of domestic products (both end products and construction materials), except when the domestic product is not available, the domestic product is only available at an unreasonable cost, or it would not be in the public interest to buy the domestic product.
E.O. 13881 supersedes E.O. 10582, Prescribing Procedures for Certain Determinations under the Buy American Act. E.O. 13881 establishes that under the Buy American statute a product is foreign if the cost of all foreign components used in such product constitutes 45 percent or more of the cost of all components, except that iron and steel products are foreign if the cost of foreign iron and steel equals or exceeds 5 percent of the cost of all components. This rule strengthens domestic preferences under the Buy American statute, as required by E.O. 13881, by changing how a domestic product is defined, while also maintaining the exception for qualifying countries.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments is provided. There were no changes made to the proposed rule as a result of those comments.
A respondent further stated that currently, a COTS item is considered compliant with the Buy American statute if its final stage of manufacturing occurs in the United States, without regard for the origin of the COTS components. The respondent also stated that this policy stands in stark contrast with the goals of other domestic content preferences, particularly the Buy America statute that applies to Federal assistance infrastructure programs that explicitly provides that products are only considered American-made if all manufacturing processes from the initial melting stage through the application of coatings take place in the United States. The COTS waiver takes the opposite approach with negative consequences for upstream suppliers of raw materials and subcomponents of products and allows for products that are entirely comprised of foreign material to be considered American-made so long as the final processing stage occurs in the United States.
Additionally, a respondent provided comments regarding the OMB Memorandum M-21-26, Increasing Opportunities for Domestic Sourcing and Reducing the Need for Waivers from Made in America Laws, and impacts on COTS waivers. The respondent also recommended keeping the fastener language in DFARS 252.225-7009, Restriction on Acquisition of Specialty Metals, for fasteners provided to the six major DoD programs as it allows for improved efficiency for U.S. fastener manufacturers providing both commercial and defense applications to the same prime contractor, while still protecting the domestic steel and fastener industries.
Another respondent provided comments in response to the final rule for FAR case 2019-016 published at 86 FR 6180 on January 19, 2021.
The respondent's comment referencing the OMB Memorandum M-21-26, Increasing Opportunities for Domestic Sourcing and Reducing the Need for Waivers from Made in America Laws, is outside the scope of this rule.
Lastly, the comment referencing the requirements in DFARS 252.225-7009, Restriction on Acquisition of Specialty Metals, is outside the scope of this rule.
Paragraph (2) of the definition of “domestic construction material” has been revised in the following clauses to refer to the definition of “cost of components” instead of paragraph (1)(ii)(A) of the definition of “domestic construction material”: 252.225-7044 (basic clause and alternate I) and 252.225-7045 (basic clause and alternates I through III). Paragraph (1)(ii)(A) does not provide information regarding the cost of components, which is located in the definition of that term.
This final rule does not add any new provisions or clauses, nor change the applicability of existing provisions or clauses to contracts at or below the simplified acquisition threshold, contracts for the acquisition of commercial products including commercially available off-the-shelf items, and for commercial services.
The current FAR contract clauses implementing the Buy American statute apply to a narrow set of procurements. In addition, because the Federal Acquisition Regulatory Council retained the COTS items exception for most COTS items in its implementation of E.O. 13881 in the FAR, the heightened domestic content requirements will not be applicable to those procurements. (See the final rule for FAR Case 2019-016 published at 86 FR 6180 on January 19, 2021.) This final DFARS rule takes the same approach.
Domestic industries supplying domestic end products are likely to benefit from a competitive advantage as a result of the FAR and DFARS implementation. Based on the E.O., it is unclear if the pool of qualified suppliers would be reduced, resulting in less competition and a possible increase in prices that the Government will pay to procure these products. At least three arguments point to the likelihood that any increase in burden on contractors would be small, if not de minimis:
(1) Familiarization costs should be low.
(2) Some, if not many, contractors may already be able to meet the more stringent threshold.
(3) Costs incurred by contractors who adjust their supply chains, so that their end products qualify as domestic, will enjoy a larger price preference that should help to offset these costs over time.
Each of these arguments is explained below.
First, DoD does not anticipate significant costs from contractor familiarization with the rule given the publication of the FAR final rule implementing E.O. 13881 and the history of rulemaking and E.O.s in general in this area. The basic mechanics of the Buy American statute (
Second, some, if not many, contractors may already be able to comply with the lower foreign content requirement needed to meet the definition of domestic end product under E.O. 13881 and the final rule. Laws such as the SECURE Technology Act (Pub. L. 115-390), which requires a series of actions to strengthen the Federal infrastructure for managing supply chain risks, are placing significantly increased emphasis on Federal agencies and Federal Government contractors to identify and reduce risk in their supply chains.
One way to reduce supply chain risk is to increase domestic sourcing of content. In addition, in the context of iron and steel, many laws already in place call for more stringent accounting of domestic sourcing of content. For example, the Recovery Act required that all construction material for a project for the construction, alteration, maintenance, or repair of a public building or a public work in the United States, consisting wholly or predominantly of iron or steel, had to be produced in the United States when using Recovery Act funds, to the extent consistent with trade agreements (see FAR 25.602-1, implementing section 1605 of the Recovery Act).
In addition, Federal contractors who also work on contracts funded under Federal grants may, in some cases, find
Third, it is anticipated that some contractors' products and construction materials may not meet the definition of domestic end product and domestic construction material unless the contractors take steps to adjust their supply chains to increase the domestic content. Those contractors that make a business decision not to modify their supply chains will still be able to bid on DoD contracts but will no longer enjoy a price preference.
Accordingly, it is likely that the Federal market for iron and steel has already completed significant retooling and could meet the requirements of E.O. 13881 without too much additional effort.
This rule amends the clauses that implement the Buy American statute. There are four clauses affected by the changes in this rule:
(1) 252.225-7001, Buy American and Balance of Payments Program (Basic and Alternate I).
(2) 252.225-7036, Buy American—Free Trade Agreements—Balance of Payments Program (Basic and Alternates I-V).
(3) 252.225-7044, Balance of Payments Program—Construction Material (Basic and Alternate I).
(4) 252.225-7045, Balance of Payments Program—Construction Material (Basic and Alternates I-III).
This rule changes the definitions of “domestic end product” and “domestic construction material.” The rule also adds the definitions of “steel” and “predominantly of iron or steel or a combination of both” in the clauses to conform the DFARS with the FAR implementation of E.O. 13881.
According to the Federal Procurement Data System (FPDS) data for fiscal year (FY) 2017, FY 2018, and FY 2019 for new awards with a foreign place of performance for construction valued over the micro-purchase threshold and for awards for supplies, DoD awarded an average of 3,222 construction contracts with a foreign place of performance per year. In addition, DoD awarded an average of 332,607 supply contracts per year during FY 2017 through FY 2019.
In summary, the rule will strengthen domestic preferences under the Buy American statute and provide both large and small businesses the opportunity and incentive to deliver U.S. manufactured products from domestic suppliers. It is expected that this rule will benefit large and small U.S. manufacturers, including those of iron or steel.
Therefore, based on public comments received, DoD has concluded that the initial assessment is correct that the cost impact of this rule is not significant, and any impact is predominantly positive.
Executive Orders (E.O.s) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is required to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Executive Order (E.O.) 13881, Maximizing Use of American-Made Goods, Products, and Materials, and also to make conforming changes to the applicable clauses as a result of implementation of the E.O. in the Federal Acquisition Regulation (FAR).
The objective of this rule is to strengthen domestic preferences under the Buy American statute, as required by E.O. 13881, by changing how a domestic end product and domestic construction material are defined.
There were no significant issues raised by the public comments in response to the initial regulatory flexibility analysis.
Data was obtained from the Federal Procurement Data System (FPDS) for new awards valued over the micro-purchase threshold in fiscal year (FY) 2017, FY 2018, and FY 2019 that had a foreign place of performance and were for construction. DoD awarded an average of 3,222 construction contracts with a foreign place of performance per year during FY 2017 through FY 2019. Of those construction contracts, approximately 65 were awarded to 32 unique small entities per year.
Data was also obtained from FPDS for FY 2017 through FY 2019 for new awards valued over the micro-purchase threshold for supplies made in the United States. DoD awarded an average of 332,607 supply contracts per year during FY 2017 through FY 2019. Of those supply contracts, approximately 154,422 supply contracts were awarded to 13,480 unique small entities per year.
The rule will strengthen domestic preferences under the Buy American statute and provide small businesses the opportunity and incentive to deliver U.S. manufactured products from domestic suppliers. It is expected that this rule will benefit U.S. small business manufacturers, including those of iron or steel. Small business manufacturers who do not already meet the increased domestic content requirements of this proposed rule may need to adjust their supply chains. DoD does not have data on how many small business manufacturers may decide to make such adjustments.
This rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses, other than to increase the percentages used in the domestic content test applied to offers of manufactured end products.
There are no known significant alternative approaches to the rule that would meet the requirements of E.O. 13881.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 225 and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revision and additions read as follows:
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a commercially available off-the-shelf (COTS) item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(ii)(A) Except for an end product that consists wholly or predominantly of iron or steel or a combination of both, the cost of its U.S. and qualifying country components exceeds 55 percent of the cost of all its components. This test is applied to end products only and not to individual components.
(B) For an end product that consists wholly or predominantly of iron or steel or a combination of both, the cost of iron and steel not produced in the United States or a qualifying country must constitute less than 5 percent of the cost of all the components used in the end product. The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding commercially available off-the-shelf (COTS) fasteners. The domestic content test of the Buy American statute has not been waived for acquisitions of COTS items in this category, except for COTS fasteners.
The revisions and additions read as follows:
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
The revisions and additions read as follows:
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(C) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron and steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
(a) * * *
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States; or
(ii) An end product manufactured in the United States if—
(A) The cost of its qualifying country components and its components that are mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. The cost of components includes transportation costs to the place of incorporation into the end product and U.S. duty (whether or not a duty-free entry certificate is issued). Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic. A component is considered to have been mined, produced, or manufactured in the United States (regardless of its source in fact) if the end product in which it is incorporated is manufactured in the United States and the component is of a class or kind for which the Government has determined that—
(
(
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of iron and steel not produced in the United States or a qualifying country constitutes less than 5 percent of the cost of all the components used in the end product (produced in the United States or a qualifying country means that all manufacturing processes of the iron or steel must take place in the United States or a qualifying country, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States or a qualifying country includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States or a qualifying country, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States or a qualifying country, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the explanation of cost of components in paragraph (1)(ii)(A) of this definition.
(1) An unmanufactured end product mined or produced in a qualifying country; or
(2) An end product manufactured in a qualifying country if—
(i) The cost of the following types of components exceeds 50 percent of the cost of all its components:
(A) Components mined, produced, or manufactured in a qualifying country.
(B) Components mined, produced, or manufactured in the United States.
(C) Components of foreign origin of a class or kind for which the Government has determined that sufficient and reasonably available commercial quantities of a satisfactory quality are not mined, produced, or manufactured in the United States. Components of unknown origin are treated as foreign; or
(ii) The end product is a COTS item.
The revisions and additions read as follows:
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States, utilized in the manufacture of the end product and a good faith estimate of the cost of all iron or steel components not produced in the United States, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the construction material contains multiple components, the cost of all the materials used in such construction material is calculated in accordance with the definition of “cost of components” in this clause.
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in
The revisions and additions read as follows:
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States, utilized in the manufacture of the construction material and a good faith estimate of the cost of all iron or steel components not produced in the United States, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the construction material contains multiple components, the cost of all the materials used in such construction material is calculated in accordance with the definition of “cost of components” in this clause.
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States, utilized in the manufacture of the construction material and a good faith estimate of the cost of all iron or steel components not produced in the United States, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the construction material contains multiple components, the cost of all the materials used in such construction material is calculated in accordance with the definition of “cost of components” in this clause.
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in
(a) * * *
(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured construction material mined or produced in the United States; or
(ii) A construction material manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or
(B) The construction material is a COTS item; or
(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of iron and steel not produced in the United States (excluding fasteners) as estimated in good faith by the contractor, constitutes less than 5 percent of the cost of all the components used in such construction material (produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, except metallurgical processes involving refinement of steel additives). The cost of iron and steel not produced in the United States includes but is not limited to the cost of iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings, not produced in the United States, utilized in the manufacture of the construction material and a good faith estimate of the cost of iron or steel components not produced in the United States, excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the construction material contains multiple components, the cost of all the materials used in such construction material is calculated in accordance with the definition of “cost of components” in this clause.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2016-10-08, AD 2017-05-10, and AD 2019-01-05, which apply to certain Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes; and AD 2019-20-13, which applies to certain Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2016-10-08 requires determining the flight cycles accumulated on certain trimmable horizontal stabilizer actuators (THSAs), and replacing the THSA if necessary. AD 2017-05-10, AD 2019-01-05, and AD 2019-20-13 require revising the existing maintenance or inspection program, as applicable. Since the FAA issued those ADs, the FAA has determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by August 8, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For EASA material that will be incorporated by reference (IBR) in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email
The FAA issued AD 2016-10-08, Amendment 39-18519 (81 FR 31844, May 20, 2016) (AD 2016-10-08), which applies to certain Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-200, A340-300, A340-500, and A340-600 series airplanes. Airbus SAS Model A340-200, A340-300, A340-500, and A340-600 series airplanes were included in AD 2016-10-08, but are not included in this proposed AD. Airbus SAS Model A340-200, A340-300, A340-500, and A340-600 series airplanes are not included in this proposed AD because EASA included these airplanes in EASA AD 2021-0250, dated November 17, 2021 (EASA AD 2021-0250), and the FAA has added the MCAI to the required airworthiness actions list (RAAL) for Model A340 airplanes. AD 2016-10-08 requires inspecting certain THSAs to determine the number of total flight cycles the THSA has accumulated, and replacing the THSA if necessary. The FAA issued AD 2016-10-08 to detect and correct premature wear of the carbon friction disks on the no-back brake of the THSA. Such a condition could lead to reduced braking efficiency in certain load conditions and, in conjunction with the inability of the power gear train to keep the ball screw in its last commanded position, could result in uncommanded movements of the trimmable horizontal stabilizer and loss of control of the airplane.
The FAA issued AD 2017-05-10, Amendment 39-18821 (82 FR 13379, March 13, 2017) (AD 2017-05-10), which applies to certain Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. AD 2017-05-10 requires revising the maintenance or inspection program to incorporate new maintenance requirements and airworthiness limitations. The FAA issued AD 2017-05-10 to prevent reduced structural integrity and reduced control of these airplanes due to the failure of system components.
The FAA issued AD 2019-01-05, Amendment 39-19544 (84 FR 4310, February 15, 2019) (AD 2019-01-05), which applies to certain Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. AD 2019-01-05 requires revising the existing maintenance or inspection program to incorporate new maintenance requirements and airworthiness limitations. The FAA issued AD 2019-01-05 to prevent reduced airplane control due to the failure of system components. AD 2019-01-05 specifies that accomplishing the revision required by paragraph (g) of that AD terminates all requirements of AD 2017-05-10.
The FAA issued AD 2019-20-13, Amendment 39-19766 (84 FR 56378, October 22, 2019) (AD 2019-20-13), which applies to certain Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. AD 2019-20-13 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA issued AD 2019-20-13 to address the failure of system components, which could reduce the controllability of the airplane. AD 2019-20-13 specifies that accomplishing the actions required by that AD terminates all requirements of AD 2019-01-05. Additionally, AD 2019-20-13 specifies that accomplishing the action required by task number 274400-00004-1-E of Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, within the compliance time specified for that task in Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, terminates all requirements of AD 2017-25-13, Amendment 39-19127 (82 FR 59960, December 18, 2017) (AD 2017-25-13), for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only. Lastly, AD 2019-20-13 specifies that accomplishing the action required by task number 213100-00001-1-E of Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, within the compliance time specified for that task in Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, terminates all requirements of AD 2014-16-22, Amendment 39-17946 (79 FR 49442, August 21, 2014) (AD 2014-16-22) for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only.
Since the FAA issued AD 2016-10-08, AD 2017-05-10, AD 2019-01-05, and AD 2019-20-13, the FAA has determined that new or more restrictive airworthiness limitations are necessary. The required actions mandated in AD 2016-10-08 are incorporated into Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 08, dated July 1, 2021 (which is referred to in EASA AD 2021-0250, dated November 17, 2021) (EASA AD 2021-0250) (also referred to as the MCAI).
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0250 to correct an unsafe condition for all Airbus SAS Model A330-201, -202, -203, -223, and -243 airplanes; Model A330-223F and -243F airplanes; Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; Model A330-841 airplanes; and Model A330-941 airplanes.
Airplanes with an original airworthiness certificate or original export certificate of airworthiness issued after July 1, 2021, must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet; this AD therefore does not include those airplanes in the applicability.
This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to address the failure of system components, which could reduce the controllability of the airplane. See the MCAI for additional background information.
EASA AD 2021-0250 describes airworthiness limitations for system equipment maintenance requirements.
This proposed AD would require Airbus Service Bulletin A330-27-3199, dated July 15, 2014, which the Director of the Federal Register approved for incorporation by reference as of June 24, 2016 (81 FR 31844, May 20, 2016).
This proposed AD would also require A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, which the Director of the Federal Register approved for incorporation by reference as of November 26, 2019 (84 FR 56378, October 22, 2019).
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain the requirements of AD 2016-10-08 and AD 2019-20-13. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, which are specified in EASA AD 2021-0250 described previously, as proposed for incorporation by reference. Accomplishing the actions required by this proposed AD would terminate all requirements of AD 2014-16-22 for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only, and would terminate all requirements of AD 2017-25-13 for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only. Any differences with EASA AD 2021-0250 are identified as exceptions in the regulatory text of this AD.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0250 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0250 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0250 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0250. Service information required by EASA AD 2021-0250 for compliance will be available at
The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.
For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).
The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions (
The FAA estimates that this proposed AD affects 138 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the total cost per operator for the retained actions from AD 2016-10-08 to be $255 per product (3 work-hours × $85 per work-hour) for inspecting the THSA for a total cost for U.S. operators of $35,190. The retained on-condition cost for AD 2016-10-08 is $724,511 per product (23 work-hours × $85 per work-hour). The FAA estimates the total cost per operator for the retained actions from AD 2019-20-13 to be $7,650 (90 work-hours × $85 per work-hour).
The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate.
The FAA estimates the total cost per operator for the new proposed actions to be $7,650 (90 work-hours × $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by August 8, 2022.
(1) This AD replaces the ADs identified in paragraphs (b)(1)(i) through (iv) of this AD.
(i) AD 2016-10-08, Amendment 39-18519 (81 FR 31844, May 20, 2016) (AD 2016-10-08).
(ii) AD 2017-05-10, Amendment 39-18821 (82 FR 13379, March 13, 2017) (AD 2017-05-10).
(iii) AD 2019-01-05, Amendment 39-19544 (84 FR 4310, February 15, 2019) (AD 2019-01-05).
(iv) AD 2019-20-13, Amendment 39-19766 (84 FR 56378, October 22, 2019) (AD 2019-20-13).
(2) This AD affects AD 2014-16-22, Amendment 39-17946 (79 FR 49442, August 21, 2014) (AD 2014-16-22); and AD 2017-25-13, Amendment 39-19127 (82 FR 59960, December 18, 2017) (AD 2017-25-13).
This AD applies to Airbus SAS airplanes specified in paragraphs (c)(1) through (5) of this AD, certificated in any category, with an original airworthiness certificate or original export certificate of airworthiness issued on or before July 1, 2021.
(1) Model A330-201, -202, -203, -223, and -243 airplanes.
(2) Model A330-223F and -243F airplanes.
(3) Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(4) Model A330-841 airplanes.
(5) Model A330-941 airplanes.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address the failure of system components, which could reduce the controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2016-10-08, with removed references to certain models. For Model A330-200 Freighter, A330-200, and A330-300 series airplanes: Within 90 days after June 24, 2016 (the effective date of AD 2016-10-08), inspect the THSA to determine if it has part number 47147-500, 47147-700, 47172-300, 47172-500, 47172-510, or 47172-520, and to determine the total number of flight cycles accumulated since the THSA's first installation on an airplane, or since the most recent no-back brake (NBB) replacement. A review of airplane delivery or maintenance records is acceptable in lieu of this inspection if the part number of the THSA can be conclusively determined from that review. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (h) of AD 2016-10-08, with removed references to certain models and service information. For Model A330-200 Freighter, A330-200, and A330-300 series airplanes having a THSA with a part number specified in paragraph (g) of this AD: At the applicable time specified in paragraph (h)(1), (2), or (3) of this AD, replace each affected THSA with a serviceable THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-27-3199, dated July 15, 2014. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
The THSA life limits specified in Part 4—Aging System Maintenance of the Airbus A330 Airworthiness Limitations Sections are still relevant, as applicable to airplane model and THSA part number.
(1) For a THSA that has accumulated or exceeded 20,000 total flight cycles since the THSA's first installation on an airplane, or since the most recent NBB replacement, whichever is later, as of June 24, 2016 (the effective date of AD 2016-10-08): Within 6 months after June 24, 2016.
(2) For a THSA that has accumulated or exceeded 16,000 total flight cycles, but less than 20,000 total flight cycles since the THSA's first installation on an airplane, or since the most recent NBB replacement, whichever is later, as of June 24, 2016 (the effective date of AD 2016-10-08): Within 12 months after June 24, 2016, but without exceeding 20,000 total flight cycles.
(3) For a THSA that has accumulated less than 16,000 total flight cycles since first installation on an airplane, or since the most recent NBB replacement, whichever is later, as of June 24, 2016 (the effective date of AD 2016-10-08): At the applicable time specified in paragraph (i) of this AD.
This paragraph restates the requirements of paragraph (i) of AD 2016-10-08, with removed references to certain models and service information. The requirements of this paragraph apply to Model A330-200 Freighter, A330-200, and A330-300 series airplanes having a THSA with a part number specified in paragraph (g) of this AD that has accumulated less than 16,000 total flight cycles since first installation on an airplane, or since the most recent NBB replacement, whichever is later, as of June 24, 2016 (the effective date of AD 2016-10-08). Not later than the date specified in paragraphs (i)(1), (2), and (3) of this AD, as applicable: For any THSA having reached or exceeded on that date the corresponding number of total flight cycles as specified in paragraphs (i)(1), (2), and (3) of this AD, as applicable, replace the THSA with a serviceable unit, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-27-3199, dated July 15, 2014. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
(1) As of 12 months after June 24, 2016 (the effective date of AD 2016-10-08): The THSA flight-cycle limit (since first installation on an airplane, or since last NBB replacement,
(2) As of July 31, 2017: The THSA flight-cycle limit (since first installation on an airplane, or since last NBB replacement, whichever occurs later) is 14,000 total flight cycles.
(3) As of July 31, 2018: The THSA flight-cycle limit (since first installation on an airplane, or since last NBB replacement, whichever occurs later) is 12,000 total flight cycles.
This paragraph restates the requirements of paragraph (k) of AD 2016-10-08, with removed service information. For Model A330-200 Freighter, A330-200, and A330-300 series airplanes with any part installed, as required by paragraph (h) or (i) of this AD, having a part number identified in paragraph (g) of this AD: From the dates specified in paragraph (i) of this AD, as applicable, and prior to exceeding the accumulated number of total flight cycles corresponding to each time, replace each affected THSA with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-27-3199, dated July 15, 2014. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (l) of AD 2016-10-08, with updated paragraph references. For the purposes of paragraphs (g) through (j) and (l) of this AD, a serviceable THSA is a THSA:
(1) Having a part number identified in paragraph (g) of this AD that has not exceeded any of the total accumulated flight cycles identified in paragraphs (i)(1) through (3) of this AD; or
(2) Having a part number that is not identified in paragraph (g) of this AD.
This paragraph restates the requirements of paragraph (m) of AD 2016-10-08, with updated paragraph references. For Model A330-200 Freighter, A330-200, and A330-300 series airplanes: From each date specified in paragraphs (i)(1), (2), and (3) of this AD, a THSA having a part number identified in paragraph (g) of this AD may be installed on any airplane, provided the THSA has not exceeded the corresponding number of accumulated total flight cycles. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (g) of AD 2019-20-13, with no changes. For Model A330-200 Freighter, A330-200, and A330-300 series airplanes with an original airworthiness certificate or original export certificate of airworthiness issued on or before October 15, 2018: Within 90 days after November 26, 2019 (the effective date of AD 2019-20-13), revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018. The component life limits and the initial compliance time for doing the tasks are at the times specified in Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, or within 90 days after November 26, 2019, whichever occurs later. Accomplishing the revision of the existing maintenance or inspection program required by paragraph (o) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (h) of AD 2019-20-13, with a new exception. Except as required by paragraph (o) of this AD, after the existing maintenance or inspection program has been revised as required by paragraph (m) of this AD, no alternative actions (
Except as specified in paragraph (p) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2021-0250, dated November 17, 2021 (EASA AD 2021-0250). Accomplishing the revision of the existing maintenance or inspection program required by this paragraph terminates the requirements of paragraphs (g), through (j), (l), and (m) of this AD.
(1) Where EASA AD 2021-0250 refers to its effective date, this AD requires using the effective date of this AD.
(2) The requirements specified in paragraphs (1) and (2) of EASA AD 2021-0250 do not apply to this AD.
(3) Paragraph (3) of EASA AD 2021-0250 specifies to “revise the AMP” within 12 months after its effective date, but this AD requires revising the existing maintenance or inspection program, as applicable, within 90 days after the effective date of this AD.
(4) The initial compliance time for doing the tasks specified in paragraph (3) of EASA 2021-0250 is at the applicable “limitations and associated thresholds” as incorporated by the requirements of paragraph (3) of EASA AD 2021-0250, or within 90 days after the effective date of this AD, whichever occurs later.
(5) The provisions specified in paragraphs (4) and (5) of EASA AD 2021-0250 do not apply to this AD.
(6) The “Remarks” section of EASA AD 2021-0250 does not apply to this AD.
After the existing maintenance or inspection program has been revised as required by paragraph (o) of this AD, no alternative actions (
(1) Accomplishing the action required by task number 213100-00001-1-E of Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, or using “The ALS” specified in EASA AD 2021-0250, within the compliance time specified for that task terminates all requirements of AD 2014-16-22 for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only.
(2) Accomplishing the action required by task number 274400-000041-E of Airbus A330 Airworthiness Limitations Section (ALS) Part 4, System Equipment Maintenance Requirements (SEMR), Revision 07, dated October 15, 2018, or using “The ALS” specified in EASA AD 2021-0250, within the compliance time specified for that task terminates all requirements of AD 2017-25-13 for Airbus SAS Model A330-200, -200 Freighter, and -300 series airplanes only.
The following provisions also apply to this AD:
(1)
(2)
(1) For EASA AD 2021-0250, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email
(3) For Airbus SAS service information identified in this AD, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission or FCC) seeks comments on the annual collection of data relating to price and subscription rates of internet service offerings received by households enrolled in the Affordable Connectivity Program, mechanism for collecting such data, and format for the data's publication, as required by Section 60502(c) of the Infrastructure Investment and Jobs Act.
Comments are due on or before July 25, 2022 and reply comments are due on or before August 8, 2022. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this document, you should advise the listed contact as soon as possible.
You may submit comments, identified by WC Docket No. 21-450, by any of the following methods:
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Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020) (
Eric Wu, Wireline Competition Bureau, 202-418-7400 or by email at
This is a synopsis of the Commission's Notice of Proposed Rulemaking (NPRM) in WC Docket No. 21-450; FCC 22-44, adopted on June 7, 2022, and released on June 8, 2022. The full text of this document is available for public inspection at the following internet address:
1. On November 15, 2021, the President signed the Infrastructure Investment and Jobs Act (Infrastructure Act or Act), which modified and extended the Emergency Broadband Benefit Program (EBB Program) to a longer-term broadband affordability program called the Affordable Connectivity Program (ACP). The Infrastructure Act also mandates that the Commission issue final “broadband transparency rules” regarding the annual collection of information about the price and subscription rates of internet service offerings received by households enrolled in the Affordable Connectivity Program. Consistent with the directive to adopt rules no later than one year after enactment of the Act, the Commission herein seek comment on the data to be collected, mechanism for collecting this data, and format for the data's publication.
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3. The Commission next seeks comment on the collection of subscription rates. The Commission interprets “subscription rate” as the total program subscribership to a unique internet service offering over time, and seek comment on this approach. In other words, the Commission proposes to collect the number of ACP households that subscribe to each unique internet service offering, where offerings are differentiated by price and service characteristics. Should the Commission collect the number of households of an internet service offering as of a certain moment in time (
4. Some providers offer plans nationwide. How should that be taken into account when collecting subscription rate information? Should the subscription rate be for a particular geographic location if plans are offered nationally or across large geographic regions, such as statewide? Are large geographic regions (
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6. The Commission seeks comment on what ACP plan characteristics the Commission should collect. The Commission first proposes to collect upload and download speeds. For upload and download speeds, should the Commission collect the advertised or maximum speeds? Are there other speed measurements the Commission should consider collecting instead? Should the Commission collect information about ACP service plan data caps, including the amount of the data cap and the number of subscribers who have reached their cap? What about information concerning associated equipment, including whether or not a plan includes or requires a modem or router rental? For bundled service plans should the Commission collect information concerning the characteristics of the bundle, including whether voice is included in the bundle, voice characteristics (
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8. As proposed, the broadband labels may include information concerning plan pricing, performance, and data caps and will be required to be displayed at the point of sale. How
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11. If the Commission was to collect the data at an aggregated level, and not at the subscriber level, what collection mechanism should the Commission use? It may be difficult to modify NLAD to collect data on an aggregated level within the time necessary to launch the ACP data collection and, thus, USAC or the Commission may have to develop a new system. The Commission seeks comment on this view. The Commission also seeks comment on the ways that USAC could modify NLAD or another existing system to collect aggregate plan data. Are there ways that USAC could collect subscriber level information via NLAD and aggregate that data? Should the Commission collect this aggregated data instead of USAC? Developing a new system and standing up a collection of this magnitude would require significant resources, so the Commission seeks comment on the feasibility of the Commission hosting this collection. Finally, the Commission seeks comment on how the level of aggregation impacts the collection mechanism the Commission should employ. Commenters are encouraged to explain whether their suggested collection mechanism is particular to a specific level of aggregation, or if it can
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15. In a subscriber-level collection, the provider would submit plan information to NLAD for each subscriber enrolled in the Affordable Connectivity Program. Having plan information for each subscriber would allow Commission staff to track the subscriber take-up rate of different plans over time and study how subscriber plan choices and preferences for plan characteristics vary by geographic area and household demographics. Subscriber-level information would provide insight into whether the Affordable Connectivity Program is meeting the broadband needs of eligible households and how those needs change over time, and would assist our understanding of whether plan choice is influenced by available technologies and speeds in a geographic area. For example, subscriber-level data would allow us to examine the preference for fixed versus mobile plans across geography and demography.
16. In addition to helping the Commission understand what choices subscribers have available to them and their preferences, subscriber-level data would also help us understand how the Affordable Connectivity Program affects overall broadband adoption and how the program furthers the Commission's efforts to close the digital divide. Subscriber-level plan information would more easily be combined with subscription data already collected by the Commission, which could improve estimates of ACP subscribers that are first time broadband adopters. Subscriber-level data may also improve consumer outreach efforts, including the outreach efforts the Infrastructure Act permits the Commission to pursue, as described in the
17. The Commission also seeks comment on benefits and drawbacks of collecting more aggregated data. If the Commission did not collect subscriber-level data from providers, the Commission will need to collect the data at some level of aggregation. For an aggregated data approach, the Commission seeks comment on the level of data aggregation and what, if any, other information should be collected from providers. Should aggregated data be the number of individuals in a geographic area subscribed to a unique plan? And if so, what is the appropriate geographic level (
18. The Commission further seeks comment on how useful aggregated data of providers' ACP offerings would be in evaluating the performance and administration of the Affordable Connectivity Program as compared to subscriber-level data. For example, at a high level of aggregation, such as the provider-state level, how could one analyze differences between rural and urban plan choices or subscription rates within a state? Even if aggregation were at the census tract level, the Commission may not be able to match subscribers between Lifeline and the Affordable Connectivity Program, and would be unable to determine if Lifeline subscribers are gaining additional value for their ACP subsidy. Would aggregated data make it easier for the Commission to analyze or publish the data? The Commission also seeks comment on the relative burdens to providers in submitting aggregated data of their ACP service offerings as compared with subscriber-level data. As discussed above, for subscriber-level data, providers would be required to input additional data in NLAD at enrollment in addition to the information already required to enroll a household. For aggregated data, providers may not need to enter additional data into NLAD, but they would be required to submit such aggregated data to the Commission. The Commission seeks comment on the burdens raised by these data collection approaches. Are there specific steps the Commission could take to the reduce such burdens (
19. The Commission also seeks comment on other data collection alternatives. What about a collection that requires the production of a combination of both subscriber-level data and more aggregated data? What would be the benefits and challenges of a hybrid approach that collects aggregated data and subscriber-level information from all ACP subscribers? The Commission seeks comment on whether and in what circumstances a hybrid approach assists in evaluating the Affordable Connectivity Program.
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21. The Commission also seeks comment on what the impacts and costs would be to stakeholders for the collection of aggregated data. For aggregated data, providers would be responsible for collecting all the information of their ACP subscribers and compiling that information in the manner required by the Commission. The Commission seeks comment on our view that collecting aggregated data, especially depending on the level of aggregation, may be burdensome for providers. Are there any tools or steps USAC or the Commission can take to reduce burdens? The Commission seeks comment on the burdens of this data collection on providers. Does the burden vary depending on the level of data aggregation? Could any other of USAC's systems be modified to allow for aggregated data? Should the Commission requires providers to give us information in specific popular machine-readable formats? How could the Commission structure an aggregate-level broadband transparency data collection to minimize the burdens associated with handling the ACP transparency data? For small providers, what are the benefits and burdens associated with an aggregate level data collection? How can the Commission structure the collection to minimize any economic impact on small providers?
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23. Additionally, the Commission seeks comment on the extent to which collecting additional subscriber-level data through the ACP transparency data collection implicates statutory privacy regimes, including the Electronic Communications Privacy Act (ECPA). The Commission concluded a decade ago that it had sufficient authority under the Communications Act to require eligible telecommunications carriers (ETCs) to provide Lifeline subscriber-specific information to the NLAD notwithstanding ECPA. The Commission explained that the Communications Act clearly demonstrated “Congress's intent that other provisions of law should not be held to override our specific authority to access information needed to perform oversight, including non-content information, which generally is less sensitive than the contents of communications.” The Commission also concluded that ETCs could divulge information about Lifeline and Link Up subscribers to the Commission under an
24. To ameliorate privacy concerns and ensure that subscribers are cognizant of the uses of their personal information, the Commission currently requires subscribers to consent to the transmittal of their data to the Commission or USAC. In the Affordable Connectivity Program, prior to obtaining consent, a participating provider must describe to the subscriber the “specific information being transmitted, that the information is being transmitted the Administrator to ensure the proper administration of the Affordable Connectivity Program and that the failure to provide consent will result in subscriber being denied the affordable connectivity benefit.” The Commission seeks comment on the need for any additional subscriber consent as well as how that consent should be obtained.
25. The Commission further request comment on how to best balance the burdens for providers and subscribers associated with obtaining consent with the benefits of a subscriber-level collection. How would providers obtain such consent from new ACP applicants and from existing ACP households? Can consent be collected by USAC either when consumers complete an application in the National Verifier or at the time of their recertification? The Commission seeks comment on how consent can be collected at the time of recertification, particularly where a subscriber's eligibility is confirmed by querying the appropriate eligibility database. If consent can be obtained only for a portion of the ACP subscriber base, is it worth collecting partial subscriber-level data? The Commission seeks comment on other ways in which providers, the Commission, or USAC can obtain a consumer's consent to permit their provider to submit ACP service plan information consistent with any requirements the Commission adopt in this proceeding. How can the Commission structures the consent process to minimize the cost or burdens of consent? What burdens would be imposed on participating providers if they are required to provide additional notice to, and obtain additional consent from, existing ACP subscribers? Can the Commission collects opt-out consent, or should consenting to participation in a subscriber-level collection be strictly opt-in? For the millions of households that are already participating in the Affordable Connectivity Program, the Commission seeks comment on the process by which providers, USAC, or the Commission would collect consent for the subscriber-level data collection? Would requiring this additional consent from subscribers risk depressing subscriber participation in Affordable Connectivity Program? What role should providers play in obtaining consent from their existing ACP subscribers for a subscriber-level data collection? What is the cost to providers of any requirement that they play a part in obtaining consent? How long would it take for providers to obtain additional consents from existing subscribers? If subscriber-level information is collected outside of NLAD, should the Commission require providers to mask personally identifiable information? Would requesting consent bias the data in a way that would substantially reduce its usability?
26. If the Commission were to engage in an aggregate-level collection, are there any separate privacy concerns that would arise from such a collection? Are there any privacy concerns with the sharing of aggregated information for areas or plans with low ACP enrollments, including areas or plans with only a single subscriber? What is the minimum level of geographic data specificity (
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30. The Commission seeks comment on definitions of “personally identifiable information” that might be appropriate in this context. Should the Commission borrow a definition from another statute, regulation, Executive order, or Government-wide guidance? If so, which authority and why? For instance, Office of Management and Budget (OMB) Circular A-130 defines “personally identifiable information,” for purposes of agency information resources management activities, as “information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Similarly, the E-Government Act of 2002, defines “identifiable form” as “any representation of information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means.”
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32. Additionally, regardless of whether proprietary information means that of subscribers, participating providers, or both, commenters should address what constitutes proprietary information. Should the Commission treat “proprietary information” as limited to trade secrets and or privileged or confidential commercial, financial, or technical data? If so, what type of participating provider data collected under section 60502(c) could be considered proprietary? What other statutes or regulations might the Commission look to in interpreting “proprietary information” in this context? Does aggregate data become proprietary, for either a subscriber or a participating provider, at a certain level of granularity? Is it sufficient if subscribers or participating providers have an opportunity to request non-publication of proprietary information under procedures such as § 0.459 of the Commission's rules?
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41. Finally, the Commission seeks comment on how to evaluate and enforce the accuracy of the information presented in the ACP transparency data collection. How can the Commission verify the accuracy of the information that a broadband provider provides? How should the Commission protect against inaccuracies in the information provided? The Commission seeks comment on our proposal to require an officer of each provider to certify, under penalty of perjury, to the accuracy of the data and information provided prior to the submission of each data collection. The Commission seeks comment on further certifications and enforcement tools the Commission can use to ensure full and accurate participation in the data collection. The Commission seeks comment on whether a failure to comply with the rules the Commission establishes for the ACP data collection could subject a provider to the involuntary removal process the Commission established in the
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43. The Commission also seeks comment on the statutory requirement to revise the rules to verify the accuracy of the data within six months from when the Commission adopts final rules and its impact on this proceeding. What is intended by the language providing that “the Commission shall revise the rules to verify the accuracy of data submitted pursuant to the rules”? What is the purpose of the language limiting revisions to the final rules to verify accuracy? How should the Commission track and verify the accuracy of data submitted? What are the outer bounds on the period of time when the Commission must update its final rules? What circumstances should warrant revision of the rules? Should the updates to the rules include the possibility of adding new variables to improve or refine the data collected? How should the Commission determine when it is necessary to update the final rules? What other considerations should the Commission take into account when determining the necessity of updating the final rules for this data collection?
44. The Commission also seeks comment on the requirements of the Paperwork Reduction Act and the timing of the inaugural collection. In establishing the EBB Program and the Affordable Connectivity Program, the Consolidated Appropriations Act exempted the Commission from certain rulemaking requirements under the Administrative Procedure Act and the Paperwork Reduction Act. The Commission seeks comment on whether this exemption applies to rules established in this proceeding. Assuming the Paperwork Reduction Act requirements do apply to this collection, the Commission seeks comment on how this impacts the timing of the launch of the collection.
45.
46. This document contains proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the Commission seeks specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.
47. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this notice of proposed rulemaking (NPRM). Written comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the notice of proposed rulemaking provided on the first page of the item. The Commission will send a copy of the
48. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
49. In the Infrastructure Investment and Jobs Act (Infrastructure Act), Congress established the Affordable Connectivity Program (ACP), which is designed to promote access to broadband internet access services by households that meet specified eligibility criteria by providing funding for participating providers to offer certain services and connected devices to these households at discounted prices. The Affordable Connectivity Program provides funds for an affordable connectivity benefit consisting of a $30.00 per month discount on the price of broadband internet access services that participating providers supply to eligible households in most parts of the country and a $75.00 per month discount on such prices in Tribal areas. The Commission established rules governing the affordable connectivity benefit and related matters in the ACP Report and Order, 87 FR 8346 (Feb. 14, 2022).
50. The Infrastructure Act also directs the Commission to issue “final rules regarding the annual collection by the Commission relating to the price and subscription rates of each internet service offering of a participating provider under the Affordable Connectivity Program.”
51. This NPRM proposes rules to implement section 60502(c) of the Infrastructure Act, to provide greater transparency into broadband services provided by ACP participating providers, and to allow the Commission to assess its progress towards the ACP program goals. Specifically, the NPRM proposes establishing a mandatory annual data collection, collecting price, subscription rate, and plan characteristic information at the subscriber level through the National Lifeline Accountability Database (NLAD).
52. The NPRM seeks comment on what plan characteristics, data formats, and collection methods and timing should be collected or adopted. For example, the NPRM seeks comment on whether the Commission should collect information about plan speed or bundle characteristics, and it also seeks comment on what common data formats the Commission should collect and how the Commission should approach scheduling the annual collection of ACP transparency data. The NPRM also seeks comment on the burdens and benefits of requiring providers to submit information at the subscriber level, aggregate level, and alternative approaches.
53. In executing its obligations under the Infrastructure Act, the Commission intends to establish rules and requirements that implement the relevant provisions of the Infrastructure Act efficiently, with minimal burden on participating providers. These actions are consistent with our ongoing efforts to bridge the digital divide by ensuring that low-income households have access to affordable, high-quality broadband internet access service.
54. The proposed actions are authorized pursuant to the Infrastructure Act, div. F, tit. V, sec. 60502(c).
55. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one that: (1) is independently owned and operated; (2) is not dominant in its field of operation; (3) satisfies any additional criteria established by the Small Business Administration (SBA).
56.
57. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2020, there were approximately 447,689 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.
58. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicates that there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 general purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, the Commission estimates that at least 48,971 entities fall into the category of “small governmental jurisdictions.”
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61. In this NPRM, the Commission seeks comment on its proposal to require providers to provide subscriber level price, subscription rate, and plan characteristic information to the Commission. To the extent the Commission imposes an annual data collection, participating providers of all sizes would be required to maintain and report information concerning plan prices, subscription rates, and plan characteristics. Any recordkeeping or reporting requirements adopted in this proceeding however will apply only to those providers that choose to participate in the Affordable Connectivity Program.
62. In assessing the cost of compliance for small entities, at this time the Commission cannot quantify the cost of compliance with the potential rule changes that may be adopted and is not in a position to determine whether the proposals in the NPRM will require small entities to hire professionals in order to comply. The Commission seeks comment on its proposals and their likely costs and benefits as well as alternative approaches. The Commission expects the comments received will include information on the costs and benefits, service impacts, and other relevant matters that should help us identify and evaluate relevant issues for small entities, including compliance costs and other burdens (as well as countervailing benefits), so that the Commission may develop final rules that minimize such costs.
63. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
64. The NPRM seeks comments from all interested parties. The Commission is aware that some of the proposed collections under consideration will impact small entities. The NPRM does seek comment on the impact of its proposed rules on providers, and small entities are encouraged to bring to the Commission's attention any specific concerns that they may have with the proposals outlined in the NPRM.
65. The Commission will evaluate the economic impact on small entities, as identified in comments filed in response to the NPRM and this IRFA, in reaching its final conclusions and taking actions in this proceeding.
66. None.
67.
68.
69.
Internet telecommunications, Reporting and recordkeeping requirement, Telephone.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 54 as follows:
47 U.S.C. 151, 154(i), 155, 201, 205, 214, 219, 220, 229, 254, 303(r), 403, 1004, 1302, 1601-1609, and 1752, unless otherwise noted.
(e) * * *
(2) * * *
(ii) * * *
(A) Violations of the rules or requirements of the Affordable Connectivity Program, including rules and requirements related to the Affordable Connectivity Program transparency data collection, the Emergency Broadband Benefit Program, the Lifeline program, the Emergency Connectivity Fund or successor programs, or any of the Commission's Universal Service Fund program.
Participating providers shall transmit to the National Lifeline Accountability Database in a format prescribed by the Administrator each new and existing Affordable Connectivity Program (ACP) subscriber's full name; contact information; total monthly charge for internet service prior to any discounts (including bundled components, associated equipment, taxes, and fees); itemized breakdown of monthly charge including cost of ACP-supported service, associated equipment, discounts, taxes, and fees; plan characteristics, including upload and download speeds, average latency and packet loss, data caps, associated equipment requirements, for bundles, voice and video characteristics (
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2021 that prohibits the award of any DoD contracts to an entity that requires its employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict its employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative of DoD authorized to receive such information.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 22, 2022, to be considered in the formation of the final rule.
Submit comments identified by DFARS Case 2021-D018, using any of the following methods:
○
○
Comments received generally will be posted without change to
Ms. Kimberly R. Ziegler, telephone 703-901-3176.
DoD is proposing to amend DFARS subpart 203.9 to implement section 883 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283). Section 883 prohibits the award of a DoD contract to an entity that requires its employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict such employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative within DoD authorized to receive such information. The statute also requires entities to inform their employees of the limitations on confidentiality agreements or other statements. Offerors are required to represent compliance with the statutory restrictions prior to submitting an offer or quote.
The requirements of section 883 closely resemble those provided in section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), which was implemented at Federal Acquisition Regulation (FAR) 3.909, Prohibition on providing funds to an entity that requires certain internal confidentiality agreements or statements (82 FR 4717, dated January 13, 2017).
Differences between the statutory requirements are negligible; the most notable is that section 743 applies the prohibition to entities who require their employees or contractors to sign the internal confidentiality agreements or statements. Section 883, however, applies the prohibition to entities who require their employees to sign them. Since the prohibition at section 743 applies Governmentwide, DoD is currently complying with section 883 based on the FAR application of section 743 to employees and contractors.
The proposed rule implements section 883 of the NDAA for FY 2021 by utilizing the existing Governmentwide prohibition at FAR subpart 3.9 and clarifies the applicability of Governmentwide statutory guidance at DFARS 203.900. Section 883 provides
FAR 3.909-2(a) provides the representation in the System for Award Management required by section 883(a)(1). The representation refers to Government contracts and Federal departments or agencies, which includes DoD. FAR 3.909-2(b) provides direction to the contracting officer regarding reliance on an offeror's representation, as required in section 883(b).
FAR 3.909-3 prescribes the use of the solicitation provision at 52.203-18, Prohibition on Contracting with Entities That Require Certain Internal Confidentiality Agreements or Statements-Representation, and the contract clause at 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements, in all solicitations and contracts except those for a personal services contract with an individual. The contract clause at 52.203-19 requires the contractor to notify its current employees and subcontractors of these prohibitions and restrictions, fulfilling the requirement at section 883(a)(2).
The proposed rule revises the scope of DFARS subpart 203.9 to reconcile with FAR 3.900. The clause prescription at 203.970 is revised to clarify that DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights, which implements 10 U.S.C. 2409 (redesignated as 10 U.S.C. 4701), is applicable to solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items. The rule makes a conforming change to DFARS 212.301, Solicitation provisions and contract clauses for the acquisition of commercial items. While the clause was always applicable to all solicitations and contracts, the proposed revision is intended to reduce the risk of noncompliance.
This proposed rule implements section 883 of the NDAA for FY 2021 (Pub. L. 116-283) but does not create any new solicitation provisions or contract clauses. The rule revises the prescription for DFARS clause 252.203-7002, Requirement to Inform Employees of Whistleblower Rights, which implements 10 U.S.C. 2409, to require use of the clause in contracts valued at or below the simplified acquisition threshold and to acquisitions of commercial services and commercial products, including COTS items. Therefore, DoD intends to apply the rule to contracts at or below the SAT, and DoD intends to apply the rule to contracts for the acquisition of commercial products including COTS items and for the acquisition of commercial services.
The proposed rule, at DFARS 203.909-3, also prescribes use of FAR solicitation provision 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation, and FAR contract clause 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. The FAR clause and provision, except for personal services contracts, are already prescribed for use in acquisitions valued at or below the SAT; and the FAR clause 52.203-19 is also prescribed for use in commercial acquisitions.
41 U.S.C 1905 governs the applicability of laws to contracts or subcontracts in amounts not greater than the SAT. It is intended to limit the applicability of laws to such contracts or subcontracts. 41 U.S.C. 1905 provides that if a provision of law contains criminal or civil penalties, or if the Federal Acquisition Regulatory Council makes a determination that it is not in the best interest of the Federal Government to exempt contracts or subcontracts at or below the SAT, the law will apply to them. The Principal Director, Defense Pricing and Contracting (DPC), is the appropriate authority to make comparable determinations for regulations to be published in the DFARS, which is part of the FAR system of regulations. DoD does intend to make that determination. Therefore, this rule will apply at or below the SAT.
10 U.S.C. 3452 (previously 10 U.S.C. 2375) exempts contracts and subcontracts for the acquisition of commercial products, including COTS items, and commercial services from provisions of law enacted after October 13, 1994, unless the Under Secretary of Defense for Acquisition and Sustainment (USD (A&S)) makes a written determination that it would not be in the best interest of DoD to exempt contracts for the procurement of commercial products and commercial services from the applicability of the provision or contract requirement, except for a provision of law that—
• Provides for criminal or civil penalties;
• Requires that certain articles be bought from American sources pursuant to 10 U.S.C. 4862 (previously 10 U.S.C. 2533c), or that strategic materials critical to national security be bought from American sources pursuant to 10 U.S.C. 4863 (previously 10 U.S.C. 2533b); or
• Specifically refers to 10 U.S.C. 3452 and states that it shall apply to contracts and subcontracts for the acquisition of commercial products (including COTS items) and commercial services; or
• USD (A&S) determines in writing that it would not be in the best interest of the Government to exempt contracts or subcontracts for the acquisition of commercial products or commercial services from the applicability of the provision or contract clause requirement.
The statutes implemented in this rule do not impose criminal or civil penalties, do not require purchase pursuant to 10 U.S.C. 4862 or 4863, and do not refer to 10 U.S.C. 3452. Therefore, 10 U.S.C. 2409 will not apply to the acquisition of commercial services or commercial products including COTS items unless a written determination is made. Due to delegations of authority, the Principal Director, DPC is the appropriate authority to make this determination. DoD intends to make a determination to apply this rule and the corresponding statutes (10 U.S.C. 2409 and section 883 of the NDAA for FY 2021) to acquisitions at or below the SAT and for commercial services and commercial products, including COTS items.
DoD is proposing to apply the requirements of 10 U.S.C. 2409 and section 883 of the NDAA for FY 2021 to contracts at or below the SAT and to the acquisition of commercial services and commercial products, including COTS items, because the statutory protections are intended to apply to any employee of a contractor or subcontractor who discloses or may be restricted from disclosing evidence of waste, fraud, or abuse. The statutes only exempt the application to elements of the intelligence community.
10 U.S.C. 2409 provides contractor employees protection from reprisal for disclosure of waste, fraud, and abuse to designated persons and bodies identified in the statute. An employee of a contractor or subcontractor may not be discharged, demoted, or otherwise discriminated against as a reprisal for such a disclosure. The statute does not apply to elements of the intelligence committee.
Section 883 prohibits the award of any DoD contract to an entity that requires its employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict its employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative of DoD authorized to receive such information.
It is not in the best interest of the Federal Government to exempt application of this rule to actions below the SAT or to commercial services and commercial products, including COTS items. An exception for contracts below the SAT and those for commercial services and commercial products, including COTS items, would exclude the majority of the contracts and individuals intended to be protected under the laws, thereby undermining the overarching public policy purpose of the laws.
This proposed rule is not expected to have a significant impact on the public or Government agencies, because the requirements of section 883 have already been implemented Governmentwide at FAR 3.909. DoD-specific implementation of section 883 would duplicate the previous implementation of section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) as implemented Governmentwide in the FAR.
Executive Orders (E.O.s) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules Under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule proposes to amend the DFARS to implement section 883 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283). Section 883 prohibits the award of a DoD contract to an entity that requires its employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict such employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative within DoD authorized to receive such information.
The objective of the rule is to implement the DoD-specific statute that removes restrictions on the ability of employees to report waste, fraud, or abuse to the appropriate DoD authorities. The legal basis of the rule is section 883 of the NDAA for FY 2021.
This rule will apply to all small entities that are eligible to receive DoD contracts; however, the requirements of section 883 are already met through the Governmentwide implementation of a previously published prohibition at FAR 3.909 and in the System for Award Management (SAM) representations and certifications. As a result, the 361,000 unique small entities registered in SAM as of January 12, 2021, are already compliant with these requirements and will not be required to take any additional action to comply with the DoD-specific prohibition in section 883.
The rule does not impose any new reporting, recordkeeping, or compliance requirements.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no practical alternatives that will accomplish the objectives of the statute.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2021-D018), in correspondence.
This rule does not contain any information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government Procurement.
Therefore, 48 CFR parts 203 and 212 are proposed to be amended as follows:
41 U.S.C 1303 and 48 CFR chapter 1.
This subpart implements 10 U.S.C. 2409 and section 883 of the National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283).
(a)(i) 10 U.S.C. 2409 provides DoD whistleblower protection policies and procedures for contractor employees. Use sections 203.901 through 203.906 of this subpart in lieu of FAR sections 3.901 through 3.906 to implement 10 U.S.C. 2409.
(ii) 10 U.S.C. 2409 does not apply to any element of the intelligence community, as defined in 50 U.S.C. 3003(4). Sections 203.901 through 203.906 do not apply to any disclosure made by an employee of a contractor or subcontractor of an element of the intelligence community if such disclosure—
(A) Relates to an activity or an element of the intelligence community; or
(B) Was discovered during contract or subcontract services provided to an element of the intelligence community.
(c) Section 883 of the National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283) prohibits the award of a DoD contract to contractors that require their employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict such employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative within DoD authorized to receive such information.
Use the provision at FAR 52.203-18, Prohibition on Contracting with Entities That Require Certain Internal Confidentiality Agreements or Statements—Representation, and the clause at FAR 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements, prescribed at FAR 3.909-3 to implement section 883 of the National Defense Authorization Act for Fiscal Year 2021.
Use the clause at 252.203-7002, Requirement to Inform Employees of Whistleblower Rights, in all solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items.
41 U.S.C 1303 and 48 CFR chapter 1.
(f) * * *
(i) * * *
(C) Use the clause at 252.203-7002, Requirement to Inform Employees of Whistleblower Rights, as prescribed in 203.970, to comply with 10 U.S.C. 2409.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to allow for the efficient and accurate identification of contracts subject to excise tax withholding. DoD is also proposing to prohibit use of the Governmentwide commercial purchase card as a method of payment when the tax on certain foreign procurements applies. These changes will promote the efficient administration of the excise tax.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 22, 2022, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2021-D029, using any of the following methods:
○
○
Comments received generally will be posted without change to
David E. Johnson, telephone 202-913-5764.
DoD is proposing to revise the DFARS to allow for the accurate identification of contracts subject to excise tax withholding, as well as the proper identification of those contracts for which the contractor claimed a full exemption from the tax. Section 301 of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), codified at 26 U.S.C. 5000C, imposes a two-percent excise tax on specified Federal procurement payments to certain foreign persons; it does not apply to payments to United States persons. With certain exceptions, to administer this tax DoD must withhold an amount equal to two percent of the amount of specified Federal procurement payments.
Federal Acquisition Regulation (FAR) solicitation provision 52.229-11, Tax on Certain Foreign Procurements—Notice and Representation, provides offerors an opportunity to claim a full exemption from the tax at the time of their offer. The proposed DFARS contract clause 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, is needed because presently no guidance, requirement, or mechanism exists to document an offeror's claim of full exemption from the tax.
Currently, the contract clause at FAR 52.229-12, Tax on Certain Foreign
DoD is also proposing to prohibit use of the Governmentwide commercial purchase card (GCPC) as a method of payment on contracts subject to the two-percent excise tax. When the GCPC is used as a method of payment, a third party,
This proposed rule is intended to promote efficient administration of the two-percent excise tax. It does not impose a new requirement or burden on contractors or the public. Rather, this proposed rule likely benefits contractors by minimizing the likelihood of erroneous withholding of the two-percent excise tax.
This proposed rule applies to Federal Government contracts that include FAR clause 52.229-12, that are valued over $250,000, and that are awarded to foreign persons for goods or services, if the goods are manufactured or produced or the services are provided in any country that is not a party to an international procurement agreement with the United States (see FAR 25.003 for the definitions of “World Trade Organization Government Procurement Agreement (WTO GPA) country” and “Free Trade Agreement country”). FAR 29.402-3(b) requires FAR clause 52.229-12 to be included in solicitations in which FAR provision 52.229-11 is included and in the resulting contract when the contractor represented that it is a foreign person.
Paragraph (d)(2) of FAR provision 52.229-11 allows the offeror to claim either a “full exemption” or a “partial or no exemption” from the excise tax. However, in accordance with FAR 29.402-3, FAR 52.229-12 will be included in the resulting contract where the offeror had indicated that it is a foreign person, regardless of whether the offeror may have claimed a full exemption as part of their offer.
The DoD finance and accounting systems utilize the presence of various FAR clauses in contracts to determine entitlement to payment, including required offsets and withholds. However, the presence or absence of FAR 52.229-12 in contracts does not in itself allow DoD payment systems or networks to determine whether withholding the two-percent excise tax is correct for a given contract or whether a contractor had claimed a full exemption in their initial offer.
The proposed clause at DFARS 252.229-70XX, by its inclusion in the contract, will provide for a simple and efficient method for contracting officers to alert the DoD payment systems and networks that a contractor claimed a full exemption in its offer, thereby preventing erroneous withholding of the two-percent excise tax. This clause would also complement FAR 52.229-12 in applicable contracts where FAR 52.229-12 requires contractors to notify contracting officers of a change in circumstances concerning the full exemption during the performance of the contract, causing the contractor to be subject to the tax.
This rule proposes to create a new DFARS clause 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, to implement section 301 of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), codified at 26 U.S.C. 5000C. The clause at DFARS 252.229-70XX is prescribed at DFARS 229.402-70(k) for use in contracts that include the clause at FAR 52.229-12, Tax on Certain Foreign Procurements, for which the contractor represented in its offer that it is a foreign person and is fully exempt from the tax for reasons cited on their IRS Form W-14. FAR 52.229-12 is used when FAR 52.229-11, Tax on Certain Foreign Procurements—Notice and Representation, is used; and FAR 52.229-11 does not apply to acquisitions that do not exceed the simplified acquisition threshold. Accordingly, DoD does not intend to apply the rule to acquisitions at or below the SAT but does intend to apply the rule to the acquisition of commercial services and commercial products, including COTS items.
41 U.S.C. 1905 governs the applicability of laws to contracts or subcontracts in amounts not greater than the simplified acquisition threshold. It is intended to limit the applicability of laws to such contracts or subcontracts. 41 U.S.C. 1905 provides that if a provision of law contains criminal or civil penalties, or if the Federal Acquisition Regulatory Council makes a written determination that it is not in the best interest of the Federal Government to exempt contracts or subcontracts at or below the SAT, the law will apply to them. The Principal Director, Defense Pricing and Contracting (DPC), is the appropriate authority to make comparable determinations for regulations to be published in the DFARS, which is part of the FAR system of regulations. DoD does not intend to make that determination. Therefore, this rule will not apply at or below the SAT.
10 U.S.C. 3452 (previously 10 U.S.C. 2375) exempts contracts and subcontracts for the acquisition of commercial products, including COTS items, and commercial services from provisions of law enacted after October 13, 1994, unless the Under Secretary of Defense for Acquisition and Sustainment (USD(A&S)) makes a written determination that it would not be in the best interest of DoD to exempt contracts for the procurement of commercial products and commercial services from the applicability of the provision or contract requirement, except for a provision of law that—
• Provides for criminal or civil penalties;
• Requires that certain articles be bought from American sources pursuant to 10 U.S.C. 4862 (previously 10 U.S.C. 2533c), or that strategic materials critical to national security be bought from American sources pursuant to 10 U.S.C. 4863 (previously 10 U.S.C. 2533b); or
• Specifically refers to 10 U.S.C. 3452 and states that it shall apply to contracts and subcontracts for the acquisition of commercial products (including COTS items) and commercial services; or
• USD(A&S) determines in writing that it would not be in the best interest of the Government to exempt contracts or subcontracts for the acquisition of commercial products or commercial services from the applicability of the provision or contract clause requirement.
Section 301 of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), codified at 26 U.S.C. 5000C and implemented by this rule, does not impose criminal or civil penalties; does not require purchase pursuant to 10 U.S.C. 4862 or 4863; and does not refer to 10 U.S.C. 3452. Section 301 will not apply to the acquisition of commercial services or commercial products including COTS items unless a written determination is made. Due to delegations of authority from USD(A&S), the Principal Director, DPC, is the appropriate authority to make the written determination. DoD intends to make that determination to apply this rule to the acquisition of commercial services and commercial products including COTS items, if otherwise applicable.
The proposed clause at 252.229-70XX is intended to provide a simple and efficient way for contracting officers to alert the DoD payment systems and networks that a contractor claimed a full exemption from the two-percent excise tax in its offer, thereby preventing erroneous withholding of the tax. Not applying the clause to contracts for the acquisition of commercial services and commercial products, including COTS items, would exclude contracts intended to be covered by this proposed rule and undermine the overarching purpose of the rule. Consequently, DoD plans to apply the proposed rule to contracts for the acquisition of commercial services and commercial products, including COTS items.
This proposed rule will promote efficient administration of the two-percent excise tax. It imposes no new requirement or burden on contractors or the public. Rather, this proposed rule likely benefits contractors by minimizing the possibility of erroneous withholding of the two-percent excise tax. Additionally, the two-percent excise tax applies only to specified Federal procurement payments to certain foreign persons; it does not apply to payments to U.S. persons.
Executive Orders (E.O.s) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This proposed rule aids the administration of the two-percent excise tax on specified Federal procurement payments to certain foreign persons by prescribing inclusion of a new DFARS clause in contracts when the tax on certain foreign procurements applies and the contractor claimed a full exemption from the tax. Further, this proposed rule prohibits use of the Governmentwide commercial purchase card as a method of payment when the tax on certain foreign procurements applies and the contractor did not claim a full exemption.
The objective of this proposed rule is to promote efficient administration of the two-percent excise tax on specified Federal procurement payments to certain foreign persons. The legal basis for the rule is 41 U.S.C. 1303 and section 301 of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), codified at 26 U.S.C. 5000C.
The proposed rule applies to Federal Government contracts that include the clause at FAR 52.229-12, Tax on Certain Foreign Procurements; that are valued over $250,000; and that are awarded to foreign persons for goods or services, if the goods are manufactured or produced or the services are provided in any country that is not a party to an international procurement agreement with the United States (see FAR 25.003 for the definitions of “World Trade Organization Government Procurement Agreement (WTO GPA) country” and “Free Trade Agreement country”). Data for fiscal year 2021 was obtained from the Federal Procurement Data System for contract awards reflecting these criteria. There were 123 total contract awards; 117 were awarded to 56 unique large entities and 6 were awarded to 4 unique small entities for a total of 60 unique foreign entities. Accordingly, the proposed rule is not expected to have a significant impact on small entities based in the United States.
This rule imposes no reporting, recordkeeping, or other compliance requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known available alternatives to the proposed rule to accomplish the desired objective.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2021-D029), in correspondence.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 1545-2263, entitled Tax on Certain Foreign Procurement.
Government procurement.
Therefore, 48 CFR parts 213, 229, 232, and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(4) The contracting officer shall not authorize the Governmentwide commercial purchase card as a method of payment during any contract period of performance if the contract includes the clause at FAR 52.229-12, Tax on Certain Foreign Procurements, unless the contract also includes the clause at 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, indicating that the contractor is fully exempt from the tax.
The contracting officer shall not authorize the Governmentwide commercial purchase card as a method of payment during any contract period of performance if the contract includes the clause at FAR 52.229-12, Tax on Certain Foreign Procurements, unless the contract also includes the clause at 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, indicating that the contractor is fully exempt from the tax.
(k) Use the clause at 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, in contracts that include the clause at FAR 52.229-12, Tax on Certain Foreign Procurements, when the contractor has—
(1) Represented that it is a foreign person in response to the provision at FAR 52.229-11, Tax on Certain Foreign Procurements—Notice and Representation; and
(2) Indicated that it is fully exempt from the tax for reasons cited on their IRS Form W-14, Certificate of Foreign Contracting Party Receiving Federal Procurement Payments.
The contracting officer shall not authorize the Governmentwide commercial purchase card as a method of payment during any contract period of performance if the contract includes the clause at FAR 52.229-12, Tax on Certain Foreign Procurements, unless the contract also includes the clause at 252.229-70XX, Full Exemption from Two-Percent Excise Tax on Certain Foreign Procurements, indicating that the contractor is fully exempt from the tax.
As prescribed in 229.402-70(k), use the following clause: FULL EXEMPTION FROM TWO-PERCENT EXCISE TAX ON CERTAIN FOREIGN PROCUREMENTS (DATE)
(a) As the Contractor represented in its offer, any item, including any item delivered under subcontract; any service; or any combination thereof delivered under this contract is fully exempt from the 2-percent excise tax withholding imposed by 26 U.S.C. 5000C and implemented by Federal Acquisition Regulation (FAR) 52.229-12, Tax on Certain Foreign Procurements.
(b) If the full exemption no longer applies due to a change in circumstances during the performance of the contract, causing the Contractor to become subject to the withholding for the 2-percent excise tax as imposed by 26 U.S.C. 5000C, then the Contractor shall immediately comply with the notification and billing requirements of FAR clause 52.229-12.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to reclassify
We will accept comments received or postmarked on or before August 22, 2022. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments on this proposed rule by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Edwin Muñiz, Field Supervisor, U.S. Fish and Wildlife Service, Caribbean Ecological Services Field Office, P.O. Box 491, Boquerón, PR 00622; telephone: (787) 851-7297. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
The status of
Although population numbers and abundance of
We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule.
We particularly seek comments concerning:
(1) Reasons we should or should not downlist
(2) Information on the historical and current status, range, distribution, and population size of
(3) Information on the known and potential threats to
(4) Information regarding the life history, ecology, and habitat use of
(5) Current or planned activities within the geographic range of
(6) Information on regulations that are necessary and advisable to provide for the conservation of
(7) Information concerning the extent to which we should include any of the Act's section 9 prohibitions in the 4(d) rule or whether we should consider any additional exceptions from the prohibitions in the 4(d) rule (to the extent permitted by Commonwealth law).
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act (16 U.S.C. 1531
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation used in preparing this proposed rule will be available for public inspection at Docket No. FWS-R4-ES-2021-0058 on
Because we will consider all comments and information we receive during the comment period, our final determination may differ from this proposal. Based on the new information we receive (and any comments on that new information), we may conclude that the species should remain listed as endangered instead of being reclassified as threatened, or we may conclude that the species no longer warrants listing as either an endangered species or a threatened species. In addition, we may change the parameters of the proposed prohibitions or the proposed exceptions to those prohibitions if we conclude it is appropriate in light of comments and new information we receive. For example, we may expand the proposed prohibitions to include prohibiting additional activities if we conclude that those additional activities are not compatible with conservation of the species. Conversely, we may establish additional exceptions to the prohibitions in the final rule if we conclude that the activities would facilitate or are compatible with the conservation and recovery of the species.
Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in
In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” which was published on July 1, 1994 (59 FR 34270) and our August 22, 2016, Director's Memorandum “Peer Review Process,” we will seek the expert opinion of at least three appropriate and independent specialists regarding scientific data and interpretations contained in this proposed rule. We will send copies of this proposed rule to the peer reviewers immediately following publication in the
On September 9, 1994, we published in the
On September 27, 2006, and August 22, 2016, we initiated 5-year reviews for the species (71 FR 56545 and 81 FR 56692, respectively) and completed them on April 27, 2011 (Service 2011, entire), and September 25, 2018 (Service 2018a, entire). In those two reviews, we determined the species no longer met the definition of an endangered species and should be reclassified to threatened. The 5-year reviews are available at
For additional details on previous Federal actions, see Recovery, below. See
A thorough review of the taxonomy, life history, ecology, and overall viability of
The reproductive biology of
The timing and spatial distribution of seedlings indicate the species produces viable seeds that stay in the soil seedbank until the next rain event (Service 2018b, p. 6).
We have little information about
In Puerto Rico,
When listed,
At the time of listing and in the subsequent 5-year status reviews, occurrences of
Since the time of listing and the recovery plan development, new information on abundance and distribution has been gained through targeted surveys (Service 2007 and 2017, unpubl. data) and incidental observations. By 2011, seven
To date, 10 natural localities and 1 introduced locality comprise the Puerto Rico population; 8 of these are within the GCF and 3 are on private properties (Ballena beach, Cerro Toro, and Monte de la Ventana, which extends into the GCF). Based on the surrounding vegetation structure and the presence of exposed limestone observed in aerial images of the GCF, additional suitable habitat for the species has been identified and may contain unknown localities of
The increase in the number of localities recorded in Puerto Rico reflects additional survey efforts since the time of listing, while the increase in the number of individuals likely reflects the species' seasonal response to rain events (Service 2018b, p. 3). The species shows a large reproductive output after the rainy season (high number of seedlings) followed by a low number of mature adults counted during the next rainy season. Therefore, timing and seasonality of surveys affects abundance estimates.
On Saba Island, current information indicates the species occurs in several localities along the road between The Bottom and Windward Side towns in the southern section of the island (Rojer 1997, p. 19); however, no population estimate is available and the 1997 assessment does not include a population estimate. On Anegada Island, surveys for
Throughout its range in Puerto Rico,
On Saba Island, the best available information indicates the species occurs on Gile's cherty sandy loam soil found between The Bottom and Windward Side towns. This arid section of the island is located in the south portion of
Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the Lists of Endangered and Threatened Wildlife and Plants.
Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species, or to delist a species, is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.
There are many paths to accomplishing recovery of a species, and recovery may be achieved without all criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the Act's definition of an endangered species or a threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all the guidance provided in a recovery plan.
The following discussion provides an analysis of the recovery criteria and goals as they relate to evaluating the status of the taxon. The recovery plan for
Criterion 1 states that threat reduction and management activities have been implemented to a degree that the species will remain viable into the foreseeable future. This criterion has been partially met. Eighty-nine percent of the currently known
Two localities on private lands are subject to potential development pressure. The Ballena beach locality is subject to development pressure in the past with proposals for the development of a hotel in that area. Although this project has not been constructed to date, the threat remains. In Monte de la Ventana, development of a wind farm project is expected to affect the species. This project and the effects to
Evidence of fire has been recorded on or adjacent to
These threats of fire, development, nonnative and invasive species, and road and trail maintenance, coupled with competition with other plant species for specific habitat requirements such as holes and cracks for seed germination, and observed lack of dispersal mechanisms, reduce the species' ability to colonize other areas. Therefore, we determined that, while threat reduction and management activities at GCF have been implemented and have improved the species' viability, they have not been
Criterion 2 states that existing natural populations of
Criterion 3 states that at least three new populations of
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an endangered species or a threatened species. The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:
(A) The present or threatened destruction, modification, or curtailment of its habitat or range;
(B) Overutilization for commercial, recreational, scientific, or educational purposes;
(C) Disease or predation;
(D) The inadequacy of existing regulatory mechanisms; or
(E) Other natural or manmade factors affecting its continued existence.
These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects. We consider these same five factors in downlisting a species from endangered to threatened (50 CFR 424.11(c) and (d)).
We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.
However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.
The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term foreseeable future extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.
It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of
In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability. In addition, the 5-year review (Service 2018a, entire) documents our comprehensive biological status review for the species, including an assessment of the potential threats to the species. The following is a summary of this status review and the best available information gathered since that time that have informed this decision.
Habitat destruction and modification (Factor A) were identified as factors affecting the continued existence of
Currently,
The largest cluster of
Fires are not a natural event in the subtropical dry forests in Puerto Rico, and the native vegetation in the Caribbean is not adapted to this type of disturbance (Brandeis and Woodall 2008, p. 557; Santiago-García
Fire affects
Human-caused fires lead to the destruction of native vegetation by direct impacts to individuals and to the seedbank (which is not fire-adapted). Therefore, it is very likely that fires reduce or eliminate
Fire negatively impacts
Caribbean dry forests generally have seedbanks with low numbers and variety of species, and forest regeneration in areas disturbed through mechanical vegetation removal or through burning is largely dependent on propagules or seeds from nearby habitats (Wolfe 2009, p. 28). Nonnative species typically become established more quickly and may have less specific habitat or life-history requirements than native species. When nonnative species become established in a disturbed habitat, they outcompete native species for resources including space, nutrients, water, and sunlight. The impacts of nonnative invasive species are second only to habitat loss and degradation as a threat to global biodiversity and are among the greatest threats to the persistence of native rare species and their habitats in Puerto Rico (Thomson 2005, p. 615, García-Cancel 2013, entire). Nonnative species like guinea grass, buffel grass, pajón, and African grass (
As previously mentioned, 89 percent of the currently known
Since 2010, we have been working with the landowner on the development and implementation of conservation measures to avoid or minimize adverse effects on the species and its habitat caused by the proposed development of the wind farm project. This wind farm project is covered by an incidental take permit (ITP) under a habitat conservation plan (HCP) that includes conservation measures to minimize adverse effects to listed species in the project area (Service 2013, p. 3). Although a substantial portion of this property is identified as a conservation area under the HCP, the conservation areas do not include habitat for
The Ballena beach locality has been subject to development pressure in the past with proposals for the development of a hotel in that area. Although this hotel development project has not been constructed, we do not have evidence it will not be pursued in the future.
On Anegada and Saba Islands,
In summary, impacts associated with habitat destruction and modification due to vegetation clearance for maintenance and improvement activities of roads and trails, urbanization and tourism development, human-caused fires, and encroachment of nonnative plant species have been documented as current threats to
At the time of listing, we identified the species' limited distribution (
Small population size can exacerbate other threats acting on the species. Most species' populations fluctuate naturally, responding to various factors such as weather events, disease, and predation. These factors have a relatively minor impact on a species with large, stable local populations and a wide and continuous distribution. However, populations that are small, isolated by habitat loss or fragmentation, or impacted by other factors are more vulnerable to extirpation by natural, randomly occurring events (such as predation or stochastic weather events), and to genetic effects that plague small populations, collectively known as small population effects (Purvis
The Mesetas trail locality in GCF, the most abundant locality with 13,064 adults, is numerically strong; the remaining 9 natural localities on Puerto Rico are smaller localities with varying degrees of connectivity and cross-pollination between localities. The information regarding
The Intergovernmental Panel on Climate Change (IPCC) concluded that evidence of warming of the climate system is unequivocal (IPCC 2014, pp. 2, 40). Observed effects associated with climate change include widespread changes in precipitation amounts, increased extreme weather events including droughts, heavy precipitation, heat waves, more intense tropical cyclones, and an increase in sea level (IPCC 2014, pp. 40-44). Rather than assessing climate change as a single threat in and of itself, we examined the potential consequences to the species and its habitat that arise from changes in environmental conditions associated with various aspects of climate change (temperature, precipitation, and sea level rise). Climatic changes may affect the phenology, abundance, and distribution of many species (Walther
The IPCC-modelled scenarios for the Caribbean islands predict precipitation declines, sea level rise, stronger and more frequent extreme weather events, and temperature increases by 2050 (Penn 2010, p. 45; Khalyani
Modeling shows dramatic changes to Puerto Rico through 2100; however, the divergence in these projections increases after mid-century (Khalyani
The IPCC global models and scenarios analyzed for the downscaled models apply to the Caribbean islands. Downscaled general circulation models predict dramatic shifts in the life zones of Puerto Rico with potential loss of subtropical rain, moist, and wet forest, and the appearance of tropical dry and very dry forests anticipated (Khalyani
Sea level rise is another expected effect of climate change that may affect coastal communities and habitat in the Caribbean islands (Penn 2010, entire; Lorde 2011, entire; Strauss and Kulp 2018, p. 1). Integrated sea level rise projection and flood risk analysis predict floods reaching 0.5 m (1.64 ft) above current high tide levels will become common events throughout most of the Caribbean by 2050 (Strauss and Kulp 2018, p. 2). Other scenarios using RCP4.5 and 8.5 forecast that by mid-century, sea level is expected to increase by 0.24 m (0.8 ft) to 0.85 m (2.8 ft) (Church
In summary, other natural and human-caused factors, such as the limited distribution of the three known natural populations and the effects of climate change (
In the final listing rule (59 FR 46715; September 9, 1994), we identified the inadequacy of existing regulatory mechanisms as one of the factors affecting the continued existence of
Presently,
Although there are legal mechanisms in place (
On Anegada Island, various conservation and education efforts are taking place for the protection of rare plant and animal species (Gardner
Outside of the protections provided by the Act, as previously indicated, the Commonwealth of Puerto Rico legally protects
We have carefully assessed the best scientific and commercial information available regarding the threats faced by
Species viability, or the species' ability to sustain populations over time, is related to the species' ability to withstand catastrophic events (redundancy), to adapt to changing environmental conditions (representation), and to withstand stochastic disturbance of varying magnitude and duration (resiliency). The viability of a species is also dependent on the likelihood of new stressors or continued threats, now and in the future, that act to reduce a species' redundancy, representation, and resiliency.
We evaluated the biological status of this species, both currently and into the future, considering the species' viability as characterized by its resiliency, redundancy, and representation.
For
We broadly define categories of resiliency for
Currently, three
The short time it takes
The species' viability is also affected by its ability to adapt to changing environmental conditions. We have no information on the genetic variability of
The ability of the species to adapt is also a function of the level of gene flow between populations. The three populations are disconnected; thus, gene flow is limited to individuals within populations. Small, isolated populations are susceptible to the loss of genetic diversity, genetic drift, and inbreeding, which will affect the ability of the species to adapt to changing environmental conditions over time. At this time, the most updated information shows that the species' occurrences remain stable; thus, the species does not appear to be affected by genetic drift at present. However, gene flow is limited to individuals within populations due to the lack of connectivity that would allow cross-pollination among populations. As fragmentation increases, gene flow will be reduced further, and the populations will become more vulnerable to genetic drift and inbreeding, thereby reducing the species' ability to adapt to changing conditions. We determined
Lastly, the species' viability depends on its ability to withstand catastrophic events, which is a function of the number and distribution of
In summary, the current abundance of
Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. For a more detailed discussion on the factors considered when determining whether a species meets the definition of an endangered species or a threatened species and our analysis on how we determine the foreseeable future in making these decisions, please see Regulatory and Analytical Framework.
After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we have determined that
At the time of listing, the known range of
However, although now known to be more widespread and abundant than previously thought, the remaining 11 percent of individuals on Puerto Rico and individuals on Saba and Anegada Islands occur on private lands and are at risk due to habitat destruction and modification from wind farm projects, urbanization, and tourism development. Accidental damage to
Furthermore, the species' distribution is wider than known at the time of listing, and the species' listing by the Commonwealth of Puerto Rico provides some level of protection to
In summary,
Based on biological factors and stressors to the species' viability, we determined 25 years to be the foreseeable future within which we can reasonably project threats and the species' response to those threats. The foreseeable future for the individual factors and threats varies. We reviewed available information including forest management plans, proposed development projects, and fire history within the range of the species, to inform our assessment of likely future levels for each threat. Projections out to the year 2050 predict increases in temperature and decreases in precipitation (Khalyani
The 25-year period includes multiple generations of the species and allows adequate time for impacts from conservation efforts or changes in threats to be observed through population responses. For example, this timeframe accounts for the species' reproductive biology, and thus the time required by multiple generations of
Although population numbers and abundance of
Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. The court in
Following the court's holding in
For
Habitat modification poses a threat to most of the 11
Small population size can exacerbate other threats acting on the species. The information regarding
Overall, we found that threats are likely acting on individuals or populations similarly across the species' range. These threats are certain to occur, and populations are facing the same extent of threats, even though certain populations may have fewer occurrences. We found no concentration of threats in any portion of
Our review of the best available scientific and commercial information indicates that
It is our policy, as published in the
Section 4(d) of the Act contains two sentences. The first sentence states that the Secretary shall issue such regulations as she deems necessary and advisable to provide for the conservation of species listed as threatened. The U.S. Supreme Court has noted that statutory language like “necessary and advisable” demonstrates a large degree of deference to the agency (see
The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, courts have upheld rules developed under section 4(d) as a valid exercise of agency authority where they prohibited take of threatened wildlife or include a limited taking prohibition (see
The provisions of this proposed 4(d) rule would promote the conservation of
Exercising this authority under section 4(d) of the Act, we have developed a proposed rule that is designed to address
The protective regulations we are proposing for
In particular, this proposed 4(d) rule would provide for the conservation of
Despite these prohibitions regarding threatened species, we may under certain circumstances issue permits to carry out one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened plants state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species (50 CFR 17.72). Those regulations also state that the permit shall be governed by the provisions of § 17.72 unless a special rule applicable to the plant is provided in §§ 17.73 to 17.78. Therefore, permits for threatened species are governed by the provisions of § 17.72 unless a species-specific 4(d) rule provides otherwise. However, under our recent revisions to § 17.71, the prohibitions in § 17.71(a) will not apply to any plant listed as a threatened species after September 26, 2019. As a result, for threatened plant species listed after that date, any protections must be contained in a species-specific 4(d) rule. We did not intend for those revisions to limit or alter the applicability of the permitting provisions in § 17.72, or to require that every species-specific 4(d) rule spell out any permitting provisions that apply to that species and species-specific 4(d) rule. To the contrary, we anticipate that permitting provisions would generally be similar or identical for most species, so applying the provisions of § 17.72 unless a species-specific 4(d) rule provides otherwise would likely avoid substantial duplication. Moreover, this interpretation brings § 17.72 in line with the comparable provision for wildlife at 50 CFR 17.32, in which the second sentence states that the permit shall be governed by the provisions of § 17.32 unless a special rule applicable to the wildlife, appearing in 50 CFR 17.40 to 17.48, provides otherwise. Under 50
We recognize the beneficial and educational aspects of activities with seeds of cultivated plants, which generally enhance the propagation of the species and, therefore, would satisfy permit requirements under the Act. We intend to monitor the interstate and foreign commerce and import and export of these specimens in a manner that will not inhibit such activities, providing the activities do not represent a threat to the species' survival in the wild. In this regard, seeds of cultivated specimens would not be subject to the prohibitions above, provided that a statement that the seeds are of “cultivated origin” accompanies the seeds or their container (50 CFR 17.71(a)).
We recognize the special and unique relationship with our State and Territorial natural resource agency partners in contributing to conservation of listed species. State and Territorial agencies often possess scientific data and valuable expertise on the status and distribution of endangered, threatened, and candidate species of wildlife and plants. State and Territorial agencies, because of their authorities and their close working relationships with local governments and landowners, are in a unique position to assist us in implementing all aspects of the Act. In this regard, section 6 of the Act provides that the Service shall cooperate to the maximum extent practicable with the States and Territories in carrying out programs authorized by the Act. Therefore, any qualified employee or agent of a Territorial conservation agency that is a party to a cooperative agreement with us in accordance with section 6(c) of the Act, who is designated by his or her agency for such purposes, would be able to conduct activities designed to conserve
Nothing in this proposed 4(d) rule would change in any way the recovery planning provisions of section 4(f) of the Act, the consultation requirements under section 7 of the Act, or our ability to enter into partnerships for the management and protection of
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We have determined that no Tribes will be affected by this proposed reclassification.
A complete list of references cited in this rulemaking is available on the internet at
The primary authors of this proposed rule are the staff members of the Caribbean Ecological Services Field Office.
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
(l)
(1)
(i) Import or export, as set forth at § 17.61(b) for endangered plants.
(ii) Remove and reduce to possession the species from areas under Federal jurisdiction; maliciously damage or destroy the species on any such area; or remove, cut, dig up, or damage or destroy the species on any other area in knowing violation of any law or regulation of the Territory or in the course of any violation of a Territorial criminal trespass law.
(iii) Interstate or foreign commerce in the course of commercial activity, as set forth at § 17.61(d) for endangered plants.
(iv) Sale or offer for sale, as set forth at § 17.61(e) for endangered plants.
(2)
(i) Conduct activities as authorized by permit under § 17.72.
(ii) Remove, cut, dig up, damage, or destroy on areas not under Federal jurisdiction if you are a qualified employee or agent of the Service or Territorial conservation agency which is a party to a cooperative agreement with the Service in accordance with section 6(c) of the Act, and you have been designated by that agency for such purposes, when acting in the course of official duties.
(iii) Engage in any act prohibited under paragraph (l)(1) of this section with seeds of cultivated specimens, provided that a statement that the seeds are of “cultivated origin” accompanies the seeds or their container.
Agricultural Marketing Service, USDA.
Notice to solicit nominees.
The Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is seeking nominations for individuals to serve on the USDA Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets no less than once annually to advise AMS on the programs and services it delivers under the U.S. Grain Standards Act (USGSA). Recommendations by the Advisory Committee help AMS better meet the needs of its customers who operate in a dynamic and changing marketplace.
AMS will consider nominations received before or on August 8, 2022.
Submit nominations for the Advisory Committee by completing form AD-755 and send via email as an attachment to:
Kendra Kline, Telephone (202) 690-2410 or Email
As required by section 21 of the USGSA (7 U.S.C. 87j), as amended, the Secretary of Agriculture (Secretary) established the Advisory Committee on September 29, 1981, to provide advice to the AMS Administrator on implementation of the USGSA. As specified in the USGSA, no member may serve successively for more than 2 terms.
The Advisory Committee consists of 15 members, appointed by the Secretary, who represent the interests of grain producers, processors, handlers, merchandisers, consumers, exporters, and scientists with expertise in research related to the policies in section 2 of the USGSA (7 U.S.C. 74). While members of the Advisory Committee serve without compensation, USDA reimburses them for travel expenses, including per diem in lieu of subsistence, for travel away from their homes or regular places of business in performance of Advisory Committee service (see 5 U.S.C. 5703).
A list of current Advisory Committee members and other relevant information are available on the USDA website at:
The grain industry that utilizes Official Inspection and Weighing services for barley, canola, corn, flaxseed, oats, rye, soybeans, sorghum, sunflower seed, triticale, wheat, and mixed grain is diverse. AMS is seeking nominations for the Advisory Committee that will reflect the diversity of the grain industry, including, but not limited to, grain producers, processors, handlers, merchandisers, consumers, exporters, and scientists. Therefore, when making recommendations for appointments, the industry must consider the diversity of the population served and the knowledge, skills, and abilities of the members to serve a diverse population.
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.
Persons with disabilities who require alternative means of communication for program information (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
The final selection of Advisory Committee members is made by the Secretary.
Agricultural Marketing Service, USDA.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, as amended, the Agricultural Marketing Service (AMS), U.S. Department of Agriculture (USDA), is announcing a meeting of the National Organic Standards Board (NOSB). The NOSB assists the USDA in the development of standards for substances to be used in organic production and advises the Secretary of Agriculture on any other aspects of the implementation of the Organic Foods Production Act (OFPA).
An in-person meeting will be held October 25-27, 2022, from 8:30 a.m. to approximately 5:00 p.m. Pacific Time (PT) each day and will include a virtual broadcast. The NOSB will hear oral public comments via webinars on Tuesday, October 18, 2022, and
The webinars are virtual and will be accessed via the internet and/or phone. Access information will be available on the AMS website prior to the webinars. The in-person meeting will take place at the Holiday Inn Sacramento Downtown—Arena, 300 J Street, Sacramento, California 95814, United States and may be broadcast virtually. Detailed information pertaining to the webinars and in-person meeting, including virtual viewing options, can be found at
Michelle Arsenault, Advisory Committee Specialist, National Organic Standards Board, USDA-AMS-NOP, 1400 Independence Avenue SW, Room 2642-S, STOP 0268, Washington, DC 20250-0268; Phone: (202) 997-0115; Email:
In accordance with the Federal Advisory Committee Act, 5 U.S.C. App. 2 and 7 U.S.C. 6518(e), as amended, AMS is announcing a meeting of the NOSB. The NOSB makes recommendations to USDA about whether substances should be allowed or prohibited in organic production and/or handling, assists in the development of standards for organic production, and advises the Secretary on other aspects of the implementation of the Organic Foods Production Act, 7 U.S.C. 6501
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 (FACA) that the Tennessee Advisory Committee to the Commission will hold a virtual (online) meeting on Wednesday, August 3, 2022, at 12:00 p.m.-1:30 p.m. (CT). The purpose of the meetings is for the Committee to discuss their project on Voting Rights in the state of Tennessee.
The meetings will be held on: Wednesday, August 3, 2022; 12:00 p.m. CT.
Join via phone 800-360-9505 USA Toll Free; Access Code: 2762 551 1582#.
Victoria Moreno at
This meeting is available to the public through the WebEx link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. 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 call-in number found through registering at the web link provided above for the meeting.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the respective meeting. Written comments may be emailed to Victoria Moreno at
Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at the
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the South Carolina State Ports Authority, grantee of FTZ 21, requesting subzone status for the facilities of DMA Sales, LLC, located in Marion and Nichols, South Carolina. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on June 16, 2022.
The proposed subzone would consist of the following sites:
In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
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
For further information, contact Christopher Kemp at
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open public meeting.
Notice is hereby given of a meeting of the Office of National Marine Sanctuaries' (ONMS) Sanctuary System Business Advisory Council. The meeting is open to the public. ONMS will provide an opportunity for oral and written comments.
The meeting will be held on Thursday, July 28, 2022, from 1 p.m. to 2 p.m. ET. The public will be provided with an opportunity to comment around 1:40 p.m. ET. The meeting times and agenda topics are subject to change. Up-to-date information about the meeting time and agenda topics can be found at
The meeting will be held virtually using Google Meet. To participate, please use the weblink provided below. If you are unable to participate online, you can also connect to the public meeting using the phone number provided below.
Additional information, including instructions on how to join the meeting, can be found at
Katie Denman, Office of National Marine Sanctuaries, 1305 East West Highway, Silver Spring, Maryland 20910 (Phone: 240-533-0702; Email:
ONMS serves as the trustee for a network of underwater parks encompassing more than 620,000 square miles (16,000 square kilometers) of marine and Great Lakes waters from Washington State to the Florida Keys, and from Lake Huron to American Samoa. The network includes a system of 15 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. National marine sanctuaries protect our Nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustain healthy environments that are the foundation for thriving communities and stable economies.
One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. The Sanctuary System Business Advisory Council (council) has been formed to provide advice and recommendations to the Director of ONMS regarding the relationship between ONMS and the business community. Additional information on the council can be found at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of issuance of Letter of Authorization.
In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico, notification is hereby given that a Letter of Authorization (LOA) has been issued to BHP Billiton Petroleum (GOM) Inc. for the take of marine mammals incidental to geophysical survey activity in the Gulf of Mexico.
The LOA is effective from the date of issuance through January 31, 2023.
The LOA, LOA request, and supporting documentation are available online at:
Kim Corcoran, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in Federal waters of the U.S. Gulf of Mexico (GOM) over the course of 5 years (86 FR 5322; January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses. The rule became effective on April 19, 2021.
Our regulations at 50 CFR 217.180
BHP plans to conduct zero offset vertical seismic profile (VSP) survey within Green Canyon Block 564. See Attachment 5 of BHP's application for a map. BHP plans to use a 6-element, 1,500 cubic inch (in
Consistent with the preamble to the final rule, the survey effort proposed by BHP in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (86 FR 5322, 5398; January 19, 2021). In order to generate the appropriate take number for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone
No VSP surveys were included in the modeled survey types, and use of existing proxies (
In addition, all available acoustic exposure modeling results assume use of a 72-element, 8,000 in
The survey is planned to occur for a maximum of 2 days in Zone 5. The survey may occur in either season. Therefore, the take estimates for each species are based on the season that has the greater value for the species (
In this case, use of the exposure modeling produces results that are smaller than average GOM group sizes for multiple species (Maze-Foley and Mullin, 2006). NMFS' typical practice in such a situation is to increase exposure estimates to the assumed average group size for a species in order to ensure that, if the species is encountered, exposures will not exceed the authorized take number. However, other relevant considerations here lead to a determination that increasing the estimated exposures to average group sizes would likely lead to an overestimate of actual potential take. In this circumstance, the very short survey duration (two days) and relatively small Level B harassment isopleths produced through use of the 6-element, 1,500 in
Additionally, for some species, take estimates based solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, our rule acknowledged that other information could be considered (see,
Rice's whales (formerly known as GOM Bryde's whales)
Although it is possible that Rice's whales may occur outside of their core habitat, NMFS expects that any such occurrence would be limited to the narrow band of suitable habitat described above (
Killer whales are the most rarely encountered species in the GOM, typically in deep waters of the central GOM (Roberts
As discussed in the final rule, the density models produced by Roberts
NOAA surveys in the GOM from 1992-2009 reported only 16 sightings of killer whales, with an additional three encounters during more recent survey effort from 2017-18 (Waring
The rarity of encounter during seismic surveys is not likely to be the product of high bias on the probability of detection. Unlike certain cryptic species with high detection bias, such as
In summary, killer whales are the most rarely encountered species in the GOM and typically occur only in particularly deep water. While this information is reflected through the density model informing the acoustic exposure modeling results, there is relatively high uncertainty associated with the model for this species, and the acoustic exposure modeling applies mean distribution data over areas where the species is in fact less likely to occur. NMFS' determination in reflection of the data discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for killer whales would result in high estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected killer whale take (86 FR 5322, 5403; January 19, 2021).
In past authorizations, NMFS has often addressed situations involving the low likelihood of encountering a rare species such as killer whales in the GOM through authorization of take of a single group of average size (
Based on the results of our analysis, NMFS has determined that the level of taking authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See Table 1 in this notice and Table 9 of the rule (86 FR 5322; January 19, 2021).
Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small. For more information please see NMFS' discussion of the MMPA's small numbers requirement provided in the final rule (86 FR 5322, 5438; January 19, 2021).
The take numbers for authorization, which are determined as described above, are used by NMFS in making the necessary small numbers determinations, through comparison with the best available abundance estimates (see discussion at 86 FR 5322, 5391; January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR;
Based on the analysis contained herein of BHP's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes and therefore is of no more than small numbers.
NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to BHP authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of receipt of an application for exempted fishing permit; request for comments.
NMFS announces the receipt of an application for an exempted fishing permit (EFP) from the Sustainable Seas Technology, LLC. If granted, the EFP would authorize the applicant to deploy modified black sea bass pots with Subsea Buoy Retrieval Systems (SBRS) in South Atlantic Federal waters off North Carolina, South Carolina, Georgia, and Florida. The project would continue to examine the potential usefulness of SBRSs for use in the black sea bass pot component for the commercial sector of the snapper-grouper fishery in minimizing impacts to protected species.
Written comments must be received on or before July 8, 2022.
You may submit comments on the application, identified by “NOAA-NMFS-2022-0059” by any of the following methods:
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Electronic copies of the application and may be obtained from the Southeast Regional Office website at
Frank Helies, 727-824-5305; email:
The EFP is requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C 1801
Currently, vertical end lines and buoys, such as those utilized with black sea bass pots in the South Atlantic, present an entanglement risk to the North Atlantic right whale, a species that is listed as endangered under the Endangered Species Act (ESA). Each fall, some right whales travel from their feeding areas in the waters off New England and Canada to the shallow, coastal waters of North Carolina, South Carolina, Georgia, and northeastern Florida. SBRSs are a type of fishing gear that allows fish traps, including black sea bass pots, buoys, and their retrieval devices to be stored at depth until triggered for retrieval at the surface. These gear systems allow for trap and pot buoys and vertical lines to exist in the water column for minutes instead of hours or days, as they are activated via acoustic or timed release only when fishers are present. As described in the application, the applicant believes that adaptation of SBRSs or “ropeless” systems for black sea bass pot fishing in the South Atlantic could reduce the risk to these whales and other marine animals that are subject to entanglements from vertical lines and buoys.
The project seeks to build upon previous research and continue to examine the potential usefulness of the modified black sea bass pot gear in minimizing impacts to protected species. This would be the third EFP authorizing this applicant to conduct this type of proposed research. NMFS approved the applicant's first EFP (August 24, 2020, through October 20, 2020) for the pilot research that allowed gear testing outside the black sea bass pot closed season (85 FR 42831; July 15, 2020). NMFS approved a second EFP on February 2, 2022, to be effective through August 31, 2024, that was similar to the first EFP but it allowed testing during the black sea bass pot closed season (87 FR 2595; January 22, 2022). Those EFPs allowed gear testing in offshore Federal waters of North Carolina, South Carolina, Georgia, and Florida.
If granted, this EFP would allow similar gear testing throughout the year, as discussed below. The EFP would exempt limited fishing gear testing activities from certain regulations for the black sea bass pot component for the commercial sector of the South Atlantic snapper-grouper fishery, specifically gear identification at 50 CFR 622.177(a)(4), area and seasonal closures at 50 CFR 622.183 (622.183(a)(1)(ii)(E), 622.183(a)(2)(vii)(E), and 622.183(b)(6)), black sea bass pot configuration restrictions and requirements at 50 CFR 622.189 (622.189(b), 622.189(e)(1), and 622.189(g)) and Atlantic large whale gear marking requirements at 50 CFR
The applicant seeks an EFP to determine the following: if the SBRS gear would continue to show a greater than 99 percent successful deployment and retrieval rate; if SBRS gear significantly increases the time and/or expense for gear retrieval and recovery versus the current fishing method such that it might affect profitability; if SBRS gear significantly increases time and/or expense for the repacking of gear for redeployment versus the current fishing method such that it might affect profitability; if bycatch rates for the modified black sea bass pot fishing configuration are greater than those for the traditional single pots; and if the harvest of black sea bass in the preferred inshore areas that are currently closed, would still yield enough catch to offset the cost of SBRS fishing gear and modifications. If granted, the project would allow for expansion of gear testing conducted under the currently issued EFP to allow gear testing year round, including during the seasonal closure of the commercial black sea bass pot component of the snapper-grouper fishery. This proposed EFP would provide additional time to the applicant to train new participants and conduct tests with the gear, to perform gear configuration adjustments, and to liaise with SBRS manufacturers on modifications that might best suit the particular needs of the black sea bass pot component of the snapper-grouper fishery.
Under the EFP, the applicant would collect data through an ongoing collaborative effort among different SBRS manufacturers and fishery industry partners. If granted, the EFP would be effective from the date of issuance through April 30, 2025. If granted, the EFP issued to the applicant on February 2, 2022, for this type of gear research would be ended and replaced by the new EFP as described here and in the application. In addition to this EFP request for exemption from Magnuson-Stevens Act regulations, the applicant would consult with NMFS to ensure the EFP would be consistent with North Atlantic right whale conservation measures currently in place through the ESA and Marine Mammal Protection Act. Fishers participating in this project are assumed to be receiving grant funding and/or self-funding the work. These fishers would be allowed to keep and sell all catch lawfully harvested by black sea bass pots. The proposed EFP testing area would occur in offshore Federal waters of North Carolina, South Carolina, Georgia, and Florida out to a depth of 65 meters. The inshore water depth for testing in Federal waters would not be less than 20 meters. Sampling would occur year round, including the November 1 through April 30 closed season, of each year. The testing would not occur in any special management zones listed in 50 CFR 622.182 or in the North Atlantic Right Whale Critical Habitat Area.
Up to 11 different SRBS designs would be fished as singles, two pot trawls, and four pot trawls in inshore areas. This would be done year round, including during the black sea bass pot closure period each year (November 1 through April 30), to compare against control pots fished under previous EFPs to yield data relative to the time expended to retrieve and rebait traditional traps pursuant to the current regulations. Using the SBRS, the applicant would utilize virtual gear marking of the pots (marking of gear deployment location with chart plotters, GPS, and manufacturer-provided software). The applicant would also evaluate the feasibility of use of various virtual gear marking systems and share the results with fishery management partners.
Participating permitted commercial fishers would deploy experimental gear for up to 10 days each year in supervised field trials and additional unsupervised fishing trials, not to exceed 2,500 gear hauls per vessel over the length of the EFP, to evaluate the performance of SBRS with both the experimental and standard black sea bass pot configurations. Each deployment under the EFP would be limited to 35 total pots per vessel, with an average soak time of 90 minutes per configuration. Some overnight sampling would occur for acoustic releases.
Under the EFP, four regulation-sized pots would be connected together with wire connecting clips or zip ties so that only one SBRS gear device is needed to retrieve four connected pots. Each pot would have the standard black sea bass pot single entrance and would possess one back panel of 2-inch (5.1-cm) uniform mesh. The connected four traps would test both one and two single entrances (on adjacent sides of single traps to replace the allowable two opposite entrances) to four regulation-sized trap interiors, and would otherwise comply with the requirements for black sea bass pot dimensions and construction in the South Atlantic. This experimental gear design of the four connected pots is not a chevron-style fish trap, it is a design of standard black sea bass pots connected to adjacent standard black sea bass pots. The goal of this modification is to examine ways to reduce procurement and implementation costs associated with the number of required SBRSs to fish 35 pots.
In addition to this configuration, the applicant would also test a new adaptation to their gear research, which is a simplified version of the four pot trawl design in which only two traps are connected, allowing for both a normal number of trap entrances as well as half the number of trap entrances, as described above. This configuration was developed to assist vessel captains that fish without crew, who found the four pot trawl configuration difficult to service singlehanded.
Two of the technologies that would be used in the EFP utilize lift bags and buoys and are therefore unable to be line-marked as they do not incorporate line into their design. For the other technologies being tested under the EFP, all buoy lines on SBRS gear types that use stored line would be marked in accordance with the most recent requirements pursuant to the Atlantic Large Whale Take Reduction Plan and other Federal regulations, and would have weak links with a maximum breaking strength of 600 lb (272 kg), 1,700 lb (771 kg) maximum breaking strength sleeves, and line with a breaking strength of less than 2,200 lb (998 kg).
Six of the eight currently available SBRS devices require the use of a line for retrieval that is contained and stored at depth by a line management system. The other two release devices do not use line, but instead, utilize the inflation of either a lift bag or inflatable buoy to pull a lead trap to the surface. The styles of line storage vary with device design and includes square, rectangular, domed, circular, and conical cages, oyster mesh bags, canisters, and spools. These have been successfully used in trials and testing in a variety of active fishing operations in the United States and worldwide.
Four of the SBRS devices in the EFP require floating line to return the buoy or buoys to the surface for retrieval. Currently, the average time for appearance of buoys at depths greater than 100 ft (30.5 m) is approximately 3 minutes. Retrieval generally takes less than 2 minutes, which means that any floating line would be at the surface for less than 5 minutes, and during which time the fishing vessel would be within 20-30 ft (6.1-9.1 m) of the line. Two of
NMFS finds the application warrants further consideration based on a preliminary review. Possible conditions the agency may impose on the permit, if granted, include but are not limited to, a prohibition on conducting fishing gear testing within marine protected areas, marine sanctuaries, special management zones, or areas where they might interfere with managed fisheries without additional authorization. Additionally, NMFS may require special protections for ESA-listed species and designated critical habitat, and may require particular gear markings. A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the appropriate fishery management agencies of the affected states, the South Atlantic Fishery Management Council, and the U.S. Coast Guard, and a determination that the activities to be taken under the EFP are consistent with all applicable laws.
The United States Patent and Trademark Office (USPTO) will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The USPTO invites comment on this information collection renewal, which helps the USPTO assess the impact of its information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
A complaint submitted to the USPTO must be clearly marked, or otherwise identified, as a complaint. The complaint must include: (1) The name and address of the complaint; (2) the name and address of the invention promoter; (3) the name of the customer; (4) the invention promotion services offered or performed by the invention promoter; (5) the name of the mass media in which the invention promoter advertised providing such services; (6) and example of the relationship between the customer and the invention promoter; and (7) a signature of the complainant. Identifying information is necessary so that the USPTO can both forward the complaint to the invention promoter or promotion firm as well as notify the complainant that the complaint has been forwarded. Complainants should understand that the complaints will be forwarded to the invention promoter for response and that the complaint and response will be made available to the public as required by the Inventors' Rights Act. If the USPTO does not receive a response from the invention promoter, the complaint will be published without a response. The USPTO does not accept under this program complaints that request confidentiality.
This information collection contains one form, Complaint Regarding Invention Promoter (PTO/2048A), which is used by the public to submit a complaint under this program. This form is available for download from the USPTO website. Use of this form is voluntary, and the complainant may submit his or her complaint without the form via any of the approved methods of collection as long as the complainant includes the necessary information and the submission is clearly marked as a complaint filed under the Inventors' Rights Act. There is no associated form for submitting responses to a complaint.
• PTO/2048A (Complaint Regarding Invention Promoter).
This information collection request may be viewed at
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website
Further information can be obtained by:
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Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau or CFPB) is publishing this notice seeking comment on a Generic Information Collection titled, “Sample Form Usability Research and Communication Testing,” prior to requesting the Office of Management and Budget's (OMB's) approval of this collection under the Generic Information Collection “Generic Information Collection Plan for the Development and Testing of Disclosures and Related Materials” under OMB Control number 3170-0022.
Written comments are encouraged and must be received on or before July 25, 2022 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
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Please note that due to circumstances associated with the COVID-19 pandemic, the Bureau discourages the submission of comments by mail, hand delivery, or courier. Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or Social Security numbers, should not be included.
Documentation prepared in support of this information collection request is available at
We intend to conduct qualitative research to learn more about potential concerns that small business owners may have about providing demographic data to lenders while applying for business credit, including audience research with small business owners to assess their knowledge and understanding of the upcoming 1071 rule, as well as concerns that may impact their willingness to complete a form of this type. There are two purposes for this research:
• The Sample Form Usability Research is intended to identify possible concerns or issues small business owners may have with submitting demographic data via sample forms and explore possible approaches to form design and language that might bear on willingness to provide the data.
• The Communication Testing Research is intended to identify small business owners' knowledge and understanding of the upcoming 1071 rule as well as concerns that may impact their willingness to complete a form of this type. It will help develop implementation materials to facilitate lenders' compliance with the statutory requirements.
Department of Defense (DoD).
Renewal of Federal Advisory Committee.
The DoD is publishing this notice to announce that it is renewing the Defense Business Board (DBB).
Jim Freeman, DoD Advisory Committee Management Officer, 703-692-5952.
The DoD is renewing the DBB in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C., Appendix) and 41 CFR 102-3.50(d). The charter and contact information for the DBB's Designated Federal Officer (DFO) are found at
The DBB provides the Secretary of Defense and Deputy Secretary of Defense with independent advice and actionable recommendations to address critical matters and challenges to accelerate adoption of effective and efficient business processes and functions, organizational management constructs, and business and organizational cultural changes within the DoD in response to specific tasking from the Secretary of Defense or the Deputy Secretary of Defense (“the DoD Appointing Authority”). The DBB examines and advises on DoD executive management, innovative business processes, and governance from private, public, and academic sector perspectives. The DBB is composed of no more than 20 members who meet one of more of the following criteria: (a) proven track record of sound judgement in leading or governing large, complex public or private-sector organizations, including academia; (b) significant management-level (executive level managers that are titled “chief” followed by their function) global business or academic experience including, but not limited to the areas of executive management, corporate strategy, governance, business process improvement and innovation, global business services/shared services, audit and finance, supply chain and logistics, human resources/talent management, data/analytics management and use, real property management, organizational design and optimization, energy and climate, or technology; (c) demonstrated performance in developing new business theories, innovation, and concepts; (d) career as a distinguished academic or researcher in business at an accredited college or institute of higher education; or (e) a proven track record as an innovative leader in small and minority owned businesses.
Individual members are appointed according to DoD policy and procedures, and serve a term of service of one-to-four years with annual renewals. One member will be appointed as Chair of the DBB. No member, unless approved according to DoD policy and procedures, may serve more than two consecutive terms of service on the DBB, or serve on more than two DoD Federal advisory committees at one time.
DBB members who are not full-time or permanent part-time Federal civilian officers or employees, or active duty members of the Uniformed Services, are appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee members. DBB members who are full-time or permanent part-time Federal civilian officers or employees, or active duty members of the Uniformed Services are appointed pursuant to 41 CFR 102-3.130(a), to serve as regular government employee members.
All DBB members are appointed to provide advice based on their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official DBB-related travel and per diem, members serve without compensation.
The public or interested organizations may submit written statements about the DBB's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the DBB. All written statements shall be submitted to the DFO for the DBB, and this individual will ensure that the written statements are provided to the membership for their consideration.
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Secretary is publishing the following list of correspondence from the U.S. Department of Education (Department) received by individuals during quarters two, three, and four of calendar year 2020, all four quarters of calendar year 2021, and the first quarter of calendar year 2022. The correspondence describes the Department's interpretations of the Individuals with Disabilities Education Act (IDEA) or the regulations that implement IDEA. These letters or other documents described in this list, with personally identifiable information redacted, as appropriate, can be found at
Rebecca Walawender, U.S. Department of Education, 400 Maryland Avenue SW, Room 5103, Potomac Center Plaza, Washington, DC 20202-2500. Telephone: (202) 245-7399. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
On request to the person listed under
The following list identifies correspondence for eight quarters, April 1, 2020, through March 31, 2022. Under section 607(f) of IDEA, the Secretary is required to publish this list in the
○ Letter dated June 8, 2020, to anonymous, regarding the use of IDEA Part B funds to pay hearing officers to conduct due process hearings under IDEA.
○ Letter dated July 31, 2020, to anonymous, addressing whether a parent may be required to sign a confidentiality agreement in order to participate in mediation under Part B of the IDEA.
No letters.
No letters.
○ Letter dated May 12, 2021, to Garth Tymeson, Center on Disability Health and Adapted Physical Activity, University of Wisconsin-La Crosse, regarding the provision of special education, including physical education and adapted physical education, for children with disabilities.
○ Letter dated September 24, 2021, to Daniel Frumkin, addressing a petition for rulemaking to modify the IDEA regulations in order to establish a timeline to provide access to a child's IEP to teachers and service providers.
○ Letter dated November 15, 2021, to WIDA Founder and Director, Timothy Boals, addressing whether IDEA requires the inclusion of language development goals in an IEP if the child is an English learner with a disability.
○ Letter dated November 17, 2021, to anonymous, regarding whether a local educational agency may file a due process complaint against a parent when a parent refuses to consent to a change in the child's IEP and whether a party has met the IDEA exhaustion requirements if a hearing officer determines that a State educational agency is not a proper party to a due process hearing.
No letters.
You may also access documents of the Department published in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), Brownfields Program—Accomplishment Reporting (Renewal) (EPA ICR Number 2104.09, OMB Control Number 2050-0192) 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 December 31, 2024. Public comments were previously requested via the
Additional comments may be submitted on or before July 25, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-SFUND-2012-0104, 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
Kelly Gorini, Office of Brownfields and Land Revitalization, (5105T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1702; fax number: (202) 566-1476; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice of objections and public hearing.
The Environmental Protection Agency (EPA) has received objections and hearing requests in response to its issuance of a Notice of Intent to Suspend registration of a pesticide containing dimethyl tetrachloroterephthalate (DCPA). EPA will hold a public hearing to receive evidence related to the proposed suspension of DCPA.
A public hearing will be held beginning at 9 a.m. July 6, 2022 and continue as necessary through July 8, 2022.
The public hearing will take place in the EPA Administrative Courtroom, EPA East Building, Room 1152, 1201 Constitution Ave. NW, Washington, DC 20460.
Mary Angeles, Headquarters Hearing Clerk, Office of Administrative Law Judges, 1200 Pennsylvania Ave. NW, Mail Code 1900R, Washington, DC 20460; telephone number: (202) 564-6281; email address:
This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The regulatory docket for this action, identified by docket identification number EPA-HQ-OPP-2011-0374, is available electronically at
The adjudication docket for the proceeding in which petitioners have requested a public hearing, captioned in re FIFRA Section 3(c)(2)(B) Notice of Intent to Suspend Dimethyl Tetrachloroterephthalate (DCPA) Technical Registration and identified by docket number FIFRA-HQ-2022-0002, is available electronically on the website of EPA's Office of Administrative Law Judges at
EPA previously published (87 FR 25262, April 28, 2022) a Notice of Intent to Suspend (NOITS) the registration of DCPA pursuant to its authority under Section 3(c)(2)(B)(iv) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136a(c)(2)(B)(iv). Section 3(c)(2)(B)(iv) of FIFRA provides that any person adversely affected by the NOITS may request a hearing on the proposed suspension within thirty days of the registrant receiving the notice. On May 24, 2022, the Western Plant Health Association filed an objection to the NOITS. On May 27, 2022, AMVAC Chemical Corporation, the DCPA registrant, filed an objection to the NOITS and requested a hearing. Also on May 27, 2022, the Grower-Shipper Association of Central California, Sunheaven Farms, LLC, J&D Produce, Ratto Bros., Inc., and Huntington Farms jointly filed an objection to the NOITS and requested a hearing.
The hearing requests commenced a proceeding under Section 6(d) of FIFRA, 7 U.S.C. 136d(d), and EPA's procedural rules, 40 CFR 164, before EPA's Office of Administrative Law Judges. The proceeding includes a public hearing that will be held to receive evidence from the parties relevant and material to issues raised by petitioners objecting to the proposed suspension of DCPA. FIFRA section 3(c)(2)(B)(iv) specifically limits the scope of the hearing to two questions: (1) whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required; and (2) whether the Administrator's determination with respect to the disposition of existing stocks is consistent with FIFRA.
As set forth in
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Land Disposal Restrictions (EPA ICR Number 1442.24, OMB Control Number 2050-0085) 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, 2022. Public comments were previously requested via the
Additional comments may be submitted on or before July 25, 2022.
Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-2018-0198, 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
Peggy Vyas, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-0453; email address:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
The regulations implementing these requirements are codified in the Code of Federal Regulations (CFR) Title 40, Part 268. EPA requires that facilities maintain the data outlined in this ICR so that the Agency can ensure that land disposed waste meets the treatment standards. EPA strongly believes that the recordkeeping requirements are necessary for the agency to fulfill its congressional mandate to protect human health and the environment.
Environmental Protection Agency (EPA).
Notice of proposed settlement; request for public comment.
In accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (“CERCLA”), notice is hereby given that the Environmental Protection Agency (EPA), has entered into a proposed settlement, embodied in an Administrative Settlement Agreement for Recovery of Past Response Costs (“Settlement Agreement”), with Powerine Oil Company and Lakeland Development Company. Under the Settlement Agreement, Powerine and Lakeland agree to pay a total of $150,000 to reimburse EPA for costs EPA has incurred at the Omega Chemical Corporation Superfund Site (“Omega”).
Comments must be received on or before July 25, 2022.
Please contact Michael Massey at
Michael Massey, Assistant Regional Counsel (ORC-3), Office of Regional Counsel, U.S. EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105; Email:
Notice of this proposed Settlement Agreement is made in accordance with Section 122(i) of CERCLA, 42 U.S.C. 9622(i). The Settlement Agreement concerns costs incurred by EPA in connection with Omega, a CERCLA response action in Los Angeles County, California, where groundwater contamination has come to be located. Powerine and Lakeland, which agree to pay EPA a total of $150,000, are the only parties to the Settlement Agreement. EPA has collected costs from other responsible parties at Omega and intends further cost recovery from additional parties in the future; however, because EPA is not recovering one hundred percent of its past costs at this time, this Settlement Agreement represents a compromise of EPA's costs. The settlement includes a covenant not to sue pursuant to Sections 106 and 107(a) of CERCLA, 42 U.S.C 9606 and 9607(a).
EPA will consider all comments received on the Settlement Agreement in accordance with the
Federal Communications Commission.
Notice.
The agency must receive comments on or before August 22, 2022.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
Rolanda F. Smith, 202-418-2054.
The following applicants filed AM or FM proposals to change the community of license: TOP O' TEXAS EDUCATIONAL BROADCASTING FOUNDATION, INC., KIJN-FM, Fac. ID No. 65458, FROM FARWELL, TX, TO UMBARGER, TX, File No. 0000190783; DIMES MEDIA CORPORATION, KSGG(FM), Fac. ID No. 762378, FROM KING CITY, CA, TO SOLEDAD, CA, File No. 0000189549; MIDWAY BROADCASTING COMPANY, WFLM(FM), Fac. ID No. 42065, FROM WHITE CITY, FL, TO PALM BEACH SHORES, FL; File No. 0000193154; ONDAS DE VIDA, INC., NEW(FM), Fac. ID No. 768304, FROM COALINGA, CA, TO STRATFORD, CA, File No. 0000192882; and CLARITY COMMUNICATIONS, INC., Fac. ID No. 59387, FROM STAMPING GROUND, KY, TO PARIS, KY, File No. 0000189436. The full text of these applications is available electronically via the Licensing and Management System (LMS),
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before August 22, 2022. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC or Commission) Task Force for Reviewing the Connectivity and Technology Needs of Precision Agriculture in the United States (Task Force) will hold its next meeting via live internet link.
July 21, 2022. The meeting will come to order at 12:00 p.m. EDT.
The meeting will be held via conference call and be available to the public via live feed from the FCC's web page at
Elizabeth Cuttner, Designated Federal Officer, at (202) 418-2145, or
The meeting will be held on July 21, 2022 at 12:00 p.m. EDT and may be viewed live, by the public, at
Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before August 22, 2022. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information collection requirements that are approved under this information collection are contained in 95.2593, 95.2595 and 95.2509 which relate to the Medical Device Radiocommunication Service (MedRadio). The former rule sections for this collection were 95.1215, 95.1217, 95.1223 and 95.1225.
The information is necessary to allow the coordinator and parties using the database to contact other users to verify information and resolve potential conflicts. Each user is responsible for determining in advance whether new devices are likely to cause or be susceptible to interference from devices already registered in the coordination database.
Federal Communications Commission.
The liquidation of the assets for each receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receiverships will serve no useful purpose. Consequently, notice is given that the receiverships shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person
No comments concerning the termination of the above-mentioned receiverships will be considered which are not sent within this timeframe.
10:28 a.m. on Tuesday, June 21, 2022.
The meeting was held in the Board Room located on the sixth floor of the FDIC Building located at 550 17th Street NW, Washington, DC.
Closed.
In calling the meeting, the Board determined, on motion of Director Michael J. Hsu (Acting Comptroller of the Currency), seconded by Director Rohit Chopra (Director, Consumer Financial Protection Bureau), and concurred in by Acting Chairman Martin J. Gruenberg, that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B) of the “Government in the Sunshine Act” (5 U.S.C. 552b (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B).
Requests for further information concerning the meeting may be directed to Debra A. Decker, Executive Secretary of the Corporation, at 202-898-8748.
Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Pro Transport Charleston, Inc. (Pro Transport), hereinafter “Complainant”, against Allround Midwest Forwarding, Inc. (Allround), hereinafter “Respondent”. Complainant alleges that Respondent is an ocean transportation intermediary (OTI) organized as a corporation under the laws of Delaware with Cleveland, OH as its principal place of business.
Complainant alleges that Respondent violated 46 U.S.C. 40902 for its failure to maintain a surety bond. The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by June 13, 2023, and the final decision of the Commission shall be issued by January 9, 2024.
The Commission hereby gives notice of filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than July 8, 2022.
1.
2.
1.
Board of Governors of the Federal Reserve System.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than July 8, 2022.
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Board of Governors of the Federal Reserve System.
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Senior Credit Officer Opinion Survey on Dealer Financing Terms (FR 2034; OMB No. 7100-0325).
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829.
Office of Management and Budget (OMB) Desk Officer for the Federal Reserve Board, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.
On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB
Responding to the FR 2034 is voluntary. To the extent the information contained in responses to the core questions of the FR 2034 is nonpublic commercial or financial information, which is both customarily and actually treated as private by the respondent, the Board may keep such information confidential pursuant to exemption 4 of the Freedom of Information Act (FOIA).
Federal Trade Commission.
Proposed consent agreement; request for comment.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis of Proposed Consent Orders to Aid Public Comment describes both the allegations in the complaint and the terms of the consent orders—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before July 25, 2022.
Interested parties may file comments online or on paper, by following the instructions in the Request for Comment part of the
Kurt Herrera-Heintz (202-326-3542), Bureau of Competition, Federal Trade Commission, 400 7th Street SW, Washington, DC 20024.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis of Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 25, 2022. Write “ARKO/GPM Investments; File No. 211 0087” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the
Due to protective actions in response to the COVID-19 pandemic and the agency's heightened security screening, postal mail addressed to the Commission will be delayed. We strongly encourage you to submit your comments online through the
If you prefer to file your comment on paper, write “ARKO/GPM Investments; File No. 211 0087” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580.
Because your comment will be placed on the publicly accessible website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC website at
The Federal Trade Commission (“Commission”) has accepted an Agreement Containing Consent Order (“Consent Agreement”) from ARKO Corp., GPM Investments, LLC, GPM Southeast, LLC, and GPM Petroleum, LLC (collectively “Respondents”). The Consent Agreement is designed to remedy the anticompetitive effects that resulted from GPM's acquisition of retail fuel assets from Corrigan Oil Company (“Corrigan”).
Pursuant to an Asset Purchase Agreement dated March 8, 2021, GPM Petroleum, LLC, and GPM Southeast, LLC, which are directly controlled by GPM Investments, LLC (collectively “GPM”) and indirectly controlled by ARKO Corp., acquired 60 branded Express Stop retail fuel locations in Michigan and Ohio from Corrigan (the “Acquisition”). GPM consummated the Acquisition in May 2021 for total consideration of approximately $94 million. As part of the Asset Purchase Agreement, Corrigan agreed not to compete for a period of time and within a specified radius around approximately 190 GPM owned, operated, and leased locations, in addition to the Express Stop locations purchased by GPM.
The Commission's Complaint alleges that the Acquisition violated Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition for the retail sale of gasoline in five local markets in Michigan, and for the retail sale of diesel fuel in one of those same local markets. The Commission's Complaint also alleges that the noncompete agreements violated Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by unreasonably lessening potential competition for the retail sale of gasoline and diesel fuel within the noncompete territories.
Under the terms of the Decision and Order (“Order”) contained in the Consent Agreement, Respondents are required to rescind parts of an Asset Purchase Agreement with Corrigan and release back to Corrigan retail fuel assets in the five local markets in Michigan. Respondents must transfer these assets back to Corrigan no later than the Closing Date listed in the Reacquisition Agreement of June 28, 2022. In addition, the Order resolves concerns raised by the noncompete agreements in the parties' Asset Purchase Agreement.
The Consent Agreement has been placed on the public record for thirty days to solicit comments from interested persons. The Commission issued the accompanying Order as final prior to seeking public comment, as provided in Section 2.34(c) of the Commission's Rules. This will allow the Commission to enforce the Order if there are any violations of its provisions during the public comment period. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the Consent Agreement and comments received and decide whether it should withdraw from the Consent Agreement or modify the accompanying Order as provided in Section 2.34(e) of the Commission's Rules.
Respondent ARKO Corp., through its wholly owned subsidiary GPM, operates or supplies stores in thirty-three states and Washington, D.C. GPM is the sixth largest convenience store chain in the country, with approximately 3,000 locations comprising approximately 1,400 company-operated stores and 1,625 independent dealer locations.
GPM derives most of its revenue from the retail sale of fuel and products sold in its convenience stores. GPM retains control over the fuel operation at its company-operated stores and sets wholesale fuel prices on a delivered basis to its dealer-operated network.
Relevant product markets in which to analyze the Acquisition are the retail sale of gasoline and the retail sale of diesel fuel. Consumers require gasoline for their gasoline-powered vehicles and can purchase gasoline only at retail fuel outlets. Likewise, consumers require diesel fuel for their diesel-powered vehicles and can purchase diesel fuel only at retail fuel outlets. The retail sale of gasoline and the retail sale of diesel fuel constitute separate relevant markets because the two are not interchangeable. Vehicles that run on gasoline cannot run on diesel fuel, and vehicles that run on diesel fuel cannot run on gasoline.
The Commission alleges that the relevant geographic markets in which to assess the competitive effects of the Acquisition with respect to the retail sale of gasoline are five local markets in and around the following cities: Saginaw, Chesaning, Mt. Morris, and Mason, Michigan. The relevant geographic market in which to analyze the effects of the Acquisition on the retail sale of diesel fuel include one local market in and around one of the Saginaw, Michigan retail gasoline markets.
The geographic markets for retail gasoline and retail diesel fuel are highly localized, depending on the unique circumstances of each area. Each relevant market is distinct and fact-dependent, reflecting many considerations, including commuting patterns, traffic flows, and outlet characteristics. Consumers typically choose between nearby retail fuel outlets with similar characteristics along their planned routes. The geographic markets for the retail sale of diesel fuel are similar to the corresponding geographic markets for retail gasoline, as many diesel fuel consumers exhibit preferences and behaviors similar to those of gasoline consumers.
The Acquisition substantially lessened competition in each of these local markets, resulting in five highly concentrated markets for the retail sale of gasoline and one highly concentrated market for the retail sale of diesel fuel. Retail fuel outlets compete on price, store format, product offerings, and location, and pay close attention to competitors in close proximity, on similar traffic flows, and with similar store characteristics.
In each of the local gasoline and diesel fuel retail markets where the Commission alleges harm, the Acquisition reduced the number of competitively constraining independent market participants around the locations GPM is returning to Corrigan to two or fewer. Absent the Acquisition, Respondents and Corrigan would have continued to compete directly in these local markets. Because of the Acquisition, GPM is likely able to raise prices unilaterally in markets where GPM and Corrigan were close competitors.
Moreover, the Acquisition would enhance the incentives for interdependent behavior in local markets where only two competitively constraining, independent market participants would remain. Two aspects of the retail fuel industry make it vulnerable to such coordination. First, retail fuel outlets post their fuel prices on price signs that are visible from the street, allowing competitors to easily observe each other's fuel prices. Second, retail fuel outlets regularly track their competitors' fuel prices and change their own prices in response. These repeated interactions give retail fuel outlets familiarity with how their competitors price and how changing prices affect fuel sales.
The Commission's Complaint also alleges that, absent the Consent Agreement, the agreement not to compete harms customers in local retail gasoline and retail diesel fuel markets throughout Michigan and Ohio. By prohibiting Corrigan from competing with (1) each acquired retail fuel outlet and (2) a list of specified GPM locations, whether those GPM locations are anywhere near an acquired Corrigan location, the noncompete provision unreasonably restricts potential competition between Corrigan and GPM that would otherwise benefit consumers.
A general desire to be free from competition following a transaction is not a legitimate business interest. First, Corrigan's agreement not to compete with the 190 GPM-identified retail fuel outlets goes well beyond what is reasonably necessary to protect GPM's investment in the 60 acquired retail Express Stop locations. Second, the Corrigan noncompete agreements around the 60 acquired Express Stop stations, based on the unique facts and conditions present in those markets, is unreasonably overbroad in geographic scope and longer than reasonably necessary to protect a legitimate business interest.
Entry into each relevant market would not be timely, likely, or sufficient to deter or counteract the anticompetitive effects arising from the Acquisition. Significant entry barriers include the availability of attractive real estate, the time and cost associated with constructing a new retail fuel outlet, and the time and uncertainty associated with obtaining necessary permits and approvals.
The Order remedies the Acquisition's likely anticompetitive effects by requiring Respondents to return to Corrigan the retail fuel outlets included in the Acquisition in each of the five local markets. Corrigan is an experienced operator of retail fuel sites and remains an active market participant by continuing to operate a retail fuel business and a wholesale fuel supply business in Michigan.
The transfer of assets must be completed no later than the Closing Date listed in the Reacquisition Agreement of June 28, 2022. The Order further requires Respondents to maintain the economic viability, marketability, and competitiveness of each retail fuel business until Corrigan reacquires the five retail fuel locations.
The Order also requires Respondents to obtain prior approval from the Commission before acquiring retail fuel assets within a 3-mile driving distance of any of the returned locations for 10 years. The prior approval provision is necessary because the purchase of a retail fuel business near any of the five retail fuel locations would likely raise the same competitive concerns as the Acquisition and may not be reportable under the Hart-Scott-Rodino Act.
The Order also resolves the competitive concerns raised by the agreements not to compete. The Order requires that Respondents amend the noncompete obligation in the Asset Purchase Agreement to (i) only apply to retail fuel businesses acquired by GPM in this Acquisition, excluding the five locations to be returned to Corrigan, and (ii) limit the noncompete terms relating to each acquired retail fuel business to no broader than 3 years in duration and no more than 3 miles from each Express Stop location. The Order further (1) requires Respondents not enter into or enforce any noncompete agreement related to acquisitions of a retail fuel business that restrict competition around a retail fuel business that GPM already owns or operates, as opposed to the acquired retail fuel business, and (2)
Retail fuel competition varies based on many factors, including driving patterns, population density, and consumer demand. The reasonableness of agreements not to compete will necessarily differ with local retail fuel competition. A 3-year and 3-mile radius around each acquired location in this transaction resembles a reasonable duration and geographic scope given the local competitive conditions around each Express Stop location. Noncompete agreements affecting areas geographically distinct from acquired retail fuel outlets, and noncompete agreements untethered to protecting goodwill acquired in the acquisition, are highly suspect and warrant Commission scrutiny.
The purpose of this analysis is to facilitate public comment on the Consent Agreement. The Commission does not intend this analysis to constitute an official interpretation of the Consent Agreement or to modify its terms in any way.
By direction of the Commission.
Last year, in an unreportable transaction valued at approximately $94 million, GPM Petroleum, LLC, GPM Southeast, LLC, GPM Investments, LLC, and ARKO Corp. (collectively “GPM”) acquired 60 retail gasoline, diesel, and convenience stores from Corrigan Oil Company (“Corrigan”). Today, after a thorough investigation of this deal, the Commission announced an enforcement action alleging that GPM illegally acquired five of those retail fuel stations from Corrigan, and imposed illegitimate, overbroad agreements not to compete in connection with that acquisition. This action marks an important step forward in protecting the public from harm when rivals agree not to compete. Firms proposing mergers should take note that the Commission will scrutinize contract terms in merger agreements that impede fair competition.
Noncompete agreements affect millions of Americans every day, but they come in a variety of forms. Much of the discussion surrounding noncompete clauses in recent years has focused on their inclusion in employment contracts and the resulting harm to workers. Noncompete covenants, however, can also govern businesses that are direct or potential competitors, and sometimes are included in merger agreements. Today's Commission action highlights that noncompete clauses in a merger agreement may unduly and illegitimately restrain competition when both of the parties remain competitors in other markets.
By its very nature, an agreement not to compete between two businesses reduces competition if it restrains the activities of actual and potential rivals during the term of the agreement. Indeed, noncompete agreements between competing businesses are suspect: for instance, an agreement not to compete may constitute a thinly veiled market allocation scheme, a per se violation of the antitrust laws.
In the context of mergers, parties sometimes assert that noncompete clauses are necessary to protect a legitimate business interest in connection with the sale of a business, such as the goodwill acquired in a transaction. When the seller is exiting the business or selling off assets needed to compete with the buyer, a noncompete that limits prospects for reentry may in certain instances reflect that goodwill, if appropriately limited in geographic scope and duration.
In this matter, as alleged in the Commission's complaint, GPM's agreement to purchase Corrigan's retail fuel stations contained noncompete terms that were overbroad and facially unrelated to protecting any goodwill GPM might hope to acquire with the Corrigan stations. According to the complaint, these noncompete provisions are illegal because they were designed to ensure that GPM would not face direct or indirect competition from Corrigan—not only in the competitively overlapping areas, but even in geographic areas far from the acquired stations.
As today's consent agreement makes clear, firms may not use a merger as an excuse to impose overbroad restrictions on competition or competitors. The Commission will evaluate agreements not to compete in merger agreements with a critical eye.
We look forward to reviewing input and comments from the public about the approach this settlement has taken with respect to the noncompetes at issue here. The Commission is committed to acting in the public interest, and comments from the public are vital to ensuring that we are successful in doing so.
Notice is hereby given of a change in the meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—CE22-007: Reduce Health Disparities and Improve Traumatic Brain Injury (TBI) Related Outcomes Through the Implementation of CDC's Pediatric Mild TBI Guideline, June 7-8, 2022, 8:30 a.m.-5:30 p.m., EDT, Videoconference.
The meeting was published in the
The meeting notice is being amended in the first column (FR Doc 2022-01950) to change the meeting date and should read as follows:
CE22-007: Reduce Health Disparities and Improve Traumatic Brain Injury (TBI) Related Outcomes Through the Implementation of CDC's Pediatric Mild TBI Guideline, June 7, 2022.
The meeting is closed to the public.
Mikel Walters, Ph.D., Scientific Review Officer, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE, Mailstop F-63, Atlanta, Georgia 30341; Telephone: (404) 639-0913; Email:
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS).
Notice of Request for Information.
The Office on Trafficking in Persons (OTIP) requests information on forced labor, a form of human trafficking, in healthcare supply chains including monitoring, training, and research efforts. This request for information (RFI) is part of OTIP's ongoing efforts to seek public comments to inform implementation of Executive Order 14001 (
Comments on this notice must be received by midnight Eastern Daylight Time (EDT) 30 days after posting. OTIP will not respond individually to responders but will consider all comments submitted by the deadline.
Please submit all responses via email to
Alyssa Wheeler, Policy Analyst, Office on Trafficking in Persons, Email:
OTIP is responsible for the development of anti-trafficking strategies, policies, and programs to prevent human trafficking, build health and human service capacity to respond to human trafficking, increase victim identification and access to services, and strengthen health and well-being outcomes of trafficking survivors. OTIP funds the National Human Trafficking Hotline, where an analysis of 32,000 cases reported into the hotline identified healthcare services as one of 25 industries impacted by human trafficking.
In July 2021, HHS published the
As part of this response, the Procurement and Supply Chains Committee of the Senior Policy Operating Group under the President's Interagency Taskforce to Monitor and Combat Trafficking in Persons established a subgroup on Forced Labor in Global Supply Chains. This subgroup is coordinating relevant federal efforts on corporate accountability and compliance, including with the healthcare industry.
Public comments responding to this RFI may inform OTIP, HHS, and federal interagency efforts on trainings, policy guidance, resources, and coordination on data and due diligence tailored to healthcare organizations, procurement professionals, and suppliers.
The term “forced labor” is defined for U.S. enforcement purposes in two separate sections of the United States Code. First, the criminal statutes of Title 18 encompass the range of activities involved in obtaining the labor or services of a person including (1) force, threats of force, physical restraint, or threats of physical restraint; (2) serious harm, threats of serious harm; (3) abuse or threatened abuse of the legal process; (4) or by a “scheme, plan or pattern” designed to cause fear of serious harm or physical restraint (18 U.S.C. 1589). Once a person's labor is obtained by such means, the person's previous consent or effort to obtain employment with the trafficker does not preclude the person from being considered a victim, or the government from prosecuting the offender. Title 18 also defines forced labor as occurring when an individual or entity “knowingly benefits, financially or by receiving anything of value, from participating in a venture which has engaged in providing or obtaining labor or services by prohibited means, knowing or in reckless disregard of the fact that the venture has engaged in providing or obtaining labor or services by such prohibited means.”
Second, the customs-related statute of Title 19 defines forced labor in connection with the prohibition on the importation of goods mined, produced, or manufactured wholly or in part by convict labor, forced labor, and/or indentured labor (19 U.S.C. 1307). In this context, forced and/or indentured labor includes children and is defined as “all work or service which is exacted from any person under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily.”
Forced labor is also referenced in connection to human trafficking protections codified in Title 22, specifically in forms of labor trafficking (22 U.S.C. 7102). Labor trafficking, one type of “severe forms of trafficking in persons,” means “the recruitment, harboring, transportation, provision, or
Pursuant to concepts set out in the
For purposes of this RFI, “healthcare product” will mean any item sourced or produced in the healthcare supply chain, and “healthcare services” will refer to any services procured by an organization in the healthcare sector, including clinical and support services.
OTIP is interested in all the questions listed below, but respondents are welcome to address as many or as few as they choose and to address additional areas of interest not listed.
• Does your organization or another organization have established standard operating procedures for preventing, identifying, reporting, and addressing suspected forced labor or unfair labor practices by staffing agencies or other subcontractors providing workforce personnel?
• What are your current reporting mechanisms in procuring clinical services and services in general? Would it be feasible to incorporate measures on forced labor in those mechanisms?
• How can service contracting practices be strengthened in the healthcare sector?
• Are there mechanisms in place for individuals delivering clinical or supporting services in the healthcare sector to report abuse, fraud, or forced labor? If so, what are those practices and mechanisms? What protections from retaliation are in place for individuals reporting? Are these mechanisms being successfully utilized?
• What steps does your organization take to investigate and, if needed, remediate forced labor violations?
• Are there any barriers in federal policies, programs, and systems that make it challenging to monitor and address forced labor risks in healthcare services procurement? If so, what are those barriers?
• Does your organization or another organization have established standard operating procedures for preventing, identifying, reporting, and addressing suspected forced labor or unfair labor practices by potential suppliers or contractors for healthcare products?
• What are your current due diligence and reporting mechanisms in procuring healthcare products in general? Would it be feasible to incorporate measures on forced labor in those mechanisms?
• How can supply chain transparency practices be strengthened to combat forced labor in the healthcare products?
• Are there practices and mechanisms in place for procurement professionals, administrators, contractors, and/or anyone else who might become aware of forced labor risks in procurement of goods to report abuse, fraud, or forced labor? If so, what are those practices and mechanisms? What protections from retaliation are in place for individuals reporting? Are these mechanisms being successfully utilized?
• What steps does your organization take to investigate and, if needed, remediate forced labor violations?
• Are there any barriers in federal policies, programs, and systems that make it challenging to monitor and address forced labor risks in healthcare product procurement? If so, what are those barriers?
• Do you think healthcare procurement professionals and suppliers are aware of forced labor in supply chains (
• What resources currently exist to help healthcare procurement professionals and suppliers prevent, identify, report, and address forced labor in supply chains? Please provide links to resources or information on organizations developing resources.
• What trainings, information sharing, or information collection efforts have successfully integrated content on forced labor in the acquisition of healthcare products and services?
• What are the gaps in training, technical assistance, and awareness on identifying, monitoring, and addressing forced labor in healthcare supply chains?
• Who do you consider a subject matter expert on forced labor in healthcare supply chains and/or in supply chains more broadly? Please provide the name, affiliation, and email for any individuals you list.
• Do you currently rely on research, data, or information on forced labor in healthcare supply chains to inform your organization's practices to prevent, monitor, and respond to concerns? If so, what type of information and where do you access that information?
• What research, data, or information would be helpful to inform and/or strengthen due diligence processes for healthcare procurement professionals and suppliers?
• What diversity, equity, and inclusion considerations should inform understanding of how forced labor occurs in healthcare supply chains from both the administrative and workforce perspectives?
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 the Government to provide support for any ideas identified in response to it. OTIP will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future solicitation(s), policies, or publications. Respondents will not be identified in any published reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response, unless marked as Business Confidential Information (BCI). Materials submitted may be made public.
Material submitted by members of the public that is properly marked as BCI with a valid statutory basis will not be disclosed publicly. For any comments that contain BCI, the file name of the business confidential version should begin with the characters `BCI'. Any
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.
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.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Novel and Exceptional Technology and Research Advisory Committee.
The meeting will be held as a virtual meeting and is open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
Any interested person may file written comments by forwarding the statement to the Contact Person listed on this notice at least two business days prior to the meeting date. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Other than name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your comments. Please note that any written comments NIH receives may be posted
Information is also available on the NIH Office of Science Policy website:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of 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.
In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102-3.65(a), notice is hereby given that the Charter for the National Cancer Institute Clinical Trials and Translational Research Advisory Committee, was renewed for an additional two-year period on April 14, 2022.
It is determined that the National Cancer Institute Clinical Trials and Translational Research Advisory Committee, is in the public interest in connection with the performance of duties imposed on the National Cancer Institute by law, and that these duties can best be performed through the advice and counsel of this group.
Inquiries may be directed to Claire Harris, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable 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, DOS; Office of the Secretary, DHS.
Notice of determination.
Following consultations with the Attorney General, the Secretary of State and Secretary of Homeland Security have determined that the grounds of inadmissibility at section 212(a)(3)(B) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(a)(3)(B), bar certain individuals who do not pose a national security or public safety risk from admission to the United States and from obtaining immigration benefits or other status. Of particular concern, these grounds of inadmissibility bar some individuals who actively assisted U.S. efforts in Afghanistan and now seek and deserve the protection of our Government.
Accordingly, consistent with prior exercises of the exemption authority, the Secretary of State and the Secretary of Homeland Security hereby conclude, as a matter of discretion in accordance with the authority granted by section 212(d)(3)(B)(i) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(d)(3)(B)(i), as amended, after considering the foreign policy and national security interests deemed relevant in these consultations, that section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), excluding subclause (i)(II), shall not apply with respect to an individual for any activity or association relating to actions:
(1) Directed against the Afghan Taliban or Afghan Taliban-affiliated militia groups;
(2) Directed against any other organization that was engaged in violent activities that targeted the United States or allied entities, including (a) any entity or contractor of the United States government or any individual employed by or on behalf of the United States government, (b) the International Security Assistance Force (ISAF) or any successor name of such Force, (c) the United Nations, or (d) the government of the Islamic Republic of Afghanistan or the Afghan Transitional Authority during the time period from December 22, 2001 to August 15, 2021; or
(3) Directed against the army of the Union of Soviet Socialist Republics (USSR) or the government of the Democratic Republic of Afghanistan between April 27, 1978 and April 28, 1992,
(a) Is seeking a benefit or protection under the INA and has been determined to be otherwise eligible for the benefit or protection;
(b) Has undergone and passed all relevant background and security checks;
(c) Has fully disclosed, to the best of their knowledge to relevant U.S. government entities, the nature and circumstances of all activities or associations falling within the scope of section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B);
(d) Has not participated in, or provided material support for the commission of, a terrorist activity that they knew or reasonably should have known targeted noncombatant persons or U.S. interests;
(e) Is not otherwise inadmissible under section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), for which no exemption applies;
(f) Has not been indicted by any international tribunal or the International Criminal Court;
(g) Has not voluntarily and knowingly engaged in any terrorist activities on behalf of, or provided any material support to any organization which has ever been designated a terrorist organization as described in section 212(a)(3)(B)(vi)(I) or (II) of the INA, at any time, including prior to that organization's designation, unless the activities are otherwise exempted;
(h) Has not committed, ordered, incited, assisted, or otherwise participated in acts of torture, as defined in 18 U.S.C. 2441(d)(1)(A), or genocide, as defined in 18 U.S.C. 1091(a); or recruited or used child soldiers, as described in 18 U.S.C. 2442;
(i) Has not been identified in either Executive Order 13224, as amended, or otherwise designated by the Secretary of State or the Secretary of the Treasury pursuant to the Specially Designated Nationals List (SDNL), or in lists established by United Nations Security Council Committee pursuant to Resolutions 1267 (1999) or 1988 (2011) concerning Al-Qaida and the Taliban and associated individuals and entities;
(j) Poses no danger to the safety and security of the United States; and
(k) Warrants an exemption from the relevant inadmissibility provision(s) in the totality of the circumstances.
Implementation of this determination will be made by U.S. Citizenship and Immigration Services (USCIS) or by U.S. consular officers, as applicable, and in consultation with relevant U.S. government entities, who shall ascertain, to their satisfaction, and in their discretion, that the particular applicant meets each of the criteria set forth above.
This exercise of authority may be revoked as a matter of discretion and without notice at any time, with respect to any and all persons subject to it. Any determination made under this exercise of authority as set out above can inform but shall not control a decision regarding any subsequent benefit or protection application, unless such exercise of authority has been revoked.
This exercise of authority shall not be construed to prejudice, in any way, the ability of the U.S. government to commence subsequent criminal or civil proceedings in accordance with U.S. law involving any beneficiary of this exercise of authority (or any other person). This exercise of authority creates no substantive or procedural right or benefit that is legally enforceable by any party against the United States or its agencies or officers or any other person.
In accordance with section 212(d)(3)(B)(ii) of the INA, 8 U.S.C. 1182(d)(3)(B)(ii), a report on the individuals to whom this exercise of authority is applied, on the basis of case-by-case decisions by the U.S. Department of Homeland Security or by
This determination is based on an assessment related to the national security and foreign policy interests of the United States as they apply to the particular persons described herein and shall not have any application with respect to other persons or to other provisions of U.S. law.
Office of the Secretary, DOS; Office of the Secretary, DHS
Notice of determination.
Following consultations with the Attorney General, the Secretary of Homeland Security and the Secretary of State have determined that grounds of inadmissibility at section 212(a)(3)(B) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(a)(3)(B), bar certain individuals who do not pose a national security or public safety risk from admission to the United States and from obtaining immigration benefits or other status. Accordingly, consistent with prior exercises of the exemption authority, the Secretary of Homeland Security and the Secretary of State, in consultation with the Attorney General, hereby conclude, as a matter of discretion in accordance with the authority granted by section 212(d)(3)(B)(i) of the INA, 8 U.S.C. 1182(d)(3)(B)(i), as amended, after considering the foreign policy and national security interests deemed relevant in these consultations, that section 212(a)(3)(B)(iv)(VI)(cc) of the INA, 8 U.S.C. 1182(a)(3)(B)(iv)(VI)(cc), shall not apply with respect to an individual who provided: (1) insignificant material support (
(a) Did not voluntarily and knowingly engage in terrorist activity on behalf of a designated terrorist organization as described in section 212(a)(3)(B)(vi)(I) or (II) of the INA, 8 U.S.C. 1182(a)(3)(B)(vi)(I) or (II);
(b) Is seeking a benefit or protection under the INA and has been determined to be otherwise eligible for the benefit or protection;
(c) Has undergone and passed all relevant background and security checks;
(d) Has fully disclosed, to the best of their knowledge, in all relevant applications and interviews with government representatives and agents, the nature and circumstances of any material support provided and any other activity or association falling within the scope of section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), as well as all contact with a terrorist organization and its members;
(e) Has not provided the material support with any intent or desire to assist any terrorist organization or terrorist activity;
(f) Has not provided material support that the individual knew or reasonably should have known could directly be used to engage in terrorist or violent activity;
(g) Has not provided material support to terrorist activities that they knew or reasonably should have known targeted noncombatant persons, U.S. citizens, or U.S. interests;
(h) Has not provided material support that the individual knew or reasonably should have known involved providing weapons, ammunition, explosives, or components thereof, or the transportation or concealment of such items;
(i) Is not otherwise inadmissible under section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), for which no exemption applies;
(j) Poses no danger to the safety and security of the United States; and
(k) Warrants an exemption from the relevant inadmissibility provision(s) in the totality of the circumstances.
Implementation of this determination will be made by U.S. Citizenship and Immigration Services (USCIS), in consultation with U.S. Immigration and Customs Enforcement (ICE), or by U.S. consular officers, as applicable, who shall ascertain, to their satisfaction, and in their discretion, that the particular applicant meets each of the criteria set forth above.
This exercise of authority may be revoked as a matter of discretion and without notice at any time, with respect to any and all persons subject to it. Any determination made under this exercise of authority as set out above can inform but shall not control a decision regarding any subsequent benefit or protection application, unless such exercise of authority has been revoked.
This exercise of authority shall not be construed to prejudice, in any way, the ability of the U.S. government to commence subsequent criminal or civil proceedings in accordance with U.S. law involving any beneficiary of this exercise of authority (or any other person). This exercise of authority creates no substantive or procedural right or benefit that is legally enforceable by any party against the United States or its agencies or officers or any other person.
In accordance with section 212(d)(3)(B)(ii) of the INA, 8 U.S.C. 1182(d)(3)(B)(ii), a report on the applicant or beneficiaries to whom this exercise of authority is applied, on the basis of case-by-case decisions by the U.S. Department of Homeland Security or by the U.S. Department of State, shall be provided to the specified congressional committees not later than 90 days after the end of the fiscal year.
This determination is based on an assessment related to the national security and foreign policy interests of the United States as they apply to the particular persons described herein and shall not have any application with respect to other persons or to other provisions of U.S. law.
Office of the Secretary, DOS; Office of the Secretary, DHS.
Notice of determination.
Following consultations with the Attorney General, the Secretary of State and the Secretary of Homeland Security have determined that the grounds of inadmissibility at section 212(a)(3)(B) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(a)(3)(B), bar certain individuals who do not pose a national security or public safety risk from admission to the United States and from obtaining immigration benefits or other status. Accordingly, consistent with prior exercises of the exemption authority, the Secretary of State and the Secretary of Homeland Security hereby conclude, as a matter of discretion in accordance with the authority granted by section 212(d)(3)(B)(i) of the INA, 8 U.S.C. 1182(d)(3)(B)(i), as amended, after considering the foreign policy and national security interests deemed relevant in these consultations, that section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), excluding subclause (i)(II), shall not apply with respect to an individual who was employed as a civil servant in Afghanistan at any time from September 27, 1996 to December 22, 2001, or from August 15, 2021, or thereafter, if the individual establishes that they did not voluntarily and knowingly engage in terrorist activity on behalf of the Taliban or another designated terrorist organization, and provided that the individual satisfies the relevant agency authority that the individual:
(a) Is seeking a benefit or protection under the INA and has been determined to be otherwise eligible for the benefit or protection;
(b) Has undergone and passed all relevant background and security checks;
(c) Has fully disclosed, to the best of their knowledge, in all relevant applications and interviews with U.S. government representatives and agents, the nature and circumstances of any activities or associations falling within the scope of section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B);
(d) Has not participated in, or provided material support for the commission of, a terrorist activity that they knew or reasonably should have known targeted noncombatant persons or U.S. interests;
(e) Is not otherwise inadmissible under section 212(a)(3)(B) of the INA, 8 U.S.C. 1182(a)(3)(B), for which no exemption applies;
(f) Poses no danger to the safety and security of the United States; and
(g) Warrants an exemption from the relevant inadmissibility provision(s) in the totality of the circumstances.
Implementation of this determination will be made by U.S. Citizenship and Immigration Services (USCIS), in consultation with U.S. Immigration and Customs Enforcement (ICE), or by U.S. consular officers, as applicable, who shall ascertain, to their satisfaction, and in their discretion, that the particular applicant meets each of the criteria set forth above.
This exercise of authority supersedes a similar exercise of authority by then Secretary of Homeland Security Jeh Johnson and then Secretary of State John Kerry signed on January 18, 2017, expanding the covered time period of employment as a civil servant in Afghanistan to include the period from “August 15, 2021, or thereafter,” in addition to the period from September 27, 1996 to December 22, 2001. This exercise of authority may be revoked as a matter of discretion and without notice at any time with respect to any and all persons subject to it. Any determination made under this exercise of authority as set out above can inform but shall not control a decision regarding any subsequent benefit or protection application, unless such exercise of authority has been revoked.
This exercise of authority shall not be construed to prejudice, in any way, the ability of the U.S. government to commence subsequent criminal or civil proceedings in accordance with U.S. law involving any beneficiary of this exercise of authority (or any other person). This exercise of authority creates no substantive or procedural right or benefit that is legally enforceable by any party against the United States or its agencies or officers or any other person.
In accordance with section 212(d)(3)(B)(ii) of the INA, 8 U.S.C. 1182(d)(3)(B)(ii), a report on the individuals to whom this exercise of authority is applied, on the basis of case-by-case decisions by the U.S. Department of State or by the U.S. Department of Homeland Security, shall be provided to the specified congressional committees not later than 90 days after the end of the fiscal year.
This determination is based on an assessment related to the national security and foreign policy interests of the United States as they apply to the particular persons described herein and shall not have any application with respect to other persons or to other provisions of U.S. law.
Bureau of Land Management, Interior.
Notice of intent.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Colorado River Valley Field Office (CRVFO), Silt, Colorado, and Grand Junction Field Office (GJFO), Grand Junction, Colorado, intend to prepare a supplemental environmental impact statement (EIS) for the CRVFO and GJFO Resource Management Plans (RMPs). This notice announces the beginning of the scoping process to solicit public involvement and identify issues.
This notice initiates the public scoping process for the supplemental
You may submit comments related to this planning effort electronically via the ePlanning website at
Bruce Krickbaum, Project Manager, email
This document provides notice that the BLM CRVFO and GJFO intend to prepare a joint supplemental EIS for their respective RMPs. The planning area is in Garfield, Mesa, Eagle, Pitkin, Routt, Rio Blanco and Montrose counties, Colorado, and encompasses approximately 1.56 million acres of public land and 1.95 million acres of Federal mineral estate.
The purpose of the supplemental EIS is to supplement the EISs completed in 2014 for the CRVFO RMP and 2015 for the GJFO RMP by considering one or more additional alternatives with respect to the lands that are allocated as open or closed to oil and gas leasing in the planning decision areas, and to provide additional analysis of greenhouse gas emissions associated with the fluid mineral management alternatives considered in the final EISs and the supplemental EIS.
The need for this supplemental EIS is to address the issues identified by the court in litigation involving the Colorado River Valley RMP (
The BLM has identified the following preliminary issues that may arise in the consideration of alternatives with different acreages potentially eligible for oil and gas leasing and is accepting public input during the scoping period consistent with 43 CFR 1610.4-1: environmental consequences of downstream combustion of the oil and gas resources; economic impacts; impacts to affected biological, physical, and heritage resources, resource uses, and special designations; and impacts to recreation. A potential new alternative for each RMP would have no future oil and gas leasing in areas with no-known, low, and moderate fluid mineral potential. Under the potential new alternative, high and very high fluid mineral potential areas would remain open for oil and gas leasing, except for areas that were considered for closure in the conservation alternative (alternative C) from the proposed RMP/final EISs. Apart from oil and gas management planning, this potential alternative would retain existing management as described in the 2015 CRVFO and GJFO RMP Records of Decision and applicable amendments. The supplemental EIS will include an updated analysis of greenhouse gas emissions associated with fluid mineral management planning decisions. The BLM welcomes comments on the potential new alternative as well as suggestions for additional alternatives.
The BLM has identified the following preliminary planning criteria and is accepting public input during the scoping period consistent with 43 CFR 1610.4-2(c):
• The supplemental EIS will comply with NEPA, FLPMA, and other applicable laws, executive orders, regulations, and policy;
• Lands covered in the supplemental EIS will be Federal lands where BLM makes mineral leasing eligibility decisions and split-estate lands with Federal minerals;
• The supplemental EIS will address the issues identified by the court in
• The scope of analysis will be appropriate to the planning scale and in accordance with Bureau-wide standards and program guidance; and
• The BLM will consider Tribal, State, and local plans that are germane in the development of land use plans for public lands, and specifically, the planning decisions considered in the supplemental EIS, to the extent the plans are consistent with the purposes, policies, and programs of Federal laws and regulations applicable to public lands.
The supplemental EIS will evaluate impacts from potential oil and gas leasing and future development to the extent they are reasonably foreseeable at the planning stage. Impacts are not known at this time except as described in the 2014 and 2015 final EISs. The analysis in the supplemental EIS may consider potential effects on wildlife, threatened and endangered species habitat, recreation, visual resources, water resources, air quality, cultural resources, special designations, social and economic conditions, fluid minerals, and other resources and uses. The BLM will use an interdisciplinary approach that incorporates the expertise of specialists in the relevant resource fields.
The BLM will provide additional opportunities for public participation consistent with the NEPA and land use planning processes, including a 90-day comment period on the draft supplemental EIS and a 30-day public protest period and a 60-day Governor's consistency review on the final supplemental EIS. The draft supplemental EIS is anticipated to be available for public review in Spring 2023 and the final supplemental EIS is anticipated to be available for public protest in Winter 2023/2024 with a Record of Decision in Spring 2024.
The BLM encourages comments concerning the scope of the analysis in the supplemental EIS, the potential new alternative, other potential alternatives, identification of issues for analysis, and any other information relevant to this project. You may submit comments by using one of the methods listed in the
The BLM is the lead Federal agency for the supplemental EIS. The BLM has invited the following to participate as cooperating agencies: the seven counties that are entirely or partially in the planning area, municipalities that participated as cooperating agencies during the RMPs/EISs, Colorado Department of Natural Resources, Colorado Parks and Wildlife, Colorado River Water Conservation District, U.S. Fish and Wildlife Service, and U.S. Bureau of Reclamation.
The Colorado State Director is the deciding official for this planning effort.
The nature of the decision to be made will be the State Director's selection of land use planning decisions for managing BLM-administered lands under the principles of multiple use and sustained yield in a manner that best addresses the purpose and need. The decision resulting from this supplemental EIS will specify which areas are allocated as open or closed to oil and gas leasing in the decision area.
The BLM will identify, analyze, and consider mitigation to address the reasonably foreseeable impacts to resources from all reasonable alternatives and, in accordance with 40 CFR 1502.14(f), include appropriate mitigation measures not already included in the alternatives. Mitigation may include avoidance, minimization, rectification, reduction, or elimination over time, and compensation; and may be considered at multiple scales, including the landscape scale.
The BLM will utilize and coordinate the NEPA and land use planning processes for this planning effort to help support procedural requirements under the Endangered Species Act (16 U.S.C. 1536) and Section 106 of the National Historic Preservation Act (54 U.S.C. 306108) as provided in 36 CFR 800.2(d)(3), including public involvement requirements of Section 106. The information about historic and cultural resources and threatened and endangered species within the area potentially affected by the proposed plan will assist the BLM in identifying and evaluating impacts to such resources.
The BLM will consult with Indian Tribes on a government-to-government basis in accordance with Executive Order 13175, BLM Manual section 1780, and other Departmental policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Federal, State, and local agencies, along with Tribes and stakeholders that may be interested in or affected by the supplemental EIS that the BLM is evaluating, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate in the development of the environmental analysis as a cooperating agency.
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.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act, as amended, the Federal Advisory Committee Act, and the Federal Lands Recreation Enhancement Act, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Grand Staircase-Escalante National Monument Advisory Committee will meet as indicated below.
The Grand Staircase-Escalante National Monument Advisory Committee will hold virtual meetings on July 12, 2022; October 18, 2022; and December 13, 2022. All meetings will occur from 9 a.m. to 4:30 p.m. Public comments will be received on July 12, 2022 at 3:30 p.m., October 18, 2022 at 2:45 p.m., and on December 13, 2022 at 1:45 p.m. The meetings are open to the public.
The agenda and meeting access information (including how to log in and participate in virtual meetings) will be announced on the Grand Staircase-Escalante National Monument Advisory Committee web page 15 days before the meeting at
David Hercher, Paria River District Public Affairs Specialist, 669 S Highway 89A, Kanab, UT 84741, via email with the subject line “GSENM MAC” to
Presidential Proclamation 6920, as modified by Presidential Proclamations 9682 and 10286, established the Grand Staircase-Escalante National Monument Advisory Committee to provide advice and information to the Secretary of the Interior through the Director of the BLM to consider for managing the Grand Staircase-Escalante National Monument. The 15-member committee represents a wide range of interests including local and state government, paleontological and archaeological expertise, the conservation community, livestock grazing permittees, Tribal members, developed and dispersed recreation interests, private landowners, local business owners, and the public at large.
Planned agenda items for the July meeting include: administrative business; introduction of the Oct. 8, 2021, Proclamation 10286, as the foundational legal instrument for the management of the Monument; presentation of the interim guidance issued by the BLM Dec. 16, 2021, as providing interim management direction for land managers, while a new Monument management plan is being developed; and the role of the guidance in ongoing management. Additional agenda items include introduction of the National Landscape Conservation System 15-Year Strategy (2010-2025) and how this strategy will apply to Monument management, review of the status of BLM efforts toward preparing and adopting a science plan for the Monument, and a brief update on other ongoing National Environmental Policy Act (NEPA) planning within the Monument. Planned agenda items for the October
A public comment period will be offered during these meetings. Depending on the number of people wishing to comment and the time available, the time for individual comments may be limited. Written comments may also be sent to the Grand Staircase-Escalante National Monument at the address listed in the
Please make requests in advance for sign language interpreter services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed in the
Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
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.
Detailed meeting minutes for the Grand Staircase-Escalante National Monument Advisory Committee meeting will be maintained in the Paria River District Office and will be available for public inspection and reproduction during regular business hours within 90 days following the meeting. Minutes will also be posted to the Grand Staircase-Escalante National Monument Advisory Committee web page.
Bureau of Land Management, Interior.
Public Land Order.
This Public Land Order (PLO) extends the duration of the withdrawal created by PLO No. 7531, which would otherwise expire on August 5, 2022, for an additional 20-year term. PLO No. 7531 withdrew 1.25 acres of public land from settlement, sale, location, or entry under the public land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, subject to valid existing rights, for the United States Air Force (USAF) to protect the King Salmon Remediation Project.
This PLO takes effect on August 6, 2022.
Chelsea Kreiner, BLM Alaska State Office, 222 West Seventh Avenue, Mailstop 13, Anchorage, AK 99513-7504, (907) 271-4205, or
The purpose for which the withdrawal was first made requires this extension to continue the protection of the King Salmon Environmental Remediation Project in King Salmon, Alaska.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:
1. Subject to valid existing rights, PLO No. 7531, (67 FR 50894 (2002)), which withdrew 1.25 acres of public land from settlement, sale, location, or entry under the public land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, subject to valid existing rights, and reserved it for environmental remediation and protection by the United States Air Force, is hereby extended for an additional 20-year period.
2. The withdrawal extended by this Order will expire on August 5, 2042, unless, as a result of a review conducted prior to the expiration date, pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be further extended.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Velodyne Lidar USA, Inc. on June 16, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain rotating 3-d lidar devices, components thereof, and sensing systems containing the same. The complainant names as respondent: Ouster, Inc. of San Francisco, CA; and Benchmark Electronics, Inc. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondent, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On June 14, 2022, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of New Jersey in the lawsuit entitled
The publication of this notice opens a period for public comment on the proposed consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $4.75 (25 cents per page reproduction cost), payable to the United States Treasury.
The Finance Committee of the Legal Services Corporation Board of Directors will meet virtually on June 30, 2022. The meeting will commence at 2:30 p.m. EDT, and will continue until the conclusion of the Committee's agenda.
LSC will conduct the June 30, 2022 meetings via Zoom.
• To join the Zoom meeting by computer, please use this link.
• To join the Zoom meeting with one tap from your mobile phone, please click dial:
• To join the Zoom meeting by telephone, please dial one of the following numbers:
Once connected to Zoom, please immediately mute your computer or telephone. Members of the public are asked to keep their computers or telephones muted to eliminate background noise. To avoid disrupting the meetings, please refrain from placing the call on hold if doing so will trigger recorded music or other sound.
From time to time, the Finance Committee Chair may solicit comments from the public. To participate in the meeting during public comment, use the `raise your hand' or `chat' functions in Zoom and wait to be recognized by the Chair before stating your questions and/or comments.
Open.
Kaitlin Brown, Executive and Board Project Coordinator, at (202) 295-1555. Questions may also be sent by electronic mail to
The Operations and Regulations Committee of the Legal Services Corporation Board of Directors will meet virtually on June 30, 2022. The meeting will commence at 12:00 p.m. EDT, and will continue until the conclusion of the Committee's agenda.
LSC will conduct the June 30, 2022 meeting via Zoom.
To join the Zoom meeting by computer, please use this link.
•
• To join the Zoom meeting with one tap from your mobile phone, please click dial:
• To join the Zoom meeting by telephone, please dial one of the following numbers:
Once connected to Zoom, please immediately mute your computer or telephone. Members of the public are asked to keep their computers or telephones muted to eliminate background noise. To avoid disrupting the meetings, please refrain from placing the call on hold if doing so will trigger recorded music or other sound.
From time to time, the Operations and Regulations Committee Chair may solicit comments from the public. To participate in the meeting during public comment, use the `raise your hand' or `chat' functions in Zoom and wait to be recognized by the Chair before stating your questions and/or comments.
Open.
Kaitlin Brown, Executive and Board Project Coordinator, at (202) 295-1555. Questions may also be sent by electronic mail to
The Governance and Performance Review Committee of the Legal Services Corporation Board of Directors will meet virtually on July 1, 2022. The meeting will commence at 2:30 p.m. EDT, and will continue until the conclusion of the Committee's agenda.
LSC will conduct the July 1, 2022 meeting via Zoom.
• To join the Zoom meeting by computer, please use this link.
• To join the Zoom meeting with one tap from your mobile phone, please click dial:
• To join the Zoom meeting by telephone, please dial one of the following numbers:
Once connected to Zoom, please immediately mute your computer or telephone. Members of the public are asked to keep their computers or telephones muted to eliminate background noise. To avoid disrupting the meetings, please refrain from placing the call on hold if doing so will trigger recorded music or other sound.
From time to time, the Governance and Performance Review Committee Chair may solicit comments from the public. To participate in the meeting during public comment, use the `raise your hand' or `chat' functions in Zoom and wait to be recognized by the Chair before stating your questions and/or comments.
Open.
Kaitlin Brown, Executive and Board Project Coordinator, at (202) 295-1555. Questions may also be sent by electronic mail to
Office of National Drug Control Policy.
60-Day notice and request for comments. Revisions of currently approved collection: Drug-Free
In accordance with the Paperwork Reduction Act of 1995, the Office of National Drug Control Policy (ONDCP) announces it will submit to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) an information collection request.
ONDCP encourages and will accept public comments on or before 60 days after the date of this publication.
Address all comments in writing within 60 days to Helen Hernandez. Email is the most reliable means of communication. Ms. Hernandez's email address is
Under reauthorization legislation (21 U.S.C. 1521), Congress mandated an evaluation of the DFC program to determine its effectiveness in meeting objectives. Under the CARA Local Drug Crisis program statute, CARA Local Drug Crisis data collection is authorized and required by Public Law 114-198 Sec 103, “a grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipients of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing abuse of opioids or methamphetamines”. ONDCP awarded a contract for a DFC grant oversight system at the end of 2014, following a competitive request for proposals process. The DFC Management and Evaluation (DFC Me) system was launched in 2016. An additional award was made in 2019, with the requirement to include CARA Local Drug Crisis recipients in the system and DFC & CARA Me continues to be used and updated (
ONDCP's Drug-Free Communities office will continue to utilize the case study protocols previously approved by OMB to document coalition practices, successes and challenges. Approximately nine DFC grant award recipients are selected each year to highlight in the case studies. The information from the case studies will be used to illustrate not only what works to reduce drug use in a community setting, but also how and why it works.
The CARA Local Drug Crisis program evaluation makes use of a shortened version of the DFC progress report to support evaluation, monitoring and tracking of progress annually for grant award recipients and will provide information to ONDCP and the Administration's effort to address the opioid crisis.
National Endowment for the Arts, National Foundation on the Arts and the Humanities.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 16 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference or videoconference.
See the
National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC, 20506.
Further information with reference to these meetings can be obtained from Daniel Beattie, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the NEA Chair of March 11, 2022, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
The upcoming meetings are:
National Science Foundation.
Submission for OMB review; comment request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to
As required by 5 CFR 1320.8(d), comments on the information collection activities as part of this study were solicited through publication of a 60-Day Notice in the
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number, and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Data are published in NSF's annual publication series Higher Education Research and Development, available on the web at
The Federally Funded Research and Development Centers R&D survey will also provide continuity of statistics on R&D expenditures by source of funding (federal, state and local, business, nonprofit, or other, and federal agency source), and type of R&D (basic research, applied research, or development). Beginning with FY 2022, the FFRDC R&D survey will collect headcounts and full-time equivalents of R&D personnel (researchers, R&D technicians, and R&D support staff).
Data are published in NSF's annual publication series FFRDC Research and Development Survey, available on the web at
The total annual calculated burden across all forms is 44,613 hours. Additional details on the burden calculation can be found in the first
Nuclear Regulatory Commission.
Public meeting and request for comment.
On December 4, 2019, Pacific Gas and Electric Company (PG&E, the licensee) submitted to the U.S. Nuclear Regulatory Commission (NRC) letters enclosing the post-shutdown decommissioning activities report (PSDAR), the site-specific decommissioning cost estimate (SSDCE), and the irradiated fuel management plan (IFMP), for the Diablo Canyon Nuclear Power Plant, Units 1 and 2 (Diablo Canyon, Units 1 and 2). The PSDAR, including the SSDCE and IFMP, provide an overview of PG&E's planned activities, schedule, projected costs, and environmental impacts for the decommissioning of Diablo Canyon, Units 1 and 2. On February 21, 2020, the NRC solicited comments on these documents. Subsequently, PG&E submitted a notification of changes on October 19, 2021. The NRC planned to hold a public meeting in the vicinity of Diablo Canyon, Units 1 and 2, to discuss the PSDAR's content, including the SSDCE and IFMP, and receive comments but decided to reschedule the public meeting due to concerns with the coronavirus disease 2019 (COVID-19) public health emergency. The NRC has rescheduled the public meeting to discuss the PSDAR, including the SSDCE and IFMP, and receive comments.
The public meeting will be held on Thursday, July 21, 2022, from 6:00 p.m. until 9:00 p.m. Pacific Time (PT), at the San Luis Obispo County Government Building, located at 1055 Monterey Street, in San Luis Obispo, California. The public meeting is also accessible through an online webinar. Submit comments by October 19, 2022. Comments received after this date will be considered, if it is practical to do so,
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Samson S. Lee, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-3168, email:
Please refer to Docket ID NRC-2022-0132 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
PG&E is the holder of Facility Operating License Nos. DPR-80 and DPR-82 for Diablo Canyon, Units 1 and 2, respectively. The license provides, among other things, that the facility is subject to all relevant rules, regulations, and orders of the NRC now or hereafter in effect. The facility consists of a pair of Westinghouse four loop pressurized water reactors located in San Luis Obispo County, California. By letter dated November 27, 2018, PG&E informed the NRC that it will permanently cease power operations at Diablo Canyon, Units 1 and 2, on November 2, 2024, and August 26, 2025, respectively.
Paragraph 50.82(a)(4)(i) of title 10 of the
Accordingly, pursuant to 10 CFR 50.82(a)(4)(ii), the NRC noticed receipt of the Diablo Canyon, Units 1 and 2 PSDAR, including the SSDCE and IFMP, and made them available for public comment on February 21, 2020 (85 FR 10200). The public comment period closed on June 22, 2020. The purpose of the
The NRC is requesting public comments on the PSDAR, including the SSDCE and IFMP, for Diablo Canyon, Units 1 and 2. The NRC is planning to hold the PSDAR meeting and receive comments on Thursday, July 21, 2022, from 6:00 p.m. until 9:00 p.m. (PT), at the San Luis Obispo County Government Building, located at 1055 Monterey Street, in San Luis Obispo, California. Please contact Samson Lee no later than July 8, 2022, if accommodations or special equipment is needed to attend or to provide comments. Information regarding the public meeting, including webinar information, will be posted on the NRC's public meeting website at least 10 calendar days before the meeting. The NRC's public meeting website is located at
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Indirect transfer of license; order.
The U.S. Nuclear Regulatory Commission (NRC, the Commission) is issuing an order approving the indirect transfer of Renewed Facility Operating License No. DPR-43 for the Kewaunee Power Station (KPS) and the general license for the KPS independent spent fuel storage installation, held by Dominion Energy Kewaunee, Inc. (DEK), to Kewaunee Solutions, Inc. (Kewaunee Solutions). The transfer assigns control of the licenses from DEK's parent entity, Dominion Nuclear Projects, Inc. (Dominion), to Energy
The order was issued on March 31, 2022 and is effective for 1 year.
Please refer to Docket ID NRC-2021-0185 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Karl J. Sturzebecher, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8534; email:
The text of the order is attached.
For the Nuclear Regulatory Commission.
Dominion Energy Kewaunee, Inc. (DEK) is the holder of Renewed Facility Operating License No. DPR-43 for Kewaunee Power Station (KPS) and the general license for the KPS independent spent fuel storage installation (ISFSI), and Dominion Nuclear Projects, Inc. (Dominion) is the parent entity of DEK. KPS permanently ceased power operations on May 7, 2013, and DEK certified to the U.S. Nuclear Regulatory Commission (NRC) by letter dated May 14, 2013 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML13135A209) that as of May 14, 2013
By letter dated May 10, 2021 (ADAMS Accession No. ML21131A141), as supplemented by letters dated May 13, 2021 (ADAMS Accession No. ML21145A118), October 28, 2021 (ADAMS Accession No. ML21301A177), February 16, 2022 (ADAMS Accession No. ML22047A057), and March 15, 2022 (ADAMS Accession No. ML22076A065), DEK and Energy
Upon an NRC approval of the license transfer application and the consummation of the proposed transfer transaction, the same legal entity would remain the KPS licensee, and its name would change from DEK to Kewaunee Solutions. Kewaunee Solutions would continue to hold title to and ownership of any real estate encompassing the KPS site, any improvements to the site, and title to and ownership of spent nuclear fuel. Kewaunee Solutions would have responsibility for all licensed activities at the KPS site, including responsibility under the license to complete decommissioning pursuant to NRC regulations. However, Kewaunee Solutions would operate under new management and would be a direct and wholly owned subsidiary of Energy
On October 12, 2021, the NRC published in the
In accordance with 10 CFR 50.80, no license for a production or utilization facility, or any right thereunder, shall be transferred, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission gives its consent in writing. In accordance with 10 CFR 72.50, no license or any part included in a license for an ISFSI shall be transferred, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the NRC gives its consent in writing. Upon review of the information in the license transfer application, as supplemented, and other information before the Commission, and relying upon the representations and agreements contained in the application, the NRC staff has determined that Kewaunee Solutions, as a direct and wholly owned subsidiary of Energy
Upon review of the application, as supplemented, for a conforming administrative license amendment to reflect the transfer, the NRC staff has determined that:
(1) The application for amendment complies with the standards and requirements of the AEA and the Commission's regulations set forth in 10 CFR Chapter I.
(2) The facility will operate in conformity with the application, the provisions of the AEA, and the Commission's regulations.
(3) There is reasonable assurance that the activities authorized by the amendment can be conducted without endangering the health and safety of the public and that such activities will be conducted in compliance with the Commission's regulations.
(4) The issuance of the amendment will not be inimical to the common defense and security or to the health and safety of the public.
(5) The issuance of the amendment is in accordance with 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” of the Commission's regulations and all applicable requirements have been satisfied.
The findings set forth above are supported by an NRC staff safety evaluation dated March 31, 2022, which is publicly available at ML22014A394.
Accordingly, pursuant to Sections 161b, 161i, and 184 of the AEA; 42 United States Code §§ 2201(b), 2201(i), and 2234; and 10 CFR 50.80, 10 CFR 72.50, and 10 CFR 50.90,
(1) At least two business days before the planned closing date of the purchase transaction, Energy
(2) At least two business days before the planned closing date of the purchase transaction, Energy
This order is effective upon issuance.
For further details with respect to this order, see the application dated May 10, 2021, as supplemented by letters dated May 13, 2021, October 28, 2021, February 16, 2022, and March 15, 2022, and the associated NRC staff safety evaluation dated March 31, 2022, which are available for public inspection electronically through ADAMS in the NRC Library at
Dated: March 31, 2022.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
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This Notice will be published in the
On April 20, 2022, NYSE Chicago, Inc. (“NYSE Chicago” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On April 20, 2022, NYSE National, Inc. (“NYSE National” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On April 20, 2022, New York Stock Exchange LLC (“NYSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
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”),
ICE Clear Europe Limited (“ICE Clear Europe” or the “Clearing House”) proposes to modify its Clearing Rules (“Clearing Rules” or “Rules”) to provide greater certainty and additional detail with respect to: (i) the correction of settlement prices in the case of certain external events and (ii) the cash settlement of transactions in lieu of delivery where a Clearing Member is in default or there are grounds for declaring a default in respect of a Clearing Member, each of the foregoing in respect of F&O Contracts. A copy of the proposed amendments is set forth in Exhibit 5.
In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
ICE Clear Europe is proposing to amend its Clearing Rules to provide greater certainty and additional detail in relation to (i) the scenarios where there is an external or other change in a relevant price or event which results in a need for the Clearing House to correct settlement prices; and (ii) the cash settlement of transactions in lieu of delivery where a Clearing Member is in default or there are grounds for declaring a default in respect of a Clearing Member.
Although the Exchange Delivery Settlement Price (“EDSP”) for a futures contract is generally determined based on data provided by the relevant Market, Rule 701(c) provides that in a number of scenarios the Clearing House may itself determine the Exchange Delivery Settlement Price. The amendments would add the cases of Force Majeure Event, Illegality or Impossibility as circumstances in which the Clearing House could take such
A new subsection (d) would be added to Rule 701 and would provide that the Clearing House would be entitled to amend any previously communicated EDSP, including in respect of futures contracts already settled or delivered, in the following two scenarios: (i) a Market or other external pricing source has made an error in or amends the EDSP or the basis for, or any element or input data in respect of the EDSP, or (ii) there has been an error by the Clearing House. In such scenarios, the Clearing House would be able to order revised payments to reflect the amended EDSP, including in respect of settled or delivered Contracts. Any amended EDSP determined by the Clearing House under each new such subsection would be communicated to affected Clearing Members, and any revised payments ordered by the Clearing House in connection therewith would be promptly processed by the Clearing House as part of its usual operational processes. The amendments are intended to provide greater certainty under the Rules as to the situations in which a change of price might take place and the consequences of such change, including the rights and obligations of the Clearing House in the event of a change in a settlement price, or an input in the settlement price, and the rights and obligations of the Clearing House and F&O Clearing Members to make appropriate payments in the event of a resulting change in an EDSP, including following settlement of a Contract. Such a change could occur, for example, where an input for the EDSP is based by the relevant Market on a price reporting service or prices in a spot or cash market for an underlying commodity, or where an input price is subject to or affected by action of relevant governmental or other authorities with jurisdiction over those markets. Although the Clearing House has other existing general authority, including under Rule 701(c) and Rule 109, that it might potentially use to address such situations, the Clearing House believes it is appropriate for the Clearing House to have explicit, specific rules addressing the possibility of such a change in a relevant price, in light of experiences with errors involving underlying prices and other cases in which underlying or related markets have considered such changes that could potentially have affected the EDSP. The amendments would also provide increased certainty for Clearing Members and other market participants as to the likely consequences of such changes occurring. ICE Clear Europe does not expect that Rule 701(d) would be commonly used in the ordinary course of business.
The amendments would also redesignate the ultimate paragraph in Rule 705 as subsection (b). This non-substantive update is intended to improve the organization and readability of the Rules, and to align with the parallel provision in Rule 805. A further conforming change would be made to the same paragraph provide that the discharge of the rights and obligations of Clearing Members upon settlement would be made expressly subject to Rule 701(d) (as discussed above), a change which reflects the Clearing House's present interpretation of how these two provisions interrelate.
Parallel changes would be made for Options Contracts in Rules 802(c) and (d). Rule 802(c) would be amended to add Force Majeure Event, Illegality or Impossibility to the list of scenarios that entitle the Clearing House to determine the EDSP at its discretion. The amendments would also remove a redundant reference to the Clearing House acting in its discretion. Rule 802(c) would be updated to provide that any EDSP determined under such Rule would be communicated to affected Clearing Members, for the reasons discussed for Rule 701(c) above.
A new subsection (d) would also be added to Rule 802 and would provide that the Clearing House would be entitled at its discretion to amend any previously communicated EDSP for option contracts, including in respect of contracts already settled or delivered, in the following two scenarios: (i) a Market or other external pricing source has made an error in or amends the EDSP or the basis for, or any element or input data in respect of the EDSP, or (ii) there has been an error by the Clearing House. In such scenarios, the Clearing House would be able to order revised payments, including in respect of settled or delivered Contracts. Any amended EDSP determined by the Clearing House under each new such subsection would be communicated to affected Clearing Members, and any revised payments ordered by the Clearing House in connection therewith would be promptly processed by the Clearing House as part of its usual operational processes. The purpose and rationale for these amendments is substantially the same as for the amendments to Rule 701(d), as discussed above.
Similar to the changes to Rule 705 discussed above, a conforming change would be made to Rule 807 to provide that the discharge of Clearing Members on settlement would be subject to Rule 802(d) (as discussed above). Likewise, a change would be made to Rule 808(b) to provide that the termination of rights and obligations upon abandonment of an option would be subject to Rule 802(d), for similar reasons.
The Clearing House proposes to amend Rule 703(h) to provide greater certainty as to the treatment of delivery obligations under F&O Contracts in the event of a default by a Clearing Member or when there are grounds for declaring a default in respect of a Clearing Member. Depending upon the kind of F&O Contract, pursuant to existing Rule 703(f) and the Delivery Procedures, selling Clearing Members may be matched with buying Clearing Members to effect delivery between them, in satisfaction of the selling Clearing Member's delivery obligation to the Clearing House and the Clearing House's delivery obligation to the buying Clearing Member. In the case of other F&O Contracts, there is no such matching and delivery is made by Sellers to the Clearing House and then by the Clearing House to Buyers, pursuant to Rules 703(b) to (e) and the Delivery Procedures.
The proposed amendments to Rule 703(h) would provide further detail, consistent with existing Clearing House practices and interpretations, as to what happens when a Clearing Member which has been matched for purposes of delivery fails to perform its delivery obligations. Rule 703(h) applies to a Clearing Member that has been declared a Defaulter or is subject to grounds for declaring an Event of Default or Force Majeure Event. In such a case, the Clearing House already has under Rule 703(h) the ability to direct that delivery obligations be substituted for cash, including as against non-defaulting Clearing Members. This enables it to ensure that the number of Contracts under delivery remain matched and that the Clearing House does not need to source deliverable commodities in the physical marketplace. Amended Rule
ICE Clear Europe believes that the proposed amendments to the Clearing Membership Procedures are consistent with the requirements of Section 17A of the Act
The proposed changes to the Rules are intended to provide greater certainty and additional detail as to (i) the rights and obligations of the Clearing House and F&O Clearing Members in scenarios where there is an external or other change of price which results in a need to change or correct the EDSP, including after settlement occurs; and (ii) the way in which the Clearing House could effect cash settlement in lieu of delivery in the case of an F&O Clearing Member default or where a Clearing Member is subject to ground for declaring a default. The amendments relating to changes in EDSP are intended to provide greater certainty as to the actions the Clearing House may take in circumstances where there is a potential change in a settlement price, including where settlement has already occurred and additional payments would be required. The Clearing House believes it is important to have clear provisions in the Rules for this scenario given the potential impact on market participants. The amendments with respect to cash settlement of delivery obligations in case of default are not intended to materially change the substance of the rights or obligations of the Clearing House and Clearing Members but would provide greater clarity as to the applicable process. The amendments also remove certain overlapping or duplicative information in order to improve organization and readability. In ICE Clear Europe's view the amendments would thus facilitate the clearing and settlement process, as well as default management, by the Clearing House. The proposed amendments would therefore facilitate the prompt and accurate clearing of cleared Contracts, the safeguarding of securities and funds in the custody or control of the Clearing House or for which it is responsible, and the protection of investors and the public interest in the sound operations of the Clearing House, consistent with the requirements of Section 17A(b)(3)(F).
For similar reasons, the amendments to the Rules are also consistent with relevant provisions of Rule 17Ad-22.
Rule 17Ad-22(e)(8) provides that “[e]ach covered clearing agency shall establish, implement, maintain and enforce written policies and procedures reasonable designed to, as applicable [. . .] define the point at which settlement is final to be no later than the end of the day on which the payment or obligation is due. . . .”.
Rule 17Ad-22(e)(10) provides that “[e]ach covered clearing agency shall establish, implement, maintain and enforce written policies and procedures reasonable designed to, as applicable [. . .] establish and maintain transparent written standards that state its obligations with respect to the delivery of physical instruments, and establish and maintain operational practices that identify, monitor and manage the risks associated with such physical deliveries.”
ICE Clear Europe does not believe the proposed amendments would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The amendments are being adopted to update and provide greater legal certainty under the Rules to address scenarios in which the Clearing House may need to amend an EDSP, including as a result of a change in a relevant input. Other amendments would elucidate the rights and obligations of Clearing Members with respect to physical delivery in the case of a Clearing Member default. The amendments would apply to all F&O Clearing Members. Although the amendments address scenarios where a market participant may be obligated to make a payment as a result of a change in an EDSP, which could impose costs on such market participant, that result would depend on the market participant's own positions and reflect a change in the underlying relevant price or input to correctly reflect the value of the relevant Contract. Similarly, the amendments address the ability of the Clearing House to impose cash settlement in lieu of physical settlement, including on non-defaulters, which could impose a cost on such market participant. However, that result would depend on the Clearing Member's own positions and reflects a cost and risk to which the Clearing Members are already exposed and which arise commonly in clearing systems. ICE Clear Europe does not believe the amendments would otherwise affect the costs of clearing, the ability of market participants to access clearing, or the market for clearing services generally. Therefore, ICE Clear Europe does not believe the proposed rule change imposes any burden on competition that is inappropriate in furtherance of the purposes of the Act.
ICE Clear Europe consulted with a number of market participants, including a relevant futures industry group, in connection with the development of the proposed rule changes, and considered feedback from such participants in preparing the specific rule changes that are now proposed to be adopted. In particular, market participants raised questions concerning (i) the circumstances in which settlement prices might be changed, and (ii) the appropriate timeframe in which a change to EDSP may be made. In developing the current proposal, ICE Clear Europe notes that the amendments are generally intended to deal with changes from external pricing sources, which may be permitted to make such changes in a variety of circumstances, and with a variety of characterizations, that are outside the control of ICE Clear Europe and may be difficult to define more specifically in advance. ICE Clear Europe also notes that it has not defined a specific timeframe in which a change to EDSP may be made, in light of the fact that different Markets cleared by ICE Clear Europe and different external pricing sources may have their own time period in which changes to relevant prices may be made. ICE Clear Europe has thus sought to maintain appropriate flexibility to deal with the range of potential changes to relevant prices as they may arise.
ICE Clear Europe has also conducted a formal public consultation with respect to the proposed rule changes.
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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2022-011 and should be submitted on or before July 14, 2022.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On April 20, 2022, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On April 20, 2022, NYSE American LLC (“NYSE American” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change, so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Surface Transportation Board.
Approval of rail cost adjustment factor.
The Board has approved the third quarter 2022 Rail Cost Adjustment Factor (RCAF) and cost index filed by the Association of American Railroads. The third quarter 2022 RCAF (Unadjusted) is 1.250. The third quarter 2022 RCAF (Adjusted) is 0.512. The third quarter 2022 RCAF-5 is 0.487.
Pedro Ramirez at (202) 245-0333. Assistance for the hearing impaired is available through the Federal Relay Service at (800) 877-8339.
Additional information is contained in the Board's decision, which is available at
By the Board, Board Members Fuchs, Hedlund, Oberman, Primus, and Schultz.
Susquehanna River Basin Commission.
Notice.
As part of its regular business meeting held on June 16, 2022, Baltimore, Maryland, the Commission approved the applications of certain water resources projects, and took additional actions, as set forth in the Supplementary Information below.
June 16, 2022.
Susquehanna River Basin Commission, 4423 N Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel and Secretary, telephone: (717) 238-0423, ext. 1312, fax: (717) 238-2436; email:
In addition to the actions taken on projects identified in the summary above and the listings below, the following items were also acted upon at the business meeting: (1) election of Commission officers for FY2023; (2) reconciliation of FY2023 budget; (3) a motion related to the Conowingo Watershed Implementation Plan; (4) ratification of contracts/grants; (5) revision of Commission By-laws; (6) proposed Water Resources Program for 2022-2024; and (7) three regulatory program waiver requests.
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Federal Aviation Administration (FAA), DOT.
Notice.
The Federal Aviation Administration is requesting public comment on a request by Metropolitan Nashville Airport Authority (MNAA), to release five access easements (8.1 acres) at John C. Tune Airport from federal obligations.
Comments must be received on or before July 25, 2022.
Comments on this notice may be emailed to the FAA at the following email address:
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Keith Wilschetz, Director, Strategic Planning, Metropolitan Nashville Airport Authority at the following address:
L. Bernard Green, Community Planner, Federal Aviation Administration, Memphis Airports District Office, 2600, Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118-2482,
The FAA proposes to rule and invites public comment on the request to release five access easements at John C. Tune Airport, 110 Tune Airport Drive, Nashville, TN 37209, under the provisions of 49 U.S.C. 47107(h)(2). The FAA determined that the request to release the five access easements at John C. Tune Airport (JWN) submitted by the Sponsor meets the procedural requirements of the Federal Aviation Administration and the release of these properties does not and will not impact future aviation needs at the airport. The FAA may approve the request, in whole or in part, no sooner than thirty days after the publication of this notice.
The request consists of the following:
The Metropolitan Nashville Airport Authority is proposing the release of five access easements totaling 8.1 acres, more or less. All five locations are located on the west side of the Cumberland River from the Airport, within two miles of the airport and include a radio tower easement, an access easement, and three tower easements. The five access easements are no longer required.
This request will release this property from federal obligations. This action is taken under the provisions of 49 U.S.C. 47107(h)(2).
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the request, notice and other documents germane to the request in person at John C. Tune Airport (JWN).
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew a previously approved information collection. The FAA assesses the information collected and issues operations specifications to foreign air carriers. These operations specifications assure the foreign air carrier's ability to navigate and communicate safely within the U.S. National Airspace System.
Written comments should be submitted by August 22, 2022.
Please send written comments:
By Electronic Docket:
By email at:
Danuta Pronczuk or Paul Thoren by email at:
Issued in Washington, DC.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), Council on Environmental Quality NEPA implementing regulations, and FAA Order 1050.1F,
Amy Hanson, Environmental Protection Specialist, Federal Aviation Administration, 800 Independence Avenue SW, Suite 325, Washington, DC 20591; email
The FAA is the lead agency responsible for completing the EA. The National Aeronautics and Space Administration (NASA) and U.S. Coast Guard (USCG) are cooperating agencies for the EA for the Huntsville International Airport Reentry Site Operator License and Sierra Space Corporation Vehicle Operator License due to their special expertise and jurisdictions. The FAA evaluated (1) the Huntsville-Madison County Airport Authority's (Authority) proposal to operate a commercial reentry site at Huntsville International Airport, which would require the FAA to issue a Reentry Site Operator License, and (2) Sierra Space Corporation's (Sierra Space) proposal to land the Dream Chaser at Huntsville International Airport, which would require the FAA to issue a Vehicle Operator License. Issuing a Reentry Site Operator License and Vehicle Operator License are considered Federal actions subject to environmental review under NEPA. Under the Proposed Action, the FAA would issue a Reentry Site Operator License to the Authority and a Vehicle Operator License to Sierra Space to land the Dream Chaser at Huntsville International Airport.
The Final EA evaluated the potential environmental impacts of the Proposed Action and the No Action Alternative. Under the No Action Alternative, the FAA would not issue a Reentry Site Operator License to the Authority, nor would the FAA issue a Vehicle Operator License to Sierra Space for landing the Dream Chaser at Huntsville International Airport. Sierra Space's Dream Chaser reentry operations would not occur at Huntsville International Airport and Huntsville International Airport would not offer its site for commercial space reentries.
The FAA published a Draft EA for public review and comment on November 12, 2021 through December 22, 2021. The FAA received 40 public comments on the Draft EA. The FAA posted the Final EA and FONSI/ROD on the FAA Office of Commercial Space Transportation website on May 12, 2022, linked here:
The FAA's ROD contains the agency's decision to approve the Proposed Action, and includes numerous finding and determinations pursuant to Executive Orders and special purpose laws, including the Department of Transportation Act, the National Historic Preservation Act, the Clean Air Act, the Clean Water Act, and the Endangered Species Act.
Federal Highway Administration (FHWA), DOT.
Notice of request for extension of currently approved information collection.
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of an existing information collection that is summarized below under
Please submit comments by August 22, 2022.
You may submit comments identified by DOT Docket ID Number 2022-0020 by any of the following methods:
Mr. Kenneth Petty, (202) 366-6654, Office of Planning, Environment, and Realty, Federal Highway Administration, Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5p.m. ET, Monday through Friday, except Federal holidays.
Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT).
Notice; Request for comment.
The Moving Ahead for Progress in the 21st Century Act (MAP-21) established the Surface Transportation Project Delivery Program that allows a State to assume FHWA's responsibilities for environmental review, consultation, and compliance under the National Environmental Policy Act (NEPA) and other Federal environmental laws for Federal highway projects. When a State assumes these Federal responsibilities, the State becomes solely responsible and liable for carrying out the responsibilities it has assumed in lieu of FHWA. This program mandates annual audits during each of the first 4 years of State participation to ensure compliance with program requirements. This notice announces and solicits comments on the fourth and final audit report for the Utah Department of Transportation (UDOT).
Comments must be received on or before July 25, 2022.
Mail or hand deliver comments to Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, Washington, DC 20590. You may also submit comments electronically at
Ms. Lana Lau, Office of Project Development and Environmental Review, (202) 366-2052,
An electronic copy of this notice may be viewed online at
The Surface Transportation Project Delivery Program, codified at 23 U.S.C. 327, commonly known as the NEPA Assignment Program, allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal highway projects. When a State assumes these Federal responsibilities, the State becomes solely liable for carrying out the responsibilities it has assumed in lieu of FHWA. The UDOT published its application for NEPA assumption on October 9, 2015, and made it available for public comment for 30 days. After considering public comments, UDOT submitted its application to FHWA on December 1, 2015. The application served as the basis for developing a memorandum of understanding (MOU) that identified the responsibilities and obligations that UDOT would assume. The FHWA published a notice of the draft MOU in the
Section 327(g) of Title 23, U.S.C., requires the Secretary to conduct annual audits to ensure compliance with the MOU during each of the first 4 years of State participation and, after the fourth year, monitor compliance. The FHWA must make the results of each audit available for public comment. The FHWA published the first audit report of UDOT compliance on September 17, 2018 (83 FR 46992), the second report on November 13, 2019 (84 FR 61680), and the third report on September 17, 2020 (85 FR 58102). This notice announces the availability of the fourth and final audit report for UDOT and solicits public comments.
This report summarizes the results of the Federal Highway Administration's (FHWA) fourth audit of the Utah Department of Transportation's (UDOT) National Environmental Policy Act (NEPA) review responsibilities and liabilities that FHWA has assigned and UDOT has assumed pursuant to 23 U.S.C. 327. Throughout this report, FHWA uses the term “NEPA Assignment Program” to refer to the program codified at 23 U.S.C. 327. Pursuant to 23 U.S.C. 327, UDOT and FHWA executed a memorandum of understanding (MOU) on January 17, 2017, to memorialize UDOT's NEPA responsibilities and liabilities for Federal-aid highway projects and certain other FHWA approvals in Utah. The section 327 MOU covers environmental review responsibilities for projects that require the preparation of environmental assessments (EA), environmental impact statements (EIS), and non-designated documented categorical exclusions (DCE). A separate MOU, pursuant to 23 U.S.C. 326, authorizes UDOT's environmental review responsibilities for other categorical exclusions (CE), commonly known as CE Program Assignment. The scope of this audit does not cover the CE Program Assignment responsibilities.
As part of FHWA's review responsibilities under 23 U.S.C. 327, FHWA formed a team (the “Audit Team”) in August 2020 to plan and conduct an audit of NEPA responsibilities UDOT assumed. The Audit Team conducted its review during the period from November 9 to December 2, 2020. As part of this audit, the Audit Team reviewed UDOT's NEPA project files, UDOT's response to FHWA's pre-audit information request (PAIR), UDOT's NEPA Assignment Self-Assessment Report, UDOT's NEPA Quality Assurance/Quality Control (QA/QC) Guidance, and UDOT's NEPA Assignment Training Plan. The Audit Team conducted videoconference interviews with four members of UDOT central office staff, six of UDOT's legal counsel (one current Assistant Attorney General assigned to UDOT, one former Assistant Attorney General assigned to UDOT, and four outside counsel), three staff members from the U.S Environmental Protection Agency, and two staff members from the U.S. Fish and Wildlife Service (FWS) as part of the audit.
Overall, the Audit Team found that UDOT continues to successfully carry out its DCE, EA, and EIS project review responsibilities. The UDOT has also made efforts to respond to the FHWA findings from the third audit, including improving document management and QA/QC procedures. In the third audit, the Audit Team had found that UDOT issued an environmental document without a final legal sufficiency finding, and observed that there were ways UDOT could improve their training.
In this fourth and final audit, the Audit Team identified four observations and two successful practices. The Audit Team finds UDOT is carrying out the responsibilities it has assumed and is in substantial compliance with the provisions of the MOU. This report also concludes with the status of FHWA's non-compliance observation from the third audit review, including any UDOT self-imposed corrective actions. After the fourth year of UDOT's participation in the program, FHWA will continue to monitor UDOT's compliance with the terms of this MOU, in accordance with 23 U.S.C. 327(h).
The NEPA Assignment Program allows a State to assume FHWA's environmental responsibilities for review, consultation, and compliance for Federal-aid highway projects and certain FHWA approvals. Under 23 U.S.C. 327, a State that assumes these Federal responsibilities becomes solely responsible and solely liable for carrying them out. Effective January 17, 2017, UDOT assumed FHWA's responsibilities under NEPA and other related environmental laws. Examples of responsibilities UDOT has assumed in addition to NEPA include section 7 consultation under the Endangered Species Act and consultation under section 106 of the National Historic Preservation Act.
Audits are the primary mechanism through which FHWA oversees UDOT's compliance with the MOU and the NEPA Assignment Program requirements. This includes ensuring compliance with applicable Federal laws and policies, evaluating UDOT's progress toward achieving the performance measures identified in MOU Section 10.2, and collecting information needed for the Secretary's annual report to Congress. The FHWA must present the results of each audit in a report and make it available for public comment in the
Through this fourth and final audit, FHWA will satisfy provisions of 23 U.S.C. 327(g) and Part 11 of the MOU. This report summarizes the results of the fourth audit in Utah and includes a summary discussion that describes progress since the last audit. This audit is the last of the required audits.
The MOU (Part 3.1.1) states that “[p]ursuant to 23 U.S.C. 327(a)(2)(A), on the Effective Date, FHWA assigns, and UDOT assumes, subject to the terms and conditions set forth in 23 U.S.C. 327 and this MOU, all of the U.S. Department of Transportation Secretary's responsibilities for compliance with the NEPA, 42 U.S.C. 4321
The Audit Team consisted of NEPA subject matter experts from the FHWA Utah Division, FHWA Resource Center, the Volpe Center, FHWA Headquarters, and FHWA Office of the Chief Counsel. These experts received training on how to evaluate implementation of the NEPA Assignment Program.
The Audit Team conducted an examination of UDOT's NEPA project files, UDOT's responses to the PAIR, and UDOT's self-assessment. The audit
The focus of the audit was on UDOT's process and program implementation. Therefore, while the Audit Team reviewed project files to evaluate UDOT's NEPA process and procedures, the Audit Team did not evaluate UDOT's project-specific decisions to determine if they were, in FHWA's opinion, appropriate or not. The Audit Team reviewed 20 NEPA Project files with DCEs, EAs, EISs, and re-evaluations, representing all projects with decision points or other actionable items between July 1, 2019, and June 30, 2020. The Audit Team also interviewed environmental staff in UDOT's headquarters office.
The PAIR consisted of 25 questions about specific elements in the MOU. The Audit Team used UDOT's response to the PAIR to develop specific follow-up questions for the UDOT staff.
The Audit Team conducted four interviews with UDOT environmental staff, one virtual interview with staff from the U.S. Environmental Protection Agency (EPA), one interview with staff from the FWS, two interviews with UDOT's outside legal counsel, and one interview with legal counsel from the Utah Attorney General's office. All interviews were conducted as videoconference interviews.
Throughout the document reviews and interviews, the Audit Team verified information regarding the UDOT NEPA Assignment Program including UDOT policies, guidance, manuals, and reports. This included the NEPA QA/QC Guidance, the NEPA Assignment Training Plan, and the NEPA Assignment Self-Assessment Report.
The Audit Team compared the procedures outlined in UDOT environmental manuals and policies to the information obtained during interviews and project file reviews to determine if there were discrepancies between UDOT's performance and documented procedures. The Audit Team documented observations under the six NEPA Assignment Program topic areas. Below are the audit results.
Overall, UDOT has carried out the environmental responsibilities it assumed through the MOU and the application for the NEPA Assignment Program, and as such the Audit Team finds UDOT is substantially compliant with the provisions of the MOU.
This section summarizes the Audit Team's observations of UDOT's NEPA Assignment Program implementation, including successful practices UDOT may want to continue or expand. Successful practices are positive results FHWA would like to commend UDOT for developing. These may include ideas or concepts that UDOT has planned but not yet implemented. Observations are items the Audit Team would like to draw UDOT's attention to, which may benefit from revisions to improve processes, procedures, or outcomes. The UDOT may have already taken steps to address or improve upon the Audit Team's observations, but at the time of the audit they appeared to be areas where UDOT could make improvements. This report addresses all six MOU topic areas as separate discussions. Within each area, this report discusses successful practices followed by observations.
This audit report provides an opportunity for UDOT to implement actions to improve their NEPA Assignment Program. The FHWA and UDOT will continue to work together to monitor UDOT's compliance with the terms of this MOU, as required by 23 U.S.C. 327(h).
The Audit Team identified one of UDOT's project websites which included detailed information about the proposed noise impact analyses, traffic noise abatement measures, and the proposed relocation of the existing noise barriers as a successful practice. The noise impact and abatement information presented to the public was comprehensive and easy to understand.
Section 5.1.4 of UDOT's NEPA Assignment MOU outlines an interagency planning and coordination protocol to make sure that all programmatic agreements reflect UDOT's new roles and responsibilities under NEPA Assignment. The Audit Team observed that UDOT's Section 106 programmatic agreements with four Tribal governments predate NEPA Assignment, and they do not reflect UDOT's assigned roles and responsibilities. We recommend that UDOT reach out to these Tribal governments and implement the interagency planning and coordination provisions of Section 5.1.4, which may include amending the programmatic agreements or obtaining a “written consent”. The recommended path forward would enable UDOT to clarify its assigned roles and responsibilities during Section 106 consultations.
The overall consistency across all five of the Section 106 programmatic agreements is important to clarify the organizational roles and responsibilities between UDOT and FHWA for both Section 106 and Government-to-Government consultations, resulting in more predictable lines of communication, more productive and meaningful interagency dialogue with the Tribes, and a positive reinforcement of FHWA's retained Tribal trust responsibilities.
In the course of reviewing the most recent Manual of Instruction (MOI), the Audit Team identified several areas that do not address the most recent requirements and guidelines associated with the Fixing America's Surface Transportation Act; FHWA's 2019 Re-evaluation Q&A Guidance; Moving Ahead for Progress in the 21st Century Act (MAP-21) Section 1319 interim guidance relating to the appropriate use of the combined Final Environment Impact Statement/Record of Decision (FEIS/ROD) documents; FHWA's 2011 Environmental Justice and NEPA guidance for identifying, disclosing and mitigating impacts to environmental justice communities; or FHWA's October 2018 memorandum addressing activities that may be completed prior to issuance of a Notice of Intent to prepare an EIS. During interviews, UDOT informed us that they make regular updates to the MOI, as needed. However, these examples illustrate that the MOI would benefit from a regularly scheduled, comprehensive review to ensure that it reflects current national policy and guidance.
During this audit period, the Audit Team reviewed re-evaluations for two EIS projects that appeared to use the same format. While it is not explicitly required by the MOI, UDOT did appear to use a standard procedure for these re-evaluations. For example, both included a Summary of Re-evaluation Analysis Table that functions like an environmental checklist. This table creates a standard process for looking at changes in both the magnitude of
The team reviewed multiple re-evaluations for the West Davis Corridor Project. Each individual re-evaluation addressed the changes on that portion of the larger project. The FHWA suggests UDOT also add language that summarizes the changes across all the re-evaluations, such as providing a listing of all the related re-evaluations and a statement correlating them, to clearly demonstrate and document that UDOT has considered impacts across the entirety of the project.
The UDOT has made improvements to its QA/QC procedures. These improvements are discussed in the Legal Sufficiency section of this report.
During the audit period outside counsel issued three findings of legal sufficiency per the requirements of 23 CFR 771.125(b) and 23 CFR 774.7(d), copies of which were provided to the Audit Team. These include legal sufficiency reviews of one EIS and two Section 4(f) evaluations. The UDOT has continued using the legal sufficiency process it put in place for both Section 326 CE and Section 327 NEPA Assignment; that is, contracting with outside counsel who have extensive experience in NEPA, other environmental laws, and Federal environmental litigation.
Since the signing of the initial FHWA-UDOT MOU for the NEPA Assignment Program in January 2017, no lawsuits have been filed against NEPA-assigned projects in the State of Utah.
The UDOT has continued to develop an annual training plan, in compliance with Section 12.2 of the MOU.
The UDOT has continued to assess its performance as required under the terms of the MOU. The UDOT's annual self-assessment report indicates that they are meeting their performance targets. The process of, and results from, the State's self-assessment have been an important factor in the improvement of UDOT's NEPA Program.
Section 10.2.1.C.i of the MOU requires UDOT to assess change in and ensure effective communication among UDOT, Federal and State resource agencies resulting from assumption of responsibilities under the MOU.
In interviews, resource agency staff at the EPA and the FWS stated that overall they have a good working relationship with UDOT staff. Some FWS staff indicated that they could utilize additional information on the differences between the 23 U.S.C. 326 (CE Assignment) program and the 23 U.S.C. 327 (NEPA Assignment) program. The audit team also learned that neither FWS nor EPA had responded to UDOT's annual resource agency survey. These are examples of where UDOT's program may benefit from more consistent, program-level discussions with resource agencies to ensure that all parties understand their respective roles and responsibilities, as well as the provisions of the 326 and 327 programs. Stronger managerial-level communications with the resource agencies may increase their understanding of the importance of the survey and improve the response rate.
Non-compliance observations are instances where the team found UDOT was out of compliance or deficient in proper implementation of a Federal regulation, statute, guidance, policy, the terms of the MOU, or UDOT's own procedures for compliance with the NEPA process. Such observations may also include instances where UDOT has failed to maintain technical competency, adequate personnel, and/or financial resources to carry out the assumed responsibilities. Other non-compliance observations could suggest a persistent failure to adequately consult, coordinate, or consider the concerns of other Federal, State, Tribal, or local agencies with oversight, consultation, or coordination responsibilities. The FHWA expects UDOT to develop and implement corrective actions to address all non-compliance observations.
The Audit Team did not identify any non-compliance observations during this audit.
The FHWA reported a non-compliance observation relating to UDOT not complying with the State's environmental review procedures as a part of Audit #3.
As noted earlier, in response to the 2019 audit finding that legal sufficiency review documentation was not provided prior to approval of a project FEIS, UDOT and outside counsel implemented a more formalized system by instituting a Legal Sufficiency Review Form to be completed by outside counsel. The form ensures a record that the review occurred. This form has already been used for legal sufficiency reviews during this audit period.
The FHWA provided this draft audit report to UDOT for a 30-day review and comment period. The Audit Team considered UDOT comments in developing this draft audit report. The FHWA will publish this notice in the
Federal Transit Administration, Department of Transportation (DOT).
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describe the nature of the information collection and their expected burdens.
Comments must be submitted on or before July 25, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Tia Swain, Office of Administration, Management Planning Division, 1200 New Jersey Avenue SE, Mail Stop TAD-10, Washington, DC 20590, (202) 366-0354 or
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, Section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On March 22, 2022 FTA published a 60-day notice (87 FR 16306) in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d);
The summaries below describe the nature of the information collection requirements (ICRs) and the expected burden. The requirements are being submitted for clearance by OMB as required by the PRA.
Each Public Transportation Agency Safety Plan must include, at minimum:
• An approval from the recipient's Board of Directors, or an Equivalent Authority;
• Methods for identifying and evaluating safety risks throughout all elements of the recipient's public transportation system;
• Strategies to minimize the exposure of the public, personnel, and property to hazards and unsafe conditions;
• A process and timeline for conducting an annual review and update of the plan;
• Performance targets based on the safety performance measures established in FTA's National Public Transportation Safety Plan;
• Assignment of an adequately trained safety officer who reports directly to the general manager, president, or equivalent officer; and
• A comprehensive safety training program for operations personnel and personnel directly responsible for safety that includes the completion of a safety training program and continuing safety education and training.
• A rail transit agency must include or incorporate by reference in its Agency Safety Plan an emergency preparedness and response plan or procedures.
Information collection requirements associated with this regulation include information collected by the agency to support its internal SMS processes and information collected by recipients to distribute to FTA.
The information collection conducted at the agency level to support internal SMS processes includes the regulatory requirement to maintain:
• Documents that set forth the Agency Safety Plan, including those related to implementing the SMS;
• Results from SMS processes and activities; and
• Documents included in whole, or by reference, that describe the programs, policies, and procedures used to carry out the Agency Safety Plan.
Transit agencies must maintain this documentation for a minimum of three years and must make this documentation available upon request to FTA, other Federal entities having jurisdiction, and the relevant State Safety Oversight Agency, if applicable.
The information collection exchange between FTA and its recipients consists of:
• Annual Certifications and Assurances. FTA requires operators of public transportation systems and States to certify compliance with 49 CFR part 673 through its annual submittal of Certifications and Assurances to FTA.
• Triennial Review Process. FTA incorporated questions specific to the Public Transportation Agency Safety Plan Rule into FTA's existing oversight questionnaire for transit agencies to evaluate areas of compliance.
• State Management Review Process. FTA also ensures compliance with this rule through its existing triennial State Management Review oversight process.
The information collection will continue to help guide transit agency and FTA's safety program priorities.
Federal Transit Administration, Department of Transportation (DOT).
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requirements (ICRs)
Comments must be submitted on or before July 25, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Tia Swain, Office of Administration, Management Planning Division, 1200 New Jersey Avenue SE, Mail Stop TAD-10, Washington, DC 20590, (202) 366-0354 or
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, Section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On March 1, 2022 FTA published a 60-day notice (87 FR 11507) in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d);
The summaries below describe the nature of the information collection requirements (ICRs) and the expected burden. The requirements are being submitted for clearance by OMB as required by the PRA.
Federal Transit Administration, Department of Transportation (DOT).
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requirements (ICRs) abstracted below have been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describe the nature of the information collection and their expected burdens.
Comments must be submitted on or before July 25, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Tia Swain, Office of Administration, Management Planning Division, 1200 New Jersey Avenue SE, Mail Stop TAD-10, Washington, DC 20590 (202) 366-0354 or
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, Section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On March 1, 2022 FTA published a 60-day notice (87 FR 11508) in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d);
The summaries below describe the nature of the information collection requirements (ICRs) and the expected burden. The requirements are being submitted for clearance by OMB as required by the PRA.
The current Federal Public Transportation Law, 49 U.S.C. 5309, has not changed the statutorily defined project justification and local financial commitment criteria that are the subject of this information collection. In addition, the statutorily required approval steps for projects seeking CIG funds have not changed. The current request for renewal of this information collection does not reflect any changes as a result of the Bipartisan Infrastructure Law (BIL). FTA will seek comment from stakeholders through the publication of a separate
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Michelin North America, LLC (MNA), has determined that certain Michelin Pilot Sport All Season 4 replacement passenger car tires do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
Send comments on or before July 25, 2022.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
•
•
•
• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
Jayton Lindley, General Engineer, NHTSA, Office of Vehicle Safety Compliance, (325) 655-0547.
MNA has determined that certain Michelin Pilot Sport All Season 4 replacement passenger car tires do not fully comply with the requirements of paragraph S5.5.4(b) of FMVSS No. 139,
This notice of receipt of MNA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.
According to MNA approximately 3,589 Michelin Pilot Sport All Season 4, size 295/40ZR21 111Y XL, replacement passenger car tires, manufactured between October 7, 2020, and August 20, 2021, and sold in the United States and Canada were affected by the subject noncompliance. MNA says that of the 3,589 tires, 1,729 tires entered the U.S. market, 110 entered the Canadian market, and the remaining 1,750 were blocked in Michelin's inventory control system to be repaired or scrapped. For the 110 tires that entered the Canadian market, the agency cannot exempt MNA from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance for those tires. Therefore, the agency's decision will only apply to the 1,729 tires that entered U.S. market.
MNA explains that the noncompliance was due to a mold error in which one sidewall, the serial sidewall, of the subject tires incorrectly state the maximum load range as required by paragraph S5.5.4(b) of FMVSS No. 139. Specifically, the subject tires were marked with a maximum load of 1090 kg (1433 lbs.) when they should have been marked with a maximum load of 1090 kg (2403 lbs.).
Paragraph S5.5.4(b) of FMVSS No. 139 includes the requirements relevant to this petition. For passenger car tires, if the maximum inflation pressure of a tire is 240, 280, 300, 340, or 350 kPa, then each marking of the tire's maximum load rating in kilograms must be followed in parenthesis by the equivalent load rating in pounds, rounded to the nearest whole number.
The following views and arguments presented in this section, “V. Summary of MNA's Petition,” are the views and arguments provided by MNA. They have not been evaluated by the Agency and do not reflect the views of the Agency. MNA describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety for the following reasons:
MNA asserts that although erroneously marked, the subject tires were “designed as a load index 111 tire, with a maximum load rating of 1090 kilograms, or 2403 pounds.” MNA says that the subject tires “fully comply with Michelin performance requirements” and with all applicable FMVSSs. According to MNA, other than the tire maximum load rating in pounds, the tires are correctly marked and “provide both dealers and consumers with the necessary information to enable proper selection and application of the tires.” MNA says that if a consumer were to go by the erroneous maximum load, in pounds, based on the markings on the tire, the tire would be put “into service respecting a maximum load of 1433 lbs., which is less than the actual designed maximum load of 2403 lbs.”
MNA cites the following past inconsequentiality petitions NHTSA has granted that MNA claims are similar to the subject petition:
• Bridgestone Americas Tire Operations, LLC, Grant of Petition for Decision of Inconsequential Noncompliance.
• The Goodyear Tire & Rubber Company, Grant of Petition for Decision of Inconsequential Noncompliance.
• Continental Tire North America Inc., Grant of Application for Decision of Inconsequential Noncompliance.
• Michelin North America, Inc., Grant of Petition for Decision of Inconsequential Noncompliance.
• Bridgestone/Firestone, Inc., Grant of Application for Decision That Noncompliance Is Inconsequential to Motor Vehicle Safety.
MNA states that they have “captured and retained” a total of 1,750 tires with the intent to either repair or scrap them. MNA also states that they have corrected the tire specification drawing and updated the mold to reflect the correct maximum load in pounds.
MNA concludes that the subject noncompliance is inconsequential as it relates to motor vehicle safety and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that MNA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after MNA notified them that the subject noncompliance existed.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of petition denial.
Goodyear Tire & Rubber Company (Goodyear), has determined that certain Kelly Armorsteel KDM 1 commercial truck tires do not comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 119,
Jayton Lindley, Office of Vehicle Safety Compliance, NHTSA, telephone (325) 655-0547.
Notice of receipt of Goodyear's petition was published with a 30-day public comment period in the
Accordingly, Goodyear described the subject noncompliance and stated that the noncompliance is inconsequential as it relates to motor vehicle safety.
1. Goodyear believes this noncompliance is inconsequential to motor vehicle safety because these tires were manufactured as designed and meet or exceed all applicable FMVSS. All of the sidewall markings related to tire service (load capacity, corresponding inflation pressure, etc.) are correct. The mislabeling and irregular date code is not a safety concern and has no impact on the retreading, repairing, and recycling industries. The affected date code stencil has been corrected, and all future production will not contain the irregularity in the date code.
2. Goodyear states that the date code portion of the TIN becomes important in
Goodyear concluded by expressing the belief that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA recognizes that Goodyear has addressed one safety related concern by ensuring that the subject tires with the insufficient date code depth will be included in any relevant future recall. However, the Agency finds that this measure does not address all safety concerns associated with a missing or illegible date code.
A significant source of tire related accidents is tire age. This is especially a concern in recreational vehicles (RVs) on which the subject tires could be installed because of the tire's size. RVs often sit in storage, unused, for extensive periods of time. NHTSA's website provides guidance for replacing a tire due to age and states the following: “As tires age, they are more prone to failure. Some vehicle and tire manufacturers recommend replacing tires that are six to 10 years old regardless of treadwear.”
Finally, Goodyear stated and believes this noncompliance is inconsequential to motor vehicle safety because these tires were manufactured as designed and meet or exceed all applicable Federal Motor Vehicle Safety Standards. Further, Goodyear stated all the sidewall markings related to tire service (load capacity, corresponding inflation pressure, etc.) are correct. NHTSA does not find these arguments to be relevant to the safety concerns presented by the noncompliance because they do not relate to the information provided by the date code.
Office of Foreign Assets Control (OFAC), Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See Supplementary Information section for effective date(s).
OFAC: Andrea Gacki, Director, tel.: 202-622-2490; Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On June 17, 2022, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. LOPEZ DELGADO, Ruy, Carretera Masaya, Km 6.5, Plaza 800 Mts Sur Lomas Santo Domingo, Casa #6, Managua, Nicaragua; DOB 30 Jun 1949; POB Managua, Nicaragua; nationality Nicaragua; Gender Male; Passport C01850896 (Nicaragua) issued 11 May 2015 expires 11 May 2025; National ID No. 0013006490003J (Nicaragua) (individual) [NICARAGUA].
Designated pursuant to section 1(a)(iii) of Executive Order 13851 of November 27, 2018, “Blocking Property of Certain Persons Contributing to the Situation in Nicaragua (“E.O. 13851”), for being an official of the Government of Nicaragua or having served as an official of the Government of Nicaragua at any time on or after January 10, 2007.
1. EMPRESA NICARAGUENSE DE MINAS (a.k.a. ENIMINAS), Residencial Bolonia, de la Embajada Alemania, 2 cuadras Oeste, 1 cuadra Norte, Managua, Nicaragua; Organization Established Date 2017; Organization Type: Mining of other non-ferrous metal ores; Target Type State-Owned Enterprise [NICARAGUA] (Linked To: LOPEZ DELGADO, Ruy).
Designated pursuant to section 1(a)(v) of E.O. 13851, for being owned or controlled by, or having acted or purported to act for or on behalf of, directly or indirectly, Ruy DELGADO LOPEZ, a person whose property and interests in property are blocked pursuant to E.O. 13851.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Notice of Medical Necessity Criteria under the Mental Health Parity and Addiction Equity Act of 2008.
Written comments should be received on or before August 22, 2022 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of this collection should be directed to Sara Covington, at (202) 317-5744, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet
The following paragraph applies to all the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
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 Lamont-Doherty Earth Observatory (L-DEO) for authorization to take marine mammals incidental to geophysical surveys at the Cascadia Subduction Zone and Juan de Fuca Plate in the Northeast Pacific Ocean. 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 25, 2022.
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
Kim Corcoran, 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.
On December 14, 2021, NMFS received a request from L-DEO for an IHA to take marine mammals incidental to a marine geophysical survey off the coasts of Oregon and Washington in the northeast Pacific Ocean. The application was deemed adequate and complete on April 4, 2022. L-DEO request is for take of small numbers of 23 species of marine mammals by Level B harassment only. Neither L-DEO nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
NMFS previously issued an IHA to L-DEO for larger surveys in a similar location in the Northeast Pacific (
Researchers from New Mexico Institute of Mining and Technology (NMT) and Oregon State University (OSU), with funding from the U.S. National Science Foundation (NSF) propose to conduct low-energy seismic surveys from the Research Vessel (R/V)
The proposed study would acquire high-resolution 2-D seismic reflection data in conjunction with densely-spaced heat flow measurements to better understand the thermal structure of the Juan de Fuca plate as it enters the Cascadia subduction zone. The seismic and heat flow data would be acquired across several distinct structures that have not been previously studied, including a pseudofault, complex buried seamounts, and small outcrops that represent the summit of much larger buried seamounts.
The proposed survey is expect to last for 23 days, with approximately six days of seismic operations, three days of transit and 14 days of heat flow measurements. R/V
The proposed survey would occur within ~42-47°N, ~125-127°W off the coast of Washington and Oregon in the Northeast Pacific ocean. Four regions where the surveys are proposed to occur are depicted in Figure 1; the tracklines could occur anywhere within the boxes shown in Figure 1. No representative survey tracklines are shown, as actual track lines and order of survey operations are dependent on science objectives and weather. The surveys are proposed to occur within the EEZ of the U.S., in waters >1600 m deep.
The procedures to be used for the proposed surveys would be similar to those used during previous seismic surveys by L-DEO and would use conventional seismic methodology. The surveys would involve one source vessel, R/V
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, incorporated here by reference, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs;
Table 1 lists all species or stocks for which take is expected and proposed to be authorized for this action, 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 authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprise that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. Pacific SARs (Carretta et al., 2021). All values presented in Table 1 are the most recent available at the time of publication and are available in the 2020 SARs (Carretta et al., 2021) and draft 2021 SARs (available online at:
As indicated above, all 23 species (with 25 managed stocks) in Table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. While North Pacific right whales (
The North Pacific right whale is one of the rarest marine mammals in the world (Muto
The eastern North Pacific stock that occurs in the United States is estimated to contain 31 whales for the Bering sea and Aleutian Islands. A Biologically Important Area (BIA) for feeding for North Pacific right whales was designated east of the Kodiak Archipelago, which includes the Gulf of Alaska critical habitat and extends south of 56 degrees north and north of 58 degrees north and beyond the shelf edge. South of 50 degrees north, only 29 reliable sightings were recorded from 1900-1994 (Scarff 1986, 1991; Carretta
Bottlenose dolphins are distributed worldwide in tropical and warm-temperate waters. Bottlenose dolphins occur frequently off the coast of California, and sightings have been made as far north as 41 degrees north, but few records exist for Oregon and Washington (Carretta
Short-finned pilot whales are found in tropical and warm temperate waters (Olson 2018) and seen as far south as 40 degrees south and as far north as 50 degrees north (Jefferson
Two separate populations of gray whales have been recognized in the North Pacific: the eastern North Pacific and western North Pacific stocks (LeDuc
NOAA (2021b) declared an unusual mortality event (UME) for gray whales in 2019, as an elevated number of strandings have occurred along the coast of the Pacific Northwest since January 2019. As of 1 October 2021, a total of 212 dead gray whales have been reported, including 248 in the U.S. (55 in Washington; 12 in Oregon), 225 in Mexico, and 19 in B.C.; some of the whales were emaciated. A UME for gray whales was also declared for 1999-2000 (NOAA 2021c).
The proposed survey is planned during the summer feeding season, when most individuals from the eastern North Pacific stock occur farther north. Although individuals, particularly from the Pacific Coast Feeding Group (PCFG), could be encountered in nearshore waters less than 10 km from shore, the likelihood that any gray whales will be encountered as far offshore as the proposed survey area is discountable. Gray whales have been observed to have a distinct ecological niche in nearshore and shallow waters (Darling
Lastly, the false killer whale is found worldwide in tropical and temperate waters, generally between 50 degrees north and 50 degrees south (Odell and McClune 1999). It is widely distributed, but not abundant anywhere (Carwardine 1995). The false killer whale generally inhabits deep, offshore waters, but sometimes is found over the continental shelf and occasionally moves into very shallow water (Jefferson
Its occurrence in Washington/Oregon is associated with warm-water incursions (Buchanan
The humpback whale is found throughout all of the oceans of the world (Clapham 2009). The worldwide population is divided into northern and southern ocean populations, but genetic analyses suggest some gene flow (either past or present) between the North and South Pacific (
Prior to 2016, humpback whales were listed under the ESA as an endangered species worldwide. Following a 2015 global status review (Bettridge
NMFS has identified three DPSs of humpback whales that are found off the coasts of Washington, Oregon and California. These are: the Hawaii DPS (found predominately off Washington and southern British Columbia), which is not listed under the ESA; the Mexico DPS (found all along the west coast), which is listed as threatened under the ESA; and the Central America DPS (found all along the west coast, but most common off California and Oregon), which is listed as endangered under the ESA. According to Wade (2021), the probability that whales encountered in Oregon and California waters are from a given DPS are as follows: Central America DPS (42 percent); Mexico DPS (58 percent); Hawaii DPS (0 percent). The probability that humpback whales encountered in Washington and British Columbia waters are as follows: Central America DPS (6 percent); Mexico DPS (25 percent); Hawaii DPS (69 percent). Wade (2021) notes that the majority of humpback whales that may be found off of Washington are likely moving north of the United States border and feeding primarily off of southern British Columbia.
Humpback whales are the most common species of large cetacean reported off the coasts of Oregon and Washington from May to November (Green
On April 21, 2021, NMFS designated critical habitat in nearshore waters of the North Pacific Ocean for the endangered Central America and Western North Pacific DPSs and the threatened Mexico DPS of humpback whales (NMFS 2021). Critical habitat for the Central America and Mexico DPSs include waters within the California Current Ecosystem (CCE) off the coasts of California, Oregon, and Washington (Figure 1). Off Washington, critical habitat includes waters from the 50 m to 1200 m isobaths, as well as the strait of Juan de Fuca eastward to Angeles Point; however, there is an exclusion area of 1461 nautical square miles (nmi
The blue whale has a cosmopolitan distribution and tends to be pelagic, only coming nearshore to feed and possibly to breed (Jefferson
The distribution of the species, at least during times of the year when feeding is prevalent, occurs in areas that provide large seasonal concentrations of euphausiids (Yochem and Leatherwood 1985). The eastern North Pacific stock feeds in California waters from June through November (Calambokidis
Blue whales are considered rare off Oregon, Washington, and B.C. (Buchanan et al. 2001; Gregr
The fin whale is widely distributed in all the World's oceans (Gambell 1985b), although it is most abundant in temperate and cold waters (Aguilar and García-Vernet 2018). Nonetheless, its overall range and distribution are not well known (Jefferson
Most populations migrate seasonally between temperate waters where mating and calving occur in winter, and polar waters where feeding occurs in summer (Aguilar and García-Vernet 2018). Some animals may remain at high latitudes in winter or low latitudes in summer (Edwards
North Pacific fin whales summer from the Chukchi Sea to California and winter from California southwards (Gambell 1985b). Information about the seasonal distribution of fin whales in the North Pacific has been obtained from the detection of fin whale calls by bottom-mounted, offshore hydrophone arrays along the U.S. Pacific coast, in the central North Pacific, and in the western Aleutian Islands (Moore
Fin whales are routinely sighted during surveys off Oregon and Washington (Barlow and Forney 2007; Barlow 2010, 2016; Adams
The sei whale occurs in all ocean basins (Horwood 2018), but appears to prefer mid-latitude temperate waters (Jefferson et al. 2015). It undertakes seasonal migrations to feed in subpolar latitudes during summer and returns to lower latitudes during winter to calve (Horwood 2018). The sei whale is pelagic and generally not found in coastal waters (Harwood and Wilson 2001). It occurs in deeper waters characteristic of the continental shelf edge region (Hain
Sei whales are rare in the waters off Washington, Oregon, and California (Brueggeman
The minke whale has a cosmopolitan distribution that spans from tropical to polar regions in both hemispheres (Jefferson
The International Whaling Commission (IWC) recognizes three stocks of minke whales in the North Pacific: the Sea of Japan/East China Sea, the rest of the western Pacific west of 180° N, and the remainder of the Pacific (Donovan 1991). Minke whales are relatively common in the Bering and Chukchi seas and in the Gulf of Alaska but are not considered abundant in any other part of the eastern Pacific (Brueggeman
Sightings have been made off Oregon and Washington in shelf and deeper waters (Green
The sperm whale is the largest of the toothed whales, with an extensive worldwide distribution (Rice 1989). Sperm whale distribution is linked to social structure: Mixed groups of adult females and juveniles animals of both sexes generally occur in tropical and subtropical waters, whereas adult makes are commonly found alone or in the same-sex aggregations, often occurring in higher latitudes outside the breeding season (Best 1979; Watkins and Moore 1982; Arnbom and Whitehead 1989; Whitehead and Waters 1990). Males can migrate north in the summer to feed in the Gulf of Alaska, Bering Sea, and waters around the Aleutian Islands (Kasuya and Miyashita 1988). Females generally inhabit waters over 1000 m deep at latitudes under 40 degrees where sea surface temperatures are under 15 degrees Celsius; adult males move to higher latitudes as they grow older and larger in size, returning to warm-water breeding grounds according to an unknown schedule (Whitehead 2018).
Sperm whales are distributed widely across the North Pacific (Rice 1989). Off California, they occur year-round (Dohl
Baird's beaked whale has a fairly extensive range across the North Pacific north of 30° N, and strandings have occurred as far north as the Pribilof Islands (Rice 1986). Two forms of Baird's beaked whales were previously recognized—the common slate-gray form and a smaller, rare black form (Morin
Along the U.S. west coast, Baird's beaked whales have been sighted primarily along the continental slope (Green
Green
Cuvier's beaked whale is probably the most widespread of the beaked whales, although it is not found in polar waters (Heyning 1989). Cuvier's beaked whale appears to prefer steep continental slope waters (Jefferson
MacLeod
Four beaked whale sightings were reported in water depths over 2000 m off Oregon/Washington during surveys in 2008 (Barlow 2010). None were seen in 1996 or 2001 (Barlow 2003), and several were recorded from 1991-1995 (Barlow 1997). One Cuvier's beaked whale sighting was made during surveys in 2014 (Barlow 2016). Acoustic monitoring in Washington offshore waters detected Cuvier's beaked whale calls between January and November 2011 (Sirovic
Blainville's beaked whale is found in tropical and warm temperate waters of all oceans (Pitman 2018). It has the widest distribution throughout the world of all Mesoplodon species (Pitman 2018). Like other beaked whales, Blainville's beaked whale is generally found in waters 200-1400 m deep (Gannier 2000; Jefferson
There was one acoustic encounter with Blainville's beaked whales recorded in Quinault Canyon off Washington in waters 1400 m deep during 2011 (Baumann-Pickering
Hubbs' beaked whale occurs in temperate waters of the North Pacific (Mead 1989). Its distribution appears to be correlated with the deep subarctic current (Mead
Stejneger's beaked whale occurs in subarctic and cool temperate waters of the North Pacific (Mead 1989). Most records are from Alaskan waters, and the Aleutian Islands appear to be its center of distribution (Mead 1989; Wade
The striped dolphin has a cosmopolitan distribution in tropical to warm temperate waters from ~50° N to 40° S (Perrin
The common dolphin is found in tropical and warm temperate oceans around the world (Jefferson
The distribution of short-beaked common dolphins along the U.S. west coast is variable and likely related to oceanographic changes (Heyning and Perrin 1994; Forney and Barlow 1998). It is the most abundant cetacean off California; some sightings have been made off Oregon, in offshore waters (Carretta
The Pacific white-sided dolphin is found in cool temperate waters of the North Pacific from the southern Gulf of California to Alaska. Across the North Pacific, it appears to have a relatively narrow distribution between 38° N and 47° N (Brownell
Results of aerial and shipboard surveys strongly suggest seasonal north-south movements of the species between California and Oregon/Washington; the movements apparently are related to oceanographic influences, particularly water temperature (Green
Based on year-round aerial surveys off Oregon/Washington, the Pacific white-sided dolphin was the most abundant cetacean species, with nearly all (97%) sightings occurring in May (Green
Fifteen Pacific white-sided dolphin sightings (231 animals) were made off Washington/Oregon during the June-July 2012 L-DEO Juan de Fuca plate seismic survey (RPS 2012b). There were fifteen Pacific white-sided dolphin sightings (462 animals) made during the July 2012 L-DEO seismic surveys off southern Washington (RPS 2012a). This species was not sighted during the July 2012 L-DEO seismic survey off Oregon (RPS 2012c). Numerous Pacific white-sided dolphin sightings were made during L-DEO's Cascadia summer survey off Oregon and Washington (RPS 2021b). Pacific white-sided dolphins are likely to be common in the proposed survey regions.
The northern right whale dolphin is found in cool temperate and sub-arctic waters of the North Pacific, from the Gulf of Alaska to near northern Baja California, ranging from 30° N to 50° N (Reeves
Aerial and shipboard surveys suggest seasonal inshore-offshore and north-south movements in the eastern North Pacific Ocean between California and Oregon/Washington; the movements are believed to be related to oceanographic influences, particularly water temperature and presumably prey distribution and availability (Green
Becker et al. (2014) predicted relatively high densities off southern Oregon, and moderate densities off northern Oregon and Washington. Based on year-round aerial surveys off Oregon/Washington, the northern right whale dolphin was the third most abundant cetacean species, concentrated in slope waters but also occurring in water out to ~550 km offshore (Green
Risso's dolphin is distributed worldwide in mid-temperate and tropical oceans (Kruse
Off the U.S. west coast, Risso's dolphin is believed to make seasonal north-south movements related to water temperature, spending colder winter months off California and moving north to waters off Oregon/Washington during the spring and summer as northern waters begin to warm (Green
The killer whale is cosmopolitan and globally fairly abundant, being observed in all oceans of the world (Ford 2018). It is very common in temperate waters and also frequents tropical waters, at least seasonally (Heyning and Dahlheim 1988). There are three distinct ecotypes, or forms, of killer whales recognized in the north Pacific: Resident, transient, and offshore. The three ecotypes differ morphologically, ecologically, behaviorally, and genetically. Resident killer whales exclusively prey upon fish, with a clear preference for salmon (Ford and Ellis 2006; Hanson
Currently, there are eight killer whale stocks recognized in the U.S. Pacific: (1) Alaska Residents, occurring from Southeast Alaska to the Aleutians and Bering Sea; (2) Northern Residents, from British Columbia through parts of the Southeast Alaska; (3) Southern Residents, mainly in inland waters of Washington State and southern British Columbia; (4) Gulf of Alaska, Aleutians, and Bering Sea Transients, from Prince William Sound through the Aleutians and Bering Sea; (5) AT1 Transients, from Prince William Sound through the Kenai Fjords; (6) West Coast Transients, from California through Southeast Alaska; (7) Offshore, from California through Alaska; and (8) Hawaiian (Muto
The main diet of transient killer whales consists of marine mammals, in particular porpoises and seals. West coast transient killer whales (also known as Bigg's killer whales) range from Southeast Alaska to California (Muto
Little is known about offshore killer whales, but they occur primarily over shelf waters and feed on fish, especially sharks (Ford 2014). Dahlheim
During L-DEO's Cascadia surveys during June through July 2021 in the Northeast Pacific Ocean, a sighting of 20 killer whales was made near the shelf edge off northern Oregon (RPS 2021b). Killer whales could be encountered during the proposed survey, although it is unlikely the endangered Southern Resident Killer whales would occur as far offshore as the survey regions.
Dwarf and pygmy sperm whales are distributed throughout tropical and temperate waters of the Atlantic, Pacific, and Indian oceans, but their precise distributions are unknown because much of what we know of the species comes from strandings (McAlpine 2018). They are difficult to sight at sea, because of their dive behavior and perhaps because of their avoidance reactions to ships and behavior changes in relation to survey aircraft (Würsig
Both
Pygmy and dwarf sperm whales are rarely sighted off Oregon and Washington, with only one sighting of an unidentified
Dall's porpoise is found in temperate to subarctic waters of the North Pacific and adjacent seas (Jefferson
Off Oregon and Washington, Dall's porpoise is widely distributed over shelf and slope waters, with concentrations near shelf edges, but is also commonly sighted in pelagic offshore waters (Morejohn 1979; Green
Encounter rates reported by Green
Nineteen Dall's porpoise sightings (144 animals) were made off Washington/Oregon during the June-
The northern fur seal is endemic to the North Pacific Ocean and occurs from southern California to the Bering Sea, Okhotsk Sea, and Honshu Island, Japan (Muto
During the breeding season, adult males usually come ashore in May-August and may sometimes be present until November; adult females are found ashore from June-November (Carretta
Northern fur seals were seen throughout the North Pacific during surveys conducted during 1987-1990, including off Washington and Oregon (Buckland
Bonnell
Northern fur seals could be observed in the proposed survey regions, in particular females and juveniles. However, adult males are generally ashore during the reproductive season from May-August; adult females are generally ashore from June through November.
Most breeding and births occur at Isla Guadalupe, Mexico; a secondary rookery exists at Isla Benito del Este (Maravilla-Chavez and Lowry 1999; Aurioles-Gamboa
During the summer breeding season, most adults occur at rookeries in Mexico (Norris 2017 in USN 2019; Carretta
The primary range of the California sea lion includes the coastal areas and offshore islands of the eastern North Pacific Ocean from B.C. to central Mexico, including the Gulf of California (Jefferson
California sea lion rookeries are on islands located in southern California, western Baja California, and the Gulf of California (Carretta
In California and Baja California, births occur on land from mid-May to late-June. During August and September, after the mating season, the adult males migrate northward to feeding areas as far north as Washington (Puget Sound) and B.C. (Lowry
California sea lions are coastal animals that often haul out on shore throughout the year, but peak numbers off Oregon and Washington occur during the fall (Bonnell
During aerial surveys over the shelf and slope off Oregon and Washington (Adams
The Steller sea lion occurs along the North Pacific Rim from northern Japan to California (Loughlin
Steller sea lions typically inhabit waters from the coast to the outer continental shelf and slope throughout their range; they are not considered migratory, although foraging animals can travel long distances (Loughlin
Non-breeding adults use haulouts or occupy sites at the periphery of rookeries during the breeding season (NMFS 2008). Pupping occurs from mid-May to mid-July (Pitcher and Calkins 1981) and peaks in June (Pitcher
During surveys off the coasts of Oregon and Washington, Bonnell
The northern elephant seal breeds in California and Baja California, primarily on offshore islands, from Cedros off the west coast of Baja California, north to the Farallons in Central California (Stewart
When not at their breeding rookeries, adults feed at sea far from the rookeries. Adult females and juveniles forage in the California current off California to B.C. (Le Boeuf
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 includes a discussion of the ways that L-DEO's specified activity may impact marine mammals and their habitat. The Estimated Take 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 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 how those impacts on individuals may or may not impact marine mammal species or stocks.
This section contains a brief technical background on sound, the characteristics of certain sound types, and on metrics used in this proposal inasmuch as the information is relevant to the specified activity and to a discussion of the potential effects of the specified activity on a marine mammals found later in this document.
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in hertz (Hz) or cycles per second. Wavelength is the distance between two peaks or corresponding points of a sound wave (length of one cycle). Higher frequency sounds have shorter wavelengths than lower frequency sounds, and typically attenuate (decrease) more rapidly, except in certain cases in shallower water. Amplitude is the height of the sound pressure wave or the “loudness” of a sound and is typically described using the relative unit of the dB. A sound pressure level (SPL) in dB is described as the ratio between a measured pressure and a reference pressure (for underwater sound, this is 1 microPascal (μPa)) and is a logarithmic unit that accounts for large variations in amplitude; therefore, a relatively small change in dB corresponds to large changes in sound pressure. The source level (SL) represents the SPL referenced at a distance of 1 m from the source (referenced to 1 μPa) while the received level is the SPL at the listener's position (referenced to 1 μPa).
Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Root mean square is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Root mean square accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
Sound exposure level (SEL; represented as dB re 1 μPa
When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in a manner similar to ripples on the surface of a pond and may be either directed in a beam or beams or may radiate in all directions (omnidirectional sources), as is the case for pulses produced by the airgun arrays considered here. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.
Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson
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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 human 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 this dependence on a large number of varying factors, ambient
Sounds are often considered to fall into one of two general types: Pulsed and non-pulsed (defined in the following). The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
Airgun arrays produce pulsed signals with energy in a frequency range from about 10-2,000 Hz, with most energy radiated at frequencies below 200 Hz. The amplitude of the acoustic wave emitted from the source is equal in all directions (
Here, we discuss the effects of active acoustic sources on marine mammals.
Richardson
We describe the more severe effects of certain non-auditory physical or physiological effects only briefly as we do not expect that use of airgun arrays are reasonably likely to result in such effects (see below for further discussion). Potential effects from impulsive sound sources can range in severity from effects such as behavioral disturbance or tactile perception to physical discomfort, slight injury of the internal organs and the auditory system, or mortality (Yelverton
When PTS occurs, there is physical damage to the sound receptors in the ear (
Relationships between TTS and PTS thresholds have not been studied in marine mammals, and there is no PTS data for cetaceans but such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several dBs above (a 40-dB threshold shift approximates PTS onset;
For mid-frequency cetaceans in particular, potential protective mechanisms may help limit onset of TTS or prevent onset of PTS. Such mechanisms include dampening of hearing, auditory adaptation, or behavioral amelioration (
TTS is the mildest form of hearing impairment that can occur during exposure to sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises, and a sound must be at a higher level in order to be heard. In terrestrial and marine mammals, TTS can last from minutes or hours to days (in cases of strong TTS). In many cases, hearing sensitivity recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals.
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Finneran
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin, beluga whale, harbor porpoise, and Yangtze finless porpoise) exposed to a limited number of sound sources (
Critical questions remain regarding the rate of TTS growth and recovery after exposure to intermittent noise and the effects of single and multiple pulses. Data at present are also insufficient to construct generalized models for recovery and determine the time necessary to treat subsequent exposures as independent events. More information is needed on the relationship between auditory evoked potential and behavioral measures of TTS for various stimuli. For summaries of data on TTS in marine mammals or for further discussion of TTS onset thresholds, please see Southall
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (
Changes in dive behavior can vary widely, and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive (
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 (
Visual tracking, passive acoustic monitoring, and movement recording tags were used to quantify sperm whale behavior prior to, during, and following exposure to airgun arrays at received levels in the range 140-160 dB at distances of 7-13 km, following a phase-in of sound intensity and full array exposures at 1-13 km (Madsen
Variations in respiration naturally vary with different behaviors and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that respiration rates may either be unaffected or could increase, depending on the species and signal characteristics, again highlighting the importance in understanding species differences in the tolerance of underwater noise when determining the potential for impacts resulting from anthropogenic sound exposure (
Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can occur for any of these modes and may result from a need to compete with an increase in background noise or may reflect increased vigilance or a startle response. For example, in the presence of potentially masking signals, humpback whales and killer whales have been observed to increase the length of their songs or amplitude of calls (Miller
Cerchio
Castellote
Seismic pulses at average received levels of 131 dB re 1 μPa
Avoidance is the displacement of an individual from an area or migration path as a result of the presence of a sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson
Forney
A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response (
Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention (
Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors such as sound exposure are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
Stone (2015) reported data from at-sea observations during 1,196 seismic surveys from 1994 to 2010. When arrays of large airguns (considered to be 500 in
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 sufficiently to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals (
Under certain circumstances, significant masking could disrupt behavioral patterns, which in turn could affect fitness for survival and reproduction. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.
The frequency range of the potentially masking sound is important in predicting any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals (
Masking affects both senders and receivers of acoustic signals and can potentially have long-term chronic effects on marine mammals at the population level as well as at the individual level. Low-frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, with most of the increase from distant commercial shipping (Hildebrand, 2009). All anthropogenic sound sources, but especially chronic and lower-frequency signals (
Masking effects of pulsed sounds (even from large arrays of airguns) on marine mammal calls and other natural sounds are expected to be limited, although there are few specific data on this. Because of the intermittent nature and low duty cycle of seismic pulses,
Some baleen and toothed whales are known to continue calling in the presence of seismic pulses, and their calls usually can be heard between the pulses (
Vessel noise from the
Ship noise, through masking, can reduce the effective communication distance of a marine mammal if the frequency of the sound source is close to that used by the animal, and if the sound is present for a significant fraction of time (
Baleen whales are thought to be more sensitive to sound at these low frequencies than are toothed whales (
Many odontocetes show considerable tolerance of vessel traffic, although they sometimes react at long distances if confined by ice or shallow water, if previously harassed by vessels, or have had little or no recent exposure to ships (Richardson
There are few data on the behavioral reactions of beaked whales to vessel noise, though they seem to avoid approaching vessels (
Sounds emitted by the
Vessel collisions with marine mammals, or ship strikes, can result in death or serious injury of the animal. Wounds resulting from ship strike may include massive trauma, hemorrhaging, broken bones, or propeller lacerations (Knowlton and Kraus, 2001). An animal at the surface may be struck directly by a vessel, a surfacing animal may hit the bottom of a vessel, or an animal just below the surface may be cut by a vessel's propeller. Superficial strikes may not kill or result in the death of the animal. These interactions are typically associated with large whales (
Pace and Silber (2005) also found that the probability of death or serious injury increased rapidly with increasing vessel speed. Specifically, the predicted probability of serious injury or death increased from 45 to 75 percent as vessel speed increased from 10 to 14 kn, and exceeded 90 percent at 17 kn. Higher speeds during collisions result in greater force of impact, but higher speeds also appear to increase the chance of severe injuries or death through increased likelihood of collision by pulling whales toward the vessel (Clyne, 1999; Knowlton
The
It is possible for ship strikes to occur while traveling at slow speeds. For example, a hydrographic survey vessel traveling at low speed (5.5 kn) while conducting mapping surveys off the central California coast struck and killed a blue whale in 2009. The State of California determined that the whale had suddenly and unexpectedly surfaced beneath the hull, with the result that the propeller severed the whale's vertebrae, and that this was an unavoidable event. This strike represents the only such incident in approximately 540,000 hours of similar coastal mapping activity (
Although the likelihood of the vessel striking a marine mammal is low, we propose a robust ship strike avoidance protocol (see Proposed Mitigation), which we believe eliminates any foreseeable risk of ship strike during transit. We anticipate that vessel collisions involving a seismic data acquisition vessel towing gear, while not impossible, represent unlikely, unpredictable events for which there are no preventive measures. Given the proposed mitigation measures, the relatively slow speed of the vessel towing gear, the presence of bridge crew watching for obstacles at all times (including marine mammals), and the presence of marine mammal observers, the possibility of ship strike is discountable and, further, were a strike of a large whale to occur, it would be unlikely to result in serious injury or mortality. No incidental take resulting from ship strike is anticipated, and this potential effect of the specified activity will not be discussed further in the following analysis.
Marine mammals strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, ship strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in
There is no conclusive evidence that exposure to airgun noise results in behaviorally-mediated forms of injury. Behaviorally-mediated injury (
To understand why Navy MFA sonar affects beaked whales differently than airguns do, it is important to note the distinction between behavioral sensitivity and susceptibility to auditory injury. To understand the potential for auditory injury in a particular marine mammal species in relation to a given acoustic signal, the frequency range the species is able to hear is critical, as well as the species' auditory sensitivity to frequencies within that range. Current data indicate that not all marine mammal species have equal hearing capabilities across all frequencies and, therefore, species are grouped into hearing groups with generalized hearing ranges assigned on the basis of available data (Southall
Navy MFA sonar affects beaked whales differently than airguns do because it produces energy at different frequencies than airguns. Mid-frequency cetacean hearing is generically thought to be best between 8.8 to 110 kHz,
It is important to distinguish between energy (loudness, measured in dB) and frequency (pitch, measured in Hz). In considering the potential impacts of mid-frequency components of airgun noise (1-10 kHz, where beaked whales can be expected to hear) on marine mammal hearing, one needs to account for the energy associated with these higher frequencies and determine what energy is truly “significant.” Although there is mid-frequency energy associated with airgun noise (as expected from a broadband source), airgun sound is predominantly below 1 kHz (Breitzke
Aside from frequency content, there are other significant differences between MFA sonar signals and the sounds produced by airguns that minimize the risk of severe behavioral reactions that could lead to strandings or deaths at sea,
The available scientific literature also provides a useful contrast between airgun noise and MFA sonar regarding the likely risk of behaviorally-mediated injury. There is strong evidence for the association of beaked whale stranding events with MFA sonar use, and particularly detailed accounting of several events is available (
A more recent review of possible stranding associations with seismic surveys (Castellote and Llorens, 2016) states plainly that, “[s]peculation concerning possible links between seismic survey noise and cetacean strandings is available for a dozen events but without convincing causal evidence.” The authors' “exhaustive” search of available information found ten events worth further investigation via a ranking system representing a rough metric of the relative level of confidence offered by the data for inferences about the possible role of the seismic survey in a given stranding event. Only three of these events involved beaked whales. Whereas D'Amico
However, one of these stranding events, involving two Cuvier's beaked whales, was contemporaneous with and reasonably associated spatially with a 2002 seismic survey in the Gulf of California conducted by L-DEO, as was the case for the 2007 Gulf of Cadiz seismic survey discussed by Castellote and Llorens (also involving two Cuvier's beaked whales). However, neither event was considered a “true atypical mass stranding” (according to Frantzis [1998]) as used in the analysis of Castellote and Llorens (2016). While we agree with the authors that this lack of evidence should not be considered conclusive, it is clear that there is very little evidence that seismic surveys should be considered as posing a significant risk of acute harm to beaked whales or other mid-frequency cetaceans. We have considered the potential for the proposed surveys to result in marine mammal stranding and have concluded that, based on the best available information, stranding is not expected to occur.
Placement of equipment, such as the heat flow probe in the seafloor, could damage areas of hard bottom where direct contact with the seafloor occurs and could crush epifauna (organisms that live on the seafloor or surface of other organisms). Damage to unknown or unseen hard bottom could occur, but because of the small area covered by most bottom-founded equipment and the patchy distribution of hard bottom habitat, contact with unknown hard bottom is expected to be rare and impacts minor. Seafloor disturbance in areas of soft bottom can cause loss of small patches of epifauna and infauna due to burial or crushing, and bottom-feeding fishes could be temporarily displaced from feeding areas. Overall, any effects of physical damage to habitat are expected to be minor and temporary.
SPLs of sufficient strength have been known to cause injury to fish and fish mortality and, in some studies, fish auditory systems have been damaged by airgun noise (McCauley
A recent comprehensive review (Carroll
Available data suggest that cephalopods are capable of sensing the particle motion of sounds and detect low frequencies up to 1-1.5 kHz, depending on the species, and so are likely to detect airgun noise (Kaifu
With regard to potential impacts on zooplankton, McCauley
A modeling exercise was conducted as a follow-up to the McCauley
Notably, a recently described study produced results inconsistent with those of McCauley
A recent review article concluded that, while laboratory results provide scientific evidence for high-intensity and low-frequency sound-induced physical trauma and other negative effects on some fish and invertebrates, the sound exposure scenarios in some cases are not realistic to those encountered by marine organisms during routine seismic operations (Carroll
In summary, impacts of the specified activity on marine mammal prey species will likely be limited to behavioral responses, the majority of prey species will be capable of moving out of the area during the survey, a rapid return to normal recruitment, distribution, and behavior for prey species is anticipated, and, overall, impacts to prey species will be minor and temporary. Prey species exposed to sound might move away from the sound source, experience TTS, experience masking of biologically relevant sounds, or show no obvious direct effects. Mortality from decompression injuries is possible in close proximity to a sound, but only limited data on mortality in response to airgun noise exposure are available (Hawkins
Soundscapes are also defined by, and acoustic habitat influenced by, the total contribution of anthropogenic sound. This may include incidental emissions from sources such as vessel traffic, or may be intentionally introduced to the marine environment for data acquisition purposes (as in the use of airgun arrays). Anthropogenic noise varies widely in its frequency content, duration, and loudness and these characteristics greatly influence the potential habitat-mediated effects to marine mammals (please see also the previous discussion on masking under “Acoustic Effects”), which may range from local effects for brief periods of time to chronic effects over large areas and for long durations. Depending on the extent of effects to habitat, animals may alter their communications signals (thereby potentially expending additional energy) or miss acoustic cues (either conspecific or adventitious). For more detail on these concepts see,
Problems arising from a failure to detect cues are more likely to occur when noise stimuli are chronic and overlap with biologically relevant cues used for communication, orientation, and predator/prey detection (Francis and Barber, 2013). Although the signals emitted by seismic airgun arrays are generally low frequency, they would also likely be of short duration and transient in any given area due to the nature of these surveys. As described previously, exploratory surveys such as these cover a large area but would be transient rather than focused in a given location over time and therefore would not be considered chronic in any given location.
Based on the information discussed herein, we conclude that impacts of the specified activity 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 be by Level B harassment only, primarily in the form of behavioral disruption and including through Temporary Threshold Shift (TTS) for low frequency cetaceans resulting from exposure to sound from seismic airguns. TTS is not expected for all other hearing groups and is considered to be unlikely for low frequency cetaceans. Given the small size of the Level A harassment isopleths (28.6 m for LF cetaceans and less than one meter for all other species) and the anticipated effectiveness of the mitigation measures (
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) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of 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).
L-DEO's proposed survey includes the use of impulsive seismic sources (
For more information, see 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.
The proposed 2D survey would acquire data using a 2 GI-airgun cluster with a total discharge volume of 90 in
For deep and intermediate-water cases, the field measurements cannot be used readily to derive mitigation radii, as at those sites the calibration hydrophone was located at a roughly constant depth of 350-500 m, which may not intersect all the sound pressure level (SPL) isopleths at their widest point from the sea surface down to the maximum relevant water depth (~2000 m) for marine mammals. At short ranges, where the direct arrivals dominate and the effects of seafloor interactions are minimal, the data recorded at the deep sites are suitable for comparison with modeled levels at the depth of the calibration hydrophone. At longer ranges, the comparison with the mitigation model—constructed from the maximum SPL through the entire water column at varying distances from the airgun array—is the most relevant.
In deep and intermediate-water depths, comparisons at short ranges between sound levels for direct arrivals recorded by the calibration hydrophone and model results for the same array tow depth are in good agreement (Fig. 12 and 14 in Appendix H of L-DEO's PEIS). Consequently, isopleths falling within this domain can be predicted reliably by the L-DEO model, although they may be imperfectly sampled by measurements recorded at a single depth. At greater distances, the calibration data show that seafloor-reflected and sub-seafloor-refracted arrivals dominate, whereas the direct arrivals become weak and/or incoherent. Aside from local topography effects, the region around the critical distance is where the observed levels rise closest to the mitigation model curve. However, the observed sound levels are found to fall almost entirely below the mitigation model curve. Thus, analysis of the Gulf of Mexico calibration measurements demonstrate that although simple, the L-DEO model is a robust tool for conservatively estimating isopleths and the deep water radii obtained from model results down to a maximum water depth of 2000 m.
A recent retrospective analysis of acoustic propagation of R/V
The proposed surveys would acquire data with two 45 in
Predicted distances to Level A harassment isopleths, which vary based on marine mammal hearing groups, were calculated based on modeling performed by L-DEO using the PGS Nucleus source modeling software program and the NMFS User Spreadsheet, described below. The acoustic thresholds for impulsive sounds (
In order to more realistically incorporate the Technical Guidance's weighting functions over the seismic array's full acoustic band, unweighted spectrum data for the
Note that because of some of the assumptions included in the methods used (
Auditory injury for all species is unlikely to occur given the small modeled zones of injury (estimated zone less than 30 m for low-frequency cetaceans and near zero for all other species). Additionally, animals are expected to have aversive/compensatory behavior in response to the activity (Nachtigall
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 U.S. Navy (USN) primarily use the Southwest Fishery Science Center (SWFSC) habitat-based cetacean density models to develop a marine species density database for the Northwest Training and Testing Study Area, which encompasses the proposed survey area (USN 2019). For species where density spatial modeling was unavailable, other data sources were used. The USN marine species density database is currently the most comprehensive density data set available for the California Current Ecosystem (CCE) which encompasses waters off the coast of California, Oregon, and Washington. However, GIS data layers are currently unavailable for this database; thus, in this analysis the USN data were only used for species for which density data were not available from an alternative spatially-explicit model (
For most pinnipeds, L-DEO used the highest densities for spring, summer, or fall from USN (2019), but corrected the estimates by projecting the most recent population growth/updated population estimates to 2022, when available. This same approach was used by NMFS for previous L-DEO surveys (
Spatially-explicit density data from summer/fall from the NOAA CetSound website (NOAA 2022) were used for most other species (
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. In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in Level B harassment, radial distances from the airgun array to the predicted isopleth corresponding to the Level B harassment thresholds are calculated, as described above. Those radial distances are then used to calculate the area(s) around the airgun array predicted to be ensonified to sound levels that exceed the Level B harassment threshold. The distance for the 160-dB threshold (based on L-DEO model results) was used to draw a buffer around the area expected to be ensonified (
The marine mammals predicted to occur within these respective areas, based on the estimated densities, are assumed to be incidentally taken. Estimated exposures for the proposed survey are shown in Table 6.
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, 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, impact on operations.
L-DEO reviewed mitigation measures employed during seismic research surveys authorized by NMFS under previous incidental harassment authorizations, as well as recommended best practices in Richardson
To reduce the potential for disturbance from acoustic stimuli associated with the activities, L-DEO proposed to implement mitigation measures for marine mammals. Mitigation measures that would be adopted during the planned survey include, but are not limited to: (1) Vessel speed or course alteration, provided that doing so would not compromise operation safety requirements. (2) GI-airgun shut down within EZs, and (3) ramp-up procedures.
Visual monitoring requires the use of trained observers (herein referred to as visual protected species observers (PSOs)) to scan the ocean surface visually for the presence of marine mammals. The area to be scanned visually includes primarily the exclusion zone, within which observation of certain marine mammals requires shutdown of the acoustic source, but also the buffer zone. The buffer zone means an area beyond the exclusion zone to be monitored for the presence of marine mammals that may enter the exclusion zone. During pre-start clearance (
L-DEO must use independent, dedicated, trained visual PSOs, meaning that the PSOs must be employed by a third-party observer provider, must not have tasks other than to conduct observational effort, collect data, and communicate with and instruct relevant vessel crew with regard to the presence of protected species and mitigation requirements, and must have successfully completed an approved PSO training course. PSO resumes shall be provided to NMFS for approval.
At least one visual PSO must have a minimum of 90 days at-sea experience working in that role during a shallow penetration or low-energy survey, with no more than 18 months elapsed since the conclusion of the at-sea experience. One PSO with such experience shall be designated as the lead for the entire protected species observation team. The lead PSO shall serve as primary point of contact for the vessel operator and ensure all PSO requirements per the IHA are met. To the maximum extent practicable, the experienced PSOs should be scheduled to be on duty with those PSOs with the appropriate training but who have not yet gained relevant experience.
During survey operations (
PSOs shall establish and monitor the exclusion and buffer zones. These zones shall be based upon the radial distance from the edges of the acoustic source (rather than being based on the center of the array or around the vessel itself). During use of the acoustic source (
During use of the airgun, detections of marine mammals within the buffer zone (but outside the exclusion zone) should be communicated to the operator to prepare for the potential shutdown of the acoustic source. Visual PSOs will immediately communicate all observations to the on duty acoustic PSO(s), including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination. Any observations of marine mammals by crew members shall be relayed to the PSO team. During good conditions (
Visual PSOs may be on watch for a maximum of four consecutive hours followed by a break of at least one hour between watches and may conduct a maximum of 12 hours of observation per 24-hour period.
An exclusion zone (EZ) is a defined area within which occurrence of a marine mammal triggers mitigation action intended to reduce the potential for certain outcome,
The 100 m EZ, with additional 100 m buffer zone, is intended to be precautionary in the sense that it would be expected to contain sound exceeding the injury criteria for all cetacean hearing groups, (based on the dual criteria of SEL
An extended 500 m exclusion zone must be established for all beaked whales, dwarf and pygmy sperm whales, killer whales, a large whale with a calf, and groups of six or more large whales during all survey effort. No buffer zone is required.
Ramp-up (sometimes referred to as “soft start”) is the gradual and systematic increase of emitted sound levels from an airgun array. Ramp-up would begin with one GI airgun 45 cu in first being activated, followed by the second after 5 minutes. The intent of pre-clearance observation (30 minutes) is to ensure no marine mammals are observed within the buffer zone prior to the beginning of ramp-up. During pre-clearance is the only time observations of marine mammals in the buffer zone would prevent operations (
• 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 minutes prior to the planned ramp-up in order to allow PSOs time to monitor the exclusion and buffer
• Ramp-ups shall be scheduled so as to minimize the time spent with the source activated prior to reaching the designated run-in;
• One of the PSOs conducting pre-clearance observations must be notified again immediately prior to initiating ramp-up procedures and the operator must receive confirmation from the PSO to proceed;
• Ramp-up may not be initiated if any marine mammal is within the applicable exclusion or buffer zone. If a marine mammal is observed within the applicable exclusion zone or the buffer zone during the 30 minutes pre-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 (15 minutes for small odontocetes and pinnipeds, and 30 minutes for Mysticetes and all other odontocetes, including sperm whales, pygmy sperm whales, dwarf sperm whales, beaked whales, pilot whales, killer whales, Risso's dolphin);
• PSOs must monitor the exclusion and buffer zones during ramp-up, and ramp-up must cease and the source must be shut down upon detection of a marine mammal within the applicable exclusion zone. Once ramp-up has begun, detections of marine mammals within the buffer zone do not require shutdown, but such observation shall be communicated to the operator to prepare for the potential shutdown.
• If the acoustic source is shut down for brief periods (
• Testing of the acoustic source involving all elements requires ramp-up. Testing limited to individual source elements or strings does not require ramp-up but does require pre-start clearance watch.
The shutdown of an airgun array requires the immediate de-activation of all individual airgun elements of the array. Any PSO on duty will have the authority to delay the start of survey operations or to call for shutdown of the acoustic source if a marine mammal is detected within the applicable exclusion zone. The operator must also establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the acoustic source to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. When both visual and acoustic PSOs are on duty, all detections will be immediately communicated to the remainder of the on-duty PSO team for potential verification of visual observations by the acoustic PSO or of acoustic detections by visual PSOs. When the airgun array is active (
Following a shutdown, airgun activity would not resume until the marine mammal has clear the EZ. The animal would be considered to have cleared the EZ if it is visually observed to have departed the EZ, or it has not been seen within the EZ for 15 minutes in the case of small odontocetes and pinnipeds, and 30 minutes for Mysticetes and all other odontocetes, including sperm whales, beaked whales, pilot whales, killer whales, and Risso's dolphin) with no further observation of the marine mammal(s).
The shutdown requirement can be waived for small dolphins if an individual is visually detected and localized within an exclusion zone. As defined here, the small dolphin group is intended to encompass those members of the Family Delphinidae most likely to voluntarily approach the source vessel for purposes of interacting with the vessel and/or airgun array (
We propose this small dolphin exception because shutdown requirements for small dolphins under all circumstances represent practicability concerns without likely commensurate benefits for the animals in question. Small dolphins are generally the most commonly observed marine mammals in the specific geographic region and would typically be the only marine mammals likely to intentionally approach the vessel. As described above, auditory injury is extremely unlikely to occur for mid-frequency cetaceans (
A large body of anecdotal evidence indicates that small dolphins commonly approach vessels and/or towed arrays during active sound production for purposes of bow riding, with no apparent effect observed in those delphinids (
Upon implementation of shutdown, the source may be reactivated after the marine mammal(s) has been observed exiting the applicable exclusion zone (
L-DEO must implement shutdown if a marine mammal species for which take was not authorized, or a species for which authorization was granted but the takes have been met, approaches the Level B harassment zones.
These measures apply to all vessels associated with the planned survey activity; however, we note that 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. These measures include the following:
1. Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down, stop their vessel, or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammal. A single marine mammal at the surface may indicate the presence of submerged animals in the vicinity of the vessel; therefore, precautionary measures should be exercised when an animal is observed. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel (specific distances detailed below), to ensure the potential for strike is minimized. Visual observers monitoring the vessel strike avoidance zone can be either third-party observers or crew members, but crew members responsible for these duties must be provided sufficient training to distinguish marine mammals from other phenomena and broadly to identify a marine mammal to broad taxonomic group (
2. Vessel speeds must be reduced to 10 kn or less when mother/calf pairs, pods, or large assemblages of any marine mammal are observed near a vessel;
3. All vessels must maintain a minimum separation distance of 100 m from large whales (
4. All vessels must attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an exception made for those animals that approach the vessel; and
5. When marine mammals are sighted while a vessel is underway, the vessel should take action as necessary to avoid violating the relevant separation distance (
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.
As described above, PSO observations would take place during daytime airgun operations. During seismic operations, at least three visual PSO would be based aboard the
• PSOs shall be independent, dedicated and trained and must be employed by a third-party observer provider;
• PSOs shall have no tasks other than to conduct visual observational effort, collect data, and communicate with and instruct relevant vessel crew with regard to the presence of protected species and mitigation requirements (including brief alerts regarding maritime hazards);
• PSOs shall have successfully completed an approved PSO training course appropriate for their designated task (visual or acoustic);
• NMFS must review and approve PSO resumes accompanied by a relevant training course information packet that includes the name and qualifications (
• NMFS shall have one week to approve PSOs from the time that the necessary information is submitted, after which PSOs meeting the minimum requirements shall automatically be considered approved;
• PSOs must successfully complete relevant training, including completion of all required coursework and passing (80 percent or greater) 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; and
• 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. Requests shall be granted or denied (with justification) by NMFS within one week of receipt of submitted information. 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 protected species surveys; or (3) previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.
PSOs must use standardized data collection forms, whether hard copy or electronic. PSOs must record detailed information about any implementation of mitigation requirements, including the distance of animals to the acoustic source and description of specific actions that ensued, the behavior of the animal(s), any observed changes in behavior before and after implementation of mitigation, and if shutdown was implemented, the length of time before any subsequent ramp-up of the acoustic source. If required mitigation was not implemented, PSOs should record a description of the circumstances. At a minimum, the following information must be recorded:
• Vessel name and call sign;
• PSO names and affiliations;
• Date and participants of PSO briefings (as discussed in General Requirement);
• Dates of departure and return to port with port name;
• Dates and times (Greenwich Mean Time) of survey effort and times corresponding with PSO effort;
• Vessel location (latitude/longitude) when survey effort began and ended and vessel location at beginning and end of visual PSO duty shifts;
• Vessel heading and speed at beginning and end of visual PSO duty shifts and upon any line change;
• Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions changed significantly), including BSS and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon;
• Factors that may have contributed to impaired observations during each PSO shift change or as needed as environmental conditions changed (
• Survey activity information, such as acoustic source power output while in operation, number and volume of airguns operating in the array, tow depth of the array, and any other notes of significance (
The following information should be recorded upon visual observation of any marine mammal:
• Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
• PSO who sighted the animal;
• Time of sighting;
• Vessel location at time of sighting;
• Water depth;
• Direction of vessel's travel (compass direction);
• Direction of animal's travel relative to the vessel;
• Pace of the animal;
• Estimated distance to the animal and its heading relative to vessel at initial sighting;
• Identification of the animal (
• Estimated number of animals (high/low/best);
• Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition,
• 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);
• Detailed behavior observations (
• Animal's closest point of approach (CPA) and/or closest distance from any element of the acoustic source;
• Platform activity at time of sighting (
• Description of any actions implemented in response to the sighting (
L-DEO must 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. A final report must be submitted within 30 days following resolution of any comments on the draft report. The report would describe the operations that were conducted and sightings of marine mammals near the operations. The report would provide full documentation of methods, results, and interpretation pertaining to all monitoring. The 90-day report would summarize the dates and locations of seismic operations, and all marine mammal sightings (dates, times, locations, activities, associated seismic survey activities). The report would also include estimates of the number and nature of exposures that occurred above the harassment threshold based on PSO observations and including an estimate of those that were not detected, in consideration of both the characteristics and behaviors of the species of marine mammals that affect detectability, as well as the environmental factors that affect detectability.
The draft report shall also include geo-referenced time-stamped vessel tracklines for all time periods during which airguns were operating. Tracklines should include points recording any change in airgun status (
Discovery of injured or dead marine mammals—In the event that personnel involved in survey activities covered by the authorization discover an injured or dead marine mammal, the L-DEO shall report the incident to the Office of Protected Resources (OPR), NMFS and to the NMFS West Coast Regional Stranding Coordinator as soon as feasible. The report must include the following information:
• 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.
Vessel strike—In the event of a ship strike of a marine mammal by any vessel involved in the activities covered by the authorization, L-DEO shall report the incident to OPR, NMFS and to the NMFS West Coast Regional Stranding Coordinator as soon as feasible. The report must include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Vessel's speed during and leading up to the incident;
• Vessel's course/heading and what operations were being conducted (if applicable);
• Status of all sound sources in use;
• Description of avoidance measures/requirements that were in place at the time of the strike and what additional measure were taken, if any, to avoid strike;
• Environmental conditions (
• Species identification (if known) or description of the animal(s) involved;
• Estimated size and length of the animal that was struck;
• Description of the behavior of the animal immediately preceding and following the strike;
• If available, description of the presence and behavior of any other marine mammals present immediately preceding the strike;
• Estimated fate of the animal (
• To the extent practicable, photographs or video footage of the animal(s).
In the event of a live stranding (or near-shore atypical milling) event within 50 km of the survey operations, where the NMFS stranding network is engaged in herding or other interventions to return animals to the water, the Director of OPR, NMFS (or designee) will advise L-DEO of the need to implement shutdown procedures for all active acoustic sources operating within 50 km of the stranding. Shutdown procedures for live stranding or milling marine mammals include the following: If at any time, the marine mammal the marine mammal(s) die or are euthanized, or if herding/intervention efforts are stopped, the Director of OPR, NMFS (or designee) will advise the IHA-holder that the shutdown around the animals' location is no longer needed. Otherwise, shutdown procedures will remain in effect until the Director of OPR, NMFS (or designee) determines and advises L-DEO that all live animals involved have left the area (either of their own volition or following an intervention).
If further observations of the marine mammals indicate the potential for re-stranding, additional coordination with the IHA-holder will be required to determine what measures are necessary to minimize that likelihood (
Additional Information Requests—if NMFS determines that the circumstances of any marine mammal stranding found in the vicinity of the activity suggest investigation of the association with survey activities is warranted, and an investigation into the stranding is being pursued, NMFS will submit a written request to L-DEO indicating that the following initial available information must be provided as soon as possible, but no later than 7 business days after the request for information:
• Status of all sound source use in the 48 hours preceding the estimated time of stranding and within 50 km of the discovery/notification of the stranding by NMFS; and
• If available, description of the behavior of any marine mammal(s) observed preceding (
In the event that the investigation is still inconclusive, the investigation of the association of the survey activities is still warranted, and the investigation is still being pursued, NMFS may provide additional information requests, in writing, regarding the nature and location of survey operations prior to the time period above.
To support NMFS's goal of improving our understanding of occurrence of marine mammal species or stocks in the area (
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 all the species listed in Table 6, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar, except where a species- or stock-specific discussion is warranted. NMFS does not anticipate that serious injury or mortality would occur as a result from low-energy surveys, even in the absence of mitigation, and no serious injury or mortality is proposed to be authorized. As discussed in the Potential Effects of Specified Activities on Marine Mammals and their Habitat section, non-auditory physical effects and vessel strike are not expected to occur. NMFS expects that all potential take would be in the form of Level B behavioral harassment in the form of temporary avoidance of the area or decreased
In addition to being temporary, the maximum expected Level B harassment zone around the survey vessel is 553 m. Therefore, the ensonified area surrounding the vessel is relatively small compared to the overall distribution of 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 short duration (6 days) and 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.
The entire U.S. West Coast within 47 km of the coast is a BIA for migrating gray whale potential presence January to July and October to December. The BIA for northbound gray whale migration is broken into two phases, Phase A (within 8 km of shore) and Phase B (within 5 km of shore), which are active from January to July and March to July, respectively. The BIA for southbound migration includes waters within 10 km of shore and is active from October to March. All planned survey areas are outside of all gray whale BIAs and no takes of gray whales are proposed for authorization. There are also two humpback whale feeding BIAs (Stonewall and Heceta Bank) adjacent to the survey area, however no overlap occurs between the survey area and the BIAs. There are no rookeries, mating or calving grounds known to be biologically important to marine mammals within the proposed survey area.
Critical habitat for the Mexico and Central America DPSs of humpback whales has been established along the U.S. West Coast (86 FR 21082; May 5, 2021), and NMFS has expanded the Southern Resident killer whale critical habitat to include coastal waters of Washington, Oregon, and California (86 FR 41668; August 2, 2021). No part of L-DEO's proposed seismic survey will occur in or near these critical habitats.
No permanent hearing impairment (Level A harassment) is anticipated or proposed to be authorized. Authorized takes of killer whales is expected to comprise almost entirely of the West Coast Transient and/or North Pacific Offshore stocks as Southern Resident killer whales are typically confined to coastal and inland waters. Therefore take of Southern Resident killer whales is unlikely given the far offshore location of the proposed survey, and no take of Southern Resident killer whales is proposed for authorization.
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 proposed activity is temporary and of relatively short duration (6 days);
• The anticipated impacts of the proposed activity on marine mammals would be temporary behavioral changes due to avoidance of the area around the vessel;
• No take by Level A harassment is proposed for authorization;
• The availability of alternative areas of similar habitat value for marine mammals to temporarily vacate the survey area during the proposed survey to avoid exposure to sounds from the activity is readily abundant;
• The potential adverse effects on fish or invertebrate species that serve as prey species for marine mammals from the proposed survey would be temporary and spatially limited, and impacts to marine mammal foraging would be minimal; and
• The proposed mitigation measures, including visual, shutdowns, and enhanced measures for areas of biological importance (
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 above, only small numbers of incidental take 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 proposes to authorize is below one third of the estimated stock abundance for all species (in fact, take of individuals is less than ten percent of the abundance of the affected stocks, see Table 6). This is likely a conservative estimate because we assume all takes are of different individual animals, which is likely not the case. Some individuals may be encountered multiple times in a day, but PSOs would count them as separate individuals if they cannot be 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
NMFS is proposing to authorize take of blue whales, fin whales, sei whales, sperm whales, Central America DPS humpback whales, Mexico DPS humpback whales, and Guadalupe fur seal, which are listed under the ESA. The NMFS OPR Permits and Conservation Division has requested initiation of Section 7 consultation with the NMFS OPR ESA Interagency Cooperation Division for the issuance of this IHA. NMFS will conclude the ESA consultation prior to reaching a determination regarding the proposed issuance of the authorization.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to L-DEO for conducting geophysical surveys in the Northeast Pacific Ocean during Summer 2022, 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 survey. 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 Activities section of this notice is planned or (2) the activities as described in the Description of Proposed Activities 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).
• 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.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule would set forth routine updates to the Medicare home health and home infusion therapy services payment rates for calendar year (CY) 2023 in accordance with existing statutory and regulatory requirements. This proposed rule discusses home health utilization; proposes a methodology for determining the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the Patient Driven Groupings Model (PDGM) case-mix adjustment methodology; and proposes a temporary retrospective and permanent prospective adjustment to the CY 2023 home health payment rates. This rule proposes reassignment of certain diagnosis codes under the PDGM. and proposes to establish a permanent mitigation policy to smooth the impact of year-to-year changes in home health payments related to changes in the home health wage index. This rule also proposes recalibration of the PDGM case-mix weights and updates the low utilization payment adjustment (LUPA) thresholds, functional impairment levels, comorbidity adjustment subgroups for CY 2023 and the fixed-dollar loss ratio (FDL) used for outlier payments. Additionally, this rule discusses the future collection of data regarding the use of telecommunications technology during a 30-day home health period of care on home health claims. In addition, this rule proposes changes to the Home Health Quality Reporting Program (HH QRP) requirements; changes to the expanded Home Health Value-Based Purchasing (HHVBP) Model; and updates to the home infusion therapy services payment rates for CY 2023.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 16, 2022.
In commenting, please refer to file code CMS-1766-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Brian Slater, (410) 786-5229, for home health and home infusion therapy payment inquiries.
For general information about home infusion payment, send your inquiry via email to
For general information about the Home Health Prospective Payment System (HH PPS), send your inquiry via email to
For information about the Home Health Quality Reporting Program (HH QRP), send your inquiry via email to
For more information about the expanded Home Health Value-Based Purchasing Model, please visit the Expanded HHVBP Model web page at
As required under section 1895(b) of the Social Security Act (the Act), this proposed rule would update the payment rates for HHAs for CY 2023. In addition, the rule would: recalibrate the case-mix weights under section 1895(b)(4)(A)(i) and (b)(4)(B) of the Act for 30-day periods of care in CY 2023; determine the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate expenditures for CYs 2020-2021 in accordance with section 1895(b)(3)(D)(i) of the Act; propose a permanent payment adjustment to the CY 2023 30-day payment rate and solicit comments on a temporary payment adjustment to the 30-day payment rate in accordance with section 1895(b)(3)(D)(ii) and (iii) of the Act; update the LUPA thresholds, functional impairment levels, and comorbidity subgroups for CY 2023; and update the CY 2023 fixed-dollar loss ratio (FDL) for outlier payments (so that outlier payments as a percentage of estimated total payments are not to exceed 2.5 percent, as required by section 1895(b)(5)(A) of the Act). This proposed rule also includes a solicitation of comments on the collection of data on the use of telecommunications technology on home health claims.
This proposed rule proposes to end the suspension of the collection of Outcome and Assessment Information Set (OASIS) data on non-Medicare and non-Medicaid patients under section 704 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and to require HHAs to report all-payer OASIS data for purposes of the HH QRP, beginning with the CY 2025 program year. We are proposing to amend the regulatory text to make a technical change that consolidates the statutory references to data submission. We also propose to codify in our regulations the factors we adopted in the CY 2019 HH PPS final rule as the factors we will consider when determining whether to remove measures from the HH QRP measure set. Finally, we are requesting feedback on a Request for Information on Health Equity in the HH QRP.
In accordance with the statutory authority at section 1115A of the Act, we are proposing updated policies, new definitions and modifying existing definitions, and conforming regulation text changes for the expanded Home Health Value-Based Purchasing (HHVBP) expanded Model and requesting comment on a potential future approach to health equity in the expanded HHVBP Model.
This proposed rule discusses updates to the home infusion therapy services payment rates for CY 2023 under section 1834(u) of the Act.
In section II.B.1. of this proposed rule, we provide monitoring and data analysis on PDGM utilization for CYs 2020 and 2021. In section II.B.2. of this rule, we propose payment adjustments to reflect the impact of differences between assumed behavior changes and actual behavior changes on estimated aggregate payment expenditures under the HH PPS. In section II.B.3 of this rule, we discuss the proposal to reassign certain ICD-10-CM codes related to the PDGM clinical groups and comorbidity subgroups.
In section II.B.4. of this rule, we are proposing the recalibration of the PDGM case-mix weights, LUPA thresholds, functional levels, and comorbidity adjustment subgroups for CY 2023.
In section II.B.5. of this rule, we propose to update the home health wage index, the CY 2023 national, standardized 30-day period payment rates and the CY 2023 national per-visit payment amounts by the home health payment update percentage. The proposed home health payment update percentage for CY 2023 would be 2.9 percent. This rule also proposes a permanent 5-percent cap on HHA's applicable wage index reductions from their wage index from the prior year, regardless of the circumstances causing the decline. Additionally, this rule proposes the FDL ratio to ensure that aggregate outlier payments do not exceed 2.5 percent of the total aggregate payments, as required by section 1895(b)(5)(A) of the Act.
In section II.B.6. of this proposed rule, we include a comment solicitation on the collection of data on the use of telecommunications technology on home health claims.
In section III.D. of this proposed rule, we are proposing to end the temporary suspension of non-Medicare/non-Medicaid data under section 704 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and, in accordance with section 1895(b)(3)(B)(v) of the Act, to require HHAs to report all-payer OASIS data for purposes of the HH QRP, beginning with the CY 2025 program year. In section III.E. of this rule, we are proposing technical changes in § 484.245(b)(1). In section III.F. of this rule, we are proposing to codify in our regulations the factors we adopted in the CY 2019 HH PPS final rule as the factors we will consider when determining whether to remove measures from the HH QRP measure set. Lastly, in section III.G. of this rule, we are requesting feedback on a Request for Information on Health Equity in the HH QRP.
In section IV. of this proposed rule, we are proposing to change the HHA baseline year to CY 2022 for all HHAs that were certified prior to January 1, 2022 starting in the CY 2023 performance year. We would make conforming regulation text changes at § 484.350(b) and (c). We are also proposing to amend the Model baseline year from CY 2019 to CY 2022 starting in the CY 2023 performance year to enable CMS to measure competing HHAs performance on benchmarks and achievement thresholds that are more current. We are making conforming amendments to definitions in § 484.345. In section IV.C. of this proposed rule, we have included an RFI related to a potential future approach to health equity in the expanded HHVBP Model.
In section V. of this proposed rule, we discuss updates to the home infusion therapy services payment rates for CY 2023, under section 1834(u) of the Act.
The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their digital health information.
To further interoperability in post-acute care settings, CMS and the Office of the National Coordinator for Health Information Technology (ONC) participate in the Post-Acute Care Interoperability Workgroup (PACIO) to facilitate collaboration with industry stakeholders to develop Health Level Seven International® (HL7) Fast Healthcare Interoperability Resources® (FHIR) standards.
The CMS Data Element Library (DEL) continues to be updated and serves as a resource for PAC assessment data elements and their associated mappings to health IT standards, such as Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS' goal of data standardization and interoperability. Standards in the DEL (
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted December 13, 2016) required HHS and ONC to take steps to further
We invite readers to learn more about these important developments and how they are likely to affect HHAs.
Section 1895(b)(1) of the Act requires the Secretary to establish a Home Health Prospective Payment System (HH PPS) for all costs of home health services paid under Medicare. Section 1895(b)(2) of the Act requires that, in defining a prospective payment amount, the Secretary will consider an appropriate unit of service and the number, type, and duration of visits provided within that unit, potential changes in the mix of services provided within that unit and their cost, and a general system design that provides for continued access to quality services. In accordance with the statute, as amended by the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted August 5, 1997), we published a final rule in the July 3, 2000
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) to the Act, requiring home health agencies (HHAs) to submit data for purposes of measuring health care quality, and linking the quality data submission to the annual applicable payment percentage increase. This data submission requirement is applicable for CY 2007 and each subsequent year. If an HHA does not submit quality data, the home health market basket percentage increase is reduced by 2 percentage points. In the November 9, 2006
Section 51001(a)(1)(B) of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123) amended section 1895(b) of the Act to require a change to the home health unit of payment to 30-day periods beginning January 1, 2020. Section 51001(a)(2)(A) of the BBA of 2018 added a new subclause (iv) under section 1895(b)(3)(A) of the Act, requiring the Secretary to calculate a standard prospective payment amount (or amounts) for 30-day units of service furnished that end during the 12-month period beginning January 1, 2020, in a budget neutral manner, such that estimated aggregate expenditures under the HH PPS during CY 2020 are equal to the estimated aggregate expenditures that otherwise would have been made under the HH PPS during CY 2020 in the absence of the change to a 30-day unit of service. Section 1895(b)(3)(A)(iv) of the Act requires that the calculation of the standard prospective payment amount (or amounts) for CY 2020 be made before the application of the annual update to the standard prospective payment amount as required by section 1895(b)(3)(B) of the Act.
Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in calculating the standard prospective payment amount (or amounts), the Secretary must make assumptions about behavior changes that could occur as a result of the implementation of the 30-day unit of service under section 1895(b)(2)(B) of the Act and case-mix adjustment factors established under section 1895(b)(4)(B) of the Act. Section 1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide a description of the behavior assumptions made in notice and comment rulemaking. CMS finalized these behavior assumptions in the CY 2019 HH PPS final rule with comment period (83 FR 56461).
Section 51001(a)(2)(B) of the BBA of 2018 also added a new subparagraph (D) to section 1895(b)(3) of the Act. Section 1895(b)(3)(D)(i) of the Act requires the Secretary to annually determine the impact of differences between assumed behavior changes, as described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior changes on estimated aggregate expenditures under the HH PPS with respect to years beginning with 2020 and ending with 2026. Section 1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a manner determined appropriate, through notice and comment rulemaking, to provide for one or more permanent increases or decreases to the standard prospective payment amount (or amounts) for applicable years, on a prospective basis, to offset for such increases or decreases in estimated aggregate expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the Act requires the Secretary, at a time and in a manner determined appropriate, through notice and comment rulemaking, to provide for one or more temporary increases or decreases to the payment amount for a unit of home
For home health periods of care beginning on or after January 1, 2020, Medicare makes payment under the HH PPS on the basis of a national, standardized 30-day period payment rate that is adjusted for case-mix and area wage differences in accordance with section 51001(a)(1)(B) of the BBA of 2018. The national, standardized 30-day period payment rate includes payment for the six home health disciplines (skilled nursing, home health aide, physical therapy, speech-language pathology, occupational therapy, and medical social services). Payment for non-routine supplies (NRS) is also part of the national, standardized 30-day period rate. Durable medical equipment (DME) provided as a home health service, as defined in section 1861(m) of the Act, is paid the fee schedule amount or is paid through the competitive bidding program and such payment is not included in the national, standardized 30-day period payment amount. Additionally, the 30-day period payment rate does not include payment for certain injectable osteoporosis drugs and negative pressure wound therapy (NPWT) using a disposable device, but such drug and services must be billed by the HHA while a patient is under a home health plan of care, as the law requires consolidated billing of osteoporosis drugs and NPWT using a disposable device.
To better align payment with patient care needs and to better ensure that clinically complex and ill beneficiaries have adequate access to home health care, in the CY 2019 HH PPS final rule with comment period (83 FR 56406), we finalized case-mix methodology refinements through the Patient-Driven Groupings Model (PDGM) for home health periods of care beginning on or after January 1, 2020. The PDGM did not change eligibility or coverage criteria for Medicare home health services, and as long as the individual meets the criteria for home health services as described at 42 CFR 409.42, the individual can receive Medicare home health services, including therapy services. For more information about the role of therapy services under the PDGM, we refer readers to the Medicare Learning Network (MLN) Matters article SE2000 available at
Under this case-mix methodology, case-mix weights are generated for each of the different PDGM payment groups by regressing resource use for each of the five categories (admission source, timing, clinical grouping, functional impairment level, and comorbidity adjustment) using a fixed effects model. A detailed description of each of the case-mix variables under the PDGM have been described previously, and we refer readers to the CY 2021 HH PPS final rule (85 FR 70303 through 70305).
CMS routinely analyzes Medicare home health benefit utilization, including but not limited to, overall total 30-day periods of care and average periods of care per HHA user; distribution of the type of visits in a 30-day period of care; the percentage of periods that receive the LUPA; estimated costs; the percentage of 30-day periods of care by clinical group, comorbidity adjustment, admission source, timing, and functional impairment level; GG items by response type; and the proportion of 30-day periods of care with and without any therapy visits, nursing visits, and/or aide/social worker visits. For the monitoring included in this rule, we examine simulated CY 2018 and CY 2019 data and actual CY 2020 and CY 2021 data for 30-day periods of care. We provide interpretation of results for CY 2020 and CY 2021. We refer readers to the CY 2022 HH PPS final rule (86 FR 35881) for discussion about simulated data for CYs 2018 and 2019.
Table B2 shows the overall utilization of home health and Table B3 shows the average utilization of visits per 30-day period of care by home health discipline. This data indicates the average number of 30-day periods of care per unique HHA user is similar per 30-day period of care between CY 2020 and CY 2021. Table B3 shows utilization of visits per 30-day period of care by home health discipline over time. The data indicates that the number of 30-day periods of care decreased between CY 2018 and CY 2021. Table B4 shows the proportion of 30-day periods of care that are LUPAs and the average number of visits per discipline of those LUPA 30-day periods of care over time.
In the CY 2020 HH PPS final rule with comment period (84 FR 60483), we provided a summary of analysis on FY 2017 HHA cost report data and how such data, if used, would impact our estimate of the percentage difference between the CY 2020 30-day payment amount and estimated, average HHA costs for a 30-day period of care. In that rule, we utilized FY 2017 cost reports and CY 2017 home health claims to estimate the costs of both 60-day episodes of care and 30-day periods of care. We then updated the estimated CY 2017 60-day episode costs and 30-day period of care costs by the home health market basket update, reduced by the productivity adjustment for CYs 2018, 2019, and 2020 to calculate the 2020 estimated 60-day episode costs and 30-day period of care costs. As stated in the CY 2020 HH PPS final rule with comment period (84 FR 60485), we estimated that the CY 2020 30-day payment amount was approximately 16 percent higher than the average costs for a 30-day period of care. In MedPAC's March 2020 Report to Congress,
In this proposed rule, we examined 2020 HHA Medicare cost reports, as this is the most recent and complete cost report data at the time of rulemaking, and CY 2021 home health claims, to estimate 30-day period of care costs. We excluded LUPAs and PEPs in the average number of visits. The 2020 average NRS costs per visit is $4.53. To update the estimated 30-day period of care costs, we begin with the 2020 average costs per visit with NRS for each discipline and multiply that amount by the CY 2021 home health payment update percentage of 2.0 percent. That amount for each discipline is then multiplied by the 2021 average number of visits by discipline to determine the 2021 Estimated 30-day Period Costs. Table B5 shows the estimated average costs for 30-day periods of care by discipline with NRS and the total 30-day period of care costs with NRS for CY 2021.
The CY 2021 national, standardized 30-day period payment rate was $1,901.12, which is approximately 34 percent more than the estimated CY 2021 30-day period average facility cost of $1,420.35. Note that in the CY 2020 HH PPS final rule with comment period (84 FR 60484), the average number of visits for a 30-day period of care in 2017 was estimated to be 10.5 visits for non-LUPA, non-PEP 30-day periods of care. Using actual CY 2021 claims data, the average number of visits in a non-LUPA-non-PEP 30-day period of care was 8.81 visits—a decrease of approximately 16 percent. We recognize that with the COVID-19 public health emergency (PHE), the 2020 data on the Medicare cost reports may not reflect the most recent changes such as increased telecommunications technology costs, increased personal protective equipment (PPE) costs, and hazard pay. In its March 2022 Report to Congress, MedPAC assumed a cost growth of 3.47 percent for both CY 2021 and CY 2027.
Each 30-day period of care is grouped into one of 12 clinical groups, which describe the primary reason for which a patient is receiving home health services under the Medicare home health benefit. The clinical grouping is based on the principal diagnosis reported on the home health claim. Table B6 shows the distribution of the 12 clinical groups over time.
Thirty-day periods of care will receive a comorbidity adjustment category based on the presence of certain secondary diagnoses reported on home health claims. These diagnoses are based on a home health specific list of clinically and statistically significant secondary diagnosis subgroups with similar resource use. We refer readers to section II.B.4.c. of this proposed rule and the CY 2020 final rule with comment period (84 FR 60493) for further information on the comorbidity adjustment categories. Home health 30-day periods of care can receive a low or a high comorbidity adjustment, or no comorbidity adjustment. Table B7 shows the distribution of 30-day periods of care by comorbidity adjustment category for all 30-day periods.
Each 30-day period of care is classified into one of two admission source categories—community or institutional—depending on what healthcare setting was utilized in the 14 days prior to receiving home health care. Thirty-day periods of care for beneficiaries with any inpatient acute care hospitalizations, inpatient psychiatric facility (IPF) stays, skilled nursing facility (SNF) stays, inpatient rehabilitation facility (IRF) stays, or long-term care hospital (LTCH) stays within 14-days prior to a home health admission will be designated as institutional admissions. The institutional admission source category will also include patients that had an acute care hospital stay during a previous 30-day period of care and within 14 days prior to the subsequent, contiguous 30-day period of care and for which the patient was not discharged from home health and readmitted.
Thirty-day periods of care are classified as “early” or “late” depending
Each 30-day period of care is placed into one of three functional impairment levels (low, medium, or high) based on responses to certain OASIS functional items associated with grooming, bathing, dressing, ambulating, transferring, and risk for hospitalization. The specific OASIS items that are used for the functional impairment level are found in Table B7 in the CY 2020 HH PPS final rule with comment period (84 FR 60490). Responses to these OASIS items are grouped together into response categories with similar resource use and each response category has associated points. A more detailed description as to how these response categories were established can be found in the technical report, “Overview of the Home Health Groupings Model” posted on the HHA web page.
The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185, enacted on October 6, 2014) amended Title XVIII of the Act to include new data reporting requirements for certain post-acute care (PAC) providers, such as HHAs. Section 1899B(b)(1)(A) of the Act requires that HHAs report standardized patient assessment data beginning no later than January 1, 2019. Since the standardized patient assessment data categories included functional status, such as mobility and self-care at admission and discharge, in accordance with section 1899B(b)(1)(B)(i) of the Act, CMS finalized adding the functional items, Section GG, “Functional Abilities and Goals”, to the OASIS data set, effective January 1, 2019, in order to measure functional status across PAC providers. However, for payment purposes under the PDGM, CMS did not have the data to determine the effect, if any, of these newly added items on resource costs during a home health period of care. Therefore, the GG functional items are not currently used to determine the functional impairment level under the PDGM. CMS continues to use the M1800-1860 items to determine functional impairment level for case-mix purposes. As such, the purpose of the following analysis is to explore the relationship between the M1800-1860 items used in the PDGM and the analogous GG items. The analysis of the M1800 functional items and the analogous GG items shows there was a small decline in the percentage of individuals who were associated with the “most independent” responses with a large percentage of the responses using the “Activity not Attempted” (ANA) response option. If the activity was not attempted, there are various codes that explain the reason for this response, such as “Not attempted due to medical or safety concerns,” and “Not applicable.”
To conduct this analysis, we reviewed OASIS data from January 1, 2019, to December 31, 2021, that was linked to 30-day home health periods. Responses for each of the M1800 functional items used in the PDGM functional scores were compared to the responses of the analogous GG items. There is a correlation between the current responses to the M1800-1860 items and the GG items; however, certain information in the M1800 items is collected at follow—up, but is not collected at follow-up for the GG items (for example, the M1800 items associated with upper and lower body dressing are collected at follow up, but the analogous GG item is not collected at follow-up). Additionally, ongoing analysis of the GG items shows a significant amount of ANA responses, making it difficult to map to the corresponding M1800-1860 item responses. Figure B2 demonstrates the frequencies by response type in CY 2021 of the OASIS GG items.
Beginning in CY 2020, section 1895(b)(4)(B)(ii) of the Act eliminated the use of therapy thresholds in calculating payments for CY 2020 and subsequent years. Prior to implementation of the PDGM, HHAs could receive an adjustment to payment based on the number of therapy visits provided during a 60-day episode of care. We examined the proportion of actual 30-day periods of care with and without therapy visits. To be covered as skilled therapy, the services must require the skills of a qualified therapist (that is, physical therapy (PT), occupational therapy (OT), or speech-language pathology (SLP)) or qualified therapist assistant and must be reasonable and necessary for the treatment of the patient's illness or injury.
Both Table B10 and Figure B3, as previously discussed, indicate there have been changes in the distribution of both therapy and non-therapy visits in CY 2021 compared to CY 2020. For example, the percent of 30-day periods with seven or less therapy visits during a 30-day period increased in CY 2021 compared to CY 2020.
In addition, we also examined the proportion of 30-day periods of care with and without skilled nursing, social work, or home health aide visits. Table B11 shows the number of 30-day periods of care with only skilled nursing visits, at least one skilled nursing visit and one other visit type (therapy or non-therapy), and no skilled nursing visits. Table B12 shows the number of 30-day periods of care with and without home health aide and/or social worker visits.
We will continue to monitor the provision of home health services, including any changes in the number and duration of home health visits, composition of the disciplines providing such services, and overall home health payments to determine if refinements to the case-mix adjustment methodology may be needed in the future.
As discussed in section II.A.1. of this rule, starting in CY 2020, the Secretary was statutorily required to change the unit of payment under the HH PPS from a 60-day episode of care to a 30-day period of care. CMS was also required to make assumptions about behavior changes that could occur as a result of the implementation of the 30-day unit of payment and the case-mix adjustment factors that eliminated the use of therapy thresholds, when calculating the standard prospective payment amount for CY 2020. In the CY 2019 HH PPS final rule with comment period (83 FR 56455), we finalized the following three behavior assumptions:
As described in the CY 2020 final rule with comment period (84 FR 60512), in order to calculate the CY 2020 budget neutral 30-day payment amounts both with and without behavior assumptions, we first calculated the total, aggregate amount of expenditures that would occur under the pre-PDGM case-mix adjustment methodology (60-day episodes under 153 case-mix groups). We then calculated what the 30-day payment amount would need to be set at in order for CMS to pay the same total expenditures in CY 2020 with the application of a 30-day unit of payment under the PDGM.
We initially determined a negative 8.39 percent behavior change adjustment to the base payment rate would be needed in order to ensure that the payment rate in CY 2020 would be budget neutral, as required by law. However, based on the comments received and reconsideration as to the frequency of the assumed behaviors during the first year of the transition to a new unit of payment and case-mix adjustment methodology, we finalized in the CY 2020 HH PPS final rule with comment period (84 FR 60519) a negative 4.36 percent behavior change assumption adjustment (“assumed behaviors”) in order to calculate the 30-day payment rate in a budget-neutral manner for CY 2020. After applying the wage index budget neutrality factor and the home health payment update, the CY 2020 30-day payment rate was set at $1,864.03.
Our data analysis in section II.B.1. of this proposed rule compares the 2018 simulated 30-day periods with behavior assumptions applied and actual 30-day periods. Specifically, Tables B4, B6, and B7 indicate that the three assumed behavior changes did occur as a result of the implementation of the PDGM. Additionally, this monitoring shows that other behaviors, such as changes in the provision of therapy and changes in functional impairment levels also occurred. Overall, the actual 30-day periods are similar to the simulated 30-day periods, which is supporting evidence that HHAs did make behavioral changes. However, we remind readers that by law we are required to ensure that estimated aggregate expenditures under the HH PPS during CY 2020 are equal to the estimated aggregate expenditures that otherwise would have been made under the HH PPS during CY 2020 in the absence of the change to a 30-day unit of payment. Regardless of the magnitude and frequency of individual behavior change (for example, LUPAs, therapy, etc.), the occurrence of any behavior change is captured by the methodology to determine the impact on aggregate expenditures.
We remind readers that in the CY 2020 HH PPS final rule (84 FR 60513), we stated that we interpret actual behavior changes to encompass both behavior changes that were previously outlined as assumed by CMS, and other behavior changes not identified at the
Each Health Insurance Prospective Payment System (HIPPS) code is assigned a case-mix weight and the case-mix weight determines the base payment of non-LUPA claims prior to any other adjustments (for example outlier). Prior to the PDGM, the first position of the HIPPS code was a numeric value that represented the interaction of episode timing and number of therapy visits (grouping step). The second, third, and fourth positions of the pre-PDGM HIPPS code reflected clinical severity, functional severity, and service utilization respectively. Therefore, to evaluate how the decrease in therapy visits related to payments, we compared the average case mix weights of CY 2018 actual 60-day episodes and CY 2021 simulated 60-day episodes. Prior to the PDGM, the average case-mix weight for CY 2018 60-day episodes was 1.0176. When we set therapy levels at the pre-PDGM (that is, CY 2018) level and kept the clinical and functional levels at the PDGM levels (that is, CY 2021) the average case-mix weight was 1.0389. After the PDGM, the average case-mix weight for CY 2021 simulated 60-day episodes was 0.9664. When we kept therapy levels at the PDGM (that is, CY 2021) level and set the clinical and functional levels at the pre-PDGM levels (that is, CY 2018) the average case-mix weight was 0.9361. By controlling for therapy levels, we were able to determine the change in 60-day episode case-mix weights were largely driven by therapy utilization. The decrease in therapy visits led to a decrease in case-mix weight, and therefore a decrease in aggregate expenditures under the pre-PDGM HH PPS.
As required by section 1895(b)(3)(D)(i) of the Act, CMS must annually determine the impact of differences between assumed and actual behavior changes on estimated aggregate expenditures under the HH PPS with respect to years beginning with 2020 and ending with 2026. Section 1895(b)(3)(D)(ii) and (iii) of the Act requires that CMS make permanent and temporary adjustments to the payment rate to offset for such increases or decreases in estimated aggregate expenditures through notice and comment rulemaking. Therefore, to evaluate the impact of assumed versus actual behavior changes for CYs 2020 through 2026, we developed a methodology that uses actual claims data for 30-day periods under the 432-group case-mix model (PDGM claims) to simulate 60-day episodes under the 153-group case-mix model (representing pre-PDGM HH PPS claims) in order to estimate what aggregate expenditures would have been in the absence of the PDGM. This methodology mirrors the initial approach used to calculate the CY 2020 30-day period payment amount for the PDGM, where we used a single year of claims data (that is, CY 2018 claims data for 60-day episodes of care under the 153-group case-mix model) and simulated payments for 30-day periods of care with the application of the PDGM case-mix adjustment methodology. We then compared actual aggregate expenditures under the existing system (that is, 60-day episodes of care under the 153-group case-mix model) to simulated payments under the PDGM for 30-day periods of care with assumed behavior changes, and used the difference between the two amounts to construct the budget neutrality factor. We described this methodology in the CY 2022 HH PPS proposed rule (86 FR 35889 through 35892). For determining the impact of the difference between assumed and actual behavior changes on overall expenditures for CY 2020 and CY 2021, we analyzed a single year of claims data (for example, CY 2020 claims data for 30-day periods of care under the 432-group PDGM case-mix model) and simulated payments for 60-day episodes of care under the 153-group case-mix model. We then compared the actual aggregate expenditures under the PDGM to what aggregate expenditures would have been pre-PDGM.
In the CY 2022 HH PPS proposed rule (86 FR 35892), we solicited comments on this approach (86 FR 35892). Commenters raised concerns about this methodology, most notably about the elimination of therapy thresholds, the onset of the COVID-19 PHE, interpretation of section 1895(b)(3)(D)(i) of the Act, the differing case-mix weight systems (153 vs 432 case-mix groups), and inappropriate data exclusions and assumptions when creating the simulated 60-day episodes.
Commenters stated that there has been a large decrease in therapy utilization since the implementation of the PDGM. Commenters stated several possible reasons for the decrease in therapy utilization, including that the PDGM resulted in significant differences in payment incentives. Specifically, commenters noted that HHAs could have received higher payments if certain therapy volume thresholds were met pre-PDGM; whereas that incentive no longer exists under the PDGM. Therefore, many commenters indicated the estimated aggregate expenditures calculated with simulated 60-day episodes (pre PDGM) is inaccurate because it does not control for the payment incentives which would have been present under the old system. However, we stated in the CY 2019 HH PPS final rule with comment period (83 FR 56481), that the PDGM is not limiting or prohibiting the provision of therapy services or the number of home health periods of care. In addition, we believe that regardless of the case-mix system in place, HHAs should continue to provide the most appropriate care to Medicare home health beneficiaries, in accordance with the home health CoP requirements at § 484.60.
While overall utilization may have decreased in the early months of CY 2020 due to the onset of the COVID-19 PHE, the methodology described in the CY 2022 HH PPS proposed rule used the same claims dataset (for example, CY 2020) to compare aggregate expenditures under the two payment systems. Any effect of the COVID-19 PHE is included in the estimated aggregate expenditures for both simulated 60-day episodes and actual 30-day periods, and therefore this methodology ensures that any differences between the two calculated amounts is not attributable to the COVID-19 PHE. In other words, any potential changes due to the COVID-19 PHE (for example, decreased utilization) in the 30-day periods would also be present in the simulated 60-day episodes, making the two datasets comparable.
However, we recognize that the COVID-19 PHE presented unique challenges for all healthcare settings, including HHAs. For example, we understand elective procedures were
Commenters stated that the statute requires CMS to analyze solely the differences between the three assumed behavior changes (clinical group coding, comorbidity coding, LUPA threshold) that were incorporated into the original CY 2020 rate setting and what the actual behavior change was for just those three assumptions. Commenters stated that any adjustments to the 30-day payment amount must be related to the impact of those three assumed behavior changes and the actual behavior changes for those same three assumptions on estimated aggregate expenditures; rather than other behavior changes that occurred that impacted aggregate expenditures. As such, commenters presented an alternative method that compares aggregate expenditures between the CY 2018 simulated 30-day periods with the three behavior assumptions applied to the CY 2020 actual 30-day periods. As we have stated previously in the CY 2020 HH PPS final rule with comment period and in the CY 2022 HH PPS final rule (84 FR 60513, 86 FR 62248), we interpret actual behavior changes to encompass both behavior changes that were previously outlined, as assumed by CMS, and other behavior changes not identified at the time that the budget neutral 30-day payment amount for CY 2020 was determined. We use claims data to calculate estimated aggregate expenditures under the HH PPS, regardless of methodology. All claims data are products of behavior changes, (whether or not acknowledged in previous rules), as well as interactions between behaviors. Therefore, any behavior changes observed under the PDGM are considered when determining an adjustment.
A few commenters also proposed determining the extent to which nominal case-mix changes affected aggregate expenditures under the PDGM versus the old payment system as an alternative methodology to evaluate the behavior change assumptions. In order to evaluate case-mix changes, CMS previously utilized a regression model that estimated whether changes in case-mix were due to changes in agency coding practices or other nominal factors, versus real changes in patient characteristics or acuity. While changes in nominal case-mix may be supplemental to our findings, the law requires CMS to determine the effect of the difference between assumed versus actual behavioral changes on estimated aggregate expenditures, which are not factored into our calculations of case-mix adjustment authority. Section 1895(b)(3)(B)(iv) of the Act states that CMS has the authority to adjust for case-mix changes that are a result of changes in the coding or classification of different units of services that do not reflect real changes in case mix. Therefore, at this time we do not believe analyses of nominal case-mix change is the most accurate method to evaluate what aggregate expenditures would have been in absence of the PDGM. Upon continued review of what the law requires us to do in regards to determining the difference between assumed versus actual behaviors on estimated aggregate expenditures, we continue to believe that the best reading of the law requires us to retrospectively determine if the 30-day payment amount in CY 2020 resulted in the same estimated aggregate expenditures that would have been made if the change in the unit of payment and the PDGM case-mix adjustment methodology had not been implemented.
Furthermore, if the estimated aggregate expenditures are determined not to be equal, we are required, by law, to make permanent and temporary adjustments to the PDGM payment rate so that the expenditures across the two payments systems would be equal. We believe using the methodology described previously in the CY 2022 HH PPS proposed rule (85 FR 35890 through 35892 and in this proposed rule, best satisfies our interpretation of section 1895(b)(3)(D)(i) of the Act.
Lastly, commenters raised concerns about the differing case-mix weight systems and that the data exclusions and assumptions made when creating the simulated 60-day episodes introduced some level of bias. Commenters stated that each case-mix system are unique to each payment system as they are dependent on the underlying variables used to describe clinical characteristics or resource use. For this reason, commenters had concerns that the two case-mix weight systems (153 vs 432 case-mix groups) are not comparable. We recognize that the underlying variables in the payment regression are different, but a case-mix of 1.0 is interpreted the same way under both systems. For example, a case-mix of 1.000 means the predicted resource use for a particular home health 60-day episode or 30-day period is equal to overall average resource use. Therefore, we disagree with commenters that comparing the two case-mix systems is flawed. We note there may be some selection bias present due to the data exclusions and assumptions described in section II.B.2.b. of this proposed rule, but we believe this is minimal and does not significantly affect the overall calculation of estimated aggregate expenditures. For example, when we dropped fewer claims we got approximately the same results. Therefore, if we did not exclude claims (for example, there was no linked OASIS data available in the CCW VRDC) or make assumptions about which two 30-day periods to combine, we would further introduce informational and analytical bias.
We reiterate that this methodology uses simulated 60-day episodes priced using the pre-PDGM payment system parameters to determine what the estimated aggregate expenditures would have been in the absence of the PDGM and a 30-day unit of payment. The resulting estimated aggregate expenditures from the pre-PDGM payment system are compared to actual aggregate expenditures from the PDGM 30-day periods to determine, if a permanent prospective adjustment and/or a temporary retrospective adjustment are needed to offset the difference in estimated aggregate expenditures. We propose to use this methodology, as described in this section of this rule, for CYs 2020 through 2026. We refer readers to sections II.B.2.d and II.B.2.e of this proposed rule for our preliminary results of our analysis for CYs 2020 and 2021, respectively.
We analyzed data to determine if the CY 2020 30-day payment amount resulted in the same estimated aggregate expenditures that would have been paid if the PDGM and change in the unit of payment had not been implemented. To evaluate if the 30-day budget neutral payment amount for CY 2020 maintained budget neutrality given the change to a 30-day unit of payment and the implementation of a new case-mix adjustment methodology without
The first step in repricing CY 2020 PDGM claims was to calculate estimated aggregate expenditures under the pre-PDGM, 153-group case-mix system and 60-day unit of payment, by determining which PDGM 30-day periods of care could be grouped together to form simulated 60-day episodes of care. To facilitate grouping, we made some exclusions and assumptions as described later in this section prior to pricing out the simulated 60-day episodes of care. We note in the early months of CY 2020, there were 60-day episodes which started in 2019 and ended in 2020 and therefore, some of these exclusions and assumptions may be specific to the first year of the PDGM. We identify, through footnotes, if an exclusion or assumption is specific to CY 2020 only. The following describes the steps in determining the annual estimated aggregate expenditures including the exclusions and assumptions made when simulating 60-day episodes from actual 30-day periods.
• Claims where the claim occurrence code 50 date (OASIS assessment date) occurred on or after October 31 of that year. This exclusion was applied to ensure the simulated 60-day episodes contained both 30-day periods from the same year and would not overlap into the following year (for example, 2021, 2022, 2023). This is done because any 30-day periods with an OASIS assessment date in November or December might be part of a simulated 60-day episode that would continue into the following year and where payment would have been made based on the “through” date. For CYs 2021 through 2026, we also excluded claims with an OASIS assessment date before January 1 of that year.
• Beneficiaries and all of their claims if they have overlapping claims from the same provider (as identified by CMS Certification Number (CCN)).
• Beneficiaries and all of their claims if three or more claims from the same provider are linked to the same occurrence code 50 date.
• If two 30-day periods of care from the same provider reference the same OASIS assessment date (using occurrence code 50), then we assume those two 30-day periods of care would have been billed as a 60-day episode of care under the 153-group system.
• If two 30 day-periods of care reference different OASIS assessment dates and each of those assessment dates is referenced by a single 30-day period of care, and those two 30-day periods of care occur together close in time (that is, the “from” date of the later 30-day period of care is between 0 to 14 days after the “through” date of the earlier 30-day period of care), then we assume those two 30-day periods of care also would have been billed as a 60-day episode of care under the 153-group system.
• For all other 30-day periods of care, we assume that they would not be combined with another 30-day period of care and would have been billed as a single 30-day period.
After application of the exclusions and assumptions described previously we have the simulated the 60-day episode datasets for each year. Starting with CY 2020, we assign each 60-day episode of care as a normal episode, PEP, LUPA, or outlier based on the payment parameters established in the CY 2020 final rule with comment period (84 FR 60478) for 60-day episodes of care. Next, using the October 2019 3M Home Health Grouper (v8219)
Next, we calculated the PDGM aggregate expenditures for CY 2020 using those specific 30-day periods that were used to create the simulated 60-day episodes. Therefore, both the actual CY 2020 PDGM expenditures and the simulated pre-PDGM CY 2020 aggregate expenditures are based on the same claims for the permanent adjustment calculation.
To offset for such increases or decreases in estimated aggregate expenditures as a result of the impact of differences between assumed behavior changes and actual behavior changes, in any given year, we calculate a permanent prospective adjustment by determining what the 30 day base payment amount should have been in order to achieve the same estimated aggregate expenditures as obtained from the simulated 60-day episodes. This would be our recalculated base payment rate. The percent change between the actual 30-day base payment rate and the recalculated 30-day base payment rate would be the permanent prospective adjustment.
To calculate a temporary retrospective adjustment for each year we would determine the dollar amount difference between the estimated aggregate expenditures from all 30-day periods using the recalculated 30-day base payment rate, and the aggregate expenditures for all 30-day periods using the actual 30-day base payment rate for the same year. In determining the temporary retrospective dollar
Using the methodology described previously, we simulated 60-day episodes using actual CY 2020 30-day periods to determine what the CY 2020 permanent and temporary payment adjustments should be to offset for such increases or decreases in estimated aggregate expenditures. For CY 2020, we began with 8,423,688 30-day periods and dropped 603,157 30-day periods that had a claim occurrence code 50 date after October 31, 2020. We also eliminated 79,328 30-day periods that didn't appear to group with another 30-day period to form a 60-day episode if the 30-day period had a “from date” before January 15, 2020 or a “through date” after November 30, 2020. This was done to ensure a 30-day period would not have been part of a 60-day episode that would have overlapped into CY 2021. Applying the additional exclusions and assumptions as described previously, an additional 14,062 30-day periods were excluded from this analysis. Additionally, we excluded 66,469 simulated 60-day episodes of care where no OASIS information was available in the CCW VRDC or could not be grouped to a HIPPS due to a missing primary diagnosis or other reason. Our simulated 60-day episodes of care produced a distribution of two 30-day periods of care (70.6 percent) and single 30-day periods of care (29.4 percent). This distribution is similar to what we found when we simulated 30-day periods of care for implementation of the PDGM. After all exclusions and assumptions were applied, the final dataset included 7,618,061 actual 30-day periods of care and 4,463,549 simulated 60-day episodes of care for CY 2020.
Using the final dataset for CY 2020 (7,618,061 actual 30-day periods which made up the 4,463,549 simulated 60-day episodes) we determined the estimated aggregate expenditures under the pre-PDGM HH PPS was lower than the actual estimated aggregate expenditures under the PDGM HH PPS (see Table B13). This indicates that aggregate expenditures under the PDGM were higher than if the 153-group payment system was still in place in CY 2020. As described previously, we recalculated what the CY 2020 30-day base payment rate should have been to equal aggregate expenditures that we calculated using the simulated CY 2020 60-day episodes. The percent change between the two payment rates would be the permanent adjustment. Next, we calculated the difference in aggregate expenditures for all CY 2020 PDGM 30-day claims using the actual and recalculated payment rates. This difference is the retrospective dollar amount needed to offset payment. Our results are shown in Table B13.
As shown in Table B13, a permanent prospective adjustment of −6.52 percent to the CY 2023 30-day payment rate would be required to offset for such increases in estimated aggregate expenditures in future years. Additionally, we determined that our initial estimate of base payment rates required to achieve budget neutrality resulted in excess expenditures of HHAs of approximately $873 million in CY 2020. This would require a temporary adjustment to offset for such increase in estimated aggregate expenditures for CY 2020.
We will continue the practice of using the most recent complete home health claims data at the time of rulemaking. The CY 2021 analysis presented in this proposed rule is considered preliminary and as more data become available from the latter half of CY 2021, we will update our results in the final rule. Using the methodology described previously, we simulated 60-day episodes using actual CY 2021 30-day periods to determine what the permanent and temporary payment adjustments should be to offset for such increases or decreases in estimated aggregate expenditures as a result of the impact of differences between assumed behavior changes and actual behavior changes. For CY 2021, we began with 8,962,690 30-day periods of care and dropped 478,105 30-day periods of care that had claim occurrence code 50 date after October 31, 2021. We also excluded 968,361 30-day periods of care that had claim occurrence code 50 date before January 1, 2021 to ensure the 30-day period would not be part of a simulated 60-day episode that began in
Additionally, we excluded 11,143 simulated 60-day episodes of care where no OASIS information was available in the CCW VRDC or could not be grouped to a HIPPS due to a missing primary diagnosis or other reason. Our simulated 60-day episodes of care produced a distribution of two 30-day periods of care (69.1 percent) and single 30-day periods of care (30.9 percent) that was similar to what we found when we simulated two 30-day periods of care for implementation of the PDGM. After all exclusions and assumptions were applied, the final dataset included 7,494,836 actual 30-day periods of care and 4,431,238 simulated 60-day episodes of care for CY 2021.
Using the final dataset for CY 2021 (7,494,836 actual 30-day periods which made up the 4,431,238 simulated 60-day episodes) we determined the estimated aggregate expenditures under the pre-PDGM HH PPS was lower than the actual estimated aggregate expenditures under the PDGM HH PPS. This indicates that aggregate expenditures under the PDGM were higher than if the 153-group payment system was still in place in CY 2021. As described previously, we recalculated what the CY 2021 30-day base payment rate should have been to equal aggregate expenditures that we calculated using the simulated CY 2021 60-day episodes. We note, the actual CY 2021 base payment rate of $1,901.12 does not account for any adjustments previously made for CY 2020 and therefore to evaluate changes for only CY 2021 we need to control for the −6.52 percent prospective adjustment that we determined for CY 2020. Therefore, using the recalculated CY 2020 base payment rate of $1,742.52, multiplied by the CY 2021 wage index budget neutrality factor (0.9999) and the CY 2021 HH payment update (1.020), the CY 2021 base payment rate for assumed behavior would have been $1,777.19. The percent change between the two payment rates would be the permanent adjustment. Next, we calculated the difference in aggregate expenditures for all CY 2021 PDGM 30-day claims using the actual and recalculated payment rates. This difference is the retrospective dollar amount needed to offset payment. Our results are shown in Table B14.
As shown in Table B14, a permanent prospective adjustment of −1.26 percent and would be required to offset for such increases in estimated aggregate expenditures in future years. Additionally, we determined that our initial estimate of base payment rates required to achieve budget neutrality resulted in excess expenditures of approximately $1.1 billion in CY 2021. This would require a one-time temporary adjustment factor to offset for such increases in estimated aggregate expenditures for CY 2021.
The percent change between the actual CY 2021 base payment rate of $1,901.12 and the CY 2021 recalculated base payment rate of $1,754.88 is the total permanent adjustment for CYs 2020 and 2021, because no previous adjustments were applied to the CY 2020 rate to reset the CY 2021 rate. The summation of the dollar amount for CYs 2020 and 2021 is the amount that represents the temporary payment adjustment to offset for increased aggregate expenditures in both CYs 2020 and 2021. Our results are shown in Table B15 and B16.
To offset the increase in estimated aggregate expenditures for CYs 2020 and 2021 based on the impact of the differences between assumed and actual behavior changes, CMS would need to apply a −7.69 percent permanent adjustment to the CY 2023 base payment rate as well as implement a temporary adjustment of approximately $2.0 billion to reconcile retrospective overpayments in CYs 2020 and 2021. We recognize that applying the full permanent and temporary adjustment immediately would result in a significant negative adjustment in a single year. However, if the PDGM base 30-day payment rate remains higher than it should be, then there would likely be a compounding effect potentially creating the need for a larger reduction in future years. Therefore, we propose initially to apply only the permanent adjustment of −7.69 percent to the CY 2023 base payment rate. We believe this could mitigate the need for a larger permanent adjustment and could reduce the amount of any additional temporary adjustments in future years. We are soliciting comments on the application of only the permanent payment adjustment to the CY 2023 30-day payment rate. Additionally, we solicit comments on how best to collect the temporary payment adjustment of approximately $2.0 billion for CYs 2020 and 2021. As noted previously, we will update these permanent and temporary adjustments in the final rule to reflect more complete claims data for CY 2021.
3. Proposed Reassignment of Specific ICD-10-CM Codes Under the PDGM
The 2009 final rule, “HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS”
Although it is not our intent to review all ICD-10-CM diagnosis codes each year, we recognize that occasionally some ICD-10-CM diagnosis codes may require changes to their assigned clinical group and/or comorbidity subgroup. For example, there may be an update to the MCE unacceptable principal diagnosis list, or we receive public comments from interested parties requesting specific changes. Any addition or removal of a specific diagnosis code to the ICD-10-CM code set (for example, three new diagnosis codes, Z28.310, Z28.311 and Z28.39, for
We rely on the expert opinion of our clinical reviewers (for example, nurse consultants and medical officers) and current ICD-10-CM coding guidelines to determine if the ICD-10-CM diagnosis codes under review for reassignment are significantly similar or different to the existing clinical group and/or comorbidity subgroup assignment. As we stated in the CY 2018 proposed rule (82 FR 35313), the intent of the clinical groups is to reflect the reported principal diagnosis, clinical relevance, and coding guidelines and conventions. Therefore, for the purposes of assignment of ICD-10-CM diagnosis codes into the PDGM clinical groups we would not conduct additional statistical analysis as such decisions are clinically based and the clinical groups are part of the overall case-mix weights.
In the CY 2019 final rule with comment period (83 FR 56486), we stated the home health-specific comorbidity list is based on the principles of patient assessment by body systems and their associated diseases, conditions, and injuries to develop larger categories of conditions that identified clinically relevant relationships associated with increased resource use meaning the diagnoses have at least as high as the median resource use and are reported in more than 0.1 percent of 30-day periods of care. If specific ICD-10-CM diagnosis codes are to be reassigned to a different comorbidity subgroup (including NA), we will first evaluate the clinical characteristics (as discussed previously for clinical groups) and if the ICD-10-CM diagnosis code does not meet the clinical criteria, then no reassignment will occur. However, if an ICD-10-CM diagnosis code does meet the clinical criteria for a comorbidity subgroup reassignment, then we will evaluate the resource consumption associated with the ICD-10-CM diagnosis codes, the current assigned comorbidity subgroup, and the proposed (reassigned) comorbidity subgroup. This analysis is to ensure that any reassignment of an ICD-10-CM diagnosis code (if reported as secondary) in any given year would not significantly alter the overall resource use of a specific comorbidity subgroup. For resource consumption, we use non-LUPA 30-day periods to evaluate the total number of 30-day periods for the comorbidity subgroup(s) and the ICD-10-CM diagnosis code, the average number of visits per 30-day periods for the comorbidity subgroup(s) and the ICD-10-CM diagnosis code, and the average resource use for the comorbidity subgroup(s) and the ICD-10-CM diagnosis code. The average resource use measures the costs associated with visits performed during a home health period, and was previously described in the CY 2019 final rule with comment period (83 FR 56450).
The following section proposes reassignment of 320 diagnosis codes to a different clinical group when listed as a principal diagnosis, reassignment of 37 diagnosis codes to a different comorbidity subgroup when listed as a secondary diagnosis, and the establishment of a new comorbidity subgroup for certain neurological conditions and disorders. Due to the amount of diagnosis codes proposed for reassignment this year, we have posted the “CY 2023 Proposed Reassignment of ICD-10-CM Diagnosis Codes for HH PDGM Clinical Groups and Comorbidity Subgroups” supplemental file on the Home Health Prospective Payment System Regulations and Notices web page.
We remind readers that in the CY 2019 final rule with comment period (83 FR 56473) we stated that whenever possible, the most specific code that describes a medical disease, condition, or injury should be used. Generally, “unspecified” codes are used when there is lack of information about location or severity of medical conditions in the medical record. However, we would expect a provider to use a precise code whenever more specific codes are available. Furthermore, if additional information regarding the diagnosis is needed, we would expect the HHA to follow-up with the referring provider in order to ensure the care plan is sufficient in
We also determined that B78.9 strongyloidiasis, unspecified was assigned to clinical group C (Wounds), and should be reassigned to clinical group K (MMTA—Infectious Disease, Neoplasms, and Blood-Forming Diseases) because it would be consistent with the assignment of the other strongyloidiasis codes. We also identified that N83.201 unspecified ovarian cyst, right side was assigned to clinical group A (MMTA-Other) and should be reassigned to clinical group J (MMTA—Gastrointestinal Tract and Genitourinary System) because it would be consistent with the assignment of other ovarian cyst codes. We propose to reassign these two ICD-10-CM diagnosis codes' clinical groups as shown in Table B17.
We identified that certain groups of gout-related ICD-10-CM diagnosis codes, such as idiopathic gout and drug-induced gout, were assigned to clinical group E (musculoskeletal rehabilitation) when listed as a principal diagnosis. However, other groups of gout related ICD-10-CM diagnosis codes, such as gout due to renal impairment, were assigned to “no clinical group” (NA). Therefore, we reviewed all gout-related codes and determined there are 144 gout related codes with an anatomical site specified, not currently assigned to a clinical group that should be moved to clinical group E (musculoskeletal rehabilitation) for consistency with the aforementioned gout codes. In the ICD-10-CM code set, gout codes and osteoarthritis codes are found in chapter 13 Diseases of the Musculoskeletal System and Connective Tissue (M00-M99). Gout and osteoarthritis affect similar joints such as the fingers, toes, and knees and they can initially be treated with medications. However, generally, as a part of a treatment program, once the initial inflammation is reduced, physical therapy can be started to stretch and strengthen the affected joint to restore flexibility and joint function. Because those cases may require therapy, we believe gout codes are more appropriately placed into MS rehab along with other codes affecting the musculoskeletal system. We refer readers to Table 1.B of the CY 2023 Proposed Reassignment of ICD-10-CM Diagnosis Codes supplemental file for the list of the 144 gout related codes. We propose to reassign these 144 gout-related ICD-10-CM diagnosis codes to clinical group E (musculoskeletal rehabilitation).
We identified 12 ICD-10-CM diagnosis codes related to crushing injury of the face, skull, and head that warrant reassignment. These codes are listed in Table B18.
Our clinical advisors reviewed the 12 ICD-10-CM diagnosis codes related to crushing injury of the face, skull, and head and determined that reassignment of these codes to clinical group B (Neurological Rehabilitation) is clinically appropriate because they are consistent with other diagnosis codes in clinical group E that describe injuries requiring neurological rehabilitation. Therefore, we propose to reassign the ICD-10-CM diagnosis codes listed in Table B18 from clinical group A (MMTA-Other) to clinical group B (Neurological Rehabilitation).
We received questions from interested parties regarding three lymphedema codes with conflicting clinical group assignments when listed as a principal diagnosis. These codes are listed in Table B19.
Our clinical advisors reviewed the three ICD-10-CM diagnosis codes related to lymphedema and determined that assessing and treating lymphedema is similar to the assessment and staging of wounds. It requires the assessment of pulses, evaluation of the color and amount of drainage, and measurement. In addition, some lymphedema can require compression bandaging, similar to wound care. Because of these similarities, we determined the reassignment of the three ICD-10-CM diagnosis codes related to lymphedema to clinical group C (Wounds) is clinically appropriate. Therefore, we propose to reassign the ICD-10-CM diagnosis codes listed in Table B19 from clinical group E (Musculoskeletal Rehabilitation) and clinical group A (MMTA-Other) to clinical group C (Wounds).
Our clinical advisors reviewed the ICD-10-CM diagnosis code F60.5
We reviewed Q82.0 (hereditary lymphedema) for clinical group reassignment, as described in section II.B.3.4. of this rule. During this review, we discovered Q82.0 is not currently assigned to a comorbidity subgroup when listed as a secondary diagnosis. The comorbidity subgroup circulatory 10 includes ICD-10-CM diagnosis codes related to varicose veins and lymphedema and our clinical advisors determined that Q82.0 should be assigned to the comorbidity subgroup circulatory 10 similar to other lymphedema diagnosis codes. In addition, we evaluated resource consumption related to the comorbidity subgroup circulatory 10 and Q82.0 and found no significant variations negating a reassignment. Therefore, we propose to assign diagnosis code Q82.0 to circulatory 10 (varicose veins and lymphedema) when listed as a secondary diagnosis.
In response to interested parties' questions regarding upper respiratory malignant neoplasms, we reviewed 14 ICD-10-CM diagnosis codes related to malignant neoplasms of the upper respiratory tract currently assigned to the comorbidity subgroup neoplasm 6 (malignant neoplasms of trachea, bronchus, lung, and mediastinum). These 14 codes are listed in Table B20.
Our clinical advisors reviewed the codes listed in Table B20 and determined that C32.3, C32.8, and C32.9 are currently assigned to the most clinically appropriate neoplasm comorbidity subgroup (neoplasm 6), and therefore no further analysis was conducted for these three ICD-10 CM diagnosis codes. However, upon review of all the neoplasm comorbidity subgroups, they determined that the remaining 11 codes listed in Table B20 should be reassigned to neoplasm 1 (malignant neoplasms of lip, oral cavity, and pharynx, including head and neck
Therefore, we propose to reassign diagnosis codes C30.0, C30.1, C31.0, C31.1, C31.2, C31.3, C31.8, C31.9, C32.0, C32.1, or C32.2 from neoplasm 6 to neoplasm 1 when listed as a secondary diagnosis.
While reviewing unspecified codes for a change in clinical group, we noticed that ICD-10-CM diagnosis codes C74.00 (malignant neoplasm of cortex of unspecified adrenal gland) and C74.90 (malignant neoplasm of unspecified part of unspecified adrenal gland) were coded as “N/A” instead of placed in a comorbidity subgroup. The comorbidity subgroup neoplasm 15 currently includes ICD-10-CM diagnosis codes related to malignant neoplasm of adrenal gland, endocrine glands and related structures; specifically, C74.10 (malignant neoplasm of medulla of unspecified adrenal gland). At this time, we believe that C74.00 and C74.90 should be reassigned to neoplasm 15 based on clinical similarities of other codes currently assigned. In addition, we evaluated resource consumption related to the comorbidity subgroup neoplasm 15, as well as diagnosis codes C74.00, and C74.90 and found no significant variations negating a reassignment. Therefore, we propose to reassign diagnosis codes C74.00 and C74.90 from “NA” to neoplasm 15 (malignant neoplasm of adrenal gland, endocrine glands and related structures) when listed as secondary diagnoses.
In response to a comment received, we discussed in the CY 2022 final rule (86 FR 62263, 62264) our review of ICD-10-CM diagnosis codes related to specified neuropathy or unspecified polyneuropathy. These include specific ICD-10-CM G-codes. We stated that the codes were assigned to the most clinically appropriate subgroup at the time. However, upon further clinical review we believe a new neurological comorbidity subgroup to include ICD-10-CM diagnosis codes related to nondiabetic neuropathy is warranted. We identified 18 ICD-10-CM diagnosis codes for potential reassignment to a proposed new comorbidity subgroup, neurological 12. We refer readers to Table 1.C of the CY 2023 Proposed Reassignment of ICD-10-CM Diagnosis Codes supplemental file for a list of the G-codes related to specified neuropathy or unspecified polyneuropathy. Of the 18 codes, 11 diagnosis codes were not currently assigned a comorbidity group and seven diagnosis codes were assigned to neurological 11 comorbidity subgroup.
Using claims data from the CY 2021 HH PPS analytical file, we identified that the 18 diagnosis G-codes related to specified neuropathy or unspecified polyneuropathy would have sufficient claims (>400,000) for a new comorbidity subgroup. The removal of the seven codes from the neurological 11 comorbidity subgroup, would still allow for sufficient claims (>250,000) and include the remaining 146 diagnosis codes currently listed in the neurological 11 comorbidity subgroup. We evaluated resource consumption related to the comorbidity subgroup neurological 11, the 18 diagnosis G-codes, and the proposed comorbidity subgroup neurological 12 and found no significant variations negating a reassignment. A new neurological comorbidity subgroup allows more clinically similar codes, nondiabetic neuropathy, to be grouped together. Therefore, we propose to reassign the 18 diagnosis codes listed in Table 1.C of the CY 2023 Proposed Reassignment of ICD-10 CM Diagnosis Codes supplemental file, to the new comorbidity subgroup neurological 12 (nondiabetic neuropathy) when listed as secondary diagnoses. In conjunction with the proposed new comorbidity subgroup, we propose to change the description of the current comorbidity subgroup, neurological 11, from “Diabetic Retinopathy and Macular Edema” to “Disease of the Macula and Blindness/Low Vision”.
Our clinical advisors reviewed the ICD-10-CM diagnosis code J18.2 (hypostatic pneumonia, unspecified organism) which is currently assigned to the comorbidity subgroup respiratory 4 (bronchitis, emphysema, and interstitial lung disease). However, respiratory 2 (whooping cough and pneumonia) contains other pneumonia with unspecified organism (for example, J18.1 and J18.8). Clinically, J18.2 is similar to the other pneumonias in respiratory 2 and therefore, should be reassigned from comorbidity subgroup respiratory 4 to comorbidity subgroup respiratory 2. In addition, we evaluated resource consumption related to the comorbidity subgroups respiratory 2 and respiratory 4, and J18.2 and found no significant variations negating a reassignment.
Therefore, we propose to reassign diagnosis code J18.2 (hypostatic pneumonia, unspecified organism) to respiratory 2 when listed as a secondary diagnosis.
Our clinical advisors reviewed the ICD-10-CM diagnosis codes J98.2, interstitial emphysema and J98.3, compensatory emphysema, which are currently assigned to the comorbidity subgroup respiratory 9 (respiratory failure and atelectasis). However, respiratory 4 (bronchitis, emphysema, and interstitial lung disease) contains other emphysema codes (for example, J43.0 through J43.9) and therefore clinically we believe it is appropriate to reassign J98.2 and J98.3 to the comorbidity subgroup respiratory 9. In addition, we evaluated resource consumption related to the comorbidity subgroups respiratory 4 and respiratory 9, as well as diagnosis codes J98.2, and J98.3 and found no significant variations negating a reassignment. Therefore, we propose to reassign diagnosis codes J98.2 and J98.3 to respiratory 4 when listed as a secondary diagnosis.
Our clinical advisors reviewed the ICD-10-CM diagnosis code U09.9 (post COVID-19 condition, unspecified), which is currently assigned to the comorbidity subgroup, respiratory 2 (whooping cough and pneumonia). However, respiratory 10 (2019 novel Coronavirus) contains other COVID-19 codes (for example, U07.1). Therefore, we believe clinically that U09.9 should be reassigned to the comorbidity subgroup, respiratory 10. In addition, we evaluated resource consumption related to the comorbidity subgroups respiratory 2 and respiratory 10, and diagnosis codes U09.9 and found no significant variations negating a reassignment.
Therefore, we propose to reassign diagnosis code U09.9 to respiratory 10 when listed as a secondary diagnosis.
We solicit comments on all of the proposed clinical group and
Under the HH PPS, LUPAs are paid when a certain visit threshold for a payment group during a 30-day period of care is not met. In the CY 2019 HH PPS final rule (83 FR 56492), we finalized that the LUPA thresholds would be set at the 10th percentile of visits or 2 visits, whichever is higher, for each payment group. This means the LUPA threshold for each 30 day period of care varies depending on the PDGM payment group to which it is assigned. If the LUPA threshold for the payment group is met under the PDGM, the 30-day period of care will be paid the full 30-day period case-mix adjusted payment amount (subject to any PEP or outlier adjustments). If a 30-day period of care does not meet the PDGM LUPA visit threshold, then payment will be made using the CY 2023 per-visit payment amounts as described in Section II.B.5.c. of this proposed rule. For example, if the LUPA visit threshold is four, and a 30-day period of care has four or more visits, it is paid the full 30-day period payment amount; if the period of care has three or less visits, payment is made using the per-visit payment amounts.
In the CY 2019 HH PPS final rule with comment period (83 FR 56492), we finalized our policy that the LUPA thresholds for each PDGM payment group would be reevaluated every year based on the most current utilization data available at the time of rulemaking. However, as CY 2020 was the first year of the new case-mix adjustment methodology, we stated in the CY 2021 final rule (85 FR 70305, 70306) that we would maintain the LUPA thresholds that were finalized and shown in Table 17 of the CY 2020 HH PPS final rule with comment period (84 FR 60522) for CY 2021 payment purposes. We stated that at that time, we did not have sufficient CY 2020 data to reevaluate the LUPA thresholds for CY 2021.
In the CY 2022 HH PPS final rule (86 FR 62249), we finalized the proposal to recalibrate the PDGM case-mix weights, functional impairment levels, and comorbidity subgroups while maintaining the LUPA thresholds for CY 2022. We stated that because there are several factors that contribute to how the case-mix weight is set for a particular case-mix group (such as the number of visits, length of visits, types of disciplines providing visits, and non-routine supplies) and the case-mix weight is derived by comparing the average resource use for the case-mix group relative to the average resource use across all groups, we believe the PHE would have impacted utilization within all case-mix groups similarly. Therefore, the impact of any reduction in resource use caused by the PHE on the calculation of the case-mix weight would be minimized since the impact would be accounted for both in the numerator and denominator of the formula used to calculate the case-mix weight. However, in contrast, the LUPA thresholds are based on the number of overall visits in a particular case-mix group (the threshold is the 10th percentile of visits or 2 visits, whichever is greater) instead of a relative value (like what is used to generate the case-mix weight) that would control for the impacts of the PHE. We noted that visit patterns and some of the decrease in overall visits in CY 2020 may not be representative of visit patterns in CY 2022. Therefore, to mitigate any potential future and significant short-term variability in the LUPA thresholds due to the COVID-19 PHE, we finalized the proposal to maintain the LUPA thresholds finalized and displayed in Table 17 in the CY 2020 HH PPS final rule with comment period (84 FR 60522) for CY 2022 payment purposes.
For CY 2023, we are proposing to update the LUPA thresholds using CY 2021 Medicare home health claims (as of March 21, 2022) linked to OASIS assessment data. After reviewing the CY 2021 home health claims utilization data we determined that visit patterns have stabilized. Our data analysis indicates that visits in 2021 were similar to visits in 2020. We believe that CY 2021 data will be more indicative of visit patterns in CY 2023 rather than continuing to use the LUPA thresholds derived from the CY 2018 data pre-PDGM. Therefore, we are proposing to update the LUPA thresholds for CY 2023 using data from CY 2021. In general, there is not much variation in the updated LUPA thresholds; 280 case-mix groups had no change in their LUPA threshold. There are 120 case-mix groups that had their LUPA threshold go down by one visit and 18 case-mix groups that have their LUPA threshold go up by a visit. There are 12 case-mix groups that had their LUPA threshold go down by two visits and 2 case-mix groups that had their LUPA threshold go down by three visits.
The proposed LUPA thresholds for the CY 2023 PDGM payment groups with the corresponding Health Insurance Prospective Payment System (HIPPS) codes and the case-mix weights are listed in Table B26. We solicit public comments on the proposed updates to the LUPA thresholds for CY 2023.
Under the PDGM, the functional impairment level is determined by responses to certain OASIS items associated with activities of daily living and risk of hospitalization; that is, responses to OASIS items M1800-M1860 and M1033. A home health period of care receives points based on each of the responses associated with these functional OASIS items, which are then converted into a table of points corresponding to increased resource use. The sum of all of these points results in a functional score which is used to group home health periods into a functional level with similar resource use. That is, the higher the points, the higher the response is associated with increased resource use. The sum of all of these points results in a functional impairment score which is used to group home health periods into one of three functional impairment levels with similar resource use. The three functional impairment levels of low, medium, and high were designed so that approximately one-third of home health periods from each of the clinical groups fall within each level. This means home health periods in the low impairment level have responses for the functional OASIS items that are associated with the lowest resource use, on average. Home health periods in the high impairment level have responses for the functional OASIS items that are associated with the highest resource use on average.
For CY 2023, we propose to use CY 2021 claims data to update the functional points and functional impairment levels by clinical group. The CY 2018 HH PPS proposed rule (82 FR 35320) and the technical report from December 2016, posted on the Home Health PPS Archive webpage located at:
Thirty-day periods of care receive a comorbidity adjustment category based on the presence of certain secondary diagnoses reported on home health claims. These diagnoses are based on a home-health specific list of clinically and statistically significant secondary diagnosis subgroups with similar resource use, meaning the diagnoses have at least as high as the median resource use and are reported in more than 0.1 percent of 30-day periods of care. Home health 30-day periods of care can receive a comorbidity adjustment under the following circumstances:
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In the CY 2019 HH PPS final rule with comment period (83 FR 56406), we stated that we would continue to examine the relationship of reported comorbidities on resource utilization and make the appropriate payment refinements to help ensure that payment is in alignment with the actual costs of providing care. For CY 2023, we propose to use the same methodology used to establish the comorbidity subgroups to update the comorbidity subgroups using CY 2021 home health data.
For CY 2023, we propose to update the comorbidity subgroups to include 23 low comorbidity adjustment subgroups as identified in Table B23 and 94 high comorbidity adjustment interaction subgroups as identified in Table B24. The proposed 23 low comorbidity adjustment subgroups and 94 high comorbidity adjustment interactions reflect the proposed coding changes detailed in section II.B.3.c. of this proposed rule. The proposed CY 2023 low comorbidity adjustment subgroups and the high comorbidity adjustment interaction subgroups including those diagnoses within each of these comorbidity adjustments will also be posted on the HHA Center webpage at
We invite comments on the proposed updates to the low comorbidity adjustment subgroups and the high comorbidity adjustment interactions for CY 2023.
As finalized in the CY 2019 HH PPS final rule with comment period (83 FR 56502), the PDGM places patients into meaningful payment categories based on patient and other characteristics, such as timing, admission source, clinical grouping using the reported principal diagnosis, functional impairment level, and comorbid conditions. The PDGM case-mix methodology results in 432 unique case-mix groups called home health resource groups (HHRGs). We also finalized a policy in the CY 2019 HH PPS final rule with comment period (83 FR 56515) to recalibrate annually the PDGM case-mix weights using a fixed effects model with the most recent and complete utilization data available at the time of annual rulemaking. Annual recalibration of the PDGM case-mix weights ensures that the case-mix weights reflect, as accurately as possible, current home health resource use and changes in utilization patterns. To generate the proposed recalibrated CY 2023 case-mix weights, we used CY 2021 home health claims data with linked OASIS data (as of March 21, 2021). These data are the most current and complete data available at this time. We believe that recalibrating the case-mix weights using data from CY 2021 would be reflective of PDGM utilization and patient resource use for CY 2023. The proposed recalibrated case-mix weights will be updated based on more complete CY 2021 claims data for the final rule.
The claims data provide visit-level data and data on whether non-routine supplies (NRS) were provided during the period and the total charges of NRS. We determine the case-mix weight for each of the 432 different PDGM payment groups by regressing resource use on a series of indicator variables for each of the categories using a fixed effects model as described in the following steps:
The case-mix weight is then used to adjust the base payment rate to determine each 30-day period's payment. Table B25 shows the coefficients of the payment regression used to generate the weights, and the coefficients divided by average resource use.
The case-mix weights proposed for CY 2023 are listed in Table B26 and will also be posted on the HHA Center web-page
For CY 2023, there are 238 groups that experience a −5% to 0% change in case-mix weights and 183 groups that experience a 0% to +5% change in weights compared to their CY 2022 case-mix weights. There are 10 groups that experience a change between +5% and +10% and one group that experiences a 10% to 12% increase in weights compared to the CY 2022 case-mix weights. Changes to the PDGM case-mix weights are implemented in a budget neutral manner by multiplying the CY 2023 national standardized 30-day period payment rate by a case-mix budget neutrality factor. Typically, the case-mix weight budget neutrality factor
We invite comments on the CY 2023 proposed case-mix weights and proposed case-mix weight budget neutrality factor.
Section 1895(b)(3)(B) of the Act requires that the standard prospective payment amounts for home health be increased by a factor equal to the applicable home health market basket update for those HHAs that submit quality data as required by the Secretary. In the CY 2019 HH PPS final rule with comment period (83 FR 56425), we finalized a rebasing of the home health market basket to reflect 2016 cost report data. A detailed description of how we rebased the HHA market basket is available in the CY 2019 HH PPS final rule with comment period (83 FR 56425 through 56436).
Section 1895(b)(3)(B) of the Act requires that in CY 2015 and in subsequent calendar years, except CY 2018 (under section 411(c) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015)), and CY 2020 (under section 53110 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted February 9, 2018)), the market basket percentage under the HHA prospective payment system, as described in section 1895(b)(3)(B) of the Act, be annually adjusted by changes in economy-wide productivity. Section 1886(b)(3)(B)(xi)(II) of the Act 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 fiscal year, calendar year, cost reporting period, or other annual period). The United States Department of Labor's Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the United States economy. We note that previously the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) was published by BLS as private nonfarm business multifactor productivity. 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. As a result of the BLS name change, the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as “private nonfarm business total factor productivity”. We refer readers to
The proposed home health update percentage for CY 2023 is based on the estimated home health market basket update, specified at section 1895(b)(3)(B)(iii) of the Act, of 3.3 percent (based on IHS Global Inc.'s first-quarter 2022 forecast with historical data through fourth-quarter 2021). The estimated CY 2023 home health market basket update of 3.3 percent is then reduced by a productivity adjustment, as mandated by the section 3401 of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), currently estimated to be 0.4 percentage point for CY 2023. In effect, the proposed home health payment update percentage for CY 2023 is a 2.9 percent increase. Section 1895(b)(3)(B)(v) of the Act requires that the home health update be decreased by 2 percentage points for those HHAs that do not submit quality data as required by the Secretary. For HHAs that do not submit the required quality data for CY 2023, the home health payment update would be 0.9 percent (2.9 percent minus 2 percentage points). If more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, more recent estimates of the home health market basket update and productivity adjustment), we would use such data, if appropriate, to determine the home health payment update percentage for CY 2023 in the final rule.
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to provide appropriate adjustments to the proportion of the payment amount under the HH PPS that account for area wage differences, using adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services. Since the inception of the HH PPS, we have used inpatient hospital wage data in developing a wage index to be applied to home payments. We propose to continue this practice for CY 2023, as we continue to believe that, in the absence of home health-specific wage data that accounts for area differences, using inpatient hospital wage data is appropriate and reasonable for the HH PPS.
In the CY 2021 HH PPS final rule (85 FR 70298), we finalized our proposal to adopt the revised Office of Management and Budget (OMB) delineations with a 5-percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5-percent in CY 2021 only, meaning no cap would be applied to wage index decreases for the second year (CY 2022). Therefore, we proposed and finalized the use of the FY 2022 pre-floor, pre reclassified hospital wage index with no 5-percent cap on decreases as the CY 2022 wage adjustment to the labor portion of the HH PPS rates (86 FR 62285). For CY 2023, we propose to base the HH PPS wage index on the FY 2023 hospital pre-floor, pre-reclassified wage index for hospital cost reporting periods beginning on or after October 1, 2018, and before October 1, 2019 (FY 2019 cost report data). The proposed CY 2023 HH PPS wage index would not take into
To address those geographic areas in which there are no inpatient hospitals, and thus, no hospital wage data on which to base the calculation of the CY 2023 HH PPS wage index, we propose to continue to use the same methodology discussed in the CY 2007 HH PPS final rule (71 FR 65884) to address those geographic areas in which there are no inpatient hospitals. For rural areas that do not have inpatient hospitals, we propose to use the average wage index from all contiguous Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we do not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas). Instead, we propose to continue to use the most recent wage index previously available for that area. The most recent wage index previously available for rural Puerto Rico is 0.4047, which is what we propose to use. For urban areas without inpatient hospitals, we use the average wage index of all urban areas within the State as a reasonable proxy for the wage index for that CBSA. For CY 2023, the only urban area without inpatient hospital wage data is Hinesville, GA (CBSA 25980). Using the average wage index of all urban areas in Georgia as proxy, we propose the CY 2023 wage index value for Hinesville, GA to be 0.8535.
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing revisions to the delineations of MSAs, Micropolitan Statistical Areas, and CBSAs, and guidance on uses of the delineation of these areas. In the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted OMB's area delineations using a 1-year transition.
On August 15, 2017, OMB issued Bulletin No. 17-01 in which it announced that one Micropolitan Statistical Area, Twin Falls, Idaho, now qualifies as a Metropolitan Statistical Area. The new CBSA (46300) comprises the principal city of Twin Falls, Idaho in Jerome County, Idaho and Twin Falls County, Idaho. The CY 2022 HH PPS wage index value for CBSA 46300, Twin Falls, Idaho, will be 0.8803. Bulletin No. 17-01 is available at
On April 10, 2018, OMB issued OMB Bulletin No. 18-03, which superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14, 2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10, 2018, OMB Bulletin No. 18-03. These bulletins established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. A copy of OMB Bulletin No. 18-04 may be obtained at:
On March 6, 2020, OMB issued Bulletin No. 20-01, which provided updates to and superseded OMB Bulletin No. 18-04 that was issued on September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided detailed information on the update to statistical areas since September 14, 2018, and were based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2017, and July 1, 2018. (For a copy of this bulletin, we refer readers to
The proposed CY 2023 wage index is available on the CMS website at:
As discussed in section II.B.5.b.1 of this proposed rule, we have proposed and finalized temporary transition policies in the past to mitigate significant changes to payments due to changes to the home health wage index. Specifically, in the CY 2015 HH PPS final rule (79 FR 66086), we implemented a 50/50 blend for all geographic areas consisting of the wage index values using the then-current OMB area delineations and the wage index values using OMB's new area delineations based on OMB Bulletin No. 13-01. In the CY 2021 HH PPS final rule (85 FR 73100), we adopted the revised OMB delineations with a 5-percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5-percent in CY 2021. We explained that we believed the 5-percent cap would provide greater transparency and would be administratively less complex than the prior methodology of applying a 50/50 blended wage index. We noted that this transition approach struck an appropriate balance by providing a transition period to mitigate the resulting short-term instability and negative impacts on providers and time for them to adjust to their new labor market area delineations and wage index values.
In the CY 2022 HH PPS final rule (86 FR 62285), a few commenters stated that providers should be protected against substantial payment reductions due to dramatic reductions in wage index values from one year to the next. Because we did not propose any transition policy in the CY 2022 proposed rule, we did not extend the transition period for CY 2022. In the CY 2022 HH PPS final rule, we stated that we continued to believe that applying the 5-percent cap transition policy in year one provided an adequate safeguard against any significant payment reductions associated with the adoption of the revised CBSA delineations in CY 2021, allowed for sufficient time to make operational
In the past, we have established transition policies of limited duration to phase in significant changes to labor market areas. In taking this approach in the past, we sought to mitigate short-term instability and fluctuations that can negatively impact providers due to wage index changes. Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act requires the Secretary to provide appropriate adjustments to the proportion of the payment amount under the HH PPS that account for area wage differences, using adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services. We have previously stated that, because the wage index is a relative measure of the value of labor in prescribed labor market areas, we believe it is important to implement new labor market area delineations with as minimal a transition as is reasonably possible. However, we recognize that changes to the wage index have the potential to create instability and significant negative impacts on certain providers even when labor market areas do not change. In addition, year-to-year fluctuations in an area's wage index can occur due to external factors beyond a provider's control, such as the COVID-19 PHE, and for an individual provider, these fluctuations can be difficult to predict. We also recognize that predictability in Medicare payments is important to enable providers to budget and plan their operations.
In light of these considerations, we are proposing a permanent approach to smooth year-to-year changes in providers' wage indexes. We are proposing a policy that increases the predictability of home health payments for providers and mitigates instability and significant negative impacts to providers resulting from changes to the wage index.
As previously discussed, we believe that applying a 5-percent cap on wage index decreases for CY 2021 provided greater transparency and was administratively less complex than prior transition methodologies. In addition, we believe this methodology mitigates short-term instability and fluctuations that can negatively impact providers due to wage index changes. Lastly, we note that we believe the 5-percent cap we applied to all wage index decreases for CY 2021 provided an adequate safeguard against significant payment reductions related to the adoption of the revised CBSAs. However, as discussed earlier in this section of this proposed rule, we recognize there are circumstances that a one-year mitigation policy would not effectively address future years in which providers continue to be negatively affected by significant wage index decreases.
Typical year-to-year variation in the home health wage index has historically been within 5-percent, and we expect this will continue to be the case in future years. Therefore, we believe that applying a 5-percent cap on all wage index decreases in future years, regardless of the reason for the decrease, would effectively mitigate instability in home health payments due to any significant wage index decreases that may affect providers in any year that commenters raised in the CY 2022 HH PPS final rule. Additionally, we believe that applying a 5-percent cap on all wage index decreases would increase the predictability of home health payments for providers, enabling them to more effectively budget and plan their operations. Lastly, we believe that applying a 5-percent cap on all wage index decreases, from the prior year, would have a small overall impact on the labor market area wage index system. As discussed in further detail in section VII.C. of this proposed rule, we estimate that applying a 5-percent cap on all wage index decreases, from the prior year, will have a very small effect on the wage index budget neutrality factors for CY 2023. Because the wage index is a measure of the value of labor (wage and wage-related costs) in a prescribed labor market area relative to the national average, we anticipate that most providers will not experience year-to-year wage index declines greater than 5-percent in any given year. We believe that applying a 5-percent cap on all wage index decreases, from the prior year, would continue to maintain the accuracy of the overall labor market area wage index system.
Therefore, for CY 2023 and subsequent years, we are proposing to apply a permanent 5 percent cap on any decrease to a geographic area's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. That is, we are proposing that a geographic area's wage index for CY 2023 would not be less than 95 percent of its final wage index for CY 2022, regardless of whether the geographic area is part of an updated CBSA, and that for subsequent years, a geographic area's wage index would not be less than 95 percent of its wage index calculated in the prior CY. We further propose that if a geographic area's prior CY wage index is calculated based on the 5-percent cap, then the following year's wage index would not be less than 95 percent of the geographic area's capped wage index. For example, if a geographic area's wage index for CY 2023 is calculated with the application of the 5-percent cap, then its wage index for CY 2024 would not be less than 95 percent of its capped wage index in CY 2023. Likewise, we are proposing to make the corresponding regulations text changes at § 484.220(c) as follows: Beginning on January 1, 2023, CMS will apply a cap on decreases to the home health wage index such that the wage index applied to a geographic area is not less than 95 percent of the wage index applied to that geographic area in the prior CY. This 5-percent cap on negative wage index changes would be implemented in a budget neutral manner through the use of wage index budget neutrality factors.
In section VII.C. of this proposed rule, we estimate the impact to payments for providers in CY 2023 based on this proposed policy. We also note that we would examine the effects of this policy on an ongoing basis in the future in order to assess its appropriateness.
The HH PPS has been in effect since October 1, 2000. As set forth in the July 3, 2000 final rule (65 FR 41128), the base unit of payment under the HH PPS was a national, standardized 60-day episode payment rate. As finalized in the CY 2019 HH PPS final rule with comment period (83 FR 56406), and as described in the CY 2020 HH PPS final rule with comment period (84 FR 60478), the unit of home health payment changed from a 60-day episode to a 30-day period effective for those 30-
As set forth in § 484.220, we adjust the national, standardized prospective payment rates by a case-mix relative weight and a wage index value based on the site of service for the beneficiary. To provide appropriate adjustments to the proportion of the payment amount under the HH PPS to account for area wage differences, we apply the appropriate wage index value to the labor portion of the HH PPS rates. In the CY 2019 HH PPS final rule with comment period (83 FR 56435), we finalized rebasing the home health market basket to reflect 2016 Medicare cost report data. We also finalized a revision to the labor share to reflect the 2016-based home health market basket compensation (Wages and Salaries plus Benefits) cost weight. We finalized that for CY 2019 and subsequent years, the labor share would be 76.1 percent and the non-labor share would be 23.9 percent. The following are the steps we take to compute the case-mix and wage-adjusted 30-day period payment amount for CY 2023:
• Multiply the national, standardized 30-day period rate by the patient's applicable case mix weight.
• Divide the case-mix adjusted amount into a labor (76.1 percent) and a non labor portion (23.9 percent).
• Multiply the labor portion by the applicable wage index based on the site of service of the beneficiary.
• Add the wage-adjusted portion to the non-labor portion, yielding the case-mix and wage adjusted 30-day period payment amount, subject to any additional applicable adjustments.
We provide annual updates of the HH PPS rate in accordance with section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the specific annual percentage update methodology. In accordance with section 1895(b)(3)(B)(v) of the Act and § 484.225(i), for an HHA that does not submit home health quality data, as specified by the Secretary, the unadjusted national prospective 30-day period rate is equal to the rate for the previous calendar year increased by the applicable home health payment update, minus 2 percentage points. Any reduction of the percentage change would apply only to the calendar year involved and would not be considered in computing the prospective payment amount for a subsequent calendar year.
The final claim that the HHA submits for payment determines the total payment amount for the period and whether we make an applicable adjustment to the 30-day case-mix and wage-adjusted payment amount. The end date of the 30-day period, as reported on the claim, determines which calendar year rates Medicare will use to pay the claim.
We may adjust a 30-day case-mix and wage-adjusted payment based on the information submitted on the claim to reflect the following:
• A LUPA is provided on a per-visit basis as set forth in §§ 484.205(d)(1) and 484.230.
• A PEP adjustment as set forth in §§ 484.205(d)(2) and 484.235.
• An outlier payment as set forth in §§ 484.205(d)(3) and 484.240.
Section 1895(b)(3)(A)(i) of the Act requires that the standard prospective payment rate and other applicable amounts be standardized in a manner that eliminates the effects of variations in relative case-mix and area wage adjustments among different home health agencies in a budget-neutral manner. To determine the CY 2023 national, standardized 30-day period payment rate, we apply a permanent behavioral adjustment factor, a case-mix weights recalibration budget neutrality factor, a wage index budget neutrality factor and the home health payment update percentage discussed in section II.C.2. of this proposed rule. As discussed in section II.B.2.f. of this proposed rule, we are implementing a permanent behavior adjustment of −7.69 percent to prevent further overpayments. The permanent behavior adjustment factor is 0.9231 (1−0.0769). As discussed previously, to ensure the changes to the PDGM case-mix weights are implemented in a budget neutral manner, we apply a case-mix weights budget neutrality factor to the CY 2022 national, standardized 30-day period payment rate. The proposed case-mix weights budget neutrality factor for CY 2023 is 0.9895. Additionally, we also apply a wage index budget neutrality to ensure that wage index updates and revisions are implemented in a budget neutral manner. Typically, the wage index budget neutrality factor is calculated using the most recent, complete home health claims data available. However, in the CY 2022 HH PPS final rule due to the COVID-19 PHE, we looked at using the previous calendar year's home health claims data (CY 2019) to determine if there were significant differences between utilizing 2019 and 2020 claims data. Our analysis showed that there was only a small difference between the wage index budget neutrality factors calculated using CY 2019 and CY 2020 home health claims data. Therefore, for CY 2022 we decided to continue our practice of using the most recent, complete home health claims data available; that is, we used CY 2020 claims data for the CY 2022 payment rate updates. For CY 2023 rate setting, we do not anticipate significant differences between using pre COVID-19 PHE data (CY 2019 claims) and the most recent claims data at the time of rulemaking (CY 2021 claims). Therefore, we will continue our practice of using the most recent, complete utilization data at the time of rulemaking; that is, we are using CY 2021 claims data for CY 2023 payment rate updates.
To calculate the wage index budget neutrality factor, we first determine the payment rate needed for non-LUPA 30-day periods using the CY 2023 wage index so those total payments are equivalent to the total payments for non-LUPA 30-day periods using the CY 2022 wage index and the CY 2022 national standardized 30-day period payment rate adjusted by the case-mix weights recalibration neutrality factor. Then, by dividing the payment rate for non-LUPA 30-day periods using the CY 2023 wage index with a 5-percent cap on wage index decreases by the payment rate for non-LUPA 30-day periods using the CY 2022 wage index, we obtain a wage index budget neutrality factor of 0.9975. We then apply the wage index budget neutrality factor of 0.9975 to the 30-day period payment rate.
Next, we would update the 30-day period payment rate by the CY 2023 home health payment update percentage of 2.9 percent. The CY 2023 national, standardized 30-day period payment rate is calculated in Table B27.
The CY 2023 national, standardized 30-day period payment rate for a HHA that does not submit the required quality data is updated by the CY 2023 home health payment update of 2.9 percent minus 2 percentage points and is shown in Table B28.
The national per-visit rates are used to pay LUPAs and are also used to compute imputed costs in outlier calculations. The per-visit rates are paid by type of visit or HH discipline. The six HH disciplines are as follows:
• Home health aide (HH aide).
• Medical Social Services (MSS).
• Occupational therapy (OT).
• Physical therapy (PT).
• Skilled nursing (SN).
• Speech-language pathology (SLP).
To calculate the CY 2023 national per-visit rates, we started with the CY 2022 national per-visit rates. Then we applied a wage index budget neutrality factor to ensure budget neutrality for LUPA per-visit payments. We calculated the wage index budget neutrality factor by simulating total payments for LUPA 30-day periods of care using the CY 2023 wage index with a 5-percent cap on wage index decreases and comparing it to simulated total payments for LUPA 30-day periods of care using the CY 2022 wage index (with no 5-percent cap). By dividing the total payments for LUPA 30-day periods of care using the CY 2023 wage index by the total payments for LUPA 30-day periods of care using the CY 2022 wage index, we obtained a wage index budget neutrality factor of 0.9992. We apply the wage index budget neutrality factor in order to calculate the CY 2022 national per visit rates.
The LUPA per-visit rates are not calculated using case-mix weights. Therefore, no case mix weights budget neutrality factor is needed to ensure budget neutrality for LUPA payments. Additionally, we are not applying the permanent adjustment to the per visit payment rates but only the case-mix adjusted payment rate. Lastly, the per-visit rates for each discipline are updated by the CY 2023 home health payment update percentage of 2.9 percent. The national per-visit rates are adjusted by the wage index based on the site of service of the beneficiary. The per-visit payments for LUPAs are separate from the LUPA add-on payment amount, which is paid for episodes that occur as the only episode or initial episode in a sequence of adjacent episodes. The CY 2023 national per visit rates for HHAs that submit the required quality data are updated by the CY 2023 home health payment update percentage of 2.9 percent and are shown in Table B29.
The CY 2023 per-visit payment rates for HHAs that do not submit the required quality data are updated by the CY 2023 home health payment update percentage of 2.9 percent minus 2 percentage points and are shown in Table B30.
Prior to the implementation of the 30-day unit of payment, LUPA episodes were eligible for a LUPA add-on payment if the episode of care was the first or only episode in a sequence of adjacent episodes. As stated in the CY 2008 HH PPS final rule, the average visit lengths in these initial LUPAs are 16 to 18 percent higher than the average visit lengths in initial non-LUPA episodes (72 FR 49848). LUPA episodes that occur as the only episode or as an initial episode in a sequence of adjacent episodes are adjusted by applying an additional amount to the LUPA payment before adjusting for area wage differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed the methodology for calculating the LUPA add-on amount by finalizing the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and 1.6266 for SLP. We multiply the per-visit payment amount for the first SN, PT, or SLP visit in LUPA episodes that occur as the only episode or an initial episode in a sequence of adjacent episodes by the appropriate factor to determine the LUPA add-on payment amount.
In the CY 2019 HH PPS final rule with comment period (83 FR 56440), in addition to finalizing a 30-day unit of payment, we finalized our policy of continuing to multiply the per-visit payment amount for the first skilled nursing, physical therapy, or speech-language pathology visit in LUPA periods that occur as the only period of care or the initial 30-day period of care in a sequence of adjacent 30-day periods of care by the appropriate add-on factor (1.8451 for SN, 1.6700 for PT, and 1.6266 for SLP) to determine the LUPA add-on payment amount for 30-day periods of care under the PDGM. For example, using the proposed CY 2023 per-visit payment rates for HHAs that submit the required quality data, for LUPA periods that occur as the only period or an initial period in a sequence of adjacent periods, if the first skilled visit is SN, the payment for that visit would be $297.65 (1.8451 multiplied by $161.32), subject to area wage adjustment.
In order to implement Division CC, section 115, of CAA 2021, CMS finalized changes to regulations at § 484.55(a)(2) and (b)(3) that allowed occupational therapists to conduct initial and comprehensive assessments for all Medicare beneficiaries under the home health benefit when the plan of care does not initially include skilled nursing care, but either PT or SLP (86 FR 62351). This change, led to us
As stated in the CY 2022 HH PPS final rule with comment period (86 FR 62289) since there was not sufficient data regarding the average excess of minutes for the first visit in LUPA periods when the initial and comprehensive assessments are conducted by occupational therapists we finalized the use of the PT LUPA add-on factor of 1.6700 as a proxy. We also stated that we would use the PT LUPA add-on factor as a proxy until we have CY 2022 data to establish a more accurate OT add-on factor for the LUPA add-on payment amounts (86 FR 62289). Therefore, we continue to believe the similarity in the per-visit payment rates for both PT and OT make the PT LUPA add-on factor the most appropriate proxy until we have CY 2022 data to propose a LUPA add-on factor specific to OT in future rulemaking.
Section 1895(b)(5) of the Act allows for the provision of an addition or adjustment to the home health payment amount otherwise made in the case of outliers because of unusual variations in the type or amount of medically necessary care. Under the HH PPS and the previous unit of payment (that is, 60-day episodes), outlier payments were made for 60-day episodes whose estimated costs exceed a threshold amount for each HHRG. The episode's estimated cost was established as the sum of the national wage-adjusted per visit payment amounts delivered during the episode. The outlier threshold for each case-mix group or PEP adjustment defined as the 60-day episode payment or PEP adjustment for that group plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS, the FDL amount is calculated by multiplying the home health FDL ratio by a case's wage-adjusted national, standardized 60-day episode payment rate, which yields an FDL dollar amount for the case. The outlier threshold amount is the sum of the wage and case-mix adjusted PPS episode amount and wage-adjusted FDL amount. The outlier payment is defined to be a proportion of the wage-adjusted estimated cost that surpasses the wage-adjusted threshold. The proportion of additional costs over the outlier threshold amount paid as outlier payments is referred to as the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 70399), section 3131(b)(1) of the Affordable Care Act amended section 1895(b)(3)(C) of the Act to require that the Secretary reduce the HH PPS payment rates such that aggregate HH PPS payments were reduced by 5 percent. In addition, section 3131(b)(2) of the Affordable Care Act amended section 1895(b)(5) of the Act by redesignating the existing language as section 1895(b)(5)(A) of the Act and revised the language to state that the total amount of the additional payments or payment adjustments for outlier episodes could not exceed 2.5 percent of the estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of the Affordable Care Act also added section 1895(b)(5)(B) of the Act, which capped outlier payments as a percent of total payments for each HHA for each year at 10 percent.
As such, beginning in CY 2011, we reduced payment rates by 5 percent and targeted up to 2.5 percent of total estimated HH PPS payments to be paid as outliers. To do so, we first returned the 2.5 percent held for the target CY 2010 outlier pool to the national, standardized 60-day episode rates, the national per visit rates, the LUPA add-on payment amount, and the NRS conversion factor for CY 2010. We then reduced the rates by 5 percent as required by section 1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the Affordable Care Act. For CY 2011 and subsequent calendar years we targeted up to 2.5 percent of estimated total payments to be paid as outlier payments, and apply a 10 percent agency-level outlier cap.
In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 43742 and 81 FR 76702), we described our concerns regarding patterns observed in home health outlier episodes. Specifically, we noted the methodology for calculating home health outlier payments may have created a financial incentive for providers to increase the number of visits during an episode of care in order to surpass the outlier threshold; and simultaneously created a disincentive for providers to treat medically complex beneficiaries who require fewer but longer visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 76702), we finalized changes to the methodology used to calculate outlier payments, using a cost-per-unit approach rather than a cost-per-visit approach. This change in methodology allows for more accurate payment for outlier episodes, accounting for both the number of visits during an episode of care and the length of the visits provided. Using this approach, we now convert the national per-visit rates into per 15-minute unit rates. These per 15-minute unit rates are used to calculate the estimated cost of an episode to determine whether the claim will receive an outlier payment and the amount of payment for an episode of care. In conjunction with our finalized policy to change to a cost-per-unit approach to estimate episode costs and determine whether an outlier episode should receive outlier payments, in the CY 2017 HH PPS final rule we also finalized the implementation of a cap on the amount of time per day that would be counted toward the estimation of an episode's costs for outlier calculation purposes (81 FR 76725). Specifically, we limit the amount of time per day (summed across the six disciplines of care) to 8 hours (32 units) per day when estimating the cost of an episode for outlier calculation purposes.
In the CY 2017 HH PPS final rule (81 FR 76724), we stated that we did not plan to re-estimate the average minutes per visit by discipline every year. Additionally, the per unit rates used to estimate an episode's cost were updated by the home health update percentage each year, meaning we would start with the national per visit amounts for the same calendar year when calculating the cost-per-unit used to determine the cost of an episode of care (81 FR 76727). We will continue to monitor the visit length by discipline as more recent data becomes available, and may propose to update the rates as needed in the future.
In the CY 2019 HH PPS final rule with comment period (83 FR 56521), we finalized a policy to maintain the current methodology for payment of high-cost outliers upon implementation of PDGM beginning in CY 2020 and calculated payment for high-cost outliers based upon 30-day period of care. Upon implementation of the PDGM and 30-day unit of payment, we finalized the FDL ratio of 0.56 for 30-day periods of care in CY 2020. Given that CY 2020 was the first year of the PDGM and the change to a 30-day unit of payment, we finalized to maintain the same FDL ratio of 0.56 in CY 2021 as we did not have sufficient CY 2020 data at the time of CY 2021 rulemaking to proposed a change to the FDL ratio for CY 2021. In the CY 2022 HH PPS final rule with comment period (86 FR 62292), we estimated that outlier payments would be approximately 1.8 percent of total HH PPS final rule payments if we maintained an FDL of 0.56 in CY 2022. Therefore, in order to
For a given level of outlier payments, there is a trade-off between the values selected for the FDL ratio and the loss-sharing ratio. A high FDL ratio reduces the number of periods that can receive outlier payments, but makes it possible to select a higher loss-sharing ratio, and therefore, increase outlier payments for qualifying outlier periods. Alternatively, a lower FDL ratio means that more periods can qualify for outlier payments, but outlier payments per period must be lower.
The FDL ratio and the loss-sharing ratio are selected so that the estimated total outlier payments do not exceed the 2.5 percent aggregate level (as required by section 1895(b)(5)(A) of the Act). Historically, we have used a value of 0.80 for the loss-sharing ratio, which, we believe, preserves incentives for agencies to attempt to provide care efficiently for outlier cases. With a loss-sharing ratio of 0.80, Medicare pays 80 percent of the additional estimated costs that exceed the outlier threshold amount. Using CY 2021 claims data (as of March 21, 2022) and given the statutory requirement that total outlier payments do not exceed 2.5 percent of the total payments estimated to be made under the HH PPS, we are proposing an FDL ratio of 0.44 for CY 2023. CMS will update the FDL, if needed, once we have more complete CY 2021 claims data.
Even prior to the COVID-19 PHE, CMS acknowledged the importance of technology in allowing HHAs the flexibility of furnishing services remotely. In the CY 2019 HH PPS final rule with comment (83 FR 56406), for purposes of the Medicare home health benefit, we finalized the definition of “remote patient monitoring” in regulation at 42 CFR 409.46(e) as the collection of physiologic data (for example, electrocardiogram (ECG), blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the HHA. In the CY 2019 HH PPS final rule with comment, we also finalized in regulation at § 409.46(e) that the costs of remote patient monitoring are considered allowable administrative costs (operating expenses) if remote patient monitoring is used by the HHA to augment the care planning process (83 FR 56527).
With the declaration of the COVID-19 PHE in early 2020, the use of telecommunications technology has become more prominent in the delivery of healthcare in the United States. Anecdotally, many beneficiaries preferred to stay home than go to physician's offices and outpatient centers to seek care, while also limiting the number and frequency of care providers furnishing services inside their homes to avoid exposure to COVID-19. Accordingly, CMS implemented additional policies under the HH PPS to make providing and receiving services via telecommunications technology easier. In the first COVID-19 PHE interim final rule with comment period (IFC) (85 FR 19230), we changed the plan of care requirements at § 409.43(a) on an interim basis, for the purposes of Medicare payment, to state that the plan of care must include any provision of remote patient monitoring or other services furnished via a telecommunications system. The plan of care must also describe how the use of such technology is tied to the patient-specific needs as identified in the comprehensive assessment and will help to achieve the goals outlined on the plan of care. The amended plan of care requirements at § 409.43(a) also state that these services cannot substitute for a home visit ordered as part of the plan of care and cannot be considered a home visit for the purposes of patient eligibility or payment, in accordance with section 1895(e)(1)(A) and (B) of the Act. The CY 2021 HH PPS final rule with comment period (85 FR 70298) finalized these changes on a permanent basis, as well as amended § 409.46(e) to include not only remote patient monitoring, but other communication or monitoring services consistent with the plan of care for the individual, on the home health cost report as allowable administrative costs.
Sections 1895(e)(1)(A) and (B) of the Act specify that telecommunications services cannot substitute for in-person home health services ordered as part of the plan of care certified by a physician and are not considered a home health visit for purposes of eligibility or payment under Medicare. Though the use of telecommunications technology is not to be used as a substitute for in-person home health services, as ordered on the plan of care, and services provided through the use of telecommunications technology (rather than in-person) are not considered a home health visit, anecdotally we have heard that HHAs are using telecommunication services during the course of a 30-day period of care and as a result of the COVID-19 PHE, as described previously. In the first COVID-19 PHE IFC, we provided an example describing a situation where the use of technology is not a substitute for the provision of in-person visits as ordered on the plan of care, rather the plan of care is updated to reflect a change in the frequency of the in-person visits and to include “virtual visits” as part of the management of the home health patient (85 FR 19248).
Currently, the collection of data on the use of telecommunications technology is limited to overall cost data on a broad category of telecommunications services as a part of an HHA's administrative costs on line 5 of the HHA Medicare cost reports.
Collecting data on the use of telecommunications technology on home health claims would allow CMS to analyze the characteristics of the beneficiaries utilizing services furnished remotely, and will give us a broader understanding of the social determinants that affect who benefits most from these services, including what barriers may potentially exist for certain subsets of beneficiaries. Furthermore, in their March 2022 Report to the Congress: Medicare's Payment Policy, MedPAC recommended tracking the use of telehealth in the home health care benefit on home health claims in order to improve payment accuracy.
In accordance with section 40.2 in Chapter 10 of the Medicare Claims Processing Manual (Pub. 100-04), we plan to issue instructions that these forthcoming G-codes are to be used to report services in line item detail and each service must be reported as a separate line under the appropriate revenue code (04x—Physical Therapy, 043x—Occupational Therapy, 044x—Speech-Language Pathology, 055x—Skilled Nursing, 056x—Medical Social Services, or 057x—Home Health Aide). While we do not plan on limiting the use of these G-codes to any particular discipline, we would not anticipate use of such technology would be reported under certain revenue codes such as 027x or 0623—Medical Supplies, or revenue code 057x—Home Health Aide. We are interested in comments from the public on our belief that, due to the hands-on nature of home health aide services, the use of telecommunications technology would generally not be appropriate for such services. We remind interested parties that if there is a service that cannot be provided through telecommunications technology (for example, wound care that requires in-person, hands-on care from a skilled nurse), the HHA must make an in-person visit to furnish such services (85 FR 39428). We are also requesting comments regarding the appropriateness of such technology for particular services in order to more clearly delineate when the use of such technology is appropriate. This may help inform how we use this analysis, for instance, connecting how such technology is impacting the provision of care to certain beneficiaries, costs, quality, and outcomes, and determine if further requirements surrounding the use of telecommunications technology are needed.
We are also soliciting comments on future refinement of these G-codes beginning July 1, 2023. Specifically whether the codes should differentiate the type of clinician performing the service via telecommunications technology, such as a therapist versus therapist assistant; and whether new G-codes should differentiate the type of service being performed through the use of telecommunications technology, such as: skilled nursing services performed for care plan oversight (for example, management and evaluation or observation and assessment) versus teaching; or physical therapy services performed for the establishment or performance of a maintenance program versus other restorative physical therapy services.
We will issue program instruction outlining the use of new codes for the purposes of tracking the use of telecommunications technology under the home health benefit with sufficient notice to enable HHAs to make the necessary changes in their electronic health records and billing systems. As stated previously, we will begin collecting this information on home health claims by January 1, 2023, on a voluntary basis by HHAs, and will require this information be reported on home health claims beginning in July, 2023. We would issue further program instruction prior to July 1, 2023, if the G-code description changes between January 1, 2023, and July 1, 2023, based on comments in this proposed rule. However, we reiterate that the collection of information on the use of telecommunications technology does not mean that such services are considered “visits” for purposes of eligibility or payment. In accordance with section 1895(e)(1)(A) and (B) of the Act, such data will not be used or factored into case-mix weights, or count towards outlier payments or the LUPA threshold per payment period.
The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and subsequent years, each home health agency (HHA) submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality. To the extent that an HHA does not submit data in accordance with this clause, the Secretary shall reduce the home health market basket percentage increase applicable to the HHA for such year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage increase applicable for a particular year, as further reduced by the productivity adjustment (except in 2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act, the reduction of that increase by 2 percentage points for failure to comply with the requirements of the HH QRP may result in the home health market basket percentage increase being less than 0.0 percent for a year, and may result in payment rates under the Home Health PPS for a year being less than payment rates for the preceding year. The HH QRP regulations can be found at 42 CFR 484.245 and 484.250.
For a detailed discussion of the considerations we historically use for measure selection for the HH QRP quality, resource use, and other measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 68695 through 68696). In the CY 2019 HH PPS final rule with comment period (83 FR 56548 through 56550), we finalized the factors we consider for removing previously adopted HH QRP measures.
The HH QRP currently includes 20 measures for the CY 2023 program year, as described in Table C1.
In 1987, Congress added a new section 1891(d) to the Act (section 4021(b) of Pub. L. 100-203 (December 22, 1987)). The statute required the Secretary to develop a comprehensive assessment for Medicare-participating HHAs. In 1993, CMS (then known as HCFA) developed an assessment instrument that identified each patient's need for home care and that meets the patient's medical, nursing, rehabilitative, social and discharge planning needs. As part of this assessment, Medicare-certified HHAs were required to use a standard core assessment data set, the “Outcome and Assessment Information Set” (“OASIS”). Section 1891(d) of the Act requires, as part of the home health assessment, a survey of the quality of care and services furnished by the agency as measured by indicators of medical, nursing, and rehabilitative care provided by the HHA. OASIS is the designated assessment instrument (or instruments) for use by an HHA in complying with the requirement. In the January 25, 1999, final rule titled, “Medicare and Medicaid Programs: Comprehensive Assessment and Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies,” we also required HHAs to submit the data collected by the OASIS assessment to HCFA as an HHA condition of participation (64 FR 3772).
Early on, privacy concerns were raised by HHAs around the collection of all-payer data and the release of personal health information. As we indicated in the study, any new collection requirements such as this raise concerns and this was no exception. In response to the privacy concerns, CMS took steps to mask the personal health information before the data was transmitted to the Quality Improvement and Evaluation System (QIES). In the study, we collected information from HHAs and the industry including the surveying of Agencies by one of the trade organizations and note that the privacy concerns initially raised were not raised as an ongoing concern. Based upon this feedback, we conclude that the privacy issues raised initially are no longer a concern.
Subsequently, Congress enacted section 704 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which suspended the legal authority of the Secretary to require HHAs to report OASIS information on non-Medicare/non-Medicaid patients until at least 2 months after the Secretary published final regulations on CMS's collection and use of those data following the submission of a report to Congress on the study required under section 704(c) of the MMA. This study required the Secretary to examine the use of non-Medicare/non-Medicaid OASIS data by large HHAs, including whether there were unique benefits from the analysis of that information that CMS could not obtain from other sources, and the value of collecting such data by small HHAs versus the administrative burden of collection. In conducting the study, the Secretary was also required to obtain recommendations from quality assessment experts on the use of such information and the necessity of HHAs collecting such information.
The Secretary conducted the study required under section 704 of the MMA in 2004 to 2005 and submitted it to Congress in December 2006 (
• There are significant differences between private pay and Medicare/Medicaid patients in terms of diagnosis, patient characteristics, and patient outcomes. Within-agency correlation between Medicare/Medicaid and private pay patient outcomes was low, indicating that outcomes based on Medicare/Medicaid patient data cannot be generalized to serve as a proxy for private pay patients.
• Risk adjustment models at the time did not account for all of the sources of variation in outcomes across different payer groups and as a result, measures could produce misleading information.
• Requiring OASIS data collection on private pay patients at Medicare-certified HHAs could increase staff and patient burden and would require CMS to develop a mechanism for these agencies to receive reports from CMS on their private pay patients.
• A change to all-payer assessment data collection would strengthen CMS's ability to assess and report indicators of the quality of care furnished by HHAs to their entire patient population.
After considering the study's findings, the Secretary noted that the suspension of OASIS collection from non-Medicare patients would continue because “it would be unfair to burden the providers with the collection of OASIS at this time since the case mix and outcomes reports are not designed to include private pay patients.” The Secretary also noted that it would be inappropriate for CMS to collect the private pay OASIS data and not use it. The Secretary further stated that “if funding for the development of HHA patient outcome and case mix reports for private pay patients is identified as a priority function, CMS would not hesitate to call for the removal of the suspension of OASIS for private pay patients.”
In the November 9, 2006, final rule, “Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2007 and Deficit Reduction Act of 2005 Changes to Medicare Payment for Oxygen Equipment and Capped Rental Durable Medical Equipment”, we finalized our policy that the agency would continue to suspend collection of OASIS all payer data (71 FR 65883 and 65889).
Since 2006, CMS has laid the groundwork for the resumption of all-payer data submission because we want to represent overall care being provided to all patients in an HHA. CMS implemented the QIES and iQIES provider data reporting systems to securely transfer and manage assessment data across QRPs, including HH. These systems can now support an extensive range of provider reports, including case-mix reports for private pay patients. The HH QRP program expanded quality domains to include patient reported outcome measures and new assessment and claims-based quality measures. We sought and received public comment on several occasions regarding data reporting on all HHA patients, regardless of payer type. In February 2012, the NQF-convened MAP also issued a report that encouraged establishing a data collection and transmission infrastructure for all payers that would work across PAC settings.
We believe that collecting OASIS data on all HHA patients, regardless of payer, would align our data collection requirements under the HH QRP with the data collection requirements for the LTCH QRP and Hospice QRP. We also believe that the most accurate representation of the quality of care furnished by HHAs is best captured by calculating the assessment-based measures rates using OASIS data submitted on all HHA patients, regardless of payer. New risk adjustment models with all-payer data would better represent the full spectrum of patients receiving skilled care in HHAs. The submission of all-payer OASIS data would also enable us to meaningfully compare performance on quality measures across PAC settings. For example, Changes in Skin Integrity Post-Acute Care is currently reported by different PAC payers on different denominators of payer populations, which greatly inhibits our ability to compare performance on this measure across PAC settings. Standardizing the denominator for cross setting PAC measures to include all patients will enable us to make these comparisons, which we believe will realize our goal of establishing consistent measures of quality across PAC settings.
The concerns raised surrounding privacy outlined above have been mitigated. We take the privacy and security of individually identifiable health information of all patients very seriously. CMS data systems conform to all applicable Federal laws, regulations and standards on information security and data privacy. The systems limit data access to authorized users and monitor such users to help protect against unauthorized data access or disclosures. CMS anticipates updating the current provider data reporting system in iQIES to address the addition of private payer patients.
For these reasons, we are proposing to end the suspension of non-Medicare/Medicaid OASIS data collection and to require HHAs to submit all-payer OASIS data for purposes of the HH QRP beginning with the CY 2025 HH QRP program year. We would use the OASIS data to calculate all measures for which OASIS is a data source. Although the 2006 report recommended that the suspension continue, the subsequent passage of the IMPACT Act (Pub. L. 113-185) in 2014, requiring us to create a uniform quality measurement system which would allow us to compare outcomes across post-acute care providers, requires us to revisit the policy. We have indeed established such a uniform quality measurement system, based on standardized patient assessment data leading us to propose OASIS data collection on Non-Medicare/Non-Medicaid patients. There are now cross-setting quality measures in place that should have consistent reporting parameters but currently do not have consistent reporting parameters because they currently have only Medicare and Medicaid populations. The goal of CMS is to have these measures reported for all patients for all payer sources. The iQIES system utilized by providers is robust enough to make feasible the generation of outcome and case mix reports for private pay patients whereas the 2006 QIES system lacked this functionality. The HH QRP program also has a more robust measure set, including patient reported outcomes, a criteria of importance for CMS to move forward with all-payer collection. We believe that the maturation of the HH QRP as described previously argues for the collection of OASIS all-payer data. It will improve the HH QRP program's ability to assess HHA quality and allow the HH QRP to foster better quality care for patients regardless of payer source. It will also support CMS's ability to compare standardized outcome measures across PAC settings.
Consistent with the two-quarter phase-in that we typically use when adopting new reporting requirements for the HHAs, we are proposing that for the CY 2025 HH QRP, the expanded reporting would be required for patients discharged between January 1, 2024, and June 30, 2024. Beginning with the CY 2026 HH QRP, HHAs would be required to report assessment based quality measure data and standardized patient assessment data on all patients, regardless of payer, for the applicable 12 month performance period (which for the CY 2026 program, would be patients discharged between July 1, 2024, and June 30, 2025).
While we appreciate that submitting OASIS data on all HHA patients regardless of payer source may create additional burden for HHAs, we also note that the current practice of separating and submitting OASIS data on only Medicare beneficiaries has clinical and workflow implications with an associated burden. As noted previously, we also understand that it is common practice for HHAs to collect OASIS data on all patients, regardless of payer source. Requiring HHAs to report OASIS data on all patients will provide CMS with the most robust, accurate reflection of the quality of care delivered to Medicare beneficiaries as compared with non-Medicare patients.
We are proposing to amend the regulation text in § 484.245(b)(1) as a technical change to consolidate the statutory references to data submission
In this technical change we specifically propose moving quality data required under section 1895(b)(3)(B)(v)(II) from § 484.245(b)(1)(iii) to § 484.245(b)(1)(i).
We invite public comments on this proposal.
In the CY 2019 HH PPS final rule with comment period (83 FR 56548 through 56550), we adopted eight measure removal factors that we consider when determining whether to remove measures from the HH QRP measure set:
• Factor 1. Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
• Factor 2. Performance or improvement on a measure does not result in better patient outcomes.
• Factor 3. A measure does not align with current clinical guidelines or practice.
• Factor 4. A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
• Factor 5. A measure that is more proximal in time to desired patient outcomes for the particular topic is available.
• Factor 6. A measure that is more strongly associated with desired patient outcomes for the particular topic is available.
• Factor 7. Collection or public reporting of a measure leads to negative unintended consequences other than patient harm.
• Factor 8. The costs associated with a measure outweigh the benefit of its continued use in the program. To align the HH QRP with similar quality reporting programs (that is SNF QRP, IRF QRP, and LTCH QRP) we are proposing to amend 42 CFR 484.245 to add eight HH QRP measure removal factors in a new paragraph (b)(3). We welcome comments on this proposal.
CMS defines health equity as the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.
Belonging to an underserved community is often associated with worse health outcomes.
We are committed to achieving equity in health care outcomes for beneficiaries by supporting providers in quality improvement activities to reduce health disparities, enabling beneficiaries to make more informed decisions, and promoting provider accountability for health care disparities.
We thank commenters for previous input to our request for information on closing the health equity gap in home health care in the CY 2022 HH PPS final rule (86 FR 62240). Many commenters shared that relevant data collection and appropriate stratification are very important in addressing any health equity gaps. These commenters noted that CMS should consider potential stratification of health outcomes. Stakeholders, including providers, also shared their strategies for addressing health disparities, noting that this was an important commitment for many health provider organizations. Commenters also shared recommendations for additional social determinants of health (SDOH) data elements that could strengthen their assessment of disparities and issues of health equity. SDOH are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.
• What efforts does your HHA employ to recruit staff, volunteers, and board members from diverse populations to represent and serve underserved populations? How does your HHA attempt to bridge any cultural gaps between your personnel and beneficiaries/clients? How does your HHA measure whether this has an impact on health equity?
• How does your HHA currently identify barriers to access to care in your community or service area?
• What are the barriers to collecting data related to disparities, SDOH, and equity? What steps does your HHA take to address these barriers?
• How does your HHA collect self-reported demographic information such as information on race and ethnicity, disability, sexual orientation, gender identity, veteran status, socioeconomic status, and language preference?
• How is your HHA using collected information such as housing, food security, access to interpreter services, caregiving status, and marital status to inform its health equity initiatives?
In addition, we are considering the adoption of a structural composite measure for the HH QRP, which could include organizational activities to address access to and quality of home health care for underserved populations. The composite structural measure concept could include HHA reported data on HHA activities to address underserved populations' access to home health care. An HHA could receive a point (for a total of three points for the three domains) for each domain where data are submitted to a CMS portal, regardless of the action in that domain.
HHAs could submit information such as documentation, examples, or narratives to qualify for the measure numerator. The domains under consideration for the measure, as well as how an HHA could satisfy each of those domains and earn a point for that domain, are the following:
• HHAs attest to whether their strategic plan includes approaches to address health equity in the reporting year.
• HHAs report community engagement and key stakeholder activities in the reporting year.
• HHAs report on any attempts to measure input they solicit from patients and caregivers about care disparities they may experience as well as recommendations or suggestions for improvement.
• HHAs attest as to whether their employed staff were trained in culturally sensitive care mindful of (SDOH in the reporting year and report data relevant to this training, such as documentation of specific training programs or training requirements.
• HHAs attest as to whether they provided resources to staff about health equity, SDOH, and equity initiatives in the reporting year and report data such
Domain 3: HHA leaders and staff can improve their capacity to address health disparities by demonstrating routine and thorough attention to equity and setting an organizational culture of equity. This candidate domain could capture activities related to organizational inclusion initiatives and capacity to promote health equity. Examples of equity-focused factors include proficiency in languages other than English, experience working with diverse populations in the service area, and experience working with individuals with disabilities. Submission of relevant data for all elements could be required to qualify for the measure numerator.
• HHAs attest as to whether they considered equity-focused factors in the hiring of HHA senior leadership, including chief executives and board of trustees, in the applicable reporting year.
• HHAs attest as to whether equity-focused factors were included in the hiring of direct patient care staff (for example, therapists, nurses, social workers, physicians, or aides) in the applicable reporting year.
• HHAs attest as to whether equity focused factors were included in the hiring of indirect care or support staff (for example, administrative, clerical, or human resources) in the applicable reporting year.
We are interested in developing health equity measures based on information collected by HHAs not currently available on claims, assessments, or other publicly available data sources to support development of future quality measures. We are soliciting public comment on the conceptual domains and quality measures described in this section. Furthermore, we are soliciting public comments on publicly reporting a composite structural health equity quality measure; displaying descriptive information on Care Compare from the data HHAs provide to support health equity measures; and the impact of the domains and quality measure concepts on organizational culture change.
The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their digital health information.
To further interoperability in post-acute care settings, CMS and the Office of the National Coordinator for Health Information Technology (ONC) participate in the Post-Acute Care Interoperability Workgroup (PACIO) to facilitate collaboration with industry stakeholders to develop Health Level Seven International® (HL7) Fast Healthcare Interoperability Resources® (FHIR) standards.
The CMS Data Element Library (DEL) continues to be updated and serves as a resource for PAC assessment data elements and their associated mappings to health IT standards, such as Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS' goal of data standardization and interoperability. Standards in the DEL (
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted December 13, 2016) required HHS and ONC to take steps to further interoperability for providers in settings across the care continuum. Section 4003(b) of the Cures Act required ONC to take steps to advance interoperability through the development of a trusted exchange framework and common agreement aimed at establishing a universal floor of interoperability across the country. On January 18, 2022, ONC announced a significant milestone by releasing the Trusted Exchange Framework
We invite readers to learn more about these important developments and how they are likely to affect HHAs.
As authorized by section 1115A of the Act and finalized in the CY 2016 HH PPS final rule (80 FR 68624), the Center for Medicare and Medicaid Innovation (Innovation Center) implemented the
• Provide incentives for better quality care with greater efficiency;
• Study new potential quality and efficiency measures for appropriateness in the home health setting; and,
• Enhance the current public reporting process.
The original HHVBP Model resulted in an average 4.6 percent improvement in HHAs' total performance scores (TPS) and an average annual savings of $141 million to Medicare without evidence of adverse risks.
On January 8, 2021, CMS announced the certification of the HHVBP Model for expansion nationwide, as well as the intent to expand the Model through notice and comment rulemaking.
In the CY 2022 HH PPS final rule (86 FR 62292 through 62336) and codified at 42 CFR part 484, subpart F, we finalized the decision to expand the HHVBP Model to all Medicare certified HHAs in the 50 States, territories, and District of Columbia beginning January 1, 2022. We finalized that the expanded Model will generally use benchmarks, achievement thresholds, and improvement thresholds based on CY 2019 data to assess achievement or improvement of HHA performance on applicable quality measures and that HHAs will compete nationally in their applicable size cohort, smaller-volume HHAs or larger-volume HHAs, as defined by the number of complete unique beneficiary episodes for each HHA in the year prior to the performance year. All HHAs certified to participate in the Medicare program prior to January 1, 2022, will be required to participate and will be eligible to receive an annual Total Performance Score based on their CY 2023 performance.
We finalized the quality measure set for the expanded Model, as well as policies related to the removal, modification, and suspension of applicable measures, and the addition of new measures and the form, manner and timing of the OASIS-based, Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) survey-based, and claims-based measures submission in the applicable measure set beginning CY 2022 and subsequent years. We also finalized an appeals process, an extraordinary circumstances exception policy, and public reporting of annual performance data under the expanded Model.
Additionally, in the CY 2022 HH PPS proposed rule (86 FR 35929) we solicited comments on the challenges unique to value-based purchasing frameworks in terms of health equity and ways in which we could incorporate health equity goals into the expanded HHVBP Model. We received comments related to the use of stabilization measures to promote access to care for individuals with chronic illness or limited ability to improve; collection of patient level demographic information for existing measures; and stratification of outcome measures by various patient populations to determine how they are affected by social determinants of health (SDOH). In the CY 2022 HHPPS final rule (86 FR 62312) we summarized and responded to these comments received.
In this proposed rule, we are proposing to replace the term
Benchmarks, achievement thresholds, and improvement thresholds are used to assess achievement or improvement of HHA performance on applicable quality measures. As codified at § 484.345,
Since that final rule, it has come to our attention that there could be some confusion and we would like to explain our terminology more clearly by proposing to differentiate between two types of baseline years used in the expanded HHVBP Model. The Model baseline year is used to determine the benchmark and achievement threshold for each measure for all HHAs. For example, as finalized, CY 2019 data is used in the calculation of the achievement thresholds and benchmarks for all applicable measures for both the small cohort and for the large cohort. The HHA baseline year is used to determine the HHA improvement threshold for each measure for each individual competing HHA. For example, if an HHA is certified in CY 2021, CY 2022 data would be used in the calculation of the improvement thresholds for all applicable measures for that HHA.
Therefore, we are proposing to amend § 484.345 to remove the existing
We invite public comments on these proposals.
As previously discussed, in the CY 2022 HH PPS final rule (86 FR 62300), we finalized our proposal to use CY 2019 as the baseline year for the expanded HHVBP Model. Our intent was that the Model baseline year used to determine achievement thresholds and benchmarks is CY 2019 for all HHAs and the HHA baseline year used to determine an individual HHA's improvement threshold is 2019 for HHAs certified prior to January 1, 2019. As discussed in the section IV.B.1.b. of this rule, we are proposing to replace the term
As mentioned earlier, in that same rule (86 FR 62423), we codified at § 484.350(b), that for a new HHA that is certified by Medicare on or after January 1, 2019, the baseline year is the first full calendar year of services beginning after the date of Medicare certification, with the exception of HHAs certified on January 1, 2019, through December 31, 2019, for which the baseline year is calendar year (CY) 2021, and the first performance year is the first full calendar year (beginning with CY 2023) following the baseline year. Table D1 depicts what was finalized in the CY 2022 HH PPS final rule.
As discussed in the CY 2022 final rule, we stated that we may conduct analyses of the impact of using various baseline periods and consider any changes for future rulemaking (86 FR 62300). Due to the continuing effects of the COVID-19 public health emergency (PHE), we conducted a measure-by-measure comparison of performance for CY 2019 to CY 2021 for the expanded HHVBP Model's measure set relative to the historical trends of those measures. We found that, while performance scores on the five applicable HHCAHPS measures and the OASIS-based “Discharged to Community” remained stable from CY 2019 to CY 2021, there was a general trend upwards following historical trends for four of the five applicable OASIS-based measures. These trends were consistent with the historical national data that CMS used to monitor the original HHVBP Model beginning 2015.
In contrast, Figures D1 and D2 that were derived from the archived HH quality data from
We note that for HHAs with sufficient data on each of the 12 applicable measures, performance on the two claims-based measures (Acute Care Hospitalization During the First 60 Days of Home Health Use and Emergency Department Use without Hospitalization During the First 60 Days of Home Health) makes up 35 percent of the total performance score used to determine payment adjustments under the Model. While average national performance on these measures in CY 2021 was similar to average national performance in CY 2020, CY 2022 is the first year where the vast majority of beneficiaries are vaccinated; as of January 27, 2022, 95 percent of Americans ages 65 years or older had received at least one dose of vaccine and 88.3 percent were fully vaccinated.
As discussed in the CY 2022 HH PPS final rule, we understand that HHAs want to have time to examine their baseline data as soon as possible, and we stated that we anticipated making available baseline reports using the CY
This proposal is made in conjunction with our proposal to add the definition of the term HHA baseline year discussed previously. We believe that this proposal would allow all eligible HHAs, starting with the CY 2023 performance year, to compete on a level playing field with all HHA baseline data being after the peak of the pandemic. Accordingly, we are proposing to amend § 484.350(b) to reflect that for a new HHA, specifically an HHA that is certified by Medicare on or after January 1, 2022, the HHA baseline year is the first full calendar year of services beginning after the date of Medicare certification, and to add § 484.350(c) to reflect that for an existing HHA, specifically an HHA that is certified by Medicare before January 1, 2022, the HHA baseline year is CY 2022. Table D3 depicts these proposals.
In developing this proposal, we considered changing the HHA baseline year to CY 2021 for all HHAs for all of the applicable measures or, alternatively, not changing the HHA baseline year for any of the applicable measures. We decided against those alternatives for the reasons explained previously in support of our proposal to change the HHA baseline year to CY 2022. We also considered changing the HHA baseline for only some of the applicable measures. For example, we considered changing the HHA baseline to CY 2022 only for the claims-based measures and using the HHA baseline of CY 2019 or CY 2021 (see Table D1) for applicable HHAs for the OASIS-based and HHCAHPS-based measures. However, for the reasons previously discussed, we are instead proposing to change the HHA baseline year to CY 2022 for all applicable measures used in the expanded HHVBP Model, which would allow all HHAs certified by Medicare prior to CY 2022 to have the same baseline period for all measures, using the most recent available data, for the performance year beginning CY 2023.
We invite public comments on these proposals.
As mentioned earlier, under the policy finalized in the CY 2022 HH PPS final rule (86 FR 62300), we previously adopted CY 2019 as the Model baseline year for the expanded HHVBP Model for all HHAs. This baseline year is used to determine the benchmarks and achievement threshold for each measure for all HHAs.
Consistent with our proposal to update the HHA baseline year to CY 2022 for all HHAs that are certified by Medicare before January 1, 2022, and in conjunction with our proposal to more clearly define the Model baseline year in previous section IV.B.1.b., we are also proposing to change the Model baseline year from CY 2019 to CY 2022 for the CY 2023 performance year and subsequent years. This would enable us to measure competing HHAs' performance using benchmarks and achievement thresholds that are based on the most recent data available. This would also allow the benchmarks and achievement thresholds to be set using data from after the most acute phase of the COVID-19 PHE, which we believe would provide a more appropriate basis for assessing performance under the expanded Model than the CY 2019 pre-PHE period. As previously discussed, CY 2022 is the first year where the vast majority of beneficiaries are vaccinated, there are viable treatments available and healthcare providers had nearly two years of experience managing COVID-19 patients. We anticipate that this more recent data from the CY 2022 time period would more likely be aligned with performance years' data under the expanded Model. As discussed in connection with our proposal to use CY 2022 data for the HHA baseline year, if we were to finalize this proposal to use CY 2022 rather than CY 2019 data for the Model baseline year, we would anticipate providing HHAs with the final achievement thresholds and benchmarks in the July 2023 IPR in the summer of CY 2023. This would be consistent with the rollout of the original HHVBP Model in which benchmarks and achievement thresholds using 2015 data were made available to HHAs during the summer of the first performance year (CY 2016).
We invite public comments on this proposal.
Significant and persistent inequities in healthcare outcomes exist in the United States. Belonging to a racial or ethnic minority group; living with a disability; being a member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; living in a rural area; being a member of a religious minority; or being near or below the poverty level, is often associated with worse health
As we continue to leverage our value-based purchasing initiatives to improve the quality of care furnished across healthcare settings, we are interested in exploring the role of health equity in creating better health outcomes for all populations in our programs and models. As the March 2020 Assistant Secretary for Planning and Evaluation (ASPE) Report to Congress on Social Risk Factors and Performance in Medicare's Value-Based Purchasing Program notes, it is important to implement strategies that cut across all programs and health care settings to create aligned incentives that drive providers to improve health outcomes for all beneficiaries.
As we continue to develop policies for the expanded HHVBP Model, we are requesting public comments on policy changes that we should consider on the topic of health equity. We specifically request comments on whether we should consider incorporating adjustments into the expanded HHVBP Model to reflect the varied patient populations that HHAs serve around the country and tie health equity outcomes to the payment adjustments we make based on HHA performance under the Model. These adjustments could be made at the measure level in forms such as stratification (for example, based on dual status or other metrics), or we could propose to adopt new measures of social determinants of health (SDOH). These adjustments could also be incorporated at the scoring level in forms such as modified benchmarks, points adjustments, or modified payment adjustment percentages (for example, peer comparison groups based on whether the HHA includes a high proportion of dual eligible beneficiaries or other metrics). We request commenters' views on which of these adjustments, if any, would be most effective for the expanded HHVBP Model.
In accordance with section 1834(u)(3) of the Act and 42 CFR 414.1550, our national home infusion therapy (HIT) services payment rates for the initial and subsequent visits in each of the home infusion therapy payment categories for CY 2023 are required to be the CY 2022 rate adjusted by the percentage increase in the Consumer Price Index (CPI) for all urban consumers (United States city average) for the 12 month period ending with June of the preceding year reduced by a productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act as the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity. Section 1834(u)(3) of the Act further states that the application of the productivity adjustment may result in a percentage being less than 0.0 for a given year, and may result in payment being less than such payment rates for the preceding year. We note that § 414.1550(d) does not permit any exercise of discretion by the Secretary. The single payment amounts are also adjusted for geographic area wage differences using the geographic adjustment factor (GAF). We remind stakeholders that the GAFs are a weighted composite of each Physician Fee Schedule (PFS) localities work, practice expense (PE) and malpractice (MP) expense geographic practice cost indices (GPCIs). The periodic review and adjustment of the GPCIs is mandated by section 1848(e)(1)(C) of the Act. At each update, the proposed GPCIs are published in the PFS proposed rule to provide an opportunity for public comment and further revisions in response to comments prior to implementation. The GPCIs and the GAFs are updated triennially with a 2 year phase in and were last updated in the CY 2020 PFS final rule
The updated GAFs, national home infusion therapy payment rates, and locality-adjusted home infusion therapy payment rates will be posted on CMS' Home Infusion Therapy Services web page
Under the Paperwork Reduction Act of 1995, we are required to provide a 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.
In this proposed rule, we are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
In section III. of this proposed rule, we are proposing to end the suspension of the collection of OASIS data on non-Medicare and non-Medicaid patients and to require HHAs to submit all-payer OASIS data for purposes of the HH QRP, beginning with the CY 2025 program year. We believe that the burden associated with this proposal is the time and effort associated with the submission of non-Medicare and non-Medicaid OASIS data. The submission of OASIS data on HH patients regardless of payor source will ensure that CMS can appropriately assess the quality of care provided to all patients receiving skilled care by all Medicare-certified HHAs that participate in the HH QRP. As of January 1, 2022, there are approximately 11,354 HHAs reporting OASIS data to CMS under the HH QRP.
The OASIS is completed by RNs or PTs, or very occasionally by occupational therapists (OT) or speech language pathologists (SLP/ST). Data from 2020 show that the SOC/ROC OASIS is completed by RNs (approximately 76.50 percent of the time), PTs (approximately 20.78 percent of the time), and other therapists, including OTs and SLP/STs (approximately 2.72 percent of the time). Based on this analysis, we estimated a weighted clinician average hourly wage of $79.41, inclusive of fringe benefits, using the hourly wage data in Table F1. Individual providers determine the staffing resources necessary.
For purposes of calculating the costs associated with the information collection requirements, we obtained mean hourly wages for these from the U.S. Bureau of Labor Statistics' May 2020 National Occupational Employment and Wage Estimates (
We estimate that this proposed new requirement would result in HHAs having to increase by 30 percent the number of assessments they complete at each timepoint, with a corresponding 30 percent increase in their estimated hourly burden and estimated clinical cost.
Table F2 shows the total number of OASIS assessments that HHAs actually completed in CY 2020, as well as how those numbers would have increased if non-Medicare and non-Medicaid OASIS assessments had been required at that time.
Table F3 summarizes the estimated clinician hourly burden for Medicare only, non Medicare, and all-payer patients receiving HH care for each OASIS assessment type using CY 2020 assessment totals.
The calculations we used to estimate the total all-payer hourly burden with CY 2020 assessment totals and OASIS-E data elements at each time point of OASIS data collection are as follows:
Table F4 summarizes the estimated clinician costs for the completion of the OASIS-E assessment tool for Medicare only, Non-Medicare, and All-Payer patients receiving HH care for each OASIS assessment type using CY2020 assessment and cost data.
Outlined later are the calculation for estimates used to derive total all-payer costs with OASIS E data elements for each OASIS assessment type using CY2020 assessment and cost data:
Based on the data in Tables F1 to F3 for the 11,354 active Medicare-certified HHAs, we estimate the total increase in costs associated with the changes in the HH QRP to be approximately 23,529.82 per HHA annually or $267,157,680.3 all HHAs. This corresponds to an estimated increase in clinician burden associated with the changes to the HH QRP of approximately 296.3 hours per HHA or approximately 3,364,285 hours for all HHAs. This additional burden would begin with January 1, 2024 HHA discharges. We have also included a request for information (RFI) related to potentially applying health equity to the expanded HHVBP Model in the future. Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the expanded HHVBP Model, from the provisions of the PRA. Specifically, this section provides that the provisions of the PRA do not apply to the testing and evaluation of Innovation Center models or to the expansion of such models.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection requirements. The requirements are not effective until they have been approved by OMB.
We invite public comments on these information collection requirements. If you wish to comment, please identify the rule (CMS-1766-P) and, where applicable, the preamble section, and the ICR section. See this rule's
Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of home health services paid under Medicare. In addition, section 1895(b) of the Act requires: (1) the computation of a standard prospective payment amount include all costs for home health services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary; (2) the prospective payment amount under the HH PPS to be an appropriate unit of service based on the number, type, and duration of visits provided within that unit; and (3) the standardized prospective payment amount be adjusted to account for the effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the home health applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard prospective payment amount be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of appropriate case-mix adjustment factors for significant variation in costs among different units of services. Lastly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to home health services furnished in a geographic area compared to the applicable national average level.
Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with the authority to implement adjustments to the standard prospective payment amount (or amounts) for subsequent years to eliminate the effect of changes in aggregate payments during a previous year or years that were the result of changes in the coding or classification of different units of services that do not reflect real changes in case-mix. Section 1895(b)(5) of the Act provides the Secretary with the option to make changes to the payment amount otherwise paid in the case of outliers because of unusual variations in the type or amount of medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data for purposes of measuring health care quality, and links the quality data submission to the annual applicable percentage increase. Section 50208 of the BBA of 2018 (Pub. L. 115-123) requires the Secretary to implement a new methodology used to determine rural add-on payments for CYs 2019 through 2022.
Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, required the Secretary to implement a 30-day unit of service, for 30-day periods beginning on and after January 1, 2020. The HH PPS wage index utilizes the wage adjustment factors used by the Secretary for purposes of sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for hospital wage adjustments.
Section 1895(b)(3)(B)(v) of the Act authorizes the HH QRP, which requires HHAs to submit data in accordance with the requirements specified by CMS. Failure to submit data required under section 1895(b)(3)(B)(v) of the Act with respect to a program year will result in the reduction of the annual home health market basket percentage increase otherwise applicable to an HHA for the corresponding calendar year by 2 percentage points.
In the CY 2022 HH PPS final rule (86 FR 62292 through 62336) and codified at 42 CFR part 484, subpart F, we finalized our policy to expand the HHVBP Model to all Medicare certified HHAs in the 50 States, territories, and District of Columbia beginning January 1, 2022. CY 2022 was designated as a pre-implementation year during which CMS will provide HHAs with resources and training. This pre-implementation year as intended to allow HHAs time to prepare and learn about the expectations and requirements of the expanded HHVBP Model without risk to payments.
We also finalized that the expanded Model will use a baseline year to establish the benchmarks and achievement thresholds for each cohort on each measure for HHAs. The baseline year is currently 2019. In this rule, we are proposing to establish a separate HHA baseline year to determine HHA improvement thresholds by measure for each individual agency to assess achievement or improvement of HHA performance on applicable quality measures. As codified at § 484.350(b), for an HHA that is certified by Medicare on or after January 1, 2019, the baseline year is the first full calendar year of services beginning after the date of Medicare certification, with the exception of HHAs certified on January 1, 2019, through December 31, 2019, for which the baseline year is calendar year (CY) 2021, and the first performance year is the first full calendar year (beginning with CY 2023) following the baseline year. As discussed in that final rule, we stated that we may conduct analyses of the impact of using various baseline periods and consider any changes for future rulemaking.
Due to the continuation of the COVID-19 PHE through CY 2021 and its effects on the quality measures in the expanded HHVBP Model used to determine payment adjustments for eligible HHAs (as described in section IV.B.2.b. of this proposed rule), we believe an HHA's baseline year that would be CY 2021 should be adjusted to CY 2022. This policy aligns with similar proposals in the Hospital VBP and SNF VBP Programs to account for the continued effects of the PHE on measures in 2021. Additionally, amending the HHA baseline year (and defining this term) for HHAs certified prior to 2022 starting in the CY 2023 performance year as well as changing the Model baseline year (and defining this term) to CY 2022 starting in the CY 2023 performance year allows eligible HHAs to be scored on measure data that is more current and is intended to compare HHAs to a base year that is 2 years after the peak of the pandemic.
Section 1834(u)(1) of the Act, as added by section 5012 of the 21st Century Cures Act, requires the Secretary to establish a home infusion therapy services payment system under Medicare. This payment system requires a single payment to be made to a qualified home infusion therapy supplier for items and services furnished by a qualified home infusion therapy supplier in coordination with the furnishing of home infusion drugs. Section 1834(u)(1)(A)(ii) of the Act states that a unit of single payment is for each infusion drug administration calendar day in the individual's home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to consider variation in utilization of nursing services by therapy type. Section 1834(u)(1)(A)(iii) of the Act provides a limitation to the single payment amount, requiring that it shall not exceed the amount determined under the Physician Fee Schedule (under section 1848 of the Act) for infusion therapy services furnished in a
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2))
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). 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 $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (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 novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive order. Therefore, we estimate that this rule is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that presents our best estimate of the costs and benefits of this rule.
This rule proposes updates to Medicare payments under the HH PPS for CY 2023. The net transfer impact related to the changes in payments under the HH PPS for CY 2023 is estimated to be −$810 million (−4.2 percent). The $810 million decrease in estimated payments for CY 2023 reflects the effects of the proposed CY 2023 home health payment update percentage of 2.9 percent ($560 million increase), an estimated 6.9 percent decrease that reflects the effects of the permanent behavioral adjustment ($1.33 billion decrease) and an estimated 0.2 percent decrease that reflects the effects of an updated FDL ($40 million decrease).
We use the latest data and analysis available, however, we do not adjust for future changes in such variables as number of visits or case-mix. This analysis incorporates the latest estimates of growth in service use and payments under the Medicare home health benefit, based primarily on Medicare claims data for periods that ended on or before December 31, 2021. We note that certain events may combine to limit the scope or accuracy of our impact analysis, because such an analysis is future-oriented and, thus, susceptible to errors resulting from other changes in the impact time period assessed. Some examples of such possible events are newly-legislated general Medicare program funding changes made by the Congress or changes specifically related to HHAs. In addition, changes to the Medicare program may continue to be made as a result of new statutory provisions. Although these changes may not be specific to the HH PPS, the nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon HHAs.
Table F5 represents how HHA revenues are likely to be affected by the finalized policy changes for CY 2023. For this analysis, we used an analytic file with linked CY 2021 OASIS assessments and home health claims data for dates of service that ended on or before December 31, 2021. The first column of Table F5 classifies HHAs according to a number of characteristics including provider type, geographic region, and urban and rural locations. The second column shows the number of facilities in the impact analysis. The third column shows the payment effects of the permanent behavioral adjustment on all payments. The fourth column shows the payment effects of the recalibration of the case-mix weights offset by the case-mix weights budget neutrality factor. The fifth column shows the payment effects of updating to the CY 2023 wage index with a 5-percent cap on wage index decreases. The sixth column shows the payment effects of the final CY 2023 home health payment update percentage. The seventh column shows the payment effects of the new FDL, and the last column shows the combined effects of all the finalized provisions.
Overall, it is projected that aggregate payments in CY 2023 would decrease by 4.2 percent which reflects the 6.9 percent decrease from the permanent behavioral adjustment, the 2.9 payment update percentage increase, and the 0.2 percent decrease from increasing the FDL. As illustrated in Table F5, the combined effects of all of the changes vary by specific types of providers and by location. We note that some individual HHAs within the same group may experience different impacts on payments than others due to the distributional impact of the CY 2023 wage index, the percentage of total HH PPS payments that were subject to the LUPA or paid as outlier payments, and the degree of Medicare utilization.
Failure to submit HH QRP data required under section 1895(b)(3)(B)(v) of the Act with respect to a program year will result in the reduction of the annual home health market basket percentage increase otherwise applicable to an HHA for the corresponding calendar year by 2 percentage points. For the CY 2022 program year, 1,169 of the 11,128 active Medicare-certified HHAs, or approximately 10.4 percent, did not receive the full annual percentage increase because they did not meet assessment submission requirements. The 1,169 HHAs that did not satisfy the reporting requirements of the HH QRP for the CY 2022 program year represent $437 million in home health claims payment dollars during the reporting period out of a total $17.3 billion for all HHAs.
As discussed in section III. of this proposed rule, we are proposing to end the temporary suspension of non-Medicare/Medicaid data under section 704 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and, in accordance with section 1895(b)(3)(B)(v) of the Act, to require HHAs to report all-payer OASIS data for purposes of the HH QRP, beginning with the CY 2025 program year.
Section III. of this proposed rule provides a detailed description of the net increase in burdens associated with these proposed changes. We are proposing that HHAs would be required to begin reporting all-payer OASIS data beginning with January 1, 2024, discharges. The cost impact of this proposal is estimated to be a net increase of $267,157,680.3 in annualized cost to HHAs, discounted at 7 percent relative to year 2020, over a perpetual time horizon beginning in CY 2025. We described the estimated burden and cost reductions for these measures in section V1V1.B.1. of this proposed rule. In summary, the submission of data on non-Medicare/Medicaid patients for the HH QRP is estimated to increase the burden on HHAs to $23,529.82 per HHA annually, or $267,157,680.3 for all HHAs annually.
In the CY 2022 HHPPS final rule (86 FR 62402 through 62410), we estimated that the expanded HHVBP Model would generate a total projected 5-year gross FFS savings, CYs 2023 through 2027, of $3,376,000,000. The proposed changes to the baseline years in this proposed rule will not change those estimates because they do not change the number of HHAs in the Model or the payment methodology.
There are no new proposals in this rule related to payments for home infusion therapy services in CY 2023. The CY 2023 home infusion therapy service payments will be updated by the CPI-U reduced by the productivity adjustment and geographically adjusted in a budget neutral manner using the GAF standardization factor. The CY 2023 final GAF values (and the CPI-U as of June 2022) were not available at the time of rulemaking, therefore, we are unable to estimate the impact of these adjustments on the CY 2023 HIT service payment amounts compared to the CY 2022 HIT service payment amounts.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed or final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We seek comments on the approach used in estimating the number of entities reviewing 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 rule is $115.22 per hour, including overhead and fringe benefits
For the CY 2023 HH PPS proposed rule, we considered alternatives to the provisions articulated in section II.B.2. of this proposed rule. Specifically, we considered other potential methodologies to determine the difference between assumed versus actual behavior change on estimated aggregate expenditures in response to the comment solicitation in the CY 2022 HH PPS proposed rule (86 FR 35892). However, most of the alternate methodologies controlled for certain actual behavior changes (for example, the reduction in therapy visits) and this is not in alignment with what the statute requires at section 1895(b)(3)(D)(i) of the Act where we must examine actual behavior change. Therefore, any method that would control for an actual behavior change would be counter to what is required by law. Additionally, we considered alternative approaches to the implementation of the permanent and temporary behavior assumption adjustments. As described in section II.B.2. of this rule, to help prevent future over or underpayments, we calculated a permanent prospective adjustment by determining what the 30-day base payment amount should have been in CYs 2020 and 2021 in order to achieve the same estimated aggregate expenditures as obtained from the simulated 60-day episodes. One alternative to the proposed −7.69 percent permanent payment adjustment included a phase-in approach, where we could reduce the permanent adjustment, by spreading out the adjustment over a period of a few years. Another alternative would be to delay the permanent adjustment to a future year. However, we believe that a phase-in approach or delay for the permanent adjustment would not be appropriate, as phasing in or delaying the permanent adjustment would further impact budget neutrality and likely lead to a compounding effect creating the need for a larger reduction to the payment rate in future years.
Finally, we considered proposing to implement the one-time temporary adjustment to reconcile retrospective overpayments in CYs 2020 and 2021. We note that MedPAC's March 2022 Report to Congress
We did not consider any alternatives in this proposed rule.
We discuss the alternative we considered to the proposed change to the HHA baseline year for each applicable measure in the expanded HHVBP Model in section IV.B.2.b. of this proposed rule.
We did not consider any alternatives in this proposed rule.
As required by OMB Circular A-4 (available at
As required by OMB Circular A-4 (available at
As required by OMB Circular A-4 (available at
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. In addition, HHAs and home infusion therapy suppliers are small entities, as that is the term used in the RFA. Individuals and States are not included in the definition of a small entity.
The North American Industry Classification System (NAICS) was adopted in 1997 and is the current standard used by the Federal statistical agencies related to the U.S. business economy. We utilized the NAICS U.S. industry title “Home Health Care Services” and corresponding NAICS code 621610 in determining impacts for small entities. The NAICS code 621610 has a size standard of $16.5 million
The economic impact assessment is based on estimated Medicare payments (revenues) and HHS's practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. The majority of HHAs' visits are Medicare paid visits and therefore the majority of HHAs' revenue consists of Medicare payments. Based on our analysis, we conclude that the policies proposed in this rule would result in an estimated total impact of 3 to 5 percent or more on Medicare revenue for greater than 5 percent of HHAs. Therefore, the Secretary has determined that this HH PPS proposed rule would have significant economic impact on a substantial number of small entities. We estimate that the net impact of the policies in this rule is approximately $810 million in decreased payments to HHAs in CY 2023. The $810 million in decreased payments is reflected in the last column of the first row in Table F5 as a 4.2 percent decrease in expenditures when comparing CY 2023 payments to estimated CY 2022 payments. The 4.2 percent decrease is mostly driven by the impact of the permanent behavior assumption adjustment reflected in the third column of Table F5. Further detail is presented in Table F5, by HHA type and location.
With regards to options for regulatory relief, we note that section
Guidance issued by HHS interpreting the Regulatory Flexibility Act considers the effects economically ‘significant’ only if greater than 5 percent of providers reach a threshold of 3- to 5-percent or more of total revenue or total costs. Among the over 7,500 HHAs that are estimated to qualify to compete in the expanded HHVBP Model, we estimate that the percent payment adjustment resulting from this rule would be larger than 3 percent, in magnitude, for about 28 percent of competing HHAs (estimated by applying the proposed 5-percent maximum payment adjustment under the expanded Model to CY 2019 data). As a result, more than the RFA threshold of 5-percent of HHA providers nationally would be significantly impacted. We refer readers to Tables 43 and 44 in the CY 2022 HH PPS final rule (86 FR 62407 through 62410) for our analysis of payment adjustment distributions by State, HHA characteristics, HHA size and percentiles.
Thus, the Secretary has certified that this proposed rule would have a significant economic impact on a substantial number of small entities. Though the RFA requires consideration of alternatives to avoid economic impacts on small entities, the intent of the rule, itself, is to encourage quality improvement by HHAs through the use of economic incentives. As a result, alternatives to mitigate the payment reductions would be contrary to the intent of the rule, which is to test the effect on quality and costs of care of applying payment adjustments based on HHAs' performance on quality measures.
In addition, section 1102(b) of the Act requires us to prepare a Regulatory Impact Analysis (RIA) 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 603 of 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. This rule is not applicable to hospitals. Therefore, the Secretary has certified that this proposed rule would not have a significant economic impact on the operations of small rural hospitals.
Section 202 of UMRA 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 2022, that threshold is approximately $165 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 $165 million in any one year.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have reviewed this proposed rule under these criteria of Executive Order 13132, and have determined that it would not impose substantial direct costs on State or local governments.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on June 10, 2022.
Health facilities, Health professions, Medicare, and 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 follows:
42 U.S.C. 1302 and 1395hh.
(c) Beginning on January 1, 2023, CMS applies a cap on decreases to the home health wage index such that the wage index applied to a geographic area is not less than 95 percent of the wage index applied to that geographic area in the prior calendar year. The 5-percent cap on negative wage index changes is implemented in a budget neutral manner through the use of wage index budget neutrality factors.
The addition reads as follows:
(b) * * *
(3) CMS may remove a quality measure from the HH QRP based on one or more of the following factors:
(i) Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made.
(ii) Performance or improvement on a measure does not result in better patient outcomes.
(iii) A measure does not align with current clinical guidelines or practice.
(iv) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic.
(v) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic.
(vi) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic.
(vii) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm.
(viii) The costs associated with a measure outweigh the benefit of its continued use in the program.
The additions read as follows:
(b)
(1) The HHA baseline year is the first full calendar year of services beginning after the date of Medicare certification.
(2) The first performance year is the first full calendar year following the HHA baseline year.
(c)