The information collection request has been approved by OMB under the control number of 0503-0028; Expiration Date: October 31, 2027. CCC will issue payments to producers using the following forms: CCC-556, CCC-901, CCC-902E, CCC-902I, CCC-941, and AD-1026. The AD-1026 is exempt. 1 In addition, for the information collection under 0503-0028, the agency is seeking to use CCC-556 with this data collection. Farm Service Agency (FSA) will pre-fill ASCF Program applications (CCC-556) using the acres of eligible planted commodities that were previously reported to FSA on FSA-578, Report of Acreage by April 24, 2026. The CCC-556 is the only new data collection activity associated with this request. The total annual burden hours for this information collection is 30,320.

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this IFR via one of the methods and by the deadline stated above. All comments must be submitted in English or accompanied by an English translation. The Department also invites comments that relate to the economic, environmental, or federalism effects that might result from this IFR. Comments that will provide the most assistance to the Department will reference a specific portion of the IFR; explain the reason for any recommended change; and include data, information, or authority that support such recommended change.

Please note that all comments received are considered part of the public record and made available for public inspection at https://www.regulations.gov. Such information includes personally identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on https://www.regulations.gov.

Personally identifying information located as set forth above will be placed in the agency's public docket file but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. The Department may withhold from public viewing information provided in comments that they determine may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. To inspect the agency's public docket file in person, you must make an appointment with the agency. Please see the FOR FURTHER INFORMATION CONTACT paragraph above for agency contact information.

On July 4, 2025, a Congressional budget reconciliation bill (H.R. 1), commonly referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law. 1 Public Law 119-21, 139 Stat. 72 (2025). As relevant to EOIR, OBBBA introduced or increased numerous immigration-related fees. See OBBBA, Title X, Subtitle A, Part I, secs. 100002, 100009, 100013; 8 U.S.C. 1802, 1808, 1812. Specifically, these fee changes relate to: applications for relief and protection from removal; appeals before the Board of Immigration Appeals (“Board”); and motions to reopen or reconsider before the Immigration Courts and the Board. In addition, OBBBA foreclosed aliens from seeking fee waivers for certain application fees, as well as limited the fee exceptions for motions to reopen and reconsider. See, e.g., id., secs. 100002(e), 100013(g)(3); 8 U.S.C. 1802(e), 1812(g)(3). And, importantly, OBBBA fees apply in addition to any other fees authorized by law. See, e.g., id., secs. 100002(a), 100013(a)-(j); 8 U.S.C. 1802(a), 1812(a)-(j) (all noting that the OBBBA fees are “[i]n addition to any other fees authorized by law”).

To better facilitate payment of the OBBBA fees, on September 23, 2025, EOIR announced the expanded capabilities of the EOIR Payment Portal to enable electronic payment of relevant fees for appeals, motions, and applications to EOIR. See EOIR, Notice: Updates to the EOIR Payment Portal (Sept. 23, 2025), https://www.justice.gov/eoir/media/1414551/dl?inline [ https://perma.cc/2UBL-8M4Q ].

OBBBA also requires that all EOIR-collected OBBBA fees be adjusted annually for inflation. See, e.g., OBBBA secs. 100002, 100009; 8 U.S.C. 1802, 1808. Thus, in compliance with those mandates, EOIR published a Federal Register Notice that provided notice to the public of the inflationary fee adjustments that would apply to EOIR-collected OBBBA fees beginning February 1, 2026, for the remainder of Fiscal Year (“FY”) 2026. See Inflation Adjustment for EOIR OBBBA Fees; Fiscal Year 2026, 91 FR 2561 (Jan. 21, 2026).

The statutory language of OBBBA necessarily supersedes any conflicting language in EOIR's existing regulations. See, e.g., Nat'l Family Planning and Reproductive Health Ass'n, Inc. v. Gonzales, 468 F.3d 826, 829 (D.C. Cir. 2006) (noting that “of course a valid statute always prevails over a conflicting regulation”). As a result, EOIR is issuing this rule to update the relevant EOIR regulations to ensure consistency with OBBBA's provisions and to account for EOIR's expanded fee collection capabilities.

This rule amends EOIR fees listed in 8 CFR 1103.7 to reflect the minimum fee amounts required by OBBBA. Compare 8 CFR 1103.7 (2025), with OBBBA, sec. 100013, 8 U.S.C. 1812.

OBBBA established that, beginning in FY 2025, in addition to assessing any other fees authorized by law, agencies must assess new OBBBA fees, in either the minimum amount set out in OBBBA or in a greater amount set by regulation by the Secretary of Homeland Security or the Attorney General, as applicable. See, e.g., OBBBA, sec. 100013(i)(2)(A), 8 U.S.C. 1812(i)(2)(A). Then, beginning in FY 2026, OBBBA also requires EOIR to annually adjust all EOIR-collected OBBBA fees for inflation using the appropriate formula set forth in OBBBA. See, e.g., id., sec. 100013(i)(2)(B), 8 U.S.C. 1812(i)(2)(B); see also U.S. House of Reps., Glossary of Terms, https://www.house.gov/the-house-explained/open-government/statement-of-disbursements/glossary-of-terms (defining “Fiscal Year” as “The federal government's fiscal year beginning on October 1 and ending on September 30 of the following year.”).

Importantly, as explicitly provided in OBBBA, these OBBBA fees are “[i]n addition to any other fee[s] authorized by law,” which includes fees set by EOIR pursuant to its separate statutory authority. See, e.g., OBBBA, sec. 100013(a)(1); 8 U.S.C. 1812(a)(1). For example, separate from its OBBBA-provided fee collection authority, EOIR has statutory fee collection authority pursuant to section 286(m) of the Immigration and Nationality Act (“INA”), 8 U.S.C. 1356(m), which authorizes the Attorney General to charge fees for adjudication and naturalization services at a rate that would ensure recovery of both the full costs of providing all such services, including the costs of similar services that may be provided without charge to certain categories of aliens, and any additional administrative costs associated with the fees collected. 2 This section 286(m) statutory authority served as the basis for EOIR's fees before OBBBA was enacted. As such, the fees imposed by OBBBA do not replace EOIR's section 286(m) fees; rather, OBBBA fees are required to be charged “in addition” to these existing fees. Therefore, this rulemaking updates EOIR's fee regulations to add the statutorily required OBBBA fees to EOIR's preexisting, legally authorized section 286(m) fees, such that the fee amount listed in EOIR's regulations includes both fees. 3 See 8 CFR 1103.7(b).

EOIR will update OBBBA fee amounts annually for inflation as required—generally at the beginning of each FY—including on its website and electronic payment portal and through notice published in the Federal Register . 4 See, e.g., EOIR, Types of Appeals, Motions, and Required Fees (Feb. 1, 2026), https://www.justice.gov/eoir/types-appeals-motions-and-required-fees [ https://perma.cc/V8AD-VJDT ]; EOIR, EOIR Forms (Feb. 1, 2026), https://www.justice.gov/eoir/eoir-forms [ https://perma.cc/2VX5-KCUE ]; EOIR, EOIR Payment Portal, https://epay.eoir.justice.gov/index; 91 FR 2561. Notably, this rule itself does not substantively change any section 286(m) fee amounts but simply updates the EOIR fee amounts to reflect the sum of existing section 286(m) fee amounts and statutorily required OBBBA fees. 5

Next, this IFR amends provisions related to motions to reopen or reconsider at 8 CFR 1003.8(a)(2)  6 and 1003.24(b)(2) to ensure consistency with OBBBA's fee requirements for such motions. See OBBBA, secs. 100013(g)(1)-(3), 8 U.S.C. 1812(g)(1)-(3). OBBBA mandates a fee for motions to reopen or reconsider a decision of an Immigration Judge or the Board filed by an alien, subject to two limited exceptions. Id. First, the OBBBA fee does not apply to a motion to reopen a removal order entered in absentia if such motion is filed in accordance with section 240(b)(5)(C)(ii) of the INA, 8 U.S.C. 1229a(b)(5)(C)(ii). 7 Id., sec. 100013(g)(3)(A), 8 U.S.C. 1812(g)(3)(A). Second, the OBBBA fee is not required for a motion to reopen an in absentia deportation order if the motion is filed in accordance with former section 242B(c)(3)(B) of the INA, 8 U.S.C. 1252b(c)(3)(B) (1994), as it existed prior to April 1, 1997. Id., sec. 100013(g)(3)(B), 8 U.S.C. 1812(g)(3)(B).

Accordingly, the Department is removing two inconsistent regulatory fee exceptions that previously allowed an alien to file a motion to reopen or reconsider without paying a filing fee in circumstances other than those identified in the two OBBBA exceptions. 8 See 8 CFR 1003.8(a)(2)(ii)-(iii), 1003.24(b)(2)(i)-(ii) (2025) (removing exceptions for motions to reopen or reconsider based exclusively on current or prior applications for relief that do not—or did not—require a fee).

In doing so, however, the Department notes that removing these two exceptions only ensures that aliens are paying the required OBBBA fee and does not create any new 286(m) fee obligations. To make this clear, this rule adds language to the chart in 8 CFR 1103.7(b)(2) stating that no 286(m) fees are required when a motion to reopen or reconsider is based exclusively on current or prior applications for relief that do not—or did not—require a fee.

Third, the Department is adding language reflecting OBBBA's new asylum-related fees by revising 8 CFR 1003.24(d), 1103.7(b), and 1208.3(a)(1) to reference the initial application fee required for all asylum applications, see OBBBA, sec. 100002, 8 U.S.C. 1802, as well as an annual asylum fee (“AAF”)  9 required “for each calendar year that an alien's application for asylum remains pending,” see OBBBA, sec. 100009, 8 U.S.C. 1808. It is also deleting conflicting language in various regulations reflecting that no fee is required for an asylum application.

Fourth, the Department is amending various regulatory sections to reflect that filing fees are now paid directly to EOIR. See 8 CFR 1003.3(a)(3), 1003.8(a)(4)(i), 1003.23(b)(1)(ii), 1003.24(a) and (c)(1)-(2), 1003.31(g), 1103.7(a)(1) and (3).

Previously, EOIR did not have the ability to collect filing fees, except for certain appeals and motions before the Board. All other payments for filing fees related to EOIR proceedings—most notably Immigration Court fees—were paid to and accepted by the Department of Homeland Security (“DHS”). However, the functionality of the EOIR Payment Portal has been expanded to allow payment of the required filing fees for appeals, motions, applications, and other forms filed with the Immigration Courts and the Board directly to EOIR. 10

As such, the regulatory sections listed above have been amended to remove any language requiring or referencing making payments to DHS and to instead state that fees are paid to EOIR in a manner and form authorized by EOIR, and that filings must be accompanied by proof of payment of such fees. Additionally, the Department is adding language to clarify that the only accepted form of fee payment is payment through the EOIR Payment Portal, and that such fees are generally non-refundable. 11 See 8 CFR 1103.7(a)(1). While these regulatory changes merely reflect the expanded EOIR Payment Portal, the Department anticipates this payment change will create significant efficiencies for aliens and their representatives, who are now able to pay their fees online and directly to the agency where they are submitting their relevant filings. 12

Fifth, the Department is amending 8 CFR 1240.11(f) and 1240.49(e) to remove language stating that aliens filing multiple relevant applications must only pay the filing fee for the application with the highest cost. Pursuant to OBBBA, Congress explicitly requires the payment of fees for all listed applications and has spoken directly when providing a fee waiver or exception. See, e.g., OBBBA, sec. 100002(e), 8 U.S.C. 1802(e) (no asylum fee waiver); sec. 100013(g)(3), 8 U.S.C. 1812(g)(3) (providing motion to reopen exceptions). In light of this clear statutory language, EOIR is removing these conflicting regulatory provisions that would otherwise act as de facto fee waivers for the lower cost application(s).

Lastly, the Department is making minor technical changes to fix the capitalization of Immigration Judge and Immigration Court and to replace “Service” with “DHS” in the relevant sections discussed herein. The Department is also updating a cross-reference in 8 CFR 1240.63(a) to properly reference the correct fee paragraph in 8 CFR 1103.7 relating to suspension of deportation applications.

Under the Administrative Procedure Act (“APA”), agencies generally must provide “notice of proposed rule making” in the Federal Register and, after such notice, “give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments.” 5 U.S.C. 553(b)-(c). The APA further provides that the required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except in certain circumstances. Id. at 553(d). However, this rule qualifies for certain exceptions to these requirements, as discussed below. Although prior notice and comment is not required because such exceptions apply, the Department nonetheless invites public comment on this IFR and will consider any public comments submitted in conformity with the requirements set forth in Section I of this preamble before issuing a final rule.

The Department may forgo notice and comment and a delayed effective date because this rule is a rule of “agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A); 5 U.S.C. 553(d) (delayed effective date requirement only applies to “substantive” rules). 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).

In determining whether a rule is substantive or procedural, courts “must look at [the rule's] effect on those interests ultimately at stake in the agency proceeding.” Neighborhood TV Co., Inc. v. FCC, 742 F.2d 629, 637 (D.C. Cir. 1984). But “an otherwise-procedural rule does not become a substantive one, for notice-and-comment purposes, simply because it imposes a burden on regulated parties.” James V. Hurson Assocs., Inc. v. Glickman, 229 F.3d 277, 281 (D.C. Cir. 2000). In fact, a rule is not necessarily a substantive rule for APA notice-and-comment purposes even if it has “a `substantial impact' upon the persons subject to it.” Elec. Priv. Info. Ctr. v. DHS, 653 F.3d 1, 5 (D.C. Cir. 2011).

The Department has determined that this rule is procedural and therefore exempt from the APA's notice-and-comment and delayed-effective-date requirements because it merely updates EOIR's regulations to conform with OBBBA's statutory provisions, which are already in effect. Importantly, this rule does not itself substantively raise any section 286(m) EOIR fees.

Moreover, changes directing that payments for all filings with EOIR be made to EOIR, and requiring that those payments be made electronically, affect only the “manner in which parties present themselves” to the agency. JEM Broad Co., Inc., 22 F.3d at 326 (quoting Batterton, 648 F.2d at 707). These changes do not affect an alien's underlying legal claim, only the process the alien must follow to gain access to the agency proceeding in which they will present their legal claim. See Neighborhood TV Co., Inc., 742 F.2d at 637.

Additionally, pursuant to the APA, a rule is excepted from notice-and-comment procedures when an agency for good cause finds that such procedures are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). A rule is also excepted from the delayed-effective-date requirement when good cause is found by the agency to forgo this requirement and is published with the rule. Id. at 553(d)(3); Riverbend Farms, Inc. v. Madigan, 958 F.2d 1479, 1485 (9th Cir. 1992) (differentiating the APA's two “good cause” exceptions: 5 U.S.C. 553(b)(B), which applies to the notice and comment process; and 5 U.S.C. 553(d)(3), which applies to the delayed effective date). Consistent with the APA and for the reasons explained below, this IFR is excepted from the APA's notice-and-comment and delayed-effective-date requirements because the Department has found good cause to proceed with an immediately effective IFR. 5 U.S.C. 553(b)(B), (d)(3).

OBBBA was signed into law on July 4, 2025, and its changes to immigration-related fee provisions went into effect upon enactment, including explicitly amending EOIR fees for FY 2025, which ran from October 1, 2024, through September 30, 2025. See U.S. House of Reps., Glossary of Terms, https://www.house.gov/the-house-explained/open-government/statement-of-disbursements/glossary-of-terms (last visited Apr. 22, 2026) (“Fiscal Year” definition).

Consequently, upon OBBBA's enactment, the fee provisions contained in EOIR's regulations prior to this IFR became inconsistent with OBBBA's statutorily mandated fee changes. Compare 8 CFR 1103.7 (2025), with OBBBA, sec. 100013, 8 U.S.C. 1812. Importantly, as this IFR only amends EOIR's regulations to be consistent with the applicable law, the notice-and- comment and delayed-effective-date requirements are unnecessary, impracticable, and contrary to the public interest as the Department was bound to comply with OBBBA's new immigration-related fee provisions from the moment OBBBA was signed into law. Moreover, to the extent that the fee provisions contained in EOIR's regulations prior to this IFR were inconsistent with OBBBA, those regulations were no longer valid and new statutorily compliant regulations are necessary. See, e.g., Norman v. United States, 942 F.3d 1111, 1117 (Fed. Cir. 2019) (finding that a regulation setting forth a maximum penalty was no longer valid, because it was inconsistent with the maximum penalty mandated by statute).

Similarly, Executive Order 14247, Modernizing Payments To and From America's Bank Account, “mandat[es] the transition to electronic payments for all Federal . . . receipts by digitizing to the extent permissible under applicable law . . . .” 90 FR 14001. Specifically, this Executive Order mandates that “[a]ll executive departments and agencies” must transition to digital payment options and that “all payments made to the Federal Government shall be processed electronically,” with limited exceptions, as soon as practicable. Id.

Moreover, the Department considered whether Executive Order 14247's exception for “individuals who do not have access to banking services or electronic payment systems” applies here. See 90 FR 14001, sec. 4(i). However, the Department determined that EOIR's electronic payment system (the EOIR Payment Portal) is available to all aliens, and that general online access has become so widespread that EOIR anticipates all aliens—or their families or representatives on their behalf—will be able to make electronic payments as needed. The Department further weighed this concern against the important interests served by Executive Order 14247, which explains that “checks and money orders . . . impose[ ] unnecessary costs; delays; and risks of fraud, lost payments, theft, and inefficiencies.” See 90 FR 14001.

This IFR therefore updates EOIR's regulations to require electronic payment through the EOIR Payment Portal, in implementation of Executive Order 14247's mandate. Further, practically, to ensure that all EOIR fees are collected only through electronic means, the Department must collect all EOIR fees itself, rather than continuing to allow some payments of EOIR fees to be made to DHS. As this IFR only amends EOIR's regulations to be consistent with the applicable law, the notice-and-comment and delayed-effective-date requirements are unnecessary, impracticable, and contrary to the public interest as the Department is bound to comply with Executive Order 14247.

This rule does not trigger the requirements of the Regulatory Flexibility Act because the agency was not required “to publish a general notice of proposed rulemaking” prior to issuing this IFR. See 5 U.S.C. 604(a).

Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Sept. 30, 1993), and Executive Order 13563, Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 18, 2011), each 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 (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). Executive Order 13563 further emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.

The Department has determined that this rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and, therefore, it has not been reviewed by the Office of Management and Budget. Nevertheless, the Department certifies that this regulation has been drafted in accordance with the principles of Executive Orders 12866 and 13563.

The primary changes made by this rule to EOIR's fee regulations do not impose a cost on the public beyond the terms of OBBBA, as these changes are merely reflecting statutorily mandated fee requirements. These regulatory changes also provide important clarity regarding the current fee amounts and the availability of exceptions or waivers. They also streamline where to pay relevant fees, which the Department expects to benefit fee submitters, as they will no longer have to determine whether to send their fee to EOIR or DHS or navigate a correction if they paid the wrong entity. The Department further anticipates that paying fees through the EOIR Payment Portal will create significant efficiencies for aliens and their representatives by allowing them to pay their fees online and directly to the agency where they are submitting their relevant filings. Moreover, the Department considered whether requiring online fee payment would create any additional costs, including for pro se aliens and other populations such as detained aliens, but ultimately determined that online payments have become so ubiquitous due to the widespread availability of general online access, for both the aliens and their families or representatives, that any such costs would be de minimis.

Thus, overall, the changes made by this rule provide important benefits and, conversely, do not impact the public in a way that would render it in tension with the principles of Executive Orders 12866 or 13563.

This rule is not a regulatory action under Executive Order 14192 because it is being issued with respect to an immigration-related function of the United States.

This 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 (inflation adjusted) in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, the Department has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rule does not propose new “collection[s] of information,” or revisions to existing ones, as that term is defined under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320. However, the Department notes that EOIR is separately making de minimis changes to EOIR forms to address the incorrect fee amounts on the forms in light of OBBBA.

This rule is not a major rule as defined by section 804 of the Congressional Review Act. 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”). Further, this is a rule of agency procedure that does not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). Accordingly, it is not a “rule” as defined in 5 U.S.C. 804(3), and reporting to Congress and the GAO is not required.

Accordingly, for the reasons set forth in the preamble, and by the authority vested in the Director, Executive Office for Immigration Review, by the Attorney General Order Number 6260-2025, the Department amends parts 1003, 1103, 1208, and 1240 of title 8 of the CFR as follows:

By this rule, EDA removes 13 CFR part 315, “Trade Adjustment Assistance for Firms,” effective September 30, 2028. Part 315 was promulgated via final rule (40 FR 44303) on September 26, 1975, to implement the Trade Act of 1974 (Pub. L. 93-618), and it was substantially amended via final rule (74 FR 41598) on August 18, 2009. However, the statutory authorization for the Trade Adjustment Assistance for Firms (TAAF) program lapsed in two stages, in 2021 and 2022, pursuant to the sunset and termination provisions of the Trade Adjustment Assistance Reauthorization Act of 2015 (Title IV of Pub. L. 114-27). As of July 1, 2022, EDA has been unable to accept new petitions from firms for certification of eligibility for trade adjustment assistance through this program. Further, by September 30, 2028, all grants with EDA's Trade Adjustment Assistance Centers will have been closed out, without the possibility of renewal. The TAAF program will therefore no longer be active as of September 30, 2028, and the regulations at part 315 will be obsolete.

Accordingly, part 315 is appropriate for removal, effective September 30, 2028. Removing part 315 will properly reflect both the lapse of the underlying statutory authorization as well as the inactive status of this assistance program by that date. Removing part 315 will also streamline EDA's body of regulations and ensure that it remains accurate and up-to-date, thereby reducing the possibility of public confusion. And the publication of this rule well in advance of the effective date furthers the interests of government transparency and accountability.

The Department issues this final rule without prior public notice and comment pursuant to the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” 5 U.S.C. 553(a)(2). This rule falls into that exception, as part 315 pertains to a federal assistance program.

In addition, pursuant to 5 U.S.C. 553(b)(B), the Department finds good cause to waive the prior notice and opportunity for public participation requirements of the Administrative Procedure Act for this final rule. The Department considers this rule to be uncontroversial, and has determined that prior notice and opportunity for public participation is unnecessary, because this rule will only remove outdated regulations that lack a valid statutory authorization and no longer serve any actual function as of the effective date. The continued maintenance of these regulations would create a genuine risk of public confusion and/or distraction; this removal will reduce that risk and enhance clarity. The Department therefore finds good cause to waive the public notice and comment period under 553(b)(B).

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

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

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

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

The FAA published an NPRM for Docket No. FAA 2026-3372 in the Federal Register (91 FR page 17910; April 9, 2026), proposing to modify the Class E airspace area at Omak Airport, Omak, WA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

After publication of the NPRM, the FAA determined that an administrative amendment to the legal description of the affected airspace was needed to better describe the Class E airspace area. The FAA finds good cause that recirculating the proposal for notice and comment is unnecessary because the changes are ministerial in nature and do not have a substantive effect on airspace boundaries or operating requirements.

Class E airspace area designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the ADDRESSES section of this document.

This action amends 14 CFR part 71 due to the development of a special instrument approach procedure (IAP) at Omak Airport, Omak, WA: the Area Navigation (RNAV) (Global Positioning System [GPS]) M Runway (RWY) 35.

In particular, the central radius of the Class E airspace area is expanded by 0.8 miles to more appropriately contain IFR departure and missed approach operations until reaching 1,200 feet above the surface. Additionally, the airspace east of the airport is narrowed and extended 2.2 miles, as circling maneuvers are not authorized east of RWY 17/35.

Lastly, the Class E airspace area southern boundary is extended to nine miles and the southwestern boundary to 12 miles to more appropriately contain IFR arrival aircraft to RWY 35 operating below 1,500 feet above the surface.

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 Order 2100.6B, “Rulemaking and Guidance Procedure” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321, et seq. ) and in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures,” paragraph B-2.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This rule removes Commerce's regulations at 15 CFR part 5 (“Operation of Vending Stands”). The regulations at part 5 were promulgated on July 31, 1963 (28 FR 7772), and purport to implement the Randolph-Sheppard Vending Stand Act (20 U.S.C. 107 et seq. ), which establishes that blind persons shall be given priority with respect to the operation of vending stands on federal property. That Act, however, specifically authorizes the Secretary of Education to prescribe government-wide implementing regulations, see 20 U.S.C. 107(b), and those regulations are located at 34 CFR part 395. No statutory provision specifically authorizes or requires Commerce to issue its own vending stand regulations, and the regulations at part 5 do not contain any Commerce-specific detail that is up-to-date and either necessary or significant; rather, much of the Commerce-specific detail actually poses some risk of confusion, see, e.g., 15 CFR 5.3 and 5.7 (contemplating the performance of certain administrative functions by the Office of Administrative Services, which has since been renamed), and none of it is necessary to effectively implement either the Randolph-Sheppard Vending Stand Act or the government-wide regulations at 34 CFR part 395.

In sum, Commerce has determined that the regulations at part 5 are appropriate for removal to (i) ensure that Commerce's regulations do not exceed its lawful authority, (ii) avoid creating a risk of confusion in connection with a subject-matter area sufficiently addressed by the government-wide regulations at 34 CFR part 395, and (iii) streamline the Code of Federal Regulations. This removal is not expected to diminish any obligation or entitlement established by either the Randolph-Sheppard Vending Stand Act or the regulations at 34 CFR part 395; nor is it expected to otherwise impact the regulated public in any meaningful way.

Pursuant to 5 U.S.C. 553(b)(B), Commerce finds good cause to waive the prior notice and opportunity for public participation requirements of the Administrative Procedure Act for this final rule. Commerce considers this rule to be uncontroversial, and has determined that prior notice and opportunity for public participation is unnecessary, because this rule merely removes a regulatory part that lacks a specific Commerce statutory authorization, pertains to a subject-matter area sufficiently addressed by the government-wide regulations at 34 CFR part 395, and poses some risk of confusion ( e.g., regarding the scope and applicability of the government-wide regulations). The regulatory language being removed by this rule is not necessary to effectively implement either the Randolph-Sheppard Vending Stand Act or the government-wide regulations at 34 CFR part 395, and this removal is not expected to diminish or otherwise meaningfully affect any obligation or entitlement established by either of those authorities or any related reliance interest. For the same reasons, Commerce has determined that delaying the effectiveness of these amendments would be contrary to the public interest. The immediate removal of this regulatory part will streamline Commerce's regulations, ensure statutory conformity, and reduce the risk of public confusion, at little-to-no cost to the public. Commerce therefore finds good cause to waive the public notice and comment period under 553(b)(B) and to waive the 30-day delay in effectiveness under 553(d).

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

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

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

This rule removes 15 CFR part 11, which is titled “Uniform Relocation Assistance and Real Property Acquisition for Federal and Federally Assisted Programs” and consists of a single provision, § 11.1. That section simply cross-references the Federal Highway Administration's regulations at 49 CFR part 24, which implement the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 for the government. No authority requires Commerce to maintain any regulatory provision like § 11.1. Moreover, the application of the regulations at 49 CFR part 24 does not depend on any specific cross-reference or acknowledgement by Commerce; instead, the unnecessary language at part 11 has the potential to cause some confusion regarding the applicability of government-wide regulations, either in this particular context or in general. Accordingly, for the sake of streamlining its body of regulations, and to avoid contributing any confusion, Commerce has determined that the removal of part 11 is warranted. This removal will not at all affect any legal obligations or entitlements, and it is not expected to affect any practical or reliance interests.

Pursuant to 5 U.S.C. 553(b)(B), Commerce finds good cause to waive the prior notice and opportunity for public participation requirements of the Administrative Procedure Act for this final rule. Commerce considers this rule to be uncontroversial, and has determined that prior notice and opportunity for public participation is unnecessary, because this rule merely removes a redundant regulatory part that does not serve any meaningful independent purpose and that poses some risk of public confusion ( e.g., regarding the applicability of uniform rules in the absence of a specific cross-reference by a particular agency). For the same reasons, Commerce has determined that delaying the effectiveness of these amendments would be contrary to the public interest. The immediate removal of this redundant regulatory part will streamline Commerce's regulations and reduce the possibility of public confusion, at little to no cost, without affecting any substantive obligations or entitlements. Commerce therefore finds good cause to waive the public notice and comment period under 553(b)(B) and to waive the 30-day delay in effectiveness under 553(d).

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

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

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

The Census Bureau, as delegated by the Secretary of Commerce, is responsible for collecting, compiling, and publishing import and export trade statistics for the United States under the provisions of Title 13, United States Code (U.S.C.), Chapter 9, Section 301(a). Under 13 U.S.C. 302, the Secretary of Commerce is authorized to promulgate regulations necessary or proper to carry out the purposes of and prevent the circumvention of the requirements of Chapter 9 of Title 13. The Secretary also may promulgate regulations covering the confidentiality, publication, and disclosure of information collected under Chapter 9. Under the aforementioned authorities, the Census Bureau is issuing this final rule to revise the note to § 30.2(a)(1)(iv). Due to an oversight, the note inadvertently references a removed section, § 30.16.

Pursuant to 5 U.S.C. 553(b)(B), the Department finds good cause to waive the prior notice and opportunity for public participation requirements of the Administrative Procedure Act for this final rule. The Department has determined that prior notice and opportunity for public participation is unnecessary because this rule only removes a reference to regulatory language that no longer exists. The Department has also determined that delaying the removal of this reference for the sake of carrying out the notice and comment process would be contrary to the public interest, as the reference being removed no longer serves any meaningful function but does pose a risk of confusion and distraction. The Department therefore finds good cause to waive the public notice and comment period under 553(b)(B) and, for the same reason, to waive the 30-day delay in effectiveness under 553(d).

For the reasons set out in the preamble, the Census Bureau is amending 15 CFR part 30 as follows:

Upon request, FDA (the Agency or we) has classified the Spinal Muscular Atrophy (SMA) newborn screening test system into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

On July 8, 2020, FDA received PerkinElmer Inc.'s request for De Novo classification of the Eonis SCID-SMA Kit. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on November 9, 2022, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.5980. 1 We have named the generic type of device “Spinal Muscular Atrophy newborn screening test system,” and it is identified as a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing.

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

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

At the time of classification, Spinal Muscular Atrophy newborn screening test systems are for prescription use only. Therefore, these devices are subject to the prescription labeling requirements for in vitro diagnostic (IVD) products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)).

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for Spinal Muscular Atrophy newborn screening test systems. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA (the Agency or we) has classified the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

On June 16, 2022, FDA received Quidel Corporation's request for De Novo classification of the Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on March 8, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.3982. 1 We have named the generic type of device “simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings,” and it is identified as an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area ( e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

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

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

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for simple point-of-care devices to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

In the Infrastructure Investment and Jobs Act (IIJA), 1 Congress created a new requirement that State highway safety programs funded by NHTSA highway safety grants “result[] from meaningful public participation and engagement from affected communities, particularly those most significantly impacted by traffic crashes resulting in injuries and fatalities.”  2 NHTSA implemented the public participation and engagement (PP&E) requirement in the highway safety grant program through a final rule published on February 6, 2023. 3 The final rule was the result of extensive efforts to facilitate opportunities for States and other stakeholders to provide input throughout the rulemaking process, including a published request for comments and three public hearings in addition to NHTSA's solicitation of comment on the notice of proposed rulemaking (NPRM). 4

To support State implementation of PP&E requirements, NHTSA provided extensive training and technical assistance. States began implementing the PP&E requirements in Federal Fiscal Year (FY) 2024 and have now completed these requirements for nearly the full triennial grant cycle.

Public participation and engagement are statutory conditions of the use of NHTSA grant funds and remain a priority for DOT in the overall implementation of State highway safety programs. 5 6 These requirements serve as an important activity in ensuring meaningful opportunities for communities and community members to be engaged in the planning and development of these activities.

As a result of feedback received from State recipients and the Governors Highway Safety Association (GHSA), and NHTSA's own experience implementing the current requirement, NHTSA recognized the need to adjust the PP&E documentation requirements to eliminate unnecessary burdens and facilitate compliance for State highway safety offices. After consideration of this input, NHTSA published a notice of proposed rulemaking (NPRM) on September 19, 2025. 7

In the NPRM, NHTSA proposed eliminating the PP&E documentation section in the triennial Highway Safety Plan (HSP) (23 CFR 1300.11(b)(2)) while maintaining the PP&E reporting requirement in the Annual Report. In the Annual Report, States would demonstrate compliance with the statutory PP&E requirement through “a narrative description of the public participation and engagement efforts carried out and how those efforts informed projects implemented under countermeasure strategies during the grant year.” 23 CFR 1300.35(b)(2). With this proposal, NHTSA sought to lessen administrative burden and to increase flexibility for State grant programs while still allowing NHTSA to fulfill its duty to ensure that States satisfy the statutory requirement.

NHTSA also proposed minor related amendments to three parts of the regulatory text that reference the PP&E section of the triennial HSP. Specifically, NHTSA proposed to remove the term “public participation and engagement” from the definition of triennial Highway Safety Plan (23 CFR 1300.3) and from the clarifying clause in 23 CFR 1300.11(b)(1)(i) that lists the triennial HSP sections. In addition, NHTSA proposed to delete the reference to 23 CFR 1300.11(b)(2) in the local expenditure section at 23 CFR 1300.13(b)(3)(i) and to rewrite the clause to reference PP&E activities more generally as an example of a way that a State may solicit political subdivision involvement during the highway safety planning process.

In response to the NPRM, the following groups submitted comments to the public docket on www.regulations.gov: Arizona Game and Fish Department (AZGFD);  8 Bureau of Indian Affairs (BIA); Colorado Highway Safety Office (CO HSO); Connecticut Department of Transportation (CTDOT); the Departments of Transportation of Idaho, Montana, North Dakota, South Dakota, and Wyoming, jointly (Joint State DOTs); Florida Department of Transportation (FDOT); GHSA; Iowa Governor's Traffic Safety Bureau (IA GTSB); Maine Bureau of Highway Safety (MeBHS); Michael Ravnitzky;  9 Minnesota Department of Public Safety Office of Traffic Safety (MN DPS OTS); Nevada Office of Traffic Safety (NV OTS); North Carolina Governor's Highway Safety Program (NC GHSP); Oregon Transportation Safety Office (OR TSO); South Carolina Office of Highway Safety and Justice Programs (SC OHSJP); Tennessee Highway Safety Office (TN HSO); Texas Department of Transportation (TxDOT); Virginia Highway Safety Office (VA HSO); Washington Traffic Safety Commission (WTSC); and two anonymous commenters. MeBHS expressed general support for the comments submitted by GHSA, IA GTSB, NV OTS, and the Joint State DOTs. NHTSA appreciates the input of all commenters and addresses their comments in this preamble.

Several commenters submitted general input about public participation and engagement that cannot be tied to a single regulatory provision. Those comments are discussed below.

Several commenters  10 expressed strong support for PP&E in highway safety programs and described longstanding State efforts to ensure public engagement in their programs. NHTSA appreciates the shared commitment to PP&E and recognizes the valuable work that States have already put into incorporating PP&E and community feedback into their programs. We believe the input received by States through PP&E yields better informed and more effective programs.

The AZGFD emphasized the importance of PP&E in supporting coordination between State wildlife agencies and highway safety offices to address highway safety concerns related to wildlife-vehicle collisions and requested that NHTSA require SHSOs to coordinate with affected stakeholders like the game and fish department. NHTSA encourages SHSOs to work with all relevant State partners, including game and fish departments. However, intra-State government coordination, while valuable, is not public participation and is therefore outside the scope of this rulemaking. That said, NHTSA notes that States may, and many do, work with other partners within the State to leverage their expertise and networks to reach broader segments of the public.

The IA GTSB commented that PP&E activities are challenging for SHSOs to facilitate and are usually carried out on the local level by municipalities and counties. However, the statute requires that the State highway safety program result from meaningful public participation and engagement from affected communities. 23 U.S.C. 402(b)(1)(B). NHTSA recognizes that local jurisdictions frequently carry out engagement specific to their communities and that States may benefit from the knowledge locals can share with the SHSO. In this regard, we emphasize that States can use Section 402 funds to enter into project agreements with local jurisdictions that include PP&E components that the locals carry out, and the information collected and the outcomes produced are used to inform the State's highway safety program.

Seven commenters  11 noted that they have experienced an increase in the administrative burden associated with the funding that States receive from NHTSA over the past several years. AZGFD recognized the benefits of reducing administrative burden and stated its support for the steps taken by the proposal to reduce administrative burden. The Joint State DOTs and BIA agreed that removal of the PP&E requirements from the triennial HSP is a good starting point and encouraged NHTSA to continue efforts to reduce administrative burden. NHTSA agrees with the comments: reduction of administrative burden and general streamlining of requirements in a way that allows NHTSA to provide appropriate stewardship over taxpayer dollars remain major priorities. This rulemaking seeks to reduce burden associated with public participation and engagement requirements, and NHTSA is committed to working with stakeholders to seek other opportunities for reducing administrative burden throughout all aspects of its grant programs.

An anonymous commenter noted that the public participation requirements in the 2023 final rule were well-intended, but led to excessive paperwork that substituted formality for substance. Similarly, the CO HSO commented that it believes NHTSA's original implementation of the PP&E requirements focused too much on process oversight instead of achieving engagement outcomes. Nine other commenters  12 agreed and added that States need to be able to design and conduct data-driven PP&E appropriate for their unique communities. Those nine commenters and an anonymous citizen noted the importance of maintaining flexibility for States. SC OHSJP stated that it felt that PP&E requirements limited its flexibility to adjust its highway safety program, stating that it felt constrained to follow only the PP&E plan laid out in the triennial HSP and that it was unable to implement feedback gained from engagement with communities not identified in the triennial HSP. NHTSA regrets this perception but respectfully disagrees with the assertion; States can update their PP&E plans based on feedback or changing facts and are not limited to conducting only engagement that fell within the triennial HSP plan. NHTSA confirms that States may always amend their triennial HSP—PP&E or otherwise—to adapt to changing data or other conditions, as provided in 23 CFR 1300.32. Further, NHTSA clarifies that States retain the authority to make management and programmatic decisions without conducting public engagement opportunities for each decision they make and are not required to implement every request from a participating community. Public participation and engagement should inform, not dictate, State highway safety programs.

Several States  13 submitted comments detailing specific problems they experienced during the three years that NHTSA and the States have been implementing IIJA's PP&E requirements.

OR TSO explained that the rapid turnaround time between publication of the 2023 final rule and submission of the FY24 grant application required the State to redirect its PP&E efforts quickly to meet the requirement. OR TSO also stated that updated rules under IIJA added to the administrative burden that the State faced and caused the State not to meet a separate statutory provision requiring that at least 40 percent of Section 402 grant funds be expended by political subdivisions. 14 NHTSA recognizes that IIJA transformed many aspects of the grant program and appreciates the effort that Oregon and all States put into implementing the new IIJA requirements for the first triennial cycle. As the States and NHTSA enter into the second triennial cycle under IIJA, the agency anticipates that the States' efforts in the first triennial cycle will make the second cycle easier. NHTSA will also continue to provide States with guidance and technical assistance as needed or upon request by States.

CO HSO expressed concerns about allowable uses of funds to pay for PP&E activities. Allowable use of funds in the NHTSA highway safety grant program is based on the programmatic scope laid out in Section 402 and the government-wide cost principles set out by the Office of Management and Budget, 15 and is therefore outside the scope of this rulemaking. However, NHTSA issued guidance on June 17, 2025  16 to provide clarification on the types of funds that States may use for PP&E activities and encourages States to reach out to their Regional Office with any specific use of funds questions.

CTDOT stated that it felt an expectation to have a highway safety office staff member attend every PP&E event, which was unnecessarily burdensome. NHTSA would like to clarify that attendance by a SHSO employee is not required for every PP&E event. A State may enter into agreements with subrecipients for the subrecipient (or even another State agency) to carry out some PP&E efforts on behalf of the State, provided the State provides direction on the implementation of the PP&E (for example, the State could identify the affected communities or specific traffic safety problems where the PP&E should be directed) and the subrecipient conducts engagement with the affected community and conveys feedback from the effort to the State to inform the State's program. In its June 17, 2025 guidance, 17 NHTSA clarified that States may use Section 402 program funds for PP&E efforts. The information makes clear that a State is able to use NHTSA grant funds to pay subrecipients that conduct PP&E efforts for the State's highway safety program.

All commenters supported the agency's proposal to eliminate the PP&E requirements from the triennial HSP. Fifteen commenters  18 expressed strong support for NHTSA's proposal to remove PP&E requirements from the triennial HSP and affirmed that the removal would reduce administrative burden. AZGFD argued that the existing PP&E requirements provide transparency and that their removal could lead to inconsistency in how PP&E is conducted and reported on by various States. They later submitted a second comment to clarify that it supports consolidation of PP&E reporting requirements, but urged NHTSA to continue to ensure public participation and transparency. OR TSO expressed support because it believes the triennial HSP and Annual Report requirements are redundant. The Joint State DOTs noted the proposed removal of PP&E requirements from the triennial HSP should enhance safety by allowing departments to redirect staff time and resources towards implementing effective safety programs, rather than meeting reporting requirements. TxDOT added that while public input is valuable, it is important to have an adaptable approach that allows States to consider public input thoughtfully while ensuring timely coherent program decisions. An anonymous citizen stated that they support NHTSA's proposed streamlining of public participation documentation in the grant program to maintain essential accountability without Federal overreach and stressed the importance of maintaining transparency. NHTSA appreciates the comments and, consistent with the proposal in the NPRM, is removing 23 CFR 1300.11(b)(2)—which laid out the public participation and engagement requirements for the triennial HSP—in its entirety.

In addition to removing the PP&E planning requirements from the triennial HSP, fifteen commenters  19 recommended that NHTSA should also remove the PP&E reporting requirements from the Annual Report at 23 CFR 1300.35(b)(2). These commenters argue that NHTSA can verify State implementation of the PP&E requirement through added Certifications and Assurances  20 that States submit with their Annual Grant Applications. These comments mirror the comment GHSA submitted  21 in response to the Department's April 3, 2025 Request for Information. 22 The Joint DOTs submitted a related comment recommending wholesale elimination of the annual report requirement, or alternatively, limiting PP&E reporting to every other annual report. The CO HSO argued that streamlining PP&E requirements by removing both the triennial HSP and Annual Report requirements would allow each State to adopt a flexible PP&E strategy best suited to its communities and programs. VA HSO explained that streamlining PP&E requirements would ensure States retain flexibility to design, adapt and evaluate lifesaving programs.

CTDOT explained that it believes the annual report narrative is redundant with the certification already in the Appendix A certifications and assurances that States will comply with requirements in Section 402. Seven commenters  23 argue that verification through the certifications and assurances would be similar to other section 402 requirements already covered in the certifications and assurances. Some commenters  24 argued that requiring only a certification and assurance would minimize administrative burden while providing appropriate oversight to ensure States meet the statutory requirements. Commenters argued that eliminating the triennial HSP and Annual Report PP&E requirements and instead relying on an annual certification and assurance would decrease a perceived disproportionate emphasis on PP&E  25 and still require States to conduct meaningful PP&E activities. 26 NHTSA clarifies that, while it implements several threshold grant requirements through certifications and assurances up front, the agency ensures that States have met those assurances through a variety of means, including routine oversight during the grant year and State year-end reporting in the Annual Report.

NHTSA carefully considered the relative benefits and burdens associated with the annual report narrative versus certifications and assurances (supported with routine oversight). NHTSA believes that retaining the annual report narrative is the least burdensome approach for States while still allowing the agency to conduct proper oversight of statutory requirements. Under a certifications and assurances model, NHTSA would need to conduct additional oversight to ensure that a State is meeting the statutory PP&E requirement. This approach would require States to maintain sufficient documentation to demonstrate their PP&E activities, as well as how those activities informed their highway safety program. In NHTSA's experience, documentation of more qualitative statutory requirements creates confusion over what level and type of documentation is acceptable and creates serious challenges for States to cure insufficient documentation during oversight reviews. This concern is compounded if the statutory compliance issue is not discovered for longer periods of time, decreasing the potential solutions available to resolve the issue and increasing the risk that a recovery or payback of grant funds is required. A requirement to provide a high-level narrative summary of PP&E activities in an Annual Report allows States simply to describe how they meet the requirement—avoiding confusion over documentary support sufficiency and allowing for an easier cure if the initial narrative is insufficient to demonstrate compliance. Accordingly, NHTSA concludes that a summary statement in the annual report balances the need for streamlining and burden reduction across the program while providing enough insight into the State's efforts that reasonable concerns over compliance are mitigated.

NHTSA appreciates the information provided in the comments and the viewpoints expressed over this requirement. As NHTSA continues to review other requirements of the program as part of streamlining and burden reduction efforts, NHTSA expects that a robust dialogue will continue with the States and stakeholder organizations on how best to improve the program.

As is explained in further detail in the preamble to this final rule, the Annual Report narrative is intended to be only a high-level discussion of PP&E efforts and should impose minimal burden on States.

The Joint DOTs expressed appreciation for NHTSA's statement in the NPRM that the Annual Report narrative is intended to be a high-level discussion and requested that NHTSA reaffirm this in the final rule. Commenter Michael Ravnitzky asked that NHTSA describe the standards the agency will use to determine whether an Annual Report PP&E narrative is adequate, and explain what happens if NHTSA determines the narrative is inadequate. Mr. Ravnitzky recommended that NHTSA require that the narrative describe the outreach methods used, the main affected communities identified, and one concrete example of how engagement changed a project or its design. NHTSA reaffirms that the Annual Report narrative is a high-level discussion. A narrative should discuss, in general terms, engagement activities the State carried out in the year, the communities engaged in those activities, and how the State's PP&E efforts informed projects implemented during the grant year. States need not describe how PP&E efforts informed every individual project. Instead, States can describe in more general terms how the efforts conducted informed the projects it implemented. NHTSA does not set a minimum required number of PP&E events, nor does the agency require a specific outcome from those efforts. To provide States with additional clarity, NHTSA will separately provide examples of successful Annual Report narratives. In recent years, States have submitted successful Annual Report narratives that were as short as two to three paragraphs. Other States opted to provide several pages to detail their activities and report on their PP&E accomplishments. Though PP&E requirements will be removed from the triennial HSP, States may wish to consider developing brief narrative descriptions of PP&E efforts as they are conducted throughout the grant year so the information is available easily at year end for the Annual Report.

NC GHSP encouraged NHTSA to ensure that guidance and feedback provided to States are clear and consistent. Michael Ravnitzky similarly recommended that NHTSA issue concise guidance materials and optional templates illustrating acceptable PP&E approaches and documentation for the Annual Report. He suggested providing targeted technical assistance and a limited transition period for States to update internal HSP formats. After publication of the 2023 Final Rule, NHTSA provided extensive training and technical assistance, including examples of sufficient Annual Report narratives. NHTSA will continue to provide guidance and webinars as needed and upon request by States. NHTSA will also continue to offer technical assistance to any State that seeks it. As this rule simply removes requirements, rather than adding new ones, NHTSA has determined that a transition period is not necessary.

Michael Ravnitzky submitted several comments aimed at NHTSA's rulemaking process and guidance for the PP&E requirement. Specifically, he recommended that NHTSA amend all regulatory text to remove any components that require prospective PP&E content in the triennial HSP. NHTSA proposed to do so, and this final rule maintains the removal of 23 CFR 1300.11(b)(2) as proposed. Mr. Ravnitzky also requested that NHTSA use a single definition for PP&E in 23 CFR 1300.3 (definitions), 1300.11 (triennial Highway Safety Plan), and 1300.13 (local expenditure). To preserve flexibility for each State to conduct PP&E and solicit feedback from affected communities in a manner that is conducive to data trends and conditions in the State, NHTSA does not create a regulatory definition for public participation and engagement at this time. In the proposal, NHTSA proposed to eliminate the term “public participation and engagement” from the definition of triennial Highway Safety Plan in 23 CFR 1300.3 and to rewrite 1300.13(b)(3)(i) to remove the reference to 1300.11(b)(2) to reference PP&E activities more generally. The agency finalizes those proposed revisions in this action.

Michael Ravnitzky also advised NHTSA to create a brief one-page prospective notice that would be required for States with weak annual reports to describe their planned PP&E approach for major program areas. NHTSA declines to do so. As stated in the NPRM, NHTSA's experience implementing the first triennial cycle under IIJA led the agency to determine that the prospective triennial planning information provided limited value to States in implementing PP&E or to NHTSA in conducting oversight. 27 If NHTSA finds that a State has not submitted a sufficient annual report narrative, NHTSA will provide technical assistance to assist the State in meeting the minimum requirements.

NHTSA has considered the impact of this rulemaking action under Executive Order (E.O.) 12866. 28 This rulemaking does not meet the criteria of a “significant regulatory action” under E.O. 12866. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under that E.O.

Submission of a triennial Highway Safety Plan is required for any State to receive a highway safety grant. The triennial HSP is submitted only once every three years, and there are a total of 57 eligible respondents (fifty States, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the Bureau of Indian Affairs). NHTSA projects that this rulemaking would save each applicant 64 hours that was used previously to collect, review, and submit the PP&E section of the triennial HSP.

For the costs associated with respondents preparing application materials, NHTSA used the estimated average wage for “Management Analysts,” Occupation Code 13-1111. The Bureau of Labor Statistics estimates that the average hourly wage for management analysts in State and local government is $34.63. 29 The Bureau of Labor Statistics estimates that wages for State and local government workers represent 61.5 percent of total compensation costs. 30 Therefore, NHTSA estimates the hourly labor costs to be $56.31 and estimates that hourly labor cost associated with preparing the PP&E section of the triennial HSP to be $3,603.84 per respondent. Historically, all eligible States apply for and receive grants, so the total labor costs saved by all respondents by this action would be $205,418.88, once every three years.

This rulemaking is an E.O. 14192  31 deregulatory action. The rulemaking decreases States' administrative burden by removing requirements to document public participation and engagement in triennial Highway Safety Plan submissions.

NHTSA estimates the cost savings of this rule would be $205,418.88, once every three years. See discussion in section V.A., E.O. 12866, Regulatory Planning and Review, above for more information.

The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601 et seq. ) requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations, and small governmental jurisdictions. Section 605 of the RFA allows agencies to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-21, 110 Stat. 857) amended the RFA to require Federal agencies to provide a statement of the factual basis for certifying that an action would not have a significant economic impact on a substantial number of small entities.

This final rule makes a limited revision to the uniform procedures implementing State highway safety grant programs, which were determined previously not to have a significant impact on a substantial number of small entities. The grant programs impacted by this rule will affect State governments, which are not considered to be small entities as that term is defined by the RFA. Therefore, NHTSA certifies that the rule will not have a significant impact on a substantial number of small entities and finds that preparing a Regulatory Flexibility Analysis is unnecessary.

E.O. 13132, “Federalism,” requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” 64 FR 43255 (Aug. 10, 1999). “Policies that have federalism implications” are defined in the E.O. to include regulations that 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.” Under E.O. 13132, an agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs not required by statute unless the Federal Government provides the funds necessary to pay the direct compliance costs incurred by State and local governments or the agency consults with the State and local government in the process of developing the regulation. An agency also may not issue a regulation with federalism implications that preempts a State law without consulting with State and local officials.

NHTSA analyzed this rulemaking action in accordance with the principles and criteria set forth in E.O. 13132. The revisions made in this rulemaking will decrease reporting requirements for States submitting triennial Highway Safety Plans as a basis to receive grant funding. Therefore, NHTSA determines that this action would not have federalism implications as defined in the Order that warrant formal consultation with State and local officials or preparation of a federalism summary impact statement.

With respect to the review of the promulgation of a new regulation, section 3(b)(2) of E.O. 12988, “Civil Justice Reform” (61 FR 4729, Feb. 7, 1996) requires that executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General.

NHTSA has reviewed this rulemaking action and determined that it conforms to the applicable standards in section 3(b)(2) of E.O. 12988, Civil Justice Reform. The issue of preemption is discussed above in connection with E.O. 13132 (Federalism). NHTSA believes that this final rule specifies clearly the removal of the PP&E requirements from the triennial HSP and the related technical changes to the regulatory text to reflect the change to the triennial HSP. The amendments do not take effect retroactively. NHTSA notes further that there is no requirement that a recipient submit a petition for reconsideration before they may file suit in court.

Under the procedures established by the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq. ), Federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations. A person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. NHTSA sought public comment on revisions to the existing information collection described below in the NPRM that was published on September 19, 2025 and submitted a revision to the existing information collection request (ICR) to OMB for approval. The OMB Control Number for the information collection is 202212-2127-0730.

NHTSA did not receive any comments in response to the ICR but received several comments to the rulemaking docket that pertain to the information collection. Those comments are discussed in full in the preamble to this final rule, above. As explained in the preamble, in this action NHTSA sought to reduce administrative burden consistent with the agency's legal responsibilities. NHTSA finalizes the proposed regulatory amendments that eliminated the PP&E section of the triennial HSP.

NHTSA is submitting a supporting statement to OMB explaining how the final rule's collection of information responds to the comments received from the public. The final rule does not affect the estimates in the NPRM of these requirements.

The Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted annually for inflation with the base year of 1995). This rulemaking would not result in annual State expenditures exceeding the minimum threshold; instead, this rule likely will decrease administrative costs for States. Further, this rulemaking action updates NHTSA's State highway safety grant program, a voluntary program, and States become eligible in part based on the choice to submit an application.

The Department has analyzed the environmental impacts of this final rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ). NHTSA has determined that this rule is categorically excluded pursuant to 23 CFR 771.118(c)(4). Categorical exclusions are categories of actions that the agency has determined normally do not significantly affect the quality of the human environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). See DOT Order 5610.1D § 9. In analyzing the applicability of a categorical exclusion (CE), the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. § 9(b). The Department's Operating Administrations (OAs) may apply CEs established in another OA's procedures. Id. § 9(f). To do so, the Operating Administration “must evaluate the action for extraordinary circumstances identified in the OA procedures in which the CE is established to determine if a normally excluded action may have a significant impact and coordinate with the originating OA to ensure that the CE is being applied correctly.” Id. This rulemaking, which eliminates reporting requirements related to public participation and engagement from the triennial Highway Safety Plan, is categorically excluded pursuant to 23 CFR 771.118(c)(4), “Planning and administrative activities not involving or leading directly to construction, such as: Training, technical assistance and research; promulgation of rules, regulations, directives, or program guidance; approval of project concepts; engineering; and operating assistance to transit authorities to continue existing service or increase service to meet routine demand.” NHTSA has coordinated with the Federal Transit Administration to ensure that this CE is being applied correctly. NHTSA does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

E.O. 13175 (65 FR 67249, Nov. 9, 2000) requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that 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. NHTSA has assessed the impact of this rule on Indian tribes and determined that this action would not have Tribal implications that require consultation under E.O. 13175.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. NHTSA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the Federal Register . Because this rule does not meet the criteria in 5 U.S.C. 804(2) for a major rule, it will be effective upon publication in the Federal Register .

DOT assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda twice a year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, NHTSA encourages commenters to provide their name, or the name of their organization; however, submission of names is optional. Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.

For the reasons stated in the preamble, under the authority of 23 U.S.C. 401 et seq., the National Highway Traffic Safety Administration amends 23 CFR part 1300 as follows:

In FR Doc 2026-10849 beginning on page 32556 in the Federal Register of Monday, June 1, 2026, the following corrections are made:

This document and additional information concerning OFAC is available on OFAC's website ( https://ofac.treasury.gov ).

On February 16, 2024, OFAC adopted a final rule (89 FR 12233) amending the North Korea Sanctions Regulations, 31 CFR part 510 (the “Regulations”), to, among other things, add a new general license at § 510.521 authorizing the exportation or reexportation to North Korea of certain agricultural commodities, medicine, medical devices, and replacement parts and components that are not subject to the Export Administration Regulations, 15 CFR parts 730 through 774. Section 510.521(b)(3) defines a medical device to mean an item that (i) falls within the definition of “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), and (ii) is not on the List of Medical Devices Requiring Specific Authorization (the “List”), as maintained on OFAC's website ( https://ofac.treasury.gov ) on the North Korea Sanctions page. OFAC is now publishing the List in the Federal Register and on its website.

The text of the List is provided below.

The list below comprises the List of Medical Devices Requiring Specific Authorization as identified in 31 CFR 510.521(b)(3)(ii).

The Coast Guard will enforce special local regulations in 33 CFR 100.704 for the Low Country Splash regulated area from 7:30 a.m. to 10:00 a.m. on June 13, 2026. This action is being taken to provide for the safety of life on navigable waterways during this swim event. Our regulation for marine events within the Captain of the Port Charleston, § 100.704, specifies the location of the regulated area for the Low Country Splash event which encompasses portions of the Wando and Cooper River. During the enforcement periods, as reflected in § 100.704(c), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide notice of the regulated area via Local Notice to Mariners, Marine Safety Information Bulletins, Broadcast Notice to Mariners, and on-scene designated representatives.

The Coast Guard will enforce the special local regulation in 33 CFR 100.701 for the College of the Florida Keys Swim Around Key West regulated area listed in paragraph (B), item no. 2 in table 1 to § 100.701, from 6:00 a.m. until 4:00 p.m. on June 13, 2026.

This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Southeast Coast Guard District, § 100.701, table 1, paragraph (B), item no. 2, specifies the location of the regulated area for the College of the Florida Keys Swim Around Key West. During the enforcement periods, as reflected in § 100.701(c), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners, marine information broadcasts, and on-scene designated representatives.

An organization notified the Coast Guard that from 9 p.m. to 10 p.m. on July 3, 2026 they will sponsor a fireworks show on the Ohio River. The Coast Guard received a request under 33 CFR 100.15 from the Henderson Chamber of Commerce. The firework show will include one tug and barge from which the fireworks will be launched.

The Captain of the Port Ohio Valley (COTP) is issuing this Special Local Regulation (SLR) under the authority in 46 U.S.C. 70041. The COTP has determined that potential hazards associated with this event include launching of explosive projectiles, falling debris, and the presence of a stationary barge and tug in the center of the navigable channel. The purpose of this rulemaking is to protect event participants, non-participants, and transiting vessels before, during, and after the scheduled event.

Because of these potential hazards, 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 must establish this SLR by July 3, 2026, to protect personnel, vessels, and the marine environment. Therefore, we 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 temporary SLR from 9 p.m. until 10 p.m. on July 3, 2026. The special local regulation will cover all navigable waters of the Ohio River from Mile Markers 803-805. No vessel or person will be permitted to enter the regulated area 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 et seq. ), 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 special local regulation. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

The Coast Guard will enforce The Coast Guard will enforce multiple safety zones for annual events in the Captain of the Port Eastern Great Lakes Zone listed in Table 1 to 33 CFR 165.939, for events occurring in the month of July as listed in the DATES section above. Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within these safety zones during an enforcement period is prohibited unless authorized by the Captain of the Port (COTP) Eastern Great Lakes or his designated representative. Those seeking permission to enter the safety zone may request permission from the COTP Eastern Great Lakes via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of COTP Eastern Great Lakes or his designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the COTP Eastern Great Lakes determines that the safety zone need not be enforced for the full duration stated in this notice, he may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

The Coast Guard will enforce the safety zone listed in item (2) of Table 2 to 33 CFR 165.941 for the Put-In-Bay 4th of July Fireworks event in Put-In-Bay, OH, from 9:30 p.m. to 11 p.m. on July 4, 2026. This action is being taken to provide for the safety of life on certain navigable waters of Lake Erie in the vicinity of Put-In-Bay. Our regulation for recurring marine events within the Captain of the Port Detroit Zone in § 165.941 specifies the location of the regulated area, in item (2) to Table 2. During the enforcement period, if you are the operator of a vessel in the regulated area, you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

The Coast Guard will enforce the safety zone listed in item (12) of table 2 to 33 CFR 165.941 for the City of Toledo 4th of July Fireworks event in Toledo, OH, from 9:30 p.m. to 11 p.m. on July 4, 2026, and as necessary due to inclement weather from 9:30 p.m. to 11 p.m. on July 5, 2026. This action is being taken to provide for the safety of life on certain navigable waters of the Maumee River. Our regulation for recurring marine events within the Captain of the Port Detroit Zone in § 165.941 specifies the location of the regulated area, in item (12) to table 2. During the enforcement period, if you are the operator of a vessel in the regulated area, you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

The Coast Guard received notification that fireworks will be launched from Rapids Road near the Maumee River in Perrysburg, OH. The Captain of the Port (COTP) Detroit has determined that potential hazards associated with fireworks are a safety concern for anyone within a 375-yard radius 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.

Because of these potential hazards, 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 May 20, 2026, but we must establish this safety zone by July 3, 2026, to protect personnel, vessels, and the marine environment. Therefore, we do not have enough time to solicit and respond to comments.

For the same reason, 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 on July 3, 2026. The safety zone will cover all navigable waters of the Maumee River within a 375-yard radius of a fireworks site on Rapids Road in Perrysburg, OH. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the Captain of the Port.

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 et seq. ), 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 will enforce safety zones listed in 33 CFR 165.1315 for the following events, during the designated enforcement periods, and within a 450-yard radius of the launch site at the listed locations. This action is being taken to provide for the safety of life on navigable waterways during these events. Table 1 to paragraph (a) of 33 CFR 165.1315 was amended by 91 FR 31666, which goes into effect on June 29, 2026. The only event included in this NOE that will occur prior to June 29, 2026 is the Umatilla Landing Days, which was not amended.

Our regulation for fireworks displays within the Coast Guard Northwest District designates the safety zones and identifies the approximate dates for these events. The specific dates and times are specified below. These safety zones are subject to enforcement at least one hour prior to the start and one hour after the conclusion of the events.

All coordinates are listed in reference Datum NAD 1983.

During the enforcement periods, as reflected in § 165.1315, persons and vessels are prohibited from entering or remaining in the safety zone unless authorized by the Captain of the Port Sector Columbia River or a designated representative. In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide notification of these enforcement periods via the Local Notice to Mariners and Broadcast Notice to Mariners.

On January 12, 2026, New Hampshire Department of Transportation notified the Coast Guard they are nearing completion of temporary trestles needed for the demolition of the General Sullivan Bridge, Piscataqua River, Newington, NH. This phase of the demolition includes removing deck and superstructure of spans. Due to the presence of crane barges and other construction equipment located in the navigational channel vessels transiting through the bridge will be limited to a beam of less than 160 feet from approximately June 2026 to December 2026. Based on the hazardous conditions created by this demolition project, the Northeast Coast Guard District Commander has determined that establishment of a temporary RNA through rulemaking is warranted to ensure the safety of life, property, and the environment within the regulated area.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Commander of the Northeast Coast Guard District has determined that potential hazards associated with this bridge demolition will continue to exist through March 31, 2027, creating a safety concern for anyone transiting the Piscataqua River in the vicinity of the General Sullivan Bridge demolition project. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the regulated area while bridge replacement operations are taking place.

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. Demolition of the General Sullivan Bridge is currently underway, creating a hazardous condition. Therefore, there is an urgent need for the RNA to protect the safety of both the construction crew and the waterway users operating in the vicinity of the bridge demolition. An interruption of the project to accommodate a full notice and comment period would also delay necessary operations, result in increased costs, and postponement to the completion date of the demolition project. We did not receive sufficient notice to solicit comments prior to the establishment of this RNA.

Because of the hazards associated with the bridge construction and replacement, 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 . Delaying the effective date of this rule would be impracticable and contrary to public interest because immediate action is needed to respond to the hazardous conditions created by the demolition of the bridge that is about to commence.

Although this regulation is published as a temporary interim rule without prior notice, public comment is nevertheless desirable to ensure that the regulation is both workable and reasonable. Accordingly, persons wishing to comment may do so by submitting written comments as set out under ADDRESSES section in this preamble. Commenters should include their names and addresses, identify the docket number for the regulation, and give reasons for their comments. If the Coast Guard determines that changes to the temporary interim rule are necessary, we will publish a temporary final rule or other appropriate document.

This rule establishes an RNA from 12:01 a.m. on June 10, 2026, until 11:59 p.m. on March 31, 2027.

The Coast Guard is creating a RNA as shown in figure 1, to include all navigable waters of the Piscataqua River in the vicinity of the General Sullivan Bridge, Newington, NH, surface to bottom, encompassed by a line connecting the following approximated positions, beginning at 43°07′17.04″ N, 070°49′27.99″ W; thence to 43°07′04.67″ N, 070°49′51.61″ W; thence to 43°06′53.12″ N, 070°49′39.59″ W; thence to 43°07′08.01″ N, 070°49′16.03″ W; and thence to the point of origin, expressed in Degrees (°) Minutes (′) Seconds (″) (DMS) based on North American Datum 1983 (NAD 83).

The RNA will establish the following operating restrictions on vessels:

(i) Entry and movement within the RNA is subject to a “Slow-No Wake” speed limit. All vessels may not produce a wake and may not attain speeds greater than five (5) knots unless a higher minimum speed is necessary to maintain bare steerageway.

(ii) No vessel with a beam greater than 160 feet may transit this area.

(iii) Any vessel transiting through the RNA must make a direct passage. No vessel may stop, fish, moor, anchor, or loiter within the RNA at any time.

(iv) Vessels may not pass (overtake) another vessel within the RNA.

(v) The operator of any vessel transiting in the RNA must comply with all lawful directions given to them by the COTP or the COTP's on-scene representative.

(vi) When a full enforcement period of the regulated area is activated, only vessel authorized by COTP may enter or remain within the regulated area.

The “Slow-No Wake” speed limit, vessel beam restriction of less than 160 feet, and other restrictions—except for the limited full enforcement period prohibiting vessels from entering the regulated area—will be enforced throughout the entire effective period.

Full enforcement periods of the regulated area, which entail prohibiting all vessel entry within the regulated area, will be implemented only during hazardous construction operations involving crane pulls above the navigable channel for demolition activities at the General Sullivan Bridge. These intermittent full closures are anticipated to occur between August 1, 2026, and September 1, 2026. These dates are tentative and subject to change due to weather, construction or supply chain delays, or other unforeseen circumstances. The COTP will provide email updates to all stakeholders as the project progresses and as the full closure dates and times are finalized based on demolition progress.

This regulated area and duration are intended to ensure the safety of personnel, vessels, and these navigable waters during the bridge demolition.

The dates and times of the full enforcement periods, during which all vessel transits through the regulated area will be prohibited, will be published in the Local Notice to Mariners, posted on the Coast Guard Navigation Center Maritime Safety Information Products page at https://www.navcen.uscg.gov/msi, and issue a Broadcast Notice to Mariners via marine channel 16 (VHF-FM) as soon as practicable in response to an emergency or hazardous condition.

This rule will remain in effect through March 31, 2027, which should accommodate the possibility of project delays due to unforeseen circumstances. If the project is completed before March 31, 2027, enforcement of the regulated navigation area will be suspended, and notice will be provided via the Local Notice to Mariners.

The navigational channel width in vicinity of the bridge will be reduced to 160 ft from June 10, 2026, to December 1, 2026. Markings will be placed to mark the new width of the channel in accordance with Private Aids to Navigation requirements in 33 CFR part 66. These dates are tentative and subject to change due to weather, construction or supply chain delays, or other unforeseen circumstances.

The Coast Guard Northeast District Local Notice to Mariners can be found at: https://www.navcen.uscg.gov/maritime-safety-information.

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 et seq. ), 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 regulated navigation area. 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 will be available in the docket.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2026-0401 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this rule for alternate instructions.

Viewing material in the docket. To view available documents, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. We will post public comments in our online docket. Additional information is on the https://www.regulations.gov Frequently Asked Questions web page.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

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

In response to a request by the Naval Support Activity Annapolis (NSAA), and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps is amending its regulations in 33 CFR part 334 to establish three danger zones in the waters of Carr Creek and Whitehall Bay, Annapolis, Maryland. The danger zones are necessary to enable the safe operation of the United States Naval Academy firing range.

The proposed rule was published in the December 5, 2022 (88 FR 74348) edition of the Federal Register . The regulations.gov docket number was COE-2022-0009. Concurrently, a local public notice for the proposed danger zone was sent out from the Baltimore District. Comments received during the initial 30-day public notice focused on the physical location and siting of the firing range, the general need for the danger zones and enforcement mechanisms if established, effects of the danger zones on public access to Greenbury Point, and consideration of alternatives such as relocating the firing range. Several commenters requested an extension of the comment period for the proposed rule. Recognizing the considerable interest in the proposed action, the Baltimore District re-opened the public notice comment period from 19 January 2023 until 5 March 2023 to coincide with the re-opened comment period for the proposed rule in the January 19, 2023, edition of the Federal Register (88 FR 3372), Docket Number COE-2022-0009. Approximately 142 comments were received. Those comments are summarized below, with the Corps' response to those comments.

Many commenters questioned the location of the existing danger zones and the firing range's conformity with range regulations.

At the time of creation in 1963, the partially baffled 50-year rifle range was sited properly with existing regulations and this request is an effort to conform with DOD range design criteria that was not published at the time of design and creation of the outdoor range. Unified Facilities Criteria 4-179-02, require surface danger zones for non-fully baffled ranges like the one at NSAA. These requirements are outlined at relevant sections of UFC 4-179-02. Further, there are no regulations currently in place giving the Navy the legal authority to prohibit individuals from entering, or removing individuals from waters of Carr Creek and Whitehall Bay during range operations. The establishment of these danger zones would give Navy the legal authority to ensure public safety during periods when the range is active. The Corps also recognizes that the NSAA safety team is taking steps to modernize the safety precautions at the range, such as the design of a fully baffled 50-yard firing range on NSA Annapolis. On September 29, 2023, the Naval Facilities Engineering Systems Command Washington awarded a contract to Raymond Pond Full-Service Solutions, Conyers, Georgia, to design the fully baffled range. If the design is eventually funded, this regulation would serve as a temporary measure to ensure public safety and to comply with existing regulation until the range is fully baffled.

Several commenters questioned the need for the danger zones and wanted clarification on what enforcement mechanisms would be in place once the danger zones are established. Many commenters stated that United States Coast Guard (USCG) firing range announcements only occur on certain channels and many mariners to do not receive the local notice to mariners.

Concerning the need for the danger zones, this request comes in response to a safety deficiency that was identified by NSAA's Safety Department in 2019 due to a lack of established surface danger zones around a non-fully baffled firing range and continued issues with members of the public disregarding current safety precautions. The Corps has determined that the safety deficiency identified around a non-fully baffled firing range and concerns regarding public safety are sufficient justification for the establishment of the danger zones. NSAA is making a good faith effort to come into compliance with the Unified Facilities Criteria 4-179-02, Small Arm Ranges, which notes that surface danger zones are required for non-fully baffled ranges. Further, the enforcement measures and procedures for the proposed danger zones are the same process that NSAA currently uses and no changes in enforcement will occur as a result of this regulation. NSAA will advertise the firing schedule for each danger zone in the weekly Fifth CG District's Local Notice to Mariners. In addition, the NSAA will post the danger zones closure schedule on its official Navy website and Facebook page. If the danger zones are established, they will be charted on NOAA Nautical Charts to ensure that the public is aware of their location in Carr Creek and Whitehall Bay.

Many commenters questioned the effects of the danger zone on public access to Greenbury Point and voiced concerns about additional closures to Greenbury Point because of this proposed regulation. A few commenters stated that this proposal is an attempt to find a work around for a new golf course that is proposed and vocally opposed by local citizens.

The Corps is not evaluating any restrictions in place on Greenbury Point, or any other area that is not waters of the U.S. area, as our regulatory authority is limited to the proposed establishment of danger zones in Carr Creek and Whitehall Bay, per DA regulations 33 CFR 334.4. The proposed Danger Zones will allow the Commanding Officer at NSAA to continue to safeguard personnel, both military and civilian, and will be a benefit to public safety.

Several commenters were concerned about Danger Zones 2 and 3 in the proposed regulation, with few commenters opposed to the restrictions in Carr Creek. The comments in reference to Danger Zones 2 and 3 expressed concerns related to recreational and commercial boating access and safety concerns in a narrower navigation channel during times when Danger Zones 2 and 3 are active.

The proposed regulation will allow NSAA to legally engage with watercraft, which they have been doing without formal authority/regulation for the last 50 years. This regulation will have minimal effect, if any effect, on navigation through Whitehall Bay and access to Carr Creek. The proposed regulation will limit the closure of Danger Zones 2 and 3 to no more than 10 times per calendar year. When the range is not operational, persons, vessels, and other craft can enter, transit, drift, moor and anchor in the designated danger zones without permission of NSAA.

Many commenters questioned the environmental impacts from the firing range, specifically, the range's compliance with environmental and EPA standards, lead contamination from discharged munitions, and impacts to water quality that may affect drinking water.

The Corps regulates the discharge of dredged or fill material into waters of the United States under Section 404 of the Clean Water Act. The inadvertent firing of errant ammunition into the water does not meet the definition of fill, i.e., it is expected that the very limited amount of errant ammunition inadvertently fired into the water would not change the bottom elevation of Carr Creek or Whitehall Bay, or any aquatic resources located on Greenbury Point. The discharge of ammunition is regulated by the DOD's Munitions Response Program, and investigations would occur if the range closed. EPA also has regulations to protect health and human safety when discharging hazardous ammunitions; however, that is not an authority that has been delegated to USACE. Furthermore, NSAA has indicated that the risk of projectiles leaving the range is extremely small given the impact berm and use of small arms ammunitions; therefore, it is unlikely that the range has resulted in a major quantity of ammunition entering into the waters of Carr Creek and Whitehall Bay or onto Greenbury Point.

A few commenters questioned if the NSAA had evaluated alternative range sites rather than implementing the danger zones. Other commenters questioned if NSAA could use an indoor or local firing range, recommended that the NSAA fully baffle the firing range, and asked if NSAA could create a downrange perm to prevent bullets from exiting the range.

Alternatives to implementation of the danger zones and other outdoor range safety precautions are continuously evaluated by NSAA. Relocation of the range is not feasible, as proximity to the brigade of midshipmen is of paramount importance to ensure they receive mandatory firearms training in a timely and efficient manner. Alternate range locations are not readily available in the local area. Personnel from several federal and state agencies, such as the Secret Service, FBI, Reserve Units, and Maryland State Police, regularly utilize NSAA's outdoor ranges for training and qualification purposes due to the lack of other options in the local area. Further, NSAA continues to request funds for a fully baffled shooting range. Since relocation is not feasible, indoor and digital ranges are not readily available, and funds are not yet available to construct a fully baffled range, the Corps has determined that the establishment of danger zones in the waters of Carr Creek and Whitehall Bay are reasonable and necessary to ensure public safety and to ensure that NSAA is in compliance with DOD outdoor range design, such as the Unified Facilities Criteria 4-179-02, Small Arms Ranges, which states danger zones are required for non-fully baffled ranges as a risk mitigation measure.

Many commenters stated that the restrictions in Danger Zones 2 and 3 would affect crabbers and commercial fishermen. Other commenters stated that the closures would create a financial hardship for watermen, stated that the range will need to coordinate with local watermen to avoid significant economic impact, and questioned if firing could be limited to times when crabbing is closed.

NSAA has a responsibility to provide safe public access while balancing the operational use of the outdoor range. Per the regulation, closure of Danger Zones 2 and 3 is limited to no more than 10 times per calendar year and NSAA is responsible for furnishing in advance the firing schedule to the Commander, Fifth Coast Guard District, for publication in a local notice to mariners. The regulation cannot contain a detailed description of the times, dates and extent of restriction as various factors sometimes preclude the establishment of firing schedules, including weather and environmental factors, shifting military operational schedules, and ongoing maintenance on the impact berm at the range. It is therefore unreasonable to restrict range operations to only the period of December through March. The proposed approximate frequency of closures in Whitehall Bay and the comprehensive notification of danger zone activation schedules will minimize any major economic impact if crabbers and commercial fisherman are aware of restrictions in these danger zones ahead of time. When the range is not operational, persons, vessels, and other craft can enter, transit, drift, moor and anchor in the designated danger zones without permission of NSAA. Further, Department of the Army (DA) regulations state the USACE should ensure that the danger zones should not unreasonably interfere or restrict the food fishing industry. Danger Zones 2 and 3 are to be operational no more than 10 times per calendar year, which means that the waterway will be open for unfettered access and fishing approximately 97% of the year. Given the frequency of closures in Danger Zones 2 and 3 (restricted to no more than 10 times per calendar year), the local notice to mariners, and other areas of Whitehall Bay that will be available for fishing and crabbing even when the range is operational, the Corps has determined that the proposed danger zones will not unreasonably interfere or restrict the food fishing industry.

A few commenters stated that there were deficiencies in the Corps PN and that it did not include sufficient information to give a clear understanding of the proposed action. Other commenters stated that the public notice comment period should be extended, and that the applicant's request does not comply with 33 CFR 334.4 establishment and amendment procedures.

According to 33 CFR 334.4, the Corps PN must include sufficient information to give a clear understanding of the proposed actions and should include the following: applicable statutory authority, a reasonable comment period, applicant name, name and telephone number of the Corps employee whom additional information concerning the proposal may be obtained, project description and purpose, and a map of sufficient detail to show the boundaries of the areas and its relationship to the surrounding area.

On 5 December 2022, the Baltimore District issued an initial 30-day PN. In addition, as part of proposed rulemaking, HQ USACE posted the proposed regulation concurrently in the Federal Register for public comment, Docket Number COE-2022-0009, with a comment period ending 4 January 2023. The Corps recognizes that there was a typo in our PN, which stated that the PN comment period ended on 4 January 2022, however, this did not interfere with the public's ability to submit comments. In response to public comments received and recognizing the considerable interest in the proposed action, the Baltimore District re-opened the PN comment period from 19 January 2023 until 5 March 2023 to coincide with the re-opened comment period for the proposed rule in the Federal Register . The Corps reviewed the initial PN and extended PN and has determined that the information in the PN gives a clear understanding of the proposed actions and all other requirements listed above were included in both PN's. The PN clearly describes the purpose and need to enable safe operation of the United States Naval Academy firing range and to reflect the routine and periodic usage of the firing range for training Sailors, Midshipmen, and law enforcement personnel. The map included in the PN clearly shows the boundaries of the proposed danger zones and the language in the proposed regulation further clarifies the waterbodies where Danger Zones 1, 2, and 3 will occur.

The Corps is not evaluating closures at the US Naval property at Greenbury Point as that is an independent decision by the installation. Therefore, it is not part of the danger zone action being reviewed by the Corps and not required to be labeled on the map. Further, the Corps PN was distributed in accordance with 33 CFR 325.3 (d)(1), which states that PNs should be sent to the applicant, to appropriate city and county officials, adjoining property owners, tribal representatives, concerned federal agencies, conservation organizations, River Basin Commissions, and United States Senators and Representatives. In addition to the Corps PN mailing list, which contains over 460 interested parties, to include several River Basin Commissions, federal agencies, city and county officials, tribal representatives, and conservation organizations, the PN was also distributed to Congressman John Sarbanes, Senator Benjamin Cardin, and Senator Chris Van Hollen, the Annapolis Mayor, nearby commercial marinas, homeowner associations, and several Anne Arundel County officials. In addition, the proposal was coordinated directly with the USFWS, Maryland DNR, NMFS, Maryland Department of the Environment, Maryland Historical Trust, the Delaware Tribe, and EPA. Any comments received from these agencies are summarized in Section B. In an effort to reach more than just adjoining property owners, the Corps sent PN postcards describing the proposal and where to find more information to over 300 waterfront property owners on Mill Creek, portions of the Severn River and portions of Whitehall Bay. The waterfront property owners were those that the Corps determined would be most affected by this proposal.

A few commenters questioned NSAA's plan to hold public meetings, stated concerns about the installation's encroachment into public waters, and requested that the Corps review specific inspection reports that have been publicly denied by NSAA. Other commenters wanted to know how much NSAA would spend on patrol boats and expressed concern about the effects of firing range noise within the community and on downtown businesses.

Throughout the comment period, NSAA responded to the public's comments and concerns in an attempt to clarify misconceptions and answer questions regarding the proposed regulation. NSAA emphasized that the surface danger zones in Whitehall Bay, which were the majority of the concern, would only be in effect one to four times a year and has provided that information to all parties who have contacted NSAA to discuss the proposed regulation.

The establishment of danger zones in the waters of Carr Creek and Whitehall Bay are reasonable and necessary to ensure public safety and to ensure that NSAA is in compliance with DOD outdoor range design, such as the Unified Facilities Criteria 4-179-02, Small Arms Ranges, which states danger zones are required for non-fully baffled ranges as a risk mitigation measure. NSAA is responsible for furnishing the firing schedule in advance to the Commander, Fifth Coast Guard District, for publication in a local notice to mariners. The Corps is not evaluating any restrictions and effects outside of 33 CFR 334, as our Regulatory authority is limited to the proposed establishment of danger zones in Carr Creek and Whitehall Bay, per DA regulations located in 33 CFR 334.4. The Corps has determined that this regulation will have minimal effect on noise as the use of the range facility has not changed and this request is an effort to conform with DOD range design criteria. The proposed danger zones will allow the Commanding Officer at NSAA to continue to safeguard personnel, both military and civilian and will be a benefit to public safety.

After receipt of the June 24, 2022 proposal, the Corps made a preliminary determination that the proposed rule does not require the preparation of an Environmental Impact Statement, and that an environmental assessment would be prepared for the final rule. The regulations governing the National Environmental Policy Act do not require draft environmental assessments to be available for public comment. Federal agencies are only required to solicit public comments during the preparation of Environmental Impact Statements. Given the administrative nature of the proposed rule and the substance of the comments received, we have determined that an environmental assessment is the appropriate mechanism for complying with National Environmental Policy Act requirements. Public input on the proposed action was solicited using Federal Register noticing and local public noticing. Public comments received in response to the notices were documented and fully considered during final agency decision making.

a. Review Under Executive Order 12866. This rule is issued with respect to a military function of the Department of Defense and the provision of the Executive Order 12866 do not apply.

b. Regulatory Flexibility Act, as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq. This rule has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354), which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities ( i.e., small businesses and small governments). The Corps determined that the establishment of the new danger zones will not have a significant economic impact on a substantial number of small entities. For an analysis of potential economic impacts of this rule, please see the regulatory analysis in the environmental assessment.

c. Review under the National Environmental Policy Act. An environmental assessment (EA) has been prepared. We have concluded that the establishment of three danger zones in the vicinity of the Naval Support Activity Annapolis will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement is not required. The final EA and Finding of No Significant Impact may be reviewed at the Baltimore District Office.

d. Unfunded Mandates Act. This rule does not impose an enforceable duty among the private sector and, therefore, is not a federal private sector mandate and is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501 et seq. ). We have also found, under Section 203 of the Act, that small governments will not be significantly or uniquely affected by this rule.

e. Congressional Review Act. The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The Corps will submit a report containing the 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. The rule will take effect 30 days after it is published in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons stated in the preamble, the United States Army Corps of Engineers amends 33 CFR part 334 as set forth below:

On May 5, 2010, the President signed into law the Caregivers and Veterans Omnibus Health Services Act of 2010 (2010 Act), Public Law (Pub. L.) 111-163. Section 506 of the 2010 Act, codified as a note to section 523 of title 38, United States Code (U.S.C.), required VA establish a two-year pilot program to assess the feasibility and advisability of using community-based organizations and local and State government entities to assist veterans who are transitioning from military service to civilian life in rural or underserved communities and their families. Section 506(d) of the 2010 Act authorized that the pilot program be carried out through the award of grants to community-based organizations and local and State government entities. VA implemented section 506 as the Grants for the Rural Veterans Coordination Pilot (RVCP) program in regulations in part 64 of title 38, Code of Federal Regulations (CFR). 78 FR 12617 (February 25, 2013). Such regulations became effective on March 27, 2013.

Under 38 CFR 64.4(c), the two-year grant program period was determined to begin on the date that the RVCP grants were awarded. VA subsequently awarded the RVCP grants. On September 29, 2016, section 108 of the Department of Veterans Affairs Expiring Authorities Act of 2016, Public Law 114-228, amended section 506(g)(1) of the 2010 Act to extend the deadline for the report on the pilot program to September 30, 2017. Since that time, the authority for the RVCP program has not been extended or renewed.

The RVCP grant program was authorized as a temporary pilot initiative to assist veterans transitioning from military service to civilian life in rural or underserved communities and their families by coordinating outreach and services through community organizations. With the expiration of statutory authority and completion of all grant activities, VA no longer has the legal authority to administer or implement this program. Accordingly, 38 CFR part 64 no longer has any legal effect, and removing and reserving part 64 is necessary to ensure that VA's regulations remain current and accurate.

The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) to publish this rule without prior opportunity for public comment and with an immediate effective date. Pursuant to 5 U.S.C. 553(b)(B), general notice and opportunity for public comment are not required with respect to a rulemaking when an “agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”

This rule rescinds regulations for a program that is no longer authorized. VA has no discretion in whether to continue to implement this program or its regulations. These regulations in 38 CFR part 64 are now obsolete. Thus, the Secretary finds it is unnecessary to delay the issuance of this final rule for purposes of soliciting prior public comment.

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 not a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. This final rule is a deregulatory action under Executive Order 14192.

Economic Impact: VA does not anticipate any costs or transfers to be associated with this rule. This action is deregulatory under Executive Order 14192 because it removes an obsolete grant program from the Code of Federal Regulations whose statutory authority has fully expired and whose operations ended years ago. Eliminating 38 CFR part 64 reduces unnecessary regulatory text, improves clarity about which VA programs remain active, and prevents confusion among stakeholders who might mistakenly believe the RVCP grant program is still authorized. Because the program has no current grantees, obligations, funding, or administrative activity, rescinding the regulation imposes no costs and produces modest qualitative benefits by streamlining VA's regulatory code. In line with Executive Order 14192's directive to modernize and update agency rules, this action cleans up outdated provisions and enhances transparency by ensuring VA's regulations accurately reflect current law and agency practice.

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). This certification is based on the fact that the grant program is no longer in effect or authorized by law. 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.

This rule rescinds the program requirements at 38 CFR 64.10 and 64.16 constituting collections of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), and no new or revised collections of information are associated with this rule.

The Assistance Listing number and title for the program affected by this document is 64.038, Grants for the Rural Veterans Coordination Pilot.

Douglas A. Collins, Secretary of Veterans Affairs, approved this document on June 5, 2026, 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.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On November 20, 2025 (90 FR 52288), EPA published a Notice of Proposed Rulemaking (NPRM) for the State of Connecticut proposing approval of SIP revisions. The formal SIP revision was submitted by Connecticut on April 30, 2025, and consisted of revisions to Regulations of Connecticut State Agencies (RCSA) sections 22a-174-24 and 22a-174-44. The revisions include adding the 0.070 parts per million ozone standard in RCSA 22a-174-24 and clarifying the volatile organic compound calculation methods available for adhesive and sealant products in RCSA 22a-174-44. The evaluation and rationale for EPA's proposed action are explained in the NPRM and will not be restated here.

The EPA received one comment during the comment period, which is available in the docket of this rulemaking action. The commenter claimed that the EPA did not adhere to the following statutory requirements based on the five arguments below:

Comment 1: The final [sic] action incorporates by reference Connecticut regulations. Those State rules in turn typically reference test methods and technical standards used to determine VOC content and compliance for adhesives and sealants . . . and may reference model rule provisions. When an EPA rule incorporates material by reference (IBR), EPA must comply with 1 CFR 51.5: identify the specific material being incorporated, ensure it is reasonably available to interested persons, and place copies in the docket and at EPA/NARA for inspection . . . Absent this, the public did not have a fair opportunity to review the full content of the rule as approved, which is a procedural deficiency under the APA and IBR regulations.

Response: The proposed action identified the Connecticut regulations in the text of the proposed rulemaking and attached the application regulations in the docket. EPA also included copies of the referenced OTC model rule and related CARB RACT determination in the docket of the proposed rule.

Comment 2: The adhesives and sealants regulation applies broadly to numerous small entities in Connecticut which adds Federal enforceability and citizen-suit exposure, alters compliance assurance and can shift product markets toward compliant formulations with higher unit costs or different performance characteristics. Although the Regulatory Flexibility Act focuses on direct effects, EPA should at minimum provide a tailored certification with data or analysis addressing the incremental impacts and enforcement consequences of Federal approval, not just a boilerplate statement.

Response: The Regulatory Flexibility Act (RFA) is inapplicable to this rulebecause the EPA has certified that this rule will not have a significant economic impact on a substantial number of small entities. The regulatory analysis provisions of the RFA are only triggered by a threshold determination by the Agency that this rule will have a significant economic impact on a substantial number of small entities. Because the Agency has certified this rule will not have a significant economic impact, section 603 and 604 of the RFA do not apply to this action. 5 U.S.C. 605(b).

Comment 3: EPA should clarify its basis for concluding that the action could not plausibly lead to expenditures State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year when federally approving a rule that applies across numerous sectors statewide, and becomes enforceable by EPA and citizens.

Response: With regard to the Unfunded Mandates Reform Act (UMRA), the EPA has complied by making its own determination that this rule will not result in expenditures of $100M+, and therefore the Agency does not need to complete a statement under 2 U.S.C. 1532.

Comment 4: EPA does not provide an assessment of whether State and Federal recordkeeping and reporting obligations constitute a collection of information; EPA should obtain OMB approval to clarify why the Paperwork Reduction Act (PRA) does not apply.

Response: The EPA has complied with the PRA by certifying in the rule that the PRA does not apply because the action does not involve an information collection burden as defined by the PRA.

Comment 5: EPA states the proposed rulemaking is classified as not significant, though the adhesives and sealants program intersects with model rules and evolving compliance methods which may raise policy issues.

Response: The Agency has complied with E.O. 12866 by determining that this rule is not a significant regulatory action as defined in E.O. 12866.

EPA is approving Connecticut's revisions to RCSA 22a-174-24 and 22a-174-44 into the Connecticut SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Connecticut RCSA 22a-174-24 to update the definition of the ozone standard, and 22a-174-44 to clarify certain volatile organic compound calculation methods, described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and at the EPA Region 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rule of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, 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 Orders 12866 (58 FR 51735, October 4, 1993);

• Is not subject to an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant 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 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 August 10, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

Hereafter, the New York Metropolitan Area (NYMA) refers to the New York portion of the NY-NJ-CT maintenance area, which is comprised of the following counties: Bronx, Kings, Nassau, New York, Orange, Queens, Richmond, Rockland, Suffolk, and Westchester. EPA promulgated the designations for the NYMA as a PM 2.5 nonattainment area for the 1997 annual PM 2.5 NAAQS on January 5, 2005 (70 FR 944) which was then supplemented on April 14, 2005 (70 FR 19844) due to measured violations of the standards.

On June 27, 2013, the New York State Department of Environmental Conservation (NYSDEC) submitted a request to EPA to redesignate the nonattainment area to attainment for both the 1997 annual and 2006 24-hour PM 2.5 NAAQS. Concurrently, NYSDEC submitted a maintenance plan for the area as a State Implementation Plan (SIP) revision to ensure continued attainment. NYSDEC provided supplemental submissions to EPA on September 18, 2013, and February 27, 2014, to clarify portions of the redesignation request, maintenance plan, and emissions information. EPA redesignated the NYMA to attainment for the 1997 and 2006 PM 2.5 NAAQS on April 18, 2014 (79 FR 21857) and approved the associated maintenance plan into the SIP. The purpose of NYSDEC's October 15, 2024, LMP submission is to fulfill the second ten-year planning requirement of CAA section 175A(b), thus ensuring PM 2.5 NAAQS attainment through the end of the second maintenance period for PM 2.5 .

In its LMP submission, NYSDEC has requested approval for both the 2006 24-hour standard and the 1997 annual standard. However, the EPA is addressing only the 2006 24-hour NAAQS, in accordance with the PM 2.5 SIP Requirements Rule (81 FR 58010, August 24, 2016), because a second ten-year maintenance plan is not required for the now-revoked 1997 annual PM 2.5 standard.

On February 12, 2026 (91 FR 6561), the EPA published a notice of proposed rulemaking to approve a SIP revision submitted by the State of New York on October 15, 2024 for the purpose of fulfilling the second ten-year planning requirement of CAA section 175A(b), thus ensuring PM 2.5 NAAQS attainment through the end of the second maintenance period for PM 2.5 . New York's October 15, 2024, SIP submittal consisted of PM 2.5 emissions data for the New York portion of the NY-NJ-CT 2006 PM 2.5 NAAQS maintenance area.

Within EPA's proposed action, PM 2.5 historic design values for each monitoring site within the NYMA were analyzed for 2012-2024. The EPA found that the NYMA meets the critical design value (CDV) demonstration for an LMP. Additionally, EPA reviewed transportation conformity, attainment inventory, and the air quality monitoring network. The EPA found that NYSDEC's submittal satisfies the transportation conformity regulation in 40 CFR 93.109(e) and contains the necessary emissions inventory. NYSDEC also continues to operate a PM 2.5 monitoring network sited and maintained in accordance with Federal siting and design criteria in 40 CFR part 58, and in consultation with EPA Region 2. Finally, NYSDEC continues to adhere to the contingency plan it submitted with its first maintenance plan, which includes the required contingency provisions to ensure that New York State will promptly correct any violation of the 2006 PM 2.5 NAAQS in the area (79 FR 8133, February 11, 2014).

All these steps were taken to ensure that this LMP satisfies the CAA section 175A requirements for the second ten-year maintenance period. The specific details of New York's SIP submittals and the rationale for the EPA's approval action are explained in the EPA's proposed rulemaking and are not restated in this final action. For this detailed information, the reader is referred to the EPA's February 12, 2026, proposed rulemaking (91 FR 6561).

The EPA provided a 30-day review and comment period for the February 12, 2026 proposed rule (91 FR 6561). The comment period ended on March 16, 2026. We received no comments on the EPA's action. Therefore, no changes have been made to the proposed action.

The EPA is approving the New York Metropolitan Area Second Ten-Year Limited Maintenance Plan for the 2006 24-Hour PM 2.5 Standard, dated February 12, 2026 (91 FR 6561), for the purposes of satisfying the second ten-year planning requirement of CAA section 175A(b), thus ensuring PM 2.5 NAAQS attainment through the end of the second 10-year period for PM 2.5 .

EPA's review of the air quality data for the maintenance area indicates that the State continues to show attainment well below the level of the 2006 PM 2.5 NAAQS and that NYSDEC's LMP meets all the LMP qualifying criteria set forth in the “Guidance on Limited Maintenance Plan Option for Moderate PM 2.5 Nonattainment Areas and PM 2.5 Maintenance Areas.”  1 EPA's approval of this LMP will satisfy the CAA section 175A requirements for the second 10-year period for the New York Metropolitan maintenance area. EPA also finds the LMP to be adequate as it pertains to transportation conformity requirements.

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

Under section 109 of the CAA, the EPA has established NAAQS for certain pervasive air pollutants (referred to as “criteria pollutants”) and conducts periodic reviews of the NAAQS to determine whether they should be revised or whether new NAAQS should be established. In 2006, the EPA strengthened the 24-hour PM 2.5 NAAQS by lowering the level from 65 to 35 micrograms per cubic meter (µg/m 3 ). 1 The 24-hour standards are based on a three-year average of 98th percentile 24-hour average PM 2.5 concentrations. The EPA established these standards after considering substantial evidence from numerous health studies demonstrating that serious health effects are associated with exposures to PM 2.5 concentrations above these levels.

The EPA initially designated the San Joaquin Valley  2 as a nonattainment area for the 2006 24-hour PM 2.5 NAAQS effective December 14, 2009, 3 and subsequently reclassified the area as a “Serious” nonattainment area for these NAAQS on January 20, 2016. 4 On July 22, 2020, the EPA approved the State's attainment plan for meeting the Serious area attainment planning requirements for the 2006 24-hour PM 2.5 NAAQS (referred to herein as the “SJV PM 2.5 Plan”) and approved the State's request for an extension of the attainment date from December 31, 2019, to December 31, 2024, under section 188(e) of the Act.

On April 2, 2026, the EPA proposed two actions related to the San Joaquin Valley and the 2006 24-hour PM 2.5 NAAQS. 5 First, the EPA proposed to correct our July 22, 2020, final rule granting a CAA section 188(e) attainment date extension for the 2006 24-hour PM 2.5 NAAQS from December 31, 2019, to December 31, 2024, and to instead deny the extension request. The EPA proposed this action in response to a decision from the Ninth Circuit Court of Appeals in Medical Advocates for Healthy Air et al. vs. EPA (“ Medical Advocates” ), 6 which established that the EPA was mistaken in its approval of the aggregate commitment in the SJV PM 2.5 Plan. Because the Agency had relied on its approval of the aggregate commitment in its decision to also grant the attainment date extension, 7 the EPA reasoned that it was in error to grant the extension. Thus, pursuant to CAA section 110(k)(6), the EPA proposed to revise its granting of the extension and to instead deny the extension. The EPA explained that if finalized, the action would have the effect of reestablishing the December 31, 2019 attainment date for the San Joaquin Valley for the 2006 24-hour PM 2.5 NAAQS.

Second, based on our proposal to reestablish the December 31, 2019 attainment date, and in accordance with CAA section 179(c)(1), the EPA proposed to determine that the San Joaquin Valley Serious nonattainment area failed to attain the 2006 24-hour PM 2.5 NAAQS by the December 31, 2019 applicable attainment date. This proposed determination was based on quality-assured and certified data from 2017 through 2019.

The April 2, 2026 proposed rulemaking described the CAA requirements that would apply if the EPA were to finalize the finding of failure to attain. 8 Our proposal explained that CAA section 189(d) establishes that a state will submit the required SIP revision within 12 months after the applicable attainment date; however, because the submission deadline for a revised plan pursuant to CAA section 189(d) has already passed, it is impossible for the State to submit a revision by that date. Consistent with the EPA's past practice when application of the PM-specific requirements of subpart 4 would be impractical, we proposed to apply the applicable deadline found in CAA subpart 1, section 179(d)(1) and require that California submit a SIP revision that complies with CAA sections 179(d) and 189(d) within one year of the EPA's final determination that the San Joaquin Valley area failed to attain the 2006 24-hour PM 2.5 NAAQS. 9

The Department is rescinding portions of its Title VI implementing regulations to align with the language that Congress enacted in Title VI prohibiting intentionally discriminatory conduct, pursuant to Title VI, 42 U.S.C. 2000d-1. See 42 U.S.C. 2000d. There are serious statutory and constitutional concerns with the legality of the Department's Title VI regulations, which go beyond intentional discrimination by prohibiting conduct that has an unintentional disparate impact. This rule accordingly rescinds those portions of the regulations that prohibit conduct having a disparate impact, which are in considerable tension with both the statute and the Constitution and do not serve the public interest. First, this rule rescinds the full text of 49 CFR 21.5(b)(2), which prohibits the use of “criteria or methods of administration which have the effect of subjecting persons to discrimination because of their race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program with respect to individuals of a particular race, color, or national origin.” Second, this rule removes the two uses of the phrase “or effect” from 49 CFR 21.5(b)(3). Third, this rule rescinds the full text of 49 CFR 21.5(b)(7), which authorizes affirmative action even in the absence of a finding of prior discrimination in a program or activity “to assure that no person is excluded from participation in or denied the benefits of the program or activity.” Fourth, this rule removes one sentence regarding affirmative action from 49 CFR 21.5(c)(1) and rescinds the full text of 49 CFR 21.5(c)(3), which addresses employment practices subject to Federal financial assistance. Fifth, this rule removes the phrases “or its effect when made” and “or its effect when made will” from 49 CFR 21.5(d).

The rule's revisions also conform to Executive Order 14281, Restoring Equality of Opportunity and Meritocracy, 90 FR 17537 (Apr. 23, 2025). That Order states that “[i]t is the policy of the United States to eliminate the use of disparate-impact liability in all contexts to the maximum degree possible to avoid violating the Constitution, Federal civil rights laws, and basic American ideals.” Id. at 17537. Although the Department, in consultation with the Department of Justice (DOJ), would take this action independently of Executive Order 14281, Executive Order 14281 supports this action.

This rule makes clear that the Department's Title VI regulations prohibit only intentional discrimination, not conduct or activities that have a disparate impact. The Department thus will not take action under Title VI premised on disparate-impact liability.

Title VI of the Civil Rights Act of 1964, as amended, provides: “No person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” 42 U.S.C. 2000d. Title VI also directs Federal departments and agencies that extend Federal financial assistance to “effectuate the provisions of” Title VI “by issuing rules, regulations, or orders of general applicability.” 42 U.S.C. 2000d-1. The section of Title VI that sets forth the prohibited conduct, 42 U.S.C. 2000d, prohibits intentional discrimination and makes no reference to unintentional disparate effects or impact. See Alexander v. Sandoval, 532 U.S. 275, 280 (2001) (“[I]t is . . . beyond dispute—and no party disagrees—that § 601 [of Title VI] prohibits only intentional discrimination.”). The statute does not explicitly provide any Federal department or agency with authority to prohibit conduct having an unintentional disparate impact. And despite having ample opportunities, Congress has enacted no subsequent amendments to Title VI to impose disparate-impact liability.

Pursuant to Executive Order 12250, “[t]he Attorney General . . . coordinates the implementation and enforcement by Executive agencies of . . . Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq. ).” 45 FR 72995, 72995 (Nov. 2, 1980). Accordingly, DOJ is primarily responsible for defining the nature and scope of Title VI's prohibition of discrimination on the basis of race, color, and national origin in programs or activities receiving Federal financial assistance. Executive Order 12250 directs DOJ, among other things, to “develop standards and procedures for taking enforcement actions and for conducting investigations and compliance reviews.” Id. Further, as part of this responsibility, Executive Order 12250 provides that other agencies' regulations implementing Title VI are subject to the Attorney General's approval. Id. at 72996.

DOJ's Title VI regulations are codified at 28 CFR 42.101, 42.112. The then-Department of Health, Education, and Welfare issued the initial set of model regulations for Title VI on December 4, 1964, which included only one reference to the “effect of” language in the “discrimination prohibited” provision of the rule. See 29 FR 16298, 16299 (Dec. 4, 1964) (codified at 45 CFR 80.3(b)(2)). DOJ adopted these model regulations in 1966, which likewise contained a single instance of the “or effect” language at 28 CFR 42.104(b)(2). 31 FR 10265, 10266 (July 29, 1966). In 1973, DOJ substantively amended its regulatory description of prohibited discrimination. See 38 FR 17955 (July 5, 1973). These substantive changes included, among other things, the addition of 28 CFR 42.104(b)(3) (adding the “or effect” language to an additional provision), 28 CFR 42.104(b)(6) (introducing the “affirmative action” language to the regulations), and 28 CFR 42.104(c)(2) (extending the rule to Federal financial assistance whose primary objective is not to provide employment). Id. at 17955. In 2003, the Department added language regarding “program or activity” to reflect the amendment of Title VI by the Civil Rights Restoration Act of 1987. See 68 FR 51334, 51364 (Aug. 26, 2003); Public Law 100-259, sec. 6, 102 Stat. 28, 31 (1988). Prior to its recent amendment, see 90 FR 57141 (Dec. 10, 2025), DOJ's regulation describing the scope of prohibited discriminatory conduct, 28 CFR 42.104, included prohibitions on conduct that had an unintentional disparate impact, discussed more fully below.

DOT's initial Title VI regulations at 49 CFR part 21 followed DOJ's model, taking effect on June 18, 1970. 35 FR 10080 (June 18, 1970). The initial regulations included the “or effect” language that exists in the current regulation. Id. In 1973, DOT amended its regulation to incorporate affirmative-action liability into 49 CFR 21.5(b)(7). 38 FR 17997 (July 5, 1973). In 2003, DOT added language regarding “program or activity” to reflect the amendment of Title VI by the Civil Rights Restoration Act of 1987 and further revised the affirmative action provision in 49 CFR 21.5(b)(7).

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

In 2001, the Supreme Court, in Alexander v. Sandoval, reaffirmed that settled understanding. 532 U.S. at 280 (“[I]t is . . . beyond dispute . . . that § 601 [of Title VI] prohibits only intentional discrimination.”). In Sandoval, the Supreme Court held that private plaintiffs lacked a private right of action to enforce DOJ's “disparate-impact regulations.” Id. at 285-87. Although the Supreme Court had previously found a private cause of action to enforce Title VI's bar on intentional discrimination, id. at 279-80, that conclusion did not extend to enforcing DOJ's “disparate-impact regulations.” Id. at 285. As the Supreme Court explained, it is “clear” that “the disparate-impact regulations do not simply apply” the statutory prohibition, as the regulations “forbid conduct that [Title VI] permits,” so it is equally “clear that the private right of action to enforce [Title VI] does not include a private right to enforce these regulations.” Id. While the Supreme Court in Sandoval “assume[d],” without deciding, that DOJ's disparate-impact regulations were valid, the Court explained that the then-current version of the regulations were in “considerable tension” with the Supreme Court's Title VI precedents. Id. at 282. Similarly, the regulations did not “authoritatively” construe Title VI because the regulations “forbid conduct”—namely, policies that unintentionally result in a disparate impact—that Title VI “permits.” Id. at 281-82, 284-85; see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). The Court has not ruled specifically on DOT's Title VI regulations.

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

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

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

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

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

Imposing disparate-impact liability endangers these policy objectives. Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with the original public meaning of Title VI, creates confusion, increases the costs of compliance, and does not serve the public interest. In addition, DOT's Title VI regulations have always substantively mirrored DOJ's regulations, and DOJ's recent amendments to its Title VI regulations support these changes to the DOT regulations.

After considering the relevant issues and factors and weighing the relevant considerations, the Department concludes that these reasons support eliminating disparate-impact liability from the Department's Title VI regulations. In any event, the Department concludes that each reason is a separate and independent basis for eliminating disparate-impact liability from the Department's Title VI regulations.

The Department's regulation at 49 CFR 21.5, titled “Discrimination prohibited,” contains several provisions that go beyond the statutory text and constitutional requirements by prohibiting facially neutral policies that have a disparate impact and in some instances encourage or even require unlawful discrimination labeled as “affirmative action.” Section 21.5(b)(2) is the current regulation's general disparate-impact prohibition, which states that a “recipient . . . may not . . . utilize criteria or methods of administration which have the effect of subjecting persons to discrimination because of their race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program with respect to individuals of a particular race, color, or national origin.” 49 CFR 21.5(b)(2).

Beyond that general prohibition, section 21.5(b)(3) addresses a Federal funding recipient's selection of the site or location of facilities and includes two references to “effect” that extend the scope of prohibited conduct to include conduct with unintentional disparate impact. Id. 21.5(b)(3). Section 21.5(b)(7) concerns the use of “affirmative action” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects.” But this provision does not expressly specify that the funding recipient must narrowly tailor such use nor that this use must serve a compelling governmental interest, as is required to satisfy strict scrutiny. Id. 21.5(b)(7). Section 21.5(c)(1) includes additional language regarding affirmative action. Id. 21.5(c)(1). Section 21.5(c)(3) addresses prohibited discriminatory employment practices and extends beyond intentional discrimination by prohibiting conduct that “tends” to have a discriminatory effect. Id. 21.5(c)(3). Section 21.5(d) provides that funding recipients may not select a site or location for a facility if the purpose or effect of that selection is to discriminate on the grounds of race, color, or national origin. Id. 21.5(d).

There are serious statutory and constitutional concerns with the legality of the Department's Title VI disparate-impact regulations. The Department also has serious policy concerns with its current disparate-impact regulations because they create confusion, undermine public confidence in the Nation's civil rights laws and the rule of law, and produce burdensome litigation and compliance costs.

There are serious statutory concerns as to whether the Title VI statute authorizes the disparate-impact provisions of the current regulations. As the Supreme Court has made clear, Title VI prohibits “only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Sandoval, 532 U.S. at 280, 286 n.6. That is the “single, best meaning” of Title VI. Loper Bright, 603 U.S. at 400. Sandoval calls into serious doubt the legality of DOJ's former “disparate-impact regulations.” Sandoval, 532 U.S. at 281-82, 284-85 (noting that the DOJ regulations were in “considerable tension” with the Supreme Court's Title VI precedents); see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”)

Although Sandoval resolved only the question of private enforceability, subsequent cases such as Loper Bright have made clear that agencies cannot extend Title VI beyond its original public meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). The same goes for DOT's Title VI regulations. Sandoval and Loper Bright thus also call into question the legality of DOT's Title VI disparate-impact regulations, even though the Court has not ruled specifically on DOT's Title VI regulations. And even in the absence of Supreme Court precedent, the Department would have concluded that the best reading of Title VI is that it prohibits only intentional discrimination, not unintentional disparate outcomes.

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

There are also serious concerns about whether the Department's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in SFFA, “the Equal Protection Clause . . . applies without regard to any differences of race, of color, or of nationality—it is universal in its application” and the “guarantee of equal protection cannot mean one thing when applied to one individual and something else when applied to a person of another color.” 600 U.S. at 206 (internal quotation marks omitted) (first quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886); and then quoting Bakke, 438 U.S. at 289-90 (Powell, J.)). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under DOT's regulations is triggered by unintentional disparate outcomes, which the recipient may not even know about without investigation. To evaluate and avoid this risk, the funding recipient must incur investigatory costs, such as conducting an impact analysis, and is coerced to consider race, color, and national origin proactively and potentially use it to change the unintended disparate outcomes.

In short, disparate-impact liability encourages, and in some cases requires, covered entities to engage in the intentional use of race and racial balancing to eliminate disparate outcomes by treating certain racial groups differently from others—the exact conduct the Equal Protection Clause forbids. See id. The serious constitutional concerns raised by these perverse incentives further confirm that the best reading of Title VI is that it prohibits only intentional discrimination and does not authorize DOT to impose disparate-impact liability. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575 (1988) (“[W]here an otherwise acceptable construction of a statute would raise serious constitutional problems, the Court will construe the statute to avoid such problems unless such construction is plainly contrary to the intent of Congress.” (citing NLRB v. Catholic Bishop of Chi., 440 U.S. 490, 499-501, 504 (1979))).

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

Similarly, the “affirmative action” provisions authorize and sometimes require the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, it encourages intentional racial balancing “to overcome the effects of” unintended racial disparities. 49 CFR 21.5(b)(7), (c)(1). Thus, for substantially the same reasons as above, the “affirmative action” provision raises serious constitutional concerns.

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

The Department also has serious policy concerns with the imposition of disparate-impact liability. While the Department expresses its policy concerns with disparate-impact liability independent of Executive Order 14281, that Order sets forth many valid policy concerns with disparate-impact liability. As noted in Section 1 of the Order,

On a practical level, disparate impact liability has hindered businesses from making hiring and other employment decisions based on merit and skill, their needs, or the needs of their customers because of the specter that such a process might lead to disparate outcomes, and thus disparate impact lawsuits. Disparate impact liability has made it difficult, and in some cases impossible, for employers to use bona fide job-oriented evaluations when recruiting, which prevents job seekers from being paired with jobs to which their skills are most suited—in other words, it deprives them of opportunities for success.

90 FR at 17537. Moreover, the legal concerns identified above have caused uncertainty and confusion for Federal financial assistance recipients as to whether and when they need to comply with the disparate-impact regulations and when they can or must consider race, color, and national origin. As explained above, Sandoval casts substantial doubt on the validity of the disparate-impact regulations that many Federal departments and agencies, including DOT, have promulgated pursuant to Title VI. 532 U.S. at 280-82.

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

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized by Harvard and University of North Carolina were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). The Department believes these policy concerns independently justify repealing certain parts of its regulation to cure this confusion, remove the incentive for covered entities to engage in racial balancing, and maintain clarity and public confidence in the Nation's civil rights laws.

The Department has considered the view that looking at disparate effects can sometimes be useful in uncovering or deterring subtle intentional discrimination or intentional indifference to unnecessary and arbitrary barriers. But that view's alleged benefits are outweighed by the other issues and factors the Department has considered. And in any event, the concern is mitigated by the fact that eliminating disparate-impact liability does not preclude the use of data on disparate outcomes to help prove intentional discrimination. Indeed, the current changes do not alter the Department's Title VI regulations insofar as they provide that “recipients should have available for the Secretary racial and ethnic data showing the extent to which members of minority groups are beneficiaries of programs receiving Federal financial assistance.” 49 CFR 21.9(b). Both the Department and private litigants rely on such data as a potential indicator of intentional discrimination. This use of statistical disparity to help establish, as an evidentiary matter, liability for intentional discrimination materially differs from using it to impose liability for an unintentional disparate impact. This regulatory revision does not affect the Department's authority to collect and use such data to help prove intentional discrimination.

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

The Department has also considered the potential reliance interests of financial-assistance recipients and others on the disparate-impact regulations. These interests may include personnel or contracting actions taken by DOT recipients that were taken, either in whole or in part, based on the need to assess and mitigate potential disparate impacts in their programs and projects. Sandoval, however, cast serious doubt on the continuing viability of the regulations more than 20 years ago. Executive Order 14281 directed all agencies to “deprioritize enforcement of all statutes and regulations to the extent they include disparate-impact liability.” 90 FR at 17538. The Department accordingly believes that any reliance interests should be minimal and do not outweigh the Department's legal and other policy concerns. Further, each of the Department's concerns, whether considered cumulatively or separately, outweighs any reliance interests.

The Department notes that Sandoval has also led to a divergence between Title VI enforcement by private plaintiffs and enforcement by Federal departments and agencies. After Sandoval, private plaintiffs can enforce only Title VI's statutory prohibition on intentional discrimination, while the Department of Justice, on behalf of Federal agencies, including DOT, could continue to pursue disparate-impact liability. Repealing the disparate-impact regulations eliminates this incongruent enforcement and restore public confidence in Title VI by aligning the Department's regulations with the Constitution.

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

This rule's regulatory changes address the concerns regarding the statutory authority that the Supreme Court questioned in Sandoval and the other legal and policy concerns discussed above, harmonize the implementing regulations' scope with the conduct that Congress intended Title VI to prohibit, promote consistent enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to the courts and Federal financial assistance recipients and beneficiaries.

For the reasons summarized above, the Department amends the following provisions in its Title VI implementing regulation that explain the particular types of discrimination prohibited, located at 49 CFR 21.5.

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

Section 21.5(b)(2) is the current regulation's general prohibition of conduct with unintentional disparate impact. It expands prohibited conduct from purposeful discrimination to impose liability on recipients of Federal funding and assistance who “utilize criteria or methods of administration which have the effect of subjecting persons to discrimination.” Because section 21.5(b)(2)'s only purpose is to extend the scope of Title VI to reach unintentional disparate-impact discrimination, this rule deletes this paragraph in its entirety. It thus amends the Department's Title VI implementing regulations to conform to the scope of coverage Congress intended when it enacted Title VI and to address the legal and policy considerations and determinations described in this document. The rule replaces paragraph (b)(2) with a “Reserved” placeholder to maintain the numbering accuracy of previous citations and other references to parts of this section.

Section 21.5(b)(3) addresses a recipient's or applicant's selection of the site or location of facilities. It provides that a recipient may not make selections with the “purpose or effect” of discriminating, or “with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of” Title VI or the Department's implementing regulations. The paragraph's two references to “effect” extend its scope to unintentional disparate impacts. This rule deletes both “or effect” references to conform paragraph (b)(3) to the scope of coverage Congress intended when it enacted Title VI and to address the legal and policy considerations and determinations described in this document.

Section 21.5(b)(7) deals with “affirmative action.” This section authorizes affirmative action even in the absence of a finding of prior discrimination in a program or activity “to assure that no person is excluded from participation in or denied the benefits of the program or activity.” It consequently encourages intentional racial classifications, racial preferences, and other race-based actions that run counter to the principles of the Equal Protection Clause.

Additionally, paragraph (b)(7) requires that a recipient “take affirmative action to remove or overcome the effects of the prior discriminatory practice or usage” when “prior discriminatory practice or usage tends, on the grounds of race, color, or national origin to exclude individuals from participation in, to deny them the benefits of, or to subject them to discrimination under any program or activity.” This provision goes beyond the Equal Protection Clause, which permits in limited circumstances, but does not mandate, a government to take narrowly tailored action to remedy the effects of its identified past discrimination. See, e.g., Bakke, 438 U.S. at 307 (Powell, J.). Moreover, even putting aside the mandatory language, this provision does not expressly require narrow tailoring to counter the particular past discrimination, but rather simply “affirmative action” to “overcome the effects” of prior discrimination. This provision accordingly promotes potentially illegal race, color, and national origin discrimination. Moreover, in some instances, it may even coerce recipients to consider and use race preferences when the recipient does not want to. This is detrimental to the Department's goal of promoting and defending a culture of nondiscrimination and is destructive to the public's understanding of and faith in the Nation's civil rights laws. This rule, therefore, removes paragraph (b)(7) to address the legal and policy considerations and determinations described in this document.

Section 21.5(c)(1) addresses prohibited discriminatory employment practices. Paragraph (c)(1) prohibits intentionally discriminatory employment practices in a program when a primary objective of the Federal funding or assistance that program receives is to provide employment. This paragraph also includes one sentence regarding “affirmative action” that recipients must take: “Such recipient shall take affirmative action to insure that applicants are employed, and employees are treated during employment, without regard to their race, color, or national origin.” While this use of “affirmative action” language may not raise the same legal concerns given its directive “without regard to their race, color, or national origin,” this rule removes this sentence to avoid potential confusion, while the rest of the paragraph will remain, consistent with the DOJ regulation.

Section 21.5(c)(3) extends the prohibition on discrimination to employment practices of the recipient even “where a primary objective of the Federal financial assistance is not to provide employment” if discrimination in the non-funded “employment practices of the recipient or other persons subject to the regulation tends, on the grounds of race, color, or national origin, to exclude individuals from participation in, to deny them the benefits of, or to subject them to discrimination under any program to which this regulation applies.” This paragraph does not prohibit only intentional discrimination but rather extends the prohibition to conduct that “tends” to have a discriminatory effect.

Moreover, the Department notes that paragraph (c)(3)'s extension to employment practices where the Federal funding's primary objective is not to provide employment explicitly conflicts with the statutory limitation found in 42 U.S.C. 2000d-3. That section states that “[n]othing contained in [Title VI] shall be construed to authorize action under [Title VI] by any department or agency with respect to any employment practice of any employer, employment agency, or labor organization except where a primary objective of the Federal financial assistance is to provide employment.” 42 U.S.C. 2000d-3; see also Johnson v. Transp. Agency, Santa Clara Cnty., 480 U.S. 616, 627-28 n.6 (1987) (citing the statutory limitation and noting Congress's intent that Title VI not “impinge” on Title VII, which prohibits discriminatory employment practices). The rule deletes paragraph (c)(3) so that the regulation more closely adheres to Title VI, which addresses the legal and policy considerations and determinations described in this document.

The Department's position is that each of the amendments serve a vital, related, but distinct purpose. The Department also confirms that each of the amendments is intended to operate independently of each other and that the potential invalidity of one amendment should not affect the other amendments. The Department would adopt any of the amendments independently of the invalidity of a separate amendment.

The Department issues this final rule without prior public notice and comment or a delayed effective date pursuant to the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” 5 U.S.C. 553(a)(2).

Title VI concerns non-discrimination conditions on the receipt of Federal financial assistance, and more particularly to the receipt of Federal “[g]rants and loans,” “property,” “personnel” and “[a]ny Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance.” 49 CFR 21.23(c); see also 49 CFR 21.7 (requiring funding recipient sign contractual assurance of compliance with Title VI); Cummings v. Premier Rehab Keller, P.L.L.C., 596 U.S. 212, 217-18 (2022) (observing that Congress enacted Title VI “[p]ursuant to its authority to `fix the terms on which it shall disburse federal money' ” (internal citation omitted)). Cf. Education Programs or Activities Receiving or Benefitting from Federal Financial Assistance, 82 FR 46655, 46655 (Oct. 6, 2017) (invoking the section 553(a)(2) exception to amend Title IX regulations to “promote consistency in the enforcement of Title IX for [the Department of Agriculture] financial assistance recipients”); Preserving Community and Neighborhood Choice, 85 FR 47899 (Aug. 7, 2020) (invoking the exception to repeal Housing and Urban Development rule regarding Federal grantees); Participation by Minority Business Enterprise in Department of Transportation Programs, 53 FR 18285 (May 23, 1988) (invoking the exception to expand coverage of Department of Transportation regulation regarding Federal Aviation Administration's airport financial assistance program); Nondiscrimination on the Basis of Handicap in Federally Assisted Programs—Suspension of Guidelines with Respect to Mass Transportation, 46 FR 40687 (Aug. 11, 1981) (invoking the exception to suspend Department of Justice guidelines regarding prohibiting disability discrimination in transportation programs and activities receiving Federal financial assistance).

Indeed, invoking 5 U.S.C. 553(a)(2) is consistent with the Office for Management and Budget's (OMB) definition for “Federal financial assistance” under 2 CFR 200.1, which defines “Federal financial assistance” with the same categories as the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” 5 U.S.C. 553(a)(2). With potentially limited exceptions not applicable to the Department, all the forms of Federal financial assistance set forth under 2 CFR 200.1 that the Department administers would fall under the “public property, loans, grants, benefits, or contracts” exception. Thus, the Department issues this final rule without prior public notice and comment or a delayed effective date under 5 U.S.C. 553(a)(2).

The Department has determined that this rulemaking is a “significant regulatory action” under Section 3(f) of Executive Order 12866, 58 FR 51735, 51738 (Sep. 30, 1993) and DOT Order 2100.6B (Mar. 10, 2025), 1 but it is not an “economically significant” action.

This regulation has been drafted and reviewed in accordance with Executive Order 12866 Section 1(b), 58 FR at 51735, and in accordance with Executive Order 13563 Section 1(b), 76 FR 3821, 3821 (Jan. 18, 2011), which supplements and reaffirms the principles of Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. 58 FR at 51735; 76 FR at 3821. Executive Order 13563 also recognizes that some benefits and costs are difficult to quantify and provides, where appropriate and permitted by law, that agencies may consider and discuss qualitatively values that are difficult or impossible to quantify. Id.

As explained in the preamble, the regulatory modifications this rule makes are necessary to conform Department regulations to Executive Order 14281, address serious concerns regarding the Department's Title VI regulation that the Supreme Court raised in Sandoval, harmonize the implementing regulation with Title VI, promote consistency in enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to courts and the recipients and beneficiaries of Federal funding and assistance. Indeed, with respect to 49 CFR 21.5, the changes are clearly necessary to bring the regulations into compliance with 42 U.S.C. 2000d-3. In short, this rule is necessary to conform the Department's regulation to existing statutory law, as interpreted by the U.S. Supreme Court.

Data limitations make the costs and benefits of the rule difficult to quantify. Title VI attaches to any recipient of Federal funds, and DOT awarded grants to approximately 3,600 recipients from fiscal year (FY) 2021 through 2025. During this time period, DOT announced approximately $466.7 billion in grants; of that total, approximately $118.0 billion was awarded as part of approximately 13,600 discretionary grants, and approximately $348.7 billion was awarded in formula grants. In FY2025 alone, DOT issued over 3,500 discretionary grant awards, to over 1,160 unique recipients, for total discretionary awards of approximately $22.5 billion. In FY2025, DOT also announced approximately $71.2 billion in formula grant awards.

Specific to its Title VI program, DOT opened approximately 330 Title VI complaints between 2021 and 2025. DOT does not have reliable tracking information regarding the number of compliance reviews related to Title VI or disparate-impact discrimination during the period of 2021 through 2025. The Department does not track which of its complaints involved allegations of disparate-impact discrimination, or which of its compliance reviews contained criteria related to disparate-impact discrimination. Consequently, the Department cannot reliably quantify the costs attributable to the varying disparate-impact portions of complaint investigations, compliance reviews, or enforcement actions. Furthermore, that the existence of a disparate impact is sometimes a factor that may be considered in determining whether discrimination was intentional further impedes monetizing costs and benefits.

In addition, at least one DOT operating administration has regular Title VI program submission requirements for its recipients that are related to disparate impact. The Federal Transit Administration (FTA), in FTA Circular 4702.1B, requires that the following to be included in recipients' triennial Title VI Program submissions: facility siting equity analysis, system-wide service monitoring and service and fare equity analyses (for fixed-route transit providers), State investments analyses (for State departments of transportation), and metropolitan planning organization (MPO) investment analyses (for MPOs). FTA estimates the total annual burden of the Title VI program submission is 45 hours for each of the 100 larger transit entities, and with more specific Title VI program submission requirements, including the disparate impact-related submissions, the total is approximately 4,500 hours of work by recipient staff each year. However, FTA and DOT do not maintain data regarding the cost or burden for these specific disparate-impact-related requirements within the Title VI Program submissions.

Therefore, the overall cost effect on the Department is difficult to quantify. This deregulatory action should decrease the Department's enforcement costs as a result of fewer and less in-depth compliance reviews and complaint investigations. Although it is difficult to quantify, this deregulatory action will also have the benefit of bringing the Department's conduct in line with the law. The Department is also unable to quantify how funding recipients will respond to the regulatory changes. In addition, with the reduction of the Department's enforcement of Title VI as it applies to disparate-impact liability, the deregulatory action should result in lower compliance costs for recipients, including shorter program submissions that no longer need to include items such as disparate-impact policies and disproportionate-burden policies.

The Department recognizes that a recipient may receive additional Federal funds or assistance from sources other than the Department. The Department does not envision that this rule will appreciably increase administrative costs or compliance costs for funding recipients who must also adhere to the regulations of another department or agency. This deregulatory action does not create any new obligations for its recipients. On the contrary, by eliminating disparate-impact liability from the regulation, it eliminates a source of regulatory confusion, narrows the conduct prohibited, and thus lessens the costs of compliance and potential liability. Moreover, recipients who receive funds for the same program or activity from more than one Federal entity already enter into separate contractual assurances with each funding entity, see, e.g., 49 CFR 21.7. These contractual assurances already impose varying requirements that each Federal funding source deems necessary. Funding recipients will continue to be held to the most stringent contractual assurance and regulation.

Based on the analysis of the practical qualitative costs and benefits noted above, the Department believes this rule is consistent with the principles of Executive Orders 12866 and 13563, including the requirements, to the extent permitted by law, that the Department adopt a regulation only upon a reasoned determination that its benefits justify its costs and choose a regulatory approach that maximizes net benefits. See 58 FR at 51735; 76 FR at 3821.

This final rule is expected to be an Executive Order 14192 deregulatory action. This rule eliminates unnecessary regulation by revising the Department's current Title VI regulations, which extend prohibited conduct to include unintentional disparate impacts and thus expand the scope of those regulations to a vastly broader range of conduct than the statute prohibits. Details on the estimated cost savings of this final rule can be found in the rule's economic analysis provided above.

This rule will not have a substantial, direct effect on the relationship between the national government and the States, on distribution of power and responsibilities among various levels of government, or on States' policymaking discretion. States that choose to receive Federal financial assistance from the Department do so voluntarily and agree to comply with relevant statutory requirements as a condition of receiving such funding. This rule does not subject States or any other funding recipients or beneficiaries to new obligations. This rule amends and clarifies existing regulations that are required by statute. Therefore, in accordance with Section 6 of Executive Order 13132, 64 FR 43255, 43257-58 (Aug. 4, 1999), the Department has determined these amendments do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601 et seq. ) requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations, and small governmental jurisdictions. Whenever an agency is required by 5 U.S.C. 553, or any other law, to publish general notice of proposed rulemaking for any proposed rule, the agency must conduct and publish for public comment a regulatory flexibility analysis. Because the Department is not required to publish a proposed rulemaking for this action, an analysis under the RFA is not required.

Further, the Department, in accordance with 5 U.S.C. 605(b), has reviewed these regulations and certifies that the rule's changes will not have a significant economic impact on a substantial number of small entities, in large part because these regulatory changes do not impose any new substantive obligations on Federal funding recipients. The rule amends and clarifies existing regulations that are required by Title VI. The rule merely brings the Department into compliance with the Equal Protection Clause and harmonizes the scope of its regulations to conform with the scope of Title VI, which does not prohibit conduct having an unintentional disparate impact. All Federal funding recipients have been bound by the existing standards that will remain in place after this rule since their initial promulgation.

Pursuant to Executive Order 12250, the Department of Justice has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes such as Title VI in order to identify those which are inadequate, unclear or unnecessarily inconsistent.” Additionally, Executive Order 12250 delegated the President's responsibility to approve Title VI regulations to the Attorney General. See 42 U.S.C. 2000d-1. The Department of Justice has reviewed and approved this rule.

The Department has analyzed the environmental impacts of this action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ) and has determined that it is categorically excluded pursuant to DOT Order 5610.1D, available at https://www.transportation.gov/mission/dots-procedures-considering-environmental-impacts. Categorical exclusions are actions identified in an agency's NEPA implementing procedures that do not normally have a significant impact on the environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). The purpose of this rulemaking is to eliminate disparate-impact liability. Section 9(f) of DOT Order 5610.1D states that a DOT Operating Administration can use the categorical exclusions developed by another Operating Administration. This action is covered by the categorical exclusion listed in the Federal Transit Administration's implementing procedures, “[p]lanning and administrative activities that do not involve or lead directly to construction, such as: . . . promulgation of rules, regulations, directives. . . .” 23 CFR 771.118(c)(4). In analyzing the applicability of a categorical exclusion, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. The Department does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

The Unfunded Mandates Reform Act of 1995 (“UMRA”), 2 U.S.C. 1501 et seq., requires agencies to prepare several analytic statements before proposing any rule that may result in annual expenditures of $100 million by State, local, or Tribal governments, or the private sector. 2 U.S.C. 1532(a). The UMRA also, however, excludes from its coverage any proposed or final Federal regulation that “establishes or enforces any statutory rights that prohibit discrimination on the basis of race, color, religion, sex, national origin, age, handicap, or disability.” 2 U.S.C. 1503(2). Accordingly, this rulemaking is not subject to the provisions of the UMRA.

The Office of Information and Regulatory Affairs has determined that this rule is not a “major rule” as defined by the Congressional Review Act, 5 U.S.C. 804(2).

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

Accordingly, for the reasons set forth above, and by the authority vested in me as the Secretary of Transportation, part 21 of title 49 of the Code of Federal Regulations is amended as follows: