The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in title 14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all comments received without change to www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and the indicated comments will not be placed in the public docket of these special conditions. Send submissions containing CBI to the individual listed in the For Further Information Contact section above. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these proposed special conditions.

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On January 23, 2026, ALOFT applied for a supplemental type certificate for the installation of rechargeable lithium batteries and battery systems in the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes. These airplanes, approved under Type Certificate No. A12EA, are twin-engine transport category airplanes with a maximum seating capacity of 19 passengers. These airplanes have a maximum takeoff weight between 46,500 and 91,400 pounds, depending on the model.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, ALOFT must show that the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. A12EA or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes must comply with the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes, as modified by ALOFT, will incorporate the following novel or unusual design features:

Installation of a main ship rechargeable lithium battery.

Rechargeable lithium batteries and battery systems are considered to be a novel or unusual design feature in transport category airplanes, with respect to the requirements in § 25.1353. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes. These batteries and battery systems introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.

Special Condition 1 requires that each individual cell within a battery and battery system be designed to maintain safe temperatures and pressures. Special Condition 2 addresses these same issues but for the entire battery system.

Special Condition 2 requires that the batteries and battery system be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.

Special Conditions 1 and 2 are intended to ensure that the cells and battery system are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special Conditions 3, 7, and 8 are self-explanatory.

Special Condition 4 clarifies that the flammable-fluid fire-protection requirements of § 25.863 apply to rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Rechargeable lithium batteries contain electrolyte that is a flammable fluid.

Special Condition 5 requires each rechargeable lithium battery and battery system installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

Special Condition 6 requires each rechargeable lithium battery and battery system installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting special conditions 5 and 6 may be the same, but they are independent requirements addressing different hazards. Special Condition 5 addresses corrosive fluids and gases, whereas special condition 6 addresses heat.

Special Condition 9 requires rechargeable lithium batteries and battery systems to have “automatic” means, for charge rate and disconnect, due to the fast acting nature of lithium battery chemical reactions. Manual intervention would not be timely or effective in mitigating the hazards associated with these batteries.

These special conditions apply to all rechargeable lithium batteries and battery system installations in lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments. Those regulations will remain in effect for other battery installations on these airplanes.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes, as modified by ALOFT. Should ALOFT apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A12EA to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on the Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Gulfstream Model G-IV, GIV-X, GV, and GV-SP series airplanes, as modified by ALOFT.

In lieu of Title 14, Code of Federal Regulations (14 CFR) 25.1353(b)(1) through (4) at amendment 25-123 or § 25.1353(c)(1) through (4) at earlier amendments, each rechargeable lithium battery installation must:

Be designed to maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.

2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure, and automatically control the charge rate of each cell to protect against adverse operating conditions, such as cell imbalance, back charging, overcharging, and overheating.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure, that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of § 25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure sensing and warning system to alert the flightcrew if its failure affects safe operation of the airplane.

8. Have a monitoring and warning feature that alerts the flightcrew when its charge state falls below acceptable levels if its function is required for safe operation of the airplane.

9. Have a means to automatically disconnect from its charging source in the event of an over-temperature condition, cell failure or battery failure.

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in title 14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all comments received without change to www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and the indicated comments will not be placed in the public docket of these special conditions. Send submissions containing CBI to the individual listed in the FOR FURTHER INFORMATION CONTACT section above. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these proposed special conditions.

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On January 8, 2026, Honeywell applied for a supplemental type certificate for the installation of non-rechargeable lithium batteries in the ULB in the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes. These airplanes, approved under Type Certificate No. A2NM, are twin engine transport category airplanes. The Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes have a maximum passenger range between 7 and 239 passengers, and a maximum takeoff weight range between 230,500 and 273,000 pounds, depending on model and configuration.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Honeywell must show that the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. A2NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 757-200, 757-200PF, 757-200CB, and 757-300 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the Honeywell apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes must comply with the exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes, as modified by Honeywell, will incorporate the following novel or unusual design feature:The installation of non-rechargeable lithium batteries in the underwater locator beacon (ULB).

The FAA derived the current regulations governing installation of batteries in transport-category airplanes from Civil Air Regulations (CAR) 4b.625(d), as part of the recodification of CAR 4b, which established 14 CFR part 25 in February 1965. This recodification essentially reworded the CAR 4b battery requirements, which are currently in §  25.1353(b)(1) through (4). Non-rechargeable lithium batteries and battery systems are novel and unusual with respect to the state of technology considered when these requirements were codified. Non-rechargeable lithium batteries and battery systems introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduce failure modes that require unique design considerations, such as provisions for thermal management.

In January 2013, two independent events involving rechargeable lithium-ion batteries revealed unanticipated failure modes. A National Transportation Safety Board letter to the FAA, dated May 22, 2014, which is available at https://www.ntsb.gov, filename A-14-032-036.pdf, describes these events.

On July 12, 2013, an event involving a non-rechargeable lithium battery in an ELT installation demonstrated unanticipated failure modes. The United Kingdom's Air Accidents Investigation Branch Bulletin S5/2013  1 describes this event. These events, involving rechargeable and non-rechargeable lithium batteries, prompted the FAA to initiate a broad evaluation of these energy-storage technologies.

On April 22, 2016, the FAA published special conditions No. 25-612-SC in the Federal Register (81 FR 23573), applicable to Gulfstream Aerospace Corporation, for the Model GVI airplane. Those were the first special conditions the FAA issued for non-rechargeable lithium battery installations. In that document, the FAA explained its decision to make those special conditions effective on April 22, 2017, one year after publication in the Federal Register . In those special conditions, the FAA stated its intention to apply non-rechargeable lithium battery and battery system special conditions to design changes on other airplane makes and models applied for after this same date.

Special condition 1 of these special conditions requires that each individual cell within a non-rechargeable lithium battery and battery system be designed to maintain safe temperatures and pressures. Special condition 2 addresses these same issues but for the entire battery. Special condition 2 requires the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrollable increases in temperature or pressure from one cell to adjacent cells.

Special conditions 1 and 2 are intended to ensure that the non-rechargeable lithium battery and its cells are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the battery designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special conditions 3, 7, and 8 are self-explanatory.

Special condition 4 makes it clear that the flammable-fluid fire-protection requirements of §  25.863 apply to non-rechargeable lithium battery and battery system installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable-fluid leakage from airplane systems. Non-rechargeable lithium batteries and battery systems contain an electrolyte that is a flammable fluid.

Special condition 5 requires that each non-rechargeable lithium battery and battery system installation not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

While special condition 5 addresses corrosive fluids and gases, special condition 6 addresses heat. Special condition 6 requires that each non-rechargeable lithium battery and battery system installation have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat the battery installation can generate due to any failure of it or its individual cells. The means of meeting special conditions 5 and 6 may be the same, but the requirements are independent and address different hazards.

These special conditions apply to all non-rechargeable lithium battery and battery system installations, in lieu of §  25.1353(b)(1) through (4) at amendment 25-123. Sections 25.1353(b)(1) through (4) at amendment 25-123 remain in effect for other battery installations.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes, as modified by Honeywell. Should Honeywell apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A2NM to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Boeing Model 757-200, 757-200PF, 757-200CB, 757-300 series airplanes, as modified by Honeywell.

In lieu of §  25.1353(b)(1) through (4) at amendment 25-123, or §  25.1353(c)(1) through (4) at earlier amendments, each non-rechargeable lithium battery and battery system installation must:

1. Be designed to maintain safe cell temperatures and pressures, under all foreseeable operating conditions, to prevent fire and explosion.

2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure, that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of §  25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure-sensing and warning system to alert the flight crew, in the event its failure affects safe operation of the airplane.

8. Have a means for the flight crew or maintenance personnel to determine the battery charge state if the battery's function is required for safe operation of the airplane.

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, pilots do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, pilots do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

The Department is revising and rescinding portions of its regulations promulgated pursuant to Title VI, 42 U.S.C. 2000d-1, to more closely align its regulations to the language that Congress enacted in Title VI prohibiting intentionally discriminatory conduct, see 42 U.S.C. 2000d. The Department is cross-referencing and incorporating the reasoning of the Department of Justice (DOJ) final rule published in the Federal Register on December 10, 2025. 90 FR 57141. There are serious statutory and constitutional concerns with the legality of the Department's Title VI regulations, which go beyond intentional discrimination to additionally prohibit conduct having an unintentional disparate impact. This rule accordingly rescinds those portions of the regulations that prohibit conduct having a disparate impact, which are in considerable tension with both Title VI and the Constitution and do not serve the public interest.

The rule's revisions also conform to Executive Order 14281, “ Restoring Equality of Opportunity and Meritocracy ” (Apr. 28, 2025; 90 FR 17537). That Order states that “[i]t is the policy of the United States to eliminate the use of disparate-impact liability in all contexts to the maximum degree possible to avoid violating the Constitution, Federal civil rights laws, and basic American ideals.” Id. at 17537. Although the Department would take this action independent of Executive Order 14281, the Order supports this action.

This rule makes clear that (i) the Department's Title VI regulations do not prohibit conduct or activities that have a disparate impact and instead prohibit only intentional discrimination, and (ii) the Department thus will not pursue Title VI disparate-impact liability against its Federal-funding recipients.

Title VI of the Civil Rights Act of 1964, as amended, provides: “No person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” 42 U.S.C. 2000d. Title VI also directs Federal departments and agencies that extend Federal financial assistance to “effectuate the provisions of” Title VI “by issuing rules, regulations, or orders of general applicability.” 42 U.S.C. 2000d-1. The section of Title VI that sets forth the prohibited conduct, 42 U.S.C. 2000d, prohibits intentional discrimination and makes no reference to unintentional disparate effects or impact. See Alexander v. Sandoval, 532 U.S. 275, 280 (2001) (“[I]t is . . . beyond dispute—and no party disagrees—that [Title VI] prohibits only intentional discrimination.”). The statute does not explicitly provide any Federal department or agency with authority to prohibit conduct having an unintentional disparate impact. And despite having ample opportunities, Congress has not amended Title VI to impose disparate-impact liability.

The Department originally published these regulations in a final rule on July 5, 1973 (38 FR 17938). The rule was issued under Section 602 of the Civil Rights Act of 1964 (42 U.S.C. 2000d-1). Its issuance was part of a coordinated effort among Federal departments and agencies, based on recommendations from the Interagency Committee for Uniform Title VI Regulation Amendments, to clarify and standardize the application of Title VI. Shortly thereafter, the Department published a correction notice on September 4, 1973 (38 FR 23777), to fix minor typographical errors in the original publication.

In 2003, the Department added language defining “program or activity” and “program” to reflect the amendment of Title VI by the Civil Rights Restoration Act of 1987, Public Law 100-259. 68 FR 51334; see 15 CFR 8.3(g). Thus, beyond the required updating of the phrases “program or activity” and “program” pursuant to the Civil Rights Restoration Act, the Department has not substantively updated its Title VI regulations since 1973.

The Supreme Court has found that Title VI, 42 U.S.C. 2000d, does not prohibit facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Rather, it prohibits only intentional discrimination. In 1978, the Supreme Court found that Congress intended Title VI to prohibit “only those racial classifications that would violate the Equal Protection Clause” if committed by a government actor. Regents of the Univ. of Cal. v. Bakke, 438 U.S. 265, 287 (1978) (Powell, J., announcing the judgment of the Court); id. at 325, 328, 352-53 (Brennan, White, Marshall, and Blackmun, JJ., concurring in part and dissenting in part); see also Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 600 U.S. 181, 198 n.2 (2023) ( SFFA ). Shortly before Bakke' s Title VI holding, the Supreme Court held that the Equal Protection Clause prohibits only intentional discrimination and that “a law or other official act” that has a “racially disproportionate impact” alone does not violate that Clause. Washington v. Davis, 426 U.S. 229, 239 (1976); see also Vill. of Arlington Heights v. Metro. Hous. Dev. Corp., 429 U.S. 252, 265 (1977) (“Proof of racially discriminatory intent or purpose is required to show a violation of the Equal Protection Clause.”). Taken together, these Supreme Court cases establish that Title VI's statutory prohibition, like the Equal Protection Clause, extends only to intentional discrimination.

In 2001, the Supreme Court, in Alexander v. Sandoval, reaffirmed that settled understanding. See 532 U.S. at 280 (“[I]t is . . . beyond dispute . . . that [Title VI] prohibits only intentional discrimination.”). In Sandoval, the Supreme Court held that private plaintiffs lacked a private right of action to enforce DOJ's “disparate-impact regulations.” Id. at 285-87. Although the Supreme Court had previously found a private cause of action to enforce Title VI's bar on intentional discrimination, id. at 279-80, that conclusion did not extend to enforcing DOJ's “disparate-impact regulations.” Id. at 285. As the Supreme Court explained, it is “clear” that “the disparate-impact regulations do not simply apply” the statutory prohibition, as the regulations “forbid conduct that [Title VI] permits,” so it is equally “clear that the private right of action to enforce [Title VI] does not include a private right to enforce these regulations.” Id. While the Supreme Court in Sandoval “assume[d]” without deciding that DOJ's disparate-impact regulations were valid, the Court explained that the then-current version of the regulations were in “considerable tension” with the Supreme Court's Title VI precedents. Similarly, the regulations did not “authoritatively” construe Title VI because the regulations “forbid conduct”—namely, policies that unintentionally result in a disparate impact—that Title VI “permits.” Id. at 281-82, 284-85; see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”).

Finally, in 2024, the Supreme Court overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 409-12 (2024). In reaching that result, the Supreme Court made clear that “statutes . . . have a single, best meaning” that is “ `fixed at the time of enactment.' ” Id. at 400 (quoting Wis. Cent. Ltd. v. United States, 585 U.S. 274, 284 (2018)). Thus, Title VI's bar on discrimination can have only one meaning. And under Supreme Court precedent, the single, best meaning of Title VI is that it “prohibits only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes so long as there is no discriminatory intent. Sandoval, 532 U.S. at 280, 286 n.6.

On April 23, 2025, the President issued Executive Order 14281. This Order restated the “bedrock principle of the United States . . . that all citizens are treated equally under the law.” 90 FR at 17537. The Order explained that this “principle guarantees equality of opportunity, not equal outcomes,” and “promises that people are treated as individuals, not components of a particular race or group.” Id.

That Order also explained that disparate-impact liability “endangers this foundational principle.” Id. Disparate-impact liability, the Order reasoned, “all but requires individuals and businesses to consider race and engage in racial balancing to avoid potentially crippling legal liability.” Id. As the Order explained, disparate-impact liability “not only undermines our national values but also runs contrary to equal protection under the law and, therefore, violates our Constitution.” Id.

The Order relayed that because of these problems, “[i]t is the policy of the United States to eliminate the use of disparate-impact liability in all contexts to the maximum degree possible to avoid violating the Constitution, Federal civil rights laws, and basic American ideals.” Id. Accordingly, this rule revises the Department's currently existing Title VI regulations, consistent with the Order's policy and purpose.

In any event, the Department would have independently initiated steps toward making these changes regardless of Executive Order 14281. Even if Executive Order 14281 did not exist, in other words, the Department would have taken steps to adopt the policy to eliminate the use of disparate-impact liability under Title VI. The Order states, and the Department firmly agrees, that a “bedrock principle of the United States is that all citizens are treated equally under the law. This principle guarantees equality of opportunity, not equal outcomes. It promises that people are treated as individuals, not components of a particular race or group. It encourages meritocracy and a colorblind society,” not race-, color-, or national-origin-based favoritism. 90 FR at 17537. And adherence to this principle, including in the issuance of grants, “is essential to creating opportunity, encouraging achievement, and sustaining the American Dream.” Id.

Imposing disparate-impact liability endangers these policy objectives. Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with the original public meaning of Title VI, creates confusion, increases the costs of compliance, and does not serve the public interest. After considering the relevant issues and factors and weighing the relevant considerations, the Department concludes that these reasons support eliminating disparate-impact liability from the Department's Title VI regulations. In any event, the Department concludes that each reason is a separate and independent basis for eliminating disparate-impact liability from the Department's Title VI regulations.

The Department's regulation at 15 CFR 8.4, entitled “Discrimination prohibited,” outlines the core prohibitions against discrimination and includes several provisions that go beyond the statutory text and constitutional requirements by prohibiting facially neutral policies that have a disparate impact. Specifically, § 8.4(a) establishes the general principle that no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any program to which the part applies. Section 8.4(b) enumerates specific discriminatory acts that are prohibited. These include, among others, providing different services or benefits, subjecting individuals to segregation or separate treatment, restricting the enjoyment of advantages or privileges afforded to others, and using criteria or administrative methods that have the effect of discriminating. This section also prohibits recipients from selecting sites or locations for facilities with the purpose or effect of excluding individuals on prohibited grounds. Furthermore, § 8.4(b)(6) requires a recipient to take affirmative action to overcome the effects of prior discrimination. Section 8.4(c) addresses employment practices. It establishes that where a primary objective of the Federal financial assistance is to provide employment, a recipient is prohibited from discriminating in its employment practices. Even where providing employment is not a primary objective, the rule specifies that the same prohibitions apply if a recipient's discriminatory employment practices tend to exclude individuals from participation in or deny them the benefits of the federally assisted program.

There are serious statutory and constitutional concerns with the legality of the Department's Title VI disparate-impact regulations. The Department also has serious policy concerns with its current disparate-impact regulations, including that the disparate-impact standard creates confusion, undermines public confidence in the nation's civil rights laws and the rule of law, and produces burdensome litigation and compliance costs.

In accordance with the reasoning of the DOJ final rule, this Department recognizes that there are serious statutory concerns as to whether the Title VI statute authorizes the disparate-impact provisions of the current regulations. As summarized above, the Supreme Court's Sandoval decision makes clear that Title VI prohibits “only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Sandoval, 532 U.S. at 280-81, 286 n.6. That is the “single, best meaning” of Title VI. Loper Bright, 603 U.S. at 400. Sandoval calls into serious doubt the legality of the Department's “disparate-impact regulations.” Sandoval, 532 U.S. at 281-82, 284-85 (noting that DOJ's substantially identical regulations were in “considerable tension” with the Supreme Court's Title VI precedents); see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Although Sandoval resolved only the question of private enforceability, subsequent cases such as Loper Bright have made clear that the Department cannot extend Title VI beyond its original public meaning. See Loper Bright, 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). And even in the absence of Supreme Court precedent, the Department would have concluded that the best reading of Title VI is that it prohibits only intentional discrimination.

Title VI authorizes agencies to promulgate regulations “to effectuate” the statute's prohibition of intentional discrimination. 42 U.S.C. 2000d-1. The current regulations' extension of prohibited conduct to include conduct with an unintentional disparate impact reaches a vastly broader scope than the statute itself. This scope is too broad to be considered a simple prophylactic measure aimed at preventing intentional discrimination. See Sandoval, 532 U.S. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Thus, the disparate-impact regulations do not “effectuate” Title VI. 42 U.S.C. 2000d-1.

There are also serious concerns about whether the Department's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in SFFA, “the Equal Protection Clause . . . applies without regard to any differences of race, of color, or of nationality—it is universal in its application” and the “guarantee of equal protection cannot mean one thing when applied to one individual and something else when applied to a person of another color.” 600 U.S. at 206 (internal quotation marks omitted) (first quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886); and then quoting Bakke, 438 U.S. at 289-90 (Powell, J.)). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under the Department's regulations is triggered by unintentional disparate outcomes, which the recipient may not even know about without investigation. To evaluate and avoid this risk, the funding recipient must incur investigatory costs, such as conducting an impact analysis, and is coerced to proactively consider race, color, and national origin, and potentially use it to change the unintended disparate outcomes. In short, disparate-impact liability encourages and, in some cases, requires covered entities to engage in the intentional use of race and racial balancing to eliminate those disparate outcomes by treating certain racial groups differently from others—the exact conduct the Equal Protection Clause forbids. See id. The serious constitutional concerns raised by these perverse incentives further confirm that the best reading of Title VI is that it prohibits only intentional discrimination and does not authorize the Department to impose disparate-impact liability. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575 (1988) (“[W]here an otherwise acceptable construction of a statute would raise serious constitutional problems, the Court will construe the statute to avoid such problems unless such construction is plainly contrary to the intent of Congress.” (citing NLRB v. Catholic Bishop of Chi., 440 U.S. 490, 499-501, 504 (1979))).

This encouraged or coerced use of race, color, or national origin violates the Equal Protection Clause unless it survives review under the “daunting” strict-scrutiny standard. SFFA, 600 U.S. at 206; see also Free Speech Coal., Inc. v. Paxton, 145 S. Ct. 2291, 2310 (2025) (“Strict scrutiny—which requires a restriction to be the least restrictive means of achieving a compelling governmental interest—is `the most demanding test known to constitutional law.'” (quoting City of Boerne v. Flores, 521 U.S. 507, 534 (1997))). The use of race, color, or national origin necessitated by the disparate-impact provisions runs into serious issues with the requirement of narrow tailoring to achieve a compelling interest. SFFA, 600 U.S. at 206-07.

Similarly, the “affirmative action” provision authorizes and sometimes requires the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, it encourages intentional racial balancing “to overcome the effects of” unintended racial disparities. 28 CFR 42.104(b)(6). Thus, for substantially the same reasons as above, the “affirmative action” provision raises serious constitutional concerns.

As summarized above, there are serious statutory and constitutional concerns with the Department's disparate-impact regulations. But even if the regulations were consistent with the statute, the Department finds that eliminating the potential constitutional concerns addressed above would independently justify the amendment of the regulations. Cf. U.S. Tel. Ass'n v. FCC, 188 F.3d 521, 528 (D.C. Cir. 1999) (concluding it was not “arbitrary and capricious” to adopt a certain policy in order to “avoid[ ] raising a non-trivial constitutional question”). And even if the regulations did not raise serious constitutional concerns, the Department finds that eliminating the costs and confusion caused by the mismatch between the statute and the disparate-impact regulations would independently justify the repeal of the regulations.

The Department also has serious policy concerns with the Title VI regulations' imposition of disparate-impact liability. While the Department expresses its policy concerns with disparate-impact liability independent of Executive Order 14281, that Order sets forth many valid policy concerns with disparate-impact liability:

Additionally, in practice, and as explained above, disparate-impact liability leads covered entities to engage in racial balancing even as the underlying Title VI statute forbids intentional racial discrimination. This tension tends to create confusion and undermine public confidence in the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized by Harvard and University of North Carolina were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”).

The Department has considered, among other views, the view that looking at disparate effects can sometimes be useful in uncovering or deterring subtle discrimination or indifference to unnecessary and arbitrary barriers; the view that placing a focus on disparate outcomes can help undo the impact of prior instances of intentional discrimination; the view that placing a focus on disparate outcomes is critical for advancing the Department's goals of promoting economic development and creating conditions that facilitate economic opportunities for all communities; the view that covered entities and affected individuals have already structured their policies and conduct around the disparate-impact provisions at issue; the view that meeting certain racial and/or ethnic thresholds carries benefits regarding experience, knowledge, empathy, and cooperation; and the view that the elimination of disparate-impact provisions is a disruption to the status quo that places an unnecessary and inappropriate focus on race and ethnicity. But all these alleged benefits are outweighed by the other issues and factors the Department has considered.

The Department has also considered the alternative of trying to adopt a modified version of disparate-impact liability, for example, by requiring covered entities to try to remedy disparate impacts and/or unintentional discrimination for only certain types of cases regarding education, housing, or employment; or by requiring covered entities to consider disparate impacts for special economic development and opportunity purposes. But any version of imposing liability for unintentional discrimination is inconsistent with Title VI's original public meaning, and even a modified version of disparate-impact liability would not sufficiently eliminate the Department's serious legal and policy concerns. The Department determines that any benefits from adopting alternative versions of disparate-impact liability are outweighed by the Department's legal and policy concerns. And even if possible, developing such a rule would not solve the confusion or rule-of-law concerns expressed above, nor reduce the compliance and litigation costs that covered entities face. The Department believes that the better course is to avoid the complexities and litigation associated with this alternative, which ultimately would leave some parts of the problems unaddressed and others inadequately addressed.

The Department also considered the potential reliance interests of funding recipients and others on the disparate-impact regulations. Sandoval, however, cast serious doubt on the regulations more than 20 years ago. And Executive Order 14281 also directed all agencies to “deprioritize enforcement of all statutes and regulations to the extent they include disparate-impact liability,” including specifically the Department's Title VI disparate-impact regulations. 90 FR at 17538. The Department accordingly believes that any reliance interests should be minimal and do not outweigh the Department's legal and other policy concerns. Further, each of the Department's concerns, whether considered cumulatively or separately, outweighs any reliance interests.

The Department notes that Sandoval has also led to a divergence between Title VI enforcement by private plaintiffs and enforcement by Federal departments and agencies. After Sandoval, private plaintiffs can enforce only Title VI's statutory prohibition on intentional discrimination, while the Department can continue to pursue disparate-impact liability. Repealing the disparate-impact regulations would eliminate this incongruent enforcement.

Overall, after considering the relevant issues and factors and weighing the relevant considerations, the Department finds that, regardless of the legality of the Department's disparate-impact regulations, the above summarized policy concerns, when viewed separately or cumulatively, independently justify the repeal of its disparate-impact regulations.

This rule's regulatory changes address the concerns regarding the statutory authority supporting the scope of these regulations that the Supreme Court questioned in Sandoval and the other legal and policy concerns discussed above, harmonize the implementing regulations' scope with the original public meaning of Title VI, promote consistent enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to the courts and Federal funding recipients.

For the reasons summarized above, the Department amends the following provisions in its Title VI implementing regulation that explain the particular types of “Discrimination prohibited,” located at 15 CFR 8.4.

The table below indicates the exact wording changes. For each section indicated in the left column, the text shown in the middle column is removed and the text shown in the right column is added:

The Department originally published the regulations at 15 CFR part 8 and 15 CFR part 20 in final rules on July 5, 1973 (38 FR 17938), and August 13, 1986 (51 FR 28926), respectively. The regulations at 15 CFR part 8 were promulgated to effectuate Section 602 of the Civil Rights Act of 1964 (42 U.S.C. 2000d-1), which directs each Federal department and agency to issue regulations implementing the statutory prohibition on discrimination on the basis of race, color, or national origin. Similarly, the regulations at 15 CFR part 20 were promulgated to effectuate the Age Discrimination Act of 1975, as amended (42 U.S.C. 6101 et seq. ), and the corresponding government-wide regulations at 45 CFR part 90, which establish a general prohibition against discrimination on the basis of age. Both 15 CFR part 8 and 15 CFR part 20 include a regulation defining the term “United States” to include “the Canal Zone”—a reference to the Panama Canal Zone. See 15 CFR 8.3(c); 15 CFR 20.3(o). As relevant for 15 CFR part 20, the government-wide regulations at 45 CFR part 90 likewise set forth a definition of “United States” that includes “the Canal Zone.” 45 CFR part 90.4.

The Panama Canal Zone was an exclusive concession of the United States from 1903 to 1979. Thereafter, the Canal was jointly controlled by the United States and the country of Panama until 1999. Then, on December 31, 1999, the United States officially transferred full control of the Canal to Panama. The regulatory definitions of the term “United States” set forth in 15 CFR 8.3(c) and 15 CFR 20.3(o) have not been updated to reflect these historical developments and still indicate that the Canal Zone is part of the United States.

By this rule, the Department is updating the definitions of the term “United States” set forth in 15 CFR 8.3(c) and 15 CFR 20.3(o) to accurately reflect the current scope of the United States and its territories and possessions. In particular, the Department is removing from both §§ 8.3(c) and 20.3(o) references to the Panama Canal Zone, as that Zone is no longer considered part of the United States. This removal will promote not only accuracy but also consistency across the Department's regulations, as 15 CFR 801.2(a), for instance, does not define “United States” to include the Canal Zone. See 15 CFR 801.2(a) (defining the term “United States, “when used in a geographic sense,” to mean “the several States, the District of Columbia, the Commonwealth of Puerto Rico, and all territories and possessions of the United States.”). This removal will, however, create some inconsistency between the Department's age discrimination regulations (15 CFR part 20) and the government-wide age discrimination regulations (45 CFR part 90), since “United States” is defined in 45 CFR 90.4 to include the Canal Zone. The Department nevertheless finds it appropriate to amend §§ 8.3(c) and 20.3(o) to ensure the accuracy of—and consistency throughout—the Department's own regulations.

The Department also finds it appropriate to make two other minor amendments to ensure that §§ 8.3(c) and 20.3(o) are identical. Specifically, the Department is (i) ensuring that both definitions explicitly mention the Northern Mariana Islands, and (ii) adopting uniform language for the reference to the States (“the fifty States”).

Pursuant to 5 U.S.C. 553(a)(2), the provisions of the APA requiring notice of proposed rulemaking and the opportunity for public participation are inapplicable to this rule because it relates to “agency management or personnel or to public property, loans, grants, benefits, or contracts.” This rule modifies definitions set forth in 15 CFR parts 8 and 20, both of which establish nondiscrimination requirements in connection with Federal assistance. Additionally, pursuant to 5 U.S.C. 553(b)(B), the Department finds good cause to waive notice of proposed rulemaking and the opportunity for public participation because public participation would be unnecessary. This rule only removes an outdated definition of the United States that no longer aligns with its current boundaries and territories. Public participation would not affect the legal and accurate definition of the United States.

The Office of Management and Budget has determined this rule is not significant pursuant to E.O. 12866. This rule is an E.O. 14192 deregulatory action. This rule does not contain policies having federalism implications as the term is defined in E.O. 13132.

Because a notice of proposed rulemaking and an opportunity for public participation are not required to be given for this rule by 5 U.S.C. 553(a)(2), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

Pursuant to Executive Order 12250, the Department of Justice has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes such as Title VI in order to identify those which are inadequate, unclear or unnecessarily inconsistent.” The Department of Justice has reviewed and approved this rule.

This rule will not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq.

Accordingly, for the reasons set forth above, parts 8 and 20 of title 15 of the Code of Federal Regulations are amended as follows:

Commerce is amending its regulations at 15 CFR part 28, “New Restrictions on Lobbying.” These regulations implement section 319 of Public Law 101-121 (31 U.S.C. 1352), which established government-wide restrictions on the use of appropriated funds for lobbying activities in connection with federal contracts, grants, loans, and cooperative agreements. The primary purpose of part 28 is to ensure transparency and accountability by requiring certification and disclosure of lobbying activities intended to influence federal executive or legislative branch officials regarding such federal awards.

Commerce, along with numerous other executive branch agencies, originally established these regulations through a government-wide interim final rule published on February 26, 1990 (55 FR 6735, 6748).

On January 15, 2026, Commerce issued a proposed rule to amend part 28 by removing §§ 28.405 and 28.410, because they merely restate 31 U.S.C. 1352(c)(3) and 31 U.S.C. 1352(f), and by removing 28.600 and 28.605, because they establish reporting requirements that are no longer statutorily required or warranted (91 FR 1724). As stated in the proposed rule, these removals are intended to streamline part 28, eliminate regulatory clutter, reduce the possibility of confusion, and promote administrative efficiency.

Commerce requested comment on the proposed rule. The comment period closed on February 17, 2026. No comments were received during the public comment period, and no changes were made from the proposed rule.

This rule has been determined to be not significant for the purposes of Executive Order 12866.

This rule is an Executive Order 14192 deregulatory action.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this rule will not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required, and none was prepared.

This rule contains no new information collection requirements under the Paperwork Reduction Act of 1995.

Accordingly, for the reasons set forth above, part 28 of title 15 of the Code of Federal Regulations is amended as follows:

We are adopting an updated Filer Manual, Volume I: “General Information,” Version 43 (effective March 16, 2026) and Volume II: “EDGAR Filing,” Version 77 (March 16, 2026) and amendments to 17 CFR 232.301, Rule 301 of Regulation S-T. The updated Filer Manual Volumes are incorporated by reference into the Code of Federal Regulations.

The Filer Manual contains information needed for filers to make submissions on EDGAR. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format. 1 Filers must consult the Filer Manual in conjunction with our rules governing mandated electronic filings when preparing documents for electronic submission.

Volume I of the Filer Manual, which sets forth the requirements for becoming an EDGAR filer, was amended to reflect the implementation of technical changes adopted in EDGAR Filer Access and Account Management, Release No. 33-11313 (Sept. 27, 2024) (“EDGAR Next rulemaking”). 2 Among other things, the EDGAR Next rulemaking eliminated the use of EDGAR access codes such as passwords and passphrases and instead required the use of individual account credentials and individual permissions as maintained in the EDGAR Filer Management dashboard. Pursuant to the EDGAR Next rulemaking, these EDGAR access codes were discontinued on December 19, 2025, however, corresponding changes to the EDGAR Filer Manual planned for December 2025 were not implemented due to the impact of the lapse in appropriations from October 1, 2025, through November 12, 2025. Consequently, Section 4 of Volume I related to the use of EDGAR access codes has been removed from the EDGAR Filer Manual and Sections 5 through 9 of Volume I are renumbered as Sections 4 through 8.

Volume I was also amended to clarify the situations in which a cover letter or other supporting information must be included in a Form ID application for access for an existing CIK. Section 3(c) the Filer Manual was amended to clarify that a cover letter is required for all applicants that seek access to an existing EDGAR account, but other supporting information such as official documents from the relevant Secretary or State or Register of Corporations that identify the signatory listed on the Form ID application as an “authorized individual” is only required if applicants assert that they assumed legal control of the filer listed on the existing account but did not receive EDGAR access information from the filer.

EDGAR was updated pursuant to EDGAR Release 26.1, and corresponding amendments to Volume II of the Filer Manual were made to reflect those changes, as described below.

Starting March 16, 2026, EDGAR generally will suspend filings rather than issue warnings for incorrect or incomplete structured filing fee-related information for all filers. EDGAR will continue to issue warnings in some instances.

Separately, the ACH limit for filing fees changed from a maximum of $99,999,999.99 per transaction to $24,999,999.99 per transaction. Filers that need to exceed that limit may make multiple transactions.

As of March 16, 2026, Schedules 13D and 13G (including associated submission types) have been updated to accommodate up to 20 CUSIP numbers. At least one CUSIP entry is required.

Information regarding the submission of Inline XRL documents was removed from Chapter 5.2.5. That same information has been incorporated into the EDGAR XBRL Guide, which is referenced in Chapter 5.2.5 and which contains additional information and guidance regarding the submission of Inline XBRL documents for EDGAR.

As of March 24, 2025, Form X-17A-5 Part III no longer requires the oath or affirmation to be notarized. Therefore, the text and checkbox acknowledging notarization of the oath or affirmation have been removed from the submission template for Form X-17A-5 Part III on the EDGAR Filing website and are no longer required in filer-constructed submissions.

On October 3, 2025, the submission template for Form 13H (and associated submission types) on the EDGAR Filing website was updated to allow reordering of entries in Item 6 (List of broker-dealers at which the large trader or its securities affiliates has an account), including additions and deletions in the middle of the list per filer preference. This change does not impact the XML technical specifications for Form 13H.

Beginning March 18, 2026, each director or officer of a foreign private issuer that has securities registered under Section 12(b) or 12(g) of the Securities Exchange Act of 1934 (“Exchange Act”) must file reports under Section 16(a) of the Exchange Act, pursuant to the Holding Foreign Insiders Accountable Act (enacted December 18, 2025). Starting March 18, 2026, Forms 3, 4, and 5 include a Country field that requires a country name for all reporting persons and a field to provide a Foreign Trading Symbol.

Along with the adoption of the updated Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference of the revised Filer Manual into the Code of Federal Regulations. This incorporation by reference is approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

The updated EDGAR Filer Manual is available at https://www.sec.gov/edgar/filer-information/current-edgar-filer-manual.

Because the Filer Manual and rule amendments relate solely to agency procedures or practice and do not substantially alter the rights and obligations of non-agency parties, publication for notice and comment is not required under the Administrative Procedure Act (“APA”). 3 It follows that the amendments do not require analysis under requirements of the Regulatory Flexibility Act  4 or a report to Congress under the Small Business Regulatory Enforcement Fairness Act of 1996. 5

The Office of Management and Budget has determined that this action is not a significant regulatory action as defined in Executive Order 12866, as amended, and therefore it was not subject to Executive Order 12866 review.

The updated Filer Manual became operational on March 16, 2026, when EDGAR Release 26.1 was deployed in the EDGAR system. The effective date for use of the updated Filer Manual and the related rule amendments is April 16, 2026. In accordance with the APA, 6 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manual with the related system upgrades.

We are adopting the amendments to Regulation S-T under the authority in sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933, 7 sections 3, 12, 13, 14, 15, 15B, 23, and 35A of the Securities Exchange Act of 1934, 8 section 319 of the Trust Indenture Act of 1939, 9 and sections 8, 30, 31, and 38 of the Investment Company Act of 1940. 10

In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:

FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during October, November, and December 2025, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

The sponsors of the approved applications listed in table 2 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 3 are amended to reflect these actions.

Ivaoes Animal Health (drug labeler code 086064 in 21 CFR 510.600(c)), Kinetic Technologies, LLC, (drug labeler code 051031 in 21 CFR 510.600(c)), and Qbiotics Group Ltd., (drug labeler code 086132 in 21 CFR 510.600(c)) have informed FDA that they have changed their address. The entries in § 510.600(c) are amended to reflect these actions.

FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations.

• 21 CFR 510.600(c) is amended to remove the entries for Agri Laboratories, Ltd., as the firm is no longer the sponsor of approved applications, and to add an entry for TriviumVet.

• 21 CFR 520.1660d is amended to reflect a 2016 and 2018 change of sponsorship for oxytetracycline powder that did not get recorded in the CFR.

• 21 CFR 520.2345d is amended to reflect a 2018 change of sponsorship for tetracycline powder.

• 21 CFR 522.2100 is revised to clarify the dosage is in pounds of body weight for all species listed.

• 21 CFR 524.1055h is amended to add clarity to the dosage directions for dogs.

• 21 CFR 558.78 is amended to remove inadvertent text.

• 21 CFR 558.500 is amended to present additional language for labeling and to add clarity to indications for use and limitations.

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed a rule under the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 516, 520, 522, 524, and 558 are amended as follows:

Upon request, FDA (the Agency or we) has classified the transcutaneous electrical nerve stimulator for the relief of congestion as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On February 13, 2020, FDA received Tivic Health Systems Inc.'s request for De Novo classification of the ClearUP Sinus Relief device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 5, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 874.6000. 1 We have named the generic type of device “transcutaneous electrical nerve stimulator for the relief of congestion,” and it is identified as a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

Under the FD&C Act, submission of a premarket notification under section 510(k) (21 U.S.C. 360(k)) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for the transcutaneous electrical nerve stimulator for the relief of congestion. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows:

Upon request, FDA has classified the manual surgical instrument for appropriate patient selection for orthopedic implant as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness for its intended use. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into the appropriate device class based on risk and the regulatory controls sufficient to provide reasonable assurance of safety and effectiveness.

FDA may classify a device through an accessory classification request under section 513(f)(6) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision allows manufacturers or importers to request classification of an accessory distinct from another device upon written request. The classification is based on the risks of the accessory when used as intended as well as the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness, notwithstanding the classification of any other device with which such accessory is intended to be used. Until an accessory is reclassified by FDA, the classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, will continue to apply.

Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or importer may request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request. FDA must grant or deny the request not later than 85 days after receipt and, if granting, publish a notice in the Federal Register within 30 days of announcing the classification.

Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person filing a PMA or 510(k) may include a written request for the proper classification of an accessory that has not been classified distinctly from another device based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. When the written request is included in a submission for marketing authorization, FDA must grant or deny the request along with the response to the PMA or 510(k). Upon granting, FDA will publish a notice in the Federal Register within 30 days of announcing the classification.

On March 4, 2019, FDA received Intrinsic Therapeutics Inc.'s request for accessory classification of the Defect Measurement Tool for the Barricaid Anular Closure Device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on May 28, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.4510. 1 We have named the generic type of device “manual surgical instrument for appropriate patient selection for orthopedic implant,” and it is identified as an orthopedic manual surgical instrument used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for the orthopedic implant in terms of geometry, surgical technique and use of the device.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. At a future date, we may publish a separate notice in the Federal Register announcing our intent to exempt this device type. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in the guidance document “Medical Device Accessories—Describing Accessories and Classification Pathways” have been approved under OMB control number 0910-0823; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until (1) the Food and Drug Administration (FDA, the Agency, or we) reclassifies the device into class I or II; or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices using the procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and our implementing regulations (21 CFR part 807, subpart E).

A postamendments device that has been initially classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3) of the FD&C Act, which provides that FDA, acting by administrative order, can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of safety and effectiveness of the device for its intended use.

FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices. In general, to be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available and excludes trade secret and/or confidential commercial information, such as the contents of a pending premarket approval application (PMA) (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act (the “six-year rule”) provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of the device, but it does not include descriptions of methods of manufacture and product composition and other trade secrets.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the requirements under section 510(k) of the FD&C Act if FDA determines that a premarket notification (510(k)) is not necessary to provide reasonable assurance of the safety and effectiveness of the device.

On August 17, 2020, FDA published in the Federal Register a proposed order  1 to reclassify non-invasive bone growth stimulators intended to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions  2 (product codes LOF and LPQ)  3 4 from class III into class II, subject to premarket notification (85 FR 49986 (August 17, 2020), the “proposed order”). FDA has considered the information available to the Agency, including certain information in PMAs in accordance with the six-year rule, 5 peer-reviewed literature, the deliberations of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee convened on September 8-9, 2020 (the “Panel”) to discuss non-invasive bone growth stimulators and the proposed reclassification (as discussed in section II of this final order), as well as comments from the public docket on the proposed order (as discussed in section III of this final order), to determine whether there is sufficient information to establish special controls to effectively mitigate the risks to health (updated, as discussed in section IV of this final order). FDA has also determined based on this information that the special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to these devices.

Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order  6 to reclassify non-invasive bone growth stimulators intended to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions from class III to class II (special controls). Absent the special controls identified in this final order, general controls applicable to the device type are insufficient to effectively mitigate the risks identified for this device type, and therefore insufficient to provide reasonable assurance of the safety and effectiveness of these devices.

For these class II devices, instead of a PMA, manufacturers may submit a premarket notification and obtain FDA clearance of the devices before marketing them. This action will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for these types of devices but can instead submit a 510(k) to the Agency for clearance prior to marketing their device. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately provides patients with more timely access to these types of devices. FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients will benefit from increased access to non-invasive bone growth stimulators for which there is a reasonable assurance of safety and effectiveness.

On September 8, 2020, the Panel met to discuss and make recommendations regarding the proposed reclassification of non-invasive bone growth stimulators from class III into class II (Ref. 1). At the Panel meeting, FDA presented the regulatory history, 7 risks to health, mitigations, and special controls described in the proposed order (85 FR 49986).

The Panel generally agreed with the risks to health identified by FDA and provided recommendations to better qualify and define some of the risks to health, as discussed in section II.B of this final order.

The Panel unanimously agreed that general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness for non-invasive bone growth stimulators. The Panel also unanimously agreed that non-invasive bone growth stimulators are not life-supporting or life-sustaining. The Panel generally agreed with FDA that these devices are not of substantial importance in preventing impairment of human health, though one Panel member disagreed on the grounds that if the device failed to work as intended to treat an established nonunion, that failure may have significant health impacts rising to the level of substantial importance in preventing impairment of human health. The Panel unanimously agreed that non-invasive bone growth stimulators do not present a potential unreasonable risk of illness or injury.

The Panel unanimously agreed that sufficient information exists to develop special controls for these devices. The Panel deliberated on whether the special controls proposed by FDA appropriately mitigate the identified risks to health for this device type, and whether additional or different special controls should be considered. The Panel generally agreed with FDA's proposed special controls and recommended additional special controls. The Panel recommended that the special controls include specific requirements to ensure a rigorous clinical data set and postmarket surveillance as a means of assessing longer-term performance. The Panel also recommended that the special controls include measures beyond labeling to address risks related to interference with other electronic devices.

In conclusion, while the Panel recommended revisions to the risks to health and additional special controls (as discussed in section II.B of this final order), it generally agreed that non-invasive bone growth stimulators met each of the criteria that would support FDA's proposed reclassification of these devices from class III into class II, subject to premarket notification and special controls to mitigate the identified risks to health for these devices.

FDA considered the Panel's comments and recommendations and, as described below, either modified the final order in response to Panel feedback or explained why we disagreed with the Panel.

The Panel recommended that FDA clarify the risk of adverse interactions with other devices and include additional mitigation measures for these risks beyond labeling. Accordingly, FDA reevaluated the risks to health and mitigation measures for adverse interaction with internal/external fixation devices and electromagnetic interference (EMI). FDA made minor revisions in section IV of this final order to clarify in the identified risks that tissue damage is a result of heating of the fixation device which, in turn, leads to heating (damage) of the tissue. FDA also reconsidered mitigations for this risk to health and concluded that thermal safety is an important consideration, as signal outputs could induce currents in metal implants (for modalities that employ electromagnetic fields) or could cause deep tissue heating (for ultrasound-based devices). We therefore revised the mitigation measures for this risk in section IV of this final order to include non-clinical performance testing, which would include an evaluation of thermal safety and thermal reliability. FDA also revised relevant parts of the non-clinical performance testing special control at 21 CFR 890.5870(b)(2) to clarify that thermal safety and thermal reliability must be verified and validated. This could be demonstrated through non-clinical performance testing, for example, using applicable consensus standards ( e.g., IEC 60601 series of standards for the basic safety and essential performance of medical electrical equipment), or other validated methods.

In addition, we revised the EMI risk in section IV of this final order to clarify that patient harms could result from interference between non-invasive bone growth stimulators and electrically powered implanted devices ( i.e., non-invasive bone growth stimulators may interfere with implanted devices and vice versa), and also due to interference from electronically powered devices in the environment (such as radio-frequency emitting household electrical equipment). While implanted electrical devices ( e.g., pacemakers or nerve stimulators) may have been designed to have immunity to certain electromagnetic fields, there is potential for the electromagnetic fields of non-invasive bone growth stimulators to interfere with implanted devices, or for the electromagnetic fields of implanted devices to cause electromagnetic interference with non-invasive bone growth stimulators. Furthermore, internal/external fixation devices in the proximity of non-invasive bone growth stimulators may similarly interfere with the treatment signal or lead to heating of the fixation device, which could lead to heating and damage of the surrounding tissue. We believe the mitigation measures (electromagnetic compatibility (EMC) testing and labeling) address these risks, and that no further revisions to the mitigation measures for the EMI risk are necessary. As a potential method of EMC testing to mitigate EMI risks, FDA suggests using FDA-recognized consensus standards  8 for medical electrical equipment safety and electromagnetic compatibility, including IEC 60601-1-2 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests (Ref. 2). Additional collateral standards within the IEC 60601 series of standards may also apply, depending on the technology used in the device. Additionally, the labeling special control requires appropriate warnings for patients with implantable devices. Consistent with aforementioned consensus standards, such warnings in the labeling should specify appropriate separation distances, when applicable.

The Panel recommended that the risk of adverse biological effects either be better defined or otherwise removed from the list of risks to health associated with non-invasive bone growth stimulators. FDA maintains that this risk should be included, given that signals with select characteristics could induce adverse biologic effects outside of thermal risks. We have revised the description of this risk to health in section IV of this final order to address the Panel's recommendation and list the signal characteristics that may lead to adverse biologic effects.

During the Panel's discussion of the risks to health, the Panel Chair summarized an additional concern as “if the signal characteristics themselves need to be defined in a way that characterized safety and efficacy in a way that was independent from the field characteristics” (Ref. 3 at lines 3135-37). FDA does not believe any changes beyond those already detailed in this section are necessary to address this concern. The Panel did not identify a specific risk to health, and the stated concerns are already captured in the risks identified in section IV of this final order such as failure or delay of osteogenesis, adverse interaction with internal/external fixation devices, adverse biologic effects, and burn.

Most of the Panel agreed that non-invasive bone growth stimulators met the criteria for classification into class II. The Panel unanimously agreed that general controls alone are not sufficient to provide reasonable assurance of safety and effectiveness, that non-invasive bone growth stimulators do not present a potential unreasonable risk of illness or injury, and that sufficient information exists to establish special controls for non-invasive bone growth stimulators. All but one Panel member agreed that non-invasive bone growth stimulators are not “life-supporting or life-sustaining, or of substantial importance in preventing impairment of human health.” This Panel member disagreed on the grounds that if the device failed to work as intended to treat an established nonunion, that failure may have significant health impacts rising to the level of substantial importance in preventing impairment of human health. Other Panel members responded with the view that the impairment was the nonunion and a failure to heal the nonunion was not itself the cause of the nonunion. We additionally note that FDA identified (and the Panel concurred) that failed or delayed osteogenesis is a risk for this device, but measures such as clinical and non-clinical performance testing would mitigate the risk of failed or delayed osteogenesis and provide a reasonable expectation of the effectiveness of various treatment uses. FDA agrees with the majority of the Panel that this device type meets all of the criteria for regulation as a class II device.

The Panel recommended adding a special control for postmarket surveillance to monitor device effectiveness in real-world clinical practice. FDA disagrees. Postmarket surveillance as described by the Panel is not necessary to demonstrate reasonable assurance of safety and effectiveness. The safety profile of non-invasive bone growth stimulators is based on a long history of use of these devices and supports FDA's position that these devices do not pose sufficient safety concerns to warrant postmarket surveillance beyond standard postmarket requirements ( i.e., medical device reporting (MDR) requirements). Consistent with this safety profile, none of the non-invasive bone growth stimulator devices currently on the market under an approved PMA has required or relied on post-approval studies. Additionally, FDA's clinical data special control will help ensure there is sufficient evidence that the device performs as intended without the need to rely upon postmarket data for this determination.

The Panel additionally recommended that the clinical data special control include specific requirements to ensure a rigorous data set, such as specifying imaging modalities and a follow-up study of at least one year to confirm that the device is effective for its intended use. As discussed in more detail in our response to comment 2 in section III of this final order, the clinical data special control sets the expectation that manufacturers will provide robust clinical data to demonstrate that the device performs as intended under the anticipated conditions of use. FDA disagrees that it is necessary to specify prescriptive imaging modalities or the length of follow-up for a premarket clinical study. Appropriate timeframes for follow-up studies depend on the type of fracture and anatomic site being treated, as the timeframes to achieve fusion may vary. As such, the special control for clinical performance data has been purposefully written in a way to allow for flexibility in the endpoints and measures used to demonstrate patient benefits and mitigation of risks for this device type. However, to help ensure that clinical data meets appropriate fusion endpoints for the device's intended use, we added a requirement in the clinical data special control at 21 CFR 890.5870(b)(1) that “[i]maging data must demonstrate fusion at the treatment site.”

FDA received comments from fewer than 10 commenters on the proposed order (85 FR 49986) published in the Federal Register on August 17, 2020. The comment period on the proposed order closed on October 16, 2020. Comments received by the close of the comment period were from Congressional representatives, a trade organization, an orthopaedic scientist-surgeon, and other interested parties. Some of the comments contained one or more comments on one or more issues. Some comments supported the proposed reclassification, and others recommended against reclassification. Various comments included recommendations for special controls that commenters believed were necessary to establish reasonable assurance of safety and effectiveness.

We describe and respond to the comments in section III.B of this final order. The order of the comments and responses is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. To provide organized and efficient responses to similar issues, we grouped comments by similar subject matter, and, in some cases, we treated different subjects presented by the same commenter as distinct comments.

(Comment 1) Various commenters agreed with the proposal to reclassify non-invasive bone growth stimulators into class II. These comments generally spoke to the importance of patient access and the relatively low risk of these devices. They also stated that a lower classification ( i.e., class II instead of class III) could expedite bringing new non-invasive bone growth stimulators to market. Two comments, representing multiple interested parties, disagreed with FDA, asserting that non-invasive bone growth stimulators should be retained in class III because class II controls are insufficient to provide reasonable assurance of safety and effectiveness.

(Response 1) FDA agrees with the comments supporting reclassification of non-invasive bone growth stimulators into class II and disagrees that these devices should be retained in class III. Based on publicly available scientific evidence presented in the proposed order and to the Panel, and taking into consideration feedback from the Panel and comments received on the proposed order, FDA has determined that reclassification of non-invasive bone growth stimulators into class II, subject to premarket notification, is appropriate because general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness and there is sufficient information to establish special controls to provide such assurance. The Panel also unanimously agreed that non-invasive bone growth stimulators met the criteria for classification into class II.

Additionally, class III is inappropriate because FDA has determined, and a large majority of the Panel agreed, that non-invasive bone growth stimulators are not for use in supporting or sustaining human life, are not of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury.

We also agree with commenters that this reclassification may have a positive impact on bringing new non-invasive bone growth stimulators to market more quickly. As discussed in section I of this final order, reclassifying non-invasive bone growth stimulators into class II will reduce regulatory burdens on industry because instead of submitting a PMA, manufacturers may submit a less burdensome 510(k) to obtain FDA clearance of the device before marketing it, among other lesser regulatory requirements. We expect that this would, in turn, increase access to safe and effective therapeutics for which there is still a reasonable assurance of safety and effectiveness. The 510(k) pathway is less burdensome and generally more cost-effective for industry and FDA than the PMA pathway, the most stringent type of device marketing application required by FDA. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately provides more timely access of these types of devices to patients.

(Comment 2) A couple commenters provided recommendations regarding the quality of clinical performance data that FDA should require to support future marketing submissions for non-invasive bone growth stimulators. One commenter suggested that special controls should require high-quality clinical data without commenting on whether non-invasive bone growth stimulators should be reclassified. Another commenter stated that non-invasive bone growth stimulators should remain a class III device, but if FDA proceeds with reclassification, certain data quality standards should apply. These commenters emphasized the importance of prospective, randomized clinical trials to ensure these submissions include robust clinical evidence. One commenter additionally recommended that future clinical studies employ similar clinical trial design parameters as those used in pivotal studies for currently approved non-invasive bone growth stimulators, using clinically relevant endpoints based on imaging data and clinical measures of a subject's healing or functioning. The commenter also specified that the clinical data should be derived from clinical trials rather than citation of published literature.

(Response 2) While FDA agrees that high-quality clinical data is necessary to support 510(k)s for non-invasive bone growth stimulators, FDA disagrees that the clinical data special control should specifically require prospective, randomized clinical trials to demonstrate the effectiveness of new devices brought to the market. FDA also agrees that imaging data should be required to demonstrate device effectiveness and we have revised the clinical data special control accordingly, as further described in section II.B.3 of this final order.

We also note that data supporting approved PMAs for non-invasive bone growth stimulators were based on a range of sources that did not always include prospective randomized clinical trials. While a randomized, controlled clinical study is the highest standard for data quality, there are many sources of robust, quality clinical data that meet FDA standards for “valid scientific evidence” (21 CFR 860.7), including non-randomized studies compared to registry data, or other sources of real-world evidence. Therefore, the special controls we are finalizing for non-invasive bone growth stimulators are intentionally flexible and purposefully not intended to limit the types of clinical evidence that may support a 510(k) for these devices.

As discussed in the proposed order, differences in treatment waveform and frequency can have unknown effects on the healing pathway, resulting in significant effects on reported device effectiveness (85 FR 49986 at 49991). Therefore, to demonstrate substantial equivalence, clinical performance data must demonstrate that the device performs as intended in the indicated patient population. FDA recommends that the clinical study be sufficiently robust to adequately support the proposed indications for use for the device. A randomized prospective clinical trial would suffice, however, in certain circumstances, other forms of clinical evidence, such as real-world evidence, would also be adequately robust to support a substantial equivalence determination. Such data should be scientifically valid and include sufficient information to demonstrate a clinically meaningful benefit of the device and describe the expected safety profile, as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2).

Additionally, to demonstrate that the device performs as intended under anticipated conditions of use, the data should represent the intended patient population and intended anatomic location of the device. The study should include appropriate, clinically relevant endpoints. While the endpoint will depend on the device's specific indications for use, independent radiographic assessment of bone fusion using a clinically recognized scale and validated assessments of clinical healing are examples of appropriate endpoints. To support a demonstration of substantial equivalence, the study should also include sufficient evidence that the device performs equivalently to a legally marketed predicate device. If the subject device is not studied in conjunction with the predicate device, we recommend that the study design demonstrate a clinically meaningful and statistically significant improvement compared to an appropriate control ( e.g., sham device). A side-by-side study could also be used to demonstrate substantial equivalence in clinically relevant endpoints ( e.g., time to radiographic and clinical healing) between the subject device and a legally marketed predicate.

In lieu of using new clinical data to support a 510(k), applicants may be able to rely on clinical data from a legally marketed non-invasive bone growth stimulator with the same intended use and indications for use, if the applicant demonstrates that the critical signal parameters and operational modality of their device are sufficiently similar to those of the legally marketed device. This approach is consistent with leveraging publicly available data to support approval of a PMA. 9 Further, we revised the labeling special control in this final order to require “a detailed summary of the supporting clinical data” rather than “a detailed summary of the clinical testing” as initially proposed to more accurately represent the sources of data that may be relied upon for a 510(k). As stated above, if the applicant demonstrates that the critical signal parameters of their device are sufficiently similar to those of a legally marketed predicate device, then the “supporting clinical data” may include clinical data sets generated using that predicate device. 10

The special controls for non-invasive bone growth stimulators include controls for clinical data and non-clinical performance testing that could support unique study designs that are appropriate for the specific indications for use and technological characteristics for each device that would be reviewed in a 510(k). 11 While every clinical study developed to support a premarket submission for non-invasive bone growth stimulators should be designed to demonstrate that the device performs as intended when used in the intended patient population, the final special controls for these devices allow for customized study designs tailored specifically for each device considering the device technology and indications for use. Reclassification of these devices from class III into class II does not exclude the need for device-specific clinical data and non-clinical performance testing. Rather, the special controls establish requirements for such data and testing that is necessary to support reasonable assurance of safety and effectiveness.

This flexibility is also important for non-clinical performance testing special control requirements, which include validation and verification of thermal safety and thermal reliability, that signal characteristics are within safe physiologic limits, and that device reliability is consistent with the expected use-life. An applicant may validate and verify these safety and performance characteristics in a variety of ways, as discussed in the following paragraphs. Note that the non-clinical performance testing special control also requires validation and verification of critical performance characteristics, which we discuss in our response to comment 4 in this section of the final order.

Given the potential for devices of this type to cause patient harm due to heating from multiple sources, the non-clinical special control requires validation and verification of thermal safety and thermal reliability. First, as the control units are often worn on a patient's belt and are battery powered, excessive heating of the control unit for prolonged duration may cause thermal damage to the patient's skin and subdermal tissue. Second, the transducer itself may heat up during use, causing similar injury at the treatment site if it is patient-contacting. Finally, the signal itself may cause heating of deep tissue. This could be due to the electromagnetic fields generated by pulsed electromagnetic field (PEMF) and combined magnetic field (CMF) devices inducing currents in nearby metal implants, current leaks in capacitive coupling (CC) devices causing electrical burns, or low intensity pulsed ultrasound (LIPUS) devices causing deep tissue heating due to the mechanical effects of ultrasound signals. Testing results to appropriate standards (if applicable) to demonstrate that the device does not cause unsafe heating should be included in support of a 510(k). Literature or other scientific evidence can also be used to support the generally accepted thermal safety of the subject device's treatment signal.

Validation and verification that signal characteristics are within safe physiologic limits is required to mitigate the potential for patient harm from the generated signal, which could be due to various factors such as ultrasonic heating or tissue cavitation, excessive electrical current which could damage tissue, or electromagnetic fields which may interfere with biological function. Applicants should provide signal characterization to evaluate the nature of their device and provide scientific evidence and rationale demonstrating that the device generates a physiologically safe signal, which may include non-clinical animal testing, 12 side-by-side bench testing to demonstrate that the device signal falls within the range of a predicate device, or literature to demonstrate that similar signals have a history of safe use.

Validation and verification that device reliability is consistent with the expected use-life of the device is required because these devices are generally used daily by patients for several months and may be exposed to a large amount of physical wear. A 510(k) should provide evidence that the device can perform within specifications throughout its labeled use-life. One form this evidence may take is simulated use testing of the device. Considerations for the reliability testing special control (21 CFR 890.5870 (b)(2)(iv)) should include (as applicable), but not be limited to, continued integrity of all connection ports, repeated battery connection and disconnection, battery performance after repeated charging/discharging, integrity of all buttons/switches, performance of components after repeated reprocessing, activation of transducer for the full use-life of the device, and environmental exposure ( e.g., humidity).

(Comment 3) One commenter expressed concern that, by publishing the proposed order in the Federal Register in advance of the Panel meeting, “FDA has already prejudged the outcome” of the meeting and would potentially influence the Panel's recommendations.

(Response 3) FDA complied with all statutory and regulatory requirements in its proposal to reclassify non-invasive bone growth stimulators under section 513(f)(3) of the FD&C Act, which allows, but does not require, FDA to convene a classification panel and does not prescribe when the panel meeting and proposed order must occur in relation to each other. In the preamble to the final rule updating FDA's medical device classification procedures regulations to reflect updates made to the FD&C Act in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 122-144), FDA stated its intent to issue a reclassification proposed order under section 513(f)(3) before holding the classification panel meeting (83 FR 64443 at 64451 (December 17, 2018)). FDA's statement was in response to comments from interested parties suggesting that Congress intended this order when they passed FDASIA (83 FR at 64450). Since then, in cases when FDA has elected to convene a classification panel for a potential reclassification action under section 513(f)(3) of the FD&C Act, FDA has generally issued the proposed order before convening the panel.

(Comment 4) More than one commenter noted the wide range of technologies that have been approved as non-invasive bone growth stimulators and expressed concern that class II special controls could not be established to provide reasonable assurance of safety and effectiveness for the generic device type at least in part because of this wide range of technologies.

(Response 4) While we acknowledge that FDA has approved PMAs for non-invasive bone growth stimulators with an array of different technologies ( e.g., PEMF, CMF, CC, and LIPUS), we disagree that special controls cannot be established to provide reasonable assurance of safety and effectiveness. Furthermore, as discussed in section II.A of this final order, the Panel also unanimously agreed with FDA's conclusion that sufficient information exists to establish special controls.

In evaluating whether non-invasive bone growth stimulators should be reclassified into class II, we considered the risks to health and risk mitigations associated with the different technologies of approved devices. As part of this assessment, we evaluated peer-reviewed literature, MDRs, recalls, and additional information ( e.g., the Summary of Safety and Effectiveness from PMAs subject to the six-year rule  13 ). FDA concluded that the risks to health associated with approved non-invasive bone growth stimulators, and the appropriate mitigations of those risks, are the same across all modalities. For this reason, the special controls provide flexibility while still requiring manufacturers to account for the critical characteristics of their particular technology. While the specific testing necessary to mitigate risks for a particular device may differ by technology, the special controls are written broadly enough to apply to all non-invasive bone growth stimulators, regardless of technology.

For example, the non-clinical performance data special control (21 CFR 890.5870(b)(2)) requires validation and verification of critical performance characteristics to ensure that intended design outputs are delivered to the patient. This particular special control is broadly written to allow for flexibility in terms of which specific design outputs are relevant based upon the modality of the device. To fully describe the specific device and allow for a comparison to the predicate, we suggest providing a full and complete characterization of both the device and the therapeutic signal in the 510(k). We recommend that characterization of the signal waveform include images and a sufficiently detailed description to ensure continued treatment effectiveness. Because of the wide range of signal modalities applicable to non-invasive bone growth stimulators ( e.g., PEMF, CMF, CC, and LIPUS), it is not possible to list every treatment signal parameter that should be assessed; however, in general, we recommend including the following (as applicable): output signal shape, magnitude, primary frequency, carrier frequency, duty cycle, focal depth, magnetic flux, effective radiating area, total average power, spatial average-temporal average intensity, beam non-uniformity ratio, and any other measure needed to fully characterize the treatment signal.

Additionally, different treatment signals will pass through human tissue and bone in different ways. Consequently, while the device may be generating a treatment signal of a specific amplitude or waveform, the treatment site may be receiving a different signal. This could be caused by signal loss from the transducer/air/skin interface, or due to absorption of signal power or certain frequencies as the signal passes through soft and hard tissue. Therefore, we recommend applicants include results from validation testing to assess the signal reaching the treatment site. While it is not possible to consider every treatment attenuation scenario, we recommend applicants demonstrate that the intended treatment parameters are delivered throughout a sufficient volume to encompass the treatment site in the indicated patient population. Examples of testing may include measurement of the signal in an appropriate surrogate ( e.g., phantom model).

(Comment 5) One commenter requested that FDA issue a special controls guidance to outline additional detail regarding “key parameters for clinical studies and other data (labeling comprehension and device usability testing) to support marketing of never before-authorized [non-invasive] bone growth stimulator devices.”

(Response 5) While we do not intend to issue a guidance document to accompany the special controls identified in this final order for non-invasive bone growth stimulators at this time, the preamble to this final order has recommendations and examples for how manufacturers may comply with the special controls. In section II.B of this final order, in response to Panel feedback, we provide examples of recognized consensus standards for EMC testing that would mitigate EMI risks to satisfy the performance data special control for EMC. In our responses to comments 2 and 4 in this section of this final order, we provide examples of the different types of clinical data, clinical studies, and non-clinical performance data that could support a 510(k) for non-invasive bone growth stimulators. FDA reviews the non-clinical and clinical data and related valid scientific evidence included in a 510(k) to assess substantial equivalence to a legally marketed predicate device, including, as appropriate, conformance to special controls.

We have also revised the special controls for non-invasive bone growth stimulators to provide more detail and clarity on FDA's expectations for clinical data and non-clinical performance testing. Additionally, as discussed in section II.B.3 and in our response to comment 2 in this section of the final order, the clinical data special control now requires imaging data to further support device effectiveness. Non-clinical performance testing now more clearly requires verification and validation of critical performance and safety characteristics, which we discuss in our responses to comments 2 and 4 in this section of the final order.

(Comment 6) One commenter requested that FDA consider adding a requirement for human factors testing and/or a labeling comprehension study to the special controls.

(Response 6) FDA agrees with this comment. Based on literature and clinical data from other sources, FDA concurs that user compliance with the instructions for use is a significant factor in the effectiveness of these devices and maintaining user compliance is a known issue for these devices. These devices are used by patients, and the instructions for use should be clear and easy to follow. Additionally, labeling comprehension testing is currently relied upon to support PMA approvals of non-invasive bone growth stimulators. As such, we have added a special control to require labeling comprehension testing.

(Comment 7) One commenter stated that FDA should conduct premarket clinical and manufacturing inspections for these devices, even if they are reclassified from class III into class II.

(Response 7) FDA generally does not consider premarket clinical and manufacturing inspections to be necessary to provide reasonable assurance of safety and effectiveness for class II devices, including non-invasive bone growth stimulators. Preapproval inspections conducted in the context of a PMA approval allow FDA to assess the firm's capability to design and manufacture the device as claimed in the PMA and confirm that the firm's Quality Management System is in compliance with 21 CFR part 820, Quality Management System Regulation. FDA generally does not conduct similar premarket inspections for class II devices or when reviewing a 510(k).

Additionally, the hardware of these devices can generally be characterized with well-established methods and standards. The special controls identified in this final order establish requirements for validating both software and hardware components of these devices premarket, including that testing must verify and validate critical performance and safety characteristics of the device. The special controls also establish requirements relating to electromagnetic compatibility, electrical and thermal safety, biocompatibility, and software verification, validation, and hazard analysis.

For class II devices, routine and for cause inspections, which may consider compliance with quality management system requirements applicable to the manufacturing of the device, allow for appropriate postmarket oversight. Mechanisms and procedures for reporting safety concerns, such as MDRs and recalls, also provide additional postmarket surveillance to help ensure continued safety for marketed devices.

(Comment 8) One commenter requested that FDA either “retain control over all postmarket [non-invasive bone growth stimulator] modifications” through controls applicable to class III devices, or, if non-invasive bone growth stimulators are reclassified, that FDA include recommendations in guidance to explain which device modifications would be subject to premarket review. The commenter highlighted the importance of regulatory oversight of postmarket changes to ensure that device performance is not negatively impacted, noting that the 2006 Advisory Committee  14 and FDA previously recognized that device modifications that change device output may have unknown impacts on clinical response to treatment.

(Response 8) FDA disagrees that the requirements applicable to modifications of PMA-approved products ( i.e., premarket approval or annual reporting of changes as required for class III devices) are necessary for this device type. Consistent with 21 CFR 807.81(a)(3), a new 510(k) is required for any change or modification to a cleared device that could significantly affect the safety or effectiveness of the device, or for a major change or modification in intended use. 15 Changes and modifications that could significantly affect the safety or effectiveness of the device and may require a new 510(k) for a non-invasive bone growth stimulator device include:

• Modifications of the therapeutic signal or modifications to the transducer such that there is change to the delivered therapeutic signal.

• Changes to the indicated patient population (age range, anatomic location, fracture or fusion type, etc.).

These examples are not exhaustive. Guidance on when device changes or modifications may require a new 510(k) can be found in “Deciding When to Submit a 510(k) for a Change to an Existing Device” (Ref. 9) and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” (Ref. 10).

Regardless of whether a new 510(k) is necessary, a modified device must continue to comply with the special controls. Additionally, manufacturers may wish to use predetermined change control plans (PCCPs) as a way to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification  16 while continuing to provide reasonable assurance of device safety and effectiveness. 17 FDA reviews a PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. When used appropriately, PCCPs authorized by FDA are expected to be least burdensome for manufacturers and FDA. 18

As described in sections II and III of this final order, FDA has made revisions in this final order in response to Panel feedback and comments submitted to the public docket on the proposed order (85 FR 49986).

Additionally, as noted in footnote 2, FDA has revised the identification language from the proposed order to add the phrase “or as a treatment for established nonunions or failed fusions” to the identification language codified in this final order. (See 21 CFR 890.5780(a)). This language was included in the proposed order as an indication presented to explain the intended use, but FDA has determined that for completeness it belongs in the identification language as part of the intended use. FDA has also moved the clause in the identification language that notes the device is only for prescription use from the second sentence of the identification to the first sentence of the identification. This change was made for consistency with other device types whose classification regulations fall into 21 CFR part 890. This change does not have any substantive effect.

Furthermore, in considering the revisions to the final order, FDA identified and added two additional risks to health: (i) use error or improper device use, and (ii) infection. While the labeling special control in the proposed order included cleaning instructions for reusable components, we recognize that adding the risk of infection clarifies the importance of validated cleaning instructions as a mitigation measure to address this risk to health. Accordingly, we updated the labeling special control to clarify that cleaning instructions must be validated. As discussed in our response to comment 6, FDA added a risk of use error or improper device use because user compliance with the instructions for use is a significant factor in the effectiveness of these devices and maintaining user compliance is a known issue for these devices. Accordingly, we added a special control to require that labeling comprehension testing must demonstrate the patient can correctly use the device based solely on reading the instructions for use.

Based in part on Panel feedback and comments on the proposed order, FDA revised the list of risks to health, the special controls that FDA determined will mitigate these risks, and Table 1, “Risks to Health and Risk Mitigation Measures for Non-Invasive Bone Growth Stimulators”.

FDA has identified the following risks to health associated with the use of non-invasive bone growth stimulators:

• Failure or delay of osteogenesis. A patient could receive ineffective treatment, contributing to failure or delay of osteogenesis that may lead to clinical symptoms ( e.g., pain) and the need for surgical interventions. Ineffective treatment could be a result of various circumstances ( e.g., inadequate therapeutic signal output or device malfunction).

• Use error or improper device use. Use error or improper device use may result from a device design that is difficult to operate and/or labeling that is difficult to comprehend, leading to misuse of the device resulting in patient harm or ineffective treatment.

• Burn. A patient or health care professional could be burned from the use and operation of the device. This could be a result of various circumstances including device malfunction ( e.g., electrical fault) or misuse of the device ( e.g., use while sleeping).

• Electrical shock. A patient or health care professional could be shocked from the use and operation of the device. This could be a result of various circumstances including device malfunction ( e.g., electrical fault) or misuse of the device ( e.g., use of alternating current source during treatment).

• Electromagnetic interference (EMI). A patient with electrically powered implanted devices (such as cardiac pacemakers, cardiac defibrillators, and neurostimulators) could experience harm due to device malfunction as a result of electromagnetic interference between the implanted device and the non-invasive bone growth stimulator. Electronically powered devices in the environment (such as radiofrequency emitting household electrical equipment), may similarly interfere with the non-invasive bone growth stimulator device.

• Adverse tissue reaction. A patient could experience skin irritation and/or allergic reaction associated with the use and operation of the device via the use of non-biocompatible device materials.

• Infection. A patient could experience an infection if the patient-contacting components are not properly cleaned between uses.

• Adverse interaction with internal/external fixation devices. The signal output could be impacted by certain metallic internal or external fixation devices leading to inadequate treatment signals, device malfunction, or tissue heating and damage as a result of heating of the fixation device.

• Adverse biologic effects. A patient may experience adverse biologic effects resulting from prolonged exposure to the treatment signal via biologic interaction with the treatment signal at a cellular level. This could be due to various factors such as ultrasonic heating or tissue cavitation, excessive electrical current which could damage tissue, or electromagnetic fields which may interfere with biological function.

FDA has determined that the following special controls will mitigate these risks to health, and that these special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for non-invasive bone growth stimulators:

• The risk of failure or delay of osteogenesis can be mitigated by clinical data that demonstrates that the device performs as intended under anticipated conditions of use, including imaging data to demonstrate fusion at the treatment site. This risk can also be mitigated by non-clinical performance testing which additionally demonstrates that the device performs as intended under anticipated conditions of use, specifically through verification and validation of critical performance characteristics of the device. These include ensuring delivery of intended design outputs to the patient, thermal safety and reliability, the signal characteristics are within safe physiologic limits, and reliability of the device is consistent over the expected use-life. Software verification, validation, and hazard analysis will also help mitigate the risk of failure or delay of osteogenesis by ensuring that any device software performs as intended. Finally, labeling will also mitigate this risk by providing appropriate instructions for use ( e.g., duration, frequency of use) to the end user.

• The risk of use error or improper device use can be mitigated through labeling, including adequate warnings and instructions for use, and labeling comprehension testing that demonstrates the patient can correctly use the device based solely on reading the instructions for use.

• The risk of burns can be mitigated by non-clinical performance testing of the device to verify and validate critical performance characteristics, which include ensuring thermal safety and reliability, signal characteristics are within safe physiologic limits, and reliability of the device is consistent with its expected use-life. The risk of burns can be further mitigated by electrical safety testing to minimize the risk of thermal burns to the patient, and specific instructions regarding proper usage and specific warnings associated with the risk of burns.

• The risk of electrical shock can be mitigated by electrical safety testing to minimize the risk of shock to the patient. This risk can be further mitigated by labeling that includes instructions on appropriate usage and maintenance, and specific warnings regarding electrical shock.

• The risk of EMI can be mitigated through performance testing that demonstrates the EMC of the device and labeling to minimize the risk of adverse interaction with other electronic devices, such as implanted electronic devices.

• The risk of adverse tissue reaction can be mitigated by a biocompatibility evaluation to ensure that the materials used in patient-contacting components of the device are safe for skin contact and labeling that includes warnings against use on compromised skin or when there are known skin sensitivities, as well as validated instructions on appropriate cleaning of any reusable components.

• The risk of infection can be mitigated by labeling that includes validated instructions for appropriate cleaning of any reusable components.

• The risk of adverse interaction with internal/external fixation devices can be mitigated through labeling that includes appropriate warnings for patients with implanted medical devices, as well as non-clinical performance testing, which would include an evaluation of thermal safety and thermal reliability.

• The risk of adverse biologic effects can be mitigated by non-clinical performance testing to verify and validate critical performance characteristics of the device, which include ensuring thermal safety and reliability, signal characteristics are within safe physiologic limits, and reliability of the device over the expected use-life. The risk of adverse biological effects is further mitigated by software verification, validation, and hazard analysis, which will help ensure the device operates as intended.

In this final order, FDA is adopting relevant findings from the August 17, 2020, proposed order (85 FR 49986). FDA has made revisions in this final order in response to the Panel deliberations (see section II) and comments received (see section III). FDA is issuing this final order to reclassify non-invasive bone growth stimulators from class III into class II under a new device classification regulation with the name non-invasive bone growth stimulator, and to establish special controls by revising 21 CFR part 890 (adding 21 CFR 890.5870). The identification for § 890.5870(a) has been revised from the proposed order to provide a more accurate description of the devices in this classification regulation.

Further, in this final order, FDA has identified the special controls under section 513(b)(1)(B) of the FD&C Act that, along with general controls, provide a reasonable assurance of the safety and effectiveness for non-invasive bone growth stimulators. In this final order, the Agency has made refinements to the special controls as previously described in the proposed order to further mitigate the risks to health associated with the use of non-invasive bone growth stimulators. Specifically, and among other things, FDA revised certain special controls for clarity, added imaging criteria to demonstrate effectiveness, and added a new special control for labeling comprehension. The clinical data special control now includes a requirement for imaging to demonstrate fusion at the treatment site as evidence that the device performs as intended. There is a new special control for labeling comprehension testing to demonstrate that patients can correctly use the devices based solely on the instructions for use. We made other minor revisions to several of the special controls for clarity.

Under the FD&C Act, 510(k)s are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m). 19 FDA has not made this determination for non-invasive bone growth stimulators and, therefore, this class II device type is not exempt from 510(k) requirements. Thus, under sections 510(k) and 513(f) of the FD&C Act, persons who intend to market this device type must submit a 510(k) containing information on non-invasive bone growth stimulators that they intend to market and must obtain FDA clearance of the device prior to marketing.

Under this final order, non-invasive bone growth stimulators are prescription use devices under § 801.109 (21 CFR 801.109). Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of § 801.109 are met. The device would continue to be subject to the submission and device clearance requirements of sections 510(k) and 513 of the FD&C Act and of part 807, subpart E of FDA's regulations (21 CFR part 807).

This final order is effective 30 days after the date of its publication in the Federal Register .

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order refers to previously approved collections of information found in FDA regulations. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 807, subpart E (Premarket Notification Procedures), have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 (Quality Management System Regulation) have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 (Investigational Device Exemptions) have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts A through E (Premarket Approval of Medical Devices), have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 (Device Labeling) have been approved under OMB control number 0910-0485.

Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. In accordance with section 513(f)(3) of the FD&C Act, we are codifying in this final order the classification of non-invasive bone growth stimulators in the new 21 CFR 890.5870, under which these devices are reclassified from class III into class II.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this final order, please note that websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended) and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows:

In 2024, Congress enacted the FEND Off Fentanyl Act, 1 which, among other things, added 21 U.S.C. 2313a  2 (section 2313a). Section 2313a grants the Secretary of the Treasury (Secretary) the authority to make a finding that “reasonable grounds exist for concluding” that any of the following is of primary money laundering concern in connection with illicit opioid trafficking:

(1) One or more financial institutions operating outside of the United States;

(2) One or more classes of transactions within, or involving, a jurisdiction outside of the United States; or

(3) One or more types of accounts within, or involving, a jurisdiction outside of the United States. 3

Upon making such a finding, the Secretary is authorized to require domestic financial institutions and domestic financial agencies to take certain “special measures.” Those special measures are safeguards that may be employed to defend the United States financial system from money laundering risks connected to illicit opioid trafficking. 4 Pursuant to section 2313a, the Secretary may impose one or more of six special measures. 5 The authority of the Secretary to administer section 2313a has been delegated to FinCEN. 6

On June 25, 2025, FinCEN issued an order (“June 2025 Order”) identifying CIBanco, a Mexico-based commercial bank, as being a financial institution operating outside of the United States of primary money laundering concern in connection with illicit opioid trafficking—specifically, through its provision of financial services that facilitate illicit opioid trafficking by Mexico-based drug trafficking organizations, including the Gulf Cartel, the Beltran-Leyva Organization Cartel, and the Cartel Jalisco Nueva Generación—and imposed a prohibition on certain transmittals of funds involving CIBanco by any covered financial institution. 7 The June 2025 Order was published in the Federal Register on June 30, 2025, and through two subsequent orders, the effective date was extended to October 20, 2025. 8 The Government of Mexico has intervened in CIBanco's operations, including taking over management of CIBanco, to safeguard the Mexican financial system. Through this process, the Government of Mexico oversaw the sale of CIBanco's major assets and has taken steps to ensure that the sales of CIBanco's assets did not create additional money laundering risks to the U.S. financial system. To facilitate the Government of Mexico's efforts to liquidate and dissolve CIBanco, FinCEN finds it appropriate to amend the order to permit certain transmittals of funds. Therefore, FinCEN amends its order, published on June 30, 2025 (as amended by 90 FR 30826 (July 11, 2025) and 90 FR 40974 (August 22, 2025)).

This order defines the June 25, 2025 Order as the order published on June 30, 2025 in the Federal Register   9 prohibiting certain transmittals of funds involving CIBanco S.A., Institución De Banca Multiple (as amended by 90 FR 30826 (July 11, 2025) and 90 FR 40974 (August 22, 2025)).

All terms used but not otherwise defined herein shall have the meaning set forth in 31 CFR Chapter X, 31 U.S.C. 5312, and 21 U.S.C. 2302.

This order amends Section B (“Prohibition on Transmittals of Funds Involving CIBanco”) of the June 25, 2025 Order to read:

A covered financial institution is prohibited from engaging in any transmittal of funds from or to CIBanco. Effective beginning April 16, 2026, all transmittals of funds prohibited by this order, that are ordinarily incident and necessary for the Government of Mexico to liquidate CIBanco, are authorized, provided that (1) the Government of Mexico's appointed liquidator has determined that such transmittal of funds is necessary to liquidate CIBanco, and (2) the transmittal of funds is not otherwise prohibited by law.

All other provisions of the June 25, 2025 Order remain unchanged.

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

On June 4, 2025 (90 FR 23653), the EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Clean Air Act, the EPA is approving this rule into the California SIP. The November 13, 2024 version of Rule 425.3 will replace the previously approved version of this rule in the SIP. This approval resolves all deficiencies forming the basis for our previous limited disapproval in 2023 of the prior version of Rule 425.3. 1 The deficiencies, which related to exemptions from NO X emission limitations, have been remedied by replacing the exemptions during startup and shutdown periods with alternative NO X emission limits and removing the exemption during breakdown conditions. This action also permanently terminates all sanctions clocks and FIP clocks triggered by our June 5, 2023 limited disapproval action.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of EKAPCD Rule 425.3, “Portland Cement Kilns (Oxides of Nitrogen),” amended on November 13, 2024, which regulates emissions of NO X from Portland cement kilns. Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rule of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 2 The EPA has made, and will continue to make, these documents available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;

• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 15, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:

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

On October 23, 2025, the EPA proposed to approve the SIP revisions submitted by the State of Arizona on December 11, 2015, and on February 10, 2022, (collectively referred to herein as “Arizona's 2012 PM 2.5 I-SIP submittals”) with respect to the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2012 PM 2.5 NAAQS. 1 Based on our evaluation summarized in our proposed rulemaking and fully detailed in the accompanying technical support document, we proposed to find that Arizona's 2012 PM 2.5 I-SIP submittals contained adequate provisions to prohibit any source or other type of emissions activity within the state from emitting air pollutants in amounts that will significantly contribute to nonattainment of the 2012 PM 2.5 NAAQS in another state (prong 1) or interfere with maintenance of the 2012 PM 2.5 NAAQS in another state (prong 2). Additionally, we proposed that Arizona's 2012 PM 2.5 I-SIP submittals met the procedural requirements for public participation under CAA section 110(a)(2) and 40 CFR 51.102.

The EPA's proposed action provided a 30-day public comment period that ended on November 24, 2025. During this period, the EPA received two comments, one from a private citizen and the other from a private organization. 2 The comment submission from the private citizen was supportive of our proposed approval of the Arizona's 2012 PM 2.5 I-SIP submittals with respect to the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I). This supportive comment does not require a response. The comment submittal from the private organization raised several issues in opposition to our proposed action, so we address each one individually in this section.

Comment 1A: First, the commenter references the Regulatory Flexibility Act (RFA) and Small Business Regulatory Flexibility Act (SBREFA) and states that the EPA has done a conclusory certification under 5 U.S.C. 605(b) that the action will not have a significant economic impact on a substantial number of small entities. They state that by approving Arizona's 2012 PM 2.5 I-SIP submittals, state control measures relied upon by the EPA and the State in its submittal become enforceable under Federal law, materially changing the legal risk for small entities. The commenter states that the EPA should either prepare an initial Federal regulatory flexibility analysis under 5 U.S.C. 603 or supplement the certification with a broader analysis than what was provided in the proposal.

Response 1A: The EPA disagrees with this comment. The regulatory analysis provisions of the RFA are only triggered by a threshold determination by the Agency that this rule will have a significant economic impact on a substantial number of small entities. This action approving Arizona's 2012 PM 2.5 I-SIP submittals for the interstate transport provisions of CAA section 110(a)(2)(D)(i)(I) will not have a significant economic impact on a substantial number of small entities under the RFA or SBREFA. This action merely approves Arizona's weight of evidence analysis that emissions from sources in Arizona will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM 2.5 NAAQS in any other state, as required by the CAA, and does not impose any additional requirements beyond those already approved into the SIP or otherwise required by State law. Because the Agency has certified this rule will not have a significant economic impact, section 603 of the RFA does not apply to this rulemaking. 3

Comment 1B: Citing the Paperwork Reduction Act (PRA) and its implementing regulations at 5 CFR 1320, the commentor asserts that Federal agencies must obtain OMB approval for “ `collection of information' that an agency `conducts or sponsors,' including third-party or state submissions when a Federal agency requires persons to obtain, maintain, or disclose information to third parties.” The commentor states that many SIP provisions relied upon by Arizona in its submittal require recordkeeping, plan preparation, and third-party disclosure, such as maintaining dust control logs onsite for inspectors and maintaining vendor records. The commentor states that once these provisions are “federally approved” as part of the EPA's action on Arizona's 2012 PM 2.5 I-SIP submittals for interstate transport, EPA inspectors can require production of these records. The commentor states that the EPA must clarify whether any SIP recordkeeping or reporting obligations relied upon in Arizona's submittal are subject to the requirements of the PRA and if not, provide a reasoned explanation as to why the recordkeeping and reporting requirements are not collections of information “conducted or sponsored” by the EPA.

Response 1B: The PRA does not apply to this action. The PRA generally provides that every Federal agency must obtain Office of Management and Budget approval before using identical questions to collect information from 10 or more persons. 4 The EPA is not conducting nor sponsoring the collection of information from 10 or more persons. The EPA is merely approving Arizona's weight of evidence analysis that emissions from sources in Arizona do not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM 2.5 NAAQS in any other state, as required by the CAA, and does not impose any additional requirements beyond those already approved into the SIP or otherwise required by State law.

Comment 1C: Citing 2 U.S.C. 1532, the commentor states that “the [Unfunded Mandates Reform Act (UMRA)] requires a written statement for any rule that includes a `Federal mandate' that may result in expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year.” The commentor asserts that the EPA should either provide an UMRA analysis that shows expenditures from the EPA's approval of Arizona's interstate transport plan will not approach the $100 million threshold or explain why the proposed approval falls outside the UMRA's definition of a “Federal mandate.”

Response 1C: The EPA disagrees that this action triggers any obligations under the UMRA. The EPA has complied by making its own determination that this rule will not result in expenditures of $100 million or more in any one year, and therefore the Agency does not need to complete a statement under 2 U.S.C. 1532. As previously stated, this action merely approves Arizona's weight of evidence analysis that emissions from sources in Arizona do not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM 2.5 NAAQS in any other state, as required by the CAA. This action therefore does not impose any Federal mandate on Arizona as that term is defined in the Act. 2 U.S.C. 1555 (“Notwithstanding section 3 of this Act [2 U.S.C. 1502], for purposes of this title [2 U.S.C. 1551 et seq. ] the term “Federal mandate” means any provision in statute or regulation or any Federal court ruling that imposes an enforceable duty upon State, local, or Tribal governments including a condition of Federal assistance or a duty arising from participation in a voluntary Federal program.”).

Comment 1D: The commentor claims that the proposed action “raises novel policy and legal issues in the current administrative law landscape (including post-Loper Bright interpretive standards) and has broad intergovernmental and economic implications by federalizing source-level obligations across a large number of small entities in Arizona.” The commentor states that the “novel policy issues” and “intergovernmental implications” of the action warrant review by the Office of Information and Regulatory Affairs (OIRA), pursuant to Executive Order (E.O.) 12866. The commentor states that the EPA should either submit the rulemaking for review by OIRA or explain why “federalizing SIP obligations” does not present novel legal or policy issues and explain why the “intergovernmental implications” are not significant for purposes of E.O. 12866.

Response 1D: The EPA disagrees that a non-significance analysis is required under E.O. 12866. The Agency has complied with E.O. 12866 by determining that this rulemaking is not a significant regulatory action as defined in E.O. 12866. This action is not “federalizing SIP obligations.” As stated above, the EPA is merely approving Arizona's weight of evidence analysis that emissions from sources in Arizona do not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM 2.5 NAAQS in any other state, as required by the CAA. This action is consistent with the EPA's actions on other states' plans across the country. Accordingly, this action does not raise any novel legal or policy issues but merely concludes that Arizona's 2012 PM 2.5 I-SIP submittals meet the requirements of prongs 1 and 2 of CAA section 110(a)(2)(D)(i)(I).

Comment 1E: The commentor notes that Arizona contains numerous Tribal lands that can be affected by the downwind transport of air emissions. Because Tribal governments' air quality interests are at stake, the commentor asserts that the EPA should clarify whether any consultation was undertaken or provide a reasoned basis for concluding that there are no Tribal implications. The commentor states that the EPA should also revisit E.O. 13132 statement on federalism “in light of the practical enforcement and programmatic effects on counties that administer key SIP measures relied upon in the transport demonstration.”

Response 1E: The EPA has complied with E.O. 13175 relating to consultation with Indian tribes by certifying that the action does not fall under “policies that have Tribal implications” as that term is defined in E.O. 13175. As stated elsewhere, our action merely approves Arizona's weight of evidence analysis that it does not cause or contribute to nonattainment or interfere with maintenance in any other state, including on downwind Tribal lands. The action also does not incorporate any new rules or control measures into the Arizona SIP for which there might be federalism implications as defined by E.O. 13132.

For the reasons set forth in our proposed rulemaking and summarized herein, the EPA is taking final action to approve Arizona's 2012 PM 2.5 I-SIP submittals for compliance with the 2012 PM 2.5 NAAQS infrastructure SIP requirements of CAA section 110(a)(2)(D)(i)(I). Specifically, the EPA is finalizing our determination that the Arizona SIP, through the 2012 PM 2.5 I-SIP submittals, contains adequate provisions to ensure that emissions from sources in Arizona will not significantly contribute to nonattainment or interfere with the maintenance of the 2012 PM 2.5 NAAQS in any other state.

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;

• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 15, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:

The EPA is correcting the final rule, National Emission Standards for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating Units: Final Repeal, which published in the Federal Register at 91 FR 9088, February 24, 2026. Following publication of this document, the EPA discovered inadvertent typographical errors and omitted text in the regulatory text of the MATS NESHAP.

The EPA is correcting the following errors published in Federal Register Document Number (FR Doc.) 2026-03638, which do not change the requirements finalized in the MATS NESHAP rule that published on February 24, 2026:

• At 91 FR 9127, fourth column of Table 5 to Subpart UUUUU of Part 63—Performance Testing Requirements, the final MATS NESHAP rule amendatory instruction number 18 amended table 5 to subpart UUUUU. The regulatory text in entry 3.e.1(D) is missing part of the Reported Result equation. The EPA corrects this equation to read as: “Reported Result = (Measured Concentration in Stack)/(%R)x100.”

• At 91 FR 9133, third column, Appendix E to Subpart UUUUU of Part 63—Data Elements, the final MATS NESHAP rule amendatory instruction number 23 amended section 31.0 of appendix E to subpart UUUUU. The EPA now amends the regulatory text of section 31.0 for clarity, adding the word “data” in front of the third instance of the word “file” in the first sentence in section 31.0 to read: “You must provide each test included in the data file described in this appendix with supporting documentation, in a PDF file submitted concurrently with the data file, such that all the data required to be reported by § 63.7(g) are provided.”

Section 553 of the Administrative Procedure Act provides that when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the Agency may issue a rule without providing notice and opportunity for public comment. 1 The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because the changes to the rule are minor technical corrections, are noncontroversial in nature, and do not substantively change the requirements of the MATS NESHAP final rule. Rather, the changes correct inadvertent typographical errors and minor omitted text. Additionally, the corrections to the regulatory text match the revisions described in the preamble to the final MATS NESHAP rule. Thus, notice and opportunity for public comment are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

In FR Doc. 2026-03638 appearing at 91 FR 9088 in the Federal Register of Tuesday, February 24, 2026, the following corrections are made:

1. On page 9127, in the fourth column, the text “(D) The %R value for each compound must be reported in the test report and all field measurements corrected with the calculated %R value for that compound using the following equation: Reported Result = (Measured Concentration in Stack)/(%R)x.” is corrected to read “(D) The %R value for each compound must be reported in the test report and all field measurements corrected with the calculated %R value for that compound using the following equation: Reported Result = (Measured Concentration in Stack)/(%R)x100.”

2. On page 9133, in the third column, first sentence of section “31.0 Other Information for Each Test or Test Series”, the text “You must provide each test included in the data file described in this appendix with supporting documentation, in a PDF file submitted concurrently with the file, such that all the data required to be reported by § 63.7(g) are provided.” is corrected to read “You must provide each test included in the data file described in this appendix with supporting documentation, in a PDF file submitted concurrently with the data file, such that all the data required to be reported by § 63.7(g) are provided.”

Throughout this document, wherever “we,” “us,” or “our” are used, it is intended to refer to the EPA.

Fine particulate pollution can be emitted directly from a source (primary PM 2.5 ) or formed secondarily through chemical reactions in the atmosphere involving precursor pollutants emitted from a variety of sources. The main precursors of secondary PM 2.5 are sulfur dioxide (SO 2 ), nitrogen oxides (NO X ), ammonia (NH 3 ), and volatile organic compounds (VOCs). 1 Sulfates are a type of secondary particulate formed from SO 2 emissions from power plants and industrial facilities. Nitrates, another common type of secondary particulate, are formed from combustion emissions of NO X from power plants, mobile sources, and other combustion sources.

On January 15, 2013 (78 FR 3086), the EPA promulgated a revised primary annual PM 2.5 NAAQS to provide increased protection of public health from fine particle pollution. In that action, the EPA strengthened the primary annual PM 2.5 standard from 15.0 micrograms per cubic meter (µg/m 3 ) to 12.0 µg/m 3 , which is attained when the 3-year average of the annual arithmetic mean does not exceed 12.0 µg/m 3 . On January 15, 2015 (80 FR 2206), the EPA published air quality designations for the 2012 annual PM 2.5 NAAQS. In that action, the EPA designated all municipalities in Allegheny County, Pennsylvania as one moderate nonattainment area (Allegheny County Area) for the 2012 annual PM 2.5 NAAQS. See 40 CFR 81.339. On September 4, 2025 PADEP, on behalf of ACHD, formally submitted a redesignation request for the Allegheny County Area for the 2012 annual PM 2.5 NAAQS.

Section 107(d)(3)(E) of the CAA allows redesignation of an area to attainment of the NAAQS provided that: (1) the Administrator (EPA) determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the State containing the area has met all requirements applicable to the area for purposes of redesignation under section 110 and part D of the CAA.

On November 20, 2025 (90 FR 52319), the EPA published a notice of proposed rulemaking (NPRM) for the Commonwealth of Pennsylvania. In the NPRM, the EPA proposed approval of Pennsylvania's September 4, 2025 request to redesignate the Allegheny County Area to attainment for the 2012 annual PM 2.5 NAAQS. Notably, the EPA approved the relevant maintenance plan in a previous action. See 90 FR 34770 (July 25, 2025).

The EPA reviewed Pennsylvania's redesignation request and found that the requirements for redesignating the Allegheny County Area to attainment for the 2012 annual PM 2.5 NAAQS have been satisfied pursuant to CAA section 107(d)(3)(E). The EPA is thus approving Pennsylvania's request to change the designation of the Allegheny County Area from nonattainment to attainment for the 2012 annual PM 2.5 NAAQS. The details of Pennsylvania's request and the rationale for the EPA's now final action are explained in the NPRM and will not be restated here.

The EPA's November 20, 2025 NPRM (90 FR 52319) opened a 30-day public comment period, which closed on December 22, 2025. The EPA received comments from two commenters. Those comments and the EPA's responses are discussed below. All of the comments received and any submitted attachments are included in the docket for this rule, available at, www.regulation.gov , Docket ID Number EPA-R03-OAR-2025-1777.

On December 22, 2025, Midwest Ozone Group (MOG) submitted comments on the NPRM. In summary, MOG agrees with and supports the EPA's proposed action to redesignate the Allegheny County Area to attainment for the 2012 annual PM 2.5 NAAQS. The EPA acknowledges and appreciates MOG's comments.

On November 20, 2025, the Citizens Rulemaking Alliance (CRA) submitted comments on the NPRM. The following is a summary of CRA's comments and the EPA's responses.

Comment: The commenter claimed that the EPA did not comply with multiple statutory requirements, Executive Order 12866, and transportation conformity requirements. The commenter attributes each of these alleged procedural and statutory deficiencies to a claim that this action proposes to approve a CAA section 175A maintenance plan, including motor vehicle emissions budgets (“budgets”) for transportation conformity under CAA section 176(c) and 40 CFR part 93. First, the commenter claims that the EPA did not comply with the Regulatory Flexibility Act/Small Business Regulatory Enforcement Fairness Act (RFA/SBREFA) because the approval of budgets will impact transportation conformity determinations within the state, and as a result, impact small entities. The commenter states that the action either lacks a 605(b) certification or provides only a conclusory statement. Second, the commenter claims that the EPA did not comply with the Unfunded Mandates Reform Act (UMRA) because the approval of a maintenance plan and its contingency measures will make them federally enforceable, and budgets immediately impact transportation planning. As a result, local jurisdictions can incur planning, modeling, and project costs. The commenter claims that the EPA did not quantify these expenditures or explain why they are below UMRA thresholds. Third, the commenter claims that the EPA did not comply with the Paperwork Reduction Act (PRA) because the approved maintenance plan may contain recordkeeping, monitoring, and reporting provisions administered by ACHD and local transportation agencies. The commenter states that the EPA should clearly state if there are any information collection requirements and include the relevant Office of Management and Budget (OMB) control number. Fourth, the commenter claims that the EPA did not comply with Executive Order 12866, and that the notice should include a clear statement as to whether the action is a significant regulatory action, and if not, the basis for that determination. The commenter states that given the implication of budgets on a large metropolitan area, the EPA should provide a short explanation regarding the significance demonstration. Fifth, the commenter claims the EPA did not comply with the transportation conformity budgets adequacy process under 40 CFR part 93 because the document and docket do not appear to include the required adequacy materials or make them available for public comment. Lastly, the commenter states that if this was a direct final rule, the EPA must withdraw the direct final rule and proceed via notice-and-comment if adverse comment is received.

Response: The EPA disagrees with the commenter with respect to each issue raised. This action does not approve a maintenance plan under CAA section 175A or budgets under CAA section 176(c) and 40 CFR part 93. Therefore, the commenter's claims that the EPA did not comply with the RFA/SBREFA, UMRA, PRA, Executive Order 12866, and the transportation conformity budget adequacy process with respect to approval of a maintenance plan or budgets, or due to provisions in the maintenance plan and budgets, are beyond the scope of this action, which is limited to redesignation of the nonattainment area to attainment. The cause of noncompliance cited by the commenter for each statute, Executive Order 12866, and transportation conformity is not part of this rulemaking. The EPA previously approved, in a separate rulemaking, Pennsylvania's maintenance plan for the Allegheny County Area for the 2012 annual PM 2.5 NAAQS as a revision to the Pennsylvania SIP because it met the requirements of CAA section 175A. 2 The maintenance plan included 2017, 2026, and 2035 PM 2.5 and NO X budgets for the Allegheny County Area for the 2012 annual PM 2.5 NAAQS. The EPA's analysis of the budgets for the Allegheny County Area can be found in the EPA's budget technical support document (TSD) prepared for that rule, available online at www.regulations.gov, Docket ID: EPA-R03-OAR-2024-0586. The maintenance plan became federally enforceable on August 25, 2025, the effective date of the EPA's approval. ACHD must implement the provisions of the maintenance plan, including budgets and contingency provisions, irrespective of this action, which merely approves Pennsylvania's request to redesignate the Allegheny County Area from nonattainment to attainment for the 2012 annual PM 2.5 NAAQS. Of note, the EPA did not receive any comments on that action specific to the RFA, UMRA, PRA, Executive Order 12866, or the EPA's adequacy determination and approval of budgets.

Additionally, this action was not a direct final rule. The EPA published a proposed rule on November 20, 2025 (90 FR 52319) which opened a 30-day public comment period that closed on December 22, 2025. In this action, we are finalizing the November 20, 2025 proposed rule. The generic statement from the commenter that if this was a direct final rule, the EPA must withdraw the direct final and proceed via notice-and-comment if adverse comment is received, along with the mistaken claim that this action approves a maintenance plan and budgets, highlights that the commenter seems to have compiled a series of generic comments that were not specific to this action.

The EPA is approving Pennsylvania's request to redesignate the Allegheny County Area to attainment for the 2012 annual PM 2.5 NAAQS. The EPA has evaluated Pennsylvania's redesignation request and determined that ambient air monitoring data demonstrates that the Allegheny County Area has attained the NAAQS and the Area has met the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. The effect of this final action is to change the designation status of the Allegheny County Area from nonattainment to attainment for the 2012 annual PM 2.5 NAAQS.

Under the CAA, the redesignation of an area to attainment is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because this action is exempt from review under Executive Order 12866:

• 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); and

• 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.

In addition, this action 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).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 15, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, the EPA amends 40 CFR part 81 as follows:

This is a summary of the Commission's Direct Final Rule in GN Docket No. 25-133; FCC 25-68, adopted on September 30, 2025, and released on September 30, 2025. The full text of this document is available at the following internet address: https://www.fcc.gov/document/deleting-obsolete-and-duplicative-wireline-rules-0 .

1. The Direct Final Rule continues the Commission's efforts to modernize its regulatory framework by rescinding facially obsolete provisions of its rules. In the proceeding, the Commission has undertaken a sweeping review aimed at eliminating outdated rules, reducing unnecessary regulatory burdens, accelerating infrastructure deployment, promoting network modernization, and spurring innovation. The Commission's objective is to streamline, simplify, and smartly deregulate across multiple fronts simultaneously to better serve the public and support technological progress.

2. In initiating this proceeding, the Commission generally sought to identify rules that are obsolete, outdated, unlawful, anticompetitive, or otherwise no longer in the public interest. In the item, the Commission specifically focuses on the repeal of certain rules managed by the Consumer and Governmental Affairs Bureau (CGB) and the Wireline Competition Bureau (WCB) in Parts 1, 6, 7, 14, 43, 51, 53, 54, 61, 64, 65, 68, and 69 for which prior notice and comment are unnecessary, but for which the Commission elects to provide an opportunity for input on that assessment. Absent any significant adverse comments in response to the Direct Final Rule, these rules will be repealed.

3. Good Cause to Forgo Notice and Comment. Under the Administrative Procedure Act, when an agency for good cause finds that notice and public comment “are impracticable, unnecessary, or contrary to the public interest,” it need not follow notice and comment procedures before modifying or repealing rules. Prior notice and comment are “unnecessary” when “ `the administrative rule is a routine determination, insignificant in nature and impact, and inconsequential to the industry and to the public.' ”

4. The Commission has identified 89 rule provisions, including 386 rules and requirements, that plainly no longer serve the public interest because they regulate obsolete technology, are no longer used in practice by the Commission or carriers, or are otherwise outdated or unnecessary. Applying the “good cause” standard discussed in this document, the Commission concludes that prior notice and comment are unnecessary before repealing the rules identified in the following.

5. Direct Final Rule Process. In the Direct Final Rule, the Commission follows the processes previously outlined regarding direct final rules, which it briefly summarizes here. At times when the Commission has found prior notice and comment unnecessary before modifying or repealing rules, it simply adopted the relevant rule change without any additional process. Although the Commission reserves the right to proceed in that manner, it elects in this decision to proceed using what is known as a “direct final rule” process. By proceeding through a direct final rule, the Commission chooses to provide expanded opportunities for public comment when it is not legally required to do so under the “good cause” standard. Under a direct final rule process, rule changes are adopted without prior notice and comment, but are accompanied by an opportunity for the public to file comments—and if the Commission concludes that significant adverse comments have been filed, the relevant rule changes would not take effect until after a full notice and comment process.

6. In particular, the Commission will publish the item adopting direct final rules in the Federal Register , and allow for comment from interested parties within 20 days of Federal Register publication. Until 20 days after Federal Register publication, this shall be a “permit-but-disclose” proceeding for purposes of the Commission's ex parte rules. Because the comment process is directed toward the discrete objective of the direct final rule process, and to avoid unwarranted delay in that process, the Commission prohibits filings addressing the rule changes contemplated in the Direct Final Rule more than 20 days after Federal Register publication, absent further direction from the Commission published in the Federal Register . This both accords with the purpose of the comment process for direct final rules, and is similar (though not identical) to actions the Commission has taken in other contexts to provide a defined end-point for public filings to enable the Commission to focus its attention on the submissions already before it.

7. The direct final rules will be effective 60 days after Federal Register publication. To the extent that the Commission receives comments on these direct final rules, it will evaluate whether they are significant adverse comments that warrant further procedures before changing the rules. In the Commission's assessment, it plans to be guided by the Administrative Conference of the United States's recommendation that “[a]n agency should consider any comment received during direct final rulemaking to be a significant adverse comment if the comment explains why: a. The [direct final] rule would be inappropriate, including challenges to the rule's underlying premise or approach; or b. The [direct final] rule would be ineffective or unacceptable without a change.”

8. In the event that the Commission concludes that significant adverse comments have been filed, WCB and/or CGB will publish a timely withdrawal in the Federal Register so that this Direct Final Rule does not become effective until any appropriate additional procedures have been followed. If significant adverse comments are filed only with respect to particular amendments within this Direct Final Rule, WCB and/or the CGB, as appropriate, will withdraw the amendatory instructions that were subject to significant adverse comments. For example, if a significant adverse comment is filed regarding a single amendatory instruction within a direct final rule that contains multiple amendatory instructions, the Commission will publish a withdrawal addressing only that instruction.

9. In the event that no comments are filed in response to this Direct Final Rule, the Commission does not anticipate publishing a confirmation of the effective date in the Federal Register , but simply will allow the rule changes to take effect as originally specified. Where comments are filed but none of the comments are significant adverse comments, where warranted by the record WCB and/or the CGB will issue a Public Notice that will briefly explain why any comments filed were not determined to be significant adverse comments.

10. This document does not contain new or modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3521. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, 44 U.S.C. 3506(c)(4).

11. 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 Direct Final Rule to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).

12. Interested parties may file comments on or before the date indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).

• Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: https://www.fcc.gov/ecfs/.

• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.

○ Filings can be sent by hand or messenger delivery, by commercial courier, or by the U.S. Postal Service. All filings must be addressed to the Secretary, Federal Communications Commission.

○ Hand-delivered or messenger-delivered paper filings for the Commission's Secretary are accepted between 8:00 a.m. and 4:00 p.m. by the FCC's mailing contractor at 9050 Junction Drive, Annapolis Junction, MD 20701. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

○ Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.

○ Filings sent by U.S. Postal Service First-Class Mail, Priority Mail, and Priority Mail Express must be sent to 45 L Street NE, Washington, DC 20554.

• 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 or call CGB at (202) 418-0530 or TTY: 202-418-0432.

13. Accordingly, it is ordered that, pursuant to sections 4(i), 4(j), and 303(r) of the Communications Act, 47 U.S.C. 154(i), 154(j), and 303(r), the Direct Final Rule is adopted. Except as specified in paragraph 8, the Direct Final Rule shall be effective upon Federal Register publication of the rule changes set forth in the following, which shall also serve as the date of public notice of that action.

14. It is further ordered that the amendments of the Commission's rules as set forth in the following shall be effective 60 days after Federal Register publication. In the event that significant adverse comments are filed, WCB and/or the CGB shall publish a timely document in the Federal Register withdrawing the rule so that the rule change does not become effective until any additional procedures have been followed. In the event that significant adverse comments are filed with respect to only particular amendments, the Commission directs WCB and/or CGB, as appropriate, to publish a timely document in the Federal Register withdrawing only such amendatory instructions, so that those amendments do not become effective until any additional procedures have been followed.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1, 6, 7, 14, 43, 51, 53, 54, 61, 64, 65, 68, and 69 as follows: