Congress directed the Secretary of Agriculture (Secretary) to provide economic adjustment assistance to domestic users of upland cotton under the Economic Adjustment Assistance to Users of Upland Cotton program in section 1207(c) of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-234; May 22, 2008). Under the program domestic users of upland cotton may qualify for financial assistance that can be used to acquire, construct, install, modernize, develop, convert, or expand land, plant, buildings, equipment, facilities, or machinery. Payments for such assistance are issued by CCC. Section 1203(b) of the Agriculture Improvement Act of 2018 (Pub. L. 115-334; December 20, 2018) renamed the program “Economic Assistance Adjustment to Textile Mills” (EAATM). Regulations implementing the EAATM are found at 7 CFR part 1427, in subpart C, in §§ 1427.100 to 1427.105.

In a memorandum dated July 1, 2019, 1 the Secretary redelegated authority to administer EAATM from the Farm Service Agency to the Agricultural Marketing Service (AMS). A final rule published October 15, 2020 (85 FR 65500), amended 7 CFR part 2 to reflect the redelegation. Amended § 2.79(a)(23) authorizes the AMS Administrator to administer the EAATM program (7 U.S.C. 9037(c)). The redelegation of authority necessitates the transfer of corresponding regulations to AMS, giving the AMS Administrator authority to issue, maintain, and revise the regulations pertaining to EAATM. This final rule completes the necessary transfer.

Currently, Title 7, Chapter XIV, part 1427 of the Code of Federal Regulations (CFR) contains the EAATM regulations (in §§ 1427.100 to 1427.105), under CCC administration. This final rule removes the EAATM regulations from 7 CFR part 1427 and adds them in a new part 870—Economic Adjustment Assistance to Textile Mills—to 7 CFR chapter VIII, Subchapter B. Currently Subchapter B is titled “Regulations for Warehouses” and contains part 869—Regulations for the United States Warehouse Act (USWA). This final rule revises the title for Subchapter B to read “Fair Trade Practices” to reflect the delegation of administrative authority for both USWA and EAATM activities to the AMS Administrator. The Deputy Administrator of AMS's Fair Trade Practices Program (FTPP) oversees USWA and EAATM activities for the Administrator. Finally, this rule makes a conforming change to the text of the EAATM regulations to reflect the program's revised name.

This final rule is administrative in nature and reflects changes in USDA's organization. Accordingly, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required, and this rule may be made effective in fewer than 30 days after publication in the Federal Register . Therefore, this final rule is effective upon publication.

Additionally, this rule is exempt from the provisions of Executive Order 12866, as it is limited to agency management. This action is not a rule as defined by the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq., and thus is exempt from the provisions of those Acts. This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act (5 U.S.C. 801 et seq. ) provides exemptions for rules “of particular applicability;” “relating to agency management or personnel;” or “of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties.” This action qualifies for this exemption.

AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

For the reasons stated in the preamble, as authorized by the Secretary's Memorandum implementing the Agriculture Improvement Act of 2018, dated July 1, 2019, the Department of Agriculture amends 7 CFR chapters VIII and XIV as follows:

Please refer to Docket ID NRC-2021-0135 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:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2021-0135. Address questions about NRC dockets to Dawn Forder, telephone: 301-415-3407, email: Dawn.Forder@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• Attention: The PDR, where you may examine and order copies of public documents, is currently closed. You may submit your request to the PDR via email at pdr.resource@nrc.gov or call 1-800-397-4209 between 8:00 a.m. and 4:00 p.m. (EST), Monday through Friday, except Federal holidays.

Please include Docket ID NRC-2021-0135 in your comment submission. The NRC requests that you submit comments through the Federal rulemaking website at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

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 https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

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.

This rule is limited to the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 to Certificate of Compliance No. 1008 and does not include other aspects of the Holtec International HI-STAR 100 Cask System design. The NRC is using the “direct final rule procedure” to issue this renewal because it represents a limited and routine change to an existing certificate of compliance that is expected to be non-controversial. Adequate protection of public health and safety continues to be reasonably assured. The amendment to the rule will become effective on December 15, 2021. However, if the NRC receives any significant adverse comment on this direct final rule by November 1, 2021, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC to make a change (other than editorial) to the rule, certificate of compliance, or technical specifications.

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended, requires that “[t]he Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the Nuclear Waste Policy Act states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on September 3, 1999 (64 FR 48259) that approved the HI-STAR 100 Cask System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1008.

On December 7, 2018, Holtec International submitted a request to the NRC to renew, for an additional 40 years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 for the HI-STAR 100 Cask System. Holtec International supplemented its request on June 28, 2019, October 10, 2019, December 12, 2019, June 1, 2020, June 11, 2020, November 13, 2020, and November 24, 2020.

The renewal of the initial certificate and Amendment Nos. 1, 2, and 3 were conducted in accordance with the renewal provisions in § 72.240. This section of the NRC spent fuel storage regulations authorizes NRC staff to include any additional certificate conditions it deems necessary to ensure the safe operation of the cask during the certificate's renewal period. The NRC included three additional conditions to the renewal of the initial certificate of compliance and Amendment Nos. 1, 2, and 3:

• The submittal of an updated final safety analysis report (UFSAR) to address aging management activities resulting from the renewal of the certificate of compliance. This condition ensures that the UFSAR changes are made in a timely fashion to enable general licensees using the storage system during the period of extended operation to develop and implement necessary procedures.

• The requirement that general licensees initiating or using spent fuel dry storage operations with the HI-STAR 100 Cask System ensure that their evaluations are included in the reports required by § 72.212, “Conditions of general license issued under § 72.210.” These reports will include appropriate considerations for the period of extended operation, a review of the UFSAR changes resulting from the certificate of compliance renewal, and a review of the NRC safety evaluation report (SER) related to the certificate of compliance renewal.

• The requirement that future amendments and revisions to this certificate of compliance include evaluations of the impacts to aging management activities to ensure that they remain adequate for any changes to the structures, systems, and components (SSCs).

The NRC made one corresponding change to the technical specifications for the initial certificate of compliance and Amendment Nos. 1, 2, and 3 on the aging management program. The change added a new section, which ensures that general licensees using the storage system develop procedures to address aging management activities required in the period of extended operation.

As documented in the preliminary SER, the NRC performed a safety evaluation of the proposed certificate of compliance renewal request. The NRC determined that this renewal does not change the cask design or fabrication requirements in the proposed certificate of compliance renewal request. The NRC determined that the design of the cask would continue to maintain confinement, shielding, and criticality control in the event of each evaluated accident condition. In addition, any resulting occupational exposure or offsite dose rates from the renewal of the initial certificate of compliance and Amendment Nos. 1, 2, and 3 would remain well within the limits specified by 10 CFR part 20, “Standards for Protection Against Radiation.” Thus, the NRC found there will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents. In its SER for the renewal of the HI-STAR 100 Cask System, the NRC has determined that if the conditions specified in the certificate of compliance to implement these regulations are met, adequate protection of public health and safety will continue to be reasonably assured.

This direct final rule revises the HI-STAR 100 Cask System listing in § 72.214 by renewing, for 40 more years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008. The renewal consists of the changes previously described, as set forth in the renewed initial certificate and amendments and their revised technical specifications. The revised technical specifications are identified in the SER.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC revises the Holtec International HI-STAR 100 Cask System Cask System design listed in § 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the Federal Register on October 18, 2017 (82 FR 48535), this rule is classified as Compatibility Category NRC—Areas of Exclusive NRC Regulatory Authority. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR chapter I. Therefore, compatibility is not required for program elements in this category. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category “NRC” does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular State's administrative procedure laws.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885).

Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this direct final rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

The action is to amend § 72.214 to revise the Holtec International HI-STAR 100 Cask System listing within the “List of approved spent fuel storage casks” to renew, for an additional 40 years, the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008.

This direct final rule renews the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 for the Holtec International HI-STAR 100 Cask System design within the list of approved spent fuel storage casks to allow power reactor licensees to store spent fuel at reactor sites in casks with the approved modifications under a general license. Specifically, this rule extends the expiration date for the Holtec International HI-STAR 100 Cask System certificate for an additional 40 years, allowing a power reactor licensee to continue using it under general license provisions in an independent spent fuel storage installation to store spent fuel in dry casks in accordance with 10 CFR part 72.

On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act of 1969, as amended. As required by § 72.240, applications for renewal of a spent fuel storage certificate of compliance design are required to demonstrate that SSCs important to safety will continue to perform their intended function for the requested renewal term. As discussed in the NRC staff's SER for the renewal of the initial certificate and Amendment Nos. 1, 2, and 3, the NRC staff has approved conditions in the renewed initial certificate and Amendment Nos. 1, 2, and 3 requiring the general licensee to implement the aging management activities described in the renewal application and incorporated into the UFSAR. These conditions ensure that the Holtec International HI-STAR 100 Cask System will continue to perform its intended safety functions and provide reasonable assurance of adequate protection of public health and safety throughout the renewal period.

Incremental impacts from continued use of the HI-STAR 100 Cask System under a general license for an additional 40 years are not considered significant. When the general licensee follows all procedures and administrative controls, including the conditions established because of this renewal, no effluents are expected from the sealed dry cask systems. Activities associated with cask loading and decontamination may result in some small incremental liquid and gaseous effluents, but these activities will be conducted under 10 CFR parts 50 and 52 reactor operating licenses, and effluents will be controlled within existing reactor site technical specifications. Because reactor sites are relatively large, any incremental offsite doses due to direct radiation exposure from the spent fuel storage casks are expected to be small, and when combined with the contribution from reactor operations, well within the annual dose equivalent of 0.25 mSv (25 mrem) limit to the whole body specified in § 72.104. Incremental impacts on collective occupational exposures due to dry cask spent fuel storage are expected to be only a small fraction of the exposures from operation of the nuclear power station.

The HI-STAR 100 Cask System is designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

During the promulgation of the amendments that added subpart K to 10 CFR part 72 (55 FR 29181; July 18, 1990), the NRC staff assessed the public health consequences of dry cask storage accidents and sabotage events. In the supporting analyses for these amendments, the NRC staff determined that a release from a dry cask storage system would be comparable in magnitude to a release from the same quantity of fuel in a spent fuel storage pool. As a result of these evaluations, the NRC staff determined that, because of the physical characteristics of the storage casks and conditions of storage that include specific security provisions, the potential risk to public health and safety due to accidents or sabotage is very small.

Considering the specific design requirements for each accident or sabotage condition, the design of the cask would maintain confinement, shielding, and criticality control. If confinement, shielding, and criticality control are maintained, the environmental impacts from an accident would be insignificant.

There are no changes to cask design or fabrication requirements in the renewed initial certificate or Amendment Nos. 1, 2, and 3. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 would remain well within the 10 CFR part 20 limits.

Decommissioning of dry cask spent fuel storage systems under a general license would be carried out as part of a power reactor's site decommissioning plan. In general, decommissioning would consist of removing the spent fuel from the site, decontaminating cask surfaces, and decontaminating and dismantling the independent spent fuel storage installation where the casks were deployed. Under normal and off-normal operating conditions, no residual contamination is expected to be left behind on supporting structures. The incremental impacts associated with decommissioning dry cask storage installations are expected to represent a small fraction of the impacts of decommissioning an entire nuclear power station.

In summary, the proposed changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. Compliance with the requirements of 10 CFR parts 20 and 72 would provide reasonable assurance that adequate protection of public health and safety will continue. The NRC, in its SER for the renewal of the HI-STAR 100 Cask System, has determined if the conditions specified in the certificate of compliance to implement these regulations are met, adequate protection of public health and safety will continue to be reasonably assured.

Based on the previously stated assessments and its SER for the requested renewal of the HI-STAR 100 Cask System certificates, the NRC has determined that the expiration date of this system in 10 CFR 72.214 can be safely extended for an additional 40 years, and that commercial nuclear power reactor licensees can continue using the system during this period under a general license without significant impacts on the human environment.

The alternative to this action is to deny approval of the renewal and not issue the direct final rule. Under this alternative, the NRC would either (1) require general licensees using the HI-STAR 100 Cask System to unload the spent fuel from these systems and either return it to a spent fuel pool or re-load it into a different dry storage cask system listed in § 72.214; or (2) require that users of the existing HI-STAR 100 Cask System request site-specific licensing proceedings to continue storage in these systems.

The environmental impacts of requiring the licensee to unload the spent fuel and either return it to the spent fuel pool or re-load it into another NRC-approved cask system would result in increased radiological doses to workers. These increased doses would be due primarily to direct radiation from the casks while the workers unloaded, transferred, and re-loaded the spent fuel. These activities would consist of transferring the dry storage canisters to a cask-handling building, opening the canister lid welds, returning the canister to a spent fuel pool or dry transfer facility, removing the fuel assemblies, and re-loading them, either into a spent fuel pool storage rack or another NRC-approved dry storage system. In addition to the increased occupational doses to workers, these activities may also result in additional liquid or gaseous effluents.

Alternatively, users of the dry cask storage system would need to apply for a site-specific license. Under this option for implementing the no-action alternative, interested licensees would have to prepare, and the NRC would have to review, each separate license application, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

In summary, the no-action alternative would entail either (1) more environmental impacts than the preferred action from transferring the spent fuel now in the HI-STAR 100 Cask System; or (2) cost and administrative impacts from multiple licensing actions that, in aggregate, are likely to be the same as, or more likely greater than, the preferred action.

Renewal of the initial certificate and Amendment Nos. 1, 2, and 3 to Certificate of Compliance No. 1008 would result in no irreversible commitment of resources.

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

The environmental impacts of the action have been reviewed under the requirements in the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing environmental assessment, the NRC concludes that this direct final rule, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STAR 100 Cask System, Certificate of Compliance No. 1008, Renewal of Initial Certificate and Amendment Nos. 1, 2, and 3,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing collections of information were approved by the Office of Management and Budget, approval number 3150-0132.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec International. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if (1) it notifies the NRC in advance; (2) the spent fuel is stored under the conditions specified in the cask's certificate of compliance; and (3) the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On September 3, 1999 (64 FR 48259), the NRC issued an amendment to 10 CFR part 72 that approved the HI-STAR 100 Cask System design by adding it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1008.

On December 7, 2018, Holtec International requested a renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of the HI-STAR 100 Cask System for an additional 40 years beyond the initial certificate term. Holtec International supplemented its request on June 28, 2019, October 10, 2019, December 12, 2019, June 1, 2020, June 11, 2020, November 13, 2020, and November 24, 2020. Because Holtec International filed its renewal application at least 30 days before the certificate expiration date of October 4, 2019, pursuant to the timely renewal provisions in § 72.240(b), the initial issuance of the certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 did not expire.

The alternative to this action is to deny approval of the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 and end this direct final rule. Under this alternative, the NRC would either (1) require general licensees using the HI-STAR 100 Cask System to unload spent fuel from these systems and return it to a spent fuel pool or re-load it into a different dry storage cask system listed in 10 CFR 72.214; or 2) require that users of the existing HI-STAR 100 Cask System request site-specific licensing proceedings to continue storage in these systems. Therefore, the no-action alternative would result in a significant burden on licensees and an additional inspection or licensing caseload on the NRC. In addition, the no-action alternative would entail either (1) more environmental impacts than the preferred action from transferring the spent fuel now in the HI-STAR 100 Cask System; or (2) cost and administrative impacts from multiple licensing actions that, in aggregate, are likely to be the same as, or more likely greater than, the preferred action.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the preliminary SER and environmental assessment, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory; therefore, this action is recommended.

The NRC has determined that the backfit rule (§ 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Certificate of Compliance No. 1008 for the Holtec International HI-STAR 100 Cask System, as currently listed in § 72.214, to extend the expiration date of the initial certificate and Amendment Nos. 1, 2, and 3 by 40 years. The renewed initial certificate and Amendment Nos. 1, 2, and 3 consist of the changes previously described, as set forth in the renewed certificate of compliance and technical specifications.

Extending the effective date of the initial certificate and Amendment Nos. 1, 2, and 3 for 40 more years and requiring the implementation of aging management activities does not impose any modification or addition to the design of a cask system's SSCs, or to the procedures or organization required to operate the system during the initial 20-year storage period of the system, as authorized by the current certificate. General licensees that have loaded these casks, or that load these casks in the future under the specifications of the applicable certificate, may continue to store spent fuel in these systems for the initial 20-year storage period consistent with the original certificate. The aging management activities required to be implemented by this renewal are only required after the storage cask system's initial 20-year service period ends. As explained in the 2011 final rule that amended 10 CFR part 72 (76 FR 8872, Question I), the general licensee's authority to use a particular storage cask design under an approved certificate of compliance terminates 20 years after the date that the general licensee first loads the particular cask with spent fuel, unless the cask's certificate of compliance is renewed. Because this rulemaking renews the initial certificate and Amendment Nos. 1, 2, and 3, and renewal is a separate licensing action voluntarily implemented by vendors, the renewal of the initial certificate and Amendment Nos. 1, 2, and 3 is not an imposition of new or changed requirements from which these licensees would otherwise be protected by the backfitting provisions in § 72.62.

Even if renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 could be considered a backfit, Holtec International, as the holder of the certificate of compliance and vendor of the casks, is not protected by the backfitting provisions in § 72.62.

Unlike a vendor, general licensees using the existing systems subject to this renewal would be protected by the backfitting provisions in § 72.62 if the renewal constituted new or changed requirements applicable during the initial 20-year storage period. But, as previously explained, renewal of the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008 does not impose such requirements. The general licensee using the initial certificate or Amendment Nos. 1, 2, or 3 of Certificate of Compliance No. 1008 may continue storing material in their respective cask systems for the initial 20-year storage period identified in the applicable certificate or amendment with no changes. If general licensees choose to continue to store spent fuel in HI-STAR 100 Cask Systems after the initial 20-year period, these general licensees will be required to implement aging management activities for any cask systems subject to a renewed certificate of compliance, but such continued use is voluntary.

For these reasons, renewing the initial certificate and Amendment Nos. 1, 2, and 3 of Certificate of Compliance No. 1008, and imposing the additional conditions previously discussed, does not constitute backfitting under § 72.62, or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

This direct final rule is not a rule as defined in the Congressional Review Act.

The documents identified in the following table are available to interested persons as indicated.

The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2021-0135.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

FCA's objectives in adopting this rule are to:

• Provide technical corrections, amendments and clarification to certain provisions in the Tier 1/Tier 2 Capital Framework; and

• Ensure the System's capital requirements maintain comparability with the standardized approach that the Federal banking regulatory agencies  1 have adopted (U.S. Rule) while accommodating the cooperative structure and the organization of the System.

In 1916, Congress created the System to provide permanent, stable, affordable, and reliable sources of credit and related services to American agricultural and aquatic producers. 2 As of June 30, 2021, the System consists of 3 Farm Credit Banks, 1 agricultural credit bank, 66 agricultural credit associations, 1 Federal land credit association, service corporations, and the Federal Farm Credit Banks Funding Corporation (Funding Corporation). Farm Credit banks (including both the Farm Credit Banks and the agricultural credit bank) issue System-wide consolidated debt obligations in the capital markets through the Funding Corporation, 3 which enable the System to extend short-, intermediate-, and long-term credit and related services to farmers, ranchers, aquatic producers and harvesters, their cooperatives, rural utilities, exporters of agricultural commodities products, farm-related businesses, and certain rural homeowners. 4 The System's enabling statute is the Farm Credit Act of 1971, as amended (Act). 5

FCA's Tier 1/Tier 2 Capital Framework, the 2017 Capital Rule, was published in the Federal Register in July 2016. 6 The objectives of the 2017 Capital Rule were:

• To modernize capital requirements while ensuring that institutions continue to hold enough regulatory capital to fulfill their mission as a Government-sponsored enterprise (GSE);

• To ensure that the System's capital requirements are comparable to the Basel III framework and the standardized approach in the U.S. Rule, but also to ensure that the rules take into account the cooperative structure and the organization of the System;

• To make System regulatory capital requirements more transparent; and

• To meet the requirements of section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act). 7

To date, FCA believes the 2017 Capital Rule has met, and continues to meet, these stated objectives. 8

On December 22, 2016, the FCA Board adopted FCA Bookletter—BL-068—Tier 1/Tier 2 Capital Framework Guidance (Capital Bookletter). 9 The Capital Bookletter provided guidance to ensure System institutions had the necessary information to correctly implement the requirements of the 2017 Capital Rule. The Capital Bookletter included clarification and technical fixes on 18 separate items. The Capital Bookletter also stated our intention to incorporate some of these items into the regulation in a future rulemaking project.

On September 10, 2020, 10 FCA published in the Federal Register a notice of proposed rulemaking seeking public comment on revisions to our regulatory capital requirements to incorporate some of the guidance in the Capital Bookletter, with various adjustments, 11 as well as other revisions, as follows:

• Eliminate the stand-alone capital requirements for Farm Credit Leasing Services Corporation (Farm Credit Leasing or FCL);

• Change the computation of the lending and leasing limit base in § 614.4351, by using total capital instead of permanent capital in the calculation  12 and eliminating the exceptional treatment of certain purchased stock in § 614.4351(a)(1);

• Simplify ”Safe Harbor” provisions that determine when System institutions have “deemed prior approval” from FCA to distribute cash payments;

• Revise and clarify certain criteria that capital instruments must meet to be included in common equity tier 1 (CET1) and tier 2 capital;

• Further clarify when the holding period starts for certain Common Cooperative Equities included in CET1 or tier 2 capital; and

• Amend the requirement to adopt an annual board resolution with respect to prior approval requirements and the minimum holding periods for certain equities included in CET1 or tier 2 capital.

We additionally proposed technical revisions to:

• Amend the definitions of “Collateral agreement,” “Eligible margin loan,” “Qualifying master netting agreement (QMNA),” and “Repo-style transaction” to incorporate amendments made to these definitions in the U.S. Rule;

• Amend § 615.5220(a)(6) to replace references to parts 615 and 628 with a general reference to FCA regulations;

• Make certain amendments to § 620.5 to ensure institutions report financial information as we intended;

• Clarify the appropriate risk-weighting of cash and gold bullion held in a System institution's own vaults;

• Correct securitization formulas as provided in the Capital Bookletter;

• Specify the deductions and adjustments required for calculating the requirement in § 628.10 that at least 1.5 percent of the 4 percent tier 1 leverage ratio minimum must consist of unallocated retained earnings (URE) and URE equivalents;

• Revise the deductions required under existing § 628.22(a)(6) to include allocated equity investments in System service corporations;

• Add to the regulation certain guidance in the call report instructions on the treatment of accruals of patronage or dividend payables or receivables recorded prior to the governing board declaration or resolution;

• Clarify certain requirements for regulatory capital disclosures of System banks in §§ 620.3, 628.62(c), and 628.63(b)(4); and

• Clarify that institutions may retire minimum amounts of statutory borrower stock without prior approval from FCA so long as, after the retirement, the institution continues to comply with all minimum regulatory capital requirements. The proposal also provided clarification and guidance on continuously redeemable preferred stock (or “H Stock”), responded to a letter received from the Farm Credit Council addressing various capital related topics, and sought comment on potential changes to FCA's existing permanent capital regulations.

FCA received seven comment letters on the proposed rule. 13 The Farm Credit Council, a trade association representing System institutions, submitted a letter on behalf of its membership after soliciting comments from all institutions (System Comment Letter). 14 Two System banks  15 and three System associations  16 also submitted individual comment letters in support of the System Comment Letter. One System association, Compeer Financial, ACA (Compeer), raised additional concerns. The American Bankers Association (ABA), a trade association representing the U.S. banking industry, submitted the remaining comment letter. 17 We address the comments in the preamble sections that follow.

The System Comment Letter stated that the Farm Credit Council and its members “generally support” the proposed rule, including provisions that incorporate the Capital Bookletter and call report instructions, but that certain aspects of the proposal were “problematic.” Many of the comments from System institutions reiterated recommendations they had previously communicated to FCA (in comments on the September 4, 2014, proposed rulemaking)  18 and requested changes that were beyond the scope of the proposal. The balance of the comments from System institutions were supportive of the proposed amendments or requested specific technical changes.

The ABA asserted that the proposed rule would increase risks to the safety and soundness of the System and increase competitive inequities between the System and commercial banks. The ABA also requested that we clarify certain matters we did not expressly address in the proposal. In some cases, the ABA's comments did not directly relate to the amendments we proposed.

In the preamble to the proposed rule, we discussed certain matters that were not the subject of the proposed rule, 19 and we also sought comments on potential changes to our permanent capital regulations to reduce regulatory burden. We may consider proposing specific changes to the permanent capital requirements and calculations in a future rulemaking.

As discussed in Section 2—Substantive Revisions to the Capital Rule and Section 3—Clarifying and Other Revisions to the Capital Rule, the final rule adopts the revisions we proposed with minor adjustments in response to comments received.

Under existing § 628.20(f), System institutions are required to obtain prior approval from FCA before retiring equities included in tier 1 or tier 2 capital and making cash payments for dividends and patronage (collectively, cash distributions). Institutions have “deemed prior approval” from FCA for such distributions provided the conditions in § 628.20(f)(5) and (6) are satisfied (Safe Harbor). One of the conditions stipulates that, after any such cash payment, the dollar amount of CET1 capital must equal or exceed the dollar amount of CET1 on the same date in the previous calendar year. 20 Using the same date in the previous calendar year has made monitoring and enforcing this requirement difficult because regulatory capital numbers for System institutions are reported to FCA quarterly, rather than daily.

We proposed to simplify the Safe Harbor provisions of § 628.20(f) by replacing the requirement to use the exact calendar date of the cash distribution with a requirement to use the quarter-end date of the quarter in which the cash payment is made. A System institution would have “deemed prior approval” from FCA if, after making the cash distribution, the dollar amount of CET1 capital at the quarter-end equals or exceeds the dollar amount of CET1 capital on the same quarter-end in the previous calendar year. We provided two examples in the preamble to the proposed rule. 21 We stated that we do not believe the amendment as proposed would increase or decrease the amount of cash patronage System institutions would be able to pay when compared to the provision in the 2017 Capital Rule.

The ABA expressed concern that the proposal was “liberalizing” the provisions of the “Safe Harbor Deemed Prior Approval” in § 628.20(f)(5) and suggested that the Safe Harbor framework gives inadequate consideration to an institution's risk profile. The comments appear to be based in part on concerns regarding the proposal's omission of specific reference to capital distribution limitations already in the 2017 Capital Rule and unchanged by the proposal.

We disagree with the assertion that the proposal would “liberalize” the Safe Harbor. The proposed rule would change the date for determining compliance with the Safe Harbor provision in order to simplify the administration, enforcement, and monitoring of compliance with the Safe Harbor requirements. As we state above, we do not believe the proposal would increase or decrease the amount of cash patronage System institutions could pay when compared to the existing provision. The proposed changes would in no way “liberalize” the Safe Harbor or create any greater opportunity for capital distributions under the Safe Harbor.

In response to the ABA's concerns regarding the Safe Harbor giving inadequate consideration to an institution's risk profile, the commenter's assertion that the Safe Harbor permits “cash payouts based only on maintaining the dollar amount of CET1 capital in a prior year” is incorrect. As we stated in the preamble to the proposed rule, in order to make a cash distribution under the Safe Harbor, a System institution must remain in compliance with all regulatory capital requirements and any supervisory or enforcement actions after such distribution. 22 FCA's regulatory capital requirements are comparable to the U.S. Rule and include regulatory capital measures using both risk-adjusted and non-risk-adjusted computational methods. 23 Furthermore, FCA has comparable authorities to the Federal banking regulatory agencies to establish minimum capital ratios for an individual institution  24 as well as to place further restrictions on institutions' capital distributions as part of supervisory agreements and enforcement actions. 25 Lastly, cash distributions under the Safe Harbor are subject to the capital buffers in § 628.11, which reduce the amount of capital distributions an institution can make when its capital levels fall within the leverage buffer or capital conservation buffer ranges. These requirements are unaltered by the proposed or final rule.

Compeer requested that we expand the Safe Harbor to allow institutions to retire the allocated equities of a borrower, irrespective of compliance with minimum holding periods, 26 to offset losses when a borrower defaults on a loan. The commenter asserted that present hurdles to retiring equities in these scenarios ( i.e., requesting prior approval from FCA under § 628.20(f)) present an unnecessary administrative burden.

Compeer's requested revision is beyond the scope of the present rulemaking. We note, however, that as we stated in the preamble to the 2017 Capital Rule, equities are issued to capitalize the institution, not the loan. Accordingly, these equities should not be viewed or treated as compensating loan balances. 27 Furthermore, the preamble to the 2017 Capital Rule also explains in detail our position on the necessity for minimum holding periods to address the “expectation criterion” in the Basel III Framework and the U.S. Rule, maximizing comparability of our rule with the rules applicable to commercial banks. 28 We note that, under § 628.20(f)(6), System institutions may offset allocated equities against a loan in default if mandated by a court of competent jurisdiction or under § 615.5290 in connection with a restructuring plan.

The balance of comments received supported this proposed amendment, and we are adopting it as proposed.

The 2017 Capital Rule stipulates conditions and criteria that must be met in order to include an instrument in an institution's regulatory capital. 29 Among these are the requirements for the institution's board of directors to affirm its commitment to adhere to the regulatory minimum redemption or revolvement periods; to obtain prior approval from FCA prior to redeeming, revolving, redesignating, cancelling or removing equities included in regulatory capital;  30 and to obtain prior approval from FCA for certain other actions that could impact the institution's capital quantity or quality. 31 Such affirmation must be set forth in the institution's capitalization bylaws or in a board resolution that the board must re-affirm annually. Where this requirement is satisfied by a board resolution, we proposed to reduce the administrative burden by no longer requiring an annual re-affirmation by the board. We proposed to replace the annual re-affirmation with a one-time requirement to adopt the board resolution and, in subsequent annual capital adequacy plans, to expressly acknowledge the continuing and binding effect of this resolution.

We proposed to move the existing requirements of § 615.5200(d) to a new section, § 628.21, and to revise them to provide that an institution's board must adopt either a capitalization bylaw requirement or a binding board resolution. New § 615.5200(b) would add to existing capital planning provisions a requirement that the capital adequacy plan must expressly acknowledge the continuing and binding effect of all board resolutions adopted pursuant to §§ 628.20(b)(1)(xiv), (c)(1)(xiv), and (d)(1)(xi) and 628.21. We proposed conforming changes as necessary to refer to new § 628.21 rather than § 615.5200(d).

We received no specific comments on this amendment and are adopting it as proposed.

Common cooperative equities  32 included in CET1 capital have a minimum holding period of 7 years before redemption or revolvement, and common cooperative equities included in tier 2 capital have a minimum holding period of 5 years. 33 These holding periods also must be met for equities (other than the statutory borrower stock minimum) to be retireable under the Safe Harbor. To clarify when the minimum redemption and revolvement period starts for a common cooperative equity, we proposed to add a new definition, common cooperative equity issuance date, in § 628.2 and to make conforming changes to other sections of the regulations. Similar to our guidance in the Capital Bookletter, we proposed to define the common cooperative equity issuance date as the quarter-end in which an institution recognizes newly issued purchased stock in its financial statements and, for newly allocated equities, the quarter-end in which the institution's board has declared a patronage refund and the applicable accounting treatment has taken place. We provided examples of the proposed treatment in the proposed rule preamble. 34

The System Comment Letter and Compeer requested that we eliminate altogether the minimum holding period requirements for allocated equities. The System made the same request and supporting arguments in comments on our 2014 Tier 1/Tier 2 proposed capital rule, and FCA responded to those comments in the final rule preamble to the 2017 Capital Rule. 35

The System's request not only is beyond the scope of this rulemaking but also presents no new arguments that would persuade us to reevaluate the need for minimum holding periods. We discussed at length the stock-like attributes of allocated equities (as distinct from unallocated retained earnings) and the reasons for the minimum holding periods in the preamble to the 2017 Capital Rule. 36

The System Comment Letter suggested we add the word “calendar” before “quarter-end” in the proposed definition of “common cooperative equity issuance date” to clarify that the issuance date would be the calendar quarter-end. We agree and have incorporated the suggestion into the final rule. FCA also fully acknowledges the legal stock issuance date may be different from the quarter-end date used for financial reporting and regulatory capital calculations. Beyond this minor change, we are adopting the new definition as proposed.

The proposed rule would recognize the current ownership status of Farm Credit Leasing as a wholly-owned subsidiary of CoBank, ACB (CoBank) by removing FCL from the definition of “System institution” in §§ 615.5201 and 628.2 for the purposes of the regulatory capital requirements. 37 In so doing, FCA would no longer require FCL to meet minimum capital and related regulatory requirements under part 615, subpart H, and part 628 of our regulations on a stand-alone basis. As a wholly-owned subsidiary of CoBank, FCL is a business unit of the bank with profits and losses accrued to the bank, and its assets and liabilities are consolidated with the bank's assets and liabilities for financial and regulatory reporting purposes. To the extent the bank is adequately capitalized overall, CoBank's consolidation ensures FCL's assets are adequately capitalized. This amendment will reduce the administrative burden of separately applying the regulatory capital requirements to FCL and will not reduce the capital to be held against FCL and CoBank's combined assets. If FCL's ownership status were to change in the future, we will reassess whether to separately apply our regulatory capital requirements. 38

Commenters supported this change, and we are adopting it as proposed.

Since adopting the 2017 Capital Rule, FCA has relied on tier 1 and tier 2 capital, not on permanent capital, to evaluate the safety and soundness of System institutions. In order to better align the lending and leasing limit base with FCA's supervisory focus on tier 1 and tier 2 capital, we proposed to shift the base of the lending and leasing limit from permanent capital  39 to total capital as defined and adjusted in §§ 628.20-628.22 and to continue to include otherwise eligible third-party capital that must be excluded under § 628.23. We further proposed to align the treatment of investments in other System institutions under the lending and leasing limit base with the treatment under regulatory capital calculations by eliminating the exceptional treatment of stock purchased in connection with a loan participation under § 614.4351(a)(1). 40 We estimated that the impacts to lending limits at System institutions resulting from these changes would be small. 41 The System Comment Letter supported the change to the use of total capital as the lending limit base and noted that most institutions have internal lending limit policies that are lower than the lending limit base in the regulation. We received no other comments and are adopting the amendment as proposed.

In 2017, the Federal banking regulatory agencies adopted rules establishing certain restrictions and requirements for the financial contracts (QFC Rules) of global systemically important banking institutions (GSIBs). 42 We provided details on the background and impetus for these regulatory changes in the preamble to the proposed rule. 43 The QFC Rules prompted related definitional changes in the U.S. Rule to ensure regulated entities continued to benefit from recognition of the risk-mitigating effects of netting and financial collateral on certain financial transactions. This recognition likely results in reduced capital requirements for those transactions.

To incorporate amendments made to the U.S. Rule  44 and to ensure System institutions would also continue to benefit from recognition of the risk-mitigating effects of netting and financial collateral, we proposed changes to the definitions of “Collateral agreement,” “Eligible margin loan,” “Qualifying master netting agreement (QMNA),” and “Repo-style transaction.” The proposed changes to QMNA would also harmonize that definition with the definition of “Eligible master netting agreement” as used in FCA's Margin and Capital requirements for Covered Swap Entities regulation. 45 The System Comment Letter supported these revisions, and we are adopting them as proposed.

Consistent with the Basel III regulatory capital framework  46 and the U.S. Rule, we proposed to add the term “paid-in” to the eligibility criteria for CET1 capital in § 628.20(b)(1)(i). Basel III defines “paid-in” capital as capital that (1) has been received with finality by the institution, (2) is reliably valued, (3) is fully under the institution's control, and (4) does not directly or indirectly expose the institution to the credit risk of the investor. 47

As discussed in the preamble to the proposed rule, we proposed this amendment to the eligibility criteria for CET1 capital after re-evaluating the attributes of System allocated equities, which we have subsequently determined meet the Basel definition of “paid-in.”  48 We further discussed our reexamination of the attributes of allocated equities and the financing of statutorily required borrower stock at System institutions. 49 The System Comment Letter supported our recognition of allocated equities as meeting the definition of “paid-in” and expressed no concern with the additional criteria for an instrument's inclusion in CET1 capital. 50 We are adopting the revision as proposed.

We also proposed a conforming change in § 628.20(d)(1)(i) to clarify that all instruments included in tier 2 capital must be issued and paid-in. We received no comments on this proposed change and are adopting it as proposed.

Lastly, we proposed clarifying, non-substantive changes to § 628.20(b)(1)(i) and (b)(1)(ii), both to align our language more closely with the language in the U.S. Rule and to emphasize a difference between the rules' prioritization of a capital instrument holder's claim on the residual assets of an institution in a receivership, insolvency, liquidation, or similar proceeding. We received no comments on these proposed revisions and are adopting them as proposed.

Section 615.5220(a)(6) requires a System institution to include in its capitalization bylaws a provision stating that equities other than those protected under Section 4.9A of the Act are retireable at the sole discretion of the board, provided minimum capital adequacy standards established in subpart H of part 615 and part 628 are met. We proposed to amend this section by replacing the reference to parts 615 and 628 with a general reference to FCA's capital adequacy standards. This would satisfy the requirement to refer to parts 615 and 628 and would include all existing capital requirements of the FCA as well as any future capital requirements that we may adopt in other parts of our regulations.

As we noted in the proposal, 51 changes to bylaws to conform to this regulatory requirement should not change any substantive rights of the System institution or its member-borrowers. 52 System institutions that have already amended their capitalization bylaws to include a reference to parts 615 and 628 do not need to amend their capitalization bylaws to comply with this revision.

We received no comments on this amendment and are adopting it as proposed.

We proposed technical revisions to § 620.5, which lists the required contents of a System institution's annual report to shareholders, to ensure institutions report financial data as we intended. First, we proposed to move the requirement that System associations report their tier 1 leverage ratio in each annual report for each of the last 5 fiscal years from § 620.5(f)(4)(iv) to § 620.5(f)(3)(v), as we had originally intended. In addition, we proposed to amend the requirement in § 620.5(f)(4) that institutions report core surplus, total surplus, and the net collateral ratio (banks only) in a comparative columnar form for each fiscal year ending in 2012 through 2016. This requirement resulted in System institutions reporting capital ratios beyond the 5-year requirement established in § 620.5(f), which was not our intention. Accordingly, we proposed to require these disclosures in each annual report through 2021, but only as long as these ratios are part of the previous 5 fiscal years for which disclosures are required. We received no comments on these revisions and are adopting them as proposed.

We proposed to delete provisions in § 628.32(l)(1) pertaining to the risk weighting of cash that were redundant and potentially confusing. Specifically, existing § 628.32(l)(1) states that System institutions must assign a 0-percent risk weight to cash held in accounts at a depository institution, which created potential confusion pertaining to the proper risk weight for deposits that exceed the limit of FDIC deposit insurance coverage (currently set at $250,000). In addition, existing § 628.32(l)(1) also states that System institutions must assign a 0-percent risk weight to cash held in accounts at a Federal Reserve Bank. As the risk weighting of cash on deposit with a U.S. depository institution or at the Federal Reserve Bank is adequately and more accurately addressed in § 628.32(a)(1)(i)(A) and (B) and (d)(1), we proposed eliminating the duplicative and potentially confusing provisions in § 628.32(l)(1). We received no comments on these revisions and are adopting them as proposed.

We additionally proposed to revise § 628.32(l)(1) to add a provision assigning a 0-percent risk weight to gold bullion held in a System institution's own vaults, consistent with the risk weight assigned to gold bullion held in the vaults of a depository institution. We received no comments on this revision and are adopting it as proposed.

Consistent with corrections previously provided in the Capital Bookletter, we proposed to correct 3 formulas used in the simplified supervisory formula approach (SSFA) to risk-weighting securitizations under § 628.43(d), and one formula used in the simple risk-weight approach (SRWA) for risk-weighting equity exposures under § 628.52. These formulas were printed incorrectly in the Federal Register version of the 2017 Capital Rule. We received no comments on these corrections and are finalizing them as proposed.

Under § 628.10, at least 1.5 percent of the 4 percent tier 1 leverage ratio minimum must consist of URE and URE equivalents (UREE). As the 2017 Capital Rule did not specify how to calculate this requirement, we proposed to prescribe the calculation methodology. Specifically, we proposed to incorporate the guidance in the Capital Bookletter requiring the deductions in § 628.22(a) from the numerator and the deductions used in calculating the tier 1 leverage ratio from the denominator. 53 We also proposed to require that institutions deduct from the numerator any purchased equity investments that must be deducted under the corresponding deduction approach in § 628.22(c). The use of differing deductions for the computation of the tier 1 leverage ratio and the URE and UREE measure, which is a component of the tier 1 leverage ratio, resulted in the URE and UREE measure, when calculated on a stand-alone basis, exceeding the tier 1 leverage ratio at many System institutions. 54 This was not our intent. The System Comment Letter generally supported our proposed revisions, and we are adopting them as proposed.

In addition, we are adopting technical conforming amendments in § 628.10(c)(4) to incorporate adjustments required under proposed § 628.22(b)  55 into the computation of both the tier 1 leverage ratio and the URE and UREE measure. More specifically, we are amending the calculation of average total consolidated assets described in § 628.10(c)(4)(i) to include the deduction or adjustment required by § 628.22(b). Furthermore, we are amending the calculation of the URE and UREE measure described in § 628.10(c)(4)(ii) to include the deduction or adjustment required by § 628.22(b). These conforming changes are consistent with existing call report instructions, 56 are technical in nature, and are necessary to maintain consistency in the deductions for the computation of the tier 1 leverage ratio and the URE and UREE measure, consistent with the intent of the proposed rule.

The FAA published FR Doc. 2021-18759 (86 FR 48905) on September 1, 2021, with an effective date of October 7, 2021. This docket did not allow sufficient time to accomplish charting, and the FAA re-published the same document as FR Doc. 2021-19275 (86 FR 50453) on September 9, 2021, with a later effective date of December 2, 2021, without withdrawing the first document. The FAA is withdrawing the first document.

The FAA published FR Doc. 2021-18708 (86 FR 48496) on August 31, 2021, with an effective date of October 7, 2021. This docket did not allow sufficient time to accomplish charting, and the FAA re-published the same document as FR Doc. 2021-19278 (86 FR 50247) on September 8, 2021, with a later effective date of December 2, 2021, without withdrawing the first document. The FAA is withdrawing the first document.

The FAA published FR Doc. 2021-18709 (86 FR 48494) on August 31, 2021, with an effective date of October 7, 2021. This docket did not allow sufficient time to accomplish charting, and the FAA re-published the same document as FR Doc. 2021-19276 (86 FR 50248) on September 8, 2021, with a later effective date of December 2, 2021, without withdrawing the first document. The FAA is withdrawing the first document.

Accordingly, pursuant to the authority delegated to me, the final rule published in the Federal Register on August 31, 2021, (86 FR 48494) FR Doc. 2021-18709 is hereby withdrawn.

The FAA published FR Doc. 2021-18707 (86 FR 48493) on August 31, 2021, with an effective date of October 7, 2021. This docket did not allow sufficient time to accomplish charting, and the FAA re-published the same document as FR Doc. 2021-19235 (86 FR 49918) on September 7, 2021, with a later effective date of December 2, 2021, without withdrawing the first document. The FAA is withdrawing the first document.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface in Bangor, ME, to support IFR operations in the area.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 38419, July 21, 2021) for Docket No. FAA-2021-0066 to amend Class E airspace extending upward from 700 feet above the surface at Bangor, ME, by establishing airspace for Eastern Maine Medical Center Heliport, and removing the Bangor VORTAC from the Bangor International Airport descriptor, as it is no longer used.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in Paragraph 6005, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by amending the Class E airspace extending upward from 700 feet above the surface in Bangor, ME, by establishing controlled airspace for Eastern Maine Medical Center Heliport to accommodate new RNAV standard instrument approach procedures serving this heliport. Also, this action amends Class E airspace extending upward from 700 feet above the surface for Bangor International Airport, omitting the Bangor VORTAC, as well as removing the extension to the north, reducing the radius to 8.4 miles (previously 10 miles), and amending the extension to the southeast to a 134° bearing from the airport, extending from the 8.4-mile radius to 15.5-miles southeast of the airport (previously 136° bearing extending from the 10-mile radius to 16.7 miles southeast of the airport). Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is minimal. Since this is a routine matter that only affects air traffic procedures an air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

I. Statutory Authority II. History of the Rule III. Overview of Rule IV. Changes From Proposed Rule to Final Rule V. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866, 13563, and 13771) B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement and Fairness Act D. Unfunded Mandates Reform Act of 1995 E. Takings (E.O. 12630) F. Federalism (E.O. 13132) G. Civil Justice Reform (E.O. 12988) H. Paperwork Reduction Act I. National Environmental Policy Act (NEPA) J. Consultation With Indian Tribes (E.O. 13175) K. Energy Effects (E.O. 13211) I. Statutory Authority

BIA is finalizing this rule under the authority of the Act of June 28, 1906, Public Law 59-321, 34 Stat. 539, as amended by the Act of December 3, 2004, Public Law 108-431, 118 Stat. 2609.

The Department of the Interior provided testimony in support of the legislation proposed by the Osage Nation when the Nation sought to exercise its inherent sovereign rights. Thereafter, the United States Congress reaffirmed in 2004 the Nation's rights to determine its membership and form of government. The following discussion sets forth a brief historical account of the relationship between the Osage Nation and the Federal government.

In 1906, the Congress enacted the Osage Allotment Act, which is unique among Federal Indian laws in that it restricted the Osage Nation from defining its own membership rules, and prescribes a particular form of government, which the Nation could not change without seeking amendment or clarification of Federal law. In 2002, the 31st Osage Tribal Council, formed pursuant to the Osage Allotment Act, actively began seeking a legislative remedy to address the restrictions contained in the Osage Allotment Act.

On July 25, 2003, Congressman Frank Lucas (R-OK) introduced H.R. 2912, a bill reaffirming the rights of the Osage Nation to form its own membership rules and tribal government, provided that no rights to any shares in the mineral estate of the Nation's reservation are diminished. The bill also directs the Secretary of the Interior to assist the Nation in holding appropriate elections and referenda at the request of the Nation.

H.R. 2912 was referred to the Committee on Resources. On March 15, 2004, that Committee held a hearing on the bill in Tulsa, Oklahoma. Osage Nation officials, a BIA representative, and Osage people testified in favor of the bill. On May 5, 2004, the bill was favorably reported to the House of Representatives by unanimous consent. See H. Rpt. 108-502. On June 1, 2004, the House of Representatives passed the bill and then sent it to the Senate, and it was referred to the Committee on Indian Affairs.

On July 14, 2004, the Committee on Indian Affairs favorably reported H.R. 2912 to the Senate with a “do pass” recommendation. President Bush signed H.R. 2912 into law on December 3, 2004, and became Public Law 108-431, 118 Stat. 2609.

The Commission began conducting town hall meetings in April 2005. Meetings were conducted in all Osage communities and other geographic areas with large concentrations of Osages. This was followed by a written survey mailed to all Osages with a Certificate of Degree of Indian Blood (CDIB) card. Input from the meetings and data obtained from the survey results were compiled to formulate key questions put forward to the Osage people for a vote in a referendum in November 2005.

The results from the referendum were used to draft an Osage Constitution, which was ratified on March 11, 2006, in a second referendum vote. The Osage Nation adopted a new constitutional form of government reorganized from a Tribal Council system into a tripartite system, which now includes an executive, legislative and judicial branch with a separation of powers between the three branches.

This was followed on June 5, 2006, by the election of a Principal Chief and Assistant Principal Chief, Osage Nation Congress, and Osage Minerals Council. At the request of the Nation, the BIA provided technical assistance in conducting the election in accordance with Public Law 108-431, 118 Stat. 2609. With the elections completed, all elected officials were sworn into their respective offices on July 3, 2006. Upon the swearing in of these elected officials, governmental authority passed from the Osage Tribal Council to the Osage Nation Constitutional Government. Thereafter, the Osage Tribe of Indians of Oklahoma became the Osage Nation.

In 2008, the BIA formally acknowledged the name change of the Tribe from the Osage Tribe of Indians of Oklahoma to the Osage Nation and published the change in the Federal Register in the list of Indian Entities Recognized and Eligible to Receive Services from the United States Bureau of Indian Affairs. (See, 73 FR 18553, April 4, 2008). Further communication between the Nation and the BIA eventually resulted in an agreement to begin an informal negotiated rulemaking process. In February 2010, representatives from the Osage Nation, the BIA Eastern Oklahoma Region, Osage Agency, the BIA Eastern Oklahoma Region, Eastern Oklahoma Regional Office, the Tulsa Field Solicitor's Office, and the BIA Central Office convened to form a joint regulation negotiation team. The team completed new and revised regulations to cover 25 CFR parts 90, 91, 117, and 158. The June 2010 Election resulted in a change of administration of the Osage Nation, thereby, starting the process over again with a new vision from Osage Nation. The Osage Nation formed a new team in 2019 and they have reviewed and revised regulations to cover 25 CFR part 90. The team will continue working on parts 91, 117, and 158.

This rule governs BIA's role in providing information to the Osage Minerals Council Election Board for purposes of notice. The existing 25 CFR part 90 is the authority for the release of otherwise potentially confidential information to the Osage Minerals Council Election Board. The alternative to these amendments would deprive the Osage Nation of the information it needs to accurately identify Osage voters. Amendments to this part focus on the BIA's procedures in compiling a complete annuitant list with addresses and headright interests to the Osage Minerals Council Election Board for purposes of identifying Osage voters.

This rule deletes most provisions of part 90 in their entirety because of the enactment of the Public Law 108-431, 118 Stat. 2609, and subsequent adoption of the Constitution of the Osage Nation. Thus, the remaining purpose of this part is the authority for BIA to provide a list to the Osage Minerals Council Election Board of eligible headright interest owners in the manner requested by the Osage Nation. The Department may not generally release this information but this part provides authority for the release solely to the Osage Minerals Council Election Board for purposes of conducting elections for the Osage Minerals Council. The Privacy Act does not prohibit disclosure of the headright interests of eligible Osage voters for this purpose. The Department may provide the list of eligible headright interest owners as a routine use under the Privacy Act.

In response to the Constitution of the Osage Nation, the BIA significantly reduced its role in the elections of the Osage Nation as of June 2006. The only remaining portion in part 90 describes the current role of the BIA in the Osage Minerals Council election process.

The following distribution table indicates where each of the current regulatory sections in 25 CFR part 90 is located in the new 25 CFR part 90.

On December 4, 2020 (85 FR 78300), the BIA published a proposed rule to update Federal regulations related specifically to the Osage Nation so that the regulations align with the Osage Nation's new form of government and address outdated regulations. The proposed rule was developed through a consensus-oriented process conducted between the BIA and the Osage Nation.

During the public comment period on the proposed rule, the BIA received two comments: One from an individual in support of the rule, the other from the Osage Minerals Council expressing general support for the proposed rule but requesting a change in the nomenclature of the titles and entities that conduct the elections to reflect the sovereign authority of the Osage Nation and the Osage Minerals Council to change that nomenclature. Specifically, the Osage Minerals Council requested that “supervisor of the Osage Minerals Council Election Board” be changed to the “Osage Minerals Council's designee charged with carrying out Osage Minerals Council elections.” The final rule makes this change.

The Osage Nation also requested clarification that the list of names the Osage Agency Superintendent provides be based on the quarterly annuity roll at the Osage Agency as of the last quarterly payment “of the last full quarter” immediately preceding the date of the election. To clarify which quarterly annuity roll is intended as the basis for the list, the final rule specifies that it will be the March quarterly annuity payment. Elections are held in June so the voters list would reflect the March annuity payment. This revision avoids the potential for misinterpretation of which quarter's annuity roll is intended.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this rule is not significant.

E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The E.O. directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

The Department of the Interior certifies that this rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. Because this rule is exclusively confined to the Federal Government, Osage Indians, and the Osage Nation, this rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a monetarily significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

This rule does not affect a taking of private property or otherwise have taking implications under Executive Order 12630 because this rule does not affect individual property rights protected by the Fifth Amendment or involve a compensable “taking.” A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. Specifically, this rule: (a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and (b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with federally recognized Indian Tribes through a commitment to consultation with these Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has substantial direct effects on one federally recognized Indian Tribe because the rule directly addresses the Osage Nation. The Department consulted with the Osage Nation on this rule. This rulemaking is a result of a consensus-oriented process conducted between the Department of the Interior and the Osage Nation to identify a rulemaking strategy to address issues and concerns contained in the regulations related specifically to the Osage Nation, which no longer align with the Nation's form of government. The purpose of this rulemaking is to allow the Department of the Interior to better meet its fiduciary trust responsibilities and to carry out the policies established by the Congress to strengthen Tribal sovereignty with regard to elections of Osage Nation officers.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) is not required. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because this is an administrative and procedural regulation. (For further information see 43 CFR 46.210(i)). We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

On July 14, 2021, the Office of Legal Policy (OLP) published in the Federal Register a System of Records Notice (SORN) for an OLP system of records titled, “Judicial Nominations Files,” JUSTICE/OLP-002. 86 FR 37192. On July 23, 2021, the Department published a notice of proposed rulemaking (NPRM) proposing to exempt records maintained in JUSTICE/OLP-002 from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k), and inviting public comment on the proposed exemptions. 86 FR 38955. The comment period was open through August 13, 2021, for the SORN and through August 23, 2021, for the NPRM. The Department received no comments on the proposed rule. After providing the opportunity for public comment, exemptions necessary to protect the ability of OLP to do its judicial nomination functions have been codified in this final rule as proposed in the NPRM.

The exemptions are necessary because certain classified information may be maintained in JUSTICE/OLP-002, including but not limited to, records related to a potential nominee that maintained a previous or current position with access to classified information and/or assigned to a national security sensitive position. Moreover, given the law enforcement information that may be discovered as part of the nomination investigation and/or evaluations, certain investigatory materials for law enforcement purposes may be maintained in this system of records. In addition, investigatory material may also be used in determining suitability, eligibility, or qualification decisions, and such information may require exemption to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Department under an express promise that the identity of the source would be held in confidence. Finally, the Department also utilizes various examination materials to determine individual qualifications for appointment, which if disclosed, could compromise the objectivity or fairness of the Department's examination and vetting process.

In its Judicial Nominations Files SORN, published on July 14, 2021, and its Judicial Nominations Files NPRM, published on July 23, 2021, the Department invited public comment. The comment period for the SORN closed on August 13, 2021, and the comment period for the NPRM closed on August 23, 2021. The Department received no comments. Because no comments were submitted, and because OLP continues to assert the rationales in support of the exemptions as stated in the NPRM, the Department adopts in this final rule the exemptions and rationales proposed in the NPRM.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), Principles of Regulation, and Executive Order 13563 “Improving Regulation and Regulatory Review” section 1(b), General Principles of Regulation.

The Department of Justice has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this rule has not been reviewed by the Office of Information and Regulatory Affairs within the Office of Management and Budget pursuant to Executive Order 12866.

This regulation will only impact Privacy Act-protected records, which are personal and generally do not apply to an individual's entrepreneurial capacity, subject to limited exceptions. Accordingly, the Chief Privacy and Civil Liberties Officer, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities.

This regulation will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This regulation will have no implications for Indian Tribal governments. More specifically, it does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Therefore, the consultation requirements of Executive Order 13175 do not apply.

This regulation will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000, as adjusted for inflation, or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by 5 U.S.C. 804 of the Congressional Review Act.

This rule imposes no information collection or recordkeeping requirements.

Pursuant to the authority vested in the Attorney General by 5 U.S.C. 552a and delegated to me by Attorney General Order 2940-2008, the Department of Justice amends 28 CFR part 16 as follows:

DoD now has a single DoD-level Privacy Program rule at 32 CFR part 310 (84 FR 14728) that contains all the codified information required for the Department. The Defense Logistics Agency Program regulation at 32 CFR part 323, last updated on July 9, 2015 (80 FR 39381), is no longer required and can be removed.

It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on the removal of policies and procedures that are either now reflected in another CFR part, 32 CFR part 310, or are publicly available on the Department's website. To the extent that the Defense Logistics Agency internal guidance concerning the implementation of the Privacy Act within the Defense Logistics Agency is necessary, it will be issued in an internal document.

This rule is one of 20 separate component Privacy rules. With the finalization of the DoD-level Privacy rule at 32 CFR part 310, the Department is eliminating the need for this separate component Privacy rule and reducing costs to the public as explained in the preamble of the DoD-level Privacy rule published on April 11, 2019, at 84 FR 14728.

This rule is not significant under Executive Order 12866, “Regulatory Planning and Review.”

On November 18, 2020, the Discovery Clean Water Alliance notified the Coast Guard that it would begin construction on the Phase 5A Project: Columbia River Outfall and Effluent Pipeline from 12:01 a.m. on October 1, 2021 through 11:59 p.m. on March 15, 2022, to remove and replace existing pipeline. The construction project includes the removal and replacement of an existing navigation marker (3-pile dolphin), installation of a 48″ pipeline in the riverbed outside the navigation channel, and removal of an existing 30″ pipeline from the riverbed. The scope of work may include the need to construct temporary pile-supported work platforms, or dredge, to access shallow water areas. Lighted barges will be used in deeper water. The Captain of the Port Sector Columbia River (COTP) has determined that potential hazards associated with the construction project would be a safety concern for anyone within the designated area of the Columbia River Outfall and Effluent Pipeline construction project. In response, on August 28, 2021 the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Columbia River Outfall Project, Columbia River, Vancouver, WA (86 FR 47611). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this safety zone. During the comment period that ended September 10, 2021 we received no comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with the Columbia River Outfall Projects.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that potential hazards associated with construction project would be a safety concern for anyone within the designated area of the Columbia River Outfall Project. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone during the scheduled construction period.

As noted above, we received no comments on our NPRM published August 28, 2021. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone from October 1, 2021, through March 15, 2022. The safety zone will cover all navigable waters of the Columbia River, surface to bottom, encompassed by a line connecting the following points beginning at the shoreline at 45°43′57.0″ N, 122°45′21.0″ W, west to 45°43′58.0″ N, 122°45′33.0″ W, south to 45°43′39.0″ N, 122°45′35.0″ W, thence east to 45°43′39.0″ N, 122°45′21″ W, and along the shoreline back to the beginning point. The duration of the zone is intended to ensure the safety of vessels and these navigable waters while the pipeline construction project is underway. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative means any Coast Guard commissioned, warrant, or petty officer who has been authorized by the COTP to act on his behalf, or a Federal, State, and local officer designated by or assisting the COTP in the enforcement of the safety zone. Vessel operators desiring to enter or operate with the safety zone would contact the COTP's on-scene designated representative by calling (503) 209-2468 or the Sector Columbia River Command Center on Channel 16 VHF-FM. Those in the safety zone would comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on size, location, duration, and time-of-year of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the Columbia River during the construction project. Moreover, the Coast Guard would issue a Notice to Mariners about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 166 days that would prohibit vessel traffic to transit the area during construction operations. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On July 7, 2021 (86 FR 35610), EPA published a final rule in the Federal Register entitled “Air Plan Approval; AL; NO X SIP Call and Removal of CAIR” which became effective on August 6, 2021. The final rule approved the addition of regulations to Alabama's State Implementation Plan (SIP) to maintain compliance with their nitrogen oxides (NO X ) SIP Call obligations for large non-electricity generating units (non-EGUs), the repeal of the State's regulations previously sunsetted regarding the NOx Budget Trading Program, and the repeal of the State's Clean Air Interstate Rule (CAIR) regulations. 1 Additionally, the final rule conditionally approved state regulations into the SIP that establish monitoring and reporting requirements for units subject to the NO X SIP Call, including alternative monitoring options for certain sources.

However, the rule contained two errors in the instructions regarding amendments to the table titled “EPA-Approved Alabama Regulations” found at 40 CFR 52.50(c). See 86 FR at 35614. Because of the errors in the amendatory instructions, the Office of the Federal Register was not able to incorporate some of the changes and placed an editorial note at the bottom of 40 CFR 52.50. Although the rational for incorporating these changes remains the same as presented in the July 7, 2021, rule, EPA is now correcting the CFR to appropriately display the approved rules in the South Carolina SIP.

For the reasons set out in the preamble, the EPA corrects 40 CFR part 52 by making the following correcting amendment:

On July 1, 2021 (86 FR 35042), the EPA published a notice of proposed rulemaking that proposed to approve a revision to the State Implementation Plan (SIP) submitted by the State of New York on February 5, 2019, and supplemented on March 25, 2021, for purposes of revising Title 6 of the New York Codes, Rules and Regulations (6 NYCRR) Part 212, “General Process Emission Sources.” The EPA is also approving attendant revisions to Part 200, “General Provisions,” Subpart 200.1, “Definitions.”

The revisions to Part 212, which is now entitled, “Process Operations,” apply to process emission sources and/or emission points associated with a process operation. The changes to Part 212 include establishing consistent terminology between Part 212, Part 200, and Part 201, “Permits and Registrations”; establishing a Toxic Best Available Control Technology (T-BACT) standard for toxic air contaminants; clarifying the interaction between Part 212 and the National Emission Standards for Hazardous Air Pollutants (NESHAPs); offering a streamlined approach for demonstrating compliance with regulatory standards for air contaminants by adopting a mass emission rate option; replacing the current Part 212 control requirement, which provides the New York State Department of Environmental Conservation (NYSDEC) Commissioner with discretion to establish the degree of required air cleaning upon performance of air dispersion modeling analyses in order to demonstrate compliance with the NYSDEC Guideline Concentrations or National Ambient Air Quality Standards (NAAQS); controlling High Toxicity Air Contaminants (HTACs) to the greatest extent possible; and generally reorganizing and clarifying Part 212. These revisions streamline and update provisions, align those provisions with permitting regulations, and provide regulatory certainty for the regulated community.

New York's March 25, 2021 comprehensive supplemental submittal also included Part 201 Operating Permit Program requirements; however, the EPA will be acting on these revisions under a separate action.

The specific details of New York's SIP submittals and the rationale for the EPA's approval action are explained in the EPA's proposed rulemaking and are not restated in this final action. For this detailed information, the reader is referred to the EPA's July 1, 2021 proposed rulemaking. See 86 FR 35042.

The EPA did not receive any comments on the July 1, 2021 proposed approval of Title 6 of the New York Codes, Rules and Regulations, Part 212, “Process Operations” and Part 200, “General Provisions,” Subpart 200.1, “Definitions.”

The EPA is approving the revisions to the State Implementation Plan (SIP) submitted by the State of New York on February 5, 2019, and supplemented on March 25, 2021, for purposes of revising Title 6 of the New York Codes, Rules and Regulations (6 NYCRR) Part 212, “Process Operations”. The EPA is also approving attendant revisions to Part 200, “General Provisions,” Subpart 200.1, “Definitions.”

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of 6 NYCRR Part 212, “Process Operations” and Part 200, “General Provisions,” Subpart 200.1, “Definitions,” as described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 2 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the New York State Implementation Plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act, 42 U.S.C. 7401 et seq., as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law that meets Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 30, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review, nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See Clean Air Act section 307(b)(2)).

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

The SUPPLEMENTARY INFORMATION section is arranged as follows:

On July 1, 2021 (86 FR 35030), the EPA published a notice of proposed rulemaking (NPRM) for the New York State Implementation Plan submitted on November 13, 2017. The NPRM proposed approval of the 2011 calendar year ozone season daily and annual ozone precursor emission inventory for carbon monoxide (CO), oxides of nitrogen (NO X ), and volatile organic compounds (VOCs) for the New York portion of New York-New Jersey-Long Island NY-NJ-CT (NYMA) serious nonattainment area; and for the Jamestown, NY marginal nonattainment area. In addition, the NPRM proposed approval of the 2011 calendar year ozone emission inventory that was developed statewide for New York.

The pollutants included in the inventory are annual emissions for CO, NO X , and VOC. These submittals were made, in part to meet requirements for serious areas for the 2008 ozone national ambient air quality standard (NAAQS). Other specific requirements of New York's SIP revisions for the 2008 ozone NAAQS and the rationale for the EPA's proposed action are explained in the NPRM and will not be restated here.

The EPA did not receive any comments on the July 1, 2021 NPRM.

The EPA is approving revisions to the New York SIP which pertains to the following: 2011 calendar year ozone season daily and annual ozone precursor emission inventories for CO, NO X , and VOC for the NYMA portion of New York-New Jersey-Long Island NY-NJ-CT serious nonattainment area, and for the Jamestown marginal nonattainment area. In addition, the EPA is approving the 2011 calendar year ozone emissions inventory that was developed statewide for New York. The pollutants included in the inventory are annual emissions for CO, NO X , and VOC.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735 (October 4, 1993)) and 13563 (76 FR 3821 (January 21, 2011));

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255 (August 10, 1999));

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885 (April 23, 1997));

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355 (May 22, 2001));

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629 (February 16, 1994)).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249 (November 9, 2000)).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 30, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

EPA is approving changes to 401 Kentucky Administrative Regulation (KAR) 52:100, Public, affected state, and U.S. EPA review, of the Kentucky SIP and Title V program, submitted by the Commonwealth on August 12, 2020, and March 29, 2021. The August 12, 2020, and March 29, 2021, SIP and Title V program revisions seek to establish a revised method of publication of public notices for public hearings and public comment periods, establish a revised method of notification of the opportunity to be placed on a mailing list of permit actions, change how documents related to permit proceedings will be available for public inspection, and make minor changes to 401 KAR 52:100 that do not alter the meaning of the regulation. The SIP revisions, which address public notice rule provisions for the NSR and FESOP programs, updates the current SIP-approved version of 401 KAR 52:100 (Version 1) to Version 2. The Title V revision updates the approved version of 401 KAR 52:100 originally approved in the Kentucky Title V program to Version 2 as well. 1

On October 5, 2016, EPA finalized revised public notice provisions for the NSR, Title V, and Outer Continental Shelf permitting programs of the CAA. See 81 FR 71613 (October 18, 2016). These rule revisions removed the mandatory requirement to provide public notice of permitting actions through publication in a newspaper and allow for internet e-notice as an option for permitting authorities implementing their own EPA-approved SIP rules and Title V rules, such as Kentucky's EPA-approved permitting programs. Permitting authorities are not required to adopt e-notice. Nothing in the revised rules prevents a permitting authority with an EPA-approved permitting program from continuing to use newspaper notification and/or from supplementing e-notice with newspaper notification and/or additional means of notification. For the noticing of draft permits issued by permitting authorities with EPA-approved programs, the rule requires the permitting authority to use “a consistent noticing method” for all permit notices under the specific permitting program. When e-notice is provided, EPA's rule requires electronic access (e-access) to the draft permit for the duration of the public comment period.

A full description of the e-notice and e-access provisions are contained in EPA's October 18, 2016 rulemaking document. See 81 FR 71613.

The SIP and Title V permit programs are revised through changes to 401 KAR 52:100, Public, affected state, and U.S. EPA review, which establishes the procedures used by the Cabinet to provide for the review of federally-enforceable permits by the public, affected states, and EPA. Specifically, 401 KAR 52:100 applies to permit actions established in 401 KAR 52.020, Title V Permits and 401 KAR 52.030, Federally-enforceable permits for non-major sources. In addition, the public participation provisions of Kentucky's major source NSR permitting programs at 401 KAR 51:017, Prevention of significant deterioration of air quality (PSD), and 401 KAR 51:052, Review of new sources in or impacting upon nonattainment areas (addressing nonattainment new source review (NNSR)) cross reference the public notice procedures of 401 KAR 52:100.

In a notice of proposed rulemaking (NPRM) published on May 28, 2021 (86 FR 28740), EPA proposed to approve Kentucky's SIP and Title V program revisions provided on August 12, 2020, and March 29, 2021. The NPRM provides additional detail regarding the background and rationale for EPA's action. Comments on the NPRM were due on or before June 28, 2021. EPA did not receive any comments on the NPRM.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of 401 KAR 52:100, Public, affected state, and U.S. EPA review, Version 2, State effective June 2, 2020, into the Kentucky SIP. The incorporation includes minor textual changes and establishes a revised means of publication for public notices for public hearing, public comment periods, and the opportunity to join mailing lists, and a revised means to inspect documents related to permit proceedings. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 2

EPA is approving the changes to the 401 KAR 52:100 Public, affected state, and U.S. EPA review, of the Kentucky SIP and Title V program, as submitted on August 12, 2020, and March 29, 2021, as these changes are consistent with the CAA and implementing Federal regulations.

Under the CAA, the Administrator is required to approve SIP and Title V submissions that comply with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k) and 7661a(d); 40 CFR 52.02(a) and 70.4(e). Thus, in reviewing SIP and Title V submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The Kentucky SIP and Title V program are not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rules do not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will they impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 30, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons stated in the preamble, the EPA amends 40 CFR parts 52 and 70 as follows:

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B), provides that when an agency for good cause finds that notice and public procedures are impracticable, unnecessary, or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment.

The EPA is issuing this final rule solely because Environment and Climate Change Canada's revisions to its import-export recovery and disposal code numbers and descriptions become effective on October 31, 2021. The EPA must revise twelve of its import-export recovery and disposal code numbers and descriptions in 40 CFR 262.81 to reflect the revised Canadian regulatory definitions so that export and import notices and subsequent movement documents exchanged between Canada and the United States on or after October 31, 2021, do not contain conflicting information. Consequently, the EPA has determined that there is good cause for making the conforming changes in this final rule without prior proposal and opportunity for comment, because notice and public comment would have no impact on the need to parallel as closely as possible the Canadian regulatory revisions that triggered this final rule.

With respect to the effective date, EPA finds that it has good cause for the October 31, 2021 effective date under section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. 553(d), and section 3010(b) of RCRA, 42 U.S.C. 6930(b). EPA has good cause because this rule must be effective on October 31, 2021 to match the effective date for the Canadian regulatory changes. The purpose of section 553(d) of the APA is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. FCC, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). Notwithstanding this purpose, section 553(d) authorizes an Agency to establish an effective date for a rule that is sooner than 30 days from its publication, “as otherwise provided by the agency for good cause found and published with the rule.” Similarly, whether the regulated community needs a period of time to come into compliance is relevant to the application of RCRA section 3010(b).

With respect to the effective date, U.S. exporters and U.S. importers will have sufficient time to comply with this rule. They must use EPA's Waste Import Export Tracking System (WIETS) to create and submit their notices to the Agency, and WIETS will reflect the changes in the recovery and disposal operation lists for exporters and importers to use in notices submitted to EPA on or after October 31, 2021, so the regulated community will not need to change how they use the system. As explained above, EPA has good cause for this effective date because this rule must be effective on October 31, 2021 in order to match the effective date for the Canadian regulatory changes. For these reasons, the EPA has concluded that the regulated community will have sufficient time to comply with this rule and that good cause exists for making the changes in this final rule effective October 31, 2021.

These revisions to the regulations related to twelve recovery and disposal codes used by exporters and importers in this action generally affect two groups: (1) All persons who export or import (or arrange for the export or import of) hazardous waste for recycling or disposal, including those hazardous wastes subject to the alternate management standards for (a) universal waste for recycling or disposal, (b) spent lead-acid batteries (SLABs) being shipped for reclamation, (c) industrial ethyl alcohol being shipped for reclamation, (d) hazardous waste samples of more than 25 kilograms being shipped for waste characterization or treatability studies, and (e) hazardous recyclable materials being shipped for precious metal recovery; and (2) all persons who export or arrange for the export of conditionally excluded cathode ray tubes being shipped for recycling or conditionally excluded hazardous secondary materials being shipped for recycling. Potentially affected entities may include, but are not limited to:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

To obtain electronic copies of this document and other related information that are available electronically, please visit www.epa.gov/hwgenerators.

This action makes conforming changes to regulations related to twelve (12) hazardous waste import-export recovery and disposal operations used in hazardous waste export and import notices submitted to EPA by U.S. exporters and importers, and in movement documents that must accompany such shipments. Changes in these regulations related to twelve recovery and disposal operations are needed to reflect changes to regulations related to Canadian import-export recovery and disposal operations that Canada promulgated in the Canada Gazette Part II on March 17, 2021 (“Cross-border Movement of Hazardous Waste and Hazardous Recyclable Material Regulations,” Canada Gazette Part II, volume 155, number 6, pp. 324-543) and that will become effective on October 31, 2021. The changes to the regulations related to the twelve import-export disposal and recovery operations will ensure that the disposal and recovery operation codes listed in U.S export notices proposing exports to Canada facilities and subsequent movement documents will continue to reflect the accurate Canadian code numbers and description of the operations, enabling matching to the information listed in the Canadian import notices and movement documents.

The current and revised regulatory text for the twelve affected disposal and recovery operations are as follows:

These revised codes and descriptions will be automatically available for exporters and importers to use in EPA's WIETS on October 31, 2021 when they create export or import notices to submit to EPA. Exporters and importers shipping hazardous waste between the U.S. and Canada generally comply with the movement document requirements in 40 CFR 262.83(d) and 40 CFR 262.84(d) respectively, by relying on the use of a Canadian movement document that will be required to reflect the modified recovery and disposal operation code numbers for consents issued by either the EPA or Environment and Climate Change Canada based on notices submitted on or after October 31, 2021 due to the Canadian regulatory revisions.

The EPA is issuing this document under its authority in sections 1002, 2002(a), 3001-3004, and 3017 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (RCRA), and as amended by the Hazardous and Solid Waste Amendments, 42 U.S.C. 6901 et seq., 6912, 6921-6924, and 6938.

Under section 3006 of RCRA, EPA may authorize qualified States to administer their own hazardous waste programs in lieu of the federal program within the State. Following authorization, EPA retains enforcement authority under sections 3008, 3013, and 7003 of RCRA, although authorized States have primary enforcement responsibility. The standards and requirements for State authorization are found at 40 CFR part 271.

Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a State with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the federal program in that State. The federal requirements no longer applied in the authorized State, and EPA could not issue permits for any facilities in that State, since only the State was authorized to issue RCRA permits. When new, more stringent federal requirements were promulgated, the State was obligated to enact equivalent authorities within specified time frames. However, the new federal requirements did not take effect in an authorized State until the State adopted the federal requirements as State law.

In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which was added by HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized States at the same time that they take effect in unauthorized States. The EPA is directed by the statute to implement these requirements and prohibitions in authorized States, including the issuance of permits, until the State is granted authorization to do so. While States must still adopt HSWA related provisions as State law to retain final authorization, EPA implements the HSWA provisions in authorized States until the States do so.

Authorized States are required to modify their programs only when EPA enacts federal requirements that are more stringent or broader in scope than existing federal requirements. RCRA section 3009 allows the States to impose standards more stringent than those in the federal program (see also 40 CFR 271.1). Therefore, authorized States may, but are not required to, adopt federal regulations, both HSWA and non HSWA, that are considered less stringent than previous federal regulations.

Because of the federal government's special role in matters of foreign policy, EPA does not authorize States to administer Federal import/export functions in any section of the RCRA hazardous waste regulations. This approach of having Federal, rather than State, administering of the import/export functions promotes national coordination, uniformity and the expeditious transmission of information between the United States and foreign countries.

Although States do not receive authorization to administer the Federal government's import/export functions in 40 CFR part 262 subpart H, or the import/export relation functions in any other section of the RCRA hazardous waste regulations, State programs are still required to adopt the provisions in this rule to maintain their equivalency with the Federal program (see 40 CFR 271.10(e)). The States that have already adopted 40 CFR part 262 subpart H, 40 CFR part 264, and 40 CFR part 265 must adopt the revisions to those provisions in this final rule. When a State adopts the import/export provisions in this final rule, they must not replace Federal or international references or terms with State references or terms.

The provisions of this rule will take effect in all States on the effective date of the rule, since these import and export requirements will be administered by the Federal government as a foreign policy matter and will not be administered by States.

This final rule changes the regulations related to code numbers and descriptions for twelve hazardous waste import-export recovery and disposal operations used in hazardous waste export and import notices and subsequent movement documents to reflect changes to regulations related to Canadian import-export recovery and disposal operations that Canada promulgated in the Canada Gazette Part II on March 17, 2021 and that become effective on October 31, 2021. This action is not a “significant regulatory action” and is therefore not subject to OMB review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Additionally, this action is not a significant regulatory action and does not impose any new information collection burden under the Paperwork Reduction Act. The changes made to the regulations because of this action merely revise certain recovery and disposal operations that are listed in export and import notices and related movement documents. They impose no new reporting requirements on regulated parties. Because this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) or Sections 202 and 205 of the Unfunded Mandates Reform Act of 1999 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments. This action does not create new binding legal requirements that substantially and directly affect Tribes under Executive Order 13175 (65 FR 67249, November 9, 2000). This action does not have significant Federalism implications under Executive Order 13132 (64 FR 43255, August 10, 1999). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any new information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994). This action does not involve technical standards; thus, the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

The Congressional Review Act (CRA), 5 U.S.C. 801 et seq., generally provides that before certain actions may take effect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. This final action is subject to the CRA, and the EPA will submit a rule report to each House of Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by U.S.C. 804(2).

For the reasons stated in the preamble, EPA amends title 40, chapter 1 of the Code of Federal Regulations as follows:

You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in 40 CFR 716.120(d) of the regulatory text of this document. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Chemical manufacturers (including importers), (NAICS codes 325 and 324110), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.

EPA promulgated a final rule in the Federal Register of June 29, 2021 (86 FR 34147) (FRL-10020-38) to require manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. The chemical substances subject to this rule are listed in this document and consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA), The Agency.is extending the submission deadline established in that final rule from September 27, 2021 to December 1, 2021 for the following chemicals:

EPA is also extending the deadline established in the June 29, 2021 final rule from September 27, 2021 to January 25, 2022 for the following chemicals:

The Agency is taking this action to provide additional time for the regulated community to familiarize themselves with new TSCA Health and Safety Data Reporting requirements. EPA has not added chemicals to the TSCA section 8(d) rule in a manner that would affect a large group of stakeholders since 2006, for the orphan High Production Volume chemicals. With respect to the timing of this action, the need for the Agency to extend the deadline arose, in part, as a result of receiving a sizable number of requests to extend the reporting deadline. Additionally, the Agency recognizes that complications exist for certain entities subject to this rule resulting from the COVID-19 pandemic, which can present challenges to accessing records that may only be available in hard copy formats ( e.g., microfiche).

EPA therefore believes it is appropriate to extend the reporting period to allow the regulated community additional time for data reporting. EPA is making available a historic question and answer document about reporting under TSCA 8(d) and additional content on its web page for the rulemaking (available at https://www.epa.gov/chemicals-under-tsca/health-and-safety-data-reporting-addition-20-high-priority-substances-and-30 ), providing reporting entities additional time to review these materials and prepare any necessary submissions to improve reporting quality for this rule.

EPA's timeline for risk evaluations under TSCA section 6 necessitates that data received via the TSCA section 8(d) action be received in time for use in risk evaluations for chemical substances that have been designated as high-priority substances. Thus, EPA is limiting the deadline extension to December 1, 2021 for these chemical substances. Receiving TSCA section 8(d) submissions on these high-priority substances by December 1, 2021 will ensure that such information will be received in time for use in risk evaluations on these chemical substances. For the remaining organohalogen flame retardants subject to the rule, EPA is extending the deadline to January 25, 2022.

EPA promulgated the Health and Safety Data Reporting rule under TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR part 716. EPA is using this TSCA section 8(d) rule in accordance with 40 CFR 716.105 to gather information on chemical substances. Under section 553(b)(B) of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), an agency may issue a final rule without providing notice and an opportunity for public comment if it for good cause finds that notice and public procedures are impracticable, unnecessary, or contrary to the public interest. In this instance, the Agency finds that notice and public comment procedures are unnecessary because this is merely an extension of the reporting period that does not alter the substantive TSCA section 8(d) reporting requirements in any way and are impracticable because there is insufficient time for notice and comment on an extension to the deadline prior to the reporting deadline, and EPA only became aware of the need for the extension upon receiving numerous requests recently. The Agency believes the extension will not result in a significant delay in the processing and availability of information to EPA for TSCA section 6 risk evaluations or to Consumer Product Safety Commission's (CPSC) evaluation for risks under the Federal Hazardous Substances Act (FHSA). Receiving TSCA section 8(d) submissions pursuant to these deadlines ( i.e., December 1, 2021 for the high-priority substances and January 25, 2022 for the Organohalogen Flame Retardants) will ensure that such information will be received in time for use in these respective activities ( i.e., evaluations pursuant to TSCA and FHSA). Further, any impact on the regulated community is expected to be beneficial to the public interest given that the extension provides additional time to submit complete and accurate unpublished health and safety studies to EPA.

This final rule is effective immediately upon publication. Section 553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1), provides that final rules shall not become effective until 30 days after publication in the Federal Register “except . . . a substantive rule which grants or recognizes an exemption or relieves a restriction.” The purpose of this provision is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when the agency grants or recognizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the effect is not adverse. EPA has determined that this rule relieves a restriction because it provides manufacturers (including importers) additional time to comply with the Health and Safety Data Reporting rule.

Additional information about these statutes and Executive Orders can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(d) related to the Health and Safety Data Reporting rule from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993). As such, this final rule was not reviewed by OMB under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not contain any new or revised information collections subject to OMB approval under the PRA, 44 U.S.C. 3501 et seq. Information collection activities contained in the TSCA 8(d) rule are already approved by the Office of Management and Budget (OMB) under OMB Control No. 2070-0004.

This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements under the APA because the Agency has invoked the APA “good cause” exemption.

This action will not impose any enforceable duty or contain any unfunded mandate as described under Title II of UMRA, 2 U.S.C. 1531-1538 et seq.

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, E.O. 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not a covered regulatory action because it is not “economically significant” under Executive Order 12866 and it does not concern an environmental health risk or safety risk. Although this action would not establish an environmental standard intended to mitigate health or safety risks, the information that would be submitted to EPA in accordance with this rule would be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information may also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, which would allow the Agency and others to take appropriate action to investigate and mitigate those risks.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not otherwise been designated by the Administrator of OMB's Office of Information and Regulatory Affairs as a “significant energy action.”

Because this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994). However, the Agency believes that the information collected through this rule will inform the TSCA risk evaluations that are planned for these chemicals and will thereby enable the Agency to better protect human health and the environment, including in low-income and minority communities.

This action is subject to the CRA (5 U.S.C. 801 et seq. ), and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

On June 16, 2021, HHS published a Notice of Proposed Rulemaking (2021 NPRM) in the Federal Register (86 FR 32008) to rescind the “Implementation of Executive Order on Access to Affordable Life-Saving Medications” rule. The 2021 NPRM provided for a 30-day comment period, and HHS received 332 comments. HHS carefully considered all comments in developing this rule, as outlined in Section VI below, and presents a summary of all significant comments and HHS responses.

HHS published the subject NPRM in the Federal Register on September 28, 2020 (85 FR 60748), and the 2020 Rule on December 23, 2020 (85 FR 83822). The 2020 Rule established a new requirement directing all health centers receiving grants under section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) that participate in the 340B Program (42 U.S.C. 256b), to the extent that they plan to make insulin and/or injectable epinephrine available to their patients, to provide assurances that they have established practices to provide these drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program (plus a minimal administration fee) to health center patients with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or who have no health insurance.

On June 16, 2021, after a careful reassessment of the comments submitted in response to the proposed rule published at 85 FR 60748 (September 28, 2020) and consideration of the comments received on the proposed rule to delay the effective date published at 86 FR 13872 (March 11, 2021), HHS published the 2021 NPRM to rescind the 2020 Rule. The 2021 NPRM cited significant concerns regarding health centers needing to divert vital resources to implement the 2020 Rule. The 2021 NPRM requested comment on the administrative burden and costs to comply with the 2020 Rule and thus maintain eligibility for future Health Center Program grants. The 2021 NPRM also requested comment on whether a rescission would assist health centers in continuing to provide primary care services to medically underserved and vulnerable populations. HHS noted the administrative burdens associated with the 2020 Rule, particularly in light of health centers' continuing role in ensuring equitable access to COVID-19 vaccination and maintaining the capacity to provide primary and preventive care that addresses the ongoing and evolving needs of hard-to-reach and disproportionately affected populations. HHS also noted that the 2020 Rule would carry increased administrative costs and administrative burden and would result in reduced resources being available to support services to health center patients. In addition, most comments submitted previously noted that, in many cases, health centers already voluntarily provided medications at reduced prices to their patients.

The 2021 NPRM comment period ended on July 16, 2021. After review and consideration of all submitted comments, HHS has concluded that the 2020 Rule created excessive administrative burden for health centers, which in turn would have resulted in reduced resources for health center patient services. HHS has determined that the overall impacts of the administrative burden outweigh benefits to patients from the reduction in prices of insulin and injectable epinephrine. Therefore, HHS is issuing this final rule rescinding the 2020 Rule, which was published at 85 FR 83822.

The 2020 Rule became effective on July 20, 2021, prior to publication of this rescission. Due to the timing of Health Center Program funding, grants awarded in Fiscal Year 2022 would be the first opportunity for HRSA to impose the requirements of the “Implementation of Executive Order on Access to Affordable Life-Saving Medications” rule, and so the requirements have not yet been implemented.

The statement of authority for 42 CFR part 51c cites to sections 330 (42 U.S.C. 254b) and 215 of the Public Health Service Act, (42 U.S.C. 216), respectively.

HHS is rescinding the 2020 Rule and therefore deleting the associated revision to the regulations codified at 42 CFR 51c.303(w). 42 CFR 51c.303(w) stated: “To the extent that an applicant for funding under Section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) has indicated that it plans to distribute, either directly, or through a written agreement, drugs purchased through the 340B Drug Pricing Program (42 U.S.C. 256b), and to the extent that such applicant plans to make insulin and/or injectable epinephrine available to its patients, the applicant shall provide an assurance that it has established practices to provide insulin and injectable epinephrine at or below the discounted price paid by the health center grantee or subgrantee under the 340B Drug Pricing Program (plus a minimal administration fee) to health center patients with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or have no health insurance.”

This final rule also states that the program term established by the “Implementation of Executive Order on Access to Affordable Life-Saving Medications” rule will not be included on any Notices of Award issued to health centers receiving grant funds under section 330(e) of the Public Health Service Act. Due to the timing of Health Center Program funding, placement of that program term on health center awards would have first been applied to funds awarded in Fiscal Year 2022. As HHS has issued this final rule prior to the issuance of such awards, this program term has not been placed on Health Center Program awards.

This final rule does not revoke Executive Order 13937, which may only be revoked by executive order. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order.

HHS is rescinding the 2020 Rule because the overall impact of the additional administrative costs and burden that the 2020 Rule would have placed on health centers would have harmed health centers and the patients they serve.

In implementing the requirement of the 2020 Rule, health centers would have had to absorb significant additional costs in financial resources, time, and ongoing support staff to create and maintain new reporting, monitoring, technical and administrative re-engineering, staff training, and workflow re-designs to assess eligibility based on the numerous different categories set forth in the 2020 Rule for patients to receive insulin and injectable epinephrine.

The 2020 Rule would have significantly increased the administrative burden on health centers because it would have required health centers to track and monitor in real time: (1) Whether patients were receiving insulin or injectable epinephrine through a 340B pharmacy, (2) whether patients' incomes met the threshold in the 2020 Rule (which is different from the standard used for the Health Center Program sliding fee discount schedule and therefore would have had to be calculated separately), and (3) whether patients had a high unmet deductible each time they filled their prescriptions—which may have been further complicated due to medical billing and claims processing delays or whether they had a high deductible or high cost-sharing requirement as part of their insurance plan. These burdens would have also required that health centers work with their contract pharmacies to implement these new requirements, which would have created extra administrative costs. HHS has determined that, under the 2020 Rule, health centers and pharmacies would have found it challenging to ascertain in real time a patient's eligibility for discounted pricing under the 2020 Rule based on whether or not that patient continued to have a high unmet deductible, as defined in the 2020 Rule, particularly due to delays in medical billing and claims processing.

HHS also notes that the 2020 Rule codified a new definition, applicable only to these two classes of drugs, for “individuals with low income,” to include those individuals with incomes at or below 350 percent of the amount identified in the Federal Poverty Guidelines (FPG). This new definition contrasted with the Health Center Program's sliding fee discount schedule requirement for Health Center Program grantees applicable to individuals with incomes at or below 200 percent of the FPG, pursuant to 42 CFR 51c.303(f). Under this subsection, health centers must establish a sliding fee discount schedule for services provided to patients with incomes between 100 and 200 percent of the FPG, with a full discount to individuals and families with annual incomes at or below 100 percent of those set forth in the FPG. Health centers also may collect nominal fees for services from individuals and families at or below 100 percent of the FPG, and no sliding fee discount may be provided to individuals and families with annual incomes greater than 200 percent of the FPG. Health centers must also demonstrate to HHS that they maintain and apply such sliding fee discount schedules to the provision of health services, which requires them to establish and maintain processes for identifying patient income levels for billing purposes consistent with these requirements.

In its decision to rescind the 2020 Rule, HHS notes the concerns expressed by the vast majority of commenters that the “low income” definition of 350 percent of the FPG, applicable to patients receiving these two classes of drugs, would have created significant administrative challenges for health centers. HHS is issuing this rule in recognition that the 2020 Rule would have resulted in additional administrative burden and costs, resulting in a diversion of resources from needed patient care, especially during the COVID-19 pandemic, in order to cover such increased administrative costs.

As commenters have noted, the rule would have forced health centers to construct two different eligibility systems. As the 2020 Rule's definition of “low income” is inconsistent with standards applied in the Health Center Program and in other comparable federal programs with an income eligibility threshold, this would have imposed new administrative burdens on health centers to implement. Furthermore, the 2020 Rule would require health center staff, who are not clinicians, to ask patients at the time of screening if they use insulin or injectable epinephrine, which may raise concerns related to the sharing of protected health information if not conducted in a confidential setting.

Rescinding the 2020 Rule prevents unnecessary costs to health centers that are on the front lines of fighting COVID-19 and providing care to millions of Americans. The 2020 Rule would have resulted in increased administrative costs and administrative burden and reduced resources available to support critical services to health center patients, including those who use insulin or injectable epinephrine and who receive other services from health centers.

HRSA received a total of 332 comments from the public, including: Health centers, associations and organizations representing health centers, a health center controlled network, individual health center staff and clinical professionals, individuals and organizations concerned with the high cost of insulin or injectable epinephrine, an association representing pharmacies, an association representing hospitals participating in the 340B Program, a health insurance issuer, a health innovation and research non-profit organization, a pharmaceutical manufacturer, and an association representing pharmaceutical manufacturers.

The vast majority of comments (318) favored rescission of the 2020 Rule. There were 12 comments opposing rescission of the 2020 Rule and supporting its implementation. Two remaining comments did not explicitly support or oppose the rescission of the 2020 Rule.

All comments were considered in developing this final rule. This section presents a summary of all major issues raised by commenters, grouped by subject, as well as responses to the comments. Commenters used the terms “Federally Qualified Health Centers (FQHCs)” and “health centers” interchangeably. This final rule only applies to health centers funded under Section 330(e) of the Public Health Service Act, and not to other FQHCs. For consistency, this final rule uses “health center” throughout.

Approximately 318 commenters supported rescission of the 2020 Rule. Commenters cited a number of reasons for their support, which are summarized below.

Comment: Approximately 316 commenters expressed concern that the net impact of implementing the 2020 Rule would be a reduction in access to care for underserved populations. These commenters described the anticipated administrative burden and cost for health centers to implement the rule and noted that these costs would reduce resources available to provide essential primary care services to patients.

A subset of these commenters (61) detailed the specific administrative burdens and costs that would result if the 2020 Rule were implemented, including:

• Determining in real time whether a patient has a high remaining deductible. The remaining deductible amount can be inaccurate as it may change as a result of pending and delayed medical bills;

• Adjusting the charge for qualifying patients for every form of insulin and injectable epinephrine every quarter, when the 340B price changes; and

• Keeping pharmacy partners/contractors informed and ensuring their compliance with new charges and eligibility rules.

Another subset of commenters (59) also noted that HRSA estimated it would require one full-time equivalent (FTE) staff member per health center to implement the 2020 Rule, resources the commenters stated would be better spent increasing access in other ways. For example, commenters stated that one FTE would have greater impact on patient pharmaceutical access by focusing efforts such as helping patients apply to pharmaceutical manufacturers' Patient Assistance Programs and for enabling services to connect patients to other services in the community.

Response: HHS agrees with these commenters' concerns regarding reduced access to care resulting from the additional burden required of health centers to implement the 2020 Rule. Specifically, the 2020 Rule would necessitate some health centers redirecting resources that might have otherwise gone to support patient care to support additional staff to ascertain whether a high unmet deductible has been met in real time.

Comment: Approximately 305 commenters noted that the 2020 Rule's definition of “low income” as persons below 350 percent of the FPG was inconsistent with other federal programs. These commenters further stated that having different definitions across programs increases administrative burden of implementing the 2020 Rule.

A subset of these commenters (58) outlined specific issues that these differing “low income” definitions would cause for health centers implementing the 2020 Rule:

• Health centers would need to establish new policies and procedures for eligibility determinations;

• Eligibility workers would need to ask all patients if they use insulin or injectable epinephrine to appropriately screen them, which would require patients to share protected health information with non-clinicians;

• The higher income threshold would reduce health center savings on these medications, reducing revenue that could be used to support patient services for all patients; and

• A higher income threshold would reduce the cost that health centers could charge insurers for insulin and injectable epinephrine, effectively transferring savings from the health centers to insurers. The commenters explained that this is because insurance contracts generally prohibit health centers from billing insurers more than their “usual and customary” rate for each specific drug, and if the 2020 Rule were not rescinded, it would be very difficult for health centers to argue that the 340B price is not their usual and customary, as very few cash patients would not qualify for the 340B price.

Response: HHS agrees with these commenters' concerns that the definition of “low income” in the 2020 Rule increases the administrative burden of implementing this rule. For example, the 2020 Rule's inconsistency with current health center requirements would require health centers to create new policies, procedures, and workflows to ensure that eligible patients would be charged the 340B price or less for insulin and injectable epinephrine. Additionally, HHS shares commenters' concerns regarding the sharing of protected health information with non-clinicians.

Comment: Approximately 300 commenters expressed concern that implementation of the 2020 Rule would divert health center resources away from the COVID-19 pandemic response.

A subset of these commenters (57) further noted that health centers are making meaningful contributions to COVID-19 testing, treatment, and vaccination, and that these contributions are very resource-intensive. These commenters stated that reducing burden by rescinding the 2020 Rule would allow this vital work to continue.

Response: HHS appreciates the role health centers continue to play in the response to the COVID-19 pandemic. HHS shares commenters' concerns about the potential for implementation of the 2020 Rule to divert resources away from health centers' ongoing critical role in the COVID-19 pandemic response, stabilization, and recovery.

Comment: Approximately 301 commenters stated that implementing the 2020 Rule would only improve medication access for a small population of patients, and health center services would be drastically reduced for all health center patients given the increase in administrative costs and loss of 340B savings.

A subset of these commenters (59) noted that the 2020 Rule would have no impact on the overall price of the covered medications outside of the 340B Program; those prices are set by manufacturers and would not be changed by this rule. Further, these commenters stated that 90 percent of diabetic patients in the United States are not health center patients, and therefore the 2020 Rule would not impact what the majority of diabetic patients pay for insulin. Commenters also stated that health center patients with diabetes are already likely to qualify for discounted pricing through health centers.

Response: HHS appreciates the detail provided by commenters in support of their conclusion that the 2020 Rule would not meaningfully impact medication access for health center patients or individuals who are not health center patients. HHS agrees that the 2020 Rule would be unlikely to impact the underlying price of these two medications. HHS also agrees that the 2020 Rule would likely improve medication access for only a small population of health center patients.

Comment: One commenter, an association of chain drug stores, stated that the 2020 Rule would place undue burdens on 340B-covered entities as well as their contract pharmacies. The commenter also stated that the 2020 Rule had not sufficiently resolved several concerns, including concerns regarding the need for specific guidance to 340B-covered entities for determining the patient's deductible at the pharmacy point-of-sale and communicating patient eligibility to contract pharmacies and additional clarity with respect to administration fees. The commenter argued that because these concerns were not addressed in the 2020 Rule, the proper course of action would be for HRSA to rescind the 2020 Rule.

Response: HHS acknowledges that the 2020 Rule would result in significant administrative burden on health centers, which may be passed on to the pharmacies with which they contract to provide access to medications.

Comment: One commenter, a health insurance issuer, stated support for rescinding the 2020 Rule. The commenter also stated that as HHS considers alternative approaches to implementation of Executive Order 13937, it should prioritize options that can be implemented with minimal administrative burden to the parties involved in the 340B Program, including health centers, their private sector partners, and patients served. The commenter further stated that any alternative approaches should ensure that HRSA maintains a regularly updated directory of health centers, require health centers to adjudicate 340B claims of patients who have health insurance, and require pharmacy providers to adhere to 340B claim stamping using the National Council for Prescription Drugs Programs submission clarification code.

Response: HHS acknowledges the comment and support for minimizing administrative burden. Alternative methods for implementation of Executive Order 13937 are beyond the scope of this rulemaking.

Twelve commenters opposed the proposed rescission of the 2020 Rule. Commenters cited a number of reasons for their opposition, which are summarized below.

Comment: Six commenters opposed HHS's proposed rescission of the 2020 Rule noting the importance of insulin and the additional costs that could be imposed on the health system if patients were not taking the necessary amounts of insulin to avoid additional complications.

Response: HHS shares commenters' concerns about the additional health care costs that can result from a lack of access to timely and appropriate primary health care. The fundamental purpose of the Health Center Program is to ensure access to care for underserved and vulnerable populations; Section 330 of the Public Health Service Act requires health centers to provide comprehensive primary health care to patients without regard to the patient's ability to pay. HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to help provide comprehensive primary health care to as many health center patients as possible and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit.

Comment: Five commenters opposed HHS's proposed rescission of the 2020 Rule noting that the cost of monthly medications poses a financial burden to patients which can be life-threatening, especially for underserved populations who depend on lower medication costs. These commenters further stated that HHS should consider the cost to patients and not just the financial burden on healthcare systems. A subset of these commenters (3) stated that if medication costs increase, these patients will likely stop taking their medication or be forced to choose between food, rent, or medication. Another subset of these commenters (2) opposed HHS's proposed rescission of the 2020 Rule noting that human life is of greater value than costs to institutions, and that the increased burden on health centers does not justify taking away affordable medications from underserved populations.

Response: HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to the availability of fewer resources to help provide comprehensive primary health care to as many health center patients as possible and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit. HHS believes the 2020 Rule would improve medication access for only a small percentage of health center patients while not meaningfully impacting medication access for the majority of health center patients.

Comment: Four commenters opposed HHS's proposed rescission of the 2020 Rule noting that they disagree with HHS's reasoning for rescinding the 2020 Rule. The commenters stated that administrative burden and administrative costs do not justify limiting access to lifesaving medications to low income patients who do not have insurance or otherwise cannot afford their medications.

Response: HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to help provide comprehensive primary health care to as many health center patients as possible and that decreased resources would result in the cost of the 2020 Rule outweighing its benefit. Executive Order 13937 remains in effect and HHS is exploring alternative approaches to address the high costs of prescription drugs, such as insulin or injectable epinephrine.

Comment: Two commenters opposed HHS's proposed rescission of the 2020 Rule noting that health care institutions (including health centers) can address increasing costs of providing essential programs, including during the COVID-19 pandemic, without HHS rescinding this rule. Comments included suggested alternative health center cost cutting methods such as allocating resources, improving workflows, and using employee retention strategies.

Response: HHS is rescinding the 2020 Rule to maximize resources health centers have to provide access to high quality, comprehensive primary health care in the most efficient way and to as many health center patients as possible. HHS believes the 2020 Rule would improve medication access for only a small percentage of health center patients. Examining other cost cutting measures to decrease the burden on health centers is beyond the scope of this proposed rulemaking.

Comment: Two commenters opposed HHS's proposed rescission of the 2020 Rule noting that it would benefit numerous health center patients through greater access to affordable insulin and it should be kept for that reason. One of those commenters further noted that, unlike patients under 200 percent of the FPG who already receive significant discounts from health centers and would be less impacted by the 2020 Rule, patients between 200 and 350 percent of the FPG would greatly benefit from this rule going into effect.

Response: While the 2020 Rule would likely provide benefits to a small number of health center patients with diabetes and severe allergic reactions, HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to provide comprehensive primary health care to as many health center patients as possible. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order.

Comment: One commenter opposed HHS's proposed rescission of the 2020 Rule noting that HHS should not place a charge on American families to pay for administrative costs at health centers, nor administrative costs caused by the COVID-19 pandemic.

Response: HHS appreciates this comment and is committed to maximizing resources for health centers to provide comprehensive primary health care to health center patients without regard for patients' ability to pay.

Comment: One commenter opposed HHS's proposed rescission of the 2020 Rule noting that it would allow health centers to divert resources to other services at the expense of the community's health needs during the COVID-19 pandemic, specifically, access to the lifesaving medications of insulin and injectable epinephrine.

Response: HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to provide comprehensive primary health care to as many health center patients as possible, including those who use insulin or injectable epinephrine, and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit. In addition, as noted in the 2020 Rule, in many cases, health centers already voluntarily provide medications, including insulin and injectable epinephrine, to their patients at reduced prices.

Comment: One commenter, a pharmaceutical manufacturer, opposed HHS's proposed rescission of the 2020 Rule noting that most of its insulin products are available to covered entities for pennies and rescinding the 2020 Rule would make covered entity patients pay more for the medications. The commenter also noted that covered entity patients in most cases could receive larger discounts from the company's own discount programs for medications.

Response: Nothing in this rule rescinding the 2020 Rule prohibits health center patients from accessing pharmaceutical company and charity discount programs to find the most affordable medications, including for insulin or injectable epinephrine.

Comment: One commenter, a pharmaceutical manufacturer, opposed HHS's proposed rescission of the 2020 Rule, noting that it provides insulin to several charitable organizations including its own foundation, which provide insulin for free for qualifying patients at or below 400 percent of FPG and covered entities should be held to the same standard. Additionally, this commenter noted that it participates in a number of programs that allow patients, regardless of their income, to purchase insulin at no more than $35 a month.

Response: HHS commends those who are working to ensure underserved patients are able to access discounted medications. As noted above, HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to provide comprehensive primary health care to as many health center patients as possible, including those who use insulin or injectable epinephrine.

Comment: One commenter, a pharmaceutical manufacturer, opposed HHS's proposed rescission of the 2020 Rule, noting that grantees that are covered entities under the 340B Program should not be able to charge large markups on drugs purchased through the 340B Program to uninsured or underinsured individuals to fund their operations.

Response: With regard to the commenter's concern regarding the general requirements of the 340B Program, those requirements, including charges for drugs purchased through the 340B Program by covered entities, are beyond the scope of this rulemaking.

Comment: One commenter, a pharmaceutical manufacturer, opposed HHS's proposed rescission of the 2020 Rule, noting that the commenter is able to verify income and insurance information with minimal burden and that six covered entities have worked with the commenter to provide insulin to their patients for pennies, demonstrating that the 2020 Rule would not be overly burdensome.

Response: HHS has concerns that under the 2020 Rule's definition of “high unmet deductible,” health centers and pharmacies with which they contract may find it challenging to ascertain in real time a patient's eligibility for pricing based on whether or not the patient continues to have a “high unmet deductible” that meets the 2020 Rule's definition of the term. The 2020 Rule defined “high unmet deductible” as “the amount a patient owes toward their high deductible at any time during a plan year in which the portion of the patient's high deductible for the plan year that has not yet been met exceeds 20 percent of the deductible.” Determining whether a patient's plan year spending toward their deductible meets this definition has the potential to be particularly challenging due to medical billing and claims processing delays. For these and other reasons, HHS believes the administrative burden and costs the 2020 Rule places on health centers outweigh the benefits.

Comment: One commenter, an association of pharmaceutical manufacturers, while not opposing rescission of the 2020 Rule, noted that the 340B Program has grown exponentially in recent years without a commensurate benefit to the underserved patients.

Response: The growth of the 340B Program is beyond the scope of this rulemaking.

Comment: One commenter stated that the 340B Program is essential to the well-being of all patients that receive care at health centers and asked that the 340B Program be kept in place.

Response: HHS acknowledges the importance of the 340B Program to patients served by health centers. This rulemaking does not change the 340B Program.

Comment: Approximately 300 commenters urged revocation of the “Executive Order on Access to Affordable Lifesaving Medications,” on which the 2020 Rule was based. These commenters expressed many concerns with the underlying Executive Order and requested that it be revoked.

Response: Revoking Executive Order 13937, “Access to Affordable Lifesaving Medications” is beyond the authority of HHS and outside the scope of this final rule.

Other commenters raised a variety of issues that HHS determined did not pertain to the rescission of the 2020 Rule. This rulemaking does not address those issues as they are outside of its scope.

HHS has examined the effects 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 8, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. 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. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB). HRSA estimates that, on average, each health center would have needed to hire one additional full-time equivalent (FTE) eligibility assistance worker at approximately $50,000 to support necessary additional administrative processes, totaling approximately $68,750,000 across health centers.

As stated in the RIA for the 2020 Rule, HRSA determined that the 2020 Rule was not economically significant, given that the administrative burden of $68.7 million described above fell below the “economically significant” threshold of $100 million. HRSA relies on that same analysis now, finding that rescission of that rule will have an economic impact of the same amount, $68,750,000, in administrative savings to health centers, and that such amount is below the “economically significant” threshold of $100 million. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options for implementation.

HHS welcomed but did not receive comments on whether the proposed rescission of the 2020 Rule is a “significant regulatory action” under Section 3(f) of Executive Order 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. As we did in the “Implementation of Executive Order on Access to Affordable Life-Saving Medications” rule, HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities.

For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or by being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $8 million to $41.5 million. As of September 31, 2020, the Health Center Program provides grant funding under section 330(e) of the Public Health Service Act to 1,315 organizations to provide health care to medically underserved communities. HHS has determined, and the Secretary certifies, that this rule will not have a significant impact on the operations of a substantial number of small health centers; therefore, we are not preparing an analysis of impact for purposes of the RFA. HHS estimates the economic impact on small entities as a result of rescinding the 2020 Rule will be minimal. HHS welcomed but did not receive comments concerning the economic impact of the proposed rescission of the “Implementation of Executive Order on Access to Affordable Life-Saving Medications” rule on health centers for the purposes of the RFA.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. As stated in the RIA for the 2020 Rule, HRSA determined that the administrative burden of $68.75 million described above fell below the Unfunded Mandates Reform Act's threshold of $158 million. HRSA relies on that same analysis now, finding that rescission of that rule will have an economic impact of the same amount, $68.75 million in administrative savings to health centers, and that such amount is below the threshold of $158 million.

HHS has reviewed this rule in accordance with Executive Order 13132 regarding federalism and has determined that it does not have “federalism implications.” This rule will not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This rule will not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a federal agency from the public before they can be implemented. This rule is projected to have no impact on current reporting and recordkeeping burden for health centers. This rule will result in no new reporting burdens. HHS welcomed but did not receive comments that this rule would result in new reporting burdens for health centers.

In final rule FR Doc. 2021-10807, beginning on page 27985 in the issue of May 25, 2021, make the following correction: On page 27985, in the third column, the Regulation Identifier Number is corrected to read “RIN 3145-AA63.”

This is a summary of the Commission's Order, FCC 21-87, adopted and released on July 13, 2021. The full text of this document is available at https://docs.fcc.gov/public/attachments/FCC-21-87A1.pdf. To request materials in accessible formats for people with disabilities, send an email to FCC504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

Because these rule changes are being adopted without notice and comment, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., does not apply to this Order.

This Order does not contain new or substantively modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, 44 U.S.C. 3501-3520. Specifically, the changes to existing information collections, including mandatory electronic filing for Section 325(c) Applications, IHF Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports are non-substantive. Because these changes are non-substantive, there is also no new or modified information collection burden for small business concerns with fewer than 25 employees pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

After the adoption and release of this Order, the Commission submitted the changes to the Office of Management and Budget (OMB) and received the OMB approvals. The Commission also received emergency approval from OMB for certain requirements that were inadvertently omitted from existing information collections. The relevant OMB Control numbers are 3060-0678, 3060-0686, 3060-1035, 3060-1133, and 3060-1290.

The Commission will not send a copy of this Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties.

1. Over the past decades, the Commission has made significant progress to upgrade and modernize its licensing systems and filing procedures. 1 Today, we continue these efforts and require that any remaining applications and reports administered by the International Bureau and filed on paper or through an alternative filing process be filed only electronically through the Commission's International Bureau Filing System (IBFS). 2 Specifically, we modify our rules to mandate the electronic filings of Section 325(c) Applications, 3 applications for International High Frequency Broadcast (IHF) Stations (IHF Applications), 4 and Dominant Carrier Section 63.10(c) Quarterly Reports, 5 and to remove a duplicate paper filing requirement for satellite cost-recovery declarations. 6 These mandatory electronic filing requirements will reduce costs and administrative burdens, result in greater efficiencies, facilitate faster and more efficient communications, and improve transparency to the public.

2. Electronic and Paper Filings. The Commission has been committed to streamlining its processes by mandating the electronic filing of applications and other filings related to telecommunications services over the past several decades. 7 Today, the majority of applications and other filings are filed electronically with the Commission. 8 Applications and other filings for which an electronic form is not available and/or is not yet required to be filed electronically by rule must be filed by paper or by modified electronic filing. 9 Currently, for international licenses, authorizations, or other filings that are processed by the International Bureau, almost all applications must be filed electronically through IBFS, including all applications for international and satellite services for which an IBFS form is available. 10 The exceptions to mandatory electronic filing in IBFS, however, remain for Section 325(c) Applications, 11 IHF Applications, 12 and Dominant Carrier Section 63.10(c) Quarterly Reports. 13 Section 325(c) and IHF Applications are submitted through a modified electronic filing process that involves filing a non-docketed pleading through the Commission's Electronic Comment Filing System (ECFS). 14 For Dominant Carrier Section 63.10(c) Quarterly Reports, certain authorization holders are required to mail a paper copy to the Commission within ninety (90) days from the end of each calendar quarter. 15 Section 25.111(d) also requires a paper copy of satellite cost-recovery declarations to be submitted in addition to the version filed electronically. 16

3. Given the well-established benefits of electronic filing, in this Order we amend our rules to require the electronic filing of Section 325(c) Applications, IHF Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports in IBFS, which will reduce the overall burden associated with these filings and increase significantly the efficiency of our administrative processes. 17 We modify our rules involving procedural filing of Section 325(c) Applications and IHF Applications, and require electronic filing of these applications in IBFS and remove a duplicate paper filing requirement for satellite cost-recovery declarations. We also eliminate paper filing of Dominant Carrier Section 63.10(c) Quarterly Reports and require their submission in IBFS within ninety (90) days after the end of each calendar quarter. Finally, we set a process for any changes to take effect.

4. As part of the Commission's continuing efforts to modernize its IBFS, electronic forms will be available for Section 325(c) Applications, IHF Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports. Accordingly, we require such filings to be submitted to the Commission electronically in IBFS, subject to the transition period set forth below. We have long-recognized the benefits of mandatory electronic filing, including reducing regulatory burdens and environmental waste while streamlining the filing process. 18 As the Commission explained in its 2005 IBFS Order, electronic filing eliminates delays from mail delivery and does not require Commission staff to convert the filings into electronic format. 19 Electronic filing also reduces time needed to process applications and can allow the Commission to more quickly place applications on public notice. 20 Filers also benefit from electronic filing because an electronic filing system can automatically notify users of critical errors or omissions in their filings, 21 and electronic filing creates a digital record of users' submissions to the Commission and establishes proof of delivery. 22 The Commission benefits from a reduced workload because the data fields on electronic forms are automatically populated. 23 Other interested parties benefit as well because electronic filings are transmitted nearly instantaneously, making the filings available to the other interested parties around the same time that they become available to the Commission. 24

5. For Section 325(c) Applications and IHF Applications, we eliminate the paper mailing and modified electronic filing requirements through ECFS and require applicants to file electronically in IBFS when the electronic forms are available. 25 The changes we adopt herein will improve the filing process and expedite review of the applications in an orderly manner as IBFS will automatically identify initial filing deficiencies in the electronic forms and route the filed applications to appropriate Commission staff without delay, thereby facilitating timely review. Additionally, any properly filed amendments, renewals, transfers, assignments, surrenders, notifications of limitation or discontinuance of operations, notifications of broadcast service resumption, equipment tests, program tests, post-season reports, pre-season operation notifications, or modifications, will be linked to other relevant applications or filings and similarly routed to the relevant Commission staff, decreasing processing time and administrative cost serving the public interest. 26

6. For Dominant Carrier Section 63.10(c) Quarterly Reports, we eliminate the paper filing option and require carriers to submit these reports electronically in IBFS within ninety (90) days after the end of each calendar quarter. 27 This change will provide a number of benefits to carriers and Commission staff, including cost savings, convenience, and speed. As the Commission noted in the 2020 Wireless Radio Order, “[e]lectronic filing reduces paper, printing, and delivery expenses,” and is more convenient as users can submit their filings “nearly 24 hours a day, 7 days a week . . . .”  28 Further, the electronic filing of Dominant Carrier Section 63.10(c) Quarterly Reports will eliminate the delay of waiting for these filings to be delivered to the Commission, processed, and provided to the relevant Commission staff. Carriers will receive confirmation of their filing from the system, and Commission staff will no longer need to manually digitize these quarterly reports, reducing burdens and decreasing costs to carriers and the Commission.

7. With the actions taken herein, we take another key step to modernize our filings processes, enable cost savings, increase convenience, and decrease processing time and complete the process of mandating that all International Bureau forms and filings must be submitted electronically in IBFS.

8. Section 63.10. Section 63.10(d) specifies the number of copies and where to file each quarterly report. However, it misstates the relevant provisions of section 63.10(c)(2)-(4) identifying these quarterly reports. To correct the error, we revise paragraph (d) to remove the erroneous reference to section 63.10(c)(3)-(5) and replace this portion of the rule with the correct reference to section 63.10(c)(2)-(4), as well as to reflect the new electronic filing requirement for these reports. 29

9. The Commission's part 25 rules governing satellite services contain one paper filing requirement. Before the Commission will submit a satellite network filing to the International Telecommunication Union (ITU), the party requesting the filing must submit a signed declaration of unconditional acceptance of all consequent ITU cost-recovery responsibility. 30 This cost-recovery declaration ensures that the ITU filing charges are paid by the operator, not the United States as notifying administration. 31 The cost-recovery declaration must be filed electronically in IBFS. A paper copy must also be mailed to the Satellite Division of the International Bureau. Our experience has shown that this duplicate, paper copy is unnecessary to ensure that cost-recovery responsibility is properly assumed by the requesting party. We therefore modify our rules and remove the paper filing requirement.

10. We direct the International Bureau to release any relevant public notices announcing the availability of electronic filing for Section 325(c) Applications, IHF Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports as the rules and forms become effective and available in IBFS. Until the International Bureau announces the availability of electronic filing, the current filing processes will continue to apply.

11. Waiver Requests. There may be limited instances where electronic filing rather than paper filing may be unduly burdensome or create a hardship for some potential applicants. For such cases, we will permit applicants and filers to file a request for waiver of our electronic filing requirements under limited circumstances for good cause shown, pursuant to section 1.3 of our rules. 32 To qualify for a waiver, the applicant must plead with particularity the facts and circumstances warranting relief. 33 For example, the applicant must set forth the specific reasons why electronic filing would constitute an unreasonable burden or expense, including the special circumstances at hand that justify a waiver and how a waiver would serve the public interest. We expect the number of waiver requests to be small, and we will not routinely grant waivers of our mandatory filing requirement.

12. Confidential Filings. Applicants or other filers that seek to file confidentially or to preserve the confidentiality of a piece of information in a filing may request such treatment under section 0.459 of the Commission's rules. 34

13. Regulatory Flexibility Analysis. Because these rule changes are being adopted without notice and comment, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., does not apply. 35

14. Paperwork Reduction Act. This Order does not contain new or substantively modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13 (44 U.S.C. 3501-3520). Specifically, the changes to existing information collections, including mandatory electronic filing for Section 325(c) Applications, IHF Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports are non-substantive. 36 Because these changes are non-substantive, there is also no new or modified information collection burden for small business concerns with fewer than 25 employees pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

15. Congressional Review Act. The Commission will not send a copy of this Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 37

13. Accordingly, it is ordered that pursuant to Sections 1, 4(i), 214, 218, 301, 303, 307, 308(b), and 325(c) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 214, 218, 301, 303, 307, 308(b), 325(c), this Order is hereby adopted .

14. It is further ordered that pursuant to Sections 1, 4(i), 214, 218, 301, 303, 307, 308(b) and 325(c) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 214, 218, 301, 303, 307, 308(b), 325(c), the rules discussed herein are adopted and Parts 63 and 73 of the Commission's rules, 47 CFR 63 and 73 are amended as set forth in Appendix A.

15. It is further ordered that this Order, including the revisions to Title 47 of the Code of Federal Regulations shown in Appendix A, shall be effective upon publication in the Federal Register . 38

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 25, 63 and 73 as follows:

The purpose of this rule is to make minor final revisions and edits to three completed parts that are necessary to conform with FAR writing style, standard Government publication formats and drafting standards. VA is updating these parts to ensure standardization in titles with FAR drafting principles, as well as to update any VA organizational changes subsequent to the final rules. In particular, this rulemaking makes technical administrative amendments to part 802, Definitions; part 852, Solicitation Provisions and Contract Clauses; and part 853, Forms.

The three parts addressed in this action have been reviewed and revised as affected parts during the course of the VAAR rewrite project. This is, therefore, a technical, non-substantive change to the texts of these three parts to ensure conformity with those standards.

Technical corrections include the following:

a. For part 802:

(1) Section 802.101 is amended to revise the definition for the Chief Acquisition Officer; the definition for COTR has been removed; the definition for COR has been added to reflect the current use of COR; the definitions for HCA and SPE have been revised to reflect the current organization structure of VA, and to update the website listed for Vendor Information Pages (VIP) has been updated.

(2) Section 802.101 is also amended to delete the following definitions: Deputy Senior Procurement Executive (DSPE) and Resident Engineer. The DSPE role is currently inactive at the VA and the current definition for “Resident Engineer” is inaccurate and unnecessary.

b. For part 852:

(1) Section 852.101 is redesignated as section 852.101-70 to conform with the VAAR numbering convention.

(2) Section 852.102 is amended to correct the word “chapter” because it was misspelled and to update website addresses in paragraphs (e) and (f) that have since changed.

(3) Subpart 852.2 is amended to capitalize all the major words in the section titles of the provisions and clauses.

(4) Section 852.216-75 is amended to delete the word “clause” in the title and to capitalize the major words in the title of the clause.

c. For part 853:

(1) Subpart 853.2 is amended to remove section 853.201 and section 853.201-1 as they include references to the “VA Contracting Officer Certification Program” which no longer exists.

(2) Subpart 853.2 is amended to remove section 853.215 and section 853.215-70 as they are no longer referenced within the VAAR.

(3) Amend Section 853.236 as well as sections 853.236-70, 853.236-71, and 853.236-72 to standardize the format and style convention.

(4) Amend subpart 853.2 to remove sections 853.271-1 and 853.271-2 as this coverage is no longer needed in the VAAR as the authority to perform the functions outlined in these sections are established by other provisions of law.

This rule makes administrative changes that do not require notice and comment procedures, consistent with 41 U.S.C. 1707, 48 CFR 1.301, and related authority. The changes will not have a significant effect on any party and will not have a significant cost or administrative impact on contractors or offerors.

Executive Order 12866—Regulatory Planning and Review directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563—Improving Regulation and Regulatory Review emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

The Office of Management and Budget (OMB) has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This rulemaking does not change VA's policy regarding small businesses, does not have an economic impact to individual businesses, and there are no increased or decreased costs to small business entities. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

This final rule does not contain any information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, approved this document on September 3, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set out in the preamble, VA amends 48 CFR parts 802, 852, and 853 as set forth below.

As prescribed in 816.203-4(e)(5), insert the following clause:

On June 30, 2020, VA published a proposed rule in the Federal Register (85 FR 39151) which announced VA's intent to amend regulations for VAAR Case RIN 2900-AQ76 (parts 852 and 871). VA provided a 60-day comment period for the public to respond to the proposed rule and submit comments. The comment period for the proposed rule ended on August 31, 2020, and VA received no comments. This rule adopts as a final rule, with two technical non-substantive changes to the proposed rule published in the Federal Register on June 30, 2020.

These changes seek to align the VAAR with the FAR and remove outdated and duplicative requirements and reduce burden on contractors. The VAAM incorporates portions of the removed VAAR as well as other internal agency acquisition policy. VA will rewrite certain parts of the VAAR and VAAM, and as VAAR parts are rewritten, will publish them in the Federal Register .

VA is removing proposed section 871.209, Records and reports. VA has determined this section is unnecessary and no information collection requirements are required under subpart 871.2. Any records and reports requirements related to Veterans training are captured under other existing Veterans Benefits Administration policy and information collection requirements unrelated to this text or are covered by standard record keeping requirements and retention periods as set forth in FAR subpart 4.7. Accordingly, VA has renumbered the remaining proposed sections to 871.209, Prohibition on advertising—training of Veterans (from 871.209), and 871.210, Contract clauses (from 871.211), a result of this removal.

VA has updated the Table of Contents in subpart 817.2 to reflect the above removals and renumbering.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that require approval by the Office of Management and Budget (OMB).

The Secretary hereby certifies that this final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This rulemaking does not change VA's policy regarding small businesses, does not have an economic impact to individual businesses, and there are no increased or decreased costs to small business entities. On this basis, the final rule would not have an economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 as they do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal Governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule would have no such effect on State, local, and tribal Governments or on the private sector.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, approved this document on August 24, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set out in the preamble, VA amends 48 CFR parts 852 and 871 as follows:

The 2021 annual management measures for ocean salmon fisheries (86 FR 26425, May 14, 2021), announced management measures for the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, effective from 0001 hours Pacific Daylight Time (PDT), May 16, 2021, until the effective date of the 2022 management measures, as published in the Federal Register . NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Chairman of the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions).

Management of the salmon fisheries is divided into two geographic areas: North of Cape Falcon (NOF) (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). The actions described in this document affected the NOF recreational salmon fishery, as set out under the heading Inseason Action.

Consultation on these inseason actions occurred on August 20, 2021, August 26, 2021, and September 2, 2021. Representatives from NMFS, Washington Department of Fish and Wildlife (WDFW), Oregon Department of Fish and Wildlife (ODFW), and Council staff participated in the consultations.

These inseason actions were announced on NMFS' telephone hotline and U.S. Coast Guard radio broadcast on the date of the consultations (50 CFR 660.411(a)(2)).

Description of the action: Inseason action #26 modified the bag limit in the NOF recreational salmon fishery Queets River to Leadbetter Point (Westport subarea), from a two salmon per day bag limit, no more than one of which may be a Chinook salmon, to a two salmon per day bag limit, beginning at 12:01 a.m. on Friday, August 21, 2021.

Effective date: Inseason action #26 took effect on August 21, 2021, and remains in effect until superseded.

Reason and authorization for the action: The 2021 management measures opened the recreational ocean salmon fishery in the Westport subarea with a bag limit of two salmon per day, no more than one of which may be a Chinook salmon (86 FR 26425, May 14, 2021). Modifying the bag limit to two salmon is consistent with preseason planning and management objectives and provisions of the Pacific Coast Salmon Fishery management Plan (FMP) because the measure would provide greater fishing opportunity for the public to access the available coho quota and Chinook salmon guideline, provide economic benefit to the fishery dependent communities, and was not expected to result in reducing season length or to exceed the recreational quotas.

The NMFS West Coast Region Regional Administrator (RA) considered the landings of Chinook and coho salmon in the NOF recreational salmon fishery, fishery effort that had occurred as well as effort anticipated under the proposal, and the recreational Chinook salmon guideline and coho quotas remaining. The RA determined that inseason action #26 was necessary to meet preseason planning and management objectives to allow access to available salmon quota and support the economy of fishery dependent communities while remaining consistent with the applicable salmon management and conservation objectives. The modification of recreational fishing bag limits is authorized by 50 CFR 660.409(b)(1)(iii).

Consultation date and participants: Consultation on inseason action #26 occurred on August 20, 2021. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

Description of the action: Inseason action #27 closed the NOF recreational salmon fishery from Leadbetter Point, WA to Cape Falcon, OR (Columbia River subarea) due to anticipated attainment of the quota and guideline.

Effective date: Inseason action #27 took effect at 12:01 a.m., August 30, 2021, and remains in effect until superseded.

Reason and authorization for the action: The purpose of inseason action #27 was to avoid exceeding the subarea quota for coho salmon and the guideline for Chinook salmon in the Columbia River subarea recreational salmon fishery. The NMFS West Coast Region RA considered the landings of coho and Chinook salmon in the NOF recreational salmon fishery to date, fishery catch and effort to date as well as anticipated under the proposal, and the recreational coho salmon quota and Chinook salmon guideline remaining in the Columbia River subarea. The recreational ocean salmon fishery in the Columbia River subarea opened June 19, 2021, with a coho salmon quota of 42,400 and a Chinook salmon guideline of 7,200. Through August 22, 34,800 coho salmon (80 percent of the subarea quota) and 5,547 Chinook salmon (77 percent of the subarea guideline) were caught in the Columbia River subarea. Projected catch in the Columbia River subarea for the week of August 23 to August 29 was 8,027 coho salmon and 973 Chinook salmon, which would result in a cumulative catch of 99 percent of the subarea coho salmon quota and 91 percent of the subarea Chinook salmon guideline. The RA determined that inseason action #27 was necessary to avoid exceeding the subarea quota and guideline set preseason. The modification of recreational fishing season is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #27 occurred on August 26, 2021. Representatives from NMFS, WDFW, and ODFW participated in this consultation.

Description of the action: Inseason action #28 closed the NOF recreational salmon fishery from Cape Alava to Queets River (La Push subarea) due to anticipated attainment of the coho salmon quota.

Effective date: Inseason action #28 took effect at 12:01 a.m., September 4, 2021, and remains in effect until superseded.

Reason and authorization for the action: The purpose of inseason action #28 was to avoid exceeding the subarea quota for coho salmon in the La Push subarea recreational salmon fishery. The NMFS West Coast Region RA considered the landings of coho salmon in the NOF recreational salmon fishery to date, catch and fishery effort to date as well as anticipated under the proposal, and the recreational coho salmon quota remaining in the La Push subarea. The recreational ocean salmon fishery in the La Push subarea opened June 19, 2021, with a coho salmon quota of 1,430. Through August 29, 2021, 1,152 coho salmon were caught in the La Push subarea (81 percent of the subarea quota). Projected catch through September 3, 2021 in the La Push subarea was 1,334 coho salmon, which would result in a cumulative catch of 93 percent of the subarea coho salmon quota. The RA determined that inseason action #28 was necessary to avoid exceeding the subarea quota set preseason. The modification of recreational fishing season is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #28 occurred on September 2, 2021. Representatives from NMFS, WDFW, ODFW, and Council staff participated in this consultation.

Description of the action: Inseason action #29 closed the NOF recreational salmon fishery from Queets River to Leadbetter Point (Westport subarea) due to anticipated attainment of the coho salmon quota.

Effective date: Inseason action #29 took effect at 12:01 a.m., September 8, 2021, and remains in effect until superseded.

Reason and authorization for the action: The purpose of inseason action #29 was to avoid exceeding the subarea quota for coho salmon in the Westport subarea recreational salmon fishery. The NMFS West Coast Region RA considered the landings of coho salmon in the NOF recreational salmon fishery to date, catch and fishery effort to date as well as anticipated under the proposal, and the recreational coho salmon quota remaining in the Westport subarea. The recreational ocean salmon fishery in the Westport subarea opened June 19, 2021, with a coho salmon quota of 20,440. Through August 29, 2021, 13,942 coho salmon (68 percent of the subarea quota) were caught in the Westport subarea. Projected catch through September 7, 2021 in the Westport subarea was 20,113 coho salmon, which would result in a cumulative catch of 98 percent of the subarea coho salmon quota. The RA determined that inseason action #29 was necessary to avoid exceeding the subarea quota set preseason. The modification of recreational fishing season is authorized by 50 CFR 660.409(b)(1)(i).

Consultation date and participants: Consultation on inseason action #29 occurred on September 2, 2021. Representatives from NMFS, WDFW, ODFW, and Council staff participated in this consultation.

Description of the action: Inseason action #30 for the commercial salmon troll fishery from the U.S./Canada border to Cape Falcon, OR, modified the landing and possession limit from 20 marked coho salmon per vessel per landing week (Thursday-Wednesday) to 50 marked coho salmon per vessel per landing week (Thursday-Wednesday).

Effective date: Inseason action #30 took effect at 12:01 a.m. on September 3, 2021, and remains in effect until superseded.

Reason and authorization for the action: The purpose of inseason action #30 was to allow greater access to the coho salmon quota in the commercial salmon troll fishery and result in increased fishing interest and the quota being met prior to the scheduled season ending date of September 30, 2021. The RA considered the landed catch of coho and Chinook salmon to date and the amount of quota and guideline remaining, projected catch under the proposal, and the timing of the action relative to the length of the season, and determined that inseason action #30 was necessary to meet management goals set preseason including fully attaining the coho quota. The modification of recreational fishing season is authorized by 50 CFR 660.409(b)(1)(ii).

Consultation date and participants: Consultation on inseason action #30 occurred on September 2, 2021. Representatives from NMFS, WDFW, ODFW, and Council staff participated in this consultation.

All other restrictions and regulations remain in effect as announced for the 2021 ocean salmon fisheries (86 FR 26425, May 14, 2021), as modified by previous inseason action (86 FR 34161, June 29, 2021; 86 FR 37249, July 15, 2021; 86 FR 40182, July 28, 2021; 86 FR 43967, August 11, 2021; 86 FR 48343, August 30, 2021).

The NMFS West Coast Region RA determined that these inseason actions were warranted based on the best available information on Pacific salmon abundance forecasts, landings to date, and anticipated fishery effort and projected catch. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone (3-200 nautical miles (5.6-370.4 kilometers) off the coasts of the states of Washington, Oregon, and California) consistent with these Federal actions. As provided by the inseason notice procedures at 50 CFR 660.411, actual notice of the described regulatory action was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act. This action is authorized by 50 CFR 660.409, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(3)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. Prior notice and opportunity for public comment on this action was impracticable because NMFS had insufficient time to provide for prior notice and the opportunity for public comment between the time Chinook and coho salmon abundance, catch, and effort information was developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best scientific information available. As previously noted, actual notice of the regulatory action was provided to fishers through telephone hotline and radio notification. This action complies with the requirements of the annual management measures for ocean salmon fisheries (86 FR 26425, May 14, 2021), the FMP, and regulations implementing the FMP under 50 CFR 660.409 and 660.411.

There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date, as a delay in effectiveness of this action would restrict fishing at levels inconsistent with the goals of the FMP and the current management measures.