Title: Egg Products HACCP and Sanitation Standard Operating Procedures.

OMB Number: 0583-0172.

Type of Request: Renewal of an approved information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53), as specified in the Egg Products Inspection Act (EPIA; 21 U.S.C. 1031, et seq. ). This statute mandates that FSIS protect the public by verifying that egg products are safe, wholesome, and properly labeled.

FSIS is requesting renewal of the approved information collection related to egg products HACCP and Sanitation SOPs requirements. There are no changes to the information collection. The approval for this information collection will expire on January 31, 2027.

FSIS requires official egg products plants to develop and maintain HACCP plans and Sanitation SOPs, as well as various associated records (9 CFR 590.149, 591.1, and 591.2; 9 CFR parts 416 and 417). Plants must ensure individuals performing HACCP plan development and reassessment functions have successfully completed HACCP training (9 CFR 417.7 and 591.1). Plants must develop written HACCP plans that include: identification of hazards reasonably likely to occur in the production process; identification and description of the critical control point (CCP) for each identified hazard; specification of the critical limit that may not be exceeded at the CCP, and if appropriate, a target limit; description of the monitoring procedure or device to be used; description of the corrective action to be taken if the limit is exceeded; description of the records that would be generated and maintained regarding this CCP; and description of the facility verification activities and the frequency at which they are to be conducted (9 CFR 417.2(c) and 591.1). The adequacy of a plant's HACCP plan must be reassessed at least annually and whenever changes occur that could affect the hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)(i) and 591.1).

Each official egg products plant must also develop, implement, and maintain a Sanitation SOP in accordance with the requirements of 9 CFR part 416 (9 CFR 416.11, 590.149, 591.1, and 591.2). The Sanitation SOP must describe the procedures that the plant will conduct daily, before and during operations, to prevent direct contamination or adulteration of product, including, at a minimum, the cleaning of food contact surfaces of facilities, equipment, and utensils (9 CFR 416.12(a) and (c); 9 CFR 591.1). The Sanitation SOP must also specify the frequency with which each procedure in the plant's Sanitation SOP is to be conducted and identify the establishment employee responsible for the implementation and maintenance of such procedures (9 CFR 416.12(d) and 591.1). The burden of documenting adherence to the Sanitation SOP includes recording, reviewing, and maintaining records (see 9 CFR 416.16 and 591.1).

FSIS has made the following estimates based upon an information collection assessment:

Respondents: Official egg products plants.

Estimated No. of Respondents: 132.

Estimated No. of Responses: 138,596.

Estimated Total Annual Burden on Respondents: 76,280 hours.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; 202-720-5046.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of FSIS' functions, including whether the information will have practical utility; (b) the accuracy of FSIS' estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, OMB, Washington, DC 20253.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication online through the FSIS web page located at: https://www.fsis.usda.gov/federal-register .

FSIS will also announce and provide a link to this Federal Register publication through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service that provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. The available information ranges from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

In accordance with Federal civil rights law and 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 State or local Agency that administers the program or contact USDA through the Telecommunications Relay Service at 711 (voice and TTY). Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Mail Stop 9410, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov .

USDA is an equal opportunity provider, employer, and lender.

On May 16, 2022, based on timely requests for review, in accordance with 19 CFR 351.221(c)(1)(i), we initiated an administrative review of the antidumping duty (AD) order on organic soybean meal from India. 1 On August 27, 2025, Commerce selected Ecopure Specialities Ltd. (Ecopure) and Bergwerff Organic (India) Pvt., Ltd. (Bergwerff) as the mandatory respondents in this review. 2 On September 23, 2025, Perdue Agribusiness LLC (Perdue) timely withdrew its request for review. 3 On September 23, 2025, Organic Soybean Producers of America (OSPA) timely withdrew its request for review for all companies except Ecopure. 4

Due to the lapse in appropriations and Federal Government shutdown on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 5 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 6 On April 7, 2026, Commerce extended the deadline for the preliminary results of this review by 113 days. 7 On July 24, 2026, Commerce extended the deadline for the preliminary results of this review by 7 days. 8 Accordingly, the deadline for Commerce to issue these preliminary results is August 7, 2026.

For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 9 A list of the topics discussed in the Preliminary Decision Memorandum is attached as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via ACCESS, which is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed at https://access.trade.gov/frnotices.

The merchandise subject to the Order is organic soybean meal from India. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if a party who requested a review withdraws its request within 90 days of the date of publication of notice of initiation. As noted above, Commerce received timely-filed withdrawal requests with respect to the companies listed in Appendix III, and no other parties requested an administrative review of these companies. Therefore, we are rescinding this administrative review with respect to these companies, pursuant to 19 CFR 351.213(d)(1).

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

There is one company for which a review was requested and Commerce does not intend to rescind review, which had reviewable entries, and which was not selected as a mandatory respondent or found to be cross-owned with a mandatory respondent ( see Appendix II). The Act does not address the establishment of a rate to apply to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce's regulation at 19 CFR 351.109(g) states that Commerce will determine the rate for non-selected companies by following the process set forth in 19 CFR 351.109(f)(1)-(2), which generally parallels the process for determining the all-others rate in an investigation under section 735(c)(5) of the Act. Section 735(c)(5)(A) of the Act and 19 CFR 351.109(f) state that for companies not investigated, in general, we will determine an all-others rate by weight averaging the AD rates established for each of the companies individually investigated, excluding rates that are zero, de minimis, or based entirely on facts available.

In this administrative review, we preliminarily calculated a weighted-average dumping margin for Ecopure, the sole individually examined respondent in this review. Because this estimated weighted-average dumping margin is not zero, de minimis, or based entirely on facts otherwise available, we are preliminarily assigning the estimated weighted-average dumping margin calculated for Ecopure to the companies under review that were not selected for individual examination, consistent with the guidance in section 735(c)(5)(A) of the Act.

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

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

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. 11 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. 12 Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 13 All briefs must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety in ACCESS by 5:00 p.m. Eastern Time on the established deadline.

As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public executive summary for each issue raised in their briefs. 14 Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 15

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants, and whether any participant is a foreign national; and (3) a list of issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce will inform parties of the scheduled date for the hearing. 16

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

If Ecopure'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. 17 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 Ecopure'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. 18

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Ecopure for which it did not know that the merchandise was destined for the United States, we intend to instruct CBP to liquidate those entries at the all-others rate calculated in the less-than-fair-value (LTFV) investigation if there is no rate for the intermediate company(ies) involved in the transaction. 19

For the companies listed in Appendix II which were not selected for individual review, we will assign an assessment rate based on the review-specific rate, calculated as noted in the “Rate for Non-Individually Examined Companies” section, above. The final results of this 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. 20

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

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

The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for 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 by this review, the cash deposit rate will continue to be the company-specific cash deposit rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, or the LTFV investigation, but the manufacturer is, then the cash deposit rate will be the rate established for the most recent segment for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 3.07 percent, the all-others rate established in the LTFV investigation. 21 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing 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 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 the countervailing duties.

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

On May 21, 2018, Commerce published in the Federal Register the antidumping duty order on wire rod from Korea. 1 On April 8, 2019, Commerce revoked, in part, the Order with respect to grade 1078 and higher tire cord quality wire rod used in the production of tire cord wire. 2 On June 13, 2019, Commerce revoked, in part, the Order with respect to valve spring quality wire rod. 3 On June 25, 2025, in accordance with 19 CFR 351.221(c)(1)(i), we initiated this review identifying POSCO as the sole producer and exporter subject to this review. 4

Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 5 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 6 In March, June, and July, 2026, we extended the deadline for these preliminary results by 120 days, until August 7, 2026. 7

For a detailed description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 8 The Preliminary Decision Memorandum is a public document and is on file electronically via ACCESS. ACCESS is available to registered users at https://access.trade.gov. In addition, the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/frnotices.

Commerce is conducting this administrative review in accordance with section 751(a)(1)(B) of Tariff Act of 1930, as amended (the Act).

The scope of the Order includes certain hot-rolled products of carbon steel and alloy steel, in coils, of approximately round cross section, less than 19.00 mm in actual solid cross-sectional diameter. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum. 9

Commerce is conducting this review in accordance with section 751(a) of the Act. Constructed export prices are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is attached as an appendix to this notice.

We preliminarily determine the following estimated weighted-average dumping margin exists for the period May 1, 2024, through April 30, 2025:

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

As provided in 782(i)(3) of the Act, Commerce intends to verify the information relied upon in the final results.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the verification report is issued. 11 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. 12 Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 13

As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 14 Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 15

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 via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. 16 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 the respective case briefs. 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 these preliminary results in the Federal Register , pursuant to section 751(a)(3)(A) of the Act, unless extended.

Pursuant to section 751(a)(1)(A) of the Act, upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. 17 The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable. 18 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).

Pursuant to 19 CFR 351.212(b)(1), if POSCO'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 will calculate an importer-specific ad valorem duty assessment rate based on the ratio of the total amount of dumping calculated for the U.S. sales for a given importer to the total entered value of those sales. If, in the final results, either POSCO's weighted-average dumping margin is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), or an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. 19

For entries of subject merchandise during the POR produced by POSCO for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate such unreviewed entries pursuant to the reseller policy , 20 i.e., the assessment rate for such entries will be equal to the all-others rate established in the investigation ( i.e., 41.10 percent), if there is no rate for the intermediate company(ies) involved in the transaction.

The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for POSCO will be equal to POSCO's 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 companies not participating in this review, the cash deposit will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, or the underlying investigation, and does not have a cash deposit rate from a completed segment of this proceeding, but the producer of the subject merchandise does have a cash deposit rate, then the cash deposit rate will be the rate established for the completed segment for the most recent POR for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 41.10 percent, the all-others rate established in the underlying investigation. 21 These deposit requirements, when imposed, shall remain in effect until further notice.

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

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

On February 10, 2026, Commerce published the Preliminary Results of the 2023-2024 and invited interested parties to comment. 1 The review covers one mandatory respondent, PT. Kenertec Power System (Kenertec). We received timely case and rebuttal briefs from Kenertec and the Wind Tower Trade Coalition (petitioner). 2 On March 3 and August 3, 2026, Commerce extended the deadline for the final results of this administrative review, in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(h)(2);  3 accordingly, the deadline for these final results is now August 10, 2026.

For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 4 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, which 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/frnotices. Commerce conducted this administrative review in accordance with section 751 of the Act.

The merchandise subject to the Order is wind towers from Indonesia. A full description of the scope of the Order is contained in the Issues and Decision Memorandum.

All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum and are listed in the appendix to this notice.

Based on a review of the record and comments received from interested parties regarding our Preliminary Results, and for the reasons explained in the Issues and Decision Memorandum, Commerce made certain changes to the weighted-average dumping margin calculations for Kenertec. 6

We determine that the following weighted-average dumping margin exists for the period August 1, 2023, through July 31, 2024:

Commerce intends to disclose the calculations performed in connection with these final results of review to parties in this review within five days after public announcement of the final results 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 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 of subject merchandise in accordance with the final results of this review. Because we calculated a zero percent margin in the final results of this review for Kenertec, in accordance with 19 CFR 351.212, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by the respondent and the respondent did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate established in the original less-than-fair-value (LTFV) investigation ( i.e., 8.53 percent)  7 if there is no rate for the intermediate company(ies) involved in the transaction.

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 upon publication of this notice in the Federal Register 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 Kenertec will be zero, the rate established in the final results of this review; (2) for merchandise exported by a company not covered in this review but covered in a prior completed segment of the proceeding, the cash deposit will continue to be the company-specific rate published in the completed segment for the most recently completed period; (3) if the exporter is not a firm covered in this review, a prior review, or the original LTFV investigation, but the producer has been covered in a prior completed segment of this proceeding, then the cash deposit rate will be the rate established in the completed segment for the most recent period for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 8.53 percent, the all-others rate established in the LTFV investigation for this proceeding. 8 These 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 serves as the only reminder to parties subject to APO of their responsibility concerning the disposition 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 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 subject to sanction.

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

On February 11, 2026, Commerce published the Preliminary Results of this administrative review. 1 On March 31, 2026, Commerce invited interested parties to comment on the Preliminary Results. 2 On May 21, 2026, Commerce extended the deadline for issuing the final results of this review by 53 days. 3 On July 28, 2026, Commerce extended the deadline for the final results by an additional 4 days. 4 On August 6, 2026, Commerce extended the deadline for the final results by an additional 3 days. 5 Accordingly, the deadline for these final results is now August 10, 2026. Commerce conducted this administrative review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 6 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/frnotices.

The products covered by the Order are fish fillets from Vietnam. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR subject to the antidumping duty order for which liquidation is suspended, Commerce may rescind an administrative review, in whole or only with respect to a particular exporter or producer. 8 At the end of the administrative review, any suspended entries are liquidated at the assessment rate computed for the review period. 9 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry to be liquidated at the newly calculated assessment rate.

In the Preliminary Results, Commerce preliminarily rescinded this review with respect to 24 companies and the Vietnam-wide entity because all review requests from the interested parties with standing were withdrawn, and the only remaining review request is from an interested party that did not have standing in this review. We invited interested parties to comment. 10 We received no comment other than how Commerce inadvertently listed I.D.I. International Development under “Appendix IV—Vietnam-Wide Entity” instead of under “Appendix II—Companies for Which Commerce is Rescinding the Review.”  11 To rectify this error, we are rescinding this administrative review with respect to this company. 12 Therefore, in the absence of suspended entries of subject merchandise during the POR, we are hereby rescinding this administrative review, in part, with respect to 25 companies  13 and the Vietnam-wide entity, 14 in accordance with 19 CFR 351.213(d)(3).

All issues raised in case and rebuttal briefs filed by interested parties in this administrative review are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is provided in Appendix I to this notice.

Based on our review of the record and analysis of the comments received, we made certain changes to the Preliminary Results. For a more detailed description of the issues raised by parties, see the Issues and Decision Memorandum. 15

We received no comments and made no changes to the methodology in the Preliminary Results regarding the separate-rate companies. We continue to find that two companies not individually examined, Cantho Import Export Seafood Joint Stock Company and Nam Viet Corporation, are eligible for separate rates in this administrative review. Accordingly, to determine the rate for companies not selected for individual examination, Commerce's practice is to weight average the net subsidy rates for the selected mandatory respondents, excluding rates that are zero, de minimis, or based entirely on facts available. 16 Therefore, for the final results of this review, we are assigning to the non-selected separate rate respondents a weighted-average dumping margin based on the average of Bien Dong and NTSF's rates weighted by their ranged, publicly available U.S. sales values. 17

As stated in the Preliminary Results, because there was no valid request for review of the Vietnam-wide entity in this review, the Vietnam-wide entity is hereby rescinded from review and the Vietnam-wide entity's rate ( i.e., $2.39 per kilogram (kg)) is not subject to change. 18 Commerce considers all other companies for which a review was requested, and which did not demonstrate separate rate eligibility, to be part of the Vietnam-wide entity.

Commerce determines that the following weighted-average dumping margins exist for the period covered August 1, 2023, through July 31, 2024:

Commerce intends to disclose the calculations performed in connection with these final results of review to interested parties in this review within five days after public announcement of the final results 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 section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review. Pursuant to 19 CFR 351.212(b), for Bien Dong and NTSF, we calculated importer-specific assessment rates based on the resulting per-unit ( i.e., per kilogram) rates by the weight in kilograms of each entry of the subject merchandise during the POR. Specifically, we calculated importer specific duty assessment rates on a per-unit rate basis by dividing the total dumping margins (calculated as the difference between normal value and export price, or constructed export price) for each importer by the total sales quantity of subject merchandise sold to that importer during the POR.

For all non-selected separate rate respondents subject to this review, we will instruct CBP to liquidate all entries of subject merchandise that entered the United States during the POR at the average of the rates calculated for Bien Dong and NTSF as listed above. For entries of subject merchandise during the POR produced by Bien Dong and NTSF for which they did not know their merchandise was destined for the United States, we intend to instruct CBP to liquidate such entries at the Vietnam-wide rate if there is no rate for the intermediate company or companies involved in the transaction.

For the company for which the review is rescinded, any suspended entries that entered under that exporter's case number ( i.e., at that exporter's rate) will be liquidated at the rate as entered. For all other companies, we will instruct CBP to apply the antidumping duty assessment rate of the Vietnam-wide entity, ( i.e., $2.39 per kilogram (kg)), to all entries of subject merchandise exported by these companies. 19

These final results of administrative review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by these final results of this review and for future deposits of estimated duties, where applicable. 20 For the individually calculated respondent and non-selected separate rate respondents under review, 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 the final results of this administrative review, as provided in section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies subject to this review will be the rate established in these final results of the review; (2) for previously investigated or reviewed Vietnamese and non-Vietnamese exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) for all Vietnamese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be equal to the rate for the Vietnamese-wide entity ( i.e., $2.39 per kilogram ((kg); and (4) for all non-Vietnamese exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the Vietnamese exporter(s) that supplied that non- Vietnamese exporter. 21 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 has 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.

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

On May 1, 2026, pursuant to section 702(h) of the Trade Agreements Act of 1979, as amended (the Act), Commerce published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period October 1, 2025, through December 31, 2025. 1 In the Fourth Quarter 2025 Update, we requested that any party that had information on foreign government subsidy programs that benefited articles of cheese subject to an in-quota rate of duty submit such information to Commerce. 2 We received no comments, information, or requests for consultation from any party.

Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period January 1, 2026, through March 31, 2026. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed.

This determination and notice are in accordance with section 702(a) of the Act.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in U.S. waters of the GOA  1 over the course of 5 years (86 FR 5322, January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses, and became effective on April 19, 2021.

The regulations at 50 CFR 217.180 et seq. allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.

NMFS subsequently discovered that the 2021 rule was based on erroneous take estimates. We conducted another rulemaking using correct take estimates and other newly available and pertinent information relevant to the analyses supporting some of the findings in the 2021 final rule and the taking allowable under the regulations. We issued a final rule in April 2024, effective May 24, 2024 (89 FR 31488, April 24, 2024).

On August 28, 2025, NMFS Office of Protected Resources (OPR) received a request from NMFS Office of Policy (Policy) for reimplementation of the current Incidental Take Regulation (ITR) to avoid a lapse in ITRs offering incidental take coverage for GOA geophysical survey activities. On October 20, 2025, Bureau of Ocean Energy Management (the original petitioner for the current ITRs) submitted a request to be included in the process as a co-petitioner. In response to these requests, NMFS issued a new final rule, effective April 20, 2026, through April 19, 2031 (91 FR 20784, April 17, 2026).

The reimplementation of the regulations continues the established framework for authorization of incidental take through LOAs. The final rule made no changes to the specified activities or the specified geographical region in which those activities would be conducted, and there are no changes to the associated mitigation, monitoring, and reporting requirements.

WesternGeco plans to conduct a long offset sparse bottom node (OBN) survey over 1,023 lease blocks in the Keathley Canyon, Alaminos Canyon, Garden Banks, and East Banks areas, with water depths ranging from approximately 900 to 3,000 meters (m). See section F of the LOA application for a map of the area. WesternGeco anticipates using two source vessels with either a conventional airgun array source consisting of 28 elements with a total volume of 5,000 cubic inches (in 3 ) (0.082 cubic meter) or a low-frequency tuned pulse source (TPS) in tandem with a conventional 28-element, 5,000 in 3 airgun array. Each source vessel will be towing identical sources but the sources will not be used simultaneously. Please see the LOA application for additional detail.

The TPS was not included in the acoustic exposure modeling developed in support of the rule; however, the TPS was previously described and evaluated in support of previous LOAs (86 FR 37309, 37310, July 15, 2021; 87 FR 55790, 55791, September 12, 2022). We rely on the prior analyses for the TPS here. For additional details regarding sources, see section C of the LOA application. Based on this information we have determined there will be no effects of a magnitude or intensity different from those evaluated in support of the rule. Because WesternGeco's proposed survey plan includes use of the TPS paired with the conventional 5,000 in 3 airgun array (they do not plan to use the TPS source by itself), the 5,000 in 3 airgun array was used to evaluate take as it is the most impactful source planned for use.

Consistent with the preamble to the final rule, the survey effort proposed by WesternGeco in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (91 FR 20784, April 17, 2026). In order to generate the appropriate take number for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone;  2 ) (3) number of days; (4) source; and (5) month. 3 To determine the most appropriate proxy array from the exposure modeling, the directionally dependent source level in a plane parallel to the sea surface was compared to the three airgun array sources which were originally modeled, including the 4,130, 5,110, and 8,000 in 3 arrays. Out of these three proxies, the source which had the smallest relative error (arithmetic mean difference taken over the azimuthal or vessel bearing angle) was chosen as the most representative proxy. In this case, because WesternGeco plans to use the specified 28-element, 5,000 in 3 airgun array source, the 5,110 in 3 had the lowest mean error (1.1 decibels (dB)) and was the airgun array proxy that was selected as most appropriate for the planned survey. The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled source and survey type in each zone and month.

No OBN surveys were included in the modeled survey types, and use of existing proxies ( i.e., two-dimensional (2D), three-dimensional (3D) narrow-azimuth (NAZ), 3D wide-azimuth (WAZ), Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (91 FR 9014, 9018, February 24, 2026). Coil was selected as the best available proxy survey type in this case because the spatial coverage of the planned survey is most similar to the coil survey pattern. The planned OBN survey will involve two source vessels sailing along closely spaced survey lines, with daily survey area coverage of approximately 66 square kilometers (km 2 ) per day (33 km 2 per day per vessel), most similar to that assumed for the coil survey proxy. Among the different parameters of the modeled survey patterns ( e.g., area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although WesternGeco is not proposing to perform a survey using the coil geometry, the coil proxy is most representative of the effort planned by WesternGeco in terms of predicted Level B harassment exposures.

The survey will take place over approximately 150 days with 100 days of sound source operation, with approximately 7 days planned in Zone 5, 68 days planned in Zone 6, and approximately 25 days planned in Zone 7. The monthly distribution of survey days is not known in advance, though we assume that the planned 100 days of source operation would occur contiguously. Take estimates for each species are based on the time period that produces the greatest value.

For the Rice's whale, take estimates based on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information concerning Rice's whale habitat preferences considered during the rulemaking process. NMFS' 2026 proposed rule provided detailed discussion regarding Rice's whale habitat (see 91 FR 9014, 9026, February 24, 2026). In summary, recent survey data, sightings, and acoustic data support Rice's whale occurrence in waters throughout the GOA between approximately 100 m and 400 m depth along the continental shelf break, and associated habitat-based density modeling has identified similar habitat ( i.e., approximately 100-400 m water depths along the continental shelf break) as being Rice's whale habitat (Garrison et al., 2023; Soldevilla et al., 2022, 2024).

Although Rice's whales may occur outside of the general depth range expected to provide suitable habitat, we expect that any such occurrence would be rare. WesternGeco's planned activities will occur in water depths of approximately 900-3,000 m in the central GOA. Thus, NMFS does not expect that take of Rice's whale is likely in association with this survey and, accordingly, does not authorize take of Rice's whale through the LOA.

Based on the results of our analysis, NMFS has determined that the level of taking expected for this survey and authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See table 1 in this notice and table 7 of the rule (91 FR 20784, April 17, 2026).

Under the rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small (see 91 FR 20784, April 17, 2026). For more information, please see NMFS' discussion of small numbers in the 2026 final rule (91 FR 20784, April 17, 2026).

The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios (except in the cases where the take estimate has been rounded up to reflect a group size) to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than 1 day (see 91 FR 20784, April 17, 2026). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1.

This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 91 FR 20784, 20812, April 17, 2026). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and model-predicted abundance information ( https://seamap.env.duke.edu/models/Duke/GOM/ ). Information supporting the small numbers determinations is provided in table 1.

Based on the analysis contained herein of WesternGeco's planned survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes ( i.e., less than one-third of the best available abundance estimate) and therefore the taking is of no more than small numbers.

NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to WesternGeco authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

On July 9, 2026 (91 FR 42426), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3.

After consideration of the relevant matter presented, the Committee has determined that the product(s) and service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.

Accordingly, the following product(s) and service(s) are deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

The following product(s) and service(s) are proposed for deletion from the Procurement List:

Title; Associated Form; and OMB Number: Personality Personnel Assessment; OMB Control Number 0702-APPA.

Needs and Uses: The Army uses personality assessments alongside cognitive testing to help place personnel in the right roles. To keep these assessments accurate and effective, they must be regularly updated. However, active-duty personnel are often fully committed to missions, making it difficult to collect feedback. This proposed study focuses on testing and calibrating the questions themselves, allowing researchers to use civilian participant groups that match Army demographics. This approach preserves operational readiness while ensuring the assessments remain scientifically valid.

Affected Public: Individuals or households.

Annual Burden Hours: 4,500.

Number of Respondents: 2,250.

Responses per Respondent: 2.

Annual Responses: 4,500.

Average Burden per Response: 60 minutes.

AnnuaL Burden Hours: 133.

Number of Respondents: 4,000.

Responses per Respondent: 1.

Annual Responses: 4,000.

Average Burden per Response: 2 minutes.

Annual Burden Hours: 2,000.

Number of Respondents: 2,000.

Responses per Respondent: 1.

Annual Responses: 2,000.

Average Burden per Response: 60 minutes.

Annual Burden Hours: 6,633.

Number of Respondents: 6,250 (2,250 in Part A and 4,000 in Part B).

Annual Responses: 10,500.

Frequency: On occasion.

Section 709 of the NDAA for FY 2025 requires the Department to conduct a demonstration project to reimburse covered members specifically for the cryopreservation of gametes. This demonstration project will allow the Department to evaluate covered member participation, cost trends, administrative feasibility, and potential long-term readiness impacts.

The demonstration authorizes reimbursement of the following services (“covered services”): gamete retrieval procedures (including associated medications, laboratory evaluation, and imaging); medical testing required for retrieval and cryopreservation; cryopreservation of gametes; shipping of gametes; and storage of gametes in an appropriate private storage facility during the demonstration period.

Participation is voluntary. As DHA does not have the ability to authenticate operational orders issued to covered members by their Military Department or Military Service, Commanders will validate eligibility under Section 709 and this notice. To receive reimbursement under this demonstration, covered members will need to obtain written Command attestation via DHA Form 459 (detailed below) indicating that they met one of the statutory eligibility conditions at the time covered services were rendered. Covered members must consult their unit's specific policies and procedures regarding participation in this program and to request any leave or permissive temporary duty, as necessary. Eligibility conditions are as follows:

(1) Has received orders (including deployment orders) for duty for which the covered member may receive hazardous duty pay under section 351 of title 37, United States Code;

(2) Whom the Secretary determines is likely to receive such orders in the next 120 days; or

(3) Who will, under orders, be geographically separated from a spouse, domestic partner, or dating partner for a period of not less than 180 days, including sea duty.

Covered members meeting at least one of the eligibility criteria may obtain gamete cryopreservation service(s) from a provider of their selection. Covered services may be rendered either through military medical treatment facilities (MTFs) that have reproductive endocrinology and infertility (REI) programs, or through a civilian fertility clinic of the covered member's choosing. The use of MTFs is encouraged, and a list of participating MTFs are listed here: https://tricare.mil/CoveredServices/IsItCovered/AssistedReproductiveServices. Civilian providers are not required to be TRICARE authorized. Information regarding civilian providers will be made available on the program website.

Note, REI covered services provided at these MTFs are generally first-come, first-serve, and individual locations may not be able to accommodate covered services in a timeline that aligns with the covered member's pertinent orders. There is no requirement for MTFs to provide preference for covered members participating in this program. There is also variability as to the scope of Assisted Reproductive Technology (ART) performed within each MTF as well as the cost to the beneficiary for components of care that are not provided by the MTF or DoD health care providers based upon the specific private-sector collaboration. Reimbursement is available only for covered services paid for by the covered member.

Except for recurring storage fees or subsequent shipping costs, for covered members meeting the first two eligibility criteria (orders (including deployment orders) for duty for which the covered member may receive hazardous duty pay; or likely to receive such orders), all cryopreservation service(s) (testing, gamete retrieval procedures, cryopreservation of gametes), must be obtained prior to the start date of the pertinent orders ( e.g., prior to deployment) to be eligible for reimbursement. For covered members meeting the third eligibility criteria (those who will, under orders, be geographically separated from a spouse, domestic partner, or dating partner for a period of not less than 180 days, including sea duty), cryopreservation service(s) may be obtained either prior to the geographic separation start date or during the period of geographic separation should such covered services be available at the location where the covered member has been sent on orders. Reimbursement for recurring storage fees or shipping during the course of the demonstration may be processed separately.

There is no requirement to meet eligibility criteria again for reimbursement of subsequent shipping or storage costs not incurred at time of initial cryopreservation ( i.e., annual storage fees, transport of gametes at time of intended fertilization), covered members must have previously received reimbursement under this program. For those determined to be eligible and previously reimbursed under this program, storage and shipment costs will be reimbursed for the entirety of the program duration, up to statutory limitations.

At the time of request for reimbursement, the covered member's Commander (or designee) must attest, via DHA Form 459, that on the date the medical covered services for which the covered member is seeking reimbursement were rendered (except for recurring storage or shipping as outlined), that the covered member met eligibility criteria. Reimbursement must be sought within 120 days from the date which covered services were rendered ( e.g., 120 days from the date gamete retrieval, 120 days from the date of laboratory procedure, 120 days from receipt of prescription, etc.) and may be submitted as separate requests throughout the process or as a single consolidated request for reimbursement within 120 days of the completion of gamete retrieval and cryopreservation. To receive reimbursement, the covered member must complete DHA Form 459, sign, and submit proof of payment to dha.ncr.medical-affairs.mbx.dha-cryopreservation-demo@health.mil.

• This form is available on the program website.

• Covered members must provide complete, itemized invoices reflecting the dates of the covered services provided for all covered services submitted for reimbursement.

• DHA Form 459 must be completed and signed by the covered member and their Commander (or designee).

• Incomplete forms or forms submitted more than 120 days after the covered services were rendered to the member will be denied. Participating covered members will receive reimbursement upon review and processing of required invoices and documentation.

Reimbursement is limited to $500 per year for sperm cryopreservation services and $10,000 per year for oocyte cryopreservation services, as established in statute. For purposes of the per year cap on reimbursement, a one-year period will be individualized for each covered member and measured from the first date on which reimbursable covered services are rendered. The one-year period will include any additional requests for reimbursement of costs incurred by the covered member within the 365-day window. Any claims for reimbursement for covered services provided in subsequent years will be processed in a similar manner. As this is a reimbursement demonstration, clear rules are required so that covered members have a precise understanding of what will be reimbursable and how the annual caps will be applied to their claims.

A covered member may participate more than once during the three year program duration, so long as they meet the eligibility criteria ( i.e., have, or anticipate having, new orders (including deployment orders) for duty for which the covered member may receive hazardous duty pay; or who will, under orders, be geographically separated from a spouse, domestic partner, or dating partner for a period of not less than 180 days, including sea duty) and remain under annual coverage limitations.

Services dated prior to program initiation or after program termination are not eligible for reimbursement. This includes new costs for storage or shipment incurred after termination of the program.

Participants are required to attest to having an advanced medical directive specifying disposition of gametes upon death. Covered members should consult their local legal assistance office for assistance in completing an advanced medical directive.

The demonstration will be evaluated using the following measures: participation rates, including by covered Armed Force and deployment status; total cost and cost per participant; administrative burden and claims processing outcomes; covered member experience and satisfaction; and impact on perceived readiness and retention indicators.

• The program covers only the categories of services listed, also known as “covered services”. A list of possible services covered is provided on the cryopreservation demonstration website, available at https://dha.mil/CryopreservationDemo; anything not included on this list will be reviewed on a case-by-case basis. No other services—such as embryo creation, in-vitro fertilization, or other elective procedures—are eligible for reimbursement.

• The Department is not a party to any agreement between a covered member and a private medical or storage provider and assumes no liability related to gamete handling or storage conditions. Decisions regarding continued storage, disposition, or later use of gametes are solely the responsibility of the covered member and outside the scope of the program.

• All covered services must be rendered prior to or on the final date of the demonstration program; requests for reimbursement will be accepted up to 30 days thereafter. Any costs, including storage, incurred after the end of this program are not eligible for reimbursement.

• Reimbursement is limited to services provided to eligible covered members.

• Participating covered members must be on active duty in one of the covered Armed Forces ( i.e., Army, Navy, Marine Corps, Air Force, or Space Force), during the provision of covered services and at the point of reimbursement.

• Decisions regarding continued storage following the end of the demonstration program, as well as later use and disposition of gametes, are solely a responsibility of the covered member, and outside the scope of this program.

This demonstration project will operate for three years, beginning on the effective date specified above. The Department may extend or modify the demonstration based on evaluation results or statutory requirements.

Title; Associated Form; and OMB Number: “Data for Payment of Retired Pay” DD Form 2656, “Reserve Component Survivor Benefit Plan (RCSBP) Election Certificate” DD Form 2656-5, “Survivor Benefit Plan (SBP)/Reserve Component Survivor Benefit Plan (RCSBP) Election Change Certificate” DD Form 2656-6, “Verification for Survivor Annuity” DD Form 2656-7, “Survivor Benefit Plan (SBP)/Reserve Component Survivor Benefit Plan (RCSBP)—Automatic Coverage Fact Sheet” DD Form 2656-8, “Survivor Benefit Plan (SBP) Former Spouse Request for Deemed Election” DD Form 2656-10; OMB Control Number 0704-0569.

Type of Request: Revision.

Number of Respondents: 10,950.

Responses per Respondent: 1.

Annual Responses: 10,950.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 27,738.

Needs and Uses: This information collection requirement is necessary for the Department of Defense to collect information regarding a uniformed service member's military retired pay and their election to participate in and designate beneficiaries under the Survivor Benefit Plan (SBP or RCSBP), as well as elections of the eligible family member(s) or Insurable Interest Beneficiary to receive coverage under SBP or RCSBP.

Affected Public: Individuals or households.

Frequency: As required.

Respondent's Obligation: Voluntary.

DoD Clearance Officer: Mr. Reginald Lucas.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. 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: National Special Education Spending Study.

OMB Control Number: 1850-1000.

Type of Review: Revision of a currently approved collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 14,956.

Total Estimated Number of Annual Burden Hours: 15,406.

Abstract: The Institute of Education Sciences (IES), within the U.S. Department of Education (ED), requests clearance from the Office of Management and Budget (OMB) for data collection activities for the National Study of Special Education Spending—Full Study (NSSES). The study will produce national estimates of spending on special education services for students with disabilities (SWDs), including expenditures made by states, districts, and schools, and provide policymakers and education leaders with critical information on the factors that influence special education spending, what this spending pays for, and to what extent federal appropriations from the Individuals with Disabilities Education Act of 2004 (IDEA) cover special education spending.

IES previously received OMB approval for the study's recruitment and sampling activities (OMB #1850-1000). That approval supported developing a nationally representative sample of local education agencies (LEAs) and schools; contacting state education agencies (SEAs) and LEAs to secure their participation; and collecting the directory and enrollment data needed to sample students. IES contracted with the American Institutes for Research® (AIR®) and its partner organizations—the National Opinion Research Center at the University of Chicago (NORC) and Allovue, a PowerSchool company (Allovue)—for the study's design, pilot study, and initial recruitment activities for the full study. IES will contract with an organization to carry out the full study's data collection.

This request covers the full study's data collection activities, including surveys of SEA staff, LEA administrators, and school-based personnel, as well as collecting financial data from LEAs. These data collection activities will take place during the 2026-27 and 2027-28 school years and are designed to produce nationally representative estimates of special education spending overall and by student disability category, LEA and student characteristics, and geographic context. All collection activities support the NSSES. District-level financial data files may also support future intramural or extramural research on district-level spending and use of funds.

The data collection plan and survey instruments were developed and refined through an OMB-approved pilot study (OMB #1850-0952 v.10, v.12), which tested recruitment strategies, survey content, and data collection procedures. Pilot study findings informed revisions to the study design, including improvements to data collection instruments and procedures to reduce burden and enhance data quality.

In the Federal Register of July 21, 2026, in FR Doc. 2026-14658, on page 45798, in the third column, correct the ADDRESSES caption to read:

Signing Authority: This document of the Department of Energy was signed on August 11, 2026, 2026, by David Borak, Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Quality Bonus Payment Appeals; Use: Sections 1853(n) and 1853(o) of the Social Security Act (the Act) require CMS to make Quality Bonus Payments (QBPs) to MA organizations that achieve at least 4 stars in a 5-star quality rating system. In addition, section 1854(b)(1)(C) of the Act ties the share of savings that MA organizations must provide to enrollees as the beneficiary rebate to the level of an MA organization's QBP rating. The administrative review process for an MA contract to appeal their QBP status is laid out at § 422.260(c). §§ 422.260(c)(1) and (2) describe a two-step administrative review process that includes a request for reconsideration and a request for an informal hearing on the record, and § 422.260(c)(3) describes limits to requesting an administrative review. Historically, every November CMS has released the preliminary QBP ratings for MA contracts to review their ratings and to submit an appeal request under § 422.260(c) if they believe there is a calculation error or incorrect data are used. Each MA organization continues to be afforded the right to request an administrative review of CMS's determination concerning the organization's qualification for a QBP.

The information collected on the Request for Reconsideration form from MA organizations is considered by the reconsideration official and potentially the hearing officer and CMS Administrator to review CMS's determination of the organization's eligibility for a QBP. The form asks MA organizations to select the Star Ratings measure(s) they believe was miscalculated or used incorrect data and describe what they believe is the issue. Under § 422.260(c)(3)(ii) these are the only bases for appeals. In conducting the reconsideration, the reconsideration official will review the QBP determination, the evidence and findings upon which it was based, and any other written evidence submitted by the organization with their Request for Reconsideration or by CMS before the reconsideration determination is made.

Form Number: CMS-10346.

OMB Control Number: 0938-1129.

Frequency: Yearly.

Affected Public: Private Sector, Business or other for-profit and Not-for-profit institutions.

Number of Respondents: 120.

Total Annual Responses: 20.

Total Annual Hours: 160.

For policy questions regarding this collection contact Joy Binion at 410-786-5004.

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: The Medicare Advantage and Prescription Drug Programs: Part C and Part D Explanation of Benefits; Use: Sections 1852(k)(2)(C)(i) and 1860D-(4)(a)(4) of the Act give CMS authority to require EOBs in Part C and Part D, respectively. Corresponding Part C and Part D regulations at §§ 422.111(k) and 423.128(e) further specify the requirements to provide a written EOB directly to enrollees following their use of benefits.

These requirements and the CMS model documents help ensure that Part C and Part D enrollees receive consistent and timely information about costs associated with their medical claims. Part C and Part D EOBs allow enrollees to track their out-of-pocket expenses and benefit utilization in relation to their plan's deductible and out-of-pocket threshold. This customized information positions enrollees to make informed decisions about their healthcare options. Further, the proposed updates to the Part C EOB allow enrollees to better track their utilization of supplemental benefits, which previously were not included in the EOBs in a consistent way, while the proposed updates to the Part D EOB improve clarity and accuracy of information. The EOBs also enable enrollees to make a more practical use of the information found in plans' Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents, as well as information available through tools such as the Medicare Plan Finder. Given the complexity of the health care system, providing readable and plain language information in the EOBs supports improved transparency.

Form Number: CMS-10453.

OMB Control Number: 0938-1228.

Frequency: Monthly.

Affected Public: Private Sector, Business or other for-profit and Not-for-profit institutions.

Number of Respondents: 1,723.

Total Annual Responses: 1,723.

Total Annual Hours: 17,230.

For policy questions regarding this collection contact Lucia Patrone at 410-786-8621.

Under the Medicare Quality Payment Program, an eligible clinician who participates in an Advanced Alternative Payment Model (APM) and meets or exceeds the applicable payment amount or patient count thresholds for a performance period is a qualifying APM participant (QP) for that year. For payment years 2019 through 2026, which respectively correspond to the QP performance periods for 2017 through 2024, an eligible clinician who attains QP status for a year earns a lump sum APM incentive payment that is paid in the payment year. For payment years 2021 through 2024, the amount of the APM incentive payment is equal to 5 percent of the estimated aggregate paid amounts for covered professional services furnished by the QP during the calendar year immediately preceding the payment year. The APM incentive payment percentage is 3.5 percent for the 2023 performance year and 2025 payment year, and 1.88 percent for the 2024 performance year and 2026 payment year.

The Centers for Medicare & Medicaid Services (CMS) has identified those eligible clinicians who attained QP status in the 2024 performance period and earned a 1.88 percent APM incentive payment for the 2026 payment year based on aggregate paid amounts for the covered professional services they furnished in the calendar year 2025 base period.

When CMS processed the 2026 APM incentive payments, CMS was unable to identify a taxpayer identification number (TIN) or TINs associated with some QPs and was therefore unable to disburse the payment. To successfully issue the APM incentive payment for the 2026 payment year, CMS is requesting assistance identifying current Medicare billing information for these QPs in accordance with 42 CFR 414.1450(c)(8).

CMS has compiled a list of QPs for whom we were unable to identify any associated TIN to which we can make the APM incentive payment. These QPs, and any others who anticipated receiving an APM Incentive Payment but have not, should follow the instructions to provide CMS with updated Medicare billing information at the following web address: 2026 QP Notice for APM Incentive Payment.

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

All information must be received by October 13, 2026. After that date, any claim to an APM incentive payment for the 2026 payment period based on an eligible clinician's QP status for the 2024 QP performance period will be forfeited. To facilitate payment, please include all required documentation as specified in the previous link.

All submissions received on or before October 13, 2026, will be held and processed after the close of the response period. CMS will not accept requests for additional payment review or reprocessing after October 13, 2026. Any claim related to a 2025 APM Incentive that is submitted after October 13, 2026, will be forfeited and will not be considered for review. If your banking information has changed within the last year, we strongly recommend submitting a voided check and CMS Form 588  1 to help avoid payment delays. Please note that CMS will not notify you if there is an issue processing your payment.

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

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

FDA is announcing the availability of a guidance for industry titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products as agreed upon during the Prescription Drug User Fee Act (PDUFA) VII negotiations. This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The guidance describes the different meeting types, formats, and timelines associated with those requests. It also provides industry with the information necessary to have a complete meeting request and background package to help facilitate the meeting to gain useful feedback for product development. The guidance provides examples to help guide stakeholders on selecting and requesting the proper meeting type for a given scenario.

This guidance finalizes the draft guidance titled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” issued on September 22, 2023 (88 FR 65395). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include additional scenarios for Type D meetings, clarification on Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs meetings, and the addition of information on meeting formats that FDA may grant. In addition, editorial changes were made to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 relating to submission of investigational new drug applications and related meetings, including pre-IND meetings, INTERACT meetings, meetings at the “End-of-phase 2” and “pre-NDA” stages, pre-new drug application (pre-NDA/pre-sNDA)/pre-biologics license application (pre-BLA/pre-sBLA) meetings governed by 21 CFR 312.47, and dispute resolution meetings under 21 CFR 312.48, have been approved under OMB control number 0910-0014. The collections of information in 21 CFR part 314 relating to submission of new drug applications, amendments and supplemental applications and related meetings, including meetings between sponsors or applicants and FDA under 21 CFR 314.102, meetings requested within 30 days of FDA issuance of a refuse-to-file letter under 21 CFR 314.101, and dispute resolution meetings under 21 CFR 314.103, as well as the guidance “Formal Dispute Resolution: Sponsor Appeals Above the Division Level,” have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 601 relating to the submission of biologics license applications and related meetings, including formal meetings between sponsors or applicants and FDA, have been approved under OMB control number 0910-0338.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

CONCERTA (methylphenidate hydrochloride) extended-release tablets, 18 mg, 27 mg, 36 mg, 54 mg, are the subject of the new drug application 021121, held by Janssen Pharmaceuticals, Inc., which FDA approved on August 1, 2000. CONCERTA is a central nervous system stimulant intended for the treatment of attention deficit hyperactivity disorder in children 6 years of age and older, adolescents, and adults up to the age of 65. CONCERTA is a multiphasic modified-release product that is formulated to release a bolus of methylphenidate, resulting in an initial rapid rise in plasma concentration of the drug comparable to the effect of an immediate-release methylphenidate formulation, followed by sustained delivery later in the day, thereby allowing for once-daily dosing. According to its approved labeling, CONCERTA is expected to have a 12-hour duration of effectiveness. The relative bioavailability of CONCERTA in adults is comparable to immediate-release methylphenidate administered three times daily, but the CONCERTA formulation minimizes the fluctuations between peak and trough concentrations associated with immediate-release methylphenidate administered three times daily.

FDA approved ANDA 091695, held by Kremers, for a generic version of CONCERTA under the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and FDA's implementing regulations. 1 FDA approved ANDA 091695 on July 9, 2013, for the 18 mg and 27 mg strengths and on September 23, 2013, for the 36 mg and 54 mg strengths.

At the time of approval, FDA determined that ANDA 091695 included data sufficient to demonstrate the bioequivalence of the Kremers product to CONCERTA. The bioequivalence testing and data submitted in the ANDA were consistent with the recommendations provided in a draft guidance for industry on “Methylphenidate Hydrochloride,” issued on September 14, 2012 (77 FR 56851). The draft guidance provided information and recommendations for establishing bioequivalence to CONCERTA that reflected FDA's understanding, at that time, of how to evaluate the pharmacokinetic properties of such methylphenidate hydrochloride extended-release tablets to support a demonstration of bioequivalence. The demonstration of bioequivalence was necessary to the approval of Kremers' product. Unlike the sponsor of CONCERTA, Kremers was not required to submit clinical studies to demonstrate the safety and effectiveness of its product. Instead, FDA approved Kremers' ANDA based on a finding that the product was bioequivalent to CONCERTA and met the other requirements for ANDA approval in section 505(j) of the FD&C Act and FDA's implementing regulations.

After approval of ANDA 091695, FDA received adverse event reports describing an insufficient therapeutic effect of Kremers' product, particularly during the latter part of the 12-hour period after dosing. Due to those adverse event reports, CDER initiated a “tracked safety issue” to investigate the reports of insufficient therapeutic effect together with other data and information related to the Kremers product. After reevaluating the question of what evidence is needed to demonstrate bioequivalence to CONCERTA, FDA concluded that, to ensure therapeutic effect throughout the 12-hour therapeutic time course, an absence of a significant difference in drug exposure between a proposed generic product and CONCERTA must be shown during the entire therapeutic time course, including the latter part of the 12-hour period after drug administration. On November 6, 2014 (79 FR 65978), FDA issued a revised draft guidance for industry on “Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets” with recommendations for establishing bioequivalence to CONCERTA that reflected CDER's new understanding that there would need to be a comparison of the extent of methylphenidate exposure produced by a generic drug versus CONCERTA during the specific time period that corresponds to the latter part of the expected 12-hour duration of effectiveness.

CDER reanalyzed Kremers' original bioequivalence data submitted to support approval under the new recommendations in the revised draft guidance and concluded that the data failed to show an absence of a significant difference in the extent of drug exposure between the 54-mg strength of the Kremers product (on which the in vivo bioequivalence testing was conducted) and CONCERTA during the 7- to 12-hour time period after administration under fasting conditions and during the 8- to 12-hour time period after administration under fed conditions. CDER also analyzed new data submitted by Kremers in June 2015 under the recommendations in the revised draft guidance and found that Kremers' product failed to meet the recommendations for bioequivalence because the data did not show an absence of a significant difference in the extent of drug exposure between the Kremers product and CONCERTA during the 8- to 12-hour time period after administration under fed conditions.

On October 18, 2016, CDER published a notice of opportunity for hearing (NOOH) on its proposal to withdraw approval of ANDA 091695 held by Kremers for methylphenidate hydrochloride extended-release tablets (81 FR 71741). Kremers submitted a timely request for hearing on November 10, 2016, and its summary of data, information, and analyses in support of its request for hearing on December 4, 2017. Kremers submitted a supplement to its submission on May 2, 2018.

The Office of the Commissioner hereby appoints Administrative Law Judge Kourtney LeBlanc, at the Department of Health and Human Services' Departmental Appeals Board, to serve as presiding officer under 21 CFR 12.60 and to conduct the hearing in accordance with authority prescribed in 21 CFR 12.70.

In the NOOH, published October 18, 2016, CDER proposed to withdraw approval of ANDA 091695 under section 505(e)(3) of the FD&C Act (21 U.S.C. 355(e)(3)) and 21 CFR 314.150(a)(2)(iii). Section 505(e)(3) of the FD&C Act requires FDA to withdraw an approval if it finds “on the basis of new information before [FDA] with respect to such drug, evaluated together with the evidence available to [FDA] when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof.” The NOOH explained that, absent information showing bioequivalence between the Kremers product and CONCERTA, there is no basis to conclude that the finding of safety and effectiveness for CONCERTA can support approval of the Kremers product.

Kremers has the burden of proof in this proceeding. See 21 CFR 12.87(d) (putting the burden of proof on the hearing participant contesting withdrawal of approval of a drug application).

The central factual issue for this hearing is whether the Kremers methylphenidate product has been shown to be bioequivalent to CONCERTA. On February 24, 2026, pursuant to 21 CFR 12.85(a)(4), CDER submitted to the Dockets Management Staff, inter alia, a narrative position statement that identifies two specific sub-issues for the hearing:

The Office of the Commissioner is granting a hearing on the question raised by the second of the two sub-issues identified by CDER. But the first sub-issue identified by CDER appears to be a legal question turning on the meaning of “bioequivalent” in section 505(j)(2)(A)(iv) of the FD&C Act (21 U.S.C. 355(j)(2)(A)(iv)) ( see also 21 CFR part 320). Under 21 CFR 12.24(b)(1), however, “[a] hearing will not be granted on issues of policy or law.” As a result, the Office of the Commissioner is granting a hearing on the first sub-issue only to the extent that it raises a factual or scientific question not captured by the second sub-issue. 2 The presiding officer may also further revise these factual issues for the hearing under 21 CFR 12.35(b).

The parties to the hearing will be FDA's CDER and Kremers. Other interested persons shall be permitted to participate as nonparty participants as provided by 21 CFR 12.45 and 12.89.

In accordance with 21 CFR 12.85(a), CDER has filed with the Dockets Management Staff a narrative statement setting forth its position on the issues of the hearing and a summary of the types of evidence to be introduced in support of its position in the hearing, together with copies of data and information contained in the Center's files that relate to the issues to be resolved at the hearing. Hearing participants other than CDER, including Kremers, shall disclose data and information and submit their narrative statements pursuant to 21 CFR 12.85(b) to the Dockets Management Staff (see Addresses ) on or before October 13, 2026, or within another period of time set by the presiding officer. Interested persons may also examine the data on the drug subject to this hearing notice (with the exception of any data identified as confidential pursuant to the provisions of 21 CFR 10.20(j)) via https://www.regulations.gov or at the Dockets Management Staff, between 9 a.m. and 4 p.m., Monday through Friday (see Addresses ).

The prehearing conference will be held on September 28, 2026, beginning at 10:00 a.m. Eastern Daylight Time, by videoconference with instructions to be provided. The hearing will be held on a date to be set at the prehearing conference. Written notices of participation shall be filed with the Dockets Management Staff no later than September 14, 2026. All participants are required both to attend the prehearing conference and to be prepared to comply with the provisions of 21 CFR 12.92.

In accordance with the foregoing, under section 505 the FD&C Act (21 U.S.C. 355) and under authority delegated to me, I order that a formal evidentiary public hearing be held on the issues set out in this notice. The hearing will be open to the public by visiting the HHS Live Streaming page at www.hhs.gov/live. A direct link for the hearing will be visible on the HHS Live Streaming page once a hearing date has been set by the presiding officer after the prehearing conference. Interested persons are encouraged to monitor the docket for any updated links for public access.

Technology description follows.

Available for licensing and commercial development are patent rights covering a new class of spironolactone anti-inflammatory drugs, pharmaceutical compositions thereof, and their uses in treating inflammation. These new compounds present treatment options for treating a broad range of chronic inflammatory conditions such as atherosclerosis, autoimmune diseases, and chronic inflammatory lung disease.

Inflammation contributes to many forms of acute and chronic diseases such as cardiovascular disease and chronic respiratory disease, which result in a substantial percent of mortality worldwide. There is still need for clinically approved therapeutic strategies that effectively reduce pathologic inflammation. One promising candidate is Spironolactone (SPL), a mineralocorticoid receptor antagonist that was originally utilized by NIH investigators against pulmonary arterial hypertension. It has become recently elucidated that SPL suppresses inflammation by promoting proteasomal degradation of xeroderma pigmentosum type B (XPB), an integral subunit of the transcription factor TFIIH that activates inflammatory genes. Researchers at the National Heart, Lung, and Blood Institute (NHLBI) have developed twenty-nine (29) different SPL-based analogues, all of which demonstrate an effective potency at safe dosage levels, making them advantageous compared to known SPLs. Several lead compounds demonstrate potent, dose-dependent XPB degradation and inhibition of key inflammatory signaling pathways, including AP-1 and NF-kB, at concentrations significantly lower than those required for SPL. These analogs may be useful for treating multiple inflammatory disease and related conditions without deleterious side effects.

Potential Commercial Applications:

A class of novel anti-inflammatory drugs (long-term immunosuppressants) for the treatment for a wide variety of inflammatory disorders, such as (but not limited to):

• Pulmonary arterial hypertension

• Atherosclerosis

• Lupus erythematosus

• Rheumatoid arthritis

• Chronic obstructive pulmonary disease (COPD)

• Asthma

Development Stage:

• Early Stage

• In vitro data available

Inventors: Jason Elinoff (NHLBI), Li-Yuan Chen (NHLBI), Rolf Swenson (NHLBI), and Venkatareddy Sabbasani (NHLBI).

Intellectual Property:

• NIH Reference No. E-029-2026-0-US-01; U.S. Provisional Patent Application 64/044,506 filed April 20, 2026.

Licensing Contact: Vidita Choudhry, Ph.D.; 301-594-4095; vidita.choudhry@nih.gov . This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Comments: Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of SAMHSA, including whether the information will have practical utility; (b) the accuracy of SAMHSA's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, use, and clarity of the information to be collected, including through the use of automated collection techniques or other forms of information technology; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated or other forms of information technology.

Title III of the Foundations for Evidence-Based Policymaking Act of 2018 (44 U.S.C. 3583) mandates that the Director of OMB establish a standard application process (SAP) for requesting access to certain confidential data assets. The Center for Behavioral Health Statistics and Quality (CBHSQ) is a federally recognized statistical unit and the adoption of the SAP is required for statistical agencies/units designated under the Confidential Information Protection and Statistical Efficiency Act of 2018 (CIPSEA). The SAP Portal is a single web-based common application designed to collect information from individuals requesting access to confidential data assets from federal statistical agencies/units.

The SAP allows agencies, the Congressional Budget Office, State, local, and Tribal governments, researchers, and other individuals, as appropriate, to apply to access confidential data assets held by a federal statistical agency or unit for the purposes of developing evidence. With the Interagency Council on Statistical Policy (ICSP) as advisors, the entities upon whom this requirement is levied are working with the SAP Project Management Office (PMO) and with OMB to implement the SAP.

The SAP Portal is a single web-based common application designed to collect information from individuals requesting access to confidential data assets from federal statistical agencies and units. When an application for confidential data is approved through the SAP Portal, SAMHSA will collect information to fulfill its data security requirements. This is a required step before providing the individual with access to restricted use microdata for the purpose of evidence building. SAMHSA's data security agreements and other paperwork, along with the corresponding security protocols, allow SAMHSA to maintain careful controls on confidentiality and privacy, as required by law. SAMHSA's collection of data security information will occur outside of the SAP Portal.

The following bullets outline the major components and processes in and around the SAP Portal, leading up to SAMHSA's collection of security requirements.

• SAP Policy: At the recommendation of the ICSP, the SAP Policy establishes the SAP to be implemented by statistical agencies and units and incorporates directives from the Evidence Act. The SAP Policy may be found in OMB Memorandum 23-04.

• The SAP Portal: The SAP Portal is an application interface connecting applicants seeking data with a catalog of metadata for data assets owned by the federal statistical agencies and units. The SAP Portal is not a new data repository or warehouse; confidential data assets will continue to be stored in secure data access facilities owned and hosted by the federal statistical agencies and units. The Portal provides a streamlined application process across agencies, reducing redundancies in the application process.

• Data Discovery: Individuals begin the process of accessing restricted use data by discovering confidential data assets through the SAP metadata catalog, maintained by federal statistical agencies at https://sap.nsf.gov/.

• SAP Portal Application Process: Individuals who have identified and wish to access confidential data assets apply through the SAP Portal. Applicants must create an account and follow all steps to complete the application. Applicants enter personal, contact, and institutional information for the research team and provide summary information about their proposed project.

• Submission for Review: Agencies approve or reject an application within a prompt timeframe. Agencies may also request applicants to revise and resubmit their application.

• Access to Confidential Data: Approved applicants are notified through the SAP Portal that their proposal has been accepted. This concludes the SAP Portal process. Agencies will contact approved applicants to initiate completion of their security documents. The completion and submission of the agency's security requirements will take place outside of the SAP Portal.

• Collection of Information for Data Security Requirements: In the instance of a positive determination for an application requesting access to a SAMHSA-owned confidential data asset, SAMHSA will contact the applicant(s) to initiate the process of collecting information to fulfill its data security requirements. This process allows SAMHSA to place the applicant(s) in a trusted access category.

The estimated response burden is as follows:

The amount of time to complete the agreements and other paperwork that comprise SAMHSA's security requirements will vary based on the confidential data assets requested. To obtain access to SAMHSA confidential data assets, it is estimated that the average time to complete and submit SAMHSA's data security agreements and other paperwork is 40 minutes. This estimate does not include the time needed to complete and apply within the SAP Portal. All efforts related to SAP Portal applications occur prior to and separate from SAMHSA's effort to collect information related to data security requirements.

The expected number of applications in the SAP Portal that receive a positive determination from SAMHSA each year may vary. Overall, per year, SAMHSA estimates it will collect data security information for 15 application submissions that received a positive determination within the SAP Portal. SAMHSA estimates that the total burden for the collection of information for data security requirements over the course of the three-year OMB clearance will be about 30 hours and, as a result, an average annual burden of 10 hours.

This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, USCG-2025-0196, and must be received by September 14, 2026.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice as being available in the docket, and public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. If you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the Coast Guard in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020). For more about privacy and submissions to OIRA in response to this document, see the https://www.reginfo.gov, comment-submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0016.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (90 FR 40615, August 20, 2025) required by 44 U.S.C. 3506(c)(2). We received four unique and eight duplicate submissions to the 60-day notice. None of the submissions were related to the notice. Based on the comments received, no change was made to the Collection.

Title: Welding and Hot Work Permits; Posting of Warning Signs.

OMB Control Number: 1625-0016.

Summary: This information collection helps to ensure that waterfront facilities and vessels are in compliance with safety standards. A permit must be issued prior to welding or hot work at certain waterfront facilities; and, the posting of warning signs is required on certain facilities.

Need: The information is needed to ensure safe operations on certain waterfront facilities and vessels.

Forms: CG-4201, Welding and Hot Work.

Respondents: Owners and operators of certain waterfront facilities and vessels.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 497 hours to 519 hours a year, due to an increase in the estimated annual number of responses.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended.

Section 504 of the 21st Century ROAD to Housing Act includes the Reforming Disaster Recovery Act that authorizes the CDBG-Disaster Recovery program and specifically requires HUD to issue a notice in the Federal Register containing the latest formula allocation methodologies used to determine the total estimate of unmet needs related to housing, economic revitalization, and infrastructure in the most impacted and distressed areas resulting from a catastrophic major disaster. The statute requires HUD to solicit public comments on the described methodologies and seek alternative methods for formula allocation within a similar total amount of funding; the impact of formula methodologies on rural areas and Tribal areas; adjustments to improve targeting to the most serious needs; objective criteria for grantee capacity and concentration of damage to inform grantee determinations and minimum allocation thresholds; and research and data to inform an additional amount to be provided for mitigation depending on type of disaster, which shall be up to 18 percent of the total estimate of unmet needs.

On December 20, 2022, HUD requested comment on the CDBG-DR formula in use at the time through an RFI (December 2022 Notice). 1 HUD published a later notice on January 16, 2025 (the January 2025 Notice), 2 announcing a revised formula, which is substantially similar to the methodology published for public comment in the December 2022 Notice. HUD intends to use the formula published in January 2025 as the allocation methodology until such time as HUD publishes an updated formula notice or completes rulemaking.

HUD's intent is for future modifications to make the formula simpler and more transparent to help ensure allocations are quickly delivered based on the scale and severity of unmet need. To that end, HUD is seeking additional comment on the current allocation formula, as described in the December 2022 Notice and in the January 2025 Notice, and the following specific questions:

1. Are there alternative methods for formula allocation HUD should consider within a similar total amount of funding? Some ideas HUD is considering and seeking comment are:

a. Housing need multipliers. HUD is seeking comment on changing the multiplier for determining a dollar amount of unmet housing needs. HUD is seeking comment on adding a new category—“destroyed”—separate from its current severe definition, for having a specific multiplier calculated. In addition, HUD is seeking comment on no longer matching to SBA data to determine the amount used for the multiplier and instead use historic experience of multipliers by disaster type and adjusting for cost differences by geography using private sector construction cost data (similar to the methods used for the HOME and Housing Trust Fund formulas) and inflation over time. HUD is also seeking comment on how to define reasonable costs to rebuild, including comment on how to incorporate standards for determining if local regulations are causing unreasonable higher costs to rebuild and how to best assess whether and to what extent a locality has taken action(s) consistent with HUD's State and Local Best Practices for Home Construction. HUD is seeking comment on using rental unit multipliers different than owner unit multipliers to reflect generally fewer square feet for rental units than owner units. Discussion: HUD has found that disasters with large numbers of destroyed housing have much different recovery needs than those with only damaged homes. In addition, the timing of when there is reliable SBA disaster loan data on cost to repair for a disaster and the timing for allocating CDBG-DR funds are not well synchronized. To facilitate a faster CDBG-DR allocation, HUD is seeking comment on no longer relying on the SBA disaster loan data to determine the multipliers.

b. Economic revitalization. For economic revitalization, HUD is seeking comment on not using SBA business disaster loan data, but instead presuming that economic revitalization unmet need equals some percentage of the calculated housing unmet need. Discussion: Data on grantee action plans for the major CDBG-DR appropriations years for disasters in 2011-2013, 2016, 2017, 2018, 2020/21, 2022, and 2023/24 show that relatively little funding has been planned for economic development, ranging from 0 percent to 7 percent, the median is 2 percent. HUD is seeking comment on this approach of basing economic revitalization need off of housing need; and if that percentage should be a flat amount, such as 2 percent, or adjusted based on type of disaster and what percentages HUD should consider.

c. Infrastructure. For infrastructure, HUD is seeking comment on no longer using FEMA Public Assistance Category C to G estimates for determining infrastructure need. Instead, HUD is considering determining unmet infrastructure need as a percentage of the calculated housing unmet needs. Discussion: Similar to the issue with SBA business data, FEMA's estimates for infrastructure need often change significantly over time so the timing of the formula allocation is often not in alignment with the timing for the best estimates for FEMA Public Assistance needs. At the same time, HUD knows that some grantees often do expend considerable share of CDBG-DR on infrastructure, and others very little. Data on grantee plans for the major appropriations for disasters in 2011-2013, 2016, 2017, 2018, 2020/21, 2022, and 2023/24 show a range by appropriation on planned infrastructure expenditures of 9 percent to 31 percent, median of 22 percent. HUD is seeking comment on this approach of basing infrastructure need off of housing need; and if that percentage should be adjusted based on type of disaster and what percentages HUD should consider.

d. Extraordinary Circumstances. The expectation is that the vast majority of estimated unmet needs for CDBG-DR allocations would use the standard methodology. However, due to the unpredictability of natural disasters, HUD is seeking comment on including an element to the formula that reserves the right for the Secretary to use alternative data or methods in the case of extraordinary circumstances. Discussion. Over the more than 25 years HUD has calculated formula allocations for CDBG-DR, there have been occasional disasters where there was a particular type of unmet need not previously considered. For example, in 2018, HUD made an adjustment for undamaged homes permanently inaccessible due to lava flow in Hawaii.

2. How should HUD measure the impact of formula methodologies on rural areas and Tribal areas? HUD is seeking comment on revising its definition for most impacted and distressed areas to have separate thresholds for metropolitan, non-metropolitan (a proxy for rural areas), and tribal areas.

3. What adjustments to the formula should HUD consider to improve its targeting to the most serious needs? The 21st Century ROAD to Housing Act limits grantee eligibility to those impacted by “catastrophic disasters.” For a “catastrophic” standard solely used for determining CDBG-DR eligibility, HUD is seeking comment on what that standard might be. For example, HUD is exploring limiting the disasters it funds to those of large scale as measured by a large number of housing units with major-high or severe damage with unmet needs (as defined in the 2022 RFI, except that major high includes homes with 1 foot or more flooding on first floor) or a high concentration of homes with major-high or severe need relative to all occupied homes in a small geography. These standards could be set differently based on whether the disaster is in a metropolitan area, a non-metropolitan area, or a tribal area.

4. How might HUD determine separate thresholds for metropolitan, non-metropolitan, and tribal areas to inform its determinations of most serious need?

5. Should HUD consider updating thresholds for the housing damage definitions of minor-low, minor-high, major-low, major-high, and severe, given these thresholds were originally established for Hurricane Sandy and have been used since; and if so, how should they be updated?

6. Are there objective criteria to measure grantee capacity and concentration of damage in regards to determining the appropriate jurisdiction to receive the allocation? HUD is seeking comment on a policy that assumes states are generally going to have more capacity and HUD's preference will be to award grants to states unless HUD's review of capacity and concentration of damage warrant allocation to local governments or Indian tribes. For tribes, HUD is seeking comments on a general policy that, if a tribe receives a disaster declaration and the disaster meets the definition of catastrophic, HUD's Office of Native American Programs make the determination of tribal capacity to administer the grant.

7. Are there other objective criteria HUD should consider for assessing concentration of damage to inform grantee determinations and minimum allocation thresholds?

8. Is there research and data that could inform HUD on how to calculate an additional amount to be provided for mitigation depending on type of disaster? HUD is seeking comments offering research that would recommend different percentages (not to exceed 18 percent) by disaster type.

9. How might HUD consider repetitive loss data ( i.e., properties that have experienced damage from multiple disasters) or damage to critical infrastructure in the allocation formula?

For comments submitted by mail responses should not exceed 35 pages. Please provide the following information at the start of your response to this notice: Company/institution name (if applicable); contact information, including address, phone number, and email address. Do not submit Confidential Business Information (CBI) in your response to this notice. Responses identified as containing CBI will not be reviewed and will be discarded.

Please identify each answer by responding to a specific question or topic if applicable. You may answer as many or as few questions as you wish. To help you prepare your comments, please see the How Do I Prepare Effective Comments segment of the Commenting on HUD Rules web page, https://www.hud.gov/program_offices/general_counsel/Commenting-On-HUD-Rules#1 . While that web page is written for commenting on regulatory proposals, these tips are generally applicable to this RFI.

The Department of Housing and Urban Development (HUD), Office of Chief Information Officer (OCIO), maintains the “Sumo Logic” system of records. This system enhances enterprise-wide cybersecurity monitoring and incident response. By consolidating log data from HUD systems and platforms, Sumo Logic supports real-time threat detection, reporting and compliance with federal information security standards.

In accordance with the Paperwork Reduction Act (PRA; 44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR part 1320, all information collections require approval under the PRA. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number.

On March 2, 2026, we published in the Federal Register (91 FR 10109) a notice of our intent to request that OMB approve this information collection. In that notice, we solicited comments for 60 days, ending on May 1, 2026. We also published the notice on Regulations.gov (Docket No. FWS-HQ-MB-2026-0166). We received two comments in response to that notice. However, the commenters did not address the information collection requirements; therefore, no response is required to those comments.

As part of our continuing effort to reduce paperwork and respondent burdens, we are again inviting the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

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

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

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

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

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

Abstract: The Migratory Bird Treaty Act (16 U.S.C. 703-712) designates the Department of the Interior as the primary agency responsible for managing migratory bird populations frequenting the United States and setting hunting regulations that allow for the well-being of migratory bird populations. These responsibilities dictate that we gather accurate data on various characteristics of migratory bird populations.

The North American Woodcock Singing Ground Survey is an essential part of the migratory bird management program. Federal, State, Provincial, Tribal, and local conservation agencies conduct the survey annually to provide the data necessary to determine the population status of the American woodcock. In addition, the information is vital in assessing the relative changes in the geographic distribution of the species. We use the information primarily to develop recommendations for hunting regulations. Without information on the population's status, we might promulgate hunting regulations that:

• Are not sufficiently restrictive, which could cause harm to the woodcock population, or

• Are too restrictive, which would unduly restrict recreational opportunities afforded by woodcock hunting.

State, local, Tribal, Provincial, and Federal conservation agencies, as well as other participants, use Form 3-156 to conduct annual field surveys. Instructions for completing the survey and reporting data are on the reverse of the form and on the internet. Observers scan/email or scan/upload (via the link provided) Form 3-156 to State and Province coordinators and/or enter the information electronically through the internet at https://naturecounts.ca/nc/amwo/main.jsp.

We collect observer information (name and email address) so that we can contact the observer if questions or concerns arise. Observers provide information on:

• Sky condition, temperature, wind, and precipitation;

• Stop number;

• Odometer reading;

• Time at each stop;

• Number of American Woodcock males heard peenting (calling);

• Disturbance level; and/or

• Comments concerning the survey.

Data results are entered via a web browser application by the observer or a State or Province coordinator. A mobile application which operates on portable electronic devices is also available to enter data while in the field. Substantial improvements are still being made to the browser that will mimic the user experience of the mobile application. The data entry feature for both will still be collecting data on all the same fields within the survey form. For those routes with spatial data within the mobile application, a mapping feature allows observers to see each stop location along the route and keep track of their current location. This will assist in stop location verification efforts and help maintain a verified spatial reference for the survey. Stop location verification, or more broadly, device location verification, is the process of confirming the physical location of a user's device (phone, computer) using GPS, Wi-Fi, or cellular network data.

The administrator sends paper-based survey forms to every observer; however, the observer is not required to submit the paper-based results to the Service. They are advised to send a copy to State and Province coordinators for data entry, quality assurance and quality control checks, and/or follow up.

With our November 2023 submission, we also included the following collections: North American Woodcock Singing Ground Survey—CAN and North American Woodcock Singing Ground Survey—U.S. These two collections were for observers who only submitted their survey form with no data entry; therefore, Service staff entered their data for them. This no longer occurs so we removed these two information collections for the current renewal.

We use the information that we collect to analyze the survey data and prepare reports. Assessment of the population's status serves to guide the Service, the States, and the Canadian Government in the annual promulgation of hunting regulations.

Title of Collection: North American Woodcock Singing Ground Survey.

OMB Control Number: 1018-0019.

Form Number: Form 3-156 (US) and Form 3-156 (CAN).

Type of Review: Renewal, without change, of a currently approved collection.

Respondents/Affected Public: State, local, Tribal, and Provincial governments.

Respondent's Obligation: Voluntary.

Frequency of Collection: Annually.

Total Estimated Annual Nonhour Burden Cost: None.

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

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection (IC) requirements and minimize the public's reporting burden. It also helps the public understand our IC requirements and provide the requested data in the desired format.

As part of our continuing effort to reduce paperwork and respondent burdens, we are soliciting comments from the public and other Federal agencies on the proposed ICR described below. We are especially interested in public comments addressing the following:

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

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

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

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

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

Abstract: The U.S. Fish and Wildlife Service (Service) is the Federal agency primarily responsible for managing migratory birds, including bald eagles and golden eagles. Our authority derives primarily from the Migratory Bird Treaty Act of 1918, as amended (MBTA; 16 U.S.C. 703-712), which implements migratory bird conventions with Canada, Mexico, Japan, and the Russian Federation. As part of this effort, we collect information to determine the eligibility of applicants in certain activities in accordance with the criteria in various Federal wildlife conservation laws and international treaties, including the MBTA and the Bald and Golden Eagle Protection Act (Eagle Act; 16 U.S.C. 668-668d).

Regulations implementing these statutes are in Chapter I, Subchapter B of Title 50, Code of Federal Regulations (CFR), which stipulate general and specific requirements that, when met, allow us to issue permits to authorize activities that are otherwise prohibited:

With this notice, we are submitting four simultaneous ICRs to the Office of Management and Budget (OMB) requesting approval of existing, revised, new, and discontinued ICs associated with the following OMB Control Numbers:

• 1018-0022, Federal Fish and Wildlife Permit Applications and Reports — Migratory Birds; 50 CFR 10, 13, 20, 21, expires 12/31/2026;

• 1018-0146, Depredation and Control Orders Under 50 CFR 21, Subpart D, expires 08/31/2026;

• 1018-NEW1, Federal Fish and Wildlife Permit Applications and Reports—Possession of Migratory Bird Specimens; 50 CFR 10, 13, 21; and

• 1018-NEW2, Federal Fish and Wildlife Permit Applications and Reports—Falconry Standards and Permitting; 50 CFR 10, 13, 21.

We will request OMB approval of the existing, revised, new, and discontinued ICs as described below:

1. OMB Cont. No. 1018-0022, Federal Fish and Wildlife Permit Applications and Reports—Possession of Live Migratory Birds; 50 CFR 10, 13, 21—

A. Revised Title —We propose to change the title of this collection from “Federal Fish and Wildlife Permit Applications and Reports—Possession of Live Migratory Birds; 50 CFR 10, 13, 20, 21” to “Federal Fish and Wildlife Permit Applications and Reports—Possession of Live Migratory Birds; 50 CFR parts 10, 13, 21”.

B. Monitoring and Reporting —Most permit types require the permittee to submit a report of their activities on an annual basis. The Service uses these reports to ensure the applicant remains in compliance with the terms of their permit. We use the number of birds reported by activity to ascertain the effects of the permit and the permitting program on populations of migratory birds to ensure the program is not causing a population decline that could be avoided.

Submission of reports is generally on an annual basis, although some are dependent on specific events. Events that result in the death of an unusually large number of birds or federally listed threatened or endangered species or eagles requires the permittee to report such events within 48 hours or as soon as practical. Service biologists use these immediate reports to provide technical assistance to minimize additional take during the existing event and to prevent these events in the future.

We continually review the application and report forms in this collection to clarify the questions asked and the information requested and to be consistent across all applications. This effort focuses on questions frequently misinterpreted or not addressed by applicants to ensure they (a) are easier to understand and complete and (b) will accommodate future electronic permitting.

C. Applications —All Service permit applications are in the 3-200 series of forms, each tailored to a specific activity based on the regulatory requirements for specific types of permits. Sections A through D on the applications are the same for all permit types. These sections collect standard identifier information, such as the name and address, telephone numbers, tax identification number, and email address for the applicant. Regulations at 50 CFR 13.12, “General information requirements on applications for permits”, require submission of this information. With this revision, we propose to amend the information contained in Sections A through D. Standardizing general information common to the application forms makes filing applications easier for the public as well as expedites our review of applications. We use this information to establish a permit record that is unique to the applicant.