Pursuant to Marketing Order No. 905, as amended (7 CFR part 905; the Order), and the applicable provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674) (the Act), it is hereby directed that a referendum be conducted to ascertain whether continuance of the Order is favored by fresh citrus producers. The referendum will be conducted from October 19 through November 9, 2026, among Florida fresh citrus producers in the Order's production area. Only current Florida citrus producers engaged in the production of oranges, grapefruit, tangerines, or pummelos for the fresh market during the period of August 1, 2025, through July 31, 2026, may participate in the continuance referendum.

USDA has determined that continuance referenda are an effective means for determining whether producers favor the continuation of marketing order programs. In accordance with § 905.83(c), USDA must conduct a referendum every six years. USDA would consider termination of the Order if less than two-thirds of the producers voting in the referendum, and less than two-thirds of the citrus volume represented in the referendum, vote in favor of continuance. In evaluating the merits of continuance versus termination, USDA will not exclusively consider the results of the continuance referendum. USDA will also consider all other relevant information concerning the operation of the Order and relative benefits and costs to producers, handlers, and consumers to determine whether continued operation of the Order would tend to effectuate the declared policy of the Act.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the ballot materials used in the referendum have been approved by the Office of Management and Budget (OMB) and have been assigned OMB No. 0581-0189, Fruit Crops. It has been estimated it will take an average of 20 minutes for each of the approximately 200 citrus producers to cast a ballot. Participation is voluntary. Ballots delivered to AMS via U.S. mail or electronic ballot must show proof of delivery by no later than 11:59 p.m. Eastern Time on November 9, 2026, to be included in the vote tabulation.

Delaney Fuhrmeister, Rebecca Geller, Steven Kauffman, Christian Nissen, and Jennie Varela of the Southeast Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA, are hereby designated as the referendum agents of the Secretary of Agriculture to conduct this referendum. The procedure applicable to the referendum shall be the “Procedure for the Conduct of Referenda in Connection with Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended” (7 CFR part 900.400 et seq. ).

Ballots and voting instructions will be sent by U.S. mail or through electronic mail to all Florida citrus producers of record and may also be obtained from the referendum agents or their appointees.

In accordance with sections 705(d) and 777(i) of the Tariff Act of 1930 as amended (the Act) on July 30, 2026, Commerce published in the Federal Register its affirmative final determinations in the countervailing duty investigations of rebar from Vietnam and Egypt. 1 On September 11, 2026, the ITC notified Commerce of its final affirmative determinations pursuant to sections 705(b)(1)(A)(i) and 705(d) of the Act, that an industry in the United States is materially injured by reason of subsidized imports of rebar from Vietnam and Egypt. 2

The product covered by these orders is rebar from Vietnam and Egypt. For a complete description of the scope of these orders, see the appendix to this notice.

Based on the above-referenced affirmative final determinations by the ITC that an industry in the United States is materially injured by reason of subsidized imports of rebar from Vietnam and Egypt, in accordance with sections 705(c)(2) and 706(a) of the Act, Commerce is issuing these CVD orders. Because the ITC determined that imports of rebar from Vietnam and Egypt are materially injuring a U.S. industry, unliquidated entries of such merchandise entered, or withdrawn from warehouse, for consumption, are subject to the assessment of countervailing duties.

Therefore, in accordance with section 706(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, countervailing duties on unliquidated entries of rebar from Vietnam and Egypt. With the exception of entries occurring after the expiration of the provisional measures period and before the publication of the ITC's final affirmative injury determinations, as further described below, countervailing duties will be assessed on unliquidated entries of rebar from Vietnam and Egypt entered, or withdrawn from warehouse, for consumption on or after January 13, 2026, the date of publication of the Preliminary Determinations in the Federal Register . 3

On July 30, 2026, Commerce published its affirmative final determinations in the less-than-fair-value investigations of rebar from Bulgaria, Egypt, and Vietnam, in accordance with sections 735(d) and 777(i) of the Tariff Act of 1930, as amended (the Act). 1 On September 11, 2026, pursuant to section 735(d) of the Act, the ITC notified Commerce of its final affirmative determinations that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act by reason of dumped imports of rebar from Bulgaria, Egypt, and Vietnam. 2

The products covered by these orders are rebar from Bulgaria, Egypt, and Vietnam. For a complete description of the scope of the orders, see the appendix to this notice.

Based on the above-referenced affirmative final determinations by the ITC, in accordance with sections 735(c)(2) and 736 of the Act, Commerce is issuing these AD orders. Because the ITC determined that an industry in the United States is materially injured by reason of imports of rebar from Bulgaria, Egypt, and Vietnam, unliquidated entries of such merchandise from the countries, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.

Therefore, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise on all relevant entries of rebar from Bulgaria, Egypt, and Vietnam. Antidumping duties will be assessed on unliquidated entries of rebar from Bulgaria, Egypt, and Vietnam entered, or withdrawn from warehouse, for consumption on or after March 13, 2026, the date of publication of the Preliminary Determinations, 3 but will not include entries occurring after the expiration of the provisional measures period and before publication of the ITC's final injury determination under section 735(b) of the Act, as further described in the “Provisional Measures” section of this notice below.

Except as noted in the “Provisional Measures” section of this notice, in accordance with sections 735(c)(1)(B) and 736 of the Act, Commerce intends to instruct CBP to continue to the suspend liquidation on all relevant entries of rebar from Bulgaria, Egypt, and Vietnam. These instructions suspending liquidation will remain in effect until further notice.

Commerce also intends to instruct CBP to require cash deposits equal to the estimated weighted-average dumping margins indicated in the tables below, adjusted by the relevant export subsidy offsets for Vietnam. 4 Effective on the date of publication in the Federal Register of the notice of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated customs duties on subject merchandise, a cash deposit equal to the rates listed in the tables below. The all-others rates apply to all producers or exporters not specifically listed, as appropriate.

The estimated weighted-average dumping margins are as follows:

Section 733(d) of the Act states that suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except where exporters representing a significant proportion of exports of the subject merchandise request that Commerce extend the four-month period to no more than six months. At the request of exporters that account for a significant proportion of rebar from Bulgaria, Egypt, and Vietnam, Commerce extended the four- month period to six months in each of these investigations. 5

The extended provisional measures period began on the date of the publication of the Preliminary Determinations, i.e., March 13, 2026, and ended on September 8, 2026. As a result, entries of rebar from Bulgaria, Egypt, and Vietnam made on or after September 9, 2026, and before the date of publication of the ITC's final injury determination in the Federal Register are not subject to the assessment of antidumping duties. Therefore, in accordance with section 736(a)(1) of the Act and its practice, Commerce will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of rebar from Bulgaria, Egypt, and Vietnam entered, or withdrawn from warehouse, for consumption on or after September 9, 2026, the first day provisional measures were no longer in effect, until and through the day preceding the date of publication of the ITC's final injury determination in the Federal Register . Suspension of liquidation and the collection of cash deposits will resume on the date of publication of the ITC's final determination in the Federal Register .

On September 20, 2021, Commerce published the Final Rule in the Federal Register . 6 On September 27, 2021, Commerce also published the Procedural Guidance in the Federal Register . 7 The Final Rule and Procedural Guidance provide that Commerce will maintain an annual inquiry service list for each order or suspended investigation, and any interested party submitting a scope ruling application or request for circumvention inquiry shall serve a copy of the application or request on the persons on the annual inquiry service list for that order, as well as any companion order covering the same merchandise from the same country of origin.

In accordance with the Procedural Guidance, for orders published in the Federal Register after November 21, 2021, Commerce will create an annual inquiry service list segment in Commerce's online e-filing and document management system, Antidumping and Countervailing Duty Electronic Service System (ACCESS), available at https://access.trade.gov, within five business days of publication of the notice of the order. Each annual inquiry service list will be saved in ACCESS, under each case number, and under a specific segment type called “AISL-Annual Inquiry Service List.”  8

Interested parties who wish to be added to the annual inquiry service list for an order must submit an entry of appearance to the annual inquiry service list segment for the order in ACCESS within 30 days after the date of publication of the order. For ease of administration, Commerce requests that law firms with more than one attorney representing interested parties in an order designate a lead attorney to be included on the annual inquiry service list. Commerce will finalize the annual inquiry service list within five business days thereafter. As mentioned in the Procedural Guidance, 9 the new annual inquiry service list will be in place until the following year, when the Opportunity Notice for the anniversary month of the order is published.

Commerce may update an annual inquiry service list at any time as needed based on interested parties' amendments to their entries of appearance to remove or otherwise modify their list of members and representatives, or to update contact information. Any changes or announcements pertaining to these procedures will be posted to the ACCESS website at https://access.trade.gov.

In the Final Rule, Commerce stated that, “after an initial request and placement on the annual inquiry service list, both petitioners and foreign governments will automatically be placed on the annual inquiry service list in the years that follow.”  10 Accordingly, as stated above, the petitioner and foreign governments should submit their initial entries of appearance after publication of this notice in order to appear in the first annual inquiry service lists for these orders. Pursuant to 19 CFR 351.225(n)(3), the petitioner and foreign governments will not need to resubmit their entries of appearance each year to continue to be included on the annual inquiry service list. However, the petitioner and foreign governments are responsible for making amendments to their entries of appearance during the annual update to the annual inquiry service list in accordance with the procedures described above.

This notice constitutes the AD orders with respect to rebar from Bulgaria, Egypt, and Vietnam, pursuant to section 736(a) of the Act. Interested parties can find a list of AD and countervailing duty orders currently in effect at https://www.trade.gov/data-visualization/adcvd-proceedings.

These AD orders are published in accordance with section 736(a) of the Act and 19 CFR 351.211(b).

On July 8, 2026, Commerce published in the Federal Register the Preliminary Determination in this investigation and invited interested parties to comment. 1 Because no comments were submitted by interested parties, we have adopted our Preliminary Determination for purposes of this final determination. Accordingly, no decision memorandum accompanies this Federal Register notice.

The product covered by this investigation is wire rod from Algeria. For a complete description of the scope of this order, see the appendix to this notice.

No interested party commented on the scope of the investigation as it appeared in the Preliminary Determination. 2 Therefore, we made no changes to the scope of the investigation from that published in the Preliminary Determination.

Commerce conducted this investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, Commerce determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific. 3 In making this final determination, Commerce relied on facts available, including with an adverse inference, pursuant to sections 776(a) and (b) of the Act. 4

Because the sole respondent, SPA Algerian Qatar Steel, did not participate in this investigation and because the Government of Algeria did not provide information Commerce requested, Commerce did not conduct a verification in this investigation. 5

Sections 703(d) and 705(c)(5)(A) of the Act provide that Commerce shall determine an estimated all-others rate for companies not individually examined. Pursuant to section 705(c)(5)(A)(ii) of the Act, if the individual estimated countervailable subsidy rates established for all exporters and producers individually examined are zero, de minimis, or determined based entirely on section 776 of the Act, Commerce may use any reasonable method to establish the estimated subsidy rate for all other producers or exporters. In this investigation, Commerce has determined the estimated subsidy rate for the individually examined respondent under section 776 of the Act. This is the only rate available in this proceeding for deriving the all-others rate. Consequently, pursuant to sections 703(d) and 705(c)(5)(A)(ii) of the Act, Commerce established the all-others rate by applying the countervailable subsidy rate assigned to the non-responsive company listed below. For a full description of the methodology underlying Commerce's analysis, see the Preliminary Determination. 6

Commerce determines that the following estimated countervailable subsidy rates exist:

Normally, Commerce discloses to interested parties the calculations performed in a final determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the final determination in the Federal Register , in accordance with 19 CFR 351.224(b). However, because the program rates assigned in the Preliminary Determination are unchanged, there are no new calculations to disclose.

No material injury determination is necessary in this countervailing duty investigation, pursuant to section 701(c)(1) of the Act, because the United States Trade Representative has determined that Algeria is not a “Subsidies Agreement country” within the meaning of section 701(b) of the Act. 7 Therefore, in accordance with section 705(c)(2) of the Act, Commerce is issuing this CVD order.

In accordance with section 706 of the Act, Commerce intends to instruct CBP to continue the suspension of liquidation of wire rod from Algeria, as described in Appendix I to this notice, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in in the Federal Register , and to assess, upon further instruction by Commerce, pursuant to section 706(a)(1) of the Act, countervailing duties on each entry of subject merchandise in an amount based on the net countervailable subsidy rates above. These instructions suspending liquidation will remain in effect until further notice. Commerce also intends, pursuant to section 706(a)(1) of the Act, to instruct CBP to require cash deposits equal to the amounts as indicated above. Accordingly, effective on the date of publication of this notice in the Federal Register , CBP will require, at the same time as importers would normally deposit estimated customs duties on the subject merchandise, a cash deposit for each entry of subject merchandise equal to the subsidy rates listed above. The all-others rate applies to all producers or exporters not specifically listed, as appropriate.

As noted above, no material injury determination is necessary in this countervailing duty investigation, pursuant to section 701(c)(1) of the Act, because the United States Trade Representative has determined that Algeria is not a “Subsidies Agreement country” within the meaning of section 701(b) of the Act. 8 Should it later be determined that the ITC requires information related to this determination, we will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information either publicly or under administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

This notice will serve as the only reminder to parties subject to the APO of their responsibility concerning the destruction of proprietary information disclosed under APO, in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

On September 20, 2021, Commerce published the Final Rule in the Federal Register . 9 On September 27, 2021, Commerce also published the Procedural Guidance in the Federal Register . 10 The Final Rule and Procedural Guidance provide that Commerce will maintain an annual inquiry service list for each order or suspended investigation, and any interested party submitting a scope ruling application or request for circumvention inquiry shall serve a copy of the application or request on the persons on the annual inquiry service list for that order, as well as any companion order covering the same merchandise from the same country of origin.

In accordance with the Procedural Guidance, for orders published in the Federal Register after November 4, 2021, Commerce will create an annual inquiry service list segment in Commerce's online e-filing and document management system, Antidumping and Countervailing Duty Electronic Service System (ACCESS), available at https://access.trade.gov, within five business days of publication of the notice of the order. Each annual inquiry service list will be saved in ACCESS, under each case number, and under a specific segment type called “AISL-Annual Inquiry Service List.”  11

Interested parties who wish to be added to the annual inquiry service list for an order must submit an entry of appearance to the annual inquiry service list segment for the order in ACCESS within 30 days after the date of publication of the order. For ease of administration, Commerce requests that law firms with more than one attorney representing interested parties in an order designate a lead attorney to be included on the annual inquiry service list. Commerce will finalize the annual inquiry service list within five business days thereafter. As mentioned in the Procedural Guidance, 12 the new annual inquiry service list will be in place until the following year, when the Opportunity Notice for the anniversary month of the order is published.

Commerce may update an annual inquiry service list at any time as needed based on interested parties' amendments to their entries of appearance to remove or otherwise modify their list of members and representatives, or to update contact information. Any changes or announcements pertaining to these procedures will be posted to the ACCESS website at https://access.trade.gov.

In the Final Rule, Commerce stated that, “after an initial request and placement on the annual inquiry service list, both petitioners and foreign governments will automatically be placed on the annual inquiry service list in the years that follow.”  13 Accordingly, as stated above, the petitioner and foreign governments should submit their initial entries of appearance after publication of this notice in order to appear in the first annual inquiry service lists for this order. Pursuant to 19 CFR 351.225(n)(3), the petitioner and foreign governments will not need to resubmit their entries of appearance each year to continue to be included on the annual inquiry service list. However, the petitioner and foreign governments are responsible for making amendments to their entries of appearance during the annual update to the annual inquiry service list in accordance with the procedures described above.

This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act, and 19 CFR 351.210(c).

In addition, this notice constitutes the CVD order with respect to wire rod from Algeria, pursuant to section 706(a) of the Act. Interested parties can find a list of antidumping duty and CVD orders currently in effect at https://www.trade.gov/data-visualization/adcvd-orders-and-suspension-agreements.

This CVD order is issued and published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).

On July 2 and October 1, 2003, Commerce published in the Federal Register the AD orders on polyvinyl alcohol from Japan and China, respectively. 1 On March 2, 2026, the ITC instituted, 2 and Commerce initiated, 3 the fourth sunset reviews of the Orders, pursuant to section 751(c) and 752(a) of the Tariff Act of 1930, as amended (the Act). As a result of its reviews, Commerce determined that revocation of the Orders would likely lead to the continuation or recurrence of dumping, and therefore, notified the ITC of the magnitude of the margins of dumping likely to prevail should the Orders be revoked. 4

On September 11, 2026, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The merchandise covered by these Orders is PVA. This product consists of all PVA hydrolyzed in excess of 80 percent, whether or not mixed or diluted with commercial levels of defoamer or boric acid, except as noted below.

The following products are specifically excluded from the scope of these Orders:

(1) PVA in fiber form.

(2) PVA with hydrolysis less than 83 mole percent and certified not for use in the production of textiles.

(3) PVA with hydrolysis greater than 85 percent and viscosity greater than or equal to 90 cps.

(4) PVA with a hydrolysis greater than 85 percent, viscosity greater than or equal to 80 cps but less than 90 cps, certified for use in an ink jet application.

(5) PVA for use in the manufacture of an excipient or as an excipient in the manufacture of film coating systems which are components of a drug or dietary supplement and accompanied by an end-use certification.

(6) PVA covalently bonded with cationic monomer uniformly present on all polymer chains in a concentration equal to or greater than one mole percent.

(7) PVA covalently bonded with carboxylic acid uniformly present on all polymer chains in a concentration equal to or greater than two mole percent, certified for use in a paper application.

(8) PVA covalently bonded with thiol uniformly present on all polymer chains, certified for use in emulsion polymerization of non-vinyl acetic material.

(9) PVA covalently bonded with paraffin uniformly present on all polymer chains in a concentration equal to or greater than one mole percent.

(10) PVA covalently bonded with silan uniformly present on all polymer chains certified for use in paper coating applications.

(11) PVA covalently bonded with sulfonic acid uniformly present on all polymer chains in a concentration level equal to or greater than one mole percent.

(12) PVA covalently bonded with acetoacetylate uniformly present on all polymer chains in a concentration level equal to or greater than one mole percent.

(13) PVA covalently bonded with polyethylene oxide uniformly present on all polymer chains in a concentration level equal to or greater than one mole percent.

(14) PVA covalently bonded with quaternary amine uniformly present on all polymer chains in a concentration level equal to or greater than one mole percent.

(15) PVA covalently bonded with diacetoneacrylamide uniformly present on all polymer chains in a concentration level greater than three mole percent, certified for use in a paper application.

The merchandise subject to these Orders is currently classifiable under subheading 3905.30.00 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, Commerce hereby orders the continuation of the Orders. U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

The effective date of the continuation of the Orders will be September 11, 2026. 6 Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year reviews of the Orders not later than 30 days prior to fifth anniversary of the date of the last determination by the ITC.

This notice also serves as a final reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

These five-year (sunset) reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i) of the Act, and 19 CFR 351.218(f)(4).

On May 4, 2026, in accordance with section 751(a) of the Tariff Act of 1930, as amended, (the Act) and 19 CFR 351.221(c)(1)(i), based on a timely request for review from Arkema, Inc. (the petitioner), 1 Commerce published the initiation notice in the Federal Register . 2 On May 7, 2026, we notified interested parties that information from U.S. Customs and Border Protection (CBP) indicated that there were no entries of the subject merchandise during the POR. 3 On May 21, 2026, the petitioner submitted comments regarding Commerce's May 7, 2026, memorandum and respondent selection. 4 Further, on July 27, 2026, we notified interested parties of our intent to rescind this administrative review due to a lack of suspended entries. 5 We also received comments from the petitioner regarding our intent to rescind. 6

Pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review of an AD order where it concludes that there were there are no entries of subject merchandise during the POR for which liquidation is suspended. 7 Normally, upon completion of an administrative review, the suspended entries are liquidated at the AD rates calculated for the review period. 8 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry that Commerce can instruct CBP to liquidate at the calculated AD rates for the review period. 9

As noted above, Commerce notified all interested parties of its intent to rescind the review because there were no reviewable, suspended entries of subject merchandise during the POR and invited interested parties to comment. 10 We received comments from the petitioner, arguing that Commerce should not rescind its review of Sam Gas (Thailand) Co., Ltd. (Sam Gas) because, according to the petitioner, information suggests that Sam Gas made imports of subject merchandise that were transshipped  11 through Thailand during the POR. 12 However, as noted above, CBP data shows there were no suspended entries of R-32 from China during the POR. Therefore, consistent with our practice, 13 in the absence of any suspended entries of subject merchandise during the POR, we are rescinding this administrative review, in accordance with 19 CFR 351.213(d)(3).

As Commerce has proceeded to a final rescission of this administrative review, no cash deposit rates will change. Accordingly, the current cash deposit requirements shall remain in effect until further notice.

Commerce will instruct CBP to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit rate of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of this rescission notice in the Federal Register .

This notice serves as a final reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of the APO materials or conversion to judicial protective order is hereby requested. Failure to comply with regulations and terms of an APO is a violation, which is subject to sanction.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(l) of the Act, and 19 CFR 351.213(d)(4).

Healthcare accounts for 18% of the GDP in the US and is projected to increase to 20.6% by 2034. 1 It is one of the most socially and commercially important sectors in our economy. Critical components of the healthcare infrastructure are the underlying measurements that are required for accurate screening and diagnostic evaluations and subsequent therapeutic planning and application. Metrology refers to the science of establishing precise reproducible measurements with well-defined uncertainties. A variety of measurement standards exist to ensure measurements are accurate, precise, comparable across all involved sites, and durable over time. Most of the standards are consensus standards established by a large body of stakeholders including professional societies and standards organizations. Government agencies, such as NIST, assist where primary traceability and validation are required.

To help ensure that future medical measurements and standards are developed appropriately and efficiently, a NIST/NIBIB Symposium on Medical Metrology and Standards for American Healthcare and Commerce Medical Imaging, Devices, Diagnostics will be held on September 24, 2026 at the joint NIST/UMD Institute for Bioscience and Biotechnology Research (IBBR), 9600 Gudelsky Dr, Rockville, MD 20850.

NIST, along with other government agencies, have hosted workshops in the past on different aspects of medical metrology resulting in highly cited documents. 2 With the advent of rapidly advancing medical technology and artificial intelligence (AI), the future requirements for medical metrology and standards may change considerably. Agility and evolving standards may be required to address a rapidly changing US healthcare system. Better medical metrology and standards are expected to be an important component of the healthcare infrastructure allowing for improved and cost-effective healthcare.

The NIST/NIBIB Symposium on Medical Metrology and Standards for American Healthcare and Commerce Medical Imaging, Devices, Diagnostics will be held as indicated in the DATES and ADDRESSES section. Requests to participate must be received via the symposium website at https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare no later than 5:00 p.m. Eastern Time on Friday, September 11, 2026 for in person attendance, and 5:00 p.m. Eastern Time on Tuesday, September 22, 2026 for virtual attendance. The symposium will be recorded and transcribed for internal NIST use only.

The NIST/NIBIB symposium is meant to be a general meeting with a wide selection of stakeholders. There will be invited speakers who have a very broad range of expertise and will include representatives from clinical sites, government, industry, professional societies, and academia. The goal of the speakers is to highlight the role of medical metrology and standards in their work, discuss future directions and challenges, and potentially show how their work overlaps with the broader medical metrology and standards framework needed for the US healthcare system. At the end of each session, there will be panel discussions where the speakers can address questions and discuss common themes. Between sessions, there will be a break and poster presentations from researchers, standards organizations, and companies providing medical metrology and standards.

The final agenda will be posted on the Symposium website https://www.nist.gov/news-events/events/2026/09/nistnibib-symposium-medical-metrology-and-standards-american-healthcare in a downloadable pdf file, along with directions to the IBBR site and suggested local accommodations. Information regarding the virtual attendance link and parking vouchers will be sent to registrants after registration is completed.

All visitors attending the Symposium on the joint NIST/University of Maryland Institute (UMD) for Bioscience and Biotechnology Research (IBBR) site are required to pre-register to be admitted. Presentation of ID, driver's license or passport will be required to pick up badge and enter. Limited space is available on a first-come, first-served basis for anyone who wishes to attend in person. For detailed information please visit: https://www.ibbr.umd.edu/events/visiting-ibbr.

NIST provides reasonable accommodation to individuals with disabilities where appropriate. If you are a person who requires a reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation to Sabina Mohan, Conference Program Specialist, sabina.mohan@nist.gov, no later than 5:00 p.m. Eastern Time on September 11, 2026, so appropriate arrangements can be made. Determinations for reasonable accommodation will be made on a case-by-case basis.

In this notice, NIST and NIBIB seek information from organizations, companies, and individuals who are impacted by medical metrology and standards in the areas of Medical Imaging, Devices, Diagnostics and Therapy as well as any other interested stakeholders.

Respondents need not address all topic areas described in this notice, though all responses should specify which statements are being responded to. All relevant responses that comply with the requirements listed in the DATES and ADDRESSES sections of this RFI will be considered.

NIST and NIBIB seek information on the following topic areas, including but not limited to:

• Areas where there is a need for improved medical measurements relating to medical imaging, devices, diagnostics and therapy and how we can provide the needed standards and validation of these measurements.

• Identification of future medical standards efforts for new measurement areas that may not be currently addressed.

• Suggested changes to the medical metrology and standards process to allow improved and cost-effective healthcare in a time of rapidly changing technology and incorporation of AI.

• Examples of how medical metrology and standards have improved diagnostics, therapeutic outcomes, and cost efficiency. Examples where they are detrimental.

Authority: 15 U.S.C. 272(b) and 272(c).

Meeting information, including the agenda, overview, briefing book materials, and an online public comment form will be posted on the Council's website at: https://safmc.net/advisory-panel-meetings/ 2 weeks prior to the meeting. The meeting is open to the public and available via webinar as it occurs. The webinar registration link will be available from the Council's website. Public comment will also be taken during the meeting.

The agenda for the Snapper Grouper AP meeting includes discussions of developing amendments to the Fishery Management Plan (FMP) for the Snapper Grouper Fishery of the South Atlantic Region: Amendment 60 (commercial permit and trip efficiency), Amendment 44 (yellowtail snapper and mutton snapper), and Regulatory Amendment 38 (headboat vessel limits). The AP will provide input and recommendations on these amendments for the Council's consideration.

The AP will also develop a fishery performance report and evaluate the stock risk rating for red grouper. The AP will also receive updates on other ongoing Council projects and initiatives and address other items as needed.

The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

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

The purpose of this online meeting is for the MPC to consider current marine planning issues, including oil and gas leasing, NOAA Aquaculture Opportunity Areas, deep-sea mineral mining, and other ocean development or planning activities that may impact commercial or recreational fishing and West Coast fishing dependent communities. The MPC will provide a report in the Advanced Briefing Book for the Pacific Council's November 2026 meeting.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Hayden York (see FOR FURTHER INFORMATION CONTACT ) at least 10 days prior to the meeting date.

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

The following items are on the agenda, although agenda items may be addressed out of order (changes will be noted on the Council's website when possible).

Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c).

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to Shelley Spedden, (302) 526-5251, at least 5 days prior to the meeting date.

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

Authority: Title I, Section 112(b)(3) of the Trade and Development Act of 2000 (TDA 2000), Public Law (Pub. L.) 106-200, as amended by Division B, Title XXI, section 3108 of the Trade Act of 2002, Public Law 107-210; Section 7(b)(2) of the AGOA Acceleration Act of 2004, Public Law 108-274; Division D, Title VI, section 6002 of the Tax Relief and Health Care Act of 2006 (TRHCA 2006), Public Law 109-432, and section 1 of The African Growth and Opportunity Amendments (Pub. L. 112-163), August 10, 2012; Presidential Proclamation 7350 of October 2, 2000 (65 FR 59321); Presidential Proclamation 7626 of November 13, 2002 (67 FR 69459); Title I, Section 103(b)(2) and (3) of the Trade Preferences Extension Act of 2015, Public Law 114-27, June 29, 2015; Division I, Section 5019 of the Consolidated Appropriations Act, 2026 (Pub. L. 119-75); and Division B, Section 2008 of the Continuing Appropriations and Extensions Act, 2027 (Pub. L. 119-103).

Title I of TDA 2000 provides for duty-free treatment for certain textile and apparel articles imported from designated beneficiary sub-Saharan African countries. Section 112(b)(3) of TDA 2000 provides duty-free treatment for apparel articles wholly assembled in one or more beneficiary sub-Saharan African countries from fabric wholly formed in one or more beneficiary sub-Saharan African countries from yarn originating in the United States or one or more beneficiary sub-Saharan African countries or former beneficiary sub-Saharan African countries, subject to quantitative limitations. This preferential treatment is also available for apparel articles assembled in one or more lesser-developed beneficiary sub-Saharan African countries, regardless of the country of origin of the fabric used to make such articles, subject to quantitative limitation. Public Law 119-103 extended preferential treatment under these programs through December 31, 2028.

The AGOA Acceleration Act of 2004 provides that the quantitative limitation will be an amount not to exceed seven percent of the aggregate square meter equivalents of all apparel articles imported into the United States in the preceding 12-month period for which data are available. See Section 112(b)(3)(A)(ii)(I) of TDA 2000, as amended by Section 2008(b)(2) of the Continuing Appropriations and Extensions Act, 2027. Of this overall amount, apparel imported during the same period under the special rule for lesser-developed countries is limited to an amount not to exceed 3.5 percent of all apparel articles imported into the United States in the preceding 12-month period for which data are available. See Section 112(b)(3)(B)(ii)(II) of TDA 2000, as amended by Section 2008(b)(3) of the Continuing Appropriations and Extensions Act, 2027. Presidential Proclamation 7350 of October 2, 2000 directed CITA to publish the aggregate quantity of imports allowed during each 12-month period in the Federal Register .

For the period beginning on October 1, 2026, and extending through September 30, 2027, the aggregate quantity of imports eligible for preferential treatment under these provisions is 1,690,799,016 square meters equivalent. Of this amount, 845,399,508 square meters equivalent is available to apparel articles imported under the special rule for lesser-developed countries. Apparel articles entered in excess of these quantities will be subject to otherwise applicable tariffs.

These quantities are calculated using the aggregate square meter equivalents of all apparel articles imported into the United States, derived from the set of Harmonized System lines listed in the Annex to the World Trade Organization Agreement on Textiles and Clothing (ATC), and the conversion factors for units of measure into square meter equivalents used by the United States in implementing the ATC.

A final rule published in the Federal Register (FR) on February 15, 2019 (84 FR 4326-4333) established the requirement for the Director, Defense Health Agency (DHA), to provide notice of TRICARE program changes to Military Health System (MHS) beneficiaries each CY in connection with the annual open season enrollment period. The following changes or improvements to the TRICARE program benefits apply for CY 2027.

Open Season is an annual period when beneficiaries may enroll in a health plan or make changes to their health care, dental, and/or vision coverage for the next CY.

During the TRICARE Open Season running from November 9 through December 8, 2026, qualified MHS beneficiaries may enroll in or change their TRICARE Prime or TRICARE Select plan.

During the Federal Employee Dental and Vision Insurance Program (FEDVIP) Open Season running from November 9 through December 7, 2026, qualified MHS beneficiaries, including TRICARE For Life beneficiaries, may enroll in or make changes to their dental and/or vision plans. FEDVIP is operated by the U.S. Office of Personnel Management.

Any changes MHS beneficiaries make during Open Season will take effect on January 1, 2027. If a beneficiary remains eligible and does not make any changes during Open Season, then his/her coverage will remain the same for 2027. TRICARE enrollees can ensure they receive important health plan information by promptly entering any change in mailing address, email address, and other information in the Defense Enrollment Eligibility Reporting System (DEERS) and verifying their preference for receipt of information digitally or by paper mailings with their respective regional contractors. TRICARE enrollees can avoid any health care coverage gaps by ensuring changes in their payment information are also updated with their regional contractors. See https://tricare.mil/Plans/Eligibility/DEERS as a guide for when to update information in DEERS throughout the year.

The following TRICARE program features are subject to a year-to-year determination and are announced each year prior to the annual TRICARE Open Season:

Urgent Care Visits: The number of urgent care visits remains unlimited without referrals for TRICARE Prime enrollees for Plan CY 2027. Beneficiaries may receive urgent care from TRICARE-authorized urgent care centers (UCCs) and convenience clinics (CCs), either network or non-network, without a referral. They may also receive urgent care from any TRICARE network provider ( i.e., family medicine; internal medicine-general practice; pediatricians). In situations when a TRICARE Prime enrollee seeks care from a non-network TRICARE authorized provider (outside of a TRICARE-authorized UCC or CC), the usual TRICARE Prime Point of Service deductible and cost-shares will apply. Private sector care for active duty Service members is subject to different rules. Covered beneficiaries in the U.S. who want assistance with decisions on whether to seek urgent care, except those enrolled in the Uniformed Services Family Health Plan (USFHP) or in a plan under the Competitive Plans Demonstration (CPD), may call the MHS Nurse Advice Line (NAL) at 1-800-874-2273 for health care guidance from a specially trained registered nurse. The NAL is available 24/7 to eligible TRICARE beneficiaries. USFHP and CPD enrollees should contact their contractor's designated nurse advice line. Beneficiaries residing overseas can call the NAL for health care advice when traveling in the U.S. but must coordinate care with their Overseas Regional Call Center. For additional information, call the servicing TRICARE contractor or visit https://www.tricare.mil/ContactUs and click on “MHS Nurse Advice Line.”

Prime Service Area (PSA) Changes: PSAs are geographic areas around military medical treatment facilities and Base Realignment and Closure sites where TRICARE Prime is available. PSAs support the medical readiness of active-duty members of the Uniformed Services by adding to the capability and capacity of military hospitals and clinics. There are no changes to the existing PSAs for CY 2027.

The following changes or improvements to TRICARE program benefits apply to CY 2027 (although some changes were implemented in 2026):

Prescription Copay Waiver for Certain Dependents Enrolled in TRICARE Prime Remote: Active-duty family members enrolled in TRICARE Prime Remote in the United States and who live more than 50 miles or a one-hour drive from a military medical treatment facility pharmacy will no longer pay copayments for covered prescription medications filled at retail network pharmacies, effective February 28, 2026. Eligible families will see the copayment waiver applied automatically at the pharmacy.

Competitive Plans Demonstration: Again for 2027, TRICARE-eligible active duty family members, retirees, and retiree family members who reside within certain ZIP Codes in metro Atlanta, Georgia, and metro Tampa, Florida, have additional options for their TRICARE coverage. Eligible individuals in these areas may opt to voluntarily enroll in a Competitive Plans Demonstration health plan, also known as TRICARE Prime Demo, regardless of whether they are currently enrolled in TRICARE Prime or TRICARE Select. See https://tricare.mil/Plans/HealthPlans/TRICARE-Prime-Demo for more information. Details are available in an April 28, 2025, Federal Register notice at https://www.federalregister.gov/documents/2025/04/28/2025-07258/tricare-tricare-competitive-plans-demonstration-cpd.

Childbirth and Breastfeeding Support Demonstration (CBSD): The CBSD was extended for five years and will now end on December 31, 2031. Until the CBSD ends, beneficiaries may access the services of certified labor doulas, certified lactation consultants, and certified lactation counselors. The CBSD is available to beneficiaries in the United States and overseas. Details are available at https://tricare.mil/cbsd.

Pre-Hospital Blood Transfusions (PHBT) Demonstration: Beginning January 1, 2027, a five-year nationwide demonstration will be used to evaluate an alternative payment method for PHBT. This demonstration will evaluate whether providing a supplementary reimbursement for PHBT will improve beneficiary access to this life-saving care, enhance clinical outcomes for patients in hemorrhagic shock, and prove to be administratively feasible. Details are available in a July 6, 2026, Federal Register notice at: https://www.federalregister.gov/documents/2026/07/06/2026-13515/tricare-demonstration-project-for-tricare-ambulance-add-on-reimbursement-for-pre-hospital-blood.

Ambulatory Blood Pressure Monitoring: TRICARE expanded coverage for ambulatory blood pressure monitoring to include diagnosis of masked hypertension in children and adults; diagnosis of abnormal nocturnal blood pressure in children; and management of certain conditions as recommended by the American Academy of Pediatrics or American Heart Association.

Optune TM Tumor Treating Fields (TTF) Device: Optune TTF device for treatment of adult beneficiaries, 22 years of age or older, with newly diagnosed glioblastoma multiforme, following surgery and radiation is covered.

Ablative Fractional Laser (e.g., Carbon Dioxide and Erbium Yag): Ablative fractional laser for the treatment of symptomatic scars resulting from burns and other trauma is covered. Care must be preauthorized, including subsequent sessions following the first treatment to ensure ongoing therapy is medically necessary and appropriate for the treatment of symptomatic scars. This treatment was previously provided under Provisional Coverage and was converted to a permanent benefit effective February 24, 2026.

Autologous Hematopoietic Stem Cell Transplantation: Benefits may be cost-shared for a single event of myeloablative or non-myeloablative therapy with autologous hematopoietic stem cell transplant for the treatment of multiple sclerosis when criteria are met.

Stereotactic Laser Amygdalohippocampectomy (SLAH): SLAH including magnetic resonance imaging guided laser interstitial thermal therapy may be covered for the treatment of mesial temporal lobe epilepsy when performed in accordance with American Society for Stereotactic and Functional Neurosurgery recommendations.

Liver Transplant for Metastatic Colorectal Cancer: Liver transplantation for colorectal cancer with liver metastasis is covered for beneficiaries who meet specified inclusion requirements and do not meet exclusion criteria, with prior authorization and tumor board approval.

Peripheral Nerve Stimulation: Peripheral nerve stimulation, a non-opioid, and minimally invasive pain treatment, for the treatment of chronic pain, including chronic post-operative pain, chronic post-amputation pain, chronic phantom limb pain, and chronic migraine and headache conditions, is covered. Additionally, peripheral nerve stimulation for the treatment of acute post-operative and acute post-amputation pain for up to 60 days following surgery using temporary peripheral nerve stimulations, such as SPRINT®, is covered.

Vertebral Body Tethering: Vertebral body tethering, a minimally invasive alternative to spinal fusion therapy, is covered under the Provisional Coverage Program for certain adolescents with adolescent idiopathic scoliosis.

Transcutaneous Electrical Nerve Stimulation (TENS): Effective July 1, 2026, TENS devices and supplies are excluded for all conditions except acute post-operative pain.

Certain TRICARE enrollee out-of-pocket costs (enrollment fees, premiums, catastrophic caps, deductibles, and copayments) are adjusted annually by Federal law and regulations based on the annual Cost of Living Adjustment (COLA) applied to Uniformed Service member retired pay. A difference in copayments remains between those who entered Uniformed Service before January 1, 2018 (Group A), and those who entered on or after that date (Group B).

The retiree COLA is typically announced after the Federal fiscal year begins in October. Beneficiary out-of-pocket expenses impacted by the 2026 COLA will be posted to the tricare.mil/changes web page before the start of TRICARE Open Season, November 10, 2026.

The CY 2027 monthly premiums for TRICARE Reserve Select, TRICARE Retired Reserve, and TRICARE Young Adult and the quarterly premiums for the Continued Health Care Benefit Program will be posted to the tricare.mil/changes web page once announced.

TRICARE Pharmacy copayments are unchanged for January 1, 2027:

This notice originally published in the Federal Register on September 16, 2026 (91 FR 58663). The necessary waiver language was missing from the SUPPLEMENTARY INFORMATION section. The notice is being reprinted in its entirety to include the waiver language.

Due to circumstances beyond the control of the DFO, the U.S. Strategic Command Strategic Advisory Group was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its September 21-22, 2026 meeting. Accordingly, the Advisory Committee Management Officer for the Department of War, pursuant to 41 CFR 102-3.150(b), waives the 7-calendar day notification requirement.

This meeting is being held under the provisions of chapter 10 of the United States Code (U.S.C.) (commonly known as the Federal Advisory Committee Act or FACA), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140.

Purpose of the Meeting: The purpose of the meeting is to provide advice and recommendations on scientific, technical, intelligence, nuclear, and policy-related issues to the Commander, U.S. Strategic Command.

Agenda: Topics include: Annual Stockpile Assessment, Strategic Landscape and Threats, Strategy and Policy Development, Readiness and Current Operations, Sustainment/Modernization and Transition Risk, Risk and Hard Problems, Developing Technologies Impact on the Strategic Environment.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b, and 41 CFR 102-3.155, the DoW has determined that the meeting shall be closed to the public. Per delegated authority by the Chairman, Joint Chiefs of Staff, Admiral Richard A. Correll, Commander, U.S. Strategic Command, in consultation with his legal advisor, has determined in writing that the public interest requires that all sessions of this meeting be closed to the public because they will be concerned with matters listed in 5 U.S.C. 552b(c)(1).

Written Statements: Pursuant to 41 CFR 102-3.140(c), the public or interested organizations may submit written statements to the membership of the Strategic Advisory Group at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the Strategic Advisory Group's DFO; the DFO's contact information can be obtained from the GSA's FACA Database— http://www.facadatabase.gov/ . Written statements that do not pertain to a scheduled meeting of the Strategic Advisory Group may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than five business days prior to the meeting in question. The DFO will review all submitted written statements and provide copies to all the committee members.

Title: FERC-521, Payments for Benefits from Headwater Improvements

OMB Control No.: 1902-0087

Type of Request: Three-year extension of the FERC-521 information collection requirements with no changes to the reporting requirements.

Abstract: The purpose of FERC-521 is to implement information collections pursuant to Section 10(f) of the Federal Power Act (FPA). Section 10(f) of the FPA requires hydropower licensees to reimburse upstream headwater project owners for an equitable portion of the benefits it receives as a result of construction work related to headwater improvements. These benefits, referred to as headwater benefits, are the additional energy production possible at a downstream hydropower project resulting from the regulation of river flows by an upstream storage reservoir. The Commission requires federal agencies and owners of non-federal hydropower projects to file data for determining headwater benefits as outlined in 18 Code of Federal Regulations (CFR) Part 11.

Type of Respondents: There are two types of entities that respond, Federal and Non-Federal storage and hydropower project owners. The Federal entities that typically respond include the U.S. Army Corps of Engineers and the U.S. Department of Interior Bureau of Reclamation. The Non-Federal entities may consist of any Municipal or Non-Municipal hydropower project owner.

Estimate of Annual Burden   1 and cost:  2 The Commission estimates the total Public Reporting Burden for this information collection as:

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that ten or more persons submit information to a third party.

Section 3506(c)(2)(A) of title 44 and 5 CFR 1320.8(d) requires Federal agencies to provide a 60-day notice  1 in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection of information to OMB for approval. FHFA's collection of information set forth in this document is titled “Federal Home Loan Bank Capital Stock” (assigned control number 2590-0002 by OMB). To comply with the PRA requirement, FHFA is publishing notice of a proposed three-year extension of this collection of information and renewal of the control number, which is due to expire on November 30, 2026.

The Federal Home Loan Bank System consists of eleven regional Federal Home Loan Banks (Banks) and the Office of Finance (a joint office of the Banks that issues and services the Banks' debt securities). The Banks are wholesale financial institutions, organized under the authority of the Federal Home Loan Bank Act (Bank Act) to serve the public interest by enhancing the availability of residential housing finance and community lending credit through their member institutions and, to a limited extent, through certain eligible nonmembers. Each Bank is structured as a regional cooperative that is owned and controlled by member institutions located within its district, which are also its primary customers. An institution that is eligible for membership in a particular Bank must purchase and hold a prescribed minimum amount of the Bank's capital stock in order to become and remain a member of that Bank. With limited exceptions, only an institution that is a member of a Bank may obtain access to low cost secured loans, known as advances, or other products provided by that Bank.

Section 6 of the Bank Act establishes capital requirements for the Banks and requires FHFA to issue regulations prescribing uniform capital standards applicable to all of the Banks. 2 Section 6 also establishes parameters relating to the Banks' capital structures and requires that each Bank adopt a “capital structure plan” (capital plan) to establish, within those statutory parameters, its own capital structure and to establish requirements for, and govern transactions in, the Bank's capital stock. 3 FHFA's regulations on Bank Capital Requirements, Capital Stock, and Capital Plans are located at 12 CFR part 1277.

Both the Bank Act and FHFA's regulations state that a Bank's capital plan must require its members to maintain a minimum investment in the Bank's capital stock, but both permit each Bank to determine for itself what that minimum investment is and how each member's required minimum investment is to be calculated. 4 Although each Bank's capital plan establishes a slightly different method for calculating the required minimum stock investment for its members, each Bank's method is tied to some degree to both the level of assets held by the member institution (typically referred to as a “membership stock purchase requirement”) and the amount of advances or other business engaged in between the member and the Bank (typically referred to as an “activity-based stock purchase requirement”).

A Bank must collect information from its members to determine the minimum capital stock investment each member is required to maintain at any point in time. Although the information needed to calculate a member's required minimum investment and the precise method through which it is collected differ somewhat from Bank to Bank, the Banks typically collect two types of information. First, in order to calculate and monitor compliance with its membership stock purchase requirement, a Bank typically requires each member to provide and/or confirm an annual report on the amount and types of assets held by that institution. Second, each time a Bank engages in a business transaction with a member, the Bank typically confirms with the member the amount of additional Bank capital stock, if any, the member must acquire in order to satisfy the Bank's activity-based stock purchase requirement and the method through which the member will acquire that stock.

FHFA has analyzed the time burden imposed on respondents by the two collections under this control number and estimates that the average total annual hour burden imposed on all respondents over the next three years will be 19,898 hours. This estimate is derived from the following calculations:

FHFA estimates that the average annual number of current and former members and applicants for membership required to report information needed to calculate a membership stock purchase requirement will be 6,425, and that each institution will submit one report per year, resulting in an estimated total of 6,425 submissions annually. The estimate for the average time required to prepare, review, and submit each report is 0.7 hours. Accordingly, the estimate for the annual hour burden associated with membership stock purchase requirement submissions is (6,425 reports × 0.7 hours per report) = 4,498 hours.

FHFA estimates that the average number of daily transactions between Banks and members that will require the exchange of information to confirm the member's activity-based stock purchase requirement will be 295, and that there will be an average of 261 working days per year, resulting in an estimated 76,995 submissions annually. The estimate for the average preparation time per submission is 0.1 hours. Accordingly, the estimate for the annual hour burden associated with activity-based stock purchase requirement submissions is (76,995 submissions × 0.2 hours per submission) = 15,400 hours.

FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that ten or more persons submit information to a third party.

Section 3506(c)(2)(A) of title 44 and 5 CFR 1320.8(d) requires Federal agencies to provide a 60-day notice  1 in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection of information to OMB for approval. FHFA's collection of information set forth in this document is titled “Members of the Banks” (assigned control number 2590-0003 by OMB). To comply with the PRA requirement, FHFA is publishing notice of a proposed three-year extension of this collection of information and renewal of the control number, which is due to expire on November 30, 2026.

The Federal Home Loan Bank System consists of eleven regional Federal Home Loan Banks (Banks) and the Office of Finance (a joint office of the Banks that issues and services the Banks' debt securities). The Banks are wholesale financial institutions, organized under the authority of the Federal Home Loan Bank Act (Bank Act) to serve the public interest by enhancing the availability of residential housing finance and community lending credit through their member institutions and, to a limited extent, through certain eligible nonmembers. Each Bank is structured as a regional cooperative that is owned and controlled by member institutions located within its district, which are also its primary customers. The Banks carry out their public policy functions primarily by providing low-cost loans, known as advances, to their members. With limited exceptions, an institution may obtain advances and access other products and services provided by a Bank only if it is a member of that Bank.

The Bank Act limits membership in any Bank to specific types of financial institutions located within the Bank's district that meet specific eligibility requirements. Section 4 of the Bank Act specifies the types of institutions that may be eligible for membership and establishes eligibility requirements that each type of applicant must meet in order to become a Bank member. 2 That provision also specifies that (with limited exceptions) an eligible institution may become a member only of the Bank of the district in which the institution's “principal place of business” is located. 3 With respect to the termination of Bank membership, section 6(d) of the Bank Act sets forth requirements pursuant to which an institution may voluntarily withdraw from membership or a Bank may terminate an institution's membership for cause. 4

FHFA's “Members of the Banks” regulation, set forth at 12 CFR part 1263, implements those statutory provisions on Bank membership and otherwise establishes substantive and procedural requirements relating to the initiation and termination of Bank membership. Many of the provisions in the membership regulation require that an institution submit information to a Bank or to FHFA, in most cases to demonstrate compliance with statutory or regulatory requirements or to request action by the Bank or FHFA.

There are four types of information collections that may occur under part 1263. First, the regulation provides that (with limited exceptions) no institution may become a member of a Bank unless it has submitted to that Bank an application that documents the applicant's compliance with the statutory and regulatory membership eligibility requirements and that otherwise includes all required information and materials. 5 Second, the regulation provides applicants that have been denied membership by a Bank the option of appealing the decision to FHFA. To file such an appeal, an applicant must submit to FHFA a copy of the Bank's decision resolution denying its membership application and a statement of the basis for the appeal containing sufficient facts, information, and analysis to support the applicant's position. 6 Third, the regulation provides that, in order to initiate a voluntary withdrawal from Bank membership, a member must submit to its Bank a written notice of intent to withdraw. 7 Fourth, under certain circumstances, the regulation permits a member of one Bank to transfer its membership to a second Bank “automatically” without either initiating a voluntary withdrawal from the first Bank or submitting a membership application to the second Bank. Despite the regulatory reference to such a transfer as being “automatic,” a member meeting the criteria for an automatic transfer must initiate the transfer process by filing a request with its current Bank, which will then arrange the details of the transfer with the second Bank. 8

The Banks use most of the information collected under part 1263 to determine whether an applicant satisfies the statutory and regulatory requirements for Bank membership and should be approved as a Bank member. The Banks may use some of the information collected under part 1263 as a means of learning that a member wishes to withdraw or to transfer its membership to a different Bank so that the Bank can begin to process those requests. FHFA may also use the collected information to determine whether an institution that has been denied membership by a Bank should be permitted to become a member of that Bank.

FHFA has analyzed the time burden imposed on respondents by the four collections under this control number and estimates that the average total annual hour burden imposed on all respondents by those collections over the next three years will be 1,637 hours. This estimate is derived from the following calculations:

FHFA estimates that the average number of applications for Bank membership submitted annually will be 105 and that the average time to prepare and submit an application and supporting materials will be 15 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of applications for Bank membership is (105 applications × 15 hours per application) = 1,575 hours.

FHFA estimates that the average number of applicants that have been denied membership by a Bank that will appeal such a denial to FHFA will be 1 and that the average time to prepare and submit an application for appeal will be 50 hours. Accordingly, the estimate for the annual hour burden associated with the preparation and submission of membership appeals is (1 appellants × 50 hours per application) = 50 hours.

FHFA estimates that the average number of Bank members submitting a notice of intent to withdraw from membership annually will be 4 and that the average time to prepare and submit a notice will be 1.5 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of notices of intent to withdraw is (4 withdrawing members × 1.5 hours per application) = 6 hours.

FHFA estimates that the average number of Bank members submitting a request for transfer to another Bank will be 3 and that the average time to prepare and submit a request will be 2 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of requests for automatic transfer is (3 transferring members × 2 hours per request) = 6 hours.

FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Pursuant to section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of 30 days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained at https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 19, 2026. Write “Beretta and Ruger: File No. 261 0091” on your comment. Your comment—including your name and your State—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

We encourage you to submit comments through the https://www.regulations.gov website. Postal mail addressed to the Commission will be subject to delay because of heightened security screening. If you prefer to file your comment on paper, write “Beretta and Ruger: File No. 261 0091” on your comment and on the envelope, and send it via overnight service to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Mail Stop H-144 (Annex G), Washington, DC 20580.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure your comment does not include any sensitive or confidential information. In particular, your comment should not include sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other State identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the https://www.regulations.gov website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from that website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit https://www.ftc.gov to read this document and the news release describing the proposed settlement. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all responsive public comments it receives on or before October 19, 2026. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Order (“Consent Agreement”) from Beretta Holding S.A. (“Respondent”), a subsidiary of Upifra S.A. Pursuant to a Cooperation Agreement dated May 2, 2026, Beretta may acquire up to 25% of the outstanding shares of Sturm, Ruger & Company, Inc. (“Ruger”) for $44.80 per share, for a total transaction value of approximately $167 million (“Proposed Transaction”). In addition to this consideration, Beretta gained the right to “source” two members to be appointed and thereafter nominated to Ruger's Board of Directors. The Consent Agreement is designed to be a prophylactic safeguard against any anticompetitive effects that may result from Beretta's agreement with its direct competitor, Ruger. The Commission alleges in its Complaint that the Proposed Transaction, if consummated, would violate section 8 of the Clayton Act, as amended, 15 U.S.C. 19, and section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45.

The Proposed Transaction raises section 8 concerns. Specifically, Ruger's obligation to facilitate the appointment of two Beretta-sourced directors to Ruger's board raises concerns that Beretta could have access to Ruger's competitively significant, nonpublic information and could participate in, or have influence over, competitive decision-making at Ruger. The agreement expressly provides that the parties could waive any restrictions on Beretta officers, employees, agents, representatives, or directors from serving as Ruger directors. Under section 8 of the Clayton Act, it is illegal for directors and officers to serve, whether directly or indirectly, on the boards of competitors (subject to limited safe harbors), as would occur here because of Beretta's right to source two of its designees to the board of its competitor, Ruger.

The Consent Agreement is designed to remedy allegations in the Commission's Complaint that Beretta's proposed acquisition would provide the right to source two Beretta designees to appoint and nominate for a seat on the Ruger Board of Directors. This would result in an illegal interlocking directorate in violation of section 8 of the Clayton Act, 15 U.S.C. 19, and an unfair method of competition in violation of section 5 of the Federal Trade Commission Act, 15 U.S.C. 45 due to the potential exchange of confidential, competitively sensitive information.

The proposed settlement provides significant relief for this concern. The Consent Agreement and proposed Decision and Order (“D&O”) prohibit Beretta from appointing, sourcing, nominating, or occupying any director position on Ruger's Board unless that director is independent of Beretta.

The proposed D&O imposes effective relief, while continuing to set important Commission precedent on the application of section 8 of the Clayton Act and section 5 of the FTC Act. By restricting future opportunities for the parties to engage in conduct that would result in section 8 violations, the proposed D&O signals the antitrust risks of excessive influence and anticompetitive information exchange.

The Commission has placed the Consent Agreement on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the comments received and decide whether it should withdraw, modify, or make the proposed Order final.

Respondent Beretta is the largest firearms manufacturer in the world. Beretta's headquarters are in Luxembourg, and its primary corporate offices in the United States are in Accokeek, Maryland.

On May 2, 2026, Beretta and Ruger entered into a Cooperation Agreement, under which Beretta seeks to acquire up to 25% of Ruger's outstanding shares at $44.80 per share, for a total transaction value of approximately $167 million. Beretta already owns 9.96% of Ruger's shares. The Proposed Transaction would make Beretta one of Ruger's largest shareholders. Additionally, the Ruger Board of Directors “shall” “take such actions as are necessary to appoint two directors sourced by Beretta Holding” and renominate the Beretta directors at the 2027 and 2028 annual board meetings. The Cooperation Agreement refers to these appointments as the “Beretta Holding Director Appointments” and the directors are the “Beretta Holding Directors.”

The Commission's Complaint alleges that the Proposed Transaction, as structured, would violate section 8 of the Clayton Act, 15 U.S.C. 19, as an illegal interlocking directorate, and that the Proposed Transaction constitutes an unfair method of competition in violation of section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, due to the risk of the exchange of competitively sensitive, nonpublic information.

The production and sale of firearms, including pistols, shotguns, and rifles, are the relevant lines of commerce. Firearms serve a wide range of uses in the United States, including personal protection, sport shooting, hunting, law enforcement, and collecting. Buyers of firearms typically cannot substitute other products for these purposes without significant compromises in functionality.

The firearms market is characterized by a large set of established manufacturers. Major competitors include companies such as Smith & Wesson, SIG Sauer, Glock, Springfield Armory, and Browning Arms Company, among others, with each offering broad portfolios of firearms across price points and performance categories. Beretta is recognized as a premium, globally established manufacturer, with particular historical strength in shotguns and semiautomatic pistols, while Ruger is known as a purely U.S. manufacturer with significant share in rifles and handguns. Both companies sell to overlapping customer groups, including recreational shooters, hunters, sports shooters, and law-enforcement agencies.

The Commission's Complaint addresses the theory of harm that interlocking directorates can present opportunities or temptations for anticompetitive conduct. Beretta's placement of a director or officer on Ruger's board—in violation of section 8 of the Clayton Act—would make Beretta a direct participant in Ruger's corporate governance. This interlocking directorate arrangement would provide Beretta with the ability to sway or influence Ruger's competitive decision-making and to access Ruger's competitively sensitive information. As an interlocked director or officer, Beretta's representative would have the opportunity to communicate directly within Ruger's highest levels of leadership and could discuss confidential business information or direct or otherwise influence Ruger's competitive actions or strategies. Knowledge gained via this prohibited interlocking relationship could also influence Beretta's own competitive decisions or development of new businesses involved in the production and sale of firearms.

The proposed Order imposes several obligations designed to address the competitive concerns arising from Beretta's proposed acquisition of voting securities of Ruger and the potential for interlocking directorates or improper access to competitively sensitive information.

First, the proposed Order limits Beretta's ability to place representatives or agents on Ruger's board of directors. Beretta may not, directly or indirectly, including through its parent, appoint, nominate, or otherwise cause any person to serve on Ruger's board unless that person qualifies as independent from Beretta, i.e., an “Independent Director” as defined in the Order. The proposed Order defines an Independent Director as a person who is not affiliated with Beretta, Upifra, or their controlled entities; has not recently served as an employee, officer, director, representative, or agent of a relevant person; has not recently received compensation from a relevant person; and does not have a material relationship that would reasonably be expected to impair the objectivity of the director's judgment when serving on Ruger's board.

Second, the proposed Order requires Beretta to provide the Commission with advance written notice at least 15 days before appointing, designating, nominating, electing, or otherwise causing any person to become a member of Ruger's board of directors.

Third, the proposed Order restricts Beretta's relationships with any Independent Director it nominates to Ruger's board. Beretta may not, directly or indirectly, including through its parent, hire or enter into any financial or other relationship with such Independent Director that would involve violating the Independent Director's fiduciary duties or involve the exchange of Ruger's nonpublic information with Beretta, Upifra, or their affiliates. These restrictions remain in place until one year after the Independent Director has ceased serving on Ruger's board.

Fourth, the proposed Order prohibits Beretta from directly or indirectly seeking, receiving, or attempting to receive Ruger's nonpublic information from any Independent Director appointed pursuant to the Order. The Order defines nonpublic information broadly to include information not in the public domain, such as customer lists, price lists, strategic plans, contracts, expansion projects, cost information, marketing methods, competitively sensitive data or information, and other nonpublic information.

Fifth, the proposed Order requires Beretta to distribute the Order to each of its respective board members, officers, and directors, and to design, maintain, and operate an antitrust compliance program.

The purpose of this analysis is to facilitate public comment on the Consent Agreement and proposed Order to aid the Commission in determining whether it should make the proposed Order final. This analysis is not an official interpretation of the proposed Order and does not modify its terms in any way.

FDA is issuing this draft guidance document to introduce submitters of certain PMAs to CDRH and CBER to the current resources and associated content developed and made publicly available to support electronic submissions of certain PMAs/PMA supplements to FDA. These include Original PMAs, Panel-Track Supplements, 180-day Supplements, Real Time Supplements, and 30-Day Notices/135-Day Supplements. This draft guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. When finalized, this guidance will also facilitate the implementation of the FDA's mandate under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), to provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.

FDA's final guidance document published on July 15, 2020 (85 FR 42864): “Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” (hereafter referred to as the “745A(b) device parent guidance”) provides a process for the development of templates to facilitate the preparation, submission, and review of regulatory submissions for medical devices solely in electronic format. As described in the 745A(b) device parent guidance, FDA plans to implement the requirements of section 745A(b)(3) of the FD&C Act with individual guidances specifying the formats for specific submissions and corresponding timetables for implementation. When finalized, this guidance will provide such information for electronic submissions of certain PMAs/PMA supplements solely in electronic format.

In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the statutory requirement for electronic submissions solely in electronic format by providing standards, a timetable, and criteria for waivers and exemptions. To the extent that this draft guidance provides such requirements under section 745A(b)(3) of the FD&C Act ( i.e., standards, timetable, criteria for waivers of and exemptions), indicated by the use of the mandatory words, such as must or required, this document is not subject to the usual restrictions in FDA's good guidance practice regulations, such as the requirement that guidances not establish legally enforceable responsibilities (see §  10.115(d)). To the extent that this draft guidance describes recommendations that are not standards, timetable, criteria for waivers of, or exemptions under section 745A(b)(3) of the FD&C Act, it is being issued consistent with FDA's good guidance practices regulation (§  10.115).

The draft guidance, when finalized, will represent the current thinking of FDA on Electronic Submission Template for PMAs/PMA supplements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

As we develop final guidance on this topic, FDA will consider comments on costs or cost savings the guidance may generate, relevant for Executive Order 14192.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007079 and complete title to identify the guidance you are requesting.

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:

FDA is announcing the availability of the draft Strategy Document titled “BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document.” In section II.D.3 of the BsUFA III commitment letter (available at https://www.fda.gov/media/152279/download?attachment ), FDA agreed to hold a public scientific workshop on the development of interchangeable biosimilar products to help identify future needs ( e.g., guidance, research). FDA also agreed to issue a draft strategy document for public comment outlining the specific actions FDA will take to facilitate interchangeable biosimilar product development within 12 months following the public workshop. The public workshop was held on September 19, 2025 (90 FR 39395), with both virtual and in-person attendance, and representatives from trade associations (Association for Accessible Medicines (AAM), Pharmaceutical Research and Manufacturers of America (PhRMA), and Biosimilars Forum) provided their perspectives on future needs for development and adoption of interchangeable biosimilar products. FDA speakers from the Center for Drug Evaluation and Research discussed scientific topics related to analytical data considerations, user interface and human factors considerations, and other considerations to facilitate development of interchangeable biosimilar products. The draft Strategy Document summarizes the discussion that occurred during the workshop as well as comments received in the public docket. The major themes identified during the workshop and in comments submitted to the docket included timely communication of new scientific and policy developments, challenges with user interface development and human factors analyses, and approaches to interchangeability that follow the evolving science. Over the last 5 years, the development and approval of interchangeable biosimilar products have advanced considerably. FDA's future efforts will focus on continuing to follow the evolving science, providing educational resources for healthcare providers and patients, and helping to ensure that stakeholders have confidence in the safety and effectiveness of interchangeable biosimilar products.

The draft Strategy Document is available on the FDA web page for the public workshop at https://www.fda.gov/industry/fda-public-workshop-future-needs-development-interchangeable-products-09192025#event-information.

FDA is announcing the availability of a draft GFI #298 (VICH GL62) titled “Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products.”

Currently, no VICH GL specifically supports marketing applications for VMAPs in the regions participating in the VICH. The VICH GLs available for TAS ( i.e., VICH GL43 for pharmaceutical products and VICH GL44 for vaccines) do not fully address the TAS evaluation for a VMAP. Furthermore, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) S6 (R1) for the preclinical safety evaluation of biotechnology-derived pharmaceuticals is not fully applicable to VMAPs. Hence, there is a need for specific guidance on the TAS evaluation of a VMAP. Therefore, this guideline summarizes scientifically acceptable general principles for the TAS evaluation of a VMAP and should be used in conjunction with VICH GL43.

This guideline is for VMAPs intended for use in companion animals and livestock animals. The active ingredient of a VMAP is a monoclonal antibody (mAb) or a mAb fragment, which could be engineered to be specific for a target animal and target(s). When needed, advice should be sought from the relevant regulatory authority for specific guidance on the design of the TAS study(ies) prior to their initiation or if the applicant determines an alternative approach to the TAS evaluation of a VMAP may be more appropriate.

FDA has participated in efforts to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The goal of the VICH is to develop harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and receives input from both regulatory and industry representatives.

The VICH Steering Committee is composed of founding member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA's Center for Veterinary Medicine; U.S. Department of Agriculture's Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 standing members to the VICH Steering Committee: 1 representative from government and 1 representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.

This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

As we develop final guidance on this topic, FDA will consider comments on costs or cost savings the guidance may generate, relevant for Executive Order 14192.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) and in 21 CFR part 514 have been approved under OMB control number 0910-0032. The collections of information in 21 CFR part 511 have been approved under OMB control number 0910-0117.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance- documents, or https://www.regulations.gov.

Intended Recipient of the Award: The University of North Carolina at Chapel Hill.

Amount of Non-Competitive Award: One supplemental award for $800,000.

Project Period: September 30, 2025, to September 29, 2030.

Assistance Listing Number: 93.746.

Award Instrument: Cooperative Agreement Supplement for Services.

Authority: Section 711 of the Social Security Act (42 U.S.C. 912).

Justification: This funding will provide a one-time supplement to the University of North Carolina at Chapel Hill through the RRPD-TA Cooperative Agreement with a budget period of September 30, 2026, through September 29, 2027. This supplement will allow the University of North Carolina at Chapel Hill to build on past and ongoing projects supported by HRSA to support health care in rural areas by advancing the knowledge base regarding the unique considerations and barriers facing rural providers developing graduate medical education programs. The University of North Carolina at Chapel Hill is the recipient of the only award under the RRPD-TA program and has established relationships with rural stakeholders and has longstanding experience developing resources related to rural graduate medical education. The supplement to the RRPD-TA Cooperative Agreement will allow the University of North Carolina at Chapel Hill to provide additional technical assistance and develop additional resources to promote rural graduate medical education development and sustainability.

Intended Recipient of the Award: ZERO TO THREE National Center for Infant, Toddler and Families, Inc.

Amount of Award: $2,750,000.

Project Period: September 30, 2026, to September 29, 2027.

Assistance Listing Number: 93.110.

Award Instrument: Non-competitive supplemental funding to the existing Cooperative Agreement.

Authority: 42 U.S.C. 701(a)(2) (Title V, § 501(a)(2) of the Social Security Act).

Justification: In FY 2022, under the authority for Special Projects of Regional and National Significance (SPRANS) (42 U.S.C. 701(a)(2) (Title V, § 501(a)(2) of the Social Security Act)), HRSA awarded the ITCP NRC to ZERO TO THREE National Center for Infant, Toddler and Families, Inc (HRSA-22-074). This award included expectations for the recipient to provide technical assistance to the ITCP (HRSA-22-073) state recipients and support the nationwide implementation and sustainability of the evidence-based ITC approach.

A Congressional Report accompanying the Further Consolidated Appropriations Act, 2024 (Pub. L. 118-47) included funding for this program to “continue and expand research-based Infant-Toddler Court Teams to change child welfare practices to improve wellbeing for infants, toddlers, and their families” (Senate Report 118-84). In addition, the Joint Explanatory Statement accompanying the FY 2024 appropriations act directed HRSA to “allocate funding to ensure continuation of existing grantees, technical assistance, and other activities.” In FY 2024, HRSA provided a supplement of $1,750,000 in SPRANS to the NRC Program recipient to continue work initiated in FY 2023 with an increased SPRANS appropriation, to expand technical assistance to ITC teams, provide financial and technical support to local infant-toddler court sites that previously received funding under HRSA-18-123, and advance national-level reach and impact of the program.

In addition, a Congressional Report accompanying the FY 2025 appropriations act directed HRSA to “allocate funding to ensure continuation of existing grantees, technical assistance, and support other expansion activities,” (House Report 118-585). In response to the congressional intent, HRSA provided a supplement of $1,750,000 to the NRC Program recipient in FY 2025 to continue work initiated in prior years to expand technical assistance to ITC teams, provide financial and technical support to local infant-toddler court sites that previously received funding under HRSA-18-123, and advance national-level reach and impact of the program.

A Congressional Report accompanying the Consolidated Appropriations Act, 2026 (Pub. L. 119-75) included an additional $2,000,000, for a total of $20,000,000 in funding “for research-based Infant-Toddler Court Teams to change child welfare practices to improve well-being for infants, toddlers, and their families,” (House Report 119-271). The Report also included a directive to “allocate funding to ensure continuation of existing grantees, technical assistance, and support other expansion activities,” (House Report 119-271).

Consistent with congressional intent, HRSA, through its Maternal and Child Health Bureau, will provide a supplement of $2,750,000 in SPRANS funding to the ITCP NRC Program recipient. This funding will continue the number of ITC teams funded through subawards and continue to provide technical assistance to ITC teams, increase the number of ITC teams funded through subawards to new ITC teams, expand technical assistance to ITC teams funded under HRSA-22-073/074, and advance the national reach and impact of the program.

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the United States Court of Federal Claims and to serve a copy of the petition to the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register .” Set forth below is a list of petitions received by HRSA on August 1, 2026, through August 31, 2026. This list provides the name of the petitioner, city, and state of vaccination (if unknown then the city and state of the person or attorney filing the claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by one of the vaccines referred to in the Table, or

b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Health Systems Bureau, 5600 Fishers Lane, 14W-17, Rockville, Maryland 20857. The Court's caption ( Petitioner's Name v. Secretary of HHS ) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of Title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

Intended Recipient(s) of the Award: The National Institute for Children's Health Quality.

Amount of Non-Competitive Award: $500,000.

Project Period: June 1, 2026, to May 31, 2027.

Assistance Listing Number: 93.926.

Award Instrument: Cooperative agreement.

Authority: 42 U.S.C. 254c-8 (Title III, § 330H of the Public Health Service Act).

Justification: NICHQ, as the current Healthy Start Technical Assistance and Support Center (TASC), provides national technical assistance and support to all HRSA-funded Healthy Start award recipients. Supplemental funds will support the expansion of a self-measured blood pressure (SMBP) monitoring initiative within Healthy Start communities to promote earlier identification of preeclampsia and other hypertensive disorders of pregnancy. Hypertensive disorders of pregnancy are a leading cause of maternal morbidity and mortality in the United States and disproportionately affect the types of populations served by Healthy Start. Preeclampsia, a life-threatening hypertensive disorder of pregnancy, affects as many as one in 12 pregnancies and can be effectively monitored through regular blood pressure measurement.

HRSA supplemented NICHQ's award with $175,000 in FY 2023 and $214,000 in FY 2024 ($389,000 total) to support a successful SMBP monitoring pilot previously implemented across 15 Healthy Start sites in 12 states. In FY 2026, Congress directed HRSA to expand this effort by providing no less than $250,000 to increase the number of states and Healthy Start sites able to benefit from the SMBP monitoring initiative. Specifically, the Explanatory Statement accompanying the Consolidated Appropriations Act, 2026 (Pub. L. 119-75) included “no less than $250,000 for the Healthy Start blood pressure monitoring pilot, as described in Senate Report 119-55.” In Senate Report 119-55, the Committee provided “no less than $250,000 for more States to benefit from this pilot, and to the Healthy Start program to continue to support the self-measured blood pressure monitoring pilot, which works to identify preeclampsia during pregnancy at an earlier stage in high-risk communities by distributing blood pressure cuffs and patient information.”

As the Healthy Start TASC, NICHQ is well-positioned to support expanded implementation of the SMBP monitoring initiative among Healthy Start sites. Through this supplemental funding, NICHQ, as the Healthy Start TASC, will support Healthy Start award recipients in at least 15 states to expand access to SMBP monitoring for pregnant and postpartum women. This initiative will provide training, technical assistance, implementation guidance, and resources to selected Healthy Start sites in partnership with a subject matter expert in hypertensive disorders of pregnancy. This effort builds on lessons learned from the previous SMBP monitoring pilot and is intended to broaden participation beyond the original pilot sites so that additional Healthy Start communities may benefit. Further information on Healthy Start is available at: https://www.hrsa.gov/services/healthy-start.

Intended Recipient of the Award: The University of North Dakota.

Amount of Non-Competitive Award: One supplemental award for $835,000.

Project Period: June 1, 2025, to May 31, 2030.

Assistance Listing Number: 93.223.

Award Instrument: Cooperative Agreement Supplement for Services.

Authority: Social Security Act § 711(b) (42 U.S.C. 912(b)).

Justification: This funding provided a one-time supplement to the University of North Dakota via the National Rural Health Information Clearinghouse Program with a budget period of June 2026 through May 2027. This supplement allows the University of North Dakota to build on past and ongoing projects supported by the Federal Office of Rural Health Policy to improve health care in rural areas by advancing the knowledge base regarding strategies to support and enhance rural community health. The University of North Dakota is the recipient of the only award under the program and has longstanding experience identifying, developing and disseminating resources like toolkits and webinars to support a broad range of rural health topics. The supplement will allow the University of North Dakota to create new tools and resources on important topics related to rural community health and health care.

Intended Recipient of the Award: Rural Health Resource Center.

Amount of Non-competitive award: $486,745.

Project Period: September 1, 2026, to August 31, 2027.

Assistance Listing Number: 93.912.

Award Instrument: Cooperative Agreement.

Authority: Section 711(b) of the Social Security Act (42 U.S.C. 912(b)).

Justification: The Delta Region Community Health Systems Development Program provides comprehensive, multi-year TA to rural health care organizations in rural counties and parishes of the Delta region to strengthen health care delivery by improving financial and operational performance and quality of care. This funding will provide a one-time supplement to the Rural Health Resource Center to provide sustainability TA to hospitals and clinics that have previously completed program TA. This support may include targeted consultations, assessment of ongoing financial and operational challenges, review of progress on quality and performance improvement activities, and assistance with sustaining service delivery improvements.

This supplemental funding is consistent with the program's focus on helping rural health care organizations implement best practice recommendations, sustain the impacts of TA, and respond to additional TA needs related to innovation, adaptability, and sustainability in rural health care organizations located in the Delta region.

Intended Recipient of the Award: The National Rural Health Association.

Amount of Non-Competitive Award: One supplemental award for $660,000.

Project Period: August 1, 2024, to July 31, 2029.

Assistance Listing Number: 93.692.

Award Instrument: Cooperative Agreement Supplement for Services.

Authority: Section 711 of the Social Security Act (42 U.S.C. 912).

Justification: This funding will provide a one-time supplement to the National Rural Health Association through National Rural Health Policy, Community, and Collaboration Program with a budget period of August 1, 2026, through July 31, 2027. This supplement will allow the National Rural Health Association to identify, engage, educate, and collaborate with rural stakeholders on national rural health issues and promising practices to improve health care in rural areas nationwide. These activities build on past and ongoing National Rural Health Association projects supported by HRSA and align with the goals of the program to educate rural stakeholders and facilitate collaboration with key stakeholders to improve the exchange of information and promising practices that support rural health.

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize s the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title: Public Health Service (PHS) Post-award Reporting Requirements Revision, OMB 0925-0002, Expiration Date 11/30/2027, Revision, Office of the Director, National Institutes of Health (NIH).

Need and Use of Information Collection: In Fiscal Year 2025, OMB approved through information collections 0925-0001 and 0925-0002, NIH's request to address progress on data management and sharing of NIH-funded research using the Research Performance and Progress Report (RPPR). The DMS Plan format contains six (6) Elements for applicants and recipients to submit free-text narratives explaining how scientific data will be managed and shared for NIH-funded research. Current public reporting burden for the DMS Plan as part of the RPPR information collection is an estimated 2 hours per response, including the time for reviewing instructions, gathering and maintaining the data, and reviewing the collection of information. After several years of implementation experience, NIH is updating the DMS Plan Elements to provide a structured, simplified format to reduce burden and promote consistent information collection. Effective Fiscal Year 2026, NIH will require applicable recipients to use the updated DMS Plan format when reporting on data management and sharing progress. The updated plan format consists of “Yes, No, or Not Applicable” questions. Narrative text is required only for “No” and “Not Applicable” responses and the narrative response is limited to 300 words. This updated format continues building on trans-NIH initiatives to reduce the public reporting burden and promote consistency across all NIH. The RPPR is required to be used by all NIH, Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) recipients. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. Pre-award reporting requirements are simultaneously consolidated under 0925-0001 and the changes to the collection here are related.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 24,270.

The Deputy Director for Extramural Research, Jon Lorsch, having reviewed and approved this document, authorizes Alycia Booth, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize s the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title: Public Health Service (PHS) Applications and Pre-Award Reporting Requirements, Revision, OMB 0925-0001 Expiration Date 12/31/2027, Revision, Office of the Director, National Institutes of Health (NIH).

Need and Use of Information Collection: Effective for due dates on or after May 25, 2026, NIH will be implementing a structured, simplified Data Management and Sharing (DMS) Plan format. With the release of the 2023 Data Management and Sharing (DMS) Policy, NIH issued supplemental information outlining desired elements of a DMS Plan. The NIH DMS Plan format contains six (6) Elements for applicants and recipients to submit free-text narratives explaining how scientific data will be managed and shared. Current public reporting burden for the DMS Plan information collection is an estimated two (2) hours per response, including the time for reviewing instructions, searching for existing data sources, gathering, and maintaining the data needed and reviewing the collection of information. DMS Plans are provided to NIH through OMB approved information collections 0925-0001 and 0925-0002. After several years of implementation experience, NIH is updating the DMS Plan Elements to provide a structured, simplified format to reduce burden and promote consistent information collection. Effective Fiscal Year 2026, NIH will require applicable recipients to use the updated DMS Plan format containing “Yes, No, or Not Applicable” questions. A narrative response will be required only for “No” responses and the narrative response is limited to 300 words. This updated format continues building on trans-NIH initiatives to reduce the public reporting burden and promote consistency across all NIH. The application forms and associated instructions will be updated to align with these new requirements. The Data Management and Sharing (DMS) Plan form expires on 12/31/2027. Post-award reporting requirements are simultaneously consolidated under 0925-0002 and include the Research Performance Progress Report (RPPR).

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 73,117.

The Deputy Director for Extramural Research, Jon Lorsch, having reviewed and approved this document, authorizes Alycia Booth, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

The National Environmental Policy Act, 42 U.S.C. 4321-4347 (NEPA), requires all Federal agencies to consider the environmental impacts of their proposed actions before deciding whether and how to proceed. 42 U.S.C. 4321, 4332. Congress enacted NEPA to encourage productive and enjoyable harmony between humans and the environment, recognizing the profound impact of human activity and the critical importance of restoring and maintaining environmental quality to the overall welfare of humankind. 42 U.S.C. 4321, 4331. NEPA's aims are to ensure agencies consider the potential environmental effects of their proposed actions in their decision-making processes and inform and involve the public in that process. 42 U.S.C. 4332.

Under NEPA, a Federal agency may establish categorical exclusions (CE)—categories of actions that the agency has determined normally do not significantly affect the quality of the human environment, individually or in the aggregate, and, therefore, do not require preparation of an environmental assessment (EA) or an environmental impact statement (EIS)—in its agency NEPA procedures. 42 U.S.C. 4336e(1). If an agency determines that a CE covers a proposed action, the agency then evaluates the proposed action for any extraordinary circumstances in which a normally excluded action may have a significant effect. If no extraordinary circumstances are present, the agency may rely on the CE to approve the proposed action without preparing an EA or EIS. 42 U.S.C. 4336(a)(2). If extraordinary circumstances are present, and the proposed action has the potential to result in significant effects, the agency is required to prepare an EA or EIS.

Section 109 of NEPA, 42 U.S.C. 4336c, provides that an agency may adopt a CE listed in another agency's NEPA procedures for a category of proposed agency actions. To adopt another agency's CE, the adopting agency must (1) identify the CE listed in the other agency's (“establishing agency”) NEPA procedures that covers a category of proposed actions or related actions, (2) consult with the establishing agency to ensure the proposed adoption of the CE for a category of proposed actions is appropriate, (3) identify to the public the CE the agency plans to use for its proposed actions, and (4) document adoption of the CE. 42 U.S.C. 4336c.

The ACHP does not have any agency-specific NEPA regulations or procedures. The ACHP will maintain a list of CEs available to the ACHP at w ww.achp.gov/ACHP_NEPA_Compliance.

The ACHP has identified the following CE established by the DOI at 43 CFR 46.210(i) for adoption.

Policies, directives, regulations, and guidelines: that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case.

The ACHP intends to use this CE to cover its promulgation of policies, directives, regulations, and guidelines as described in the CE.

The ACHP does not have an agency-specific list of extraordinary circumstances. To ensure the ACHP's application of the CE is consistent with how the DOI applies the CE, the ACHP will evaluate proposed actions for whether there are any extraordinary circumstances using the DOI's list of extraordinary circumstances at 43 CFR 46.215. The DOI's list of extraordinary circumstances include, in part, consideration of impacts on public health and safety; natural resources; unique geographic characteristics; historic or cultural resources; park, recreation, or refuge lands; wilderness areas; wild or scenic rivers; national natural landmarks; sole or principal drinking water aquifers; prime farmlands; wetlands; floodplains; national monuments; migratory birds; other ecologically significant or critical areas; unresolved conflicts concerning alternative uses of available resources; unique or unknown environmental risks; precedent for future decision-making; historic properties; listed species or critical habitat; access by Indian religious practitioners to, and for ceremonial use of, Indian sacred sites and the physical integrity of those sites; and contribution to the introduction, continued existence, or spread of invasive weeds or non-native invasive species. The responsible official will assess whether an extraordinary circumstance is present. If the responsible official cannot rely on the CE to support a decision to authorize or take a particular proposed action due to extraordinary circumstances, the responsible official will prepare an EA or EIS before doing so.

In July 2026, the ACHP consulted with the DOI on the appropriateness of the ACHP's adoption of the CE. The consultation included a review of the DOI's experience in establishing and applying the CE, as well as the ACHP's intended uses for the CE. Based on the consultation, the ACHP has determined that the types of actions the ACHP proposes to authorize are substantially similar to the actions for which the DOI has applied the CE. Accordingly, the impacts of the ACHP's actions would be substantially similar to the impacts of the DOI's actions, which are not significant, absent the existence of extraordinary circumstances. Therefore, the ACHP has determined that its adoption of the CE, as described within this notice, is appropriate.

This notice identifies to the public and documents the ACHP's adoption of the DOI CE at 43 CFR 46.210(i) for the promulgation of policies, directives, regulations, and guidelines as described in the CE. The notice identifies the category of actions to which the ACHP would apply the CE, as well as the considerations that the ACHP would use in determining whether an action is within the scope of the CE. Documentation of the adoption will also be available at www.achp.gov/ACHP_NEPA_Compliance . The CE is available for use by the ACHP, effective immediately.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation will be available at https://www.reginfo.gov upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

OMB Control Number 1652-0063; Law Enforcement Officer (LEO) Reimbursement Request. TSA has authority to enter into agreements with airport operators to reimburse them for expenses incurred in the provision of LEOs to support screening at airport checkpoints. See 49 U.S.C. 106(l) and (m) and 114(m). Consistent with these authorities, TSA created the LEO Reimbursement Program.

TSA requires participants in the LEO Reimbursement Program to record the details of all reimbursements sought. In order to provide for the orderly tracking of reimbursements, the LEO Reimbursement Program uses TSA Form 3503, LEO Reimbursement Request Invoice. The information collected includes, but is not limited to, information regarding the invoice, invoicing point of contact, banking and checkpoint log worksheet.

In 2024, TSA requested discontinuation of this collection due to the unavailability of funding to continue the LEO Reimbursement Program. See ICR Reference Number 202109-1652-0005. On April 30, 2026, however, Congress approved funding for the LEO Reimbursement Program as part of the Homeland Security and Further Additional Continuing Appropriations Act, 2026 (Pub. L. 119-86; 140 Stat. 773). TSA is now requesting the reinstatement of the collection, along with a revision.

The TSA Form 3503, LEO Reimbursement Request Invoice, is provided to participants upon the start of the agreement and is also available via request. Upon completion, participants submit the LEO Reimbursement Request form directly to the LEO Reimbursement Program via email, mail, or in person. Upon receipt, TSA reviews all request for reimbursement forms. The revision involves changes to Section I of the form, where TSA is replacing “DUNS” with “UEI, 1 ” and in Section IV, where TSA will update links and contact numbers.

TSA estimates that there will be an average of 260 participant responses monthly, or 3,120 yearly. TSA estimates each respondent will spend approximately 1 hour to complete the request for reimbursement form, for a total annual hour burden of 3,120 hours.

The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before September 5, 2026. Pursuant to 36 CFR 60.13, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Nominations submitted by State or Tribal Historic Preservation Officers.

Key: State, County, Property Name, Multiple Name(if applicable), Address/Boundary, City, Vicinity, Reference Number.

A request for removal has been made for the following resource(s):

Additional documentation has been received for the following resource(s):

Authority: 36 CFR 60.13.

In accordance with the Paperwork Reduction Act of 1995, (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct, or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on June 11, 2026, (91 FR 35550). No comments were received.

We are especially interested in public comments addressing the following:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility.

(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used.

(3) Ways to enhance the quality, utility, and clarity of the information to be collected.

(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology ( e.g., permitting electronic submission of response).

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.

Abstract: In most cases, people are not allowed to collect plants in national parks. However, federal law and certain regulations (36 CFR 2.1(c)) allow exceptions, including situations where a federally recognized Tribe has the legal right to gather plants for traditional purposes.

Under 36 CFR 2.6, members of federally recognized Tribes may gather plants or plant parts in a park if their Tribe has a gathering agreement with the National Park Service (NPS). These agreements honor Tribal sovereignty, support government-to-government relationships, and ensure that NPS applies the rules consistently across parks.

Section 2.6(f) of the regulations explains how NPS and a Tribe work together to create a plant-gathering agreement. After an agreement is completed, NPS issues a permit that authorizes Tribal members to gather specific plants. Only enrolled Tribal members who are designated by the tribe to gather and whose Tribe has a long-standing, historical connection to the park—and whose connection existed before the park was created—may gather plants. The gathering must be for traditional cultural purposes, must be sustainable, and cannot be for commercial use. The information collection covered by these rules includes:

• A Tribe's request to enter into a plant-gathering agreement.

• Information needed to develop the agreement, such as the Tribe's traditional connection to the park, the cultural purpose for gathering, and details about the types and amounts of plants to be gathered.

• Information submitted if a Tribe appeals an NPS decision denying a request, such as documentation of the Tribe's historical connection to the park, traditional practices, or potential effects on park resources.

Title of Collection: Gathering of Certain Plants or Plant Parts by Federally Recognized Indian Tribes for Traditional Purposes.

OMB Control Number: 1024-0271.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Indian Tribes.

Total Estimated Number of Annual Responses: 30.

Estimated Completion Time per Response: Varies from 4 to 80 hrs. (times vary depending upon the activity).

Total Estimated Number of Annual Burden Hours: 530 hrs.

Respondent's Obligation: Required to obtain or retain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Non Hour Burden Cost: None.

An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).