This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Order No. 983, as amended (7 CFR part 983), regulating the handling of pistachios grown in California, Arizona, and New Mexico. Part 983 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of pistachios operating within the production area, and a public member.

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

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

This final rule has been reviewed under Executive Order 12988—Civil Justice Reform. Under the Order now in effect, pistachio handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate will be applicable to all assessable pistachios for the 2024-2025 production year, and continue until amended, suspended, or terminated.

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

This final rule decreases the assessment rate for pistachios handled under the Order from $0.0007 per pound, the rate that was established for the 2021-2022 and subsequent production years, to $0.0003 per pound for the 2024-2025 and subsequent production years.

Sections 983.70 and 983.71 of the Order authorize the Committee, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are familiar with the Committee's needs and the costs of goods and services in their local area and are able to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting and all directly affected persons have an opportunity to participate and provide input.

For the 2021-2022 and subsequent production years, the Committee recommended, and AMS approved, an assessment rate of $0.0007 per pound of assessable pistachios within the production area (87 FR 22105). That rate continues in effect from production year to production year unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS. This final rule decreases the assessment rate from $0.0007 to $0.0003 per pound of assessable pistachios for the 2024-2025 and subsequent production years.

The Committee held a public meeting on April 9, 2024, and unanimously recommended an assessment rate of $0.0003 per pound of assessable pistachios for the 2024-2025 and subsequent production years. The Committee also met on July 10, 2024, and unanimously recommended 2024-2025 production year expenditures of $956,700. In comparison, last period's budgeted expenses were $1,145,161. The assessment rate of $0.0003 is $0.0004 less than the rate currently in effect. The Committee recommended decreasing the assessment rate to help ensure the Committee's compliance with § 983.74, which stipulates that assessments will be reduced to bring reserve funds to an amount that is less than or equal to two production years' budgeted expenses.

The major expenditures recommended by the Committee for the 2024-2025 production year include $512,900 for salaries and related expenses, $125,000 for research, $100,000 for a contingency fund, $73,500 for administrative expenses, and $10,000 for compliance expenses. By comparison, budgeted expenses for these items during the 2023-24 production year were $631,900, $125,000, $200,000, $76,450, and $10,000, respectively.

The Committee derived the recommended assessment rate by considering anticipated expenses, anticipated production of assessable pistachios, and the amount of funds available in the authorized reserve. The expected 1 billion pounds of pistachios for the 2024-2025 production year would generate $300,000 in assessment revenue at the assessment rate (1,000,000,000 pounds multiplied by $0.0003 assessment rate). Income derived from handler assessments, along with the California Pistachio Research Board (CPRB) management income and funds from the Committee's authorized reserve, should be adequate to cover budgeted expenses of $956,700. Funds available in the reserve (currently about $844,000) will be kept within the maximum level of approximately two production years' budgeted expenses as authorized by the Order.

The assessment rate will continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information. Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each production year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2024-2025 budget, and those for subsequent production years will be reviewed and, as appropriate, approved by AMS.

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

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

There are 19 handlers subject to regulation under the Order, and approximately 1,871 producers of pistachios in the production area. Small agricultural producers of pistachios are defined by the Small Business Administration (SBA) as those having annual receipts equal to or less than $3.75 million (NAICS code 111335, Tree Nut Farming). Small agricultural service firms (handlers) have been defined as those whose annual receipts are equal to or less than $34 million (NAICS code 115114, Postharvest Crop Activities) (13 CFR 121.201).

Data from USDA's National Agricultural Statistics Service (NASS) can be used to characterize the proportion of small versus large pistachio producers and handlers according to the SBA standards. Due to the significant year-to-year variation in pistachio production and crop value, it is helpful to use two-year averages. The average value for crop years 2022 and 2023 ($1.861 and $2.98 billion, respectively) is $2.42 billion. Dividing $2.42 billion by 1,871 producers yields an estimated average sales receipt per producer estimate of about $1.29 million, which is well below the $3.75 million threshold for small producers. Assuming normal distribution, the majority of pistachio producers may be classified as small entities.

Estimating the proportion of small handlers requires an additional computation. An average price per handler can be estimated using AMS Market News prices for pistachio packages at the San Francisco terminal market. The average terminal market price for 12 one-pound packages of pistachios at the San Francisco terminal market from January to July 2024 was $41 per package. Dividing $41 by the weight of the package (12 pounds) yields a handler average price estimate of $3.417 per pound. Dividing the SBA size standard of $34 million by $3.417 by yields an estimate of 9.951 million pounds per year (just under 10 million pounds). The Committee reported that 12 out of 19 handlers (63 percent) handled under 10 million pounds per year. Therefore, 63 percent of the pistachio handlers would be considered small handlers under the SBA standard.

The Committee's recommended assessment rate of $0.0003 per pound of assessable pistachios complies with section 983.71(b) of the Order, which states that any assessment rate must not exceed one-half of one percent of the average price received by producers in the preceding production year. The decreased assessment rate of $0.0003 per pound is well below the computed maximum allowable rate of $0.01 per pound (0.5 percent times $2.00, the 2023 average producer price reported by NASS).

Using the new rate, 2024-2025 annual Committee assessment as a percent of producer revenue (crop value) can be approximated using average production and crop value for the two prior years. NASS reported utilized inshell pistachio production of 882 million pounds and 1.49 billion pounds, respectively, for the 2022 and 2023 crop years, with an average of 1.186 billion pounds. Multiplying 1.186 billion pounds by $0.0003 per pound yields estimated annual Committee revenue of $355,800. Dividing estimated Committee revenue of $355,800 by the two-year average crop value of $2.42 billion crop yields an estimate of 0.01 percent. That is, the $355,800 estimated annual assessment total represents one hundredth of one percent of estimated producer revenue.

This final rule decreases the assessment rate collected from handlers for the 2024-2025 and subsequent production years from $0.0007 to $0.0003 per pound of assessable pistachios. The Committee unanimously recommended 2024-2025 production year expenditures of $956,700 and an assessment rate of $0.0003 per pound of assessable pistachios. The assessment rate of $0.0003 is $0.0004 lower than the rate currently in effect. The volume of assessable pistachios for the 2024-2025 production year is estimated at one billion pounds. Thus, the $0.0003 per pound of assessable pistachios should provide $300,000 in assessment income (1,000,000,000 pounds multiplied by $0.0003 assessment rate). Income derived from handler assessments, along with CPRB management income of approximately $220,200 and funds from the Committee's authorized reserve of approximately $436,500, should be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2024-2025 production year include $512,900 for salaries and related expenses, $125,000 for research, $100,000 for a contingency fund, $73,500 for administrative expenses, and $10,000 for compliance expenses. By comparison, budgeted expenses for these activities for the 2023-24 production year were $631,900, $125,000, $200,000, $76,450, and $10,000, respectively.

The Committee recommended decreasing the assessment rate to utilize funds from the authorized reserve to cover Committee expenditures and ensure the financial reserve remains in compliance with Order requirements.

Prior to arriving at this budget and assessment rate, the Committee considered alternate potential expenditure levels and the impact of reducing the assessment rate more and/or less than the rate herein. However, the Committee determined that the recommended assessment rate would achieve its goals of both adequately funding Committee operations and reducing the reserve to an appropriate level.

A review of historical information and preliminary information pertaining to the upcoming production year indicates the average producer price for the 2024-2025 season should be approximately $2 per pound. Therefore, the estimated assessment revenue for the 2024-2025 production year as a percentage of total producer revenue is expected to be about .015 percent ($0.0003 divided by $2 multiplied by 100).

This action decreases the assessment obligation imposed on pistachio handlers. Assessments are applied uniformly on all handlers, and some of the cost may be passed on to producers. However, these costs are expected to be offset by the benefits derived by the operation of the Order.

The Committee's meetings are widely publicized throughout the pistachio industry and all interested persons are invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the April 9, 2024, and July 10, 2024, meetings were public and all entities, both large and small, were able to express views on this issue. Finally, interested persons were invited to submit comments on this rule, including the regulatory and information collection impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0215, Pistachios. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

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

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

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

A proposed rule concerning this action published in the Federal Register on October 30, 2024 (89 FR 86287). A 30-day comment period ending November 29, 2024, was provided to all interested persons to respond to the proposal. AMS received three comments regarding this proposal. One comment supported the decreased assessment rate and two comments did not address the merits of the proposed rule. Accordingly, AMS made no changes to the rule as proposed.

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

After consideration of all relevant material presented, including the information and recommendations submitted by the Committee and other available information, AMS has determined that this rule is consistent with and will effectuate the declared policy of the Act.

For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 983 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:

The Commission is adopting amendments to 17 CFR 201.431 (“Rule 431”).

Rule 431 of the Commission's Rules of Practice governs Commission review of actions made pursuant to delegated authority. 1 Rule 431(e)  2 provides that an action made pursuant to delegated authority shall have immediate effect and be deemed the action of the Commission. The rule also provides that, upon filing with the Commission of a notice of intention to petition for Commission review by an aggrieved person, or upon the vote of one member of the Commission that a matter be reviewed, an action made pursuant to delegated authority is automatically stayed until the Commission orders otherwise. The automatic stay does not apply to certain delegated actions specified in Rule 431(e). The Commission is now amending Rule 431(e) to add determinations of the effectiveness of a registration statement and post-effective amendments to a registration statement and determinations of the date and time of qualification of an offering statement and post-qualification amendments to an offering statement under Regulation A  3 to the list of actions for which there shall be no automatic stay of delegated action when the Commission reviews an action taken by delegated authority.

Section 5 of the Securities Act of 1933 (“Securities Act”)  4 requires that a registration statement be in effect as to a security before an issuer may sell it. 5 Under section 8(a) of the Securities Act (“section 8(a)”), 6 a registration statement becomes effective automatically, without Commission or staff action, on the twentieth day after the registration statement is filed. Securities Act Rule 461  7 and Rule 473, 8 implementing section 8(a), provide for an alternative process that allows an issuer to delay automatic effectiveness of a Securities Act registration statement by including a “delaying amendment.”  9

If an issuer includes a delaying amendment, effectiveness of the registration statement is delayed until: (i) the issuer files an amendment specifically stating that the registration statement shall become automatically effective in accordance with section 8(a) of the Securities Act, or (ii) such date as the Commission, acting pursuant to section 8(a), may determine (the “acceleration process”). 10 To use the acceleration process, the issuer submits a request that the Commission accelerate the effective date of a registration statement pursuant to Securities Act Rule 461. Following the issuer's request for acceleration of effectiveness, the staff, acting pursuant to its delegated authority, will accelerate the effective date of the registration statement if it meets the criteria under section 8(a) and Securities Act Rule 461. 11

Regulation A provides an exemption from the Securities Act registration requirements for certain offers and sales of securities. 12 Any issuer relying on this exemption must file an offering statement, 13 and the Commission must qualify the offering statement before the issuer may sell securities. 14 As with a registration statement, the Commission has delegated its authority to qualify an offering statement to the Division of Corporation Finance. 15

The ability to use the acceleration and qualification processes provides issuers flexibility to time their securities offerings based on prevailing market conditions and other transactional considerations. Once a registration statement is effective, market participants such as issuers, underwriters, and the exchange on which the securities will be listed, if any, can immediately engage in market activities related to sales in reliance on the effective registration statement, and often do. Similar considerations apply to sales made in reliance on Regulation A.

We believe that when the acceleration and qualification processes are used, having a stay of the staff's determination go into effect automatically upon the filing of a notice of intent or petition for review, or upon the vote of one member of the Commission that a matter be reviewed, would be unnecessary and disruptive to the registration and qualification processes. 16 Once the registration statement is effective, or the offering statement is qualified, the issuer, underwriters, if any, and other market participants may commence sales of the securities. As a result, an automatic stay of the staff's determination to accelerate effectiveness or to qualify an offering statement after sales have commenced would disrupt the sales process, and market participants could experience costs and uncertainty as a result.

For example, an offering delay or interruption due to an automatic stay could adversely impact the issuer's or selling securityholder's access to capital by delaying the ability to raise the necessary financing, as well as subjecting the issuer or selling securityholder to the risk of adverse changes in financing conditions during the automatic stay, which could result in a decrease in the amount of financing or a worsening of financing terms, or even jeopardize offering completion. An automatic stay implemented after an offering has commenced could similarly negatively affect the issuer or any selling securityholders and also create uncertainty for underwriters that have sold securities and investors that have purchased securities in the affected offering.

Because of the potential disruptive consequences of an automatic stay in this scenario, we are amending Rule 431(e). Rather than automatically stay delegated actions to accelerate the effectiveness of registration statements or to determine the qualification of offering statements, we believe that it is appropriate that the Commission consider on a case-by-case basis whether to impose a stay when, in the context of an effectiveness or qualification decision, (1) a person aggrieved by an action taken pursuant to delegated authority files a notice of intention to petition for Commission review of a staff delegated action pursuant to Rule 430  17 or (2) a single member of the Commission votes to bring a staff delegated action before the full Commission for review pursuant to Rule 431. This will allow the full Commission, on a case-by-case basis, to assess, among other appropriate considerations, whether: (1) there is a likelihood of inadequate disclosure in the registration or offering statement; and (2) the balance of harms from the potential inadequate disclosures are sufficient to justify the imposition of a stay given the potential disruptive consequences that a stay would cause.

Furthermore, we are extending this approach to include post-effective amendments to a registration statement and post-qualification amendments to an offering statement. Under section 8(c) of the Securities Act, a post-effective amendment to a registration statement becomes effective on a date determined by the Commission so long as the amendment does not, “upon its face, appear[ ] . . . to be incomplete or inaccurate in any material respect.” The Commission similarly determines the date and time to qualify post-qualification amendments to an offering statement. 18 Staff has, and exercises, delegated authority to take effective post-effective amendments and qualify post-qualification amendments. 19 Just as an automatic stay would be disruptive and create unnecessary uncertainty in the context of a staff determination to take a registration statement effective or to qualify an offering statement, similar consequences could flow from an automatic stay when the staff takes effective a post-effective amendment or qualifies a post-qualification amendment.

Although we are eliminating the automatic stay for determinations of the effectiveness of a registration statement and post-effective amendments and determinations of the qualification of an offering statement and post-qualification amendments under Regulation A, there are still important safeguards to help ensure robust investor protection. For example, Securities Act section 8(b) allows the Commission to issue an order preventing a registration statement from becoming effective, 20 and section 8(d) permits the Commission to issue a stop order to suspend the effectiveness of a registration statement. 21 Similarly, Securities Act Rule 258 allows the Commission to enter an order suspending a Regulation A exemption at any time. 22 We therefore believe that this amendment to Rule 431(e) will provide issuers, investors, and other market participants with greater predictability and certainty in the registration and qualification processes while also maintaining investor protection and appropriate regulatory safeguards. 23

The Commission finds, in accordance with section 553(b)(A) of the Administrative Procedure Act (“APA”), that these revisions relate solely to agency organization, procedures, or practice and do not constitute a substantive rule. They are therefore not subject to the APA provisions regarding notice of rulemaking, opportunity for public comment, and advance publication of the amendments. For the same reason, and because these amendments do not affect the rights or obligations of non-agency parties, the provisions of the Small Business Regulatory Enforcement Fairness Act are not applicable. Additionally, the provisions of the Regulatory Flexibility Act, which apply only when notice and comment are required by the APA, are not applicable. These amendments do not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995.

We are adopting amendments relating to procedures governing Commission review of staff actions made pursuant to delegated authority. These amendments expand the list of actions for which there will be no automatic stay when a delegated action is reviewed by the Commission; they do not impose any substantive regulatory obligations on any person or otherwise. Staff already reviews certain registration statements and post-effective amendments for compliance with the Securities Act and Exchange Act and regulations thereunder before declaring a registration statement effective pursuant to delegated authority. Staff similarly reviews certain offering statements and post-qualification amendments to those offering statements filed under Regulation A before qualifying them.

The amendments are likely to benefit an affected issuer (as well as underwriters, investors, and any selling securityholders) by avoiding the costs and uncertainty resulting from an automatic stay in the event that a petition for review is filed pursuant to Rule 430 by a person aggrieved by an action taken pursuant to delegated authority, or the Commission reviews the action on its own initiative under Rule 431. The amendments do not preclude an aggrieved party from filing a petition for Commission review of an action taken by delegated authority, or a member of the Commission from bringing such an action before the full Commission.

In light of this, we do not believe the amendments will have a substantial economic impact, including an effect on efficiency, competition, or capital formation. Further, we do not believe that the amendments would impose substantial new burdens on private parties or have significant impacts on competition for purposes of section 23(a)(2) of the Exchange Act.

These technical amendments are being adopted pursuant to statutory authority granted to the Commission under sections 4A and 23(a) of the Exchange Act.

For the reasons stated in the preamble, the Commission is amending title 17, Chapter II of the Code of Federal Regulations as follows:

This statement concerns requests to accelerate the effective date of registration statements filed under the Securities Act of 1933 (“Securities Act”)  1 by issuers with a mandatory arbitration provision for investor claims arising under the Federal securities laws  2 (“issuer-investor mandatory arbitration provision”). 3 As discussed in further detail in section II.C. there have been a number of developments involving the U.S. Supreme Court's (“Supreme Court” or “Court”) interpretation and application of the Federal Arbitration Act of 1925 (“FAA” or “Arbitration Act”)  4 that inform such acceleration requests. In addition, as discussed in further detail in Section II.B., potential uncertainty exists regarding the intersection of the FAA and state law. For example, Delaware recently amended its General Corporation Law in a way that may prohibit certificates of incorporation or bylaws from including an issuer-investor mandatory arbitration provision. 5 Other states may adopt different approaches on this issue. Notwithstanding these developments and potential uncertainty, the Commission has not spoken publicly on this topic even though, during the registration process, issuers have on occasion sought to include such a provision in their Securities Act registration statements. 6

In order to provide issuers with greater certainty concerning the Commission's approach to requests to accelerate the effective date of a registration statement disclosing an issuer-investor mandatory arbitration provision, we are issuing this policy statement. For the reasons explained in this statement, we have determined that the presence of an issuer-investor mandatory arbitration provision  7 will not impact decisions whether to accelerate the effectiveness of a registration statement under the Securities Act. 8 Accordingly, when considering acceleration requests pursuant to Securities Act section 8(a)  9 and Rule 461 thereunder, 10 the staff will focus on the adequacy of the registration statement's disclosures, including disclosure regarding issuer-investor mandatory arbitration provisions. 11

Section 5 of the Securities Act requires that a registration statement must be in effect as to a security before an issuer may sell it. 12 Section 8(a) provides that a Securities Act registration statement becomes effective automatically 20 calendar days after it is filed. Securities Act Rule 473(a)  13 permits an issuer to include a “delaying amendment” on the front page of a registration statement that extends the effective date to: (1) 20 calendar days after the issuer complies with Rule 473(b);  14 or (2) an indefinite period that will end when the Commission grants the issuer's request to accelerate the effective date of the registration statement. The issuer may submit a request for acceleration under Rule 461 specifying when it wants the registration statement declared effective. The staff, acting pursuant to its delegated authority, will accelerate the effective date of a registration statement if it meets the criteria under section 8(a) and Rule 461. 15

The section 8(a) criteria are primarily focused on ensuring complete and adequate disclosure of material information to the public. Additionally, the criteria require consideration of “the public interest and the protection of investors.”  16 Courts have considered the scope of the public interest and investor protection standard in the context of the Federal securities laws and determined that, when applying this standard, it is only permissible to consider those matters over which the Commission has authority under the Federal securities laws. 17

During the registration process, issuers have on occasion asked whether the presence of an issuer-investor mandatory arbitration provision would impact acceleration of the effectiveness of their registration statement. 18 An issuer-investor mandatory arbitration provision may implicate the Arbitration Act, which establishes a “liberal Federal policy favoring arbitration agreements.”  19 Section 2 of the statute, which is the FAA's principal substantive provision, provides in pertinent part that “[a] written provision in . . . a contract evidencing a transaction involving commerce to settle by arbitration a controversy thereafter arising out of such contract or transaction . . . shall be valid, irrevocable, and enforceable.”  20

Whether the FAA may apply to an issuer-investor mandatory arbitration provision turns in the first instance on whether there is a valid and enforceable written agreement to arbitrate. 21 Assuming it is written, whether an agreement to arbitrate is valid and enforceable is generally determined based on “the contract law of the state governing the agreement.”  22 However, a state law that “target[s] the enforceability of [mandatory] arbitration agreements either by name or by more subtle methods, such as by `interfering with fundamental attributes of arbitration' ” may be preempted by the Arbitration Act. 23 The applicability of the FAA to a particular issuer-investor mandatory arbitration provision is a legal matter implicating the intersection of a Federal statute that Congress did not authorize the Commission to administer, and the unique laws of the state or other jurisdiction governing the provision. 24 Accordingly, we do not consider it within the Commission's purview to conclude whether any particular issuer-investor mandatory arbitration provision is enforceable for purposes of the FAA.

Assuming the FAA applies to a particular issuer-investor mandatory arbitration provision, there is a separate question whether the Federal securities statutes override the FAA. In the past, the Federal securities statutes were thought to potentially override the FAA because issuer-investor mandatory arbitration provisions could be viewed as inconsistent with the Federal securities statutes in at least two respects: (1) issuer-investor mandatory arbitration provisions could violate the anti-waiver provisions of the Federal securities statutes by foreclosing a judicial forum;  25 and (2) such provisions could unduly impede the ability of investors to bring private actions to vindicate their rights under the Federal securities laws by foreclosing class action litigation in courts.

After considering the Supreme Court's jurisprudence relating to the FAA and analyzing case-law developments involving the intersection of the FAA and other Federal statutes, we have concluded that, in the context of issuer-investor mandatory arbitration provisions, the Federal securities statutes do not override the Arbitration Act's policy favoring enforcement of arbitration agreements. This conclusion follows from the fact that nothing in the text of the anti-waiver provisions or any other provision of the Federal securities statutes demonstrates a clearly expressed congressional intention to except issuer-investor mandatory arbitration provisions from the Arbitration Act's policy favoring arbitration. Because the Federal securities statutes do not override the Arbitration Act when it applies to the enforceability of an issuer-investor mandatory arbitration provision, the existence of such a provision is not within the ambit of appropriate considerations under section 8(a)'s public interest and investor protection standard and will not impact determinations whether to accelerate the effective date of a registration statement. 26

Applying current and relevant Supreme Court precedent, there is no basis to conclude that either the anti-waiver provisions or any other provision of the Federal securities statutes displaces the primacy of the Arbitration Act in the context of issuer-investor mandatory arbitration provisions.

For many decades, the anti-waiver provision set forth in section 14 was understood to prohibit issuer-investor mandatory arbitration provisions relating to Federal securities law claims. In a 1953 decision involving the enforceability of an arbitration agreement between a brokerage firm and its customers, the Supreme Court held that “the right to select the judicial forum is the kind of `provision' that cannot be waived under [section] 14 of the Securities Act.”  27 In reaching this conclusion, the Court agreed with the firm's customer (who purchased the securities at issue in the dispute) that “the purpose of Congress [in enacting the anti-waiver provision] was to assure that sellers could not maneuver buyers into a position that might weaken their ability to recover under the Securities Act.”  28 The Court expressed the view that, “[w]hile a buyer and seller of securities, under some circumstances, may deal at arm's length on equal terms, it is clear that the Securities Act was drafted with an eye to the disadvantages under which buyers labor. Issuers of and dealers in securities have better opportunities to investigate and appraise the prospective earnings and business plans affecting securities than buyers. It is therefore reasonable for Congress to put buyers of securities covered by that [Securities] Act on a different basis from other purchasers” who are otherwise subject to the terms of the FAA. 29

But in a pair of decisions in the late 1980s, the Supreme Court took a different course. 30 The first of these was a 1987 decision in which the Court considered whether the anti-waiver provision in section 29(a) precludes enforcement of an arbitration agreement between a broker-dealer and its customer. Even though the text of the Exchange Act's anti-waiver provision is substantively identical to the Securities Act's provision, the Court held that it does not prohibit the enforcement of arbitration agreements. 31 The Court explained that by its terms the provision declares void only an agreement that waives “compliance with any provision of” the Exchange Act, which the Court read to prohibit only waiver of the act's substantive obligations. 32 Based on that understanding, the Court concluded that the anti-waiver provision does not render unenforceable agreements that waive section 27 of the Exchange Act, 33 which confers Federal courts with exclusive subject matter jurisdiction over violations of that Act, because this jurisdictional provision does not impose any statutory duties. 34

Two years later, in another dispute involving a brokerage firm and its customer, the Court reconsidered whether the anti-waiver provision in section 14 precludes the enforcement of mandatory arbitration arrangements. Based on the text of the anti-waiver provision, the Court held that section 14 applies only to the substantive provisions of the Securities Act, not to its jurisdictional or procedural provisions. 35 Further, the Court explained that its prior holding in 1953 reflected a judicial hostility to arbitration that it has since abandoned:

The Court also explained that “[t]o the extent that [its prior decision] rested on suspicion of arbitration as a method of weakening the protections afforded in the substantive law to would-be complainants, it has fallen far out of step with our current strong endorsement of the Federal statutes favoring this method of resolving disputes.”  37 The Court concluded that “resort to the arbitration process does not inherently undermine any of the substantive rights afforded to petitioners under the Securities Act.”  38

Although these two Supreme Court decisions applying the anti-waiver provisions did not involve the precise issue of issuer-investor mandatory arbitration provisions, we discern no reason to believe that any different result should follow. 39 Accordingly, we believe that the inability to proceed in a judicial forum as a result of an issuer-investor mandatory arbitration provision would not violate the anti-waiver provisions of the Federal securities statutes.

Moreover, in subsequent decisions, the Supreme Court has noted that, in any Federal statute enacted after the Arbitration Act, which would include each of the Federal securities statutes, there must be a “clearly expressed congressional intention” to override the act. 40 As the Court has explained, “the intention must be ‘clear and manifest,’ ”  41 and while the Court has not gone so far as to require unambiguous statutory language overriding the Arbitration Act, the Court has explained that when Congress does not displace the FAA using unambiguous statutory language, there is a “strong presumption” that the FAA applies exclusively to any issues regarding the enforceability of the arbitration agreement, and the other Federal statute that gives rise to the underlying substantive claims has no relevance to any arbitration issues. 42

In applying this standard, we can discern nothing in the Federal securities statutes that demonstrates a clear and manifest congressional intention to displace the FAA in the context of issuer-investor mandatory arbitration agreements. The absence of any clearly expressed congressional intent is particularly striking given that in 2010 Congress expressly granted the Commission rulemaking authority to limit, condition, or prohibit arbitration agreements between broker-dealers and their customers and comparable authority over arbitration agreements between, among others, investment advisers and their clients. 43

When considering section 8(a) and Rule 461's public interest and investor protection standard for accelerating the effectiveness of registration statements, a concern has been that issuer-investor mandatory arbitration provisions, which are presumed to be bilateral in nature, 44 could unduly impede the ability of investors to bring private actions to enforce the Federal securities laws by foreclosing class-wide proceedings. 45

But in 2013, the Supreme Court rejected a nearly identical argument involving private claims under the Federal antitrust statutes. In American Express Co. v. Italian Colors Restaurant, 46 the Court held that the Arbitration Act requires the enforcement of a mandatory arbitration agreement for bilateral arbitration even though the plaintiff's cost of individually arbitrating the antitrust claims would exceed the potential recovery. In the Court's view, enforcement of the arbitration requirement would not “contravene the policies of the antitrust laws” because those laws “do not guarantee an affordable procedural path to the vindication of every claim.”  47

In support of this conclusion, the Court observed that nothing in the Federal antitrust statutes affords a right to bring a class action and, in fact, those statutes were enacted years before class actions were even authorized in Federal courts. 48 No person seeking to vindicate a claim under the Federal antitrust statutes in a bilateral arbitration proceeding that forecloses class-action or collective proceedings would, in the Court's view, be any worse off than a person proceeding under those statutes when they were enacted because at that time there was no allowance for class or collective procedures. 49 Based on that historical perspective, the Court ultimately found no difficulty with enforcing the agreement for bilateral arbitration and concluded that the FAA controls. 50 As the Court explained, because nothing in the Federal antitrust statutes affords a right to vindicate one's private claims through class or collective actions, the “contrary congressional command” required by the Court's decisions to displace the Arbitration Act's policy favoring arbitration was lacking. 51

Similar to the Court's findings with the Federal antitrust statutes, no provision in the Federal securities statutes “guarantee[s] an affordable procedural path to the vindication of every claim.”  52 Further, like the Federal antitrust statutes, the Federal securities statutes do not expressly include a right to proceed through class actions or collective actions. Finally, because the Securities Act and the Exchange Act (like the antitrust statutes at issue in Italian Colors ) were enacted before class-action proceedings were permitted, it stands to reason that “the individual suit” based on claims under those acts that was considered adequate and consistent at the time those statutes were enacted remains so notwithstanding the advent of class-action litigation. 53 Accordingly, the potential for an issuer-investor mandatory arbitration provision to diminish, or even eliminate, the economic incentive for some investors to bring private claims under the Federal securities laws is not a sufficient basis to conclude that the Federal securities statutes displace the Arbitration Act's mandate. 54

For the reasons discussed above, the Commission has determined that the presence of an issuer-investor mandatory arbitration provision will not impact decisions regarding whether to accelerate the effectiveness of a registration statement. While the discussion above focuses on the Court's application of the FAA, we acknowledge there may be instances in which the FAA does not apply, such as where there is no valid and enforceable written agreement for purposes of the FAA. Given that neither the Commission nor the staff is well-positioned to conclusively determine when the FAA applies, 55 and in light of the case-law developments discussed above, we believe that any relevant issues concerning an issuer-investor mandatory arbitration provision are best addressed through complete and adequate disclosure of material information in the registration statement. Accordingly, when considering acceleration requests pursuant to section 8(a) and Rule 461, the staff will focus on the adequacy of the registration statement's disclosures, including disclosure regarding issuer-investor mandatory arbitration provisions. Nothing in this statement should be understood to express any views on the specific terms of an arbitration provision, or whether arbitration provisions are appropriate or optimal for issuers or investors.

Pursuant to the Congressional Review Act, 56 the Office of Information and Regulatory

Affairs has designated this policy statement as not a “major rule,” as defined by 5 U.S.C. 804(2). This statement is a significant regulatory action under Executive Order 12866, as amended, and has been reviewed by the Office of Management and Budget.

This statement does not impose any new rules, regulations, or other requirements on issuers, but could influence issuer behavior to the extent that an issuer did not previously have an issuer-investor mandatory arbitration provision. This is in part due to concerns about potential impacts on acceleration requests. After publication of this statement, it is possible that some issuers may adopt issuer-investor mandatory arbitration provisions, which could potentially deter or prevent some investors from filing civil actions arising under the Federal securities laws. For both issuers and investors, adoption of such provisions would likely impact the cost of resolving future investor claims for damages and the extent of any monetary or other relief that might be awarded in connection with such claims. However, it is difficult to estimate how many issuers are likely to adopt issuer-investor mandatory arbitration provisions, or the ultimate economic impact of any such provisions, if adopted.

Some issuers may choose not to include such provisions due to potential state law considerations or concern about potential negative reactions from shareholders and other investors. Actions or potential actions by others, including proxy voting advice businesses, stock exchanges, and institutional investors, can be expected to influence the number of issuers who adopt arbitration of issuer-investor claims arising under the Federal securities laws. Further, some issuers may already have issuer-investor mandatory arbitration provisions, irrespective of this statement. A number of other issuers may have no plans to register an offering or class of securities, and thus would not be affected by this statement.

The statement contained in this release is being adopted pursuant to the authority set forth in section 19 of the Securities Act and section 23 of the Exchange Act.

For the reasons set forth in the preamble, the Commission is amending title 17, chapter II of the Code of Federal Regulations as follows:

The Commissions are extending the compliance date of the Final Form PF under the Investment Advisers Act of 1940 (the “Advisers Act”). 1

On February 8, 2024, the Commissions adopted amendments to Form PF [17 CFR 279.9]  2 under the Advisers Act (as amended, the “Final Form PF”). 3 Form PF is the form that certain SEC-registered investment advisers, including those that also are registered with the CFTC as a CPO or a CTA, use to report confidential information about the private funds  4 that they advise.

The Commissions initially established a single effective and compliance date for the Final Form PF of March 12, 2025, which was one year from its date of publication in the Federal Register (the “Initial Compliance Date”). On January 29, 2025, the Commissions extended the compliance date of Final Form PF to June 12, 2025, to address certain challenges associated with the timing of reporting cycles for Form PF. 5

Subsequently, the Commissions became aware of remaining significant challenges associated with coming into compliance with the Final Form PF by June 12, 2025, and further extended the compliance date to October 1, 2025 (the “Current Compliance Date”). 6 Accordingly, filers have been allowed to file the version of Form PF in effect prior to the Final Form PF amendments (the “Current Form PF”) until the Current Compliance Date.

Since the Initial Compliance Date extension, commenters have stated that the Final Form PF raises questions related to a January 2025 Presidential Memorandum or that it otherwise requires additional consideration. 7 Specifically, on January 20, 2025, President Donald J. Trump signed a Presidential Memorandum directing agencies to consider postponing the effective date of any rules that had been published in the Federal Register , or that were issued but had not yet taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise. 8 Although the Presidential Memorandum prescribed an initial review period of only 60 days, it also directed agencies to consider further delaying, or publishing for notice and comment, proposals to further delay such rules beyond the 60-day period where necessary to continue to review these questions of fact, law, and policy. The Presidential Memorandum further provides that, for those rules that raise substantial questions of fact, law, or policy, agencies should provide notice and take further appropriate action. 9

In light of these comments, when extending the June 2025 compliance date for Final Form PF, the Commissions indicated that we may continue to review whether Final Form PF raises substantial questions of fact, law, or policy during the extended compliance period. 10 Having now initiated that review, we believe more time is needed to complete a substantive review of Form PF and determine whether any further action is needed. Therefore, we are granting a further compliance date extension to October 1, 2026 to provide time for the Commissions to complete their review in accordance with the Presidential Memorandum and, to the extent there are substantial questions of fact, law, or policy, take any further appropriate actions, which may include proposing new amendments to Form PF. 11 This time period will allow such review, and any related action, to occur in a manner that could reduce the costs advisers may incur to comply with any amendments that could change. As part of this review, the Commissions will continue to consider the costs and benefits of Final Form PF. 12 If the Commissions determine that no further amendments to Form PF are needed after the completion of their review, the delayed compliance date in this release is intended to provide advisers with sufficient time to comply with the amendments after being notified that the Commissions' review is complete. 13

The SEC is mindful of the economic effects, including the costs and benefits, of the compliance date extension. Section 202(c) of the Advisers Act provides that when the SEC is engaging in rulemaking under the Advisers Act and is required to consider or determine whether an action is necessary or appropriate in the public interest, the SEC shall also consider whether the action will promote efficiency, competition, and capital formation, in addition to the protection of investors.

The baseline against which the costs, benefits, and the effects on efficiency, competition, and capital formation of the compliance date extension are measured consists of the current state of the market, Form PF filers' current practices, and the current regulatory framework, including recently adopted rules. The changes to the Form PF represented in the Final Form PF will impact all categories of private fund advisers. These include, but are not limited to, advisers to hedge funds, private equity funds, real estate funds, securitized asset funds, liquidity funds, and venture capital funds. 14

As discussed above, the Commissions extended the Initial Compliance Date for the Final Form PF from March 12, 2025, to June 12, 2025, and later adopted another extension until the Current Compliance Date of October 1, 2025 to address certain challenges associated with coming into compliance with the Final Form PF that had nevertheless remained. 15 The latter extension allows Form PF filers to continue to file the Current Form PF until the Current Compliance Date.

This final rule will extend the compliance date for the Final Form PF to October 1, 2026 to provide further time for the Commissions to complete their review in accordance with the Presidential Memorandum and, to the extent there are substantial questions of fact, law, or policy, take any further appropriate actions, which may include proposed amendments to Form PF. 16 The additional extension will affect all advisers required to file the Final Form PF. 17 Regardless of whether the Commissions determine to further amend the Final Form PF following their review, the delayed compliance date will save the affected advisers the incremental costs of complying with the Final Form PF during the one-year extension. 18 If the Commissions determine that no further amendments to Form PF are needed after the completion of their review, the delayed compliance date in this release is also intended to provide advisers with sufficient time to comply with the amendments after being notified that the Commissions' review is complete. 19

The costs of extending the compliance date to October 1, 2026 are related to the Commissions and the Financial Stability Oversight Council (the “FSOC”) not receiving the updated information collected on Final Form PF during the extended compliance period, because the extension delays the realization of economic benefits from the new information on Final Form PF. 20 For example, to the extent that there are significant market events during the extension period, extending the compliance date may result in forgone benefits from the Commissions and the FSOC not receiving this information on Final Form PF.

The extension of the compliance date also will further delay the accrual of any effects on market efficiency, competition, and capital formation described in the 2024 Adopting Release.

As an alternative, we could have provided a shorter or longer compliance date extension ( e.g., 6-month or 2-year extension). However, we believe that a shorter extension would not provide enough time for the Commissions' review of the Final Form PF and, after notification that the review is complete, provide advisers with sufficient time to comply with the amendments if the Commissions determine that no further amendments to Form PF are needed. Conversely, a longer extension would extend the accrual of benefits from the augmented information on Final Form PF longer than necessary if there are no further amendments.

The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a rulemaking in the Federal Register and provide an opportunity for public comment. This requirement does not apply, however, if the agency “for good cause finds . . . that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.”  21

The Commissions, for good cause, find that notice and solicitation of public comment to further extend the compliance date for the Final Form PF are impracticable, unnecessary, or contrary to the public interest. 22 This extension does not impose any new substantive regulatory requirements on any person and merely reflects the further extension of the compliance date for the Final Form PF. For the reasons discussed above, an extension of the compliance date to October 1, 2026, is designed to provide the Commissions sufficient time to complete their review in accordance with the Presidential Memorandum and, to the extent there are substantial questions of fact, law, or policy, take any further appropriate actions. Given the time constraints, a notice and comment period could not reasonably be completed prior to the Current Compliance Date.

For similar reasons, although the publication of a rule is generally required at least 30 days before its effective date, the requirements of 5 U.S.C. 553(d)(3) and 808(2) are satisfied (notwithstanding the requirement of 5 U.S.C. 801)  23 and therefore the good cause exception applies to this action. 24

Pursuant to the Congressional Review Act, the Office of Information and Regulatory Affairs has designated these amendments as not a “major rule,” as defined by 5 U.S.C. 804(2). The Office of Management and Budget has determined that this action is not a significant regulatory action as defined in Executive Order 12866, as amended, and therefore it was not subject to Executive Order 12866 review.

In the Federal Register document 2025-16079 published on August 22, 2025 (90 FR 40966), the amendatory language in instruction 24 directing revisions in paragraph (e)(1)(vii) was an error. On page 40971, the table under § 558.68 Avilamycin, contained an extra row with information that was not part of this drug application. This document corrects these errors.

In FR Doc. 2025-16079, published August 22, 2025, at 90 FR 40966, make the following correction:

In the Federal Register of May 6, 2024, FDA published a final rule entitled “Medical Devices; Laboratory Developed Tests” (89 FR 37286) (codified at 21 CFR 809.3) (the Rule). The Rule added the words “including when the manufacturer of these products is a laboratory” to the Agency's regulations at 21 CFR 809.3(a).

On March 31, 2025, the United States District Court for the Eastern District of Texas issued a final judgment in Am. Clinical Lab'y Ass'n v. FDA, No. 4:24-CV-479-SDJ, 2025 U.S. Dist. LEXIS 59869 (E.D. Tex. Mar. 31, 2025), vacating and setting aside the Rule and remanding the matter to the Secretary of Health and Human Services for further consideration.

FDA is removing the words “including when the manufacturer of these products is a laboratory” from 21 CFR 809.3(a), reverting to the text of the regulation as it existed prior to the effective date of the Rule. This update is being made to reflect the court's order vacating the Rule. 1

Under the Administrative Procedure Act (APA) at 5 U.S.C. 551(4), a rule means “the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency.” Under the APA at 5 U.S.C. 553(b)(B), notice and comment rulemaking procedures generally do not apply when an agency for good cause finds that such procedures would be “impracticable, unnecessary, or contrary to the public interest.”

FDA has determined that this final rule meets the APA's notice and comment exemption under 5 U.S.C. 553(b)(B). On March 31, 2025, the United States District Court for the Eastern District of Texas vacated and set aside the Rule. Because the Rule has already been vacated, this action is ministerial in nature and merely removes text from the Code of Federal Regulations to reflect the court's order. Accordingly, FDA for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.

The APA allows an effective date less than 30 days after publication of a rule as “provided by the agency for good cause found and published with the rule” (5 U.S.C. 553(d)(3)). An effective date 30 or more days from the date of publication is unnecessary because a court has already vacated the Rule. This action does not impose any new regulatory requirements on affected parties, and affected parties do not need time to “adjust to the new regulation” before the rule takes effect. Am. Federation of Government Emp., AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir. 1981). Therefore, FDA for good cause finds that this action may become effective on the date of its publication.

We have examined the impacts of this action under Executive Order 12866, Executive Order 13563, and Executive Order 14192.

Executive Orders 12866 and 13563 direct us to assess all benefits and costs of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits. Rules are economically significant under Executive Order 12866 if they have an annual effect on the economy of $100 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The Office of Information and Regulatory Affairs (OIRA) has determined that this action is a significant regulatory action under Executive Order 12866.

Executive Order 14192 requires that any new incremental costs associated with certain significant regulatory actions “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This action is considered an Executive Order 14192 deregulatory action.

On May 6, 2024, FDA published the Rule. The primary estimate of the total annualized cost of the Rule over a 20-year time horizon was $1.29 billion at a 7 percent discount rate and $1.37 billion at a 3 percent discount rate, both reported in constant 2022 dollars. We report these costs in constant 2024 dollars as $1,384.98 million at 7 percent discount rate and $1,475.93 million at 3 percent discount rate after adjusting for inflation using the GDP deflator. For purposes of estimating the cost savings of the vacatur of the Rule, costs for reading and understanding the Rule represent sunk costs while the remaining costs constitute cost savings. 2 The estimated sunk cost of the Rule is $0.34 million at 7 percent discount rate and $0.25 million at 3 percent discount rate.

Table 1 summarizes the estimated forgone benefits and cost savings resulting from the Rule no longer being in effect. A simple reversal of the estimates published with the Rule indicates that now, the annualized forgone benefits over 20 years would be $3,723.39 million and $4,606.01 million and at 7 and 3 percent discount rate, respectively. The total annualized cost savings are $1,444.45 million and $1,539.50 million at 7 and 3 percent discount rate, respectively. The annualized cost savings of $1,444.45 million represent $1,365.53 million to domestic entities and $78.92 million in pass-through cost savings from foreign entities at a 7 percent discount rate. Similarly, the annualized cost savings of $1,539.50 million represent $1,455.14 million to domestic entities and $84.35 million in pass-through cost savings from foreign entities at a 3 percent discount rate. 3 Portions of the broader benefit and cost uncertainty ranges overlap, thus indicating the possibility of negative net benefits of the Rule and positive net benefits of its no longer being in effect. Moreover, the quantitative estimates omit various regulatory consequences that are especially challenging to assess, such as any possible effect on innovation related to laboratory-developed tests (LDTs) associated with the Rule.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 809 is amended as follows:

This document, as well as the notice of proposed rulemaking (NPRM), and all comments received may be viewed online at www.regulations.gov using the docket number listed above. Electronic retrieval assistance and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of Federal Register's website at www.federalregister.gov and the U.S. Government Publishing Office's website at www.GovInfo.gov.

FHWA is rescinding the rule, issued on February 27, 2004 at 69 FR 9483 that established regulations at Title 23 of the Code of Federal Regulations (CFR) part 972 concerning FWS Management Systems. The rule provided for the development and implementation of safety, bridge, pavement, and congestion management systems for transportation facilities serving the National Wildlife Refuge System (Refuge System) funded under the Federal Lands Highway Program (FLHP), as required by the Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178) (1998). For the reasons explained below, FHWA has determined that this part is unnecessary and will rescind it in full.

Section 1115(d)(1) of TEA-21 amended the version of 23 U.S.C. 204 that existed at the time to add a paragraph (a)(6) stating: “The Secretary and the Secretary of each appropriate Federal land management agency shall, to the extent appropriate, develop by rule safety, bridge, pavement, and congestion management systems for roads funded under the Federal lands highway program.” The roads funded under FLHP included Refuge Roads. Through 23 CFR part 972, FHWA addressed the management systems for the Fish and Wildlife and the Refuge Roads programs. See 69 FR 9484.

On July 6, 2012, Congress enacted the Moving Ahead for Progress in the 21st Century Act (MAP-21) (Pub. L. 112-141). Section 1119(a) of MAP-21 removed FLHP under 23 U.S.C. 204, replacing that program with the Tribal Transportation Program (TTP) (23 U.S.C. 202), the Federal Lands Transportation Program (FLTP) (23 U.S.C. 203), and the Federal Lands Access Program (FLAP) (23 U.S.C. 204). In doing so, Congress repealed the previous version of 23 U.S.C. 204(a)(6) and replaced it with a similar provision at 23 U.S.C. 201(c)(5), which has remained unchanged. Under that provision, FHWA “and the Secretary of each appropriate Federal land management agency shall, to the extent appropriate, implement safety, bridge, pavement, and congestion management systems for facilities funded under the tribal transportation program and the Federal lands transportation program in support of asset management.”

FHWA first notes that the current regulations have become outdated due to subsequent statutory changes, and FHWA has issued more up-to-date guidance. 1 FHWA also finds it significant that Congress, in enacting MAP-21, retained the same general requirements for asset management in 23 U.S.C. 201(c)(5) but replaced the phrase “develop by rule” with the word “implement.” To the extent that FHWA and Federal land management agencies agree that safety, bridge, pavement, and congestion management systems are appropriate for certain facilities, such systems can be implemented without the need for regulations.

On May 30, 2025, at 90 FR 22887, FHWA published an NPRM to rescind 23 CFR part 972 in full and sought comments on all aspects of that proposal. FHWA received one public comment, urging FHWA to retain certain elements of the rule in updated guidance to ensure continued standardization, accountability, and data-driven planning. As outlined above, FHWA believes that the statutory provisions for TTP (23 U.S.C. 202), FLTP (23 U.S.C. 203), and FLAP (23 U.S.C. 204), in addition to existing guidance, provide the necessary framework to ensure these goals. As such, this final rule adopts the proposal without change.

This rule does not meet the criteria of a “significant regulatory action” under Executive Order (E.O.) 12866, as amended by E.O. 14215 and E.O. 13563. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under those orders.

This rule rescinds outdated regulations regarding management systems pertaining to FWS and the Refuge Roads Program. FHWA does not believe there are any costs to this rulemaking. FHWA anticipates some unquantified cost-savings associated with removal of unnecessary provisions from the CFR. In addition, it could result in some cost savings for FWS, but FHWA does not have the data to estimate the reduction in costs that would result from this final rule. The Agency requested comment on any impacts that could result from removing the provisions identified in its NPRM but did not receive any additional information.

These changes would not adversely affect, in a material way, any sector of the economy. In addition, these changes would not interfere with any action taken or planned by another agency and would not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Consequently, a full regulatory evaluation is not required.

This final rule is an E.O. 14192 deregulatory action. Cost-savings are not quantified.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act of 1996; 5 U.S.C. 601 et seq. ), agencies must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). No regulatory flexibility analysis is required; however, if the head of an agency or an appropriate designee certifies that the rule will not have a significant economic impact on a substantial number of small entities. FHWA has concluded and hereby certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities; therefore, an analysis is not included. This rule would only remove obsolete regulations that had provided for the development and implementation of management systems for transportation facilities serving the Refuge System funded under FLHP, as required by an outdated and superseded statutory provision.

This rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, 109 Stat. 48) for State, local and Tribal governments, or the private sector of $100 million or more in any one year. Thus, the rulemaking is not subject to the requirements of sections 202 and 205 of UMRA.

This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132. FHWA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism assessment. FHWA has also determined that this action does not preempt any State law or State regulation or affect the States' ability to discharge traditional State governmental functions.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. This rule is deregulatory and so would not impose any additional information collection requirements.

FHWA has analyzed this rule pursuant to the National Environmental Policy Act (NEPA) and has determined that it is categorically excluded under 23 CFR 771.117(c)(20), which applies to the promulgation of rules, regulations, and directives. Categorically excluded actions meet the criteria for categorical exclusions under 23 CFR 771.117(a) and normally do not require any further NEPA approvals by FHWA. This rulemaking would remove requirements regarding management systems that are currently outdated. FHWA does not anticipate any adverse environmental impacts from this rule, and no unusual circumstances are present under 23 CFR 771.117(b).

E.O. 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. FHWA has assessed the impact of this rule on Indian Tribes and determined that this rulemaking would not have Tribal implications that require consultation under E.O. 13175. This rule would only remove obsolete regulations, previously required by an outdated and superseded statutory provision. To the extent that FHWA and Federal land management agencies agree that safety, bridge, pavement, and congestion management systems are appropriate for certain facilities, such systems can be implemented without the need for regulations under the authorities provided by TTP (23 U.S.C. 202), FLTP (23 U.S.C. 203), and FLAP (23 U.S.C. 204).

A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in the spring and fall of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found at www.regulations.gov , under the docket number.

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists to waive prior notice and public comment for this temporary final rule. A permanent annual special local regulation for this event has already been published in the Code of Federal Regulations at 33 CFR 100.801 Table 1, Line 95. However, this action is necessary to accommodate the event's shift to an earlier date in September, rather than the event's usual date in October, making it impracticable to conduct a full notice and comment period before the event's scheduled occurrence this year.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with Shoals Scholar Dollar occurring on September 27, 2025, will be a safety concern for anyone within Tennessee River Mile Marker 255 to 257 due to the occurrence of this paddleboat event. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the special local regulation while the regatta is in progress.

This rule establishes a temporary special local regulation from 8 a.m. until 4 p.m. on September 27, 2025. The special local regulation will cover all navigable waters between Tennessee River Mile Marker 255 to 257. The duration of the special local regulation is intended to protect personnel, vessels, and the marine environment in these navigable waters during the regatta. No vessel or person will be permitted to enter the regulated area without first 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 analysis 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 not subject to notice and comment. As 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), we want to assist small entities in understanding this rule. If the rule affects your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves special local regulation lasting only 8 hours that will prohibit entry within Tennessee River Mile Markers 255 to 257 for the Shoals Scholar Dollar. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

For the reasons stated in the preamble, the Coast Guard amends 33 CFR part 100 as set forth below:

The primary purpose of this final rule is to amend the regulations pertaining to disclosure requirements under 42 CFR 422.111 for the Medicare Advantage (MA) (that is, Part C) program. In this final rule, CMS is finalizing a new requirement that will increase beneficiaries' access to provider data while comparing plans in the CMS Medicare Plan Finder (MPF) tool, which will contribute to the beneficiaries' ability to make more informed decisions about their health care.

CMS is finalizing the proposed requirement for MA provider directory data to be submitted to CMS/HHS for publication online in accordance with guidance from CMS/HHS. In addition, CMS is finalizing the proposal that MA provider directory data be updated within 30 days of the date an MA organization becomes aware of changes to that data. CMS is also finalizing the proposal to require MA organizations to attest at least annually that the MA provider directory information is accurate when the attestation is provided to CMS. These regulatory changes will further promote informed beneficiary choice and transparency found in online resources, empowering people with Medicare to make informed choices about their coverage. CMS is not finalizing the portion of the proposal that would have required MA organizations to attest that their MA provider directory data are consistent with data submitted to comply with CMS's MA network adequacy requirements under § 422.116(a)(2)(i). MA organizations already attest that they have an adequate network for access and availability of a specific provider or facility type.

The proposed rule titled “Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” appeared in the December 10, 2024, Federal Register (89 FR 99340) (hereinafter referred to as the “December 2024 proposed rule”).

In response to the December 2024 proposed rule, CMS received approximately 31,227 timely pieces of correspondence containing multiple comments on the proposed rule, with approximately 130 received about the provision to format provider directories for MPF being finalized here. CMS notes that some of the public comments were outside of the scope of the proposed rule.

In the subsequent final rule of the same title that appeared in the April 15, 2025, Federal Register (90 FR 15792) (hereinafter referred to as the “April 2025 final rule”), CMS finalized several of the provisions from the proposed rule and noted the provisions of the proposed rule that would not be addressed or finalized. CMS also indicated that any remaining provisions may be finalized in subsequent rulemaking, as appropriate. For more information, see the April 2025 final rule (90 FR 15891).

CMS continues to take steps to improve the usability of MPF to assist beneficiaries in making informed choices about their Medicare coverage. It is important that Medicare beneficiaries have the information they need to make the best choice for their health when they are exploring their plan options. Understanding which providers are in a plan's network is a vital piece for beneficiaries to make an informed choice. Provider directories allow beneficiaries and their caregivers to weigh Medicare options and decide if a plan's network meets their needs. Beneficiaries can check a provider directory to see if their existing providers are in the plan's network and which other contracted providers are available to deliver medical care. As the landscape of MA has evolved, CMS has implemented rules and made modifications to required materials, disclaimers, and website requirements to ensure that people with Medicare and the trusted individuals they rely on to aid in their decision making have the information necessary to make decisions about their Medicare options.

In the December 2024 proposed rule, CMS proposed additional regulatory changes to allow the agency to leverage technological methods that streamline the beneficiary experience so that beneficiaries have the provider network information they need to make the best choice for their needs. CMS proposed to make changes that would allow MA provider directory data to be viewable on MPF for the 2026 Annual Election Period (AEP). In addition, to ensure the accuracy of the data being submitted, CMS proposed that MA organizations would be required to update the provider directory data being made available to CMS for inclusion online in MPF within 30 days of receiving information from providers of a change, and to require MA organizations to attest to the accuracy of the provider directory data being submitted. In total, CMS articulated the expectation that these proposed changes, if finalized, would result in an advancement of informed beneficiary choice and transparency benefiting people with Medicare, while also promoting robust competition within the Medicare market.

Section 1851(d)(1) of the Social Security Act (the Act) states that the Secretary shall provide for activities to broadly disseminate information to current and prospective Medicare beneficiaries on MA plan coverage options to promote an active, informed selection among such options. Specifically, per section 1851(d)(2)(A)(ii) of the Act, at least 15 days before the beginning of each annual coordinated election period, the Secretary shall provide MA-eligible individuals with a list identifying the MA plans that are (or will be) available to residents of the areas in which they reside, including certain information concerning such MA plans, presented in a comparative form. This information is described in section 1851(d)(4) of the Act and includes plan benefits, premiums, service area, quality and performance indicators, and supplemental benefits. Section 1851(d)(4)(A)(vii) of the Act also sets forth that information comparing MA plan options must specifically include the extent to which an enrollee may select among in-network providers and the types of providers participating in the plan's network. In addition, section 1851(d)(7) of the Act provides that MA organizations shall provide CMS with such information about the MA organization and each MA plan that it offers, as may be required for the preparation of the information for Medicare Open Enrollment described in section 1851(d)(2)(A) of the Act.

Section 1852(d)(1) of the Act requires access to services for MA enrollees and states that MA organizations offering an MA plan may select the providers from whom the benefits under the plan are provided if the MA organization complies with several conditions, including access to appropriate providers (section 1852(d)(1)(D) of the Act). Specifically, network-based MA plans must demonstrate an adequate contracted provider network that is sufficient to provide access to covered services in accordance with the access standards at section 1852(d)(1) of the Act. Section 422.116(a)(2) further clarifies this obligation by providing network adequacy access requirements for MA plans. Section 422.116(a)(2)(i) requires that MA organizations must attest that they have an adequate network for access and availability of a specific provider or facility type that CMS does not independently evaluate in a given year.

Section 1852(c)(1)(C) of the Act further requires MA plans to disclose the number, mix, and distribution of plan providers, among other disclosures. Based on this statutory requirement, CMS has implemented regulations at § 422.111(b)(3)(i) that require MA plans to disclose the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services. These regulations establish the overarching requirements for the MA provider directory content.

The Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers (85 FR 25510) (hereinafter referred to as the “May 2020 Interoperability and Patient Access final rule”) became effective on June 30, 2020, and required MA organizations, beginning on January 1, 2021, to make standardized information about their provider networks accessible through a Provider Directory Application Programming Interface (API) that conforms with the CMS/HHS technical standards at § 422.119(c). The May 2020 Interoperability and Patient Access final rule also included in § 422.120 that the Provider Directory API must be accessible via a public-facing digital endpoint on the MA organization's website to ensure that this information is viewable and accessible to prospective and current enrollees as well as third-party application developers, who can create services to help patients find providers for care and treatment. Requirements at § 422.120 further specify that the MA plan's directory of contracted providers must be complete and accurate and include names, addresses, phone number, specialties and (as applicable for MA-PDs) the number of pharmacies in the network and mix of pharmacy types. MA organizations must ensure this information is updated within 30 calendar days of receiving updated provider directory information. Provider Directory API technical standards were also modified for more specificity in the February 2024 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program Final Rule (89 FR 8758), which was effective on April 8, 2024.

To comply with the previously referenced statutory and regulatory requirements, CMS has historically taken a two-pronged approach. CMS implemented MPF as an online resource where current and prospective beneficiaries and their caregivers can explore their Medicare coverage options. On MPF, individuals can look for MA and Part D plans and make informed choices based on the information provided, such as plan benefits, premiums, deductibles, and Star Ratings, to name a few. While CMS has implemented improvements to MPF over the years to incorporate more data, MPF does not currently include information on MA plans' contracted provider networks, such as the specific providers with which a plan contracts and from which an enrollee may receive health care services.

In addition to creating MPF, CMS has implemented regulations that require each MA organization to disclose or otherwise make available certain required information, including hardcopy and electronic provider directory requirements under § 422.2267(e)(11), as well as a searchable online directory as required under § 422.2265(b)(4). Through these requirements, the provider directory information is made available to prospective and existing MA plan enrollees so they may view MA plans' in-network providers and other relevant information as required under § 422.111(b)(3)(i), such as the provider's specialty and location in the MA organization's online PDF or a printable copy of their provider directory (§ 422.2265(b)(3)). However, using MPF while also searching multiple plan websites to determine a provider's network status can be cumbersome. Prospective and current MA plan enrollees must toggle between different MA plan websites and MPF to find and review the plans' provider directories to determine if the providers they currently see are in the various plans' networks, as well as review the information provided by MPF.

In order to simplify and streamline the Medicare beneficiary shopping experience, CMS proposed to expand on the existing requirements applicable to MA organizations regarding their provider directories at a newly established § 422.111(m) to include a new paragraph that requires MA organizations to: (1) make the information described in § 422.111(b)(3)(i) available to CMS/HHS for publication online in accordance with guidance from CMS/HHS; (2) submit or otherwise make available their plan provider directory data, that is the requirements found under § 422.111(b)(3)(i), available to CMS/HHS in a format, manner, and timeframe determined by CMS/HHS; (3) update the information subject to § 422.111(m) within 30 days of the date an MA organization becomes aware of a change; and (4) attest, in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(2)(i). The combined intent of the proposed requirements was to allow CMS to use the MA organization's provider directory data to be integrated online by CMS/HHS for display on MPF. As noted in the preamble of the December 2024 proposed rule (89 FR 99431) and earlier in this final rule, CMS has previously adopted regulations to implement requirements applicable to MA organizations for publicly accessible, accurate, and timely provider directory information through the May 2020 Interoperability and Patient Access final rule. The provider directory requirements of the May 2020 Interoperability and Patient Access final rule aid in establishing the groundwork for MA plan provider directory information to be readily accessible for MA organizations to submit to CMS for inclusion on MPF.

In the December 2024 proposed rule (89 FR 99432), CMS also highlighted that the requirements being proposed at 42 CFR 422.111(m) would closely mirror the provider directory submission requirements at 45 CFR 156.230(c) for Qualified Health Plan (QHP) issuers on the federally facilitated Exchange (FFE). Currently, 45 CFR 156.230(c) requires issuers seeking certification to offer QHPs on the FFE to submit provider information in a format and manner and at times determined by HHS/CMS to HHS/CMS. This information is then used to feed HealthCare.gov and its Direct Enrollment partner websites to allow consumers to filter available QHPs based on the providers and drugs covered by those QHPs. The proposed requirements for MA organizations took a substantially similar approach. Given that many health insurance carriers offer both MA plans and QHPs, CMS explained in the December 2024 proposed rule that this was a reasonable approach that would help lessen the burden associated with meeting the MA requirements. CMS also noted that the proposed requirements set forth in the December 2024 proposed rule would only apply to MA organizations (not Part D sponsors).

In response to the December 2024 proposed rule, CMS received comments from various stakeholders including advocates, health plans, providers, trade organizations, drug manufacturers, and a few individuals. The following are comments on this proposal as they pertain to the provisions, which CMS proposed to include in its regulations at § 422.111(m)(1) through (3), that would require MA organizations, including MA organizations that offer MA plans with Part D coverage, to make provider directory data available to CMS/HHS for publication online in MPF, to submit or otherwise make available their plan provider directory data available to CMS/HHS in a format, manner, and timeframe determined by CMS/HHS; and to update the information within 30 days of the date an MA organization becomes aware of a change. Note that CMS has outlined and responded to comments received regarding the related attestation requirement, which CMS proposed at § 422.111(m)(4), in a later section of this final rule.

Comment: The majority of commenters expressed support for this provision. Some commenters acknowledged that it is critical when serving some of the nation's most vulnerable patients that enrollees have dependable information about their providers. Other commenters encouraged CMS to finalize this provision because they believed it would streamline the current provider directory review process while improving transparency for beneficiaries who are navigating their healthcare options. Lastly, a commenter stated that meaningful and accurate network comparisons on MPF will greatly improve enrollment decisions as well as meaningful competition between plans.

Response: CMS agrees and thanks commenters for their feedback. The goal of this provision is to improve the plan comparison experience and help beneficiaries make an informed choice by making provider information accessible on MPF.

Comment: Several commenters expressed concerns with this proposal, stating that it failed to address key underlying causes of inaccuracy, which drive provider directory problems, and that this proposal may cause MA plans to be penalized due to circumstances beyond their control. Specifically, when providers fail to promptly update their address, telephone number, or other provider directory information, MA plans are held accountable for inaccurate provider directories.

Response: Thank you for your comments. CMS understands the complexities that may contribute to provider directory accuracy issues. However, CMS notes that there are existing regulatory requirements to ensure provider directory accuracy, including those under §§ 422.111(a)(2), 422.2262(a)(1)(i), 422.2267(c)(1), and 422.2267(e)(11)(iv). In addition, CMS's annual CY 2026 Medicare Advantage and Section 1876 Cost Plan Provider Directory Model and Instructions, issued June 16, 2025, strongly encourages MA organizations to institute procedures that support the ongoing accuracy of their provider directory. Therefore, the MA organization retains responsibility for data accuracy through the implementation of best practices. Moreover, while the focus of this provision is not provider directory accuracy, CMS notes that including provider directory data on MPF is another tool to help provide more accurate provider directory data for Medicare beneficiaries. CMS will bear in mind the information that was provided by these commenters as CMS considers future policymaking regarding underlying provider directory accuracy issues.

Comment: Several commenters stated that the inclusion of the information on MPF would be redundant since provider directories were already available on plan websites and there were already requirements to inform beneficiaries when changes to networks occurred.

Response: With regard to the concerns expressed associated with redundancy of effort, CMS acknowledges that there are other provider directory requirements such as those that MA organizations provide their members with a provider directory (§ 422.2267(e)(11)) and make provider directories accessible on plan websites (§ 422.2265(b)(4)). However, while prospective enrollees can view this information on individual plan websites, without a central repository of provider directory information across all MA plans, it is not easy for beneficiaries to compare networks among various MA plan choices. As such, CMS notes that any redundancy is offset by the benefit of complete and meaningful provider network comparisons made possible by inclusion of this directory information in MPF, so that beneficiaries may more readily consider and choose the best plan for their health care needs.

Comment: Some commenters raised concerns regarding operational guidance as it pertains to the timing and implementation of this provision. A few commenters expressed their concerns about receiving guidance early enough to allow ample time to prepare before MA organizations are required to submit their provider directory data to CMS. Additionally, a few commenters requested clearer guidance pertaining to provider directory content and MA organization networks. More specifically, a commenter requested that CMS clarify the provider types that must be included in the provider directory and whether the requirements will be consistent across plans. Another commenter questioned whether the provider directory information that will be included in MPF would pertain solely to providers in the plans' service area or whether the information would also include providers covered under travel benefits. Regarding the plan's network, a commenter questioned if the plan-provided information to CMS supersedes the delegated entity when inconsistencies in the plan's network arise. Lastly, several other commenters inquired about the process for updating submitted provider data and whether there will be a pilot program to validate such submissions.

Response: To ensure that MA plans have sufficient time to implement these provider directory requirements, CMS intends to issue an operational guide soon after the publication of this final rule. CMS anticipates that the operational guide will include technical information about how MA plans will format and submit the provider directory data files for purposes of this new regulatory requirement. The January 1, 2026, applicability date is the date by which plans will be required to conform with the new requirements in § 422.111(m) by making their provider directory data available to CMS; however, this data may not be accessible to the public on MPF by January 1, 2026. Additionally, CMS intends to offer technical support prior to January 1, 2026, as well as a testing period prior to having the new MPF functionality available to Medicare beneficiaries, to provide technical feedback to MA organizations in the period before they are expected to comply with these new requirements. The testing period will allow the parties to test that the directory data made available to Medicare beneficiaries through MPF reflects the data that the MA organizations provided.

With respect to the information regarding which providers are considered network providers for the purposes of inclusion in the provider directory and submitted to CMS, provider types required for inclusion are outlined annually in the Medicare Advantage and Section 1876 Cost Plan Provider Directory Model and Instructions. For example, the 2026 instructions can be found at https://www.cms.gov/medicare/health-drug-plans/managed-care-marketing/models-standard-documents-educational-materials. CMS also regularly provides MA plans with a provider directory model that contains required content to ensure consistency among plans. The current provider directory requirements at §§ 422.111(b)(3) and 422.2267(e)(11) do not include providers outside of their network (for example, traveling providers); therefore, the provider directory data that is submitted for publication online in MPF should mimic these requirements and exclude out-of-network travel providers.

Regarding the commenter's inquiry about whether plan-provided information to CMS supersedes a delegated entity when inconsistencies in the plan's network arise, CMS is interpreting this question to be about discrepancies between an MA plan and a provider as it applies to the accuracy of the provider network data required at §§ 422.111 and 422.2262(a). CMS's focus is on accuracy as it applies to a beneficiary enrolled in an MA plan being able to identify, contact, and schedule an appointment with providers within that MA plan's network in question. For example, if a provider office was not aware that they were in the plan's network and were telling enrollees of the plan that they cannot make an appointment, the “who is right” is irrelevant, as the outcome is that the beneficiary is unable to make an appointment. CMS views the MA organization's contracted provider to be a first-tier entity, and hence the responsibility of the MA organization per § 422.504(i)(1). Ultimately, it is up the MA organization to determine how best to work with providers to meet the requirements for accurate provider directories.

Comment: Commenters provided technical input on how they believe provider directory data should be formatted once it is incorporated into MPF. Overall, commenters requested that CMS require the collection of the provider directory data in a format similar to that which is currently used. A few commenters requested that CMS build machine-readable JavaScript Object Notation (JSON) files, which are currently used by health plans on the Health Insurance Marketplace, while others requested that CMS not establish additional reporting formats and utilize only the application programming interface (API) specifications used under the existing May 2020 Interoperability and Patient Access final rule.

Other commenters provided more general comments pertaining to how they would like provider directory data displayed in MPF. Some commenters expressed that they want real-time updates that display provider network comparisons on a simplified interface using basic language and advanced filtering options to narrow down choices.

Response: CMS appreciates the input from commenters. As discussed, CMS intends to develop and distribute an operational guide with details such as file formatting so plans have the resources available in advance to ensure compliance with this provision. Additionally, CMS understands the preference for utilizing established reporting formats like the API. As previously mentioned, the technical details for implementation will be provided as a part of operational guidance. CMS appreciates the suggestion that the provider directories on MPF include real-time updates. CMS reiterates that § 422.111(m)(3) of this provision requires that the data being made available for use in populating MPF be updated within 30 days of the date an MA organization becomes aware of a change. As noted, this requirement mirrors existing requirements for provider directories. Through operational guidance, CMS will also provide more detail on how quickly those changes are reflected on MPF.

After carefully reviewing and responding to all comments as they pertain to proposed § 422.111(m)(1) through (3), CMS is finalizing these requirements as proposed.

In the December 2024 proposed rule (89 FR 99432) CMS noted that, while publishing MA plan provider directory information on MPF is an important step, doing so in a way that ensures that beneficiaries are accessing accurate information is a critical part of improving the Medicare beneficiary experience while using MPF. In order to enhance the accuracy of the information that will be published online by CMS/HHS on MPF, CMS proposed to add new § 422.111(m)(4), which would require an MA organization to attest in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(2)(i). Given the significance of the choice that a beneficiary is making based on the information provided by the MA organization, CMS asserted in the proposal that it was critical to include this attestation requirement to ensure that the information being submitted by MA organizations is accurate and consistent with data submitted to comply with CMS's MA network adequacy criteria when it is submitted to CMS for the purpose of incorporating it into MPF. The December 2024 proposed rule stated that it was imperative that MA organizations' provider directory data remains consistent with the contracted provider network data submitted to CMS to provide sufficient access to covered services (89 FR 99432).

However, regarding the attestation, because provider directory data changes so frequently, CMS acknowledged in the December 2024 proposed rule that it may be impractical to require an attestation with each update. In the proposed rule, CMS stated that the agency was considering how to best balance the need for accountability of accurate data with the burden of the attestation. CMS stated that, if this proposed rule was finalized, CMS would provide operational guidance that would explain how the attestation process would be implemented. CMS also stated in the December 2024 proposed rule that the agency envisioned an attestation taking place when the data is first made available to CMS, and then a yearly attestation thereafter (89 FR 99432). CMS requested feedback on the attestation process, including the intervals for the attestation and received the following comments in response.

Comment: Some commenters mentioned that the attestation requirement would increase the accountability of MA organizations, which would reduce inaccurate provider directories that have contributed to reduced access to services. Another commenter believed that requiring an attestation was a great first step in helping to eliminate “ghost networks”—providers listed in directories who were not actually contracted with the MA plan. Other commenters did not support the attestation requirement, citing that MA plans would be held accountable for provider directory errors even though providers input the source data. Commenters also feared that additional reporting requirements and penalties could increase burden and compliance actions. As a result, a commenter requested that CMS define accuracy and its parameters, as CMS proposed to require an attestation to ensure that the information being submitted by MA organizations was accurate and consistent with data submitted to comply with CMS's MA network adequacy criteria. Several other commenters offered suggestions on how to improve overall provider directory accuracy. Some suggestions included allowing MA plans to demonstrate the adequacy of their networks through provider claims data and requiring MA plans to use an independent third-party verification company to confirm their provider directory information met a minimum accuracy threshold.

Response: CMS thanks commenters for their support regarding the provider directory data attestation requirement. The agency also acknowledges the concern expressed through comments regarding additional burden and potential compliance problems. CMS notes that MA plans are required to have accurate provider directories and maintain compliance with existing regulatory accuracy requirements that include: (1) disclosure requirements under § 422.111(a)(2), which mandate that MA organizations provide information in a clear, accurate, and standardized format; (2) provider directory access requirements at § 422.120(b), which require MA organizations' APIs to maintain complete and accurate directories of their contracted provider networks updated within 30 calendar days of receiving provider directory changes; (3) general communication requirements under § 422.2262(a)(1)(i), ensuring that all provided information is neither misleading nor inaccurate; and (4) required materials regulations at § 422.2267(c)(1) and (e)(11)(iv) that require MA organizations to accurately convey essential information and promptly update provider directory data upon becoming aware of any changes.

After careful consideration of all comments received associated with the proposed attestation requirement under § 422.111(m)(4), CMS is finalizing the portion of the attestation proposal that requires MA organizations to attest, in a format and manner and at times determined by CMS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) be accurate. CMS is finalizing this part of its regulation with one modification, to make clear that at a minimum, MA organizations will be required to attest at least annually. Additional details about the format, manner, and timing/frequency of such attestation will be provided in the operational guidance.

CMS has decided not to finalize the portion of the proposed attestation requirement that would require MA organizations to attest that their provider directory data is consistent with data submitted to meet CMS's MA network adequacy requirements at § 422.116(a)(2)(i). CMS has determined it is more appropriate to distinguish provider directory accuracy from network adequacy for this purpose. CMS notes that MA organizations have separate obligations to ensure network adequacy and already attest that they have an adequate network for access and availability of a specific provider or facility type. CMS believes that an attestation submitted at least annually and specifically addressing the provider directory data would work in conjunction with the existing regulatory accuracy requirements to further strengthen data accuracy and enhance CMS's ability to ensure reliable provider directory data for beneficiaries. In addition, to strike a balance between burden and accountability, CMS intends to collect the attestation at least annually, at a timeframe prior to the AEP. Further details will be provided in the previously mentioned operational guidance.

The provider directory data attestation will complement CMS's existing regulatory accuracy requirements, oversight mechanisms, and compliance monitoring through the current regulatory framework established under §§ 422.111, 422.2262(a), and 422.2267(e)(11), all of which will allow CMS to maintain accountability for provider directory accuracy, including addressing “ghost networks” and other issues referenced by commenters. CMS encourages MA plans to continue working with providers and exploring other options to maintain clear, current, and accurate provider directories.

Comment: A few commenters provided comments associated with the timing of the effective date and rollout of these requirements, as well as when CMS is expecting the required data to be available to beneficiaries on MPF. A few commenters suggested delaying implementation of this provision due to timing and burden concerns. Specifically, commenters stated that implementation of this provision could require substantial financial and resource investments resulting in financial burden. Additionally, another commenter mentioned the administrative burden of having to attest with each data update while implementing other provider directory requirements and rushing implementation due to short timeframes. However, the commenters did not provide any specifics to further elaborate on the concerns associated with financial or administrative burdens associated with this rule. Commenters did suggest alternative implementation dates from as early as the 2027 AEP (October 15, 2026) to as late as July 1, 2028, which is 3 months before the 2029 AEP, to allow plans to fully comply.

Response: CMS appreciates the commenters' suggestions regarding the effective date of the policy and alternative implementation dates. In the December 2024 proposed rule, CMS stated that in order to operationalize the proposed Format Provider Directories for Medicare Plan Finder provision at § 422.111(m), the agency anticipated that 2025 plan year provider directory data would need to be made available online for testing purposes in the summer of 2025, and 2026 plan year data would need to be available online on October 1, 2025. Therefore, an applicability date of July 1, 2025, was proposed for this provision (89 FR 99340). However, CMS has delayed the finalization of this provision to allow for further consideration of the impacts and burden on plans and providers. As such, because this provision was not finalized in the April 2025 final rule, CMS notes that the anticipated implementation timeline discussed in the preamble of the December 2024 proposed rule should also be adjusted. CMS is therefore finalizing an applicability date of January 1, 2026, meaning this is the date by which MA organizations will have to have directory data available to CMS. As stated in a previous response to a comment regarding provider directory formatting, CMS intends to publish an operational guide to allow MA plans to familiarize themselves with formatting and technical submission requirements before the implementation date. Therefore, CMS does not anticipate that MA plans will need 2 years from the new applicability date to fully comply with these requirements. Prior to January 1, 2026, as well as prior to having the new MPF functionality available to Medicare beneficiaries, CMS will also provide a period of time where MA organizations can raise questions and where CMS will work with MA plans to format their provider directory data as specified in the operational guide. CMS will also provide time for MA organizations to test their data with CMS. Additionally, proposed provisions at § 422.111(m) will be finalized with one modification to exclude the portion of the proposed attestation requirement within § 422.111(m)(4) that required MA organizations to attest that provider directory information is consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(2)(i). This modification is expected to decrease the administrative burden on MA organizations relative to CMS's original proposal, as the modified policy now requires MA organizations to only attest that their submitted provider directory data is accurate.

Finally, CMS received a number of comments that touched on provider directory data more generally, including provider directory data accuracy. While not the focus of the December 2024 proposed rule, accurate provider directories remain an important focus for CMS.

Comment: In an effort to ensure that provider directories are comprehensive and include all providers available to beneficiaries, some commenters recommended including additional health care providers such as physician assistants (under the specialty in which they practice), individuals providing supplemental benefits, and clinicians and their affiliated clinic types. A commenter also requested that provider capabilities specific to cultural competence be identified in the provider directory. Alternatively, a few commenters suggested excluding providers if they have given notice of their intent to terminate their contractual relationship or if the MA organization cannot verify their provider directory data or have no confidence in the information they have obtained.

Response: CMS thanks commenters and acknowledges their recommendations to ensure that provider directories reflect all providers who are available to provide health care services for enrollees of a given MA plan. CMS notes that existing regulations require that an MA organization have written policies and procedures for selecting and evaluating the contracted providers in its network, including ensuring that these providers meet applicable credential requirements (42 CFR 422.204). In accordance with this requirement, through the subsequent operational guide, CMS will provide the technical format that the provider directory data will need to take to ensure that the required elements of the provider directory under §§ 422.111(b)(3) and 422.2267(e)(11) will be accurately reflected in MPF. Additionally, CMS notes that existing MA regulations at § 422.111(b)(3)(i) require that MA organizations disclose in provider directories each provider's cultural and linguistic capabilities, including languages such as American Sign Language, offered by the provider or a qualified medical interpreter at the provider's office. With regard to comments that seek to exclude providers due to an impending contract termination or lack of verifiable data, CMS expects that the data provided to the agency will be updated as necessary to ensure that MA organizations remain compliant with provider directory accuracy requirements including §§ 422.111(a)(2), 422.120(b)(1), 422.2267(e)(11)(iv)(A), and the requirement at § 422.111(m)(3) newly finalized by this final rule.

Comment: Commenters suggested that provider directory monitoring, compliance, and enforcement include performing random provider directory audits and secret shopper surveys, incorporating provider directory attestation compliance in the Star Rating methodology, and canceling MA plan contracts for non-compliance or imposing financial penalties. Several commenters encouraged CMS to collaborate with external stakeholders to ultimately improve provider directory accuracy by focusing on public-private partnerships between the federal government, providers, payers, and solutions vendors to streamline and improve provider directory accuracy while also strengthening transparency and enhancing data workflows through additional collaborations with trade organizations and HL7.

Response: CMS believes that these comments are out of scope for this rulemaking. However, CMS appreciates the commenters' suggestions and will consider these and other recommendations during future rulemaking. CMS acknowledges commenters' recommendations to collaborate with external stakeholders as CMS recognizes the value in working together to achieve a common goal of improving a beneficiary's experience while using MPF, which will result in informed beneficiary choice, transparency, and increased access to health care.

CMS thanks commenters for their suggestions on how the agency can improve the overall accuracy of provider directories. CMS remains open to receiving suggestions to improve provider directory accuracy and will consider these recommendations for future rulemaking.

In summary, after carefully considering all of the comments, CMS is finalizing the following provider directory requirements at § 422.111(m) as proposed: that MA organizations must, for plan years beginning on or after January 1, 2026, (1) make the information described in § 422.111(b)(3)(i) available to CMS/HHS for publication online in accordance with guidance from CMS/HHS; (2) submit, or otherwise make available, the information described in § 422.111(b)(3)(i) to CMS/HHS in a format and manner and at times determined by CMS/HHS; and (3) update the information subject to paragraph (m) within 30 days of the date an MA organization becomes aware of a change.

With regard to CMS's proposed regulation text at § 422.111(m)(4), that MA organizations must attest in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(2)(i), for the reasons outlined previously in this preamble, CMS will not be finalizing this requirement as proposed. Instead, CMS is finalizing only the portion of the proposed requirement that MA organizations must attest, in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) is accurate. In addition, as discussed above, CMS is finalizing this requirement with one modification to provide that this attestation must occur at least annually.

As discussed previously in this final rule, the requirements described herein are applicable to MA organizations beginning January 1, 2026. This means that MA organizations will be required to make their directory data available to CMS by January 1, 2026, however, it does not mean that the data will be available on Medicare Plan Finder (MPF) for use by the public by January 1, 2026. CMS expects a period of testing to take place to ensure that the directory data made available to Medicare beneficiaries through MPF accurately reflects the data provided by MA organizations. As noted earlier in this final rule, the agency plans to release an operational guide soon after the publishing of this final rule. The operational guide will outline technical specifications and milestones by which MA organizations' provider directory data will be made available for CMS so that it can later be made available to beneficiaries by way of MPF.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ), CMS is required to provide notice in the Federal Register and solicit public comment before a “collection of information,” as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations, is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection requirement should be approved by OMB, 44 U.S.C. 3506(c)(2)(A) requires that CMS solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of the agency.

• The accuracy of the estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

In our December 10, 2024 (89 FR 99340) proposed rule (CMS-4208-P; RIN 0938-AV40), CMS solicited public comment on a number of proposed information collection requirements.

While a number of requirements were finalized on April 15, 2025 (90 FR 15792) under CMS-4208-F (RIN 0938-AV40), the proposed information collection requirement in section VI.B.12 of the proposed rule (89 FR 99503) titled “ICRs Regarding Formatting Medicare Advantage (MA) Organizations' Provider Directories for Medicare Plan Finder (§ 422.120(c))” was not included at that time. As indicated throughout this preamble, this provision is being finalized in this rule.

CMS received a PRA-related comment on the proposed provisions, which is summarized in section III.B. of this final rule.

For the purpose of the programming necessary to provide CMS with the provider directory data, CMS estimates that a member of an MA organization's Information Technology staff will require an average of 8 hours. This is a one-time instance. For the purpose of completing the attestation, CMS expects that an MA organization's plan officer will require 1 hour annually. The hourly wage data for both these MA organizations' staff persons are reflected in Table 2. The calculation of the one-time burden estimates for the creation of the programming necessary to provide CMS with provider directory data is in Table 3. The calculation of the annual burden estimate for the plan officer attestation is in Table 4.

To derive average (mean) costs, CMS is using data from the most current U.S. Bureau of Labor Statistics' (BLS's) National Occupational Employment and Wage Estimates for all salary estimates ( https://www.bls.gov/oes/2024/may/oes_nat.htm ), which, at the time of publication of this final rule, provides May 2024 wages. In this regard, table 2 presents BLS's mean hourly wage, CMS's estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and CMS's adjusted hourly wage.

Adjusting CMS's employee hourly wage estimates by a factor of 100 percent is a rough adjustment that is used since fringe benefits and other indirect costs vary significantly from employer to employer and because methods of estimating these costs vary widely from study to study. In this regard, CMS believes that doubling the hourly wage to estimate costs is a reasonably accurate estimation method.

The proposed rule inadvertently indicated (89 FR 99503) that the proposed collection of information request (CMS-10906) would be submitted to OMB for review. This rule corrects that statement which should have indicated that the collection of information request (CMS-10906, OMB control number 0938-TBD) will be made available for public review and comment using the standard non-rule PRA process which consists of publishing 60- and 30-day notices in the Federal Register before the collection of information request is submitted to OMB for their review/approval. CMS expects that the initial 60 day notice will publish sometime after the final rule. The PRA package associated with this burden will include a supporting statement, a clearance sheet, the language CMS expects to use for the attestation process, and further detail on the guidance that will instruct plans on how to operationalize CMS access the plan's provider data.

As indicated in section II. of this final rule, CMS is finalizing proposed requirements at § 422.111(m) for MA organizations to submit MA provider directory data to CMS/HHS for use in MPF. Under this provision, MA organizations are required to: (1) make the information described in § 422.111(b)(3)(i) available to CMS/HHS for publication online in accordance with guidance from CMS/HHS; (2) submit, or otherwise make available, the information described in § 422.111(b)(3)(i) to CMS/HHS in a format and manner and at times determined by CMS/HHS; (3) update the information subject to § 422.111(m) within 30 days of the date an MA organization becomes aware of a change; and (4) Attest at least annually, in a format and manner and at times determined by CMS/HHS, that all information submitted or otherwise made available to CMS/HHS under paragraph (m) is accurate. CMS believes this would further the agency's objective to promote informed beneficiary choice, efficiency, and transparency.

Even though the reporting of provider directory data and updated directory data by MA organizations to CMS is ongoing, it is part of an automated process that is expected to take 8 hours at $99.66/hr for a computer programmer for each plan to create the functionality within their system.

In aggregate, CMS estimates a one-time burden of 5,600 hours (700 plans * 8 hr./plan) at a cost of $558,096 (5,600 hr. * $99.66/hr). This is a measure of the burden of the programming changes necessary to provide CMS access to the provider directory data.

This document announces that, on September 8, 2025, OMB approved for a period of three years, the information collection requirements associated with the amendments to 47 CFR 64.6060 that the Commission adopted in the 2024 IPCS Order and the requirements for IPCS providers' Annual Reports and certifications that WCB and CGB adopted in the 2025 IPCS Annual Reports Order. Notices related to the information collection were published at 89 FR 77244 and 90 FR 11804, respectively. The OMB Control Number is 3060-1222. IPCS providers' responses to the data collection are due on November 3, 2025.

If you have any comments on the data collection, or how the Commission can improve the data collection and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, 45 L Street NE, Washington, DC 20002. Please include the OMB Control Number, 3060-1222, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

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

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on September 8, 2025 for the information collection requirements contained in the amendments to 47 CFR 64.6060 adopted in the 2024 IPCS Order and with the requirements for Annual Reports and certifications contained in the 2025 IPCS Annual Reports Order. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1222.

The foregoing notification is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1222.

Title: Incarcerated People's Communications Services (IPCS) Provider Annual Reporting, Certification, and Other Requirements, WC Docket Nos. 23-62, 12-375.

OMB Approval Date: September 8, 2025.

OMB Expiration Date: September 30, 2028.

Form Numbers: FCC Form 2301(a) and FCC Form 2301(b).

Respondents: Business or other for-profit.

Number of Respondents and Responses: 35 respondents; 38 responses.

Estimated Time per Response: 5-160 hours.

Frequency of Response: Annual reporting and certification requirements, third party disclosure, waiver request and on-occasion reporting requirement.

Total Annual Burden: 9,165 hours.

Total Annual Cost: No Cost.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in sections 1, 2, 4(i)-(j), 5(c), 201(b), 218, 220, 225, 255, 276, 403, and 716 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i)-(j), 155(c), 201(b), 218, 220, 225, 255, 276, 403, and 617, and the Martha Wright-Reed Act, Public Law 117-338, 136 Stat. 6156 (2022).

Needs and Uses: In July 2024, the Commission adopted the 2024 IPCS Order, which implemented the expanded authority granted to the Commission by the Martha Wright-Reed Act. Among other actions, that Order expanded the Commission's annual reporting and certification requirements to include the full scope of services and providers now subject to the IPCS rules. The Commission also eliminated the sections of the annual reporting rules mandating the reporting of information on ancillary service charges and site commissions, to reflect the prohibitions of those items adopted in the 2024 IPCS Order. Finally, the Commission reaffirmed and updated its prior delegation of authority to WCB and CGB to revise the requirements for the Annual Reports and certifications, to reflect the Commission's expanded authority under the Martha Wright-Reed Act and the other actions taken in the 2024 IPCS Order, and directed the Bureaus to pay particular attention to the video IPCS marketplace and the availability and usage of TRS in exercising this delegated authority.

On January 8, 2025, WCB and CGB released the 2025 Annual Reports Order, in which they revised the instructions, reporting templates, and certification form for the Annual Reports that IPCS providers are required to submit.

Atlantic BFT fisheries are managed under the 2006 Consolidated HMS 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. ). HMS implementing regulations are at 50 CFR part 635. Section 635.27(a) divides the U.S. BFT quota, established by the International Commission for the Conservation of Atlantic Tunas (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.

Under § 635.28(a)(1), NMFS files a closure action with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on or after the effective date and time of a closure action for that category until the opening of the relevant subsequent quota period or until such date as specified.

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 per § 635.27(a)(3)). The General category baseline quota is 710.7 mt. The General category baseline quota is suballocated to time periods. Relevant to this action, the baseline subquota for the September time period is 188.3 mt.

To date, reported landings for the BFT General category September time period total 98.5 mt. As described above, the baseline subquota for the September time period is 188.3 mt. However, landings estimates from 2024 indicate that the General, Harpoon, and Angling category quotas were exceeded. Additionally, the 2025 General category January through March time period subquota was exceeded. Thus, under § 635.27(a)(9) and consistent with ICCAT requirements, in order to ensure the overall U.S. quota is not exceeded, NMFS expects to take action later this year to reduce the various category quotas consistent with the estimated overharvest. While that action is not yet final, NMFS must still consider the implications of reduced quotas for various categories, including the General category. If both the 2024 and 2025 U.S. adjusted quotas are exceeded, under ICCAT requirements, the United States could be required to pay back 125 percent of the second year's (2025) overharvest in 2026.

Based on that consideration and the current landings data, as well as average catch rates and anticipated fishing conditions, NMFS has determined that the September time period subquota is projected to be reached and exceeded shortly. Therefore, retaining, possessing, or landing large medium or giant ( i.e., measuring 73 inches (185 cm) CFL or greater) BFT by persons aboard vessels permitted in the Atlantic Tunas General category and HMS Charter/Headboat permitted vessels (while fishing commercially) must cease at 11:30 p.m., local time on September 18, 2025.

Pursuant to Executive Order 14276, “Restoring American Seafood Competitiveness,” (April 17, 2025), NMFS is making prudent efforts to identify strategies to expand fishing opportunities within the requirements of the Magnuson-Stevens Act. Should NMFS determine that reasonable fishing opportunities are available at a later date, NMFS may reopen the September fishery. The BFT General category will automatically reopen October 1, 2025, for the October through November time period. This action applies to Atlantic Tunas General category (commercial) permitted vessels and HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT and is taken consistent with the regulations at § 635.28(a)(1).

On May 31, 2024 (89 FR 47095), NMFS published a final rule, which among other things, implemented RFDs every Tuesday, Friday, and Saturday from July 1 through November 30 of each year. Since the fishery will be closed for the remainder of the September time period, NMFS has decided to waive the previously scheduled RFDs for the remainder of that time period. Previously scheduled RFDs ( i.e., every Tuesday, Friday, and Saturday) will resume on October 1, 2025.

With the RFDs waived during a closure, consistent with § 635.23(a)(7), fishermen aboard General category permitted vessels and HMS Charter/Headboat permitted vessels may tag and release BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure/.

NMFS will continue to monitor the BFT fisheries closely. Per § 635.5(b)(2)(i)(A), dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustments, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General category and HMS Charter/Headboat 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/home, using the HMS Catch Reporting app, or calling 888-872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m. Eastern Time).

After the fishery reopens on October 1, depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas as specified under § 635.27(a)(7). If needed, subsequent adjustments will be published in the Federal Register . In addition, fishermen may access https://hmspermits.noaa.gov/home, 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. 553(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 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures 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 prior notice and an opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on the most recent landings information, the 2025 September subquota is projected to be reached shortly. Delaying this action could result in BFT landings that exceed the final 2025 General category quota, which may result in future potential quota reductions for other BFT categories or the General category quota, depending on the magnitude of a potential September subquota overharvest. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment and closure criteria.

For all of the above reasons, the AA also finds that pursuant to 5 U.S.C. 553(d)(3), there is good cause to waive the 30-day delay in effective date.

Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.111. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102, and the final 2025 allocations were published on December 10, 2024 (89 FR 99138).

The final rule implementing Amendment 5 to the FMP, as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider three criteria in the evaluation of requests for quota transfers or combinations: (1) the transfers or combinations would not preclude the overall annual quota from being fully harvested; (2) the transfers address an unforeseen variation or contingency in the fishery; and (3) the transfers are consistent with the objectives of the FMP and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The Regional Administrator has determined these three criteria have been met for the transfer approved in this notification.

North Carolina is transferring 23,702 pounds (lb; 10,751 kilograms (kg)) of summer flounder to Massachusetts through a mutual agreement between the states. This transfer was requested to repay landings made by out-of-state permitted vessels under a safe harbor agreement. The revised summer flounder quotas for 2025 are: North Carolina, 2,334,404 lb (1,058,868 kg); and Massachusetts, 594,849 lb (269,819 kg).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 648.102(c)(2)(i) through (iv), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempted from review under Executive Order 12866.

Authority: 16 U.S.C. 1801 et seq.