Section 5(b) of the CCC Charter Act provides that CCC may use its funds to “(m)ake available materials and facilities required in connection with the production and marketing of agricultural commodities (other than tobacco).” Under this authority, CCC will make approximately $1.625 billion in assistance available for specialty crops through the ASCF Program, which will be administered by the Farm Service Agency (FSA). These one-time bridge payments will help address elevated input costs incurred by producers and pressure from weak prices, persistent inflation, tight credit markets, and ongoing trade-related uncertainty heading into the 2026 crop year. To be eligible for the ASCF Program, producers must:

• Have planted eligible specialty crops for crop year 2025;

• Have timely filed a crop acreage report for those crops with FSA by April 24, 2026; and

• Comply with other requirements specified in this rule.

Eligible producers are producers of designated specialty crops, which include eligible fruits, tree nuts, and vegetables as described below. These producers play a crucial role in providing real food that supports healthy families and communities, and they are an essential component of the Make America Healthy Again policy agenda. If producers of these specialty crops are not economically able to continue their operations, American families may see a decrease in the domestic production of wholesome and nutritious fruits and vegetables they rely on to feed their families. Fruits and vegetables are essential to real food nutrition, and randomized controlled trials in generally healthy and at-risk adults show that increasing intake of vegetables and whole fruits improves blood pressure, microvascular function, and cardiometabolic risk markers, while increasing circulating antioxidants and decreasing inflammatory markers. 1 Tree nuts provide nutrients including protein, fiber, folate, magnesium, and phytonutrients. 2

The ASCF Program is designed to provide financial support to allow specialty crop producers to pay for production and marketing inputs in the face of significant market disruptions during the 2025 growing season. The increasing cost of production driven by high labor costs and the increasing cost of manufactured inputs over the last 5 years eroded margins during the 2025 crop year.

One of the key challenges in providing risk management for specialty crops is a lack of comprehensive data on cost of production—a challenge that is intrinsic to accurately calculating losses for the ASCF Program. Increases in the cost of production for the industry (for example, costs for labor, fertilizer, and fuel) suggest similar pressures on profitability; therefore, national average revenue per crop was used as a metric for development of ASCF Program payment groups and payment rates.

Eligible specialty crops are listed in Table 1. CCC has established three payment groups based on the average annual revenue per acre for specialty crops explicitly listed under the USDA Specialty Crop Definition, Appendix A (plants commonly considered fruits and tree nuts) and Appendix B (plants commonly considered vegetables)  3 and crops that are conventionally recognized as a subcategory of crops listed under, Appendices A and B, excluding beans and peas described below. The first payment group, Tier 1, has a payment rate of $650 per acre and includes eligible specialty crops with an average annual revenue in excess of $10,000 per acre. The second payment group, Tier 2, has a payment rate of $225 per acre and includes eligible specialty crops with an average annual revenue in excess of $2,300 per acre and up to $10,000 per acre. The third payment group, Tier 3, has a payment rate of $65 per acre and includes eligible specialty crops with an average annual revenue of up to $2,300 per acre.

Revenue per acre was calculated by multiplying a specialty crop's national average yield by its average price per unit. The national average yield was established for crops using the 2024 national average yield from the National Agricultural Statistics Service (NASS) as a primary source and university Extension budgets as a secondary source. The price per unit was established primarily with NASS or Agricultural Marketing Service (AMS) data for each crop. If price data for a crop was not available through NASS or AMS, AMS economists estimated the national average price per unit using a variety of publicly available data sources including recent university Extension budgets and industry reporting.

A fourth payment group with a payment rate of $25 per acre was established for all types of beans and peas (see Table 1). Though AMS identifies certain beans and peas as specialty crops and they may not qualify for the Agricultural Risk Coverage (ARC) and Price Loss Coverage (PLC) programs, their costs of production and revenue are closer to bean and pea varieties that do fall under these farm safety net programs and the Farmer Bridge Assistance (FBA) Program. 4 Therefore, CCC has established the fourth payment group, Beans and Peas, to maintain equity among the different bean and pea types. Bean and pea types that were eligible for the FBA Program are not eligible for the ASCF Program.

Eligible specialty crops include only the crops listed in Table 1 below, with the associated payment rate per acre for each payment group. Eligible beans, caneberries, melons, peas, and sweet corn include only the types identified in the definitions for those crops in § 1414.103. Eligible beets do not include sugar beets, which are excluded from the USDA definition of specialty crops. Grapes are categorized as fresh or processed based on the intended use reported on FSA-578.

As provided in § 1414.105(b), CCC may announce additional eligible specialty crops after publication of this rule if CCC determines that producers suffered decreased returns resulting from the market challenges described in section I. Any additional eligible crops will be announced on the ASCF Program web page at https://www.fsa.usda.gov/ascf.

Acres of eligible specialty crops reported to FSA as an initial, double-crop, repeat crop, or subsequent crop by April 24, 2026, will be used to determine ASCF Program payments. Acreage that is reported as a cover crop, prevented planted, or with an intended use of grazing, left standing, green manure, silage, forage, volunteer, or experimental will not be used to determine ASCF program payments.

For fruit and nuts acres, both bearing and non-bearing acreage are eligible for payment. Elevated input costs disproportionately affect non-bearing acres of fruit and nut trees and bushes, as specialty crop producers must continue to incur substantial expenses for irrigation, nutrient management, pest and disease control, labor, pruning, and a higher rate of maintenance especially during periods when the non-bearing acres generate no marketable yield or revenue. Therefore, while non-bearing acreage has been ineligible for other programs, such as the Market Facilitation Program, and may not be eligible for future programs based on crop production, the high input costs faced by fruit and nut producers on non-bearing acreage warrants non-bearing acreage to be eligible in this one-time program.

Acres of eligible specialty crops that are grown in a controlled environment will not be used to determine ASCF payments with the exception of mushrooms. 5 For ASCF Program purposes, “controlled environment” is defined in § 1414.103 as the use of structures that allow for the manipulation of various environmental factors instead of relying on nature for any period of time during the growing season. This manipulation can be either partially or fully controlled to optimize plant growth, improve consistency, grow without soil, extend the growing period, or to reduce risks from weather, pests, and disease. Examples of such factors are control over temperature, humidity, light levels, nutrient levels, and atmospheric composition such as carbon dioxide concentration. The term “controlled environment” also excludes the use of structures to produce seedlings prior to being planted for production purposes.

Acres of crops grown in a controlled environment are excluded from the ASCF Program because producing crops in a controlled environment can extend the growing season compared to field-grown crops, which mitigates market risk for the producer. A controlled environment allows specialty crop growers to optimize high-quality, marketable production, allowing growers to sustain existing markets while exploring alternative markets. Examples of controlled environments include, but are not limited to, greenhouses; high and low tunnels; hoop houses; indoor vertical farms; growth chambers; and hydroponic, aquaponic, and aeroponic systems. Practices that allow some control over factors such as temperature but do not use structures, such as the use of plastic film to increase soil temperature for germination or weed control, are not considered controlled environments.

Producers must enter the acres of any eligible specialty crops that were grown under conditions that meet the definition of controlled environment on their ASCF Program application so that those acres can be excluded from the producer's eligible acres when calculating a payment.

FSA will prepare a CCC-556, Assistance for Specialty Crop Farmers (ASCF) Program Application, for each eligible producer using the acreage timely reported for each eligible specialty crop in all states and counties. FSA will use the persons identified as producers on FSA-578, Report of Acreage, and the respective percentages of interest in the eligible specialty crop. Potential program participants will obtain their pre-filled CCC-556 from FSA through the electronic portal, which can be accessed through the ASCF Program web page at https://www.fsa.usda.gov/ascf, or by contacting any local FSA county office. The application period begins on June 1, 2026, for producers applying through the electronic portal, and June 8, 2026, for all other producers. Persons who believe that their interest in an eligible specialty crop is not accurately reflected in current FSA records must contact FSA to provide any information that the person believes is relevant to correcting this information. Form CCC-556 must be returned to FSA by August 7, 2026.

Producers must also submit the following eligibility forms to FSA by August 9, 2027, if not already on file with FSA for the 2025 program year:

• CCC-901, Member Information for Legal Entities, if applicable;

• CCC-902, Farm Operating Plan;

• CCC-941, Average Adjusted Gross Income (AGI) Certification and Consent to Disclosure of Tax Information, for individuals, legal entities, and members of legal entities, excluding joint ventures and general partnerships; and

• AD-1026 Highly Erodible Land Conservation (HELC) and Wetland Conservation (WC) Certification, for the producer and affiliated persons, as specified in 7 CFR 12.8.

Producers who file the required eligibility forms after the deadline will not receive an ASCF Program payment.

Participants are not required to purchase crop insurance or Noninsured Crop Disaster Assistance Program (NAP) coverage to be eligible for the ASCF Program; however, USDA strongly urges producers to take advantage of the new One Big Beautiful Bill Act risk management tools to best protect against price risk and volatility in the future.

A producer's ASCF Program payment will be equal to the payment rate for an eligible specialty crop multiplied by the producer's eligible acres of that crop. CCC will issue payments as applications are approved. CCC intends to issue ASCF Program payments to eligible producers beginning in June 2026.

The total amount of ASCF Program payments received, directly or indirectly, by a person or legal entity (except a joint venture or general partnership) may not exceed $250,000. The total amount of ASCF payments received, directly or indirectly, by a public school may not exceed $250,000 per public school. Total payments to all public schools within a State where the State population exceeds 1,500,000, according to the most recent U.S. Census Bureau estimate, cannot exceed $500,000. In addition, a person or legal entity, other than a joint venture or general partnership, is ineligible for ASCF Program payments, directly or indirectly, if the person's or legal entity's average adjusted gross income (AGI), using the average of the adjusted gross incomes for the 2021, 2022, and 2023 tax years, exceeds $900,000.

FSA will administer the payment limitation, payment eligibility, and average AGI limitation according to the regulations set forth at 7 CFR part 1400 as in effect for program year 2025 on June 1, 2026, except that the actively engaged provisions (Subparts C and G) and foreign person eligibility provisions (Subpart E), do not apply to the ASCF Program.

The Administrative Procedure Act (APA, 5 U.S.C. 553(a)(2)) provides that the notice and comment requirements and 30-day delay in the effective date provisions of that Act do not apply when the rule involves specified actions, including matters relating to loans, grants, benefits, and contracts. This rule falls within this exemption.

This rule is exempt from the regulatory analysis requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), because it involves matters relating to benefits. The requirements for the regulatory flexibility analysis in 5 U.S.C. 603 and 604 are specifically tied to the requirement for a proposed rule by section 553 or any other law; in addition, the definition of “rule” in 5 U.S.C. 601 is tied to the publication of a proposed rule.

The Office of Management and Budget (OMB) found this rule meets the criteria in 5 U.S.C. 804(2) of the Congressional Review Act (CRA), which would ordinarily necessitate delaying its effective date for 60 days (5 U.S.C. 801(a)(3)(A)). However, the CRA, at 5 U.S.C. 808(2), allows an agency to make such regulations effective immediately if the agency finds there is good cause to do so. CCC has determined that such good cause exists here as benefits made by this rule are critical to the financial stability of producers who participate in this program and this assistance is necessary to help those producers sustain their normal business operations. CCC further believes that good cause exists because notice and comment is not legally required, and thus unnecessary, for this action as described above. Therefore, CCC is not required to delay the effective date for 60 days from the date of publication to allow for Congressional review. Accordingly, this rule is effective upon publication in the Federal Register .

Executive Order 12866, “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 14192, “Unleashing Prosperity Through Deregulation,” announced the Administration policy to significantly reduce the private expenditures required to comply with Federal regulations to secure America's economic prosperity and national security and the highest possible quality of life for each citizen and to alleviate unnecessary regulatory burdens placed on the American people. In line with the Executive Order requirements, CCC will use existing information available to CCC to maximize benefits and minimize burden on American producers. This rule is not an Executive Order 14192 regulatory action because it does not impose any more than de minimis regulatory costs.

The Office of Management and Budget (OMB) designated this rule as economically significant under Executive Order 12866, section 3(f)(1), and therefore, OMB has reviewed this rule. The costs and benefits of this rule are summarized below. The Cost Benefit Analysis is available on regulations.gov.

CCC will make $1.625 billion available in one-time bridge payments to U.S. farmers through the ASCF Program in response to temporary market disruptions and increased production costs. The ASCF Program provides broad relief to U.S. farmers who produce specialty crops that are recognized directly by AMS Specialty Crop definition, Appendices A and B, as fruits, tree nuts, or vegetables or types of fruits, tree nuts, or vegetables. Crops included in Appendices A or B that are eligible for the FBA Program are not eligible for the ASCF Program. The final cost will depend on the number of applications that are submitted and approved.

The environmental impacts have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347) and the USDA regulation for compliance with NEPA (7 CFR part 1b).

There are no actions under this rule that have the potential to impact the human environment. Accordingly, the actions under this rule are covered by the FSA Categorical Exclusions specified in 7 CFR 1b.4(c)(16)(viii) that apply to individual farm participation in FSA programs where no ground disturbance or change in land use occurs as a result of the proposed action or participation, and 7 CFR 1b.(c)(16)(ix) that applies to safety net programs.

No Extraordinary Circumstances (§  1b.3(f)) exist because this is an administrative payment program. The ASCF Program does not constitute a major Federal action that would significantly affect the quality of the human environment, individually or cumulatively. Therefore, CCC will not prepare an environmental assessment or environmental impact statement for this action and, consistent with §  1b.3(g), this document serves as the programmatic finding of applicability and no extraordinary circumstance (FANEC) for this Federal action.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 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.

CCC has assessed the impact of this rule on Indian Tribes and determined that this rule does not, to our knowledge, have Tribal implications that require Tribal consultation at this time. If a Tribe requests consultation in the future, FSA will work with the Office of Tribal Relations to ensure meaningful consultation is provided.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments or the private sector. Agencies generally must prepare a written statement, including cost benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates, as defined in Title II of UMRA, for State, local and Tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR part 1320), requires that OMB approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. The USDA intends to use the OMB approved information collection under the control number of 0503-0028; Expiration Date: 10/31/2027 for the purposes of this regulation.

FSA 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 as specified in the Agricultural Act of 2014 (Pub. L. 113-79, Title II, Subtitle G, Funding and Administration). The CCC-556 is the only new data collection activity associated with this request. The total annual burden hours for this information collection are 30,320 hours. See table below for the breakout. This final rule is a one-time announcement of Federal financial assistance funding for the ASCF Program.

For Further Information Contact: Requests for additional information or copies of this information collection should be directed to Michael Walter; telephone: (816) 491-6934 ; or email: Michael.Walter1@usda.gov.

Title: Assistance for Specialty Crop Farmers (ASCF) Program.

Form Numbers: CCC-556, CCC-901, CCC-902E, CCC-902I, CCC-941, and AD-1026.

OMB Number: 0503-0028.

Expiration Date: 10/31/2027.

Type of Request: Information Collection.

Abstract: As authorized by Section 5(b) of the CCC Charter Act (15 U.S.C. 714c(b)), CCC is administering the ASCF Program to provide up to $1.625 billion in one-time payments to producers of eligible specialty crops in response to elevated input costs and market losses resulting from foreign competitors engaging in unfair trade practices that impede exports.

To apply for the ASCF Program, producers must execute a CCC-556, which will be pre-filled with the producer's reported planted acreage for the 2025 crop year. Producers will use one application for all eligible specialty crop acreage nationwide. Producers must also submit the following eligibility forms if not already on file with FSA due to participation in other programs: CCC-901, Member Information for Legal Entities, if applicable; CCC-902, Farm Operating Plan, for an individual or legal entity as provided in 7 CFR part 1400; CCC-941, Average Adjusted Gross Income (AGI) Certification and Consent to Disclosure of Tax Information, for individuals, legal entities, and members of legal entities, excluding joint ventures and general partnerships; and AD-1026, Highly Erodible Land Conservation (HELC) and Wetland Conservation (WC) Certification, for the participant and applicable affiliates.

Affected Public: Farms or businesses for profit (Agricultural producers).

Estimated Number of Respondents: 60,000.

Estimated Number of Responses per Respondent: 1.79333333.

Estimated Number of Total Annual Responses: 107,600.

Estimated Time per Respondent: 0.28178439 hours.

Estimated Total Annual Burden on Respondents: 30,320 burden hours.

There are an estimated 60,000 respondents anticipated for this data collection. The total estimated “Number of Respondents” is not a sum of respondents for all burden activities and forms. It represents the same respondents submitting responses related to different activities for this data collection; therefore, these respondents are not double counted.

CCC is committed to complying with the E-Government Act of 2002, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The title and number of the Federal assistance program, as found in the Assistance Listing, to which this document applies are 10.991—Assistance for Specialty Crop Farmers (ASCF).

For the reasons discussed above, Commodity Credit Corporation amends 7 CFR chapter XIV as follows:

On January 16, 2025, AMS published the final rule, “Poultry Grower Payment Systems and Capital Improvement Systems” (Payment Systems rule or final rule) (90 FR 5146, January 16, 2025), to amend 9 CFR part 201 of its regulations under the Packers and Stockyards Act (P&S Act) (7 U.S.C. 181 et seq. ). The final rule was promulgated in support of Executive Order 14036 (86 FR 36987, July 14, 2021), which Executive Order 14337 revoked on August 13, 2025 (90 FR 40227, August 19, 2025).

The Payment Systems rule addresses the relationship between live poultry dealers (LPDs) and the poultry growers under contract with them. The rule: (1) prohibits LPDs from reducing a grower's compensation based on the grower's ranking under a poultry grower ranking system (9 CFR 201.106); (2) establishes a presumptive violation of the P&S Act by LPDs when aggregate gross annual payments based upon a grower's ranking under a poultry grower ranking system exceeds a certain threshold (§ 201.106); (3) holds LPDs to a duty of fair comparison when designing and operating their poultry grower ranking system and requires documentation of compliance with that duty (§ 201.110); and (4) requires LPDs to provide certain disclosures when requesting or requiring that broiler growers make additional capital investments (§ 201.112).

At the time of publication, AMS estimated that the Payment Systems rule would result in significant costs to both LPDs and poultry growers with no quantifiable benefits. 1 AMS acknowledged it could not rule out the possibility of increased compliance costs, fewer growers participating in the market, and/or reduced production efficiencies, all of which could lead to higher consumer prices. 2

In the explanatory statement accompanying the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37), 3 Congress encouraged the Department to delay implementation of the final rule. 4

On March 18, 2026, AMS published a proposed rule, “Poultry Grower Payment Systems and Capital Improvement Systems; Delay of Effective Date” (the Proposed Delay), proposing to delay the effective date of the Payment Systems rule to December 31, 2027, to allow time for further consideration of actions that may be taken regarding the disposition of the rule (91 FR 12936).

AMS received more than 2,800 comments in response. Commenters included growers, advocacy groups, industry, members of Congress, and the general public. After consideration of the comments submitted, AMS is finalizing the Proposed Delay without change. AMS is doing so in alignment with Congressional direction, and due to the significant estimated costs and the policy and legal issues commenters have identified with the Payment Systems rule. AMS believes delaying the effective date of the rule to December 31, 2027, will allow for thorough consideration of these matters as it deliberates actions that may be taken regarding the disposition of the rule. AMS provides its analysis and response to the comments received in section B of this document.

AMS received more than 2,800 comments from farmer associations, poultry and meat industry trade associations, integrated live poultry dealers, non-integrated poultry dealers, poultry growers, farm advocacy organizations, and members of the general public. About 2,700 comments opposed the Proposed Delay, about a dozen supported it, and the remainder of the comments were outside the scope of the Proposed Delay. There were approximately 225 unique comments, meaning a comment that was not replicated by any other comments, and approximately 2,600 form letter comments. Supporters of the Proposed Delay included one large poultry integrator, two meat and poultry trade associations, and several individuals affiliated with non-integrated poultry companies that do not have control over all their inputs. Various poultry growers and grower organizations opposed this proposal.

Commenters supporting the delay suggested the delay is necessary to provide clarity to the industry, including contract growers, and to avoid the costs AMS identified in the Payment Systems rule. These commenters also advised that the delay was appropriate to further evaluate the Payment Systems rule's consistency with the P&S Act and its potential to cause significant harm to growers, processors, and American consumers. Further, supportive commenters noted the delay is consistent with Congressional intent citing the explanatory statement in the USDA appropriations bill. Finally, a few commenters recommended the rule undergo further analysis to better assess the impacts for LPDs operating without the benefit of vertical integration.

AMS Response: AMS appreciates the comments in support of the delay and agrees with the commenters. AMS believes delaying the rule is appropriate to avoid near-term implementation costs as the agency further evaluates the rule's financial and operational impacts, particularly in relation to consumer prices. AMS also acknowledges the final rule was primarily designed to address concerns related to integrated production. AMS will consider the impacts for LPDs operating without the benefit of vertical integration in addition to other identified legal and policy concerns as it deliberates actions that may be taken regarding the disposition of the rule.

The largest group of comments stated enough time has passed for consideration of the Payment Systems rule and that it should be implemented as planned. Commenters asserted AMS fully considered the costs and benefits of the final rule when it was published and did not provide any new evidence to justify its Proposed Delay. Other commenters noted both growers and LPDs have been preparing for the rule to take effect and further regulatory uncertainty would cause economic harm. More poultry farmers would be harmed by unfair practices under the currently prevailing poultry tournament compensation schemes and go out of business during the 18-month delay due to inadequate or unpredictable compensation than would be the case if the rule becomes effective as originally scheduled. One comment said the justification for delaying the effective date was unclear because a delay is unlikely to improve USDA's understanding of the rule's economic impact. Poultry contracts vary across regions, and to accurately understand the rule's impact on growers would require that USDA contact growers directly. Doing so is next to impossible given growers' concerns about retaliation from LPDs.

AMS Response: AMS appreciates the comments in support of the implementation of the Payment Systems rule and understands the concerns regarding delayed implementation. However, AMS is making no changes in response to these comments. It is AMS' view that the delay of effective date aligns with Congressional direction and is warranted due to the significant estimated costs and the policy and legal issues commenters have identified with the Payment Systems rule. AMS believes delaying the effective date of the rule to December 31, 2027, will allow further consideration of these matters as it deliberates actions that may be taken regarding the disposition of the rule. In the meantime, AMS will continue to utilize its robust enforcement authority to investigate any allegations of unfair practices.

Approximately 2,700 comments argued that there is no need to delay the Payment Systems rule's effective date to allow time for further analysis of the costs of the rule. Of these, about 2,600 were form letter comments. These commenters cited the consent decree in United States v. Cargill Meat Solutions Corp., 5 which required limits on performance pay and the elimination of base pay reductions in its contracts with poultry growers, as evidence that the Payment Systems rule would enforce transparency and fairness under the P&S Act.

One comment asserted that one of AMS' primary justifications for delaying the rule—uncertainty around the rule's provisions on grower incentives—did not accurately reflect the research on this topic. The commenter cited economic literature  6 and indicated that AMS inaccurately characterized the lack of economic research addressing how grower incentives could change in the absence of performance discounts.

AMS Response: AMS appreciates the comments against the need for further analysis. However, AMS disagrees. While the cited consent decree contains provisions similar to § 201.106 of the Payment Systems rule, it does not include provisions analogous to §§ 201.110 or 201.112. Additionally, AMS believes it is important to review these complex requirements on an industry-wide basis rather than within the confines of the operation of one LPD.

AMS disagrees with the commenter's assertion that AMS inaccurately assessed public research. The research the commenter cited is relevant to poultry tournaments and broiler contracts but the research does not specifically address how growers' incentives might change if performance discounts were not part of the tournament and if variability in performance payments were limited—both of which are changes to tournament systems under the Payment Systems rule. Further, these comments are outside the scope of the delay of the effective date of the Payment Systems Rule and speak to the substance of the rule. While the current rulemaking is limited to the delay of Payment Systems rule, AMS appreciates the comments regarding the merits of the underlying rule and believes the diversity of views underscore the need for additional consideration. The agency will consider these comments as it deliberates actions that may be taken regarding the disposition of the rule.

Comment: Commenters also argued that the Proposed Delay's benefit-cost analysis is flawed, criticizing how AMS used an assessment of the Payment Systems rule's costs and benefits to justify delaying the effective date. These commenters stated the costs are overestimated and that any claimed savings accruing to LPDs in the first year of the delay would come at the expense of the many unquantified benefits growers would gain from the final rule becoming effective as scheduled. Commenters provided examples of what they deemed were unquantified benefits, including increased certainty of minimum compensation outcomes, improved financial planning and ability to manage financial risk, reduced potential for deception and unfairness, and reduced information asymmetry that would contribute to more efficient investment and resource allocation decisions. With poultry industry sales in excess of $45 billion annually, commenters asserted the costs outlined by AMS are insignificant. When one compares the direct, quantified costs against the significant, unquantified benefits the rule would provide to poultry growers, it appears AMS is ignoring growers' concerns in favor of poultry integrators' interests.

Another commenter argued the Proposed Delay assigns significantly more quantified benefits to LPDs and ignores the qualitative benefits the Payment Systems final rule would provide to growers.

AMS Response: The benefit-cost analysis in the Proposed Delay is based on the benefit-cost analysis in the Payment Systems rule. AMS applied all of the same methods, but for quantified estimates, AMS made use of updated data. Updated wage data from the Department of Labor accounts for most of the differences. As explained further in the benefit-cost analysis of this final rule, AMS also removed certain one-time set-up costs. AMS acknowledges that quantified costs associated with delaying implementation of the Payment Systems rule are significantly less than overall industry revenues, but believes that is only one of a multitude of factors for consideration as is it deliberates actions that may be taken regarding the disposition of the rule. AMS disagrees that it has ignored grower concerns in favor of the interests of LPDs. As evident in the benefit-cost analysis in this final rule, AMS has accounted for the costs and benefits to both segments of the industry. As mentioned previously, AMS is committed to using its robust enforcement authority to investigate any grower allegations of unfair practices during the delay period.

Comment: A few commenters objected to the fact that the Proposed Delay's benefit-cost analysis assigned a cost to each contract poultry grower for review of new contracts and disclosures, even though growers would directly benefit from this activity. Several commenters stated that the time growers would spend reading these documents should not be considered a cost; however, if this time is going to be considered a cost, assuming every grower will do so is an exaggeration of this cost component because the rule does not require growers to read the documents.

AMS Response: AMS estimates some growers will spend more than the average amount of time reading contracts and disclosures. AMS also acknowledges some will spend less time, and some may not read them at all. For the benefit-cost analysis, AMS used its best estimate of the average time expected to be spent for this purpose.

The time growers spend reading the new contracts and disclosures is a cost because it is time they must invest to understand the new requirements even if they ultimately benefit from reading the documents. Time has an opportunity cost, and any hour spent reviewing materials is an hour that cannot be used for farm operations, other productive activities, or off-farm work. And while growers are not required to read every document, AMS expects that many will review the materials because they are directly affected by the rule and need to understand the changes.

Comment: A commenter asserted that AMS did not properly consider the substantial benefits of the Payment Systems rule and the significant harm a delay would cause to both growers and LPDs, undermining benefit-cost concerns; instead, AMS focused only on the implementation and compliance costs.

One commenter argued that AMS overstated the burden on LPDs by assuming each LPD would need to provide an average of 477 prior contracts and disclosure documents in years two through four. They noted these materials would only be required if a complex's average grower payment declined from the previous year, and because grower payments would not decrease at many complexes, these submissions would not always be necessary. The commenter also mentioned that in the Payment Systems rule, AMS explained that the recordkeeping and documentation requirements in the proposed rule were simplified for the final rule. However, in the final rule the agency did not reduce the cost estimate for these requirements because the precise amount of time savings would be difficult to estimate and AMS wanted to avoid underestimating costs (90 FR 5215).

AMS Response: In the regulatory analysis for the Payment Systems rule, AMS explained how it arrived at this estimate. AMS also noted that it does not have sufficient data to predict which complexes would experience a decline in average grower payments from the previous year. Because of that uncertainty, the estimate represents an upper bound scenario. As the analysis in the Payment Systems rule explains, this likely overstates the burden, since many complexes may not experience a year-to-year decline and therefore would not need to submit these materials. AMS used this conservative estimate in this final rule and the analysis in the Payment Systems rule to make sure the analysis captured the full potential burden during the transition period. For this final rule, AMS estimates that the public burden for this information collection would total approximately $1,572,000 in years two through four representing the maximum amount that AMS could have overestimated costs to growers.

Several comments disagreed with AMS' assertation that the Proposed Delay aligns with Congressional direction. They argued that because this provision was part of the explanatory statement included in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37), it does not have the force of law.

AMS Response: Several members of Congress submitted a letter to the Secretary supporting the delay in implementation of the Payment Systems final rule on behalf of their constituents, noting the delay is consistent with the Congressional direction in the explanatory statement. Conversely, AMS also acknowledges that one member of the Senate submitted a comment opposing the delay. Nevertheless, it is typical AMS practice to consider and, to the extent practicable, abide by Congressional directives provided in explanatory statements and committee reports accompanying authorizing and appropriating statutes. This rulemaking aligns with that practice.

One comment claimed AMS violated the Administrative Procedure Act by: (1) failing to provide new evidence supporting the delay; and (2) substantively revising the final rule to extend the compliance date; this can only be done with a more detailed justification. A commenter also asserted AMS failed to provide a meaningful opportunity to comment on the Proposed Delay by limiting the scope of comments to costs and benefits.

AMS Response: AMS disagrees. AMS included its justification in the Proposed Delay, explaining that the agency would require additional time to consider the policy and legal implications of the Payment Systems rule, especially in light of the rule's significant cost and the latest Congressional direction. 91 FR 12936.

Additionally, the agency did not limit the scope of comments to just those related to costs and benefits. While the agency specifically invited comments and data concerning the benefits and costs of delaying the effective date of the Payment Systems rule (91 FR 12937), the agency also generally solicited public comments on its overall proposal and supporting justifications to delay the effective date of the final rule to December 31, 2027 (91 FR 12936). The agency received substantive comments and considered them in this determination to delay this rule's implementation.

AMS received approximately 125 comments in support of the Payment System rule and against the Proposed Delay of effective date that addressed issues beyond the delay of effective date and went to the substance of the Payment Systems rule. While the current rulemaking is limited to the delay of Payment Systems rule, AMS appreciates the comments regarding the merits of the underlying rule and believes the diversity of views underscore the need for additional consideration. The agency will consider these comments as it deliberates actions that may be taken regarding the disposition of the rule.

After consideration of all comments received, AMS has decided to delay the effective date of the final rule until December 31, 2027.

This rule has been determined to be “significant” under E.O. 12866, as supplemented by Executive Orders 13563 and 14192, and, therefore, has been accordingly reviewed by the Office of Management and Budget (OMB). As a required part of the regulatory process, AMS prepared an economic analysis of the costs and benefits of delaying the effective date of §§ 201.106, 110, 112, and 290 to December 31, 2027.

AMS will delay the effective date of the Payment Systems rule. The Payment Systems rule created four specific provisions including: § 201.106 regarding LPD responsibilities for the design of broiler grower compensation arrangements; § 201.110 regarding the fair operation of broiler grower ranking systems; § 201.112 regarding disclosure requirements for LPDs when requesting additional capital investments from broiler growers; and § 201.290 regarding severability.

AMS will delay the effective day of the Payment Systems rule to allow for thorough consideration of estimated costs and the policy and legal issues associated with the final rule.

When AMS finalized the Payment Systems rule, AMS explained there was uncertainty as to whether the benefits would outweigh the costs. 7 One factor that was difficult to determine was whether the provision that prevents LPDs from applying performance discounts (§ 201.106(a)) and the provision capping variation in performance premiums (§ 201.106(b)) would impact grower incentives. Research indicates growers tend to raise broilers more efficiently with tournament contracts than with other forms of contracts or when LPDs raise broilers in their own facilities. 8 While there is existing literature on broiler tournaments and grower incentives, there is very little literature specifically addressing how growers' incentives might change if performance discounts were not part of the tournament and variability in performance payments were limited as the Payments Systems rule requires. LPDs annually spend tens of billions feeding broilers. If changes to tournament contracts due to the Payment Systems rule's amendments result in even very small decreases in feed efficiency, costs from implementation of the amendments could be considerably larger than the value of the benefits to growers due to reduced variability in compensation. Delaying the effective date will allow AMS to consider policy options with less risk of negative effects on public welfare.

AMS prepared an economic analysis of the costs and benefits of delaying the effective date of §§ 201.106, 110, 112, and 290. AMS estimated cost and benefits associated with the Payment Systems rule when it was made final in 2025. AMS provided quantitative estimates of direct administrative costs associated with the Payment Systems rule and qualitative descriptions of indirect costs and benefits. This analysis follows the same analytical approach used in the final rule.

The updated estimates incorporate the latest industry parameters and wage rates while maintaining consistency with the methodology used. Hourly wage rates were established using the following Bureau of Labor Statistics (BLS) classifications for each labor category as follows (NAICS Code-OCC code-OCC Title): Management (3116- 11-1020—General and Operations Managers) for live poultry dealers' managers, and Legal (3110-23-1011-Lawyers) for attorneys. 9 The average hourly wage rates used to estimate cost savings were updated from the final rule to include a 42.34 percent markup for benefits and are as follows: Management—$102.56, Legal—$145.93, Administrative—$48.38, and Information Technology—$101.72. For reference, the analysis in the final rule is described in detail in the Federal Register at 90 FR 5146 (see pages 5189-5206). 10

AMS expects that LPDs will incur $4.9 million in ongoing administrative costs for each of the first four years after the Payment Systems rule becomes effective and $4.1 million annually thereafter. Poultry growers will have approximately $249,000 in ongoing quantified administrative costs each year. Total ongoing administrative costs will be $5.2 million for each of the first four years and $4.3 million each year thereafter.

AMS considered three alternatives to the final rule's delay of §§ 201.106, 110, 112, and 290. The first alternative is the “do nothing” approach or maintaining the status quo. All regulations under the Packers and Stockyards Act will remain unchanged; that is, the Payment Systems final rule will become effective on July 1, 2026. This first alternative forms the baseline against which AMS compares the other alternatives.

The second alternative is this final rule. AMS will delay the effective date of the Payment Systems rule for 18 months. The Payment Systems rule will become effective on December 31, 2027, rather than July 1, 2026.

AMS considered a third alternative, the 12-Month Delay alternative, which is similar to the preferred alternative, but will delay the effective date of §§ 201.106, 110, 112, and 290 by 12 months (July 1, 2027) instead of 18 months (December 31, 2027).

With the final rule's 18-month delay of the Poultry Systems rule, much of the first-year costs in the final rule that AMS considered are one-time setup and preparation activities that processors and growers incurred before the rule became effective. AMS believes many of these costs have likely already occurred, and therefore they are not affected by the delay. The delay will affect recurring costs. The delay will save live poultry growers and LPDs administrative costs associated with the ongoing administrative costs that will otherwise occur in the first 18 months after the Payment Systems final rule becomes effective.

Delaying the effective date for 18 months will shift all costs for both LPDs and growers back by 18 months. This final rule will enable LPDs to save $4.9 million and poultry growers to save $249,000 in administrative costs for a total of $5.2 million in the first year. They will save an additional $2.5 million and $125,000, respectively, in the second year for a total of $7.7 million. Administrative costs for LPDs were expected to decrease by $800,000 in the fifth year after the Payment Systems final rule became effective. With the effective date delayed by 18 months, the decrease in costs will be delayed as well. Costs will be $800,000 higher in the fifth year and $400,000 in the sixth year for LPDs. This will result in ten-year total cost savings of $6.1 million for LPDs and $374,000 for poultry growers; a combined savings of $6.5 million. Table 1 below summarizes cost savings to poultry growers and LPDs of delaying the effective date of the Payment Systems rule until December 31, 2027.

The indirect benefits (cost savings) of this final rule represent the indirect benefits incurred during the 18-month period of the delay of the effective date. AMS expects that provisions of §§ 201.106, 110, and 112 may require LPDs to change their existing business practices, which has the potential to affect the indirect costs of the Payment Systems rule. As discussed in the Payment Systems rule, AMS does not have sufficient data to make an inference on the number of complexes that will need to change business practices or the magnitude of any changes that will be required. 11

If LPDs modify existing grower compensation structures in response to § 201.106, changes in performance-based payments could adversely affect grower performance incentives and cause growers to produce broilers less efficiently. As a result, LPDs could face increased production costs. Even a very small change in efficiency could result in relatively large increases in the cost of producing broilers. Those costs could be passed on to consumers.

If AMS enforcement of § 201.112 has the effect of preventing broiler growers from making additional capital investments, then such decisions to forgo investment will likely result in fewer benefits for LPDs, and more for growers. AMS is not able to quantify these lost benefits (costs) to LPDs.

As the preferred alternative delays the effective date of the Payment Systems rule for 18 months, LPDs and growers may experience indirect benefits proportional to this delay, though AMS expects these indirect benefits to be small relative to the benefits associated with the Payments Systems rule.

There are unquantifiable benefits to the provisions regulating LPDs in §§ 201.106, 110, and 112, which will be foregone in the 18-month period in which the Payment Systems rule will be delayed under the preferred alternative. Section 201.106 could benefit growers from increased clarity and certainty about the lowest possible revenue and reduce variability in outcomes under a growing arrangement. Section 201.110 may benefit broiler growers through improved fairness in comparison. Section 201.112 may provide broiler growers with better information to make financial decisions. The size of these unquantifiable benefits will be directly related to the extent of these reductions. However, AMS does not have sufficient data to make an inference on the number of complexes that will change business practices or the magnitude of any changes that will be required.

AMS expects broiler growers will benefit from the Payment Systems rule, though AMS is unable to predict the size of these benefits with certainty. The indirect benefits of the Payment Systems rule will still occur, they will just be delayed by 18 months. Thus, broiler growers will experience unquantifiable costs (foregone benefits) proportional to this delay, though AMS expects these unquantifiable costs to be small.

AMS also evaluated benefits and costs of delaying the effective date for 12 months (12-Month Delay Alternative). The 12-Month Delay Alternative is similar to the final alternative, but the effective date of the Payment Systems rule will be delayed 12 rather than 18 months. Under the 12-Month Delay Alternative all costs for both LPDs and growers will be shifted back by one year, resulting in a savings to LPDs of $4.9 million and poultry growers of $249,000 in administrative costs for a total of $5.2 million in savings. Because administrative costs for LPDs were expected to decrease in the fifth year after the rule became effective, costs in the fifth year will be $800,000 higher for LPDs if the effective date is delayed 12 months. The ten-year total direct administrative cost savings will be $4.3 million for the 12-Month Delay Alternative. The table below contains estimated administrative cost savings for LPDs and poultry growers for the 12-Month delay Alternative.

As in the case of the preferred alternative, the indirect benefits of the 12-Month Delay Alternative represent the indirect costs not incurred during the 12-month period of the delay of the effective date. The indirect costs of the final rule will still occur, they will just be delayed. Again, AMS cannot rule out the possibility that incentives may be affected by the Payment Systems rule, and AMS is unable to predict specific effects with certainty. LPDs and growers may experience indirect benefits (cost savings) proportional to this 12-month delay, though AMS expects these indirect benefits to be very small. Because the delay is shorter, AMS expects the indirect benefits of 12-Month Delay Alternative to be smaller than the indirect benefits of the preferred alternative.

As with the preferred alternative, a 12-month delay of the effective date of the provisions regulating LPDs in §§ 201.106, 110, and 112 will likely impose additional unquantifiable direct costs on LPDs. The nature of these unquantifiable direct costs is the same as in the preferred alternative, but these costs may be smaller do to the shorter delay of the effective date of the Payment Systems rule under the 12-Month Delay Alternative.

The nature of the costs (benefits foregone) under 12-Month Delay Alternative are the same as under the preferred alternative. As in the case of the preferred alternative, the costs of the 12-Month Alternative Delay represent the benefits not incurred during the period of the 12-month delay of the effective date. The benefits of the final rule will still occur, they will just be delayed. As the 12-Month Delay Alternative represents a shorter delay, AMS expects the costs of 12-Month Delay Alternative to be smaller than the costs of the preferred alternative.

The benefits and costs of delaying the effective date of the Payments Systems rule are very similar, but all costs and benefits are slightly smaller for the 12-Month Delay Alternative.

AMS is delaying the effective date of the Payment Systems rule to allow for thorough consideration of estimated costs and the policy and legal issues associated with the final rule. Because twelve months may not provide adequate time for the thorough consideration needed, AMS chose the preferred alternative of delaying the effective date by 18 months.

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market.

AMS is delaying implementation of the Payment Systems rule, which added §§ 201.106, 110, 112 and 290 to the regulations under the P&S Act. Sections 201.106, 110, and 112 would regulate LPDs that contract with poultry growers to raise broilers. The regulations would have no effect on LPDs that contract or process turkeys, geese, ducks or other fowl unless they also contract or process broilers. Currently, the Payment Systems rule is scheduled to go into effect on July 1, 2026. This rule delays implementation until December 31, 2027.

AMS received more than 2,800 comments from producer associations, poultry and meat industry trade associations, integrated live poultry dealers, non-integrated poultry dealers, poultry growers, farm advocacy organizations, and members of the general public. The significant majority of commenters opposed the Proposed Delay, several supported it, and the remainder were outside the scope of the Proposed Delay. There were about 225 unique comments, meaning a comment that was not replicated by any other comments, and more than 2,600 form letter comments. AMS did not receive any comments concerning the initial regulatory flexibility analysis.

Commenters opposed to delaying the effective date of the Payment Systems rule indicated that a delay is unnecessary and harmful to growers. Others criticized the benefit analysis of the proposed delay suggesting that AMS did not consider costs to broiler growers. Commenter also compared the Payment Systems rule to the Justice Department's settlement agreement in United States v. Cargill Meat Solutions Corp. Some commenters did not agree that delaying the Payment Systems rule was consistent with direction from Congress.

AMS considers the delay to be necessary to consider the cost and benefits imposed on the industry and assess the legal risk created under that rule. With the Payment Systems rule, broiler growers are expected to enjoy most of the benefits, while LPDs bear most of the costs. Consequently, delaying implementation will benefit LPDs while costing broiler growers. This is not something AMS ignored or discounted, and the benefit cost analysis explains how LPDs will benefit from a delay and broiler growers will not. While there are similarities between the United States v. Cargill Meat Solutions Corp consent decree and Payment Systems rule, there are also important differences and it is not directly comparable to the Payment Systems rule.

Comments supporting the delay suggested that Payment Systems rule was based on anecdotal evidence rather than confirmed facts. Commenters suggested that LPDs have no reason to provide broiler growers with substandard inputs. Comments were also critical of the benefit cost analysis suggesting that AMS underestimated costs such as contract renegotiations, information technology changes and increased litigation risk, which could ultimately lead to higher consumer prices. Another commenter indicated that the Payment Systems rule did not adequately consider small LPDs that are not vertically integrated.

The final rule: (1) prohibits live poultry dealers (LPDs) from reducing a grower's compensation based on the grower's ranking under a poultry grower ranking system; (2) establishes a presumptive violation of the P&S Act by LPDs when aggregate gross annual payments based upon a grower's ranking under a poultry grower ranking system exceeds a certain threshold; (3) holds LPDs to a duty of fair comparison when designing and operating their poultry grower ranking system and requires documentation of compliance with that duty; and (4) requires LPDs to provide certain disclosures when requesting or requiring that broiler growers make additional capital investments.

When AMS finalized the Payment Systems rule, AMS explained there was uncertainty as to whether the benefits would outweigh the costs. 12 There is no literature addressing how growers' incentives might change if performance discounts were not part of the tournament or if variability in performance payments were limited.

AMS is delaying the effective day of the Payment Systems rule to allow for thorough consideration of estimated costs and the policy and legal issues associated with the final rule.

The only firms that the Payment Systems rule directly regulates are LPDs. The SBA defines small businesses by their North American Industry Classification System Codes (NAICS). LPDs, NAICS 311615, are considered small businesses if they have fewer than 1,250 employees. 13

AMS maintains data on LPDs from the annual reports  14 these firms file with AMS. AMS records of annual reports identified 45 LPDs that processed broilers subject to the regulations during fiscal year 2023. Twenty-four of the LPDs were small businesses according to the SBA standard.

Delaying implementation of the Payment Systems rule will not cause significant costs for any LPD. LPDs will still be required to comply with §§ 201.106, 110, and 112 of the regulations, but will have until December 31, 2027, to do so. The regulations place restrictions on the way LPDs' contract with growers. Delaying implementation will give LPDs more time to make changes to their business practices to comply with the new regulations. No LPD, whether small or large, will be required to change any practices as result of this regulatory action. Rather, LPDs are expected to benefit from the delay of the effective date for §§ 201.106, 110, 112, and 290 due to the cost savings incurred.

In evaluating direct cost savings from delaying the Payment Systems rule, AMS follows the same analytical approach used in the final rule. The updated estimates incorporate the latest industry parameters and wage rates while maintaining consistency with the methodology used. Hourly wage rates were established using the following BLS classifications for each labor category as follows (NAICS Code—OCC code—OCC Title): Management (3116-11-1020—General and Operations Managers) for live poultry dealers' managers, and Legal (3110-23-1011—Lawyers) for attorneys. 15 The average hourly wage rates used to estimate cost savings were updated from the final rule to include a 42.34 percent markup for benefits and are as follows: Management—$102.56, Legal—$145.93, Administrative—$48.38, and Information Technology—$101.72. For reference, the analysis in the final rule is described in detail in the Federal Register at 90 FR 5146 (see pages 5189—5206). 16

With the 18-month delay of the Poultry Systems rule, much of the first-year costs in the final rule that AMS considered are one-time setup and preparation activities that processors will incur before the rule became effective. AMS believes many of these costs have likely already occurred, and therefore they are not affected by the delay.

The delay will affect recurring costs. Delaying the effective date of the final rule will enable LPDs to avoid annual administrative costs that will otherwise occur in the first 18 months after the Payment Systems rule becomes effective. Delaying the effective date for 18 months will shift all costs for small LPDs back by 18 months. This final rule will enable small LPDs to save $587,000 in administrative costs in the first year after July 1, 2026, which is the first year after the rule will otherwise become effective. They will save an additional $294,000 in the second year for a total of $881,000. Administrative costs for small LPDs were expected to decrease by $72,000 in the fifth year after the rule became effective. If the effective date is delayed, the decrease in costs will be delayed as well, and costs in the fifth year will be $72,000 higher for small LPDs. These lower administrative costs were expected to continue in the sixth year after the rule became effective. If the effective date is delayed, the decrease in costs for the first half of the sixth year will also be delayed, and costs in the sixth year will be $36,000 higher for small LPDs. This will result in a ten-year total cost savings of $773,000 for small LPDs. Column three in table 3 below summarizes cost savings to small LPDs if the effective date of the Payment Systems rule is delayed until December 31, 2027.

AMS also evaluated benefits and costs of delaying the effective date for 12 months (12-Month Delay Alternative). The 12-Month Delay Alternative is similar to the preferred alternative, but the effective date of the Payment Systems rule will be delayed 12 rather than 18 months. Under the 12-Month Delay Alternative all costs for small LPDs will be shifted back by one year, resulting in savings to small LPDs of $587,000 in administrative costs. Because administrative costs for small LPDs were expected to decrease in the fifth year after the rule became effective, costs in the fifth year will be $72,000 higher for small LPDs if the effective date is delayed 12 months. The ten-year total direct administrative cost savings will be $515,000 for the 12-Month Delay Alternative. Column two in table 3 below contains estimated administrative cost savings for small LPDs for the 12-Month Delay Alternative.

LPDs report net sales in Annual Reports to AMS. 17 While net sales are not the same as annual revenue, unless the small LPDs have diversified income, net sales is a reasonable substitute for annual revenue. Table 4 below groups small LPDs' net sales into quartiles, reports the average net sales in each quartile, and compares average net sales to average expected cost savings from delaying the Payment Systems rule for 18 months. If a significant impact is defined as 1 percent of net sales and a substantial number is 25 percent (6 firms) of the small businesses, expected direct cost savings resulting from delaying the effective date of the Payment Systems rule 18 months will not be significant. Savings will be largest for the smallest quartile, but not significant. First-year cost savings for the smallest quartile will be 0.24 percent of net revenues. Annualized savings are less than the first-year cost savings.

Congress passed the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA) to allow for regular adjustment for inflation of civil monetary penalties (CMPs), maintain the deterrent effect of such penalties and promote compliance with the law, and improve the collection of CMPs by the Federal government (Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note). On November 2, 2015, Congress amended the FCPIAA through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Improvements Act) (Sec. 701, Pub. L. 114-74, 129 Stat. 599). The 2015 Improvements Act requires that the head of each agency continue to adjust CMP amounts, rounded to the nearest dollar, on an annual basis. Specifically, each CMP is to be adjusted based on the percentage change between the Consumer Price Index (CPI) for the month of October, and the CPI for the month of October for the previous year. The NRC most recently adjusted its civil penalties for inflation according to this statutory formula on January 15, 2025 (90 FR 3612).

In a memorandum dated April 17, 2026, the Office of Management and Budget (OMB) directed all Executive Branch agencies to cancel the inflation adjustment for fiscal year 2026 based on the lack of October 2025 Consumer Price Index for All Urban Consumers (CPI-U) data due to the lapse in appropriations at the beginning of fiscal year 2026.

Per the 2015 Improvements Act, the annual civil monetary penalties cost-of-living adjustment is based on the Bureau of Labor Statistics (BLS) data from the month of October of the prior year. Due to the government shutdown in October 2026, BLS was unable to produce the October 2025 data. Based on the lack of October 2025 CPI-U data, which is needed to make adjustments under the 2015 Improvements Act, there will be no updated cost-of-living adjustment multiplier for 2026. The NRC maximum civil monetary penalty for a violation of the Atomic Energy Act of 1954, as amended (AEA), or any regulation or order issued under the AEA, will remain $372,240 per violation, per day. Additionally, the NRC provisions concerning program fraud civil penalties and the maximum civil monetary penalty under the Program Fraud Civil Remedies Act will remain $14,308 for each false claim or statement.

The NRC is discontinuing the Adjustment of Civil Penalties for Inflation for Fiscal Year 2026 rulemaking. In the next edition of the Unified Agenda, the NRC will update the entry for this rulemaking activity and reference this document to indicate that the rulemaking activity is no longer being pursued. This rulemaking will appear in the completed actions section of that edition of the Unified Agenda but will not appear in future editions. The NRC will inform the public of future civil penalty adjustments to account for inflation through new rulemaking entries in the Unified Agenda.

On April 2, 2026 (91 FR 16541), the NRC published a direct final rule amending its regulations in part 72, “Packaging and Transportation of Radioactive Material,” of title 10 of the Code of Federal Regulations to revise the certificate of compliance to include two new versions of the HI-STORM UMAX (Version B1 and B2). In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on June 16, 2026.

The NRC received and docketed one comment on the companion proposed rule (91 FR 16588; April 2, 2026). An electronic copy of the comment can be obtained from the Federal Rulemaking website at https://www.regulations.gov under Docket ID NRC-2026-0562 and is also available in ADAMS under Accession No. ML26146A078. The NRC evaluated the comment against the criteria described in the direct final rule and determined that the comment was not significant and adverse. Therefore, this direct final rule will become effective as scheduled.

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

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

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

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

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

On March 20, 2025, Honeywell applied for a supplemental type certificate for the installation of a digital system architecture that will allow increased connectivity to and access from external network sources ( e.g., operator networks, wireless devices, internet connectivity, service provider satellite communications, electronic flight bags, etc.) to the airplane's previously isolated electronic assets (networks, systems, and databases) in the Boeing Model 757-200 series airplanes. The Boeing Model 757-200 series airplanes currently approved under Type Certificate No. A2NM, are twin-engine, transport category airplanes with a maximum takeoff weight between 255,000 and 256,00 pounds, and a maximum passenger capacity of 295 persons.

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

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

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

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

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

The Boeing Model 757-200 series airplanes, as modified by Honeywell, will incorporate the following novel or unusual design feature:

The installation of a digital systems architecture that will allow increased connectivity to and access from external network sources ( e.g., operator networks, wireless devices, internet connectivity, service provider satellite communications, electronic flight bags, etc.) to the airplane's previously isolated electronic assets (networks, systems, and databases).

The Boeing Model 757-200 series airplane's electronic system architecture and network configuration change is novel or unusual for commercial transport airplanes because it may allow increased connectivity to and access from external network sources, airline operations, and maintenance networks to the airplane control domain, and airline information services domain. The airplane's control domain and airline information-services domain perform functions required for the safe operation and maintenance of the airplane. Previously, these domains had very limited connectivity with external network sources. This data network and design integration creates a potential for unauthorized persons to access the airplane's control domain and airline information-services domain and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases) critical to the safety and maintenance of the airplane.

The existing FAA regulations did not anticipate these networked airplane-system architectures. Furthermore, these regulations and the current guidance material do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks, data buses, and servers. Therefore, these special conditions ensure that the security ( i.e., confidentiality, integrity, and availability) of the airplane's systems is not compromised by unauthorized wired or wireless electronic connections. This includes ensuring that the security of the airplane's systems is not compromised during maintenance of the airplane's electronic systems. These special conditions also require the applicant to provide appropriate instructions to the operator to maintain all electronic-system safeguards that have been implemented as part of the original network design so that this feature does not allow or introduce security threats.

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

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

This action affects only a certain novel or unusual design feature on one series of airplanes. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

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

1. The applicant must ensure airplane electronic system security protection from access by unauthorized sources external to the airplane, including those possibly caused by maintenance activity.

2. The applicant must ensure that electronic system security threats are identified and assessed, and that effective electronic system security protection strategies are implemented to protect the airplane from all adverse impacts on safety, functionality, and continued airworthiness.

3. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the aircraft is maintained, including all post Type Certification modifications that may have an impact on the approved electronic system security safeguards.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Embraer Model EMB-505 airplanes. The NPRM was published in the Federal Register on November 18, 2025 (90 FR 51607). The NPRM was prompted by ANAC AD 2025-04-01, effective April 15, 2025 (ANAC AD 2025-04-01) (also referred to as the MCAI), issued by ANAC, which is the aviation authority for Brazil. The MCAI states that there is a possibility of some airplanes having invalid HS backlash test results due to the use of incorrect test procedures. The excessive backlash may result in an aeroelastic phenomenon exposing the surrounding structure and systems to unacceptable vibration levels and reduced controllability of the airplane.

In the NPRM, the FAA proposed to require inspecting the airplane's LH and RH HS backlash and replacing, as applicable, the LH and RH hinge point attachment parts, the LH or RH pitch trim actuator rod-end attachment parts, and the pitch trim actuator. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-3993.

The FAA received comments from the Citizens Rulemaking Alliance. The following presents the comments received on the NPRM and the FAA's response to each comment.

The Citizens Rulemaking Alliance requested that the FAA provide its justification for finding good cause to bypass notice and comment procedures, reopen the comment period for at least 30 days, and delay enforcement of non-time critical provisions pending comment unless the risk analysis demonstrates a truly imminent hazard. The commenter asserted the FAA has not adequately justified use of the good cause exemption to bypass notice and comment and the 30-day delayed effective date.

The FAA notes the comment was submitted in response to an NPRM for which the FAA provided a 45-day comment period. This final rule is effective 35 days after its publication in the Federal Register . Therefore, no change to this AD is necessary.

The Citizens Rulemaking Alliance stated that the FAA's current practices for IBR frequently fail to meet the legal and regulatory standards for reasonable availability. The commenter called on the FAA to guarantee that all IBR materials are easily and freely accessible to the public and affected parties for the duration of the comment period and to reopen the comment period for at least 30 days to accommodate this access. Furthermore, the commenter requested that, if the manufacturer will not consent to open posting of the IBR materials in the docket, the FAA should either obtain permission to post the materials or provide a detailed technical summary sufficient for meaningful comment.

The FAA notes that ANAC AD 2025-04-01, which is incorporated by reference in this AD, is available to the public on the ANAC website at sistemas.anac.gov.br/certificacao/DA/DAE.asp, as explained in the preamble and regulatory text of the NPRM. This material was also posted in the AD docket upon publication of the NPRM. Therefore, the FAA did not change this AD as a result of this comment.

The Citizens Rulemaking Alliance requested that the FAA either provide the factual basis for its Regulatory Flexibility Act (RFA) certification that the AD will not have a significant economic impact on a substantial number of small entities or prepare an initial regulatory flexibility analysis and consider less burdensome alternatives for small operators. The commenter stated that the FAA should also reopen the comment period to allow comment on that analysis.

FAA has considered the AD's impact on small businesses and provides the following factual basis for its RFA certification.

The Regulatory Flexibility Act of 1980, Public Law 96-354, 94 Stat. 1164 (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, Mar. 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, 124 Stat. 2504, Sept. 27, 2010), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The FAA used the definition of small entities in the RFA for this analysis. The RFA defines small entities as small businesses, small governmental jurisdictions, or small organizations. In 5 U.S.C. 601(3), the RFA defines “small business” to have the same meaning as “small business concern” under section 3 of the Small Business Act. The Small Business Act authorizes the Small Business Administration (SBA) to define “small business” by issuing regulations.

The SBA (2023) has established size standards for various types of economic activities, or industries, under the North American Industry Classification System (NAICS). These size standards generally define small businesses based on the number of employees or annual receipts. The SBA definition of a small business applies to the parent company and all affiliates as a single entity. The following table provides the SBA size standards for all industries with at least one entity impacted by this AD. Note that the FAA does not have entity data on 13 of the 41 affected airplanes, and those airplanes with missing entity data are excluded from this analysis.

To identify small entities, the FAA first identified the primary NAICS of the entity or parent company, and then used data from different sources ( e.g., company annual reports, Bureau of Transportation Statistics) to determine whether the entity meets the applicable size standard. The FAA provides the estimated number of small entities affected by this AD:

FAA estimates affected entities will incur an inspection cost of $1,360. Based upon the results of the inspection, operators could incur up to five conditional repair costs. If an operator were to incur all repair and inspection costs, FAA estimates each operator would incur $14,950 per airplane. However, according to the manufacturer, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected entities. The FAA analyzes the cost of inspections and all repair costs over the two-year analysis period for each small entity. The following table provides the estimated compliance costs at a 7 percent annualized discount rate by each NAICS industry.

The FAA evaluated the alternative of not promulgating this AD but ultimately deemed that this alternative would create a significant safety hazard. The FAA is issuing this AD to address the unsafe condition for certain Embraer Model EMB-505 airplanes, ensuring a level of safety that the alternative of no action could not provide.

Based on average compliance costs, the FAA has determined that the financial impacts of this AD are not disproportionate to small entities. The FAA did not change this AD as a result of this comment.

The Citizens Rulemaking Alliance requested that the FAA revise the proposed AD to comply with the PRA if reporting is required or remove any reporting provisions until PRA requirements are satisfied.

The FAA notes that paragraph (i) of this AD specifies that this AD does not require reporting. If an AD were to require reporting, the preamble of the AD would include a paragraph titled “Paperwork Reduction Act” that would provide the applicable OMB control number, required PRA statements, and the estimated time to collect the required information (burden). Any costs associated with the reporting requirement would be included in the Costs of Compliance section in the preamble of the AD. Therefore, the FAA did not change this AD as a result of this comment.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed ANAC AD 2025-04-01, which specifies procedures for inspecting the LH and RH HS backlash for correct values, and replacing, as applicable, the LH and RH hinge point attachment parts, the LH or RH pitch trim actuator rod-end attachment parts, and the pitch trim actuator. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The material specified in ANAC AD 2025-04-01 allows the use of alternative or similar parts in place of the ones specified in the kits, provided these alternative or similar parts are approved by Embraer, but this AD requires approval from either the Manager, International Validation Branch, FAA; ANAC; or ANAC's authorized Designee. If approved by the ANAC Designee, the approval must include the Designee's authorized signature.

The FAA estimates that this AD affects 41 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Over a two-year analysis period, the FAA estimates operators will incur an inspection cost of $1,360. Based upon the results of the inspection, operators could incur five conditional repair costs. If an operator were to incur all inspection and repair costs, the FAA estimates each operator would incur $14,950 per airplane. The FAA cannot estimate the number of conditional repairs each operator would need to undertake, but the cost of an inspection ($1,360) and the cost of an inspection and all conditional repairs ($14,950) represent the low-case and high-case costs per affected airplane.

FAA recognizes that operators might incur additional costs, such as airplane downtime. However, FAA anticipates this AD will not trigger any downtime costs because the requirements of this AD can be performed during regularly scheduled maintenance.

The FAA uses a two-year analysis period for estimating the annualized costs of this AD. Upon this AD's promulgation, all Group 1 airplanes must be inspected within 12 months or 750 flight hours, and all Group 2 airplanes must be inspected within 24 months or 1,000 flight hours. In this analysis, FAA assumes all Group 1 costs will be incurred in year 1, and all Group 2 costs will be incurred in year 2. The following tables display the annual AD compliance costs and summarize the AD's quantified and unquantified benefits and costs.

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

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

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

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

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

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

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

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

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

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 document makes technical corrections to the following rule and forms, amendments to which were published in the Federal Register on March 3, 2026 (91 FR 10320):

The corrections to Rule 16a-2 and Forms 4 and 5 are technical in nature. Rule 16a-2 is amended to remove a quotation mark and the text “after the first sentence.” appearing after the second sentence in the introductory text that inadvertently was included in the rule. Additionally, Form 4 and Form 5 are amended to remove the reference to Section 17(a) of the Public Utility Holding Company Act of 1935, which Congress repealed in 2005, that was inadvertently retained in the amended forms. 2

These technical corrections are being made under the authority set forth in Section 23(a) of the Exchange Act and the Holding Foreign Insiders Accountable Act. 3

For the reasons set out above, we are amending title 17, chapter II of the Code of Federal Regulations as follows:

Upon request, FDA (the Agency or we) has classified the von Willebrand factor (VWF) assay 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 October 28, 2020, FDA received Siemens Healthcare Diagnostics Products GmbH's request for De Novo classification of the INNOVANCE VWF Ac device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness 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 September 29, 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 864.7293. 1 We have named the generic type of device “von Willebrand factor assay,” and it is identified as a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma. This device is indicated to aid in the diagnosis and management of patients being evaluated for von Willebrand factor disorders in conjunction with other clinical and laboratory findings.

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, von Willebrand factor assays 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 von Willebrand factor assays. 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 864 is amended as follows:

Upon request, FDA (the Agency or we) has classified the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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 April 8, 2022, FDA received Intelligent Ultrasound Limited's request for De Novo classification of the ScanNav Anatomy Peripheral Nerve Block device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness 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 October 18, 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 868.1980. 1 We have named the generic type of device “real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia,” and it is identified as a device that provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.

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 real-time ultrasound anatomy visualization and labeling devices for ultrasound guided regional anesthesia. 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 part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 868 is amended as follows:

Upon request, FDA (the Agency or we) has classified the adjunctive pain measurement device for anesthesiology 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 4, 2021, FDA received Medasense Biometrics Ltd.'s request for De Novo classification of the PMD-200 device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness 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 February 17, 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 868.2200. 1 We have named the generic type of device “adjunctive pain measurement device for anesthesiology,” and it is identified as a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient's actual response to painful stimuli and is not intended to independently direct decision-making.

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, adjunctive pain measurement devices for anesthesiology are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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 adjunctive pain measurement devices for anesthesiology. 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 part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 868 is amended as follows:

Upon request, FDA (the Agency or we) has classified the intraoral cooling device 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 2, 2021, FDA received BrainCool AB's request for De Novo classification of The Cooral System. 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 October 14, 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 872.5590. 1 We have named the generic type of device “intraoral cooling device,” and it is identified as a prescription use device that is intended to cool the mouth for patients to reduce the likelihood of oral mucositis. The device consists of a removable mouthpiece that cools the oral mucosal surfaces.

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, intraoral cooling devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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 intraoral cooling devices. 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 part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 872 is amended as follows:

Upon request, FDA (the Agency or we) has classified the oropharyngeal electrical stimulator 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 April 19, 2022, FDA received Phagenesis Limited's request for De Novo classification of the Phagenyx System. 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

Upon request, FDA (the Agency or we) has classified the orally ingested transient device for constipation 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 November 30, 2021, FDA received Vibrant Ltd.'s request for De Novo classification of the Vibrant System. 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 August 26, 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 876.5940. 1 We have named the generic type of device “orally ingested transient device for constipation,” and it is identified as an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.

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 orally ingested transient devices for constipation. 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 part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

Upon request, FDA (the Agency or we) has classified the rigid sterilization container with electronic monitoring 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 February 16, 2021, FDA received Zuno Medical, Inc.'s request for De Novo classification of the Zuno Smart Sterilization Container. 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 June 17, 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 880.6855. 1 We have named the generic type of device “rigid sterilization container with electronic monitoring,” and it is identified as a device intended to be used to enclose medical devices that are to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical devices and maintain sterility of the enclosed devices until used. The device provides sterility status of the enclosed medical devices via real time electronic monitoring.

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 rigid sterilization containers with electronic monitoring. 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 part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:

The Coast Guard will enforce the special local regulation in Table 1 to Paragraph (i)(1) in 33 CFR 100.501 for the regulated area of the Around the Island Paddle from 8 a.m. through 2 p.m. on June 28, 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 USCG East District, § 100.501, specifies the location of the regulated area for the “Around the Island Paddle” which encompasses portions of Cape May Harbor, Atlantic Ocean, and Delaware Bay in Cape May, NJ. During the enforcement period, as reflected in § 100.501(g), the operator of a vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign. Non-participants are only allowed inside the regulated area to pass through or enter and remain within a designated spectator area. A non-participant must contact the Event Patrol Commander or an official patrol vessel to request permission to either enter the Spectator Area or pass through the regulated area.

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 and Broadcast Notice to Mariners.

On March 2, 2026, Race World Offshore submitted an application to the Coast Guard under 33 CFR 100.15 for a marine event permit. The application requests permission to host an offshore powerboat grand prix on a 4-mile long course on June 27, 2026, from 10 a.m. to 6 p.m., and during those same hours on June 28, 2026. The event will be held in the Atlantic Ocean, off Atlantic City, NJ and will include approximately 50 participants.

The COTP has determined that the offshore boat race could pose a risk to participants or waterway users if normal vessel traffic were allowed to interfere with the event. Possible hazards include risks of participant injury or death from near or actual collisions with spectators, and non-participant vessels transiting the area where the event will take place. Having approved the application for a marine event permit, the Captain of the Port, Delaware Bay (COTP) is issuing this Special Local Regulation (SLR) under authority in 46 U.S.C. 70041 and 33 CFR 100.35(a). The purpose of this rulemaking is to protect event participants, spectators, and transiting vessels before, during, and after the scheduled event.

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 March 2, 2026, but we must establish this SLR by June 27, 2026, to protect personnel, vessels, and the marine environment. Therefore, we have do not have enough time to solicit and respond to comments.

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

This rule establishes a temporary SLR from 10 a.m. on June 27, 2026 until 6 p.m. on June 28, 2026. The regulated area will cover all navigable waters of the Atlantic Ocean near Atlantic City, NJ, within a polygon bounded by the following: originating on the shore line at approximate position latitude 39°21′51″ N longitude 074°24′26″ W; thence southeast to approximate position 39°20′43″ N longitude 074°24′04″ W thence southwest to approximate position to latitude 39°20′03″ N, longitude 074°26′29″ W; thence northwest to the shoreline at approximate position latitude 39°20′49″ N, longitude 074°27′05″ W; thence northeast along the shoreline to the point of origin.

Inside of the regulated area detailed above, there is a spectator area reserved for non-participant vessels to watch the event. The spectator area is within a polygon bounded by the following: beginning at approximate position latitude 39°20′45″ N, longitude 074°25′33″ W; thence northeast to approximate position latitude 39°21′00″ N, longitude 074°24′44″ W; thence southeast to approximate position latitude 39°20′50″ N, longitude 074°24′39″ W; thence southwest to approximate position latitude 39°20′35″ N, longitude 074°25′28″ W; thence northwest to the point of origin. 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. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule is a 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. 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 100 as follows:

The Coast Guard will enforce a safety zone for the Delaware River, Philadelphia, PA, from 9:30 p.m. to 9:45 p.m. on June 27, 2026. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after fireworks displays. Our regulation for safety zones of fireworks displays within the USCG East District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 specifies the location of the regulated area as all waters of the Delaware River adjacent to Penn's Landing, Philadelphia, PA, within a 500-feet radius of the fireworks barge position. On June 27, 2026, the approximate position will be 39°56′52″ N, 75°8′9.28″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.

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 Broadcast Notice to Mariners.

On April 1, 2026, an organization notified the Coast Guard that they planned to launch fireworks from a barge on Lake Champlain near Essex, NY on July 3, 2026. Hazards from fireworks displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Sector Northern New England (COTP) has determined that potential hazards associated with fireworks are a safety concern for anyone within 200 yards of the fireworks display. The COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable to do so within the short time period between April 1 and July 3, 2026 .

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 safety zone for a one day event on July 3, 2026, from 9 p.m. to 10:30 p.m., unless the event is delayed because of weather conditions in which case it will be subject to enforcement of those same hours on August 1, 2026. The safety zone would cover all navigable waters within 200 yards of the fireworks barge at 44°18′31.12″ N 73°20′48.57″ W expressed in Degrees (°) Minutes (′) Seconds (″) (DMS) based on the World Geodetic System (WGS 84)/North American Datum 83 (NAD 83). No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or their designated representative. 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:

On June 13, 2026, an organization will be hosting a bicycle racing event in Chicago, Illinois that involves teams of tandem bicycle riders competing to complete a dynamic floating race course constructed on floating structures. The Captain of the Port Sector Lake Michigan (COTP) has determined that potential hazards associated with this event (temporary floating structures built over navigable waters and high likelihood of race participants falling off the course and into the water) are a safety concern for participants and spectators involved in the show. Therefore, the COTP is proposing 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. We must establish this safety zone by June 13, 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 from 7:45 a.m. through 4:15 p.m. on June 13, 2026. The safety zone will cover all navigable waters of Lake Michigan beginning at 41°51′53.3″ N, 087°36′22.3″ W thence to position 41°51′53.4″ N, 087°36′16.9″ W, thence to position 41°51′43.5″ N, 087°36′16.8″ W, thence to position 41°51′43.4″ N, 087°36′22.1″ W, thence returning to the point of origin. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the COTP.

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:

Docket. The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2016-0186. All documents in the docket are listed in https://www.regulations.gov. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available as PDF versions that can only be accessed on the EPA computers in the docket office reading room. Certain databases and physical items cannot be downloaded from the docket but may be requested by contacting the docket office at (202) 566-1744. With the exception of such material, publicly available docket materials are available electronically at https://www.regulations.gov.

Preamble acronyms and abbreviations. Throughout this preamble, the use of “we,” “us,” or “our” is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

Entities potentially affected by this final rule include Federal, State, local, and Tribal air pollution control agencies that administer title V operating permit programs, and owners and operators of emissions sources in all industry groups who hold or apply for title V operating permits.

The EPA is taking this action in response to the decision of the U.S. Court of Appeals for the D.C. Circuit in SSM Litigation Group v. EPA, 150 F.4th 593 (D.C. Cir. 2025) (“ SSM Litigation Group” ). In that decision, the D.C. Circuit found that the EPA's 2023 Affirmative Defense Rule, 1 which removed emergency-related affirmative defense provisions from Federal regulations governing title V operating permit programs and required States to remove such provisions from State operating permit programs and State-issued operating permits, was “unreasonable and not in accordance with law.”  2 The court issued the mandate in this case on January 12, 2026. The court's decision invalidated the 2023 Affirmative Defense Rule, and the EPA is now taking action to rescind the rule.

On July 21, 2023, the EPA issued the 2023 Affirmative Defense Rule that rescinded the longstanding emergency-related affirmative defense provisions previously codified in the Agency's operating permit program regulations at 40 CFR 70.6(g) and 71.6(g). 3 The previously rescinded affirmative defense provisions that are now being reinstated define an emergency as: “any situation arising from sudden and reasonably unforeseeable events beyond the control of the source, including acts of God, which situation requires immediate corrective action to restore normal operation, and that causes the source to exceed a technology-based emission limitation under the permit, due to unavoidable increases in emissions attributable to the emergency.”  4 The regulations also provide that an emergency constitutes “an affirmative defense to an action brought for noncompliance with such technology-based emission limitations” if certain conditions are met. 5

The 2023 Affirmative Defense Rule rescinded these longstanding provisions based on the EPA's conclusion that they were legally impermissible under the Clean Air Act (CAA). 6 As a result, the preamble to the 2023 Affirmative Defense Rule explained that removal of these provisions from the EPA's regulations meant that States were likewise required to remove from their operating permit program regulations and from existing operating permits any State affirmative defense provisions that were based on the rescinded Federal provisions. 7

SSM Litigation Group filed a petition for review of the 2023 Affirmative Defense Rule in the D.C. Circuit, challenging the EPA's basis for rescinding the title V affirmative defense provisions. On September 5, 2025, the court issued a decision finding that the 2023 Affirmative Defense Rule rested entirely on erroneous legal justifications. 8 On January 12, 2026, the court issued its mandate in the case. 9

Because the D.C. Circuit in SSM Litigation Group reversed the 2023 Affirmative Defense Rule, the rule is now invalid. Accordingly, the EPA must rescind the 2023 Affirmative Defense Rule and restore the longstanding regulatory text that existed prior to that rule.

The EPA is rescinding the 2023 Affirmative Defense Rule, consistent with the D.C. Circuit's decision in SSM Litigation Group. The effect of this action is to restore the text of 40 CFR 70.6(g) and 71.6(g) as these provisions existed before the EPA promulgated the 2023 Affirmative Defense Rule ( i.e., to reinstate the emergency-related affirmative defense provisions in 40 CFR 70.6(g) and 71.6(g) that the 2023 Affirmative Defense Rule rescinded). As a result of this final action, State, local, and Tribal permitting authorities are no longer required to submit revisions to their title V operating permit programs or to revise existing operating permits to implement the requirements of the 2023 Affirmative Defense Rule.

The EPA is taking this action as a final rule without providing an opportunity for public comment or a public hearing because the Agency finds that the Administrative Procedure Act (APA) “good cause” exemption applies. In general, the APA requires that general notice of proposed rulemaking be published in the Federal Register , and that such notice must provide an opportunity for public participation in the rulemaking process. However, the APA authorizes an agency to directly issue a final rulemaking in certain specific instances. This may occur when an agency for good cause finds (and incorporates the finding and a brief statement of reasons in the rule issued) that notice and public participation are “impracticable, unnecessary, or contrary to the public interest.”  10 Because the D.C. Circuit in SSM Litigation Group reversed the 2023 Affirmative Defense Rule, the rule is no longer valid and the EPA must rescind it. The EPA has determined that it is unnecessary to provide a public hearing or an opportunity for public comment on this action because the rescission of the 2023 Affirmative Defense Rule is a ministerial act necessary to carry out the D.C. Circuit's mandate in SSM Litigation Group. Because this action involves no exercise of Agency discretion and instead merely implements the binding decision of the court, it would serve no useful purpose to provide an opportunity for public comment or a public hearing on this action. For these reasons, the EPA finds good cause under 5 U.S.C. 553(b)(B) to issue a final rule without undergoing public notice and comment. For the same reasons, the EPA finds that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately.

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

This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.

This action is considered an Executive Order 14192 deregulatory action. This final rule provides burden reduction because State, local, and Tribal permitting authorities are no longer required to submit revisions to their title V operating permit programs, or to revise existing operating permits.

This action does not impose an information collection burden under the provisions of the PRA. This final action does not establish any new information collection requirement apart from what is already required by law. In this action, the EPA is reinstating certain provisions in the Agency's regulations. This action does not involve any requests for information, recordkeeping or reporting requirements, or other requirements that would constitute an information collection under the PRA

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Entities potentially affected directly by this proposal include State, local, and Tribal governments, and none of these governments would qualify as a small entity. Other types of small entities, including stationary sources of air pollution, are not directly subject to the requirements of this action.

This action does not contain an unfunded mandates as described in the UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local, or Tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This action does not have Tribal implications as specified in Executive Order 13175. This action rescinds a previous final rulemaking requiring the removal of emergency affirmative defense provisions from part 70 and part 71 operating permit programs. No Tribal government is subject to a requirement to revise their operating permit programs as a result of this action. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order.

Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.

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

This final action does not involve technical standards.

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

The statutory authority for this action is provided in CAA sections 502(b) and 502(d)(3), 42 U.S.C. 7661a(b) and (d)(3), which direct the Administrator of the EPA to promulgate regulations establishing State operating permit programs and give the Administrator the authority to establish a Federal operating permit program. Additional authority for this action is provided in 5 U.S.C. 553(b)(B) and (d)(3), which authorize the EPA to find that good cause exists to forego notice and public procedure and to issue a final rule that is effective immediately upon publication in the Federal Register .

CAA section 307(b)(1) governs judicial review of final actions by the EPA. This section generally provides that petitions for review of final actions that are nationally applicable must be filed in the U.S. Court of Appeals for the D.C. Circuit, and petitions for judicial review of actions that are locally or regionally applicable must be filed in the appropriate regional circuit. 11 However, petitions for judicial review of a final action that is locally or regionally applicable must be filed in the D.C. Circuit when “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”  12

As the Supreme Court recently articulated in EPA v. Calumet, 605 U.S. 627 (2025), the first step in determining the appropriate venue for judicial review of an EPA final action is to ascertain whether the action at issue is “nationally applicable” or “locally or regionally applicable.”  13 To determine whether an action is “nationally applicable” or “locally or regionally applicable,” courts ask “whether the action `[o]n its face' applies throughout the entire country, or only to particular localities or regions.” Calumet, 605 U.S. at 638. If the action is nationally applicable, venue lies in the D.C. Circuit. If the action is locally or regionally applicable, the second step is to determine whether the EPA has appropriately invoked the “nationwide scope or effect” exception to “override the default rule” that judicial review of a locally or regionally applicable action belongs in the appropriate regional circuit. 14

This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). This final action rescinds a previous final action that had revised both the regulatory requirements in 40 CFR part 70 that govern State, local, Tribal, and U.S. territorial operating permit programs nationwide and the regulatory requirements in 40 CFR part 71 that govern Federal operating permits nationwide. Because this action rescinds a nationally applicable action, thereby reinstating nationally applicable title V regulations that had been rescinded in that action, this final action is also nationally applicable.

Per CAA section 307(b)(1), petitions for judicial review of this action must be filed in the U.S. Court of Appeals for the D.C. Circuit by July 31, 2026. Filing a petition for reconsideration by the Administrator of this final action does not affect the finality of the action for the purposes of judicial review or extend the time within which a petition for judicial review must be filed and shall not postpone the effectiveness of such rule or action.

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

NMFS manages the Gulf reef fish fishery and greater amberjack under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The Gulf Fishery Management Council prepared the FMP, and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) through regulations at 50 CFR part 622.

All greater amberjack weights discussed in this temporary rule are in round weight. The metric conversion for the imperial measurement used in this document is 1 pound (lb) equals approximately 0.45 kilograms.

For Gulf greater amberjack, the recreational fishing year begins on August 1 and extends through July 31 of the following calendar year (50 CFR 622.7(h)). However, there are seasonal closures of the recreational sector during each January through August and November through December (50 CFR 622.34(c)). Therefore, the recreational fishing season for greater amberjack is open during September and October. The recreational annual catch limit (ACL) is 404,000 lb, and the ACT, or recreational quota, is 335,320 lb (50 CFR 622.41(a)(2)(iii) and 622.39(a)(2)(ii)). Under the recreational AM at 50 CFR 622.41(a)(2)(i), NMFS is required to close the recreational harvest of greater amberjack if NMFS projects that landings will reach the recreational ACT during a fishing year. Based on a review of recreational landings data, NMFS has projected that for the 2026-2027 fishing year, the recreational ACT of 335,320 lb (152,099 kg) will be reached by October 14, 2026. Accordingly, NMFS closes recreational harvest of greater amberjack in or from Gulf Federal waters on October 14, 2026.

During the recreational closure, the bag and possession limits for greater amberjack harvested in or from Gulf Federal waters are zero. The possession of greater amberjack is also prohibited in state waters of the Gulf for any vessel issued a valid Federal charter vessel/headboat permit for Gulf reef fish (50 CFR 622.39(c)).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.41(a)(2)(i), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the regulation associated with the closure of the greater amberjack recreational sector at 50 CFR 622.41(a)(2)(i) has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Prior notice and opportunity for public comment are contrary to the public interest because there is a need to immediately implement this action to protect the greater amberjack stock. In addition, prior notice and opportunity for public comment would require time and many of those affected by the length of the recreational fishing season, particularly charter vessel and headboat operators who book trips for clients in advance, need as much notice as possible to adjust their business plans to account for the recreational fishing season.

Atlantic BFT fisheries are managed under the 2006 Consolidated Highly Migratory Species Fishery Management Plan (HMS FMP) and its amendments, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and consistent with the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). ATCA is the implementing statute for binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT). The HMS FMP and its amendments are implemented by regulations are at 50 CFR part 635. Section 635.27(a) divides the U.S. BFT quota, established by ICCAT and as implemented by the United States among the various domestic fishing categories, per the allocations established in the HMS FMP and its amendments. NMFS is required under the Magnuson-Stevens Act at 16 U.S.C. 1854(g)(1)(D) to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). The Harpoon category baseline quota is 59.2 mt. As described in § 635.23(d)(1), the default Harpoon category daily retention limit is no more than 10 large medium and giant BFT, combined, per vessel per day/trip. As described in § 635.23(d)(2), the incidental daily catch limit is no more than two large medium BFT ( i.e., measuring 73 inches (185 cm) to less than 81 inches (206 cm) CFL) per vessel per day/trip. As such, under the default retention limit, if the vessel owner/operator retains two large medium BFT during a day/trip, they may retain a maximum of eight giant BFT on that same day/trip.

Separate from this action, NMFS published a proposed rulemaking that would implement the 2025 ICCAT recommendation (Recommendation 25-05) regarding western BFT management (91 FR 24789, May 7, 2026). Consistent with the recommendation, that proposed rule proposes increasing the baseline U.S. BFT quota from 1,316.14 mt to 1,509.98 mt and adjusting all the subquotas accordingly. In that proposed rule, the General category baseline quota would increase from 710.7 mt to 815.4 mt. The comment period on that proposed rule ends on June 8, 2026. Any final rule implementing ICCAT Recommendation 25-05 would likely be effective in mid-2026 or later.

NMFS may increase or decrease the Harpoon category daily retention limit after considering the regulatory determination criteria under § 635.27(a)(7). For the Harpoon category, NMFS may adjust the overall daily retention limit of large medium and giant BFT, combined, per vessel per day over a range of 5 to 10 BFT per vessel per day (see § 635.23(d)(1)). NMFS may also adjust the incidental daily catch limit for the Harpoon category over a range of two to four large medium BFT per vessel per day (see § 635.23(d)(2)).

As described below, NMFS has considered all relevant determination criteria for adjusting the BFT retention limit in the Harpoon category and has decided to decrease the overall daily retention limit for the Harpoon category to no more than five large medium and giant BFT, combined, per vessel per day/trip ( i.e., BFT measuring 73 inches (185 cm) CFL or greater). This action maintains the incidental daily catch limit of two large medium BFT ( i.e., measuring 73 inches (185 cm) to less than 81 inches (206 cm) CFL) per vessel per day/trip. As such, if two large medium BFT are retained during a day/trip, no more than three giant BFT may be retained on the same day/trip. Similarly, if no large medium BFT are retained, then all five BFT could be giant BFT. This adjustment would apply from June 1 through the remainder of the 2026 Harpoon category fishing season, which concludes on November 15, 2026, or until NMFS announces via a notice in the Federal Register another adjustment to the retention limit.

Regardless of the duration of a fishing trip, no more than a single day's daily retention limit may be possessed or retained at the end of the trip for Harpoon category vessels (§ 635.23(d)(3)). For example, a Harpoon category vessel cannot exceed the daily limit of five combined large medium and giant BFT, regardless of the trip's length or number of trips in a day. This retention limit is effective in all areas, except for the Gulf of America, where NMFS prohibits targeted fishing for BFT. The Harpoon category retention limit applies to those vessels permitted in the Harpoon category.

As described above, under § 635.23(d)(1), NMFS may adjust the daily retention limit of large medium and giant BFT in the Harpoon category after considering the regulatory determination criteria under § 635.27(a)(7). Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(7)(i)), biological samples collected from BFT landed by Harpoon category fishermen and provided by BFT dealers continue to provide NMFS with valuable parts and data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the Harpoon category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS also considered the catches of the Harpoon category quota in recent years ( i.e., most recently in 2025) and the likelihood of closure of the Harpoon category if no adjustment is made (§ 635.27(a)(7)(ii)). Commercial-size BFT are anticipated to migrate to the fishing grounds off the northeast U.S. coast by early June. Given the possibility of high catch rates in early June, decreasing the retention limit from a combined 10-fish limit to a combined 5-fish limit could assist in extending the time required to fully harvest the quota. If catch rates are lower than expected, NMFS could take another action later in the season to increase the retention limit.

NMFS also considered the effects of this retention limit adjustment on the BFT stock and the effects of the adjustment on accomplishing the objectives of the HMS FMP (§ 635.27(a)(7)(v) and (vi)). Adjusting the retention limit for this category would be consistent with established quotas and subquotas, which are implemented consistent with ICCAT recommendations, ATCA, and the objectives of the HMS FMP and amendments. In establishing these quotas and subquotas and associated management measures, ICCAT and NMFS considered the best scientific information available, objectives for stock management and status, and effects on the stock. Making this adjustment is in line with the established management measures and stock status determinations. It is also important that NMFS limit landings to the quotas and subquotas both to adhere to the domestic allocations and to ensure that landings are as consistent as possible with the pattern of fishing mortality ( e.g., fish caught at each age) that was assumed in the latest stock assessment. This retention limit adjustment is consistent with those objectives.

Another principal consideration in setting the retention limit is the objective of providing opportunities to harvest the available Harpoon category quota without exceeding the annual quota. This consideration is based on the objectives of the HMS FMP and its amendments, and includes achieving optimum yield on a continuing basis and optimizing the ability of all permit categories to harvest available BFT quota allocations (related to § 635.27(a)(7)(x)). NMFS will actively monitor catch rates for the Harpoon category and adjust the daily retention limit as needed throughout the fishing season to facilitate scientific data collection and maintain fishing opportunities while preventing the exceedance of available quota. For the Harpoon category, a 10-fish (combined) daily retention limit could result in diminished fishing opportunities, and the premature closure of the Harpoon category. A 5-fish (combined) daily retention limit for the remainder of the fishing season will provide equitable fishing opportunities for all Harpoon category participants.

Given these considerations, NMFS has determined that a 5-fish (combined) daily retention limit for the Harpoon category is warranted for the fishing year. This retention limit would provide a reasonable opportunity to harvest the available U.S. BFT quota, without exceeding it, while maintaining an equitable distribution of fishing opportunities; help optimize the ability of the Harpoon category to harvest the available quota; allow the collection of a broad range of data for stock monitoring purposes; and be consistent with the objectives of the HMS FMP and amendments.

NMFS will continue to monitor the BFT fishery closely. Per § 635.5(b)(2)(i)(A), dealers are required to submit landing reports within 24 hours of receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, Harpoon category permitted vessel owners are required per § 635.5(a)(4) to report their own catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing https://hmspermits.noaa.gov or by using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

Depending on the level of fishing effort and catch rates of BFT at that time, and after consideration of all the criteria specified at § 635.27(a)(7), NMFS may determine that additional adjustments are necessary to ensure the available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register . In addition, fishermen may access https://hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) and regulations at 50 CFR part 635 and this action is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 533(b)(B), there is good cause to waive prior notice of, and an opportunity for public comment on, this action because it is impracticable and contrary to the public interest for the following reasons. Specifically, the regulations implementing the HMS FMP and its amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing for prior notice and opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on available BFT quota, recent fishery performance, and the presence of BFT on fishing grounds, responsive adjustments to the Harpoon category BFT daily retention limit from its default level is warranted. This adjustment aims to enable fishermen to capitalize on the availability of fish and quota. NMFS could not have proposed this adjustment earlier, as it needed to thoroughly assess updated data and information concerning fishery conditions and this year's landings. Offering a public comment period now, after appropriately considering this data, would prevent fishermen from legally harvesting BFT in alignment with all regulatory criteria. Additionally, it could lead to the use of a retention limit unsuitable to the available quota for the period.

Adjustment of the Harpoon category retention limit needs to be effective June 1, 2026, or as soon as possible thereafter, to minimize any unnecessary disruption in fishing patterns, to allow the impacted sectors to benefit from the adjustment, and to not preclude fishing opportunities for fishermen in geographic areas with access to the fishery only during this time period. The Harpoon category will commence on June 1, and thus prior notice would be contrary to the public interest. Delays in decreasing this retention limit would adversely affect Harpoon category permitted vessels, that would otherwise have an opportunity to harvest BFT if the fishery were to remain open for as long as feasible throughout the year. Limited opportunities to harvest the available quota may have negative social and economic impacts for U.S. fishermen that depend upon catching the available quota designated in the HMS FMP and amendments. Analysis of available data shows that adjustment to the BFT daily retention limit from the default level would decrease any risks of exceeding the ICCAT-allocated quota. NMFS provides notification of retention limit adjustments by publishing the notice in the Federal Register , emailing individuals who have subscribed to the Atlantic HMS News electronic newsletter, and updating the information posted on the Atlantic Tunas Information Line and on https://hmspermits.noaa.gov.

For all of the above reasons, the AA finds that pursuant to 5 U.S.C. 553(d), there is also good cause to waive the 30-day delay in effective date.