This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. Part 930 referred to as the “Order” is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is comprised of growers and handlers of tart cherries operating within the area of production and a public member.

The Agricultural Marketing Service (AMS) is issuing this final rule in conformance with Executive Order 12866, as amended by Executive Order 13563. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This final rule has been reviewed under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined this final rule is unlikely to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule shall not be deemed to preclude, preempt, or supersede any State program covering tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 8c(15)(A) of the Act (7 U.S.C. 608c(15)(A)), any handler subject to an order may file with the U.S. Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.

Section 8c(17) of the Act (7 U.S.C. 608c(17)) and § 900.43 of the supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend Federal fruit, vegetable, and nut marketing agreements and orders. USDA may use informal rulemaking to amend marketing orders depending upon the nature and complexity of the proposed amendment, the potential regulatory and economic impacts on affected entities, and any other relevant matters.

AMS has considered these factors and has determined that the amendments in this final rule are not unduly complex and the nature of the amendments is appropriate for utilizing the informal rulemaking process to amend the Order. This final rule encompasses a number of changes that are primarily administrative and modernizing in nature. These changes clarify regulatory text or align it with current industry practices. The changes also simplify the administration of seating the Board. During the referendum, eligible producers and processors favored all the amendments. At least two-thirds of the eligible producers who voted, or those representing at least two-thirds of the eligible volume, supported each amendment. Additionally, participating processors representing more than fifty percent of the frozen or canned tart cherry volume within the production area voted in favor of each amendment. A discussion of the potential regulatory and economic impacts on affected entities is discussed later in the “Final Regulatory Flexibility Analysis” section of this final rule. Each amendment applies equally to all producers and handlers, regardless of size. Each amendment also has no additional impact on the reporting, record-keeping, or compliance costs of small businesses.

All eighteen Board members voted unanimously in favor of all the proposed amendments to the Order following deliberations at a public meeting held on February 15, 2022, except that the amendment related to the method for establishing a member's sales constituency received one dissenting vote. The Board formally submitted its recommendation to amend the Order through the informal rulemaking process on April 8, 2022. At USDA's request, the Board conducted an additional meeting on December 15, 2022, to publicly clarify its original intent that the sales constituency provisions of the proposal would apply to both growers and handlers, and that sales constituency would be established at the time of nomination. Specifically, the Board revised the language of its initial recommendation to clarify that a member's sales constituency is established at the time of nomination. The Board then unanimously affirmed, with sixteen voting members present, to clarify that the established sales constituency applies to both handlers and growers for the duration of the term of office. A separate vote to remove the words “and appointment” from the language received fifteen votes in favor and one dissenting vote from a member who believed sales constituency should be calculated at the time of appointment.

A proposed rule soliciting public comments on the proposed amendments was published in the Federal Register on December 4, 2023 (88 FR 84075). AMS received two comments: one comment from the Wisconsin Department of Agriculture in support of all proposed amendments, noting the proposed changes would have a favorable impact on the Wisconsin cherry industry, and another from a Michigan handler opposing Proposal 1 of the proposed rulemaking. After reviewing the comments, AMS published a proposed rule and referendum order in the Federal Register on July 19, 2024 (89 FR 58636). The proposed rule and referendum order addressed the comments received and also directed that a referendum among tart cherry producers and handlers (processors) be conducted from August 26, 2024, through September 16, 2024, to determine whether they favored the proposals. To become effective, each amendment had to be approved by at least two-thirds of the eligible producers voting in the referendum or by producers representing at least two-thirds of the eligible volume. In addition, each amendment had to be favored by processors representing more than fifty percent of the frozen or canned tart cherry volume within the production area. All the amendments met these requirements. A detailed summary of the referendum results is available online at https://www.ams.usda.gov/content/tart-cherry-producers-vote-amend-federal-marketing-order.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 330 tart cherry growers in the production area and approximately 29 handlers subject to regulation under the Order. At the time of this analysis, the Small Business Administration (SBA) defined small agricultural producers of tart cherries as those having annual receipts equal to or less than $3,500,000 (Other Noncitrus Fruit Farming, North American Industry Classification System Code 111339). Small agricultural service firms were defined as those having annual receipts equal to or less than $34,000,000 (Postharvest Crop Activities, North American Industry Classification System Code 115114) (13 CFR 121.201).

The National Agricultural Statistics Service (NASS) reported that the 2023-24 value of the tart cherry crop for processed utilization was approximately $41.4 million. The tart cherry production was 207.1 million pounds and the season average grower price for processed tart cherries was $0.20 per pound. Dividing the crop value by the estimated number of producers (330) yields an estimated average annual receipts per producer of $125,318 ($41.4 million divided by 330 producers). This is well below the SBA threshold for small producers.

To calculate handler value, AMS uses data from USDA purchases of dried tart cherries for feeding programs as a proxy for prices received by handlers. In 2024, the average price paid by USDA for dried tart cherry products was $4.984 per pound. The dried cherry price was converted to a raw product equivalent price of $0.997 per pound at an industry recognized ratio of five to one ($4.984 divided by 5 equals $0.997). Multiplying this price by 2023 total processed utilization of 207.1 million pounds results in an estimated handler-level tart cherry value of $206.4 million ($0.997 per pound multiplied by 207.1 million pounds). Dividing this figure by the number of handlers (29) yields estimated average annual receipts per handler of approximately $7.1 million ($206.4 million divided by 29 handlers), which is well below the SBA threshold of $34 million for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.

AMS has determined that the amendments as effectuated by this final rule will not have a significant impact on a substantial number of small businesses. Rather, these changes will help further standardize and stabilize Board membership and improve Board efficiency and decision making throughout the year. No small businesses are unduly or disproportionately burdened by the amendments.

This final rule modifies the basis for calculating district representation on the Cherry Industry Administrative Board (Board), changes the starting date for the term of office for Board members, simplifies the way a Board member's sales constituency is determined, clarifies how the sales constituency applies to alternate Board members, changes the timeframe for submitting nominations, and clarifies when districts are subject to volume regulation. The revised voting requirements will result in less confusion for some Board members, which can disrupt Board operations.

The Board considered the benefits and costs of maintaining the status quo as an alternative to this action. However, the Board believes the amendments are necessary to ensure the efficient execution of the Order.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0177, Tart Cherries Grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. No changes in those requirements are necessary because of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This final rule does not impose additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies.

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

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

The Board's meetings are widely publicized throughout the tart cherry production area. All interested persons were invited to attend the meetings and encouraged to participate in Board deliberations on all issues. Like all Board meetings, the meetings held on February 15, 2022, and December 15, 2022, were open to the public, and all entities, both large and small, were encouraged to express their views on the proposed amendments.

AMS published a proposed rule concerning this action in the Federal Register on December 4, 2023 (88 FR 84075). A copy of the rule was sent via email to Board staff for distribution to all Board members and Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin tart cherry growers and handlers. The proposed rule was also made available by USDA through the internet and the Office of the Federal Register. A 60-day comment period ending February 2, 2024, was provided to allow interested persons an opportunity to respond to the proposals. AMS received one comment in support of all the proposed amendments and one comment opposing one of the proposals. Based on all the information available to AMS, including both comments received in response to the proposed rule, no substantive changes were made to the amendments as proposed.

AMS then published a proposed rule and referendum order on July 19, 2024 (89 FR 58636). That document directed that a referendum among Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin tart cherry producers and handlers (processors) be conducted from August 26, 2024, through September 16, 2024, to determine whether they favored the proposals. To become effective, each amendment had to be approved by at least two-thirds of the eligible producers voting in the referendum or by producers representing at least two-thirds of the eligible volume. In addition, each amendment had to be favored by processors representing more than fifty percent of the frozen or canned tart cherry volume within the production area. The referendum results show each of the amendments met the requirements to become effective.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

The findings and determinations hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of Marketing Order 930; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.

1. Marketing Order 930 as amended, and as hereby amended and all the terms and conditions thereof, will tend to effectuate the declared policy of the Act;

2. Marketing Order 930 as amended, and as hereby amended regulates the handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin and is applicable only to persons in the respective classes of commercial and industrial activity specified in the Order;

3. Marketing Order 930 as amended, and as hereby amended is limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several marketing orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;

4. Marketing Order 930 as amended, and as hereby amended prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of tart cherries produced or packed in the production area; and

5. All handling of tart cherries grown or handled in the production area, as defined in Marketing Order 930 is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.

It is hereby determined that:

1. The issuance of this amendatory Order, amending the aforesaid Order, is favored or approved by at least two-thirds of the eligible producers or by producers representing at least two-thirds of the eligible volume that voted in the referendum on the question of approval and who, during the period of July 1, 2023, through June 30, 2024, were engaged within the production area in the production of such tart cherries; and is favored by handlers (processors) representing more than fifty percent of the frozen or canned tart cherry volume within the production area during the representative period.

2. The issuance of this amendatory Order advances the interests of producers of tart cherries in the production area pursuant to the declared policy of the Act.

It is therefore ordered, that on and after the effective date hereof, all handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin shall be in conformity to, and in compliance with, the terms and conditions of the said Order as hereby proposed to be amended as follows:

The provisions of the proposed marketing order amending the Order contained in the proposed rule issued by the Administrator and published in the Federal Register (88 FR 84075) on December 4, 2023, will be and are the terms and provisions of this order amending the Order and are set forth in full herein.

For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 930 as follows:

The Immigration and Nationality Act (INA), as amended, establishes the H-2A nonimmigrant classification for a temporary worker “having a residence in a foreign country which he has no intention of abandoning who is coming temporarily to the United States to perform agricultural labor or services . . . of a temporary or seasonal nature.” INA section 101(a)(15)(H)(ii)(a), 8 U.S.C. 1101(a)(15)(H)(ii)(a). Employers must petition the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS), for classification of prospective temporary workers as H-2A nonimmigrants. INA section 214(c)(1), 8 U.S.C. 1184(c)(1). DHS must approve this petition before the beneficiary can be considered eligible for an H-2A visa. Finally, the INA requires that “[t]he question of importing any alien as [an H-2A] nonimmigrant . . . in any specific case or specific cases shall be determined by [DHS], 1 after consultation with appropriate agencies of the Government . . . mean[ing] the U.S. Department of Labor and includ[ing] the U.S. Department of Agriculture.” INA section 214(c)(1), 8 U.S.C. 1184(c)(1).

Existing DHS regulations provide that an H-2A petition for temporary employment in the United States must be accompanied by a single valid temporary labor certification (TLC) from the U.S. Department of Labor (DOL) issued in accordance with INA section 218, 8 U.S.C. 1188, and DOL regulations established at 20 CFR part 655, subpart B. 8 CFR 214.2(h)(5)(i)(A), (D), (h)(5)(iv); see also INA sections 214(c)(1) and 218, 8 U.S.C. 1184(c)(1) and 1188. 2 The TLC serves as DHS's consultation with DOL regarding whether: (i) An able, willing, and qualified U.S. worker is available to fill the petitioning H-2A employer's job opportunity, and (ii) whether a foreign worker's employment in the job opportunity will adversely affect the wages or working conditions of similarly employed workers in the U.S. See INA sections 214(c)(1) and 218, 8 U.S.C. 1184(c)(1) and 1188; see also 8 CFR 214.2(h)(5)(ii); 20 CFR 655.100.

DHS regulations refer to a valid TLC by various terms including “Department of Labor determination” at 8 CFR 214.2(h)(2)(i)(E), “approved labor certification” at 8 CFR 214.2(h)(5)(x), and “temporary agricultural labor certification” at 8 CFR 214.2(h)(5)(i)(A), (h)(5)(iv)(B). The Form I-129, H-2A instructions also indicate that petitioners must submit a single valid temporary labor certification from DOL. 3

In 2019, DOL's Office of Foreign Labor Certification (OFLC) announced that it was transitioning electronic filing of H-2A applications to the new Foreign Labor Application Gateway (FLAG) system beginning October 1, 2019. 4 The transition to the FLAG system meant that employers whose TLCs were approved would receive the Form ETA-9142A, Final Determination: H-2A Temporary Labor Certification Approval, and Final Determination letter electronically, rather than receiving a paper TLC and Final Determination by mail. DOL provided a paper delivery exception for employers, including their authorized attorneys or agents who were not able to receive this documentation electronically. To effectuate this change, on March 6, 2020, USCIS published a notice in the Federal Register announcing that employers who received TLCs through DOL's FLAG system would need to provide a printed copy of the DOL Final Determination with the H-2A petition as required initial evidence and that a printed copy of the Final Determination completed and electronically signed by DOL satisfies the requirement that petitioners provide evidence of a valid TLC pursuant to 8 CFR 214.2(h)(5)(i)(A). 5

In 2022, DOL made electronic filing and issuance of temporary agricultural labor certifications in the H-2A program mandatory, except in limited circumstances. 6 A printed copy of the signed DOL Final Determination is still required to be submitted to USCIS with the paper-filed H-2A petition on Form I-129 as initial evidence of a valid TLC.

This rule modifies the timing of when USCIS must receive a valid TLC for certain H-2A petitions, as part of a larger effort by DOL and DHS (collectively, “the Departments”) to modernize and streamline the H-2A process. In light of an urgent demand for an authorized agricultural labor force  7 and requests from the regulated community and members of Congress to make the H-2A program easier to use and more efficient for U.S. agricultural producers, 8 the Departments are collaborating to create a more streamlined application and petition filing process for U.S. agricultural producers to help meet an urgent need for H-2A temporary agricultural workers while simultaneously ensuring that petitioners are complying with all statutory and regulatory requirements of the H-2A program. While both OFLC and USCIS have separately been meeting applicable processing timeframes, 9 this effort is nonetheless aimed at improving customer service by reducing the overall time across Federal departments it takes to complete the temporary agricultural labor certification and nonimmigrant petition processes for petitioners seeking to employ H-2A workers, and also make the process more modernized and streamlined for H-2A petitioners.

In furtherance of that overarching objective, DHS has received OMB approval on August 13, 2025 of a newly developed, streamlined PDF version of the Form I-129 petition, called Form I-129H2A, Petition for Nonimmigrant Worker: H-2A Classification, that H-2A petitioners may use to electronically file with USCIS. With the new Form I-129H2A, the petitioner is able to electronically submit evidence of the approved TLC to USCIS, rather than having to submit a printed copy of the approved TLC to USCIS as with the current paper-filed Form I-129. Because the streamlined Form I-129H2A is currently available for petitioners to submit electronically, this rule has no effect on the availability of electronic submission.

Under this rule, petitioners seeking unnamed beneficiaries will be able to electronically submit the H-2A petition after DOL issues a Notice of Acceptance (NOA) on the H-2A TLC application, pursuant to 20 CFR 655.143, and before the TLC is certified. New 8 CFR 214.2(h)(5)(i)(A). This change alters the earliest permissible submission date and enables USCIS to commence concurrent processing  10 of the H-2A petition while DOL processes the TLC, thereby allowing electronic filers to file earlier than currently permitted. Petitioners seeking concurrent processing under this rule must provide on the H-2A petition the ETA case number for the underlying TLC application but are not required to electronically submit a copy of the NOA or TLC as initial evidence, as USCIS will generally be able to access the relevant DOL information and verify both issuance of the NOA and subsequent approval of the TLC from the ETA case number. USCIS will continue to ensure that no H-2A petition is approved until DOL approves the TLC. New 8 CFR 214.2(h)(5)(i)(A)( 2 ). If applicable, USCIS will make necessary modifications to the concurrently processed H-2A petition to reflect any modifications made by DOL to the TLC after issuance of the NOA and before certification, such as when DOL amends the first date of need or reduces the number of workers requested through partial certification. Id. H-2A TLC applications that are ultimately denied will lead to a denial of the H-2A petition. Id. Note that concurrent processing will be optional; petitioners seeking unnamed beneficiaries may choose to wait until the underlying TLC has been approved before electronically filing their H-2A petition.

Petitioners seeking named beneficiaries will not be affected by this rule. Thus, petitioners seeking named beneficiaries will continue to be able to submit a petition to USCIS only after DOL certifies the H-2A TLC application. Named beneficiary petitions trigger additional legal and operational considerations, such as the 25-beneficiary limit requiring multiple petition filings supported by the same TLC, a more complicated fee structure, and the associated extension of stay or change of employer requests. H-2A portability, which allows a named H-2A worker to start working upon a petitioner's proper filing of an H-2A petition filed on the worker's behalf and in accordance with DHS regulations, also assumes a valid TLC, at the time the H-2A petition is filed, that accurately covers terms and conditions of employment that are applicable while the H-2A petition is pending. 11 Finally, modifications to the TLC by DOL could have significant ramifications on H-2A portability or for any named beneficiaries that USCIS cannot simply account for with corresponding modification of the petition. 12

In addition, the procedural change in this rule will not apply to paper-filed H-2A petitions; petitioners submitting paper H-2A petitions must continue to file only after DOL approves the H-2A TLC application. As electronic filing is a more efficient process than paper filing and offers greater potential for future development of further processing efficiencies, DHS believes that it is appropriate to limit the concurrent processing facilitated by this rule to electronically filed petitions as an incentive for H-2A petitioners to choose to electronically file their petitions. Since USCIS has recently made electronic filing available to H-2A petitioners, DHS anticipates fast and widespread adoption of electronic filing by H-2A petitioners covered by this rule given that H-2A petitioners already must electronically file their H-2A TLC applications with DOL. 13

In summary, this final rule amends 8 CFR 214.2(h)(5)(i)(A) and (D) to add an exception to the existing requirement that a valid temporary agricultural labor certification must be provided at the time of filing, for H-2A petitions requesting unnamed beneficiaries that are being filed electronically, and to make other conforming edits. See new 8 CFR 214.2(h)(5)(i)(A)( 1 ) and ( 2 ) and revised (h)(5)(i)(D). This change enables USCIS to commence processing of the H-2A petition while DOL is also processing the TLC in these cases. However, USCIS will continue to ensure that DOL approved the TLC before approving the H-2A petition. 14

The Administrative Procedure Act, 5 U.S.C. 553(b)-(c) requires agencies to publish a notice of proposed rulemaking and provide an opportunity for public comment when issuing rules, unless such rules are rules of agency organization, procedure, or practice. DHS has issued this final rule without prior notice and opportunity for comment because this is a rule of agency organization, procedure, or practice (“procedural rule”). 5 U.S.C. 553(b)(A). The procedural rule exception “covers agency actions that do not themselves alter the rights or interests of parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency.” JEM Broad. Co., Inc. v. FCC, 22 F.3d 320, 326 (D.C. Cir. 1994) (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980)); see also Mendoza v. Perez, 754 F.3d 1002, 1023-24 (D.C. Cir. 2014); Am. Hosp. Ass'n v. Bowen, 834 F.2d 1037, 1047 (D.C. Cir. 1987) (holding that procedural rules are those that do not “encode a substantive value judgment or put a stamp of approval or disapproval on a given type of behavior”).

This final rule merely changes the timing of when a valid TLC may be provided to USCIS when a petitioner is voluntarily filing an H-2A petition requesting unnamed beneficiaries electronically with USCIS. It does not alter the rights or interests of any party or encode a substantive value judgment on a given type of private behavior. An approved TLC still must be provided to USCIS before USCIS can complete the adjudication of the H-2A petition. Accordingly, DHS may forgo advance notice and opportunity for comment.

Section 553(d) of the APA requires that agencies publish substantive rules at least 30 days before their effective date, unless one of the enumerated exceptions applies. Because this rule governs agency procedure and does not alter the substantive rights or obligations of regulated parties, it is not a substantive rule within the meaning of section 553(d). Some courts have recognized that the 30-day delayed effective date requirement applies only to substantive rules, and therefore does not extend to rules of agency procedure. See, e.g., Rowell v. Andrus, 631 F.2d 699, 702 (10th Cir. 1980) (recognizing that 5 U.S.C. 553(d) applies to substantive rules and by implication exempts procedural rules). The D.C. Circuit has, however, suggested that section 553(d) may apply more broadly, stating that the 30-day requirement “applies even to rules of agency organization, procedure, or practice, but is not required for `interpretive rules and statements of policy.” Batterton v. Marshall, 648 F.2d 694, 701 (D.C. Cir. 1980). To the extent section 553(d) is construed to apply to this rule, we find good cause under section 553(d)(3) to make this rule effective upon publication. Courts have recognized that section 553(d) serves a distinct purpose and have applied a test weighing whether the need for immediate implementation outweighs affected parties' need to prepare for implementation of the new rule. See Riverbend Farms, Inc. v. Madigan, 958 F.2d 1479, 1485 (9th Cir. 1992); Am. Fed'n of Gov't Emps., AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir. 1981). In the case of this procedural rule, we find immediate implementation appropriate. The rule simply permits concurrent processing of electronically filed petitions with unnamed beneficiaries, allowing petitioners the flexibility to file a petition with USCIS sooner than previously permitted. As such, petitioners do not need to take any preparatory steps and delaying implementation would only postpone the intended efficiency. For these reasons, DHS may forgo a 30-day delayed effective date in implementing this procedural rule.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review), direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it.

Executive Order 14192 (Unleashing Prosperity Through Deregulation) directs agencies to significantly reduce the private expenditures required to comply with Federal regulations and provides that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This rule is not an Executive Order 14192 regulatory action because it is being issued with respect to an immigration-related function of the United States. The rule's primary direct purpose is to implement or interpret the immigration laws of the United States (as described in INA § 101(a)(17), 8 U.S.C. 1101(a)(17)) or any other function performed by the U.S. Federal Government with respect to aliens. See OMB Memorandum M-25-20, “Guidance Implementing Section 3 of Executive Order 14192, titled `Unleashing Prosperity Through Deregulation' ” (Mar. 26, 2025).

The costs to the public of this rule include the potential cost to petitioners pursuing concurrent processing whose TLC is denied by the DOL after having paid the non-refundable filing fees to USCIS. 15 We estimate that 73.0 percent of H-2A petitions are filed annually for unnamed beneficiaries, and that 94.8 percent of petitioners file unnamed beneficiary petitions. 16 Given that DOL has mandated electronic filing of H-2A TLC applications, by regulation, since November 14, 2022, we anticipate that many of those petitioners, and particularly those familiar with DOL programmatic requirements, will choose concurrent processing for electronically filed unnamed beneficiary petitions as their risk of having their TLCs denied after DOL issues a Notice of Acceptance is likely low. However, DHS cannot definitively estimate the number of petitioners who will ultimately opt for concurrent processing. The filing fees for Form I-129 for unnamed beneficiaries range from $460 for small employers and non-profits to $530 for other filers. 17 Employers that file a Form I-129 also pay the Asylum Program Fee; the standard fee is $600, but is $300 for small employer petitioners with 25 or fewer full-time equivalent employees. Nonprofit employers are exempt from the Asylum Program Fee. 18

The benefits to the employers using H-2A concurrent processing for certain electronically filed H-2A petitions, and to the resulting employees, is that productivity is shifted forward by approximately two weeks. This is not an extension of the time an H-2A employee is permitted to work in the United States; it only expedites the process. However, DHS expects that employers using this process will receive some expected benefit; otherwise, they are not expected to incur the risk associated with a denied TLC and lost filing fee. However, we are not able to monetize this expected benefit.

Given these factors, DHS has determined that this rule is not likely to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; and is therefore not economically significant under section 3(f)(1) of Executive Order 12866.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions). The RFA's regulatory flexibility analysis requirements apply only to those rules for which an agency is required to publish a general notice of proposed rulemaking pursuant to 5 U.S.C. 553 or any other law. See 5 U.S.C. 604(a). DHS did not issue a notice of proposed rulemaking for this action. Therefore, a regulatory flexibility analysis is not required for this rule.

The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of UMRA requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed rule, or final rule for which the agency published a proposed rule, which includes any Federal mandate that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. 19 The inflation adjusted value of $100 million in 1995 is approximately $206 million in 2024 based on the Consumer Price Index for All Urban Consumers (CPI-U). 20 This final rule is exempt from the written statement requirement, because DHS did not publish a notice of proposed rulemaking for this rule. In addition, this final rule does not contain a Federal mandate as the term is defined under UMRA. 21 The requirements of title II of UMRA, therefore, do not apply, and DHS has not prepared a statement under UMRA.

This final rule is not a “rule” as defined by the Congressional Review Act (CRA), enacted as part of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. See 5 U.S.C. 804(3)(C) (defining the term “rule” to exclude “any rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties”).

This final rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of E.O. 13132, Federalism, 64 FR 43255 (Aug. 4, 1999), this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This final rule was drafted and reviewed in accordance with E.O. 12988, Civil Justice Reform. This final rule was written to provide a clear legal standard for affected conduct and was reviewed carefully to eliminate drafting errors and ambiguities, so as to minimize litigation and undue burden on the Federal court system. DHS has determined that this rule meets the applicable standards provided in section 3 of E.O. 12988.

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

DHS and its components analyze proposed regulatory actions to determine whether the National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., applies to them and, if so, what degree of analysis is required. DHS Directive 023-01 Rev. 01 “Implementing the National Environmental Policy Act” (Dir. 023- 01 Rev. 01) and Instruction Manual 023-01-001-01 Rev. 01 (Instruction Manual)  22 establish the policies and procedures that DHS and its components use to comply with NEPA.

NEPA allows Federal agencies to establish, in their NEPA implementing procedures, categories of actions (“categorical exclusions”) that experience has shown do not, individually or cumulatively, have a significant effect on the human environment and, therefore, do not require an environmental assessment or environmental impact statement. See 42 U.S.C. 4336(a)(2), 4336e(1). The Instruction Manual, Appendix A lists the DHS Categorical Exclusions. 23

Under DHS NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions: (1) the entire action clearly fits within one or more of the categorical exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. 24

This procedural final rule is limited to amending DHS's existing regulations at 8 CFR 214.2(h)(5)(i)(A) and (D) to facilitate earlier filing and concurrent processing by DOL and USCIS of H-2A petitions filed on behalf of unnamed beneficiaries. DHS has reviewed this final rule and finds that no significant impact on the environment, or any change in environmental effect, will result from the amendments being promulgated in this rule.

Accordingly, DHS finds that the promulgation of this rule's amendments to current regulations clearly fits within categorical exclusion A3 established in DHS's NEPA implementing procedures as an administrative change with no change in environmental effect, is not part of a larger Federal action, and does not present extraordinary circumstances that create the potential for a significant environmental effect.

Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3512, and implementing regulations, 5 CFR part 1320, DHS must submit to the Office of Management and Budget (OMB) for review and approval, any reporting requirements inherent in a rule, unless they are exempt. This rule does not impose any new reporting or recordkeeping requirements under the PRA.

However, this rule requires the use of USCIS Form I-129H2A, Petition for Nonimmigrant Worker: H-2A Classification. OMB previously approved this form under the PRA. The OMB control number for this information collection is 1615-0009.

Accordingly, for the reasons set forth in the preamble, DHS amends 8 CFR part 214 as follows:

The Federal Reserve Banks make primary and secondary credit available to depository institutions as a backup source of funding on a short-term basis, usually overnight. The primary and secondary credit rates are the interest rates that the twelve Federal Reserve Banks charge for extensions of credit under these programs. In accordance with the Federal Reserve Act, the primary and secondary credit rates are established by the boards of directors of the Federal Reserve Banks, subject to review and determination of the Board.

On September 17, 2025, the Board voted to approve a 0.25 percentage point decrease in the primary credit rate, thereby decreasing the primary credit rate from 4.50 percent to 4.25 percent. In addition, the Board had previously approved the renewal of the secondary credit rate formula, the primary credit rate plus 50 basis points. Under the formula, the secondary credit rate decreased by 0.25 percentage points as a result of the Board's primary credit rate action, thereby decreasing the secondary credit rate from 5.00 percent to 4.75 percent. The amendments to Regulation A reflect these rate changes.

The 0.25 percentage point decrease in the primary credit rate was associated with a 0.25 percentage point decrease in the target range for the federal funds rate (from a target range of 4 1/4 percent to 4 1/2 percent to a target range of 4 percent to 4 1/4 percent) announced by the Federal Open Market Committee on September 17, 2025, as described in the Board's amendment of its Regulation D published elsewhere in today's Federal Register .

In general, the Administrative Procedure Act (“APA”)  1 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally delegated authority): (1) publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  2 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 3 The APA further provides that the notice, public comment, and delayed effective date requirements of 5 U.S.C. 553 do not apply “to the extent that there is involved . . . a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.”  4

Regulation A establishes the interest rates that the twelve Reserve Banks charge for extensions of primary credit and secondary credit. The Board has determined that the notice, public comment, and delayed effective date requirements of the APA do not apply to these final amendments to Regulation A. The amendments involve a matter relating to loans and are therefore exempt under the terms of the APA. Furthermore, because delay would undermine the Board's action in responding to economic data and conditions, the Board has determined that “good cause” exists within the meaning of the APA to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to the final amendments to Regulation A.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 5 As noted previously, a general notice of proposed rulemaking is not required if the final rule involves a matter relating to loans. Furthermore, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 6 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

For the reasons set forth in the preamble, the Board is amending 12 CFR chapter II as follows:

For monetary policy purposes, section 19 of the Federal Reserve Act (“Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions. 1 Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”). 2 Section 19 also provides that balances maintained by or on behalf of certain institutions in an account at a Reserve Bank may receive earnings to be paid by the Reserve Bank at least once each quarter, at a rate or rates not to exceed the general level of short-term interest rates. 3 Institutions that are eligible to receive earnings on their balances held at Reserve Banks (“eligible institutions”) include depository institutions and certain other institutions. 4 Section 19 also provides that the Board may prescribe regulations concerning the payment of earnings on balances at a Reserve Bank. 5 Prior to these amendments, Regulation D established IORB at 4.4 percent. 6

The Board is amending § 204.10(b)(1) of Regulation D to establish IORB at 4.15 percent. The amendment represents a 0.25 percentage point decrease in IORB. This decision was announced on September 17, 2025, with an effective date of September 18, 2025, in the Federal Reserve Implementation Note that accompanied the FOMC's statement on September 17, 2025. The FOMC statement stated that the Committee decided to lower the target range for the federal funds rate to 4 to 4 1/4 percent.

The Federal Reserve Implementation Note stated:

The Board of Governors of the Federal Reserve System voted to lower the interest rate paid on reserve balances to 4.15 percent, effective September 18, 2025.

As a result, the Board is amending § 204.10(b)(1) of Regulation D to establish IORB at 4.15 percent.

In general, the Administrative Procedure Act (“APA”)  7 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally-delegated authority): (1) publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  8 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 9

The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The rate change for IORB that is reflected in the final amendment to Regulation D was made with a view towards accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. Notice and public comment would prevent the Board's action from being effective as promptly as necessary in the public interest and would not otherwise serve any useful purpose. Notice, public comment, and a delayed effective date would create uncertainty about the finality and effectiveness of the Board's action and undermine the effectiveness of that action. Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to this final amendment to Regulation D.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 10 As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 11 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

For the reasons set forth in the preamble, the Board amends 12 CFR part 204 as follows:

In 2010, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Section 1071 of that Act  1 amended the Equal Credit Opportunity Act (ECOA)  2 to require that financial institutions collect and report to the CFPB certain data regarding applications for credit for women-owned, minority-owned, and small businesses. Section 1071's statutory purposes are to (1) facilitate enforcement of fair lending laws, and (2) enable communities, governmental entities, and creditors to identify business and community development needs and opportunities of women-owned, minority-owned, and small businesses.

Section 1071 directs the CFPB to prescribe such rules and issue such guidance as may be necessary to carry out, enforce, and compile data pursuant to section 1071. On March 30, 2023, the CFPB issued a final rule to implement section 1071 by adding subpart B to Regulation B (2023 final rule). The 2023 final rule was published in the Federal Register on May 31, 2023. 3 Further details about rulemaking pursuant to section 1071 can be found in the preamble to the 2023 final rule. On June 25, 2024, the CFPB issued an interim final rule (2024 interim final rule) to extend the rule's compliance dates in accordance with orders issued by the United States District Court for the Southern District of Texas. 4 The 2024 interim final rule was published in the Federal Register on July 3, 2024. 5

Challenges to the 2023 final rule filed remain ongoing in three jurisdictions; each of those courts have stayed the rule's compliance deadlines for some market participants. Specifically, the United States Court of Appeals for the Fifth Circuit has stayed the 2023 final rule and tolled the compliance deadlines for plaintiffs and intervenors in that case, until further order of the court. 6 The United States District Court for the Eastern District of Kentucky has stayed the deadlines for plaintiffs in that case to comply with the 2023 final rule until further order of the court. 7 And the United States District Court for the Southern District of Florida has stayed the 2023 final rule and tolled the rule's compliance deadlines with respect to that case's plaintiff and its members for the length of time that the Fifth Circuit stay order is in effect, subject to modification at any time by the court. 8 As the CFPB has noted in that litigation, it intends to initiate a new Section 1071 rulemaking and anticipates issuing a notice of proposed rulemaking as expeditiously as reasonably possible. 9

In its second interim final rule published June 18, 2025 (2025 interim final rule), the CFPB extended the compliance dates set forth in the 2023 final rule, as amended by the 2024 interim final rule, by approximately one year, and made conforming adjustments.

Although the CFPB determined that the Administrative Procedure Act's good cause exception for not requiring public comment applied to the 2025 interim final rule, the CFPB nevertheless solicited comments.

In this final rule, the CFPB confirms its findings in the 2025 interim final rule and has determined upon a review of comments received that no further changes are necessary, other than the correction of two typographical errors in official commentary identified by commenters.

The CFPB received 20 comments in response to the 2025 interim final rule. Most commenters addressed the 2025 interim final rule itself; these comments are summarized and discussed below in part IV. Other comments addressed provisions of the 2023 final rule not taken up by the 2025 interim final rule.

The CFPB finalizes the compliance dates in the 2025 interim final rule, under which covered financial institutions will begin collecting data as follows:

Further, the CFPB determines it is appropriate to maintain the other conforming changes to the compliance date provisions promulgated by the 2025 interim final rule. Covered financial institutions are permitted to continue using their small business originations from 2022 and 2023 to determine their compliance tier, or they may instead use their originations from 2023 and 2024, or from 2024 and 2025. Covered financial institutions are permitted to begin collecting protected demographic data required under the 2023 final rule 12 months before their new compliance date, in order to test their procedures and systems. As illustrated above, the deadline for submitting small business lending data will remain June 1 following the calendar year for which data are collected. Finally, the CFPB updated its grace period policy statement to reflect the revised compliance dates.

The CFPB adopted the 2023 final rule pursuant to its authority under section 1071, which directs the CFPB to adopt rules governing the collection and reporting of small business lending data. Some aspects of the 2023 final rule were also adopted under the CFPB's more general rulemaking authorities in ECOA. The CFPB's legal authorities are discussed in detail in the 2023 final rule. 10

The CFPB is finalizing the 2025 interim final rule's extension of the 2023 final rule's compliance dates, as previously amended by the 2024 interim final rule. ECOA section 704B(g)(1) grants the CFPB general rulemaking authority for section 1071.

Upon consideration of the comments received, the CFPB is finalizing the interim final rule. As discussed above, three courts had stayed the compliance dates set forth in the 2024 interim final rule for the plaintiffs and intervenors in those cases. However, compliance dates had not been stayed for those who were not plaintiffs, intervenors, or their members in those cases. To facilitate consistent compliance across all covered financial institutions, in the 2025 interim final rule, the CFPB extended the compliance dates set forth in the 2024 interim final rule by approximately one year. The CFPB now confirms its belief that this extension of the compliance date should be sufficient to ensure uniformity of compliance dates with the court-ordered stays and for the CFPB to issue a new proposal to reconsider certain aspects of the 2023 final rule. The CFPB is thus making no change to the 2025 interim final rule's adoption of new initial compliance dates of July 1, 2026, January 1, 2027, and October 1, 2027.

The 2023 final rule's compliance dates, as amended by the 2024 interim final rule, looked to a financial institution's volume of covered credit transactions for small businesses in each of calendar years 2022 and 2023, or 2023 and 2024, to determine the applicable compliance date. Under the 2024 interim final rule, covered financial institutions that originated at least 2,500 covered transactions in both years were required to comply with the requirements of the 2023 final rule beginning July 18, 2025 (sometimes referred to as Tier 1 institutions). Covered financial institutions not in Tier 1 that originated at least 500 covered transactions in both years had a compliance date of January 16, 2026 (Tier 2), and covered financial institutions not in Tier 1 or Tier 2 that originated at least 100 covered transactions in both years had a compliance date of October 18, 2027 (Tier 3).

In the 2025 interim final rule, the CFPB extended each of the compliance dates set forth in § 1002.114(b) by approximately one year. Thus, Tier 1 institutions now have a compliance date of July 1, 2026, Tier 2 institutions now have a compliance date of January 1, 2027, and Tier 3 institutions now have a compliance date of October 1, 2027. Likewise, institutions that did not originate at least 100 covered transactions in 2022 and 2023 but subsequently do in two consecutive calendar years are not required to comply with the rule until October 1, 2027 at the earliest. The CFPB made corresponding updates throughout the commentary accompanying § 1002.114(b) and (c), which provide additional guidance and examples regarding compliance dates.

Community group commenters opposed the compliance date extension, stating that an extension is unnecessary, creates confusion, hinders research and policy advocacy work, and imposes costs on borrowers, lenders, and policymakers. In addition, they argued that lenders and vendors have already invested in section 1071 compliance and now face regulatory limbo. Community group commenters also stated that the interim final rule will further delay the collection of critical small business lending data that is integral to improving access to capital for underserved small businesses across the country.

Industry groups and an independent office of a Federal agency supported the compliance date extension. Industry groups stated that an extension directly benefits covered entities, permitting them to ready their systems and processes without undue pressure. In addition, industry groups stated that given the various legal challenges to the section 1071 rule, it is prudent to extend the compliance dates for all covered lenders and eliminate the different timelines applicable to those lenders who challenged the rule and those who did not. Moreover, industry commenters stated that they support the delay to allow the CFPB the opportunity to reexamine the rule.

One industry group commenter suggested that the initial compliance dates begin on the first day of a calendar month because a beginning-of-the-month start date would make the transition to collecting data less burdensome, from an operational and systems perspective. Other stakeholders had similarly requested that data collection commence at the beginning of a calendar quarter.

The independent office of a Federal agency stated that it supports the delay to provide small financial institutions additional time to understand, prepare for, and comply with the rule. In addition, an extension provides more time for outreach, education, and technical guidance from the CFPB, trade associations, and government partners. A trade association supported the compliance start date on the first day of the calendar quarter, asserting this should make the transition to collecting data smoother and improve data analysis. A State banking association stated that compliance dates should be set on the first day of a calendar month. One commenter asserted that partial year data is not useful for data analysis and thus all data reported in 2027 and 2028 will be useless. The commenter stated that the compliance dates should be universal for all covered lenders, beginning on January 1, 2028. A coalition of community groups stated that lenders have had ample time to prepare for compliance and that staggered start dates and partial year reporting are not necessary. They also requested that compliance begin for all lenders on the calendar year following resolution of the lawsuits.

One commenter identified two typographical errors in the official commentary to § 1002.114 (in comments 114(b)(2)-4.vii and 114(c)(2)-6.vi).

The CFPB agrees with commenters asserting that it would be prudent to eliminate the different timelines applicable to those lenders who challenged the rule and those who did not. The CFPB continues to believe that its decision to delay the rule's compliance dates is critical to facilitate consistent compliance across all covered financial institutions. Such a consistent approach will help address any questions of regulatory limbo and confusion that commenters raised. Moreover, the revised compliance dates are necessary to give the CFPB time to consider the feedback it has received from stakeholders since the publication of the 2023 final rule and time to reconsider certain of its provisions.

The CFPB has extended the compliance dates by approximately one year (roughly 350 days), rather than a full year because it agrees with the comments that these compliance dates would be sensible; first-of-the-month start dates do facilitate the transition to collecting data.

The CFPB has corrected the typographical errors in the official commentary identified by a commenter in comments 114(b)(2)-4.vii and 114(c)(2)-6.vi.

The CFPB does not agree that extending the compliance dates is unnecessary or would create confusion, but rather the opposite; the 2025 interim final rule changes eliminate confusion by providing consistent dates for all financial institutions, whether or not they are plaintiffs or intervenors in litigation. The CFPB is not persuaded that these compliance date changes would hinder research and policy advocacy work; rather, uniform compliance dates would help ensure more consistent data and better analysis. Further, the CFPB does not agree that the compliance date changes impose costs on borrowers, lenders, and policymakers. The compliance dates set forth in the 2025 interim final rule, as reaffirmed in this final rule, delay the impositions of identified costs on borrowers and lenders alike. The CFPB is not persuaded that the compliance date changes impose costs on policymakers. Policymakers themselves did not comment that the 2025 interim rule would impose costs on them. Finally, while this final rule reaffirms delays in the collection of small business lending data, the delays for certain data would have occurred anyway as to some institutions because of the still outstanding litigation. The CFPB believes that the resolution of this uncertainty and addressing the underlying concerns raised by stakeholders about the 2023 final rule will, in the longer term, result in better data collection.

Section 1002.114(c) addresses several transitional issues. Section 1002.114(c)(1) permits a covered financial institution to collect protected demographic information required under the 2023 final rule from small business applicants beginning 12 months prior to its compliance date. As this provision does not list any compliance dates specifically, no revisions were needed when the 2025 interim final rule was published.

The CFPB received two comments on this provision. One trade association stated that the CFPB should not allow voluntary early compliance with the current rule. The commenter asserted that the rule is potentially headed towards dramatic changes before future implementation and permitting voluntary early compliance would open the door to significant privacy and data security risks for institutions that collect information the CFPB is not prepared to accept and may never be prepared to accept under the revised rule. Another trade association supported permitting voluntary early compliance.

After considering the comments, the CFPB determines that no changes to this provision are necessary. The CFPB continues to believe, as it has stated in the 2023 final rule, that voluntary collection is appropriate to help financial institutions prepare to comply with the rule and ensure that its systems are working properly. The CFPB observes that § 1002.114(c)(1) is optional. No financial institution is obligated to collect data under this provision, and any institution concerned that doing so would give rise to additional privacy and data security risks could simply choose not to do so.

Thus, a Tier 1 institution is permitted to begin collecting protected demographic information on or after July 1, 2025; a Tier 2 institution may begin on or after January 1, 2026; and a Tier 3 institution may begin on or after October 1, 2026, in order to test their procedures and systems for compiling and maintaining this information in advance of actually being required to collect and subsequently report it to the CFPB. 11

In the 2025 interim final rule, the CFPB revised § 1002.114(c)(3) (adopted in the 2024 interim final rule), which as revised permits (but does not require) a financial institution to use its originations of covered credit transactions in each of calendar years 2023 and 2024, or 2024 and 2025, rather than those in 2022 and 2023, to determine its compliance date. Financial institutions may use whichever set of dates they prefer ( i.e., 2022 and 2023, or 2023 and 2024, or 2024 and 2025). Existing comment 114(b)-4 provides examples illustrating how a financial institution uses its originations in 2022 and 2023, or in 2023 and 2024, to determine its compliance tier.

A trade association commenter expressed appreciation for the clarification that lenders can use 2022 and 2023, 2023 and 2024, or 2024 and 2025 to determine compliance tier.

The CFPB received no additional comments on these portions of § 1002.114(c)(3), or comment 114(b)-4, and determines that no changes to the provision are necessary.

Section 1002.114(c)(2) provides that a financial institution that is unable to determine the number of covered credit transactions it originated in 2022 and 2023 for purposes of determining its compliance tier is permitted to use any reasonable method to estimate its originations to small businesses for either or both of 2022 and 2023. Existing comment 114(c)-5 lists several reasonable methods a financial institution may use to estimate its originations.

Pursuant to revised § 1002.114(c)(3), which permits a financial institution to use its originations of covered credit transactions in each of calendar years 2023 and 2024, or 2024 and 2025, to determine its compliance date, financial institutions are likewise permitted to use any reasonable method to estimate their originations for either or both of 2023 and 2024, or 2024 and 2025. Existing comment 114(c)-6 provides examples of ways financial institutions may estimate their originations.

A trade association commenter expressed support for permitting lenders to use any reasonable method to estimate origination volume, stating that many lenders do not track gross annual revenue for small business customers.

The CFPB received no additional comments on § 1002.114(c)(2) or (3), or on comments 114(c)-5 or -6, and determines that no changes to these provisions are necessary.

Section 1002.109(a)(1) provides that covered financial institutions must submit their small business lending application registers to the CFPB on or before June 1 following the calendar year for which the data are compiled and maintained. As this provision does not list any compliance dates specifically, no revisions were needed.

The CFPB received no comments on this provision. Thus, Tier 1 institutions will make their first data submission by June 1, 2027; Tier 2 and Tier 3 by June 1, 2028.

The CFPB is adopting an effective date of 60 days after publication of this final rule in the Federal Register .

In the 2025 interim final rule, the CFPB updated its Grace Period Policy Statement to reflect the new compliance dates to avoid any doubt as to its intentions regarding a grace period when the rule goes into effect. 12

The CFPB received two supportive comments on the decision to maintain the 12-month grace period, adjusted for the new compliance dates. One individual commenter stated that the grace period fosters a cooperative regulatory environment, enabling financial institutions to refine their reporting while allowing CFPB to identify common issues and best practices. A trade association commented that while it supports the policy statement, the CFPB should consider a complete grace period such that banks are not subject to “matters requiring attention” or similar exam findings for the first year of collection. In addition, the trade association stated that the CFPB should issue a joint grace period policy statement with the banking agencies, so banks under $10 billion have the same grace period as larger banks.

The CFPB will take these recommendations under advisement. The CFPB observes that the Grace Period Policy Statement as written already states that examinations will be diagnostic and will help to identify compliance weaknesses, and that the CFPB does not intend to assess penalties with respect to errors in the initial data submissions. 13 Further, the CFPB expects to work with other regulators to encourage them to adopt similar grace period policy statement.

The Grace Period Policy Statement described in the 2025 interim final rule remains in effect, for the reasons set out in that statement.

In developing this final rule, the CFPB has considered the potential benefits, costs, and impacts as required by section 1022(b)(2) of the Consumer Financial Protection Act of 2010 (CFPA). 14 Section 1022(b)(2) calls for the CFPB to consider the potential benefits and costs of a regulation to consumers and covered persons, including the potential reduction of consumer access to consumer financial products or services, the impact on depository institutions and credit unions with $10 billion or less in total assets as described in section 1026 of the CFPA, and the impact on consumers in rural areas. In addition, section 1022(b)(2)(B) directs the CFPB to consult with appropriate prudential regulators or other Federal agencies, regarding consistency with the objectives those agencies administer. The CFPB has accordingly consulted with the appropriate prudential regulators and other Federal agencies regarding consistency with any prudential, market, or systemic objectives administered by these agencies.

This final rule confirms the determinations the CFPB made in the 2025 interim final rule, which are discussed in more detail in part VII.D below. This final rule does not make any additional substantive changes to the compliance dates or accompanying provisions.

The CFPB solicited comment on the 2025 interim final rule. This final rule confirms the determinations the CFPB made in the 2025 interim final rule. This final rule does not make any additional substantive changes to the compliance dates or accompanying provisions.

In evaluating the potential benefits, costs, and impacts of this final rule, the CFPB takes as a baseline Regulation B as amended by the 2023 final rule, the 2024 interim final rule, and the 2025 interim final rule. Part IV above summarizes the relevant provisions of the 2023 final rule, as amended by the 2024 and 2025 interim final rules. The rule being finalized does not substantively revise Regulation B beyond the 2023 final rule, as amended by the 2024 and 2025 interim final rules, and thus does not confer any costs or benefits relative to the baseline.

The CFPB received 20 comments on the 2025 impact analysis in the interim final rule. A few comments were specific to the impact analyses of the 2025 interim final rule. We discuss these comments below. Overall, the CFPB did not receive any comments that would lead it to change its assessment of the costs or benefits of the 2025 interim final rule.

The CFPB provides an overview here of the impacts of the 2025 interim final rule to provide context for the comments it received. The CFPB determined that financial institutions would benefit from the 2025 interim final rule because of the delay in the expected costs of compliance with the 2023 final rule, caused by the extension of the compliance dates by approximately one year for all covered institutions. The CFPB expected covered financial institutions to experience an annual ongoing cost of compliance with the 2023 final rule. Therefore, extending the compliance dates potentially saves financial institutions approximately one year's worth of expected annual compliance costs. The CFPB estimated that the expected cost savings from the 2025 interim final rule will be about $92 million in 2025, about $190 million in 2026, and about $75 million in 2027, not accounting for discounting for future years. The present discounted value of the total cost savings, discounting back to 2024, is about $313 million using a 3 percent discount rate or about $337 million using a 7 percent discount rate. 15 Further amortizing these savings over three years implies an annualized cost savings of about $119 million using either a 3 percent or a 7 percent discount rate.

The CFPB determined that the 2025 interim final rule will not change the nominal value of the one-time costs that will be incurred by covered institutions but does potentially delay the realization of those costs approximately one year into the future for institutions in each compliance tier. Thus, the new one-time costs of implementing the 2023 final rule and the 2024 and 2025 interim final rules are the baseline one-time costs discounted by approximately one year to the extent they have not already been incurred. The CFPB additionally expected that the compliance date extension by the 2025 interim final rule and the associated flexibility in years of origination data that can be used to determine coverage would confer a benefit to covered institutions with the additional time to prepare for compliance relative to the baseline. Finally, with the extension of the compliance dates by approximately one year, the 2025 interim final rule delays the realization of the potential benefits to covered financial institutions, thus conferring costs.

In part IX.F of the 2023 final rule, the CFPB described how small businesses would benefit from the rule through the enforcement of fair lending laws and on community development. In an environment with limited data sources on small business credit, the CFPB expected data collected under the rule to enable communities, governmental entities, and creditors to identify business and community development needs and opportunities for women-owned, minority-owned, and small businesses. The CFPB also expected data collected under the 2023 final rule to facilitate fair lending enforcement by Federal, State, and local enforcement agencies. To the extent small businesses benefit in the above ways from the 2023 final rule, the CFPB determined that the extension of the compliance dates by the 2025 interim final rule reduces the benefits accruing to small businesses by delaying the realization of these benefits, thus conferring costs. The CFPB expected that the benefits of the 2023 final rule will primarily begin with the publication of the data. Thus, small businesses' and financial institutions' realizations of the benefits arising from the 2023 final rule will likewise be delayed by at least one year by the 2025 interim final rule, reducing the real net present value of these expected future benefits. The 2023 final rule also described that the CFPB expected financial institutions to pass on a portion of their annual ongoing costs to small business borrowers in the form of higher rates or fees. While, in general, the CFPB expected the magnitude of any pass-through to be a small portion of the total cost of the average loan to a small business applicant, extended compliance dates from the 2025 interim final rule could benefit small business borrowers by delaying these increased costs.

A coalition of community groups asserted that the 2025 impact analysis in the interim final rule overestimates the costs of the 2023 final rule, and that, accordingly, the cost savings of the 2025 interim final rule were overestimated. The CFPB relied on the same cost estimates from the 2023 final rule to quantify the cost savings of the 2025 interim final rule and continues to believe that they are appropriate for estimating the impacts of the rule. The group did not provide additional estimates of the 2025 interim final rule.

The group further asserted that the 2025 interim final rule dismissed critical benefits of the 2023 final rule, thus underestimating the costs of delaying implementation. In particular, the group claims that the 2025 interim final rule does not fully account for the benefit of market transparency for lenders because of the 2023 final rule, which would offset compliance costs. The group also points out that the annualized cost savings of the rule represent only a fraction of the income of insured depository institutions in 2024. Finally, the group asserted that suggesting that these benefits are merely qualitative diminishes the costs of discriminatory treatment. The group did not provide additional substantive information on the costs of delaying benefits of the 2023 final rule but commented that these costs would be significant.

The CFPB acknowledges the difficulty of precisely estimating the benefits of the 2023 final rule, and thus the costs of delaying data collection associated with the 2025 interim final rule. However, comments raising concerns about the lack of precise estimates did not provide sufficient new sources of data or alternative methods that could be used to quantify the costs of delaying data collection. Given the available information, the CFPB continues to believe the costs of delayed benefits of the 2025 interim final rule have been well considered, even if the CFPB is unable to estimate the magnitude of the costs.

An independent office of a Federal agency commented on the 2025 interim final rule that the 2023 final rule did not fully consider costs to small entities, though the commenter relied on those estimates to describe the cost savings of the 2025 interim final rule. For example, the commenter asserted that the CFPB did not properly account for comments from the agency on the 2023 final rule regarding the costs of staff time, training, and implementing new processes. However, the commenter did not provide sufficient information upon which to update these estimates in their comments on the 2023 final rule or the 2025 interim final rule. The CFPB continues to believe that the impacts of the 2023 final rule were well considered and responsive to comments, as discussed in the 2023 final rule.

As discussed in part VII.C, the rule being finalized does not substantively revise Regulation B beyond the baseline. Further, the CFPB did not receive comments that would suggest it is necessary to reconsider the impacts of the 2025 interim final rule. Thus, the CFPB does not anticipate that this final rule will confer any additional costs or benefits to covered persons or small businesses beyond those already accounted for in the 2025 interim final rule.

The CFPB does not anticipate that this final rule will confer any additional costs or benefits to depository institutions and credit unions with $10 billion or less in total assets beyond those already accounted for in the 2025 interim final rule.

The CFPB does not anticipate that this final rule will confer any additional costs or benefits to depository institutions and credit unions with $10 billion or less in total assets beyond those already accounted for in the 2025 interim final rule.

The CFPB's Acting Director certifies that this final rule will not have any impacts on small entities and so a final regulatory flexibility analysis is not required. 16 The rule will not impose any costs on creditors, including small entities.

Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are generally required to seek approval from the Office of Management and Budget (OMB) for information collection requirements prior to implementation. Under the PRA, the CFPB may not conduct or sponsor, and, notwithstanding any other provision of law, a person is not required to respond to an information collection unless the information collection displays a valid control number assigned by OMB. The final rule amends 12 CFR part 1002 (Regulation B), which implements the small business lending rule. The CFPB's OMB control number for Regulation B is 3170-0013; its current expiration date is August 31, 2026.

The 2025 interim final rule did not add to or change the data collection requirements of the 2023 final rule; rather, it only changed the rule's compliance dates and makes other date-related conforming adjustments. The CFPB therefore determined that this 2025 interim final rule was “economically significant.” This action was considered an Executive Order 14192 deregulatory action. However, the CFPB does not anticipate that this final rule will generate any costs or benefits relative to the baseline of the 2025 interim final rule.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the CFPB will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States at least 60 days prior to the rule's published effective date. The Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) has designated this final rule as a “major rule” as defined by 5 U.S.C. 804(2).

OIRA has determined that this action is a “economically significant regulatory action” under Executive Order 12866. Accordingly, OMB has reviewed this action.

For the reasons set forth in the preamble, the CFPB amends Regulation B, 12 CFR part 1002, as follows:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2025-3427; Project Identifier MCAI-2025-01344-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Frank Carreras, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3539; email: Frank.Carreras@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0175, dated August 8, 2025 (EASA AD 2025-0175) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-200, and A340-300 series airplanes; and Model A340-541, A340-542, A340-642, and A340-643 airplanes. Model A340-542 and A340-643 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability. The MCAI states that during certification activity of revenue flight landing gear down (RFLGD) operations for the Beluga XL ( i.e., Model A330-743L) airplanes, it was determined that the brake system accumulators might be exposed to a temperature lower than the one for which the accumulator is qualified. The landing gear system for the Model A330-743L airplane is similar in design to that on the Model A330-200, A330-200 Freighter, A330-300, A340-200, A340-300, A340-500, and A340-600 series airplanes. It was also determined, in the case of loss of the blue hydraulic system, that the SOV protecting the brake accumulators from internal hydraulic pressure loss could be identically affected while performing RFLGD operations. Each of these conditions, if not corrected, could lead to damage to the brake accumulator bladder and loss of SOV function, possibly resulting in the loss of emergency braking and consequent damage to the airplane. The MCAI also states that it was determined that, if an airplane is dispatched under master minimum equipment list (MMEL) conditions associated with the Electronic Centralized Aircraft Monitor (ECAM) “L/G RETRACTION FAULT” alert message, operations for Constant Speed Motor/Generator (CSM/G) ( i.e., emergency power supply) will be prevented. This condition, if not corrected, would, after a total engine flame out, lead to total loss of electrical power and consequent loss of control of the airplane.

The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-3427.

The FAA reviewed EASA AD 2025-0175, which specifies procedures for revising the existing AFM to incorporate new procedures for flight with landing gear down and the existing MMEL to prevent dispatch with a “L/G Retraction Fault” alert. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2025-0175 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

EASA AD 2025-0175 requires operators to “inform all flight crews” of revisions to the AFM and MEL, and thereafter to “operate the aeroplane accordingly.” However, this AD does not specifically require those actions as those actions are already required by FAA regulations. FAA regulations require operators furnish to pilots any changes to the AFM (for example, 14 CFR 121.137) and to ensure the pilots are familiar with the AFM (for example, 14 CFR 91.505). As with any other flightcrew training requirement, training on the updated AFM content is tracked by the operators and recorded in each pilot's training record, which is available for the FAA to review. FAA regulations also require pilots to follow the procedures in the existing AFM including all updates. Section 91.9 requires that any person operating a civil aircraft must comply with the operating limitations specified in the AFM. FAA regulations (§ 121.628(a)(2)) require operators to provide pilots with access to all the information contained in the operator's MEL. Furthermore, § 121.628(a)(5) requires airplanes to be operated under all applicable conditions and limitations contained in the operator's MEL. Therefore, including a requirement in this AD to operate the airplane according to the revised AFM and MEL would be redundant and unnecessary.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2025-0175 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2025-0175 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2025-0175 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2025-0175. Material required by EASA AD 2025-0175 for compliance will be available at regulations.gov under Docket No. FAA-2025-3427 after this AD is published.

Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because, if an airplane is dispatched with the landing gear retraction system inoperative and “L/G Retraction Fault” alert under existing MEL conditions, and a total engine flame out occurs, this could lead to total loss of electrical power and consequent loss of control of the airplane. Further, if an airplane is operating with landing gear down, the brake system accumulators, and the SOV protecting the brake accumulators from internal hydraulic pressure loss, could be exposed to a temperature lower than one for which the accumulator and SOV are qualified, which could lead to damage to the brake accumulator bladder and loss of SOV function and result in the loss of emergency braking and consequent damage to the airplane. Additionally, the compliance time in this AD is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 153 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The NPRM was published in the Federal Register on February 19, 2025 (90 FR 9876). The NPRM was prompted by AD CF-2024-32, dated September 11, 2024 (Transport Canada AD CF-2024-32) (also referred to as the MCAI), issued by Transport Canada, which is the aviation authority for Canada. The MCAI states an Airbus Canada Limited Partnership investigation revealed a change in the feed-through connector O-ring material at frame (FR) 51 increased the electrical bonding resistance due to the current torque specification being inadequate, which may lead to electrical bonding levels which exceed allowable design limits, leaving the aircraft more susceptible to electromagnetic interference (EMI), high-intensity radiated fields (HIRF) and lightning strikes.

In the NPRM, the FAA proposed to require electrical bonding tests to determine the resistance between the feed-through connectors and the forward side of the bulkhead at FR 51, and the installation of two electrical bonding plates if any connectors have more than the specified resistance, as specified in Transport Canada AD CF-2024-32. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-0206.

The FAA received a comment from Air Line Pilots Association, International (ALPA) who supported the NPRM without change.

The FAA received additional comments from two commenters, including Delta Air Lines (Delta) and one anonymous commenter. The following presents the comments received on the NPRM and the FAA's response to each comment.

Delta requested the FAA add an exception to the proposed AD to allow all electrical bonding tests to be completed in accordance with paragraph A. of Transport Canada AD CF-2024-32, followed, before further flight, by installation of electrical bonding plates in accordance with paragraph B. of Transport Canada AD CF-2024-32. Delta stated that, in the service information referenced in Transport Canada AD CF-2024-32, the electrical bonding test at one feed-through connector, followed immediately by the applicable corrective action, is repeated 21 more times for a total of 22 feed-through connectors. Delta stated the workflow in the proposed AD would be cumbersome, requiring multiple handoffs between skills and that multiple handoffs increase the possibility of turnover error through miscommunication. Delta stated Transport Canada AD CF-2024-32 allows the completion all tests, the identification of all discrepant connectors, and turnover of all required corrective actions to technicians for completion of that corrective action. Delta stated this reduces turnover error by only turning over test results one time and the end result of reviewing all connectors and the correction of any with unsatisfactory bonding resistance, as applicable, before further flight remains the same.

The FAA agrees to clarify. The FAA notes that compliance times in ADs take precedence over any compliance time specified in referenced service information. The FAA notes that the time of “followed immediately by the applicable corrective action” is not specifically stated in the service information referenced in Transport Canada AD CF-2024-32 but is inferred. Regardless of if the service information contains a compliance time or not, operators must accomplish the required actions within the compliance time specified in Transport Canada AD CF-2024-32, except as specified in paragraphs (h)(1) and (2) of this AD.

No exception is needed to this AD because, as noted by Delta, Transport Canada AD CF-2024-32 allows for all connectors to be inspected first and then the replacement of the discrepant connectors must be done before further flight as specified in paragraph B. of Transport Canada AD CF-2024-32. Since this AD mandates the compliance times in Transport Canada AD CF-2024-32, this AD also allows for all connectors to be inspected first. The FAA has not revised this AD in this regard.

Delta requested that the FAA add an exception to specify that where Airbus Canada Service Bulletin BD500-534011 states to record the electrical bonding test result in Appendix A of the service bulletin, the AD would permit the use of either Appendix A or an equivalent form developed by the operator and recording the same information. Delta commented that paragraph (i) of the proposed AD removes the reporting requirement, but it does not remove the requirement referenced in the service information referenced in Transport Canada AD CF-2024-32 to record the test results in Appendix A. Delta stated that they do not object to the requirement to record test results but prefer to use internally developed documentation. Delta stated that operators, as a matter of practice, frequently develop their own documentation to accomplish work instructions in a manner which complies with mandated work instruction documents including the recording of test results. Delta stated the mitigation of the unsafe condition is not affected by the use of alternative forms, provided the required information is reported.

The FAA agrees to clarify. In excluding a reporting requirement, the FAA is also excluding the requirement to record test results and send them to Airbus Canada, as specified in the Airbus Canada Service Bulletin BD500-534011. Therefore, recording the test results is not required by this AD and no change to this AD is necessary.

An anonymous commenter stated the proposed AD should require operators to document and report the results of electrical bonding tests to the FAA. The commenter stated this data can support compliance verification and provide insight into broader trends in bonding degradation. The commenter noted that FAA Advisory Circular 43-210A, dated May 31, 2018, encourages structured data collection and reporting to support continued airworthiness actions.

The FAA disagrees with this request. In general, the FAA only requires reporting if the results are needed to determinate the scope of the identified unsafe condition or to develop corrective actions. For this AD, reporting is not necessary as the installation of the bonding plates addresses the unsafe condition. The FAA also notes that Transport Canada did not include reporting requirements in Transport Canada AD CF-2024-32. The FAA has not revised this AD in this regard.

An anonymous commenter stated they had questions about the specific diagnostic thresholds or engineering criteria used to determine the need for bonding plate installation, and how it will be communicated in the instructions for continued airworthiness. The commenter stated that clearly defined technical criteria reduce ambiguity and ensure consistent implementation across operators.

The FAA agrees to clarify. As specified in Transport Canada AD CF-2024-32, the electrical bonding tests are done to determine if the bonding plate installation is necessary and those tests are done as specified in the procedure of the service information identified in Transport Canada AD CF-2024-32. That procedure specifies that if the test results show that the value is more than the specified maximum resistance, then the installation must be done.

An anonymous commenter stated the proposed timeframe of 12,000 flight hours or 48 months should be evaluated for flexibility based on operator type and fleet utilization, particularly for lower-utilization carriers such as regional airlines. The commenter stated that flexible compliance windows that still prioritize safety can reduce maintenance burdens and support efficient fleet management.

The FAA disagrees with this request. In developing an appropriate compliance time for this action, the FAA considered the compliance times specified in Transport Canada AD CF-2024-32, the urgency associated with the subject unsafe condition, and the availability of required parts. In consideration of these items, the FAA has determined that the actions required by this AD must be done within the compliance time specified in this AD to ensure an acceptable level of safety. However, under the provisions of paragraph (j)(1) of this AD, the FAA will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. The FAA has not changed this AD in this regard.

An anonymous commenter stated they had questions about the FAA providing or endorsing any specific training materials or procedural guidance to ensure maintenance technicians are equipped to perform bonding tests and install bonding plates correctly. The commenter stated the FAA's Aviation Maintenance Technician Handbook outlines the importance of tailored training for novel procedures.

The FAA notes that training requirements are outside the scope of this AD. The FAA has determined that accomplishing the electrical bonding tests and the installation of two electrical bonding plates, as required by this AD, addresses the identified unsafe condition. The service information referenced in Transport Canada AD CF-2024-32 provides appropriate procedures for accomplishing those actions. The FAA has not changed this AD in this regard.

An anonymous commenter stated the FAA should coordinate with the European Union Aviation Safety Agency (EASA) and Transport Canada to harmonize compliance expectations for affected aircraft types to avoid duplicative testing or installations for multinational operators and to support global safety consistency. The commenter noted that International Civil Aviation Organization (ICAO) Annex 19 supports international alignment of airworthiness directives to improve safety and efficiency.

The FAA acknowledges the request. The FAA has coordinated with Transport Canada. As specified in the NPRM, pursuant to the FAA's bilateral agreement with the State of Design Authority for the affected aircraft, Transport Canada notified the FAA of the unsafe condition described in the Transport Canada AD referenced above. However, the FAA will not communicate directly with EASA regarding this AD, or the Transport Canada AD, because Transport Canada, as the State of Design Authority, has communicated with EASA regarding the Transport Canada AD. The FAA has not changed this AD in this regard.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

Transport Canada AD CF-2024-32 specifies procedures for electrical bonding tests to determine the resistance between the feed-through connectors and the forward side of the bulkhead at FR 51, and the installation of two electrical bonding plates if any connectors have more than the specified resistance. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 36 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 757-200, -200PF, and -200CB series airplanes. The NPRM was published in the Federal Register on July 8, 2025 (90 FR 30030). The NPRM was prompted by a report of improper grinding of the inner diameter of the MLG outer cylinders, resulting in possible heat damage to the outer cylinders. In the NPRM, the FAA proposed to require a records check or inspection to determine if an affected outer cylinder is installed and replacing all affected outer cylinders. The FAA is issuing this AD to address heat damage to the MLG outer cylinders. The unsafe condition, if not addressed, could cause failure of a principal structural element to sustain its limit load or collapse of the MLG, which could result in loss of control of the airplane or runway departure.

The FAA received comments from the Air Line Pilots Association, International (ALPA) and Boeing who supported the NPRM without change.

The FAA received an additional comment from Aviation Partners Boeing (APB). The following presents the comment received on the NPRM and the FAA's response to the comment.

APB stated that the installation of winglets per Supplemental Type Certificate (STC) ST01518SE does not affect accomplishment of the actions specified in the proposed AD.

The FAA agrees that STC ST01518SE does not affect the ability to accomplish the actions required by this AD. The FAA has not changed the AD in this regard.

The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Requirements Bulletin 757-32A0216 RB, dated January 26, 2024. This material specifies procedures for performing a maintenance records check or an inspection of the left and right MLG outer cylinders to determine if any affected part numbers and serial numbers are installed and replacing any affected outer cylinder. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 399 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any replacement that would be required based on the results of the inspection or maintenance records check. The agency has no way of determining the number of airplanes that might need this replacement:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. The NPRM was published in the Federal Register on April 7, 2025 (90 FR 14927). The NPRM was prompted by reports of corrosion on one or more of the eight lower fitting assemblies and adjacent lavatory components on certain lavatories. In the NPRM, the FAA proposed to require a detailed inspection of the lower fitting assemblies and the centerline partition threshold of the lavatories for corrosion, recording on the modification record placard, and applicable on-condition actions. The FAA also proposed to require revising the existing maintenance program to incorporate a detailed inspection of the lavatory vertical side forward fittings for corrosion or damage. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from ProTech Aero Services Limited who supported the NPRM without change.

The FAA received additional comments from five commenters, including All Nippon Airways (All Nippon), American Airlines (American), Boeing, and an anonymous commenter. The following presents the comments received on the NPRM and the FAA's response to each comment.

American requested that the FAA revise the applicability of the proposed AD to exclude Model 787-8, 787-9, and 787-10 airplanes that have never been equipped with Jamco family 95/96 lavatories. American noted Boeing Special Attention Requirements Bulletin B787-81205-SB250302-00 RB, Issue 001, dated August 21, 2024, identifies airplanes that were delivered with and without the Jamco family 95/96 lavatories and airplanes known to have been modified to be equipped with the affected lavatories. American also noted the requirements bulletin includes conditions to account for airplanes that may have been modified to either remove or install the affected lavatories. Based on this, American concluded the proposed AD is only applicable to airplanes that have, or have had, Jamco family 95/96 lavatories installed, and airplanes that have never had the affected lavatories installed are exempted from the inspections specified in the proposed AD.

The FAA agrees to exclude airplanes that were neither delivered with the affected lavatories, nor equipped with the affected lavatories after delivery. These airplanes are identified as Group 3, Configuration 1, and Group 4, Configuration 3 airplanes in table 1 of the requirements bulletin, and no actions are required for those airplanes. The FAA has revised paragraph (c) of this AD accordingly.

United requested that the FAA extend the compliance time for the inspection by 3 months. United stated that the proposed compliance time does not allow it to schedule the inspection for all of its affected airplanes during base maintenance visits, which would force some of its airplanes out of service.

The FAA disagrees with commenter's request. The FAA assessed the risk and determined that the inspection compliance times specified in the “Compliance” paragraph of Boeing Special Attention Requirements Bulletin B787-81205-SB250302-00 RB, Issue 001, dated August 21, 2024, are appropriate to mitigate the risk. The FAA considered the safety implications and normal maintenance schedules when establishing compliance times that adequately address the unsafe condition of this AD. However, under the provisions of paragraph (k) of this AD, the FAA will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. The FAA has not changed the AD in this regard.

A commenter requested that the FAA closely coordinate with operators to carefully define the inspection intervals to ensure operators can achieve compliance with minimal possible operational disruption.

The FAA acknowledges the commenter's request but has not revised the AD in this regard for the same reasons noted in the FAA's response to the previous comment.

Boeing requested the FAA add a note to paragraph (g) of the proposed AD to allow accomplishing the placard recording (condition 1, action 1 and condition 2, action 2) and maintenance plan revision (condition 1, action 2 and condition 2, action 3) within 38 months after completing the initial inspection. Boeing noted that Boeing Special Attention Requirements Bulletin B787-81205-SB250302-00 RB, Issue 001, dated August 21, 2024, specifies those actions should be completed before further flight after the inspection. Boeing, however, asserted those actions are not critical to flight safety and should not be required to be done before further flight for an airplane to return to service. Boeing stated it has no plans to revise the requirements bulletin to account for this.

The FAA partially agrees with the commenter's request. The FAA agrees that the placard recording and maintenance plan revision are administrative changes that are not critical to flight safety. However, the FAA disagrees with extending the compliance time to 38 months after accomplishing the inspection. The FAA has determined that extending the compliance time to 90 days after accomplishing the inspection or repair instructions, as applicable, is an appropriate time for accomplishing the administrative actions. Accordingly, the FAA has added a new exception to paragraph (h)(2) of this AD.

All Nippon requested that the FAA revise the proposed AD to reference any interim action, such as a service bulletin or other relevant measure, if one is issued before the proposed AD is finalized.

The FAA acknowledges the commenter's request, but no change is necessary to the AD in this regard. The FAA has determined no later service information or any other measure that would affect AD compliance has been issued in the interim. The FAA has not changed the AD in this regard.

Boeing requested that the FAA revise the proposed AD to allow accomplishment of the inspection in accordance with maintenance review board report (MRBR) Item Number 25-185-00 for lavatories with no previous repairs as an AMOC to accomplishing the inspection in accordance with paragraph 3.A., step (3) of the Accomplishment Instructions of Jamco Service Bulletin B80-25-4112, Revision 2, dated April 24, 2024. Boeing stated that the inspections in the Jamco service bulletin and MRBR item are identical, and that some operators accomplished the inspections in accordance with the MRBR item prior to the service bulletin release, and those operators would like to receive credit.

The FAA partially agrees. The FAA disagrees with adding an AMOC to this AD but agrees that an inspection accomplished before the effective date of this AD using MRBR Item Number 25-185-00 for lavatories with no previous repairs is acceptable for compliance with the inspection required by paragraph (g) of this AD. Accordingly, the FAA has added a new paragraph (j) to this AD allowing credit. The FAA notes that operators may apply for an AMOC in accordance with the provisions in paragraph (k) of this AD to use MRBR Item Number 25-185-00 as a method of compliance after the effective date of this AD.

Boeing requested that the FAA revise paragraph (h)(2) of the proposed AD to state, where Boeing Special Attention Requirements Bulletin B787-81205-SB250302-00 RB, Issue 001, dated August 21, 2024, specifies contacting Boeing for repair instructions, and if those instructions include a modification to the maintenance actions or intervals specified in section (g) of the proposed AD, then the proposed AD requires doing the repair using a method approved in accordance with the procedures specified in paragraph (j) of the proposed AD. Boeing stated repairs that do not change the inspection method or interval specified in the requirements bulletin comply with the proposed AD.

The FAA disagrees with Boeing's request. The exception in paragraph (h)(3) of this AD (corresponding to paragraph (h)(2) of the proposed AD) is intended to require an AMOC anytime a manufacturer needs to be contacted for repair instructions. Adopting the requested wording would allow operators to circumvent the procedures in 14 CFR 39.19, as specified in paragraph (k) of this AD. Since the requirements bulletin does not provide repair instructions or point to another source for repair instructions, such as an aircraft maintenance manual (AMM), an operator will need to contact Boeing if corrosion is found, and that should be done according to the procedures in paragraph (k) of this AD to ensure the FAA has awareness of all repair instructions. If certain corrosion findings can be corrected using existing procedures like an AMM task, then this can be addressed with a revision to the service information. If alternative repair instructions that go beyond what is specified in the current service information are needed to address the unsafe condition, and those repairs involve changing the inspection method or interval, then the service information can be revised to specify contacting Boeing for repair instructions for that situation. The FAA has not revised the AD in this regard.

Boeing requested the FAA add a new exception to paragraph (h) of the proposed AD to clarify that the detailed inspection in paragraph 3.A, step (4) of Jamco Service Bulletin B80-25-4112, Revision 2, dated April 24, 2024, is required for Jamco lavatories with basic part number (P/N) B80095( ) or B80096( ) on which a previous repair has been completed on a lavatory fitting. Boeing stated that Boeing Service bulletin B787-81205-SB250302-00 only points to paragraph 3.A, step (3) of the Jamco service bulletin as a method of compliance for the detailed inspection, but that step is only applicable to lavatories with no previous repairs of lavatory fittings. Boeing also stated it has no plans to revise the corresponding service bulletin to account for this.

The FAA partially agrees. The FAA agrees that paragraph 3.A., step (4) of the Jamco service bulletin is applicable to lavatories with a previous repair of a lavatory fitting with a doubler that covers the bottom of the fitting and extends below the access hole. These lavatory fittings have an additional step (4) for accessing the bottom of the fitting to do the detailed inspection because the doubler may hide corrosion. However, the FAA disagrees that paragraph 3.A., step (3) of the Jamco service bulletin is only applicable to lavatories with no previous repairs of lavatory fittings. Step (3) of the Jamco service bulletin is applicable to all lavatories with P/N B80095( ) or B80096( ) because step (3) provides details on how to inspect the visible surfaces for corrosion. The FAA has added a new exception in paragraph (h)(4) of this AD to clarify that the detailed inspection must be accomplished using step (3) and step (4), as applicable.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Special Attention Requirements Bulletin B787-81205-SB250302-00 RB, Issue 001, dated August 21, 2024. This material specifies procedures for a detailed inspection of the eight lower fitting assemblies and the centerline partition threshold of the Jamco family 95/96 lavatories for corrosion, recording on the modification record placard, and applicable on-condition actions. On condition actions include repairing any corrosion found. This material also specifies revising the existing maintenance program to incorporate MRBR item number 25-185-00 (detailed inspection of the lavatory vertical side forward fittings for corrosion or damage).

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 159 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has determined that revising the existing maintenance program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this AD.

The FAA has included all known costs in its cost estimate. According to the parts manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Comments Invited

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2025-3424; Project Identifier AD-2025-01362-A” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to David Enns, Aviation Safety Engineer, FAA, 1801 S Airport Road, Wichita, KS 67209. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA received a report that, during a production ground run for a Textron Model B200GT airplane, two rivets sheared off of a rudder control pushrod, causing the rudder control pushrod to fail. It was discovered that an incorrect type of rivet may have been installed during installation of the rudder control pushrod end that does not meet the strength requirements of the type design. Failure of a rudder control pushrod may result in a rudder jam or loss of rudder control. This condition, if not addressed, could result in loss of control of the airplane during flight or ground operations. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is issuing this AD because the agency determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

The FAA reviewed Beechcraft Mandatory Service Letter MTL-27-07, dated July 25, 2025 (Beechcraft Mandatory SL MTL-27-07), which specifies procedures for a visual inspection of the attaching rivets of the pilot and copilot rudder control pushrods for incorrect rivets and replacement if necessary. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This AD requires accomplishing the actions specified in Beechcraft Mandatory SL MTL-27-07 described previously.

Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has determined that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because incorrect rivets used during installation of the rudder control pushrod do not meet the strength requirements of the type design. Failure of a rudder control pushrod may result in a rudder jam or loss of rudder control. Rudders are critical components to maintaining controlled flight and a rudder jam could lead to a loss of rudder control, and loss of control of the airplane. This condition could result at any time and without warning. Thus, the FAA has determined that the airplanes must be inspected within 20 hours time-in-service or 30 days, whichever occurs first. This compliance time is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 89 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary replacements that would be required based on the results of the inspection. The agency has no way of determining the number of airplanes that might need these replacements:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. The NPRM was published in the Federal Register on July 8, 2025 (90 FR 30027). The NPRM was prompted by a report of improper grinding of the inner diameter of the MLG outer cylinders, resulting in possible heat damage to the outer cylinders. In the NPRM, the FAA proposed to require a records check or inspection to determine if an affected outer cylinder is installed and replacing all affected outer cylinders. The FAA is issuing this AD to address heat damage to the MLG outer cylinders. The unsafe condition, if not addressed, could cause failure of a principal structural element to sustain its limit load or collapse of the MLG, which could result in loss of control of the airplane or runway departure.

The FAA received comments from the Air Line Pilots Association, International (ALPA) and Boeing who supported the NPRM without change.

The FAA received an additional comment from Aviation Partners Boeing (APB). The following presents the comment received on the NPRM and the FAA's response to the comment.

APB stated that the installation of winglets per Supplemental Type Certificate (STC) ST00830SE does not affect accomplishment of the actions specified in the proposed AD.

The FAA agrees that STC ST00830SE does not affect the ability to accomplish the actions required by this AD. The FAA has not changed the AD in this regard.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Requirements Bulletin 737-32A1585 RB, dated January 15, 2024. This material specifies procedures for performing a maintenance records check or an inspection of the left and right MLG outer cylinders to determine if any affected part numbers and serial numbers are installed and replacing affected outer cylinders. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 1,833 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any replacement that would be required based on the results of the inspection or maintenance records check. The agency has no way of determining the number of airplanes that might need this replacement:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2025-3421; Project Identifier MCAI-2025-01202-G” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Adam Hein, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0140, dated July 7, 2025 (referred to as “the MCAI”), to correct an unsafe condition on all Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Model G103 TWIN II, G103A TWIN II ACRO, G103C TWIN III, G103C TWIN III ACRO, and G 103 C TWIN III SL sailplanes (gliders).

The MCAI states that corrosion was found on the inner sides of the welded drive plate during a teardown inspection of a rudder. This condition, if not detected and corrected, could affect the structural integrity of the rudder drive plate, which could lead to reduced control or loss of control of the glider. The MCAI requires repetitive inspections of the rudder drive plate for corrosion and possible water entry and a one-time detailed inspection and modification of the rudder drive plate either immediately or at the next service life extension inspection, depending on the results of the inspection. The MCAI also requires replacement of the rudder assembly if corrosion is found during the inspections that exceed light surface rust. The MCAI also requires applying additional sealing to the rudder drive plate, which constitutes terminating action for the repetitive inspections.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-3421.

The FAA reviewed Fiberglas-Technik Rudolf Lindner Service Bulletin SB-G10, Revision 1, dated February 27, 2025. This material specifies procedures for inspecting the rudder drive plate for corrosion and water entry, modifying the rudder drive plate to improve corrosion protection, applying additional sealing, and replacing the rudder. This material contains German to English translation.

The European Union Aviation Safety Agency (EASA) used the English translation in referencing the document. For enforceability purposes, the FAA will refer to the Fiberglas-Technik Rudolf Lindner service material in English as it appears on the document.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in the material already described, except as discussed under “Differences Between this AD and the Service Material and MCAI.”

While the MCAI applies to Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Model G103C TWIN III gliders, this AD does not because this model does not have an FAA type certificate.

Fiberglas-Technik Rudolf Lindner Service Bulletin SB-G10, Revision 1, dated February 27, 2025, requires replacing the rudder or contacting the manufacturer for approved instructions if corrosion exceeding light surface rust is detected. This AD requires replacing the rudder or contacting either the Manager, International Validation Branch, FAA; or EASA; or Fiberglas-Technik Rudolf Lindner GmbH & Co. KG's EASA Design Organization Approval (DOA) for approved instructions if corrosion exceeding light surface rust is detected. If approved by the DOA, the approval must include the DOA-authorized signature.

Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because corrosion on the inner sides of the welded steel rudder drive plate could affect the structural integrity of the rudder drive plate and lead to reduced control or loss of control of the glider. Additionally, the glider fleet has an average age of 5,400 flight hours, and due to limitations in general aviation reporting, the exact age of each glider is unknown. Based on the fleet's age distribution and an average of 10 hours time-in-service (TIS) per month, it is estimated that certain gliders will require the one-time inspection and modification within 50 hours TIS or 3 months, whichever occurs first, which is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 68 gliders of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary modification or replacement of the rudder that would be required based on the results of the inspection. The agency has no way of determining the number of gliders that might need the modification or replacement.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain ATR—GIE Avions de Transport Régional Model ATR42-500 and ATR72 airplanes. The NPRM was published in the Federal Register on July 7, 2025 (90 FR 29802). The NPRM was prompted by AD 2025-0004, dated January 7, 2025 (EASA AD 2025-0004) (also referred to as the MCAI), issued by EASA, which is the Technical Agent for the Member States of the European Union. The MCAI states that an ATR internal review of the TLU new avionics suite design identified an erroneous behavior of core processing module (CPM) 2, hosting the data concentration application (DCA) 2, that might affect the TLU command, monitoring, and indication. Further investigation results indicated that an erroneous monitoring of the TLU could occur when the airplane is flying above a certain speed due to the logic input from either ADC1 or ADC2 input.

In the NPRM, the FAA proposed to require modification of airplanes by installing one or two relays and associated wiring and testing of the TLU monitoring logic, as specified in EASA AD 2025-0004. The FAA is issuing this AD to address erroneous behavior of CPM 2, hosting the DCA 2, that could affect the TLU command, monitoring, and indication. This condition, if not corrected, could result in the rudder deflection not being limited at high airplane speed, which, if combined with a large rudder pedal input, could lead to the loss of control of the airplane.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-1354.

The FAA received a comment from the Air Line Pilots Association, International (ALPA) who supported the NPRM without change.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed EASA AD 2025-0004, which specifies procedures for modifying airplanes by installing one or two relays and associated wiring. EASA AD 2025-0004 also specifies procedures for an operational test of the TLU monitoring logic after the modification, a functional test of the rudder travel limiter unit, and obtaining and following instructions to correct any failed test. For airplanes on which a previous revision of the applicable service information has been accomplished, EASA AD 2025-0004 specifies accomplishing “Additional Work,” which consists of a functional test of the rudder travel limiter unit. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 43 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has received no definitive data on which to base the cost estimates for the on-condition actions specified in this AD.

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2019-12-13, Amendment 39-19668 (84 FR 30577, June 27, 2019) (AD 2019-12-13). AD 2019-12-13 applied to all The Boeing Company Model 757 airplanes. The NPRM was published in the Federal Register on February 12, 2025 (90 FR 9403). The NPRM was prompted by the determination that a modification must be done to address the unsafe condition. In the NPRM, the FAA proposed to continue to require the actions in AD 2019-12-13. The NPRM also proposed to require for certain airplanes a change to the lateral control box support assembly and installation of an aileron trim actuator bracket, and for certain other airplanes replacement of the existing actuator lateral control fitting with an aileron trim actuator bracket, which terminates the repetitive checks and inspections. The FAA is issuing this AD to address failure of the aileron trim actuator attachment lug and subsequent loss of feel force, wheel centering, and lateral trim. The unsafe condition, if not corrected, could cause over-control of the airplane and subsequent lateral pilot-induced oscillations that could adversely affect continued safe flight and landing.

The FAA received comments from Air Line Pilots Association, International (ALPA), Aviation Partners Boeing, Boeing, United Airlines, and one individual who supported the NPRM without change.

The FAA received additional comments from two commenters, including Delta Air Lines (Delta) and two individuals. One of the comments was outside the scope of this AD. The following presents the relevant comments received on the NPRM and the FAA's response to each comment.

Aviation Partners Boeing stated that the installation of winglets per Supplemental Type Certificate (STC) ST01518SE does not affect compliance with the proposed AD.

The FAA agrees with the commenter that STC ST01518SE does not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST01518SE does not affect the ability to accomplish the actions required by this AD. The FAA has not changed this AD in this regard.

An individual requested that the FAA change the compliance time for the modification to a phased approach, such as a 24- to 36-month compliance window, to allow operators to accomplish fleet modifications efficiently without disrupting flight operations. The commenter stated that, given the scale of this modification across the Boeing Model 757 fleet, implementing the modifications during scheduled heavy maintenance checks would minimize airplane downtime and supply chain constraints. The commenter also stated that rushing to implement the modifications could lead to parts shortages, maintenance upholds, and operational disruptions. The commenter concluded that a risk-based prioritization approach could ensure higher-risk airplanes are addressed first while maintaining operational stability, and that a flexible timeline will help achieve the intended safety improvements effectively.

The FAA disagrees with changing the compliance time. In developing an appropriate compliance time for this AD, the FAA considered the recommendations of the manufacturer, the urgency associated with the subject unsafe condition, the availability of required parts, and the practical aspect of accomplishing the required modification within a period of time that corresponds to the normal scheduled maintenance for most affected operators. In consideration of these items, the FAA has determined that compliance time of within 10,000 flight hours or 30 months from the effective date of the AD, whichever occurs first, will ensure an acceptable level of safety. However, under the provisions of paragraph (k) of this AD, the FAA will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. The FAA also clarifies that operators are allowed to implement the modification at any time within the compliance period during their normal scheduled maintenance. The FAA has not changed the AD in this regard.

Delta requested that the FAA add a note to paragraph (i) of the proposed AD that refers operators to Boeing Alert Requirements Bulletin 757-27A0160 RB, dated April 1, 2024, as a global acceptable method of compliance (AMOC) to the requirement in paragraph (h) of the proposed AD. Paragraph (h) proposed to require doing the repair using a method approved in accordance with the procedures specified in the AMOC paragraph of the proposed AD instead of contacting Boeing for repair instructions, as specified in Boeing Alert Requirements Bulletin 757-27A0159 RB, dated March 29, 2019, and Revision 1, dated April 29, 2020. The commenter stated that every operator that has not requested Boeing Alert Requirements Bulletin 757-27A0160 RB as an AMOC to paragraph (h) of the proposed AD would each have to submit an AMOC request to use that service bulletin in lieu of repair instructions. Delta stated that identifying Boeing Alert Requirements Bulletin 757-27A0160 RB as an AMOC in the proposed AD would reduce strain on operators and the FAA in processing AMOC requests.

The FAA disagrees with the request. An AMOC to the inspections required by paragraph (g) of this AD, along with the exception in paragraph (h) of this AD, is not necessary if the operator performs the modification in paragraph (i) of this AD. As stated in paragraph (i) of this AD, doing the modification required by this paragraph terminates the inspections required by paragraph (g) of this AD. The FAA has not changed the AD in this regard.

Delta requested that the FAA address typographical errors in Boeing Service Bulletin 757-27A0160, dated April 1, 2024. Delta stated that under step 2 of “Part 2: Feel and Trim Mechanism Assembly and Aileron Trim Actuator Installation,” the second substep should be renumbered from “a.” to “b.” and the text of that substep should be changed from “Install kept the . . .” to “Install the kept . . . .” Delta also stated that substep 3.a. of “Part 3: Restoration,” should be changed from “Restore electrical power from the airplane,” to “Restore electrical power to the airplane.” Delta recognized that these errors are in steps that are not required for compliance but asserted that the information is relevant to completing the modification and the errors do not properly convey the intent of the sentence.

The FAA agrees with the corrections that Delta has identified but no change to this AD is necessary. The FAA reviewed the service information and confirmed the typographical errors occur in steps that are not required for compliance.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Requirements Bulletin 757-27A0159 RB, Revision 1, dated April 29, 2020. This material specifies procedures for repetitive checks of the aileron trim actuator bearing for free rotation, repetitive detailed inspections of the aileron trim actuator attachment lug for damage or cracking, and applicable on-condition actions. On-condition actions include high frequency eddy current (HFEC) inspections of the aileron trim actuator attachment lug for cracking, repair, and replacement. This revision only adds references to AD 2019-12-13 and does not add any new actions.

The FAA also reviewed Boeing Alert Requirements Bulletin 757-27A0160 RB, dated April 1, 2024. This material specifies procedures for modifying the affected airplanes, which includes for certain airplanes changing the lateral control box support assembly (which includes doing a portable method C penetrant inspection of the machined surface of the lug for any crack and repair as applicable) and installing an aileron trim actuator bracket, and for certain other airplanes replacing the existing actuator lateral control fitting with an aileron trim actuator bracket. Accomplishment of the modification terminates the repetitive checks and inspections specified in Boeing Alert Requirements Bulletin 757-27A0159 RB.

This AD also requires Boeing Alert Requirements Bulletin 757-27A0159 RB, dated March 29, 2019, which the Director of the Federal Register approved for incorporation by reference as of July 12, 2019 (84 FR 30577, June 27, 2019).

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 460 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need these on-condition actions:

The FAA has received no definitive data on which to base the cost estimates for the on-condition repair specified in this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 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:

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:

I. Discussion

On March 6, 2024, the Commission adopted amendments to 17 CFR 242.600 and 17 CFR 242.605 (“Rule 605”), which, among other things, expand the scope of entities subject to Rule 605 (including larger broker-dealers, in addition to market centers), modify the categorization and content of information required to be disclosed in the detailed execution quality reports published under Rule 605 (including by modifying the scope of covered orders subject to disclosures), and require reporting entities to produce a summary report of execution quality in addition to the existing detailed disclosures regarding execution quality for covered orders in NMS stocks (“Rule 605 Amendments”). 1

The Commission addressed the compliance date for the Rule 605 Amendments in the Adopting Release. 2 The effective date of the Rule 605 Amendments was June 14, 2024 (“Effective Date”). In the Adopting Release, the Commission stated that the compliance date for the Rule 605 Amendments will be 18 months after the Effective Date (“Compliance Date”). 3 Accordingly, the Compliance Date is December 14, 2025. The Commission stated that the Compliance Date was designed to allow time for participants to amend the National Market System Plan Establishing Procedures Under Rule 605 of Regulation NMS (the “Rule 605 NMS Plan”), which addresses procedures for making Rule 605 reports available in a uniform, readily accessible, and usable electronic format, and time for brokers, dealers, and market centers to comply with Rule 605 as amended. 4 The Commission recognized that preexisting market centers and vendors will need time to update their systems and processes to ensure that data responsive to the amended Rule 605 requirements are correctly collected and formatted, and that larger broker-dealers and market centers newly subject to Rule 605 will need time to create such systems and processes. 5

Since the Rule 605 Amendments were adopted, Commission staff has been working with market participants to address certain technical and interpretative issues relating to the implementation of the amended rule. In connection with these efforts, market participants have requested additional time to implement the Rule 605 Amendments. For instance, in March 2025, the Financial Information Forum (“FIF”) raised concerns about whether the Compliance Date was feasible. FIF stated that it had requested that the Commission provide written clarification or guidance on numerous issues and scenarios given the “complexity of the Rule 605 reporting requirements and the complexity of order types and order handling processes in the market”  6 and that its members were unclear about the timing and content of a Rule 605 NMS Plan amendment. 7 FIF also stated that “FIF members are unable to determine the timeline that would be required for reporting firms to implement the Rule 605 amendments.”  8 In August 2025, FIF submitted an additional comment letter asking for an extension of the Compliance Date “as soon as possible.”  9 In addition, FIF requested that the Commission set the compliance date for the Rule 605 amendments as the first day of a calendar month because “implementing the Rule 605 amendments mid-month would be very costly for market participants” and would be “throwaway work that would only apply for one specific month.”  10

After consideration of these requests, and for the reasons described below, the Commission is extending the compliance date for the Rule 605 Amendments to August 1, 2026. Beginning on August 1, 2026, market centers, brokers, and dealers subject to Rule 605 must begin to collect the information needed to prepare the execution quality reports required under the Rule 605 Amendments. 11 This extension will provide market centers, brokers, and dealers with additional time to develop or modify the systems and processes necessary to collect and make publicly available the data required by the Rule 605 Amendments, while complying with required formats and procedures . 12 The extension will also provide market participants with time to continue to work with Commission staff to address outstanding interpretative and compliance questions. An extension of the compliance date until August 1, 2026, strikes an appropriate balance between the goal of the Rule 605 Amendments to update and improve the disclosure of execution quality information and market participants' request for additional time for implementation of the Rule 605 Amendments. 13 In addition, to address concerns about unnecessary costs associated with implementing the requirements mid-month, the extension will align the monthly disclosure obligation with the beginning of a month.

The Commission is mindful of the economic effects, including the benefits and costs, of the compliance date extension. Section 3(f) of the Securities Exchange Act of 1934 (“Exchange Act”) requires the Commission, when it is engaged in rulemaking pursuant to the Exchange Act and is required to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation. 14 In addition, Exchange Act section 23(a)(2) requires the Commission, when making rules pursuant to the Exchange Act, to consider among other matters the impact that any such rule would have on competition and not to adopt any rule that would impose a burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. 15

The baseline against which the benefits, costs, and the effects on efficiency, competition, and capital formation of the compliance date extension are measured consists of the current state of the market for NMS stocks, current practices related to reporting under preexisting Rule 605, and changes in reporting requirements brought by the Rule 605 Amendments. 16 As discussed above, 17 pursuant to the Adopting Release, the Compliance Date for the Rule 605 Amendments is December 14, 2025, but market participants have stated that additional time is needed to implement the Rule 605 Amendments, and that a mid-month compliance date will impose an unnecessary burden.

The Commission is extending the compliance date for the Rule 605 Amendments to August 1, 2026. 18 This extension will affect market centers that currently prepare reports under preexisting Rule 605; larger brokers and dealers and new market centers  19 that will need to begin preparing reports under the Rule 605 Amendments; vendors that currently prepare or will prepare Rule 605 reports for reporting entities; smaller brokers and dealers that will not be required to prepare reports under the Rule 605 Amendments; market participants that currently utilize Rule 605 reports or those that will utilize the detailed or summary reports under the Rule 605 Amendments; and investors that trade NMS stocks.

The extension of the compliance date will delay the realization of economic benefits associated with the Rule 605 Amendments. 20 The Rule 605 Amendments, which expand the scope of reporting entities, modernize the content of Rule 605 reports, and broaden the reports' accessibility, are expected to increase the relevance and use of the information contained in the reports, and promote competition among market centers and broker-dealers. This increase in competition is expected to ultimately lead to improved execution quality for investors. The extension of the compliance date will delay the improvement in transparency of order execution quality information, which will also delay the increased competition and improvements in execution quality resulting from this additional transparency.

The extension of the compliance date will also delay the ongoing costs of complying with the Rule 605 Amendments. We estimate these compliance cost savings from the delay to be about $7.1 million in aggregate. 21 Additional time to work with Commission staff to address outstanding interpretative and compliance questions may also reduce the likelihood that reporting entities incur additional implementation costs associated with re-programming systems to comply with the requirements of the Rule 605 Amendments. 22 Further, extending the compliance date could reduce the likelihood that reporting entities report the Rule 605 Amendments in an inconsistent manner and help ensure that amended Rule 605 reports are comparable across reporting entities. 23 Extending the compliance date and aligning it with the beginning of a calendar month will also avoid any additional costs to reporting entities to develop processes for generating partial-month reports.

In addition to delaying compliance costs, the extension of the compliance date will also delay the realization of other economic costs that may result from market participants adjusting their behavior in response to increased transparency and competition on the basis of execution quality caused by the Rule 605 Amendments. 24 Extending the compliance date will reduce the implementation costs of the Rule 605 Amendment metrics that are affected by other adopted Commission Rules with earlier compliance dates and also mitigate the potential costs associated with overlapping compliance dates. This includes the separate implementation periods for the round lot definition and odd-lot information definition, 25 as well as other provisions of the Market Data Infrastructure Rules (“MDI Rules”)  26 and other adopted Commission Rules. 27

The extension of the compliance date will delay the effects on efficiency, competition, and capital formation of the Rule 605 Amendments. 28 The extension of the compliance date will delay the increase in transparency of order execution quality information, which will delay the expected increase in competition among reporting entities on the basis of execution quality resulting from this increased transparency. 29 Finally, the extension of the compliance date will delay the increase in price efficiency, and the associated improvement in capital allocation and promotion of capital formation, that may result from improved order execution quality caused by the Rule 605 Amendments. 30

The Commission considered reasonable alternatives to the new compliance date, namely a shorter or longer extension. A shorter extension would realize some of the benefits arising from the Rule 605 Amendments sooner. However, to the degree that a shorter extension would result in inconsistent readiness and inconsistent reporting outcomes across broker-dealers and market centers, a key benefit of the Rule 605 Amendments—the ability to compare order execution quality across reporting entities—would not fully be realized. 31 A shorter extension might not allow reporting entities sufficient time to implement additional clarification and guidance on implementing the Rule 605 Amendments, which could increase their implementation costs as well as contribute to inconsistent reporting outcomes.

While a longer extension would further delay both the benefits and costs arising from the Rule 605 Amendments, reporting entities might not need additional time beyond the extended compliance date to update their systems and reporting methods. Therefore, a longer extension might not result in significant reductions to reporting entity implementation costs compared to the current extension.

The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a rulemaking in the Federal Register and provide an opportunity for public comment. This requirement does not apply, however, if the agency “for good cause finds . . . that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.”  32

The Commission, for good cause, finds that notice and solicitation of comment regarding the extension of the compliance date set forth herein is impracticable, unnecessary, or contrary to the public interest. 33 This rule does not impose any new substantive regulatory requirements on any person and merely reflects the extension of the compliance date for the Rule 605 Amendments. As discussed above, the Commission has been engaging with market participants regarding the implementation of the Rule 605 Amendments and has become aware of various logistical, operational, and interpretive challenges that raise questions about the ability of firms to come into compliance by the initial December 14, 2025, compliance date. Accordingly, the Commission has determined that an extension of the compliance date is needed in order to ensure an orderly implementation of the Rule 605 Amendments. Given the time constraints, a notice and comment period could not reasonably be completed before the December 14, 2025, compliance date. Further, given the operational challenges and associated costs firms would face in to meet the December compliance date, providing immediate certainty that the compliance date is extended will enable firms to adjust their implementation plans accordingly and facilitates an orderly implementation of the Rule 605 Amendments, consistent with the intended purpose of the extension. 34

For similar reasons, although the publication of a rule is generally required at least 30 days before its effective date, the requirements of 5 U.S.C. 553(d)(3) and 808(2) are satisfied (notwithstanding the requirement of 5 U.S.C. 801)  35 and therefore the good cause exception applies to this action.

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. Pursuant to the Congressional Review Act, the Office of Information and Regulatory Affairs has designated the extension of the compliance date not a “major rule,” as defined by 5 U.S.C. 804(2).

The Commission extends until August 1, 2026, the compliance date for the Rule 605 Amendments.

As of 12:01 a.m. on October 1, 2025, the funding of many federal government activities is set to expire. Unless appropriations are enacted for Fiscal Year 2026, federal departments and agencies whose continued operations are dependent upon such funding—including the Commission—will be required to execute contingency plans for this lapse in appropriations (commonly referred to as a “shutdown”). Under 31 U.S.C. 1341 (the “Antideficiency Act”), the Commission is prohibited from expending or obligating any funds in the absence of appropriations, subject to a narrow set of exceptions. 1 The Commission may use one of the exceptions to the Antideficiency Act set forth in 31 U.S.C. 1342, which permits agencies to obligate funds before an appropriations measure has been enacted and to accept voluntary services during a lapse when certain employees are needed to perform emergency or “excepted” functions. 2

The Department of Justice's Office of Legal Counsel has determined that government work performed so that the commodities and futures markets can continue to operate and so that trading may continue qualifies as an “excepted” function as set forth in 31 U.S.C. 1342. 3 Consequently, in the event of a lapse in appropriations, the Commission may incur obligations to allow certain employees who perform “excepted” functions to continue to perform those functions. This authority, however, does not permit the Commission to fund ongoing, regular functions, the suspension of which would not imminently threaten the safety of human life or the protection of property during a lapse in appropriations. 4 Thus, the Commission has designated certain essential personnel to fulfill its obligation to protect property.

In addition, certain employees of the Commission's Whistleblower Office (WBO) will continue to work because they have an alternative funding source.

The Commission's regulations, found in title 17 of the Code of Federal Regulations, place a number of filing obligations on registered entities, intermediaries, market participants and the public within specified time frames, establish Commission authority to stay certain actions by designated and registered entities, and also include provisions relating to requests for Commission approval and issuance of exemption and interpretative relief and guidance with specific time frames for Commission action. The Commission has reviewed its statute and regulations in light of its obligation to protect the safety of human life or the protection of property to determine which Commission operations will continue during a lapse in appropriations.

In the event of a lapse in appropriations, the Commission will not be processing or reviewing filings for Commission discretionary or mandatory approval or any other actions that are not directly related to the safety of human life or the protection of property. Matters not directly related to the protection of property include rule, rule amendment, and contract certifications filed with the Commission, rule amendments and contracts voluntarily submitted for Commission approval or review; requests for contract market designation, swap execution facility, swap data repository, derivatives clearing organization, and foreign board of trade registration; and other requests for Commission approval or other action.

The above-mentioned matters do not include any emergency notifications that may be required by Commission regulations of designated or registered entities and intermediaries, or that are required by any rule of a registered entity that has been approved by or self-certified to the Commission. This includes emergency rules certified pursuant to regulation 40.6(a)(6) and (7) and emergency changes certified by a systemically important derivatives clearing organization pursuant to regulation 40.10(h).

More specifically, matters not directly related to the protection of property include filings under judicially reinstated regulations 1.47 and 1.48 (bona fide hedge requests), part 30 (regulation 30.10 petitions for exemption and regulation 30.13 requests for certification), part 37 (swap execution facilities applications, demonstrations of compliance with core principles), part 38 (designated contract market applications, certifications of continued compliance in situations of merger or sale, and demonstrations of compliance with the core principles), part 39 (derivatives clearing organization applications, Commission review of swaps for determinations on clearing requirement, requests for orders regarding competition, and demonstrations of compliance with the core principles), part 40 (rule and contract filings-certifications and approvals and requests for confidential treatment of submissions, stays of certifications pursuant to regulation 40.12, determinations related to making swaps available to trade), part 41 (filing of notice-designated contract markets trading security futures products), part 48 (foreign board of trade registrations, adjudication of additional contracts for trading), and part 49 (swap data repository applications, registration of successor entities).

Matters not directly related to the protection of property additionally include requests pursuant to regulations 145.7 and 145.9 (requests for Commission records, petitions for confidential treatment of information submitted to the Commission, and appeals of FOIA decisions), regulation 140.99 filings (requests for exemptive, no-action and interpretive letters), and certain matters pursuant to part 165 (payments related to whistleblower awards).

For the foregoing matters that are currently pending before the Commission pursuant to any of these provisions, all applicable time deadlines for Commission action will be tolled until the Commission is able to resume full operations. For such matters, the time remaining for Commission action will begin to run on the first business day following the resumption of Commission operations. For the foregoing matters arising during a lapse in appropriations, any time limit for Commission action shall begin to run on the first business day following the resumption of Commission operations.

Matters not directly related to the protection of property also include certain procedural regulations associated with Commission adjudicatory actions, in particular certain rules under part 3 (procedure to deny, condition, or suspend, revoke, or place restrictions on registration), part 9 (related to review of exchange disciplinary, access denial or other adverse actions), part 10 (the Commission's rules of practice for adjudicatory proceedings before the Commission), part 12 (rules related to reparations proceedings), and part 171 (review of National Futures Association decisions). For these matters that are currently pending before the Commission pursuant to any of these provisions, or that arise during a lapse in appropriations, all applicable time deadlines for Commission action will be tolled until the Commission is able to resume full operations. Moreover, all applicable filing deadlines for parties to an adjudicative proceeding that arise during a lapse in appropriations will be extended until one business day after the Commission resumes its operations.

The Commission's regulations also impose filing obligations on registered entities, intermediaries, market participants and the public. The Commission has determined that certain filing requirements relate to the Commission's obligation to protect the safety of human life or property even during a lapse of appropriations. Accordingly, the Commission will continue to review, process, and take any necessary or appropriate action with respect to such filings during a lapse in appropriations for the purpose of protecting the safety of human life or the property in accordance with the Commodity Exchange Act (CEA) and its implementing regulations.

This category includes regulation 1.10, 1.32, 5.12, 22.2, 22.17, and 30.7 filings (financial reports and financial schedules of futures commission merchants (FCMs), introducing brokers (IBs), and retail foreign exchange dealers), regulation 1.12 and 5.6 filings (notice provisions required of FCMs, IBs, and RFEDs), regulation 1.15 filings (risk assessment reporting requirements), regulation 1.16 filings (reports of accountants), regulation 1.17 filings (capital requirements (business days would include those days the Commission is shut down for purposes of requirements relating to margin calls and the computation of margin) and any notice provision requirements), 5 regulation 1.18 filings (current books and records), regulation 1.65 and 5.23 filings (notice of bulk transfers (a business day would include those days the Commission is shutdown)), regulation 39.19 (derivatives clearing organization reporting requirements), regulation 40.6(a)(6) and (7) (emergency rule certifications), and regulation 40.10(h) (emergency changes certified by systemically important derivatives clearing organizations).

This category also includes part 15 filings (general reporting requirements), part 16 filings (clearing member reports), part 17 filings (FCM reports), part 18 filings (reports by traders), part 19 filings (bona fide hedge position reports), part 20 filings (large trader reporting for physical commodity swaps), part 21 filings (special call provisions), and part 190 filings (bankruptcy rules). In addition, the Commission shall process, review, and take any necessary or appropriate action related to, chief compliance officer, swap valuation dispute, and risk exposure reports, pursuant to regulations 3.3(e), 23.502(c), and 23.600(c), respectively, from swap dealers, major swap participants, and futures commission merchants, as applicable. 6 Swap execution facilities, designated contract markets, derivatives clearing organizations, and swap data repositories financial resources reports required by regulations 37.1306, 38.1101, 39.11, and 49.25, respectively, also will continue to be processed, reviewed, and subject to necessary and appropriate action.

The Commission's regulations require, and industry practice provides for, notification to the Commission and its staff of certain emergency situations. Thus, the Commission will continue to process, review, and take any necessary or appropriate action related to notifications by registered entities and intermediaries of emergency situations such as system malfunctions, cyber security incidents, or financial emergencies throughout a lapse in appropriations.

Finally, the Commission has proposed rules for which the comment period may expire while the Commission is shutdown. The Commission will be unable to process comment submissions until it resumes full operations, as such processing is unrelated to the protection of property. Therefore, the Commission is extending the comment periods for any such rules, and for any other matters that may be subject to a request for comment by the Commission, until one business day after the Commission is able to resume full operations. Notice of the resumption of Commission operations at the conclusion of a shutdown will be provided on the Commission's website.

To the extent that some of the provisions of this order may be subject to notice and comment under the Administrative Procedure Act (APA), 7 and may be subject to the provisions of the APA that require publication or service of a substantive rule be made not less than 30 days before its effective date, 8 the Commission for good cause finds that notice and comment and a delayed effective date are impracticable and contrary to the public interest. The Commission may be obligated to commence orderly shutdown of its operations at the commencement of business on October 1 and has determined that it is in the interest of the public and the markets it regulates to have established and publicized its procedures for limiting its operations to only those that are essential to the protection of property before that time.

Moreover, though the tolling of certain procedural time limits will delay the Commission's review and approval of certain industry filings, the review and approval provisions in the Commission's regulations implement review and approval provisions of the CEA in order to protect the public interest. It would be contrary to the CEA, and to the public interest, if these review and approval time limits continued to run while the Commission is unable to conduct routine business.

Finally, in order to protect the property interests of the public related to the orderly operation of the futures markets, the Commission will be supported by essential personnel in the surveillance of the markets in order to identify any emergency market situations that may require action to protect the safety of human life or property during a lapse in appropriations. It therefore is essential that reporting regulations associated with market surveillance and emergency notices continue to be processed and reviewed.

The Paperwork Reduction Act provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it has been approved by the Office of Management and Budget (OMB) and displays a currently valid control number. 9 The collections of information referenced in this notice and order have valid control numbers that are currently in effect. Therefore, the Commission is not obligated to seek a control number in connection with this order.

The Regulatory Flexibility Act (RFA) requires the Commission to consider whether a rule it proposes will have a significant economic impact on a substantial number of small entities and either provide a regulatory flexibility analysis respecting the significant impact or certify that the rule will not have such an impact. 10 The RFA is applicable only to a rule for which the Commission publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). 11

The Commission is not publishing this order as a general notice of proposed rulemaking. Therefore, neither a regulatory flexibility analysis nor a certification is required for this rulemaking action. Nonetheless, this order will impose no new regulatory obligations on any party. Rather, it simply establishes the limited regulatory framework under which the Commission will operate during a shutdown in order to ensure the protection of property.

Section 15(a) of the CEA  12 requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA. Section 15(a) specifies that the costs and benefits shall be considered against five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission may give greater weight to one or more of the five enumerated considerations to determine, in its discretion, that a particular rule is necessary or appropriate to protect the public interest or to effectuate any of the provisions or accomplish any of the purposes of the CEA.

This order imposes the cost of delay on parties with petitions for approval, self-certification filings, rights of review, and adjudicative matters before the Commission. As the Commission would be limited by law during a lapse in appropriations to function only with respect to the protection of property, these costs are unavoidable.

In terms of benefits, this order provides for the limited continuation of Commission business. The order also confirms the ongoing regulatory obligations of registered entities and intermediaries notwithstanding a shutdown, in order to ensure that the Commission has available to it all information necessary to identify emergency situations and take action to protect property and, hence, to protect market participants and the public, the efficiency and financial integrity of the futures markets, and price discovery.

The order also notifies market participants and the public of the matters in which the Commission will be engaged, as well as of the tolling and extensions of time put in place with respect to filings under Commission regulations. Tolling ensures that the Commission will have an opportunity to review routine industry filings once a lapse in appropriations is resolved and take steps if necessary to protect the interests of the market and the public before those filings are finalized. The extensions of time ensure that all persons with filing obligations in certain adjudicative proceedings that arise during a shutdown or who wish to submit comments during a comment period that will close during a shutdown will not be prejudiced by the inability of the Commission to accept those filings or comments.

In light of the foregoing, the Commission has determined to issue the following Order, pursuant to its authority under the provisions of the Commodity Exchange Act, 7 U.S.C. 1 et seq., and in compliance with the Anti-Deficiency Act, 31 U.S.C. 1341 and 1342.

It is hereby ordered that, in the event of a lapse in appropriations (also referred to as “shutdown”) commencing at 12:01 a.m. on October 1, 2025, the Commission will commence operating according to the procedures set forth in this Order, with respect to its regulations found in title 17 of the Code of Federal Regulations:

1. Tolling and Extension of Certain Procedural Time Limits. The Commission shall not process any filings, or review any matters for Commission approval or action to the extent that the matters are not directly related to the protection of property for the duration of a shutdown. This applies to rule, rule amendment and contract certifications, except for emergency rules certified pursuant to regulation 40.6(a)(6) and (7), and emergency changes certified pursuant to regulation 40.10(h); rules, rule amendments and contracts voluntarily submitted for Commission approval or review; requests for contract market designation, and swap execution facility, swap data repository, derivatives clearing organization, and foreign board of trade registration; and other requests for Commission approval or other action.

Specifically, except as otherwise provided in this order, applications under judicially reinstated sections 1.47 and 1.48, sections 30.10 and 30.13, and parts 36, 37, 38, 39, 40 41, 48, and 49 of the Commission's regulations officially shall not be processed or reviewed during a lapse in appropriations, and the time limits for Commission action shall be tolled until the resumption of Commission operations at the conclusion of a shutdown. Requests and appeals submitted under sections 145.7 and 145.9 of the Commission's regulations, requests submitted under section 140.99, and filings and payments under part 165 additionally shall not be processed until the resumption of Commission operations.

The Commission shall process and commence review of any new matters under these provisions of the Commission's regulations beginning on the first full business day after the Commission is able to resume full operations at the conclusion of a shutdown. For matters that are pending under these provisions at the time a shutdown may commence, all applicable time deadlines for Commission action shall be tolled. The time remaining for Commission action will begin to run on the first full business day after the Commission is able to resume full operations.

This tolling and extension of time limits also shall apply to certain procedural regulations associated with Commission adjudicatory actions, in particular the time-limited procedural regulations in parts 3, 9, 10, 12, and 171. For matters that are currently pending before the Commission under any of these parts, all applicable time deadlines for Commission action shall toll, and the time remaining for Commission action shall begin to run on the first full business day after the Commission is able to resume full operations. Moreover, all time deadlines for filings by a party in an adjudicative proceeding that arise during a shutdown shall be extended until one business day after the Commission resumes its full operations. When a filing in an adjudicatory action is delayed by a shutdown, the time to reply to any delayed filing shall commence on the day the delayed filing is effected under this order.

2. Procedures and Time Limits Not Extended or Tolled. In order to fulfill its obligations to protect property during a lapse in appropriations, which includes market surveillance and intermediary oversight, the Commission shall continue to process and review filings required of a registered entity or intermediary under certain Commission regulations, and take any action necessary and appropriate to preserve property with respect to these filings. These filings are contained in sections 1.10, 1.12, 1.15, 1.16, 1.17, 1.18, 1.32, 1.65, 5.6, 5.12, 5.23, 22.2, 22.17, 30.7, 39.19, 40.6(a)(6) and (7), and 40.10(h) of the Commission's regulations, and also apply to any emergency notification to the Commission that may be required by any rule of a registered entity that has been approved by or self-certified to the Commission. In addition, the Commission shall continue to process and review reports to the extent they are required by regulations 3.3(e), 23.502(c), and 23.600(c)(2). Filings under parts 15, 16, 17, 18, 19, 21, and 190 of the Commission's regulations also shall continue to be processed and reviewed.

Review and processing of any notice of emergency actions designated or registered entities are required to report related to situations such as system malfunctions, cyber-security incidents, and financial emergencies shall continue during a shutdown. The Commission additionally shall receive and process reports related to the financial resources of a swap execution facility, designated contract market, derivatives clearing organization, and swap data repository pursuant to regulations 37.1306, 38.1101, 39.11, and 49.23, respectively.

3. Extension of Open Comment Periods on Proposed Regulation and Other Matters That May Be Subject to a Request for Comment by the Commission. Any comment period for a proposed rulemaking or other matter that may be subject to a request for comment by the Commission that terminates during a shutdown shall be extended until one business day after the Commission resumes full operations after a shutdown.

4. Resumption of Commission Operations. The Commission shall provide notice of the resumption of its operations at the conclusion of a shutdown on its website at www.cftc.gov.

The Convention on Cultural Property Implementation Act (Pub. L. 97-446, 19 U.S.C. 2601 et seq. ) (CPIA), which implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (823 U.N.T.S. 231 (1972)) (the Convention), allows for the conclusion of an agreement between the United States and another party to the Convention to impose import restrictions on eligible archaeological and ethnological material. Under the CPIA and the applicable U.S. Customs and Border Protection (CBP) regulations, found in § 12.104 of title 19 of the Code of Federal Regulations (19 CFR 12.104), the restrictions are effective for no more than five years, beginning on the date on which an agreement enters into force with respect to the United States (19 U.S.C. 2602(b)). This period may be extended for additional periods, each extension not to exceed five years, if it is determined that the factors justifying the initial agreement still pertain and no cause for suspension of the agreement exists (19 U.S.C. 2602(e); 19 CFR 12.104g(a)).

On May 7, 2020, the United States entered into a bilateral agreement (2020 Agreement) with the Republic of Chile (Chile) that entered into force on September 30, 2020, to impose import restrictions on archaeological material representing Chile's cultural heritage that is at least 250 years old, dating from the Paleoindian period (approximately 31,000-8000 B.C.) to the Huri Moai phase in Chile (A.D. 1680-1868). On October 9, 2020, CBP published a final rule (CBP Dec. 20-16) in the Federal Register (85 FR 64020), which amended 19 CFR 12.104g(a) to reflect the imposition of these restrictions, including a list designating the types of archaeological material covered by the restrictions.

On December 30, 2024, the United States Department of State proposed in the Federal Register (89 FR 106721) to extend the 2020 Agreement. On August 7, 2025, after considering the views and recommendations of the Cultural Property Advisory Committee, the Acting Assistant Secretary for Educational and Cultural Affairs, United States Department of State, made the necessary determinations to extend the import restrictions for an additional five years. Following an exchange of diplomatic notes, the United States and Chile have agreed to extend the restrictions for an additional five-year period, through September 30, 2030.

Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of these import restrictions. The restrictions on the importation of archaeological material from Chile will continue in effect through September 30, 2030. Importation of such material from Chile continues to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

The Designated List of restricted material and additional information may also be found at the following website address: https://www.state.gov/current-agreements-and-import-restrictions by selecting the material for “Chile.”

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of a proposed rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions) when the agency is required to publish a general notice of proposed rulemaking for a rule. Since a general notice of proposed rulemaking is not necessary for this rule, CBP is not required to prepare a regulatory flexibility analysis for this rule.

In accordance with Treasury Order 100-20, the Secretary of the Treasury has delegated to the Secretary of Homeland Security the authority related to the customs revenue functions vested in the Secretary of the Treasury as set forth in 6 U.S.C. 212 and 215, subject to certain exceptions. This regulation is being issued in accordance with Department of Homeland Security Directive 07010.3, Revision 03.2, which delegates to the Commissioner of CBP the authority to prescribe and approve regulations related to cultural property import restrictions.

Rodney S. Scott, the Commissioner of CBP, having reviewed and approved this document, has delegated the authority to electronically sign this document to the Director of the Regulations and Disclosure Law Division of CBP, for purposes of publication in the Federal Register .

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

The Drug Enforcement Administration (DEA) implements and enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA), and the Controlled Substances Import and Export Act, as amended. 1 DEA publishes the implementing regulations for these statutes in 21 CFR part 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for the manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA authorizes the Administrator of DEA (by delegation of authority from the Attorney General) to register an applicant to manufacture, distribute or dispense controlled substances if the Administrator determines such registration is consistent with the public interest. 2 The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA. 3

DEA published a Notice of Proposed Rulemaking (NPRM) on January 7, 2021 that proposed requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. 4 The NPRM also proposed removing the paper payment option by requiring that all payments be made online using credit card at the time of submission of the application or renewal for DEA registration. 5 On April 11, 2022, DEA published a final rule adopting the regulatory changes as stated in the NPRM but expanded online payment options to include Automated Clearing House (ACH) funds transfer, credit card, and any other means available at the time of submission of the application or renewal for DEA registration. 6

As such, Section 1309.12 of Title 21 of the Code of Federal Regulations (CFR) requires all applicants shall pay the fee at the time of submission of the application for registration or reregistration using the secure application portal. 7 The online payment may be made via ACH funds transfer, credit card, or any other means available at the time of submission using the secure application portal. 8

DEA is amending 21 CFR 1301.13(e) by removing the sentence that states that fee payments may be made by personal, certified, or cashier's check or money order. As payments may only be submitted online by the means mentioned above, the reference to paper payment options found in 21 CFR 1301.13(e) is obsolete. This was an unintentional oversight and DEA is now correcting this technical error. The deletion of this sentence will eliminate any remaining confusion as to the acceptable means of payment when submitting an application for registration or reregistration.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including those requiring the publication of a prior notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if such actions are determined to be unnecessary, impracticable, or contrary to the public interest. 9 This rule contains only a technical correction; it imposes no new substantive requirement on the public or DEA registrants. Public notice and comment for this action is unnecessary because the underlying NPRM was already subject to a 60-day comment period, and this action is consistent with the purpose and rationale of the final rule, merely making technical changes and updating the regulatory text accordingly. Because this action does not change DEA's analyses or overall actions, no purpose would be served by an additional public notice and comment period. Consequently, DEA has determined that notice and the opportunity for public comment on this rule are unnecessary. 10

Additionally, DEA finds that there is good cause under APA section 553(d)(3) for this final rule to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date of less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.”  11 As stated, this final rule does not create any new regulatory requirements. It is merely a technical correction that removes a sentence and aligns the affected regulation with the previously published final rule. Because this is not a substantive rule, and as DEA finds good cause under 5 U.S.C. 553(d)(3) for the above reason, this final rule takes effect upon the date of publication in the Federal Register .

DEA has determined that this rulemaking is not a “significant regulatory action” under section 3(f) of Executive Order (E.O.) 12866, Regulatory Planning and Review. Accordingly, this proposed rule has not been submitted to the Office of Management and Budget (OMB) for review. This proposed rule has been drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation; E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation; and E.O. 14192, “Unleashing Prosperity Through Deregulation.” This rule is not subject to E.O. 14192 because it is not a significant regulatory action under section 3(f) of E.O. 12866. Because it is removing a reference to paper payments for applications to DEA registrations, it is a deregulatory action. This final rule updates an existing DEA regulation by removing the reference to paper payments by check or money order for all applications for DEA registrations and renewal of those registrations. This action makes no substantive changes to this regulation.

The paper payment option became obsolete when the final rule was promulgated requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. The removal of the obsolete sentence will add clarity to DEA's regulations.

Additionally, DEA continues to accept ACH fund transfer and card payment, and registrants are still able to pay with their checking accounts or debit cards associated with their checking accounts. All current and prospective registrants are expected to have a checking account with an online means of payment; therefore, this rulemaking would not impose any economic burdens on the registrants and is not a significant regulatory action under section 3(f)(1) of E.O. 12866.

This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government.

This final rule does not have substantial direct effects on the tribes, on the relationship between the national government and the tribes, or the distribution of power and responsibilities between the Federal government and Indian tribes.

This final rule does not reduce competition, entrepreneurship, and innovation.

E.O. 14294 specifies that all notices of proposed rulemaking (NPRMs) and final rules published in the Federal Register , the violation of which may constitute criminal regulatory offenses, should include a statement identifying that the rule or proposed rule is a criminal regulatory offense, the authorizing statute, and the mens rea requirement for each element of the offense. This final rule does not involve a criminal regulatory offense and thus E.O. 14294 does not apply.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, DEA was not required to publish a general notice of proposed rulemaking prior to this final rule. Consequently, the RFA does not apply to this final rule.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined that this action will not result in any Federal mandate that may result in the expenditure by State, local, and tribal Governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This final rule does not impose a new collection or modify an existing collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Also, this final rule does not impose a recordkeeping or reporting requirement on State or local governments, individuals, businesses, or other organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.

This final rule is not a major rule as defined by Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act or CRA). 12 Because this is a rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties, the reporting requirement under 5 U.S.C. 801 does not apply.

For the reasons stated in the preamble, DEA amends 21 CFR part 1301 as follows:

tert -Butyl 4-oxopiperidine-1-carboxylate (also known as 1-boc-4-piperidone) is a chemical that is structurally related to 4-piperidone (also known as piperidin-4-one). 4-Piperidone, including its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible, is a list I chemical at 21 CFR 1310.02(a)(38). The chemical structure of 1-boc-4-piperidone defines it as a carbamate of 4-piperidone. Accordingly, under 21 CFR 1310.02(a), 1-boc-4-piperidone, as a carbamate of 4-piperidone, is, and continues to be, a regulated list I chemical. 1

The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals. 2 A “list I chemical” is defined as “a chemical that is used in manufacturing a controlled substance in violation of [the CSA] and is important to the manufacture of the controlled substances.”  3 The current list of all list I chemicals is available in 21 CFR 1310.02(a). Pursuant to 28 CFR 0.100(b), the Attorney General has delegated her authority to designate list I chemicals to the Administrator of DEA (Administrator).

In addition, the United States is a party to the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention), Dec. 20, 1988, 1582 U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion, including measures related to international trade.

In a letter dated June 6, 2024, in accordance with Article 12, paragraph 6, of the 1988 Convention, the Secretariat of the United Nations informed the Permanent Mission of the United States of America to the United Nations (Vienna) that the Commission on Narcotic Drugs (CND) added the chemical 1-boc-4-piperidone to Table I of the 1988 Convention during its 67th Session on March 19, 2024 (CND Dec/67/7). As discussed above, the United States is a party to the 1988 Convention and has certain obligations pursuant to Article 12. Because 1-boc-4-piperidone is a carbamate of 4-piperidone, it has been regulated as a list I chemical of the CSA since May 12, 2023. 4 Therefore, all regulations and criminal sanctions applicable to list I chemicals have been, and remain, applicable to 1-boc-4-piperidone, and the United States has fulfilled its obligations under the 1988 Convention.

As discussed above, this rule does not affect the continuing status of 1-boc-4-piperidone as a list I chemical in any way. This action, as an administrative matter, establishes a separate, specific listing for 1-boc-4-piperidone in list I of the CSA and assigns a DEA chemical code number for the substance. This action will allow DEA to effectively monitor regulated transactions of 1-boc-4-piperidone, including the manufacture, distribution, importation, or exportation of 1-boc-4-piperidone, and to provide accurate reporting to the International Narcotics Control Board.

Pursuant to the final rule published on April 12, 2023, 5 chemical mixtures containing 1-boc-4-piperidone are not exempt from regulatory requirements at any concentration, unless a manufacturer of 1-boc-4-piperidone submits to DEA an application for exemption of a chemical mixture, DEA accepts the application for filing, and DEA exempts the chemical mixture in accordance with 21 CFR 1310.13.

Because even a small amount of 1-boc-4-piperidone can potentially yield a significant amount of finished controlled substances, DEA believes that the continued regulation of chemical mixtures containing any concentration of 1-boc-4-piperidone as a list I chemical is necessary to prevent its illicit extraction, isolation, and use. 1-Boc-4-piperidone is already subject to domestic control under list I as a carbamate of 4-piperidone, and DEA's current regulations provide that a chemical mixture containing any concentration of 4-piperidone is a list I chemical. As a technical conforming change in connection with the separate listing of 1-boc-4-piperidone, this rule modifies the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect that a chemical mixture containing any concentration of 1-boc-4-piperidone is subject to CSA chemical control provisions, including 21 CFR parts 1309, 1310, 1313, and 1316. No additional requirements are being imposed.

DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations. 6 Manufacturers may apply for an automatic exemption for those mixtures that do not meet the criteria set forth in 21 CFR 1310.12(d). Pursuant to 21 CFR 1310.13(a), DEA may grant an exemption of a chemical mixture, by publishing a final rule in the Federal Register , if DEA determines that: (1) the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance, and (2) the listed chemical or chemicals cannot be readily recovered.

The listing of 1-boc-4-piperidone as a list I chemical continues to subject handlers (manufacturers, distributors, importers, and exporters) and proposed handlers to all the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importation, and exportation of a list I chemical. Since May 12, 2023, persons handling 1-boc-4-piperidone, including regulated chemical mixtures containing 1-boc-4-piperidone, have been required to comply with list I chemical regulations, including the following:

1. Registration. Any person who handles (manufactures, distributes, imports, or exports), or proposes to engage in such handling, of 1-boc-4-piperidone or a chemical mixture containing 1-boc-4-piperidone, must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of 1-boc-4-piperidone. 7 Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person. 8

DEA notes that under the CSA, “warehousemen” are not required to register and may lawfully possess list I chemicals, if the possession of those chemicals is in the usual course of business or employment. 9 Under DEA implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant, and shall only distribute the list I chemical back to the DEA registrant at the registered location from which it was received. 10 A warehouse that distributes list I chemicals to persons other than the registrant, at the registered location from which they were obtained, is conducting distribution activities and is required to register as such.

2. Records and Reports. Every DEA registrant must maintain records and submit reports to DEA with respect to 1-boc-4-piperidone pursuant to 21 U.S.C. 830 and in accordance with 21 CFR 1310. Pursuant to 21 CFR 1310.04, a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.

Each regulated bulk manufacturer of a listed chemical would be required to submit manufacturing, inventory, and use data on an annual basis. 11 Existing standard industry reports containing the required information would be acceptable, provided the information is separate or readily retrievable from the report.

The CSA and its implementing regulations require that each regulated person report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA. In addition, regulated persons must report the following: any proposed regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier. 12

3. Importation and Exportation. All importation and exportation of 1-boc-4-piperidone must comply with 21 U.S.C. 957, 958, and 971 and be in accordance with 21 CFR part 1313.

4. Security. All applicants and registrants must provide effective controls against theft and diversion of list I chemicals in accordance with 21 CFR 1309.71-1309.73.

5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A. 13

6. Liability. Any activity involving 1-boc-4-piperidone not authorized by, or in violation of, the CSA is unlawful, and would subject the person to administrative, civil, and/or criminal action.

Pursuant to the Administrative Procedure Act at 5 U.S.C. 553(b)(B), DEA finds that good cause exists here to dispense with notice-and-comment rulemaking because it is unnecessary. 1-boc-4-piperidone is currently regulated as a list I chemical as a carbamate of 4-piperidone. The addition of a separate listing for 1-boc-4-piperidone and its DEA chemical code number in the list of list I chemicals in 21 CFR 1310.02(a) makes no substantive difference in the status of this chemical as a list I chemical, but instead is “a minor or merely technical amendment in which the public is not particularly interested.”  14 Therefore, DEA finds that publishing a notice of proposed rulemaking and soliciting public comment are unnecessary and good cause exists to dispense with these procedures.

In addition, DEA is concerned that delaying the effective date of this rule potentially could cause confusion regarding the regulatory status of 1-boc-4-piperidone. With 1-boc-4-piperidone currently regulated as a list I chemical, and with no additional requirements being imposed through this action, DEA finds good cause exists to make this rule effective immediately upon publication in accordance with 5 U.S.C. 553(d)(3).

This rule was developed in accordance with the principles of Executive Orders (E.O.) 12866, 13563, and 14912. This rule is not a significant regulatory action under section 3(f) of E.O. 12866. 1-boc-4-piperidone is already regulated as a list I chemical in the United States, as a carbamate of the list I chemical 4-piperidone. In this final rule, DEA is making an administrative change by amending its regulations to separately list 1-boc-4-piperidone as a list I chemical and to assign the DEA chemical code number 8331 to this chemical. A separate listing for 1-boc-4-piperidone will not alter the status of 1-boc-4-piperidone as a list I chemical. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). DEA scheduling actions are not subject to E.O. 14912, Unleashing Prosperity Through Deregulation.

E.O. 14294, Overcriminalization of Federal Regulations, requires agencies promulgating regulations with criminal regulatory offenses potentially subject to criminal enforcement to explicitly describe the conduct subject to criminal enforcement, the authorizing statutes, and the mens rea standard applicable to each element of those offenses. This final rule does not impose a criminal regulatory penalty and is thus exempt from E.O. 14924 requirements.

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

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Regulatory Flexibility Act (RFA)  15 applies to rules that are subject to notice and comment under section 553(b) of the APA or other laws. As noted in the above section regarding the applicability of the APA, DEA determined that there is good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply.

In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., DEA has determined and certifies that this rule will not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” Therefore, neither a Small Government Agency Plan nor any other action is required under the UMRA.

The action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 16 This action will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The Controlled Substances Act (CSA) grants the Attorney General authority to promulgate rules and regulations relating to: the registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals; reporting changes to professional or business addresses; and the efficient execution of his statutory functions. 1 The Attorney General is further authorized by the CSA to promulgate rules and regulations relating to the registration and control of importers and exporters of controlled substances and listed chemicals. 2 The Attorney General has delegated this authority to the Administrator of DEA. 3

The CSA defines “distribute” as “to deliver (other than by administering or dispensing) a controlled substance or a listed chemical” and “distributor” as “a person who so delivers a controlled substance or a listed chemical.”  4 The CSA further provides that it “shall be unlawful for any person to distribute a controlled substance in schedule I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) [of 21 U.S.C. 828] and regulations prescribed by him pursuant to [21 U.S.C. 828].”  5 “Every person who gives an order required under subsection (a) [of 21 U.S.C. 828] shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) [of 21 U.S.C. 828] and regulations prescribed by him pursuant to [21 U.S.C. 828], and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying. . . . ”  6 “The Attorney General shall issue forms . . . only to persons validly registered under [21 U.S.C. 823] (or exempted from registration under [21 U.S.C. 822(d)). Whenever any such form is issued to a person, the Attorney General shall, before delivery thereof, insert therein the name of such person, and it shall be unlawful for any other person (A) to use such form for the purpose of obtaining controlled substances or (B) to furnish such form to any person with intent thereby to procure the distribution of such substances.”  7

In 1971 DEA implemented the CSA's written order form requirement by publishing a final rule requiring triplicate paper DEA Form 222s. 8 In 2019, DEA amended its regulations to create a new single-sheet format for the paper DEA Form 222s. 9 The rule contained transition provisions allowing registrants to continue to use their existing stocks of the triplicate paper DEA Form 222s until October 30, 2021. 10

In 2005, DEA published a final rule amending its regulations to provide an electronic equivalent to the DEA Form 222 (also known as CSOS). 11 The amendments allowed registrants to order schedule I and II controlled substances electronically and maintain records of these orders electronically. The intent of these amendments was to reduce paperwork and transaction times for DEA registrants who sell or buy controlled substances.

The current CSOS regulations are found in 21 CFR parts 1305 and 1311. DEA Registrants use CSOS as a secure system to track schedule I and II controlled substance orders. The system allows for secure electronic controlled substance orders without the need for a paper order form (DEA Form 222). Using Public Key Infrastructure (PKI), CSOS requires that each individual supplier and purchaser enroll with DEA to acquire a CSOS digital certificate. System enhancements allow electronic documentation submission, self-service support options, and electronic processing of single and bulk applications, renewals, and revocations. Users are able to electronically search for, revoke, report, retrieve, and renew secure digital certificates.

Current regulations require registrants who wish to participate in the CSOS system to enroll using a labor-intensive manual process which relies on paper applications. The paper application must be notarized and the package mailed to DEA, creating delays in the enrollment process and putting applications at risk of being lost. 12 The purpose of this rule is to simplify the application process by requiring all CSOS enrollment applications to be submitted online. 13 All applicants for enrollment will follow the CSOS link on the deadiversion.gov website to the CSOS log-in page. From the CSOS log-in page the applicant will be redirected to Login.gov for Identification Verification. Upon arrival at the site, the applicant will be asked to create a Login.gov account by entering a valid email address, selecting a default language, and agreeing to Login.gov 's Rules of Behavior. A confirmation email will then be sent to the applicant's selected email. Once the email has been confirmed, the applicant must create a Login.gov password by providing a telephone number to which a verification code can be sent. Once the code is sent and the applicant enters the given code on the Login.gov website, the applicant must agree to the site's security statement. Login.gov next requires applicants to upload photographs of one or more forms of identification as specified by Login.gov and to enter a Social Security Number, after which the applicant is asked to verify the given information. The applicant is next asked to re-enter their Login.gov password to receive a Personal Key by separate message. The applicant is then asked to enter that Personal Key and review their information. Upon review of the information, the applicant is then directed back to the CSOS website for further processing. Upon return to the CSOS website, the applicant is asked to agree to the CSOS User Agreement and can apply for one of three system user roles (Registrant, Coordinator, or Power of Attorney in descending order of superiority) with enrollment requests approved or rejected by the superior role. After the Registrant role is established, all subordinate applications for enrollment must be approved by the Registrant. Upon establishment of a Coordinator, all subordinate applications for enrollment for the Power of Attorney role must be approved in the system by the responsible Coordinator.

This final rule amends DEA regulations to require electronic enrollment through a secure web-based system. Submission through the secure online system will be a streamlined process which will benefit both DEA and CSOS participants.

On February 2, 2023, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (hereinafter “NPRM”) proposing to amend DEA's regulations to conform to the CSOS modernization effort by requiring CSOS enrollment applications and supporting materials to be submitted through the Diversion Control secure online portal. 14 In this rulemaking, DEA is finalizing the regulatory text proposed in the NPRM and addressing concerns brought forth by commenters.

DEA received eight (8) comments in response to the NPRM. 15 The commenters included: the general public, third-party interest groups, and an online identity network company. The commenters were mostly supportive of the proposed rule. Six (6) commenters supported the new system and viewed the proposed rule's modernization effort of CSOS as positive. However, one (1) commenter disagreed with the use of Login.gov and wanted DEA to align the credential service provider requirement to current practices within the healthcare industry that coordinates with National Institute of Standards and Technology (hereinafter, “NIST”) IAL2/AAL2 standards. Most of the commenters were asking for clarification regarding certain aspects of the proposed rule. The comments will be further discussed in detail below.

Issue 1: Two (2) commenters expressed concern that the proposed rule should continue to allow the use of paper DEA Form 222s as an option. Both of the commenters noted that some states still require paper forms to transfer controlled substances between a Long-Term Care (hereinafter, “LTC”) pharmacy and emergency kit in a skilled nursing facility.

DEA Response 1: Paper DEA Form 222s will still be an available option. The proposed rule will have no impact on the continued availability and use of paper DEA Form 222s. DEA is aware of some states continuing to require the use of paper DEA Form 222s, and therefore, will keep the forms available as an option for the distribution of controlled substances.

Issue 2: Three (3) commenters asked for clarification on how DEA intends to transition registrants with existing, active certificates to CSOS 2.0.

DEA Response 2: DEA will transition existing registrants to CSOS 2.0 by transferring all active certificate holders and their associated information to CSOS 2.0. This associated information includes DEA number(s), certificate serial numbers, and other aspects. This information will be accessible when the user creates an account in the new portal. The following fields of active certificate holders are being moved into CSOS 2.0: registrant status, renewal instance number, application status code, application status date, certificate serial number, certificate expiration date, DEA number, individual identification, and role. The information that is related to current and/or active certificates will not need to be resubmitted.

Issue 3: Two (2) commenters wanted clarification on whether existing and active registrants will have to resubmit information in the new online portal.

DEA Response 3: Current and/or active registrants will not be required to re-submit information related to their current and/or active certificates.

Issue 4: One (1) commenter asked for clarification as to whether the individual accessing the CSOS login page could provide either a cellular phone or a landline phone number for the purpose of receiving the verification code. This commenter was concerned as cellular phone usage is not always available. The commenter also asked for secure alternatives to providing the verification code as phone use will not always be available for all registrants attempting to utilize the CSOS system.

DEA Response 4: Individuals logging into CSOS will receive a verification code. CSOS registrants have the option of receiving the verification code through OKTA Verify, 16 Google Authenticator, and email. OKTA Verify has recently discontinued the phone option. As a result, cell phones or land phones are no longer an option.

Issue 5: One (1) commenter sought clarification regarding the implementation of the electronic application submission process. Specifically, the commenter asked if the user will be notified upon login to the site that they have reached their two opportunities for online renewal before the certificate expires and now need to submit a new application.

DEA Response 5: Currently, the portal does not show that an individual has reached his or her two opportunities to renew online before the certificate expires. The DEA will continue working towards incorporating this feature in a future update to the portal.

Issue 6: One (1) commenter asked whether the Coordinator(s) will be notified that the subordinate's application for enrollment for the Power of Attorney role is ready for review and approval by the Coordinator, as required by the rule and if so, how.

DEA Response 6: All users in the system will have full visibility into their actions pending review and approval. Approvers will receive email notifications of pending approvals. The Coordinator will be notified via email that the subordinate's application for enrollment for the Power of Attorney role is ready for review and approval.

Issue 7: One (1) commenter asked DEA for a live chat option for registrants to contact DEA regarding enrollment issues, and the option to receive an email transcript of said chat conversation.

DEA Response 7: Currently, this option is unavailable; however, this feature can be considered in a future upgrade. A new feature to CSOS will be an email option that generates a ticket number and assigns a time frame wherein a help desk representative will respond.

Issue 8: One (1) commenter asked for DEA to further explore and clarify the implementation process.

DEA Response 8: The implementation and transition processes are being finalized. Prior to the launch date, informational announcements previewing new functionality, pertinent dates, and online application instructions will be provided to DEA registrants via email and on the DEA Diversion website. An email will be sent to users providing them with a website link. The email will come from deaecom.gov , which is a verified government email address, from which CSOS and DEA participants have received emails in the past. The email will only be sent in response to action taken by the participant, not initiated by DEA. These measures are sufficient for users to recognize valid communications from DEA. The website will provide the users with instructions. Users will be informed when the new process will go into effect as well as what steps users will need to take. Current users will continue utilizing the login page as they did in the past. Current users are not required to act until the time of renewal. There will be a pre-launch date that will enable users to perform the Login.gov identity verification process prior to creating a CSOS account. When CSOS 2.0 is launched, current users will be able to create accounts as well as take advantage of the new self-service features.

Issue 9: One (1) commenter asked whether DEA would take steps to remedy registrants experiencing excessive hold times when calling the CSOS help desk, and whether DEA would further staff the help desk with individuals that can resolve the problem as opposed to someone that records and relays information to the support team.

DEA Response 9: The newly automated system will allow subscribers to complete tasks independently on the portal that, under the current system, required users to call the help desk. This will greatly lower the number of calls made to the help desk. As a result, hold times will be significantly diminished. The call center operators are increasingly being cross-trained to handle CSOS and general registration requests. Call center operators had their initial training session and are in the process of reviewing a training manual. There is a training site for them to utilize as well.

Issue 10: One (1) commenter wanted to see improvements with the CSOS certificate retrieval process as the retrieval process is time consuming and difficult. The commenter asked DEA to standardize and streamline the CSOS certificate retrieval process, particularly with pharmacy chains. This commenter urged DEA to create an automated process in which the passwords for CSOS certificate retrieval can be uploaded into the certificate retrieval system. Furthermore, the commenter asked DEA to update its software to eliminate the need for passwords to be issued in text files, and that the automated process allow a user to be logged in for extended periods of time.

DEA Response 10: A modernized retrieval process will be a part of a later upgrade to the portal. DEA has taken this comment into consideration for future upgrades to the system.

Issue 11: One (1) commenter stated that DEA should strike Login.gov from its purpose statement and align the credential service provider (hereinafter, “CSP”) requirement to current practices within the healthcare industry, i.e., credentials aligned with NIST IAL2/AAL2 standards. This commenter also stated that DEA should enable providers to use portable, digital credentials they already have for CSOS access by providing multiple CSP solutions selected through a competitive procurement process.

DEA Response 11: The use of additional CSPs may be a future enhancement. Login.gov will conduct identity proofing, and DEA will continue as the Certification Authority. Login.gov does not meet the standard of NIST IAL2/AAL2; however, Login.gov meets the IAL1/AAL1 standard. Following the standards of NIST IAL1/AAL1 is sufficient for CSOS 2.0 as Login.gov conducts additional verification procedures similar to those used by financial institutions. Alignment with NIST IAL2/AAL2 may be an enhancement in the future.

Issue 12: One (1) commenter wanted clarification regarding the notary requirement, and which free online verification method will be used. The “Purpose of Rule” section of the NPRM discusses the use of Login.gov, which the commenter states does not appear to be an identity proofing service. Further the commenter wanted clarification as to whether ID.me is the identity proofing service that will be used, as other government agencies mention the use of Login.gov, but indicate ID.me is the actual identity proofing service.

DEA Response 12: The Technology Transformation Services within the General Services Administration operates a system, Login.gov, which provides authentication and identity verification services to federal agencies. DEA will use Login.gov for authenticating users and verifying identity. ID.me is not the identity proofing service that will be used. Login.gov conducts identity proofing, and no payment is required by the applicant during the Login.gov or CSOS account creation. Federal agencies are responsible for ensuring that users are properly authenticated and identified before accessing services, benefits, and other resources. Login.gov provides these capabilities as a shared service to agencies on a cost reimbursable basis. Strong authentication requires each account to be protected by a multi-factor option, which increases account security. Identity verification requires users to go through an identity proofing process to confirm that the user is who the user claims to be. This process may include, but is not limited to, a combination of digital technologies, government and commercial data sources, and in-person interactions to check identifying documents and evidence. Login.gov offers other settings for authentication, including requiring a user-provided second factor for authentication each time a user authenticates. This setting is required for identity verification and authentication-only services that use personal data.

Issue 13: One (1) commenter asked for clarification on whether the free online verification service is a hosted or cloud-based service, and what the level of assurance is compared with the level of assurance of the current process.

DEA Response 13: There is no payment requirement for the applicant during account creation for Login.gov and CSOS 2.0. Login.gov is cloud-based. After analyzing alternative solutions, Login.gov was selected as the preferred solution, based on comprehensive service offerings and competitive pricing. The level of assurance of the new process is comparable to the current process. The level of assurance with the current process involves a notary requirement. The Login.gov system that is going to be used for CSOS 2.0 is at the IAL1/AAL1 assurance level. DEA determined that the IAL1/AAL1 assurance level plus additional verification procedures similar to those used in financial institutions is comparable to the current process. The use of CSPs and alignment with NIST IAL2/AAL2 may be a future enhancement.

Issue 14: Two (2) commenters were concerned with the level of assurance or security of the process that will be implemented.

DEA Response 14: The assurance level for CSOS 2.0 is at IAL1/AAL1, which includes additional verification procedures similar to those used by financial institutions conducted by Login.gov. The assurance level of IAL1/AAL1 was deemed sufficient due to the additional verification procedures that Login.gov conducts.

Issue 15: One (1) commenter discussed how currently, two copies of identification are needed for obtaining a CSOS digital certificate under 21 CFR 1311.25(a)(1). The commenter asked DEA to provide clarification as to what the new process will encompass as the proposed change states to “complete the online verification proofing process.”

DEA Response 15: Applicants should be prepared to provide the following information: state issued identification, email, phone bill details, and a verified address. Social Security Numbers are being collected during the Login.gov registration process, but are not being passed, transferred, or stored within CSOS 2.0.

Issue 16: One (1) commenter asked for clarity on what the online registration process will look like through the secure online portal. This commenter further asked for clarification if it will be a web-based form with the same exact fields as the current paper DEA Forms 251, 252, 253, and 254.

DEA Response 16: DEA will update the CSOS user guide with screenshots of the new portal prior to launch. The new portal uses web-based forms that require the same information as on the paper forms.

Issue 17: One (1) commenter asked whether the secure online portal will be cloud-based and what kind of security will be implemented.

DEA Response 17: The online portal is a FedRAMP government cloud-based solution with multifactor implementation. FedRAMP is a certified system and is a government-wide program that promotes the adoption of secure cloud services across the federal government by providing a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services. FedRAMP provides a standardized approach to security authorizations for Cloud Service Offerings.

Issue 18: One (1) commenter asked for clarification for the reason of removal of the coordinator from the process in 21 CFR 1311.25, as the coordinator seems to have a significant security role in limiting who can apply for a CSOS digital certificate.

DEA Response 18: DEA is not removing the Coordinator role from the process in 21 CFR 1311.25. The individuals who are acting in the Coordinator role will be able to review and approve and/or deny applications in the online portal. Login.gov does the identification proofing on all subscriber applications; therefore, the Coordinator will no longer be tasked with verifying and approving submitted documentation for Power of Attorney applications. The requirement for the application to be notarized and physically mailed to DEA will be removed with the amending of the regulations.

Previously, the Principal Coordinator was responsible for identity proofing all applications submitted under a respective DEA registration. Although all applicants will now be verified and authenticated online, the Principal Coordinator remains an integral part of the application process. Once a Principal Coordinator is designated by the registrant, the Principal Coordinator will be involved in the issuance of, revocation of, and changes to digital certificates issued under that registrant's DEA registration and can approve subsequent applications submitted for the Power of Attorney role. The Principal Coordinator role will continue to provide security and certificate oversight.

Issue 19: One (1) commenter asked for clarification on how the Coordinator informs the Certification Authority of all digital certificate applications, and how the process will work with the Coordinator for approving applicants applying for a Power of Attorney certificate.

DEA Response 19: The Coordinator will receive an automatic email from CSOS 2.0 requesting that the Coordinator review and approve requests for the Power of Attorney role triggering issuance of the certificate. Coordinators use the portal to revoke certificates of subscribers they oversee and to approve or reject new Power of Attorney role requests and certificate renewals. Powers of Attorney submit these requests independently, which then go to the Coordinator to approve or reject the request. The Coordinator no longer needs to provide a signature on the application for submission of the request.

Issue 20: One (1) commenter stated that 21 CFR 1311.20 and 1311.25 have been changed in a way so that the Coordinator no longer has to send a copy of the DEA Form 223  17 to the CSOS Registration Authority. This commenter discussed how the NPRM proposed to remove language stating that the Coordinator is responsible for verifying the applicant's identity in 21 CFR 1311.20, as well as the Coordinator reviewing the application package, and the Coordinator submitting the completed package to the Certification Authority. Finally, the commenter asked for clarification regarding the purpose of the changes, and how security will be impacted.

DEA Response 20: The purpose of the change is to enable online registration for CSOS 2.0. DEA numbers will be validated during account creation. Coordinator applications will require approval by the registrant.

CSOS 2.0 will directly access DEA's registration database and review current DEA Form 223 status electronically, which will eliminate the need for the paper document. Due to this development, advanced security measures have been implemented.

When a registrant enrolls in CSOS 2.0, identity verification services will be provided by Login.gov . Login.gov will collect a photo of a government issued ID and other personal identifiable information (including, but not limited to, full name, date of birth, mailing address, phone number, and Social Security Number or Individual Taxpayer Identification Number). Login.gov will also validate the information submitted by the user with authoritative data sources. Depending on the information entered, the system will also perform one of the following: (1) sending a text message or call with a code to the phone number associated with the user, or (2) receiving a one-time code using face or touch unlock, security key, or third-party authentication applications such as OKTA Verify, and/or Google Authenticator. The user will need to provide this code to Login.gov in order to complete Login.gov 's identity verification process. If the user was successfully verified and provides consent, DEA may receive the user's attributes at the time of authentication. If the user was unable to successfully verify their identity, they will retain their account for authentication services.

Identity verification services may also involve in-person supervision and remote supervision of the user during the process, such as when Login.gov is unable to collect a photo of their government-issued ID, or other methods of verification such as inheriting credentials from an agency partner. In amending its regulations to transfer all paper applications for CSOS ordering to electronic submissions, the requirement for the application to be notarized and physically mailed to DEA will be removed. Previously, the Principal Coordinator role was responsible for identity-proofing all applications submitted under a respective DEA registration. As proposed, all applicants will be verified and authenticated online, however the Principal Coordinator remains an integral part of the application process. Once a Principal Coordinator is designated by the registrant, the Principal Coordinator will be involved in the issuance of, revocation of, and changes to digital certificates issued under that registrant's DEA registration and can approve subsequent applications submitted for the Power of Attorney role. The Principal Coordinator role will continue to provide security and certificate oversight.

Issue 21: One (1) commenter provided the following call center wait time calculations: savings to industry seems to represent a 94% reduction in DEA call center demand. Old process = (90 minutes per new application × 31,372 new applications per year) + (90 minutes per renewal × 62,344 renewals per year) = 8,434,440 minutes. New process = (15 minutes per new application × 31,372 new applications per year) + (0 minutes per renewal × 62,344 renewals per year) = 470,580. With the estimated numbers of new and renewal applications being found in DEA's Executive Order (E.O.) 12866 section. The commenter wanted DEA to confirm whether these calculations were correct.

DEA Response 21: The commenter seems to have misunderstood the calculation and DEA also notes that the commenter appears to have mistyped the number of new applications. As detailed in the Executive Order (E.O.) 12866 section below, DEA estimates there will be labor cost savings from reduced time to complete a new application. DEA estimates that the current time to complete a new application is three hours, which includes an estimated 1.5 hours to prepare and provide the necessary information and 1.5 hours calling DEA for assistance or to check the status of the application. Under the proposed final rule, while an applicant is expected to require the same 1.5 hours to prepare and provide the necessary information, the online system will allow self-viewing of status, reducing the need for or duration of calls to DEA. DEA estimates the required time to complete a new application would be 1.75 hours, including an estimated 0.25 hours for logging in to the CSOS system or calls to DEA for assistance. The commenter's calculation would instead be correct as follows: Old process = (180 minutes per new application × 31,172 per year) + (90 minutes per renewal × 62,344 per year) = 11,221,920 minutes. New process = (105 minutes per new application × 31,172 per year) + (15 minutes per renewal × 62,344 per year) = 4,208,220.

Issue 22: One (1) commenter stated that third-party vendors of CSOS software are required to go through audits. This commenter asked DEA whether audits will be required of any third-party software contemplated for use in this modernized registration process.

DEA Response 22: DEA does not anticipate the use of any third-party software for the modernized registration process.

Issue 23: One (1) commenter inquired as to how the modernized system will be tested and whether there will be industry involvement in testing.

DEA Response 23: DEA performs ongoing, continual, and extensive testing to include: regression, performance, security, and user acceptance. DEA is considering opportunities for industry involvement.

Issue 24: One (1) commenter asked for clarification as to whether the CSOS 2.0 enrollment processes will continue to accommodate bulk enrollment ( i.e., the enrollment of multiple registrants under a single applicant, as occurs with chain pharmacy organizations).

DEA Response 24: DEA's CSOS online portal will continue to accommodate bulk enrollment. CSOS 2.0 will enable subscribers to complete the bulk enrollment process directly online, which will simplify the process.

Issue 25: One (1) commenter asked DEA to assign specialists for each pharmacy organization that uses bulk enrollment.

DEA Response 25: It is anticipated that these updates to CSOS will mitigate the need for DEA assistance, as the bulk renewal will be done online directly by the subscriber. As such, DEA does not anticipate a need to assign specialists for each pharmacy organization that uses bulk enrollment. In the event that assistance is required, the Diversion Control Contact Center Operators (help desk) will be available 8:30 a.m.-5:50 p.m. EST, Monday through Friday.

Issue 26: One (1) commenter asked for clarification as to whether individuals who have been granted the Power of Attorney authority for DEA registration purposes can serve in the role of the registrant for CSOS purposes and could therefore designate CSOS coordinators.

DEA Response 26: Individuals who have been granted Power of Attorney authority for DEA registration purposes can also serve in the role as the registrant coordinator for CSOS purposes, if such role is authorized through an executed Power of Attorney.

An applicant for a DEA number may authorize one or more individuals to sign applications for the applicant by filing a Power of Attorney for each such individual. 18 A DEA registrant may also execute a Power of Attorney to authorize one or more individuals to issue orders for Schedule I and Schedule II controlled substances on behalf of the registrant. 19

A DEA registrant may execute a Power of Attorney that designates an individual as the registrant coordinator for said registrant's respective DEA registration number, once this individual enrolls through the CSOS 2.0 portal. The registrant coordinator may designate an individual as the Principal Coordinator over the CSOS certifications. This individual designated as the Principal Coordinator can assign himself or another as the Principal Coordinator for CSOS.

Regulatory changes are needed to conform existing DEA regulations regarding the submission of paper CSOS system enrollment forms to DEA's current requirements that other DEA forms be submitted online. 20 The paper enrollment process is prone to errors, creates wasteful and unnecessary paper records, requires manual processing, and leads to hard copy records that are expensive to process and store. This rule amends existing DEA regulations in one part—Title 21 Chapter II Part 1311. DEA is amending 21 CFR 1311 to require all CSOS enrollment applications and supporting materials to be submitted to DEA through the CSOS secure network portal. This amendment improves the submission process by aligning it with DEA's current policy of reducing and/or eliminating the reliance on wasteful paper applications and expediting enrollment by utilizing modern technology. The online submission of applications and supporting materials through the secure database will ensure DEA's receipt of documentation in a more timely and organized manner.

DEA is amending 21 CFR 1311.20, 1311.25, 1311.40, and 1311.60 by eliminating the ability of registrants to submit paper CSOS enrollment application forms. Registrants will be required to submit all their application materials through the secure online portal. Moreover, DEA is amending these regulations by eliminating certain recordkeeping requirements, as those records will now be accessible as a digital version in the system. DEA believes these amendments will expedite the enrollment process for registrants and facilitate the Agency-wide goal of reducing DEA's reliance on paper forms.

DEA is amending 21 CFR 1311.20, which describes the role and responsibilities of the CSOS Coordinator. Current regulations require the CSOS Coordinator to complete the paper application process by submitting the notarized enrollment package to the DEA Certification Authority for processing. This amendment streamlines the process by eliminating the paper process and requiring Coordinator applicants to enroll using the secure online portal.

Additionally, DEA is amending 21 CFR 1311.25, which establishes the requirements for a registrant, or authorized representative with a Power of Attorney, to complete the manual application process by submitting the notarized enrollment package to the DEA Certification Authority for processing. This amendment streamlines the process by eliminating the manual paper process and requiring all registrants, or authorized representatives with Powers of Attorney, to enroll using the secure online portal.

DEA is also amending 21 CFR 1311.40, which establishes the criteria for renewal of a CSOS digital certificate. This amendment streamlines the renewal process by eliminating the manual paper process and requiring that all renewal applications be submitted using the secure online portal.

Last, DEA is amending 21 CFR 1311.60, which establishes recordkeeping requirements on the part of the CSOS certificate holder by requiring that a copy of the subscriber agreement be maintained for the life of the certificate. This amendment removes the requirement of the CSOS certificate holder to maintain a copy of the subscriber agreement by enabling registrants to sign and access a digital version of the agreement in the online portal.

DEA has determined that this rulemaking is not a “significant regulatory action” under section 3(f) of Executive Order (E.O.) 12866, Regulatory Planning and Review. Accordingly, this proposed rule has not been submitted to the Office of Management and Budget (OMB) for review. This proposed rule has been drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation; E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation; and E.O. 14192 “Unleashing Prosperity Through Deregulation.”

Current regulations require registrants who wish to participate in the CSOS system to enroll using a labor-intensive manual process which relies on paper applications. This final rule amends DEA regulations to require electronic enrollment through a secure web-based system.

The current regulations related to CSOS enrollment are summarized below.

(1) 21 CFR 1311.20(b)-(c) requires Coordinators to enroll in writing.

(2) 21 CFR 1311.25(a)-(b) requires a registrant, or authorized representative with a Power of Attorney, to enroll in writing.

(3) 21 CFR 1311.40(c)-(d) requires submitting a new application in writing for every third renewal and for expired certificates.

(4) 21 CFR 1311.60(c) requires maintaining a copy of the subscription agreement for the life of the certificate.

The final rule would change these requirements to the following.

(1) 21 CFR 1311.20(b)-(c) requiring Coordinators to enroll online.

(2) 21 CFR 1311.25(a) (with (b) removed) requiring all registrants, or authorized representative with a Power of Attorney, to enroll online.

(3) 21 CFR 1311.40(c)-(d) requiring, for every third renewal and expiration, a new application online.

(4) 21 CFR 1311.60(c), removing this provision to allow electronic subscription agreements to be held online and no longer requiring a paper copy be maintained.

Table 1 summarizes the changes from current regulations to the final rule.

DEA has examined the benefits and costs/cost savings of this final rule and believes it is of net positive economic benefit. DEA believes the cost savings to registrants, as well as DEA, heavily outweigh any cost to DEA associated with implementing and maintaining the necessary computer systems to allow for online enrollment and renewal to CSOS.

This final rule will affect registrants who wish to participate in the CSOS system, and DEA. A registrant, designated person, or an authorized representative, who wishes to enroll in the CSOS system can apply for one of three system user roles: Registrant, Coordinator, or Power of Attorney. New and renewal enrollment applications are submitted online. DEA processes the applications in addition to operating and maintaining the systems used in the enrollment and certificate management process. The economic impact of this final rule is a function of changes in requirement for each CSOS enrollment application and the estimated number of applications.

Each year, DEA receives a mix of new and renewal applications for enrollment. In 2021, DEA received 31,172 new applications. These applications include 11,411; 6,974; and 12,787 new applications for Registrant, Coordinator, and Power of Attorney roles, respectively. For every third renewal, the CSOS certificate holder must submit a new application. 21 Therefore, for the purposes of this analysis, a third renewal is considered as a new application. Based on this renewal requirement, DEA estimates that new applications are approximately one-third of total applications and the number of renewals is approximately twice the number of new applications. Therefore, DEA estimates there were 62,344 renewal applications for a total of 93,516 (31,172 + 62,344) total applications in 2021.

As pharmacies are the largest registration business activity that participate in CSOS, representing approximately 73 percent of CSOS registered locations, 22 DEA believes the growth in the number of pharmacies registered with DEA represents a good proxy for the growth of CSOS-participating registrants, and the number of CSOS applications for enrollment.

The number of DEA registered pharmacies has declined from 72,353 in 2015 to 70,628 in 2019 and has roughly stayed constant, with no growth, from 2019 to 2021, with 70,789 and 70,670 pharmacy registrations in 2020 and 2021, respectively. So, DEA believes that zero net growth in CSOS applications is a reasonable estimate. Therefore, DEA estimates the numbers of applications will stay constant at 31,172 new and 62,344 renewal, for a total of 93,516 applications, over the 10-year analysis period.

Below is a description of the estimated impact of the final rule on new enrollment applications for Registrant, Coordinator, and Power of Attorney roles.

1. Time to Complete New Application: DEA estimates there will be labor cost savings from reduced time to complete a new application. DEA estimates that the current time to complete a new application is three hours, which includes an estimated 1.5 hours to prepare and provided the necessary information and 1.5 hours calling the DEA for assistance or status of application. Under the final rule, while an applicant is expected to require the same 1.5 hours to prepare and provide the necessary information, the online system will allow self-viewing of status, reducing the need or duration of calls to DEA. DEA estimates the required time to complete a new application would be 1.75 hours, including an estimated 0.25 hours for logging to CSOS system or calls to DEA for assistance. Using a loaded hourly rate of $93.02 for Pharmacists, 23   24   25 the labor cost would decrease from $282.06 ($94.02 × 3) to $164.54 ($94.02 × 1.75), resulting in an estimated cost savings of $117.52 ($282.06−$164.54) per application.

2. Postage Cost: Under current regulations paper application forms and supporting information need to be shipped to DEA. The final rule will eliminate the need to ship paper applications. Not having to ship the enrollment package is estimated to reduce postage costs by $13.27 per application. 26

3. Notary Cost: Under current regulations, a new application for a Registrant or a Coordinator role requires a notary. The final rule will eliminate the notary requirement. Not having to get a notary (due to online verification methods is expected to eliminate an estimated notary cost of $5.00 per enrollment package. 27 The notary requirement only applies to Registrant and Coordinator roles, and as discussed earlier, of the estimated 31,172 total new applications, 11,411 and 6,974 are for Registrant and Coordinator, respectively, making up 59 percent ((11,411 + 6,974)/31,174) of total registrations. Therefore, 59 percent of $5.00, $2.95 is the average notary cost savings for all new applications.

4. Agreement Storage Costs: Under current regulations, a CSOS certificate holder is required to maintain a copy of the subscriber agreement. The final rule will eliminate this requirement. DEA does not believe there is a material impact from not having to store written subscription agreements and having them be stored online in CSOS.

Table 2 summarizes the impact of the final rule for new applications.

Below is a description of the estimated impact of the final rule on renewal enrollment applications for Registrant, Coordinator, and Power of Attorney roles.

1. Time Spent Requested Renewal: DEA estimates there will be labor cost savings from reduced time to complete a renewal application. DEA estimates that the time spent requesting a renewal will fall from 1.5 hours using the phone method to 0.25 hours using the online method. Using a loaded hourly rate of $94.02 for Pharmacists, 28 the labor cost would decrease from $141.03 ($94.02 × 1.5) to $23.51 ($94.02 × 0.25), resulting in an estimated cost savings of $117.52 ($141.03−$23.51) per application.

Table 3 summarizes the impact of the final rule for renewal applications.

The total registrant cost savings is $11,495,610 per year, calculated by multiplying the cost of a new and renewal application by the number of new and renewal applications. Table 4 details the calculation.

There are additional benefits of the final rule. These include:

(1) Shorter end-to-end process time (submission to certificate): Allowing earlier use of CSOS for ordering Schedule II controlled substances and realizing the benefits of electronic ordering rather than using paper order forms.

(2) Insight into status and workflows to track the progress of the submission: Allowing Coordinators to get status updates online, see how the application progresses, and plan for additional CSOS users.

(3) No longer needing to wait for the call center to request Certificate management action revocations: Allowing Coordinators to self-manage and remove user certificates.

(4) Safer submission process: Allowing secure delivery of potentially sensitive information.

(5) Error checking: Allowing programmatic review for erroneous or incomplete information, reducing delays in application processing.

DEA's costs are driven by the personnel and technology resources required to process the applications. Below is a list of the cost activities and anticipated impact.

1. Certification Authority Cost: The Certification Authority serves as the central element responsible for establishing a trust relationship between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized ordering entities. Certification Authority issues user digital certificates used to digitally sign electronic transactions. DEA believes that the personnel resources and costs to certify enrollment and issue digital certificates will not change as a result of this final rule. Based on current Certification Authority resources, DEA estimates the annual Certification Authority cost will remain at $732,922. 29

2. Registration Authority Cost: The Registration Authority is the entity that collects and verifies each applicant's identity and information that are to be entered into his or her public key certificates. Receiving electronic applications eliminates the need to scan paper applications. DEA estimates that the personnel resources and costs to process enrollment applications will fall by 30 percent starting with the second year of implementation of the rule. However, in the first year of implementation, DEA anticipates the decrease in resource requirements from elimination of scanning requirement will be offset by increase in applicant questions referred to Registration Authority. DEA estimates the total annual Registration Authority cost of $597,688  30 will remain the same in year 1 and will be $418,382 ($597,688 × 0.7) in year 2 and thereafter.

3. Mail Reception Cost: Currently, DEA requires personnel to receive, sort, and deliver paper applications to the Registration Authority at an estimated annual cost of $34,562. 31 Under the final rule, applications would be received online, eliminating this cost.

4. Data Entry Cost: Currently, personnel resources are needed to verify the accuracy of the scanned paper applications and make any needed corrections. Under the final rule, online applications eliminate the need for this task. The estimated total current annual cost of $109,138  32 will be eliminated when this final rule is implemented.

5. Call Center Support Cost: DEA operates a CSOS call center to service questions, or provide assistance, regarding CSOS enrollment and certificate management. The estimated total current annual cost as $1,749,946. 33 While DEA anticipates a reduction in the number of calls and duration of each call, DEA anticipates this reduction will result in lower wait-times for callers rather than reduced call center resources. Therefore, DEA estimates this cost will remain the same at $1,749,946.

6. Information Technology Cost: DEA currently spends approximately $255,000 per year on its Information Technology enrollment-related systems and software. DEA anticipates Information Technology costs will increase to $2,935,200 per year. 34 Information Technology cost includes, but are not limited to, cloud services, workflow management, identity verification, identity management functionality, professional services for continuous development, integration and deployment, and maintenance and troubleshooting.

All costs are expected to scale with the volume of new applications, except Information Technology cost, which does not vary with the volume of applications. Table 5 summarizes the DEA's impact.

There are additional benefits to the DEA from the final rule. These include:

(1) That the CSOS System will be supported, secure, reliable, and scalable: Reducing the risk of lost or stolen data and long-term reduction in costs associated with to maintenance, operations, and growth.

(2) The Certificate management process no longer involves a help desk call: Call center resources will be freed up to reduce hold-times for registrants allowing meeting call management service level agreements and improving user satisfaction.

(3) Possible increase in CSOS adoption due to ease of enrollment process: Reducing DEA costs associated with printing and mailing paper order forms.

(4) The ease at which enhancements can be made as needed, for example Enterprise Certificates with multiple DEA numbers: Allowing efficient future improvements to CSOS.

Using the registrant and DEA impacts from table 5 the estimated net cost savings of this final rule for the 10-year analysis period is listed in Table 8.

The present value of the net cost savings over the 10-year analysis period is $77,952,542 and $64,184,410 at three and seven percent discount rates, respectively. The annualized net cost savings is $9,138,416 at three and seven percent.

The final rule is an E.O. 14192 deregulatory action because it is being finalized and has a total cost less than zero. The present value of the estimated net cost savings is $64,184,410 at seven percent discount rate in 2025 dollars.

This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burdens. DEA expects the instant validation of online registration applications to reduce ambiguity and reduce the number of errors in submissions and reduce burdens on both DEA and registrants.

This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the National government and the States, or on the distribution of power and responsibilities among the various levels of government.

The final rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The proposed rule does not reduce competition, entrepreneurship, and innovation.

Executive Order 14294 specifies that all NPRMs and final rules published in the Federal Register , the violation of which may constitute criminal regulatory offenses, should include a statement identifying that the rule or proposed rule is a criminal regulatory offense, the authorizing statute, and the mens rea requirement for each element of the offense. This final rule does not involve a criminal regulatory offense and thus E.O. 14294 does not apply.

In accordance with the Regulatory Flexibility Act (RFA), the DEA has reviewed the economic impact of this final rule on small entities. DEA's economic impact evaluation indicates that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.

The RFA requires an agency to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on substantial number of small entities. DEA has analyzed the economic impact of each provision of this final rule and estimates that it will have minimal economic impact on affected entities, including small businesses, nonprofit organizations, and small governmental jurisdictions.

This final rule will simplify the enrollment process by requiring all initial registration and renewal applications be submitted online. The rule affects all enrollment and renewals for CSOS, whose users currently use paper applications. However, once a registrant is enrolled the DEA already requires them to order using CSOS. So, there is no additional cost to obtaining access to CSOS, since registrants will already be required to use it eventually.

There is a total of 94,011 CSOS participating entities, as can be seen in Table 7, with approximately 325,000 active certificates. Certificates have to be renewed every one or three years, based on the registrants' DEA registration renewal cycle. In 2021, the number of new applications were 31,172. For every third renewal, the CSOS certificate holder must submit a new application. 35 Therefore, for the purposes of this analysis, a third renewal is considered as a new application. DEA estimate that the total applications, including renewals, is 93,516.

This final rule affects all new and renewal enrollment applications for CSOS, as applications will have to take place online, and all entities who would submit new and renewal applications. This final rule affects small entities in industries associated with the above business activities, primarily industries associated with pharmacy, hospital/clinic, and practitioner/MLP registrations, as these business activities make up 98.17 percent of the CSOS-participating registrations. Table 8 indicates the sectors, as defined by the North American Industry Classification System (NAICS), that best correlate with business activities affected by the final rule.

As shown in Table 8, the final rule affects a wide variety of entities across many industry sectors. Some industry sectors are expected to consist primarily of DEA CSOS registrants ( i.e., 446110—Pharmacies and Drug Stores, 622110—General Medical and Surgical Hospitals, etc.). Therefore, this final rule is expected to affect a substantial number of small entities in some industries.

There are no new costs associated with this final rule. The labor burden to submit an application is estimated to be the same for electronic and paper submissions. All CSOS registered location will already need to have access to the internet in order to use CSOS. DEA acknowledges some applicants prefer paper forms. DEA does not have a basis to quantify this preference; however, DEA believes any costs associated with eliminating this preference is offset by the cost savings discussion below.

DEA anticipates there will be cost savings associated with electronic submissions. Some cost savings are described qualitatively and some are quantified. Many paper applications submitted contain illegible or erroneous information or omit required information. Many such errors or omissions, such as not including a signature or paying the wrong amount, require DEA to contact applicants to correct or clarify the information in the paper form, consuming DEA's and the applicant's time and resources. Electronic submissions are expected to virtually eliminate the requirement for DEA to contact applicants for clarifications of form data or correction of submission errors, as validation features in the system will flag common errors prior to transmission. As DEA has not tracked the number of delays or the duration of such delays, DEA does not have a basis to quantify the cost savings.

Furthermore, this final rule eliminates the need to print paper forms and transmit by mail or courier service, generating an estimated cost savings of $13.27 per each paper application not submitted. 36 DEA assumes the cost savings associated with eliminating printing costs and envelopes is negligible. This final rule also eliminates the need to get a notary for new applications, which will save $5.00 each for applications for registrant and coordinator roles. 37 An application for the Power of Attorney role does not require a notary; and while there would be no notary cost savings for these applications, $5 cost savings is included in the analysis to be conservative and because applications for registrant and coordinator roles are slightly more than half of all applications.

As discussed in the E.O. 12866 section above, DEA estimates that the time savings from this final rule will save $117.52 per new and renewal application.

Total cost savings for a new application is $135.797 (117.52 + 13.27 + 5.00 = 135.79), as can be seen in Table 9.

As also calculated in the E.O. 12866 section above, total cost savings for renewals is $117.52, as can be seen in Table 10.

There were 31,172 new applications in 2021. DEA estimates there were also 62,344 renewal applications for a total of 93,516 applications. Given there are 94,011 CSOS participating entities, there is less than one application per year per entity on average (93,516/94,011 = 0.99). Given that there are at approximately 325,000 active digital certificates, the vast majority of which are on three-year renewal cycles, DEA expects approximately 108,333 certificates to be renewed annually (325,000/3 = 108,333). There are then approximately 1.15 certificates per entity (108,333/94,011 = 1.15). Given that smaller firms should have less certificates than larger firms, DEA believes using one certificate or one application per entity per year is a reasonable assumption for the smallest of small entities.

To determine whether the final rule would have a significant economic impact on small entities, DEA conducted a revenue test by comparing the estimated annual cost savings to the average annual revenue for the smallest of small entities in industries affected by the final rule. Based on the Statistics of U.S. Businesses data from the Census Bureau, table 11 lists the enterprise size, number of establishments, and the average annual revenue for the smallest of small businesses in each industry sector. 38 39

The estimated cost savings of $135.79 for new applications and $117.52 for renewal applications were compared to the average annual revenue for each of the NAICS codes in Table 11. For example, taking the smallest possible entities, HMO Medical Centers with 0-4 people, with an average revenue of $98,000, the benefit, in the form of cost savings, from new applications is $133.97 (116.27 + 12.70 + 5 = 133.97), or 0.14 percent of revenues (133.69/98,000 = 0.0014). The benefit from renewals is 0.12 percent of revenues (116.27/98,000 = 0.0012). Table 12 details the revenue test results for all affected NAICS codes.

As shown in Table 12, the revenue test for the smallest of small entities (0-4 employees) ranges from 0.00 percent with rounding for NAICS code 622110 to 0.13 percent for NAICS code 621491. Therefore, the economic impact of this final rule is not significant for the smallest of small entities, and the economic impact is estimated to be not significant on any small entity.

In conclusion, while the final rule impacts a substantial number of small entities in at least some industries, the economic impact will not be significant. Therefore, this final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act of 1995 (UMRA), 40 DEA has determined that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” Therefore, neither a Small Government Agency Plan nor any other action is required under the UMRA.

This final rule will modify existing collection(s) of information requirement under the Paperwork Reduction Act (PRA). 41 The final rule will combine all information collection into one on-line enrollment process eliminating the need for individual forms. Pursuant to the PRA, 42 DEA has identified the collections of information below related to this final rule. A person is not required to respond to a collection of information unless it displays a valid OMB control number. 43

1. Title: CSOS Certificate Application.

OMB Control Number: 1117-0038.

Form Number: DEA-251.

DEA is amending its regulations to require that all CSOS applications and supporting materials must be submitted to DEA through the DEA Diversion Control Division secure network application. This amendment will improve the submission process by aligning it with DEA's current requirements for other online form submissions. The online submission of applications and supporting material through the secure database will ensure DEA's receipt of documentation in a more timely and organized manner. This combined online form will be used for all CSOS user roles: DEA Registrant, Principal Coordinator/Alternate Coordinator, and Power of Attorney.

DEA estimates the following number of respondents and burden associated with this collection of information:

• Number of respondents: 94,011.

• Frequency of response: 0.994735 (as needed, calculated). 44

• Number of responses: 93,516.

• Burden per response: 0.75. 45

• Total annual hour burden: 70,137.

If you need additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261.

Any comments on this collection of information may be sent in writing to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB79/Docket No. DEA-732.

This final rule is not a major rule as defined by section 804 of the Congressional Review Act (hereinafter, “CRA”). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. 5 U.S.C. 804. Pursuant to the CRA, the DEA has submitted a copy of the Final Rule to both Houses of Congress and to the Comptroller General.

For the reasons stated in the preamble, DEA amends 21 CFR part 1311 as follows:

This document of the Drug Enforcement Administration was signed on September 30, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

This document amends the regulations under section 263A(f) of the Internal Revenue Code (Code) regarding the interest capitalization requirements for improvements that constitute the production of designated property under § 1.263A-8 (final regulations). The final regulations are issued under the express delegation of authority to the Secretary of the Treasury or the Secretary's delegate (Secretary) under section 263A(j), which provides, in part, that “[t]he Secretary shall prescribe such regulations as may be necessary or appropriate to carry out the purposes of [section 263A].” The final regulations are also issued under the express delegation of authority to the Secretary under section 7805(a) of the Code, which provides that “the Secretary shall prescribe all needful rules and regulations for the enforcement of [the Code], including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.”

On May 15, 2024, the Department of the Treasury (Treasury Department) and the IRS published in the Federal Register (89 FR 42404) a notice of proposed rulemaking (REG-133850-13) proposing amendments to regulations under 26 CFR part 1 (proposed regulations). The proposed regulations would remove the “associated property rule” and similar rules in § 1.263A-11(e) from the interest capitalization requirements for improvements that constitute the production of designated property under section 263A(f) and § 1.263A-8(d)(3). In addition, the proposed regulations would modify the mid-production purchases rule of § 1.263A-11(f) to clarify that the rule applies only to property purchased and further produced before it is placed in service. Finally, the proposed regulations would amend § 1.263A-8(d)(3) to update the definition of “improvement” so that it is consistent with the definition of “improvement” in § 1.263(a)-3, including the exceptions, safe harbors, and elections provided under § 1.263(a)-3.

On July 24, 2024, the Treasury Department and the IRS published a correction to the proposed regulations in the Federal Register (89 FR 59864) to amend a citation error in the preamble of REG-133850-13. No public hearing was requested or held on the proposed regulations.

The Treasury Department and the IRS received two comments in response to the notice of proposed rulemaking. Both comments are available at https://www.regulations.gov or upon request. The first comment did not address the proposed regulations. The second comment expressed support for the proposed regulations without suggesting any modifications to the proposed regulations. Accordingly, this Treasury Decision adopts the proposed regulations as final regulations with only minor, clarifying changes. Specifically, the final regulations make minor changes to proposed § 1.263A-8(d)(3)(i) to clarify the scope of improvements that constitute the “production of property” for purposes of determining whether any such improvement is designated property under § 1.263A-8.

The Office of Management and Budget's Office of Information and Regulatory Analysis has determined that the final regulations are not significant and are not subject to review under section 6(b) of Executive Order 12866. Therefore, a regulatory impact assessment is not required.

These final regulations do not impose additional recordkeeping or reporting burden related to section 263A for taxpayers. A change in a taxpayer's treatment of interest to a method consistent with §§ 1.263A-8(d)(3) and 1.263A-11(e) and (f), as applicable, is a change in method of accounting to which sections 446 and 481 of the Code apply. Taxpayers change methods of accounting by filing Form 3115, Application for Change in Accounting Method (Office of Management and Budget 1545-2070). For purposes of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA), the reporting burden associated with Form 3115 will be reflected in the PRA submission for Form 3115 (OMB 1545-2070).

These final regulations impose 0 hours and $0 of additional recordkeeping or reporting burden related to section 263A for taxpayers. Taxpayers who change their accounting method based on the revised requirements do so by filing Form 3115 (OMB 1545-2070). For purposes of the PRA, the reporting burden associated with Form 3115 will be reflected in the PRA submission for Form 3115 (OMB 1545-2070).

Because businesses with gross receipts of up to $25 million (as adjusted for inflation pursuant to sections 263A(i) and 446(c)) are exempted from the requirement to capitalize costs, including interest, under section 263A, businesses with gross receipts in excess of $25 million (as adjusted for inflation) are impacted by these final regulations. Approximately 30,000 taxpayers with gross receipts in excess of $25 million (as adjusted for inflation) reported that they were subject to section 263A during the past five years. This number is based upon the number of taxpayers who reported that they were subject to section 263A on Form 1120, U.S. Corporation Income Tax Return, Form 1125-A, Cost of Goods Sold, and Form 4562, Depreciation and Amortization (Including Information on Listed Property).

It is estimated that no more than 1 percent of these businesses will make improvements to real or tangible personal property that constitute the production of designated property for which a change in accounting method will be made in any one year. Therefore, it is estimated that approximately 300 taxpayers may be impacted by the changes in these final regulations.

Taxpayers with gross receipts of up to $25 million (as adjusted for inflation) are exempted from the requirement to capitalize costs, including interest, under section 263A. Therefore, very few, if any, small entities will be affected by these regulations. The Secretary of the Treasury hereby certifies that these final regulations will not have a significant economic impact on a substantial number of small entities within the meaning of section 601(6) of the Regulatory Flexibility Act (5 U.S.C. chapter 6).

Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these final regulations was submitted to the Chief Counsel of the Office of Advocacy of the Small Business Administration for comment on its impact on small business. No comments on that notice of proposed rulemaking were received from the Chief Counsel for the Office of Advocacy of the Small Business Administration.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). These final regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector in excess of that threshold.

Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These final regulations do not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.

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

The principal authors of these regulations are Elizabeth Boone and Max Fishman of the Office of the Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the Treasury Department and IRS participated in their development.

Accordingly, the Treasury Department and the IRS amend 26 CFR part 1 as follows:

The purpose of this rule is to update the Coast Guard's chapters in the Code of Federal Regulations (CFR) to reflect the renaming of our districts. This is a conforming amendment regarding the Coast Guard's organization.

This final rule is issued under the authority of 5 United States Code (U.S.C.) 552(a) and 553; 14 U.S.C. 102, 503, and 504; and Department of Homeland Security (DHS) Delegation No. 00170.1(II)(23) Revision No. 01.4. As explained in 33 CFR 1.05-1(h), the Chief of the Coast Guard's Office of Regulations and Administrative Law has been delegated authority to issue regulations necessary to implement technical, organizational, and conforming amendments and corrections to regulations.

We did not publish a notice of proposed rulemaking before this final rule. The Coast Guard finds that this rule is exempt from notice and comment rulemaking requirements under 5 U.S.C. 553(b)(A) because the district renaming is a conforming amendment involving agency organization. Updating the district names in the CFR imposes no substantive changes on the public's rights or obligations and will be inconsequential in impact.

The Coast Guard finds good cause exists under 5 U.S.C. 553(d)(3) to make the rule effective fewer than 30 days after publication in the Federal Register . Delaying the effective date of the rule is unnecessary because updating the district name we use in our regulations is inconsequential to the public and the name has already been adopted by the Coast Guard in agency practice.

The Coast Guard announced the renaming of the districts in a message, ALCOAST 305/25, “Force Design 2028—Renaming Coast Guard Districts” on July 3, 2025. A copy of the ALCOAST is available in the docket under the ADDRESSES section of this preamble. As explained in the ALCOAST, when the Coast Guard operated as part of the Navy during World War II it adopted the Navy's numbered district system to ensure alignment between the services. In the 80 years since the end of World War II, the Coast Guard has maintained its numbered districts. However, the Navy stopped using numbered districts over 25 years ago. Renaming Coast Guard districts to reflect their geographical location will help the public and maritime stakeholders easily find and understand which Coast Guard district they live, boat, and operate in. In the ALCOAST we explained the name change will not impact operations or change existing geographical district boundaries. The ALCOAST also stated we would change district names in the CFR in coming months.

This final rule updates the CFR to reflect the renaming of Coast Guard operational districts from numerical to geographic names. The geographic names more clearly align districts with their areas of responsibility, improve collaboration with interagency partners, and ensure the public and maritime stakeholders can easily find and understand the districts in which they live, recreate, and operate.

The new geographic names are as follows:

The Coast Guard periodically issues technical, organizational, and conforming amendments to existing regulations. These conforming amendments provide the public with accurate and current regulatory information but do not change the effect of any Coast Guard regulations on the public.

This rule also revises the authority citations in several parts of the CFR solely to update the DHS Delegation No. 00170.1 to the most current revision number 01.4.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. A summary of our analyses based on these statutes or Executive orders follows.

Executive Order 14192 (Unleashing Prosperity Through Deregulation) directs agencies to significantly reduce the private expenditures required to comply with Federal regulations and provides that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.”

This rule is not an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866. See OMB Memorandum M-25-20, “Guidance Implementing Section 3 of Executive Order 14192, titled `Unleashing Prosperity Through Deregulation' ” (March 26, 2025). The name change will have no substantive effect on the public. A regulatory analysis (RA) follows.

This rule involves non-substantive technical amendments and updates to internal agency practices and procedures and will not impose any additional costs. The technical amendments in this rule modify existing language in the CFR. The Coast Guard does not expect any additional costs for the public or the Federal Government because none of the technical and editorial changes included in this rule will change existing regulatory requirements. Specifically, renaming the districts to reflect their geographical location will help the public and maritime stakeholders easily find and understand which Coast Guard district they live, boat, and operate in, leading to less confusion. A summary of these amendments by numerical district name and geographical district name are presented in table 1.

The unquantified benefits of these non-substantive technical amendments are increased accuracy of regulatory information by removing expired or cancelled provisions that are no longer relevant. Further, these changes will improve public understanding and accessibility of Coast Guard regulations, ensuring that the public benefits from accurate regulatory text and reduced confusion.

Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000 people.

Under 5 U.S.C 604(a), a regulatory flexibility analysis is not required for this final rule because under the provision in section 553(b)(A) we were not required to publish a general notice of a proposed rulemaking. Therefore, we did not conduct a regulatory flexibility analysis for this rule.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we want to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 3520.

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

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights).

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, (Civil Justice Reform), to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks). This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

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

We have analyzed this rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

We have analyzed this rule under DHS Management Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. This final rule is categorically excluded under paragraph A3, and L54 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. The categorical exclusion (CATEX) A3 pertains to the promulgation of rules, issuance of rulings or interpretations, and the development and publication of policies, orders, directives, notices, procedures, manuals, advisory circulars, and other guidance documents of the following nature: (a) those of a strictly administrative or procedural nature, (b) those that implement, without substantive change, statutory or regulatory requirements, (c) those that implement, without substantive change, procedures, manuals, and other guidance documents, and (d) those that interpret or amend an existing regulation without changing its environmental effect, (e) technical guidance on safety and security matters, or (f) guidance for the preparation of security plans. CATEX L54 pertains to regulations which are editorial or procedural. This final rule involves non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations for district name changes.

For the reasons discussed in the preamble, under the authority of 14 U.S.C. 503 and 504, the Coast Guard amends 33 CFR chapter I and 46 CFR chapters I and III as follows:

The Coast Guard received notification that fireworks will be launched from shore on the Maumee River near Toledo Country Club in Toledo, OH. Hazards from fireworks displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port (COTP) Detroit has determined that potential hazards associated with fireworks are a safety concern for anyone within a 150 yards of the fireworks display. Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard was notified of this event on September 23rd, 2025 but we must establish this safety zone by October 3, 2025, to protect personnel, vessels, and the marine environment. Therefore, we have do not have enough time to solicit and respond to comments.

For the same reasons, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the FR.

This rule establishes a safety zone from 8 p.m. until 9 p.m. on October 3, 2025. The safety zone will cover all navigable waters of the Maumee River within a 150-yard radius of the Toledo Country Club in Toledo, OH. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or their designated representative.

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

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

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

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.

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

The Coast Guard and other Federal, State, and Local law enforcement agencies are engaging in a security related exercise in preparation for the FIFA 2026 World Cup Fan Festival. During the training exercise, participating law enforcement vessels and opposing force training vessels will be operating at high speeds in a confined area. The Captain of the Port (COTP) has identified the risk of collision with transiting vessels as a potential hazard associated with the training exercise and determined that a safety zone is required to minimize that risk. Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone from potential hazards related to the security training exercise.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable to publish an NPRM, respond to comments, and publish a final rule by October 8, 2025, to protect personnel, vessels, and the marine environment.

The Coast Guard also finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the FR as there are less than 30 days before October 8, 2025, available now.

This rule establishes a safety zone from 9 a.m. until noon on October 8, 2025. The safety zone will cover all waters from surface to bottom of the Upper Bay around Ellis and Liberty Island. The coordinates of the safety zone are provided in the regulatory text below. We have also included a chartlet in the docket to visually depict the safety zone. For instructions on viewing items in the docket, see the ADDRESSES section above.

This safety zone is being established for the protection of mariners from training exercise participants operating at high speeds during the security training exercise. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. Notification of the safety zone will be provided by Broadcast Notice to Mariners and publication in the Local Notice to Mariners. Broadcasts will continue throughout the exercise and will cease when all operations have finished.

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

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

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

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on viewing items in the docket, see the ADDRESSES section, above.

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

The Captain of the Port Los Angeles—Long Beach (COTP) has determined that navigational hazards may arise due to low-flying aircraft and stunt performances over the water, offshore of Huntington Beach, during the Pacific Air Show. This event will consist of military and civilian aircraft performing aerobatic maneuvers at high speeds within the lateral limits of an aerobatic box, extending from the ocean surface to 15,000-feet above mean sea level (MSL). The event typically attracts over 800 spectator vessels each year. Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. The Coast Guard only recently received final details for the proposed safety zone, but we must establish this safety zone by October 2, 2025, to protect personnel, vessels, and the marine environment. Therefore, we have do not have enough time to solicit and respond to comments.

For the same reasons, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

This rule establishes a safety zone from 11 a.m. until 2 p.m. on October 2, 2025, 9:30 a.m. until 4:30 p.m. on October 3, 2025, 10 a.m. until 4:30 p.m. on October 4, 2025, and 10 a.m. until 4:30 p.m. on October 5, 2025. The safety zone will cover all navigable waters within a designated 12,000-foot by 3,000-foot box offshore of Huntington Beach, CA. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or their designated representative.

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

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

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

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule involves a temporary safety zone lasting four days that will prohibit entry into all navigable waters within a designated 12,000-foot by 3,000-foot box offshore of Huntington Beach, CA. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.

This final rule incorporates classification changes adopted by the Nice Agreement that will become effective on January 1, 2026. Specifically, this rule adds new goods to, or deletes existing goods from, eight class headings to further define and identify the type of goods appropriate to the classes.

The USPTO is revising § 6.1 of 37 CFR part 6 to incorporate classification changes and modifications, as listed in the Nice Classification (13th ed., ver. 2026), published by WIPO, that will become effective on January 1, 2026. The Nice Agreement is a multilateral treaty, administered by WIPO, that establishes the international classification of goods and services for the purpose of registering trademarks and service marks. Since September 1, 1973, this international classification system is the controlling system used by the United States, and it applies, for all statutory purposes, to all applications filed on or after September 1, 1973, and their resulting registrations. See 37 CFR 2.85(a). Every signatory to the Nice Agreement must use the international classification system.

Each state party to the Nice Agreement is represented in the Committee of Experts of the Nice Union (Committee of Experts), which meets annually to vote on proposed changes to the Nice Classification. Any state that is a party to the Nice Agreement may submit proposals for consideration by the other members of the Committee of Experts, in accordance with agreed-upon rules of procedure. Proposals are currently submitted annually to an electronic forum on the WIPO website, where they are commented on, modified, and compiled for further discussion and voting at the annual Committee of Experts meeting.

In 2013, the Committee of Experts began annual revisions to the Nice Classification. The annual revisions, which are published electronically and enter into force on January 1 each year, are referred to as versions and identified by an edition number and the year of the effective date ( e.g., “Nice Classification, 10th ed., ver. 2013” or “NCL 10-2013”). Each annual version includes changes adopted by the Committee of Experts since the adoption of the previous version, consisting of: (1) the addition of new goods and services to, and the deletion of goods and services from, the Alphabetical List; and (2) any modifications to the wording in the Alphabetical List, the class headings, or the explanatory notes that do not involve the transfer of goods or services from one class to another.

As of January 1, 2023, new editions of the Nice Classification are published electronically every three years. They include all changes adopted since the previous annual version, as well as goods or services transferred from one class to another and new classes that have been created since the previous edition.

The 35th session of the Committee of Experts, comprised of member states and WIPO, was held from April 28 to May 2, 2025, at WIPO headquarters in Geneva, Switzerland. The revisions contained in this final rule consist of modifications to class headings that were voted upon and incorporated into the Nice Agreement during the session.

Under the Nice Classification, there are 34 classes of goods and 11 classes of services, each with a class heading. Class headings generally indicate the fields to which goods and services belong. Specifically, this rule adds new goods to, or deletes existing goods from, eight class headings to further define and identify the types of goods appropriate to the classes. As a signatory to the Nice Agreement, the United States adopts these revisions pursuant to Article 1.

The USPTO is revising § 6.1 as follows:

In Class 1, the wording and semicolon “putties and other paste fillers;” are deleted.

In Class 3, the word “perfumery,” is amended to “perfumes” and the comma is deleted. The wording “essential oils” is deleted.

In Class 5, the wording “veterinary use” is amended to “veterinary purposes.” The word “adhesive” is added before “plasters.” The wording “stopping teeth” is amended to “filling teeth.”

In Class 8, the wording “Hand tools and implements, hand-operated” is amended to “Hand-operated hand tools and implements.”

In Class 9, the word “media” is amended to “multimedia files.” The wording “and swimmers” is deleted.

In Class 10, the wording “spectacles, contact lenses and sunglasses;” is added between “teeth” and “orthopaedic.”

In Class 26, the word “braid” and the comma preceding it are deleted.

In Class 29, the wording “for culinary purposes” is added after “meat extracts.” The wording “and vegetables” is amended to “vegetables and seaweeds” and a comma is added after “fruits.”

A. Administrative Procedure Act: This final rule revises the regulations to reflect modifications to class headings, which indicate the classes to which goods and services belong, that were incorporated into the Nice Agreement. The changes in this final rule do not change the substantive criteria for the registration of a trademark. Therefore, the changes in this rulemaking involve rules of agency practice and procedure and/or interpretive rules and do not require notice-and-comment rulemaking pursuant to 5 U.S.C. 553(b)(B). See Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 97, 101 (2015) (explaining that interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers” and do not require notice-and-comment when issued or amended); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice-and-comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice”); In re Chestek PLLC, 92 F.4th 1105, 1110 (Fed. Cir. 2024) (noting that rule changes that “do[ ] not alter the substantive standards by which the USPTO evaluates trademark applications” are procedural in nature and thus “exempted from notice-and-comment rulemaking.”); and JEM Broadcasting Co. v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. 1994) (“[T]he `critical feature' of the procedural exception [in 5 U.S.C. 553(b)(A)] `is that it covers agency actions that do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency.' ” (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980))).

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

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

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

E. Executive Order 14192 (Deregulation): This regulation is not an Executive Order 14192 regulatory action because it has been determined to be not significant under Executive Order 12866.

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

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

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

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

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

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

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

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

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

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

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

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

Q. E-Government Act Compliance: The USPTO is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.

For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1112 and 1123 and 35 U.S.C. 2, as amended, the USPTO is amending 37 CFR part 6 as follows:

In a document published in the Federal Register (FR) on August 23, 2022, VA proposed to revise its regulations that govern a VA health care professional's practice via telehealth. 87 FR 51625. VA provided a 60-day comment period, which ended on October 24, 2022. We received a total of 18 comments, ten of which fully supported the proposed rule. We thank the commenters for their comments and do not further address them below. The remaining comments, some of which were generally supportive of the rule, raised issues and concerns that are grouped together by like topic and addressed below. We make minor changes to the rule as described below.

We received two comments regarding VA's preemption of conflicting State laws. One commenter stated that VA is prohibited by the Tenth Amendment of the Constitution from requiring States to issue or continue licenses to health care professionals who do not meet State licensing requirements, such as the requirement that the health care professional's supervisor is providing in person supervision or the requirement that the trainee be supervised by a health care professional who is licensed in the same State as the trainee. The commenter requested that VA clarify that it is not commandeering States to license those employees who do not meet State requirements for a license. We do not make any changes based on the comment.

The Tenth Amendment of the United States Constitution provides that the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people. However, VA's authority to furnish health care to veterans has not been reserved to the States or the people. Under Article I, section 8, Congress has the power to “provide for the common Defence and general Welfare of the United States”; to “raise and support Armies”, and to “provide and maintain a Navy”; and to “make Rules for the Government and Regulation of the land and naval Forces”. See Art. I, sec. 8, cls. 1, 12-14. Congress also has power to “make all Laws which shall be necessary and proper for carrying into Execution the foregoing powers”. See Art. I, sec. 8, cls. 18. Congress exercises its authority under some or all of these clauses when enacting veterans' benefits. See, e.g., Torres v. Texas Dep't of Pub. Safety, 597 U.S. 580 (2022). Exercising these powers, Congress, under section 7301(b) of title 38, United States Code (U.S.C.), established that the primary function of the Veterans Health Administration (VHA) within VA is to provide a complete medical and hospital service for the medical care and treatment of veterans. Generally, VA is allowed to employ medical professionals so long as they are licensed “in a State,” see, e.g., 38 U.S.C. 7402(b)(1)(C), rather than in every State in which they or their patients will be located while providing care through VA. See also title 38, Code of Federal Regulations (CFR) 17.419(b)(1)(i) (providing that a VA health care professional may practice in any State “irrespective of the State where they hold a valid license, registration, certification or other State qualification”). Specific to the provision of care through telehealth, Congress explicitly provided that, notwithstanding any provision of law regarding the licensure of health care professionals, a VA health care professional may practice at any location in any State, regardless of where the health care professional or the patient is located, when using telehealth to provide treatment to an individual under chapter 17. 38 U.S.C. 1730C(a). Section 1730C(d) further states that this section supersedes any State law to the extent that the State law is inconsistent with section 1730C, and that no State shall deny or revoke a license, registration, or certification who otherwise meets the qualifications of the State for holding such credential on the basis of their practice of telehealth at VA. Therefore, the rule does not encroach on any rights reserved to the States or to the people and is not a violation of the Tenth Amendment to the U.S. Constitution both because Congress has authority to enact laws regarding veterans' benefits under Article I, section 8, and because Congress asserted Federal supremacy under clause 2 of Article VI of the Constitution, which provides that the Constitution, and the laws of the United States made in pursuance thereof, are the supreme law of the land. In enacting section 1730C, Congress exercised its authority under this clause (commonly referred to as the supremacy clause) to preempt inconsistent State law.

We clarify that through this rulemaking, we are not requiring or commandeering a State to grant a license to those VA employees who do not meet the State requirements to receive a license, registration, certification, or other requirements. Rather, we are preempting any provisions of State requirements as applied to VA health care professionals to the extent that such provisions are inconsistent with a VA health care professional's practice via telehealth. If a State requirement is inconsistent with the VA employee's ability to carry out their Federal duties, that State requirement will have no force or effect on the VA employee when carrying out their VA duties. As explained above, section 1730C(d)(2) confirms that no State shall deny or revoke the license, registration, or certification of a covered health care professional who otherwise meets the qualifications of the State for holding the license, registration, or certification on the basis that the covered health care professional has engaged or intends to engage in telehealth at VA. However, the States will still determine whether the health care professional otherwise meets the State qualifications for holding the license, registration, or other requirement.

We received one comment addressing limitations in the Controlled Substances Act (CSA) and other applicable Federal law, regulation, and policy as applied to VA, to include possible limitation by State law through such authority. The commenter referenced practice guidelines regarding the prescribing of buprenorphine, citing 86 FR 22439 (April 28, 2021), that ordinarily require prescribers to be licensed to treat patients in the State in which the patient is located. As the commenter acknowledged, the practice guidelines specifically exempt Federal practitioners who are acting within the scope of their Federal employment. We do not make a substantive change based on the comment but make a non-substantive clarifying change to 38 CFR 17.417(b)(3) to avoid any potential confusion regarding the authority of VA health care professionals to prescribe controlled substances via telehealth and the impact of State law as referenced by Federal authority.

State law that would conflict with VA health care professionals prescribing via telehealth is not applicable to VA health care professionals, but Federal standards regarding prescribing via telemedicine are applicable. VA stated in proposed § 17.417(b)(3) that its health care professionals are subject to the CSA and other “applicable Federal law, regulation, and policy,” 87 FR 51631, whereas the provision it is replacing (currently in § 17.417(b)(1) requires health care professionals to comply with “the laws and practice acts of the health care providers' State license, registration, or certification” in addition to applicable Federal law. VA views the change as being authorized by, and consistent with, the relevant statutory authority.

Specifically, the CSA creates a number of standards for a prescription to be valid. See, e.g., 21 U.S.C. 829. Additional standards are applicable to prescribing via “telemedicine.” See, e.g., 21 U.S.C. 802(54) (authorizing prescribing a controlled substance when the prescriber is, inter alia, communicating with the patient via “a telecommunications system referred to in section 1395m(m) of title 42.”). These standards created by the CSA are among the applicable Federal laws addressed in proposed 38 CFR 17.417(b)(3).

The CSA also references “applicable . . . State laws” into the “practice of telemedicine.” 21 U.S.C. 802(54). VA health care professionals are specifically authorized to practice medicine through telehealth notwithstanding State law. 38 U.S.C. 1730C(a). VA does not view a conflict as existing between the two provisions. See Morton v. Mancari, 417 U.S. 535 (1974) (discussing the preference for reading statutes to co-exist if possible). Rather, section 1730C identifies a group of State laws—those that conflict with a covered health care professional's practice of health care through telehealth that are not appliable to VA health care professionals in their VA role—without specifically excluding State laws that interfere with prescribing controlled substances through telemedicine, whereas the CSA in section 802(54) identifies that health care professionals must generally comply with those State laws applicable to them. Section 1730C(d)(2) explicitly prohibits a State from denying or revoking the license, registration, or certification of a covered VA health care professional based on their practice of telehealth at VA.

Therefore, we conclude that it is possible to give effect to both 21 U.S.C. 802(54) and 38 U.S.C. 1730C, with the latter establishing that State laws interfering with VA health care professionals prescribing controlled substances are not applicable to VA health care professionals under the former. To the extent a conflict exists between the two statutes, we conclude that section 1730C(d) is the specific rule addressing State law as applied to the practice of telehealth by VA health care professionals and would control the general rule of 21 U.S.C. 802(54). See, e.g., Morales v. Trans World Airlines, Inc., 504 U.S. 374, 384 (1992) (“[I]t is a commonplace of statutory construction that the specific governs the general.”). Moreover, 38 U.S.C. 1730C was enacted (in 2018) after 21 U.S.C. 802(54) (in 2008). To the extent there is a conflict, the canon of interpretation that the later statute will generally prevail over a conflicting earlier statute would also support VA's interpretation. Indeed, to do otherwise would effectively render 38 U.S.C. 1730C(d) surplusage with regard to prescribing via telemedicine, an interpretation that is not generally favored. See, e.g., Montclair v. Ramsdell, 107 U.S. 147, 152 (1883).

VA does not view section 1730C(e) as requiring a different result. Section 1730C(e) states a rule of construction that nothing in section 1730C may “be construed to remove, limit, or otherwise affect any obligation of a covered health care professional under the [CSA]”). State law is superseded by section 1730C(a) (“notwithstanding any provision of law regarding the licensure of health care professionals”) to the extent it is inconsistent with a VA health care professional's practice of medicine through telehealth, with section 1730C(d) making clear that State may take no action against a VA health care professional's license based on a professional providing or intending to provide treatment through telehealth as part of their VA practice. Section 1730C(d)(1). In this context, such State laws are not “applicable . . . State law” under 21 U.S.C. 802(54) and create no “obligation” for VA health care professionals to follow conflicting State laws. 38 U.S.C. 1730C(e). Therefore, VA concludes that section 1730C(e) incorporates the Federal standards of the CSA, but not more. VA also notes that Congressional recognition of the unique nature of VA's Nationwide practice by removing some State-level requirements regarding prescribing is not unprecedented. For instance, in the CSA, Congress exempted VA health care professionals from some State requirements even before section 1730C was enacted. See, e.g., 21 U.S.C. 802(54)(A)(ii)(III)(bb)(AA) (exempting VA health care professionals from the requirement of being “registered . . . in the State in which the patient is located” when prescribing via telehealth if the patient is being treated by, and physically located in, a hospital or clinic registered under 21 U.S.C. 823(g)).

This addition also supports VA's “Fourth Mission” to improve the Nation's preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, State, and local emergency management, public health, safety and homeland security efforts. VA's Fourth Mission is authorized under three separate authorities 38 U.S.C. 1784, 1784A, and 1785. Section 1784 authorizes VA to furnish hospital care or medical services as a humanitarian service in emergency cases. Under section 1784A, in the case of a VA hospital that has an emergency department, if any individual comes to the hospital or the campus of the hospital and a request is made on behalf of the individual for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. Lastly, under section 1785, VA may, during and immediately following a disaster or emergency, furnish hospital care and medical services to individuals responding to, involved in, or otherwise affected by that disaster or emergency. In conjunction with other Federal entities, such as the Department of Health and Human Services (HHS) and the Department of Defense, VA serves as an asset to the nation during disasters and emergencies. As a foundational part of Federal emergency management efforts through the National Response Framework, VA leads the effort for meeting veterans' needs and has expanded authority to assist service members or civilians. Telehealth and the ability to prescribe controlled substances in these situations are important capabilities to support VA's Fourth Mission. This rulemaking will ensure VA health care providers are able to practice according to Federal standards when prescribing controlled substances during emergencies to help support VA's Fourth Mission.

We considered whether our proposed rule made this point sufficiently clear to allow the public to meaningfully comment on the issue and conclude that the issue was sufficiently explained. In the preamble to the proposed rule VA now seeks to finalize, we explicitly addressed Executive Order 13132, which “provides the requirements for preemption of State law when it is implicated in rulemaking.” 87 FR 51627-51631. We further explained that VA health care professional's practice of health care via telehealth “is subject to the limitations imposed by the Controlled Substances Act [. . .] and implementing regulations [. . .] on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law, regulation, and policy.” 87 FR 51625, 51626. See also id. at 51631 (proposed 38 CFR 17.417(b)(3)). This statement and corresponding regulatory text were intended to clarify that VA health care professionals are not excluded from Federal authority by 38 U.S.C. 1730C or the proposed rule, neither of which reference State law or suggest that the preemption of conflicting State laws does not extend to those State laws that are inconsistent with Federal standards regarding the prescription of controlled substances through telehealth.

We again note that this statement meaningfully departs from the existing regulation, which predates section 1730C. VA's initial efforts to preempt State law addressing the practice of telehealth prior to 1730C were not intended to exempt VA health care professionals from all State-law requirements. Specifically, VA engaged in rulemaking in October 2017, publishing a proposed rule entitled Authority of Health Care Providers to Practice Telehealth. 82 FR 45756 (October 2, 2017). While conflicting State law was generally preempted (“this proposed rule would preempt certain State laws”, and “conflicting State and local laws, rules, regulations, and requirements related to health care providers' practice would have no force or effect when practicing telehealth”), see id. at 45759, VA also stated that the rulemaking did not affect VA's existing requirement that all VA health care providers “adhere to restrictions imposed by their State license, registration, or certification regarding the professional's authority to prescribe and administer controlled substances.” Id. at 45758.

VA consulted with State officials before proposing the rule in 2017, with at least one response suggesting some varying interpretations about the scope of VA's rule to preempt State-law requirements interfering with VA's practice of telehealth as including controlled substances. Id. at 45760 (stating Florida's requirement that patients receive an in-person examination each time a physician issues a certification for medical marijuana would not apply to VA practitioners practicing telehealth, but VA would maintain the restrictions imposed by Federal law and policy regarding the prescription of controlled substances). See generally id. at 45759-60 (for a more fulsome discussion of the generally favorable input VA received from State agencies and National Associations for State practice groups).

In 2018, VA's rule was promulgated, 83 FR 21897 (May 11, 2018), and VA again clarified that this section “does not otherwise grant health care providers additional authorities that go beyond what is required or authorized by Federal law and regulations or as defined in the laws and practice acts of the health care providers' State license, registration, or certification.” Authority of Health Care Providers to Practice Telehealth, 83 FR 21897, 21898 (May 11, 2018). The version of 38 CFR 17.417(b)(1) that will be replaced is clear, therefore, both in plain language and regulatory history in directing compliance with prescribing requirements from a practitioner's State of licensure, save where there is a conflict with Federal duties or requirements.

Shortly after VA codified § 17.417 in regulation, 38 U.S.C. 1730C was enacted. MISSION Act of 2018, Public Law 115-182, sec. 151(a) (June 6, 2018). VA views section 1730C as a clear expansion of VA's authority to provide health care through telehealth. Congress made clear that VA health care professionals “may practice” their “health care profession . . . at any location in any State, regardless of where” the practitioner or patient were located when the practitioner was practicing via telehealth. 38 U.S.C. 1730C(a). State laws are superseded “to the extent that such provision of State law [is] inconsistent,” including that no State may “deny or revoke the license, registration, or certification of a” VA practitioner “on the basis that the covered health care professional has engaged or intends to engage in activity covered by subsection (a).” Id. at section 1730(d). While Congress made clear that VA health care professionals are subject to the provisions of the CSA in section 1730(e), it does not subject providers to the “laws and practice acts of the health care providers' State license, registration, or certification”, unlike the VA regulation that was in effect. 38 CFR 17.417(b)(1). Following the enactment of the VA MISSION Act of 2018, VA published the proposed rule it now seeks to finalize. 87 FR 51625 (August 23, 2022). In the preamble to this proposed rule, VA stated that this proposed rulemaking would state that VA health care providers' practice of medicine via telehealth “is subject to the limitations imposed by the Controlled Substances Act [. . .] and implementing regulations [. . .] on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law, regulation, and policy.” Id. at 51626. VA removed the current requirement for compliance with State-level restrictions in the providers' State of licensure, registration, or certification, echoing 38 U.S.C. 1730C, but did not address the change beyond the discussion above and the regulatory text stating that providers are subject to the CSA and “other limitations on the provision of VA care set forth in applicable Federal law, regulation and policy.” Id. at 51631 (proposed 38 CFR 17.417(b)(3)).

We explicitly address here and in updated § 17.417(b)(3) and clarify that this rulemaking supersedes any conflicting State requirements regarding the practice of telehealth, including such State or local laws, rules, regulations, and requirements related to the prescribing of controlled substances. This preemption applies both to the State's enforcement of these laws and to the CSA, to the extent the CSA could be read to reference State-level authority. See, e.g., 21 U.S.C. 802(54) (defining “practice of telemedicine” as meaning “in accordance with applicable Federal and State laws”). Conflicting State-level restrictions on the practice of telehealth are not applicable to VA health care professionals while those professionals are acting in the scope of their VA employment and practicing through telehealth, including to the extent that a State might otherwise take action regarding the license, registration, or certification of the provider. 38 U.S.C. 1730C(a), (d).

As articulated in our proposed rule, VA does not read section 1730C as removing requirements for prescribing via telehealth in the CSA or as set forth in other Federal law and policy. Section 1730C(e). Therefore, to the extent a Federal actor with authority to prescribe Federal standards, such as the U.S Department of Justice (including the Drug Enforcement Administration) or the Department of Health and Human Services, promulgate guidance binding on VA regarding the practice of telehealth, we view such authority as binding on VA health care professionals in their Federal practice. Additionally, any VA specific policies on prescribing controlled substances, i.e., checking the Prescription Drug Monitoring Program, how many days of medication VA health care professional may prescribe, etc., must be followed. VA has a robust system in place for prescribing controlled substances and, as an integrated health system, has better substance use disorder service (SUDS) outcomes. These outcomes are achieved via VA's SUDS continuum of care, which provides standard outpatient services, intensive outpatient programs, opioid replacement therapies, residential rehabilitation and acute hospital services. VA has been proactive in developing initiatives and tools to ensure VA employed health care professionals deliver safe, high-quality care to veterans within its integrated health care system, be it through in-person or virtual care. By way of example, VA highlights its Opioid Safety Initiative (OSI), implemented Nationwide in 2013, which facilitates the safe, effective prescribing of opioid containing controlled substances in alignment with evidence-based practice.

Key outcomes from this initiative demonstrate its effectiveness. Between fourth quarter of Fiscal Year (FY) 2012 and fourth quarter of FY 2024, VA's achievements include:

• A 68% reduction in patients receiving opioids (874,897 to 282,346 patients);

• A 90% reduction in patients receiving opioids and benzodiazepines together (162,444 to 15,446 patients);

• An 82% reduction in patients with high dosage opioid therapy (greater than or equal to 90 Morphine Equivalent Daily Dose) (76,466 to 13,453 patients);

• A 73% reduction in patients on long-term opioid therapy (569,027 to 155,945 patients);

• A 53% increase in patients on long term opioid therapies with urine drug screen (UDS) (from 32% to 85%); and

• An 83% reduction in new patients on long-term opioid therapy (58,417 to 10,005 patients). (VHA internal OSI dashboard data).

Furthermore, VA mandates that all veterans have their care reviewed by an interdisciplinary team of health care professionals with expertise spanning pain, mental health, addiction, pharmacy and rehabilitation when the veteran:

• Is prescribed or has recently discontinued use of opioid analgesic medications and is identified as very high risk for overdose events, suicide events, or death through the VA's Stratification Tool for Opioid Risk Mitigation (STORM); or

• Has recently suffered from a non-fatal overdose.

In a randomized program evaluation, this mandate was associated with a 22 percent reduction in all-cause mortality in the next 4 months among the very high-risk veterans targeted by this prevention program. 1 With VA's integrated health system and robust system in place for prescribing controlled substances, veterans who receive VA health care have better health outcomes than non-enrolled veterans, and VA hospitals have dramatically outperformed non-VA hospitals in overall quality ratings and patient satisfaction ratings. 2

We also note that, in the FY 2024 budget request, VA included a legislative proposal addressing prescribing via telehealth. We view this request as complementary to the interpretation of 38 U.S.C. 1730C and 21 U.S.C. 802(54) articulated above. While State law is not applicable to VA health care professionals insofar as it is inconsistent with those professionals prescribing via telehealth, our legislative proposal provides further clarity regarding standards for quality and safety that VA would need to follow and establish in partnership with the Attorney General. Our legislative proposal provides additional clarity on VA's standards for prescribing via telehealth when doing so would be inconsistent with a State law that would be preempted by 38 U.S.C. 1730C.

We note that, in order to practice telehealth pursuant to section 1730C(b), a VA health care professional must have an active, current, full, and unrestricted license, registration, or certification in a State to practice the health care profession of the health care professional or, with respect to a health care profession listed undersection 7402(b), have qualifications for such profession as set forth by the Secretary. Trainees and postgraduate employees may only participate in telehealth with clinical supervision, which must be by an employee who is licensed, registered, or certified by a State or who otherwise meets qualifications as defined by the Secretary. See 87 FR 51629. In addition, all health care professionals that require a certification, registration, or other State requirement must maintain their credentials as outlined by VA's qualification standards in VA Handbook 5005, Staffing. VA health care professionals must still follow State laws, unless there is a conflict with Federal duties or requirements, and that pursuant to section 1730C(b)(1)(C), VA health care professionals are still “required to adhere to all standards for quality relating to the provision of health care in accordance with applicable policies of the Department.” We are amending 38 CFR 17.417(b)(4) by adding a new paragraph (b)(4)(viii) to add a new example of a situation where there would be a conflict between the health care professional's State license and Federal duties or requirements. This new paragraph states that an example of where a health care professional's VA practice of telehealth may be inconsistent or conflict with a State law or State license, registration, or certification requirements related to telehealth include when the beneficiary is receiving a controlled substance medication in a State other than the health care professional's State of licensure, registration, or certification. While several of the existing examples in § 17.417(b)(4) are relevant to prescribing controlled substances, VA believes a specific example adds clarity.

Another commenter raised concerns about the lack of public and State consultation prior to the promulgation of the rule. In particular, the commenter stated that promulgating health care professional practice rules at the Federal level rather than the State level reduces opportunities for public participation and limits public accountability, as the public can impact State laws and regulations governing licensed health care professionals as well as State regulating bodies. The commenter further explained that the State consultation process used for this rule was insufficient, as VA did not consult with individual State boards of nursing. We do not make any changes to the rule based on this comment.

As an initial matter, VA reiterates that Congress enacted 38 U.S.C. 1730C to specifically authorize VA to establish rules related to telehealth on a Federal level for VA health care professionals that would explicitly preempt State requirements that are inconsistent with VA's requirements. VA further believes that appropriate opportunities for public and State participation were available for this rule. VA provided a 60-day comment period on the proposed rule, which afforded the public, including State officials and individual State boards, the opportunity to submit comments on the rule. We also consulted with appropriate State officials, including the National Council of State Boards of Nursing, prior to the publication of the proposed rule in compliance with sections 4(d) and (e) and section 6(c) of Executive Order 13132, as that was the most practicable form of consultation. In addition, VA will continue to work closely with State licensing boards to make certain that VA health care professionals continue to meet the standards of clinical practice, which will ensure patient safety.

We received several comments regarding how VA will protect VA health care professionals if a State pursues an adverse action against such professional for practicing via telehealth. While we do not consider any of these comments within the scope of the rule because they all concern internal VA processes, we will address the concerns to provide clarity and transparency. We do not make any changes based on these comments.

One commenter raised concerns that the rule does not explain how current and former VA employees should report to VA State action that is being taken against their license based on activities undertaken within the scope of VA employment. While we do not consider any of this comment within the scope of the rule because it concerns internal VA processes, we will address the concern to provide clarity and transparency, as further described below. We do not make any changes based on this comment.

Multiple commenters raised concerns about how and whether VA would support or represent VA employees who have adverse actions taken against them for practicing via telehealth inconsistent with their State requirements. One commenter specifically raised concerns about how VA would protect postgraduate health care employees, health professions trainees, and those providing clinical supervision. Another commenter suggested that VA commit to assisting its employees from State action while another raised concerns about whether VA will devote resources, financial or otherwise, to employees in such instances. One of the commenters recommended that VA implement programs and procedures to protect employees who are acting within the scope of the rule. While we do not consider any of this comment within the scope of the rule because it concerns internal VA processes, we will address the concern to provide clarity and transparency. We do not make any changes based on this comment.

We emphasize that VA is committed to providing representation to all VA health care professionals who have any State action proposed or taken against them for practicing consistent with their Federal duties. VA health care professionals who carry out their Federal duties must be allowed to do so free from the threat of liability. The Supremacy Clause of the U.S. Constitution bars States and State officials from penalizing government personnel for performing their Federal functions, whether through State criminal prosecution, license revocation proceedings, or civil litigation unless authorized by Federal law. Subject to the requirements and procedures set forth in 28 CFR 50.15(a), Department of Justice representation is available to Federal employees in civil, criminal, and professional licensure proceedings where they face personal exposure for actions performed within the scope of their Federal duties. This includes representation of any postgraduate health care employees, health professional trainees, and those providing clinical supervision, as long as they meet the definition of health care professional in 38 CFR 17.417(a)(2). We note that such defense does not extend to situations where a State Board may be taking appropriate disciplinary action against a VA health care professional when their behavior or clinical practice substantially fails to meet generally accepted standards of clinical practice as to raise reasonable concern for the safety of patients or if the VA health care professional is practicing outside of the scope of their VA employment. This is consistent with VA's current practice.

Although VA is committed to protecting its health care professionals were any State to propose or take action against them, VA does not anticipate that many, if any, actions will be taken against its professionals for practicing via telehealth within the scope of their Federal duties. As previously explained, 38 U.S.C. 1730C(d) explicitly provides that the provisions of this section shall supersede any provisions of the law of any State to the extent that such provision of State law are inconsistent with this section and that no State shall deny or revoke the license, registration, or certification of a covered health care professional who otherwise meets the qualifications of the State for holding the license, registration, or certification on the basis that the covered health care professional has engaged or intends to engage in activity covered by subsection (a). Furthermore, State officials are barred from penalizing VA employees for performing their Federal duties, whether through criminal prosecution, license revocation, or civil litigation. See, e.g., Intergovernmental Immunity for the Department of Veterans Affairs and Its Employees When Providing Certain Abortion Services, 46 Op. O.L.C., __ at *10 (Sept. 21, 2022), https://www.justice.gov/d9/2022-11/2022-09-21-va_immunity_for_abortion_services.pdf.

One commenter raised a concern about whether VA or a future non-VA employer could take adverse employment action against the health care professional due to any proposed or actual State action against them. This commenter also stated that despite VA's preemption in this rule, a State regulatory body could still pursue action against a VA employee, which could prohibit such employee from working until the issue is resolved. While we do not consider any of this comment within the scope of the rule because it concerns internal VA processes, we will address the concern to provide clarity and transparency. We do not make any changes based on this comment.

VA will not take adverse employment action if a State proposes action against a VA health care professional solely on the basis of practicing consistent with their Federal duties. A State will typically not take immediate action against a health care professional whose practice is inconsistent with State law without first providing a professional due process. Thus, VA would have an opportunity to assist providers in their defense of any action proposed by a State as described above. In order to be employed at VA in certain health care professions, VA is statutorily required to ensure the health care professional has an active license, certification, registration, or other State requirement. Section 7402. If the health care professional does not meet these qualification standards, VA must remove the individual from a patient care position, i.e., VA may move health care professionals to non-patient care positions, if necessary, while the professionals go through the process of defending their State license. VA would only take this action if a State has taken action against the health care professional's State license and the individual has no other active, current, unrestricted State license.

One commenter recommended VA include a provision in the final rule that allows VA to continue the employment of a health care professional whose licensure has been suspended, conditioned, or revoked when VA believes that the action is based on the employee's activities within the scope of their VA employment. Similar to the comments above we do not consider any of this comment within the scope of the rule because it concerns internal VA processes. We do not make any changes based on these comments.

We received several comments related to the definition of health care professional in the regulation. Although one commenter specifically thanked VA for excluding contractors from the definition of health care professional, some commenters requested that VA include contractors under its definition of health care professional. One commenter suggested that contractors be included to ensure access to care. Another commenter stated that contractors are not expressly excluded under section 1730C; thus, there are no legal barriers to including them in the definition of health care professional. Another commenter suggested that VA could create a narrow exception to the exclusion of VA contractors from this rule in the instance when they are exempted under HHS's Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (HHS Practice Guidelines) from requiring supervision or collaboration with a Drug Enforcement Agency registered physician, even if required by State law.

VA stated in the proposed rule that VA-contracted health care professionals would be excluded from the definition of health care professional. VA maintains this exclusion because 38 U.S.C. 1730C requires that a health care professional be an employee of the Department appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or under title 5 and contracted health care professionals and community care professionals are not appointed under these authorities. We do not make any changes based on these comments.

Another commenter opposed amending the definition of health care professional to include postgraduate health care employees and health care professional trainees, as there may be ambiguity about which practice standards to follow, which could lead to unsafe patient care. We do not make any changes based on this comment. The definition of health care professional in section 1730C includes those who are postgraduate health care employees and those who are health professional trainees. See section 1730C(b)(2) and (3). Thus, VA is required by law to include such individuals in its definition of health care professional for purposes of telehealth.

One commenter suggested VA include certified registered nurse anesthetists (CRNA) in the definition of health care professional. We make no changes based on this comment. The proposed rule amended VA's definition of health care professional defined in 38 CFR 17.417(a)(2) to be consistent with the statutory definition found in 38 U.S.C. 1730C(b)(1)(A), which includes those appointed pursuant to section 7401. Section 7401(1) includes registered nurses. As CRNAs are advanced practice registered nurses appointed under section 7401, they are included in the definition of health care professional in section 1730C(b)(1)(A) and proposed 38 CFR 17.417(a)(2). This definition does not list specific health care professions, but rather lists the criteria that must be met to meet the definition of health care professional.

One commenter was generally supportive of the rule, but highlighted areas that VA should consider to ensure that VA provides the highest quality of care possible. The commenter was supportive of the rule's supervision requirement, but suggested that VA ensure that the proper level of supervision ( i.e., general, direct, or personal) and oversight is provided to both trainees as well as non-physician health care professionals.

We appreciate the suggestions from the commenter; however, we will not make any changes to the rule based on the comment. We agree with the commenter that the appropriate level of supervision should be required for trainees, but do not believe it is appropriate to define that level of supervision in this regulation. The level of supervision may depend on a variety of factors, in particular which health care occupation the trainee is practicing in, and therefore would be better determined sub-regulatorily. As to the commenter's concern about oversight, this is also beyond the scope of the rulemaking for similar reasons. However, as part of its telehealth expansion efforts, VA has developed and refined its telehealth policy to include telehealth oversight responsibilities that support access to safe, high quality services for veterans. VA will continue its efforts to enhance quality management and oversight practices.

Similarly, another commenter raised concerns about the lack of VA guidance, to include a lack of clear delineation for responsibility and oversight, regarding clinical supervision of nurses who have completed their education requirements but are not yet licensed.

While we appreciate this commenter's concerns regarding the need for clear guidance addressing supervisory requirements, we consider them beyond the scope of the proposed rule as they relate to internal VA processes. This rule codifies VA's statutory authority that VA trainees, such as student nurses and unlicensed postgraduate health care employees, may participate in telehealth under appropriate clinical supervision. It does not attempt to delineate or provide guidance on supervisory requirements based on different professions or a trainee's level of experience. VA will provide internal guidance to address the standards of practice that health care professionals should follow while practicing via telehealth. No changes are being made to the rule in response to this comment.

Multiple commenters addressed practice standards for various health care professional occupations. One commenter raised concerns about how quality of care would be affected were VA to increase the scope of practice of non-physician health care professionals when they practice via telehealth particularly, as the commenter asserts, that the clinical judgment of a non-physician health care professional cannot be substituted for that of a physician. Similarly, another commenter raised concerns regarding VA's development of national standards of practice. Another commenter recommended VA remove physician supervision requirements for CRNAs, particularly as such supervision does not impact patient safety and quality of care and instead may restrict access to care and increase costs.

These comments are beyond the scope of this rulemaking. VA has a separate regulatory authority at § 17.419 which authorizes it to develop national standards of practice for VA health care professionals via sub-regulatory guidance. Each national standard of practice will be posted on the Federal Register for a 60-day comment period prior to finalization and implementation. We encourage the commenters to provide their feedback regarding any potential change in the scope of practice of non-physician providers when they are posted for public feedback in the Federal Register .

One commenter recommended that VA correct the use of a comma after 21 CFR 1300 et seq. in 38 CFR 17.417(b)(3). The commenter stated that the implementing regulations should be cited as 21 CFR 1300 et seq. without a comma.

We disagree with the commenter, as the comma is used as a description of the citation 21 CFR 1300 et seq. Usually, if something or someone is sufficiently identified, such as the CFR citation, the description that follows is considered nonessential and should be surrounded by commas. However, we acknowledge that the proposed regulatory text at 38 CFR 17.417(b)(3) had a technical error as a comma was added after 21 U.S.C. 801. As part of this final rule, we are removing the comma after 21 U.S.C. 801 from the final regulation text in 38 CFR 17.417(b)(3).

A commenter appeared to highlight for VA that VA health care professionals and contractors are exempt from certain requirements from the Controlled Substances Act as a result of the HHS Practice Guidelines when prescribing controlled substances. The commenter seemed to further highlight that the exemption, while only in practice guideline, still retained the force and effect of law. The HHS Practice Guidelines provide an exemption from certain statutory certification requirements related to training, counseling, and other ancillary services ( i.e., psychosocial services) to eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are State licensed and registered by the Drug Enforcement Agency to prescribe controlled substances. See 86 FR 22439. We presume that the commenter is suggesting VA update its regulation to include this exception from VA's adherence to the Controlled Substances Act. We are not making any changes based on this comment.

As noted by the commenter, the HHS Practice Guidelines were promulgated pursuant to 21 U.S.C. 823(h)(2)(B)(i)-(ii). 3 On December 29, 2022, the Consolidated Appropriations Act, 2023, was signed into law. Division FF, section 1262 of this Act repealed, among other subsections, 21 U.S.C. 823(h)(2)(B)(i)-(ii). Thus, because the statutory provisions granting HHS the authority to promulgate the practice guidelines have been repealed, they have no force or effect on VA health care providers. However, VA reiterates here that this rule preempts any State requirements regarding the practice of telehealth, including such State or local laws, rules, regulations, and requirements related to the prescribing of controlled substances.

Section 1730C(e) of title 38, U.S.C. provides that nothing in this section may be construed to remove, limit, or otherwise affect any obligation of a covered health care professional under the Controlled Substances Act. Similarly, 38 CFR 17.417(b)(3), provides that health care professionals' practice is subject to the Federal limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. and implementing regulations at 21 CFR 1300 et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law, regulation, and policy.

A commenter was also concerned with VA's prioritization of telehealth over in-person care, especially in instances when a patient is receiving acute hospital care in the home, as they alleged that substituting telehealth for in-person interactions can negatively impact patients, including their relationship with the health care professional, and should only be used when other options are unsafe. The commenter also opined that practicing via telehealth can be challenging for experienced health care professionals, even more so for student nurse trainees and unlicensed postgraduate Registered Nurses (RN). Another commenter supported telehealth but also noted there may be instances when telehealth should not be utilized and in-person care may be more appropriate.

As an initial matter, VA respects the decisions that veterans make as to their own health care decisions and does not force nor require any veteran to utilize telehealth if they would prefer an in-person appointment. Further, we disagree with the commenter that telehealth negatively impacts patients and their relationship with health care professionals, and we disagree that telehealth should only be used when other options are unsafe. Telehealth enhances VA's capacity to deliver essential and critical health care services to beneficiaries located in areas where health care professionals may be unavailable or to beneficiaries who may be unable to travel to the nearest VA medical facility for care because of their medical conditions. Telehealth increases the accessibility of VA health care, bringing VA medical services to locations convenient for beneficiaries, including clinics in remote communities and beneficiaries' homes. Our intent is not to replace visits that require in-person interactions with telehealth. VA must ensure that patient care is appropriate and safe. As such, a health care professional would determine if or when it would be appropriate for a patient who is receiving acute hospital care in the home to receive health care via telehealth. When clinically appropriate and preferred by a patient, telehealth is an important option to enhance health care access and convenience. With regards to the commenter's concern about the challenges of student nurse trainees and unlicensed postgraduate RNs practicing via telehealth, we note that these employees will be appropriately supervised and will benefit from exposure to telehealth during their training programs, which will better prepare them for practice upon graduation, as health care is provided via telehealth throughout the health care industry. No changes are being made to the rule in response to this comment.

Another commenter strongly encouraged VA to continue to build upon the Anywhere to Anywhere VA Health Care initiative, further deploying digital health innovations that will improve outcomes, reduce costs, and realize an improved caregiver experience and utilizing every opportunity to achieve a truly connected continuum of care, especially for those in rural communities.

While we consider this outside the scope of this rulemaking, VA appreciates this comment, agrees with the importance of integrating connected care into VA's health care delivery model, and intends to remain an innovative leader in this area. No changes are being made to the rule based on this comment.

VA is making a technical edit to the definition of telehealth in 38 CFR 17.417(a)(4). VA defines the term telehealth to mean the use of electronic information or telecommunications technologies to support clinical health care, patient and professional health-related education, public health, and health administration. VA notes that the term virtual health is used interchangeably with the term telehealth. As such, VA is making a non-substantive change to the definition of “telehealth” to add that “the term virtual health has the same meaning as the term telehealth and can be used interchangeably.” No other changes in the meaning of the definition of telehealth are made by this change.

VA is also making technical edits to capitalize the term “federal” in § 17.417(a)(2)(iv)(D)( 4 )(b)(1) and (2); correctly format the cross references to the Controlled Substances Act in § 17.417(b)(3)(i) and (iii); and to replace a hyphen with the word “through” in the reference contained in § 17.417(a)(2)(iv)(D). These were errors in the proposed rule, and making these technical edits will ensure consistency with Federal Register publishing guidelines.

Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule as final with the changes described in this rule.

Executive Order 13132 provides the requirements for preemption of State law when it is implicated in rulemaking. Where a Federal statute does not expressly preempt State law, agencies shall construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law. Through this rulemaking process, we can preempt any State law or action that conflicts with the exercise of Federal duties in providing health care via telehealth to VA beneficiaries.

In addition, any regulatory preemption of State law must be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to the regulations that are promulgated. In this rulemaking, State licensure, registration, and certification laws, rules, regulations, or other State requirements are preempted only to the extent such State laws are inconsistent with the VA health care professionals' practicing health care via telehealth while acting within the scope of their VA employment. VA also has statutory authority under 38 U.S.C. 1730C to preempt State law. Therefore, we believe that the rulemaking is restricted to the minimum level necessary to achieve the objectives of the Federal statute.

The Executive Order also requires an agency that is publishing a regulation that preempts State law to follow certain procedures. These procedures include: the agency consult with, to the extent practicable, the appropriate State and local officials in an effort to avoid conflicts between State law and Federally protected interests; and the agency provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.

Because this final rule preempts certain State laws, VA consulted with State officials prior to the publication of the proposed rule in compliance with sections 4(d) and (e), as well as section 6(c) of Executive Order 13132. VA also provided a 60-day comment period on the proposed rule, which allowed for the State officials to provide additional comments on the rule. On August 21, 2019, VA sent a letter to the following: National Association of Boards of Pharmacy, Association of State and Provincial Psychology Boards, National Governors Association, American Academy of Physicians Assistants, National Council of State Boards of Nursing, National Association of State Directors of Veterans Affairs, Association of Social Work Boards, and the Federation of State Medical Boards to state VA's intent to amend the current regulations that allow VA health care professionals to practice telehealth. VA received 11 comments from the State officials, which were addressed in the proposed rule.

VA examined the impact of this rulemaking as required by Executive Orders 12866 (Sept. 30, 1993) and 13563 (Jan. 18, 2011), which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. The Office of Information and Regulatory Affairs has determined that this rulemaking is a not significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. This final rule is an Executive Order 14192 deregulatory action because it generates incremental cost savings, while also simplifying and standardizing telehealth licensing requirements for VA health professionals. The regulatory impact analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The provisions associated with this rulemaking are not processed by any other entities outside of VA. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

This final rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not satisfying the criteria under 5 U.S.C. 804(2).

Douglas A. Collins, Secretary of Veterans Affairs, approved this document on September 23, 2025, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set forth in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as set forth below:

On April 17, 2024, the State of West Virginia, through the West Virginia Department of Environmental Protection (WVDEP), submitted a revised version of West Virginia Legislative Rule 45CSR40-Control of Ozone Season Nitrogen Oxides Emissions (WV rule) for inclusion in the West Virginia SIP. This included two state revisions dated June 1, 2020 and April 1, 2023. The submission was supplemented on October 8, 2024, with additional information related to public noticing of the June 1, 2020 revision. The revisions to the WV rule included: (1) updating the characterization of units not subject to the rule because they are subject to a Federal NO X ozone season trading program, and (2) amending monitoring requirements consistent with the Federal rule, “Emissions Monitoring Provisions in State Implementation Plans Required Under the NO X SIP Call” (84 FR 8422, March 8, 2019).

On June 11, 2025 (90 FR 24549), the EPA published a notice of proposed rulemaking (NPRM) for the state of West Virginia. In the NPRM, the EPA proposed approval of West Virginia's April 17, 2024 SIP revision pertaining to 45CSR40—Control of Ozone Season Nitrogen Oxides Emissions. For additional background information on the EPA rulemakings and court decisions relevant to this SIP revision, beginning with the EPA's October 27, 1998 (63 FR 57356), “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone” (NO X SIP Call), please refer to the June 2025 NPRM.

For the applicable units, as described in subsection 4, West Virginia rule 45CSR40 establishes: (a) ozone season NO X emissions limitations, monitoring, recordkeeping, reporting, excess emissions, and NO X budget demonstration requirements for non-EGU large industrial boilers and combustion turbines that have a maximum design heat input greater than 250 MMBtu/hr, in accordance with 40 CFR 51.121; (b) ozone season NO X reduction, compliance plan, monitoring, recordkeeping and reporting requirements for affected stationary internal combustion engines; and (c) ozone season NO X control standards, ozone season NO X for cement kilns. 1

As explained in the NPRM, WV rule 45CSR40, approved most recently into the West Virginia SIP on January 3, 2019, was adopted to implement the ozone season trading program under the Cross State Air Pollution Rule (CSAPR), and to address NO X SIP Call requirements including the requirements that apply to stationary internal combustion engines and cement manufacturing kilns. WV rule 45CSR40 was revised effective June 1, 2020, 2 and further revised effective April 1, 2023, to conform the applicability section to changes in the Federal ozone season “trading programs,” and monitoring, reporting and recordkeeping requirements set forth in the 2019 NO X SIP Call Rule amendments (84 FR 8422, March 8, 2019). Notably, West Virginia did not previously submit the June 1, 2020 revisions for approval into the SIP.

The April 17, 2024 West Virginia SIP submittal is comprised of revised WV rule 45CSR40 (both the June 2020 and April 2023 amendments) and the NO X SIP Call non-EGU Budget Demonstration, a non-regulatory supplement that is required under Section 8 of WV rule 45CSR40. Specific references to CSAPR ozone season trading program provisions were replaced with language updating the characterization of units not subject to the rule because they are subject to a Federal NO X ozone season trading program. Definitions, applicability, and other provisions responding to the NO X SIP Call including monitoring and reporting under 40 CFR part 75, were retained. New requirements were added to the WV rule for monitoring, reporting, and recordkeeping consistent with the 2019 NO X SIP Call Rule amendments (84 FR 8422, March 8, 2019) and 40 CFR part 60  3 for units that are not part of a Federal trading program. The ozone season NO X emission budget of 2,184 tons and the limits that applied to non-EGU sources, stationary internal combustion engines, and cement kilns were retained and recodified. For detailed descriptions of the revisions please see the June 2025 NPRM (90 FR 24549).

The April 17, 2024 West Virginia SIP Non-EGU Budget Demonstration submission shows that total ozone season NO X emissions from non-EGUs that are subject to the NO X SIP Call do not exceed the West Virginia ozone season budget of 2,184 tons for non-EGUs. The ozone season NO X budget for non-EGUs was established in the West Virginia SIP in 2002 in response to the NO X SIP Call. As detailed and explained further in the June 2025 NPRM, the maximum potential ozone season NO X emissions of 1,202 tons based on permit and consent order limits is less than the total West Virginia NO X non-EGU budget and leaves 982 tons available for new units which may at a later date become subject to NO X SIP Call requirements.

Whenever a new unit that meets the applicability of section 4.1 of WV rule 45CSR40 (and thus is also subject to the NO X SIP Call) commences operation, or an existing unit becomes newly applicable, West Virginia is required under subsection 8.3 of WV rule 45CSR40 to submit a revised demonstration to the EPA that shows continuing compliance with the state-wide ozone season NO X emissions cap of 2,184 tons for applicable units. The EPA finds that West Virginia's revised provisions in WV rule 45CSR40 meet the requirements for the NO X SIP Call, the CAA (including section 110) and 40 CFR 51.121.

The changes West Virginia has made to rule 45CSR40 are approvable under CAA section 110 because: (1) the applicability provisions at section 4.1 cover all existing and new NO X SIP Call non-EGUs that are not subject to a seasonal NO X trading program established under 40 CFR part 97; (2) the enforceable cap on the collective ozone season NO X emissions from covered non-EGUs does not exceed the limit set forth in Section 8.1 of the WV rule and previously approved as part of the 2016 SIP responding to the NO X SIP Call and identified in 40 CFR part 97, subpart E, appendix C; (3) monitoring, recordkeeping and reporting in accordance with 40 CFR part 75, 40 CFR part 60, and West Virginia rule 45CSR16 are required for the non-EGUs; (4) the cement kiln and internal combustion engine provisions previously applicable to such sources in the 2016 West Virginia SIP have not been substantively changed and are simply recodified; and (5) the revised WV rule 45CSR40 generally addresses the requirements for large non-EGUs for the SIP Call pursuant to 40 CFR 51.121 and is consistent with all applicable CAA requirements. As explained in the June 2025 NPRM, the SIP revision is consistent with the provisions of CAA section 110(l). The EPA does not expect any emission increases, or interference with attainment or maintenance of the NAAQS, reasonable further progress, or any other CAA requirements.

Additional information regarding West Virginia's submittal and the rationale for the EPA's action are explained in the NPRM and will not be restated here. No public comments were received on the NPRM.

The EPA is approving the April 17, 2024 West Virginia SIP revision, as supplemented on October 8, 2024. This revision pertains to the amended version of WV rule 45CSR40 that addresses CAA requirements in section 110 and 40 CFR 51.121 for the NO X SIP Call and for units subject to the NO X SIP Call.

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is incorporating by reference the revisions to West Virginia Rule 45CSR40-Control of Ozone Season Nitrogen Oxides Emissions as described in section II of this preamble. The EPA has made, and will continue to make, these materials generally available through Regulations.gov and at the EPA Region III office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air 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 Clean Air Act.

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 December 1, 2025. 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 52 as follows: