The General Conference Committee of the National Poultry Improvement Plan was established in 1971. The committee is governed in accordance with the Federal Advisory Committee Act and the regulations of title 9, Code of Federal Regulations (9 CFR), § 147.43. The duties of the committee involve assisting the U.S. Department of Agriculture (Department) in planning, organizing, and conducting the National Poultry Improvement Plan (NPIP or Plan) Biennial Conference. Between Plan Conferences, the committee represents the cooperating States in:

• Advising the Department on administrative procedures and interpretations of the Plan provisions contained in the 9 CFR;

• Helping the Department evaluate comments on proposed Plan amendments;

• Recommending to the Secretary any changes in Plan provisions when postponement until the next Plan Conference would seriously impair program operations; and

• Serving as a forum for the study of poultry health problems.

The purpose of the General Conference Committee of the National Poultry Improvement Plan (Committee) is to maintain and ensure industry involvement in Federal administration of matters pertaining to poultry health. The committee meets at least annually. In the even years, the committee meets in conjunction with the NPIP Biennial Conference. The NPIP Biennial Conference is the only national meeting where the industry and State and Federal government consider poultry health issues on a routine basis. The committee members are elected at the NPIP Biennial conference by State delegates from their respective regions. There are seven members with a 4-year staggered term. The poultry industry elects the members of the Committee. The members represent six geographic areas with one member-at-large. The Committee Chairperson and the Vice Chairperson shall be elected by the Committee from among its members.

Any interested person or organization may nominate qualified individuals for membership. Interested candidates may nominate themselves. Individuals who wish to be considered for membership on the General Conference Committee must submit a nomination with information, including a background disclosure form (Form AD-755). Applications and nominations for membership on the Committee will be solicited in subsequent notice in the Federal Register .

Equal opportunity practices, in accordance with USDA policies, will be followed in all membership appointments to the Committee.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

Title: Foreign Donation of Agricultural Commodities (section 416(b) and Food for Progress programs) and McGovern-Dole International Food for Education and Child Nutrition Program.

OMB Number: 0551-0035.

Expiration Date of Approval: April 30, 2027.

Type of Request: Addition of a new information collection to the OMB Control number 0551-0035.

Abstract: Under the section 416(b) and Food for Progress programs (the “Foreign Donation Programs”) and the McGovern-Dole International Food for Education and Child Nutrition (“McGovern-Dole”) program, information will be gathered from recipients who receive federal awards under the programs to determine the viability of requests for resources to implement activities in foreign countries. Recipients of awards under the programs must submit a Cover Letter to the Final Financial Report to assure that financial requirements and objectives are met.

Estimate of Burden: The public reporting burden for each respondent resulting from information collections under the Foreign Donation Programs or the McGovern-Dole Program varies in direct relation to the number and type of agreements entered into by such respondent. The estimated average reporting burden for the Foreign Donation Programs is 4 hours per response and for the McGovern-Dole Program is 4 hours per response.

Respondents: Private voluntary organizations, cooperatives, colleges and universities, foreign governments, and intergovernmental organizations

Estimated Number of Respondents: 11 per annum.

Estimated Number of Responses per Respondent: 2 per annum.

Estimated Total Annual Burden: 88 hours.

Copies of this information collection may be obtained from Kenneth Vernon, the Agency Information Collection Coordinator, at kenneth.vernon@usda.gov .

Requests for Comments: Send comments regarding (a) whether the information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption 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 those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be available without change, including any personal information provided, for inspection online at https://www.regulations.gov and at the mail address listed above between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.

Comments will be summarized and included in the submission for OMB approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact RARequest@usda.gov .

Title: Agriculture Wool Apparel Manufacturers Trust Fund.

OMB Control Number: 0551-0045.

Expiration Date of Approval: August 31, 2025.

Type of Request: Extension of a currently approved information collection.

Abstract: This information collection is required for affidavits submitted to FAS for claims against the Agriculture Wool Apparel Manufacturers Trust Fund. Claimants of the Agriculture Wool Apparel Manufacturers Trust Fund will be required to submit electronically a notarized affidavit and information pertaining to the production of worsted wool suits, suit-type jackets, or trousers for boys and men; or the weaving of wool yarn, wool fiber, or wool top.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average approximately 2 hours per response for affidavits related to the Agriculture Wool Apparel Manufacturers Trust Fund.

Type of Respondents: Under the Agriculture Wool Apparel Manufacturers Trust Fund there are four groups of potential respondents, as authorized by section 12315 of the Agriculture Act of 2014 (Pub. L. 113-79), and reauthorized under section 12603 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334): (1) Persons in the United States who produced worsted wool suits, suit-type jackets, or trousers for men and boys in the year prior to the application using worsted wool fabric of the kind described in headings 9902.51.11, 9902.51.15, or who wove worsted wool fabrics suitable for use in making men and boys suits under heading 9902.51.16 of the Harmonized Tariff Schedule of the United States; (2) Persons in the United States who processed wool yarn, wool fiber, or wool top of the kind described in headings 9902.51.13 or 9902.51.14 of the Harmonized Tariff Schedule of the United States in the year prior to the application; (3) Persons in the United States who wove worsted wool fabrics of the kind described in headings 9902.51.11 and or 9902.51.15 of the Harmonized Tariff Schedule of the United States in the year prior to the application and in the years 1999, 2000, and 2001; (4) Persons in the United States who manufactured certain wool articles made with certain imported wool products during calendar years 2000, 2001, and 2002; received a 2005 payment under section 505 of the Trade and Development Act of 2000; and who continue to be a manufacturer in the United States as provided for in section 505(a) of the Trade and Development Act of 2000.

Estimated Number of Respondents: 95.

Estimated Number of Responses: 95.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 260 hours.

Copies of this information collection can be obtained from Kenneth Vernon, the Agency Information Collection Coordinator, at kenneth.vernon@usda.gov .

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption 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 those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be available without change, including any personal information provided, for inspection online at https://www.regulations.gov and at the mail address listed above between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.

Comments will be summarized and included in the submission for Office of Management and Budget approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact RARequest@usda.gov .

Committee meetings are available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Angelica Trevino, Support Specialist, at atrevino@usccr.gov at least ten (10) days prior to the meeting.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Brooke Peery (DFO) at bpeery@usccr.gov .

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via www.facadatabase.gov under the Commission on Civil Rights, New Mexico Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov , or may contact the Regional Programs Coordination Unit at atrevino@usccr.gov .

Committee meetings are available to the public through a registration link (above). Any interested members of the public may attend committee meetings. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of each meeting will include a list of persons who are present. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email ebohor@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Evelyn Bohor at ebohor@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-202-656-8937.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, https://tinyurl.com/mnshz8n9. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at ebohor@usccr.gov.

This committee meeting is available to the public through the registration link above. Any interested members of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make an oral comment as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available by selecting “CC” in the meeting platform. To request additional accommodations, please email svillanueva@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received within 30 days following the meeting. Written comments may be emailed to David Barreras at dbarreras@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 656-8937.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website, https://bit.ly/4iU0Jhu. Persons interested in the work of this Committee are directed to the Commission's website, www.usccr.gov, or may contact the Regional Programs Coordination Unit at the above phone number.

On January 29, 2021, Commerce published in the Federal Register the antidumping duty order on fluid end blocks from Italy. 1 On March 5, 2024, Commerce published in the Federal Register the notice of initiation of the administrative review of the Order. 2 On May 7, 2024, Commerce selected Cogne Acciai Speciali S.p.A (Cogne) and Lucchini Mamé Forge S.p.A. 3 for individual examination as mandatory respondents in this administrative review. 4 On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days. 5 On September 9, 2024, Commerce extended the time limit for these preliminary results to February 6, 2025. 6 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by 90 days. 7 As a result, the deadline for these preliminary results is May 7, 2025. For a complete description of the events that occurred since the initiation of the administrative review, see the Preliminary Decision Memorandum. 8

A list of the topics discussed in the Preliminary Decision Memorandum is attached as the appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise subject to the Order are fluid end blocks from Italy. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(3), Commerce will rescind an administrative review when there are no reviewable suspended entries. Based on our analysis of U.S. Customs and Border Protection (CBP) information, we preliminarily determine that one company, ST9 Gas + Oil, LLC (ST9), had no entries of subject merchandise during the POR. On February 19, 2025, we notified parties of our intent to rescind this administrative review with respect to ST9, which has no reviewable suspended entries. 9 On March 3, 2025, the petitioners commented on our intent to rescind the review for ST9. 10 On March 7, 2025, Lucchini filed a response to the petitioners' rescission comments. 11 After considering these comments, we are rescinding the administrative review for the one company with no entries of subject merchandise during the POR, ST9.

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

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist for the period January 1, 2023, through December 31, 2023:

Commerce received a timely request from the petitioners to verify the information submitted in this administrative review, pursuant to 19 CFR 307(b)(1)(iv). 12 As provided in section 782(i)(3) of the Act, Commerce intends to verify information reported by Lucchini prior to issuing its final results.

We intend to disclose the calculations and analyses performed to interested parties for the preliminary results of review within five days of public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs or other written comments to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the verification report is issued in this administrative review. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 13 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case or rebuttal briefs in this administrative review must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 14

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 15 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the executive summary of each issue.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in case and rebuttal briefs. If a request for a hearing is made, parties will be notified of the date and time for the hearing. 16

All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed using ACCESS. 17 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the established deadline. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 18

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in written briefs, not later than 120 days after the date of publication of this notice in the Federal Register , pursuant to 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

Upon completion of the final results of this administrative review, pursuant to section 751(a)(2)(A) of the Act, Commerce shall determine and CBP shall assess antidumping duties on all appropriate entries of subject merchandise covered by this review. 19 If an examined respondent's weighted-average dumping margin is not zero or de minimis ( i.e., less than 0.5 percent) in the final results of this review, we intend to calculate an importer-specific assessment rate for antidumping duties based on the ratio of the total amount of dumping calculated for each importer's examined sales and the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). For the companies identified above that were not selected for individual examination, we will instruct CBP to assess antidumping duties at a rate equal to the weighted-average dumping margin established in the final results of review. If the respondent's weighted-average dumping margin or an importer-specific assessment rate is zero or de minimis in the final results of this review, we intend to instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

For entries of subject merchandise during the POR produced by either of the individually examined respondents for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate these entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 20

For the companies for which this review is rescinded with these preliminary results, we will instruct CBP to assess antidumping duties on all appropriate entries at a rate equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2023, through December 31, 2023, in accordance with 19 CFR 351.212(c)(l)(i). Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired, i.e., within 90 days of publication.

The final results of this administrative review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 21

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously investigated or reviewed companies not covered in this review, the cash deposit rate will continue to be the company-specific cash deposit rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, a prior review, or the investigation of sales at less-than-fair-value (LTFV), but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 7.33 percent, the all-others rate established in the LTFV investigation. 22 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of countervailing duties.

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

Between March 6, 2019, and May 2, 2019, Commerce published in the Federal Register the AD orders on LDWP from Canada, China, Greece, India, Korea, and Türkiye and CVD orders on LDWP from China, India, Korea, and Türkiye. 1 On February 1, 2024, the ITC instituted, 2 and Commerce initiated, 3 the first sunset review of the Orders, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). As a result of its reviews, Commerce determined that revocation of the Orders would likely lead to the continuation or recurrence of dumping and countervailable subsidies, and therefore, notified the ITC of the magnitude of the margins of dumping and subsidy rates likely to prevail should the Orders be revoked. 4

On May 2, 2025, the ITC published its determination, pursuant to section 751(c) of the Act, that revocation of the Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The product covered by the Orders is LDWP from Canada, China, Greece, India, South Korea, and Turkey. For a complete description of the scopes of the Orders, see the appendix to this notice.

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

The effective date of the continuation of the Orders will be May 2, 2025. 6 Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year reviews of the Orders not later than 30 days prior to fifth anniversary of the date of the last determination by the ITC.

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

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

On October 10, 2024, Commerce published the Preliminary Results and invited interested parties to comment. 1 On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days. 2 On December 9, 2024, Commerce tolled certain deadlines in this administrative review by 90 days. 3 As a result, the deadline for these final results of review is May 8, 2025. For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 4

Commerce is conducting this administrative review in accordance with section 751(a) of Tariff Act of 1930, as amended (the Act).

The merchandise covered by the Order is methionine from Spain. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

All issues raised in the case and rebuttal briefs filed by parties are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum are provided in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

For these final results, we determine that the following estimated weighted-average dumping margins exist for the POR, September 1, 2022, through August 31, 2023:

Normally, Commerce discloses to interested parties the calculations performed in connection with the final results of review within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b). However, because we made no changes from the Preliminary Results, there are no new calculations to disclose.

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. Pursuant to 19 CFR 351.212(b)(1), we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for examined sales to each importer to the total entered value of those sales. Where an importer-specific assessment rate is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. Pursuant to a refinement to Commerce's assessment practice, for subject merchandise that was entered into the United States, or withdrawn from warehouse, for consumption during the POR, that was produced or exported by Adisseo España for which Adisseo España did not report the sale in its U.S. sales database, we will instruct CBP to liquidate the entry of such merchandise at the all-others rate ( i.e., 37.53 percent)  6 if there is no rate for the intermediate company(ies) involved in the transaction. 7

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

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice in the Federal Register , as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for companies subject to this review will be equal to the weighted-average dumping margin listed in the “Final Results of Review” section above; (2) for merchandise that was exported by a company that is not under review and the company has a company-specific cash deposit rate from a completed segment of this proceeding, the cash deposit rate will continue to be the company-specific cash deposit rate from a completed segment of the proceeding that is currently applicable to the company; (3) if the exporter of the subject merchandise was not covered by this review or a previously completed segment of this proceeding, but the producer of the subject merchandise was covered, then the cash deposit rate will be equal to the company-specific cash deposit rate from a completed segment of this proceeding that is currently applicable to the producer of the subject merchandise; and (4) if neither the exporter nor the producer of the subject merchandise was covered by this review or a previously completed segment of this proceeding, then the cash deposit rate will be 37.53 percent ad valorem, the all-others rate established in the less than fair value investigation. 8 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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

We are issuing and publishing these final results of review and this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 351.221(b)(5).

On January 29, 2021, Commerce published the antidumping duty order on FEBs from Germany. 1 On January 31, 2024, Commerce received requests for an administrative review from BGH Edelstahl Siegen GmbH (BGH) and the Ellwood City Forge Company, Ellwood Quality Steels Company, Ellwood National Steel Company, and A. Finkl & Sons (the petitioners). 2 On March 5, 2023, in accordance with 19 CFR 351.221(c)(1)(i), Commerce initiated an administrative review of the Order, covering BGH. 3 On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days. 4 On September 30, 2024, Commerce extended the time period for issuing the preliminary results. 5 On December 9, 2024, Commerce tolled the deadline to issue the preliminary results in this administrative review by 90 days. Accordingly, the deadline for the preliminary results of this review is now May 7, 2025. 6

For a detailed description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 7 A list of topics discussed in the Preliminary Decision Memorandum is attached as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is available via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The products covered by this Order are fluid end blocks from Germany. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). We calculated export price (EP) in accordance with section 772(a) of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum.

We preliminarily determine the following estimated weighted-average dumping margins for the period January 1, 2023, through December 31, 2023:

We intend to disclose the calculations and analyses performed to interested parties for the preliminary results of review within five days of public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Pursuant to 19 CFR 351.309(c)(1)(ii), we have modified the deadline for interested parties to submit case briefs to Commerce to no later than 21 days after the date of the publication of this notice. 8 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 9 Interested parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) a table of contents listing each issue; and (2) a table of authorities. 10 All briefs must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety in ACCESS by 5:00 p.m. Eastern Time on the established deadline.

As provided to 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this administrative review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 11 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. All submissions should be filed using ACCESS, 12 and must be served on interested parties. 13 Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 14

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues the party intends to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, parties will be notified of the date and time for the hearing. 15

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

Upon completion of the final results of this administrative review, pursuant to section 751(a)(2)(A) of the Act, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review. 16 If an individually examined respondent's weighted-average dumping margin is not zero or de minimis ( i.e., less than 0.50 percent) in the final results of this review, we intend to calculate an importer-specific assessment rate for antidumping duties based on the ratio of the total amount of dumping calculated for each importer's examined sales and the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). 17 If the respondent's weighted-average dumping margin or an importer-specific assessment rate is zero or de minimis in the final results of this review, we intend to instruct CBP to liquidate the appropriate entries without regard to antidumping duties. 18

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

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

The final results of this administrative review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 22 Commerce intends to issue assessment instructions regarding the individually examined respondents to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired, i.e., within 90 days of publication.

On October 10, 2024, Commerce published the Preliminary Results of this administrative review in the Federal Register and invited interested parties to comment. 1 On February 25, 2025, Commerce released a Post-Preliminary Analysis Memorandum. 2 On December 9, 2024, Commerce tolled the deadline to issue the final results in this administrative review by 90 days. 3 Accordingly, the deadline for these final results is now May 8, 2025.

For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 4 A list of topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The product covered by this Order is lined paper. For a complete description of the scope of this Order, see the Issues and Decision Memorandum.

Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 6 The subsidy programs under review, and the issues raised in case and rebuttal briefs submitted by the interested parties, are discussed in the Issues and Decision Memorandum.

On August 12, 2024, Commerce published the Preliminary Results and invited interested parties to comment. 1 On November 25, 2024, we extended the deadline for these final results to no later than February 7, 2025. 2 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by 90 days. 3 The deadline for these final results is now May 8, 2025. For a complete description of the events that followed the Preliminary Results, see the Issues and Decision Memorandum. 4 Commerce conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The product covered by the Order is steel nails from Korea. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on comments received from interested parties, we made certain changes to the margin calculations for Korea Wire Co., Ltd. (KOWIRE) and Nailtech Co., Ltd. (Nailtech) from the Preliminary Results. 6

Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the weighted-average dumping margin for respondents that were not individually examined in an administrative review. Section 735(c)(5)(A) of the Act provides that the all-others rate should be calculated by weight averaging the weighted-average dumping margins determined for individually examined respondents, excluding rates that are zero, de minimis, or based entirely on facts available.

We calculated a weighted-average dumping margin of zero for one of the two mandatory respondents, KOWIRE. Therefore, we have assigned a dumping margin to the companies not selected for individual examination in this review based on the rate calculated for the other mandatory respondent, Nailtech. See Appendix II.

As a result of this review, we determine that the following estimated weighted-average dumping margins exist for the period July 1, 2022, through June 30, 2023:

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

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by the final results of this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication date of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

Nailtech did not report the actual entered value for its U.S. sales; thus, we calculated importer-specific per-unit duty assessment rates by aggregating the total amount of antidumping duties calculated for the examined sales and dividing this amount by the total quantity of those sales. Where an importer-specific ad valorem assessment rate is zero or de minimis, or a respondent's weighted-average dumping margin is zero or de minimis, Commerce will instruct CBP to liquidate appropriate entries without regard to antidumping duties. 8

Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by KOWIRE or Nailtech for which the reviewed companies did not know that the merchandise they sold to the intermediary ( i.e., a reseller, trading company, or exporter) was destined for the United States. 9 In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 10

Finally, for the companies not selected for individual examination, we will assign an assessment rate based on the review-specific rate, calculated as noted in the “Rate for Respondents Not Selected for Individual Examination” section, above. 11

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on, or after, the date of publication of this notice in the Federal Register , as provided for by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be equal to the weighted-average dumping margin established in the final results of this review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously investigated or reviewed companies not covered in this review, the cash deposit rate will continue to be the company-specific cash deposit rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value (LTFV) investigation, but the manufacturer is, then the cash deposit rate will be the rate established for the most recent segment for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 11.80 percent, the all-others rate established in the LTFV investigation. 12 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On January 2, 2024, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the antidumping duty order on wooden bedroom furniture (WBF) from China. 1 After receiving multiple review requests, 2 Commerce initiated this review. 3 In March and April 2024, various companies/company groupings submitted no shipment certifications. 4 Also in March and April 2024, various companies filed separate rate applications or certifications, along with responses to Commerce's quantity and value questionnaire and certain additional information requested in a document package on Commerce's website. In May and June 2024, interested parties timely withdrew all review requests for 23 companies/company groupings under review. 5

On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days. 6 On October 8, 2024, Commerce extended the deadline for issuing the preliminary results of this review until February 6, 2025. 7 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by an additional 90 days. 8 The deadline for the preliminary results of this review is now May 7, 2025.

The product covered by the Order is WBF, subject to certain exceptions. For a complete description of the scope of the Order, see Appendix I.

Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213. Additionally, given that the analysis underlying these preliminary results of review are contained herein, no decision memoranda accompany this Federal Register notice.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if a party that requested a review, withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review in the Federal Register . Interested parties timely withdrew all review requests for 25 companies/company groupings for which Commerce initiated this review. Therefore, in accordance with 19 CFR 351.213(d)(1), Commerce is rescinding this review of the Order with respect to all the companies/company groupings listed in appendix II.

Pursuant to 19 CFR 351.212(a), “{g}enerally, the amount of duties to be assessed is determined in a review of the order covering a discrete period of time.” Thus, normally, upon completion of an administrative review, suspended entries of subject merchandise are liquidated at the antidumping duty assessment rate calculated for the review period. 9 Therefore, in order to apply the final antidumping duty liability that was determined in an administrative review for a particular company, there must be at least one suspended entry of that company's subject merchandise that Commerce can instruct U.S. Customs and Border Protection (CBP) to liquidate at the antidumping duty assessment rate calculated for the review period. Pursuant to 19 CFR 351.213(d)(3), Commerce may rescind an administrative review if it concludes that, during the period covered by the review, there were no entries, exports, or sales of the subject merchandise, as the case may be. 10

Because the entry data that we obtained from U.S. Customs and Border Protection (CBP) showed no suspended entries of subject merchandise from the nine companies identified in Appendix III, on January 6, 2025, we notified parties of our intent to rescind this administrative review with respect to those companies. 11 No one commented on our intent to rescind this review with respect to these companies. Therefore, in the absence of any suspended entries of subject merchandise during the POR from the companies listed in Appendix III, we are rescinding this administrative review with respect to these companies, in accordance with 19 CFR 351.213(d)(3).

In the Initiation Notice, we informed parties that all firms for which a non-market economy (NME) review was initiated that wished to qualify for separate rate status must complete, as appropriate, either a separate rate application or a separate rate certification. 12 While Shenzhen New Fudu Furniture Co., Ltd. claimed that it “made no exports, sales, shipments, or entries of any subject merchandise . . . during the . . . period of review,”  13 record evidence contradicts this claim, namely CBP entry data. 14 Shenzhen New Fudu Furniture Co., Ltd. failed to comment on this evidence or provide a separate rate application or certification. Therefore, Commerce preliminarily determines that New Fudu Furniture Co., Ltd. failed to demonstrate that it qualifies for separate rate status, and thus is part of the China-wide entity.

Additionally, CBP entry data for the POR show no entries of subject merchandise from the following seven companies for which Commerce initiated this review and which do not have a separate rate: (1) Dorbest Ltd.; (2) Fine Furniture (Shanghai) Ltd.; (3) Rui Feng Lumber Development Co., Ltd.; (4) Rui Feng Woodwork Co., Ltd.; (5) Wanvog Furniture (Kunshan) Co., Ltd.; (6) Yeh Brothers World Trade Inc.; and (7) Zhongshan Fookyik Furniture Co., Ltd.

Because there were no entries of subject merchandise from these companies during the POR for Commerce to examine in this administrative review, and these companies did not have a separate rate, these companies remain in the China-wide entity.

Commerce's policy regarding conditional review of the China-wide entity applies to this administrative review. 15 Under this policy, the China-wide entity will not be under review unless a party specifically requests, or Commerce self-initiates, a review of the entity. Because no party requested a review of the China-wide entity, the entity is not under review and the weighted-average dumping margin assigned to the China-wide entity is not subject to change as a result of this administrative review.

Normally, Commerce discloses to parties to the proceeding the calculations that it performed in connection with a preliminary results of review within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary results of review in the Federal Register , in accordance with 19 CFR 351.224(b). However, because Commerce did not calculate any dumping margins in this review, there are no calculations to disclose.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Pursuant to 19 CFR 351.309(c)(1)(ii), we have modified the deadline for interested parties to submit case briefs to Commerce to no later than 21 days after the date of the publication of this notice. 16 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 17 Interested parties who submit case briefs or rebuttal briefs in this review must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 18

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 19 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 20

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Requests should contain: (1) the requesting party's name, address, and telephone number; (2) the number of individuals associated with the requesting party that will attend the hearing and whether any of those individuals is a foreign national; and (3) a list of the issues the party intends to discuss at the hearing. Issues raised in the hearing will be limited to those raised in the respective case briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a date and time to be determined. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice in the Federal Register .

Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review. 21 We will instruct CBP to liquidate POR entries of subject merchandise exported by the companies/company groupings for which we rescinded the review at the cash deposit rate required at the time of entry or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(l)(i). We will issue this instruction to CBP no earlier than 35 days after the date of publication of this notice in the Federal Register .

If we do not alter these preliminary results of review, we intend to instruct CBP to liquidate entries of subject merchandise exported by the companies that failed to qualify for a separate rate at the China-wide entity rate. We will issue this instruction to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register .

If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements for estimated antidumping duties will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the notice of the final results of this administrative review in the Federal Register as provided by section 751(a)(2)(C) of the Act: (1) for any previously investigated or reviewed China or non-China exporter that has a separate rate, the cash deposit rate will continue to be the exporter's existing cash deposit rate; (2) for all China exporters of subject merchandise that do not have a separate rate, including those exporters that failed to establish their separate rate eligibility in this review, the cash deposit rate will be equal to the dumping margin assigned to the China-wide entity, which is 216.01 percent; and (3) for all non-China exporters of subject merchandise that do not have a separate rate, the cash deposit rate will be equal to the dumping margin applicable to the China exporter(s) that supplied that non-China exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in case and rebuttal briefs, within 120 days of publication of these preliminary results of review in the Federal Register , pursuant to section 751(a)(3)(A) of the Act.

This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(2) and 351.221(b)(4).

On August 13, 2024, Commerce published in the Federal Register the Preliminary Results of the 2022-2023 administrative review of the antidumping duty order on PET film from Taiwan. 1 We verified the sales information submitted by Nan Ya Plastics Corporation (Nan Ya) in October 2024. 2 On November 1, 2024, we released our verification report regarding the sales information of Nan Ya. 3 We invited interested parties to submit case and rebuttal briefs;  4 however, no interested party submitted case or rebuttal briefs. On December 6, 2024, Commerce extended the deadline for these final results to February 7, 2025. 5 On December 9, 2025, Commerce tolled the deadline for these final results by 90 days. 6 Accordingly, the deadline for these final results is now due May 8, 2025. Because no interested party submitted comments, the final results of this review remain unchanged from the Preliminary Results and no Issues and Decision Memorandum accompanies this notice.

The merchandise subject to the Order is PET film. For a full description of the scope, see the Preliminary Decision Memorandum.

In the Preliminary Results, Commerce determined that Shinkong Materials Technology Corporation (SMTC)/Shinkong Synthetic Fibers Corporation (SSFC) (collectively, SMTC/SSFC)  8 had no shipments of PET film during the POR, based on U.S. Customs and Border Protection (CBP) entry data for U.S. imports of PET film from Taiwan during the POR. 9 We received no comments from interested parties on our preliminary finding. As there is no information on the record that calls into question the findings in the Preliminary Results, we continue to find in the final results of this review that SMTC/SSFC had no shipments of subject merchandise during the POR.

• We used the revised home market database incorporating the minor corrections accepted at verification.

• We used the revised U.S. sales database incorporating the minor corrections accepted at verification.

• We added language to include document courier fees and customs random check charges in our direct selling expenses which were originally not captured from the U.S. sales database.

In the Preliminary Results, we determined that Nan Ya did not make sales of subject merchandise at less than NV during the POR. As noted above, Commerce received no comments concerning the Preliminary Results. Therefore, for these final results, we continue to determine the final weighted-average dumping margin for the period July 1, 2022, through June 30, 2023, for Nan Ya is as follows:

Commerce intends to disclose the calculations performed in connection with these final results to interested parties within five days of any public announcement or, if there is no public announcement, within five days after the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries in this review, in accordance with section 751(a)(2)(C) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.212(b)(1). Because we calculated a zero percent margin in the final results of this review for Nan Ya, in accordance with 19 CFR 351.212, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. In addition, as Commerce continues to find that SMTC/SSFC did not have any shipments of subject merchandise during the POR, we will instruct CBP to liquidate any suspended entries of subject merchandise associated with SMTC/SSFC at the all-others rate of 2.40 percent.

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

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Nan Ya will be zero, the rate established in the final results of this review; (2) for previously reviewed or investigated companies not covered in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this or any previous review or in the original less-than-fair-value (LTFV) investigation but the producer is, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; and (4) if neither the exporter nor the producer is a firm covered in this or any previous review or the LTFV investigation, the cash deposit rate will continue to be 2.40 percent, which is the all-others rate established by Commerce in the LTFV investigation. 11 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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

These results are being issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 351.221(b)(5).

Pursuant to 16 U.S.C. 971b, the Advisory Committee to the U.S. Section to ICCAT will meet in open session to receive and discuss information on the outcomes of ICCAT's 2024 annual meeting and the U.S. implementation of ICCAT decisions; ICCAT intersessional meetings in 2025; relevant NMFS research and monitoring activities; and other matters relating to the international management of ICCAT species. The public will have virtual access to the open sessions of the meeting, but there will be no opportunity for public comment during the meeting. An agenda is available from the Committee's Executive Secretary upon request (see FOR FURTHER INFORMATION CONTACT section). The Committee will meet in its Species Working Groups in closed session in the afternoon of June 2, 2025, and in the morning of June 3, 2025.

The meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to Bryan Keller (see FOR FURTHER INFORMATION CONTACT section) at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 971 et seq.; 16 U.S.C. 1801 et seq.

The requested LOCs have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and the regulations governing the taking and importing of marine mammals (50 CFR part 216). The General Authorization allows for bona fide scientific research that may result only in taking by Level B harassment of marine mammals. The following LOCs were issued in the calendar year 2024 (January 1, 2024—December 31, 2024).

File No. 22587-01: This LOC, held by Dolphin Research Center (Principal Investigator [PI]: Armando Rodriguez), P.O. Box 522875, Marathon Shores, Florida 33052, was extended on January 30, 2024, while the holder's new application was in process. The LOC authorizes the use of vessel and unmanned aerial systems (UAS) for photo-identification, behavioral observations, photography, photogrammetry, passive acoustic recordings, and breath sampling of bottlenose dolphins ( Tursiops truncatus ) in the middle Florida Keys. The objective of the research is to evaluate the health, behavior, and structure of the local dolphin population. The objectives of the research did not change. The LOC was subsequently terminated on March 15, 2024, when a separate LOC was issued (No. 27595, see below).

File No. 27595: Issued to Dolphin Research Center (PI: Armando Rodriguez), 58901 Overseas Highway, Grassy Key, Florida 33050, on March 15, 2024. The LOC authorizes research on bottlenose dolphins in the middle Florida Keys using vessel surveys for counts, photo-identification, passive acoustic recording, behavioral observations, and unmanned aircraft flights for photogrammetry and breath sampling. The objectives of the research are to establish a cohesive estimation of the distribution, residency, behavior, health, and movement patterns for bottlenose dolphins in the middle Florida Keys. The LOC expires March 15, 2029.

File No. 27917: Issued to Melissa Laurino, Cape May Marine Mammal Research Center, P.O. Box 474, Cape May, New Jersey 08204, on March 26, 2024. The LOC authorizes research on bottlenose dolphins, harbor porpoises ( Phocoena phocoena ), and humpback whales ( Megaptera novaeangliae ) in Delaware Bay and adjacent Atlantic waters off Cape May, New Jersey using vessel surveys for counts, photo-identification, and behavioral observations. The main objective of the research is to assess site fidelity, distribution and abundance, habitat utilization, foraging and mating ecology, social structure and networks, anthropogenic interactions, and general health. The LOC expires March 31, 2029.

File No. 23546: This LOC, held by Donna Hauser, Ph.D., University of Alaska Fairbanks, 2160 Koyukuk Drive, Fairbanks, Alaska 99775, was extended on April 11, 2024. The LOC authorizes the close approach of spotted seals ( Phoca largha, Alaska stock) in coastal haulouts in the Chukchi and Beaufort Seas of northern Alaska using ground and UAS surveys to conduct photo-identification, behavioral observations and monitoring, and remote video monitoring. Research objectives are to investigate the distribution, habitat use, foraging ecology, health, population structure, behavior, and abundance. Scat, spew, shed skin or hair may also be collected. The extended LOC expires on April 1, 2026.

File No. 27902: Issued to Tara Cox, Ph.D., Savannah State University, P.O. Box 20467, Savannah, Georgia 31404, on April 18, 2024, with an effective date of June 1, 2024. This LOC authorizes vessel or unmanned aircraft systems surveys for close approach, photo-identification, behavioral observations, and passive acoustic recordings within Georgia waters and the adjacent Atlantic Ocean. Research objectives are to understand the social structure, foraging ecology, life history, and population structure of bottlenose, pantropical spotted ( Stenella attenuata ), and Atlantic spotted ( S. frontalis ) dolphins. The LOC expires on May 31, 2029.

File No. 27920: Issued to the Texas Marine Mammal Stranding Network (Responsible Party [RP]: Heidi Whitehead), 4700 Avenue U, Galveston, Texas 77551, on April 22, 2024. The LOC authorizes research on bottlenose dolphins in Texas waters using vessel surveys for counts, photo-identification, photography/videography, and behavioral observations. The objectives of the research are to (1) augment current photo-identification catalogs and inform spatial capture-mark-recapture analysis, (2) examine dolphin spatiotemporal habitat-use and site fidelity, (3) study dolphin behavioral ecology, and (4) assess injuries to identify localized anthropogenic risks to stocks. The LOC expires April 30, 2029.

File No. 27369: Issued to Stephen McCulloch, Protect Wild Dolphins Alliance, Inc., 307 Saint Thomas Avenue, Key Largo, Florida 33037, on August 14, 2023. This LOC authorizes research to estimate abundance, determine distribution patterns, assess habitat use, and evaluate site fidelity of bottlenose dolphins inhabiting the Upper Florida Keys. Authorized activities include close approach by vessel, for counts, photography, photo-identification, video recordings, behavioral observations, and underwater photography/videography by pole camera. This LOC was amended on April 26, 2024, to authorize passive acoustic monitoring to study dolphin communication. The LOC expires on August 31, 2028.

File No. 27993: Issued to Alaska Department of Fish and Game (RP: Lori Polasek, Ph.D.), P.O. Box 115526, Juneau, Alaska 99811-5526 on May 9, 2024. This LOC authorizes close approach by vessel, manned aerial, and UAS surveys for counts, photo-identification, and behavioral observations of harbor porpoise within southeast Alaska waters. Unintentional harassment of unidentified cetaceans and pinnipeds may occur during surveys. Research objectives are to derive estimates of abundance, density, and population structure of harbor porpoise stocks. The LOC expires on May 14, 2029.

File No. 23782-01: Issued to Janet Mann, Ph.D., Georgetown University, Department of Biology, Reiss Science Room 406, 3700 O St. NW, Washington, District of Columbia 20057, on June 7, 2024. This amended LOC authorizes photogrammetry and adds a new study objective to conduct sex-specific growth assessments of bottlenose dolphins ( Tursiops spp.) in the lower Potomac River, Virginia, following the 2015 Unusual Mortality Event. Additionally, the LOC was extended, to expire on June 30, 2026.

File No. 22856-01: This LOC, held by Patricia Fair, Ph.D., South Carolina Aquarium, 100 Aquarium Wharf, Charleston, South Carolina 29401 was extended on July 22, 2024, while the holder's new application (File No. 28083) is in process. The LOC authorizes vessel and UAS-based research for photo-identification, photogrammetry, and behavioral observations of bottlenose dolphins in waters near Charleston, South Carolina. The objectives of the research would not change. The extended LOC was set to expire on August 31, 2025. However, it was subsequently terminated on January 29, 2025, when a separate LOC was issued (No. 28083).

File No. 28117: Issued to Joseph Warren, Ph.D., Stony Brook University, Stony Brook, New York 11794, on November 14, 2024. This LOC authorizes photogrammetry, photography, video, counts, and observations during shore-based UAS flights off Long Island, New York. The objective of the research is to study marine mammals and their prey in New York's nearshore environment, including abundance, distribution, size, foraging dynamics, and surface behaviors. Targeted species include bottlenose and Atlantic white-sided dolphins, harbor porpoise, humpback and minke ( Balaenoptera acutorostrata ) whales, and gray ( Halichoerus grypus ) and harbor ( Phoca vitulina ) seals. The LOC expires on December 31, 2027.

File No. 28261: Issued to Institute for Marine Mammal Studies (RP: Mobashir Solangi, Ph.D.), 10801 Dolphin Lane, Gulfport, MS 39503 on December 11, 2024. This LOC authorizes counts, photo-identification, photography/videography, behavioral observations, and passive acoustic recordings of Atlantic spotted ( Stenella frontalis ), bottlenose, pantropical spotted ( Stenella attenuata ), and spinner ( Stenella longirostris ) dolphins; and pygmy sperm whales ( Kogia breviceps ) during vessel and aerial surveys within coastal and estuarine waters of Mississippi, Louisiana, and Alabama. The objective of the research is to evaluate the long-term population trends, behavior, acoustics, and health of cetaceans utilizing the study area. The LOC expires on December 15, 2029.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), a final determination has been made that the activities are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ) and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The applicant requests a 1-year permit to film Weddell seals ( Leptonychotes weddellii ), crabeater seals ( Lobodon carcinophagus ), and leopard seals ( Hydrurga leptonyx ) in Antarctica for an episode of “Blue Planet III”. Up to 300 Weddell seals and 50 each crabeater and leopard seals may be filming by underwater, land-based, and unmanned aircraft system platforms.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

Correction

Notice of the hybrid meeting was published in the Federal Register on Wednesday, April 30, 2025, in FR Doc. 2025-07481 at 90 FR 17913-17915. The meeting notice is being amended to update the supplementary information to revise to reflect the new time for these meetings. On page 17914 in the 3rd column make the following correction to the times of the Open and Closed sessions. The Committee on Standards, Design and Methodology Closed Session originally scheduled for Friday, May 16, 2025, 9:05 a.m. to 10:15 a.m. will now be held from 9:05 a.m. to 10:00 a.m., and the Open Session originally scheduled for Friday, May 16, 2025, 10:15 a.m. to 11:00 a.m. will now be held from 10:00 a.m. to 11:00 a.m. The meeting will end at the 11:00 a.m. as originally announced.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: 2026-2027 Free Application for Federal Student Aid.

OMB Control Number: 1845-0001.

Type of Review: A revision of a currently approved ICR.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 31,791,647.

Total Estimated Number of Annual Burden Hours: 20,412,753.

Abstract: Section 483, of the Higher Education Act of 1965, as amended (HEA), mandates that the Secretary of Education “. . . shall produce, distribute, and process free of charge common financial reporting forms as described in this subsection to be used for application and reapplication to determine the need and eligibility of a student for financial assistance . . .”.

The determination of need and eligibility are for the following Title IV, HEA, federal student financial assistance programs: the Federal Pell Grant Program; the Campus-Based programs (Federal Supplemental Educational Opportunity Grant (FSEOG) and Federal Work-Study (FWS)),; the William D. Ford Federal Direct Loan (Direct Loan) Program; the Teacher Education Assistance for College and Higher Education (TEACH) Grant; the Children of Fallen Heroes Scholarship; and the Iraq and Afghanistan Service Grant.

Federal Student Aid (FSA), an office of the U.S. Department of Education, subsequently developed an application process to collect and process the data necessary to determine a student's eligibility to receive Title IV, HEA program assistance. The application process involves an applicant's submission of the Free Application for Federal Student Aid (FAFSA®). After submission and processing of the FAFSA form, an applicant receives a FAFSA Submission Summary, which is a summary of the processed data they submitted on the FAFSA form. The applicant reviews the FAFSA Submission Summary, and, if necessary, will make corrections or updates to their submitted FAFSA data. Institutions of higher education listed by the applicant on the FAFSA form also receive a summary of processed data submitted on the FAFSA form which is called the Institutional Student Information Record (ISIR).

ED and FSA seek OMB approval of all application components as a single “collection of information.” The aggregate burden will be accounted for under OMB Control Number 1845-0001. The specific application components, descriptions, and submission methods for each are listed in Table 1.

This information collection also documents an estimate of the annual public burden as it relates to the application process for federal student aid. The Applicant Burden Model (ABM) measures applicant burden through an assessment of the activities each applicant conducts in conjunction with other applicant characteristics and, in terms of burden, the average applicant's experience. Key determinants of the ABM include:

• The total number of applicants that will potentially apply for federal student aid;

• How the applicant chooses to complete and submit the FAFSA form ( e.g., by paper or electronically);

• How the applicant chooses to submit any corrections and/or updates ( e.g., the paper FAFSA Submission Summary or electronically);

• The type of FAFSA Submission Summary document the applicant receives (paper or electronic);

• The formula applied to determine the applicant's student aid index (SAI); and

• The average amount of time involved in preparing to complete the application.

The ABM is largely driven by the number of potential applicants for the application cycle. The total application projection for 2026-2027 is based on the projected total enrollment into post-secondary education for Fall 2026. The ABM is also based on the application options available to students and parents. ED accounts for each application component based on analytical tools, survey information and other ED data sources.

For 2026-2027, ED is reporting a net burden decrease of 2,004,707 hours.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product ADBRY (tralokinumab). ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Subsequent to this approval, the USPTO received a patent term restoration application for ADBRY (U.S. Patent No. 7,935,343) from MedImmune Ltd., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2023, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ADBRY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ADBRY is 5,046 days. Of this time, 4,436 days occurred during the testing phase of the regulatory review period, while 610 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: March 6, 2008. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on March 6, 2008.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 27, 2020. FDA has verified the applicant's claim that the biologics license application (BLA) for ADBRY (BLA 761180) was initially submitted on April 27, 2020.

3. The date the application was approved: December 27, 2021. FDA has verified the applicant's claim that BLA 761180 was approved on December 27, 2021.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device SKINVIVE. SKINVIVE is indicated for intradermal injection to improve facial skin smoothness of the cheeks in adults over the age of 21. Subsequent to this approval, the USPTO received a patent term restoration application for SKINVIVE (U.S. Patent No. 11,260,015) from Allergan Industrie, SAS, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 7, 2024, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of SKINVIVE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SKINVIVE is 1,842 days. Of this time, 1,055 days occurred during the testing phase of the regulatory review period, while 787 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: April 27, 2018. FDA has verified the applicant's claim that the date the investigational device exemption for human tests to begin, as required under section 520(g) of the FD&C Act, became effective April 27, 2018.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 16, 2021. The applicant claims February 23, 2021, as the date the premarket approval application (PMA) for SKINVIVE (PMA P110033/S059) was initially submitted. However, FDA records indicate that PMA P110033/S059 was submitted on March 16, 2021.

3. The date the application was approved: May 11, 2023. FDA has verified the applicant's claim that PMA P110033/S059 was approved on May 11, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 435 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product OMVOH (mirikizumab). OMVOH is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Subsequent to this approval, the USPTO received a patent term restoration application for OMVOH (U.S. Patent No. 9,023,358) from Eli Lilly and Co., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 8, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of OMVOH represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for OMVOH is 2,984 days. Of this time, 2,408 days occurred during the testing phase of the regulatory review period, while 576 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 27, 2015. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 27, 2015.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): March 30, 2022. FDA has verified the applicant's claim that the biologics license application (BLA) for OMVOH (BLA B761279) was initially submitted on March 30, 2022.

3. The date the application was approved: October 26, 2023. FDA has verified the applicant's claim that BLA B761279 was approved on October 26, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,332 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product EPKINLY (epcoritamab-bysp). EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Subsequent to this approval, the USPTO received patent term restoration applications for EPKINLY (U.S. Patent Nos. 10,465,006 and 10,544,220) from Genmab A/S, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of EPKINLY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for EPKINLY is 1,909 days. Of this time, 1,668 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February 27, 2018. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 27, 2018.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): September 21, 2022. FDA has verified the applicant's claim that the biologics license application (BLA) for EPKINLY (BLA B761324) was initially submitted on September 21, 2022.

3. The date the application was approved: May 19, 2023. FDA has verified the applicant's claim that BLA B761324 was approved on May 19, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 675 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Section 412(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient content of infant formulas. Under section 412(i)(2) of the FD&C Act, the Secretary of Health and Human Services is authorized to revise the list of required nutrients and the required level for any required nutrient. In addition, section 412(i)(1) of the FD&C Act requires the Secretary to review the table of required nutrients “every 4 years as appropriate,” taking into consideration “any new scientific data or information related to infant formula nutrients, including international infant formula standards.” These authorities have been delegated to the Commissioner of Food and Drugs. The table in section 412(i) of the FD&C Act and FDA regulations at 21 CFR 107.100 specify that infant formulas must contain 30 nutrients; minimum levels for each nutrient and maximum levels for 10 of the nutrients are also specified.

Although FDA regularly reviews individual nutrient requirements for infant formula, our last comprehensive review was in 1998 (Ref. 1). We last updated the table in 21 CFR 107.100 in 2015 to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula (80 FR 35834 (June 23, 2015)).

On March 18, 2025, the Department of Health and Human Services and FDA announced “Operation Stork Speed” to expand options for safe, reliable, and nutritious infant formula for American families. As part of Operation Stork Speed, FDA announced a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. We are also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of infant formula—which is often the sole source of nutrition for infants—remains available for one of our nation's most vulnerable populations.

FDA is issuing this request for information to begin the nutrient review process for infant formula intended for healthy, full-term infants. Specifically, FDA is interested in information that would help us determine whether there is a need to revise the existing nutrient requirements in 21 CFR 107.100, taking into consideration any new scientific data or information related to infant formula nutrients, including international infant formula standards. For purposes of this request for information, the term “nutrient” means any vitamin, mineral, or other substance or ingredient that is required in accordance with the table set out in section 412(i)(1) of the FD&C Act or by 21 CFR 107.100, or that is identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or that has been identified as essential for infants by FDA through a Federal Register publication (see 21 CFR 106.3 (definition of “nutrient”)). We invite comment on the questions below. Please explain your answers and provide references and data, if possible.

1. What new scientific data or information since the 1998 comprehensive assessment (Ref. 1) should we consider regarding nutrient requirements for healthy, full-term infants that are associated with positive short- and/or long-term health outcomes?

2. What scientific data or information have emerged since the 1998 comprehensive assessment (Ref. 1) regarding nutrient intakes for healthy, full-term infants that are associated with poor short- and/or long-term health outcomes?

3. Which existing nutrients required in 21 CFR 107.100 should we review? Please explain your rationale.

4. For the nutrients required in 21 CFR 107.100, what, if any, adjustments should be made to existing minimum or maximum levels? For the 20 nutrients with only a minimum level, which, if any, should have a maximum level added? Please explain your rationale. For example, describe how changes might positively impact health outcomes.

5. What other nutrients ( e.g., docosahexaenoic acid and arachidonic acid) or specifications for nutrients ( e.g., ratio of linoleic acid to alpha-linolenic acid), if any, should we consider adding to 21 CFR 107.100? Please explain your rationale.

6. Which nutrients, if any, should we remove from 21 CFR 107.100? Please explain your rationale.

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

The Office of Population Affairs (OPA), within the Office of the Assistant Secretary for Health, seeks approval for a reinstatement with changes for their encounter level data collection for the Family Planning Annual Report (FPAR). This was previously approved by OMB under OMB No. 0990-0479, (expiration February 28, 2025). Annual submission of the FPAR is required of all Title X Family Planning Services grantees for purposes of monitoring and reporting program performance.

OPA's Title X Family Planning Program is the only federal grant program dedicated solely to providing comprehensive family planning and related preventive health services. The FPAR is the only source of annual, uniform reporting by all Title X services grantees funded under Section 300 of the Public Health Service Act. The FPAR 2.0 system provides consistent, national-level data on the Title X Family Planning program and its users. OPA assembles and analyzes comparable and relevant program data to answer questions about the characteristics of the population served, the provision and use of services, and the impact of the program on certain family planning outcomes. FPAR 2.0 collects a standard set of data elements pertaining to users and encounters, such as user demographics, service delivery, and family planning intentions and methods. Encounter level data collected through FPAR 2.0 improves the quality of data reported to OPA and reduces reporting burden by grantees. Additionally, the more granular data collected with FPAR 2.0 contributes to a learning healthcare environment by greatly expanding the options for data analysis and reporting—for example, through interactive data dashboards and visualizations, customized tabulations and reports, and application of analytics and statistical analyses on the encounter-level data files.

Information from FPAR 2.0 is important to OPA for many reasons, and is used to:

(1) Monitor compliance with statutory requirements, regulations, and operational guidance.

(2) Comply with accountability and federal performance requirements for Title X family planning funds.

(3) Guide strategic and financial planning, to monitor performance, to respond to inquiries from policymakers and Congress about the program, and to estimate program impact.

Type of respondent: Annual reporting; respondents are all grantees that receive Title X funding from OPA.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

Title of the Collections: SF-271 Outlay Report and Request for Reimbursement for Construction Programs.

Type of Collection: Reinstatement.

OMB No. 4040-0011.

Abstract: The SF-271 Outlay Report and Request for Reimbursement for Construction Programs form is an OMB-approved collection (4040-0011). This information collection is used by grant awardees to report on their construction grant award. This IC expired on January 31, 2025. Grants.gov is seeking reinstatement without change of this information collection and a three-year clearance.

Background: The President has issued two major, cross government Deregulatory Initiatives. First, on January 31, 2025, he issued E.O. 14192, “Unleashing Prosperity Through Deregulation” (90 FR 9065; February 6, 2025). This E.O. directs agencies to eliminate 10 regulations for each new regulation issued (“10-for-1”), as well as the direction that deregulation leads to significant cost savings. In addition, on February 19, 2025, the President issued Executive Order 14219, “Ensuring Lawful Regulation and Implementing the President's ‘Department of Government Efficiency’ Deregulatory Agenda” (90 FR 10583; February 25, 2025). That order stated the policy of the Trump Administration is to focus the executive branch's limited enforcement resources on regulations squarely authorized by constitutional Federal statutes and commence the deconstruction of the overbearing and burdensome administrative state.

To implement the President's Deregulatory Initiatives, and to better promote the health and well-being of the American people, HHS is planning the largest deregulatory effort in its history. However, HHS cannot accomplish this feat alone. As Secretary, I believe that an important component of Making America Healthy Again is making sure that providers and caretakers can focus on preventing and treating chronic diseases instead of having to do unnecessary or burdensome paperwork and otherwise comply with Administrative burdensome requirements with no clear health benefit. As such, HHS is seeking input from the American public on how to dramatically deregulate across all the areas the Department touches. Specifically, HHS welcomes submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed. Those submissions may be entered in response to this RFI.

Pursuant to E.O.14219, agencies are required to identify and report to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget on regulations in one or more of the following categories:

(i) Unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope of the power vested in the Federal Government by the Constitution;

(ii) Regulations that are based on unlawful delegations of legislative power;

(iii) Regulations that are based on anything other than the best reading of the underlying statutory authority or prohibition;

(iv) Regulations that implicate matters of social, political, or economic significance that are not authorized by clear statutory authority;

(v) Regulations that impose significant costs upon private parties that are not outweighed by public benefits;

(vi) Regulations that harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives; and

(vii) Regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship.

After receiving this report, OIRA is instructed to consult with agency heads to develop a Unified Regulatory Agenda to rescind or modify identified regulations as appropriate and consider these factors when evaluating potential new regulations.

Pursuant to E.O. 14192, agencies have been charged with the following requirements:

(a) Unless prohibited by law, whenever an agency proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least 10 existing regulations to be repealed.

(b) For fiscal year 2025, all agencies must ensure that the total incremental cost of all new regulations, including repealed regulations, being finalized is significantly less than zero, as determined by the Director of the Office of Management and Budget (OMB), unless otherwise required by law or instructions from OMB.

(c) Any new incremental costs associated with new regulations must, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations. Further, Executive Order 14192 requires that for fiscal year 2026, and each fiscal year thereafter, the head of each agency identify, on an aggregated basis, for regulations that increase incremental cost, offsetting regulations and provide the agency's best approximation of the total costs or savings associated with each new regulation or repealed regulation. During the Presidential budget process, the Director of the Office of Management and Budget will identify for each agency a total amount of incremental costs that will be allowed for such agency in issuing new regulations and repealing regulations for each fiscal year after fiscal year 2025. No regulations exceeding the agency's total incremental cost allowance will be permitted in that fiscal year, unless required by law or approved in writing by the Director. The total incremental cost allowance may allow an increase or require a reduction in total regulatory cost. Subsequent OMB Guidance Implementing section 3 of Executive Order 14192 provides the following definitions:

An “E.O. 14192 regulatory action” is: (i) A significant regulatory action as defined in section 3(f) of E.O. 12866 that has been finalized and that imposes total costs greater than zero; or (ii) A significant guidance document, broadly conceived, ( e.g., significant interpretive guidance) reviewed by OIRA under the procedures of E.O. 12866 that has been finalized and that imposes total costs greater than zero. For example, E.O. 14192 regulatory actions include negotiated rulemakings that are significant as defined in section 3(f) of E.O. 12866, that have been finalized, and that impose total costs greater than zero.

An “E.O. 14192 deregulatory action” is an action that has been finalized and has total costs less than zero. An E.O. 14192 deregulatory action qualifies as both: (1) one of the actions used to satisfy the provision to repeal or revise at least 10 existing regulations for each regulation issued, and (2) a cost savings for purposes of the total incremental cost allowance. E.O. 14192 deregulatory actions are not limited to those defined as significant under E.O. 12866 or OMB's Final Bulletin on Good Guidance Practices. An E.O. 14192 deregulatory action may be issued in the form of an action in a wide range of categories of actions, including, but not limited to: Informal, formal, and negotiated rulemaking; Guidance and interpretive/interpretative documents; Some actions related to international regulatory cooperation; and Information collection requests that repeal or streamline recordkeeping, reporting, or disclosure requirements. Significant proposed rules issued before noon on January 20, 2025, that are formally withdrawn by notice in the Federal Register and removed from the Unified Agenda of Regulatory and Deregulatory Actions may also qualify as repeal actions, but do not qualify for cost savings.

During President Trump's first administration, HHS undertook nearly 400 deregulatory actions to increase efficiency and reduce burden on the healthcare system. These efforts were facilitated by public comment received in response to HHS's Regulatory Relief To Support Economic Recovery; RFI (85 FR 75720, November 25, 2020) and HHS's RFI on Redundant, Overlapping, or Inconsistent Regulations (85 FR 76003, November 27, 2020).

Although that was a good start, HHS intends to dramatically expand its deregulatory efforts. The public should help HHS identify any opportunities to produce cost savings, increase efficiency, and stoke health and economic innovation through deregulation.

HHS's goal is to address regulations that are unnecessary, inconsistent with the law, overly burdensome, outdated, out of alignment with current Executive orders, or otherwise unsound. Consistent with Secretary Kennedy's commitment to radical transparency, HHS will involve the public in this process and values the perspectives and knowledge of those outside of the Federal Government, particularly those served by HHS and those who help carry out its mission. As HHS conducts a thorough review of all regulations in its purview pursuant to the Executive orders described above, HHS is seeking input from a full range of stakeholders, including health care providers and suppliers; State, local, territorial, and Tribal governments; health and drug plans and payers; human services agencies; public health agencies; community- and faith-based organizations; long term care facilities; pharmacist and pharmacy associations; health and human services professional organizations; farmers and food producers; patient advocacy groups and organizations; people living with chronic disease and their family members; researchers; health technology organizations; and other businesses.

The most helpful submissions are those that HHS can publish in the Federal Register with minimal revision—whether as notices of proposed rulemaking (NPRMs), direct final rules (DFRs), or other notices—rescinding previous rulemakings or provisions in the Code of Federal Regulations. These submissions should be entered at https://www.regulations.gov/deregulation.

Responses submitted at regulations.gov/deregulation should follow the format provided there. You may respond to one or more of the questions listed below and please include question numbers provided in the response. Each responding entity (person or organization) is requested to submit only one response per regulation or guidance. Unless submitted anonymously, responses should include the name(s) of the person(s) or organization(s) submitting the comment. If a comment is submitted on behalf of an organization, the individual respondent's role in the organization may also be provided.

In a clear and concise manner, please describe how the recommendation would lead to cost savings, how much savings are anticipated, and the statutory authority that would permit HHS to act on the recommendation. Respondents should identify the specific regulation, guidance, or requirement at issue along with its administering HHS division. Where practical, please also include data, legal citations, quantitative estimates, and recommended actions. Economic data to demonstrate costs and savings are strongly encouraged, with an emphasis on the especially ambitious deregulatory ideas that may require a stronger evidentiary basis. Analyses that conform to OMB guidance to Federal agencies on the development of regulatory analysis, Circular A-4 (2003), and to the HHS Guidelines for Regulatory Impact Analysis (2016), are similarly encouraged. Comments containing references, studies, research, or other empirical data that are not widely published should include electronic links or copies of the referenced materials attached as an appendix.

This RFI is voluntary, and responses may be submitted anonymously. Comments submitted in response to this RFI may be posted on HHS websites or otherwise released publicly. Please do not submit proprietary, classified, confidential, or sensitive information, to include personally identifiable (PII) or personal health information (PHI), in response to this RFI.

This RFI is for information and planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the government to provide support for any ideas in response to it. HHS will use the information submitted at its discretion and will not comment on any respondent's submission. Respondents are advised that the government is not obligated to acknowledge receipt of the information received or provide feedback to respondents concerning any information submitted. Those submitting responses are solely responsible for all expenses associated with response preparation.

1. What HHS regulations and/or guidance meet one or more of the following seven criteria identified in E.O. 14219? Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?

* Unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope of the power vested in the Federal Government by the Constitution;

* Regulations that are based on unlawful delegations of legislative power;

* Regulations that are based on anything other than the best reading of the underlying statutory authority or prohibition;

* Regulations that implicate matters of social, political, or economic significance that are not authorized by clear statutory authority;

* Regulations that impose significant costs upon private parties that are not outweighed by public benefits;

* Regulations that harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives; or

* Regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship