On April 19, 2024, the Department of Justice published an interim final rule and request for comments in the Federal Register at 89 FR 28633 that provided for the Department's implementation of the HAVANA Act of 2021, Public Law 117-46, 135 Stat. 391 (2021) (codified at 22 U.S.C. 2680b(i)). The HAVANA Act authorizes agency heads to provide payments to certain individuals who have incurred qualifying injuries to the brain. The interim final rule covers current and former Department of Justice employees and their dependents.

This document corrects an error in the numbering of two paragraphs in the interim final rule published on April 19, 2024. In § 106.1, the two paragraphs designated as (1) and (2) should have been designated as paragraphs (a) and (b).

In FR Doc. 2024-08336, appearing on page 28633 in the Federal Register of Friday, April 19, 2024, the following correction is made:

The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest to do so. The Coast Guard received insufficient notice from the event sponsor to be able to publish an NPRM, receive, consider, and respond to public comments in time to publish a final rule prior to the date of the event.

Also, 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 by 30 days is impracticable because the notice we received is also insufficient to do so if the rule is to go into effect on May 6.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port, Sector St. Petersburg (COTP) has determined that potential hazards associated with the demonstration will be a safety concern for anyone within the exercise area. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the demonstration.

This rule establishes a safety zone which will be subject to enforcement from 7:30 a.m. until 4 p.m., daily, from May 6, 2024 through May 9, 2024. The safety zone will cover an area of the Seddon Channel in the vicinity of the Tampa Convention Center, in Tampa, Florida. The US Special Operations Command capabilities demonstration (CAPE DEMO) is expected to consist of multiple airborne and waterborne activities, including people using blank ammunition, fast-roping, and jumping out of helicopters, as well as engaging in high-speed boat pursuits, and in amphibious vehicles operations.

The duration of the zone is intended to ensure the safety of the participants, spectators, and the general public during the scheduled events. No vessel or person, not involved in the events, will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP or a designated representative. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative.

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 section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the following reasons: (1) the safety zone only being enforced for a total of eight and a half hours each day; (2) although persons and vessels may not enter, transit through, anchor in, or remain within the zone without authorization from the COTP or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the areas during the enforcement period if authorized by the COTP or a designated representative.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please 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 temporary safety zone that will prohibit non-participant persons and vessels from entering, transiting through, anchoring in, or remaining within a limited area on the waters of the Seddon Channel in the vicinity of Tampa, Florida for a period, over three days. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 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:

The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to public interest to delay the effective date of this rule. Immediate action is needed to protect people and property on the waterway from potential hazards associated with the 2024 Gulf Coast Salute Airshow. The Coast Guard was unable to publish an NPRM because we must establish this safety zone by May 3, 2024, and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. Furthermore, delaying the effective date would be contrary to the safety zone's intended objectives of enhancing maritime safety and security while ensuring protection of people and property on the navigable waterway.

Also, 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 to restrict vessel traffic is needed to protect life and property and mitigate potential maritime hazards involved with the 2024 Gulf Coast Salute Airshow.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The COTP has determined that potential hazards associated with the 2024 Gulf Coast Salute Airshow beginning on May 3, 2024, will be a safety concern for anyone within the safety zone. This rule is needed to protect persons, vessels, and the marine environment in the navigable waters within the safety zone during the 2024 Gulf Coast Salute Airshow.

This rule establishes a safety zone on certain navigable waters of the Gulf of Mexico in Panama City, FL beginning 500′ from shore within the following coordinates: 30°13′17.88″ N; 85°53′42.32″ W, thence southeast to 30°12′16.44″ N; 85°51′46.60″ W, thence southwest to 30°11′55.47″ N; 85°52′01.09″ W, thence northwest to 30°12′56.60″ N; 85°53′55.85″ W. Enforcement of this safety zone is from 9 a.m. until 4:30 p.m., daily, from May 3, 2024, through May 5, 2024. The duration of the zone is intended to protect personnel, vessels, and ensure maritime safety and security in these navigable waters during the 2024 Gulf Coast Salute Airshow. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a 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 section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. This safety zone will be enforced on three days for approximately 7 1/2 hours each day and prohibit vessel movement on a portion of the Gulf of Mexico in Panama City, FL. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule 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 three days for approximately 7 1/2 hours each day and prohibit vessel movement on a portion of the Gulf of Mexico in Panama City, FL. It is categorically excluded from further review under paragraph L60(d) 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:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable.

It is impracticable to publish an NPRM because this safety zone must be established by May 28, 2024, and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

For the same reasons discussed in the preceding paragraph, a 30 day delay of the effective date would be contrary to public interest because action is needed to respond to the potential safety hazards associated with the HAUV/ROV survey of the Enbridge Line 5 pipelines and the potential hazard from other vessels transiting the Straits of Mackinac at the same time this project is being conducted.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The COTP has determined that the potential hazards associated with the HAUV/ROV survey of the Enbridge Line 5 pipelines starting May 28, 2024 will be a safety concern to anyone within a 500-yard radius of the vessels Ugle Duckling and Streak. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the HAUV/ROV survey is being conducted.

This rule establishes a safety zone from 5:30 a.m. on May 28, 2024 through 6:30 p.m. on July 31, 2024. The safety zone will cover all navigable waters within the Mackinac Regulated Navigation Area within 500 yards of vessels being used to conduct the HAUV/ROV survey of the Enbridge Line 5 pipelines. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the HAUV/ROV survey is being conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a 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 section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, duration and location of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small, designated area of the Straits of Mackinac. Moreover, the Coast Guard will issue a Local Notice to Mariners about the safety zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule 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 to cover all navigable waters within the Mackinac Regulated Navigation Area within 500 yards of vessels being used to conduct a HAUV/ROV survey of the Enbridge Line 5 pipelines. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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:

The “WIPO Handbook on Intellectual Property Information and Documentation” sets forth standards for the presentation of data in many contexts. One such standard is WIPO Standard ST.26, which is titled “RECOMMENDED STANDARD FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS USING XML (EXTENSIBLE MARKUP LANGUAGE).” WIPO Standard ST.26 defines the disclosures of nucleotide and/or amino acid sequences in patent applications that must be presented in a sequence listing in XML format in the manner specified in the standard.

In a final rule published May 20, 2022, at 87 FR 30806, the USPTO created new rules 37 CFR 1.831-1.839 that incorporate by reference WIPO Standard ST.26. 37 CFR 1.839(b)(1) specifically identifies the version of WIPO Standard ST.26 that has been incorporated by reference. In a final rule published May 26, 2023, 88 FR 34089, the USPTO updated 37 CFR 1.839(b)(1) to reflect version 1.6 of WIPO Standard ST.26. On December 8, 2023, WIPO adopted a new version (version 1.7) of WIPO Standard ST.26. As a result, the USPTO is again updating 37 CFR 1.839(b)(1).

WIPO provides free online public access to view copies of its standards, including version 1.7 of WIPO Standard ST.26, on its website at www.wipo.int/standards/en/part_03_standards.html. WIPO Standard ST.26 is also available on the USPTO's Sequence Listing Resource Center at www.uspto.gov/patents/apply/sequence-listing-resource-center.

WIPO Standard ST.26 is comprised of eight documents: the main body of the standard, a first annex (Annex I) setting forth the controlled vocabulary for use with the main body, Annex II setting forth the Document Type Definition (DTD) for the Sequence Listing, Annex III containing a sequence listing specimen (XML file), Annex IV setting forth the character subset from the Unicode Basic Latin Code Table, Annex V setting forth additional data exchange requirements for IPOs, Annex VI containing a guidance document with illustrated examples, and Annex VII setting forth recommendations for the transformation of a sequence listing from WIPO Standard ST.25 format to WIPO Standard ST.26 format, including guidance on how to avoid adding or deleting subject matter.

Revisions to WIPO Standard ST.26 under version 1.7 affect the main body and Annex VI. The changes to the main body improve the consistency of technical terminology. In paragraph 3(f), all instances of “3′-monophosphate” were changed to “5′-monophosphate” to be consistent with paragraph 3(g) and standard nucleotide naming conventions.

Similarly, the changes to Annex VI improve consistency and clarity of terminology and correct technical errors. All instances of “3′-monophosphate” were changed to “5′-monophosphate” to be consistent with the changes made to the main body. In Examples 14-1 and 30-2, scientific and grammatical corrections were made to clarify the example disclosures. In addition, Annex VI includes two new examples that demonstrate how sequences with inverted nucleotides should be included in a sequence listing. Finally, the “Example Index” in Annex VI was simplified by removing the “Cross-referenced examples.”

Thus, the changes in version 1.7 of WIPO Standard ST.26 are ministerial changes that will not have a meaningful substantive impact on disclosing parties.

Section 1.839: Section 1.839(b)(1) is amended to provide an updated citation to version 1.7 of WIPO Standard ST.26 that is being incorporated by reference.

A. Administrative Procedure Act: The changes in this rulemaking involve rules of agency practice and procedure and/or interpretive rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (changes to procedural rules are not subject to notice and comment review under the Administrative Procedure Act (APA)); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 349 (4th Cir. 2001) (rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Substantive rules “effect a change in existing law or policy or which affect individual rights and obligations,” whereas interpretative rules “clarify or explain existing law or regulation and are exempt from notice and comment” review under the APA.).

Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c) or any other law. See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))).

In addition, the USPTO finds good cause pursuant to the authority at 5 U.S.C. 553(b)(B) to dispense with prior notice and opportunity for public comment because such procedures are unnecessary in this instance. The changes in this rulemaking merely update the regulations to incorporate by reference version 1.7 of WIPO Standard ST.26, which was adopted on December 8, 2023, by the WIPO Committee on Standards. These revisions are largely procedural in nature, and do not impose any additional requirements or fees on applicants. Thus, the USPTO implements this final rule without prior notice and opportunity for comment.

B. Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a Regulatory Flexibility Act analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) is required. See 5 U.S.C. 603.

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (September 30, 1993), as amended by Executive Order 14094 (April 6, 2023).

D. Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (January 18, 2011). Specifically, and as discussed above, the USPTO has, to the extent feasible and applicable: (1) reasonably determined that the benefits of the rule justify its costs; (2) tailored the rule to impose the least burden on society consistent with obtaining the agency's regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens while maintaining flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

E. Executive Order 13132 (Federalism): This rulemaking pertains strictly to federal agency procedures and does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999).

F. Executive Order 13175 (Tribal Consultation): This rulemaking will not: (1) have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (November 6, 2000).

G. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform): This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (February 5, 1996).

I. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (April 21, 1997).

J. Executive Order 12630 (Taking of Private Property): This rulemaking will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 (March 15, 1988).

K. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this rulemaking is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

L. Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

M. National Environmental Policy Act of 1969: This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

N. National Technology Transfer and Advancement Act of 1995: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

O. Paperwork Reduction Act of 1995: This final rule does not impact information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information has a currently valid OMB control number.

P. E-Government Act Compliance: The USPTO is committed to compliance 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.

For the reasons stated in the preamble and under the authority contained in 35 U.S.C. 2, as amended, the USPTO amends 37 CFR part 1 as follows:

Throughout this document, “we,” “us,” and “our” refer to the EPA.

On September 30, 2022 (87 FR 59314), the EPA issued a limited approval and limited disapproval for the California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 10 Climate Change, Article 4 Subarticle 13: Greenhouse Gas Emission Standards for Crude Oil and Natural Gas Facilities (“CARB Oil and Gas Methane Rule”) that had been submitted by CARB to the EPA on December 11, 2018. That action also finalized a disapproval of the reasonably available control technology (RACT) demonstrations for the 2008 and 2015 ozone National Ambient Air Quality Standards (NAAQS) for sources covered by the EPA's 2016 Control Techniques Guidelines for the Oil and Natural Gas Industry (“2016 Oil and Gas CTG”) and regulated by SCAQMD, SJVUAPCD, Sacramento Metro Air Quality Management District (SMAQMD), VCAPCD, and Yolo-Solano Air Quality Management District (YSAQMD). In this 2022 action, we determined that while the CARB SIP revision submittal strengthened the SIP, the submittal contained various deficiencies related to enforceability and stringency that prevented full approval. Pursuant to section 179 of the CAA and our regulations at 40 CFR 52.31, the limited disapproval of the CARB Oil and Gas Methane Rule and the disapproval of the RACT demonstrations for the 2008 and 2015 ozone NAAQS action under title I, part D, started a sanctions clock for imposition of mandatory sanctions unless the EPA affirmatively determines that the deficiency forming the basis of the action has been corrected, the offset sanctions under section 179(b)(2) will apply 18 months after the action's effective date of October 31, 2022, and highway sanctions under section 179(b)(1) will apply 6 months after the offset sanction is imposed.

CARB submitted an amended CARB Oil and Gas Methane Rule on April 2, 2024, as well as six amended California district rules on various dates  1 that addressed the deficiencies identified in our September 30, 2022 action. In the Proposed Rules section of this Federal Register , we have proposed approval of the amended CARB Oil and Gas Methane Rule and the six California district rules into the State's SIP, as well as approval of the 2016 Oil and Gas CTG RACT requirement for four California districts, and conditional approval of the RACT demonstration for one California district. 2 Based on this proposed approval action, we are also making this interim final determination, effective upon publication, to defer imposition of the offset sanctions and highway sanctions that were triggered by our September 30, 2022 disapproval, because we believe CARB's 2024 submittal and the amended rules correct the deficiencies that triggered such sanctions.

The EPA is providing the public with an opportunity to comment on this deferral of sanctions. If comments are submitted that change our assessment described in this interim final determination and the proposed full and conditional approval of the CARB Oil and Gas Methane Rule, local California air district rules, and associated RACT demonstrations, we would take final action to lift this deferral of sanctions under 40 CFR 52.31. If no comments are submitted that change our assessment, then all sanctions and any sanction clocks triggered by our 2022 action would be permanently terminated on the effective date of our final approval of the CARB Oil and Gas Methane Rule and associated RACT demonstrations.

We are making an interim final determination to defer CAA section 179 sanctions associated with our limited disapproval on the 2018 submittal of the CARB Oil and Gas Methane Rule and disapprovals of associated RACT determinations. This determination is based on our concurrent proposal to approve SIP revisions from CARB that resolve the deficiencies that were the basis of our prior disapproval that triggered sanctions under section 179 of the CAA. This includes proposing approval and conditional approval of CARB's 2024 submittal of the CARB Oil and Gas Methane Rule, six amended California air district rules, and associated RACT demonstrations.

Because the EPA has preliminarily determined that the SIP revisions addressing the deficiencies are approvable, relief from sanctions should be provided as quickly as possible. Therefore, with respect to the effective date of this action, the EPA is invoking the good cause exception to the 30-day notice requirement of the Administrative Procedure Act (APA) because the purpose of this notice is to relieve a restriction (5 U.S.C. 553(d)(1)). The EPA believes that notice-and-comment rulemaking before the effective date of this action is impracticable and contrary to the public interest. The EPA has reviewed the State's submittal and, through its proposed action, is indicating that it is more likely than not that the State has submitted a revision to the SIP that corrects deficiencies under part D of the Act that were the basis for the action that started the sanctions clocks. Therefore, it is not in the public interest to impose sanctions. The EPA believes that it is necessary to use the interim final rulemaking process to defer sanctions while the EPA completes its rulemaking process on the approvability of the State's submittal. For the reasons outlined above, the EPA is invoking the good cause exception under the APA in not providing an opportunity for comment before this action takes effect (5 U.S.C. 553(b)(3)). However, by this action, the EPA is still providing the public with a chance to comment on the EPA's determination after the effective date, and the EPA will consider any comments received in determining whether to reverse such action.

This action defers sanctions and imposes no additional requirements. 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 the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

• 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).

• Is subject to the Congressional Review Act (CRA), 5 U.S.C. 801 et seq., and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in section II of this preamble, including the basis for that finding.

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 July 2, 2024. Filing a petition for reconsideration by the EPA Administrator of this final rule does not affect the finality of this rule for the purpose of judicial review, nor does it extend the time within which petition for judicial review may be filed, and it shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see CAA section 307(b)(2)).

The EPA is publishing this rule without a prior proposed rulemaking because we view this as a noncontroversial action and anticipate no adverse comment. In 1989, the EPA designated the Sites for the disposal of dredged material removed from the Nome Channel and harbor areas (54 FR 23481 June 1, 1989). The Sites have not been used since 2009 because the USACE has instead placed dredged material from the Nome Channel and harbor area onshore for the beneficial use of beach nourishment. The USACE intends to continue to place such dredged material onshore for the beneficial use of beach nourishment. Placement of dredged material onshore for the beneficial use of beach nourishment is not affected by this withdrawal and will continue to be available for the disposal of suitable dredged material. The ability of the USACE, the Port of Nome, and other interested parties to find suitable dredged material disposal options will not be changed by this action. Environmental assessments conducted by the USACE indicates that there will be no unacceptable adverse impacts to the marine environment once the EPA relinquishes management of the Sites. Therefore, the EPA is now taking the administrative action of withdrawing the Sites from regulation and relinquishing future management of the Sites.

In 1989, the EPA designated the Sites to be used for dredged material from the Nome channel and harbor area. The USACE is most affected by this action because it had used the Sites for disposal of Nome channel and harbor area operations and maintenance (O&M) dredged material. However, since 2009, the USACE has placed dredged material from Nome channel and harbor O&M dredging onshore for the beneficial use of beach nourishment. The USACE intends to continue to place such dredged material onshore for the beneficial use of beach nourishment. Placement of dredged material onshore for the beneficial use of beach nourishment is not affected by this withdrawal and will continue to be available for the disposal of suitable dredged material. For any questions regarding the applicability of this action to a particular person or entity, please refer to the contact person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Section 102(c) of the MPRSA, as amended, 33 U.S.C. 1402(c), provides that the Administrator of the EPA may, in a manner consistent with established criteria, designate sites for ocean dumping. On October 1, 1986, the Administrator delegated the authority to designate ocean disposal sites to the Regional Administrator of the Region in which the sites are located. This withdrawal is made pursuant to that authority.

The EPA Ocean Dumping Regulations provide that modifications in disposal site use that involve withdrawal of designated disposal sites from use or permanent changes in the total specified quantities or types of wastes permitted to be discharged to a specific disposal site will be made through promulgation of an amendment to the disposal site designation set forth in 40 CFR part 228 and will be based on the results of the analyses of impact described in 40 CFR 228.10 or upon changed circumstances concerning use of the site (40 CFR 228.11(a)). This site withdrawal is made in accordance with 40 CFR 228.11(a) based upon changed circumstances concerning use of the Sites.

The USACE began to dispose of dredged material offshore of Nome, Alaska around 1923. The disposal of dredged material offshore was necessary to keep navigation open to the Snake River and the City of Nome from Norton Sound. On January 11, 1977, the EPA published a list of “Approved and Final Ocean Dumping Sites” that established the Nome East and Nome West Sites as interim sites (42 FR 2461, January 11, 1977) The interim Sites were used by the USACE for disposal of dredged material as part of harbor maintenance. The EPA designated the Sites as final sites on June 1, 1989 (54 FR 23481).

The Nome East and Nome West Sites extend 1.75 nautical miles (2 statute miles) offshore of the coast east of the entrance to the Port of Nome (Please see map of Nome West and Nome East disposal Sites in the docket for this action). The Nome East Site covers an area of approximately 0.49 square miles (0.37 square nautical miles) and the Nome West Site covers an area of approximately 0.40 square miles (0.30 square nautical miles). Water depths at the Nome West Site ranges from 1-11 meters mean lower low water (MLLW). Water depths at the Nome East Site range from 1-12 meters MLLW. Prior to the harbor expansion, the Sites were situated in an open, dynamic ocean environment. The seafloor is characterized as relatively uniform and featureless with highly active shifting sands grading to shifting silts as it slopes along the southern boundary of the Sites into deeper water.

The Sites are trapezoidal with the following corner coordinates based upon the North American Datum of 1927:

Disposal at the Nome East Site was limited to dredged material from Nome, Alaska, and adjacent areas. Disposal at the Nome West Site was also limited to material dredged from Nome, Alaska, and adjacent areas with preference given to placement of materials in the inner third of the Site to compliment littoral drift patterns and prevent significant build-up or erosion of sediments. Coordination with the City of Nome prior to dredging was required for use of both Sites.

The Sites were used routinely for disposal of dredged material from USACE O&M dredging until the USACE opted to alter the location of the Nome harbor entrance. In 2005, the USACE began major adjustments to the harbor including re-routing the entrance to the Snake River. The old entrance was filled in and a 3,025-foot breakwater was added to the existing causeway along with a 270-foot spur. The Nome City dock was expanded, and the new harbor entrance was widened to 500 feet. As part of the harbor entrance project, the USACE also changed its method for managing dredged material. In 2009, the USACE used the dredged material for onshore placement east of the breakwater for beach nourishment. These major changes spatially overlapped with a portion of the Nome West Site, reducing the availability of the Site to receive dredged material while also altering the need for the use of the Nome East Site.

In 2020, the USACE released an Environmental Assessment and Finding of No Significant Impact (FONSI) for modification to the entrance to the Port of Nome. 1 In the 2019 FONSI, the USACE stated that they would continue to place dredged material onshore for beach nourishment, which has contributed to widening of the beach in front of the Nome seawall. The USACE does not plan to dispose of dredged material in the EPA-designated Nome East Site or Nome West Site. Based on the FONSI and communication with the USACE (email from Mr. Matthew Ferguson, October 31, 2023), the USACE does not use the Sites because they are no longer suitable for its needs.

This action is an administrative procedure to formally remove the Nome East and Nome West Sites from regulation (40 CFR 228.15(n)(12) and (13) and EPA management. The withdrawal of the Sites is necessary to remove the oversight of these Sites from EPA management. The USACE has not used the Sites for disposal of dredged material since 2009 and has no foreseeable need to use the Sites as they are no longer suitable.

The two Sites proposed for withdrawal are trapezoidal with the following corner coordinates based upon the North American Datum of 1927:

If finalized, the Sites will not exist and will not be available for the disposal of dredged material under the MPRSA from any person or for any purpose. The USACE and EPA will coordinate, consistent with the MPRSA and EPA's Ocean Dumping regulations, should the USACE decide in the future that ocean disposal of dredged material is needed for dredged material from Nome, Alaska, and/or adjacent areas.

Section 102 of the National Environmental Policy Act of 1969 (NEPA), as amended, (42 U.S.C. 4321) requires Federal agencies to prepare an Environmental Impact Statement for major Federal actions significantly affecting the quality of the human environment. NEPA does not apply to this action because the courts have exempted the EPA's actions under the MPRSA from the procedural requirements of NEPA through the functional equivalence doctrine. The EPA has, by policy, determined that the preparation of NEPA documents for certain EPA regulatory actions, including actions under the MPRSA, may be appropriate. The EPA has determined that no environmental review document is necessary for withdrawal of the Nome East and Nome West Sites.

The Coastal Zone Management Act, as amended (CZMA), 16 U.S.C. 1451 to 1465, requires Federal agencies to determine whether their actions will be consistent to the maximum extent practicable with the enforceable policies of approved state programs. By operation of Alaska State law, the federally approved Alaska Coastal Management Program expired on July 1, 2011, resulting in a withdrawal from participation in the CZMA's National Coastal Management Program. The CZMA Federal consistency provision, Section 307, no longer applies in Alaska.

The National Historic Preservation Act (NHPA), as amended, 16 U.S.C. 470 to 470a-2, requires Federal agencies to account for the effect of their actions on districts, sites, buildings, structures, or objects, included in, or eligible for inclusion in the National Register. Withdrawal of the Sites will not affect any historic properties.

This action complies with applicable Executive orders and statutory provisions as follows:

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735; October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). This action does not require persons to obtain, maintain, retain, report, or publicly disclose information to or for a Federal agency.

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., generally requires Federal agencies to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act, 5 U.S.C. 551 et seq., or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) a small business defined by the Small Business Administration's size regulations at 13 CFR part 121; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this rule, the EPA certifies that this action will not have a significant economic impact on small entities as they were formally used only by the USACE for dredged material removed from the Nome channel and harbor area. The USACE has not used the Sites since 2009 and has no foreseeable need to use the Sites as they are no longer suitable.

This action does not contain any unfunded mandates as described in the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538, and does not significantly affect small governments. The action imposes no new enforceable duty on any state, local, or tribal governments or the private sector.

This action does not have federalism implications. It does 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 various levels of government.

This action does not have tribal implications as specified in Executive Order 13175, because the withdrawal of the Sites will not have a direct effect on 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. Thus, Executive Order 13175 does not apply to this action. Although Executive Order 13175 does not apply to this action, the EPA provided electronic notification of the proposed withdrawal, including a Fact Sheet about the Sites, to the Nome Eskimo Community and the Bering Straits Native Corporation in the development of this action. EPA received no comments as a result of the electronic notification.

This action is not subject to Executive Order 13045 because it is not “economically significant” as defined in Executive Order 12866 and does not concern an environmental health or safety risk that the EPA believes may disproportionately affect children.

This action is not subject to Executive Order 13211 because it is not a “significant regulatory action” under Executive Order 12866.

This rule does not involve technical standards.

Executive Order 12898 (59 FR 7629; February 16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on communities with environmental justice concerns. Executive Order 14096 (88 FR 25251, April 21, 2023) supplements the foundational efforts of Executive Order 12898 to address environmental justice.

The EPA recognizes that the burdens of environmental pollution and climate change often fall disproportionately on communities with environmental justice concerns. Climate change will exacerbate the existing risks faced by communities with environmental justice concerns. However, the EPA does not believe that this action will have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629; February 16, 1994).

This action is subject to the Congressional Review Act. The EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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). This rule will be effective on August 1, 2024 unless the EPA receives adverse comment.

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

For the reasons set out in the preamble, the EPA amends 40 CFR part 228 as follows:

This Federal Register document is also available from the Federal Register online database through http://www.govinfo.gov, a service of the U.S. Government Publishing Office.

On December 26, 2013, the Office of Management and Budget (OMB) issued the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (UAR or uniform regulations) that “set standard requirements for financial management of Federal awards across the entire federal government.” See 78 FR 78590 (Dec. 26, 2013). On December 19, 2014, OMB and other Federal award-making agencies, including the Department, issued an interim final rule to implement the UAR. 79 FR 75867 (Dec. 19, 2014). On July 13, 2016, the Department issued a Notice of Proposed Rulemaking (2016 NPRM) proposing changes to its adoption of the 2014 UAR Interim Final Rule. See 81 FR 45270 (July 13, 2016). On December 12, 2016, the Department finalized the 2016 NPRM and the final rule went into effect on January 11, 2017 (2016 Rule). See 81 FR 89393. 1 On November 19, 2019, the Department issued a Notice of Nonenforcement, which stated that the Department would not enforce the regulatory provisions adopted or amended by the 2016 Rule. See 84 FR 63809 (Nov. 19, 2019). On the same day, the Department issued an NPRM proposing to “repromulgate some of the provisions of the [2016] Final Rule, not to repromulgate others, and to replace or modify certain provisions that were included in the Final Rule with other provisions.” 84 FR 63831 (2019 NPRM). On January 12, 2021, HHS repromulgated portions of and issued amendments to the 2016 Rule. 86 FR 2257 (2021 Rule) (Jan. 12, 2021). That rule was vacated in part and remanded back to the Department  2 after the Department noted in litigation that it had “reviewed only a small fraction of the non-duplicative comments, did not employ a sampling methodology likely to produce an adequate sample of the comment received, and did not explain its use of sampling in the final rule.”  3

On July 13, 2023, the Department published the NPRM associated with this rulemaking (2023 NPRM or Proposed Rule). See 88 FR 44750 (July 13, 2023). The Department invited comment from all interested parties. The comment period for the Proposed Rule ended on September 11, 2023, and the Department received 8,294 comments. A wide range of individuals and organizations submitted comments, including private citizens, health care workers and institutions, faith-based organizations, patient advocacy groups, civil rights organizations, and professional associations. The comments covered a variety of issues and points of view responding to the Department's requests for comments, all of which the Department reviewed and analyzed. The overwhelming majority of comments were individual comments associated with form letter campaigns from various groups and individuals. Numerous commenters, including civil rights organizations, faith-based organizations, health organizations, legal associations, and individual commenters, supported the Proposed Rule as written. Numerous other commenters, including certain faith-based providers, legal associations, and individual commenters, expressed opposition to the Proposed Rule for a variety of reasons.

This preamble is divided into multiple sections. Section II describes changes to the regulation and contains two subparts. Subpart A sets forth general comments the Department received regarding the Proposed Rule and the responses to our request for comment on the likely impact of the Proposed Rule as compared to the 2016 Rule. Subpart B sets forth the final rule's regulatory provisions and our responses to comments received. Subpart C discusses the Department's comments received in Response to E.O. 13175 Tribal Consultation. Section III sets forth the Department's compliance with Executive Order 12866 and related Executive Orders on regulatory review.

Based upon comments received, the Department has made some changes to the Proposed Rule.

The Department has revised § 75.300(e) to clarify that the provision is interpretive and does not impose any new substantive obligations on entities outside the Department.

The Department has revised § 75.300(f) to also apply to grant applicants. Section 75.300(f) also is revised to provide recipients, applicants, and the public with (1) a general timetable under which the Department will acknowledge and begin to evaluate requests for assurances of religious freedom and conscience exemptions; (2) a temporary exemption during the pendency of the Department's review of such requests; (3) a list of conscience laws that may be applied to the § 75.300(f) process; (4) information about how the Department will consider these requests under the legal standards of applicable Federal religious freedom or conscience laws; (5) notice that adjudications are to be made by both ASFR and OCR; and (6) details about the administrative appeal process for applicants and recipients that receive adverse determinations.

The Department is finalizing the other provisions of the rule as proposed.

In the 2023 NPRM, the Department sought comment on the likely impact of the Proposed Rule as compared to the 2016 Rule. The comments and our responses regarding our request, and other general comments regarding the rule, are set forth below.

Comment: A large city requested that HHS widely promote the protections set forth in the Proposed Rule such that grant recipients and those served by HHS programs and services are made aware that discrimination based on actual or perceived sexual orientation, gender identity, or gender expression will be prohibited. A State Department of Health expressed support for “purposeful implementation” of the rule's nondiscrimination protections and requested that they be diligently and efficiently enforced.

Response: The Department appreciates these commenters' suggestions on promotion and implementation. This final rule clarifies that, in the identified statutes that HHS administers that prohibit discrimination on the basis of sex, HHS interprets the prohibition against discrimination on the basis of sex to include discrimination on the basis of sexual orientation, gender identity, and sex characteristics. This interpretation is consistent with Bostock v. Clayton County, 590 U.S. 644 (2020), and other Federal court precedent applying Bostock' s reasoning that sex discrimination includes discrimination based on sexual orientation and gender identity. 4 And as OCR noted in the Proposed Rule, 88 FR 44753, Bostock's reasoning applies with equal force to claims alleging discrimination on the basis of sex characteristics, which is inherently sex-based. When the rule is finalized, HHS intends to provide grant recipients and the public at large information about the rule and raise awareness of the protections provided by the statutes addressed in the rule, for example, through stakeholder meetings, webinars, and other outreach.

Comment: Numerous commenters expressed overall support for the rule, including the Proposed Rule's reaffirmation of nondiscrimination protections and its effect on access to services and care. A coalition of 11 advocacy groups stated that, while grant programs are subject to generally applicable statutes that bar discrimination on the basis of race, color, national origin, disability, and age, the Proposed Rule would further prevent harms because of its protections against discrimination on the bases of religion and sex in grant programs. Another commenter lauded the Proposed Rule, specifically, the retention of language from the partially vacated 2021 Rule regarding Federal statutory prohibitions against discrimination and the application of Supreme Court decisions in award administration.

Numerous commenters expressed support for the rule because, in their view, it would positively impact access to Federal programs and services for lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) people. Several commenters praised the Proposed Rule's focus on nondiscrimination protections and access to care, especially for LGBTQI+ community members amidst what commenters described as a rise in anti-LGBTQI+ discrimination and increasing barriers to health care. Some commenters stated that the Proposed Rule would help protect against discrimination based on sexual orientation and gender identity in HHS-funded health programs. Another commenter opined that the rule would help protect and support the needs of LGBTQI+ individuals by protecting them from harmful discrimination and barriers to accessing needed service.

Response: The Department appreciates the commenters' support. To be clear, the final rule clarifies the Department's interpretation of existing statutory provisions that prohibit discrimination based on sex within the enumerated statutes in § 75.300(e). The Department offers this prospective interpretation in the interest of transparency and good governance so that the public is aware of the Department's position. See Attorney General's Manual on the Administrative Procedure Act 30 n.3 (1947). The Department is committed to ensuring access to its programs and compliance with all applicable Federal laws, including laws related to nondiscrimination, religious freedom, and conscience.

Comment: Many commenters in support of the rule included research and studies relating to the LGBTQI+ community as well as referencing their experiences with health and human services programs. Several of these commenters outlined specific concerns, including, among other things, that: LGBTQI+ individuals report “fair or poor” general physical health; are more likely than their non-LGBTQI+ peers to experience symptoms of anxiety and depression; and that a substantial percentage of LGBTQI+ people experience serious health conditions, including those that are life-threatening. 5 Commenters and the studies they cited attributed these disparities to pervasive discrimination against LGBTQI+ people, lack of access to care, and lack of access to providers knowledgeable about providing services to LGBTQI+ individuals. Some commenters discussed additional barriers to quality care and supportive services. A few commenters reported that discrimination, or fear of such discrimination, is a prevalent barrier to seeking health care for members of the LGBTQI+ community.

Several commenters cited studies and reports about the experiences of transgender people specifically. They included studies about high rates of intimate partner violence and suicidality, disproportionately high rates of HIV+ diagnoses, and disparities in housing and rates of poverty among transgender people, which commenters and many of the studies attributed to pervasive stigma and discrimination against transgender people. One of these commenters stated that victims of violence who are LGBTQI+ should not have to experience discrimination in government-funded services.

Some commenters specifically addressed discrimination experienced by LGBTQI+ individuals participating in HHS programs. A coalition of 11 advocacy groups stated that LGBTQI+ people experience discrimination while accessing services under Title IV-B and IV-E of the Social Security Act ( e.g., family support and foster care/adoption services) and services provided to older adults under the Older Americans Act ( e.g., Meals on Wheels). One organization commented that state laws targeting the LGBTQI+ community have worsened disparities. A coalition of 65 advocacy groups stated that LGBTQI+ youth are often subjected to discriminatory behavior while in congregate care settings.

Response: The Department acknowledges that discrimination against LGBTQI+ individuals remains pervasive, especially for individuals who experience discrimination on multiple bases, such as gender identity and race. 6 The Department's interpretation set forth in § 75.300(e) of this rule is notably limited to the scope of HHS awards and grant programs related to the statutes set forth in that section.

We note that § 75.300(e) does not include the Title IV-E Foster Care Program, which, along with applicable laws and regulations, bars discrimination on the basis of race, color, national origin, disability, and age. The Administration for Children and Families (ACF) has published a Proposed Rule concerning Title IV and foster care, 88 FR 66752 (Sept. 28, 2023); the comment period closed on November 27, 2023.

Comment: A commenter stated that several of these statutes protect against discrimination on the basis of religion and asserted that HHS should add additional provisions to protect religious grantees, parents, and participants.

Response: The Department appreciates the commenter's suggestion but declines to add additional language to the final rule. The Department is committed to fully upholding federal laws that guarantee freedom of religion and freedom of conscience. Section 75.300(c) confirms that it is against public policy of the Department for otherwise eligible persons to be discriminated against in the administration of HHS programs, activities, projects, assistance, and services, to the extent doing so is prohibited by Federal statute. This includes laws that prohibit religious discrimination against beneficiaries, including provisions of the statutes listed in § 75.300(e) that prohibit discrimination on the basis of religion, 7 and other religious freedom and conscience laws. 8 In addition, § 75.300(f) addresses an applicant's or recipient's ability to avail itself of religious freedom and conscience protections, including a process by which any entity can notify the Department of its view that it is exempt from, or entitled to a modified application of, the nondiscrimination requirements of the 13 statutes listed in § 75.300(e) due to the application of Federal religious freedom or conscience law.

Comment: A coalition of 11 civil rights organizations, citing Maddonna v. United States Department of Health & Human Services, No. 6:19-CV-3551-JD, 2023 WL 7395911 (D.S.C. Sept. 29, 2023), expressed their concerns regarding religious discrimination in government-funded services. The coalition provided examples of individuals who alleged facing religious discrimination in health and human services programs, including an agency that refused to provide a Jewish family foster-parent training and home study approval allegedly because of their religious beliefs, and a nonreligious man whom a State agency committed to various religious facilities to treat substance-use disorder, whose complaints the Department allegedly declined to investigate. 9

Response: The Department appreciates the comments. The Department appreciates the comments. In Maddonna, a plaintiff sued a foster care child placement agency, along with various federal and state defendants, alleging that they had been excluded from participation in South Carolina's foster care program on the basis of their religion. The court in Madonna ultimately dismissed the claims against the Department. The Department is committed to protecting access to health care and human services and preventing discrimination in accordance with the Constitution and applicable Federal laws, including those involving religious discrimination.

The Department is committed to protecting access to health care and human services and preventing discrimination in accordance with applicable Federal laws, including those involving religious discrimination. As discussed above, the Department's interpretation set forth in § 75.300(e) is limited to the scope of HHS awards authorized by the statutes listed, which prohibit discrimination on the basis of sex. This list does not include Title IV-E; however, ACF has separately published a Proposed Rule concerning Title IV and foster care. 88 FR 66752.

Comment: A religious policy organization stated their view that “forcing” an alternate definition of sex would result in certain organizations no longer seeking HHS grants either because of their belief they would not qualify due to their sincerely held convictions or because of concern they would be opening themselves up to a legal battle. As an example, the commenter observed that certain States sought waivers from enforcement of the nondiscrimination requirements of the 2016 Rule, which similarly interpreted “sex” to include “sexual orientation” and “gender identity.” This organization stated its view that the 2016 Rule had worse implications for faith-based organizations than the Proposed Rule, but that the Proposed Rule was still inadequate to address religious freedom and conscience concerns.

Response: The Department appreciates the comment and acknowledges that waivers of enforcement were granted in connection with the 2016 Rule. The Department disagrees, however, that it is “forcing” an alternative definition of “sex.” As the Supreme Court noted in Bostock, nothing in its approach turned on the definition of “sex” alone, including parties' debate over whether “sex” was limited to the notion that it only refers to distinctions between male and female. The Court therefore proceeded on the narrow assumption for argument's sake that “sex” signifies “biological distinctions between male and female” and still reached its conclusion. Bostock, 590 U.S. at 655.

The Department highlights as well that this final rule allows for a religious freedom and conscience exemption process which is outlined in § 75.300(f) for applicants and recipients that have religious or conscience concerns or objections.

Comment: A religious policy organization advocated that HHS and the Department of Education refrain from finalization of rules that aim to interpret and apply Title IX of the Education Amendments of 1972 until courts are able to resolve the outstanding challenges involving Bostock based on what they view as overlap of underlying provisions within these rulemakings.

Response: This rule does not interpret or apply Title IX, as it solely addresses the statutes referenced in § 75.300(e). To the extent the rules raise similar questions, or would benefit from consistency in certain areas, those concerns have been identified and addressed through interagency review processes prior to the rule's finalization.

Comment: A religious legal advocacy organization stated that HHS should disclose the process by which it reviewed comments, including the methodology and estimates used to review and respond to comments, in light of HHS's identified failure in 2020 to appropriately review comments and disclose the process used for that review, citing Motion for Remand with Vacatur, Facing Foster Care in Alaska v. U.S. Health & Human Services, No. 1:21-cv-00308 (D.D.C. June 17, 2022), ECF No. 41 ( granted by Order, (D.D.C. June 29, 2022), ECF No. 44).

Response: The Department appreciates the commenter's suggestion. We received over 8,000 submissions during the public comment period. OCR has reviewed all non-duplicative comments it received. Under the relevant legal standards and the Administrative Procedure Act (APA), OCR has identified, considered, and responded to all the significant issues raised by commenters. OCR staff's ability to read, consider, and respond to comments on this rule were not hampered by time or funding constraints.

In the 2023 NPRM, the Department proposed to repromulgate § 75.300(c) from the 2021 Rule with a slight edit to reference “HHS programs, activities, projects, assistance, and services” as opposed to just “HHS programs and services.” This edited provision reads: “It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs, activities, projects, assistance, and services, to the extent doing so is prohibited by federal statute.”

The comments and our responses regarding § 75.300(c) are set forth below.

Comment: Some commenters expressed general support for § 75.300(c). One commenter expressed support for the provision as explicitly aligning Federal regulations with the Supreme Court decisions in United States v. Windsor, 570 U.S. 744 (2013), Obergefell v. Hodges, 576 U.S. 644 (2015), and Bostock, 590 U.S. 644. Another commenter concluded that this section would help prevent what the commenter viewed as the harm caused by approaches similar to those allegedly caused by the 2019 waiver sent by ACF to South Carolina approving the state's waiver request from the nondiscrimination requirements in paragraph (c). See 88 FR 44750, 44752. 10

Response: While this rule's text does not cite Windsor or Obergefell, the Department follows all Supreme Court precedent as noted in § 75.300(d) and appreciates the commenters' support for the section. HHS is committed to respecting all applicable Federal laws and relevant precedent.

Comment: A group of commenters proposed removing § 75.300(c) altogether since § 75.300(a) makes it unnecessary for HHS to declare something contrary to “public policy” if it already contravenes Federal statute. The commenter further stated that if the Department removes § 75.300(c), it can also remove § 75.101(f), which clarifies the inapplicability of § 75.300(c) to the Temporary Assistance for Needy Families Program (Title IV-A of the Social Security Act, 42 U.S.C. 601-619) (TANF).

Response: The Department thanks commenters for the suggestions but, other than not adding language from former § 75.101(f), declines to accept the recommendations. The Department maintains that the final rule language best articulates HHS's position, provides additional regulatory clarity to the public and regulated community, and furthers the efficient and equitable administration of HHS grants. The Proposed Rule stated that the Department is proposing not to reinstate former § 75.101(f). 88 FR 44753. This final rule likewise is not reinstating former § 75.101(f).

Comment: Some commenters recommended that HHS use additional statutory authorities to establish regulatory nondiscrimination requirements across key programs and clarify interactions with other civil rights laws.

Response: The Department declines to add additional statutory authorities as described. The Department acknowledges the importance of accounting for simultaneous discrimination on multiple or overlapping prohibited bases, and the regulation at § 75.300(c) includes a broad nondiscrimination prohibition that is grounded in the range of prohibitions provided by Federal statute.” The Department is committed to ensuring consistent enforcement of these protections.

For the reasons set forth in the Proposed Rule and considering the comments received, we are finalizing § 75.300(c) as proposed, without modification.

In the 2023 NPRM, the Department proposed to repromulgate § 75.300(d) from the partially vacated 2021 Rule. It provided, “HHS will follow all applicable Supreme Court decisions in administering its award programs.”

The comments and our responses regarding § 75.300(d) are set forth below.

Comment: Some commenters opposed § 75.300(d), reasoning that it would be “unnecessary” and “pernicious” to state that HHS must follow the decisions of the Supreme Court. The commenters recommended that HHS remove this section from the Proposed Rule and instead explain how it will apply past court decisions to new disputes with grant recipients raising different but related questions or apply Federal circuit court decisions.

Response: The Department appreciates the commenters' views, but declines their recommendation. The Department is required to comply with Supreme Court precedent; Section 75.300(d) reflects that.

For the reasons set forth in the Proposed Rule and considering the comments received, we are finalizing § 75.300(d) as proposed, without modification.

In the 2023 NPRM, the Department proposed to add § 75.300(e), which clarifies that, in the identified statutes that HHS administers that prohibit discrimination on the basis of sex, HHS interprets the prohibition against discrimination on the basis of sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity. This interpretation is consistent with Bostock v. Clayton County, 590 U.S. 644 (2020), and other Federal court precedent applying Bostock' s reasoning that sex discrimination includes discrimination based on sexual orientation and gender identity. 11 Proposed § 75.300(e) referenced 13 statutes HHS administers that prohibit discrimination on the basis of sex. 12

The Department also sought comment on: (1) whether the Department administers other statutes prohibiting sex discrimination that are not set forth in proposed § 75.300(e) or whether the Department should include language or guidance in § 75.300(e) to cover current or future laws that prohibit sex discrimination that are not set forth above; and (2) whether there is anything about any of the statutes referenced in proposed § 75.300(e), such as their language, legislative history, or purpose, that would provide a legal basis for distinguishing them from Bostock' s interpretation of Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000e et seq. ), that sex discrimination includes discrimination on the basis of sexual orientation and gender identity.

The comments and our responses regarding § 75.300(e) are set forth below.

Comment: Many commenters expressed strong support for proposed § 75.300(e) because it highlights existing statutory nondiscrimination provisions and expressly codifies a critical interpretation of discrimination on the basis of sex. Many commenters opined that § 75.300(e) is both consistent with the Supreme Court's ruling in Bostock and an appropriate application of the decision. One legal institute that focuses on sexual orientation and gender identity issues expressed support for § 75.300(e), stating that it has been longstanding practice to look to Title VII case law to interpret analogous provisions in other nondiscrimination laws, and that there is no language in any of the 13 statutes that suggests that HHS or the courts should not look to Title VII case law.

Response: The Department agrees that the final rule is consistent with Bostock and that Title VII case law is relevant to the analysis of the statutes listed in § 75.300(e).

Comment: Many commenters recommended that HHS expressly codify the prohibition of discrimination on the basis of sex characteristics, including intersex traits, in the regulatory text of § 75.300(e).

Response: As the Department explained in the NPRM, the Department agrees that sex discrimination covers discrimination on the basis of sex stereotypes, which can include stereotypes regarding sex characteristics and intersex traits, consistent with longstanding Supreme Court precedent. 88 FR 44750, n.11 (July 13, 2023) see Price Waterhouse v. Hopkins, 490 U.S. 228, 251 (1989). Moreover, like gender identity and sexual orientation, intersex traits are “inextricably bound up with” sex, Bostock, 590 U.S. at 660-661, and “cannot be stated without referencing sex,” Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 608 (4th Cir. 2020) (quoting Whitaker v. Kenosha Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1051 (7th Cir. 2017)). Further, interpreting sex discrimination prohibitions to encompass discrimination based on sex characteristics is consistent with applicable statutory text and existing interpretations by HHS and other agencies. 13 The Department agrees that the final rule protects against discrimination based on sex characteristics, but does not believe it is necessary to specify this in regulatory text.

Comment: A commenter requested that HHS further expand § 75.300(e) to explicitly include “gender expression” and provided a revised version of the paragraph including language stating that discrimination is prohibited based on “actual or perceived” status.

Response: The final rule clarifies the Department's interpretation of nondiscrimination protections on the basis of sex in certain programs and is consistent with current law. The Department agrees that sex discrimination covers discrimination on the basis of sex stereotypes, which can include stereotypes regarding gender expression, as well as discrimination against an individual based on perceived status. The Department does not believe it is necessary to specify this in regulatory text.

Comment: A coalition of patient advocacy groups argued that the nondiscrimination requirements in the final rule should address both Department-wide and program-specific statutory prohibitions on sex discrimination, including references to health programs and activities covered by Section 1557 of the Affordable Care Act (42 U.S.C. 18116). A different coalition of advocacy groups urged HHS to exercise the general rulemaking authority under Section 1102(a) of the Social Security Act, 42 U.S.C. 1302(a), to promulgate nondiscrimination protections, including those that would address Titles IV-B and IV-E as well as the provision of child welfare services. The commenters reasoned that the broadest and most widely applicable nondiscrimination protections would minimize discrimination against vulnerable populations and other barriers to program access. One commenter recommended that HHS ensure all current and future statutes prohibiting sex discrimination are encompassed by the present rulemaking to ensure that the proposed rule's nondiscrimination requirements cover all HHS-funded programs and services.

Response: The Department appreciates commenters' request that this rule address Department-wide and program-specific statutory prohibitions on sex discrimination. However, as noted in the Proposed Rule, the Department identified the statutes listed in proposed § 75.300(e) because they contain specific prohibitions on sex discrimination included within program statutes, and none contain any indicia suggesting they should be construed differently than Title VII. 88 FR 44754. This was to ground the Proposed Rule's interpretation in existing statutory authority.

The Department has rulemaking authority under Section 1102(a) of the Social Security Act, 42 U.S.C. 1302(a), but declines at this time to add substantive provisions to what is otherwise an interpretive rule. In addition, the Department is unable to anticipate the way future statutes prohibiting sex discrimination may be drafted or edited, and therefore declines to include reference to such future statutes in this final rule. The Department therefore has determined at this time additional changes are not necessary.

Comment: Numerous commenters, including two separate coalitions of advocacy groups, requested that additional statutes be considered for inclusion in § 75.300(e). Specifically, these commenters asked that HHS consider four statutes in this rulemaking: (1) Title IX; (2) Section 1557; (3) Section 632 of the Community Economic Development Act of 1981, 42 U.S.C. 9821 (CEDA); and (4) the Violence Against Women Act, 34 U.S.C. 12291 (VAWA).

Response: The Department appreciates comments responding to our request regarding other statutes prohibiting sex discrimination that the Department administers. The Department is addressing Section 1557, which prohibits discrimination on the basis of sex in certain health programs and activities, under a separate rulemaking. 14 The Department also has a separate regulation that addresses the nondiscrimination provisions of Title IX. 15 The Department therefore declines to address those statutes' nondiscrimination provisions in this rule.

The Department agrees that CEDA could potentially warrant inclusion in § 75.300(e) because it authorizes Department programs and services, it prohibits sex discrimination, 16 and there is nothing in the text, history, or case law that suggests it should be interpreted differently than Bostock. However, the CED program has not been funded or active since 1998, as its funding stream authorization was repealed. 17 Accordingly, the Department will not add CEDA to the statutes listed in § 75.300(e) at this time.

As for VAWA, the statute itself expressly prohibits discrimination on the basis of sexual orientation and gender identity. 18 Therefore, VAWA's protections based on sexual orientation and gender identity apply to all HHS VAWA programs and grants operated, and the statute's inclusion in this rule is unnecessary.

Comment: A national campaign of form comments expressed concern that the Proposed Rule's prohibition against grant recipients discriminating on the basis of sex “sidesteps” State legislatures.

Response: The final rule simply states how the Department will apply precedent and existing obligations and does not implicate federalism concerns. The statutes identified in § 75.300(e) have long contained prohibitions against discrimination on the basis of sex. And the Supreme Court's decision in Bostock, not this final rule, determined that Title VII's prohibition on sex discrimination necessarily included a prohibition on discrimination on the basis of sexual orientation and gender identity. This rule, in turn, applies Bostock' s reasoning with respect to the statutes enumerated in § 75.300(e). As explained in the Proposed Rule, none of the 13 statutes referenced in § 75.300(e) contain any indicia—such as statute-specific definitions, or any other criteria—to suggest that the statutes' general prohibitions on sex discrimination should be construed differently than Title VII's sex discrimination prohibition. See 88 FR at 44754. This rule, therefore, makes clear that the Department interprets the identified statutes' prohibitions on sex discrimination to include prohibitions on sexual orientation and gender identity discrimination. The rule does not dictate, however, the outcomes in particular matters and it does not direct the outcome of any complaint of discrimination asserted under the identified statutes.

Comment: Some commenters opined that HHS lacks the authority to finalize the Proposed Rule under 5 U.S.C. 301, sometimes referred to as the “Housekeeping Statute.” One commenter stated that HHS should not insert “significant changes” into an ASFR regulation because the Housekeeping Statute authorizes the regulation of the operation of HHS—not actors outside the HHS Secretary's authority. Another commenter stated that the 2016 Rule was not constitutionally or statutorily authorized, and urged HHS to rescind the 2016 Rule, arguing that although the Housekeeping Statute authorizes the heads of agencies to regulate “the government of [their] department” and to “regulate [their] own affairs,” it does not mention protected classes or allow HHS to regulate externally.

Response: The Department recognizes that the Housekeeping Statute is “a grant of authority to the agency to regulate its own affairs . . . authorizing what the [Administrative Procedure Act] terms `rules of agency organization, procedure or practice' as opposed to `substantive rules.' ” Chrysler Corp. v. Brown, 441 U.S. 281, 309-10 (1979). The Department's clarification in this final rule with regard to the meaning of discrimination on the basis of sex is consistent with the Department's authority under 5 U.S.C. 301 to regulate its own affairs in how it interprets existing statutes that already contain such prohibitions and is consistent with Supreme Court jurisprudence. For the avoidance of doubt, the Department has added language to § 75.300(e) clarifying that the provision is interpretive and does not impose any substantive obligations on entities outside the Department. In other words, § 75.300(e) expresses the Department's current interpretation of the listed statutes; a member of the public will, upon proper request, be accorded a fair opportunity to seek modification, rescission, or waiver of § 75.300(e).

Comment: Several commenters asked HHS to remove § 75.300(e), asserting that the Department relied upon a misinterpretation of Bostock and that the Department otherwise does not have the authority to “redefine” the term “sex.” Relying on § 75.300(c)'s explanation that discrimination in HHS programs is prohibited “to the extent doing so is prohibited by federal law,” one commenter asserted that § 75.300(c) is inconsistent with the relevant statutes because the statutes and legislative history do not mention sexual orientation or gender identity. Some commenters expressed opposition to HHS's interpretation of Bostock in the Proposed Rule and suggested that Bostock' s holding is actually about the specific meaning of the “because of” language of Title VII, specific to employment. In their view, that “because of” language is not contained in other statutes; accordingly, they argue, Bostock does not apply to those statutes and is limited to Title VII only.

Several commenters opined that the statutes listed in proposed § 75.300(e) lack a textual basis for HHS to “redefine” sex to include gender identity or sexual orientation. Prohibitions against sex discrimination, in the commenters' view, should refer to a “binary, biological” definition. Other commenters flagged examples of statutes that specifically refer to one sex including: the Refugee Resettlement Programs, 8 U.S.C. 1522(a)(1)(A); the Title VII Health Workforce Programs, 42 U.S.C. 295m(i); the definition in the Maternal and Child Health Block Grant statute of an eligible family, 42 U.S.C. 711(l)(2)(a); and the Head Start program. See 42 U.S.C. 9840(a)(5)(A)(iii) & (d)(3), 9840a(c)(1) & (i)(2)(G), 9852b(d)(2)(C). Commenters also argued that 42 U.S.C. 10406 of the Family Violence Prevention and Services Act (FVPSA) be removed from the list of programs in the final rule's § 75.300(e) because, in their view, the word “sex” in the context of that statute is used in the statute.”

Response: The Department appreciates the comments but disagrees with the commenters' views. Bostock and ensuing case law provide a compelling reason to interpret other similar statutory provisions which use the same or similar nondiscrimination language as Title VII's prohibition against sex discrimination to include discrimination based on sexual orientation and gender identity, absent indicia to the contrary.

Further, given the similarity in nondiscrimination language between Title VII and Title IX, many Federal courts that have addressed the issue have interpreted Title IX consistent with Bostock' s reasoning. 19 Additionally, there is a significant amount of case law, pre-and post- Bostock, that affirms protections on the basis of either sexual orientation or gender identity, or both, pursuant to a variety of other statutes that prohibit discrimination on the basis of “sex.”  20 As noted in the Proposed Rule, none of the listed statutes in the rule contain any indicia—such as statute-specific definitions, case law, or any other criteria—to suggest that these prohibitions on sex discrimination should be construed differently than how the Supreme Court construed Title VII's sex discrimination prohibition in Bostock. The language prohibiting sex discrimination in statutes listed in § 75.300(e) is substantially similar to Title VII's sex discrimination prohibition, and so the Department interprets them similarly. In addition, while these laws may have exceptions or other provisions that affect how they apply to particular facts and circumstances, that does not change the fact that their general prohibition on “sex discrimination” should be understood consistent with the reasoning of Bostock. See Bostock, 590 U.S. at 681 (“Whether other policies and practices might or might not qualify as unlawful discrimination or find justifications under other provisions of Title VII are questions for future cases, not these.”).

Additionally, the Department disagrees that Bostock' s holding was only about the term “because of.” Indeed, in Bostock itself, the Court used both “on the basis of” and “because of” throughout the decision to describe the unlawful discrimination at issue. See, e.g., Bostock, 590 U.S. at 654 (“on the basis of sex.”); id. at 658 (“because of sex”). As noted in the Proposed Rule, the 13 listed statutes contain minor variations in the language used to prohibit sex discrimination, sometimes within the same statute, but the Department does not believe any of the variations can be reasonably understood to distinguish the various statutes from Bostock' s reasoning. See 88 FR 44754. 21

With regard to the commenters' providing statutes that explicitly reference women and men to support the argument that sex should be limited to a “binary, biological” understanding, we find this unpersuasive. As the Supreme Court noted in Bostock, nothing in its approach turned on the parties' debate over whether “sex” was limited to the notion that it only refers to distinctions between male and female, and so the Court proceeded on the narrow assumption for argument's sake that “sex” signifies “biological distinctions between male and female.” Bostock, 590 U.S. at 655. Nonetheless the Court held that the plain language of the statute included discrimination based on sexual orientation and gender identity. Finally, with regard to the FVPSA, 42 U.S.C. 10406(c)(2)(B)(i) explains that entities may “tak[e] into consideration that individual's sex in those certain instances” such as “bona fide occupational qualifications” or “programmatic factors.” The Department will apply the FVPSA faithfully, including this provision.

Comment: A group of commenters expressed their view that the Proposed Rule constitutes a “unilateral inflation” of power by the Department that invokes the “major questions doctrine” and requires Congressional approval. West Virginia v. Environmental Protection Agency, 142 S. Ct. 2587 (2022) and Biden v. Nebraska, 143 S. Ct. 2355 (2023). The group expressed concerns about the scope of the types of providers the rule would impact. The group also asserted that the Department is claiming to interpret Title VII through the Proposed Rule, despite Title VII being enforced by the Equal Employment Opportunity Commission (EEOC). One commenter argued that HHS's responsibility to comply with Supreme Court decisions includes following the major questions doctrine and upholding universal religious freedom rights.

Response: The Department appreciates the commenters' concerns but disagrees that this rule is beyond the Department's authority or that it is interpreting Title VII in lieu of the EEOC. The Department recognizes that, under the major questions doctrine, explicit Congressional authorization is required in “extraordinary cases” when the “history and breadth of the authority that [the agency] has asserted” and the “economic and political significance” of that assertion provide a “reason to hesitate before concluding that Congress” meant to confer such authority. W. Virginia v. Env't Prot. Agency, 597 U.S. 697, 721 (2022) (quoting Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159 (2000)). A majority of major-question cases apply to agency action that has not been clearly authorized by the text of the statute.

Here, § 75.300(e) is interpretive of the 13 statutes listed, each of which authorize programs administered by the Department. In Bostock, the Court interpreted language contained in—and at the heart of—the Title VII statute. 590 U.S. at 659 (observing that from “the ordinary public meaning of the statute's language at the time of the law's adoption, a straightforward rule emerges: [a]n employer violates Title VII when it intentionally fires an individual employee based in part on sex”). The Court states that “it is impossible to discriminate” against a person based on sexual orientation or gender identity “without discriminating against that individual based on sex.” Id.

Because HHS is interpreting language nearly identical to that interpreted in Bostock, the major questions doctrine does not apply to HHS's interpretation of the statutes identified in this rule. The Department therefore disagrees with the commenters who opined that this rule represents agency action in violation of Biden v. Nebraska, 143 S. Ct. 2355 (2023) or W. Virginia v. Env't Prot. Agency, 597 U.S. 697 (2022). To the contrary, HHS is relying upon all relevant statutory text and applicable case law in this interpretive rule. However, for clarity, the Department has revised § 75.300(e) in this final rule to make clear that this provision is interpretive and does not impose substantive obligations on entities outside the Department.

Comment: A group of commenters argued that § 75.300(e) would compel faith-based organizations in receipt of HHS funding to violate their religious identity and tenets. Another group of commenters opined that if a program required a religious organization to provide referrals for care that violate the religious organization's ethical standards, it would discriminate against religious providers and would be inconsistent with Trinity Lutheran Church of Columbia v. Comer, 582 U.S. 449 (2017). A group of religious organizations recommended that, absent § 75.300(e)'s removal, § 75.300(f) should be altered to explicitly state that incidental harms to third parties cannot curtail a request for religious exemption if the government action at issue is a burden on the claimant's religion. Two organizations stated that challenges could arise in shelters for unaccompanied migrant children (UC) and unaccompanied refugee minors (URMs) to accommodate gender-nonconforming individuals.

One commenter asserted that the Proposed Rule would require religious organizations to place UCs and URMs with same-sex couples as foster parents because that program is funded in part by grants issued under 8 U.S.C. 1522, 45 CFR part 400, authorization for programs for domestic resettlement of and assistance to refugees, and cited Marouf v. Azar, No. 18-cv-00378 (D.D.C. Jul. 7, 2023). More generally, several commenters argued that the rule would force faith-based providers to provide procedures with which they disagree due to religious beliefs, and raised constitutional issues, alleging that the Proposed Rule would result in disparate impact on religious entities in violation of the Equal Protection Clause.

Response: The Department disagrees that this rule discriminates against religious entities in violation of the Equal Protection Clause. Rather, this final rule clarifies HHS's interpretation of discrimination based on sex in the listed statutes, consistent with Federal law. Furthermore, § 75.300(f) provides a new administrative process not previously provided for in either the 2016 Rule or the partially vacated 2021 Rule. 22 Under § 75.300(f), the Department will address any request for an assurance of a religious freedom- or conscience-based exemption on a case-by-case basis. This new process is designed to ensure that protections are appropriately applied and that recipients have the opportunity to request assurance of exemptions consistent with their religious tenets. The process set forth in § 75.300(f) clarifies legal obligations, demonstrates the Department's concerted effort to approach its enforcement responsibilities under Federal antidiscrimination laws while respecting applicable Federal religious freedom and conscience laws, and maintains transparency about the Department's enforcement mechanisms.

With regard to the consideration of third-party harms  23 raised by commenters, the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. 2000bb et seq., provides that the Federal government may not substantially burden a person's exercise of religion unless it can demonstrate that the “application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. 2000bb-1(b). In determining whether the government action is the least restrictive means of furthering a compelling governmental interest, the Department will take into consideration any harms to third parties that may result from providing an exemption under RFRA.

In response to commenters' concerns regarding the application of this rule to religious providers in the context of UCs, URMs, and foster care because of this rule's application to 8 U.S.C. 1522 the Department notes that 8 U.S.C. 1522 applies only to URMs and not UCs or foster care. Additionally, the Department notes the process at § 75.300(f) is available to religious providers to request an assurance of an exemption from the application of the nondiscrimination requirements addressed in this rule to their programs under applicable Federal religious freedom and conscience laws.

Comment: Some commenters stated that, in their view, the Proposed Rule would affect women's access to services where an entity has been required, based on this rule, to expand its services to include a new population on top of the population they already serve. Some commenters discussed their belief that the rule would require specific programs to expand the services provided, alleging that programs like Head Start and the Community Mental Health and Maternal/Child Health Block Grants would be required to affirm LGBTQI+ children, which would require providing correspondingly affirming health care.

Response: The Department appreciates these comments, but they do not accurately characterize requirements related to women, children, and health care. The final rule clarifies HHS's interpretation of discrimination based on sex in the listed statutes, consistent with Federal law. The Department is not setting standards of care for the practice of medicine in this rule, nor is it requiring providers to provide any specific services.

Comment: Numerous commenters raised concerns that the Proposed Rule affects parental rights related to curricula taught to children and decisions about medical care.

Response: The Department appreciates the fundamental role that parents play in raising their children. The final rule clarifies HHS's interpretation of discrimination based on sex in the listed statutes, consistent with Federal law. The rule does not set standards for parental involvement and nothing in this rule derogates parental rights. The rule also does not opine on the authority of parents to choose when and how to educate their children about certain matters, or to choose when and what health care to provide their children.

Comment: A commenter expressed concern that the Proposed Rule does not clarify the extent of its nondiscrimination requirements, nor does it adequately establish what services recipients must provide or how they must operate under the Proposed Rule.

Response: The Department appreciates these comments. The Department is committed to working with recipients to ensure compliance with their particular programs' nondiscrimination requirements. The Department disagrees that the rule's approach would leave applicants with uncertainty about their antidiscrimination obligations. As discussed above, the concept that discrimination on the basis of sex includes discrimination on the basis of sexual orientation and gender identity is not new, and there exists a wide body of case law on its application in numerous circumstances. This rule memorializes the Department's interpretation as applied to 13 statutes. Indeed, many Federal courts have long interpreted Title VII's prohibition on sex-based discrimination to encompass discrimination based on gender identity. 24

It is true, however, that the Bostock Court noted it did not address the issue of how “doctrines protecting religious liberty interact with Title VII,” leaving those questions “for future cases . . .”  25 The Department will apply the law on these issues as it develops.

Comment: A few commenters expressed concern that HHS grant recipients would now be required, in their view, to use participants' preferred pronouns or adopt, according to these commenters, a “false” view of sex with which individuals may disagree, potentially burdening their speech and expressive association.

Response: This rule does not require grant recipients to adopt any particular views, and neither requires nor authorizes the restriction of any rights protected by the First Amendment or any other Constitutional provision. To reiterate, § 75.300(e) does not impose any substantive requirements on entities outside the Department. Rather, the final rule clarifies HHS's interpretation of discrimination based on sex in the listed statutes and interprets those statutes' prohibitions consistent with Federal law. This regulation neither addresses specific conduct constituting discrimination under any particular statute nor dictates any of the outcomes of any claim of discrimination. Whether discrimination has occurred is a fact-specific inquiry. 26

Comment: Several commenters discussed that at least five of the statutes referenced in § 75.300(e) prohibit sex discrimination by incorporating prohibitions in Title IX, which the commenters state provide for broad carveouts and exceptions for religious entities. 42 U.S.C. 290cc-33(a)(1), 300w-7(a)(1), 300x-57(a)(1), 708(a)(1), 10406(c)(2)(A).

Response: While each of the five statutes referenced by commenters mentions Title IX in a rule of construction, they also each contain a separate, standalone prohibition against discrimination on the basis of sex. 42 U.S.C. 290cc-33(a)(2), 300w-7(a)(2), 300x-57(a)(2), 708(a)(2), 10406(c)(2)(B)(i). These provisions are not reliant on Title IX. They are separate authorities that prohibit sex discrimination outright, and the Department disagrees that the statutory exemptions and exceptions from Title IX should be read into them.

The final rule has no effect on a covered entity's  27 or applicant's ability to maintain, seek, claim, or assert a religious exemption under Title IX. The Department remains committed to applying Title IX's religious exception for the education programs and activities of entities controlled by religious organizations under Title IX. And applicants or recipients that do not have an education program or activity that qualifies under the Title IX religious exception are able to claim assurances of a religious freedom exemption to the requirements of this regulation under this final rule's new administrative process outlined in § 75.300(f). Nothing in this rule invalidates or limits the existing rights, remedies, procedures, or legal standards available under Federal religious freedom and conscience laws.

Comment: Some organizations raised issues with compliance and the impact of instituting nondiscrimination requirements related to sexual orientation and gender identity in educational settings, particularly as applied to sex-segregated facilities or programs. Other commenters stated that the Bostock decision did not create a presumption that sex nondiscrimination statutes prohibit sexual orientation and gender identity discrimination in the context of single-sex spaces.

Response: The final rule clarifies HHS's interpretation of discrimination based on sex in the listed statutes, consistent with Federal law. To the extent warranted, the Department will provide guidance for grantees with questions about compliance with their nondiscrimination obligations. And if program recipients have a religious freedom or conscience objection to the nondiscrimination obligations addressed in this rule, the Department has set forth an administrative process at § 75.300(f). Accordingly, the Department declines to make additional revisions in response to these comments.

Comment: Two commenters asserted that the statutes in the Proposed Rule are exercises of Congress's Spending Clause authority and therefore are subject to the Pennhurst “clear statement rule,” which provides that Congress cannot impose conditions on the grant of Federal funding without providing a clear statement as to what these conditions would entail.

Response: In Pennhurst State School and Hospital v. Halderman, the Supreme Court held that “if Congress intends to impose a condition on the grant of federal moneys, it must do so unambiguously . . . , enabl[ing] the States to exercise their choice knowingly, cognizant of the consequences of their participation.” 451 U.S. 1, 17 (1981). In Bostock, the Supreme Court relied on the plain meaning of Title VII to hold that discrimination because of sex includes discrimination because of sexual orientation and gender identity. HHS is relying on the same plain meaning of the 13 statutes listed in § 75.300(e). As noted in the Proposed Rule, the statutes listed in proposed § 75.300(e) were identified because they contain prohibitions on sex discrimination similar to that in Title VII; none contain any indicia suggesting they should be construed differently than Title VII; and the Department is unaware of any reported case law with regard to these statutes that requires a contrary construction. 88 FR 44754. Indeed, since Bostock, three Federal courts of appeal have held that the plain language of statutes such as Title IX's prohibition on sex discrimination must be read similarly to Title VII's prohibition. 28 Thus, like Title VII, these 13 statutes unambiguously prohibit recipients from discriminating on the basis of sexual orientation or gender identity. The Department's interpretation in this final rule therefore does not affect the States' knowing choice in accepting Federal funds here. Recipients of Federal funds in the relevant grant programs are clearly on notice that they must comply with the antidiscrimination provisions of the 13 listed statutes. Even if one accepted the argument that the “application of [the condition] might be unclear in [some] contexts,” that would not render the condition unenforceable under the Spending Clause. Bennett v. Ky. Dep't of Educ., 470 U.S. 656, 665-66, 673 (1985). Unlike Pennhurst, in which the Federal law at issue was unclear as to whether the states incurred any obligations at all by accepting Federal funds, the 13 listed statutes clearly condition receipt of funds on complying with the statutes' prohibition on sex discrimination. See 8 U.S.C. 1522; 42 U.S.C. 290cc-33; 42 U.S.C. 290ff-1; 42 U.S.C. 295m; 42 U.S.C. 296g; 42 U.S.C. 300w-7; 42 U.S.C. 300x-57; 42 U.S.C. 708; 42 U.S.C. 5151; 42 U.S.C. 8625; 42 U.S.C. 9849; 42 U.S.C. 9918; 42 U.S.C. 10406.

For the reasons set forth in the Proposed Rule and considering the comments received, we are adding text to § 75.300(e) that states the provision is interpretive and does not impose any substantive obligations on entities outside the Department.

In the 2023 NPRM, the Department proposed to add § 75.300(f)(1), which provided that a recipient may, at any time, raise with the Department the recipient's belief that the application of a specific nondiscrimination provision or provisions addressed in this regulation as applied to the recipient would violate Federal religious freedom protections.

Section 75.300(f)(2) proposed that once the awarding agency, working jointly with ASFR or OCR (in the course of investigating a civil rights complaint or compliance review), receives a notification from a recipient seeking a religious exemption, the awarding agency, working jointly with either ASFR or OCR, would promptly consider the recipient's view that they are entitled to an exemption in responding to any complaints, or determining whether to proceed with any investigation or enforcement activity regarding that recipient's compliance with the relevant nondiscrimination provisions, or in responding to a claim raised by the recipient in the first instance, in legal consultation with the Office of the General Counsel. Any relevant ongoing investigation or enforcement activity regarding the recipient would be held in abeyance until a determination has been made.

Section 75.300(f)(3) proposed that, in determining whether a recipient is wholly or partially exempt from the application of the specific provision or provisions raised in its notification, the awarding agency, working jointly with ASFR or OCR, in consultation with the Office of the General Counsel, must assess whether there is a sufficient, concrete factual basis for making a determination and apply the applicable legal standards of the religious freedom statute at issue.

Section 75.300(f)(3) also proposed that, upon making a determination regarding whether a particular recipient is exempt from—or subject to a modified requirement under—a specific provision addressed in this part, the awarding agency, working with ASFR or OCR, will communicate that determination to the recipient in writing, noting that that determination does not otherwise limit the application of any other Federal law to the recipient.

Section 75.300(f)(4) proposed that the awarding agency, working jointly with ASFR and OCR, may determine at any time whether a recipient is wholly or partially exempt from certain provisions addressed in this part under Federal religious freedom laws, either after a complaint is made against the recipient or when the recipient seeks an exemption before any complaint is filed (provided the Department has a sufficient, concrete factual basis for determining whether the recipient is entitled to an exemption).

The comments and our responses regarding § 75.300(f) are set forth below.

Comment: A commenter expressed support for § 75.300(f) because it calls for written notification to a grantee explaining the “scope, applicable issues, duration, and all other relevant terms of any [granted] exemption.” The commenter reasoned that such a notification would minimize potential risks to LGBTQI+ individuals by restricting grantees from taking action beyond what a granted exemption allows. The commenter also asked, however, that the Department codify a requirement that this written notification be made available to the public as well as the grantee. One commenter said any determination letters from OCR granting an exemption should be made public within 10 days by posting on the Department's website.

Response: The Department thanks the commenters. The Department declines to revise § 75.300(f) to require publication of exemptions granted under this provision, consistent with Title IX regulations that do not impose a similar notification requirement for exemptions granted consistent with that statute or its implementing regulations. 29 The Department notes that nothing in this rule prevents applicants or recipients from independently disclosing any such exemptions they have received to the general public or individuals participating or seeking to participate in their programs, and we encourage applicants or recipients to do so. We recognize that individuals are not always aware that the recipients of Federal funding that administer the programs in which they participate may have religious freedom- or conscience-based exemptions, and the Department remains committed to working with recipients, applicants, and the public to improve transparency, clarity, and access to HHS funded programs and activities through implementation of this rule. HHS is also subject to FOIA, and information may be released to a requestor or made available for public inspection consistent with the agency's obligations under that statute and its implementing regulations.

Comment: A commenter expressed concern with the notification procedure in proposed § 75.300(f), because the process, in their view, would not function as a substitute for automatic exemptions authorized under the Constitution, RFRA, Title IX, and other statutes. Some commenters expressed concern that § 75.300(f) offers recipients no assurance in the form of either substance or process. Some commenters said that the exemption process in § 75.300(f) may discourage otherwise eligible entities from applying for or receiving certain Federal grant funds because the process is unclear, unpredictable, and unreliable. One commenter opined that the existence of § 75.300(f) demonstrates that the rule is rewriting the underlying terms of grants in a way that will have substantial impacts on recipients.

A commenter expressed concern that the Department's view is that RFRA requires no affirmative agency compliance or enforcement beyond what a court orders. The commenter cited to a November 2021 Federal Register notice that withdrew a prior Delegation of Authority, which had centralized authority for implementation and compliance of RFRA within the Department with OCR. See 86 FR 67067 (Nov. 24, 2021) (withdrawing 83 FR 2804 (Jan. 19, 2018). The commenter continued that with this understanding, the Proposed Rule would result in religious providers having to undergo extensive enforcement proceedings and litigation to resolve their religious freedom concerns.

A commenter asked that the Department establish some objective criteria for a religious safe harbor because proposed § 75.300(f) provides little guidance on how Federal religious freedom laws would be applied. Another commenter similarly stated that additional clarity is needed because at least three of the 13 statutes in the Proposed Rule require applicants to make affirmative representations about their compliance with the relevant law's nondiscrimination provisions, namely 42 U.S.C. 295m; 42 U.S.C. 296g; and 42 U.S.C. 9849.

Response: The Department disagrees with commenters that it views RFRA as requiring no agency compliance. The new § 75.300(f) administrative process demonstrates the Department's concerted effort to balance its enforcement responsibilities under Federal antidiscrimination laws while respecting applicable Federal religious freedom and conscience laws, including RFRA. Section 75.300(f) provides an administrative process, not provided for in either the 2016 Rule or the partially vacated 2021 Rule, under which grant applicants and recipients may either rely on the protections of Federal religious freedom or conscience law or seek assurance of an exemption directly from the Department under such laws.

Section 75.300(f) sets forth a detailed administrative process to submit exemption assurance requests, and the standards governing the relevant Federal religious freedom and conscience laws speak for themselves. To provide added predictability to grant applicants and recipients, they are afforded an automatic, temporary exemption under § 75.300(f)(2) until the Department adjudicates their request. For additional clarity, the Department is adding the following clause to § 75.300(f)(2), which states that a temporary exemption will take effect upon the submission of the request. The exemption shall be limited to the particular application of the specific provision(s) identified in the notification to the Department. The exemption includes conduct that occurred during the pendency of any administrative investigation and enforcement that is covered by the temporary exemption.

Finally, the Department disagrees that the inclusion of § 75.300(f) indicates any grant terms are being rewritten. The Department's inclusion of § 75.300(f) ensures that the Department consistently applies both Bostock and other relevant case law and complies with its obligations under applicable Federal religious freedom and conscience law.

Comment: Some comments raised concerns regarding privacy protections for organizations seeking an exemption under § 75.300(f), and others cited the need for more privacy protections for such organizations. A commenter speculated that, without such protections, such religious organizations may become targets of individuals with anti-religious animus.

Response: The Department will apply all applicable privacy laws in handling the information it receives from entities regarding requests for exemptions, will not target or retaliate against an entity that seeks an exemption under § 75.300(f), and will handle according to the applicable provisions of the of the Privacy Act of 1974. As noted above, the Department does not require publication of exemptions granted to applicants or recipients under this provision, though applicants or recipients may independently and voluntarily disclose any such exemptions they have received the public and participating or seeking to participate in their programs. As noted above, HHS is subject to the FOIA; thus, information may be requested pursuant to that statute.

Comment: Some commenters stated that § 75.300(f) does not explain what happens if a request for an exemption is submitted, but the factual record is not fully developed when the Department makes its assessment per § 75.300(f)(3). These commenters also expressed concern that § 75.300(f)(3) does not explain what facts would assist in HHS's assessment.

A group of commenters opined that § 75.300(f) should be clarified by citing the proposition that, under RFRA, the Government must show “application of the burden to the person is in furtherance of a compelling governmental interest.”

Another group of commenters requested that the Department include in the text of the regulation a requirement that it conduct an Establishment Clause analysis of any proposed exemptions. They stated that such an analysis is a constitutionally required step that previous Administrations have omitted and that the Establishment Clause commands that “an accommodation must be measured so that it does not override other significant interests,” “impose unjustified burdens on other[s],” or have a “detrimental effect on any third party.” Cutter v. Wilkinson, 544 U.S. 709, 720, 722, 726 (2005); see also Thornton v. Caldor, 472 U.S. 703, 709-10 (1985); Burwell v. Hobby Lobby Stores, 573 U.S. 682 (2014); Texas Monthly v. Bullock, 489 U.S. 1, 18 n.8 (1989) (Brennan, J., plurality op.).).

A coalition of legal advocacy groups and religious groups recommended that the Department expressly adopt a case-by-case approach to granting exemptions under the final rule, reasoning that issuance of blanket exemptions or exemptions for hypothetical burdens should be minimized.

Response: As stated above, the Department will follow all relevant legal authorities, including Supreme Court precedent, in administering § 75.300(f) and the final rule. The Department affirms, consistent with the preamble of the Proposed Rule, that it will evaluate each situation on a case-by-case basis to determine whether a recipient—or, as of this final rule, applicant—is wholly exempt from the application of, or entitled to a modification of the application of, certain provisions addressed in this part, under an applicable Federal religious freedom or conscience law. When HHS makes a case-by-case determination, this refers to the evaluation of the exemption request as a whole—which may be requesting assurance of an exemption from a category of services. An entity will not be required to submit an exemption assurance request for each time it seeks to offer a service if an exemption already applies. Such a case-by-case analysis also mitigates concerns that the Department will always evaluate the facts in a particular direction and negatively affect third parties as raised in the comment. In making such determinations, the Department will faithfully apply the legal standards set forth in the particular Federal religious freedom or conscience law at issue. The Department declines the commenter's recommendation to articulate the legal standards in RFRA in the regulatory text of § 75.300(f) as unnecessary.

However, to address commenters' concerns, the Department has revised § 75.300(f)(1) to state that a recipient or applicant may rely on applicable Federal religious freedom and conscience protections. In other words, a recipient or applicant is not required to seek an exemption assurance from the Department, although it may do so if it wishes. Revised § 75.300(f)(1) also states that, where such protections apply, the application of a particular provision(s) of the statute at issue to the specific contexts, procedures, or services at hand shall not be required. When a recipient acts based upon its good faith reliance that it is exempt from providing a particular service due to the application of relevant religious freedom and conscience protections ( e.g., RFRA), even if the recipient had not affirmatively sought a written exemption assurance under § 75.300(f)(2), HHS will not seek backward-looking relief against that recipient. But if the Department determines, after an investigation, that the recipient does not satisfy the legal requirements for an exception, it will seek forward-looking relief as appropriate under the facts.

If the applicant or recipient wishes to receive an assurance from the Department regarding an exemption under any applicable religious freedom and conscience laws, it may do so under § 75.300(f)(2) either prior to, or during the course of, an investigation.

It is important to note that Federal religious freedom and conscience laws often differ in significant ways, and the facts that would assist the Department in its assessment of such claims would be consistent with the applicable legal authorities set forth in this revision to § 75.300(f)(2). For example conscience laws frequently are tied to federal funding, while RFRA provides that the Federal government may not substantially burden a person's exercise of religion unless it can demonstrate that the “application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. 2000bb-1(b). In determining whether the government action is the least restrictive means of furthering a compelling governmental interest, the Department will take into consideration any harms to third parties that may result from providing an exemption under RFRA. The Department will apply the RFRA standard in determining whether and to what extent an applicant or recipient is exempt from the application of any provision addressed in this final rule under that law. The Department will consider the harms that an applicant or recipient's request for an assurance of an exemption may have on third parties if and when that harm is relevant when considering whether to grant an assurance under a particular Federal religious freedom or conscience law.

Given this framework for addressing third party harms, the Department notes that it remains committed to fully complying with the First Amendment, including the Free Exercise and Establishment Clause, but declines to add language relating to third party harms to the final rule.

However, for the sake of additional clarity, the Department is revising proposed § 75.300(f)(1), now § 75.300(f)(2), to explain that at any time, a grant applicant or recipient may notify the HHS awarding agency, ASFR, or OCR that it views itself as exempt from, or requires modified application of, certain provisions addressed in this rule because of the application of the Church, Coats-Snowe, and Weldon Amendments, the generally applicable requirements of the RFRA, the First Amendment, and other applicable Federal laws.

Comment: A coalition of legal advocacy groups and religious groups requested that HHS require that an awarding agency work with both ASFR and OCR in reviewing, considering, and deciding whether to grant a religious exemption or modification to the provisions of the relevant statute.

Response: The Department thanks commenters for the request and agrees that the awarding agency should work with both ASFR and OCR in reviewing, considering, and deciding requests for assurances of exemption. Accordingly, the Department is revising § 75.300(f) to replace “or” with “and” as the conjunction between ASFR and OCR where relevant in § 75.300(f).

Comment: Several commenters stated that the Department should explicitly state that the notification procedure in § 75.300(f) is optional and clarify that a recipient will not be prejudiced if they do not seek an exemption under this provision.

Additionally, a couple of commenters requested that the Department clarify in § 75.300(f) who will make the final determination on religious freedom- or conscience-based exemption requests and clarify on what basis the determination is to be made.

Response: The Department appreciates the commenters' concerns and suggestions. To start, when a recipient acts based upon its good faith reliance that it is exempt from providing a particular service due to the application of relevant religious freedom and conscience protections ( e.g., RFRA), even if the recipient had not affirmatively sought a written exemption under § 75.300(f)(2), the Department will not seek backward-looking relief against that recipient. Nothing in § 75.300(f) requires a grant applicant or recipient to seek an exemption under this process prior to an investigation, though they may do so if they so choose. Nor will an applicant or recipient be prejudiced if they do not seek an exemption under this provision; recipients may make exemption requests during an investigation or administrative enforcement proceedings as well.

In addition, the Department is adding § 75.300(f)(5) to the final rule to state that if an applicant or recipient receives an adverse determination of its exemption request, the entity may appeal the Department's determination under 45 CFR part 81. Section 75.300(f)(5) also provides the temporary exemption provided to the applicant or recipient expires upon a final decision under 45 CFR part 81. The Department is also adding § 75.300(f)(6) to the final rule, which explains that a determination of an exemption is not final for purposes of judicial review until after a final determination under 45 CFR part 81. This mirrors the process for appeals in the Section 1557 Final Rule. 30

Finally, it is the awarding agency, working jointly with ASFR and OCR, in legal consultation with the Office of the General Counsel, that will make the final determination on whether to grant the request, and will do so consistent with applicable Federal law. Applicants or recipients who have been denied an exemption under § 75.300(f) may raise their request before an administrative hearing examiner from the Department, as provided for under 45 CFR part 81. The temporary exemption would run through consideration of the administrative appeal.

Comment: A group of commenters suggested that § 75.300(f) expressly mention the “church autonomy doctrine” as a basis for an exemption.

Response: Section 75.300(f) provides for exemptions based on applicable Federal religious freedom and conscience laws, including the First Amendment. Given that the church autonomy doctrine is rooted in the religion clauses of the First Amendment, 31 its inclusion here is implied and it need not be explicitly mentioned in the regulatory text.

Comment: A couple of commenters expressed concern that the Proposed Rule's religious exemption provisions at § 75.300(f) would be duplicative of the provisions put forth in HHS's recent rulemaking on Section 1557 of the Affordable Care Act.

Response: The Department appreciates the comment and views the similarities in the processes in both this rule and the Proposed Rule with the Section 1557 rulemaking  32 as appropriate to the extent that RFRA and the other Federal religious freedom and conscience statutes would function similarly in this context as in Section 1557. However, the entities that receive grants from the Department may or may not be subject to Section 1557 by virtue of not being or operating health programs or activities, and thus, it is necessary for both rules to contain religious exemption provisions.

Comment: A group of commenters stated that the financial exemption provided by 45 CFR 75.102(b) should also apply to those with religious objections to the operation of proposed § 75.300(e). The commenters asserted that the Proposed Rule acknowledged the secular exemption in 45 CFR 75.102 but sought to discourage its application based on historical use. 88 FR 44755 n.26. The commenters stated that it would violate the Free Exercise Clause to make exemptions available for secular reasons under 45 CFR 75.102(b) but not have similar exemptions available for religious reasons unless strict scrutiny is satisfied, citing both Fulton v. Philadelphia, 141 S. Ct. 1868 (2021),) and Tandon v. Newsom, 141 S. Ct. 1294 (2021) (per curiam), for this proposition.

Response: The Department disagrees with commenters' claim. Unlike the government regulations at issue in Fulton and Tandon, under § 75.300(f), entities have numerous avenues to seek religious exemptions, including an assurance of exemption under the Church, Coats-Snowe, and Weldon Amendments, the generally applicable requirements of the RFRA, the First Amendment, and other applicable Federal laws. The Department therefore declines to apply 45 CFR 75.102(b), which has historically been used to address requests for financial and administrative exemptions, to provide exemptions. Instead, the Department directs recipients and applicants with religious objections to the process laid out under § 75.300(f).

Comment: A group of commenters stated that they approved of the fact that § 75.300(f) could be invoked even if there is no active complaint pending against the recipient. The group further stated that the Department should also provide prospective recipients of grants from the Department a procedure whereby they could seek a preclearance exemption. Relatedly, the commenter urged the Department to ensure that nothing in the electronic grant application process would require a religious applicant to affirm nondiscriminatory conduct in a manner that would be at odds with RFRA or the First Amendment.

Response: As we stated in the NPRM, the Department is fully committed to respecting religious freedom laws, including RFRA and the First Amendment, when applying the nondiscrimination requirements addressed in this rule. The final rule allows for a religious exemption process in § 75.300(f). Further, because the nondiscrimination provisions being interpreted by this rule to apply based on receipt of certain Federal funds, we decline to allow for a general preclearance process, not associated with a specific funding application, from prospective grantees. However, an applicant may submit a request for assurance of an exemption concurrently with its grant proposal, which will be reviewed on a case-by-case basis. Neither the submission nor adjudication of a grant applicant's or recipient's request for assurance of a religious exemption will have any bearing on the awarding agency's determination of award unless the organization has made clear that the exemption is necessary to its participation and HHS has determined that it would deny the request.

For the reasons set forth in the Proposed Rule and considering the comments received, we are finalizing the provisions as proposed in § 75.300(f), with the following modifications.

We are adding a new § 75.300(f)(1) to provide notice that an applicant or recipient may rely on Federal protections for religious freedom and conscience. We are revising proposed § 75.300(f)(1), now § 75.300(f)(2), to state that applicants, in addition to recipients, are allowed to submit requests for assurances of exemption, to provide a non-exhaustive list of conscience laws that may be applied to the § 75.300(f) process, and to notify recipients, applicants, and the public about the type of information the notification must include. We are also revising proposed § 75.300(f)(2), now § 75.300(f)(3), to provide a temporary exemption during the pendency of the Department's review of the request and a general timetable under which the Department will acknowledge and begin to evaluate requests for assurances of exemption; proposed § 75.300(f)(3), now § 75.300(f)(4), to provide that the awarding agency, ASFR, or OCR will inform the applicant or recipient in writing of the determination regarding the assurance of exemption request and that any such determination does not otherwise limit the application of any other provision of the relevant statute to the applicant or recipient or to other contexts, procedures, or services; and proposed § 75.300(f)(4), now § 75.300(f)(5), to provide details about the administrative appeal process for recipients and applicants receiving adverse determinations. Finally, in a new subparagraph § 75.300(f)(6), the Department notes that for purposes of judicial review, determinations made under § 75.300(f) are not final until after a final decision under 45 CFR part 81.

Comment: One commenter stated that, in their view, the proposed severability clause in § 75.300(g) makes clear that HHS will not apply any RFRA ruling beyond the parties protected in a case to similarly situated entities. The commenter viewed the proposed rule as therefore forcing objecting religious providers to each undergo years of enforcement proceedings followed by years of litigation.

Response: Section 75.300(g) ensures that, even if a court were to strike down some provision of this final rule, other portions of this rule not found to be unlawful would remain in effect. Contrary to the comment, § 75.300(g) states that any provision held to be invalid or unenforceable as applied to any person or circumstance, will not affect the application of the provision to other persons not similarly situated or to other, dissimilar circumstances. The language of § 75.300(g) is standard in severability clauses and indicates here that the provisions of this rule are able to operate independently of each other.

For the reasons set forth in the Proposed Rule and considering the comments received, we are finalizing the provision as proposed in § 75.300(g).

The Department conducted a Tribal Consultation on December 19, 2023, with 27 participants. The Department received 10 comments from tribal entities following the consultation.

Comment: Several Federally recognized Indian Tribes asked the Department to clarify that Tribal health programs exclusively benefiting American Indian and Alaska Native (AI/AN) people do not violate the discrimination provisions in the proposed § 75.300(c). The tribes said that § 75.300(c) should include an exemption modeled after Title VI's implementing regulation at 45 CFR 80.3(d), which states that for Indian Health and Cuban Refugee Services, it will not be considered discrimination if an individual is excluded from benefits because those benefits are limited by Federal law to individuals of a particular race, color, or national origin.

Response: The Department recognizes the unique relationship between the United States and Federally recognized tribal entities. 33 The regulation at 45 CFR 80.3(d) provides that an individual shall not be deemed subjected to discrimination by reason of their exclusion from benefits limited by Federal law—such as the Indian Health Service—to individuals of a different race, color, or national origin. Because of the unique relationship between the United States and Federally recognized tribal entities, Federal government preferences based on an individual's membership or eligibility in a Federally recognized tribal entity are political classifications and are not race-based. 34 Preferences based upon the unique relationship between the United States and Federally recognized tribal entities are distinct from the forms of discrimination prohibited by Federal civil rights laws, which aim to protect all individuals on the basis of race, color, or national origin (including AI/AN individuals, regardless of political affiliation). 35 The Department respects this unique relationship and the resulting benefits that are conferred by the Federal government on the basis of political classification, which remain distinct from racial classification and therefore distinct from race nondiscrimination prohibitions referenced in § 75.300(c). It is unnecessary, however, to change the regulatory text of § 75.300(c) to reflect that ongoing commitment, and the Department declines to do so here.

Comment: One commenter from a Federally recognized Indian tribe requested clarity on whether the rule impacts Indian Health Service (IHS) Compact funding and if the IHS Compact funding stream is included in the list of statutes under § 75.300(e).

Response: The IHS Compact funding stream under Title IV of the Indian Self-Determination Education Assistance Act (ISDEAA) (25 U.S.C. 5381 et seq.; 42 CFR 137 et seq. ) is not included in the list of 13 statutes in § 75.300(e). Regarding grants related to the 13 statutes listed in § 75.300(e), the Department notes that Tribes and Tribal organizations that compact with IHS to assume full funding and control over IHS Programs, Services, Functions and Activities (PSFA) can “add” statutorily mandated grants to their funding agreement once those grants have been awarded. See 42 CFR 137.60. However, the statutes listed in § 75.300(e) are not grants that can be added to a Tribe's ISDEAA funding agreement with IHS.

The Department has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Small Business Regulatory Enforcement Fairness Act of 1995 (also known as the Congressional Review Act, 5 U.S.C. 801 et seq. ), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) (UMRA). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The final rule states that: (1) grant recipients may not discriminate to the extent prohibited by Federal statute; and (2) HHS complies with applicable Supreme Court decisions. The rule likewise clarifies the Department's interpretation of nondiscrimination protections on the basis of sex in 13 statutes consistent with Supreme Court precedent. This rulemaking has been determined to be significant for the purposes of E.O. 12866 as amended by E.O. 14094 and, therefore, has been accordingly reviewed by the OMB. Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act, 5 U.S.C. 801 et seq. ), OMB's Office of Information and Regulatory Affairs has determined that this final rule does not meet the criteria set forth in 5 U.S.C. 804(2). The UMRA (section 202(a)) requires HHS to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $183 million, using the most current (2023) Implicit Price Deflator for the Gross Domestic Product. The final rule would not result in an expenditure in any year that meets or exceeds this amount.

The Department requested comment on the analysis of the impact of the Proposed Rule on small entities, and the assumptions that underlie that analysis. The Department received public comments on the likely impacts of the Proposed Rule, including its likely impacts as compared to the 2016 Rule. Below is a summary of the comments received and our response:

Comment: HHS received comments discussing the need for additional economic analysis of the effect of the Proposed Rule in addition to Information Collection Requests (ICRs) and other information gathering methods before the rule is enacted, including requests for information, regional roundtables, task forces, regulatory reviews of each grant statute, or a survey of all the relevant populations.

A number of commenters expressed concerns that familiarization costs and the effects on religious entities were not adequately captured and requested that these costs be considered as well as the impact overall it would have on the health care system.

Another commenter urged HHS to perform a family policy assessment in addition to stating its policy of reading and responding to comments.

Response: For the analysis of the final rule, HHS has included legal and other familiarization costs and has expanded the RIA to include costs specifically associated with assurance of religious freedom and conscience exemptions requests. Taking those into consideration, the Department concludes that the final rule would result in annualized costs over a five-year time horizon of approximately $4.0 million or $3.8 million annualized, discounted at 7 percent and 3 percent respectively.

Through the analysis, the Department has determined that the additional costs associated with the final rule will not have a significant impact on organizations' ability to administer the grants they receive, and therefore will not put additional strain on their ability to operate effectively.

The Department received no additional evidence or data from commenters about changes in the number or composition of grantees since the 2016 Rule.

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a policy or regulation may negatively affect family well-being. If the agency determines a policy or regulation negatively affects family well-being, then the agency must prepare an impact assessment addressing seven criteria specified in the law. HHS maintains that it is not necessary to prepare a family policymaking assessment (see Pub. L. 105-277) for this rule, because it will not have a negative impact on the autonomy or integrity of the family as an institution, or family well-being within the meaning of the legislation.

The Department considers the opportunity for grant recipients and applicants to raise recipient-specific and applicant-specific concerns to be a benefit of the final rule. For the purposes of the RIA, we do not attribute any litigation costs to the final rule.

This analysis quantifies several categories of costs to covered entities and to the Department under the final rule. Specifically, the Department quantifies costs associated with covered entities becoming familiar with the rule provisions and making a determination of applicability as well as costs associated with drafting and submitting assurance of exemption requests. HHS also quantifies the anticipated costs to adjudicate the assurance of exemption requests from covered entities. Our analysis addresses the uncertainty in quantifying the number of entities that will submit exemption requests. For the primary estimate, the Department reports cost estimates of approximately $16.47 million using a 7 percent discount rate, and a cost estimate of approximately $17.41 million using a 3 percent discount rate. All cost estimates are in 2022 dollars. The Department concludes that the final rule would result in annualized costs over a five-year time horizon of approximately $4.0 million or $3.8 million, discounted at 7 percent and 3 percent respectively. In addition to these quantified cost estimates, the main analysis includes a discussion of the potential unquantified benefits associated with the rule. Table 1 below shows the estimated annualized costs of the final rule.

To quantify the costs associated with this rule, the Department has attempted to estimate whether the number and composition of recipients changed in response to the prior two rulemakings and how those costs will impact this rule. The 2016 Rule has never been enforced; the Department issued the Notice of Nonenforcement in 2019; and the 2021 Rule never went into effect. Because of this, HHS does not have any data with regard to whether the number and composition of recipients changed in response to prior rulemakings, as there was no change in the enforcement of these rules which would impact those grants. However, the Department understands that its recipients generally fall into one of the following three categories in how they have been impacted by the prior two rulemakings.

The first category includes recipients that adopted the nondiscrimination practices prior to the 2016 Rule, whether voluntarily or as a result of State and/or local law. Their observance of nondiscrimination requirements is not the result of the 2016 Rule and thus, these recipients are not impacted by this rule. The second category includes recipients that had not adopted nondiscrimination practices prior to the 2016 Rule, but that complied since the 2016 Rule, including after the 2019 Notice of Nonenforcement was issued and until now. However, because the 2016 Rule did not contain any procedural enforcement mechanisms such as an assurance of compliance or adoption of a grievance process, it is difficult to quantity the costs, if any, incurred by this second category of recipients. These recipients would likely continue to follow such nondiscrimination practices voluntarily or because of new or newly enforced State and/or local laws, given that they could have declined to comply with the 2016 Rule requirements after the 2019 Notice of Nonenforcement issued, and yet have continued to comply with those requirements notwithstanding that notice. Thus, these recipients are similarly situated to the first category of recipients insofar as they are not impacted by whether or not the 2016 Rule is in effect. The third category includes recipients that had not followed, and continue to not follow, the 2016 Rule. However, their practice was likely not impacted by the 2016 Rule, as the rule was not enforced. In 2019, the Department issued the Notice of Nonenforcement which applied to all recipients covered by the 2016 Rule, which is still in effect to date. As such, these recipients could not have relied upon the relevant provisions of the 2021 Rule, either, since that rule was partially vacated and never went into effect. Since this final rule removes the 2016 Rule's requirements, and adds a religious and conscience exemption process, the Department expects that these grantees will continue their current practice.

The final rule specifically addresses the application of Federal religious freedom and conscience protections for grant applicants and recipients and states that an applicant or recipient may raise with the Department their belief that the application of a specific provision or provisions of the grants' requirements as explained in Section 75.300 as applied to the applicant or recipient violate Federal religious freedom or conscience protections. The final rule also states that an applicant or recipient may seek an assurance of exemption based upon the application of a Federal religious freedom or conscience law and the Department would assess whether there is a significant concrete factual basis prior to making any determination. To estimate the population of covered entities, the Department uses historical information on the number of grantees for HHS programs as well as data on the number of religious hospitals. Based on information in the Department's Tracking Accountability in Government Grant Spending (TAGGS) system, the Department estimates that there was a total of 144,817 grantees in 2023. 36 The Department acknowledges that it issues many grants on an annual basis, and many recipients receive multiple grants. There were an estimated 707 active religious hospitals as of 2020. 37

The Department does not have information on the number of grantees that will seek an assurance of exemption; therefore, it acknowledges the uncertainty with the number of grantees that will submit requests for assurance of exemption under the block grant programs. Because of the uncertainty, the Department estimates a range of covered entities will be impacted by the final rule. For the low population estimate, the Department assumes all 707 religious hospitals will request assurances of religious exemptions and receive funding under the block grants. This is likely an overestimate, as most hospitals do not receive funding under the 13 statutes at issue. Nevertheless, for the primary estimate, the Department assumes that 2% of the total population of TAGGS grantees, including religious freedom requests and those made on the basis of conscience, along with all 707 religious hospitals will request exemptions. For the high population estimate, the Department assumes 5% of the total population of TAGGS grantees along with all 707 religious hospitals will request exemption requests. To estimate the number of grantees in future years of the analysis, the final rule estimates the growth rate for the population of grantees by calculating a compound annual growth rate of 6.10% for the decade from 2013 to 2023. 38 The grantee annual growth rate is then applied to the total number of existing grantees each year during the five-year period of analysis, beginning in 2023. To account for costs to covered entities after the final rule is promulgated, the Department assumes only new entities will incur costs associated with the rule after the first year of implementation. After the first year, new entities are considered the source of associated costs, and the same percentage of religious exemptions (2%) is applied for new entities each year. Table 2 below shows the estimated population of grantees based on the annual growth rate (6.10%), and the estimated number of new grantees per year.

In this section, the Department discusses the incremental costs of the final rule, which excludes ongoing costs attributable to prior rulemaking. The Department identifies potential costs associated with grantees becoming familiar with this rule along with submitting exemption requests, and follows the analytic approach contained in its analysis. The Department considered additional potential sources of costs that would be attributable to the final rule and found that Parts (c)-(e) of the rule clarify for all covered grants what is already required by law; and therefore, do not constitute incremental costs associated with this final rule. Below are descriptions of the quantified costs associated with the final rule.

The Department anticipates that all covered entities will incur costs to familiarize themselves with the final rule. Depending on the grantee, the task of familiarization could potentially fall to the following occupation categories: (1) lawyers (23-1011), with a $65.26 median hourly wage; (2) general and operations managers (11-1021), with a $47.16 median hourly wage; (3) grantee social and community service managers (11-9151), with a $35.69 median hourly wage; (4) medical and health services managers (11-9111), with a $50.40 median hourly wage; or (5) compliance officers (13-1041), with a $34.47 median hourly wage. Across all grantees, the Department adopts a pre-tax hourly wage that is the average across the median hourly wage rates for these 5 categories, or $46.60 per hour. 39 To compute the value of time for on-the-job-activities, the Department adopts a fully loaded wage rate that accounts for wages, benefits, and other indirect costs of labor that is equal to 200% of the pre-tax wage rate, or $93.20 per hour. 40 Accordingly, the Department estimates that it would take a typical grantee approximately 0.68 hours to become familiar with the proposed provisions. 41 In Year 1, there are an estimated total of 153,647 grantees. 42

In Year 2 through Year 5, the Department also assumes that new grantees will incur a similar familiarization cost in the year they enter the market. To calculate the cost to covered entities to familiarize themselves with the final rule, the Department multiplies the total number of grantees per year (see Table 3) by the estimated familiarization hour burden (0.68 hours) and by the average loaded wage for the grantee's accountable individual responsible for rule familiarization ($93.20). In Year 1, the Department estimates the cost associated with grantee rule familiarization to be approximately $9,686,014. Over the five-year period of analysis, the total cost to covered entities associated with rule familiarization is estimated to be $12,273,485.

The final rule describes a process for applicants and recipients notifying an awarding agency that they are seeking assurance of a religious freedom- or conscience-based exemption, and for HHS to promptly consider the applicant's or recipient's views that they are entitled to an exemption. The Department has identified costs related to covered entities submitting a request for assurance of an exemption based on Federal religious freedom and conscience laws. The Department estimates this potential cost associated with such requests as the opportunity cost of time spent by covered entities to (a) assess the need for an exemption; (b) write the exemption assurance request; and (c) submit the request. To estimate the opportunity cost of time spent drafting and submitting such requests, the Department assumes that one (1) employee will spend two (2) hours assessing the need for an exemption and three (3) hours writing and submitting the exemption assurance request for a total of five (5) hours. 43 The Department further assumes that legal personnel, including lawyers and legal assistants, would perform these functions. The mean hourly wage for these occupations is $65.26 per hour for each employee, which the Department doubles to account for overhead and other costs. 44 To compute the value of time for on-the-job activities, the Department adopts a fully loaded wage rate that accounts for wages benefits and other indirect costs of labor that is equal to 200% of the pre-tax wage rate or a fully loaded wage of $130.52. 45 The Department calculates the cost per exemption assurance request for covered entities as the hour burden to determine applicability as well as drafting and submitting the exemption assurance request (5 hours) multiplied by the loaded wage for legal personnel involved in the request process ($130.52). The total cost per covered entity to draft and submit such a request is estimated to be $652.60. 46

Our cost estimate reflects a wide range of uncertainty in the number of exemption assurance requests the Department will receive. In the primary scenario, OCR adopts a central estimate of the number of such requests of 2 percent of all covered entities plus all 707 religious hospitals, which is estimated to be 3,780 requests in Year 1, covering all areas addressed under the statute and regulations. 47 In Year 1, the primary estimate of the total number of anticipated grantees seeking exemption assurance requests (3,780) is multiplied by the cost per request ($652.60) for a total cost of $2,466,794, with the range of estimates between $461,388 and $5,474,903 using the low and high population estimates respectively. In Years 2 through 5, the Department assumes that 2 percent of all new grantees will submit an exemption assurance request in the year they enter the market. Over the five-year period of analysis, the Department estimates that the primary estimate of total costs associated with covered entities drafting and submitting such requests to be $3,002,508, with the range of estimates between $461,388 and $6,814,187 using the low and high population estimates respectively.

In conjunction with covered entities drafting and submitting exemption assurance requests, the Department will incur costs associated with adjudicating such requests received from covered entities. The awarding agency, working jointly with ASFR and OCR, and in legal consultation with the Office of the General Counsel, will be responsible for reviewing the request and making a determination of applicability as well as suitability for the exemption. The Department assumes that personnel involved in adjudicating these requests received from covered entities will be a single (1) Step 1 GS-14 employee with a loaded wage of $126.86 per hour. 48 The Department also assumes it takes five hours to complete the review and adjudicate exemption assurance requests. 49 To calculate the costs associated with the adjudication of such requests, the Department multiplies the estimated number of requests received per year by the hour burden to adjudicate the request (5 hours) and by the loaded wage for the reviewer ($126.86). In Year 1, the primary estimate of costs associated with adjudicating exemption assurance requests is estimated to be $2,397,621, with a range of estimates between $448,450 and $5,321,378 using the low and high population estimates respectively. In Years 2 through 5, the Department anticipates it will receive exemption assurance requests from new covered entities that will require the same adjudication process. Over the five-year period of analysis, the primary estimate of total costs to HHS associated with adjudicating such requests received from covered entities is estimated to be $2,918,312, with a range of estimates between $448,450 and $6,623,105 using the low and high population estimates respectively.

To estimate the total cost of the exemption assurance request provision, the Department sums the estimated total costs for covered entities to draft and submit such a request with the estimated total costs to adjudicate it. In Year 1, the primary estimate of total costs associated with exemption assurance requests are estimated to be $4,864,415, with a range of estimates between $909,838 and $10,796,281 using the low and high population estimates respectively. Over the five-year period of analysis, the primary estimate of total costs associated with such requests are estimated to be $5,920,820, with a range of estimates between $909,838 and $13,437,292 using the low and high population estimates respectively.

Table 4 below shows the estimated total costs associated with exemption assurance requests using the low, primary, and high population range.

In the first year under the final rule for the primary population estimate, these costs include $9.69 million in familiarization and $4.86 million for covered entities to submit and review exemption assurance requests and HHS to adjudicate the requests for a total cost of $14.55 million. Both familiarization and these requests have costs associated with the number of new grantees in the market and submitting the requests. Total costs for the final rule are estimated to be $18.19 undiscounted and $17.41 or $16.47 when discounting at the 3 percent and 7 percent respectively. Table 5 below presents the total annual costs anticipated under the final rule for which cost estimates have been developed.

The benefits of the rule help ensure that HHS grants programs will be administered fairly and consistently with Supreme Court precedent. Section 75.300(c) makes compliance simpler and more predictable for Federal grant recipients. Likewise, § 75.300(d) notes that HHS will comply with Supreme Court decisions, which also simplifies compliance for Federal grant recipients. Section 75.300(e) clarifies that the Department interprets the prohibition of discrimination on the basis of sex in 13 listed statutes to include discrimination based on sexual orientation and gender identity, consistent with Bostock v. Clayton County, 590 U.S. 644 (2020), which provides additional clarity to the public regarding the Department's interpretation and helps facilitate the efficient and equitable administration of HHS grants. Finally, § 75.300(f) states that the Department will comply with all Federal religious freedom and conscience laws, including RFRA and the First Amendment, which will assist the Department in fulfilling that commitment by providing the opportunity for recipients and applicants to raise concerns with HHS and for those concerns to be evaluated on a case-by-case basis. The Department notes that there are other non-quantifiable benefits associated with this rule, such as protecting conscience rights; the free exercise of religion and moral convictions; allowing for more diverse and inclusive health care and service providers and professionals; improving provider-patient/recipient-beneficiary relationships that facilitate improved quality of care and services; and increased equity, fairness, nondiscrimination, and access to care and services. These benefits for the fair and nondiscriminatory enforcement of the programs covered by this rule are not quantified.

In summary, the Department expects the benefits of clarity will simplify compliance and ensure fair and nondiscriminatory administration of covered programs under this rule. Costs associated with implementing this administrative change include costs for some covered entities who may seek an exemption.

The Department carefully considered several alternatives but rejected them for the reasons explained below. Total undiscounted costs associated with the final rule are estimated to be $18.2 million. The first alternative considered assumes HHS takes no action and makes no change from the 2016 rule; therefore, when compared to the final rule, it results in a total cost savings of $17.4 million or $16.5 million when using the three percent and seven percent discount rates, respectively. HHS concluded that this first alternative would potentially lead to legal challenges, in part over the scope of the Department's authority under 5 U.S.C. 301.

The second alternative considered maintains the text of the 2016 Rule, but also promulgates a regulatory exemption for faith-based organizations as provided under proposed § 75.300(f). This alternative could address the religious exemption issues raised by the 2016 Rule's application to certain faith-based organizations that participate in, or seek to participate in, Department-funded programs or activities. As discussed earlier, total undiscounted costs for the familiarization provision are estimated to be $12.3 million. When compared to the final rule, the second alternative results in a cost savings of $11.7 million or $11.1 million when using the three percent and seven percent discount rates respectively; however, the provisions of the 2016 Rule would be subject to the same legal challenges under 5 U.S.C. 301.

The third alternative considered enumerates the Department's interpretation of applicable nondiscrimination provisions and the programs as well as recipients/subrecipients to which the nondiscrimination provisions would apply, as set forth in § 75.300(e), without including a religious freedom and conscience exemption process. This results in total costs of $12.3 million associated with only including familiarization costs, or a cost savings when compared to the preferred alternative by $5.76 million or $5.4 million using the three percent and seven percent discount rates, respectively. However, given the applicability of Federal religious freedom and conscience laws, a process by which such applicants and recipients can submit requests for assurance of a religious freedom- or conscience-based exemption that are evaluated on a case-by-case basis helps ensure that the Department complies with its legal obligations.

The Department has not quantified the potential benefits associated with the various policy alternatives. Table 6 reports the present value of total costs as well as annualized costs of these policy alternatives, adopting a three percent and seven percent discount rate. Table 7 reports the difference between the total cost of the alternatives compared to the provisions of the final rule, using the same accounting methods and discount rates.

The Department has examined the economic implications of this final rule as required by the Regulatory Flexibility Act, 5 U.S.C. 601-612 (RFA). The RFA requires an agency to describe the impact of a proposed rulemaking on small entities by providing an initial regulatory flexibility analysis unless the agency expects that the Proposed Rule will not have a significant impact on a substantial number of small entities, provides a factual basis for this determination, and proposes to certify the statement. 5 U.S.C. 603(a), 605(b). If an agency must provide a final regulatory flexibility analysis, this analysis must address the consideration of regulatory options that would lessen the economic effect of the rule on small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. HHS generally considers a rule to have a significant impact on a substantial number of small entities if it has at least a three percent impact on revenue on at least five percent of small entities. As discussed, the final rule would:

• Explain applicable Federal statutory nondiscrimination provisions.

• Provide that HHS complies with applicable Supreme Court decisions in administering its grant programs.

Affected small entities include all small entities which may apply for HHS grants; these small entities operate in a wide range of sections involved in the delivery of health and human services. Grant recipients are required to comply with applicable Federal statutory nondiscrimination provisions by operation of such laws and pursuant to 45 CFR 75.300(a); HHS is required to comply with applicable Supreme Court decisions. Thus, there would be no additional economic impact associated with §§ 75.300(c)-(e). The Department anticipates that this rulemaking would primarily serve to provide information to the public. The Department anticipates that this information will allow affected entities to better deploy resources in line with established requirements for HHS grant recipients. As a result, HHS has determined, and the Secretary proposes to certify, that this final rule, will not have a significant impact on the operations of a substantial number of small entities.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments or has Federalism implications. The Department has determined that this rule does not impose such costs or have any Federalism implications.

Pursuant to Executive Order 12250, the Department of Justice has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes that prohibit discrimination in programs and activities that receive Federal financial assistance “in order to identify those which are inadequate, unclear or unnecessarily inconsistent.” Exec. Order 12250 (reprinted at 45 Fed. Reg 72995 (Nov. 5, 1990); 28 CFR 0.51.The Department of Justice has reviewed and approved this final rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR 1320 appendix A.1), the Department has reviewed this rule and has determined that there are no new collections of information contained therein.

For the reasons set forth in the preamble, the Department revises 45 CFR part 75 to read as follows:

This is a summary of the Commission's Fourth Report and Order and Order on Reconsideration (“ Fourth Report and Order” and “ Order on Reconsideration” ), FCC 24-18, in MB Docket No. 98-204, adopted on February 7, 2024, and released on February 22, 2024. The complete text of this document is available electronically via the search function on the FCC's website at https://docs.fcc.gov/public/attachments/FCC-24-18A1.pdf.

People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov (mail to: fcc504@fcc.gov ) or call the FCC's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. By this Fourth Report and Order and Order on Reconsideration, we reinstate the collection of workforce composition data for television and radio broadcasters on FCC Form 395-B as statutorily required by the Communications Act of 1934, as amended (Act). The Commission suspended its requirement that broadcast licensees file Form 395-B, which collects race, ethnicity, and gender information about a broadcaster's employees within specified job categories, more than two decades ago. After a long period of inactivity, the Commission published in the Federal Register on August 31, 2021, at 86 FR 48610, a Further Notice of Proposed Rulemaking(MB Docket No. 98-204, FCC 21-88, 36 FCC Rcd 12055) ( FNPRM ), seeking to refresh the public record regarding the manner in which the Form 395-B data should be collected and maintained. After careful consideration of the record, we reaffirm the Commission's authority to collect this critical information and conclude that broadcasters should resume filing Form 395-B on an annual basis. Section 73.3612 of the Commission's rules provides that “[e]ach licensee or permittee of a commercially or noncommercially operated AM, FM, TV, Class A TV or International Broadcast station with five or more full-time employees shall file an annual employment report with the FCC on or before September 30 of each year on FCC Form 395-B.” We note that the filing requirements of § 73.3612 do not apply to Low Power FM Stations. Given the importance of this workforce information and Congress's expectation that such information would be collected and available, we reinstate this collection in a manner available to the public consistent with the Commission's previous, long-standing method of collecting this data.

2. Our ability to collect and access Form 395-B data is critical because it will allow for analysis and understanding of the broadcast industry workforce, as well as the preparation of reports to Congress about the same. Collection, analysis, and availability of this information will support greater understanding of this important industry. We agree with broadcasters and other stakeholders that workforce diversity is critical to the ability of broadcast stations both to compete with one another and to effectively serve local communities across the country. Without objective and industry-wide data, it is impossible to assess changes, trends, or progress in the industry. Consistent with how these data have been collected historically, we will make broadcasters' Form 395-B filings available to the public because we conclude that doing so will ensure maximum accuracy of the submitted data, is consistent with Congress's goal to maximize the utility of the data an agency collects for the benefit of the public, allows us to produce the most useful reports possible for the benefit of Congress and the public, and allows for third-party testing of the accuracy of our data analyses. Thus, with today's action, we restore the process of giving broadcasters, Congress, and ourselves the data needed to better understand the workforce composition in the broadcast sector. We find further that continuing to collect this information in a transparent manner is consistent with a broader shift towards greater openness regarding diversity, equity, and inclusion across both corporate America and government. Large media companies have begun to make publicly available copies of their EEO-1 forms, which are filed with the Equal Employment and Opportunity Commission, or variations thereof. There is also movement towards more open access to data collected by federal agencies, as shown in the Foundations for Evidence Based Policymaking Act, which directs agencies to account for their data collections and to make such data available in readable formats to support government transparency and evidence-based rulemaking. We also address a pending petition for reconsideration from 2004 regarding our use of Form 395-B data.

3. For more than 50 years, the Commission has administered regulations governing the EEO responsibilities of broadcast licensees. At their core, the Commission's EEO rules prohibit employment discrimination on the basis of race, color, religion, national origin, or sex, and require broadcasters to provide equal employment opportunities. In addition to broadly prohibiting employment discrimination, the Commission's rules also require that all but the smallest of broadcast licensees develop and maintain an EEO program. Specifically, the Commission requires each broadcast station that is part of an employment unit of five or more full-time employees to establish, maintain, and carry out a positive continuing program to ensure equal opportunity and nondiscrimination in employment policies and practices. In addition, the Commission historically collected workforce employment data from broadcasters through the annual submission of Form 395-B.

4. Between 1970 and 1992, the Commission, pursuant to its public interest authority, required broadcasters to submit annual employment reports listing the composition of the broadcasters' workforce in terms of race, ethnicity, and gender. In 1992, after finding that, among other things, “increased numbers of females and minorities in positions of management authority in the cable and broadcast television industries advances the Nation's policy favoring diversity in the expression of views in the electronic media,” Congress amended the Act, affirming the Commission's authority in this area. Specifically, Congress added a new section 334, which required the Commission to maintain its existing EEO regulations and forms as applied to television stations. The forms included the Commission's collection of workforce diversity information from broadcasters on Form 395-B. Submission of Form 395-B, however, was subsequently suspended in 2001 following two decisions by the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) vacating certain aspects of the Commission's EEO rules.

5. With its decision in 1998, the D.C. Circuit in Lutheran Church-Missouri Synod v. FCC ( Lutheran Church ) reversed and remanded a Commission action finding that a broadcast licensee had failed to make adequate efforts to recruit minorities. The court found the Commission's EEO outreach rules, which required comparison of the race and sex of a station's full-time employees with the overall availability of minorities and women in the relevant labor force, to be unconstitutional. Specifically, the court concluded that the use of broadcaster employee data to assess EEO compliance in the context of a license renewal pressured broadcasters to engage in race-conscious hiring in violation of the equal protection component of the Due Process Clause of the Fifth Amendment of the Constitution. The court applied strict constitutional scrutiny in reaching its decision, finding that standard of review was applicable to racial classifications imposed by the federal government. And pursuant to that standard, it determined that the Commission's stated purpose of furthering programming diversity was not compelling, nor were its EEO rules narrowly tailored to further that interest. The court made clear, however, that “[i]f the regulations merely required stations to implement racially neutral recruiting and hiring programs, the equal protection guarantee would not be implicated.” In reaching its decision, the court referenced the Form 395-B only tangentially in its analysis.

6. On remand, in the First Report and Order (MM Docket Nos. 98-204, 96-16, FCC 00-20, 15 FCC Rcd 2329) ( First Report and Order ) the Commission crafted new EEO rules requiring that broadcast licensees undertake an outreach program to foster equal employment opportunities in the broadcasting industry. The Commission also reinstated the requirement that broadcasters annually file employment data on Form 395-B with the Commission, which it had suspended after Lutheran Church. In adopting these revised rules and reinstating the information collection, the Commission vowed to no longer use workforce composition data when reviewing license renewal applications or assessing compliance with EEO program requirements. Rather, the Commission stated in the 2000 Reconsideration Order (MM Docket Nos. 98-204, 96-16, FCC 00-338, 15 FCC Rcd 22548) ( 2000 Reconsideration Order ) that going forward it would only use this information “to monitor industry employment trends and report to Congress,” and not to assess any aspect of the individual broadcast licensee's compliance with the Equal Employment Opportunity requirements of § 73.2080 of the Commission's rules. The Commission codified that position in the governing regulations contained in § 73.3612.

7. Following adoption of the new EEO outreach rules, which offered licensees two “Options” for establishing an EEO program, several state broadcaster associations challenged the revised EEO rules. Upon review, the D.C. Circuit in MD/DC/DE Broadcasters Associations v. FCC ( MD/DC/DE Broadcasters ) found that one element of the new rule, namely Option B, which allowed broadcasters to design their own outreach programs but required reporting of the race and sex of each applicant, was constitutionally invalid. The court determined that Option B violated the equal protection component of the Due Process Clause of the Fifth Amendment because, by examining the number of applicants and investigating any broadcasters with “few or no” minority applicants, the Commission “pressured” broadcasters to focus resources on recruiting minorities. Because the court found that Option B was not severable from Option A of the rule, it vacated the entire EEO outreach rule.

8. Although the D.C. Circuit in MD/DC/DE Broadcasters vacated and remanded the Commission's revised EEO outreach rules, it did not rule on the validity or constitutionality of Form 395-B. Nor did the court specifically identify Form 395-B or the collection of workforce diversity data as a core part of the rule at issue in its analysis. The court's only mention of the collection of workforce data was in the Background section of its decision. Thus, notably, in neither Lutheran Church nor MD/DC/DE Broadcasters did the D.C. Circuit find the collection of workforce composition data itself to be invalid on constitutional or any other grounds. After the decision, the Commission suspended its EEO rules in 2001, including Form 395-B, in order to analyze the effects of MD/DC/DE Broadcasters on the Commission's rules.

9. On November 20, 2002, the Commission released its Second Report and Order and Third NPRM (MM Docket No. 98-204, FCC 02-303, 17 FCC Rcd 24018) ( Second Report and Order and Third NPRM ), establishing new race-neutral EEO rules, eliminating the Option B rule previously invalidated by the court. The Commission's new EEO rules, which remain in place today, were divorced from any data concerning the composition of a broadcaster's workforce or applicant pool. The Commission explained that the annual employment report is “unrelated to the implementation and enforcement of our EEO program” and “data concerning the entity's workforce is no longer pertinent to the administration of our EEO outreach requirements.” The Commission, however, deferred action on issues relating to the annual employment report form, in part because it needed to incorporate new standards for classifying data on race and ethnicity adopted by the Office of Management and Budget (OMB) in 1997. The Commission's decision in January 2001 to suspend the filing of Form 395-B remained in effect at the time of the Second Report and Order and Third NPRM.

10. On June 4, 2004, the Commission released its Third Report and Order and Fourth NPRM (MM Docket No. 98-204, FCC 04-103, 19 FCC Rcd 9973) ( Third Report and Order and Fourth NPRM ) readopting the requirement that broadcasters file Form 395-B. In addition, the Commission readopted the Note to § 73.3612 of its rules that it had previously adopted in 2000, stating that the data collected would be used exclusively for the purpose of compiling industry employment trends and making reports to Congress, and not to assess any aspect of a broadcaster's compliance with the EEO rules. The Commission stated that it did not “believe that the filing of annual employment reports will unconstitutionally pressure entities to adopt racial or gender preferences in hiring,” but it acknowledged the concerns raised by broadcasters and sought comment on whether data reported on the Form 395-B should be kept confidential. Accordingly, while the Commission acted at that time to adopt revised regulations regarding the filing of Form 395-B and updated the form, the requirement that broadcasters once again submit the form to the Commission remained suspended until the agency further explored the issue of whether employment data could, or should, remain confidential. Although the requirement to file the forms on an annual basis remained suspended after 2004, the Commission regularly sought approval from OMB for the collection of information on Form 395-B. OMB most recently approved the information collection for Form 395-B through August 31, 2026, pending the Commission's resolution of whether the data will be confidential.

11. Given the passage of time since the Third Report and Order and Fourth NPRM, the Commission released a FNPRM on July 26, 2021, seeking to refresh the 2004 record with regard to Form 395-B. The FNPRM asked for additional input on relevant developments in the law relating to public disclosure of employment data, as well as the practical and technical limitations associated with implementing a system that could afford varying degrees of station-level anonymity. Interested parties filed comments, including public interest organizations and representatives of the broadcast industry. Their arguments range from asking that Form 395-B data be made publicly available to contending that reinstating the form would amount to an unconstitutional violation of race-based protections. Many of these assertions largely reiterate arguments addressed in the Commission's earlier orders, including whether the filing requirement constitutes unconstitutional pressure, the ramifications of the D.C. Circuit rulings, the directives of section 334, and the potential substitutability of the Equal Employment Opportunity Commission's (EEOC) EEO-1 form.

12. Consistent with the Commission's authority pursuant to section 334, as well as the public interest provisions of the Act, we reinstate the collection of FCC Form 395-B. In doing so, we affirm the Commission's prior determination that the earlier court decisions in no way invalidated our authority to collect this data, which remains critical for analyzing industry trends and making reports to Congress. Further, we find that reinstatement of this information collection on a publicly available basis is consistent with the protections afforded to broadcasters by the Constitution and relevant case law, as detailed further below. The clear separation of this information collection from the Commission's long-standing EEO program requirements mitigates any concerns that might be raised by the broadcasters as to the collection of this workforce data. In addition, the Commission's unequivocal statement that it will not use station-specific employment data for the purpose of assessing a licensee's compliance with the EEO regulations and the codification of that same stricture further underscore the dissociation between the EEO requirements and the form's data.

13. The Commission has a public interest in collecting Form 395-B in order to report on and analyze employment trends in the broadcast sector and also to compare trends across other sectors regulated by the Commission. In taking this action today, we note that Congress has long authorized the Commission to collect this data and that the Commission is uniquely positioned to undertake such a collection. While commenters have evinced an interest in improving the level of diversity in the broadcasting industry workforce, the lack of industry-wide employment data over the last 22 years makes it difficult to measure the extent of any such progress. While we do not anticipate that this more than two-decade long gap in data can ever be filled, with the reinstatement of this information collection the Commission can ensure that the lack of data persists no further, thereby providing it, the industry, Congress, and the public with a better understanding of, or insight into, the full scope of the broadcast industry workforce. Accordingly, in this Order, we reinstate collection of Form 395-B in the manner described below and require the form to be submitted in an electronic format. Once submitted, the form will be accessible to the public via the Commission's website.

14. Reinstating the collection of the Form 395-B data in a publicly available format, as they were collected prior to 2001, remains the best approach for achieving our ultimate goal of preparing meaningful and accurate analyses of workforce trends in the broadcast industry. First, public disclosure will increase the likelihood that erroneous data will be discovered and corrected, and it will incentivize stations to file accurate data to avoid third-party claims that submitted data is incorrect. Whether intentionally or inadvertently, a station might misreport its data or misidentify the racial, ethnic, or gender group for particular employees. Individuals or entities with a connection to the station will be in a position to correct such errors if the data are made public. Second, making the Form 395-B data publicly available is consistent with Congress's goal to maximize the utility of the data an agency collects for the benefit of the public. Third, making the data public bolsters our ability to conduct analyses of trends across different communications sectors, within individual sectors, and by region or market, without being unnecessarily hampered by concerns about inadvertent disclosures of identifiable information. We believe the utility of our reports is greatly enhanced by our ability to “slice, dice, and display” granular data about the broadcast sector. Our ability to produce the most meaningful reports possible for Congress rests, in turn, on the ability to produce the most granular reports possible ( e.g., the number of employees in a particular demographic group in a specific job category among a certain class of stations [AM, FM, TV, etc.] in a specific geographic area). If we were required, however, to keep confidential the underlying station-specific data, we would feel compelled to report our findings at a more general, and thus less useful, level to avoid the risk of inadvertently facilitating any reverse engineering of station-specific information. This problem would be especially acute in smaller markets, where the identity of stations could be discerned more easily.

15. In addition, allowing public access to datasets allows others to review the accuracy of an agency's data analyses and to question its methods for data collection with the benefit of actual datasets. We find this level of transparency to be consistent with the overall trend toward making government data more accessible, and we note that many government agencies collect and publish demographic data as part of their analysis of markets, trends, and other factors. The FNPRM sought comment on the logistics associated with collecting and maintaining the Form 395-B data completely anonymously, or where station specific information is available to the Commission, but not to the public. Only one commenter addressed this issue by stating that the Commission's Licensing and Management System (LMS) enables the shielding of certain exhibits attached forms. Irrespective of whether LMS can shield station-attributable data, we conclude for the reasons stated above that maintaining this data in a publicly available format is the most appropriate policy.

16. While broadcasters have expressed concerns with how the form's data might be used if publicly disclosed, such concerns have been addressed by the Commission's repeated statements on the appropriate use of such data and its amendment of the rules to prohibit use of the data to assess a broadcaster's compliance with Commission EEO rules. Notwithstanding the Commission's statements and actions, broadcasters were troubled in 2004 by comments made at that time positing that public disclosure of employment data would enable “citizens . . . to work closely with their local broadcaster to ensure that stations are meeting their needs and to resolve any problems with the companies in their communities.” Broadcasters pointed to those comments as evidence that third parties would misuse Form 395-B data to pressure stations to engage in preferential hiring practices. As an initial matter, as the Commission has committed to previously and we reiterate here again, we will quickly and summarily dismiss any petition, complaint, or other filing submitted by a third party to the Commission based on Form 395-B employment data. We also note that any attempt by a non-governmental third party to use the publicly available Form 395-B data to pressure stations in a non-governmental forum would not implicate any constitutional rights of the station. In any event, we find such concerns to be speculative. Despite the public availability of Form 395-B data for more than 20 years prior to 2001, the record contains no evidence of use of such data in this manner. Nonetheless, we encourage broadcasters to bring to the Commission's attention any evidence that a third party has misused or attempted to misuse Form 395-B employment data. If evidence of such misuse of the data emerges, the Commission can reconsider its approach to collection of the Form 395-B data. Based on the record before us, we find no basis to conclude that the demographic data on a station's annual Form 395-B filing would lead to undue public pressure. We find broadcasters' concerns with the public collection and availability of this workforce data to be overstated, outweighed by the promotion of data accuracy and other benefits of public disclosure noted above, and therefore not an impediment to our reinstatement of this collection.

17. Consistent with the limitations placed on our use of the Form 395-B data, we reject the commenter recommendation that the Enforcement Bureau use the data as evidence when investigating a discrimination claim against a station. We find that such use does not comport with the Commission's public interest goal behind collection of this data. The Commission has stated previously in the 2000 Reconsideration Order, and we reiterate here, that “we will summarily dismiss any petition filed by a third party based on Form 395-B employment data” and “will not use this data as a basis for conducting audits or inquiries.”

18. Some commenters have raised a concern that the Commission could decide at a later date to waive its rule regarding how the Form 395-B data can be used. We believe that the combination of the Commission's consistent position over two decades about how this data may be used, the established principle that “an agency is bound by its own regulations,” our rejection of a proposed contrary use, and our determination in the attached Order on Reconsideration should assuage concerns on this point. We will not further delay reinstatement of the form based on unfounded conjecture about what the Commission may or may not do in the future.

19. Further, we reject the argument that we should retain Form 395-B data on a confidential basis given the EEOC's confidential treatment of similar employment data collected on its EEO-1 form. Unlike the Commission, the EEOC's authorizing statute specifically limits its ability to make its collected data publicly available. In the Civil Rights Act of 1964, which created the EEOC, Congress included a provision making it unlawful for an EEOC officer or employee to disclose such information. However, when Congress adopted section 334 in 1984, despite the fact that in the preceding 20 years Congress had not lifted the prohibition on public disclosure by the EEOC, Congress imposed no such limitation on publishing the broadcast workforce data collected by the Commission. Indeed, when Congress adopted section 334 in 1984, the Commission had been collecting broadcast workforce data and making it available publicly for decades, a practice Congress endorsed in passing section 334 without any limitation on public disclosure. In addition, the manner in which the two agencies may use their data differs significantly. The EEOC may use its EEO-1 data for investigatory and enforcement purposes, but by contrast, we will not use Form 395-B data for enforcement purposes.

20. Some commenters assert that the Commission should rely on other data sources, including the EEO-1 form, in lieu of Form 395-B. Yet, section 334(a) of the Act states that “except as specifically provided in this section, the Commission shall not revise . . . the forms used by [television broadcast station] licensees and permittees to report pertinent employment data to the Commission.” Pursuant to section 334 of the Act, we may change the form's provisions only “to make nonsubstantive technical or clerical revisions . . . as necessary to reflect changes in technology, terminology, or Commission organization.” As we discuss further below, the alternative data sources suggested by commenters would both violate the section 334 prohibition on changes to the form and impede our general public interest goal of providing useful reports about employment in the broadcast sector.

21. In particular, we continue to reject the proposal, initially made nearly two decades ago and dismissed by the Commission at that time as being inadequate, to rely on the EEOC's EEO-1 form in lieu of Form 395-B. We reaffirm the Commission's prior conclusion that the EEO-1 form is not an appropriate substitute for Form 395-B, as the two forms differ greatly in the data they collect. First, unlike the EEO-1, Form 395-B distinguishes between full and part-time employees, consistent with our other employment data collections, providing a more comprehensive picture of the broadcast industry workforce. Second, and more importantly, reliance on the EEO-1 form would significantly reduce the amount of employment data available to the Commission as the vast majority of broadcast licensees do not file an EEO-1 form. While the Form 395-B collection applies to all broadcast station employment units with five or more full-time employees, the submission of an EEO-1 form is required only for entities with 100 or more employees. In 2004, in response to the same proposal to substitute the EEO-1 form for Form 395-B, the Commission calculated that the EEOC data “would not include 6,592 employment units (79%) out of a total of 8,395 units and would exclude 136,993 full-time employees (84%) out of the 163,868 full-time employees in broadcasting working at employment units employing five or more full-time employees.” Consequently, we determine that replacing Form 395-B either partly or wholly with the EEO-1 form does not constitute a permitted non-substantive modification of the form itself under section 334. Nor would such a substitution meet our public interest goal of providing a comprehensive report of employment in the broadcast sector and comparing employment trends across our regulatees. For the reasons provided above, we conclude that the EEO-1 form is an unsatisfactory replacement for Form 395-B. So as to reduce filing burdens, we also reaffirm the procedural practice of permitting broadcasters to file only one Form 395-B for all commonly-owned stations in the same market that share at least one employee.

22. Similarly, we find to be inapposite the suggestion to use the Radio Television Digital News Association (RTDNA) diversity survey as a substitute for the Form 395-B collection. As an initial matter, the RTDNA data pertains only to TV and radio newsrooms and not to the full spectrum of the broadcast industry workforce covered by Form 395-B. Moreover, the RTDNA survey ultimately is based on valid responses from those broadcasters that choose to participate in the survey, and, hence, the pool of participants is essentially a self-selected one. By contrast, all broadcast station employment units with five or more full-time employees must file the Form 395-B. Consequently, substituting Form 395-B with the RTDNA survey would be inconsistent with the section 334 prohibition on changes and would provide a less complete view of the broadcast sector.

23. Since we have determined that the benefits of making these reports public outweigh the speculative harm from doing so in light of the clear policy of the Commission about how they may and may not be used, we see no reason to afford them confidentiality. We note, however, that there is a question whether they would in fact warrant confidential treatment under the Freedom of Information Act (FOIA) or whether the Commission could satisfy the requirements of the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA). The FNPRM sought comment on the potential applicability of the CIPSEA or the FOIA exemptions to the Form 395-B data collection. As discussed below, the record and our own analysis demonstrate that CIPSEA is ill-suited for an agency such as the Commission. Similarly, the Form 395-B data does not fit neatly within FOIA Exemption 4, and in any event Exemption 4 does not prevent the Commission from disclosing information after an appropriate balancing of the interests. Accordingly, for the reasons discussed below, we find neither CIPSEA nor FOIA affords an appropriate basis to collect Form 395-B information in a confidential manner.

24. The Commission sought comment on CIPSEA in 2004 and again in 2021, in particular, seeking to explore whether the confidentiality afforded by CIPSEA to government-collected data could apply to the Form 395-B data. Commenters responding in 2004 disagreed regarding CIPSEA's applicability. Some commenters argued that CIPSEA authorizes the Commission to collect Form 395-B filings on a confidential basis and that doing so would be good public policy. Other commenters contended that neither CIPSEA nor the Communications Act permits the use of CIPSEA for Form 395-B filings. They further argued that confidential treatment would not serve CIPSEA's purpose of promoting public confidence in an agency's pledge of confidentiality, given that the Commission never made such a pledge with respect to Form 395-B, nor would it serve important policy objectives, such as ensuring the accuracy of Form 395-B data. When the Commission initially sought comment in 2004, the CIPSEA statute was barely two years old and relatively untested. Given the passage of time and the desire to obtain as complete a record as possible, the Commission sought comment anew on CIPSEA in 2021. The FNPRM sought input regarding the potential avenues under CIPSEA to collect and maintain data on a confidential basis, but the two comments in 2021 addressing CIPSEA provide insufficient discussion or analysis. As discussed further below, we find that CIPSEA is not an appropriate fit for the Commission's Form 395-B data collection.

25. A commenter suggests that the Commission could utilize any one of CIPSEA's three approaches for confidential collection and retention of the Form 395-B data: (1) have the Commission's Office of Economics and Analytics (OEA) seek recognition as a “Federal statistical agency or unit” pursuant to CIPSEA and have OEA alone collect and analyze the Form 395-B data, which would then be released in conformance with the CIPSEA confidentiality protections; (2) have the Commission collect this data independently as a “nonstatistical agency” or “unit;” or (3) as a nonstatistical agency or unit, enter into an agreement with an already recognized “Federal statistical agency or unit” and have that agency collect the data on behalf of the Commission. While the commenter asserts that these approaches are “reasonable mechanism[s]” for safeguarding Form 395-B data, it does not specify how its proposals could be satisfied under the requirements established in OMB's 2007 Guidance. For example, the commenter does not discuss how the Commission, or even a subpart of the Commission, could qualify as a “statistical agency or unit” given that OMB accords that designation only when the predominant activities of the agency or unit are the use of information for statistical purposes. The Commission plainly does not fit that description. Furthermore, the commenter does not address the costs and burdens involved with applying for and obtaining from OMB the designation needed for CIPSEA protection. Nor does it address the cost and burdens associated with adherence to CIPSEA and whether the benefit of retaining the Form 395-B data in conformance with CIPSEA outweighs these costs and burdens. Below, we address these points.

26. Contrary to the commenter's suggestion, our detailed review of CIPSEA, OMB's 2007 Guidance, and examples of other agencies that have obtained designation as a “statistical agency or unit” demonstrates that neither the Commission nor OEA would qualify for such a designation. An agency, or agency unit, seeking such a designation must demonstrate to the OMB Chief Statistician that its activities are “ predominantly the collection, compilation, processing, or analysis of information for statistical purposes.” Although OEA conducts significant data analyses, its activities do not meet the “predominantly” standard laid out by OMB. Rather, OEA's regular work also includes administrative, regulatory, and adjudicative functions, as well as the administration of the Commission's various spectrum auctions. For these reasons, we determine OEA could not satisfy the requirements for “statistical agencies or units” and, therefore, this approach is not a viable option.

27. The commenter next suggests that the Commission could collect the Form 395-B data as a “nonstatistical agency” pursuant to CIPSEA, provided it complied with CIPSEA's restriction preventing nonstatistical agencies from using “agents,” including contractors, to collect or use the protected information, and if it ensured that only internal agency staff had access to the protected information. The commenter identifies no agency that has successfully invoked this provision of CIPSEA in the more than 20 years since the passage of the act. Nor have we been able to identify one. As discussed in the FNPRM, the Commission relies extensively on information technology (IT) contractors to develop and maintain electronic filing systems, assist filers with questions, and compile reports and other information based on data in Commission forms. The Commission has outsourced these tasks for decades consistent with a broader federal government initiative to ensure that those jobs that can be conducted in a more economically efficient manner by the private sector through competitive bidding. Moreover, the Commission currently relies on multiple IT contracts to maintain and operate its systems. Therefore, it would be extremely complex and burdensome from an administrative perspective to bring functions in-house solely for one form. For these reasons, we find that collecting Form 395-B data as a nonstatistical agency under CIPSEA is not a viable option.

28. We similarly find that the final approach under CIPSEA, namely that the Commission, acting as a “nonstatistical agency,” partner with a “statistical agency,” which would collect the Form 395-B data on the Commission's behalf, is not a realistic—or even workable—one. Our detailed review of CIPSEA and OMB's 2007 Guidance shows that this is a complex process involving various logistical steps, as well as significant additional burdens and costs. Partnering with a “statistical agency” involves identifying a possible partner agency, engaging in negotiations with that agency to establish an agreement for the collection of the data, negotiating and drafting an agreement stipulating the terms associated with collection, processing, and sharing of the Form 395-B data. Any such agreement would have to comport with OMB's requirements and might also necessitate OMB review. The Commission would also have to compensate any such partner agency for the costs of collecting and storing the data, educate the partner agency about the broadcast sector, and ensure that the information is collected in an appropriate manner. Under this approach, the Commission also would have to designate specific staff who would have permission to access the data and potentially restrict access to just those individuals. Moreover, broadcasters would have the additional burden of familiarizing themselves with a different agency's document filing system. As OMB has not yet issued guidance on such a partnership approach, however, the potential logistical problems going forward are not even fully known. In addition, pursuing the approach of partnering with a “statistical agency” would lead to further delay in reinstituting this collection, which has already lagged for far too long, while also unduly increasing the complexity and cost of the collection. Going forward, such an approach would lend complexity to the process and potentially hamper the Commission's ability to review, analyze, and report on the underlying data on an ongoing basis. Consequently, we conclude that the significant time, complexity, and cost associated with formulating a partnership with a statistical agency outweigh any speculative harm that might arise from public availability of this data.

29. The FNPRM sought comment on whether any Freedom of Information Act (FOIA) exemptions might apply to our collection of Form 395-B data. Commenters assert that Form 395-B data reported by broadcasters should not be publicly disclosed because doing so would reveal trade secrets and commercial information to competitors. While FOIA Exemption 4 protects trade secrets and confidential commercial information from mandatory public disclosure by the Commission, its applicability to the information collected on Form 395-B is questionable. Further, even if we were to find FOIA Exemption 4 applicable, the Commission is not compelled to keep data covered by Exemption 4 confidential. The Commission has authority to make records that fall within Exemption 4 public if it determines that the public interest in disclosure outweighs the private interests in preserving the data's confidentiality.

30. FOIA Exemption 4 protects from mandatory disclosure information that is “obtained from a person,” as we recognize would be the case here, and that is both (1) “commercial or financial” in character and (2) “privileged or confidential.” Commenters assert that Form 395-B demographic data are “commercial information.” The case law, however, is not definitive on this question. Courts have sometimes defined commercial information broadly to include information submitted to an agency in which the submitter has a commercial interest, or to encompass information that has intrinsic commercial value, the disclosure of which would jeopardize a submitter's commercial interests or ongoing operations. Those definitions might arguably apply to the demographic information of employees. However, in a recent case very closely on point, Center for Investigative Reporting v. U.S. Department of Labor ( Center for Investigative Reporting v. DOL ), the U.S. District Court for the Northern District of California held that the federal government failed to prove that EEO-1 Consolidated Report (Type 2) employee demographic data were “commercial.” Similar to Form 395-B data, the EEO-1 Type 2 Reports do not include “salary information, sales figures, departmental staffing levels, or other identifying information.” Although the Type 2 Reports “require companies [that do business at two or more physical addresses] to report the total number of employees across all their establishments,” whereas the Form 395-B breaks down this information by station employment units, neither form links job categories to specific departments; rather, both require information aggregated by type of job across all departments. Furthermore, the EEO-1 reports utilize the same job title, gender, and ethnicity categories as the information to be provided in Form 395-B. Given these similarities between the EEO-1 reports and information to be provided in Form 395-B, Center for Investigative Reporting suggests that the Form 395-B data is at least arguably not correctly considered to involve commercial information.

31. It is likewise not entirely clear whether the data at issue here would be properly considered “privileged or confidential.” Information is confidential within the meaning of Exemption 4 “whenever it is customarily kept private, or at least closely held, by the person imparting it.” What matters is “how [a] particular party customarily treats the information, not how the industry as a whole treats [it].” Here, a commenter acknowledges that “many employers choose to publicly disclose workforce demographic data” in “a variety of forms.” And although the commenter distinguishes between Form 395-B data and the EEO-1 data that companies often elect to disclose, we see similarities between the two data sets, as discussed above.

32. In addition, as discussed further below, we note that commenters have failed to show that competitive harm would result from the collection and public release of the information provided in Form 395-B. While the Supreme Court held in Food Marketing Institute that a showing of competitive harm is not required to protect information from disclosure under Exemption 4, some courts have since declined to allow agencies to withhold information covered by Exemption 4 without showing an articulable harm from disclosure. These decisions rest on the theory that under the FOIA Improvement Act of 2016—which did not apply to the Food Marketing Institute case because it had not yet become effective at the time that case was filed—agencies must produce information otherwise covered by a FOIA exemption unless it is reasonably foreseeable that disclosure would harm an interest protected by the exemption (or disclosure is prohibited by law). However, the FOIA Improvement Act has alternatively been interpreted in the Exemption 4 context to require no demonstration of harm beyond the loss of confidentiality itself, and therefore the relevance of competitive harm to the Exemption 4 analysis remains an unsettled issue.

33. Ultimately, however, we need not decide whether Exemption 4 covers the information collected on Form 395-B or assess the relevance of the FOIA Improvement Act. The Commission has well-established authority under section 4(j) of the Act to publicly disclose even trade secrets or confidential business information if, after balancing the public and private interests at stake, we determine that it is in the public interest to do so.

34. In assessing the respective interests in the disclosure or non-disclosure of Form 395-B data, we determine that the public interest in disclosing Form 395-B data outweighs broadcasters' claims that such disclosure might cause unspecified harm. As outlined above, there are significant public interest benefits from public disclosure of Form 395-B data. Public disclosure of Form 395-B data promotes a more accurate collection and recordation process. It increases the likelihood that incomplete or inaccurate filings will be discovered and corrected, and it will incentivize stations to file accurate data to avoid third-party claims that submitted data are incorrect. It is also consistent with Congress's goal to maximize the utility of the data an agency collects for the benefit of the public. Public disclosure also allows us to produce the most granular reports possible for the benefit of Congress and the public, without being unnecessarily hampered by concerns about inadvertent disclosures of identifiable information. And public disclosure allows others to review the accuracy of our data analyses and to question our methods for data collection with the benefit of actual datasets.

35. In contrast to these significant public benefits, commenters have failed to demonstrate that availability of the Form 395-B data would cause meaningful competitive harm. For example, a commenter asserts that if Form 395-B data were disclosed, a broadcaster's competitors could exploit such information to gain competitive insights into the broadcaster's business practices. Nothing in the record, however, realistically demonstrates how the public release of Form 395-B data might afford a competitor tangible insights into another broadcaster's business practices that would lead to competitive harm. Commenters have not provided any actual instances of harm related to the Commission's previous collection and public disclosure of demographic data, but rather largely project a speculative, worst-case scenario. A commenter posits that competitors would be able to draw more detailed insights by comparing published data over a stretch of years; however, we fail to understand how any such result would have a negative commercial impact on broadcasters. Moreover, the fact that a number of broadcasters have begun to disclose workforce demographic data, albeit not at the level of detail as would be reported on Form 395-B, also calls into question the extent of the competitive harm that would result if that information were to be publicly released. Further, guided in part by the court's analysis in Center for Investigative Reporting v. United States Department of Labor, we remain unconvinced that knowing the number of employees assigned to a particular job title or category in a company without knowing other details—for example, the duties of the employees, the structure of the company, salary information—can provide any significant information to a competitor that results in reasonably foreseeable or substantial competitive harm. As noted by various commenters in the instant proceeding, Form 395-B uses the same reporting methodology in terms of job categories as the EEO-1, rather than reporting “demographic information by division, department, or `segment.' ”

36. We conclude that the public benefits of releasing the information contained in Form 395-B are significant, while the harms would be slight. Thus, balancing the public interests in disclosure against the private interests at stake here, we find that there are strong public interests in favor of disclosure and that, accordingly, section 4(j) authorizes the Commission to publicly disclose Form 395-B data.

37. Timing of Form Submission. As directed by § 73.3612 of the Commission's rules, broadcasters will be required to file Form 395-B annually on or before September 30 of each year, after the Order becomes effective. Authority is delegated to the Media Bureau to announce and provide filing instructions before the first window opens. The Commission established the September 30 deadline to align with the deadline for EEO-1 filings to enable licensees and permittees that also file similar data with the EEOC to conserve resources by using the same pay period record information for both filings. Broadcasters may report employment figures from any payroll period in July, August, or September of the relevant year, but that same payroll period must be used in each subsequent year's report by the licensee. Consistent with previous practice, the Form 395-B will be due on or before September 30 of each calendar year. To provide broadcasters adequate notice regarding the details of the electronic filing process, the Media Bureau will issue a Public Notice with instructions about how to submit the filings, prior to the first filing after the Order becomes effective. This Public Notice will provide broadcasters ample time to put into place whatever data collection processes they require, including, for example, the development of employee surveys and instructions for employees regarding which job classification to report. It also will afford the Commission time to create and test an electronic version of Form 395-B.

38. Identification of Non-Binary Gender Categories. Finally, in reinstating the collection of Form 395-B, some commenters urge us to incorporate into the form a mechanism that will enable identification of non-binary gender categories. While the EEOC has incorporated a comment box on the EEO-1 form allowing for submission of gender non-binary information, both the EEOC and the Commission traditionally track the definitions and standards on race, ethnicity and gender set forth by OMB and used widely by the federal government. To date, OMB has not prescribed conclusive classifications to capture non-binary gender data. Federal guidance, however, recognizes the “need to be flexible and adapt over time” in developing measures to collect such data. Consistent with that guidance and our record, we believe it is appropriate that the Form 395-B include a mechanism to provide further specificity about broadcaster employees' gender identities.

39. We find that such an update fits within the latitude granted to the Commission pursuant to section 334(c) of the Act to revise the forms “to reflect changes in . . . terminology.” We also find that the FNPRM provided sufficient public notice and opportunity for comment to allow us to incorporate this change to the form. The FNPRM encouraged commenters “to provide any new, innovative, and different suggestions for collecting and handling employment information on Form 395-B” and asked if there were “any other issues or developments that [the Commission] should consider.” We conclude that the suggestion to include within the Form 395-B a mechanism to account for those who identify as gender non-binary is a logical outgrowth from the FNPRM's requests for comment. Accordingly, and after receiving only support for and no opposition to the idea, we will include such a mechanism in the reinstituted Form 395-B. We delegate to the Media Bureau the authority to implement this change to the Form.

40. Reinstatement of the Form 395-B data collection in a publicly available manner is wholly consistent with the equal protection guarantee contained in the Fifth Amendment of the Constitution. As discussed below, collection of workforce data from broadcast licensees on Form 395-B is race- and gender-neutral, and no race- or gender-based government action flows from collection of the data or its public availability. Accordingly, collection and publication of Form 395-B data need only be rationally related to a legitimate governmental interest to pass constitutional muster. Since the Commission has a legitimate public interest in collecting Form 395-B data and doing so on a transparent basis is rationally related to this interest, reinstatement of Form 395-B as we propose is constitutionally permissible. Finally, we find that the limitations the Commission has placed on its own use of the data obviate the concerns raised in the record about the potential for undue pressure being placed on, or “raised eyebrow” regulation of, broadcasters.

41. As the court in Lutheran Church acknowledged, the Constitution's equal protection guarantee is not implicated if the regulation at issue is neutral with respect to protected categories. This standard is satisfied here, because both on its face and in application, the collection of workforce data from broadcast licensees on Form 395-B is race- and gender-neutral. Regardless of the demographic makeup of a particular broadcast station employment unit, all units with five or more full-time employees are required to file their workforce data with the Commission. At no point does the Commission use race and gender categories to direct units on whether they must file the form; the number of employees within a given unit is the sole criterion. Further reflecting the neutrality of the application of the form, all units required to file with the Commission use an identical Form 395-B to report their respective demographic and job category data. By using employment size as the exclusive factor to direct units to file broadcast workforce data, the completion of the form in this regard is a neutral activity, “devoid of ultimate preferences” for hiring on the basis of race or gender.

42. Furthermore, there is no race- or gender-based government action that flows from collection of the data or its public availability. Unlike the collection of this data 20 years ago, there is no connection between the Form 395-B collection at issue here and the EEO program requirements applicable to broadcasters. The court's finding in Lutheran Church that the Commission's rules impermissibly pressured broadcasters to engage in race-conscious hiring decisions stemmed from the set of criteria that the Commission had created in 1980 to determine whether its review of a station's license renewal application should include a closer examination of the station's EEO program. Under those 1980 screening guidelines, the Commission would review the adequacy of a station's EEO program if minorities and/or women employed by the station were underrepresented as compared to the available workforce. That requirement to compare the racial composition of a station's workforce with that of the local population, and not the requirement to report employment data that we reinstate today, was the trigger for the court's strict scrutiny in that case.

43. While the Commission revised the EEO program requirements after the Lutheran Church ruling, the use of race, ethnicity, and gender information (albeit not Form 395-B data) was still linked to the Commission's EEO program. The new EEO program allowed stations to choose between two options for their recruiting programs. In MD/DC/DE Broadcasters, the D.C. Circuit struck down the Commission's revised, two-option EEO program because it found that broadcasters proceeding under Option B of the program were pressured to engage in race-conscious recruiting practices, given that Option B required annual reporting of race, ethnicity, and gender information for each job applicant. The court found that such pressure would lead to outreach programs targeted at minority groups, to the potential disadvantage of non-minority groups, and thus constituted a racial classification that triggered strict scrutiny. Following the court's decision, the Commission suspended both its EEO outreach requirements and its Form 395-B filing requirement.

44. When the Commission later adopted new EEO program requirements in the Second Report and Order and Third NPRM, it deferred action on requiring the collection of workforce data, and the Form 395-B data collection has been on hold ever since. Thus, these EEO program requirements have existed independently of Form 395-B for the past 20 years. That the Commission's EEO program continued to operate even as the Form 395-B collection was held in abeyance highlights the separation of these two requirements. And we reiterate that going forward, these two requirements—the filing of annual workforce data and compliance with an EEO program—will continue to be divorced from one another. As the Commission has recognized consistently for more than 20 years, the Lutheran Church and MD/DC/DE Broadcasters decisions do not prohibit the collection of employment data for the purpose of analyzing industry trends. The Commission concluded more than two decades ago in the 2000 Reconsideration Order that collecting employment data solely for monitoring purposes would not violate Lutheran Church, and we affirm that conclusion. The D.C. Circuit never took issue with the Commission's collection of station-specific employment data from broadcasters and making this data publicly available. We continue to find the collection of this information to be consistent with the Constitution and the public interest. The Commission has stated unequivocally and emphatically that it will not use the Form 395-B for assessing a licensee's compliance with EEO program requirements. The agency even went so far as to codify that policy in the Code of Federal Regulations, amending § 73.3612 of its rules in 2004 to prohibit explicitly the use of the Form 395-B data for EEO compliance purposes. We reaffirm the Commission's previous determination that workforce data collected on Form 395-B will be used only for purposes of analyzing industry trends and reports by the Commission, and that the use of such data to assess an individual broadcast licensee's compliance with our EEO requirements will be prohibited. Moreover, in the attached Order on Reconsideration, we grant a previous request filed by the State Associations asking that we modify the prohibition on our use of the form's data to explicitly bar the Commission from employing this data to assess compliance with the nondiscrimination requirement contained in § 73.2080 of our rules. Our granting of the State Associations' request further demonstrates our commitment to use this data only for industry analysis and reporting.

45. We disagree with commenters' assertion that collection or publication of the data on a licensee- or station-attributable basis will still somehow result in unconstitutional “ sub silentio” pressures or “raised-eyebrow” regulation. We have stated repeatedly and unequivocally, and codified the proposition in our rules, that we will not use Form 395-B data for any purpose other than for analyzing and reporting trends in the broadcast industry. Nonetheless, commenters attempt to employ dicta from the D.C. Circuit in MD/DC/DE Broadcasters and Lutheran Church about implicit pressures by claiming that, despite the limitations the Commission has placed on its own use of the data, third parties may use the data to place improper pressure on a licensee to engage in preferential hiring practices to avoid having frivolous complaints filed against it with the Commission. As an example, one commenter claims that some loan agreements would require broadcasters to disclose even frivolous petitions to their lenders, thereby adding an element of risk to funding acquisitions. To address this concern, we will make every effort to dismiss as quickly as possible any petitions, complaints, or other filings that rely on a station's Form 395-B filing as the basis of the petition, complaint, or other filing. Moreover, broadcasters in that situation may apprise lenders of our intent to dismiss such complaints and point to our rule disallowing the use of the data for compliance purposes.

46. Broadcaster groups mistakenly assert that reinstating a public collection of Form 395-B violates D.C. Circuit precedent, which the commenters argue effectively invalidated the use of the Form 395-B for all purposes. In arguing that the Lutheran Church decision invalidated Form 395-B, however, the commenters erroneously treat all the EEO requirements in effect at the time of Lutheran Church as one inseparable rule that the D.C. Circuit vacated. The commenters are incorrect in asserting that the court's finding of unconstitutional pressure when the collection was combined with the then-existing EEO program somehow invalidated the Form 395-B itself for any and all other purposes. In fact, as noted above, what the Lutheran Church court found to be problematic was the requirement to compare the racial composition of a station's workforce with that of the local population, and not the requirement to report employment data to the Commission. The court's finding of unconstitutionality did not reach the Commission's use of the form to gather data purely for statistical purposes and without regard to a station's EEO compliance. Indeed, the court did not even speak to the form's use in collecting employment data for the purpose of analyzing industry trends, let alone invalidate it for that purpose.

47. Furthermore, we reject the suggestion that the finding in the MD/DC/DE Broadcasters case somehow casts doubt on the legitimate use of Form 395-B data for industry trend reporting, given that the Form 395-B was not even at issue in that case. The Form 395-B was only mentioned in the background section of that decision, as the collection of the employee diversity data was irrelevant to the data at issue in that case ( i.e., applicant data). Rather, the court found the Commission's revised EEO program problematic because it determined that broadcasters proceeding under one aspect of the program (Option B) could feel pressured to engage in race-conscious recruiting practices, given that Option B required an annual reporting of the race, ethnicity, and gender information for each job applicant.

48. Therefore, unlike applicant data required under Option B of the former EEO program, the Form 395-B workforce data played no role in assessing a broadcaster's compliance with the recruiting rules at issue in MD/DC/DE Broadcasters. In the current situation no unconstitutional use of racial or gender classifications arises from the Commission's collection of annual employee data because we will not use the collection of Form 395-B demographic data for purposes of assessing or enforcing a broadcaster's compliance with our EEO rules. Further, we find the commenter argument that the court in MD/DC/DE Broadcasters disparaged the use of “outputs” to measure “inputs” to be misplaced. First, as noted above, the court was referring to applicant data— i.e., those applying to open job positions at the station—as the output in that case, which was being used to evaluate a broadcaster's outreach efforts and the success of its EEO program in recruiting potential job applicants. Employee data— i.e., the composition of the station's workforce, which is captured by the Form 395-B—was not the “output” of concern. Second, to the extent that employee data might be considered an output, the Commission now explicitly prohibits the use of such data as a tool to measure a broadcaster's “inputs” to its EEO program. Furthermore, the court in MD/DC/DE Broadcasters never suggested that the collection of employee data for statistical purposes factored into its analysis regarding the unconstitutionality of the outreach rules.

49. Based on the above, we conclude that reinstating collection of Form 395-B in a public manner, where the form's data can only be used for reporting and analyzing industry trends, is fully consistent with the determinations in Lutheran Church and MD/DC/DE Broadcasters. The proposed action is race- and gender-neutral and crucial to Congress's and the Commission's interest in understanding broadcast employment trends. Because the Commission is the only entity with the resources and expertise to expeditiously collect and compile this data, it is vital that the agency restart this collection. With current data, the Commission, Congress, and the general public can better understand developments in the broadcast sector.

50. Although no commenter raised a First Amendment issue, we clarify that requiring stations to publicly disclose their workforce composition data does not constitute “compelled speech” on matters of race and gender, in violation of the First Amendment. A requirement to report information to the government fundamentally differs from the typical compelled speech case, which generally involves situations where “the complaining speaker's own message [is] affected by the speech it [is] forced to accommodate.” Conversely, the Form 395-B report requires reporting of factual information to the Commission—the station's own employment figures—to allow the Commission to analyze trends. There is no message being forced by the government.

51. Even assuming, arguendo, that broadcaster's speech rights are implicated, our Form 395-B requirement is consistent with the First Amendment, as it entails disclosure of “purely factual and uncontroversial” information in a commercial context. The D.C. Circuit has ruled that government interests in addition to correcting deception can be invoked to sustain a mandate for disclosure of purely factual information in the commercial context. The Zauderer test is satisfied here because disclosure of workforce data is reasonably related to a substantial governmental interest (ensuring maximum accuracy and utility of the data on which the government relies for analysis and reporting purposes), which outweighs the “minimal” interest in not disclosing purely factual, uncontroversial information. In the alternative, even assuming, arguendo, that our requirement is subject to heightened First Amendment review, we find that our disclosure requirement satisfies even this higher standard. The government has a substantial interest in analyzing broadcast industry workforce information to support greater understanding of the broadcast industry and to report to Congress about the same. Collecting this data and making broadcasters' Form 395-B filings publicly available directly advance this governmental interest because without the data it would be impossible to assess changes, trends, or progress in the industry and making the information public ensures maximum accuracy of the submitted data by increasing the likelihood that erroneous data will be discovered and corrected and incentivizing stations to file accurate data and thereby maximizes the utility of the data. Moreover, the requirement is not more extensive than is necessary to serve that interest, because the data will be collected in a manner consistent with the Commission's previous, long-standing method of collecting the data and because, as this order has made clear, the data collected will be used exclusively for the purpose of compiling industry employment trends and making reports to Congress, and not to assess any aspect of a broadcaster's compliance with the EEO rules.

52. We find sufficient authority to reinstate the collection of Form 395-B, both pursuant to the public interest provisions of the Act and section 334. The Commission's adoption of Form 395-B preceded Congress's passage of section 334 by more than two decades. As discussed above in Section II, the form and the Commission's EEO rules were rooted firmly in the Commission's public interest mandate under sections 4(i), 303, 307, 308, 309, and 310 the Communications Act. By codifying the Commission's then existing EEO requirements, as well as the collection of Form 395-B, Congress, in 1992, ratified the Commission's pre-existing authority to adopt such rules and forms through congressional acquiescence in a long-standing agency policy. As the Commission discussed extensively in the Second Report and Order and Third NPRM in this proceeding, the limitation imposed by section 334 regarding changes to the Commission's then-existing EEO rules and forms evidenced Congress's approval of the Commission's EEO approach (including the information collection) and its desire to ensure its continuance. Lawmakers' express endorsement of the rules 30 years ago did not in any way undermine the Commission's pre-existing public interest authority. Moreover, the Commission also has broad authority under the Communications Act to collect information and prepare reports.

53. Despite this settled law, commenters challenge our authority to reinstate the form's collection, reviving arguments that the Commission rejected 20 years ago in the Second Report and Order and Third NPRM. First, they assert that, rather than a grant of EEO authority, section 334 is a limitation on the Commission's authority to revise its EEO regulations and forms. They suggest that the Commission is constrained from reinstating Form 395-B because, in setting forth the permissible exceptions to its restriction on EEO changes, Congress did not include, or later add, the situation where some provisions of the EEO rules are deemed unenforceable, as occurred in Lutheran Church and MD/DC/DE Broadcasters. Second, commenters posit that the Commission is taking inconsistent positions on the current force of section 334. They argue that, if section 334 is still in force and dictates reinstatement of Form 395-B, then the Commission's current EEO outreach rules violate the statutory provision because those rules have undergone substantial revision. The commenters assert that the Commission “cannot have it both ways” by rejecting the constraints of section 334 when it previously revised its EEO rules, but now invoking the same provision to reinstate Form 395-B.

54. We find commenters' assertions unsound as a matter of law and logic. They disregard the Commission's public interest authority under the Act, which was the underpinning of the Commission's EEO rules and Form 395-B long before the passage of section 334. Further, the commenters also misconstrue the impact of the court decisions on our section 334 authority. While the Lutheran Church court invalidated elements of the EEO program requirements in effect in 1992, thereby terminating their enforceability, it did not address the constitutionality of section 334 itself. Moreover, the subsequent decision in MD/DC/DE Broadcasters did not imply that the unconstitutionality of the previous regulations rendered section 334 inoperative.

55. We therefore continue to reject the commenters' false premise that section 334 was somehow “neutered” by the D.C. Circuit decisions. Section 334 continues to provide authority for reinstating Form 395-B. Moreover, as discussed above, we find ample legal authority separate from section 334 to reinstate collection of the form.

56. In 2004, the State Associations filed a petition seeking reconsideration of the Third Report and Order and Fourth NPRM. The petition asks the Commission: (1) to amend the Note to § 73.3612 of the Commission's rules to, in their view, clarify and strengthen the Commission's pledge to refrain from using Form 395-B data for compliance or enforcement purposes; (2) to address the issue of confidential treatment for Form 395-B; and (3) to issue a Fourth Report and Order resolving issues raised in the Third Report and Order and Fourth NPRM and in petitions for reconsideration filed in response to the Second Report and Order and Third NPRM. Numerous parties jointly filed an opposition to the petition. We hereby grant the State Associations' petition in part, deny it in part, dismiss it in part, and defer it in part.

57. The State Associations seek an expansion of the Commission's pledge to not use Form 395-B data to assess an individual broadcast licensee's compliance with the EEO rules to read as follows, with their proposed changes shown in italics:

58. Based on the record stemming from the State Associations' 2004 petition for reconsideration and the determinations made in the Fourth Report and Order above, we find it appropriate to make certain changes to the language of § 73.3612 of our rules. With regard to the first of the State Associations' proposed changes, the opposing parties do not object to adding the phrase “or permittee's,” and we agree to make that change because permittees also are required to file Form 395-B. We also find that explicitly stating in the rule itself that we will not use Form 395-B data to assess compliance with both the equal employment opportunity requirements and nondiscrimination requirements of § 73.2080 of our rules is consistent with our statements in the Fourth Report and Order above and with statements made by the Commission over the past two decades.

59. While the opponents to this change argue that we should not categorically limit our discretion to use EEO data as one of many factors in assessing a complaint of discrimination, these same opponents also acknowledge that the “Note itself, along with the text of [the] 3rd R&O, make it plain that the FCC will not use annual employment data to assess compliance with the EEO rules of any individual broadcast licensee.” Hence, codifying the limitation is nothing more than memorializing in another form a prohibition that the Commission has had in place for more than 20 years. This approach minimizes confusion about our position. We do not, however, see any need to include the final sentence suggested by the State Associations, as we find that it is essentially a repetition of the preceding sentence now that we have added “nondiscrimination or” to the preceding sentence. Finally, to conform to the publishing conventions of the National Archives and Records Administration's Office of the Federal Register, we will now incorporate what currently appears as a Note to § 73.3612 into the rule itself.

60. With regard to the State Associations' petition on the issue of confidential treatment of the Form 395-B data, we respond by adopting the Fourth Report and Order above, which reinstates the Form 395-B data collection in a public manner. Most of the remaining issues raised in State Associations' petition for reconsideration of the Second Report and Order and Third NPRM are unrelated to the Form 395-B filing requirement and, hence, we defer action on them here because they are beyond the scope of this Order on Reconsideration. We dismiss as moot two specific issues raised in the petition: (1) the ability to recruit via the internet, which the Commission addressed in the intervening time period, and (2) a modification to the effective date of the then new rules.

61. Regulatory Flexibility Act. The Regulatory Flexibility Act of 1980, as amended (RFA) requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, we have prepared a Final Regulatory Flexibility Analysis (FRFA) concerning the potential impact of rule and policy changes adopted in the Fourth Report and Order on small entities. Additionally, we have prepared a Final Regulatory Flexibility Certification (FRFC) certifying that the rule and policy changes contained in the Order on Reconsideration will not have a significant economic impact on a substantial number of small entities.

62. Paperwork Reduction Act. Final Paperwork Reduction Act Analysis for Fourth Report and Order and Order on Reconsideration in MB Docket No. 98-204. This Fourth Report and Order and Order on Reconsideration may contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. All such changes will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on any new or modified information collection requirements contained in this proceeding. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees. In this present document, we have assessed the effects of reinstating the collection of information on Form 395-B from broadcasters with five or more full-time employees and adding language to our rules clarifying that restrictions regarding the Commission's use of the collected data protect broadcast permittees as well as licensees. We find that, with respect to businesses with fewer than 25 employees, the paperwork burden associated with the completion and submission of Form 395-B will be minimal and the collection is necessary to serve the purpose of obtaining complete information on employment trends in the broadcast industry. As it is customary for companies to routinely maintain employee information for various purposes, including payroll, broadcasters should not have to engage in extensive research to complete and submit their Form 395-B.

63. Congressional Review Act. The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs, that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Fourth Report and Order and Order on Reconsideration to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

64. Final Regulatory Flexibility Analysis. As required by the Regulatory Flexibility Act of 1980, as amended (RFA) an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the 2021 Further Notice of Proposed Rulemaking ( FNPRM ) to this proceeding. The Federal Communications Commission (Commission) sought written public comment on the proposals in the FNPRM, including comment on the IRFA. The Commission received no comments on the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

65. This Fourth Report and Order reinstates the Commission's annual collection of broadcast workforce composition data by race and gender on FCC Form 395-B. We will use the collected data to analyze industry trends and make reports to Congress. Before the form's prolonged suspension beginning in 2001, the Commission made the collected workforce data publicly available. As stated in the Fourth Report and Order, we will continue with the public collection and dissemination of the data, which is in alignment with the public interest. Other than the inclusion of a mechanism allowing broadcasters to account in the Form 395-B for those employees who identify as gender non-binary, the reinstated collection does not change the form's reporting requirements. The inclusion of this mechanism, which will allow for accurate data gathering, will incur only a minimal economic impact on a substantial number of small entities.

66. The reinstatement arrives after a significant period of delay in collection, which created a material gap in workforce composition data to be collected and analyzed by the Commission. Without the data, the Commission is prevented from analyzing important industry trends and reporting to Congress its analyses on the broadcast sector. A reinstituted collection of Form 395-B will allow us to carry out the public interest authority of this agency, and to implement section 334 of the Act, which instructs the Commission to collect broadcast workforce data.

67. The Fourth Report and Order is authorized under sections 1, 4(i), 4(k), 303(r), 307, 308, 309, 310, 334, and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(k), 303(r), 307, 308, 309, 310, 334, and 403.

68. There were no comments in response to IRFA notice.

69. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the FNPRM in this proceeding.

70. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small government jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. Below, we provide a description of such small entities, as well as an estimate of the number of such small entities, where feasible.

71. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small government jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. Below, we provide a description of such small entities, as well as an estimate of the number of such small entities, where feasible.

72. Television Broadcasting. This industry is comprised of “establishments primarily engaged in broadcasting images together with sound.” These establishments operate television broadcast studios and facilities for the programming and transmission of programs to the public. These establishments also produce or transmit visual programming to affiliated broadcast television stations, which in turn broadcast the programs to the public on a predetermined schedule. Programming may originate in their own studio, from an affiliated network, or from external sources. The SBA small business standard for this industry classifies businesses having $41.5 million or less in annual receipts as small. 2017 U.S. Census Bureau data indicate that 744 firms in this industry operated for the entire year. Of that number, 657 firms had revenue of less than $25,000,000. Based on this data we estimate that the majority of television broadcasters are small entities under the SBA small business size standard.

73. As of September 30, 2023, there were 1,377 licensed commercial television stations. Of this total, 1,258 stations (or 91.4%) had revenues of $41.5 million or less in 2022, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on October 4, 2023, and therefore these licensees qualify as small entities under the SBA definition. In addition, the Commission estimates as of September 30, 2023, there were 383 licensed noncommercial educational (NCE) television stations, 380 Class A TV stations, 1,889 LPTV stations and 3,127 TV translator stations. The Commission, however, does not compile and otherwise does not have access to financial information for these television broadcast stations that would permit it to determine how many of these stations qualify as small entities under the SBA small business size standard. Nevertheless, given the SBA's large annual receipts threshold for this industry and the nature of these television station licensees, we presume that all of these entities qualify as small entities under the above SBA small business size standard.

74. Radio Stations. This industry is comprised of “establishments primarily engaged in broadcasting aural programs by radio to the public.” Programming may originate in their studio, from an affiliated network, or from external sources. The SBA small business size standard for this industry classifies firms having $41.5 million or less in annual receipts as small. U.S. Census Bureau data for 2017 show that 2,963 firms operated in this industry during that year. Of this number, 1,879 firms operated with revenue of less than $25 million per year. Based on this data and the SBA's small business size standard, we estimate a majority of such entities are small entities.

75. The Commission estimates that as of September 30, 2023, there were 4,452 licensed commercial AM radio stations and 6,670 licensed commercial FM radio stations, for a combined total of 11,122 commercial radio stations. Of this total, 11,120 stations (or 99.98%) had revenues of $41.5 million or less in 2022, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Database (BIA) on October 4, 2023, and therefore these licensees qualify as small entities under the SBA definition. In addition, the Commission estimates that as of September 30, 2023, there were 4,263 licensed noncommercial (NCE) FM radio stations. The Commission however does not compile, and otherwise does not have access to financial information for these radio stations that would permit it to determine how many of these stations qualify as small entities under the SBA small business size standard. Nevertheless, given the SBA's large annual receipts threshold for this industry and the nature of radio station licensees, we presume that all of these entities qualify as small entities under the above SBA small business size standard.

76. We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, another element of the definition of “small business” requires that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific radio or television broadcast station is dominant in its field of operation. Accordingly, the estimate of small businesses to which the rules may apply does not exclude any radio or television station from the definition of a small business on this basis and is therefore possibly over-inclusive. An additional element of the definition of “small business” is that the entity must be independently owned and operated. Because it is difficult to assess these criteria in the context of media entities, the estimate of small businesses to which the rules may apply does not exclude any radio or television station from the definition of a small business on this basis and similarly may be over-inclusive.

77. In this section, we identify the reporting, recordkeeping and other compliance requirements contained in the Fourth Report and Order and consider whether small entities are affected disproportionately by any such requirements. By this Fourth Report and Order, broadcasters are required to resume filing Form 395-B, which will be available to the public. The annual filing of Form 395-B will require employment units to upload the form onto the Commission's website. As recognized by the Office of Management and Budget (OMB), the Commission has estimated in the instructions to Form 395-B that the form's paperwork burden is minimal, taking each response, or form, approximately one hour to complete. This estimate includes the time to read the instructions, look through existing records, gather and maintain the required data, and actually complete and review the form or response. Because this Fourth Report and Order contains no new reporting or recordkeeping requirements, other than the incorporation of a mechanism to enable identification of gender non-binary categories, and only resumes the filing of an existing form, the reporting, recordkeeping and other compliance requirements of small entities will be no greater than under the current rules. Additionally, broadcast employment units with less than five full-time employees are exempt from filing statistical data. Because of this minimal reporting burden and due to the fact that smaller station employment units are exempt, we conclude that small entities will not be disproportionately affected by the Fourth Report and Order.

78. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.

79. This Fourth Report and Order reinstates the collection of broadcaster employment data on Form 395-B. Collection of the Form 395-B was suspended in 2001 following two decisions by the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) vacating certain aspects of the Commission's equal employment opportunity rules. This suspension had no relation to the impact of the collection on small entities. As noted above, the filing requirement of Form 395-B importantly does not apply to broadcast employment units with less than five full-time employees, thereby exempting a large group of smaller entities from the filing requirements. The Fourth Report and Order only leads to a resumption of data collection efforts and imposes no new requirements for which the Commission can find alternatives that would minimize the economic burden on small entities.

80. The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs, that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Report & Order and Order on Reconsideration to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

81. For the reasons described below, we now certify that the policies and rules adopted in the Order on Reconsideration will not have a significant economic impact on a substantial number of small entities. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

82. In this Order on Reconsideration, we make certain changes to the language of § 73.3612 to clarify our collection and use of Form 395-B data. We add language to the rule confirming that the collection of Form 395-B data, and restrictions on the use of the data, also applies to broadcast permittees. The Order on Reconsideration adds an explicit statement to its rules that it will not use Form 395-B data to assess compliance with both the equal employment opportunity requirements and nondiscrimination requirements of § 73.2080. We find that this statement is consistent with our statements in the Fourth Report and Order and other previous statements made by the Commission over the past two decades.

83. The changes from the Order on Reconsideration will not have a significant economic impact on a substantial number of small entities because such changes do not alter the type or extent of information collected under Form 395-B. Rather, the Order on Reconsideration does nothing more than memorialize in another form a prohibition that the Commission has had in place for more than 20 years. Therefore, we certify that the changes provided in the Order on Reconsideration will not have a significant economic impact on a substantial number of small entities. The Commission will send a copy of this Order on Reconsideration, including a copy of this Final Regulatory Flexibility Certification, in a report to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Fairness Act of 1996.

84. Accordingly, it is ordered that, pursuant to the authority contained in sections 1, 4(i), 4(k), 303(r), 307, 308, 309, 310, 334, 403, and 634 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(k), 303(r), 307, 308, 309, 310, 334, 403, and 554, this Fourth Report and Order and Order on Reconsideration is adopted .

85. It is further ordered that this Fourth Report and Order and Order on Reconsideration shall be effective 30 days after publication in the Federal Register . Compliance with § 73.3612 of the Commission's rules, 47 CFR 73.3612, which may contain new or modified information collection requirements, will not be required until the Office of Management and Budget completes review of any information collection requirements that the Office of Management and Budget determines is required under the Paperwork Reduction Act. The Commission directs the Media Bureau to announce the compliance date for the Fourth Report and Order and Order on Reconsideration by subsequent Public Notice.

86. It is further ordered that the Joint Petition of the State Broadcasters Associations for Reconsideration and/or Clarification of the Third Report and Order and Fourth NPRM, MM Docket No. 98-204 (filed July 23, 2004), is granted in part, denied in part, dismissed in part , and deferred in part.

87. It is further ordered that the Media Bureau is hereby directed to make the necessary changes to Form 395-B to provide for inclusion of gender non-binary information.

88. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the Fourth Report and Order and Order on Reconsideration, including the Final Regulatory Flexibility Analysis and the Initial Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

89. It is further ordered that the Office of the Managing Director, Performance Program Management, shall send a copy of this Fourth Report and Order and Order on Reconsideration in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

The proposed rule was published at 88 FR 80256 on November 17, 2023. The Petitioner filed comments in support of the petition reaffirming its commitment to apply for channel 21. No other comments were filed.

The Bureau believes the public interest would be served by substituting channel 21 for channel 20 at Missoula. As explained in the Petition, at the same time Sinclair requested and was granted the substitution of channel 20 for channel 13 at Missoula, it also requested and was granted the substitution of UHF channel 20 for VHF channel 6 for co-owned station KTVM-TV, Butte, Montana (Butte). As a result, both KTVM-TV and KECI-TV would operate on a co-channel basis, and Sinclair had determined that predicted interference from both stations operating on channel 20 would affect less than 1 percent of the populations within the noise limited service contours (NLSC) of each station. When the Bureau granted the substitution of channel 20 for channel 13 at Missoula, it also found that the proposed channel 20 facility had a predicted service population of 227,295 persons, a net gain of potential viewers over the existing KECI-TV channel 13 facility. Sinclair now explains, however, that in preparing to construct the new facilities on channel 20 for both stations, its local engineering staff determined that despite the predictions, the actual interference consequences of both stations operating on channel 20 at Missoula and Butte would result in a more significant number of persons receiving interference, and that the interference would not be localized but spread throughout large portions of the KTVM-TV and KECI-TV service areas. An analysis provided by the Petitioner indicates that operation of KECI-TV on channel 21 instead of channel 13 would result in a net gain in persons within the Station's NLSC receiving interference-free service, as well as an increase in the population that would receive interference-free service if the Station were to remain on the currently-allotted channel 20.

We also find that the proposal complies with all relevant technical requirements for amendment of the Table of TV Allotments, including the interference protection requirements of § 73.622(a) of the rules, and further demonstrates that the proposed channel 21 facility will provide full principal community coverage to Missoula as required by § 73.618 of the rules. Moreover, the proposed channel substitution would not cause any additional loss of service, which we have already found to be de minimis, will increase the population within both KECI-TV's and KTVM-TV's NLSCs that will receive interference-free service, and resolve co-channel interference issues caused by the stations' approved co-channel operation.

As proposed, channel 21 can be substituted for channel 20 at Missoula in compliance with the principal community coverage requirements of § 73.618(a) of the rules, at coordinates 47-01′-04.0″ N and 114-00′-50.0″ W. The proposed facility is located within the Canadian coordination zone and concurrence from the Canadian government has been obtained for this allotment.

In addition, we find that this channel change meets the technical requirements set forth in § 73.622(a) of the rules.

This is a synopsis of the Commission's Report and Order, MB Docket No. 23-380; RM-11968; DA 24-381, adopted April 23, 2024, and released April 23, 2024. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed 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). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: