Title: National Animal Health Monitoring System; Poultry 2027 Upland Gamebird and Duck Study.

OMB Control Number: 0579-XXXX.

Type of Request: New information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq. ), the Secretary of Agriculture is authorized to protect the health of the livestock, poultry, and aquaculture populations in the United States by preventing the introduction and interstate spread of serious diseases and pests of livestock, and for eradicating such diseases from the United States when feasible. This authority has been delegated to the Animal and Plant Health Inspection Service (APHIS).

In connection with this mission, APHIS operates the National Animal Health Monitoring System (NAHMS) which collects on a national basis statistically valid and scientifically sound data on the prevalence and economic importance of livestock, poultry, and aquaculture disease risk factors.

NAHMS' studies have evolved into a collaborative industry and government initiative to help determine the most effective means of preventing and controlling diseases of poultry. NAHMS is the only agency responsible for collecting data on poultry health. Participation in any NAHMS study is voluntary, and all data are confidential.

NAHMS plans to conduct the Poultry 2027 Upland Gamebird and Duck Study as part of an ongoing series of NAHMS studies on the U.S. poultry population. This study will support the following objectives: (1) Establish baselines for health and management practices on U.S. upland gamebird operations to support producers and partners in advancing animal health, productivity, and marketability; (2) describe upland gamebird producer preparedness for animal health emergencies, including highly pathogenic avian influenza, to assist producers and partners in disease prevention and control; and (3) describe management protocols and the structure of the commercial duck industry, including movement and biosecurity practices.

The study will consist of two parts. The first part is in collaboration with the National Agricultural Statistics Service (NASS). A survey will be administered to upland gamebird operations in all States. The survey will be administered with three options for completion: Mail, web, or telephone call by NASS enumerators. The second part consists of a duck company-level questionnaire with options to complete the survey electronically or on paper.

The information collected through the study will be analyzed and organized into descriptive reports. Reports will be disseminated by NAHMS to producers, stakeholders, academia, veterinarians, and other interested parties. The collected data will be used to: (1) Establish national and regional production measures for producer, veterinary, and industry references; (2) predict or detect national and regional trends in disease emergence and movement; (3) address emerging issues; (4) aid in disease preparedness; (5) increase understanding about biosecurity practices of upland gamebird producers and biosecurity protocols of duck companies; (6) determine what sort of informational resources may be most useful for upland gamebird producers and how to best dispense new information to this demographic; (7) provide estimates of both outcome (disease or other parameters) and exposure (risks and components) variables that can be used in analytic studies in the future by NAHMS; (8) provide input into the design of surveillance systems for specific diseases; and (9) provide parameters for animal disease spread models.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information 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 our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.195 hours per response.

Respondents:

• Upland gamebird operations (defined as chukars, pheasants, quail, Hungarian partridges, and guineas) with inventories of at least 500 head.

• Representatives of large duck companies.

Estimated annual number of respondents: 2,812.

Estimated annual number of responses per respondent: 4.

Estimated annual number of responses: 9,320.

Estimated total annual burden on respondents: 1,816 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701-7772, 7781-7786) and the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” APHIS regulates, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340.

APHIS received a petition (APHIS Petition Number 19-316-01p) from Monsanto Company, as a wholly owned subsidiary of Bayer Crop Science (Bayer/Monsanto), seeking a determination of nonregulated status for MON 87429 maize (corn), which has been developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid (2,4-D) resistance with tissue-specific glyphosate resistance facilitating the production of hybrid maize seed. The petition provides information in support of petitioners' position that MON 87429 is unlikely to pose a plant pest risk and therefore should not be regulated under APHIS' regulations in 7 CFR part 340.

As part of our decision-making process regarding the organism's regulatory status, APHIS prepared a draft plant pest risk assessment (PPRA) to assess the plant pest risk of the organism.

On May 8, 2020, APHIS published the Bayer/Monsanto petition in the Federal Register seeking public comment for a period of 60 days (85 FR 27354-27355; Docket No. APHIS-2020-0021). APHIS received 4,112 comments on the petition. On April 28, 2021, APHIS published a Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) in the Federal Register seeking public comment for a period of 30 days (86 FR 22384-22386; Docket No. APHIS-2020-0021). APHIS received 3,069 comments on the NOI.

On March 22, 2024, APHIS published the draft PPRA and draft EIS in the Federal Register (89 FR 20424-20425, APHIS-2020-0021) and accepted public comments from March 22, 2024, through May 6, 2024. APHIS received 9,600 comments on the draft EIS and one comment on the draft PPRA. However, on August 18, 2025, APHIS published a withdrawal of the NOI (90 FR 40050; Docket No. APHIS-2025-0029). Therefore, consistent with this August 18, 2025 Federal Register notice, APHIS terminated work on the EIS.

Based on APHIS' evaluation in the PPRA of information and data submitted by Bayer/Monsanto in its petition, available scientific data, and public comments received in response to the petition and draft PPRA, APHIS has determined that MON 87429 is unlikely to pose a greater plant pest risk than the unmodified comparator and therefore is no longer subject to our regulations in 7 CFR part 340 governing the introduction of certain organisms developed using genetic engineering.

Copies of the signed determination, PPRA, and response to comments, as well as the previously published petition and supporting documents, are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Title: Land Exchanges.

OMB Number: 0596-0105.

Expiration Date of Approval: April 30, 2027.

Type of Request: Extension without revision of a currently approved information collection.

Abstract: Land exchanges are discretionary, voluntary real estate transactions between the Secretary of Agriculture (acting by and through the Forest Service) and a non-Federal exchange party (or parties). Land exchanges can be initiated by a non-Federal party (or parties), an agent of a landowner, a broker, a third party, or a non-Federal public agency.

If the authorized officer agrees to proceed with an exchange proposal, all prospective parties must execute an Agreement to Initiate as required by Title 36 Code of Federal Regulations (CFR), part 254, subpart A—section 254.4—Agreement to Initiate. The Agreement to Initiate document specifies the preliminary and non-binding intentions of the non-Federal land exchange party and the Forest Service in pursuing a land exchange. The Agreement to Initiate must contain, among other information, the description of properties being considered in the land exchange, an implementation schedule of action items, identification of the party responsible for each action item, as well as target dates for completion of each action item.

After the authorized officer decides to approve the exchange under 36 CFR 254.13, the Forest Service and the non-Federal land exchange party may enter into a binding Exchange Agreement, pursuant to Title 36 CFR part 254, subpart A, section 254.14—Exchange Agreement. Its legally binding effect is subject to the conditions specified in 36 CFR 254.14(b). The Exchange Agreement documents the conditions that must be met to complete the exchange. The Exchange Agreement must contain identification of parties, description of lands and interests to be exchanged, identification of all reserved and outstanding interest, stipulation of any necessary cash equalization, terms regarding responsibility for hazardous substances on the involved non-Federal lands, the agreed-upon values of the involved lands, and all other terms and conditions necessary to complete the exchange.

The Forest Service collects the information from the non-Federal party (or parties) necessary to complete the Agreement to Initiate and the Exchange Agreement. The information is collected by Forest Service personnel from parties involved in the exchange via telephone, email or in person. Data from this information collection is unique to each land exchange and is not available from other sources. No standardized forms are associated with this information collection.

Agreement to Initiate: 3 hours.

Exchange Agreement: 1 hour.

Type of Respondents: Non-Federal party (or parties) that can include landowners, agents of landowners, brokers, a third party or a non-Federal public agency.

Estimated Annual Number of Respondents: 25.

Estimated Annual Number of Responses per Respondent: 1.826.

Estimated Total Annual Burden on Respondents: 88.

Comment Is Invited: Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden 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 to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.

In response to a countervailing duty (CVD) petition filed by Vantage Specialty Chemicals, Inc. (the petitioner), Commerce initiated a CVD investigation of fatty acids from Indonesia on March 9, 2026. 1 On June 29, 2026, the petitioner timely alleged that critical circumstances exist with respect to imports of fatty acids from Indonesia pursuant to section 703(e)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.206. 2 On July 23, 2026, Commerce published its affirmative Preliminary Determination in the Federal Register . 3

The petitioner alleges that critical circumstances exist because it believes that: (1) there is a reasonable basis to believe that the subsidies alleged in this investigation are inconsistent with the Agreement on Subsidies and Countervailing Measures (SCM Agreement) of the World Trade Organization; and (2) there have been massive imports of subject merchandise over a relatively short period given that there was a 24.30 percent increase of U.S. imports of fatty acids from Indonesia during the period February 2026 through April 2026 compared to the period November 2025 through January 2026. 4

Section 703(e)(1) of the Act provides that if the petitioner alleges critical circumstances more than 20 days before the date of Commerce's final CVD determination, Commerce shall determine whether there is a reasonable basis to believe or suspect that: (A) the alleged countervailable subsidy is inconsistent with the SCM Agreement; and (B) there have been massive imports of the subject merchandise over a relatively short period. In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 703(e)(1)(B) of the Act and 19 CFR 351.206(h) and (i), Commerce normally examines: (i) the volume and value of the imports; (ii) seasonal trends; and (iii) the share of domestic consumption accounted for by the imports. 5 Imports must increase by at least 15 percent during the relatively short period to be considered massive. 6 Commerce normally considers the relatively short period to be the period beginning on the date the proceeding begins and ending at least three months later. In practice Commerce typically compares the volume of imports of subject merchandise after the petitioner was filed until the month of publication of the preliminary determination ( i.e., the comparison period) to the volume of imports of subject merchandise for a period of comparable duration prior to the filing of the petition ( i.e., the base period). However, if Commerce finds that importers, exporters or producers, had reason to believe, at some time prior to the beginning of the proceeding, that a proceeding was likely, Commerce may consider a period of not less than three months from that earlier time. 7

In prior proceedings, Commerce determined that use of an export subsidy program is sufficient to determine that the countervailable subsidy is inconsistent with the SCM Agreement under section 703(e)(l)(A) of the Act. In the Preliminary Determination, Commerce found the following programs to be export-contingent and thus inconsistent with the SCM Agreement: Exemption from Import Income Tax Withholding for Companies in Bonded Zones; and Import Duty Exemption on Imported Capital Goods, Machinery, and Equipment in Bonded Zones. 8

To determine whether imports of the mandatory respondent's subject merchandise were massive over a relatively short period, we compared the volume of each mandatory respondent's shipments of subject merchandise, including shipments of their cross-owned affiliates, from September 2025 through January 2026 to the volume of their shipments of subject merchandise from February 2026 through June 2026. 9 Consistent with Commerce's practice, because the petitioner filed the petition in the last half of January 2026, we included shipments during January in the base period, rather than the comparison period.

PT Wilmar Nabati Indonesia and its cross-owned affiliates reported sales volumes for the base and comparison periods, rather than reporting the shipment volumes for the period, as requested by Commerce. 10 Further, PT Wilmar Nabati Indonesia, during the base and comparison periods and reported those sales volumes on an inconsistent basis for the base and comparison periods. 11 As a result, we find that PT Wilmar Nabati Indonesia withheld information requested by Commerce that, in turn, significantly impeded the proceeding, as provided under section 776(a)(2)(A) and (C) of the Act. Thus, in the absence of the necessary information, we have relied on facts otherwise available under 776(a) of the Act to determine whether there were massive shipments by PT Wilmar Nabati Indonesia massive over a relatively short period of time, as defined under 19 CFR 351.206(h). Specifically, as facts available under section 776(a), we have used the sales volumes of in our analysis for PT Wilmar Nabati Indonesia in our analysis but adjusted those volumes to account for the inconsistent reporting basis. 12

To determine whether imports for all other Indonesian producers of fatty acids were massive over a relatively short period, we compared import volumes from the ITC DataWeb for the Harmonized Tariff Schedule codes listed in the scope for the periods October 2025 through January 2026 and February 2026 through May 2026, 13 after subtracting the shipment volumes reported by PT Musim Mas and sales volumes reported by PT Wilmar Nabati Indonesia (adjusted to account for its inconsistent reporting basis). 14

Based on the comparisons described above, we preliminarily find that there have been massive imports of the subject merchandise over a relatively short period (a greater than 15 percent increase in import volumes) for PT Wilmar Nabati Indonesia and “All others” but not for PT Musim Mas. 15

Based on the above analysis, we preliminarily find that critical circumstances exist for PT Wilmar Nabati Indonesia and “All others” because alleged countervailable subsidies are inconsistent with the SCM Agreement and there were massive imports of the subject merchandise over a relatively short period for PT Wilmar Nabati Indonesia and “All others.” However, we preliminarily find that critical circumstances do not exist for PT Musim Mas because both criteria under section 703(e)(1) of the Act have not been met, namely there have not been massive imports of subject merchandise from PT Musim Mas over a relatively short period.

In accordance with section 705(a)(2) of the Act, Commerce will issue its final critical circumstances determination when it issues its final determination in this investigation.

Interested parties may comment on Commerce's preliminary critical circumstances in their case briefs. Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 16 Interested parties who submit case briefs or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 17

As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 18 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final determination in this investigation. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 19

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

In accordance with section 703(e)(2)(A) of the Act, for PT Wilmar Nabati Indonesia and “all-other” exporters and producers, we intend to direct U.S. Customs and Border Protection (CBP) to suspend liquidation of any unliquidated entries of subject merchandise from Indonesia entered, or withdrawn from warehouse for consumption, on or after April 24, 2026, which is 90 days prior to the date of publication of the Preliminary Determination in the Federal Register . For such entries, CBP shall require a cash deposit equal to the estimated preliminary subsidy rates established in the Preliminary Determination. This suspension of liquidation will remain in effect until further notice.

In accordance with section 703(f) of the Act, we intend to notify the ITC of this preliminary determination of critical circumstances.

This determination is issued and published pursuant to sections 703(e) and 777(i) of the Act and 19 CFR 351.205(c).

Background

On June 25, 2025, based on timely requests for review, in accordance with 19 CFR 351.221(c)(1)(i), we initiated an administrative review of the antidumping duty order on diffusion-annealed, nickel-plated flat-rolled steel products (nickel-plated steel products) from Japan. 1 On July 28, 2025, Commerce selected Toyo Kohan as the mandatory respondent in this review. 2

Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days, 3 and, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 4 On March 10, 2026, we extended the preliminary results of this review. 5 Accordingly, the deadline for these preliminary results is now July 30, 2026.

For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 6 A list of the topics discussed in the Preliminary Decision Memorandum is attached as an Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via ACCESS. ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/frnotices.

The merchandise subject to the Order is nickel-plated steel products from Japan. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review of an antidumping duty order where it concludes that there were no suspended entries of subject merchandise during the POR. 7 Normally, upon completion of an administrative review, the suspended entries are liquidated at the antidumping duty assessment rate for the review period. 8 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry that Commerce can instruct U.S. Customs and Border Protection (CBP) to liquidate at the AD assessment rate calculated for the POR. 9 Commerce notified all interested parties of its intent to rescind the instant review regarding the companies listed in Appendix II because there were no reviewable, suspended entries of subject merchandise from these companies during the POR and invited interested parties to comment. 10 No party commented on this memorandum. In the absence of any suspended entries of subject merchandise from these companies during the POR, we are rescinding this administrative review for the companies listed in Appendix II, in accordance with 19 CFR 351.213(d)(3).

Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

As a result of this review, we preliminarily determine the following estimated weighted-average dumping margin exists for the period May 1, 2024, through April 30, 2025:

Commerce intends to disclose its calculations and analysis performed to interested parties for these preliminary results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

On September 12, 2025, Thomas Steel Strip Corporation, a domestic interested party, requested that Commerce conduct verification of Toyo Kohan's responses. 11 Accordingly, in June 2026, as provided in section 782(i)(3) of the Act, we verified Toyo Kohan's information relied upon for the preliminary results of this review. 12

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the verification report is issued in this review. 13 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 14 Interested parties who submit case briefs or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 15 All briefs must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety in ACCESS by 5:00 p.m. Eastern Time on the established deadline.

As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public executive summary for each issue raised in their briefs. 16 Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 17

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce will inform parties of the scheduled date for the hearing. 18

Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.

If Toyo Kohan's weighted-average dumping margin is not zero or de minimis ( i.e., less than 0.50 percent) in the final results of this review, Commerce intends to calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales to the total entered value of those sales. Where we do not have entered values for all U.S. sales to a particular importer, we will calculate an importer-specific, per-unit assessment rate on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total quantity of those sales. 19 To determine whether an importer-specific, per-unit assessment rate is de minimis, in accordance with 19 CFR 351.106(c)(2), we also will calculate an importer-specific ad valorem ratio based on estimated entered values. If Toyo Kohan's weighted-average dumping margin is zero or de minimis or where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate appropriate entries without regard to antidumping duties. 20

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Toyo Kohan for which it did not know that the merchandise was destined for the United States, we intend to instruct CBP to liquidate those entries at the all-others rate calculated in the less-than-fair-value (LTFV) investigation if there is no rate for the intermediate company(ies) involved in the transaction. 21

For the companies listed in Appendix II for which the review is being rescinded, 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 for 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 rescission instructions to CBP no earlier than 35 days after the date of publication of this notice in the Federal Register .

Commerce intends to issue assessment instructions to CBP regarding Toyo Kohan no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Toyo Kohan will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously investigated or reviewed companies not covered by this review, the cash deposit rate will continue to be the company-specific cash deposit rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, or the LTFV investigation, but the manufacturer is, then the cash deposit rate will be the rate established for the most recent segment for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 45.42 percent, the all-others rate established in the LTFV investigation. 22 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

Section 304(d) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes and requires that NMFS collect cost recovery fees for limited access privilege programs. Cost recovery fees include NMFS' actual costs directly related to its management, data collection, and enforcement of the programs. Section 304(d) of the Magnuson-Stevens Act mandates that cost recovery fees not exceed 3 percent of the annual ex-vessel value of fish harvested under any program subject to a cost recovery fee.

NMFS manages the PCTC Program as a limited access privilege program. On August 8, 2023, NMFS published a final rule to implement the PCTC Program (88 FR 53704). The PCTC Program allocates total allowable catch of Pacific cod to trawl catcher vessels and processors in the Bering Sea and Aleutian Islands Management Area (BSAI). Participants in the PCTC Program must form a cooperative and associate with a processor. The PCTC Program includes a process for calculating and administering cost recovery fees under 50 CFR 679.135. The annual PCTC Program cost recovery process builds on other existing cost recovery requirements implemented under other programs. The fee liability is based on the ex-vessel value of fish harvested in the PCTC Program. Each year, NMFS publishes a notice announcing the fee percentage in the Federal Register . The Regional Administrator sends invoices to cooperatives before August 1.

Each PCTC Program cooperative is responsible for payment of the cost recovery fee assessed on Pacific cod landed under the PCTC Program. Each cooperative must submit any cost recovery fee liability payment(s) no later than August 31. NMFS determines the total dollar amount of the fee due by multiplying the NMFS published fee percentage by the annual ex-vessel value of Cooperative Quota (CQ) landings under the PCTC Program, as described in this notice.

If a cooperative fails to pay its cost recovery fee liability by August 31, NMFS will disapprove that cooperative's application to transfer CQ and will not issue a CQ permit the following year until NMFS receives full payment of the fee liability from the cooperative. NMFS will not issue a CQ permit until NMFS receives a complete application for CQ issuance and confirmation of the full payment of any cost recovery fee liability.

For purposes of calculating cost recovery fees, NMFS uses a standard ex-vessel price (standard price) for Pacific cod. A standard price is determined using information on landings purchased (volume) and ex-vessel value paid (value). NMFS annually receives information used to calculate the Pacific cod standard price in the existing BSAI Pacific cod Ex-vessel Volume and Value Report, which is submitted in early November of each year. NMFS uses this existing data source to calculate standard prices and thus determine the annual PCTC Program fishery value, which, along with the direct program costs, is used to calculate the annual PCTC Program cost recovery fee percentage. The standard prices are described in U.S. dollars per pound for landings made during the previous year. NMFS published the standard price of $0.34 per pound for Pacific cod for Trawl Gear in 2025 in the Federal Register on December 5, 2025 (90 FR 56134).

Each landing made under the PCTC Program is multiplied by the standard price to arrive at an ex-vessel value for each landing. These values are summed together to arrive at the ex-vessel value of Pacific cod ( i.e., fishery value).

Annually, NMFS calculates the total costs directly related to the management, data collection, and enforcement of the program (direct program costs). NMFS captures direct PCTC program costs through an established accounting system that allows NMFS staff to track labor, travel, contracts, and procurement costs. For 2026, the direct program costs for the PCTC Program were tracked from July 1, 2025, to June 30, 2026. A more detailed explanation will be provided in the annual Cost Recovery Report, which will be published in May of 2027.

NMFS then calculates the applicable fee percentage according to the factors and methods described at § 679.135 for the PCTC Program. NMFS used the standard price of $0.34 to calculate the fee percentage applied to landings made in 2026. NMFS determined the fee percentage that applies to landings made in the A and B seasons, which extend from January 20 to June 10, 2025, by dividing the direct program costs by the value of the catch subject to the cost recovery fee.

Using the fee percentage formula described generally above, the estimated percentage of direct program costs to fishery value for the 2026 calendar year is 2.09. For 2026, NMFS applied the fee percentage to each PCTC landing that was debited from a CQ allocation between January 20 and June 10 to calculate the fee liability for each cooperative. A PCTC Program cooperative's 2026 fee payments must be submitted to NMFS on or before August 31, 2026. Payment must be made in accordance with the payment methods set forth in § 679.135(a)(3).

The 2026 fee percentage of 2.09 percent is lower than the 2025 fee percentage of 3.00 percent. Net fishery management costs for 2026 decreased by approximately 17 percent when compared to 2025 and total fishery value increased by approximately 42 percent.

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

The Mariana Archipelago FEP Guam AP will be held between 6 p.m. and 8:30 p.m. (Chamorro Standard Time [ChST]) on Saturday, August 8, 2026.

Public Comment periods will be provided in the agendas. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

These meetings are accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

The applicant submitted a complete application for an EFP to conduct commercial fishing activities that the regulations would otherwise restrict. This EFP would exempt the participating vessels from the following Federal regulations:

The purpose of this project is to continue to collect data in support of determining best practices and protocols for estimating discards of non-target clam species, estimating pre-landing bushel volumes of surfclams/ocean quahogs that are in mixed cages, and fully accounting for the volume of bushels separated from mixed cages, to be reported to NMFS via vessel trip reports. This project was issued a previous EFP (24080), under which 255 trips were taken. During each of those trips, volumetric data was collected by the captain/crew on target clam species, non-target clam species, bycatch, and trash/broken shells. Partner organization Rutgers University had scientists aboard 13 EFP trips and collected volumetric data on one of the same tows as the captain/crew, as well as additional tows. The processor provided data on the number of cages, the volume of non-target clams sorted from the total catch, and the volume of trash and bycatch sorted from the total catch. The data collected so far allowed for preliminary progress toward determining best practices and protocols for estimates of catch composition on mixed-catch trips. Specifically, the catch estimate collected by the captain appears to be a fair representation of the mix of target and non-target clams caught. The catch mix determined at the plants represents the mix of clams in the landed catch. This EFP would continue the data collection under the previous EFP, in support of determining the best practices and protocols for estimating catch composition on mixed-catch trips.

Under this EFP, up to 15 vessels would be authorized to fish for, retain, and land both surfclams and ocean quahogs on the same trip, either in mixed or separate cages, regardless of which species the trip was designated for. On each trip, the captain/crew would make independent estimates of mixing using protocols co-developed by scientists, industry, and the Northeast Fisheries Science Center (NEFSC). Processors would independently sort and document catch at the plant. A subset of trips (approximately two per month) would carry a project scientist to collect independent estimates using scientifically derived protocols, taking into consideration methods provided by the Northeast Fisheries Observer Program. Project scientists would also collect estimates at the processing plant, though not from the same trips on which they collected at-sea estimates.

Vessels would be required to indicate each EFP trip when making the Vessel Monitoring System (VMS) declaration in order to land both surfclams and ocean quahogs on that trip and must submit the appropriate VMS trip-start and trip-end hail forms. Individual Transferable Quota (ITQ) would be used to account for all surfclams and ocean quahogs landed during this project. Vessels would use ITQ cage tags for the target species, and those tag numbers would be reported by the vessel and the processor as usual. The project PI would submit to the Greater Atlantic Regional Fisheries Office (GARFO) processor-sort data for all EFP trips and, on a quarterly basis, ITQ cage tags to fully cover the total number of bushels of non-target clams that are sorted out of landings by the participating processors.

All independent estimates would be submitted to Rutgers University for comparison. Project results would be summarized in a report made available to the Mid-Atlantic Fishery Management Council, NEFSC assessment scientists, and GARFO.

If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

Title; Associated Form; and OMB Number: Report of Inventions and Subcontracts; Unclassified: DD Form 882-R and Classified: DD Form 882-R; OMB Control Number 0704-RCIS.

Needs and Uses: This information collection is mandated by the Bayh-Dole Act to govern rights allocation for inventions made with federal funding, requiring contractors to disclose inventions and subcontracts and report on their utilization. The DoD replaces the legacy DD Form 882 with two specialized forms: DD Form 882-R for unclassified inventions, submitted annually or at contract closeout to certify disclosures in the iEdison database, and DD Form 882-C for classified inventions, submitted securely due to national security concerns. These processes ensure government contractors comply with reporting requirements, enable the government to secure royalty-free licenses, assume ownership of abandoned inventions, and verify subcontract compliance. Additionally, the data supports enterprise-level analysis of federally funded intellectual property, enhancing contract administration and technology management. Without these collections, the government would lose critical mechanisms to protect and exercise its rights over innovations developed under its funding.

Affected Public: Business or other for profit.

Annual Burden Hours: 4,942.

Number of Respondents: 3,150.

Responses Per Respondent: 1.48.

Annual Responses: 4,662.

Average Burden Per Response: 1.06 hours.

Frequency: Annually.

Purpose of the Board: At the request of the Assistant Secretary or Field Managers, the Board may provide community-based advice and recommendations concerning any EM program activities, such as clean-up activities and environmental restoration; waste management and disposition; excess facilities; future land use and long-term stewardship; communications; and budget priorities. The Board also provides an avenue to fulfill public participation requirements outlined in the Comprehensive Environmental Response, Compensation, and Liability Act (CERLA), the Resource Conservation and Recovery Act (RCRA), Federal Facility Agreements, Consent Orders, Consent Decrees and Settlement Agreements.

Tentative Agenda: (agenda topics are subject to change; please contact Juanita Campbell at juanita.campbell@srs.gov for the most current agenda)

Public Participation: The meeting is open to the public and public comment can be given orally or in writing. Fifteen minutes are allocated during the meeting for public comment and those wishing to make oral comment will be given a minimum of two minutes to speak. Written comments received at least two working days prior to the meeting will be provided to the members and included in the meeting minutes. Written comments received within two working days after the meeting will be included in the minutes. For additional information on public comment and to submit written comment, please contact srscitizensadvisoryboard@srs.gov. The EM SSAB, Savannah River Site, welcomes the attendance of the public at its meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact srscitizensadvisoryboard@srs.gov at least seven days in advance of the meeting.

Meeting conduct: The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Questioning of board members or presenters by the public is not permitted.

Minutes: Minutes will be available at the following website: www.cab.srs.gov.

Signing Authority: This document of the Department of Energy was signed on August 3, 2026, by David Borak, Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

The Clean Air Act (CAA) provides that a small refinery  1 may at any time petition EPA for an extension of the exemption from the obligations of the RFS program for the reason of disproportionate economic hardship (DEH). 2 In evaluating such petitions, the EPA Administrator, in consultation with the Secretary of Energy, will consider the findings of a Department of Energy (DOE) study and other economic factors. 3

In the August 3, 2026 SRE Decisions Action, 4 EPA is acting on 6 individual SRE petitions from 4 refineries seeking an exemption from their RFS obligations for the 2023 and 2024 compliance years. In consultation with DOE, EPA reviewed all the information submitted by each individual refinery in support of its petition. After careful consideration of all statutory factors and the information submitted by the refineries, EPA is granting full (100 percent) exemptions to 1 petition, granting partial (50 percent) exemptions to 2 petitions, denying 0 petitions, and determining 3 petitions to be ineligible.

The August 3, 2026 SRE Decisions Action articulates EPA's interpretation of section 211(o)(9) of the CAA and EPA's authority with respect to SRE petitions. As required by CAA section 211(o)(9), EPA's final actions on the pending SRE petitions are based on the legal and factual analysis presented herein, after consulting with DOE, and considering the DOE Small Refinery Study and “other economic factors.”

The August 3, 2026 SRE Decisions Action also explains how EPA will implement SRE decisions when an exemption is granted.

Section 307(b)(1) of the CAA governs judicial review of final actions by EPA. This section generally provides that petitions for judicial review of final actions that are nationally applicable must be filed in the United States Court of Appeals for the District of Columbia Circuit, and petitions for judicial review of actions that are locally or regionally applicable must be filed in the appropriate regional circuit. 5 However, petitions for judicial review of a final action that is locally or regionally applicable must be filed in the D.C. Circuit when “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”  6

As the Supreme Court recently articulated in Calumet, the first step in determining the appropriate venue for judicial review of an EPA final action is to ascertain whether the action at issue is nationally applicable or locally or regionally applicable. 7 If the action is nationally applicable, judicial review belongs in the D.C. Circuit. If the action is locally or regionally applicable, then the second step is to determine whether EPA has appropriately invoked the “nationwide scope or effect” exception to “override the default rule” that judicial review of a locally or regionally applicable action belongs in the appropriate regional circuit. 8 The exception applies, and judicial review of EPA's action belongs in the D.C. Circuit, if EPA invokes the exception for a final action that is “based on a determination of nationwide scope or effect” and accompanied by an EPA finding of this basis. 9 A determination is “the justification [EPA] gives for it[s] action, which can be found in its explanation of its action.”  10 A determination has a nationwide scope when it applies throughout the country as a legal matter, and it has a nationwide effect when it applies throughout the country as a practical matter. 11 Finally, an action is “based on” a determination of nationwide scope or effect when the determination “lie[s] at the core of the agency action,” so as to form the most important part of the agency's reasoning. 12 Put another way, an EPA action is based on a determination of nationwide scope or effect “only if a justification of nationwide breadth is the primary explanation for and driver of EPA's action.”  13

In the August 3, 2026 SRE Decisions Action, EPA is adjudicating SRE petitions pursuant to the authority granted to the Agency by CAA section 211(o)(9)(B). Each adjudication is a separate “action” for the purposes of determining venue under CAA section 307(b)(1), and because each adjudication only applies to a single refinery, each action is locally or regionally applicable. 14 However, EPA's adjudication of the relevant petitions is based on several determinations of nationwide scope or effect that formed the core basis for the Agency's decision.

First, these adjudications are based on EPA's determination that CAA section 211(o)(9) provides EPA with the authority to find that a small refinery would experience partial DEH if required to comply with its RFS obligations and to extend a partial exemption. As detailed in section III.H of the August 3, 2026 SRE Decisions Action, CAA section 211(o)(9)(B) grants EPA authority to temporarily extend the exemption from RFS obligations to a small refinery that demonstrates “disproportionate economic hardship,” but the statute does not define that phrase or its components, suggesting Congress left it to the Agency's discretion to “fill up the details” when determining how to implement this provision. 15 EPA interprets CAA section 211(o)(9)(B), based on the plain language, structure, and objective of the statute, to provide the Agency with the authority to find that a small refinery would experience partial DEH and to extend a partial exemption. This determination has nationwide scope because it is an interpretation of a federal statute and CAA section 211(o)(9)(B)(i) by its terms applies nationwide. 16 Additionally, this determination has nationwide effect because it applies generically to all refineries nationwide, regardless of their geographic location. 17

Second, these adjudications are based on EPA's determination that the DOE matrix is a reasonable proxy for DEH, and EPA will defer to DOE's findings unless EPA's consideration of other economic factors compels a different result. As detailed in section III.E of the August 3, 2026 SRE Decisions Action, CAA section 211(o)(9)(B) permits a small refinery to petition for an extension of the exemption from its RFS obligations for the reason of DEH. The statute directs EPA to “consider the findings of the [2011 DOE study] and other economic factors” in evaluating a petition but provides no further instruction as to how to effectuate these obligations. 18 As the author of the study and through its work assessing SRE petitions in conjunction with EPA, DOE has developed extensive expertise in evaluating economic conditions at U.S. refineries that is fundamental to the process both DOE and EPA use to identify whether DEH exists for each petitioner. With limited exceptions, EPA has consistently relied upon DOE's expertise in the Agency's adjudication of SRE petitions over the life of the RFS program. Thus, EPA has determined that the best way to fulfill its obligation to “consider the findings of the [2011 DOE study]” under CAA section 211(o)(9)(B) is to defer to DOE's application of its matrix and resulting findings in evaluating whether a small refinery would experience DEH. EPA has further determined that the best way to fulfill its obligation to consider “other economic factors” is to independently assess all available information and weigh whether this information compels EPA to depart from DOE's findings. This determination has nationwide scope because it is both an interpretation of a federal statute and CAA section 211(o)(9)(B)(i) by its terms applies nationwide, and it is a rebuttable presumption that DOE's finding as to whether a given small refinery would experience DEH, based on application of the DOE matrix, is correct, unless EPA's consideration of other economic factors compels it to depart from DOE's findings. Additionally, this determination has nationwide effect because it applies generically to all refineries nationwide, regardless of their geographic location.

Third, these adjudications are based on EPA's determination that, when extending the exemption, either wholly or partially, to a small refinery that has already retired RINs to comply with its RFS obligations, CAA section 211(o) restricts EPA to returning some or all of those retired RINs, commensurate with the degree of the exemption. As detailed in section IV.B of the August 3, 2026 SRE Decisions Action, returning RINs in this manner effectuates the best reading of the statute. CAA section 211(o)(5) requires that every instance of RIN generation be associated with the refining, blending, or importation of renewable fuel. Section 211(o)(5) also requires that RINs expire after a certain amount of time, while section 211(o)(9)(B) permits small refineries to petition for an extension of the exemption “at any time.” EPA interprets these provisions of CAA section 211(o) to limit EPA to returning RINs retired for compliance, if any, when it grants an extension of the exemption. This determination has nationwide scope because it is an interpretation of a federal statute and CAA sections 211(o)(5) and 211(o)(9)(B) by their terms apply nationwide. Additionally, this determination has nationwide effect because it applies generically to all refineries nationwide, regardless of their geographic location.

This third determination also minimizes disruptions to the RIN market and RFS program, akin to the Fifth Circuit's review of the April 2022 Alternative Compliance Action  19 in Wynnewood Refining Co., LLC v. EPA, 86 F.4th 1114 (5th Cir. 2023). In Wynnewood, the Fifth Circuit concluded that the ACA was based on a determination of nationwide scope or effect because the ACA was designed to mitigate the impact of the collective denials from the April 2022 SRE Denial Action  20 on the RIN market. 21 After denying 36 SRE petitions for the 2018 compliance year, EPA estimated that the small refineries would need to retire an additional 1.4 billion RINs to satisfy their 2018 compliance obligations. 22 Concerned that such a drastic spike in need for RINs would threaten the viability of the RIN market, EPA issued the ACA, which required that the small refineries file a revised compliance report but did not require them to retire additional RINs. 23 The Fifth Circuit reasoned that, because the purpose of the ACA was to address the continuing viability of the RFS program as a whole, it was based on a determination of nationwide scope or effect. 24 Similarly here, EPA's determination that the only permissible means of implementing the extension of the exemption is by returning retired RINs is based on concerns about the integrity of the RFS program as a whole. As explained in section IV.B of the August 3, 2026 SRE Decisions Action and in the August 2025 SRE Decisions Action, were the Agency to replace the retired RINs with current vintage RINs, the sudden mass influx of new RINs would result in decreased RIN prices, leading to decreased future investments in renewable fuel production and threatening the stability of the RIN market nationwide. EPA's approach of returning retired RINs is designed to avoid these negative impacts to the RFS program. Following the reasoning from the Wynnewood decision, because the purpose of this determination is to address the continuing viability of the RFS program as a whole, it is a determination of nationwide scope or effect.

The actions discussed within the August 3, 2026 SRE Decisions Action are based on the three determinations outlined above, as these determinations lie “at the core of the agency action[s]” so as to form the most important part of EPA's reasoning. 25 The first and second determinations together form the core basis for EPA's adjudications because the Agency has used both of them to create a rebuttable presumption that application of the DOE matrix produces the correct DEH finding, and EPA defers to that finding unless the Agency's consideration of other economic factors, including refinery-specific information, compels the Agency to depart from that rebuttable presumption. EPA's first determination is the first element of EPA's rebuttable presumption: because the DOE matrix can result in a finding of full DEH, partial DEH, or no DEH, EPA must first determine that the CAA provides the Agency with authority for finding partial DEH before the Agency can consider deferring to those findings. EPA's second determination is the second element of EPA's rebuttable presumption: the DOE matrix is a reasonable proxy for determining whether a small refinery would experience DEH, and deferring to that finding is the best way of fulfilling the Agency's statutory obligation to “consider the [2011 DOE Study]” and will result in the correct DEH finding for that small refinery. Taken together, these two determinations—that EPA has the authority to find that a small refinery is experiencing partial DEH and that the DOE matrix is a reasonable proxy for determining whether a small refinery would experience DEH—form the rebuttable presumption that is “the primary explanation for and driver of EPA's action.”  26 Under this rebuttable presumption, EPA will defer to DOE's findings unless the Agency's consideration of other economic factors compels a different result.

To fulfill its statutory obligation to consider “other economic factors,” EPA did consider refinery-specific information in its adjudications. However, these confirmatory reviews were not the primary drivers of EPA's actions on these petitions. EPA considered refinery-specific facts only to determine whether to depart from its rebuttable presumption that application of DOE's matrix results in the correct DEH finding, and these considerations, for each small refinery, confirmed that none of the refinery-specific facts rebutted the presumptive disposition. For example, EPA considered information presented by small refineries regarding their financial circumstances and found that the information was already considered in the DOE matrix or did not otherwise justify departing from the finding reached by application of the DOE matrix. Thus, EPA's consideration of refinery-specific facts was peripheral in comparison to EPA's rebuttable presumption that application of the DOE matrix is the best means of determining whether DEH exists. 27 Notably, EPA's confirmatory review of refinery-specific facts did not change the final decision for any of the SRE petitions.

Additionally, EPA's third determination—that the only permissible way to implement the extension of the exemption from RFS obligations when a small refinery has retired RINs for compliance is to return those retired RINs—is a core driver of EPA's actions because EPA's adjudication of SRE petitions necessarily includes extending the exemption to meritorious petitioners. But how EPA effectuates that extension of the exemption can look different depending on whether the relevant small refinery has already demonstrated compliance with its relevant RFS obligations by retiring RINs. Generally, the RFS statutory and regulatory provisions require all obligated parties to comply with their RFS obligations. However, CAA section 211(o)(9)(B) provides an exception when a small refinery demonstrates that it would experience DEH. In other words, when EPA grants an exemption to a small refinery, that small refinery is not required to retire any RINs to demonstrate compliance if it is a full exemption, and only the number of RINs necessary to meet half of its RFS obligation if it is a partial exemption. However, simply granting a petition does not necessarily effectuate the exemption in all cases. If the exemption is granted prior to a compliance demonstration by the small refinery, then the exemption is self-implementing. But if the small refinery has already demonstrated compliance by retiring RINs, EPA needs to take an additional step to effectuate the exemption. For the reasons outlined in sections IV.B and V of the August 3, 2026 SRE Decisions Action, EPA has determined, consistent with its interpretation of the Agency's authority under CAA section 211(o) and its policy interest in treating all refineries that receive an exemption equally, that returning the retired RINs is the only permissible way of implementing the exemption where a small refinery has previously demonstrated compliance with its RFS obligations by retiring RINs. EPA's adjudications are based on this determination because extending the exemption to meritorious petitioners is necessarily a part of EPA's action on the SRE petitions and EPA's statutory interpretation and policy considerations inform its implementation of the exemption for all petitioners.

For the reasons discussed above, EPA finds that the final actions discussed within the August 3, 2026 SRE Decisions Action are based on determinations of nationwide scope or effect for purposes of CAA section 307(b)(1) and is publishing that finding in the Federal Register . Under section 307(b)(1) of the CAA, petitions for judicial review of these actions must be filed in the D.C. Circuit by October 5, 2026.

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 September 4, 2026. Write “Caremark; Docket No. 9437” 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 “Caremark; Docket No. 9437” 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 I), 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 September 4, 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 Caremark Rx, L.L.C. and Zinc Health Services, LLC (collectively, “Caremark” or “Caremark Respondents”). If and when the Commission issues the Decision and Order as final, the Consent Agreement settles (1) charges in In the Matter of Caremark Rx, Zinc Health Services, et al. (“Insulin Litigation”) that Caremark violated section 5 of the Federal Trade Commission Act, 15 U.S.C. 45, by anticompetitively and unfairly creating a system of competition that artificially prioritizes inflated rebates, and (2) the separate Commission investigation (“PBM Investigation”) into Caremark's business practices seeking to determine whether Caremark unlawfully harmed pharmacy or PBM competition. 1

Caremark is one of the nation's largest pharmacy benefit managers (“PBM”). Positioned at the center of the intricate and opaque pharmaceutical distribution chain, it wields significant influence over which drugs patients can access and at what price. Caremark administers PBM services on behalf of its plan sponsor clients, including employers that provide commercial insurance to their members. It creates drug formularies (lists of preferred drugs) as well as preferred pharmacy networks where members can go to fill their prescriptions. The Insulin Litigation alleges that Caremark Respondents created a competition system that prioritizes the size of rebates over drugs' net price in winning clients, pushed insulin manufacturers to compete for preferred formulary coverage based on the size of rebates rather than net price, and shifted the cost of artificially inflated list prices to vulnerable patients. The PBM Investigation seeks to determine whether Caremark violated section 5 by requiring its clients' members to use its affiliated pharmacies or coercing unaffiliated pharmacies to accept unfavorable contractual terms.

The purpose of the Consent Agreement is to protect the public from Caremark's anticompetitive conduct and deter others from engaging in similar anticompetitive conduct. Under the terms of the Proposed Decision and Order (“Proposed Order”), Caremark will: (1) cease to discriminate against low-WAC  2 versions of a drug on its standard formularies; (2) provide a standard offering to its plan sponsors that ensures that members will get the benefits of their share of rebates at the point of sale; (3) in the event of certain legislative and regulatory changes, provide a standard offering to its plan sponsors that counts patient payments on TrumpRx toward patient deductibles and out-of-pocket maximums, for covered drugs and drugs with most favored nation pricing; (4) create a Copay Certainty Program that caps members' out-of-pocket costs on insulin, and provide full access to the Copay Certainty Program's insulin benefits to all members when a plan sponsor adopts a formulary that includes an insulin product covered by the program, unless the plan sponsor opts out in writing; (5) provide a standard offering to all plan sponsors that allows the plan sponsor to transition off rebate guarantees and spread pricing; (6) delink, for its standard offering, drug manufacturers' compensation to Caremark from list prices; (7) increase transparency for plan sponsors; (8) include certain terms in its standard offering to retail community pharmacies; (9) allow pharmacies in its networks to work with pharmacy hub service providers; (10) promote the standard offerings to plan sponsors and retail community pharmacies; and (11) maintain its group purchasing organization (“GPO”) Zinc's activities in the United States.

The Consent Agreement has been placed on the public record for 30 days for receipt of 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 finalize the Proposed Order. 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 or the Agreement Containing Consent Order and does not modify its terms.

In September 2024, the FTC sued the three largest PBMs—Express Scripts, Caremark, and Optum—and their affiliated GPOs. The Complaint alleges that Caremark Respondents have engaged in anticompetitive and unfair rebating practices that artificially inflated the list price of insulin drugs, impaired patients' access to lower list price products, and shifted the cost of high insulin list prices to vulnerable patients.

The Complaint alleges that Caremark created a system of competition that prioritizes rebates over patient affordability. Caremark has placed high-list price, high-rebate versions of insulin on its standard commercial formularies and excluded low-list price, low-rebate versions of the same drugs, even when the two versions had comparable net prices. This system benefits Caremark, which keeps a portion of the inflated rebates and uses the rest to attract plan sponsor clients, while withholding drug-level price information from clients that would have allowed them to make more informed decisions about patients' share of drug cost. According to the Complaint, the inflated list prices hurt patients whose out-of-pocket payments are tied to the list price of the drug, such as patients in their deductible phase and those with coinsurance. While patients pay inflated prices, Caremark is enriched by the rebates tied to each filled prescription.

The Complaint alleges unfair methods of competition and unfair acts or practices under section 5 of the FTC Act.

In fall 2023, the FTC opened an investigation to determine whether certain business practices of the three largest PBMs, including Caremark, violate the laws enforced by the FTC by unlawfully harming competition for pharmacy services. Prior to and since opening the investigation, Staff has received comments from pharmacies, patients, and other market participants about Caremark's business practices. The comments contend, among other allegations, that Caremark uses its dominance to impose oppressive terms on unaffiliated pharmacies who need to join the PBMs' pharmacy networks, including reimbursement rates that make it uneconomical for unaffiliated pharmacies to dispense medications. In December 2023, the FTC issued a civil investigative demand to Caremark's parent company, CVS Health Corporation (“CVS Health”), to investigate these concerns. That investigation has been ongoing.

The Proposed Order, which lasts ten years from the Implementation Date, contains the following provisions:

Section I generally requires Caremark to place low-WAC versions of high-WAC drugs on its four standard commercial formularies at no disadvantage to the high-WAC version. The provision includes exceptions to this requirement if (1) the low-WAC version is higher net cost than the high-WAC version, or (2) the drug is listed as “Currently in Shortage” in the U.S. Food & Drug Administration's Drug Shortage Database at the time the formulary takes effect or within the 18 months prior to the formulary decision.

This provision addresses allegations that Caremark placed high-WAC versions of drugs on its standard commercial formularies and excluded low-WAC versions of the same drug, despite both versions having comparable net prices. According to the Insulin Complaint, this practice increased out-of-pocket costs to patients whose payments are based on list price ( e.g., because the patient is in the deductible stage of their insurance or owes coinsurance calculated as a percentage of list price).

Section II contains several terms designed to protect patients from excessive out-of-pocket expenses. Specifically, Section II requires Caremark to develop a “standard offering” to all plan sponsors that:

• Ensures member out-of-pocket costs are no higher than the plan sponsor's contracted rate minus any rebates;

• Prohibits member out-of-pocket costs from being tied to list price or any other benchmark higher than the plan sponsor's contracted rate minus any rebates; and

• Provides full access to Caremark's programs that reduce out-of-pocket costs for members.

These provisions, collectively, would reduce out-of-pocket costs for members of those plans that adopt the standard offering, including by ensuring consumers generally benefit from the proportional amount of any rebate in coinsurance and deductible policies. In addition to providing the above options in its standard offering to all plan sponsors, Section II also requires all fully insured health plans offered by Aetna (owned by CVS Health) to adopt the above protections on patient out-of-pocket expenses.

Under the “meeting competition” provision in Section XII, Caremark would retain the flexibility to respond to specific client requests by offering customized services that do not comply with the “standard offering.” The plan sponsors may ultimately adopt a customized plan after being served with a notice of the standard offering and acknowledging receipt in writing. This “meeting competition” exemption does not apply to the requirements that Aetna fully insured health plans adopt the patient protections in Section II.

Section III ensures that Caremark's standard offering, in the event of certain legislative or regulatory changes, will attribute patient payments made through the TrumpRx platform towards patient deductibles and out-of-pocket cost maximum amounts, so long as the drug product is covered under the plan sponsor's benefit design or certified as the most favored nation price. The terms of Section III are subject to the “meeting competition” exemption detailed in Section XII of the Proposed Order.

Section IV requires Caremark to create a Copay Certainty Program that caps members' out-of-pocket costs on insulin to $25 for a prescription claim with a 0-34 days' supply, $50 for a prescription claim with a 35-68 days' supply, and $75 for a prescription claim with a 69 or longer days' supply. Section IV requires that Caremark provide full access to this program to all members when a plan sponsor adopts a formulary that includes an insulin product covered by the program, unless the plan sponsor opts out in writing. This provision offers further protections to insulin patients against high out-of-pocket costs. The terms of Section IV are subject to the “meeting competition” exemption detailed in Section XII of the Proposed Order.

Section V addresses allegations that Caremark's use of rebates to compete for plan sponsor business—particularly where those rebates are not passed through to patients at the point of sale—can result in excessive patient out-of-pocket expenses. Specifically, Section V requires Caremark's “standard offering” to plan sponsors to:

• Enable members to receive the benefit of any rebate or discounts at the point of sale, without charging a fee other than its actual cost to pre-fund any rebate, if applicable;

• Not provide to plan sponsors rebate guarantees or other guarantees of pre-determined amounts of compensation; and

• Not employ spread pricing (the practice of a PBM charging a plan sponsor a different amount for the purchase of a drug than the PBM reimburses the pharmacy).

The terms of Section V are subject to the “meeting competition” exemption detailed in Section XII of the Proposed Order.

Section VI addresses allegations that Caremark benefits from placing higher list price products on its formularies by charging fees to manufacturers that are based on list price. Specifically, Section VI provides that compensation received by Caremark from drug manufacturers related to Caremark's “standard offering” to plan sponsors will not be based, directly or indirectly, on a drug's list price.

Section VII addresses allegations that Caremark obscures net price information from plan sponsors. Specifically, Section VII increases transparency for plan sponsors by requiring Caremark to provide as part of its standard offering an annual report disclosing each drug's costs and pharmacy claim-level reporting, as well as any compensation paid to consultants or brokers in connection with Caremark's provision of pharmacy benefit services.

Section VIII addresses Caremark's pharmacy reimbursement practices. Section VIII requires Caremark to develop a standard offering to retail community pharmacies (defined as a retail pharmacy business with three or fewer store locations) that will:

• Compensate retail community pharmacies based on the actual cost of acquiring prescription drugs plus a dispensing fee;

• Make additional payments for all non-dispensing services performed by a retail community pharmacy; and

• Not exclude any retail community pharmacy willing to agree to the terms and conditions for participation from its standard offering to retail community pharmacies.

The terms of Section VIII are subject to the “meeting competition” exemption detailed in Section XII of the Proposed Order.

Section IX addresses Caremark's practices relating to third party digital pharmacy service providers known as hubs. Section IX prohibits Caremark from imposing or enforcing, or threatening to impose or enforce, any rule, agreement, or policy that prohibits or restricts a pharmacy's engagement with a hub, so long as the pharmacy complies with law, regulation, and certain rules for transparency. Caremark also may not take any other action to interfere with the ability of a pharmacy to engage with a hub.

The provision includes exceptions for certain circumstances. Caremark may take action with documented evidence that: the pharmacy is on a Federal or State exclusion list, has been flagged by regulators, or is suspected of fraud, waste, or abuse; the action is required by law; or the action is taken pursuant to a client agreement or at a client's written request, provided Caremark does not require, coerce, or create a default option for such agreements or requests, nor materially misrepresent hubs to clients. Caremark must report all such actions to the Monitor quarterly, retain supporting documents, and post a notice of Section IX on its pharmacy portal.

In addition, Section IX provides that Caremark must apply its audit selection criteria equally to all pharmacies of the same type, including CVS affiliates.

Section X provides that Caremark will advertise its standard offerings; clearly and conspicuously disclose their existence and availability in material created to advertise, market, or otherwise promote its products to plan sponsors and retail community pharmacies; not disparage its standard offerings; and not require or coerce plan sponsors or retail community pharmacies to adopt terms that differ from its standard offerings.

Section XI provides that Caremark will maintain the operations of its GPO, Zinc, in the United States.

Section XII provides that nothing in Sections II, III, IV, V, and VIII shall prevent Caremark from responding to a written request for terms other than the standard offering from a plan sponsor or retail community pharmacy. If Caremark receives a written request from a plan sponsor for terms that differ from the standard offering, Caremark must include in its response the standard offering and a written acknowledgement (Exhibit A to the Decision and Order) that the plan sponsor has received, read, and understood the explanation of benefits of the standard offering. If Caremark and the plan sponsor ultimately agree on terms that differ from the standard offering, the plan sponsor must sign and return the acknowledgment. Aetna's fully-insured health plans are excluded from Section XII's “meeting competition” exception.

Section XIII appoints a monitor for a term beginning shortly after the Order issues and ending three years after the Implementation Date (defined as no later than January 1, 2027). The monitor has the authority to monitor Caremark's compliance with the obligations set forth in the Proposed Order, to act in consultation with, and make inquiries on behalf of, the Commission or its Staff, and to make annual reports to the Commission.

Sections XIV, XV, and XVI contain provisions designed to ensure the effectiveness of the relief, including: obtaining information from Caremark that it is complying with the Order; requiring Caremark to submit compliance reports; and requiring Caremark to notify the Commission of certain changes in its corporate structure.

Section XVII provides that Caremark will cooperate with the ongoing Insulin Litigation, including by providing a certain number of witnesses for depositions and for trial.

The single source award will support the recipient to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, activities funded under this award enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

Universidad Peruana Cayetano Heredia is in a unique position to conduct this work, as it is the designated entity responsible for leading influenza surveillance. It has the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipient: Universidad Peruana Cayetano Heredia.

Purpose of the award: The purpose of this award is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Peru.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The single source award will support the recipients to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities funded under these awards will enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

These entities are in a unique position to conduct this work, as they are either subsidiaries of the host government ministries of health or they are the designated entities responsible for leading influenza surveillance. They have the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipients: Agreement to Fund Institut National Hygiene Publique, Cote d'Ivoire; Ministry of Health-Centers for Disease Control and Prevention, Egypt; Ethiopian Public Health Institute; Noguchi Memorial Institute for Medical Research, Ghana; Institut National d Hygiene, Morocco; Institut Pasteur de Dakar, Senegal; Institut Pasteur de Tunis, Tunisia; Uganda Virus Research Institute; University Teaching Hospital, Zambia.

Purpose of the awards: The purpose of these awards is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Cote d'Ivoire, Egypt, Ethiopia, Ghana, Morocco, Senegal, Tunisia, Uganda, Zambia.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The Task Force for Global Health (TFGH), a nonprofit organization, serves as a coordinating body to bring stakeholders together at the regional and global level to advance CDC's goals, supporting the Influenza Division's priorities for timely detection and reporting of influenza viruses. The single source award will provide an innovative public-private partnership with the CDC, Ministries of Health, corporate partners, and others to create sustainable prevention and control programs for seasonal influenza and other respiratory viruses worldwide. The award will provide funding to TFGH to (1) strengthen early detection, prevention, and response efforts for influenza and other respiratory pathogens; (2) gather strategic information on epidemic and pandemic readiness; and (3) implement effective and cost-efficient strategies to prevent and control these threats through evidence-based interventions resulting in better protection for Americans from seasonal and pandemic influenza as well as other respiratory viruses.

TFGH is uniquely qualified to conduct this work, as it is recognized for its strong, established relationships with many of CDC's priority partners. Initially, TFGH brought together partners to support the use of influenza vaccines among target groups in Southeast Asia and the Americas and in succeeding years has expanded its work to include coordination of large-scale pandemic response activities in support of CDC's mission, including pandemic vaccine deployment and respiratory virus prevention and control programs. Because of this experience TFGH is the uniquely qualified partner supporting National Center for Immunization and Respiratory Diseases (NCIRD)-priority work on influenza vaccine programs and respiratory virus prevention outside the United States. Its mission aligns with the global objectives of CDC and the Influenza Division.

Recipient: Task Force for Global Health.

Purpose of the award: The purpose of this award is to support surveillance and response for pandemic and novel influenza and other infectious disease threats around the world.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The single source award will support the recipient to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities funded under this award enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

HJF Medical Research International, Inc., Kenya is in a unique position to conduct this work, as it is the designated entity responsible for leading influenza surveillance. It has the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipient: HJF Medical Research International, Inc., Kenya.

Purpose of the award: The purpose of this award is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Kenya.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The single source award will support the recipient to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities funded under this award will enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

Fondacioni SECID, Balkan Region, is in a unique position to conduct this work, as it is the designated entity responsible for leading influenza surveillance. It has the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipient: Fondacioni SECID, Balkan Region.

Purpose of the award: The purpose of this award is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in the Balkans.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The sole source awards will support the recipients to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities funded under these awards will enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

These entities are in a unique position to conduct this work, as they are either subsidiaries of the host government ministries of health or they are the designated entities responsible for leading influenza surveillance. They have the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipients: Agreement to Fund Association HEADA Cameroon; Instituto Nacional de Saude, Mozambique; Nigeria Centre for Disease Control and Prevention; National Institute of Health, Pakistan; Kinshasa School of Public Health, and Democratic Republic of the Congo.

Purpose of the awards: The purpose of these awards is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Cameroon, Mozambique, Nigeria, Pakistan, and Democratic Republic of the Congo.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k))

Period of performance: September 30, 2026, through September 29, 2031.

These sole source awards will support the recipients to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, these awards will enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

These entities are in a unique position to conduct this work, as they are either subsidiaries of the host government ministries of health or they are the designated entities responsible for leading influenza surveillance. They have the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipients: Ministry of Health, Bhutan; National Influenza Center , Mongolia; Research Institute for Tropical Medicine, Philippines; Bangkok Metropolitan Administration, Thailand.

Purpose of the awards: The purpose of these awards is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Bhutan, Mongolia, Philippines, and Thailand.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

These sole source awards will support the recipients to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities funded under these awards will enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

These entities are in a unique position to conduct this work, as they are either subsidiaries of the host government ministries of health or they are the designated entities responsible for leading influenza surveillance. They have the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipients: Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran, Argentina; Instituto de Salud Publica de Chile, Chile; Ministerio de Salud Pública de Ecuador, Ecuador; Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama; Caribbean Public Health Agency, Caribbean Region.

Purpose of the awards: The purpose of these awards is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Argentina, Chile, Ecuador, Panama, Paraguay, and the Caribbean Region.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026 through September 29, 2031.

The single source award will support the recipient to improve or maintain capacity to conduct seasonal influenza surveillance and detect and respond to pandemic and novel influenza. In addition, the activities under this award enhance capacity to detect and respond to novel influenza viruses, such as highly pathogenic avian influenza, as well as identify outbreaks of severe respiratory illness syndrome and other infectious disease threats through both epidemiologic and virologic detection. These activities will strengthen connections between national institutions, especially National Influenza Centers, to fully participate in data sharing and maintain capacity to share specimens, as well as clinical and epidemiologic data related to influenza circulation.

Fundacion Mexico-Estados Unidos Para La Ciencia, A.C. is in a unique position to conduct this work, as it is the designated entity responsible for leading influenza surveillance. It has the expertise to support health service delivery and oversee the national coordination of surveillance, preparedness, prevention, and response activities to all forms of health threats and public health emergencies.

Recipient: Fundacion Mexico-Estados Unidos Para La Ciencia, A.C.

Purpose of the award: The purpose of this award is to support surveillance and response for pandemic and novel influenza and other infectious disease threats in Mexico.

Authority: This program is authorized under §§ 307 and 317(k) of the Public Health Service Act (42 U.S.C. 242l and 247b(k)).

Period of performance: September 30, 2026, through September 29, 2031.

The Privacy Act of 1974, as amended (5 U.S.C. 552a) provides certain protections for individuals applying for and receiving federal benefits. The law governs the use of computer matching by federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to:

1. Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).

2. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).

3. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).

4. Report the matching program to Congress and the OMB, in advance and annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D).

5. Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12).

This matching program meets these requirements.

The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is the recipient agency, and the Department of War (identified in the applicable system of records notice as Department of Defense) is the source agency.

The principal authority for the matching program is 42 U.S.C. 18001, et seq.

The purpose of the matching program is to assist CMS in determining individuals' eligibility for financial assistance in paying for private health insurance coverage. In this matching program, the Department of War provides CMS with daily files, indicating whether an individual who is seeking eligibility determination for financial assistance is enrolled in TRICARE. CMS makes this data available to state administering entities (AEs) through a data services hub, under a separate matching agreement. CMS and AEs use the Department of War data to verify whether an individual who is applying for or is enrolled in private health insurance coverage under a qualified health plan through a federally-facilitated or state-based health insurance exchange is eligible for coverage under a Department of War health benefit plan, for the purpose of determining the individual's eligibility for financial assistance (including an advance tax credit and cost sharing reduction, which are types of insurance affordability programs) in paying for private health insurance coverage. The Department of War health benefit plans provide minimum essential coverage, and eligibility for such plans precludes eligibility for financial assistance in paying for private coverage. The data provided by the Department of War under this matching program will be used by CMS and AEs to authenticate identity, determine eligibility for financial assistance, and determine the amount of any financial assistance.

The categories of individuals whose information is involved in the matching program are: (1) individuals who are eligible for or enrolled in a TRICARE plan, identified in data CMS receives from the Department of War, and (2) consumers who apply for or are enrolled in private insurance coverage under a qualified health plan through a federally-facilitated or state-based health insurance exchange (and other relevant individuals, such as applicants' and enrollees' household members), whose records are matched against the data CMS receives from the Department of War.

The categories of records which will be provided by the Department of War to CMS in this matching program are identity records and minimum essential coverage period records, consisting of these data elements: Social Security Numbers (SSNs), Coverage Begin Date(s) and Coverage End Date(s).

The applicable CMS system of records is CMS Health Insurance Exchanges System (HIX), CMS System No. 09-70-0560, last published in full at 78 FR 63211 (Oct. 23, 2013), as amended at 83 FR 6591 (Feb. 14, 2018).

The applicable Department of War system of records is DMDC 02 DoD, Defense Enrollment Eligibility Reporting System (DEERS), last published in full at 87 FR 32384 (May 31, 2022).

Description: This request is to revise 5 existing forms in this collection, add 9 new forms, and discontinue 33 forms.

• Prevention of Sexual Abuse (PSA) Quarterly Report (Form M-18): This instrument is used by care providers to share with ORR quarterly PSA data on incidents and allegations of sexual abuse and sexual harassment as required under 45 CFR 411.102(c).

• Business Owner Site Visit Report (Form M-19): This instrument is used by contract business owners to conduct quarterly site visits for care provider facilities funded under a contract and document their observations and child interview responses.

• Home Study and Post-Release Services (HSPRS) Interview Tools: These tools will allow ORR to conduct interviews that are tailored specifically for monitoring HSPRS providers.

The MCB plans to move all their forms into a single web-based application (Monitoring & Compliance App). The forms will also be revised to use focused, compliance-based questions and document requests that will align with ORR's new monitoring standards.

Forms with multiple versions will be consolidated into a single tool, as outlined in the table below. Each tool will populate relevant fields based on program type, level of care, and interviewee role, as applicable.

Thus far, three tools have been developed for the web-based application for programs with the following levels of care: shelter, transitional foster care, long-term foster care, and group home. Word/Excel versions of these three tools will continue to be used for other levels of care until they can be incorporated into the web-based versions in the app. As more tools are developed, ORR will submit additional requests for approval.

• Monitoring File Checklists (Form M-20): This web-based tool is used by ORR federal and contractor monitors during monitoring visits to document review of required program files. The tool consolidates multiple Word and Excel file checklist instruments into one web-based tool. The tool includes three sub-tools: the Child File Checklist, Staff File Checklist, and Foster Parent File Checklist.

• Monitoring Interviews (Form M-21): This web-based tool is used by ORR federal and contractor monitors to conduct and document interviews during monitoring visits. The tool consolidates the previously approved program staff questionnaires, child questionnaires, foster parent questionnaire, and stakeholder/service provider questionnaires into one web-based interview tool. The tool includes four sub-tools: Child Interview, Staff Interview, Foster Parent Interview, and Stakeholder Interview. The staff interview sub-tool includes interview types such as case manager, clinician, educator, independent living skills coordinator, medical staff, ORR-funded leadership, PSA compliance manager, youth care worker, and interpreter; the stakeholder interview sub-tool includes case coordinator, child advocate, legal service provider, and state licensing representative.

• Monitoring Site Assessment (Form M-22): This web-based tool is used by ORR federal and contractor monitors during monitoring visits to document observations from the onsite portion of the review, including facility walk-throughs and assessment of whether observed conditions comply with ORR's monitoring measures. The site assessment supports standardized documentation of onsite monitoring findings and helps align monitoring observations with ORR's newly developed compliance-based monitoring measures.

• Out-of-Network Site Visit Report (Form M-3B): ORR proposes discontinuing this instrument. Form M-3B was developed for the UAC Path system, which was never implemented, and Form M-3B was never used. ORR is in the process of developing a different tool for out-of-network site visits and will submit the tool for approval when ready.

• Remote Site Visit Guides: ORR proposes discontinuing two versions of the Site Visit Guide that were created for remote monitoring visits. These versions were created in response to the COVID-19 pandemic and are no longer used.

• Foster Care Program Checklist and Questionnaires: ORR proposes discontinuing the following monitoring tools that were used for foster care programs. These tools have been replaced by the new web-based Monitoring File Checklists (Form M-20) and Monitoring Interviews (Form M-21) tools.

• Unlicensed Facility Tools: ORR proposes discontinuing the following monitoring tools developed for monitoring unlicensed (also known as delicensed) facilities. These tools will no longer be used. Instead, monitors will use the standard versions (Word, Excel, and web-based) of their tools to monitor delicensed facilities.

Respondents: ORR-funded grantees and contractors, foster parents, and unaccompanied alien children.

Annual Burden Estimates: The proposed revisions result in a 49.80 percent decrease in burden compared to the currently approved information collection.

The revised burden estimate reflects the following changes:

• A decrease in the number of care provider facilities.

• A 4-hour reduction in the time it takes to complete Site Assessment (also known as Monitoring Notes).

• Removal of several forms, including:

• Changes in site visit frequency, including:

• The addition of new forms, including:

Respondents include unaccompanied alien children, ORR care provider affiliated foster parents, care provider facilities, HS and PRS providers, legal service providers, child advocates, case coordinators, and state licensing representatives.

Description: Unaccompanied alien children in ORR custody are placed in care provider programs until unification with a qualified sponsor. Care providers ensure children receive a range of services including routine and emergency medical, dental, and mental health care. Children must also receive medical and dental baseline exams, routine well-child checks, preventive dental care, and counseling services. Care provider staff are expected to implement all recommended treatment plans ( e.g., referrals to specialists, procedures, accommodation for physical or mental impairments that impact daily living activities) as directed by the evaluating healthcare provider. All non-emergent procedures performed under anesthesia or IV sedation require ORR approval via the SMR form. Before a decision can be made by ORR, the SMR form must be completed by the treating healthcare provider ( e.g., surgeon) and submitted to ORR via the care provider program. ORR will waive the completion of the SMR form requirement if it is deemed to be in the best interest of the child ( e.g., during a hospitalization or emergency department visit, related to a medical emergency). If a child with a health condition that requires daily management or accommodation ( e.g., medication, durable medical equipment) is identified for repatriation by DHS, relevant information from their established treatment plan must be shared with DHS to ensure continuity of care. See Proposed Changes for more information.

Data from medical and dental assessments is captured through the following forms that are currently under two ORR information collections (OMB #s: 0970-0466 and 0970-0561):

Each Assessment form has a corresponding instructional Dear Colleague Letter that healthcare providers are expected to read at the initial visit with the child. The forms are used as worksheets by healthcare providers and care provider staff to compile information that would otherwise have been collected during the health assessment. Once completed, care provider staff transcribe the information from the form into ORR's secure, electronic system of record. Although the MAF is not completed during emergency or urgent care visits, hospitalizations, admission to an out-of-network facility ( e.g., medical rehab facility), or follow-up immunization visits in the absence of a healthcare provider evaluation, care providers are required to complete the respective form in ORR's electronic system of record by extracting relevant data from health records.

Data is used by ORR to monitor and support the health of unaccompanied alien children while in care, for case management of identified illnesses/conditions, and to ensure care provider compliance with ORR requirements.

Finally, ORR has updated the stated uses of data sharing to include providing relevant health information to DHS when a child with healthcare needs is identified by DHS for repatriation.

ORR is proposing the incorporation of the SMR Form currently approved under OMB #: 0970-0561 into the OMB #: 0970-0466 information collection and changing the title to Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms to group forms with a similar purpose together. Other changes to the SMR form include the removal of the first page that was completed by care provider staff, clarifying the purpose of the form in the instructions, and revising fields to reduce redundancy and enhance data quality and healthcare provider response.

The MAF and DAF would also be revised to:

• reduce duplicate documentation and encourage form completion by only requiring completion of the History section on the DAF for the initial dental exam and allowing healthcare providers the option of summarizing critical health information in the first two pages of the MAF instead of completing a third page for all scheduled visits except the initial medical exam and routine well-child visits.

• improve compliance and care tracking by strengthening the disabilities and accommodations field and adding a field for all ordered or completed labs and imaging on the MAF, and

• improve data quality through clearer instructions by visit type, a healthcare provider acknowledgement and signature section authorizing record sharing with ORR, replacement of fixed diagnosis choices with free-text fields, and broader field reformatting.

The related Dear Colleague Letter would also be updated to reflect these Mental Health Assessment Form (MHAF) changes (see Tab I for a summary of updates).

In addition, language was updated to expand the purposes of data to include sharing relevant health data captured on the MHAF with DHS when a child in ORR custody has healthcare needs and is identified by DHS for repatriation. Shared information includes:

The purpose of sharing this data is to ensure children receive healthcare services and accommodation as recommended by their treating healthcare providers.

Respondents: Healthcare providers (primary care providers, medical specialists, dentists, and surgeons).

The overall annual burden of response and recordkeeping time decreased by 91.5 percent and 88 percent, respectively. The decrease is attributed to a significantly lower census of unaccompanied alien children in ORR care which reduced the number of respondents and responses per respondent. In addition, the average burden hours per response was decreased for each form by removing unnecessary fields and introducing skip patterns for fields that are only needed for specific types of visits.

Description: The ORR-3 Report is submitted to report a youth's initial placement in the URM Program, termination from the program, or re-entry into the program. The ORR-3 is also submitted to report changes to the youth's case ( e.g., change in legal responsibility, change in foster home placement, etc.). The ORR-4 Report is submitted annually and at termination to report on the youth's receipt of services and outcomes. Proposed revisions to the forms include replacing multiple follow-up outcome reports with a single termination outcome report, replacing self-reported outcome measures from youth with provider-reported measures, eliminating select sub-types of ORR-3 reports, replacing or streamlining unclear questions and response options, removing unnecessary questions, and streamlining supplemental report instructions to integrate more guidance directly into the forms.

Respondents: URM state/replacement designee agencies and URM provider agencies.

The edits describe above will result in a reduction in annual burden estimates of approximately 41 percent once implemented. Additionally, youth have been removed as a respondent to the ORR-4 Report; youth outcome measures will no longer be self-reported, instead providers will report youth outcomes. Revisions will be implemented after a 12-month implementation timeframe; the following burden estimates are specific to the revised versions following the 12-month implementation period.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: 8 U.S.C. 1822(d).

Description: ACF programs promote the economic and social well-being of families, children, individuals, and communities. ACF conducts research on the programs, and with the populations they serve, through rigorous research and evaluation projects. These include evaluations of existing programs, evaluations of innovative approaches to helping low-income children and families, research syntheses, and descriptive and exploratory studies. ACF's research offers further understanding of current programs and service populations, explores options for program improvement, and assesses alternative policy and program designs. ACF regularly undertakes a variety of new research projects related to welfare, employment and self-sufficiency, Head Start, child care, healthy marriage and responsible fatherhood, family and youth services, home visiting, child welfare, trafficking, community services, and other areas of interest to ACF.

Under this generic clearance, ACF engages in a variety of formative data collections with researchers, practitioners, technical assistance providers, service providers, and potential participants throughout the field to fulfill the following goals: (1) inform the development of ACF research, (2) maintain a research agenda that is rigorous and relevant, (3) ensure that research products are as current as possible, and (4) inform the provision of technical assistance and supports around research and evaluation. ACF envisions using a variety of techniques including semi-structured discussions, focus groups, surveys, and telephone or in-person interviews, in order to reach these goals.

Information collected under this overarching generic is meant to inform ACF research activities and may be incorporated into documents or presentations that are made public. The following are some examples of ways in which we may share information resulting from these data collections: research design documents or reports; research or technical assistance plans; background materials for technical workgroups; concept maps, process maps, or conceptual frameworks; contextualization of research findings from a follow-up data collection that has full PRA approval; informational reports to technical assistance providers; or project specific reports, or other documents relevant to the field, such as federal leadership and staff, grantees, local implementing agencies.

Following standard OMB requirements, ACF has and will continue to submit to OMB information about individual information collection activities proposed under the generic clearance. ACF will provide OMB with a copy of the individual instruments or questionnaires, as well as other materials describing the project. ACF requests OMB's review within 10 days of submission of individual requests under this generic.

Find currently approved information collections here: https://www.reginfo.gov/public/do/PRAICList?ref_nbr=202504-0970-028.

Respondents: Respondents could include key groups involved in ACF projects and programs, state or local government officials, service providers, participants in ACF programs or similar comparison groups, experts in fields pertaining to ACF research and programs, or others involved in conducting ACF research or evaluation projects.

The request to OMB will include an extension request for approved information collections that are planned to continue beyond the submission of this request to OMB (estimated November 2026). At this time, the following are expected to be included for an extension. This will be updated, if needed, for the 30-day comment period to reflect new GenICs or changes in plans for the following information collections.

Burden for potential new requests has been adjusted to reflect agency priorities, resulting in a 30 percent decrease compared to the currently approved burden for new requests.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: Social Security Act, section 1110. [42 U.S.C. 1310].

FDA is announcing a request for information titled “Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities.” Information submitted in response to this notice will be used by CDER's Quantitative Medicine Center of Excellence (QM CoE) to inform the development and implementation of a cross-sector innovation network.

The proposed mission for the QMIN is to connect FDA scientists, academia, industry, healthcare providers, patient groups, and other regulatory partners in driving the development and application of quantitative medicine to tackle critical unmet needs of the community by fundamentally transforming drug development and clinical care.

Quantitative medicine approaches integrate mathematical and computational models with biological, clinical, and statistical data to inform drug development, regulatory, and clinical decisions. These approaches have the potential to improve the efficiency of drug development, optimize treatment strategies, and ultimately improve patient outcomes.

The QM CoE seeks to establish a collaborative ecosystem that brings together diverse stakeholders to advance the science and application of quantitative medicine toward transformative capabilities. The QMIN is envisioned as a multi-stakeholder network to accelerate the translation of quantitative approaches across the drug discovery, development, regulation, and utilization continuum, fundamentally transforming how safe and effective therapies reach patients. This request for information is designed to gather input on how best to structure and implement the QMIN to maximize its impact on public health.

FDA is interested in detailed comments on the topics listed in this section to inform the establishment of the QMIN. The topics identified in this section are not meant to be exhaustive. FDA is also interested in any other pertinent information that interested parties would like to share related to advancing quantitative medicine through collaborative networks. The Agency encourages interested parties to provide specific rationale and basis for their comments, including any available supporting data and information.

The QM CoE seeks to understand the current landscape of quantitative medicine capabilities, challenges, and opportunities across different stakeholder groups. We are interested in establishing mechanisms for problem-solving that leverage community expertise and collaborative capacity.

Specific areas of interest include the following:

• What areas of quantitative medicine ( e.g., disease modeling, trial simulation, New Approach Methodologies (NAMs) integration) would most benefit from a coordinated, cross-sector network?

• Where currently are the greatest gaps in tools, standards, or infrastructure?

• Should the QMIN prioritize a limited number of high-impact domains ( e.g., therapeutic area specific needs, methodology development) for deep investment, or a broader set of activities ( e.g., improved adoption and integration of QM approaches across therapeutic areas)?

• What activities are most appropriate for a precompetitive network versus those better addressed within individual development programs or regulatory submissions?

• How should the QMIN define its role relative to existing efforts, including those led by FDA and external stakeholders?

• What governance structures would best support a multi-stakeholder network involving FDA, industry, academia, and patient groups?

• What roles should different stakeholders play in setting priorities, developing outputs, and ensuring scientific rigor?

• What mechanisms ( e.g., working groups, pilot projects, public workshops, shared platforms) would most effectively support the QMIN's objectives?

• How should collaboration be structured to enable both innovation and broad participation?

• What incentives would encourage sustained participation from stakeholders?

• What funding or resourcing models ( e.g., public-private partnerships) should be considered?

• What types of use cases are most appropriate for initial QMIN focus?

• What criteria should be used to select and evaluate use cases?

• How should the QMIN's use cases be designed to demonstrate clear impact?

• What metrics ( e.g., reduced development time, improved decision confidence, reduced animal use) are most appropriate?

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports certain Food and Drug Administration (FDA, the Agency, us or we) Advisory Committee administrative activities. FDA Advisory Committees are established to advise or make recommendations on matters of public health that come before the Agency. The Federal Advisory Committee Act (5 U.S.C. App. 2 § 3, Pub. L. 92-463) (“FACA”) defines what constitutes an “advisory committee” under the Act and provides general procedures to follow for the operation of advisory committees. In addition, FACA is designed to ensure that the Congress and the public are kept informed with respect to the purpose, membership, and activities of advisory committees. Public advisory committee regulations in part 14 set forth requirements governing the administrative procedures to follow for the operation of advisory committees. Agency regulations in part 14, subpart A (§§ 14.1 through 14.15) identify scope of coverage, applicable definitions, and establish general provisions. The regulations in part 14, subpart B (§§ 14.20 through 14.39) set forth content and format requirements along with required schedules for submission of information. The regulations in part 14 subparts C, D, and E (§§ 14.40 through 14.95) set forth requirements governing advisory committee establishment, recordkeeping, and maintenance, respectively.

FACA does not specify the manner in which advisory committee members and staff must be appointed. ( See generally 5 U.S.C. App. 2. See also, 41 CFR 102-3.105, 102-3.130(a)). FDA's regulations, however, specify that the Commissioner “will publish one or more notices in the Federal Register each year requesting nominations for voting members of all existing standing advisory committees.” (21 CFR 14.82(a)). Nominations must specify the committee for which the nominee is recommended, include a complete curriculum vitae (CV), state that the nominee is aware of the nomination and willing to serve, and state that the nominee appears to have no conflict of interest that would preclude membership. (21 CFR 14.82(c)). In an effort to promote transparency, consistent with FDA and General Services Administration (“GSA”) policy ( See, GSA regulations encouraging agencies to “practice openness” and suggesting that “agencies may wish to explore the use of the internet to post advisory committee information . . .” 41 CFR 102-3.95(b)), and pursuant to a settlement agreement in the case Public Citizen Foundation, Inc. v. Food & Drug Administration, et al., No. 16-cv-781 (D.D.C.), FDA is also seeking consent from nominees for FDA to publicly post their CVs in the event they are selected to serve on an FDA advisory committee.

In the Federal Register of March 23, 2026 (91 FR 13852), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment. The comment suggests our process could be easier if we were to have more on-line tools available. They also commented that FDA should be clearer on how the information is used in decision making.

FDA appreciates the comment. FDA has established an applicant portal on its website at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm through which submissions are made to the Agency. To facilitate reporting we have established a standardized electronic format for information data elements and a separate functionality for uploading necessary documentation, such as CVs and letters of recommendation.

This data and information are made available to Agency staff to allow them to conduct reviews of nominations and coordinate follow-up with the potential candidate to explain the advisory committee process and confirm their willingness to serve. If a candidate is deemed acceptable for participation on a committee, further action is taken to appoint them to a specific advisory committee that is appropriate to their expertise and the committee's function. FDA publishes the CV of new advisory committee members on our website. FDA believes this will increase public confidence that FDA's review of advisory committee membership nominations and the subsequent selection process has been conducted thoroughly and objectively, without regard to politics or relationships with third parties. Applying this policy across all FDA advisory committees further supports FDA's goal of maintaining science as the primary determinant in Agency decision making.

FDA estimates the burden of this collection of information as follows: