The Census Bureau plans to request an extension of the current OMB approval to conduct a variety of small-scale questionnaire pretesting activities under this generic clearance. A block of hours will be dedicated to these activities for each of the next three years. OMB will be informed in writing of the purpose and scope of each of these activities, as well as the time frame and the number of burden hours used. The number of hours used will not exceed the number set aside for this purpose.

This research program will be used by the Census Bureau and survey sponsors to improve questionnaires and procedures, reduce respondent burden, and ultimately increase the quality of data collected in the Census Bureau censuses and surveys. The clearance will be used to conduct pretesting of decennial, demographic, and economic census and survey questionnaires prior to fielding them. Pretesting activities will involve one of the following methods for identifying measurement problems with the questionnaire or survey procedure: cognitive interviews, focus groups, respondent debriefing, behavior coding of respondent/interviewer interaction, and split panel tests.

Any of the following methods may be used: mail, telephone, face-to-face; paper-and-pencil, CATI, CAPI, internet, mobile device, or IVR.

OMB Control Number: 0607-0725.

Form Number(s): Various.

Type of Review: Regular submission, Request for an Extension, without change of a currently approved collection.

Affected Public: Individuals or households; Business or other for-profit organizations; Farms.

Estimated Number of Respondents: 5,500 per year.

Estimated Time per Response: 1 hour.

Estimated Total Annual Burden Hours: 5,500 hours annually.

Estimated Total Annual Cost to Public: $0. There is no cost to the respondent other than time to answer the information request.

Respondent's Obligation: Voluntary.

Legal Authority: Data collection for this project is authorized under the authorizing legislation for the questionnaire being tested. This may be Title 13, Sections 131, 141, 161, 181, 182, 193, and 301 for Census Bureau-sponsored surveys, and Title 13, Section 8 for surveys sponsored by other Federal agencies. We do not now know what other titles will be referenced, since we do not know what survey questionnaires will be pretested during the course of the clearance.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

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

Under the provisions of Public Law 94-171 (13 U.S.C. 141(c)), the Director of the Census Bureau is required to provide the “officers or public bodies with initial responsibility for legislative apportionment or districting of each state . . .” with the opportunity to specify small geographic areas ( e.g., tabulation blocks, voting districts) for which they wish to receive decennial census population totals for the purpose of reapportionment and redistricting.

By April 1 of the year following the census, the Secretary of Commerce is required to furnish the state officials or their designees with population counts for standard geographies such as counties, cities, census blocks, and for state-specified congressional districts, legislative districts, and voting districts.

In accordance with the provisions of 13 U.S.C. 141(c), and on behalf of the Secretary of Commerce, the Director of the Census Bureau announces the commencement of Phase 1 of the 2030 Census Redistricting Data Program. The purpose of this notice is to provide further information on the commencement of Phase 1 of the 2030 Census Redistricting Data Program: The Block Boundary Suggestion Project. Future Federal Register notices will address other phases of the 2030 Census Redistricting Data Program.

The 2030 Census Redistricting Data Program was initially announced on July 9, 2024 (89 FR 56287). The Census Bureau received two sets of comments regarding the 2030 Census Redistricting Data Program. One set of comments was determined to be out of scope, and the second set of comments discussed program operations, timing, and past successful activities. Within this set of comments, the first, to send the solicitation for a state non-partisan liaison letter to the state's legislative leadership, was implemented. The second comment, to move the timing of the program's operations from Spring to Fall, was determined to not be feasible for the overall success of the program. This determination was made based on feedback received during the planning phase of the 2030 Census Redistricting Data Program. Finally, the third comment, to solicit statewide geography layers from the commentor's state GIS coordinator to update Census Bureau geography, was out of scope for the 2030 Census Redistricting Data Program. This recommendation was forwarded to the relevant area of the Census Bureau for consideration.

State participation in the 2030 Census Redistricting Data Program under 13 U.S.C. 141 is voluntary. The 2030 Census Redistricting Data Program is partitioned into several phases, as it was in previous decades. Beginning in late 2025, the program will engage each state regarding their voluntary participation in Phase 1, through their newly designated 2030 Census Redistricting Data Program non-partisan liaison(s). The Census Bureau will make available data from its national geospatial database (MAF/TIGER System), the Geographic Update Partnership Software (GUPS), and the procedures necessary for each state to begin work on Phase 1. States are not required to use the GUPS; however, they are required to provide their Phase 1 submission to the Census Bureau electronically in Census Bureau specified formats. During the submission period, the Census Bureau will provide training in the use of the GUPS and assist the states in understanding the procedures necessary for processing files for their submission. The states will have the opportunity to verify the inclusion of their suggested tabulation block boundary features in the Census Bureau's MAF/TIGER System as part of Phase 1.

The Census Bureau will continue to communicate with each state to ensure that they are well informed about the benefits of working with the Census Bureau towards a successful 2030 Census. In addition, the Redistricting and Voting Rights Data Office will continue to work with each state to ensure they are prepared to participate in all phases of the 2030 Census Redistricting Data Program. Every state, regardless of their participation in Phase 1, will receive the official redistricting data in Phase 3 of the 2030 Census Redistricting Data Program as required by Public Law 94-171.

Ron Jarmin, Acting Director, Census Bureau, approved the publication of this notice in the Federal Register .

The Quarterly Survey of U.S. Direct Investment Abroad—Transactions of U.S. Reporter with Foreign Affiliate (Form BE-577) obtains quarterly data on transactions and positions between U.S.-owned foreign business enterprises and their U.S. parents, except certain private funds. The survey is a sample survey that covers all foreign affiliates above a size-exemption level. The sample data are used to derive universe estimates in nonbenchmark years from similar data reported in the BE-10, Benchmark Survey of U.S. Direct Investment Abroad, which is conducted every five years. The data are essential for the preparation of the U.S. international transactions accounts, the national income and product accounts, the input-output accounts, and the international investment position of the United States. The data are needed to measure the size and economic significance of direct investment abroad, measure changes in such investment, and assess its impact on the U.S. and foreign economies.

The Bureau of Economic Analysis (BEA) is proposing a change to the BE-577 survey reporting requirements that will reduce respondent burden and increase the efficiency of data collection.

The proposed change amends the reporting requirements for the BE-577 survey. Specifically, BEA proposes to increase the valuation threshold in the basic requirement for the survey. Currently, a BE-577 form is required for each (1) directly-owned foreign affiliate for which total assets; annual sales or gross operating revenue, excluding sales taxes; or annual net income after provision for foreign income taxes was greater than $60 million (positive or negative) at any time during the affiliate's fiscal reporting year and each (2) indirectly-owned foreign affiliate that met the $60 million threshold and had an intercompany receivable or payable balance with the U.S. reporter that exceeded $10 million.

BEA proposes to increase the threshold for filing the BE-577 from $60 million to $500 million. BEA has determined that this increased threshold on the BE-577 would be sufficient to collect the information necessary to provide data users with insightful statistics measuring the economic impact of these investments. This proposed change would reduce respondent burden and the BEA resources needed to collect and process these investments.

Notice of specific reporting requirements, including who is to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be mailed to potential respondents each quarter. Reports are due 30 days after the close of each calendar or fiscal quarter—45 days if the report is for the final quarter of the respondent's financial reporting year. Reports are required from each U.S. person that has a direct and/or indirect ownership interest of at least 10 percent of the voting stock in an incorporated foreign business enterprise, or an equivalent interest in an unincorporated foreign business enterprise, and that meets the additional conditions detailed in Form BE-577. Certain private funds are exempt from reporting. Entities required to report will be contacted individually by BEA. Entities not contacted by BEA have no reporting responsibilities.

Potential respondents are those U.S. business enterprises that reported owning foreign business enterprises in the 2024 benchmark survey of U.S. direct investment abroad, along with entities that subsequently entered the direct investment universe. The data collected are sample data. Universe estimates are developed from the reported sample data.

BEA offers electronic filing through its eFile system ( www.bea.gov/efile ) for use in reporting on the BE-577 survey forms. In addition, BEA posts its survey forms and reporting instructions on its website ( www.bea.gov/dia ).

OMB Control Number: 0608-0004.

Form Number: BE-577.

Type of Review: Regular submission, reinstatement without change.

Affected Public: Businesses or other for-profit organizations.

Estimated Number of Respondents: 1,500 U.S. parents filing for 12,700 foreign affiliates per quarter, 50,800 annually.

Estimated Time per Response: 1 hour is the average but may vary considerably among respondents because of differences in company structure and complexity.

Estimated Total Annual Burden Hours: 50,800.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Mandatory.

Legal Authority: International Investment and Trade in Services Survey Act (P.L. 94-472, 22 U.S.C. 3101-3108, as amended by P.L. 98-573 and P.L. 101-533).

We are soliciting public comments to permit the Department of Commerce/Bureau of Economic Analysis to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

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

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Among the exceptions is section 101(a)(5)(D) of the MMPA (16 U.S.C. 1361 et seq. ) which directs the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking by harassment of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and the public has an opportunity to comment on the proposed IHA.

Specifically, NMFS will issue an IHA if it finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least [practicable] adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to here as “mitigation”). NMFS must also prescribe requirements pertaining to the monitoring and reporting of such takings. The definitions of key terms, such as “take,” “harassment,” and “negligible impact,” can be found in the MMPA and the NMFS' implementing regulations (see 16 U.S.C. 1362; 50 CFR 216.103).

On June 4, 2025, a notice of NMFS' proposal to issue three IHAs to ADOT&PF for take of marine mammals incidental to the Prince William Sound Ferry Terminal Improvement Projects (PWS Projects) in Cordova, Chenega, and Tatitlek, Alaska was published in the Federal Register (90 FR 23814, June 4, 2025). In that notice, NMFS indicated the estimated numbers, type, and methods of incidental take proposed for each species or stock, as well as the mitigation, monitoring, and reporting measures that would be required should the IHAs be issued. The Federal Register notice also included analysis to support NMFS' preliminary conclusions and determinations that the IHAs, if issued, would satisfy the requirements of section 101(a)(5)(D) of the MMPA for issuance of the IHAs. The Federal Register notice included web links to draft IHAs for review, as well as other supporting documents.

No substantive comments were received during the public comment period. There are no changes to the specified activity, the species taken, the proposed numbers, type, or methods of take, or the mitigation, monitoring, or reporting measures in the proposed IHAs notice. No new information that would change any of the preliminary analyses, conclusions, or determinations in the proposed IHAs notice has become available since that notice was published, and therefore, the preliminary analyses, conclusions, and determinations included in the proposed IHAs notice are considered final.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of three IHAs) with respect to potential impacts on the human environment.

These actions are consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216- 6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the proposed IHAs qualifies to be categorically excluded from further NEPA review.

Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531 et seq. ) requires that each Federal agency ensures that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species.

NMFS is authorizing take of the Western DPS of Steller sea lions, and of the Mexico DPS of humpback whales, which are listed under the ESA. NMFS Office of Protected Resources has completed a section 7 consultation with the Alaska Regional Office for the issuance of these IHAs. The Alaska Regional Office's biological opinion states that the actions are not likely to jeopardize the continued existence of the listed species.

Accordingly, consistent with the requirements of section 101(a)(5)(D) of the MMPA, NMFS has issued three IHAs to ADOT&PF for authorization to take marine mammals incidental to the Prince William Sound Ferry Terminal Improvement Projects (PWS Projects) in Cordova, Chenega, and Tatitlek, Alaska.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are promulgated or, if the taking is limited to harassment, an incidental harassment authorization is issued.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to here as “mitigation measures”). NMFS must also prescribe requirements pertaining to monitoring and reporting of such takings. The definition of key terms such as “take,” “harassment,” and “negligible impact” can be found in the MMPA and NMFS's implementing regulations (see 16 U.S.C 1362; 50 CFR 216.103).

NMFS' regulations implementing the MMPA at 50 CFR 216.107(e) indicate that IHAs may be renewed for additional periods of time not to exceed 1 year for each reauthorization. In the notice of proposed IHA for the initial IHA, NMFS described the circumstances under which we would consider issuing a renewal for this activity, and requested public comment on a potential renewal under those circumstances. Specifically, on a case-by-case basis, NMFS may issue a one-time 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical, or nearly identical, activities as described in the Detailed Description of Specified Activities section of the initial IHA issuance notice is planned or (2) the activities as described in the Description of the Specified Activities and Anticipated Impacts section of the initial IHA issuance notice would not be completed by the time the initial IHA expires and a renewal would allow for completion of the activities beyond that described in the DATES section of the notice of issuance of the initial IHA, provided all of the following conditions are met:

1. A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA).

2. The request for renewal must include the following:

• An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor ( e.g., reduction in pile size) that the changes do not affect the previous analyses, mitigation and monitoring requirements, or take estimates (with the exception of reducing the type or amount of take).

• A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.

Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.

An additional public comment period of 15 days (for a total of 45 days), with direct notice by email, phone, or postal service to commenters on the initial IHA, is provided to allow for any additional comments on the proposed renewal. A description of the renewal process may be found on our website at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-harassment-authorization-renewals.

On June 6, 2024, NMFS issued an IHA to the Port to take marine mammals incidental to the Terminal 4 Expansion and Redevelopment Project at the Port of Grays Harbor, Washington (90 FR 28725, July 1, 2025), effective from July 16, 2024 through July 15, 2025. On April 16, 2025, NMFS received an application for the renewal of that initial IHA. As described in the application for renewal, the activities for which incidental take is requested are consistent with activities that are covered by the initial authorization but will not be completed prior to its expiration. As required, the applicant also provided a preliminary monitoring report (available at https://www.fisheries.noaa.gov/action/incidental-take-authorization-ag-processing-incs-port-grays-harbor-terminal-4-expansion-and ) which confirms that the applicant has implemented the required mitigation and monitoring, and which also shows that no impacts of a scale or nature not previously analyzed or authorized have occurred as a result of the activities conducted. The notice of the proposed renewal incidental harassment authorization was published on July 1, 2025 (90 FR 28725).

The purpose of the project is to construct a new export facility at Terminal 4 (T4). The activity includes removal of existing piles and the installation of both temporary and permanent piles of various sizes. Takes of marine mammals by Level A and Level B harassment are expected to occur as a result of noise produced by both impact and vibratory pile driving and vibratory removal. The initial IHA authorized take incidental to in-water construction activities associated with the installation of a new fendering system at Terminal 4A and the installation of a new commodity export facility at Terminal 4B. Ag Processing Inc. has completed the in-water construction activities for the new commodity export facility at Terminal 4B. However, a 1-year renewal of the initial IHA is needed to complete the in-water construction activities associated with the new fendering system at Terminal 4A.

A detailed description of the demolition and construction activities for which take is authorized may be found in the Notices of the Proposed (89 FR 24436, April 8, 2024) and Final (89 FR 48565, June 7, 2024) IHAs for the initial authorization. The location, timing, and nature of the activities, including the types of equipment planned for use, are similar to those described in the previous notices. The renewal IHA is effective for a period not exceeding 1 year from the date of expiration of the initial IHA (July 15, 2025).

The initial IHA authorized take incidental to the in-water pile driving/removal activities shown in tables 1 and 2. The activities in table 1 will be completed under this renewal IHA and the activities in table 2 were completed under the initial IHA. The previously planned impact proofing of 24-inch (60.96 centimeter (cm)) steel pipe piles was not required at Terminal 4B. Since the impact proofing of 24-inch (60.96 cm) steel pipe piles planned for the Terminal 4B commodity export facility portion of the Project was not required, the Port plans to conduct similar impact proofing for the fendering system construction at Terminal 4A under the renewal IHA. With the exception of impact proofing for the new fendering system, there are no new activities or modifications from the originally proposed actions. Pile removal and installation activities will occur during the in-water work window (July 16 through February 15). The most conservative estimate of time required to complete pile installation and removal activities under this renewal is 36 days of intermittent vibratory pile driving/removal and an additional 8 days of impact proofing. The renewal IHA will be effective for a period not exceeding 1 year from the date of expiration of the initial IHA.

The Gulf, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with the National Marine Fisheries Service and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data/Assessment Workshop, and (2) a series of webinars. The product of the Data and Assessment Workshops is a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf, South Atlantic, and Caribbean Fishery Management Councils and National Marine Fisheries Service Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion in the Data Workshop are as follows:

An assessment data set and associated documentation will be developed during the workshop. Participants will evaluate proposed data and select appropriate sources for providing information on topics such as life history characteristics, catch statistics, discard estimates, length and age composition, and fishery dependent and fishery independent measures of stock abundance.

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

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 5 business days prior to each workshop.

Note: The times and sequence specified in this agenda are subject to change.

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

Comments are invited 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, including the validity of the methodology and assumptions used; (c) ways to enhance 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.

This information collection request contains:

(1) OMB No.: 1910-NEW;

(2) Information Collection Request Title: EERE Small Businesses and Startups Impact Evaluation Data Collection.

(3) Type of Request: New.

(4) Purpose: The information collected through this effort is needed as an input to an evaluation study that will produce an analysis of the impact EERE's funding has had on small businesses between 2008 and 2024. The results of this evaluation study will be used by DOE leadership to understand the impact to date and opportunities for improvement in financial awards provided to small businesses. Respondents to this data collection effort will small businesses and startup companies that have applied for financial assistance, SBIR/STTR grants and prize funding from EERE between 2008 and 2024, and will include both award recipients and applicants who did not receive funding. This is planned to be a one-time data collection effort.

(5) Annual Estimated Number of Respondents: 9,000;

(6) Annual Estimated Number of Total Responses: 9,000;

(7) Annual Estimated Number of Burden Hours: 13,500;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: $751,275.

Statutory Authority: Foundations for Evidence-based Policymaking Act of 2018 (Pub. L. 115-435; Jan. 14, 2019).

This document of the Department of Energy was signed on July 25, 2025, by Lou Hrkman, Principal Deputy Assistant Secretary of the Office of Energy Efficiency and Renewable Energy, 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 .

Purpose of the Board: The purpose of the Board is to provide advice and recommendations concerning the following EM site-specific issues: clean-up activities and environmental restoration; waste and nuclear materials management and disposition; excess facilities; future land use and long-term stewardship. The Board may also be asked to provide advice and recommendations on other EM program components. The Board also provides an avenue to fulfill public participation requirements outlined in the National Environmental Policy Act (NEPA), 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 the NSSAB Administrator 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 the NSSAB Administrator. The EM SSAB, Nevada, 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 the NSSAB Administrator 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: https://www.nnss.gov/nssab/nssab-meetings/ .

Signing Authority: This document of the Department of Energy was signed on July 25, 2025, 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 .

This information collection request contains:

(1) OMB No.: 1901-0294.

(2) Information Collection Request Title: Natural Gas Imports and Exports.

(3) Type of Request: Three-year extension without change.

(4) Purpose: The Form FE-746R Natural Gas Imports and Exports collect information on the imports and exports of natural gas, including LNG, under the Natural Gas Act (NGA) (15 U.S.C. 717b).

The Federal Energy Administration Act of 1974 (15 U.S.C. 761 et seq. ) and the DOE Organization Act (42 U.S.C. 7101 et seq. ) require DOE to carry out a centralized, comprehensive, and unified energy information program. This program collects, evaluates, assembles, analyzes, and disseminates information on energy resource reserves, production, demand, technology, and related economic and statistical information.

Under section 3 of the NGA, DOE is authorized to regulate natural gas imports and exports, including LNG. To carry out DOE's statutory responsibilities, FECM (through its delegated authority) implements regulations (10 CFR part 590) that require any person seeking to import or export natural gas to file an application requesting authorization. The application requires information on the scope and nature of the proposed import/export activity. Additionally, once an importer or exporter receives an authorization from DOE under the NGA, the authorization holder is required to submit monthly reports of all import and/or export transactions on Form FE-746-R.

Form FE-746R has different reporting formats, corresponding to different import and export activities. Generally, however, Form FE-746-R requires the reporting of the following information for the authorized imports or exports on a monthly basis: name of importer/exporter; country of origin/destination; international point of entry/exit; name of supplier; volume; price; transporters; U.S. geographic market(s) served; and duration of supply contract. More information about the Form FE-746R reporting requirements is available at: https://www.energy.gov/fecm/guidelines-filing-monthly-reports.

Both EIA and FECM use the information provided by authorization holders on Form FE-746R to assess the adequacy of energy resources to meet near and longer term domestic demands, and FECM also uses it in the management of its natural gas regulatory program. Specifically, data collected on Form FE-746R are published in FECM's U.S. Natural Gas Imports and Exports Monthly Report, and in EIA's official statistics on U.S. natural gas supply and disposition. In addition, the data are used to monitor the North American natural gas trade, which, in turn, enables the Federal government to perform market and regulatory analyses; improve the capability of industry and the government to respond to any future energy-related supply problems; and keep the general public informed of international natural gas trade.

(5) Annual Estimated Number of Respondents: 396.

(6) Annual Estimated Number of Total Responses: 4,752.

(7) Annual Estimated Number of Burden Hours: 14,256.

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: The cost of the burden hours is estimated to be $1,354,177. DOE estimates that respondents will have no additional costs associated with the surveys other than the burden hours and the maintenance of the information during the normal course of business.

Comments are invited on whether : (a) The proposed collection of information is necessary for the proper performance of agency functions, including whether the information will have a practical utility; (b) DOE's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used, is accurate; (c) DOE can improve the quality, utility, and clarity of the information it will collect; and (d) DOE can minimize the burden of the collection of information on respondents, such as automated collection techniques or other forms of information technology.

Statutory Authority : 15 U.S.C. 772(b) and 42 U.S.C. 7101 et seq., 15 U.S.C. 717b.

This action is directed to the public in general and may be of particular interest to those involved in the manufacture (including import), processing, distribution, use, and disposal of PCE or products containing PCE, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, state and local governments, Tribal Nations, and/or those interested in the assessment or management of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the technical contact listed FOR FURTHER INFORMATION CONTACT .

Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the Agency determines through a TSCA section 6(b) risk evaluation that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a)(1)-(7) to the extent necessary so that the chemical substance or mixture no longer presents such risk.

On December 18, 2024, EPA released the final risk management rule for PCE titled “Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA)” (89 FR 103560, December 18, 2024) (FRL-8329-01-OCSPP) (hereinafter “PCE final rule”). Following its publication, EPA received several petitions for review related to the rule. These petitions for review were consolidated in the U.S. Court of Appeals for the Fifth Circuit. The Court granted a temporary abeyance in the litigation through August 21, 2025.

On May 12, 2025, EPA filed a declaration with the Court advising that the Agency intends to reconsider the PCE final rule through further rulemaking. In that declaration, the Agency expressed its intent to solicit early stakeholder input. EPA is now soliciting early stakeholder input regarding its intended reconsideration of the rule. EPA invites public comment on requirements and implementation of the PCE final rule (89 FR 103560), particularly on the topics described in Unit II. The information received in response to this notice will inform EPA's considerations of these provisions.

This review is being done in accordance with applicable law, Executive Orders, and Administration policies, including Executive Order 14219 “Ensuring Lawful Governance and Implementing the President's `Department of Government Efficiency' Deregulatory Initiative” (90 FR 10583, February 19, 2025) and EPA's Powering the Great American Comeback Initiative Pillar I: Clean Air, Land, and Water for Every American.

Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703, as applicable.

When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

EPA invites public comment on all aspects of the PCE final rule, including but not limited to any existing or anticipated implementation issues associated with the final rule requirements, experiences with the PCE final rule since it went into effect, and whether the Agency should consider additional or alternative measures or approaches to address the unreasonable risk presented by PCE under the conditions of use. Input on the following is of particular interest to EPA:

• The Existing Chemical Exposure Limit (ECEL) of 0.14 parts per million (ppm) as an 8-hour time weighted average (8-hr TWA) promulgated in the PCE final rule as part of the Workplace Chemical Protection Program (WCPP) (see 40 CFR 751.603 and 751.607(b)), including whether the use of a different exposure limit would be more appropriate to inform risk management. Different exposure limits might include but are not limited to: the acute non-cancer exposure limit of 0.50 ppm (8-hr TWA) and the lifetime cancer exposure limit of 0.47 ppm (8-hr TWA) as presented in the Existing Chemical Exposure Limit (ECEL) for Occupational Use of Perchloroethylene Memo available at https://www.regulations.gov/document/EPA-HQ-OPPT-2020-0720-0043.

• Conditions of use the Agency could contemplate subjecting to a WCPP as opposed to imposing a prohibition. Information such as workplace controls currently in place or other information demonstrating how regulated parties could mitigate the unreasonable risk of PCE for the condition of use would be most helpful to the Agency.

• The use of PCE in industrial dry cleaning processes including workplace controls that reduce exposure to PCE and the performance of alternatives to PCE in these operations.

To the extent possible, the Agency asks commenters to please cite and provide any public data related to or that supports comments provided, and to the extent permissible, describe and provide any supporting data that is not publicly available.

Authority: 15 U.S.C. 2605.

Proposal to renew the following currently approved collection of information:

1. Title: Interagency Charter and Federal Deposit Insurance Application.

OMB Number: 3064-0001.

Form Number: 6200-05.

Affected Public: Banks or savings associations wishing to become FDIC-insured depository institutions.

Burden Estimate:

General Description of Collection: The Federal Deposit Insurance Act requires financial institutions to apply to the FDIC to obtain deposit insurance. This collection provides the FDIC with the information needed to evaluate the applications. There is no change in the method or substance of the collection. The increase in burden hours is the result of economic fluctuation. In particular, the number of respondents has increased while the hours per response and frequency of responses have remained the same.

2. Title: Stress Testing Recordkeeping and Reporting.

OMB Number: 3064-0189.

Form Number: None.

Affected Public: Insured State nonmember banks and State savings associations.

Burden Estimate:

General Description of Collection: The FDIC has issued a rule requiring periodic stress testing by FDIC-supervised institutions having more than $250 billion in total assets, consistent with changes made by section 401 of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA). Section 165(i)(2) of the Dodd-Frank Act requires each primary Federal regulator to issue consistent and comparable regulations to (1) ensure that certain financial companies conduct stress tests; (2) establish the form and content of the required reports of such stress tests, and (3) require companies to publish a summary of the stress test results. As originally enacted, section 165(i)(2)(C) applied to all IDIs with average total consolidated assets of $10 billion or greater, required such IDIs to conduct annual stress tests, and required the use of three scenarios: baseline, adverse, and severely adverse. Consistent with the requirements of section 165(i)(2)(C), as originally enacted, the FDIC published its final rule implementing section 165(i)(2) on October 15, 2012. The requirements under 12 CFR part 325 applied to FDIC-supervised IDIs with average total consolidated assets of $10 billion or greater. The EGRRCPA, enacted on May 24, 2018, amended certain aspects of the company-run stress-testing requirements in section 165(i)(2) of the Dodd-Frank Act. The EGRRCPA amendments to the section 165(i)(2) stress testing requirements became effective eighteen months after enactment.

The aspects of 12 CFR part 325 that constitute an information collection are those that require a banking organization to (1) file stress test reports to be filed periodically with the FDIC and the Board of Governors of the Federal Reserve System (the Board) in the time, manner, and form specified by the FDIC (12 CFR 325.6); (2) establish and maintain a system of controls, oversight, and documentation, including policies and procedures that describe the covered bank's stress test practices and methodologies, as well as processes for updating such bank's stress test practices, as well as specific calculations that must be made by the banking organization during its stress tests (12 CFR 325.5); and (3) publish a summary of the results of its stress tests (12 CFR 325.7).

On May 17, 2012, the FDIC, the Office of the Comptroller of the Currency, and the Board published the 2012 Interagency Guidance on the use of stress testing as a means to better understand the range of a banking organization's potential risk exposures. The guidance is intended for IDIs with total consolidated assets of more than $10 billion and provides an overview of how a banking organization should structure its stress testing activities to ensure they fit into the banking organization's overall risk management program. The purpose of the guidance is to outline broad principles for a satisfactory stress testing framework and describe the manner in which stress testing should be used, that is as an integral component of risk management applicable at various levels of aggregation within a banking organization as well as a tool for capital and liquidity planning. The 2012 Interagency Guidance recommends that IDIs stress test in coordination with their “overall strategy and annual planning cycles” and assess and review their stress testing frameworks at least once a year to ensure that stress testing coverage is comprehensive, tests are relevant and current, methodologies are sound, and results are properly considered.

The aspects of the 2012 Interagency Guidance that constitute an information collection are the provisions that state a banking organization should (1) have a stress testing framework that includes clearly defined objectives, well designed scenarios tailored to the banking organization's business and risks, well documented assumptions, conceptually sound methodologies to assess potential impact on the banking organization's financial condition (section II); (2) maintain an internal summary of test results to document at a high level the range of its stress testing activities and outcomes, as well as proposed follow-up actions (section III); and (3) have policies and procedures for a stress testing framework (section VI). There has been no change in the substance or methodology of this information collection. The 774 hour increase in total estimated annual burden from 5,726 hours in 2023 to 6,500 hours currently is due to the doubling of annual responses to ICs 1-3 and the increased number of respondents to IC 6 and is attenuated by the decreased number of respondents to ICs 4 and 5.

Comments are invited on (a) whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Title 5, U.S. Code, 4314(c)(4), requires that the appointment of Performance Review Board members be published in the Federal Register before Board service commences. The following persons will serve on the Federal Retirement Thrift Investment Board's Performance Review Board which will review initial summary ratings to ensure the ratings are consistent with established performance requirements, reflect meaningful distinctions among senior executives based on their relative performance and organizational results and provide recommendations for ratings, awards, and pay adjustments in a fair and equitable manner: Thomas Brandt, Gisile Goethe, James Kaplan, and Sean McCaffrey.

Under the Medicare Quality Payment Program, an eligible clinician who participates in an Advanced Alternative Payment Model (APM) and meets or exceeds the applicable payment amount or patient count thresholds for a performance period is a qualifying APM participant (QP) for that year. For payment years 2019 through 2026, which respectively correspond to the QP performance periods for 2017 through 2024, an eligible clinician who attains QP status for a year earns a lump sum APM incentive payment that is paid in the payment year. For payment years 2019 through 2024, the amount of the APM incentive payment is equal to 5 percent of the estimated aggregate paid amounts for covered professional services furnished by the QP during the calendar year immediately preceding the payment year. For the 2023 performance year and 2025 payment year Congress, via section 4111 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), reduced the APM incentive payment from 5 percent to 3.5 percent. For the 2024 performance year and 2026 payment year the APM incentive payment is reduced from 3.5 percent to 1.88 percent.

The Centers for Medicare & Medicaid Services (CMS) has identified those eligible clinicians who attained QP status in the 2023 performance period and earned a 3.5 percent APM incentive payment for the 2025 payment year based on aggregate paid amounts for the covered professional services they furnished in the calendar year (CY) 2024 base period.

When the 2025 APM incentive payments were processed, CMS was unable to identify the taxpayer identification number (TIN) or TINs associated with some QPs and therefore was unable to disburse the payments. To successfully issue the APM incentive payment for the 2025 payment year, CMS is requesting assistance identifying current Medicare billing information for these under 42 CFR 414.1450(c)(8), if we have not identified any TIN associated with the QP to which we can make the APM Incentive Payment, we will attempt to contact the QP via a public notice to request their Medicare payment information.

CMS has compiled a list of QPs for whom we were unable to identify any associated TIN to which we can make the APM incentive payment. These QPs, and any others who anticipated receiving an APM Incentive Payment but have not, should follow the instructions to provide CMS with updated Medicare billing information at the following web address: https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/3369/2025%20QP%20Notice%20for%20APM%20Incentive%20Payment.zip.

If you have any questions concerning submission of information through the QPP website, please contact the Quality Payment Program Help Desk at 1-866-288-8292.

In accordance with 42 CFR 414.1450(c)(8), all information must be received by September 1, 2025. After that date, any claim to an APM incentive payment for the 2025 payment period based on an eligible clinician's QP status for the 2023 QP performance period will be forfeited. To facilitate payment, please include all required documentation as specified in the previous link. If CMS is still unable to process the APM incentive payment based on the Medicare billing information received in response to this advisory, the submitter will not be notified.

CMS will hold all timely submitted information and process the remaining 2025 APM incentive payments simultaneously as soon as possible after the deadline. It may take up to 3 months to complete the validation and verification process before these APM incentive payments are disbursed.

This advisory is intended to alert certain QPs that CMS is requesting assistance identifying current Medicare billing information so that we can disburse APM incentive payments. This request for follow-up information is exempt from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) as specified under implementing regulation 5 CFR 1320.3(h)(9) with regard to the clarification of responses.

The Administrator of the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz, having reviewed and approved this document, authorizes Chyana Woodyard, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Section 806 of the FD&C Act (21 U.S.C. 384b) directs FDA to establish a program to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program, and a process, consistent with section 808 of the FD&C Act (21 U.S.C. 384d), for the issuance of a facility certification to accompany a food offered for importation by importers participating in VQIP.

Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees from each importer participating in VQIP to cover FDA's costs of administering the program. Each fiscal year, fees are to be established based on an estimate of 100 percent of the costs for the year (section 743(b)(2)(A)(iii) of the FD&C Act). The fee rates must be published in a Federal Register notice not later than 60 days before the start of each fiscal year (section 743(b)(1) of the FD&C Act). After FDA approves a VQIP application, the user fee is to be paid before October 1, the start of the VQIP fiscal year, to begin receiving benefits for that VQIP fiscal year.

The FY 2026 VQIP user fee will support benefits from October 1, 2025, through September 30, 2026.

FDA estimates 100 percent of its costs for each activity to establish fee rates for FY 2026 (see section 743(b)(2)(A) of the FD&C Act).

Full-time Equivalent (FTE) reflects the total number of regular straight-time hours—not including overtime or holiday hours—worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered “hours worked” for purposes of defining FTE employment.

In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an FDA-wide total cost per FTE requires three primary cost elements: payroll, non-payroll, and rent.

We used an average of past year cost elements to predict the FY 2026 cost. The FY 2026 FDA-wide average cost for payroll (salaries and benefits) is $225,917; non-payroll—including equipment, supplies, IT, general and administrative overhead—is $116,581; and rent, including cost allocation analysis and adjustments for other rent and rent-related costs, is $24,627 per paid staff year, excluding travel costs.

Summing the average cost of an FTE for payroll, non-payroll, and rent, brings the FY 2026 average fully supported cost to $367,125 (total includes rounding) per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for VQIP fees for FY 2026 before including domestic or foreign travel costs as applicable for the activity.

To calculate an hourly rate, we divide the FY 2026 average fully supported cost of $367,125 per FTE by the average number of supported direct FDA work hours in FY 2024—the last FY for which data are available. See table 1.

Dividing the average fully supported FTE cost in FY 2026 ($367,125) by the total number of supported direct work hours available for assignment in FY 2024 (1,160) results in an average fully supported cost of $316 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2026.

To adjust the hourly rate for FY 2026, FDA estimates the cost of inflation in each year for FYs 2025 and 2026. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) of the FD&C Act (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2025 inflation rate to be 4.1167 percent; this rate was published in the FY 2025 PDUFA user fee rates notice in the Federal Register (July 31, 2024, 89 FR 61474). Using the method set forth in section 736(c)(1) of the FD&C Act, FDA calculated an inflation rate of 4.1167 percent for FY 2025 and 5.0313 percent for FY 2026, and FDA intends to use these inflation rates to make inflation adjustments for FY 2026.

In FY 2024, FDA's Office of Regulatory Affairs (ORA) spent a total of $7,498,059 for domestic regulatory inspection travel costs and General Services Administration Vehicle costs related to FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field activities programs. The total ORA domestic travel costs spent is then divided by the 7,851 CFSAN and CVM domestic inspections, which averages a total of $955 per inspection. These inspections average 45.09 hours per inspection. Dividing $955 per inspection by 45.09 hours per inspection results in a total and an additional cost of $21 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2024. To adjust for the $21 per hour additional domestic cost inflation increases for FY 2025 and FY 2026, FDA multiplies the FY 2025 PDUFA inflation rate adjustor (1.041167) by the FY 2026 PDUFA inflation rate adjustor (1.050313) times the $21 additional domestic cost, which results in an estimated cost of $23 (rounded to the nearest dollar) per paid hour in addition to $316 for a total of $339 per paid hour ($316 plus $23) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2026 when domestic travel is required.

In FY 2024, ORA spent a total of $3,209,026 on 487 foreign inspection trips related to FDA's CFSAN and CVM field activities programs, which averaged a total of $6,589 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,589 per trip by 120 hours per trip results in a total and an additional cost of $55 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2024. To adjust $55 for inflationary increases in FY 2025 and FY 2026, FDA multiplies it by the same inflation factors mentioned previously in this document (1.041167 and 1.050313), which results in an estimated cost of $60 (rounded to the nearest dollar) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2026 when foreign travel is required.

FDA assesses fees for VQIP annually. Table 3 provides an overview of the fees for FY 2026.

Section 743 of the FD&C Act requires that each importer participating in VQIP pay a fee to cover FDA's costs of administering the program. This fee represents the estimated average cost of the work FDA performs in reviewing and evaluating a VQIP importer. At this time, FDA is not offering an adjusted fee for small businesses. As required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA published guidelines in consideration of the burden of the VQIP fee on small businesses and provided for a period of public comment on the guidelines (80 FR 32136, June 5, 2015). While we received some comments, the comments did not address the questions posed (that is, how a small business fee reduction should be structured, what percentage of fee reduction would be appropriate, or what alternative structures FDA might consider to indirectly reduce fees for small businesses by charging different fee amounts to different VQIP participants). Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, if we determine to provide for a small business fee reduction, we will adjust the fee schedule for small businesses only through notice and comment rulemaking.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. These estimates represent FDA's current thinking, and as the program evolves, FDA will reconsider the estimated hours. We estimate that it would take, on average, 39 person-hours to review a new VQIP application (including communication provided through the VQIP Importer's Help Desk), 28 person-hours to review a returning VQIP application (including communication provided through the VQIP Importer's Help Desk), 16 person-hours for an onsite performance evaluation of a domestic VQIP importer (including travel and other steps necessary for a fully supported FTE to complete and document an onsite assessment), and 34 person-hours for an onsite performance evaluation of a foreign VQIP importer (including travel and other steps necessary for a fully supported FTE to complete and document an onsite assessment).

Based on updated data, FDA anticipates that there may be up to seven returning VQIP applicants and up to two new applicants this fiscal year. FDA employees are likely to review new VQIP applications from their worksites, so we use the fully supported FTE hourly rate excluding travel, $316/hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (39 hours) = $12,324. FDA employees are likely to review returning VQIP applications from their worksites, so we use the fully supported FTE hourly rate excluding travel, $316/hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (28 hours) = $8,848.

FDA employees may conduct a VQIP inspection to verify the eligibility criteria and full implementation of the food safety and food defense systems established in the Quality Assurance Program. For FY 2026, FDA does not anticipate conducting dedicated VQIP inspections and will instead use existing inspection programs (such as the Foreign Supplier Verification Program and Hazard Analysis and Critical Control Point regulations) for program participants.

FDA employees are likely to prepare for and report on the performance evaluation of a domestic VQIP importer at an FTE's worksite, so we use the fully supported FTE hourly rate excluding travel, $316/hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (8 hours) = $2,528. For the portion of the fee covering onsite evaluation of a domestic VQIP importer, we use the fully supported FTE hourly rate for work requiring domestic travel, $339/hour, to calculate the portion of the user fee attributable to those activities: $339/hour × 8 hours ( i.e., one fully supported FTE × (1 day onsite × 8 hours)) = $2,712. Therefore, the total cost of conducting the domestic performance evaluation of a VQIP importer is determined to be $2,528 + $2,712 = $5,240.

Coordination of the onsite performance evaluation of a foreign VQIP importer is estimated to take place at an FTE's worksite, so we use the fully supported FTE hourly rate excluding travel, $316/hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (10 hours) = $3,160. For the portion of the fee covering onsite evaluation of a foreign VQIP importer, we use the fully supported FTE hourly rate for work requiring foreign travel, $376/hour, to calculate the portion of the user fee attributable to those activities: $376/hour × 24 hours ( i.e., one fully supported FTE × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $9,024. Therefore, the total cost of conducting the foreign performance evaluation of a VQIP importer is determined to be $3,160 + $9,024 = $12,184.

Therefore, the estimated average cost of the work FDA performs in total for approving an application for a VQIP importer in FY 2026 based on these figures would be ($12,324 × 2/9 ) + ($8,848 × 7/9 ) = $9,620.

Section 743(a)(1)(C) of the FD&C Act requires FDA to assess and collect user fees from each importer participating in VQIP. An invoice will be sent to VQIP importers approved to participate in the program. Payment are to be made before October 1, 2025, to be eligible for VQIP participation for the benefit year beginning October 1, 2025. FDA will not refund the VQIP user fee for any reason.

The payments are to be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred payment method is online using an electronic check (via the U.S. Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. ( Note: only full payments are accepted. No partial payments can be made online.) Once you have found your invoice, select “Pay Now” to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available only for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments are to be made using U.S. bank accounts as well as U.S. credit cards.

When paying by wire transfer, the invoice number should be included; without the invoice number the payment may not be applied. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, the fee should be added to the payment to ensure that the invoice is paid in full. For international wire transfers, please inquire with the financial institutions prior to submitting the payment. Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name: Food and Drug Administration, Account No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33.

The tax identification number of FDA is 53-0196965.

The consequences of not paying these fees are outlined in Section J of our Guidance for Industry, “FDA's Voluntary Qualified Importer Program” (November 2024) (available at https://www.fda.gov/media/92196/download ). If the user fee is not paid before October 1, a VQIP importer will not be eligible to participate in VQIP. For the first year a VQIP application is approved, if the user fee is not paid before October 1, 2025, you are not eligible to participate in VQIP. If you subsequently pay the user fee, FDA will begin your benefits after we receive the full payment. The user fee may not be paid after December 31, 2025. For a subsequent year, if you do not pay the user fee before October 1, FDA will send a Notice of Intent to Revoke your participation in VQIP. If you do not pay the user fee within 30 days of the date of the Notice of Intent to Revoke, we will revoke your participation in VQIP.

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h) establish two different kinds of user fees. Fees are assessed as follows: (1) application fees are assessed on certain types of applications for the review of human drug and biological products and (2) prescription drug program fees are assessed on certain approved products (section 736(a) of the FD&C Act). The statute also includes conditions under which such fees may be waived or reduced (section 736(d) of the FD&C Act), or under which fee exceptions, refunds, or exemptions apply (sections 736(a)(1)(C) through (H), 736(a)(2)(B) through (C), and 736(k) of the FD&C Act).

For FY 2023 through FY 2027, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA VII. The base revenue amount for FY 2026 is $1,434,377,467. The FY 2026 base revenue amount is adjusted for (1) inflation, (2) strategic hiring and retention, and for (3) the resource capacity needs for the process for the review of human drug applications (the capacity planning adjustment (CPA). This amount is further adjusted to include the additional dollar amount as specified in the statute (see section 736(b)(1)(G) of the FD&C Act) to provide for additional full-time equivalent (FTE)  1 positions to support PDUFA VII initiatives. If applicable, an operating reserve adjustment is added to provide sufficient operating reserves of carryover user fees. The amount from the preceding adjustments is then adjusted to provide for additional direct costs to fund PDUFA VII initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue (see section 736(b)(2) of the FD&C Act).

This document provides fee rates for FY 2026 for an application requiring covered clinical data  2 ($4,682,003), for an application not requiring covered clinical data ($2,341,002), and for the prescription drug program fee ($442,213). These fees are effective on October 1, 2025, and will remain in effect through September 30, 2026. For applications that are submitted on or after October 1, 2025, the new fee schedule must be used.

The base revenue amount for FY 2026 is $1,434,377,467 (see section 736(b)(1)(A) and (b)(3) of the FD&C Act). This amount is prior to any adjustments made for inflation, the strategic hiring and retention adjustment, CPA, additional dollar amount, operating reserve adjustment (if applicable), and additional direct costs (see section 736(b)(1) of the FD&C Act).

PDUFA VII specifies that the $1,434,377,467 is to be adjusted for inflation increases for FY 2026 using two separate adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 736(c)(1) of the FD&C Act).

The component of the inflation adjustment for payroll costs is the average annual percent change in the cost of all PC&B paid per FTE positions at FDA for the first 3 of the preceding 4 fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of human drug applications for the first 3 of the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(i) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified fiscal years, provides the percent changes from the previous fiscal years, and provides the average percent changes over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

The statute specifies that this 5.4494 percent be multiplied by the proportion of PC&B costs to the total FDA costs of the process for the review of human drug applications. Table 2 shows the PC&B and the total obligations for the process for the review of human drug applications for the first 3 of the preceding 4 fiscal years.

The payroll adjustment is 5.4494 percent from table 1 multiplied by 62.9725 percent from table 2 resulting in 3.4316 percent.

The statute specifies that the portion of the inflation adjustment for non-payroll costs is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(ii)). Table 3 provides the summary data for the percent changes in the specified CPI for the Washington-Arlington-Alexandria area. 3

The statute specifies that this 4.3202 percent be multiplied by the proportion of all costs other than PC&B to total costs of the process for the review of human drug applications obligated. Because 62.9725 percent was obligated for PC&B (as shown in table 2), 37.0275 percent is the portion of costs other than PC&B (100 percent minus 62.9725 percent equals 37.0275 percent). The non-payroll adjustment is 4.3202 percent times 37.0275 percent, or 1.5997 percent.

Next, we add the payroll adjustment (3.4316 percent) to the non-payroll adjustment (1.5997 percent), for a total inflation adjustment of 5.0313 percent (rounded) for FY 2026.

We then multiply the base revenue amount for FY 2026 ($1,434,377,467) by 5.0313 percent, which produces an inflation adjustment amount of $72,167,833. Adding this amount to the base revenue amount yields an inflation-adjusted base revenue amount of $1,506,545,300.

For each fiscal year, after the annual base revenue established in section II is adjusted for inflation in accordance with section II.A, the statute directs FDA to further increase the fee revenue and fees to support strategic hiring and retention. For FY 2026, this amount is $4,000,000 (see section 736(c)(2)(A) of the FD&C Act).

The statute specifies that after the base revenue amount for FY 2026 of $1,434,377,467 has been adjusted as described in sections II.A and II.B, this amount shall be further adjusted to reflect changes in the resource capacity needs for the process of human drug application reviews (see section 736(c)(3) of the FD&C Act). Following a process agreed upon by FDA and industry during PDUFA VI reauthorization discussions and subsequently required in statute, FDA established a new CPA methodology and first applied it in the setting of FY 2021 fees. The establishment of this methodology is described in the Federal Register of August 3, 2020 (85 FR 46651). This methodology includes a continuous, iterative improvement approach, under which the Agency intends to refine its data and estimates for the core review activities to improve their accuracy over time. An adjustment for workload has been a critical aspect of the PDUFA program since PDUFA III in FY 2003 as it enables the program to adjust to shifts in review workload resulting from industry submissions to the Agency. The annual adjustment process allows greater accuracy than would be expected if workload adjustments were fixed at the start of the reauthorization period. The CPA is an evolution of the PDUFA workload adjuster and was implemented through a process agreed to by FDA and industry during PDUFA VI. The CPA builds on the concepts of the workload adjuster but realizes enhancements including the use of leading indicators of workload, use of full-time reporting data, the introduction of a managerial adjustment process as an internal check on the reasonableness of any adjustment, outputs measured in full-time equivalent employees, and the incorporation of adjustments into the base revenue amounts to ensure sustainability of payroll to support any new hires.

The CPA methodology includes four steps:

1. Forecast workload volumes: predictive models estimate the volume of workload for the upcoming FY.

2. Forecast the resource needs: forecast algorithms are generated utilizing time reporting data. These algorithms estimate the required demand in FTEs for direct review-related effort. This is then compared to current available resources for the direct review related workload.

3. A managerial adjustment to assess the resource forecast in the context of additional internal factors: program leadership examines operational, financial, and resourcing data to assess whether FDA will be able to utilize additional funds during the FY, and whether the funds are required to support additional review capacity. FTE amounts are adjusted, if needed.

4. Convert the FTE need to dollars: utilizing FDA's fully loaded FTE cost model, the final feasible FTEs are converted to an equivalent dollar amount.

FDA calculated workload models for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Fall of 2024.

Table 6 summarizes the forecasted workload volumes for CDER in FY 2026 based on predictive models, as well as historical actuals from FY 2024 for comparison.

Table 7 summarizes the forecasted workload volumes for CBER in FY 2026 based on predictive models, as well as the corresponding historical actuals from 2024 for comparison.

FDA anticipates that any FTE gains could be funded through the expected FY 2026 collections amount without further adjustment from the CPA. As such, FDA determined that in FY 2026 the PDUFA fee amounts do not need adjustment from the CPA to provide funds for the program.

PDUFA VII provides an additional dollar amount for each of the 5 fiscal years covered by PDUFA VII for additional FTEs to support enhancements outlined in the PDUFA VII commitment letter. The additional dollar amount for FY 2026 as outlined in statute is $4,864,860 (see section 736(b)(1)(G)(iv) of the FD&C Act). This amount will be added to the total FY 2026 PDUFA VII revenue amount.

PDUFA VII provides for an operating reserve adjustment that may result in an increase or decrease in fee revenue and fees for a given FY (see section 736(c)(4) of the FD&C Act). For FY 2026, FDA is required to further increase fee revenue and fees if an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees (see section 736(c)(4)(A)(iii) of the FD&C Act). If FDA has carryover balances of user fees in excess of 14 weeks of operating reserves, FDA is required to decrease fee revenue and fees to provide for not more than 14 weeks of operating reserves of carryover user fees (see section 736(c)(4)(B) of the FD&C Act).

To determine the dollar amounts for the 10-week and 14-week operating reserve thresholds, the adjustments (inflation, strategic hiring and retention, capacity planning, and additional dollar amount) discussed in sections II.A, II.B, II.C, and II.D are applied to the FY 2026 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting in $1,515,410,160. This amount is then divided by 52 to generate the 1-week operating amount of $29,142,503. The 1-week operating amount is then multiplied by 10 and 14. This results in a 10-week threshold amount of $291,425,030 and a 14-week threshold amount of $407,995,042.

To determine the FY 2025 end-of-year operating reserves of carryover user fees, the Agency assessed the operating reserve of carryover fees at the end of June 2025 and forecasted collections and obligations in the fourth quarter of FY 2025 combined. This provides an estimated end-of-year FY 2025 operating reserve of carryover user fees of $299,623,185, which equates to 10.28 weeks of operations. 4

Because the estimated FY 2025 end-of-year operating reserves of carryover user fees are within the 10-week and 14-week thresholds, FDA will not increase or reduce the FY 2026 fees or fee revenue under the statutory provision for operating reserve adjustments.

PDUFA VII specifies that an additional direct cost of $40,627,674 is to be added to the total FY 2026 PDUFA revenue amount (see section 736(c)(5)(ii) of the FD&C Act). With respect to target revenue for FY 2026, adding the additional direct cost amount of $40,627,674 to the inflation, strategic hiring and retention, CPA, additional dollar amount, and operating reserve adjustment results in the total revenue amount of $1,556,038,000 (rounded to the nearest thousand dollars).

Application fees will be set to generate 20 percent of the total revenue amount, amounting to $311,207,600 in FY 2026.

FDA has estimated the total number of fee-paying full application equivalents (FAEs) it expects to receive during the next fiscal year by averaging the number of fee-paying FAEs received in the ten most recently completed fiscal years. For FY 2026 fee setting, the 10 relevant fiscal years are FY 2015-2024. Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the fiscal year. 5

In estimating the number of fee-paying FAEs, an application requiring covered clinical data  6 counts as one FAE. An application not requiring covered clinical data counts as one-half of an FAE. An application that is withdrawn before filing, or refused for filing, counts as one-fourth of an FAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant initially paid one-half of the full application fee amount.

As table 13 shows, the average number of fee-paying FAEs received annually in FY 2015 through FY 2024 is 66.469. FDA will set fees for FY 2026 based on this estimate as the number of full application equivalents that will be subject to fees.

The FY 2026 application fee is estimated by dividing the average number of full applications that paid fees from FY 2015 through FY 2024, 66.469, into the fee revenue amount to be derived from application fees in FY 2026, $311,207,600. The result is a fee of $4,682,003 per full application requiring clinical data, and $2,341,002 per application not requiring clinical data.

PDUFA VII assesses prescription drug program fees for certain prescription drug products. Program fees will be set to generate 80 percent of the total target revenue, amounting to $1,244,830,400 in FY 2026.

An applicant will not be assessed more than five program fees for a FY for prescription drug products identified in a single approved NDA or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are assessed a program fee for a FY for user fee eligible prescription drug products identified in a human drug application approved as of October 1 of such FY. Additionally, applicants are assessed a program fee for a product that is not a prescription drug product on October 1 because it is included in the discontinued section of the Orange Book or the CDER/CBER Billable Biologics List on that date, if the product becomes a fee-eligible prescription drug product during the FY.

FDA estimates 2,971 program fees will be invoiced in FY 2026 before factoring in waivers, refunds, exceptions, and exemptions. FDA approximates that there will be 97 waivers and refunds granted. Additionally, FDA approximates that another 59 program fees will be exempted in FY 2026 based on the orphan drug exemption in section 736(k) of the FD&C Act.

FDA estimates 2,815 program fees in FY 2026, after allowing for an estimated 156 waivers and reductions, including the orphan drug exemptions, excepted and exempted fee-liable products. The FY 2026 prescription drug program fee rate is calculated by dividing the adjusted total revenue from program fees ($1,244,830,400) by the estimated 2815 program fees, resulting in a FY 2026 program fee of $442,213 (rounded to the nearest dollar).

The fee rates for FY 2026 are displayed in table 14.

The appropriate application fee established in the new fee schedule must be paid for any application subject to fees under PDUFA VII that is submitted on or after October 1, 2025. To pay, complete the Prescription Drug User Fee Cover Sheet, available at https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp, and generate a user fee identification (ID) number. Payment must be made in U.S. currency by electronic check or wire transfer. 7 The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express).

FDA has partnered with the U.S. Department of the Treasury to use Pay.gov , a web-based payment application, for online electronic payment. The Pay.gov feature is available on FDA's website after completing the Prescription Drug User Fee Cover Sheet and generating the user fee ID number. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay ( Note: only full payments are accepted. No partial payments can be made online). Once an invoice is located, “Pay Now” should be selected to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID number, the payment may not be applied, which could result in FDA not filing an application and other penalties. Note: the originating financial institution may charge a wire transfer fee, especially for international wire transfers. Applicable wire transfer fees must be included with payment to ensure fees are paid in full. Questions about wire transfer fees should be addressed to the financial institution. The account information for wire transfers is as follows: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-0196965.

FDA will issue invoices and payment instructions for FY 2026 program fees under the new fee schedule in August 2025. Under section 736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are due on October 1, 2025.

FDA will issue invoices in December 2026 for products that qualify for FY 2026 program fee assessments after the October 2025 billing.

To qualify for consideration for a waiver or reduction under section 736(d) of the FD&C Act, an exemption under section 736(k) of the FD&C Act, or the return of an application or program fee paid under section 736 of the FD&C Act, including if the fee is claimed to have been paid in error, a person must submit to FDA a written request justifying such waiver, reduction, exemption or return not later than 180 days after such fee is due (section 736(i) of the FD&C Act). A request submitted under this paragraph must include any legal authorities under which the request is made.

Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51, 379j-52, and 379j-53), as amended by BsUFA III, authorize the collection of fees for biosimilar biological products. Under section 744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due when the sponsor submits an investigational new drug (IND) application that FDA determines is intended to support a biosimilar biological product application or within 7 calendar days after FDA grants the first BPD meeting, whichever occurs first. A sponsor who has paid the initial BPD fee is considered to be participating in FDA's BPD program for that product.

Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has paid the initial BPD fee for a product, the annual BPD fee is assessed beginning with the next fiscal year. The annual BPD fee is assessed for the product each fiscal year until the sponsor submits a marketing application for the product that is accepted for filing, the sponsor discontinues participation in FDA's BPD program for the product, or the sponsor has been administratively removed from the BPD program for the product.

Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has discontinued participation in FDA's BPD program or has been administratively removed from the BPD program for a product and wants to reengage with FDA on development of the product, the sponsor must pay all annual BPD fees previously assessed for such product and still owed, and a reactivation fee to resume participation in the program. The sponsor must pay the reactivation fee by the earlier of the following dates: (1) no later than 7 calendar days after FDA grants the sponsor's request for a BPD meeting for that product or (2) upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for that product. The sponsor will be assessed an annual BPD fee beginning in the next fiscal year after payment of the reactivation fee.

BsUFA III also authorizes fees for certain biosimilar biological product applications and for each biosimilar biological product identified in an approved biosimilar biological product application (section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions, FDA will grant a small business a waiver of the biosimilar biological product application fee (section 744H(d)(1) of the FD&C Act).

For FY 2023 through FY 2027, the base revenue amounts for the total revenues from all BsUFA fees are established by BsUFA III. For FY 2026, the base revenue amount is the FY 2025 total revenue amount excluding any operating reserve adjustment, which equates to the amount of $56,011,943. The FY 2026 base revenue amount is to be adjusted by the inflation adjustment, strategic hiring and retention adjustment, capacity planning adjustment (CPA), operating reserve adjustment, and the additional dollar amount. Each of these adjustments will be discussed in the sections below.

This document provides fee rates for FY 2026 for the initial and annual BPD fee ($10,000), for the reactivation fee ($20,000), for an application requiring clinical data ($1,200,794) for an application not requiring clinical data ($600,397) and for the program fee ($209,097). These fees are effective on October 1, 2025, and will remain in effect through September 30, 2026. For applications that are submitted on or after October 1, 2025, the new fee schedule must be used.

The base revenue amount for FY 2026 is $56,011,943 prior to adjustments for inflation, strategic hiring and retention, capacity planning, operating reserves, and the additional dollar amount (see section 744H(b) and (c) of the FD&C Act).

BsUFA III specifies that the $56,011,943 is to be adjusted for inflation increases for FY 2026 using two separate adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 744H(c)(1) of the FD&C Act).

The component of the inflation adjustment for payroll costs shall be the average annual percent change in the cost of all PC&B paid per full-time equivalent (FTE  1 ) positions at FDA for the first 3 of the preceding 4 fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of biosimilar biological product applications for the first 3 of the preceding 4 fiscal years (see section 744H(c)(1)(B) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified fiscal years and provides the percent changes from the previous fiscal years and the average percent changes over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

The statute specifies that this 5.4494 percent be multiplied by the proportion of PC&B costs to the total FDA costs of the process for the review of biosimilar biological product applications. Table 2 shows the PC&B and the total obligations for the process for the review of biosimilar biological product applications for the first 3 of the preceding 4 fiscal years.

The payroll adjustment is 5.4494 percent from table 1 multiplied by 54.5437 percent (or 2.9723 percent).

The statute specifies that the portion of the inflation adjustment for nonpayroll costs is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; not seasonally adjusted; all items; annual index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than PC&B costs to total costs of the process for the review of biosimilar biological product applications for the first 3 years of the preceding 4 fiscal years (see section 744H(c)(1)(B) of the FD&C Act). Table 3 provides the summary data for the percent changes in the specified CPI for the Washington-Arlington-Alexandria area. 2

The statute specifies that this 4.3202 percent be multiplied by the proportion of all costs other than PC&B to total costs of the process for the review of biosimilar biological product applications obligated. Since 54.5437 percent was obligated for PC&B (as shown in table 2), 45.4563 percent is the portion of costs other than PC&B (100 percent minus 54.5437 percent equals 45.4563 percent). The non-payroll adjustment is 4.3202 percent times 45.4563 percent, 1.9638 percent.

Next, we add the payroll adjustment (2.9723 percent) to the nonpayroll adjustment (1.9638 percent), for a total inflation adjustment of 4.9361 percent (rounded) for FY 2026.

We then multiply the base revenue amount for FY 2026 ($56,011,943) by the inflation adjustment percentage (4.9361 percent), yielding an inflation adjustment of $2,764,806. Adding this amount yields an inflation-adjusted amount of $58,776,749.

The statute specifies that for each fiscal year, after the annual base revenue is adjusted for inflation, FDA shall further increase the fee revenue and fees by the strategic hiring and retention adjustment, which is $150,000 for FY 2026 (see section 744H(c)(2) of the FD&C Act).

The statute specifies that the fee revenue and fees shall be further adjusted to reflect changes in the resource capacity needs for the process for the review of biosimilar biological product applications (see section 744H(c)(3) of the FD&C Act). Following a process agreed upon by FDA and industry during BsUFA II reauthorization discussions and subsequently required in statute, FDA established the capacity planning adjustment methodology and first applied it in the setting of FY 2021 fees. The establishment of this methodology is described in the Federal Register at 85 FR 47220. This methodology includes a continuous, iterative improvement approach, under which the Agency intends to refine its data and estimates for the core review activities to improve their accuracy over time.

The CPA methodology consists of four steps:

1. Forecast workload volumes: predictive models estimate the volume of workload for the upcoming FY.

2. Forecast the resource needs: forecast algorithms are generated utilizing time reporting data. These algorithms estimate the required demand in FTEs for direct review-related effort. This is then compared to current available resources for the direct review-related workload.

3. A managerial adjustment to assess the resource forecast in the context of additional internal factors: program leadership examines operational, financial, and resourcing data to assess whether FDA will be able to utilize additional funds during the fiscal year and whether the funds are required to support additional review capacity. FTE amounts are adjusted, if needed.

4. Convert the FTE need to dollars: utilizing FDA's fully loaded FTE cost model, the final feasible FTEs are converted to an equivalent dollar amount.

Table 4 summarizes the forecasted workload volumes for BsUFA III in FY 2026 based on predictive models, as well as historical actuals from FY 2024 for comparison.

FDA anticipates that any FTE gains could be funded through the expected FY 2026 collections amount without further adjustment from the CPA. As such, FDA determined that in FY 2026 the BsUFA fee amounts do not need adjustment from the CPA to provide funds for the program.

For FY 2023 and FY 2024, BsUFA III provided an additional dollar amount for additional FTE for the biosimilar biological product review program to support enhancements outlined in the BsUFA III Commitment Letter. For FY 2025, FY 2026, and FY 2027, no additional amount is specified in statute.

BsUFA III sets forth an operating reserve adjustment to the fee revenue and fees. Specifically, for FY 2026, the statute directs FDA: (1) to increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications and (2) if FDA has carryover balances for such process in excess of 21 weeks of such operating reserves, to decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves (see section 744H(c)(4) of the FD&C Act).

To calculate the 10-week and 21-week threshold amounts for the FY 2026 operating reserve adjustment, the estimated adjusted revenue amount ( i.e., the base revenue amount and adjustments prior to the operating reserve adjustment), $58,926,749 is divided by 52, resulting in a $1,133,207 cost of operation for 1 week (rounded to the nearest dollar). The 1-week value ($1,133,207) is then multiplied by 10 weeks to generate the 10-week operating reserve threshold amount for FY 2026 of $11,332,067. The 1-week value is multiplied by 21 to generate the 21-week operating reserve threshold amount for FY 2026 of $23,797,341.

To calculate the estimated operating reserve of carryover user fees at the end of FY 2025, FDA estimated the operating reserves of carryover fees at the end of June 2025. The balance of operating reserves of carryover fees at the end of June 2025 is combined with the forecasted collections and obligations for the remainder of FY 2025 to generate a full year estimate for FY 2025. The estimated operating reserve of carryover user fees at the end of FY 2025 is $26,883,182.

The estimated operating reserve of carryover user fees at the end of FY 2025 of $26,883,182 is above the 21-week threshold allowable operating reserve of carryover user fees for FY 2026 of $23,797,341. As such, FDA is applying a downward operating reserve adjustment of $3,085,841 (rounded to the nearest dollar), an amount equivalent to a reduction of approximately 2.72 weeks of operations, to bring the operating reserve of carryover user fees to $23,797,341 or 21 weeks of operations at the start of FY 2026. With this operating reserve adjustment, the estimated adjusted revenue amount of $58,926,749 will be lowered by $3,085,841, yielding the FY 2026 target revenue amount of $55,841,000 (rounded to the nearest thousand), summarized below.

Under section 744H(b)(2)(A) of the FD&C Act, FDA must determine the percentage of the total revenue amount for a fiscal year to be derived from: (1) initial and annual BPD fees, and reactivation fees; (2) biosimilar biological product application fees; and (3) biosimilar biological product program fees. As described above, a downward operating reserve adjustment is required for FY 2026. The operating reserve adjustment in subsequent years may not be as large. As such, the target revenue in FY 2026 may be lower than in prior or future years, and thereby the fee amounts may also be lower than in prior or future years.

To calculate the biosimilar biological product application fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2026. A filed original 351(k) BLA with clinical data counts as one FAE. A filed original 351(k) BLA without clinical data counts as one-half of an FAE. An original 351(k) BLA that is refused to file (RTF) or withdrawn before filing (WD), counts as one-fourth of an FAE if the application required clinical data, or one-eighth of an FAE if the application did not require clinical data. After an original 351(k) BLA has been RTF or WD, the applicant has the option of resubmitting. For user fee purposes, these resubmitted original 351(k) BLAs are equivalent to original 351(k) BLA submissions. Filed original 351(k) BLA resubmissions are charged the full amount for an application with clinical data (one FAE) or without clinical data (one-half FAE). Additionally, a filed original 351(k) BLA with or without clinical data that is granted a small business waiver (SBW) from the application fee counts as zero FAE.

As discussed in II.C above, FDA estimates that 17 original 351(k) BLAs will be submitted in FY 2026. Based on recent years' data regarding SBWs, original 351(k) BLAs with or without clinical data, original 351(k) BLAs that are RTF or WD, and considering that some of these applications may be resubmitted in the same fiscal year, it is assumed that the 17 submissions will equate to 16 FAEs.

For FY 2026 the biosimilar biological product application fee for applications requiring clinical data is $1,200,794. Applications not requiring clinical data pay half that fee, or $600,397. This is estimated to provide a total of $19,212,704 representing 34 percent (rounded to the nearest whole number) of the FY 2026 target revenue amount.

Under BsUFA III, FDA assesses biosimilar biological product program fees (“program fees”). An applicant in a biosimilar biological product application shall not be assessed more than five program fees for a fiscal year for biosimilar biological products identified in a single biosimilar biological product application (see section 744H(a)(3)(D) of the FD&C Act). Applicants are assessed a program fee for a fiscal year for biosimilar biological products that are identified in a biosimilar biological product application approved as of October 1 of such fiscal year; that may be dispensed only under prescription pursuant to section 503(b) of the FD&C Act; and that, as of October 1 of such fiscal year, do not appear on a list developed and maintained by FDA of discontinued biosimilar biological products. An approved biosimilar biological product that appears on the list of discontinued biosimilar biological products as of October 1 of a fiscal year would also be assessed the program fee if it is removed from the discontinued list during the fiscal year and the other statutory criteria for fee assessment are satisfied (see section 744H(a)(3)(E)(iii) of the FD&C Act).

Based on available information, FDA estimates that 168 program fees will be invoiced for FY 2026. For products invoiced in the FY 2026 regular billing cycle, FDA anticipates that zero program fees will be refunded.

For FY 2026, the biosimilar biological product program fee is $209,097. This is estimated to provide a total of $35,128,296, representing 63 percent (rounded to the nearest whole number) of the FY 2026 target revenue amount.

To estimate the number of BPD fees to be paid in FY 2026, FDA must consider the number of new BPD programs, the number of current BPD programs, and the number of BPD programs that will be reactivated. These estimates provide information that, when aggregated, allows FDA to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).

FDA analyzed available data to estimate the total number of BPD programs for FY 2026. In FY 2026, FDA estimates approximately 30 new BPD programs, no reactivations (a single reactivation is weighted as two BPD fees), and approximately 120 BPD programs to pay the annual BPD fee, yielding a rounded total estimated equivalent of 150 BPD fees to be collected in FY 2026. The remainder of the target revenue of $1,500,000 or 3 percent is to be collected from the BPD fees. Dividing this amount by the estimated 150 BPD fees to be paid equals an initial BPD and annual BPD fee amount of $10,000 (rounded to the nearest dollar). The reactivation fee is set at twice the initial/annual BPD amount at $20,000 (rounded to the nearest dollar).

The fee rates for FY 2026 are displayed in table 7.

The fees established in the new fee schedule apply to FY 2026, i.e., the period from October 1, 2025, through September 30, 2026. The initial BPD fee for a product is due when the sponsor submits an IND that FDA determines is intended to support a biosimilar biological product application for the product or within 7 calendar days after FDA grants the first BPD meeting for the product, whichever occurs first. Sponsors who have discontinued participation in the BPD program for a product or have been administratively removed from the BPD program for a product, and seek to resume participation in the BPD program for the product must pay all annual BPD fees previously assessed for such product and still owed and the reactivation fee by the earlier of the following dates: no later than 7 calendar days after FDA grants the sponsor's request for a BPD meeting for that product, or upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for that product.

The application fee for a biosimilar biological product is due upon submission of the application (see section 744H(a)(2)(C) of the FD&C Act).

To make a payment of the initial BPD, reactivation, or application fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's website ( https://www.fda.gov/bsufa ) and https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp, and generate a user fee identification (ID) number. Payment must be made in U.S. currency by electronic check or wire transfer. 3 The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to use www.pay.gov, a web-based payment application, for online electronic payment. The www.pay.gov feature is available on the FDA website after the user fee ID number is generated. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay ( Note: only full payments are accepted. No partial payments can be made online). Once you search for your invoice, click “Pay Now” to be redirected to www.pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No: 75060099, Routing No: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-0196965.

FDA will issue invoices with payment instructions for FY 2026 annual BPD and program fees under the new fee schedule in August 2025. Under sections 744H(a)(1)(B)(ii) and 744H(a)(3)(B) of the FD&C Act, annual BPD and program fees will be due on October 1, 2025.

If sponsors join the BPD program after the annual BPD invoices have been issued in August 2025, FDA will issue invoices in December 2025 to sponsors subject to fees for FY 2026 that qualify for the annual BPD fee after the August 2025 billing. FDA will issue invoices in December 2026 for any products that qualify for the annual program fee after the August 2025 billing.

To qualify for consideration for a small business waiver under section 744H(d) of the FD&C Act, or the return of any fee paid under section 744H of the FD&C Act, including if the fee is claimed to have been paid in error, a person shall submit to FDA a written request justifying such waiver or return and, except as otherwise specified in section 744H of the FD&C Act, such written request shall be submitted to FDA not later than 180 days after such fee is due. Such written request shall include any legal authorities under which the request is made. See section 744H(h) of the FD&C Act.

The Arthritis Advisory Committee was established on April 5, 1974 (39 FR 14737-14738), to advise the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use in arthritic conditions, and as required, any other product for which FDA has regulatory responsibility. This Committee has met infrequently in recent years, and FDA has determined that the effort and expense of maintaining the Committee is no longer justified. This Committee is therefore terminated, effective on July 30, 2025, in accordance with 21 CFR 14.55. This notice is issued under the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92-463) (5 U.S.C. 1001 et seq. ). Elsewhere in this issue of the Federal Register, FDA is publishing a final rule announcing the removal of the Arthritis Advisory Committee from the Agency's list of standing advisory committees.

Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-42), as amended by GDUFA III, authorize FDA to assess and collect fees associated with human generic drug products. Fees are assessed on: (1) certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) certain DMFs associated with human generic drug products; and (4) generic drug applicants who own one or more approved ANDAs (the program fee) (see section 744B(a)(2) through (5) of the FD&C Act). For more information about GDUFA III, please refer to the FDA website ( https://www.fda.gov/gdufa ).

For FY 2026, the generic drug user fee rates are ANDA ($358,247), DMF ($102,584), domestic API facility ($43,549), foreign API facility ($58,549), domestic FDF facility ($238,943), foreign FDF facility ($253,943), domestic CMO facility ($57,346), foreign CMO facility ($72,346), large size operation generic drug applicant program ($1,918,377), medium size operation generic drug applicant program ($767,351), and small business generic drug applicant program ($191,838). These fees are effective on October 1, 2025, and will remain in effect through September 30, 2026. The fee rates for FY 2026 are set out in table 1.

Under section 744B(b)(1)(B)(ii) of the FD&C Act, the base revenue amount for FY 2026 for GDUFA III is $638,961,803. Under section 744B(c)(1) of the FD&C Act, applicable inflation adjustments to base revenue shall be made beginning with FY 2024.

Under section 744B(c)(2) of the FD&C Act, for FY 2026, FDA shall, in addition to the inflation adjustment, apply a capacity planning adjustment to further adjust, as needed, the fee revenue and fees to reflect changes in the resource capacity needs of FDA for human generic drug activities.

Under section 744B(c)(3) of the FD&C Act, for FY 2026, FDA may, in addition to the inflation and capacity planning adjustments, apply an operating reserve adjustment to further increase the fee revenue and fees if necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in such section (or as applicable, shall apply such adjustment to decrease the fee revenues and fees to provide for not more than 12 weeks of such operating reserves).

As noted above, the base revenue amount for FY 2026 is $638,961,803. This is the total revenue amount specified for the prior fiscal year, FY 2025, pursuant to the statute (see section 744B(b)(1)(A) of the FD&C Act). 1 GDUFA III specifies that the $638,961,803 is to be adjusted for inflation for FY 2026 using two separate adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see sections 744B(c)(1)(B) and (C) of the FD&C Act).

The component of the inflation adjustment for PC&B costs shall be the average annual percent change in the cost of all PC&B paid per full-time equivalent (FTE) positions at FDA for the first 3 of the 4 preceding fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of human generic drug activities for the first 3 of the preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).

Table 2 summarizes the actual cost and total FTEs for the specified fiscal years and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

The statute specifies that this 5.4494 percent should be multiplied by the proportion of PC&B expended for human generic drug activities for the first 3 of the preceding 4 fiscal years. Table 3 shows the amount of PC&B and the total amount obligated for human generic drug activities from FY 2022 through FY 2024.

The payroll adjustment is 5.4494 percent multiplied by 60.0519 percent (or 3.2725 percent).

The statute specifies that the portion of the inflation adjustment for non-PC&B costs for FY 2026 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria Area, DC-VA-MD-WV; not seasonally adjusted; all items; annual index) for the first 3 of the preceding 4 years of available data multiplied by the proportion of all costs other than PC&B costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years (see section 744B(c)(1)(C) of the FD&C Act). Table 4 provides the summary data for the percent change in the specified CPI. 2

To calculate the inflation adjustment for non-pay costs, we multiply the 3-year average percent change in the CPI (4.3202 percent) by the proportion of all costs other than PC&B to total costs of human generic drug activities obligated. Because 60.0519 percent was obligated for PC&B as shown in table 3, 39.9481 percent is the portion of costs other than PC&B. The non-pay adjustment is 4.3202 percent times 39.9481 percent, or 1.7258 percent.

To complete the inflation adjustment for FY 2026, we add the PC&B component (3.2725 percent) to the non-PC&B component (1.7258 percent) for a total inflation adjustment of 4.9983 percent (rounded), and then add 1, making an inflation adjustment multiple of 1.049983. We then multiply the base revenue amount for FY 2026 ($638,961,803) by 1.049983, yielding an inflation-adjusted amount of $670,899,031.

The statute specifies that after the base revenue amount for FY 2026 of $638,961,803 has been adjusted for inflation as described in section A above, the resulting amount shall be further adjusted to reflect changes in the resource capacity needs for human generic drug activities (see section 744B(c)(2) of the FD&C Act). Following a process required in the statute, FDA established the capacity planning adjustment (CPA) methodology that is derived from the methodology and recommendations made in the report titled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations” as announced in the Federal Register of August 3, 2020, and incorporating approaches and attributes determined appropriate by the Agency, except that the workload drivers are limited to those specified in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter). 3 This methodology includes a continuous, iterative improvement approach, under which the Agency intends to refine its data and estimates for the core review activities to improve the accuracy of its data and estimates over time. 4

The CPA methodology consists of four steps:

1. Forecast workload volumes: predictive models estimate the volume of workload for the upcoming FY.

2. Forecast the resource needs: forecast algorithms are generated utilizing time reporting data. These algorithms estimate the required demand in FTEs  5 for direct review-related effort. This is then compared to current available resources for the direct review-related workload.

3. A managerial adjustment to assess the resource forecast in the context of additional internal factors: program leadership examines operational, financial, and resourcing data to assess whether FDA will be able to utilize additional funds during the fiscal year, and whether the additional funds are required to support additional review capacity. FTE amounts are adjusted, if needed.

4. Convert the FTE need to dollars: utilizing FDA's fully loaded FTE cost model, the final feasible FTEs are converted to an equivalent dollar amount.

Table 5 summarizes the forecasted workload volumes for the Center for Drug Evaluation and Research (CDER) for FY 2026 based on predictive models, as well as historical actuals from FY 2024 for comparison.

FDA anticipates that any FTE gains could be funded through the expected FY 2026 collections amount without further adjustment from the CPA. As such, FDA determined that in FY 2026 the GDUFA fee amounts do not need adjustment from the CPA to provide funds for the program.

Under section 744B(c)(3) of the FD&C Act, for FY 2026, FDA may, in addition to the inflation and capacity planning adjustments, apply an operating reserve adjustment to further increase the fee revenue and fees if necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in such section (or as applicable, shall apply such adjustment to decrease the fee revenues and fees to provide for not more than 12 weeks of such operating reserves).

The upward operating reserve adjustment is discretionary. For FY 2026, FDA may take an adjustment to provide for not more than 10 weeks of operating reserve. If carryover is more than 12 weeks of operating reserve, FDA must decrease the fee revenues and fees to provide for not more than 12 weeks of operating reserve. To calculate the 10-week and 12-week threshold amounts for the FY 2026 operating reserve adjustment, the FY 2026 adjusted revenue amount, $670,899,031 is divided by 52, resulting in a $12,901,904 cost of operation for 1 week. The 1-week value is then multiplied by 10 weeks to generate the 10-week operating reserve threshold amount for FY 2026 of $129,019,040. The 1-week value is multiplied by 12 to generate the 12-week operating reserve threshold amount for FY 2026 of $154,822,848.

To determine the FY 2025 end-of-year operating reserves of carryover user fees, the Agency assessed the operating reserve of carryover user fees at the end of June 2025 and forecast collections and obligations in the fourth quarter of FY 2025 combined. This provides an estimated end-of-year FY 2025 operating reserve of carryover user fees of $126,429,724 which equates to 9.80 weeks of operations. As the estimated end-of-year FY 2025 operating reserve of carryover user fees is just below the 10-week discretionary increase threshold, there will not be an operating reserve adjustment.

Table 7 below summarizes FY 2026 fee revenue.

Under GDUFA III, the FY 2026 ANDA filing fee is owed by each applicant that submits an ANDA on or after October 1, 2025. 6 This fee is due on the submission date of the ANDA. Section 744B(b)(2)(B) of the FD&C Act specifies that the ANDA fee will make up 33 percent of the $670,899,000, which is $221,396,670.

To calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2026. The submissions are broken down into three categories: new originals (submissions that have not been received by FDA previously), submissions that FDA RTR for reasons other than failure to pay fees, and applications that are resubmitted after an RTR decision for reasons other than failure to pay fees. An ANDA counts as one FAE; however, 75 percent of the fee paid for an ANDA that has been RTR shall be refunded according to GDUFA III if: (1) the ANDA is refused for a cause other than failure to pay fees or (2) the ANDA has been withdrawn prior to receipt (section 744B(a)(3)(D)(i) of the FD&C Act). Therefore, an ANDA that is considered not to have been received by FDA due to reasons other than failure to pay fees or withdrawn prior to receipt counts as one-fourth of an FAE. After an ANDA has been RTR, the applicant has the option of resubmitting. For user fee purposes, these resubmissions are equivalent to new original submissions: ANDA resubmissions are charged the full amount for an application (one FAE).

As shown in table 5, FDA estimates that 618 new original ANDAs will be submitted and incur filing fees in FY 2026. Not all the new original ANDAs will be received by FDA and some of those not received will be resubmitted in the same fiscal year. After accounting for these factors, FDA expects that the FAE count for ANDAs will be 617.66, rounded to 618 for FY 2026.

The FY 2026 ANDA filing fee is estimated by dividing the number of FAEs that will incur the fee in FY 2026 (618) into the fee revenue amount to be derived from ANDA filing fees in FY 2026 ($221,396,670). The result, rounded to the nearest dollar, is a fee of $358,247 per ANDA.

The statute provides that those ANDAs that include information about the production of APIs other than by reference to a DMF will pay an additional fee that is based on the number of such APIs and the number of facilities proposed to produce those ingredients (see section 744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional fee is unlikely to be assessed often; therefore, FDA has not included projections concerning the amount of this fee in calculating the fees for ANDAs.

Under GDUFA III, the DMF fee is owed by each person that owns a type II API DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. 7 This is a one-time fee for each DMF. This fee is due on the earlier of the date on which the first generic drug submission is submitted that references the associated DMF or the date on which the DMF holder requests the initial completeness assessment. Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference.

To calculate the DMF fee, FDA assessed the volume of DMF submissions over time. FDA assessed DMFs from October 1, 2022, to April 30, 2025, and concluded that averaging the number of fee-paying DMFs provided the most accurate model for predicting fee-paying DMFs for FY 2026. The monthly average of paid DMF submissions FDA received from FY 2023 through April 2025 is 27.3. To determine the FY 2026 projected number of fee-paying DMFs, the average of 27.3 DMF submissions is multiplied by 12 months, which results in 327 estimated FY 2026 fee-paying DMFs. FDA is estimating 327 fee-paying DMFs for FY 2026.

The FY 2026 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2026. Section 744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up 5 percent of the $670,899,000, which is $33,544,950. Dividing the DMF revenue amount ($33,544,950) by the estimated fee-paying DMFs (327), and rounding to the nearest dollar, yields a DMF fee of $102,584 for FY 2026.

Under GDUFA III, the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions. 8 The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions.

Under GDUFA III, the annual FDF facility fee is owed by each person who owns an FDF facility that is identified in at least one approved generic drug submission owned by that person or its affiliates. 9 The CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA but is not identified in an approved ANDA held by the owner of that facility or its affiliates. 10 Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF and CMO facility fee revenue will make up 20 percent of the $670,899,000, which is $134,179,800.

To calculate the fees, data from FDA's Integrity Services (IS) were utilized as the primary source of facility information for determining the denominators of each facility fee type. IS is the master data steward for all facility information provided in generic drug submissions received by FDA. A facility's reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification. This information provided the number of facilities referenced as FDF manufacturers in at least one approved generic drug submission. These findings were compared against facility statuses from FDA's Office of Inspections and Investigations (OII) to exclude facilities that are no longer operational.

Based on these data, the FDF and CMO facility denominators are 153 FDF domestic, 325 FDF foreign, 84 CMO domestic, and 142 CMO foreign facilities for FY 2026.

GDUFA III specifies that the CMO facility fee is to be equal to 24 percent of the FDF facility fee. 11 Therefore, to generate the target collection revenue amount from FDF and CMO facility fees ($134,179,800), FDA must weight a CMO facility as 24 percent of an FDF facility. FDA set fees based on the estimate of 153 FDF domestic, 325 FDF foreign, 20.16 CMO domestic (84 multiplied by 24 percent), and 34.08 CMO foreign facilities (142 multiplied by 24 percent), which equals 532.24 total weighted FDF and CMO facilities for FY 2026.

To calculate the fee for domestic facilities, FDA first determines the total fee revenue that will result from the foreign facility differential by subtracting the fee revenue resulting from the foreign facility fee differential from the target collection revenue amount ($134,179,800) as follows: the foreign facility fee differential revenue equals the foreign facility fee differential ($15,000) multiplied by the number of FDF foreign facilities (325) plus the foreign facility fee differential ($15,000) multiplied by the number of CMO foreign facilities (142), totaling $7,005,000. This results in foreign fee differential revenue of $7,005,000 from the total FDF and CMO facility fee target collection revenue.

Subtracting the foreign facility differential fee revenue ($7,005,000) from the total FDF and CMO facility target collection revenue ($134,179,800) results in a remaining facility fee revenue balance of $127,174,800. To determine the domestic FDF facility fee, FDA divides the $127,174,800 by the total weighted number of FDF and CMO facilities (532.24), which results in a domestic FDF facility fee of $238,943. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $253,943.

According to GDUFA III, the domestic CMO fee is calculated as 24 percent of the amount of the domestic FDF facility fee. 12 Therefore, the domestic CMO fee is $57,346, rounded to the nearest dollar. The foreign CMO fee is calculated as the domestic CMO fee plus the foreign fee differential of $15,000. Therefore, the foreign CMO fee is $72,346.

Under GDUFA III, the annual API facility fee is owed by each person who owns a facility that is identified in at least one approved generic drug submission in which the facility is approved to produce one or more API or in a Type II API DMF referenced in at least one approved generic drug submission. 13 Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee will make up 6 percent of $670,899,000 in fee revenue, which is $40,253,940.

To calculate the API facility fee, data from FDA's IS were utilized as the primary source of facility information for determining the denominator. As stated above, IS is the master data steward for all facility information provided in generic drug submissions received by FDA. A facility's reference status in an approved generic drug submission is extracted directly from submission data rather than relying on data from self-identification. This information provided the number of facilities referenced as API manufacturers in at least one approved generic drug submission. These findings were compared against facility statuses from FDA's OII to exclude facilities that are no longer operational.

Based on these data, the total number of API facilities identified was 707; of that number, 76 were domestic and 631 were foreign facilities. The foreign facility differential is $15,000. To calculate the fee for domestic facilities, FDA must first subtract the fee revenue that will result from the foreign facility fee differential. FDA takes the foreign facility differential ($15,000) and multiplies it by the number of foreign facilities (631) to determine the total fee revenue that will result from the foreign facility differential. As a result of this calculation, the foreign fee differential revenue will make up $9,465,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($9,465,000) from the total API facility target revenue ($40,253,940) results in a remaining balance of $30,788,940. To determine the domestic API facility fee, we divide the $30,788,940 by the total number of facilities (707), which gives us a domestic API facility fee of $43,549. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $58,549.

Under GDUFA III, if a person and its affiliates own at least one but not more than five approved ANDAs on October 1, 2025, the person and its affiliates shall owe a small business generic drug applicant program fee. 14 If a person and its affiliates own at least 6 but not more than 19 approved ANDAs, the person and its affiliates shall owe a medium size operation generic drug applicant program fee. 15 If a person and its affiliates own at least 20 approved ANDAs, the person and its affiliates shall owe a large size operation generic drug applicant program fee. 16 Section 744B(b)(2)(E) of the FD&C Act specifies the GDUFA program fee will make up 36 percent of $670,899,000 in fee revenue, which is $241,523,640.

To determine the appropriate number of parent companies for each tier, FDA asked companies to claim their ANDAs and affiliates in the CDER NextGen Portal. The companies were able to confirm relationships currently present in FDA's records, while also reporting newly approved ANDAs, newly acquired ANDAs, and new affiliations.

In determining the appropriate number of approved ANDAs, FDA has factored in a number of variables that could affect the collection of the target revenue: (1) withdrawals of approved ANDAs by April 1: applicants who have submitted a written request for withdrawal of approval by April 1 of the previous fiscal year;  17 (2) inactive ANDAs: applicants who have not submitted an annual report for one or more of their approved applications within the past 2 years; (3) CBER-approved ANDAs: applicants and their affiliates with CBER-approved ANDAs are added to CDER's population of approved ANDAs; (4) Program Fee Arrears List: parent companies that are on the arrears list for any fiscal year; (5) Out of Business companies: parent companies that are no longer in operation; and (6) Tier Adjustment: the frequency of large-tier, medium-tier, and small-tier companies moving to different tiers (or as applicable, dropping out of any tier) after the completion of the program fee methodology and tier determination.

The list of original approved ANDAs from the Generic Drug Review Platform as of April 30, 2025, in addition to CBER's database, shows 259 applicants in the small business tier, 63 applicants in the medium size tier, and 88 applicants in the large size tier. Factoring in all the variables, we estimate there will be 221 applicants in the small business tier, 57 applicants in the medium size tier, and 81 applicants in the large size tier for FY 2026.

To calculate the GDUFA program fee, GDUFA III provides that large size operation generic drug applicants pay the full fee, medium size operation applicants pay two-fifths of the full fee, and small business applicants pay one-tenth of the full fee. 18 To generate the target collection revenue amount from GDUFA program fees ($241,523,640), we must weigh medium and small tiered applicants as a subset of a large size operation generic drug applicant. FDA will set fees based on the weighted estimate of 22.1 applicants in the small business tier (221 multiplied by 10 percent), 22.8 applicants in the medium size tier (57 multiplied by 40 percent), and 81 applicants in the large size tier, arriving at 125.9 total weighted applicants for FY 2026.

To generate the large size operation GDUFA program fee, FDA divides the target revenue amount of $241,523,640 by 125.9, which equals $1,918,377. The medium size operation GDUFA program fee is 40 percent of the full fee ($767,351), and the small business GDUFA program fee is 10 percent of the full fee ($191,838).

The fee rates for FY 2026 are displayed in table 8.

The new fee rates are effective on October 1, 2025, and will remain in effect through September 30, 2026. Under sections 744B(a)(4) and (5) of the FD&C Act, respectively, facility and program fees are generally due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations act providing for the collection and obligation of GDUFA fees for the fiscal year.

To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and GDUFA program fees, complete the Generic Drug User Fee Cover Sheet, available at https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and generate a user fee identification (ID) number. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. 19 The preferred payment method is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov , a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website after completing the Generic Drug User Fee Cover Sheet and generating the user fee ID number.

Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. ( Note: Only full payments are accepted; no partial payments can be made online.) Once an invoice is located, “Pay Now” should be selected to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID number, the payment may not be applied. If the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-0196965.

Section 740(a) of the FD&C Act (21 U.S.C. 379j-12), as amended by ADUFA V, establishes four different types of user fees: (1) fees for certain animal drug applications and supplemental animal drug applications; (2) annual fees for certain animal drug products; (3) annual fees for certain establishments where such products are made; and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions. When certain conditions are met, FDA will waive or reduce fees per section 740(d) of the FD&C Act.

For FYs 2024 through 2028, section 740(b)(1) of the FD&C Act establishes the base revenue amount for each fiscal year. Per section 740(c)(2) and (3) of the FD&C Act, the base revenue amounts established for fiscal years after FY 2024 are subject to adjustment for inflation and workload. Beginning in FY 2025, the annual fee revenue amount is also subject to an operating reserve adjustment to allow FDA to adjust the fee revenue amount to maintain a specified operating reserve of carryover user fees, per section 740(c)(4) of the FD&C Act. FDA may increase the fee revenue amount to maintain a 12-week minimum. If FDA has an excess operating reserve, FDA will decrease the fee revenue amount so that FDA has 22 weeks of operating reserve for FY 2025, 20 weeks for FY 2026, 18 weeks for FY 2027, and 16 weeks for FY 2028.

Per section 740(b)(2) of the FD&C Act, fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the percentages of the total revenue that are derived from each type of user fee will be as follows: (1) revenue from application fees shall be 20 percent of total fee revenue; (2) revenue from product fees shall be 27 percent of total fee revenue; (3) revenue from establishment fees shall be 26 percent of total fee revenue; and (4) revenue from sponsor fees shall be 27 percent of total fee revenue. The target revenue amounts for each fee category for FY 2026 are as follows: for application fees, the target revenue amount is $7,230,400; for product fees, the target revenue amount is $9,761,040; for establishment fees, the target revenue amount is $9,399,520; and for sponsor fees, the target revenue amount is $9,761,010.

For FY 2026, the animal drug user fee rates are: (1) $708,863 for an animal drug application; (2) $354,431 for a supplemental animal drug application for which safety or effectiveness data are required, for an animal drug application subject to the criteria set forth in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b), and for an application for conditional approval under section 571 of the FD&C Act (21 U.S.C. 360ccc) for which an animal drug application submitted under section 512(b)(1) of the FD&C Act has been previously approved under section 512(d)(1) of the FD&C Act for another intended use; (3) $13,463 for the annual product fee; (4) $200,000 for the annual establishment fee; and (5) $165,441 for the annual sponsor fee. FDA will issue invoices for FY 2026 product, establishment, and sponsor fees by December 31, 2025, and payment will be due by January 31, 2026. The application fee rates are effective for applications submitted on or after October 1, 2025, and will remain in effect through September 30, 2026. Applications will not be accepted for review until FDA has received full payment of application fees and any other animal drug user fees owed under the ADUFA program.

Section 740(b)(1) of the FD&C Act specifies that the base fee revenue amount for FY 2026 for all animal drug user fee categories totals $33,500,000.

Section 740(c)(2)(A)(ii) and (iii) of the FD&C Act specifies that the annual fee revenue amount is to be adjusted for inflation increases for FY 2025 and subsequent fiscal years using two separate adjustments: one for personnel compensation and benefits (PC&B) and one for non-PC&B costs. Section 740(c)(2)(A)(ii) of the FD&C Act specifies the component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding fiscal years of available data, multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal years of available data. The data on total PC&B paid and numbers of FTE paid, from which the average cost per FTE can be derived, are published in FDA's Justification of Estimates for Appropriations Committees.

Table 1 summarizes the total PC&B cost per FTE for the specified fiscal years, provides the percent change from the previous fiscal year, and provides the average percent change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

Section 740(c)(2)(A)(ii) of the FD&C Act specifies that this 5.4494 percent should be multiplied by the proportion of PC&B costs to total FDA costs for the first 3 of the preceding 4 fiscal years for which data are available. Table 2 shows the amount of PC&B and the total amount obligated by FDA for the same 3 fiscal years.

The portion of the inflation adjustment relating to payroll costs is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent.

Section 740(c)(2)(A)(iii) of the FD&C Act specifies that the portion of the inflation adjustment for non-payroll costs is the average annual percent change that occurred in the Consumer Price Index (CPI) (Washington-Arlington-Alexandria, DC-VA-MD-WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years of available data multiplied by the average proportion of all costs other than PC&B costs to total FDA costs for the first 3 years of the preceding 4 fiscal years. Table 3 provides the summary data for the percent change in the specified CPI for the Washington-Arlington-Alexandria area. The data from the Bureau of Labor Statistics are shown in table 3. 1

Section 740(c)(2)(A)(iii) of the FD&C Act specifies to calculate the inflation adjustment for non-payroll costs, we multiply 4.1709 percent by the average proportion of all costs other than PC&B to total FDA costs for the first 3 years of the preceding 4 fiscal years. Since 52.2090 percent was obligated for PC&B as shown in table 2, 47.7910 percent is the portion of costs other than PC&B (100 percent minus the PC&B percentage of 52.2090). The portion of the inflation adjustment relating to non-payroll costs is 4.1709 percent multiplied by 47.7910 percent, or 1.9933 percent.

Next, we add the payroll component (2.8451percent) to the non-payroll component (1.9933 percent), for an inflation adjustment of 4.8384 percent for FY 2026.

Section 740(c)(2)(B) of the FD&C Act provides for the inflation adjustment to be compounded each fiscal year after FY 2025. The inflation adjustment for FY 2026 (4.8384 percent) is compounded by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2025 (1.0393), which equals 1.0896 (rounded) (1.0393 multiplied by 1.048384). We then multiply the base revenue amount for FY 2026 ($33,500,000) by 1.0896, yielding an inflation adjusted amount of $36,502,505.

Section 740(c)(3)(A) of the FD&C Act specifies that the annual fee revenue amounts in ADUFA V for FY 2025 and subsequent fiscal years are subject to adjustment to account for changes in FDA's review workload. The workload adjustment will be applied to the inflation adjusted fee revenue amount.

To determine whether a workload adjustment applies, per ADUFA V commitments FDA calculates the weighted average of the change in the total number of each of the five types of applications and submissions specified in the workload adjustment provision (animal drug applications, supplemental animal drug applications for which data with respect to safety or efficacy are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions) received over the 5-year period that ended on September 30, 2024 (the base years; 2020 through 2024), and the average number of each of these types of applications and submissions over the most recent 5-year period that ended April 30, 2025.

The results of these calculations are presented in the first two columns of table 4. Column 3 reflects the percent change in workload over the two 5-year periods. Column 4 shows the weighting factor for each type of application/submissions, reflecting how much of the total FDA animal drug review workload was accounted for by each type of application or submission in the table during the most recent 5 years. Column 5 is the weighted percent change in each category of workload and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of the table, the sum of the values in column 5 is calculated, reflecting a total change in workload of negative 3.4253 percent for FY 2025. This is the workload adjuster for FY 2026.

Section 740(c)(3)(B) of the FD&C Act specifies that under no circumstances shall the workload adjustment result in fee revenues that are less than the base fee revenues for that fiscal year as adjusted for inflation. Additionally, section 740(c)(3)(A)(ii) states that the workload adjuster must be greater than 3 percent for a second fiscal year within ADUFA V before FDA can add the adjustment to the target revenue. For FY 2026 the workload adjuster is below the 3 percent statute threshold, therefore no workload adjustment shall be applied.

Section 740(c)(4)(A) of the FD&C Act specifies that for FY 2026, after the fee revenue amount established under section 740(b) of the FD&C Act is adjusted for inflation and workload, the Secretary shall increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks or decrease the fee revenue amount for such fiscal year, if necessary to provide for not more than 20 weeks of operating reserves.

To determine the dollar amounts for the 12-week and 20-week operating reserve thresholds, we divide the adjusted annual fee revenue amount ($36,502,505) by 52 weeks to generate a 1-week operating reserve amount of $701,971. The 1-week operating reserve amount is then multiplied by 12 and 20. This results in a 12-week minimum threshold of $8,423,544 and a 20-week maximum threshold of $14,039,420.

To estimate the FY 2025 end-of-year operating reserve of carryover user fees, the Agency projected the user fee carryover amount at the end of July 2025 using forecasted obligations, collections, and estimated recoveries but not including carryover use fees that have not been appropriated. The operating reserve of carryover user fees is projected to be $14,390,059 or 20.50 weeks ($14,390,059 divided by $701,971).

Because the estimated FY 2025 end-of-year operating reserve of carryover user fees is not below the 12-week threshold amount of $8,423,544, FDA will not increase the fee revenue amount and fees for FY 2026.

However, because the estimated FY 2025 end-of-year operating reserve of carryover user fees of $14,390,059 exceeds the 20-week threshold of $14,039,420, FDA will apply an operating reserve adjustment of $350,639 to decrease the fee revenue and fees for FY 2026.

With respect to target revenue for FY 2026, subtracting the operating reserve adjustment amount of $350,639 from the adjusted fee revenue amount of $36,502,505 results in a total target revenue amount of $36,152,000 (rounded) for FY 2026.

The fee revenue amount for FY 2026 is $36,152,000. Section 740(b)(2) of the FD&C Act specifies that this revenue amount is to be divided as follows: 20 percent, or a total of $7,260,400 is to come from application fees; 27 percent, or a total of $9,761,040, is to come from product fees; 26 percent, or a total of $9,399,520 is to come from establishment fees; and 27 percent, or a total of $9,761,040 is to come from sponsor fees.

Section 740(a)(1)(A) of the FD&C Act states that each person that submits an animal drug application or a supplemental animal drug application shall be subject to an application fee, with limited exceptions. The term “animal drug application” means an application for approval of any new animal drug submitted under section 512(b)(1) of the FD&C Act or an application for conditional approval of a new animal drug submitted under section 571 of the FD&C Act. A “supplemental animal drug application” is defined as a request to FDA to approve a change in an approved animal drug application, or a request to FDA to approve a change to an application approved under section 512(c)(2) of the FD&C Act for which data with respect to safety or effectiveness are required. Such applications are subject to ADUFA fees, except those fees may be waived under the circumstances described in section 740(d)(1)(D) and 740(i) of the FD&C Act.

Furthermore, ADUFA V continues to provide an exception from application fees for animal drug applications submitted under section 512(b)(1) of the FD&C Act by a sponsor who previously applied for conditional approval under section 571 of the FD&C Act for the same product and paid an application fee at the time they applied for conditional approval. The purpose of this exception is to prevent sponsors of conditionally approved products from having to pay a second application fee at the time they apply for full approval of their products under section 512(b)(1) of the FD&C Act, provided the sponsor's application for full approval is filed consistent with the timeframes established in section 571(h) of the FD&C Act.

The application fees are to be set so that they will generate $7,230,400 in fee revenue for FY 2026. The fee for a supplemental animal drug application for which safety or effectiveness data are required, for an animal drug application subject to criteria set forth in section 512(d)(4) of the FD&C Act, and for an application for conditional approval under section 571 of the FD&C Act of a new animal drug for which an animal drug application submitted under section 512(b)(1) of the FD&C Act has been previously approved under section 512(d)(1) for another intended use is to be set at 50 percent of the animal drug application fee.

To set animal drug application fees and supplemental animal drug application fees to realize $7,230,400, FDA must first make some assumptions about the number of fee-paying applications and supplemental applications the Agency will receive in FY 2026.

The Agency knows the number of applications that have been submitted in previous fiscal years. That number fluctuates annually. In estimating the fee revenue to be generated by animal drug application fees in FY 2026, FDA is assuming that the number of applications for which fees will be paid in FY 2026 will equal the average number of applications over the five most recently completed fiscal years of the ADUFA program (FY 2020 to FY 2024).

Over the 5 most recently completed fiscal years, the average number of animal drug applications subject to the full fee was 5.80. Over this same period, the average number of supplemental applications for which safety or effectiveness data are required, applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act, and applications for conditional approval of a new animal drug for which a section 512(b)(1) application has been previously approved for another intended use subject to half of the full fee was 8.80.

Based on the previous assumptions, FDA is estimating that it will receive a total of 10.20 fee-paying animal drug applications in FY 2026 (5.80 applications paying a full fee and 8.80 applications paying a half fee).

FDA must set the fee rates for FY 2026 so that the estimated 10.20 applications that pay the fee will generate a total of $7,230,400. To generate this amount, the fee for an animal drug application, rounded to the nearest dollar, will have to be $708,863, and the fee for a supplemental animal drug application for which safety or effectiveness data are required, for applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act, and for an application for conditional approval under section 571 of the FD&C Act of a new animal drug for which an animal drug application submitted under section 512(b)(1) of the FD&C Act has been previously approved under section 512(d)(1) for another intended use will have to be $354,431.

Section 740(a)(2) of the FD&C Act specifies that the animal drug product fee must be paid annually by the person named as the applicant in a new animal drug application or supplemental new animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003. The term “animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved (see section 739(3) of the FD&C Act). The product fees are to be set so that they will generate $9,761,040 in fee revenue for FY 2026.

To set animal drug product fees to realize $9,761,040, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2026. FDA developed data on all animal drug products that have been submitted for listing under section 510 of the FD&C Act and matched this to the list of all persons who had an animal drug application or a supplemental animal drug application pending after September 1, 2003. As of May 2025, FDA estimates that there are 740 products submitted for listing by persons who had an animal drug application or supplemental animal drug application pending after September 1, 2003. Based on this, FDA estimates that a total of 740 products will be subject to this fee in FY 2026.

In estimating the fee revenue to be generated by animal drug product fees in FY 2026, FDA is assuming that 2 percent of the products invoiced, or 15, will not pay fees in FY 2026, due to fee waivers and reductions. FDA has made this estimate at 2 percent this year, based on historical data over the past 5 completed fiscal years of the ADUFA program.

Accordingly, the Agency estimates that a total of 725 (740 minus 15) products will be subject to product fees in FY 2026.

FDA must set the fee rates for FY 2026 so that the estimated 725 products for which fees are paid will generate a total of $9,761,040. To generate this amount will require the fee for an animal drug product, rounded to the nearest dollar, to be $13,463.

Section 740(a)(3) of the FD&C Act states that the animal drug establishment fee must be paid annually by the person who: (1) owns or operates, directly or through an affiliate, an animal drug establishment; (2) is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act; (3) had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003; and (4) whose establishment engaged in the manufacture of the animal drug product during the fiscal year. An establishment subject to animal drug establishment fees is assessed only one such fee per fiscal year. The term “animal drug establishment” is defined as a foreign or domestic place of business at one general physical location, consisting of one or more buildings, all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form (see section 739(4) of the FD&C Act). The establishment fees are to be set so that they will generate $9,399,520 in fee revenue for FY 2026.

To set animal drug establishment fees to realize $9,399,520, FDA must make some assumptions about the number of establishments for which these fees will be paid in FY 2026. FDA developed data on all animal drug establishments and matched this to the list of all persons who had an animal drug application or supplemental animal drug application pending after September 1, 2003. As of May 2025, FDA estimates that there are a total of 50 establishments owned or operated by persons who had an animal drug application or supplemental animal drug application pending after September 1, 2003. Based on this, FDA believes that 50 establishments will be subject to this fee in FY 2026.

In estimating the fee revenue to be generated by animal drug establishment fees in FY 2026, FDA is assuming that 6 percent of the establishments invoiced, or three, will not pay fees in FY 2026 due to fee waivers and reductions. FDA has made this estimate at 6 percent this year, based on historical data over the past 5 completed fiscal years.

Accordingly, the Agency estimates that a total of 47 establishments (50 minus 3) will be subject to establishment fees in FY 2026.

FDA must set the fee rates for FY 2026 so that the fees paid for the estimated 47 establishments will generate a total of $9,399,520. To generate this amount will require the fee for an animal drug establishment, rounded to the nearest dollar, to be $200,000.

The animal drug sponsor fee must be paid annually by each person who: (1) is named as the applicant in an animal drug application, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive and (2) had an animal drug application, supplemental animal drug application, or investigational animal drug submission pending at FDA after September 1, 2003 (see sections 739(6) and 740(a)(4) of the FD&C Act). An animal drug sponsor is subject to only one such fee each fiscal year (see § 740(a)(4) of the FD&C Act). The sponsor fees are to be set so that they will generate $9,761,040 in fee revenue for FY 2026.

To set animal drug sponsor fees to realize $9,761,040, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2026. FDA developed data on all animal drug sponsors and matched this to the list of all sponsors who had pending submissions and applications after September 1, 2003. As of May 2024, FDA estimates that a total of 189 sponsors will meet this definition in FY 2026.

In estimating the fee revenue to be generated by animal drug sponsor fees in FY 2026, FDA is assuming that 69 percent of the sponsors invoiced, or 130, will not pay sponsor fees in FY 2026 due to fee waivers and reductions. FDA has made this estimate at 69 percent this year, based on historical data over the past 5 completed fiscal years of the ADUFA program.

Accordingly, the Agency estimates that a total of 59 sponsors (189 minus 130) will be subject to and pay sponsor fees in FY 2026.

FDA must set the fee rates for FY 2026 so that the estimated 59 sponsors that pay fees will generate a total of $9,761,040. To generate this amount will require the fee for an animal drug sponsor, rounded to the nearest dollar, to be $165,441.

The fee rates for FY 2026 are summarized in table 5.

The types of fee waivers, fee reductions, and exemptions from fees that applied during ADUFA IV still exist in ADUFA V, with one exception. After September 30, 2023, there is no longer an exemption for any person who submits to CVM a supplemental animal drug application relating to a new animal drug application approved under section 512 of the FD&C Act, solely to add the application number to the labeling of the drug in the manner specified in section 503(w) of the FD&C Act.

Remaining waivers and reductions apply for the following: barriers to innovation; where fees will exceed the cost to review the animal drug application; if the application is related to certain free-choice medicated feeds; if the application is solely for a MUMS indication; or if the sponsor is a small business submitting its first animal drug application. See section 740(d)(1) of the FD&C Act.

Under section 740(d)(1)(A) of the FD&C Act, an animal drug applicant may qualify for a waiver or reduction of one or more ADUFA fees if the fee would present a significant barrier to innovation because of limited resources available to the applicant or other circumstances. CVM's guidance for industry (GFI) #170, entitled “Animal Drug User Fees and Fee Waivers and Reductions,”  2 states that the Agency interprets this provision to mean that a waiver or reduction is appropriate when: (1) the product for which the waiver is being requested is innovative, or the requestor is otherwise pursuing innovative animal drug products or technology and (2) the fee would be a significant barrier to the applicant's ability to develop, manufacture, or market the innovative product or technology. Only those applicants that meet both criteria will qualify for a waiver or reduction in user fees under this provision (see GFI #170 at pp. 6-8). For purposes of determining whether the second criterion would be met based on limited financial resources available to the applicant, FDA has determined an applicant with financial resources of less than $20,000,000 (including the financial resources of the applicant's affiliates), adjusted annually for inflation, has limited resources available. Using the CPI for urban consumers (U.S. city average; not seasonally adjusted; all items; annual index), the inflation-adjusted level for FY 2026 will be $24,384,000; this level represents the financial resource ceiling that will be used to determine if there are limited resources available to an applicant requesting a Barrier to Innovation waiver on financial grounds for FY 2026. Requests for a waiver must be submitted in writing to FDA each fiscal year not later than 180 days from when the fees are due. A waiver granted on Barrier to Innovation grounds (or any of the other grounds listed in section 740(d)(1) of the FD&C Act) is only valid for one fiscal year. If a sponsor is not granted a waiver, they are liable for the fees.

In addition to the waivers and fee reductions described above, one fee exemption and two exceptions still apply in ADUFA V.

If an animal drug application, supplemental animal drug application, or investigational submission involves the intentional genomic alteration of an animal that is intended to produce a human medical product, any person who is the named applicant or sponsor of that application or submission will not be subject to sponsor, product, or establishment fees under ADUFA based solely on that application or submission (see section 740(d)(4) of the FD&C Act).

There is an exception from application fees for animal drug applications submitted under section 512(b)(1) of the FD&C Act by a sponsor who previously applied for conditional approval under section 571 of the FD&C Act for the same product and paid an application fee at the time they applied for conditional approval, provided the sponsor has submitted the application under section 512(b)(1) of the FD&C Act within the timeframe specified in section 571(h) of the FD&C Act. There is also an exception from application fees for previously filed applications that were not approved or were withdrawn (without waiver or refund). Both exceptions are detailed in section 740(a)(1)(C) of the FD&C Act.

The FY 2026 fee established in the new fee schedule must be paid for an animal drug application or supplement subject to fees under ADUFA V that is submitted on or after October 1, 2025. Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. 3 The preferred method for payments to FDA is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov , a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website upon receipt of an invoice or after completing the User Fee Cover Sheet and generating the user fee ID number.

Secure electronic payments to FDA can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. ( Note: Only full payments are accepted; no partial payments can be made online.) Once an invoice or cover sheet is located, “Pay Now” should be selected to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID or invoice number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID or invoice number, the payment may not be applied. If a fee is not paid in full, the fee will be treated as a claim of the U.S. Government (see section 740(h) of the FD&C Act), meaning the invoice balance due amount must be referred to collections. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-0196965.

It is important that the fee arrives at the bank at least a day or two before the application arrives at FDA's CVM. FDA records the official application receipt date as the later of the following: the date the application was received by CVM, or the date U.S. Bank notifies FDA that your payment in the full amount has been received, or when the U.S. Department of the Treasury notifies FDA of receipt of an electronic or wire transfer payment. U.S. Bank and the U.S. Department of the Treasury are required to notify FDA within 1 working day, using the PIN described previously. The tax identification number of FDA is 53-0196965.

Step One: Create a user account and password. Log on to the ADUFA website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet and, under Application Submission Information, click on “Create ADUFA User Fee Cover Sheet.” For security reasons, each firm applying will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process.

Step Two: Create an Animal Drug User Fee Cover Sheet, transmit it to the FDA, and print a copy. After logging into your account with your username and password, complete the steps required to create an Animal Drug User Fee Cover Sheet. One cover sheet is needed for each animal drug application or supplement. Once you are satisfied that the data on the cover sheet is accurate and you have finalized the cover sheet, you will be able to transmit it electronically to the FDA and you will be able to print a copy of your cover sheet showing your unique PIN.

Step Three: Send the payment for your application as described in section IX.A above.

Step Four: Submit your application.

By December 31, 2025, FDA will issue invoices and payment instructions for product, establishment, and sponsor fees for FY 2026 using this fee schedule. Payment will be due by January 31, 2026. FDA will issue invoices in November 2026 for any products, establishments, and sponsors subject to fees for FY 2026 that qualify for fees after the December 2025 billing.

Section 741(a) of the FD&C Act (21 U.S.C. 379j-21(a)), establishes four different types of generic new animal drug user fees: (1) fees for certain abbreviated applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs; and (4) JINAD file fees. When certain conditions are met, section 741(d) of the FD&C Act authorizes FDA to waive or reduce fees for generic new animal drugs intended solely to provide for a minor use or minor species indication.

Section 741(b)(1) of the FD&C Act establishes a base revenue amount for each fiscal year. Per section 741(c)(2) and (3) of the FD&C Act, the base revenue amounts established for fiscal years after FY 2024 are subject to adjustment for inflation and workload. Beginning FY 2026, the annual fee revenue amounts are also subject to adjustment to reduce workload-based increases by the amount of certain excess collections. Section 741(b) of the FD&C Act establishes fees each year so that the percentage allocations for each of the fee categories is as follows: 20 percent shall be derived from fees for abbreviated applications for a generic new animal drug and JINAD file fees; 40 percent shall be derived from fees for generic new animal drug products; and 40 percent shall be derived from fees for generic new animal drug sponsors. The target revenue amounts for each fee category for FY 2026 are as follows: for application and/or JINAD file fees, the target revenue amount is $5,448,200; for product fees, the target revenue amount is $10,896,400; and for sponsor fees, the target revenue amount is $10,896,400.

For FY 2026, the AGDUFA rates are: $137,853 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section 512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $68,927 for each abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4) of the FD&C Act; $50,000 for each JINAD file request or certain submissions to established JINAD files; $16,119 for each generic new animal drug product; $261,618 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $196,214 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $130,809 for each generic new animal drug sponsor paying 50 percent of the sponsor fee. FDA will issue invoices for FY 2026 product and sponsor fees by December 31, 2025, and payment will be due by January 31, 2026. The application fee rates are effective for all abbreviated applications for a generic new animal drug submitted on or after October 1, 2025, and will remain in effect through September 30, 2026. The fee rate for requests to establish a JINAD file, and for certain submissions to JINAD files established prior to October 1, 2023, is effective on October 1, 2025, and will remain in effect through September 30, 2026.

Applications will not be accepted for review until FDA has received full payment of application fees and any other fees owed under the AGDUFA program. Similarly, a request to establish a JINAD file or a submission to an existing JINAD file will not be accepted for action by FDA until FDA has received full payment of all fees owed under the AGDUFA program.

Section 741(b)(1) of the FD&C Act specifies that the base fee revenue amount for FY 2026 for all generic animal drug user fee categories totals $25,000,000.

Section 741(c)(2)(A) of the FD&C Act specifies that the annual fee revenue amount is to be adjusted for inflation increases for FY 2025 and subsequent fiscal years using two separate factors—one for personnel compensation and benefits (PC&B) costs and one for non-PC&B costs.

Section 741(c)(2)(A)(ii) of the FD&C Act specifies the component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B, per full-time equivalent (FTE) position of FDA, for the first 3 of the preceding 4 fiscal years of available data, multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal years of available data. The data on total PC&B paid and numbers of FTE paid, from which the average cost per FTE can be derived, are published in FDA's Justification of Estimates for Appropriations Committees.

Table 1 summarizes the total PC&B costs per FTE for the specified fiscal years, provides the percentage change from the previous fiscal year, and provides the average percentage change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

Section 741(c)(2)(A)(ii) of the FD&C Act specifies that the 5.4494 percent should be multiplied by the average proportion of PC&B costs to total FDA costs for the first 3 of the preceding 4 fiscal years for which data are available. Table 2 shows the amount of PC&B and the total costs obligated by FDA for the same 3 fiscal years.

The portion of the inflation adjustment relating to payroll costs is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent.

Section 741(c)(2)(A)(iii) of the FD&C Act specifies that the non-payroll costs adjustment factor is calculated by multiplying the average annual percentage change that occurred in the Consumer Price Index for Urban Consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All Items Less Food and Energy; Annual Index) for the first 3 years of the preceding 4 years of available data by the average proportion of all non-PC&B costs to total FDA costs for the first 3 years of the preceding 4 fiscal years. Table 3 provides the summary data for the percentage change in the specified CPI for the Washington-Arlington-Alexandria area. 1

Section 741(c)(2)(A)(iii) of the FD&C Act specifies to calculate the inflation adjustment for non-payroll costs, we multiply 4.1709 percent by the average proportion of all costs other than PC&B to total FDA costs for the first 3 years of the preceding 4 fiscal years. Since 52.2090 percent was obligated for PC&B as shown in table 2, 47.7910 percent is the portion of costs other than PC&B (100 percent minus the PC&B percentage of 52.2090). The portion of the inflation adjustment relating to non-payroll costs is 4.1709 percent multiplied by 47.7910 percent, or 1.9933 percent.

Next, we add the payroll component (2.8451 percent) to the non-payroll component (1.9933 percent), for an inflation adjustment of 4.8384 percent for FY 2026.

Section 741(c)(2)(B) of the FD&C Act provides for the inflation adjustment to be compounded each fiscal year after FY 2025. The inflation adjustment for FY 2026 (4.8384 percent) is compounded by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2025 (1.03934), which equals 1.0896 (rounded) (1.0896 × 1.0). We then multiply the base revenue amount for FY 2026 ($25,000,000) by 1.0896, yielding an inflation adjusted amount of $27,240,675

Section 741(c)(3)(A) of the FD&C Act specifies that fee revenue amounts for FY 2025 and subsequent fiscal years are subject to adjustment to account for changes in FDA's review workload. The workload adjustment would be applied to the inflation adjusted fee revenue amount.

To determine whether a workload adjustment applies, per AGDUFA IV commitments FDA calculates the weighted average of the change in the total number of each of the six types of applications and submissions specified in the workload adjustment provision (abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, investigational generic new animal drug protocol submissions, generic investigational new animal drug file requests, and generic investigational new animal drug meeting requests) received over the 5-year period that ended on September 30, 2023 (the base years; 2019 through 2023), and the average number of each of these types of applications and submissions over the most recent 5-year period that ended April 30, 2025.

The results of these calculations are presented in the first two columns of table 4. Column 3 reflects the percent change in workload over the two 5-year periods. Column 4 shows the weighting factor for each type of application/submission, reflecting how much of the total FDA generic new animal drug review workload was accounted for by each type of application or submission in the table during the most recent 5 years. Column 5 is the weighted percent change in each category of workload and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of the table, the sum of the values in column 5 is calculated, reflecting a total change in workload of 1.8988% percent for FY 2026. This is the workload adjuster for FY 2026.

Per section 741(c)(3)(C) of the FD&C Act under no circumstances shall the workload adjustment result in fee revenues that are less than the base fee revenues for that fiscal year as adjusted for inflation. For FY 2026 the workload adjustment would not result in fee revenues less than the base fee revenues as adjusted for inflation, therefore a workload adjustment of $517,110 shall be applied.

Per section 741(c)(3)(B) of the FD&C Act, for each of fiscal years 2026 through 2028, if application of the workload adjustment increases the fee revenue amounts otherwise established for the fiscal year, as adjusted for inflation, such fee revenue increase shall be reduced by the amount of any excess collections for the second preceding fiscal year, up to the amount of such fee revenue increase. The second preceding fiscal year for FY 2026 resulted in excess collections of $2,776,000, which is higher than the corresponding workload adjustment for FY 2026, and therefore, the workload adjustment is reduced to $0.

AGDUFA IV specifies that the revenue amount of $27,241,000 (rounded) for FY 2026 is to be divided as follows: 20 percent, or a total of $5,448,200, is to come from application and/or JINAD file fees; 40 percent, or a total of $10,896,400, is to come from product fees; and 40 percent, or a total of $10,896,400 is to come from sponsor fees (See section 741(b) of the FD&C Act).

Section 741(a)(1)(A) of the FD&C Act states that each person who submits an abbreviated application for a generic new animal drug shall be subject to an application fee, with limited exceptions. The term “abbreviated application for a generic new animal drug” means an abbreviated application for the approval of any generic new animal drug submitted under section 512(b)(2) of the FD&C Act. FDA will assess fees related to JINAD files under section 741(a)(4)(A)(i) of the FD&C Act when a person submits a request to establish a new JINAD file. FDA will assess a fee under section 741(a)(4)(A)(ii) and (iii) of the FD&C Act for a person's first submission, as described below, to a JINAD file on or after October 1, 2023, where the JINAD file had been established prior to that date. The JINAD file fee is set in accordance with section 741(c)(1)(C) of the FD&C Act at $50,000. FDA will set the abbreviated application fee so that such fees combined with the JINAD file fees will generate a combined total of $5,448,200 in fee revenue for FY 2026.

To set fees for abbreviated applications for generic new animal drugs, FDA must first make some assumptions about the number of fee-paying abbreviated applications it will receive during FY 2026, the number of requests to establish new JINAD files it will receive during FY 2026, and the number of existing (prior to October 1, 2023) JINAD files to which it will receive submissions during FY 2026.

Regarding the fee for a person's first submission to an existing (prior to October 1, 2023) JINAD file on or after October 1, 2023, FDA intends to assess a fee only for the first data (or “P”) submission to the Bioequivalence (BE) or Chemistry, Manufacturing, and Controls (CMC) technical sections of the JINAD file. The Agency has selected P submissions to the BE or CMC technical sections as the basis for assessing this fee because P submissions to these sections consistently entail the substantial use of FDA review hours during the phased review process.

The Agency knows the numbers of applications and submissions that have been submitted in previous years. Those numbers fluctuate annually. In estimating the fee revenue to be generated by application and submission fees in FY 2026, FDA is assuming that the number of applications and submissions for which fees will be paid in FY 2026 will equal the average number of applications and submissions over the 5 most recently completed fiscal years of the AGDUFA program (FY 2020-FY 2024).

In addition, under section 741(a)(1)(C)(ii) of the FD&C Act an abbreviated application for a generic new animal drug subject to the criteria in section 512(d)(4) of the FD&C Act and submitted on or after October 1, 2013, shall be subject to 50 percent of the fee applicable to all other abbreviated applications for a generic new animal drug.

The average number of original submissions of abbreviated applications for generic new animal drugs over the 5 most recently completed fiscal years is 21.2 applications not subject to the criteria in section 512(d)(4) of the FD&C Act and 4.0 submissions subject to the criteria in section 512(d)(4). Each of the submissions described under section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by the other applications and will be counted as one half of a fee. Adding all of the applications not subject to the criteria in section 512(d)(4) of the FD&C Act and 50 percent of the number that are subject to such criteria results in a total of 23.2 anticipated full fees.

Based on the previous assumptions, FDA is estimating that it will receive a total of 23.2 fee-paying generic new animal drug applications in FY 2026 (21.2 original applications paying a full fee and 4.0 applications paying a half fee).

For estimating the number of requests to establish a new JINAD file and the number of P submissions to the BE or CMC section of an existing (prior to October 1, 2023) JINAD file the Agency will receive in FY 2026, FDA took the number of new JINAD file requests and P submissions to the BE or CMC section of an existing JINAD file received in FY 2025. The number of requests to establish new JINAD files and P submissions to the BE or CMC section of existing JINAD files during FY 2025 as of June is 45.

Based on the previous assumptions, FDA is estimating that it will receive a total of 45 fee-paying JINAD file submissions in FY 2026 (including both requests to establish new JINAD files and first P submissions to the BE or CMC section of existing (prior to October 1, 2023) JINAD files).

FDA must set the fee rates for FY 2026 so that the estimated 23.2 abbreviated application fees and 45 JINAD file fees will generate a total of $5,448,200. The fee for a new JINAD file request or the first submission to an existing (prior to October 1, 2023) JINAD file is $50,000 under section 741(c)(1)(C) of the FD&C Act. Therefore, the JINAD fees will generate a total of $2,250,000. Abbreviated application fees will have to generate a total of $3,198,200.

To generate this amount, the fee for a generic new animal drug application will be $137,853 and for those applications that are subject to the criteria set forth in section 512(d)(4) of the FD&C Act, 50 percent of that amount, or $68,927.

The generic new animal drug product fee must be paid annually by the person named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product submitted for listing under section 510 of the FD&C Act (21 U.S.C. 360), and who had an abbreviated application or supplemental abbreviated application for a generic new animal drug product pending at FDA after September 1, 2008 (21 U.S.C. 379j-21(a)(2)). Section 741(k)(6) of FD&C Act defines “generic new animal drug product” as a specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an abbreviated application for a generic new animal drug or supplemental abbreviated application for a generic new animal drug has been approved. The product fees are to be set so that they will generate $10,896,400 in fee revenue for FY 2026.

To set generic new animal drug product fees to realize $10,896,400, FDA must make some assumptions about the number of products for which these fees will be paid in FY 2026. FDA gathered data on all generic new animal drug products that have been submitted for listing under section 510 of the FD&C Act and matched this to the list of all persons who FDA estimated would have a generic new animal drug application or supplemental abbreviated application pending after September 1, 2008. As of May 2025, FDA estimates that there is a total of 679 products submitted for listing by persons who had an abbreviated application for a generic new animal drug or supplemental abbreviated application for a generic new animal drug pending after September 1, 2008. Based on this, FDA believes that a total of 679 products will be subject to this fee in FY 2026.

Per section 741(d) of the FD&C Act in estimating the fee revenue to be generated by generic new animal drug product fees in FY 2026, FDA is estimating that 0.5 percent of the products invoiced, or 3 products, will not pay fees in FY 2026, due to fee waivers and reductions. FDA has made this estimate at 0.5 percent this year, based on historical data over the past 5 completed fiscal years of the AGDUFA program.

Accordingly, the Agency estimates that a total of 676 (679 minus 3) products will be subject to product fees in FY 2026.

FDA must set the fee rates for FY 2026 so that the estimated 676 products for which fees are paid will generate a total of $10,896,400. To generate this amount will require the fee for a generic new animal drug product, rounded to the nearest dollar, to be $16,119.

The generic new animal drug sponsor fee must be paid annually by each person who: (1) is named as the applicant in an abbreviated application for a generic new animal drug, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive; and (2) had an abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug pending at FDA after September 1, 2008. See section 741(k)(7) and (a)(3) of the FD&C Act.

Per section 741(a)(3)(C) of the FD&C Act, a generic new animal drug sponsor is subject to only one such fee each fiscal year. Applicants with more than 6 approved abbreviated applications will pay 100 percent of the sponsor fee; applicants with more than 1 and fewer than 7 approved abbreviated applications will pay 75 percent of the sponsor fee; and applicants with 1 or fewer approved abbreviated applications will pay 50 percent of the sponsor fee. The sponsor fees are to be set so that they will generate $10,896,400 in fee revenue for FY 2026.

To set generic new animal drug sponsor fees to realize $10,896,400, FDA must make some assumptions about the number of sponsors who will pay these fees in FY 2026. FDA developed data on all generic new animal drug sponsors and matched this to the list of all sponsors who had pending submissions and applications after September 1, 2008. As of May, 2025, FDA estimates that in FY 2026, 16 sponsors will pay 100 percent fees, 16 sponsors will pay 75 percent fees, and 29 sponsors will pay 50 percent fees. The total of these figures is the equivalent of 42.50 full sponsor fees (16 times 100 percent or 16, plus 16 times 75 percent or 12 plus 29 times 50 percent or 14.5).

FDA estimates that about 2 percent of all of these sponsors, or 0.85, will not pay fees in FY 2026, due to fee waivers and reductions. FDA has made the estimate of the percentage of sponsors that will not pay fees at 2 percent this year, based on historical data over the past 5 completed fiscal years of the AGDUFA program. See section 741(d) of the FD&C Act.

Accordingly, the Agency estimates that the equivalent of 41.65 full sponsor fees (42.50 minus 0.85) are likely to be paid in FY 2026.

FDA must set the fee rates for FY 2026 so that the estimated equivalent of 41.65 full sponsor fees will generate a total of $10,896,400. To generate this amount will require the 100 percent fee for a generic new animal drug sponsor, rounded to the nearest dollar, to be $261,618. Accordingly, the fee for those paying 75 percent of the full sponsor fee will be $196,214, and the fee for those paying 50 percent of the full sponsor fee will be $130,809.

The fee rates for FY 2026 are summarized in table 5.

Per section 741(d)(1), of the FD&C Act the types of fees waivers and reductions that applied last fiscal year still exist for FY 2026. However, after September 30, 2023, there is no longer an exemption for any person who submits to CVM a supplemental abbreviated application relating to a generic new animal drug approved under section 512 of the FD&C Act, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C. 352(w)(3)).

Waivers or reductions remain available for abbreviated applications for generic new animal drugs intended solely for a minor use/minor species indication; see section 741(d) of the FD&C Act.

The FY 2026 fees established in the new fee schedule must be paid for the following applications/submissions that are subject to fees under AGDUFA IV and submitted on or after October 1, 2025: a generic new animal drug application, a submission requesting to establish a JINAD file, or the first BE or CMC submission to a JINAD file that was established prior to October 1, 2023. Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. 2 The preferred method for payments to FDA is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov , a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website upon receipt of an invoice or after completing the User Fee Cover Sheet and generating the user fee ID number.

Secure electronic payments to FDA can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. ( Note: Only full payments are accepted; no partial payments can be made online.) Once an invoice or cover sheet is located, “Pay Now” should be selected to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the unique user fee ID or invoice number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID or invoice number, the payment may not be applied. If a fee is not paid in full, the fee will be treated as a claim of the U.S Government (see section 740(h) of the FD&C Act), meaning the invoice balance due amount must be referred to collections. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 53-0196965.

It is important that the fee arrives at the bank at least a day or two before the abbreviated application or JINAD submission arrives at FDA's CVM. FDA records the official abbreviated application or JINAD submission receipt date as the later of the following: the date the application or submission was received by CVM, or the date U.S. Bank notifies FDA that your payment in the full amount has been received, or when the U.S. Department of the Treasury notifies FDA of payment. U.S. Bank and the U.S. Department of the Treasury are required to notify FDA within 1 working day, using the PIN described previously.

The tax identification number of FDA is 53-0196965.

Step One: Create a user account and password. Log onto the AGDUFA website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and, under Application Submission Information, click on “Create AGDUFA User Fee Cover Sheet” and follow the directions. For security reasons, each firm submitting an application and/or a JINAD file submission will be assigned an organization identification number, and each user will also be required to set up a user account and password the first time you use this site. Online instructions will walk you through this process.

Step Two: Create an Animal Generic Drug User Fee Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with your username and password, complete the steps required to create an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed for each abbreviated application for a generic new animal drug or JINAD file submission. Once you are satisfied that the data on the cover sheet is accurate and you have finalized the cover sheet, you will be able to transmit it electronically to FDA and you will be able to print a copy of your cover sheet showing your unique PIN.

Step Three: Send the payment for your application or JINAD file submission as described in section IX.A.

Step Four: Submit your application or JINAD file submission.

By December 31, 2025, FDA will issue invoices and payment instructions for product and sponsor fees for FY 2026 using this fee schedule. Payment will be due by January 31, 2026. FDA will issue invoices in November 2026 for any products and sponsors subject to fees for FY 2026 that qualify for fees after the December 2025 billing.

Agenda: On October 7, 2025, the Center for Tobacco Product's TPSAC will convene for one open session, during which the Committee will discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. for the following products:

Discussion will focus on whether the statutory standards continue to be met.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and be posted on the FDA's website after the meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https:// www.fda.gov/AdvisoryCommittees/Calendar/default.htm. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be submitted to the contact person on or before September 25, 2025. Oral presentations from the public will be scheduled between 1:00 p.m. and 2:00 p.m. ET on October 7, 2025. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT ) and submit a brief statement describing the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and whether they would like to present online or in-person, on or before September 11, 2025. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Similarly, room for interested persons to participate in-person may be limited. If the number of registrants requesting to speak in-person during the open public hearing is greater than can be reasonably accommodated in the venue for the in-person portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate in-person. The contact person will notify interested persons regarding their request to speak by September 15, 2025.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Rachel Jang, PharmD, DFO (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

For press inquiries, please contact the HHS Press Room at www.hhs.gov/press-room/index.html or 202-690-6343.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform in conjunction with the physical meeting room (see location). This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. No participant will be prejudiced by this waiver, and that the ends of justice will be served by allowing for this modification to FDA's advisory committee meeting procedures.

The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, supplements, notices, and requests (for simplicity, this document refers to these collectively as “submissions” or “applications”); for periodic reporting on class III devices; and for the registration of certain establishments.

Under the FD&C Act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application (a premarket application is a premarket approval application (PMA), a product development protocol (PDP), or a biologics license application (BLA)). The FD&C Act specifies the base fee for a premarket application for each year from FY 2023 through FY 2027; the base fee for a premarket application received by FDA during FY 2026 is $455,000. From this starting point, this document establishes FY 2026 fee rates for certain types of submissions, and for periodic reporting, by applying criteria specified in the FD&C Act. Under statutorily defined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee (see sections 738(a)(3)(B), 738(d) and 738(e) of the FD&C Act). For more information on fee waivers, please see Section IX. Small Business Fee Reductions and Fee Waivers.

The FD&C Act specifies the base fee for establishment registration for each year from FY 2023 through FY 2027; the base fee for an establishment registration in FY 2026 is $7,575. Each establishment that is registered (or is required to register) with the Secretary of Health and Human Services under section 510 of the FD&C Act, because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device, is required to pay the annual fee for establishment registration.

The total revenue amount for FY 2026 is $366,486,300, as set forth in the statute prior to the inflation adjustment (see section 738(b)(3) of the FD&C Act). MDUFA V directs FDA to use the yearly total revenue amount as a starting point to set the standard fee rates for each fee type. The fee calculations for FY 2026 are described in this document.

MDUFA specifies that the $366,486,300 is to be adjusted for inflation increases for FY 2026 using two separate adjustments: one for payroll costs and one for non-payroll costs (see 738(c)(2)). The base inflation adjustment for FY 2026 is the sum of one plus the two separate adjustments and is compounded as specified in the statute (see section 738(c)(2)(C) and 738(c)(2)(B) of the FD&C Act).

The component of the inflation adjustment for payroll costs is the average annual percent change in the cost of all personnel compensation and benefits (PC&B) paid per full-time equivalent (FTE) position at FDA for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60 percent (see section 738(c)(2)(C)(i)(I) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified FYs, provides the percent change from the previous fiscal year, and provides the average percent change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent (rounded).

The payroll adjustment is 5.4494 percent multiplied by 60 percent, or 3.2696 percent. The statute specifies that the component of the inflation adjustment for non-payroll costs for FY 2026 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for the first 3 of the preceding 4 years of available data multiplied by 0.40, or 40 percent (see section 738(c)(2)(C)(i)(II) of the FD&C Act).

Table 2 provides the summary data and the 3-year average percent change in the specified CPI for the Washington-Arlington-Alexandria area. These data are published by the Bureau of Labor Statistics and can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0 .

The non-payroll adjustment is 4.3202 percent multiplied by 40 percent, or 1.7281 percent. Next, the payroll adjustment (3.2696 percent or 0.032696) is added to the non-payroll adjustment (1.7281 percent or 0.017281), for a total of 4.9977 percent (or 0.049977). To complete the inflation adjustment, 1 (100 percent or 1.0) is added for a total base inflation adjustment of 1.049977 for FY 2026. If the base inflation adjustment for a fiscal year is greater than 1.04, such adjustment shall be considered to be equal to 1.04 (see section 738(c)(2)(C)(ii)(II) of the FD&C Act). The total base inflation adjustment for FY 2026 is 1.04.

MDUFA V provides for this inflation adjustment to be compounded for FY 2023 and each subsequent fiscal year (see section 738(c)(2)(B) of the FD&C Act). To complete the compounded inflation adjustment for FY 2026, the FY 2025 compounded adjustment (1.122491) is multiplied by the FY 2026 base inflation adjustment (1.040000) to reach the applicable inflation adjustment of 1.167391 (rounded) for FY 2026. We then multiply the total revenue amount for FY 2026 ($366,486,300) by 1.167391, yielding an inflation adjusted total revenue amount of $427,833,000 (rounded to the nearest thousand dollars).

Under the FD&C Act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see section 738(a)(2)(A) and (b)(1)).

MDUFA specifies that the base fees of $455,000 (premarket application) and $7,575 (establishment registration) are to be adjusted for FY 2026 using the same methodology as that for the total revenue inflation adjustment in section II (see section 738(c)(2)(D)(i) of the FD&C Act). Multiplying the base fees by the compounded inflation adjustment of 1.167391 yields inflation adjusted base fees of $531,163 (premarket application) and $8,843 (establishment registration).

After the applicable inflation adjustment to fees is done, FDA may increase, if necessary to achieve the inflation adjusted total revenue amount, the base fee amounts on a uniform proportionate basis (see section 738(c)(2)(D)(ii) of the FD&C Act). After this adjustment, if necessary, FDA may further increase the base establishment registration fees to generate the inflation-adjusted total revenue amount (see section 738(c)(3)).

For FY 2026, further adjustments were required to meet the inflation adjusted total revenue amount of $427,833,000. After increasing base fees, on a uniform proportionate basis, and further increasing establishment registration fees, this yields inflation adjusted base fees of $579,272 (premarket application) and $9,760 (establishment registration).

MDUFA V has three new potential adjustments that will not change the total revenue amount but may impact collections by increasing or decreasing establishment registration base fees only. These adjustments are the performance improvement adjustment, the hiring adjustment, and the operating reserve adjustment.

Beginning with FY 2025, this adjustment allows FDA to collect fees in addition to the total revenue amount in FYs 2025, 2026, and 2027, if the Agency meets certain performance goals in FYs 2023, 2024, and 2025. If applicable, this provision further increases base establishment registration fee amounts to achieve an increase in total fee collections equal to the applicable performance improvement adjustment amount, which is set forth in the statute (see section 738(c)(4)). FDA met the FY 2024 Pre-Submission Written Feedback goal and the FY 2023 De Novo Decision goal, which determine the amount of the performance improvement adjustment for FY 2026.

For FY 2026, the performance improvement adjustment amount is equal to the product of (1) the sum of the pre-submission amount in section 738(c)(4)(B)(i)(II)(bb), $36,792,200 and the de novo classification request amount in section 738(c)(4)(B)(ii)(I), $6,323,500 and (2) the applicable inflation adjustment under section 738(c)(2)(B), 1.167391. See section 738(c)(4)(A)(ii). For FY 2026, the performance improvement adjustment is $50,332,880.

Beginning with FY 2025, this adjustment provides for the reduction of base establishment registration fees in FYs 2025, 2026, and 2027, if specified hiring goals for FYs 2023, 2024, and 2025 are not met by a certain threshold. The hiring adjustment would serve to decrease the base establishment registration fee amounts, as necessary, to achieve a reduction in total fee collections equal to the hiring adjustment amount, which is set forth in the statute (see section 738(c)(5)).

FDA met the FY 2024 statutory hiring threshold of 38 hires, so establishment registration fees will not need to be lowered by the hiring adjustment amount in FY 2026.

For FYs 2023 to 2027, the operating reserve adjustment requires FDA to decrease base establishment registration fees if the amount of operating reserves of carryover user fees exceeds the “designated amount”, and such reduction is necessary to provide for not more than such designated amount of operating reserves of carryover user fees (see section 738(c)(6)(A)). In making this calculation for FYs 2023 to 2026, a certain amount is excluded from the designated amount and is not subject to the decrease (see section 738(c)(6)(C)). For FY 2026, this excluded amount is $61,892,215.

The designated amount is equal to the sum of 13 weeks of operating reserves of carryover user fees plus 1 month of operating reserves, as described in 738(c)(8) (see 738(c)(6)(B)).

To determine the 13-week operating reserves of carryover user fees amount, the FY 2026 inflation-adjusted total revenue amount (from section II), $427,833,000, is added to the inflation-adjusted performance improvement adjustment amount (from section III.C.1), $50,332,880, resulting in $478,165,880. This amount is then divided by 52, and then multiplied by 13. The 13-week operating reserve amount for FY 2026 is $119,541,470.

To determine the 1 month of operating reserves described in section 738(c)(8) of the FD&C Act, the FY 2026 inflation-adjusted total revenue amount of $427,833,000 is added to the inflation-adjusted performance improvement adjustment amount of $50,332,880, resulting in $478,165,880. This amount is then divided by 12. The 1 month of operating reserves for FY 2026 is $39,847,157.

For FY 2026, the designated amount is equal to the 13-week operating reserve of $119,541,470 plus the 1 month of operating reserves of $39,847,157, totaling $159,388,627.

To determine the FY 2025 end-of-year operating reserves of carryover user fees amount, FDA combined the actual collections and obligations at the end of the third quarter (June 2025) and added the forecasted collections and obligations for the fourth quarter of FY 2025 to generate a full year estimate for FY 2025. The estimated end-of-year FY 2025 operating reserves of carryover user fees is $56,152,612 (Note, this amount includes the 1-month reserve).

Note that under MDUFA V, for the purposes of calculating the operating reserve adjustment, this amount does not include user fee funds considered unappropriated ($26,680,243) or unearned revenue ($65,193,572). In addition, as noted above, for purposes of the operating reserve adjustment, operating reserves of carryover user fees do not include the estimated $61,892,215 remaining to spend at the end of FY 2025 from the total of $118,000,000 intended to support the Total Product Life Cycle Advisory Program Pilot and Third-Party Review programs.

Because the estimated end-of-year FY 2025 MDUFA operating reserves of carryover user fees amount totaling $56,152,612 does not exceed the FY 2026 designated amount of $159,388,627 FDA will not decrease the base establishment registration fee amounts for FY 2026 to provide for not more than such designated amount.

As there is a performance improvement adjustment for FY 2026, but no hiring adjustment or operating reserve adjustment, establishment registration fees are increased to achieve an increase in total fee collections for FY 2026 equal to the performance improvement adjustment amount of $50,332,880. After so increasing establishment registration fees only, this yields fees of $579,272 (premarket application) and $11,423 (establishment registration).

As noted in section II, the total revenue amount after the applicable inflation adjustment is $427,833,000 (rounded to the nearest thousand dollar). As noted in section III, the performance improvement adjustment solely to registration fees for FY 2026 is $50,332,880. There is no hiring adjustment or operating reserve adjustment for FY 2026.

Table 3A provides fee-paying submission counts, excluding establishment registration, for the last 3 years and the 3-year average. Table 3B provides establishment registration fee-paying submission counts for the most recently completed fiscal year (FY 2024). Historically, FDA has estimated the total number of fee-paying submission counts it expects to receive during the next fiscal year by averaging the number of fee-paying submission counts received in the 3 most recently completed fiscal years; for FY 2026 fee-setting, this would be an average of FY 2022 through FY 2024. FDA received an abnormally high volume of fee-paying establishment registrations due to the COVID-19 pandemic in FY 2020 and FY 2021. The surge in fee-paying establishment registrations has been declining starting in FY 2022, trending back toward pre-pandemic levels. In an effort to normalize the projected volume of establishment registration submissions for the FY 2026 fee-setting calculation, and more accurately project the associated establishment registration revenue, FDA decided to utilize the number of establishment registration fee-paying submission counts from FY 2024, after making an adjustment to account for implementation of the small business registration fee waiver for FY 2026.

The information in tables 3A and 3B is necessary to estimate the amount of revenue that will be collected based on the fee amounts. Tables 4A and 4B display the FY 2026 base fees set in statute (column one) and the inflation adjusted base fees (per calculations in section III.A.) (column two). Using the inflation adjusted fees, the 3-year average of fee-paying submissions (excluding establishment registration), and the fee-paying establishment registration submissions from FY 2024, collections are projected to total $389,083,279 which is $38,749,721 lower than the inflation adjusted total revenue amount (in section II). Accordingly, the next step in the fee setting process is to increase the base fee amounts on a uniform proportionate basis to generate the inflation adjusted total revenue amounts (see 738(c)(2)(D)(ii) and table 4A, column three).

Applying these further adjusted fee rates to the 3-year average of fee-paying submissions, and the fee-paying establishment registration submissions from FY 2024 results in estimated total fee collections of $424,326,053 which is still $3,506,947 lower than the inflation adjusted total revenue amount (in Section II). The next step in the fee setting process, after the adjustment in (2)(D) is done, is to increase the base establishment registration fee amount as necessary for total fee collections to generate the inflation adjusted total revenue amount, as adjusted under paragraph (2) (see 738(c)(3)). Accordingly, the base establishment registration fee was increased by $116 for an establishment registration fee rate of $9,760 (see 738(c)(3) and table 4B, column three). The performance improvement adjustment amount is $50,332,880. Per statute, the establishment registration fee is further adjusted to account for the performance improvement adjustment amount. The inflation adjusted establishment registration fee is increased by $1,663 for an establishment registration fee of $11,423. The fees in column three in table 4A and column four in table 4B are those we are establishing for FY 2026, which are the standard fees.

The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $579,272 for FY 2026.

The fees set by reference to the standard fee for a premarket application are:

For all submissions other than a 30-day notice and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission (see 738(d)(2)(C) and (e)(2)(C)). For a 30-day notice and a 513(g) request for classification information, the small business fee is 50 percent of the standard (full) fee for the submission (see 738(d)(2)(C)).

The annual fee for establishment registration, after adjustments, is set at $11,423 for FY 2026. For FY 2026, FDA may, but is not required to, grant a waiver of the fee for annual establishment registration (excluding the initial registration) to applicants that qualify as a small business if FDA finds that the establishment is a small business and paying the fee for such a year represents a financial hardship to the establishment as determined by FDA. For more information on reduced fees and waivers for small businesses, please see Section IX. Small Business Fee Reductions and Fee Waivers.

Table 5 summarizes the FY 2026 rates for all medical device fees.

If your business, including your affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year, you may qualify for reduced small business fees. If your business, including your affiliates, has gross sales or receipts of no more than $30 million, you may also qualify for a waiver of the fee for your first premarket application ( i.e., PMA, PDP, or BLA) or premarket report. If you want to pay the small business fee rate for a submission or you want to receive a waiver of the fee for your first premarket application or premarket report, you must submit the materials showing you qualify as a small business at least 60 days before you send your submission to FDA. For more information on fee waivers or reductions, please see Section IX. Small Business Fee Reductions and Fee Waivers.

For FY 2026, FDA may, but is not required to, grant a waiver of the annual establishment registration fee (excluding the initial registration) to applicants that qualify as a small business if FDA finds that the establishment is a small business and paying the fee for such a year represents a financial hardship to the establishment as determined by FDA. For the purpose of the annual registration fee waiver, a small business is defined as one with $1,000,000 or less in gross receipts or sales in the most recent Federal (U.S.) income tax return (including the returns of its affiliates). For more information on obtaining such a waiver, see FDA's draft Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance, which, when final, will describe FDA's current thinking on the topic.

If your business qualified as a small business for FY 2025, your status as a small business will expire at the close of business on September 30, 2025. You must re-qualify for FY 2026 in order to pay small business fees during FY 2026.

If you are a domestic (U.S.) business and wish to qualify as a small business for FY 2026, submit the following to FDA:

1. A completed MDUFA Small Business Request for a Business Headquartered in the United States. The most current FDA Form may be found in the FDA Forms database: https://www.fda.gov/about-fda/reports-manuals-forms/forms.

2. A signed copy of your Federal (U.S.) Income Tax Return for the most recent tax year. The most recent tax year will be 2025, except:

• If you submit your MDUFA Small Business Request for FY 2026 before April 15, 2026, and you have not yet filed your return for 2025, you may use tax year 2024.

• If you submit your MDUFA Small Business Request for FY 2026 on or after April 15, 2026, and have not yet filed your 2025 return because you obtained an extension, you may submit your most recent return filed prior to the extension.

3. For each of your affiliates, either:

• If the affiliate is a domestic (U.S.) business, a signed copy of the affiliate's Federal (U.S.) Income Tax Return for the most recent tax year, or

• If the affiliate is a foreign business and cannot submit a Federal (U.S.) Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority, if extant, of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates of the gross receipts or sales collected. The business must also submit a statement signed by the head of the business's firm or by its chief financial officer that the business has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.

• If your affiliate is headquartered in a country without a National Taxing Authority, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov .

4. Once you have completed and signed the most current FDA Form for a MDUFA Small Business Request, submit your form and your supporting documentation (copies of the Federal (U.S.) income tax returns), using the instructions which are available at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm .

If you need assistance, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov .

If you are a foreign business, and wish to qualify as a small business for FY 2026, submit the following:

1. A completed MDUFA Foreign Small Business Request for a Business Headquartered Outside the United States. The most current FDA Form is provided in the FDA Forms database: https://www.fda.gov/about-fda/reports-manuals-forms/forms .

2. A National Taxing Authority Certification, completed by, and bearing the official seal of, the National Taxing Authority, if extant, of the country in which the firm is headquartered. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates of the gross receipts or sales collected.

If your firm is headquartered in a country without a National Taxing Authority, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov .

3. For each of your affiliates, either:

• If the affiliate is a domestic (U.S.) business, a signed copy of the affiliate's Federal (U.S.) Income Tax Return for the most recent tax year (2024 or later), or

• If the affiliate is a foreign business and cannot submit a Federal (U.S.) Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority, if extant, of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates for the gross receipts or sales collected. The business must also submit a statement signed by the head of the business's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.

• If your affiliate is headquartered in a country without a National Taxing Authority, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov .

4. Once you have completed and signed the most current MDUFA Small Business request, submit your form and your supporting documentation, including the following, using the instructions which are available at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm .

• A copy of the most recent Federal (U.S.) income tax return for each of your affiliates headquartered in the U.S. and

• A National Taxing Authority Certification for each of your foreign affiliates.

If you need assistance, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov .

If your application or submission is subject to a fee and your payment is received by FDA between October 1, 2025, and September 30, 2026, you must pay the fee in effect for FY 2026. To avoid delay in the review of your application, you should pay the application fee at the time you submit your application to FDA. The later of the date that the application is received in the reviewing center's document room or the date the U.S. Treasury recognizes the payment determines whether the fee rates for FY 2025 or FY 2026 apply. FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.

FDA requests that you follow the steps below before submitting a medical device application subject to a fee to ensure that FDA links the fee with the correct application.

Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp . Complete the Medical Device User Fee cover sheet. Be sure you choose the correct application submission date range. (Two choices will be offered until October 1, 2025. One choice is for applications and fees that will be received on or before September 30, 2025, which are subject to FY 2025 fee rates. A second choice is for applications and fees received on or after October 1, 2025, which are subject to FY 2026 fee rates.) After completing data entry, print a copy of the Medical Device User Fee cover sheet and note the unique PIN located in the upper right-hand corner of the printed cover sheet.

When you are satisfied that the data on the cover sheet is accurate, electronically transmit that data to FDA according to instructions on the screen. Applicants are required to set up a user account and password to assure data security in the creation and electronic submission of cover sheets.

1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). 1 FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov , a web-based payment system, for online electronic payment. You may make a payment via electronic check or credit card after submitting your cover sheet. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay . ( Note: Only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, select “Pay Now” to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards.

2. If paying with a wire transfer:

• Please include your application's unique PIN (from the upper right-hand corner of your completed Medical Device User Fee cover sheet) in your wire transfer. Without the PIN, your payment may not be applied to your cover sheet and review of your application may be delayed.

• The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee it is required that you add that amount to the payment to ensure that the invoice is paid in full.

Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

FDA records the official application receipt date as the later of the following: (1) the date the application was received by the FDA Document Control Center for the reviewing Center or (2) the date the U.S. Treasury recognizes the payment.

Please submit your application and a copy of the completed Medical Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.

You will be invoiced at the end of the quarter in which your PMA Periodic Report is due. Invoices will be sent based on the details included on your PMA file. You are responsible for ensuring FDA has your current billing information, and you may update your contact information for the PMA by submitting an amendment to the pending PMA or a supplement to the approved PMA.

1. The preferred payment method is online using electronic check (ACH also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay ( Note: Only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, select “Pay Now” to be redirected to Pay.gov. Note that electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

2. When paying by a wire transfer, it is required that the invoice number is included; without the invoice number the payment may not be applied. If the payment amount is not applied, the invoice amount would be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full.

Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

To pay the annual establishment registration fee, firms must access the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website address, but FDA is not responsible for any subsequent changes to the website address after this document publishes in the Federal Register .) Create a DFUF order and you will be issued a PIN when you place your order. After payment has been processed, you will be issued a payment confirmation number (PCN). You will not be able to register your establishment if you do not have a PIN and a PCN. An establishment required to pay an annual establishment registration fee is not legally registered in FY 2026 until it has completed the steps below to register and pay any applicable fee (see 738(f)(2)).

Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration (BER) system. FDA's Center for Biologics Evaluation and Research (CBER) will send establishment registration fee invoices annually to these companies.

To submit a DFUF Order, you must create or have previously created a user account and password for the user fee website listed previously in this section. After creating a username and password, log into the Establishment Registration User Fee FY 2026 store. Complete the DFUF order by entering the number of establishments you are registering that require payment. When you are satisfied that the information in the order is accurate, electronically transmit that data to FDA according to instructions on the screen. Print a copy of the final DFUF order and note the unique PIN located in the upper right-hand corner of the printed order.

If you have an approved small business waiver, please reach out to the User Fee Support Staff at UFSS@fda.hhs.gov for further instructions.

Unless paying by U.S. credit card, all payments must be in U.S. currency and drawn on a U.S. bank.

1. If paying by credit card or electronic check (ACH or eCheck): The DFUF order will include payment information, including details on how you can pay online using a credit card or electronic check. Follow the instructions provided to make an electronic payment.

2. If paying with a wire transfer: Wire transfers may also be used to pay annual establishment registration fees. To send a wire transfer, please read and comply with the following information:

Include your order's unique PIN (in the upper right-hand corner of your completed DFUF order) in your wire transfer. Without the PIN, your payment may not be applied to your facility and your registration may be delayed.

The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-0196965.

Go to the Center for Devices and Radiological Health's website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the “Access Electronic Registration” link on the left side of the page. This opens a new page with important information about the FDA Unified Registration and Listing System (FURLS). After reading this information, click on the “Access Electronic Registration” link in the middle of the page. This link takes you to an FDA Industry Systems page with tutorials that demonstrate how to create a new FURLS user account if your establishment did not create an account in FY 2025. Manufacturers of licensed biologics should register in the electronic Blood Establishment Registration (eBER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.

Enter your existing account ID and password to log into FURLS. From the FURLS/FDA Industry Systems menu, click on the Device Registration and Listing Module (DRLM) of FURLS button. New establishments will need to register, and existing establishments will update their annual registration using choices on the DRLM menu. When you choose to register or update your annual registration, the system will prompt you through the entry of information about your establishment and your devices. If you have any problems with this process, email: reglist@cdrh.fda.gov or call 301-796-7400 for assistance. ( Note: This email address and this telephone number are for assistance with establishment registration only; they are not to be used for questions related to other aspects of medical device user fees.) Problems with the eBER system should be directed to https://www.accessdata.fda .gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.

After completing your annual or initial registration and device listing, you will be prompted to enter your DFUF order PIN and PCN, when applicable. This process does not apply to establishments engaged only in the manufacture, preparation, propagation, compounding, or processing of licensed biologic devices. CBER will send invoices for payment of the establishment registration fee to such establishments.

To qualify for reduced fees for small businesses or a small business fee waiver, please see the requirements for qualification provided in Section V. How To Qualify as a Small Business for Purposes of Medical Device Fees. The applicant should submit a Small Business Request and the supporting materials showing you qualify as a small business at least 60 days before you send your submission to FDA. FDA will review your information and determine whether you qualify as a small business eligible for the reduced fee and/or fee waiver. If you make a submission before FDA finds that you qualify as a small business, you must pay the standard (full) fee for that submission.

If you need assistance, please contact the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email at DICE@fda.hhs.gov.

A small business applicant may request to pay a reduced rate for premarket approval fees. An applicant may also request a fee waiver for their first premarket application or premarket report (738(d)).

A small business applicant may request to pay a reduced rate for a premarket notification submission.

For FY 2026, FDA may, but is not required to, grant a waiver of the annual establishment registration fee (excluding the initial registration) to applicants that qualify as a small business if FDA finds that the establishment is a small business and paying the fee for such a year represents a financial hardship to the establishment as determined by FDA.

To qualify for consideration for a refund, a person shall submit to FDA a written request for a refund not later than 180 days after such fee is due. For more information on qualifying and submitting a refund, see section 738(a)(2)(D) of the FD&C Act (21 U.S.C. 379j(a)(2)(D)).

Under section 503B of the FD&C Act (21 U.S.C. 353b), a human drug compounder can register with FDA as an “outsourcing facility.” Outsourcing facilities, as defined in section 503B(d)(4), are, in part, facilities that meet all the conditions described in section 503B(a), including registering with FDA as an outsourcing facility and paying an annual establishment fee. If the conditions of section 503B are met, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) section 502(f)(1) (21 U.S.C. 352(f)(1)), concerning the labeling of drugs with adequate directions for use; (2) section 505 (21 U.S.C. 355), concerning the approval of human drug products under new drug applications or abbreviated new drug applications; and (3) section 582 (21 U.S.C. 360eee-1), concerning drug supply chain security requirements. Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), concerning current good manufacturing practice requirements for drugs.

Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to assess and collect the following fees associated with outsourcing facilities: (1) an annual establishment fee from each outsourcing facility and (2) a reinspection fee from each outsourcing facility subject to a reinspection (see section 744K(a)(1) of the FD&C Act). Under statutorily defined conditions, a qualified applicant may pay a reduced small business establishment fee (see section 744K(c)(4) of the FD&C Act).

FDA announced in the Federal Register of November 24, 2014 (79 FR 69856), the availability of a final guidance for industry entitled “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.” The guidance provides additional information on the annual fees for outsourcing facilities and adjustments required by law, reinspection fees, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee. This guidance can be accessed on FDA's website at: https://www.fda.gov/media/136683/download.

Section 744K(c)(2) of the FD&C Act specifies the annual inflation adjustment for outsourcing facility fees. The inflation adjustment has two components: one based on FDA's payroll costs and one based on FDA's non-payroll costs for the first 3 of the 4 previous fiscal years. The payroll component of the annual inflation adjustment is calculated by taking the average change in FDA's per full-time equivalent (FTE) personnel compensation and benefits (PC&B) in the first 3 of the 4 previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act). FDA's total annual spending on PC&B is divided by the total number of FTEs per fiscal year to determine the average PC&B per FTE.

Table 1 summarizes the actual cost and FTE data for the specified fiscal years and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 5.4494 percent should be multiplied by the proportion of PC&B to total costs of an average FDA FTE for the same 3 fiscal years.

The payroll adjustment is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent.

Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the portion of the inflation adjustment for non-payroll costs for FY 2026 is equal to the average annual percent change in the Consumer Price Index (CPI) for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data, multiplied by the proportion of all non-PC&B costs to total costs of an average FDA FTE for the same period.

Table 3 provides the summary data for the percent change in the specified CPI for U.S. cities. These data are published by the Bureau of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking the box marked “U.S. city average, All items—CUUR0000SA0” and then selecting “Retrieve Data.”

Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 5.0229 percent should be multiplied by the proportion of all non-PC&B costs to total costs of an average FTE for the same 3 fiscal years. The proportion of all non-PC&B costs to total costs of an average FDA FTE for FYs 2022 to 2024 is 47.7910 percent (100 percent minus 52.2090 percent equals 47.7910 percent). Therefore, the non-pay adjustment is 5.0229 percent times 47.7910 percent, or 2.4005 percent.

The PC&B component (2.8451 percent) is added to the non-PC&B component (2.4005 percent), for a total inflation adjustment of 5.2456 percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies that one is added to that figure, making the inflation adjustment 1.052456.

Section 744K(c)(2)(B) of the FD&C Act provides for this inflation adjustment to be compounded after FY 2015. This factor for FY 2026 (5.2456 percent) is compounded by adding one to it, and then multiplying it by one plus the inflation adjustment factor for FY 2025 (29.7679 percent), as published in the Federal Register on July 31, 2024 (89 FR 61470). The result of this multiplication of the inflation factors for the 11 years since FY 2015 (1.052456 × 1.297679) becomes the inflation adjustment for FY 2026. For FY 2026, the inflation adjustment is 36.5750 percent (rounded). We then add one, making the FY 2026 inflation adjustment factor 1.365750.

Section 744K(c)(3) of the FD&C Act specifies that in addition to the inflation adjustment factor, the establishment fee for non-small businesses is to be further adjusted for a small business adjustment factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small business adjustment factor is the adjustment to the establishment fee for non-small businesses that is necessary to achieve total fees equaling the amount that FDA would have collected if no entity qualified for the small business exception in section 744K(c)(4) of the FD&C Act. Additionally, section 744K(c)(5)(A) states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year.

Therefore, to calculate the small business adjustment to the establishment fee for non-small businesses for FY 2026, FDA must estimate: (1) the number of outsourcing facilities that will pay the reduced fee for small businesses for FY 2026 and (2) the total fee revenue it would have collected if no entity had qualified for the small business exception ( i.e., if each entity that registers as an outsourcing facility for FY 2026 were to pay the inflation-adjusted fee amount of $20,486).

With respect to (1), FDA estimates that 9 entities will qualify for small business exceptions and will pay the reduced fee for FY 2026. With respect to (2), to estimate the total number of entities that will register as outsourcing facilities for FY 2026, FDA used data submitted by outsourcing facilities through the voluntary registration process, which began in December 2013. Accordingly, FDA estimates that 84 outsourcing facilities, including 9 small businesses, will be registered with FDA in FY 2026.

If the projected 84 outsourcing facilities paid the full inflation-adjusted fee of $20,486, this would result in total revenue of $1,720,824 in FY 2026 ($20,486 × 84). However, 9 of the entities that are expected to register as outsourcing facilities for FY 2026 are projected to qualify for the small business exception and to pay one-third of the full fee ($6,829 × 9), totaling $61,461 instead of paying the full fee ($20,486 × 9), which would total $184,374. This would leave a potential shortfall of $122,913 ($184,374 minus $61,461).

Additionally, section 744K(c)(5)(A) of the FD&C Act states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year. FDA has determined that it is appropriate to credit excess fees collected from the last completed fiscal year, due to the inability to conclusively determine the amount of excess fees from the fiscal year that is in progress at the time this calculation is made. This crediting is done by comparing the small business adjustment factor for the last completed fiscal year, FY 2024 ($1,796), to what would have been the small business adjustment factor for FY 2024 ($576) if FDA had estimated perfectly.

The calculation for what the small business adjustment would have been if FDA had estimated perfectly begins by determining the total target collections (15,000 × [inflation adjustment factor] × [number of registrants]). For the most recent complete fiscal year, FY 2024, this was $1,672,920 ($18,588 × 90). The actual FY 2024 revenue from the 90 total registrants ( i.e., 86 registrants paying FY 2024 non-small business establishment fee and 4 small business registrants) paying establishment fees is $1,623,352. $1,623,352 is calculated as follows: (FY 2024 Non-Small Business Establishment Fee adjusted for inflation only) × (total number of registrants in FY 2024 paying Non-Small Business Establishment Fee) + (FY 2024 Small Business Establishment Fee) × (total number of small business registrants in FY 2024 paying Small Business Establishment Fee). $18,588 × 86 + $6,196 × 4 = $1,623,352. This left a shortfall of $49,568 from the estimated total target collection amount ($1,672,920 minus $1,623,352). This amount ($49,568) divided by the total number of registrants in FY 2024 paying Standard Establishment Fee (86) equals $576.

The difference between the small business adjustment factor used in FY 2024 and the small business adjustment factor that would have been used had FDA estimated perfectly is $1,220 ($1,796 minus $576). The $1,220 (rounded to the nearest dollar) is then multiplied by the number of actual registrants who paid the standard fee for FY 2024 (86), which provides us a total excess collection of $104,883 in FY 2024.

Therefore, to calculate the small business adjustment factor for FY 2026, FDA subtracts $104,883 from the projected shortfall of $122,913 for FY 2026 to arrive at the numerator for the small business adjustment amount, which equals $18,030. This number divided by 75 (the number of expected non-small businesses for FY 2026), is the small business adjustment amount for FY 2026, which is $240 (rounded to the nearest dollar).

The amount of the establishment fee for a qualified small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, divided by 3 (see section 744K(c)(4)(A) and (c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2026 is 1.365750. See section II.A.1 of this document for the methodology used to calculate the FY 2026 inflation adjustment factor. Therefore, the establishment fee for a qualified small business for FY 2026 is one third of $20,486, which equals $6,829 (rounded to the nearest dollar).

Under section 744K(c) of the FD&C Act, the amount of the establishment fee for a non-small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, plus the small business adjustment factor for that fiscal year, and plus or minus an adjustment factor to account for over or under collections due to the small business adjustment factor in the prior year. The inflation adjustment factor for FY 2026 is 1.365750. The small business adjustment amount for FY 2026 is $240. See section II.A.2 of this document for the methodology used to calculate the small business adjustment factor for FY 2026. Therefore, the establishment fee for a non-small business for FY 2026 is $15,000 multiplied by 1.365750 plus $240, which equals $20,726 (rounded to the nearest dollar).

Section 744K(c)(1)(B) of the FD&C Act provides that the amount of the FY 2026 reinspection fee is equal to $15,000, multiplied by the inflation adjustment factor for that fiscal year. The inflation adjustment factor for FY 2026 is 1.365750. Therefore, the reinspection fee for FY 2026 is $15,000 multiplied by 1.365750, which equals $20,486 (rounded to the nearest dollar). There is no reduction in this fee for small businesses.

Once an entity submits registration information and FDA has determined that the information is complete, the entity will incur the annual establishment fee. FDA will send an invoice to the entity, via email to the email address indicated in the registration file. The invoice will contain information regarding the obligation incurred, the amount owed, and payment procedures. A facility will not be registered as an outsourcing facility until it has paid the annual establishment fee under section 744K of the FD&C Act. Accordingly, it is important that facilities seeking to operate as outsourcing facilities pay all fees immediately upon receiving an invoice. If an entity does not pay the full invoiced amount within 15 calendar days after FDA issues the invoice, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fee is due.

Outsourcing facilities that registered in FY 2025 and wish to maintain their status as an outsourcing facility in FY 2026 must register during the annual registration period that lasts from October 1, 2025, to December 31, 2025. Failure to register and complete payment by December 31, 2025, will result in a loss of status as an outsourcing facility on January 1, 2026. Entities should submit their registration information no later than December 10, 2025, to allow enough time for review of the registration information, invoicing, and payment of fees before the end of the registration period.

FDA will issue invoices for each reinspection after the conclusion of the reinspection, via email to the email address indicated in the registration file. Payments must be made within 30 days of the invoice date.

1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. ( Note: only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, click “Pay Now” to be redirected to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

2. For payments made by wire transfer, the invoice number must be included. Without the invoice number, the payment may not be applied. Regarding reinspection fees, if the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that the outsourcing facility add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-0196965.

Section 808(b)(1)(A) of the FD&C Act (21 U.S.C. 384d(b)(1)(A)) directed FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities. (For the reasons explained in the third-party certification final rule (80 FR 74570 at 74578 to 74579, November 27, 2015), and for consistency with our regulations for the third-party certification program in 21 CFR parts 1, 11, and 16, this notice uses the term “third-party certification body” rather than the term “third-party auditor” used in section 808 of the FD&C Act.) Section 808(b)(1)(A)(ii) of the FD&C Act also allowed us to directly accredit certain third-party certification bodies.

Section 808(c)(8) of the FD&C Act directed FDA to establish a reimbursement (user fee) program by which we assess fees and require reimbursement for our work to administer the third-party certification program. Our regulations pertaining to the user fee program for the third-party certification program can be found at 21 CFR 1.700 through 1.725.

The FY 2026 third-party certification program user fee rates announced in this notice is effective from October 1, 2025, through September 30, 2026.

FDA estimates its costs for each activity to establish fee rates (see 21 CFR 1.705(b)).

Full-time Equivalent (FTE) reflects the total number of regular straight-time hours—not including overtime or holiday hours—worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered “hours worked” for purposes of defining FTE employment.

In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an FDA-wide total cost per FTE requires three primary cost elements: payroll, non-payroll, and rent.

We used an average of past year cost elements to predict the FY 2026 cost. The FY 2026 FDA-wide average cost for payroll (salaries and benefits) is $225,917; non-payroll (including equipment, supplies, information technology, general and administrative overhead) is $116,581; and rent (including cost allocation analysis and adjustments for other rent and rent-related costs) is $24,627 per paid staff year, excluding travel costs.

Summing the average cost of an FTE for payroll, non-payroll, and rent brings the FY 2026 average fully supported cost to $367,125 (total includes rounding) per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for third-party certification user fees for FY 2026 before including travel costs as applicable for the activity.

To calculate an hourly rate, we divide the FY 2026 average fully supported cost of $367,125 per FTE by the average number of supported direct FDA work hours in FY 2024 (the last FY for which data are available). See table 1.

Dividing the average fully supported FTE cost in FY 2026 ($367,125) by the total number of supported direct work hours available for assignment in FY 2024 (1,160) results in an average fully supported cost of $316 (rounded to the nearest dollar), excluding travel costs, per supported direct work hour in FY 2026.

To adjust the hourly rate for FY 2026, FDA estimates the cost of inflation in each year for FY 2025 and FY 2026. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) of the FD&C Act (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act. FDA previously determined the FY 2025 inflation rate to be 4.1167 percent; this rate was published in the FY 2025 PDUFA user fee rates notice in the Federal Register (July 31, 2024, 89 FR 61474). Using the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 4.1167 percent for FY 2025 and 5.0313 percent for FY 2026, and FDA intends to use this inflation rate to make inflation adjustments for FY 2026.

For the purpose of estimating the fee, we are using the travel cost rate for foreign travel because the majority of onsite assessments made by FDA under this program will require foreign travel. In FY 2024, the Office of Regulatory Affairs spent a total of $3,209,026 on 487 foreign inspection trips (averaging $6,589 per foreign inspection trip) related to FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine field activities programs. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,589 per trip by 120 hours per trip equals $55 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2024. To adjust $55 for inflation in FY 2025 and FY 2026, FDA multiplies it by the inflation factor (1.09355 or 9.355 percent), which results in an estimated cost of $60 per paid hour. That plus $316 in other costs per average supported direct work hour equals $376 per paid hour for each direct hour of work requiring foreign inspection travel. FDA will use this rate in charging fees in FY 2026 when travel is required for the third-party certification program.

The third-party certification program assesses application fees and annual fees. Specifically, FDA can collect an initial application fee for accreditation bodies seeking recognition, an annual fee for recognized accreditation bodies, an annual fee for certification bodies accredited by a recognized accreditation body, an initial application fee for a certification body seeking direct accreditation from FDA, and a renewal application fee for recognized accreditation bodies. Table 3 provides an overview of the fees for FY 2026.

Our regulations, at § 1.705(a)(1), require an application fee for accreditation bodies applying for recognition; that fee covers the estimated average cost of the work FDA performs in reviewing and evaluating applications for recognition of accreditation bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. Based on our data since starting the program, we estimate that it would take, on average, 80 person-hours to review an accreditation body's application, 48 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel ($316 per hour) to calculate the user fee attributable to those activities: $316/hour × (80 hours (application review) + 32 hours (written report)) = $35,392. We use the fully supported FTE hourly rate for work requiring travel ($376 per hour) to calculate the user fee for onsite performance evaluations, since historically most accreditation bodies are in foreign countries: $376/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $18,048. The estimated average cost of our total work for reviewing an application for recognition for an accreditation body based on these figures would be $35,392 + $18,048 = $53,440. Therefore, the application fee for accreditation bodies applying for recognition in FY 2026 will be $53,440.

To calculate the annual fee for each recognized accreditation body, FDA takes the estimated average cost of our work to monitor performance of a single recognized accreditation body and annualizes that over the average term of recognition. We assume an average term of recognition of 5 years. We also assume that FDA will monitor 10 percent of recognized accreditation bodies onsite. We estimate that one performance evaluation of a recognized accreditation body would take, on average, 22 hours to conduct records review, 8 hours to prepare a report detailing the records review and onsite performance evaluation, and 8 hours of onsite performance evaluation. Using the fully supported FTE hourly rates in table 2, the estimated average cost of our work to monitor performance of a single recognized accreditation body would be $9,480 ($316/hour × (22 hours (records review) + 8 hours (written report))) plus $3,008 ($376/hour × 8 hours (onsite evaluation)), which is $12,488. Annualizing this amount over 5 years leads to an annual fee for recognized accreditation bodies of $2,498 for FY 2026.

To calculate the annual fee for a certification body accredited by a recognized accreditation body, FDA takes the estimated average cost of our work to monitor performance of a single certification body accredited by a recognized accreditation body and annualizes that over the average term of accreditation. We assume an average term of accreditation of 4 years. We estimate that FDA would conduct, on average, the same activities for the same amount of time to monitor certification bodies accredited by a recognized accreditation body as we would to monitor an accreditation body recognized by FDA. Using the fully supported FTE hourly rates in table 2, the estimated average cost of our work to monitor performance of a single accredited certification body would be $9,480 ($316/hour × (22 hours (records review) + 8 hours (written report))) plus $3,008 ($376/hour × 8 hours (onsite evaluation)), which is $12,488. Annualizing this amount over 4 years leads to an annual fee for accredited certification bodies of $3,122 for FY 2026.

Our regulations, at § 1.705(a)(3), require an application fee for certification bodies applying for direct accreditation from FDA to cover the estimated average cost of our work to review and evaluating initial applications for direct accreditation of certification bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that it would take, on average, 80 person-hours to review a certification body's application, 48 person-hours for an onsite performance evaluation of the applicant, and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees are likely to review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $316 per hour, to calculate the portion of the user fee attributable to those activities: $316/hour × (80 hours (application review) + 32 hours (written report)) = $35,392. For the portion of the fee attributable to onsite performance evaluations, we use the fully supported FTE hourly rate for work requiring travel ($376 per hour) since historically most certification bodies are in foreign countries: $376/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $18,048. The estimated average cost of our work to review an application for direct accreditation of a certification body is $35,392 + $18,048 = $53,440. Therefore, the application fee for certification bodies applying for direct accreditation from FDA in FY 2026 will be $53,440.

Our regulations, at § 1.705(a)(2), require a renewal application fee for recognized accreditation bodies to cover the estimated average cost of our work to review and evaluate renewal applications for recognition of accreditation bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that it would take, on average, 43 person-hours to review an accreditation body's submitted renewal application, 24 person-hours for an onsite performance evaluation of the applicant, and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees are likely to review renewal applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel ($316 per hour) to calculate the portion of the user fee attributable to those activities: $316/hour × (43 hours (application review) + 32 hours (written report)) = $23,700. For the portion of the fee attributable to onsite performance evaluations, we use the fully supported FTE hourly rate for work requiring travel ($376 per hour) since historically most accreditation bodies are in foreign countries: $3763/hour × 24 hours ( i.e., fully supported FTE × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $9,024. The estimated average cost of our work for reviewing a renewal application for recognition of an accreditation body is $23,700 + $9,024 = $32,724. Therefore, the renewal application fee for recognized accreditation bodies in FY 2026 will be $32,724.

Our regulations, at § 1.705(a)(4), require application fees for certification bodies applying for renewal of direct accreditation, while § 1.705(b)(2) requires annual fees for certification bodies directly accredited by FDA.

Although to date we have not directly accredited any certification bodies under the Third-Party Certification Program, FDA notifies the public of the program fee schedule annually (21 CFR 1.710). Therefore, we are providing estimates of annual fees and renewal applications for directly accredited certification bodies, based on the fully supported FTE hourly rates for FY 2026 and estimates of the number of hours it would take FDA to perform relevant activities as outlined in the Final Regulatory Impact Analysis for the Third-Party Certification regulation. Table 4 provides an overview of the estimated fees for these other categories.

Accreditation bodies seeking recognition must submit the application fee with the application (21 CFR 1.715(a)). For recognized accreditation bodies and accredited certification bodies, an invoice will be sent annually. Payment must be made within 30 days of receipt of billing for the fee (§ 1.715(b)). The payment is to be in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred payment method is online using an electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay . (Note: The system only accepts full payments.) Alternatively, electronic invoices will have a “Pay Now” option that redirects to Pay.gov . Electronic payment options are based on the balance due. Payment by credit card is available only for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments should be made using U.S. bank accounts or credit cards.

When paying by wire transfer, the invoice number should be included; without the invoice number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, that amount should be added to the payment to ensure that the invoice is paid in full. For international wire transfers, please inquire with the financial institutions before submitting the payment. Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name: Food and Drug Administration, Account No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33.

The tax identification number of FDA is 53-0196965.

The consequences of not paying these fees are outlined in 21 CFR 1.725. If FDA does not receive an application fee with an application for recognition, the application will be considered incomplete, and FDA will not review the application. If a recognized accreditation body fails to submit its annual user fee within 30 days of the due date, we will suspend its recognition. If the recognized accreditation body fails to submit its annual user fee within 90 days of the due date, we will revoke its recognition. If an accredited certification body fails to pay its annual fee within 30 days of the due date, we will suspend its accreditation. If the accredited certification body fails to pay its annual fee within 90 days of the due date, we will withdraw its accreditation.

In the Federal Register of July 3, 2025 (90 FR 29570), FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would be held on August 13, 2025. On page 29570, in the first column, “The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 13, 2025,” the date portion of the document is changed to read as follows:

The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 13, 2025.

On page 29571, in the first column, “Background material and the link to the online teleconference and/or video conferencing meeting will be available at the location of the advisory committee meeting and at https://www.fda.gov/AdvisoryCommittees/Calendar/default.html. Scroll down to the appropriate advisory committee meeting link,” the link to the website portion of the document is changed to read as follows:

Background material and the link to the online teleconference and/or video conferencing meeting will be available at the location of the advisory committee meeting and at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll down to the appropriate advisory committee meeting link.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ) and 21 CFR part 14, relating to the advisory committees.

Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees from, in part: (1) the responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection to cover reinspection-related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees for each of these activities based on an estimate of 100 percent of the costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), and (iv) of the FD&C Act), and these fees must be made available solely to pay for the costs of each activity for which the fee was incurred (section 743(b)(3) of the FD&C Act). These fees are effective on October 1, 2025, and will remain in effect through September 30, 2026.

In section 743(b)(2)(B)(iii) of the FD&C Act, Congress directed FDA to develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. FDA issued guidance on this subject in October 2011 (2011 Fee Provision Guidance) (FDA Guidance for Industry, “Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act” (October 2011)). As stated in our 2011 Fee Provision Guidance, FDA recognizes that the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship for small businesses (id.). Therefore, as the 2011 Fee Provision Guidance explains, FDA intends to consider reducing certain fees for those firms (id.). Consistent with the 2011 Fee Provision Guidance, FDA does not intend to issue invoices for reinspection or recall order fees until FDA publishes a separate guidance document outlining the process through which firms may request a reduction in fees.

In addition, as stated in the 2011 Fee Provision Guidance, FDA is considering various issues associated with the assessment and collection of importer reinspection fees. The fee rates set forth in this notice will be used to determine any importer reinspection fees assessed in FY 2026.

FDA estimates 100 percent of its costs for each activity to establish fee rates for FY 2026 (see section 743(b)(2)(A) of the FD&C Act).

Full-time Equivalent (FTE) reflects the total number of regular straight-time hours—not including overtime or holiday hours—worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered “hours worked” for purposes of defining FTE employment.

In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an FDA-wide total cost per FTE requires three primary cost elements: payroll, nonpayroll, and rent.

We used an average of past year cost elements to predict the FY 2026 cost. The FY 2026 FDA-wide average cost for payroll (salaries and benefits) is $225,917; non-payroll (including equipment, supplies, IT, general and administrative overhead) is $116,581; and rent (including cost allocation analysis and adjustments for other rent and rent-related costs) is $24,627 per paid staff year, excluding travel costs.

Summing the average cost of an FTE for payroll, nonpayroll, and rent, brings the FY 2026 average fully supported cost to $367,125 (total includes rounding) per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2026 before including domestic or foreign travel costs as applicable for the activity.

To calculate an hourly rate, we divide the FY 2026 average fully supported cost of $367,125 per FTE by the average number of supported direct FDA work hours in FY 2024 (the last fiscal year for which data are available). See table 1.

Dividing the average fully supported FTE cost in FY 2026 ($367,125) by the total number of supported direct work hours available for assignment in FY 2024 (1,160) results in an average fully supported cost of $316 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2026.

To adjust the hourly rate for FY 2026, we estimate the cost of inflation in each year for FY 2025 and FY 2026. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) of the FD&C Act (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2025 inflation rate to be 4.1167 percent; this rate was published in the FY 2025 PDUFA user fee rates notice in the Federal Register (89 FR 61474, July 31, 2024). Using the method set forth in section 736(c)(1) of the FD&C Act, FDA calculated an inflation rate of 4.1167 percent for FY 2025 and 5.0313 percent for FY 2026, and FDA intends to use these inflation rates to make inflation adjustments for FY 2026 for several of its user fee programs.

In FY 2024, FDA's Office of Regulatory Affairs (ORA) spent a total of $7,498,059 for domestic regulatory inspection travel costs and General Services Administration Vehicle costs related to FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field activities programs. The total ORA domestic travel costs spent is then divided by the 7,851 CFSAN and CVM domestic inspections, which averages a total of $955 per inspection. These inspections average 45.09 hours per inspection. Dividing $955 per inspection by 45.09 hours per inspection results in a total and an additional cost of $21 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2024. To adjust for the $21 per hour additional domestic cost inflation increases for FY 2025 and FY 2026, we multiply the FY 2025 PDUFA inflation rate adjustor (1.041167) times the FY 2026 PDUFA inflation rate adjustor (1.050313) times the $21 additional domestic cost, which results in an estimated cost of $23 (rounded to the nearest dollar) per paid hour in addition to $316 for a total of $339 per paid hour ($316 plus $23) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2026 when domestic travel is required.

In FY 2024, ORA spent a total of $3,209,026 on 487 foreign inspection trips related to FDA's CFSAN and CVM field activities programs, which averaged a total of $6,589 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,589 per trip by 120 hours per trip results in a total and an additional cost of $55 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2024. To adjust $55 for inflationary increases in FY 2025, and FY 2026, FDA multiplies it by the same inflation factors mentioned previously in this document (1.041167 and 1.050313), which results in an estimated cost of $60 (rounded to the nearest dollar) per paid hour in addition to $316 for a total of $376 per paid hour ($316 plus $60) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2026 when foreign travel is required.

The fee will be assessed for a reinspection conducted under section 704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective actions have been implemented and are effective and compliance has been achieved to the Secretary of Health and Human Services' (the Secretary) (and, by delegation, FDA's) satisfaction at a facility that manufactures, processes, packs, or holds food for consumption necessitated as a result of a previous inspection (also conducted under section 704 of the FD&C Act) of this facility, which had a final classification of Official Action Indicated (OAI) conducted by or on behalf of FDA, when FDA determined the noncompliance was materially related to food safety requirements of the FD&C Act. FDA considers such noncompliance to include noncompliance with a statutory or regulatory requirement under section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider noncompliance that is materially related to a food safety requirement to include circumstances where the noncompliance is of a technical nature and not food safety related ( e.g., failure to comply with a food standard or incorrect font size on a food label). Determining when noncompliance, other than under sections 402 and 403(w) of the FD&C Act, is materially related to a food safety requirement of the FD&C Act may depend on the facts of a particular situation. FDA intends to issue guidance to provide additional information about the circumstances under which FDA would consider noncompliance to be materially related to a food safety requirement of the FD&C Act.

Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to assess and collect fees from the responsible party for each domestic facility (as defined in section 415(b) of the FD&C Act (21 U.S.C. 350d(b))) and the U.S. agent for each foreign facility subject to a reinspection to cover reinspection-related costs.

Section 743(a)(2)(A)(i) of the FD&C Act defines the term “reinspection” with respect to domestic facilities as 1 or more inspections conducted under section 704 of the FD&C Act subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction.

The FD&C Act does not contain a definition of “reinspection” specific to foreign facilities. In order to give meaning to the language in section 743(a)(1)(A) of the FD&C Act to collect fees from the U.S. agent of a foreign facility subject to a reinspection, we are using the following definition of “reinspection” for purposes of assessing and collecting fees under section 743(a)(1)(A) of the FD&C Act, with respect to a foreign facility: “1 or more inspections conducted by officers or employees duly designated by the Secretary subsequent to such an inspection which identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved to the Secretary's (and, by delegation, FDA's) satisfaction.”

This definition allows FDA to fulfill the mandate to assess and collect fees from the U.S. agent of a foreign facility in the event that an inspection reveals noncompliance materially related to a food safety requirement of the FD&C Act, causing one or more subsequent inspections to determine whether compliance has been achieved to the Secretary's (and, by delegation, FDA's) satisfaction. By requiring the initial inspection to be conducted by officers or employees duly designated by the Secretary, the definition ensures that a foreign facility would be subject to fees only in the event that FDA, or an entity designated to act on its behalf, has made the requisite identification at an initial inspection of noncompliance materially related to a food safety requirement of the FD&C Act. The definition of “reinspection-related costs” in section 743(a)(2)(B) of the FD&C Act relates to both a domestic facility reinspection and a foreign facility reinspection, as described in section 743(a)(1)(A) of the FD&C Act.

The FD&C Act states that this fee is to be paid by the responsible party for each domestic facility (as defined in section 415(b) of the FD&C Act) and by the U.S. agent for each foreign facility (section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send the invoice for any fees that are assessed under this section.

The fee is based on the number of direct hours spent on such reinspections, including time spent conducting the physical surveillance and/or compliance reinspection at the facility, or whatever components of such an inspection are deemed necessary, making preparations and arrangements for the reinspection, traveling to and from the facility, preparing any reports, analyzing any samples or examining any labels if required, and performing other activities as part of the OAI reinspection until the facility is again determined to be in compliance. The direct hours spent on each such reinspection will be billed at the appropriate hourly rate shown in table 2 of this document.

The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated with such order performed by the Secretary (and by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act). Noncompliance may include the following: (1) not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA in the recall order; or (3) not providing FDA with requested information regarding the recall, as ordered by FDA.

Section 743(a)(1)(B) of the FD&C Act states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423 or under section 412(f) of the FD&C Act. In other words, the party paying the fee would be the party that received the recall order.

The fee is based on the number of direct hours spent taking action in response to the firm's failure to comply with a recall order. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The direct hours spent on each such recall will be billed at the appropriate hourly rate shown in table 2 of this document.

Section 743(a)(1)(A) and (B) of the FD&C Act require FDA to assess and collect reinspection and recall fees, as appropriate, from responsible parties for domestic and foreign food facilities. Further, section 743(a)(1)(D) requires FDA to assess and collect reinspection fees from importers. An invoice will be sent to the responsible party for paying the fee after FDA completes the work on which the invoice is based. Payment is to be made within 30 days of the invoice date in U.S. currency by electronic check, credit card, or wire transfer. Detailed payment information will be included with the invoice when it is issued.

Under section 743(e)(2) of the FD&C Act, any fee that is not paid within 30 days after it is due shall be treated as a claim of the U.S. Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.

Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database OMB No. 0915-0310—Revision.

Abstract: The Stem Cell Therapeutic and Research Act of 2005 (Pub. L. 109-129, December 20, 2005) as amended and codified in Section 379A of the Public Health Service Act (42 U.S.C. 247l), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. The Public Health Service Act requires the Secretary of HHS to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using an electronic format. HRSA has established the Stem Cell Therapeutic Outcomes Database (SCTOD), a component of the C.W. Bill Young Cell Transplantation Program (Program), which necessitates certain electronic record-keeping and reporting requirements to perform functions related to hematopoietic stem cell transplantation (HCT) under contract to HHS. Data are collected from transplant centers by the Center for International Blood and Marrow Transplant Research. They are used for ongoing analysis of transplant outcomes to improve treatment and survival for patients who may benefit from cellular therapies.

The proposed revisions to this ICR reflect the most up-to-date medical evidence while also reducing the burden on hematopoietic stem cell transplantation facilities. Revisions fall into several categories: consolidating questions, implementing interactive requests (such as electronic check boxes, “check all that apply,” and pull-down menus) to reduce data entry time, adding necessary information fields, clarifying information requests, and removing items that are no longer clinically significant.

Over time, there is an expected increase in the information reported as the number of transplants performed annually increases and survivorship after transplantation improves. Similarly, because of the ongoing rapid evolution in transplant indications, methods to establish diagnoses, disease prognostic factors, treatments provided before HCT, methods to determine donor matching, and transplantation techniques, the Program anticipates incremental changes in the information collected by the SCTOD after OMB approval to reflect current clinical care, facilitate statistical modeling throughout the approval period to fulfill Program requirements, keep pace with changes in the field, and to enhance the ability to collect information in an automated fashion from respondent source systems, such as electronic health records. Interim updates to the information collected about disease indications, disease definitions, and disease prognostic factors will be triggered by the publication of peer-reviewed scientific articles or public reference materials of updated criteria by organizations such as the World Health Organization, national or international scientific consensus panels ( e.g., European LeukemiaNet, International Working Group for Prognosis in MDS), or similar. The updates mentioned above are anticipated to be reflected as changes in response options to existing information collection and will represent non-substantive changes without additional public notice. Such small incremental changes will not significantly affect the burden.

A 60-day notice published in the Federal Register on May 16, 2025, vol. 90, No. 94; pp. 21049-51. There were no public comments.

Need and Proposed Use of the Information: Per statutory responsibilities, the collection of information outlined in the “Total Estimated Annualized Burden Hours” section below is needed to collect, analyze, and publish stem cell transplantation-related data, including patient outcomes data, and provide the Secretary of HHS with an annual report of transplant center-specific survival data.

Likely Respondents: Transplant centers.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

When submitting comments or requesting information, please include the ICR title for reference.

Information Collection Request Title: The National Health Service Corps and Nurse Corps Interest Capture Form OMB No. 0915-0337—Revision.

Abstract: HRSA's National Health Service Corps (NHSC) and the Nurse Corps Scholarship and Loan Repayment Programs are committed to improving the health of the nation's underserved by uniting communities in need with caring health professionals and by supporting communities' efforts to build better systems of care. The NHSC and Nurse Corps Interest Capture Form, which can be accessed on the HRSA website at https://bhw.hrsa.gov/about-us/ask-question, is an optional form that a health profession student, licensed clinician, faculty member, clinical site administrator, or other interested individual can complete and submit to HRSA online. The purpose of the form is to enable individuals and clinical sites to ask questions about the NHSC and/or Nurse Corps Scholarship and Loan Repayment Programs, and to provide their contact information so that HRSA may provide them with periodic program updates and other general information via email. Completed forms will contain information such as the names and roles of the individual(s), their phone number(s) and email address(es), and the HRSA program(s) in which they are interested or about which they have questions. The revisions in this ICR are as follows:

(a) An increase in the annualized information collection burden due to a higher number of respondents.

(b) The addition of an online version of the NHSC and Nurse Corps Interest Capture Form, located on the HRSA website at https://bhw.hrsa.gov/about-us/ask-question.

Need and Proposed Use of the Information: The need and purpose of this information collection is to share resources and information regarding the NHSC and Nurse Corps Scholarship and Loan Repayment Programs with interested HRSA website ( https://www.hrsa.gov/ ) visitors.

Likely Respondents: Health profession students, licensed clinicians, faculty members, clinical site administrators or other individuals who are interested in learning more or have questions about NHSC and Nurse Corps Scholarship and Loan Repayment Programs.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

ETNG has applied for a BLM ROW for a 30-inch diameter pipeline and related facilities that involve approximately 5 miles of Federal lands managed by the U.S. Army Corps of Engineers and Tennessee Valley Authority. The total length of the natural gas pipeline is approximately 122.2 miles, of which approximately 111.4 miles of the pipeline would be co-located within existing utility ROW and transmission corridors. For more detailed information regarding the application, maps, and overall project, refer to the ADDRESSES section above.

The National Petroleum Reserve-Alaska (NPR-A) is a 23-million-acre tract managed by the BLM under the authority of the Naval Petroleum Reserves Production Act (NPRPA), 42 U.S.C. 6501 et seq., as amended, the Federal Land Policy and Management Act of 1976, as amended, 43 U.S.C. 1701-1787 (FLPMA), and the Alaska National Interest Lands Conservation Act, 16 U.S.C. 3101-3233 (ANILCA). On May 7, 2024, the BLM issued a final rule, entitled “Management and Protection of the National Petroleum Reserve in Alaska” (89 FR 38712), which became effective on June 6, 2024 (2024 Final Rule).

On July 17, 2024, the BLM published a request for information (RFI) in the Federal Register requesting public input on any need to: (1) identify additional significant resource values for existing special areas; (2) modify the boundaries or management of existing special areas; and (3) identify public lands that may qualify for designation as new special areas in the NPR-A. That public comment period closed on September 16, 2024, and on January 16, 2025, the BLM issued both a report entitled, “Maximizing Protection in the National Petroleum Reserve-Alaska,” (BLM Report) and a memorandum with the subject header, “BLM Interim Management of Special Areas within the National Petroleum Reserve-Alaska” (Interim Measures Guidance) pursuant to the NPR-A regulations at 43 CFR 2361.30. These documents made determinations regarding adding subsistence as a significant resource value for all special areas and proposed both new and expanded special areas.

Executive Order 14153, “Unleashing Alaska's Extraordinary Resource Potential,” (90 FR 8347) directs the BLM to rescind the RFI published in the Federal Register on July 17, 2024, and to rescind the Bureau's guidance on the protection of subsistence resource values in the existing special areas and proposed new and modified special areas in the NPR-A that was issued on January 16, 2025.

On June 3, 2025, the BLM published a notice in the Federal Register proposing to rescind the 2024 Final Rule because, in summary, the 2024 Final Rule would hamper the exploration, leasing, and development of oil and gas resources within the NPR-A, contrary to the congressional direction in the NPRPA to develop lands within the NPR-A, including special areas, as part of an expeditious program of oil and gas leasing; the rule is unnecessary to effectively manage surface resources in the NPR-A; and it is inconsistent with the priorities of the Trump administration.

This document notifies the public that the BLM is implementing the direction in Executive Order 14153, “Unleashing Alaska's Extraordinary Resource Potential,” (90 FR 8347) to rescind a notice published in the Federal Register on July 17, 2024, entitled “Special Areas Within the National Petroleum Reserve in Alaska” (89 FR 58181) that solicited public input on special areas for a period of 60 days.

This notice also serves to announce that the BLM is rescinding the report entitled, “Maximizing Protection in the National Petroleum Reserve-Alaska,” and the memorandum entitled, “BLM Interim Management of special areas within the National Petroleum Reserve-Alaska” that were issued on January 16, 2025.

These documents are being rescinded for the following reasons: First, the BLM did not comply with the regulations in developing the report or the interim guidance. The regulations at 43 CFR 2361.30(b)(3) direct the BLM authorized officer to provide the public and interested stakeholders with the opportunity to make recommendations about lands, significant resource values, and protection measures for special areas and to “evaluate and respond to recommendations that are made in completing its evaluation.” The BLM received more than 80,000 responses to the request, but the vast majority of those were form letters. However, many of the unique letters submitted in response to the RFI ( https://www.blm.gov/alaska/report/npr-special-area-rfi-unique-responses ) opposed the expansion of special areas and the addition of new significant resource values. This includes letters from small businesses, the Alaska Congressional Delegation, the oil and gas industry and trade groups, Alaska Native Corporations, local governments, and the Alaska Department of Natural Resources. The BLM Report, however, did not evaluate and respond to these public comments. Rather, it dismissed the concerns of these entities with a single line in a section entitled “Other Submissions” stating:

Likewise, the BLM received comments from some entities opposing any change in management or protections in the NPR-A, largely on procedural grounds.

This response does not comply with the requirement in 43 CFR 2361.30(b)(3) to “evaluate and respond to” public input on changes or additions to special areas. Not giving due consideration to opposing viewpoints calls into question the BLM's determinations in the BLM Report and the Interim Measures Guidance put in place to implement those determinations., This deficiency alone compels the BLM to rescind those documents.

Second, the policies contained in those documents conflict with the President's and the Department's national energy strategy that is articulated through E.O. 14153, “Unleashing Alaska's Extraordinary Resource Potential;” E.O. 14154, “Unleashing American Energy;” E.O. 14156, “Declaring a National Energy Emergency;” Secretary's Order 3417, “Addressing the National Energy Emergency;” Secretary's Order 3418, “Unleashing American Energy;” and Secretary's Order 3422, “Unleashing Alaska's Extraordinary Resource Potential.” Consistent with the direction from the President and the Secretary, the BLM's policy is to efficiently and effectively maximize the development and production of the natural resources located on Federal lands within Alaska, consistent with the statutory requirements of the NPRPA to ensure protection of surface resource values, including “the maximum protection of such surface values to the extent consistent with the requirements of this Act for the exploration of the reserve.” 42 U.S.C. 6504(a). The implementation of the BLM Report and Interim Measures Guidance would frustrate those purposes and would likely hinder the expeditious development of an oil and gas program in the Reserve as envisioned by the NPRPA. Additionally, the Interim Measures Guidance identified to protect subsistence as a significant resource value do not provide any substantive protection for subsistence use as a significant resource value and are unnecessary to effectively manage surface resources in the NPR-A.

Third, as noted above, E.O. 14153, “Unleashing Alaska's Extraordinary Resource Potential,” (90 FR 8347) directs the BLM to rescind the Bureau's guidance on the protection of subsistence resource values in the existing special areas and proposed new and modified special areas in the NPR-A that was issued on January 16, 2025.

For the reasons articulated above, the BLM is rescinding the BLM Report as well as the Interim Measures Guidance. This action is a rescission of an internal policy that was not subject to a notice and comment and does not constitute rulemaking under the Administrative Procedure Act. The BLM will continue to engage the public during project-specific National Environmental Policy Act processes and resource management planning to ensure that its decisions implement the dual mandate of the NPRPA including maximum protection of significant resource values in special areas. This change does not affect statutory obligations to conduct ANILCA sec. 810 analyses or to engage with Tribal governments and subsistence users as part of the land use planning and permitting process.

Authority: 43 U.S.C. 1701 et seq.; 42 U.S.C. 6501 et seq.; 16 U.S.C. 3101 et seq.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UTK, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing, at least, one individual have been identified. No associated funerary objects are present. This individual was recovered from an unknown site in Osage County, Kansas, by an unknown person on an unknown date. Based on a past pattern of practice, it is likely that William Bass brought these human remains with him from the University of Kansas when he began working at UTK in 1971. To our knowledge, no potentially hazardous substances have been used to treat any of the Ancestral remains.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location of the human remains described in this notice.

UTK has determined that:

• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.

• There is a connection between the human remains and associated funerary objects described in this notice and The Osage Nation.

Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, UTK must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. UTK are responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of California, Berkeley, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

Between 1954 and 1955, various individuals with the University of California Archaeological Survey removed 16 lots of objects of cultural patrimony from CA-RIV-56 in Riverside County, CA. The objects of cultural patrimony include pottery, worked stone, worked bone, projectile points, crystals, and faunal remains.

In 1881 S. B. Parrish removed one object of cultural patrimony from “Whitewater Ranch on edge of Colorado Desert, Riverside, Co.” The object was donated to the University of California Museum of Anthropology (today the Phoebe A. Hearst Museum of Anthropology) by S. B. Parrish and W. A. Setchall in 1937. The object of cultural patrimony is a steatite bowl.

A.E. Michelbacher, a professor of entomology at the University of California Berkeley, gifted two objects of cultural patrimony from Thousand Palms, Riverside County, CA to the University of California Museum of Anthropology in 1943. The objects of cultural patrimony are pottery.

Collections and collection spaces at the Phoebe A Hearst Museum of Anthropology were treated with substances for preservation and pest control, some potentially hazardous. No records have been found to date at the Museum to indicate whether or not chemicals or natural substances were used prior to 1960.

The University of California, Berkeley has determined that:

• The 19 objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a connection between the cultural items described in this notice and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the University of California, Berkeley must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The University of California, Berkeley is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Virginia Museum of Fine Arts and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

A total of three cultural items have been requested for repatriation. The three objects of cultural patrimony are baskets made of willow, sedge root, bulrush, feathers, clamshell disk beads, and ferns. One basket is dated ca. 1897 and was acquired by the museum as a gift from Katherine B. Wallace in 2011. Ms. Wallace acquired the basket as a gift from Helen Hannon, who inherited it from her father, Reverend John Hannon. Museum records indicated that Reverend Hannon acquired the basket while working as a pastor in Ukiah, California around 1897. The other two baskets are dated ca. 1900 and were acquired by the museum as a part of a gift/purchase agreement with Robert and Nancy Nooter of Washington, DC in 2017 and 2018. The basket acquired in 2017 is labelled “Coiled Gift Basket” and was purchase by the Nooters from Gene Quintana in 1986, but beyond that date no further provenance information is known. The other basket, acquired in 2018, has no known provenance. Results of consultation with the Shabaldano Kai/Sherwood Valley Rancheria of Pomo Indians of California's Tribal Historic Preservation Office representatives confirm that these three baskets are objects of cultural patrimony. To our knowledge, no potentially hazardous substances were used to treat the baskets.

The Virginia Museum of Fine Arts has determined that:

• The three objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a reasonable connection between the cultural items described in this notice and the Sherwood Valley Rancheria of Pomo Indians of California.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the Virginia Museum of Fine Arts must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Virginia Museum of Fine Arts is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing, at least, one individual have been identified from the Booth site (14JN349) in Jackson County, KS (UBS 2016-06). No associated funerary objects are present. These remains were found along a terrace of Soldier Creek and sent to the local coroner. No other provenience information is available. To our knowledge, no known hazardous substances were used to treat the human remains.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.

The KSHS has determined that:

• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.

• There is a connection between the human remains described in this notice and the Pawnee Nation of Oklahoma and the Prairie Band Potawatomi Nation.

Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UWO, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Based on the information available, human remains representing, at least, one individual have been reasonably identified and were removed from the Sandhill Site (47-JU-0428), Juneau County, WI. In 1966, G. Richard Peske, then instructor at Wisconsin State University—Oshkosh (WSU-O), now University of Wisconsin Oshkosh (UWO), was called to a mound site by Chuck Spindler. Peske's incomplete field notes from August 24, 1966, record that someone had dug into the top of the conical mound, “looking for pots” and “uncovering a burial.” Peske and Spindler conducted four shovel tests around the mound, while also recovering cultural material and human remains from the mound. The five associated funerary objects are one graver, two lots of undecorated grit tempered body sherds, one lot of mammal bone, and one lot of debitage. UWO has no knowledge or record of any potentially hazardous substances used to treat the human remains or associated funerary objects.

Based on the information available, human remains representing, at least, three individuals have been reasonably identified and were removed from the Grignon #1 (47-WN-0118) and Grignon #2 (47-WN-0119) sites, Winnebago County, WI. This site complex was originally investigated by G. Richard Peske in 1966. Later, in the 1970s when Dr. Alaric Faulkner reported the site to the Wisconsin Historical Society, he separated the location into two components which included a village site (Grignon #1 47-WN-0118/BWN-0193) and burial site (Grignon #2 47-WN-0119/BWN-0153). In 2024, collections held by the University of Wisconsin Milwaukee that were removed from Grignon #1 and #2 were legally transferred to the UWO to be included in the repatriation process, per tribal guidance. The 54 associated funerary objects are one lot of ceramics (missing); one post contact Kaolin pipe fragment; four lots of faunal remains; two lots of shell; one turtle shell; one lot of charcoal; one lot of glass; five lots of decorated grit tempered body sherds; three lots of undecorated grit tempered body sherds; five lots of decorated grit tempered rim sherds; one lot of undecorated grit tempered rim sherds; six lots of lithics; one lot of lithic debitage; one lot of lithic debitage and pottery sherds; one projectile point; two lots of post-contact ceramics; one post-contact Kaolin pipe; six lots of decorated shell tempered body sherds; eight lots undecorated shell tempered body sherds; one lot of decorated shell tempered rim sherds; and two lots of undecorated shell tempered rim sherds. UWO has no knowledge or record of any potentially hazardous substances used to treat the human remains or associated funerary objects.

Based on the information available, human remains representing, at least, one individual have been reasonably identified and were removed from the Dowling #1 site (47-WN-0141), Winnebago County, WI. The Dowling #1 site was located as part of the 1972 Middle Fox River Valley Survey, administered by Dr. Alaric Faulkner (University of Wisconsin Oshkosh Assistant Professor) and J.D. Volkman. During a survey of the site, Volkman recovered a collection of lithics, as well as the remains of a human femur. The two associated funerary objects are one chipped stone biface and one lot of debitage. UWO has no knowledge or record of any potentially hazardous substances used to treat the human remains or associated funerary objects.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location of the human remains and associated funerary objects described in this notice.

UWO has determined that:

• The human remains described in this notice represent the physical remains of five individuals of Native American ancestry.

• The 61 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a reasonable connection between the human remains and associated funerary objects described in this notice and the Assiniboine and Sioux Tribes of the Fort Peck Indian Reservation, Montana; Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Bay Mills Indian Community, Michigan; Cheyenne River Sioux Tribe of the Cheyenne River Reservation, South Dakota; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana; Citizen Potawatomi Nation, Oklahoma; Crow Creek Sioux Tribe of the Crow Creek Reservation, South Dakota; Flandreau Santee Sioux Tribe of South Dakota; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Ho-Chunk Nation of Wisconsin; Iowa Tribe of Kansas and Nebraska; Iowa Tribe of Oklahoma; Keweenaw Bay Indian Community, Michigan; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little Shell Tribe of Chippewa Indians of Montana; Lower Brule Sioux Tribe of the Lower Brule Reservation, South Dakota; Lower Sioux Indian Community in the State of Minnesota; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Menominee Indian Tribe of Wisconsin; Miami Tribe of Oklahoma; Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Nottawaseppi Huron Band of the Potawatomi, Michigan; Oglala Sioux Tribe; Otoe-Missouria Tribe of Indians, Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation; Prairie Island Indian Community in the State of Minnesota; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; Rosebud Sioux Tribe of the Rosebud Indian Reservation, South Dakota; Sac & Fox Nation of Missouri in Kansas and Nebraska; Sac & Fox Nation, Oklahoma; Sac & Fox Tribe of the Mississippi in Iowa; Saginaw Chippewa Indian Tribe of Michigan; Santee Sioux Nation, Nebraska; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; Shakopee Mdewakanton Sioux Community of Minnesota; Sisseton-Wahpeton Oyate of the Lake Traverse Reservation, South Dakota; Sokaogon Chippewa Community, Wisconsin; Spirit Lake Tribe, North Dakota; St. Croix Chippewa Indians of Wisconsin; Standing Rock Sioux Tribe of North & South Dakota; Turtle Mountain Band of Chippewa Indians of North Dakota; Upper Sioux Community, Minnesota; Winnebago Tribe of Nebraska; and the Yankton Sioux Tribe of South Dakota.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, UWO must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. UWO is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Heard Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing, at least, three individuals have been identified. The one associated funerary object is a rectangular gray stone. Circumstances and date of acquisition unknown. NA-MIS-PR-T-2: A blue shoe box containing the minimum three individuals and one associated gray stone was located and subsequently accessioned during a full collections inventory in 1991. No information was located in the original Heard catalogue. Prior consultation in 1995 and 2002 did not identify cultural affiliation for the inhumation. Information gathered from the 2002 consultation suggested a geographic location of the Plains in an area with water. Exposure to hazardous substances is unlikely.

Human remains representing, at least, one individual has been identified. No associated funerary objects are present. Circumstances and date of acquisition unknown. NA-MIS-PR-T-4: The inhumation of one individual was located and subsequently accessioned during a full collections inventory in 1991. No information was located in the original Heard catalogue. Prior consultation in 1995, 2002, and 2013 did not identify cultural affiliation. Consultation in 2002 identified red ochre. Exposure to hazardous substances is unlikely.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.

The Heard Museum has determined that:

• The human remains described in this notice represent the physical remains of four individuals of Native American ancestry.

• The one object described in this notice is reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Pawnee Nation of Oklahoma.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the Heard Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Heard Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Grand Rapids Public Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing at least 10 individuals have been identified (two of which are currently missing). During 1962-1964, human remains representing, at minimum, eight individuals were removed from Norton Mounds (20KT1) in Kent County, MI. This site was excavated by staff from the University of Michigan in cooperation with the Grand Rapids Public Museum (GRPM). The human remains consist of eight fragments of human bone that include: two rib end fragments, three fragments of shaft (these were not accompanied with any context), one fragment of a distal end of the sacrum, and one inferior border fragment. One human manubrium fragment was found in a mix of mammal bones and fill. No known individuals were identified. The two missing human remains include a right tibia fragment and a partial skull which were removed from Norton Mounds in 1894 by Captain Wright L. Coffinberry and/or in 1915 by former museum director Herbert E. Sargent. GRPM continues to look for any missing human remains.

Of the 33 lots of associated funerary objects, 19 are currently present and 14 are currently missing. The 19 present lots of associated funerary objects include ash samples; beads; bird bones (turkey, unknown); drilled tablets; faunal bones; fish bones and scales (catfish, sturgeon, walleye, unknown); historic debris; lithics; mammal bones, claws, and teeth (chipmunk, deer, mole, raccoon, skunk, weasel, woodchuck, unknown); mica; organic materials; rocks; shells (mussel, snail, unknown); sherds; soil samples; textiles; tools (bone, copper, stone); turtle shells and bones; and unknown material. The 14 missing lots of associated funerary objects include beads; bone gorgets; drilled tablets; hematite; limonite; lithics; mammal bones; ochre; organic materials; pipes; rocks; shells (mussel, unknown); tools (copper, stone); and vessels. GRPM continues to look for any missing objects.

The following non-federally recognized Indian groups were invited to consult: the Burt Lake Band of Ottawa and Chippewa and the Grand River Bands of Ottawa Indians.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.

The Grand Rapids Public Museum has determined that:

• The human remains described in this notice represent the remains of at least 10 individuals of Native American ancestry.

• The 33 lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Bay Mills Indian Community, Michigan; Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Keweenaw Bay Indian Community, Michigan; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little River Band of Ottawa Indians, Michigan; Little Traverse Bay Bands of Odawa Indians, Michigan; Match-e-be-nash-she-wish Band of Potawatomi Indians of Michigan; Nottawaseppi Huron Band of the Potawatomi, Michigan; Ottawa Tribe of Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation; Red Lake Band of Chippewa Indians, Minnesota; Sac & Fox Nation, Oklahoma; Saginaw Chippewa Indian Tribe of Michigan; and the Sault Ste. Marie Tribe of Chippewa Indians, Michigan.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the Grand Rapids Public Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Grand Rapids Public Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of California, Berkeley, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

A total of nine cultural items have been requested for repatriation. The objects of cultural patrimony are from the following accessions: Acc. 1184, Acc. 838, and Acc. 603 in the Phoebe A Hearst Museum of Anthropology at the University of California, Berkeley.

In preparation for an exhibition related to the food economy of California Indians by the University of California Museum of Anthropology (today the Phoebe A. Hearst Museum of Anthropology), Lawrence Dawson, R. K. Eckman, and others removed five lots of objects of cultural patrimony from Palm Springs, California in 1955. The objects of cultural patrimony are botanical samples.

In 1945, Grace Blair De Pue bequeathed more than 2,000 cultural belongings to the University of California Museum of Anthropology. Correspondence in the accession file indicated that Grace Blair De Pue acquired baskets from many traders, including R.B. Cregar, a prominent trader in the Coachella Valley, California. Two baskets removed from the area of Palm Springs, California by Grace Blair De Pue have been requested for repatriation.

In or before 1924, William Duncan Strong, a student at University of California, Berkeley, took two photographs of sites of importance to the Agua Caliente Band of Cahuilla Indians. The photographs were accessioned by the University of California Museum of Anthropology in 1924.

Collections and collection spaces at the Phoebe A Hearst Museum of Anthropology were treated with substances for preservation and pest control, some potentially hazardous. No records have been found to date at the Museum to indicate whether or not chemicals or natural substances were used prior to 1960.

The University of California, Berkeley has determined that:

• The nine lots of objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a connection between the cultural items described in this notice and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the University of California, Berkeley must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The University of California, Berkeley is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the San Bernardino County Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

The two associated funerary objects are one lot of ecofacts and one lot of ceramics. The Lake LeConte collection (SBCM-5922) housed at the museum was originally part of the McCown collection, who was affiliated with Archaeological Survey Association. When ASA disbanded, this collection was donated to the county museum in the early 2000s. At a different collecting event, items were taken from Lake LeConte area, near Davies Valley. These items were given the same number and have lived together with the ancestor since collection. These objects are in addition to human remains and associated funerary objects published in the Federal Register in a Notice of Inventory Completion on October 22, 2024 (89 FR 84393).

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the associated funerary objects described in this notice.

The San Bernardino County Museum has determined that:

• The two objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the associated funerary objects described in this notice and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California; Augustine Band of Cahuilla Indians, California; Cabazon Band of Cahuilla Indians ( previously listed as Cabazon Band of Mission Indians, California); Cahuilla Band of Indians; Los Coyotes Band of Cahuilla and Cupeno Indians, California; Morongo Band of Mission Indians, California; Ramona Band of Cahuilla, California; Santa Rosa Band of Cahuilla Indians, California; and the Torres Martinez Desert Cahuilla Indians, California.

Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the San Bernardino County Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The San Bernardino County Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Autry Museum of the American West, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing at least 16 individuals have been identified. The 192 associated funerary objects are 28 potsherds, three debitage, three modified faunal bone fragments, eight shell fragments, eight unmodified granite stones, 83 Olivella disk beads (two burned), four glass trade beads, four historic glass fragments, one bag of red ocher fragments, one ground stone fragment, four metal fragments, 26 faunal fragments, 10 burned faunal bone fragments, one lot of charcoal, one lot of organics, one lot of textile fragments, one lot of potsherds, one mortar fragment, two mortar fragments, one possible metate, and one awl fragment. The human remains and associated funerary objects (498.G.3468) were recovered during the Southwest Museum expedition led by museum archaeologists, William and Elizabeth Campbell, in March 1934, and potentially donated in 1959 to the Southwest Museum (now part of the Autry Museum of the American West). The remains were labeled as “Morongo Valley”. The Campbells only documented two sites in Morongo Valley from the Lower Morongo Valley District which they labeled as site 519 and site 520. Unfortunately, over the decades materials from the two sites have been combined and the remains from both sites are commingled.

Human remains representing at least one individual have been identified. The 88 associated funerary objects are one quartz Humboldt Cluster Point, one burned bone tool, one burned Olivella disc shell bead, two glass trade beads, eight decorated potsherds, 60 plain body potsherds, and 15 plain rim potsherds. Human remains and associated funerary objects (546.G.3-7) were recovered during the Southwest Museum expedition led by museum archaeologist Elizabeth Campbell in 1932 and donated in August 1932 to the Southwest Museum (now part of the Autry Museum of the American West). Records state the remains and associated funerary objects were collected from Section 13, in Lower Morongo Valley, CA.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.

The Autry Museum of the American West has determined that:

• The human remains described in this notice represent the physical remains of 17 individuals of Native American ancestry.

• The 280 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California; Cahuilla Band of Indians; Morongo Band of Mission Indians, California; Ramona Band of Cahuilla, California; Soboba Band of Luiseno Indians, California; and the Yuhaaviatam of San Manuel Nation ( previously listed as San Manuel Band of Mission Indians, California).

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the Autry Museum of the American West must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Autry Museum of the American West is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Omaha District and the University of North Dakota, and additional information on the determinations in this notice, including the results of consultation, can be found in their inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Based on information available, human remains of, at least, one individual has been reasonably identified, along with 5,023 associated funerary objects. They were removed from a site in Hughes County, South Dakota.

Based on information available, human remains of, at least, one individual has been reasonably identified, along with 123 associated funerary objects. They were removed from a site in Stanley County, South Dakota.

Based on information available, human remains of, at least, one individual has been reasonably identified, along with 5,963 associated funerary objects. They were removed from a site in Stanley County, South Dakota.

Based on information available, 10 associated funerary objects were removed from a site in Emmons County, North Dakota; four associated funerary objects were removed from a site in Campbell County, South Dakota; 14 associated funerary objects were removed from a site in Hughes County, South Dakota; 60 associated funerary objects were removed from a site in Hughes County, South Dakota; 21 associated funerary objects were removed from a site in Lyman County, South Dakota; 51 associated funerary objects were removed from a site in Lyman County, South Dakota; 81 associated funerary objects were removed from a site in Lyman County, South Dakota; one associated funerary object were removed from a site in Stanley County, South Dakota; 56 associated funerary objects were removed from a site in Stanley County, South Dakota; 131 associated funerary objects were removed from a site in Stanley County, South Dakota; 113 associated funerary objects were removed from a site in Stanley County, South Dakota; 16 associated funerary objects were removed from a site in Stanley County, South Dakota; and 14 associated funerary objects were removed from a site in Walworth County, South Dakota.

The Omaha District and UND have no record of any potentially hazardous substances being used to treat the Ancestors or associated funerary objects described in this notice.

Based upon a preponderance of the evidence, including Tribal oral history, archeological and geographical information, the Ancestors and associated funerary objects described in this Notice are consistent with cultural affiliation of the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota.

Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.

The U.S. Army Corps of Engineers, Omaha District and the University of North Dakota have determined that:

• The human remains described in this notice represent the physical remains of a minimum of three individuals of Native American ancestry.

• The 11,681 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the U.S. Army Corps of Engineers, Omaha District and the University of North Dakota must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The U.S. Army Corps of Engineers, Omaha District and the University of North Dakota are responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the KSHS, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing, at least, one individual have been identified from site 14LC307 in Lincoln County, KS (UBS 1991-08). The 14,520 associated funerary objects are beads, a possible shield, and wooden, metal, stone, shell, and cloth artifacts. A hilltop burial was exposed during earthmoving associated with a gravel pit operation. To our knowledge, no known hazardous substances were used to treat any of the human remains or associated funerary objects.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.

The KSHS has determined that:

• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.

• The 14,520 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Prairie Band Potawatomi Nation and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, & Tawakonie), Oklahoma.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the KSHS must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The KSHS is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of California, Berkeley, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

A total of 52 cultural items in the Phoebe A Hearst Museum of Anthropology at the University of California, Berkeley have been requested for repatriation.

In 1929, Theodore D. McCown, a student at University of California, Berkeley, removed one object of cultural patrimony from Turner Ranch in San Bernardino County, California. The object of cultural patrimony is one lot of pottery.

In 1949, Albert Mohr via the University of California Archaeological Survey removed 16 lots of unassociated funerary belongings from CA-SBR-66 and 35 lots of objects of cultural patrimony from the following sites in San Bernardino County, California: CA-SBR-58, CA-SBR-59, CA-SBR-60, CA-SBR-61, CA-SBR-62, CA-SBR-63, CA-SBR-65, CA-SBR-69, CA-SBR-71, and CA-SBR-72. The unassociated funerary belongings include beads, worked stone, and ground stone. The objects of cultural patrimony include ground stone, and worked stone,

Collections and collection spaces at the Phoebe A Hearst Museum of Anthropology were treated with substances for preservation and pest control, some potentially hazardous. No records have been found to date at the Museum to indicate whether or not chemicals or natural substances were used prior to 1960.

The University of California, Berkeley has determined that:

• The 16 lots of unassociated funerary objects described in this notice are reasonably believed to have been placed intentionally with or near human remains, and are connected, either at the time of death or later as part of the death rite or ceremony of a Native American culture according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization. The unassociated funerary objects have been identified by a preponderance of the evidence as related to human remains, specific individuals, or families, or removed from a specific burial site or burial area of an individual or individuals with cultural affiliation to an Indian Tribe or Native Hawaiian organization.

• The 36 lots of objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a reasonable connection between the cultural items described in this notice and the Yuhaaviatam of San Manuel Nation ( previously listed as San Manuel Band of Mission Indians, California.).

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, the University of California, Berkeley must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The University of California, Berkeley is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of SNOMNH, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Human remains representing at least, 80 individuals have been identified. The 93 associated funerary objects are 14 lots of stone projectile points, 25 lots of ceramic pottery sherds, one lot of ceramic beads, one lot of manos, 13 lots of faunal remains, four lots of stone bifaces, two lots of faunal pins, two lots of stone flakes, five lots of hematite, three lots of worked faunal remains, one lot of worked stone, one lot of boatstone, one lot of worked shell, one lot of stone celts, three lots of stone hoes, 10 lots of shell, one lot of stone drills, four lots of unmodified stone, and one lot of hammerstones. These individuals and associated funerary objects were removed from the Phillips Site, (34LF43). This mound site is located on the north side of Redwine Lake, in LeFlore County, Oklahoma, and was excavated by the Works Progress Administration in 1941-42, after which the individuals and objects removed from the site were deposited at SNOMNH. This site was occupied during the Fourche Maline phase (300-800 CE), and possibly through the Spiro Phase. To our knowledge, no potentially hazardous substances were used to treat any of the human remains or associated funerary objects.

Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.

SNOMNH has determined that:

• The human remains described in this notice represent the physical remains of 80 individuals of Native American ancestry.

• The 93 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a connection between the human remains and associated funerary objects described in this notice and the Caddo Nation of Oklahoma and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco, & Tawakonie), Oklahoma.

Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.

Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, SNOMNH must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. SNOMNH is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Autry Museum of the American West, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

A total of one cultural item has been requested for repatriation. The object of cultural patrimony is one smoothing stone. Sometime between 1911-1933, Mr. Clifford Park Baldwin, collected the cultural item from an unknown site in Morongo Valley, San Bernardino County, CA. In 1993, Mr. Baldwin sold it to the Southwest Museum (now part of the Autry Museum of the American West). The object is considered cultural patrimony, as the tribes have stated it is significant to both the Cahuilla and Serrano people.

A total of one cultural item has been requested for repatriation. The object of cultural patrimony is one olla. In 1933, Miss Marjorie Dougan collected the olla from an unknown site in Morongo Valley, San Bernardino County, CA. Miss Dougan donated the olla to the Southwest Museum in 1964. The object is considered cultural patrimony, as the tribes have stated it is significant to both the Cahuilla and Serrano people.

A total of one cultural item has been requested for repatriation. The object of cultural patrimony is one ceramic bowl. Dr. Oscar S. Brown collected the pottery bowl circa 1904 from possibly Morongo Vally in San Bernardino County, CA. His daughter, Miss Brown, donated the cultural item to the Southwest Museum in 1944. The object is considered cultural patrimony, as the tribes have stated it is significant to both the Cahuilla and Serrano people.

A total of 14 cultural items have been requested for repatriation. The 14 sacred objects are five pottery ollas, two pottery bowls, six pottery spindle whorls, and one pottery miniature bowl. Sometime between 1932-1934, Mrs. Pearly Alice Othelia Compton collected the cultural items from a cave in an unknown site in Morongo Valley, San Bernardino County, CA. Mr. John F. Compton. In 1970, her husband, Mr. John F. Compton, donated the cultural items to the Southwest Museum. The objects are considered sacred as they were found in a cave.

The Autry Museum of the American West has determined that:

• The 14 sacred objects described in this notice are specific ceremonial objects needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization.

• The three objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a reasonable connection between the cultural items described in this notice and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California; Cahuilla Band of Indians; Morongo Band of Mission Indians, California; Ramona Band of Cahuilla, California; Soboba Band of Luiseno Indians, California; and the Yuhaaviatam of San Manuel Nation ( previously listed as San Manuel Band of Mission Indians, California).

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after July 30, 2025. If competing requests for repatriation are received, the Autry Museum of the American West must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Autry Museum of the American West is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UWO, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.

Based on the information available, associated funerary objects have been identified from the St. Cloud Mound Group (47-FD-0036), Fond du Lac County, WI. In 1976, an archaeology student at Wisconsin State University—Oshkosh (WSU-O), now the University of Wisconsin Oshkosh (UWO), was called to a farm where mounds were known to exist. This student, Daniel Seurer, worked with Dr. Alaric Faulkner, Assistant Professor at WSU-O, to salvage the land before the mounds were destroyed from plowing. There were no field notes from the salvage work. The human remains and items recovered from this farm were not looked at until 2012, when University of Wisconsin—Milwaukee affiliated researcher, Mark Bruhy, analyzed the collection. He noticed that there was an original small bag labeled, “Lithics and Human Bone,” however, no bone was found in this bag. All efforts to identify the human remains from 47-FD-0036 from the UWO collection and elsewhere have failed. UWO is working under the assumption that Seurer and Dr. Faulkner removed Ancestral human remains in 1976 but they have since been disassociated from their items. The 14 associated funerary objects are six lots of lithic debitage, five lots of undecorated grit tempered body sherds, two lots of lithics, and one metal bullet casing. UWO has no knowledge or record of any potentially hazardous substances used to treat the associated funerary objects.

Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location of the associated funerary objects described in this notice.

UWO has determined that:

• The 14 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.

• There is a reasonable connection between the associated funerary objects described in this notice and the Assiniboine and Sioux Tribes of the Fort Peck Indian Reservation, Montana; Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Bay Mills Indian Community, Michigan; Cheyenne River Sioux Tribe of the Cheyenne River Reservation, South Dakota; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana; Citizen Potawatomi Nation, Oklahoma; Crow Creek Sioux Tribe of the Crow Creek Reservation, South Dakota; Flandreau Santee Sioux Tribe of South Dakota; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Ho-Chunk Nation of Wisconsin; Iowa Tribe of Kansas and Nebraska; Iowa Tribe of Oklahoma; Keweenaw Bay Indian Community, Michigan; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little River Band of Ottawa Indians, Michigan; Little Shell Tribe of Chippewa Indians of Montana; Little Traverse Bay Bands of Odawa Indians, Michigan; Lower Brule Sioux Tribe of the Lower Brule Reservation, South Dakota; Lower Sioux Indian Community in the State of Minnesota; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Menominee Indian Tribe of Wisconsin; Miami Tribe of Oklahoma; Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Nottawaseppi Huron Band of the Potawatomi, Michigan; Oglala Sioux Tribe; Otoe-Missouria Tribe of Indians, Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation; Prairie Island Indian Community in the State of Minnesota; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; Rosebud Sioux Tribe of the Rosebud Indian Reservation, South Dakota; Sac & Fox Nation of Missouri in Kansas and Nebraska; Sac & Fox Nation, Oklahoma; Sac & Fox Tribe of the Mississippi in Iowa; Saginaw Chippewa Indian Tribe of Michigan; Santee Sioux Nation, Nebraska; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; Shakopee Mdewakanton Sioux Community of Minnesota; Sisseton-Wahpeton Oyate of the Lake Traverse Reservation, South Dakota; Sokaogon Chippewa Community, Wisconsin; Spirit Lake Tribe, North Dakota; St. Croix Chippewa Indians of Wisconsin; Standing Rock Sioux Tribe of North & South Dakota; Turtle Mountain Band of Chippewa Indians of North Dakota; Upper Sioux Community, Minnesota; Winnebago Tribe of Nebraska; and the Yankton Sioux Tribe of South Dakota.

Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by:

1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.

2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the associated funerary objects in this notice to a requestor may occur on or after August 29, 2025. If competing requests for repatriation are received, UWO must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. UWO is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3003, and the implementing regulations, 43 CFR 10.10.