The regulations in 9 CFR part 93 (referred to below as the regulations) prohibit or restrict the importation of certain animals into the United States to prevent the introduction of communicable diseases and pests of livestock. Subparts C, D, E, and F of the regulations govern the importation of horses, ruminants, swine, and dogs, respectively.

Horses, ruminants, swine, and dogs may be imported into the United States from the regions where screwworm is considered to exist only if they are inspected and, if necessary, treated for screwworm according to the conditions outlined in the regulations for each type of animal. The requirements for horses are set out in § 93.308(a)(3) and include not only pre-embarkation and post-arrival inspection and treatment requirements, but also quarantine in the United States for 7 days after arrival, and examination by a veterinarian before release from quarantine. The requirements for ruminants and swine are set out in §§ 93.405(a)(3) and 93.505(b), respectively, and are the same as for horses, other than the 7-day quarantine and final examination of the animal. The requirements for dogs are set out in § 93.600 and require that all dogs from affected regions be inspected and, if necessary, treated before importation.

The Animal and Plant Health Inspection Service (APHIS) maintains a list of regions APHIS considers affected with screwworm on its website at http://www.aphis.usda.gov/animalhealth/disease-status-of-regions/. APHIS will add a region to the list upon determining that screwworm exists in the region based on reports we receive of detections of the pest from veterinary officials of the exporting country, from the World Organization for Animal Health (WOAH), or from other sources the Administrator determines to be reliable.

On December 14, 2024, WOAH received a report from El Salvador documenting an outbreak of New World screwworm ( Cochliomyia hominivorax ) in cattle. Accordingly, on December 17, 2024, APHIS added El Salvador to the list of regions APHIS considers affected with screwworm.

On January 3, 2025, WOAH received a report from Belize documenting an outbreak of New World screwworm in cattle. Accordingly, on January 7, 2025, APHIS added Belize to the list of regions APHIS considers affected with screwworm.

As a result, horses, ruminants, swine, and dogs from El Salvador and Belize are subject to APHIS import restrictions designed to mitigate risk of screwworm introduction into the United States. This notice serves as an official record and public notification of these actions.

Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Title: WIC Tribal Organizations and U.S. Territories.

Form Number: Not applicable.

OMB Number: 0584-NEW.

Expiration Date: Not yet determined.

Type of Request: New collection.

Abstract: The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) improves the health of nutritionally at-risk women and children and is recognized as one of the nation's most successful public health nutrition programs. Eighty-eight State agencies, including 5 U.S. territories (Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands) and 32 Indian Tribal Organizations (ITOs, “Tribal Organizations”), currently administer WIC. While WIC program requirements are the same across all WIC State agencies, there is flexibility in adapting the program to the local context. This flexibility can create variation in the experiences of WIC program staff and participants. For instance, WIC agencies from geographic States traditionally contract with local agencies to provide direct services to participants. However, nearly all WIC agencies in Tribal Organizations and U.S. territories conduct State agency-level functions and provide direct WIC services.

FNS is conducting the WIC Tribal Organizations and U.S. Territories Study to learn more about how WIC agencies in Tribal Organizations and U.S. territories administer and operate the program. The results will inform FNS about differences in WIC program operations and experiences among Tribal Organizations, U.S. territories, and geographic State agencies and can inform possible program improvements. Study objectives include:

1. Comprehensively describe WIC program administration and operations among ITOs and territories operating as State and local agencies.

2. Understand the facilitators and barriers to WIC program administration and operations among ITOs and territories operating State and local agencies.

3. Examine and describe the differences in WIC State agency-level policy, service delivery, and operations between ITOs and U.S. territories and geographic State agencies.

4. Obtain information to inform determination of WIC coverage rates among ITOs and territories.

The study takes a qualitative case study approach and will gather information from the following sources: (a) extant data; (b) interviews with WIC directors (all 32 State agency-level Tribal Organizations, all 5 Tribally operated local WIC agencies, and 15 geographic State agencies); and (c) site visits to 20 selected Tribal Organizations and U.S. territories. Site visits will include interviews with WIC clinic staff and observations of the clinic environment, participant appointments, and WIC-authorized retailers. 1

Affected public: (1) State, local, and Tribal governments and (2) individuals/households. Identified respondent groups include the following:

1. State, local, and Tribal governments: Staff from 57 State, local, and Tribal government agencies (32 Tribal Organizations operating WIC State agencies, 5 Tribal Organizations operating WIC local agencies, 5 U.S. territories operating WIC State agencies, and 15 geographic WIC State agencies) will participate in data collection activities. WIC staff from 20 Tribal government agencies will participate in site visits, and WIC staff from 37 State, local, and Tribal government agencies will participate in virtual interviews.

2. Individuals/households: Observations of up to 70 WIC participant appointments will be included across the 25 WIC clinics included in site visits.

Pretesting: Pretesting of new data collection instruments will be conducted in May and June 2025. No more than nine individuals will be asked to test each instrument. Three individuals will pretest the WIC director interview guide for the Tribal Organizations and U.S. territory agencies. Two individuals will pretest the geographic State agency WIC director interview guide. Three WIC agency staff will pretest the clinic staff interview guide. The clinic environment and appointment observation forms will draw on instruments used successfully in a previous study and will not be pretested again.

Estimated number of respondents: The total estimated number of respondents for both pretests and the main study is 210: 140 staff representing State, local, and Tribal government agencies, and up to 70 WIC participant individuals or households (including adult WIC participants or adults whose children participate in WIC). Only virtual interviews will be conducted with 32 of the 52 WIC State agency directors and all 5 WIC local agency directors; all other respondents (20) will participate in a site visit. Because the study respondents work for WIC agencies that would need to have consented to participate in this study, we anticipate staff at all agencies will be responsive. The breakdown of respondents follows:

1. State, local, and Tribal government staff: Of the 37 WIC agencies from State, local, and Tribal governments initially contacted for a virtual interview, 37 staff are estimated to participate in the interview and 0 to be nonresponsive. Of the 20 WIC State agencies from WIC Tribal and U.S. territories contacted for site visits, 20 are expected to participate and 95 staff (WIC directors, clinic managers, frontline staff) from these agencies are estimated to participate and 0 to be nonresponsive.

2. Individuals/households: Up to 70 WIC participant appointment observations will be conducted. Of the 70 participant appointments observed, 70 individuals or households are estimated to participate and 0 to be nonresponsive.

Estimated number of responses per respondent: 2.66—based on 558 total annual responses from the 210 respondents. See table 1 for the estimated number of responses per respondent for each type of respondent. The estimated breakout follows:

1. WIC State agency staff (55): The estimated number of responses per WIC State agency staff is 6.16. Of these 55, Directors of three WIC State agencies will receive three communications to participate in pretesting the WIC director guide. Fifty-two staff from 52 WIC State agencies will receive a study notification email. Of these staff, 37 staff from 37 WIC State agencies will receive up to 3 communications to participate in an introductory meeting. Of these staff, 20 staff from 20 WIC State agencies will receive up to 5 communications to participate in a site visit planning meeting, WIC director interview, and WIC director debrief. Thirty-two staff from 32 WIC State agencies will receive up to 3 communications to participate in a virtual interview.

2. WIC local agency staff (7): The estimated number of responses per WIC local agency staff is 7.00. Two former geographic State WIC directors will pretest these interview guides. Five staff from five tribally operated WIC local agencies will receive up to two communications to participate in an introductory meeting and three to participate in a virtual interview.

3. WIC clinic staff (78): The estimated number of responses per WIC clinic staff is 1.60. Three staff will pretest the clinic staff guide. Twenty-five clinic managers from 25 WIC clinics will receive one communication to participate in a clinic visit planning meeting and a clinic manager interview. Fifty frontline staff from 25 WIC clinics will participate in a clinic frontline staff interview.

4. Individuals/households (70): The average estimated number of responses per individual/household is 1.00. Seventy individuals/households participating in WIC will provide informed consent for appointment observation. There is no additional burden associated with observing an existing appointment.

Estimated total annual responses: 210 (210 annual responses for responsive participants and 0 annual responses for nonresponsive participants).

Estimated time per response: 0.4811 hours (0.4811 hours for responsive participants and 0.000 hours for nonresponsive participants). Among respondents, the estimated response time varies from 0.0835 hours to 1.5 hours depending on respondent group and activity, as shown in table 1.

Estimated total annual burden on respondents and nonrespondents: 268.47 hours (268.47 hours for responsive participants and 0.00 hours for nonresponsive participants). See table 1 for the estimated total annual burden for each respondent type.

The Bureau of Industry and Security (BIS) conducts surveys and assessments of critical U.S. industrial sectors and technologies. Undertaken at the request of various policy, research and development (R&D), and program and planning organizations within the Department of Defense and the Armed Services, Department of Homeland Security (DHS), NASA and other agencies, BIS research, data collection and analysis provide needed information to benchmark industry performance and raise awareness of diminishing manufacturing capabilities.

Electronic.

OMB Control Number: 0694-0119.

Form Number(s): None.

Type of Review: Regular submission, extension of a current information collection.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 28,000.

Estimated Time per Response: 8-14 hours.

Estimated Total Annual Burden Hours: 308,000 hours.

Estimated Total Annual Cost to Public: 0.

Respondent's Obligation: Mandatory.

Legal Authority: Section 705 of the Defense Production Act of 1950, as amended, Executive Orders 12656 and 13603.

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

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

Background

On June 3, 2025, Commerce published in the Federal Register , the notice entitled Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review and Join Annual Inquiry Service List. 1 We inadvertently duplicated certain cases with May anniversary dates that were previously announced in the Federal Register of May 5, 2025. 2

In the Federal Register of June 3, 2025, in FR Doc. 2025-10049, at 90 FR 23517, correct the table to remove the following antidumping duty orders:

REPUBLIC OF KOREA: Carbon and Alloy Steel Wire Rod (A-580-891); Ferrovanadium (A-580-886); Polyester Staple Fiber (A-580-839).

REPUBLIC OF TÜRKIYE: Carbon and Alloy Steel Wire Rod (A-489-831); Circular Welded Carbon Steel Pipes and Tubes (A-489-501); Large Diameter Welded Carbon and Alloy Steel Like and Structural Pipe (A-489-833); Light-Walled Rectangular Pipe and Tube (A-489-815); Mattresses (A-489-841); Certain Paper Shopping Bags (A-489-849).

SERBIA: Mattresses (A-801-002)

SOCIALIST REPUBLIC OF VIETNAM: Mattresses (A-552-827); Polyethylene Retail Carrier Bags (A-552-806).

SOUTH AFRICA: Stainless Steel Plate in Coils (A-791-805).

SPAIN: Carbon and Alloy Steel Wire Rod (A-469-816).

TAIWAN: Certain Carbon and Alloy Steel Cut-To-Length Plate (A-583-858); Certain Circular Welded Carbon Steel Pipes and Tubes (A-583-008); Polyester Staple Fiber (A-583-833); Polyethylene Retail Carrier Bags (A-583-843); Certain Stainless Steel Plate in Coils (A-583-830); Stilbenic Optical Brightening Agents (A-583-848).

THAILAND: Mattresses (A-549-841).

This notice is not required by statute but is published as a service to the international trading community.

On September 12, 2024, Commerce published the Preliminary Results of this administrative review in the Federal Register and invited comments from interested parties. 1 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by 90 days. 2 On March 10, 2025, Commerce extended the final results by 57 days. 3 Accordingly, the deadline for the final results is now June 6, 2025. 4

For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 5 Commerce conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act).

The products covered by the Order are ripe olives from Spain. For a complete description of the scope of the Order , see the Issues and Decision Memorandum.

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

Based on our analysis of comments received from interested parties and verification findings, we made changes to our substantial dependence calculation from the Preliminary Results. 6 For a discussion of these changes, see the Issues and Decision Memorandum.

Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found to be countervailable, we determine that there is a subsidy, i.e., a government- provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 7 In these final results, Commerce relied, in part, on facts otherwise available, including with an adverse inference, pursuant to sections 776(a) and (b) of the Act. For a complete description of the methodology underlying all of Commerce's conclusions, see the Issues and Decision Memorandum.

Commerce determined the following net countervailable subsidy rates exist for the period January 1, 2022, through December 31, 2022:

Commerce intends to disclose the calculations and analysis performed for these final results of review within five days of the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

In accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce shall determine, and U.S Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after 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).

In accordance with section 751(a)(1) of the Act, we also intend to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown above for the above-listed companies with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of these final results of review. For all non-reviewed firms subject to the Order, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific rate or the all-others rate ( i.e., 11.08 percent), as appropriate. 9 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

These final results 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).

Background

On September 12, 2024, Commerce published the Preliminary Results of this administrative review in the Federal Register and invited comments from interested parties. 1 On December 9, 2024, Commerce tolled the deadline to issue the final results in this administrative review by 90 days. 2 On April 2, 2025, Commerce extended the deadline of the final results of this administrative review to May 9, 2025. 3 On May 7, 2025, Commerce further extended the deadline for the final results of this administrative review to June 6, 2025. 4 For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 5

The products covered by the Order are metal lockers from China. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

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

Based on our analysis of comments from interested parties and the evidence on the record, we revised the net countervailable subsidy rate for Hangzhou Evernew Machinery and Equipment Company Limited (Hangzhou Evernew) and its cross-owned producer. In addition, we have also revised the rate applicable to companies not selected for individual review. For a discussion of these changes, see the Issues and Decision Memorandum.

Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 6 For a complete description of the methodology underlying all of Commerce's conclusions, including our reliance, on facts otherwise available, including adverse facts available (AFA), pursuant to sections 776(a) and (b) of the Act, see the Issues and Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(3), Commerce will rescind an administrative review when there are no reviewable suspended entries. Based on our analysis of U.S. Customs and Border Protection (CBP) information, we determine that Kunshan Dongchu Precision Machinery Co., Ltd., Pingchu Chenda Storage Office Co., Ltd., Tianjin Jia Mei Metal Furniture Ltd., and Zhejiang Xingyi Metal Products Co., Ltd., had no entries of subject merchandise during the POR. In the Preliminary Results, we notified parties that we intended to rescind this administrative review with respect to the four companies which have no reviewable suspended entries. 7 No parties commented on the notification of intent to rescind the review, in part. We are, therefore, now rescinding the administrative review of these companies which have no reviewable suspended entries.

The statute and Commerce's regulations do not directly address the establishment of rates to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides the basis for calculating the all-others rate in an investigation. Section 705(c)(5)(A)(i) of the Act instructs Commerce, as a general rule, to calculate an all-others rate equal to the weighted average of the countervailable subsidy rates established for exporters and/or producers individually examined, excluding any rates that are zero, de minimis, or based entirely on facts available.

There are two companies for which a review was requested and not rescinded, and which were not selected as mandatory respondents or found to be cross-owned with a mandatory respondent: Hangzhou Xline Machinery & Equipment Co., Ltd. 8 and Jiangsu Wanlong Special Containers Co., Ltd. We made changes to the calculations for the mandatory respondent Hangzhou Evernew and its cross-owned producer, which provided part of the rate assigned to the non-selected companies for the Preliminary Results. Because Hangzhou Evernew's rate is now based on total AFA, the rate for the two companies not selected for individual examination will be solely based on the subsidy rate for the cooperating mandatory respondent, Xingyi Metalworking.

As a result of this review, we determine the following net countervailable subsidy rates exist for the POR, January 1, 2022, through December 31, 2022:

Commerce intends to disclose calculations and analysis performed for the final results of review within five days after the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

In accordance with section 751(a)(1) of the Act, Commerce also intends to instruct U.S. Customs and Border Protection (CBP) to collect cash deposits of estimated countervailing duties in the amounts shown above for the above-listed companies with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of these final results of review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the all-others rate or the most recent company-specific rate applicable to the company, as appropriate. These cash deposit requirements, effective upon publication of these final results, shall remain in effect until further notice.

In accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce has determined, and CBP shall assess, countervailing duties on all appropriate entries covered by this review, for the above-listed companies at the applicable ad valorem assessment rates listed. For the companies for which we rescinded this review, Commerce will instruct CBP to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2022, through December 31, 2022. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after 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).

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

The final results 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 September 13, 2024, Commerce published the Preliminary Results of this administrative review in the Federal Register and invited interested parties to comment. 1 On October 24, 2024, Commerce extended the deadline for issuing the final results of this administrative review by 60 days, in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act). 2 On December 9, 2024, Commerce tolled certain deadlines in this administrative proceeding by 90 days. 3 The deadline for the final results is now June 10, 2025. For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 4

The merchandise covered by the Order is steel flanges from India. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 6

As noted in the Preliminary Results, based on our analysis of U.S. Customs and Border Protection (CBP) data, we determine that the companies listed in Appendix III had no reviewable entries of subject merchandise during the POR. 7 We received no comments or additional information from interested parties regarding these listed companies. Therefore, absent evidence of suspended entries of subject merchandise during the POR, we are rescinding the administrative review of these 30 companies listed in Appendix III of this notice, pursuant to 19 CFR 351.213(d)(3).

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

Based on a review of the record and analysis of comments received from interested parties, we made changes to the Preliminary Results. For a full description of this revision, see the Issues and Decision Memorandum.

Commerce conducted this administrative review in accordance with section 751(a)(l)(A) of the Act. For each of the subsidy programs found to be countervailable, Commerce finds that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific. 8 The subsidy programs under review, and the issues raised in case and rebuttal briefs submitted by the interested parties, are discussed in the Issues and Decision Memorandum.

The Act and Commerce's regulations do not directly address the establishment of rates to apply 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 normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides the basis for calculating the all-others rate in an investigation. Section 777A(e)(2) of the Act instructs Commerce, as a general rule, to calculate an all-others rate equal to the weighted average of the countervailable subsidy rates established for exporters and/or producers individually examined, excluding any rates that are zero, de minimis, or based entirely on facts available. 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. 9

There are 10 companies for which a review was requested and not rescinded, and which were not selected as mandatory respondents or found to be cross-owned with a mandatory respondent. 10 In this review, we find that Norma and RNG received countervailable subsidies at above de minimis rates and not based entirely on facts available. Therefore, we continue determine to assign the companies not selected for individual review a weighted average of the subsidy rates calculated for Norma and RNG using each company's publicly ranged data for the value of its exports of subject merchandise to the United States. 11

Commerce determines the following net countervailable subsidy rates for the period January 1, 2022, through December 31, 2022:

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

Consistent with sections 751(a)(1) and (a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this 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., without 90 days of publication).

Pursuant to section 751(a)(1) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties for each of the companies listed above on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, except where the rate calculated in the final results is zero or de minimis. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the all-others rate or the most recent company-specific rate applicable to the company, as appropriate. These cash deposit instructions, effective upon publication of these final results, shall remain in effect until further notice.

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

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

On March 26, 2025, the President issued Proclamation 10908 (90 FR 14705), “Adjusting Imports of Automobiles and Automobile Parts Into the United States,” (Proclamation 10908) finding that imports of automobiles and certain automobile parts continue to threaten to impair the national security of the United States and imposing specified tariffs to adjust imports of automobiles and certain automobile parts so that such imports will not threaten to impair national security pursuant to Section 232. Proclamation 10908 imposed a 25 percent tariff on certain imports of automobiles, effective April 3, 2025, and certain imports of automobile parts, effective May 3, 2025.

On April 29, 2025, the President issued Proclamation 10925 (90 FR 18899), which allowed for automobile manufactures assembling automobiles in the United States to apply for an import adjustment offset amount, which would offset certain tariff liability under Proclamation 10908 on imports of automobile parts. Proclamation 10925 required the Secretary of the Department of Commerce (Commerce) to establish a process by which automobile manufacturers could submit documentation supporting eligibility for an import adjustment offset amount. This notice announces procedures for administration of the import adjustment offset amount program, including application, documentation, and certification requirements, eligibility conditions, and coordination with U.S. Customs and Border Protection (CBP).

Proclamation 10925 provides that automobile manufacturers are eligible for an import adjustment offset amount calculated as a percentage of the aggregate Manufacturer's Suggested Retail Price (MSRP) value of automobiles assembled in the United States, as follows:

• 3.75% of aggregate MSRP for eligible automobiles assembled between April 3, 2025, and April 30, 2026; and

• 2.5% of aggregate MSRP for eligible automobiles assembled between May 1, 2026, and April 30, 2027.

Import adjustment offset amounts may be used to reduce Section 232 tariffs on automobile parts and may be carried forward indefinitely until fully exhausted, provided they were granted based on qualifying automobiles assembled between April 3, 2025 and April 30, 2027. While Proclamation 10925 limits the import adjustment offset to vehicles assembled in the United States between April 3, 2025 and April 30, 2027, it does not include a deadline for use of the offset amount, and providing manufacturers flexibility in this regard is consistent with the Proclamation's goals (which include to “strengthen United States vehicle assembly operations by encouraging companies to expand domestic production capacity, which is critical to a strong domestic defense industrial base” (Proclamation 10925 preamble, Section 7)) and with the flexibilities the Proclamation expressly provides to manufacturers ( e.g., to determine the importer of record eligible to decrement against that manufacturer's import adjustment offset amount (Proclamation 10925, Section 1)). Section 3 of Proclamation 10925 provides that the Secretary shall issue regulations, guidance, or procedures necessary to carry out the provisions of the Proclamation, and the Department has determined that such flexibility is necessary to effectively carry out the Proclamation. This notice establishes that no offset amounts will be granted for automobiles assembled after April 30, 2027.

For purposes of this notice, “automobile parts” means the articles classified under the subheadings of the Harmonized Tariff Schedule of the United States (HTSUS) that were made subject to Section 232 duties pursuant to section B of the Annex to Proclamation 10908, and any amendments thereto.

Manufacturers seeking an import adjustment offset amount must submit the following documentation for each period for which an import adjustment offset amount is sought ( i.e., one set of documentation for the period of April 3, 2025 through April 30, 2026; and a separate set of documentation for the period of May 1, 2026 through April 30, 2027):

1. Production Forecast: The number of automobiles ( i.e., passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans, and cargo vans) and light trucks) projected to be produced in the United States by make and model and the plant locations where the projected automobiles will undergo final production during each reporting period.

2. MSRP: The aggregate MSRP value of all such automobiles assembled in the United States during each reporting period.

3. Tariff Liability Estimate: Projected automobiles and automobile parts tariff liability under Proclamation 10908, broken down by Proclamation 10908 tariff costs the manufacturer will incur directly and Proclamation 10908 tariff costs the manufacturer's suppliers will incur.

4. Offset Calculation: Requested total import adjustment offset amount for each reporting period, including details of how such amount was calculated.

5. Importers of Record: A list of authorized importers of record eligible to decrement against the manufacturer's import adjustment offset amount. This list must include the importer's Importer of Record number and the amount of the import adjustment offset amount allotted to each importer of record. Updates to this list may be submitted electronically to Commerce at autooffset@trade.gov. Commerce will inform CBP of list updates on December 1, 2025; June 1, 2026; and December 1, 2026. At its discretion, Commerce may update this list at other times during the program period.

6. Certification: A sworn statement from a senior officer of the manufacturer confirming that the submission is true, accurate, and complete to the best of the manufacturer's knowledge under penalty of perjury, and confirming that the manufacturer has conducted reasonable diligence to verify the accuracy of the assertions and facts contained in its submissions.

7. Additional Information: Any other information the applicant feels is necessary to facilitate decision making.

Commerce will review applications for completeness. Commerce may request, in writing, supplemental documentation or clarification. Approved manufacturers will be notified in writing of approval and amount of offset granted, and relevant import adjustment offset amount data, including amounts and importer of record numbers, will be transmitted by Commerce to CBP. CBP will administer the offset at the time of entry summary filing and may request additional documentation to validate entries.

Import Adjustment Offset amounts:

• May be used only by approved importers associated with the approved manufacturer;

• May be applied only to reduce tariff liability under Proclamation 10908 on eligible automobile parts;

• May not exceed the manufacturer's total tariff liability on covered parts; and

• May not be traded, sold, or transferred.

Commerce will monitor manufacturer and importer compliance and communicate information regarding noncompliance to CBP, where appropriate. CBP may exercise its authority to conduct audits to ensure compliance with this regulation. If it is determined that inaccurate, incomplete, or false information, has been submitted, penalties may be imposed.

Under Proclamation 10908, Commerce, in consultation with the United States International Trade Commission and CBP, shall determine the modifications necessary to the HTSUS to effectuate this proclamation and shall make such modifications to the HTSUS through notice in the Federal Register . The HTSUS is modified as set forth below.

Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern daylight time on May 3, 2025:

Subdivision (g) of U.S. note 33 to subchapter III of chapter 99 of the HTSUS is modified by deleting the first paragraph, and inserting the following in lieu thereof: “Subject to a manufacturer's import adjustment offset amount that may be determined by the Secretary of Commerce under Proclamation 10925 of April 29, 2025 (90 FR 18899), the rates of duty set forth in heading 9903.94.05 applies to parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans, and cargo vans) and light trucks classifiable in the provisions of the HTSUS enumerated in this subdivision: ”

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), and the Office of Management and Budget (OMB) implementing regulations at 5 CFR 1320.13, ITA is requesting emergency processing for this information collection. In Proclamation 10925 of April 29, 2025, “Amendments to Adjusting Imports of Automobiles and Automobile Parts Into the United States,” the President determined it was necessary and appropriate to modify the system of monetary fees and related measures imposed to adjust imports of automobiles and certain automobile parts pursuant to Proclamation 10908 to more effectively eliminate the threat imports of automobiles and certain automobile parts pose on the national security of the United States. Proclamation 10925 provided that for automobiles assembled in the United States, automobile manufacturers shall be eligible to receive an import adjustment offset amount applicable to section 232 duties on automobile parts by reducing duties assessed on automobile parts accounting for 15 percent of the value of an automobile assembled in the United States for an opening period and equivalent to 10 percent of that value for an additional year after the initial period closes. Because the Proclamation requires timely implementation of the offset mechanism to support domestic automobile production and reduce the national security risk posed by automobile part imports, ITA cannot reasonably comply with the normal clearance procedures. Delaying this collection would impede the ability of manufacturers to claim offset amounts and compromise the effectiveness of the Proclamation's implementation. Therefore, ITA is requesting emergency PRA processing under 5 CFR 1320.13 to initiate this process without delay.

With the publication of the notice, ITA is requesting an emergency approval to meet the requirements of Proclamation 10925. ITA is also announcing a process for automobile manufacturers with final production in the United States to submit documentation to request an import adjustment offset amount that may only be used by importers of record authorized by that manufacturer, and the amount may only be used to offset tariff liability related to that manufacturer's automobile parts tariff liability under Proclamation 10908. ITA estimates the burden to the public for this notification will average 2,400 hours (30 respondents * 40 hours per response *2 expected responses per year), including the time for reviewing instructions, searching existing data sources, gathering the data needed, and completing and reviewing the collection of information. The estimated total annual cost to the Federal Government is $111,600.

The public may access this ITA request, including all supporting materials, at www.reginfo.gov/public/do/PRAMain and inserting the OMB control number [0625-0283] or the name of the collection. Please send written comments to Emily Davis, Director for Public Affairs, 202-482-3809, Emily.Davis@trade.gov. A comment to OMB is best assured of having its full effect if OMB receives it within 60 days of publication of this notice. All written comments submitted in response to this notice will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identity of the individuals or entities submitting the comments will be subject to public disclosure. Written comments will be publicly available on the internet via https://www.regulations.gov.

We are soliciting comments from the public (as well as affected agencies) concerning our information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility.

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

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

(4) Minimize the burden of the information collection on those who are to respond (such as 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 responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 40 hours per response.

Respondents: Private Sector.

Estimated annual number of respondents: 30.

Estimated annual number of responses per respondent: 2.

Estimated annual number of responses: 60.

Estimated total annual burden on respondents: 2,400.

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

Copies of this information collection can be obtained from Emily Davis, Director for Public Affairs, 202-482-3809, Emily.Davis@trade.gov.

Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid OMB Control Number.

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 Committee for Purchase From People Who Are Blind or Severely Disabled (operating as the U.S. AbilityOne Commission) is proposing to add products listed below to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

In accordance with 41 CFR 51-5.3(b), the Committee intends to add the product listed below to the Procurement List as a mandatory for purchase federal agencies with the proposed qualified nonprofit agency as the authorized source of supply. Prior to adding the products to the Procurement List, the Committee will consider other pertinent information, including information from Government personnel and relevant comments from interested parties regarding the Committee's intent to geographically limit this services requirement.

The following product(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

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

On 5/2/2025 (90 FR 18838) and 5/9/2025 (90 FR 19681), 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:

CPSC seeks approval for the following collection of information. 1

Title: Carbon Monoxide Poisoning Prevention Grant Program Application.

OMB Number: New.

Type of Request: New information collection request.

Type of Review Requested: Regular.

Requested Expiration Date of Approval: Three years from date of approval.

Summary of the Collection of Information: The Nicholas and Zachary Burt Memorial Carbon Monoxide Poisoning Prevention Act of 2022 (NZB Act) authorizes CPSC to provide funding for the Carbon Monoxide Poisoning Prevention Grant Program (COPPGP). 15 U.S.C 2090. The COPPGP provides two-year grants to eligible state, local or tribal governments to reduce deaths and injuries from carbon monoxide poisoning. The grant awards can range from $50,000 to $400,000 per applicant. Prospective applicants will be able to access the grant application on Grants.gov and apply electronically through GrantSolutions. Applicants will be required to complete common forms  2 used for federal grants, as well as up to six additional attachments specific to COPPGP. Awards are posted to the CPSC's website and via press release.

CPSC seeks to renew the following currently approved collection of information:

Title: Standard for Omnidirectional CB Base Antennas.

OMB Number: 3041-0006.

Type of Review: Renewal of collection.

Frequency of Response: On occasion.

Affected Public: Manufacturers, importers, and private labelers of omnidirectional citizens band base station antennas.

General Description of Collection: The Safety Standard for Omnidirectional Citizens Band Base Station Antennas (16 CFR part 1204, subpart A) establishes performance requirements for omnidirectional citizens band base station antennas to reduce unreasonable risks of death and injury that may result if an antenna contacts overhead power lines while being erected or removed from its site. Section 14 of the Consumer Product Safety Act, 15 U.S.C. 2063, and the regulations implementing the standard (16 CFR part 1204, subpart B) require manufacturers, importers, and private labelers of antennas, subject to the standard, to test the antennas for compliance with the standard, maintain records of that testing, and certify compliance with the standard.

Estimated Number of Respondents: Ten suppliers may respond to the collection annually by meeting the testing and certification requirements.

Estimated Time per Response: Staff estimates that the average annual recordkeeping burden imposed is approximately 220 hours.

Total Estimated Annual Burden: Based on ten respondents, at 220 hours per response, the total annual burden imposed by the certification regulations on manufacturers, importers and private labelers of omnidirectional citizens band base station antennas is about 2,200 hours.

The Commission staff estimates that the average hourly cost to reporting firms for the time required to perform the required testing and maintain the required records is about $74.73, based on the reported total compensation for management, professional, and related employees in goods-producing private industries. This may, however, be an overestimate because respondents to this collection may be foreign manufacturers that are compensated at a lower average wage rate. Total annual cost to the industry is approximately $164,406 ($74.73 per hour × 2,200 hours = $164,406).

Request for Comments:

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

• whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;

• whether the estimated burden of the proposed collection of information is accurate;

• whether the quality, utility, and clarity of the information to be collected could be enhanced; and

• whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.

CPSC seeks approval for the following collection of information. 1

Title: Pool Safely Grant Program Application.

OMB Number: New.

Type of Request: New information collection request.

Type of Review Requested: Regular.

Requested Expiration Date of Approval: Three years from date of approval.

Summary of the Collection of Information: The Virginia Graeme Baker Pool and Spa Safety Act (VGB Act) authorizes CPSC to grant funding for the PSGP. 15 U.S.C. 8004-8008. The PSGP provides two-year grants to eligible state, local or tribal governments to reduce deaths and injuries from drowning and drain entrapment incidents in swimming pools and spas. The grant awards can range from $50,000 to $400,000 per applicant. Prospective applicants will be able to access the grant application on Grants.gov and apply electronically through GrantSolutions. Applicants will be required to complete common forms  2 used for federal grants, as well as up to six additional attachments specific to PSGP. Awards are posted to the CPSC's website and via press release.

Description of the Need for the Information and Proposed Use of the Information: The PSGP is part of CPSC's national campaign to prevent drowning and drain entrapment. Drowning is one of the leading causes of death among young children. 3 The information collected through the application for PSGP grants is used to determine eligibility and to provide funding to reduce deaths and injuries from drowning and drain entrapment incidents in swimming pools and spas. Funding can be requested for enforcement and for education in accordance with 15 U.S.C. 8004(d).

Affected Public: State, Local or Tribal or U.S. Territory Government.

Estimated Number of Respondents: We expect up to 20 respondents annually.

Frequency: Annual.

Total Estimated Annual Burden: To apply for the PSGP, in addition to completing common forms, 4 an applicant would typically provide six attachments specific to the grant program.

• Attachment 1, the project narrative, provides a description of community needs and is estimated to take 20 hours to prepare, on average.

• Attachment 2, the budget narrative, presents each budget category with an explanation of each line item and is estimated to take 10 hours to prepare, on average.

• Attachment 3, the schedule, is a multi-year project schedule/timeline and is estimated to take six hours to prepare, on average.

• Attachment 4, the staffing plan, includes a narrative that describes and identifies each program staff member with the amount of time for the grant program funded work and is estimated to take six hours to prepare, on average.

• Attachment 5, legal eligibility, includes references necessary to support that the applicant meets the legal eligibility requirements of the VGB Act for swimming pools and spas and is estimated to take one hour to prepare, on average.

• Attachment 6, the indirect cost rate agreement, substantiates indirect costs that may be reimbursed as permissible administrative costs as stated in the VGB Act and is estimated to take one hour to prepare, on average.

CPSC estimates it would take the applicant approximately 44 hours to complete attachments 1-6. CPSC expects to receive 20 grant applications that utilize the attachments described, for a total burden hour estimate of 880 hours (44 hours per application × 20 applications).

Total Estimated Annual Burden Cost: CPSC estimates the compensation for the creation and compilation of attachments 1-6 is $62.92 per hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” September 2024, total compensation for state and local government workers: https://www.bls.gov/news.release/archives/ecec_12172024.pdf ). Therefore, the estimated annual cost of the burden requirements is $55,370 ($62.92 per hour × 880 hours = $55,369.60). Based on this analysis, the collection of information would impose a total burden to applicants of 880 hours at a cost of $55,370.

Response to Comments: The Commission received one comment in support of the collection. The commenter stated that CPSC's burden estimate for the proposed collection is accurate for first-time applicants. However, the commenter noted that for repeat applicants the burden may decrease. Specifically, the commenter stated that information such as the staffing model, legal eligibility, and indirect cost rate agreement do not change much from previous applications. The Commission agrees that subsequent grant applications may take less time than the first application, however, each complete application would contain the six updated attachments specific to the grant program. The estimated respondent burden for preparing and submitting these attachments is based on the average application time, which may be more for applicants with large and complicated packages, or less for repeat applicants that reuse application materials and for smaller entities with smaller and less complicated application packages.

Commander, U.S. Pacific Fleet is the DoN's lead action proponent, with Naval Sea Systems Command acting as an additional Navy action proponent.

In continuance of the Navy's commitment to responsible stewardship of the marine environment and building upon analyses and information included in the Navy's 2001 Final EIS/OEIS, 2007 Final SEIS, 2012 Final SEIS/Supplemental OEIS (SOEIS), 2015 Final SEIS/SOEIS, and 2019 Final SEIS/SOEIS, the Navy intends to prepare an updated supplemental assessment of the environmental effects associated with the continued employment of SURTASS LFA sonar systems. The SEIS/OEIS and associated analysis will be used to support consultations associated with expiring regulatory permits and authorizations in 2026.

The Western Pacific and Indian Oceans SURTASS LFA Study Area (hereafter referred to as the “Study Area”) is comprised of the western North Pacific and Indian Oceans. The Navy proposes to continue employing up to four SURTASS LFA sonar systems onboard U.S. Navy surveillance ships for routine training and testing in the Study Area with certain geographical restrictions and other preventive measures designed to mitigate adverse effects on the marine environment. As part of the SEIS/OEIS analyses, the Navy will continue to assess potential impacts of SURTASS LFA sonar systems to offshore biologically important areas. Effectiveness of the mitigation measures that are the foundation of the Navy's training and testing with SURTASS LFA sonar will also be re-assessed in the context of new technologies and methodologies as well as operational practicability.

Potential impacts on environmental resources resulting from activities included in the two Action Alternatives and the No Action Alternative were evaluated in accordance with NEPA. Resources evaluated include, but are not limited to, biological (including marine mammals, sea turtles, fishes, and habitats), ambient acoustic environment, and economics. The SEIS/OEIS also includes an analysis of measures that would avoid, minimize, or mitigate environmental effects potentially resulting from military readiness activities. Direct, indirect, and reasonably foreseeable effects on these resource areas are analyzed in the SEIS/OEIS.

The DoN is coordinating and consulting with appropriate federal agencies as required by the Marine Mammal Protection Act (MMPA), Endangered Species Act (ESA), and National Marine Sanctuaries Act. As part of this process, the Navy is seeking the issuance of regulatory permits and authorizations under MMPA and ESA to support at-sea military readiness activities within the Study Area, beginning in August 2026. The National Marine Fisheries Service (NMFS) is a cooperating agency in the preparation of the SEIS/OEIS. NMFS will consider the potential impacts of the Proposed Action on the marine environment. The SEIS/OEIS will support its rule making process to determine whether to issue an MMPA authorization.

The Navy distributed the Draft SEIS/OEIS to government agencies they are consulting with and to other stakeholders. The Draft SEIS/OEIS is available for public review on the project website at www.nepa.navy.mil/surtass-lfa/ and at these public libraries:

1. Hawaii State Library, 478 S King St., Honolulu, HI 96813.

2. Nieves M. Flores Memorial Public Library, 254 Martyr St., Hagåtña, Guam 96910.

3. Antonio C. Atalig Memorial Library, P.O. Box 537, Rota, MP 96951.

4. Joeten-Kiyu Public Library, The State Library of the Commonwealth of Northern Marianas Islands, P.O. Box 501092, Saipan, MP 96950-1092.

5. Tinian Public Library, P.O. Box 520704, Tinian, MP 96952.

The public involvement process is helpful in identifying public concerns and local issues to be considered during the development of the SEIS/OEIS and assessing the accuracy and adequacy of the environmental impact analysis. Federal, state, and local agencies; nongovernmental organizations; and interested persons are encouraged to provide comments that are substantive to the analysis of potential impacts on environmental resources. All comments provided electronically via the project website or mailed to the address provided in the ADDRESSES section will be taken into consideration during the development of the Final SEIS/OEIS.

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: Campus Equity in Athletics Disclosure Act (EADA) Survey.

OMB Control Number: 1840-0827.

Type of Review: An extension without change of a currently approved ICR.

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

Total Estimated Number of Annual Responses: 2,039.

Total Estimated Number of Annual Burden Hours: 11,215.

Abstract: The collection of information is necessary under section 485 of the Higher Education Act of 1965, as amended, with the goal of increasing transparency surrounding college athletics for students, prospective students, parents, employees and the general public. The survey is a collection tool to compile the annual data on college athletics. The data is collected from the individual institutions by ED and is made available to the public through the Equity in Athletics Data Analysis Cutting Tool as well as the College Navigator.

Purpose: In accordance with the Government in the Sunshine Act (Sunshine Act), Public Law 94-409, as amended (5 U.S.C. 552b), the U.S. Election Assistance Commission (EAC) will conduct an open meeting with the Massachusetts Institute of Technology on research and topics related to election administration.

Agenda: During the meeting, election officials, academics, and other key stakeholders will participate in panel discussions on election administration and related innovative and groundbreaking data and research. Topics will include the results of the 2024 Election Administration and Voting Survey (EAVS), election funding, voter list maintenance, workforce development, and more.

The full agenda will be posted in advance on the EAC website: https://www.eac.gov.

Background: The EAVS helps the EAC meet its mandate under the Help America Vote Act (HAVA) to serve as a national clearinghouse and resource for the compilation of information and to review procedures with respect to the administration of federal elections. The EAVS sections related to voter registration and the Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA) allow states to satisfy their data reporting requirements established, respectively, by the National Voter Registration Act (NVRA) and UOCAVA. The EAVS also helps the Federal Voting Assistance Program (FVAP) fulfill its obligations under UOCAVA to reduce obstacles to ensure military and overseas voting success by collecting data about how UOCAVA voters participate in elections.

This meeting will provide information on current and emerging topics in elections to help inform stakeholders as well as the general public and members of the media.

Status: This meeting will be open to the public.

The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study.

This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance.

Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study.

Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

Respondents: 1,010,650.

Responses per Respondent: ~1.

Total Annual Responses: 1,010,650.

Hours per Response: ~.063445 hours.

Total Burden Hours: 128,120.

A 60-day notice was published in the Federal Register at 90 FR 15242 on April 9, 2025. No public comments were received.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 3090-0297, Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, in all correspondence.

The Patient Safety Act, 42 U.S.C. 299b-21 to 299b-26, and the related Patient Safety Rule, 42 CFR part 3, published in the Federal Register on November 21, 2008 (73 FR 70732-70814), establish a framework by which individuals and entities that meet the definition of provider in the Patient Safety Rule may voluntarily report information to PSOs listed by AHRQ, on a privileged and confidential basis, for the aggregation and analysis of patient safety work product.

The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of PSOs.

AHRQ has accepted a notification of proposed voluntary relinquishment from the Michigan Surgical Quality Collaborative to voluntarily relinquish its status as a PSO. Accordingly, the Michigan Surgical Quality Collaborative, PSO number P0143, was delisted effective at 12:00 Midnight ET (2400) on April 21, 2025.

Michigan Surgical Quality Collaborative has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification to providers that have reported to the PSO and of section 3.108(c)(2)(ii) regarding disposition of PSWP consistent with section 3.108(b)(3). According to section 3.108(b)(3) of the Patient Safety Rule, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO's possession.

Proximie PSO failed to submit a response to the findings of deficiency in the Notice of Proposed Revocation and Delisting by the deadline. As stated in the Patient Safety Rule at 42 CFR 3.108(a)(4)(iii), this failure means that the Notice of Proposed Revocation and Delisting becomes final as a matter of law. It also serves as the basis for AHRQ to revoke acceptance of Proximie PSO certifications for listing, remove Proximie PSO from the list of PSOs, and provide public notice in the Federal Register and on the AHRQ PSO website that Proximie PSO has been delisted for cause. Accordingly, the Proximie PSO, P0244, was delisted effective at 12:00 Midnight ET (2400) on January 11, 2025.

More information on PSOs can be obtained through AHRQ's PSO website at http://www.pso.ahrq.gov.

Following is a summary of the use and burden associated with the subject information collection(s). More detailed information can be found in the collection's supporting statement and associated materials (see ADDRESSES ).

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Managed Care Rate Development Guide; Use: States must submit to CMS for review and approval all rate certifications for managed care plans. The state's actuary is responsible for certifying that the managed care program's capitation rates are actuarially sound for a specific time period and documents the rate development process and the final certified capitation rates in a rate certification. The Medicaid Managed Care Rate Development Guides outline the rate development standards and CMS' expectations for documentation included in rate certifications such as descriptions of base data used, trend factors to base data, projected benefit and non-benefit costs, and any other considerations or adjustments used when setting capitation rates. Form Number: CMS-10398 #37 (OMB control number: 0938-1148); Frequency: Once and Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 47; Total Annual Responses: 137; Total Annual Hours: 754. (For policy questions regarding this collection contact: Rebecca Burch Mack at 303-844-7355.)

2. Type of Information Collection Request: New information collection request; Title of Information Collection: Managed Care Plan (MCP) Medical Loss Ratio (MLR) Reporting Template; Use: Medicaid managed care is the predominant delivery system for Medicaid beneficiaries to access health care services. State Medicaid agencies contract with managed care plans that accept a fixed, prospective monthly payment for each enrolled beneficiary (also referred to as risk-based managed care). Section 1903(m)(2) of the Social Security Act (SSA) and 42 CFR 438.4 require that capitation rates be actuarially sound, meaning that the capitation rates are projected to provide for all reasonable, appropriate, and attainable costs that are required under the terms of the contract and for the operation of the MCP for the time period and the population covered under the terms of the contract. The MLR is a key measure of MCP financial performance and indicates the share of premium revenue (capitation payments) that a plan spends on covered health services and activities to improve health care quality compared to the share of revenue to cover administrative expenses and profit/surplus. MLRs are used as a retrospective tool to assess financial performance of MCPs. Section 438.8 provides detail on MLR calculations and MCP reporting requirements.

Section 438.8(k) requires State contracts with MCPs to include a requirement to annually report to the state specific details of the plan's MLR. The attached Medicaid managed care plan MLR reporting template provides States with a standard format for collecting the required details from their contracted MCPs. States are not required to have their MCPs use this template; it is provided in response to States' requests for a streamlined, consistent way to collect the required information. CMS' review process for managed care MLR represents an essential federal oversight function to ensure that States and MCPs are compliant with applicable federal laws and regulations.

Form Number: CMS-10398 #87 (OMB control number: 0938-1148); Frequency: Yearly; Affected Public: Private Sector and State, Local, or Tribal Governments; Number of Respondents: 47; Total Annual Responses: 47; Total Annual Hours: 2,350. (For policy questions regarding this collection contact: Amy Gentile at 410-786-3499.)

3. Type of Information Collection Request: New information collection request; Title of Information Collection: Medicaid 1915(l) State Plan Option to Provide Medical Assistance for Eligible Individuals Who Are Patients in Eligible Institutions for Mental Diseases; Use: On March 9, 2024, section 204 of the Consolidated Appropriations Act amended section 1915(l) of the SSA to remove the end date of September 30, 2023, making 1915(l) a permanent optional state plan benefit, and making additional changes to the requirements for maintenance of effort review process for eligible institutions of mental disease, patient placement and utilization management, and provider assessments.

The template is necessary for States to submit a state plan amendment on or before December 31, 2025, for an October 1, 2025, effective date. States will need adequate time to complete and vet these documents. If states do not have template, it could result in states not paying for such services, and beneficiaries not being able to receive such services. The longer the package update goes unpublished the likelihood of states missing the deadline increases.

Form Number: CMS-10398 #93 (OMB control number: 0938-1148); Frequency: Once and Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,400. (For policy questions regarding this collection contact: Marlana Thieler at 410-786-6274.)

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Prepaid Health Plan Cost Report; Use: The Cost Report outlines the provisions for implementing Sections 1876(h) and 1833(a)(1)(A) of the Social Security Act (Act). Organizations contracting with the Secretary under the Act provide health services on a prepayment basis to enrolled members and are required to submit adequate cost and statistical data, based on financial records, in order to be reimbursed on reasonable cost basis by CMS. Organizations include Health Maintenance Organizations (HMOs) and Competitive Medical Plans (CMPs) under Section 1876, in addition to, Health Care Prepayment Plans (HCPPs) under Section 1833. These entities may be collectively referred to as “Managed Care Organizations” (MCOs).

Form CMS 276, provided by CMS as excel worksheets, covers the prescribed format for the cost reports. The worksheets are designed to be of sufficient flexibility to take into account the diversity of operations, yet provide the necessary cost and statistical information to enable CMS to determine the proper amount of payment to the Plan. Cost-based MCOs must submit through HPMS an annual Budget Forecast, semi-annual interim, and final cost report to CMS, all of which are included in this collection. Additionally, HMOs/CMPs are required to submit fourth quarter interim reports annually to CMS. Please note that HCPPs are not required to submit fourth quarter interim reports. Form Number: CMS-276 (OMB control number: 0938-0165); Frequency: Yearly, semi-annually, and once; Affected Public: Private sector; Number of Respondents: 16; Number of Responses: 36; Total Annual Hours: 1,128. (For questions regarding this collection contact Frank Cisar at 410-786-7553).

Description: This is a revision to what was originally related to a larger project, the Evaluation of the Child Welfare Capacity Building Collaborative, focused on studying outcomes of TA to child welfare agencies and courts, for both states and tribes. This request will remove most of the prior instruments approved for this project under OMB #: 0970-0576. The larger project was successful in getting information about the broad array of TA. It also showed therein that there was more variation among the professional audiences being served than anticipated and thus CB had opted to pursue evaluation individually by Center going forward. There were larger scope and approach changes for the other prior Centers and those evaluations will need to be separately revisited.

Three instruments will continue to be used. These are used with legal and judicial participants in TA. Data collected through these three instruments has and will continue to be used by the CLJIA and CB to improve the development and delivery of CLJIA services, specifically the Academies and Workshops, and assess the quality, satisfaction with services, and impact on their intended outcomes, including increased knowledge and skills. Data collection includes online and paper-based surveys and assessments administered to participants in Academies and Workshops.

There are no significant changes to the instruments. The name of the TA provider was changed and that has been updated.

Respondents: Child welfare and court professionals.

Authority: 42 U.S.C. 5106(b)(5); 42 U.S.C. 5113(b)(4); 42 U.S.C. 629h.

Description: The LIHEAP statute and regulations require LIHEAP grant recipients to report certain information to the U.S. Department of Health and Human Services (HHS) concerning funds forwarded and funds subject to reallotment. The 1994 reauthorization of the LIHEAP statute, the Human Service Amendments of 1994 (Pub. L. 103-252), requires that the Carryover and Reallotment Report for one fiscal year (FY) be submitted to HHS by the grant recipient before the allotment for the next FY may be awarded.

In compliance with PRA, ACF discontinued the OMB number in June 2025, prior to the expiration date, to allow for public comment on the extension and revision request prior to OMB review.

ACF is requesting minor changes in the program's Carryover and Reallotment Report, a form for the collection of data, and the Instructions for Timely Obligation of LIHEAP Regular Block Grant, Reallotted, and Supplemental Funds and Reporting Funds for Carryover and Reallotment. The form clarifies the information being requested and ensures the submission of all the required information. The form facilitates our response to numerous queries each year concerning the amounts of obligated funds. Use of the form is mandatory for prior-year grant recipients that seek current-year LIHEAP funds except for (1) territorial grant recipients that consolidate their LIHEAP programs with the Social Services Block Grant under Public Law 95-134; and (2) tribal grant recipients that have integrated their LIHEAP programs under Public Law 102-477 for administration through the Bureau of Indian Affairs and that draw down funds solely during the integration period.

Respondents: State governments, tribal governments, territories, and the District of Columbia.

Description: The Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) amended section 437 of the Social Security Act (42 U.S.C. 629g[f]) and authorized HHS, ACF, ACYF, and CB to fund discretionary grants to improve safety, well-being, and permanency outcomes for children at risk of or in out-of-home placement because of their caregiver's substance misuse. In response, HHS launched a competitive grants program called “Targeted Grants to Increase the Well-Being of, and to Improve the Permanency Outcomes for, Children Affected by Methamphetamine and Other Substance Abuse,” which is also known as the RPG program. Reauthorized in 2011 and again most recently by the Bipartisan Budget Act of 2018 (Pub. L. 115-123) in 2018, these grants are designed to support partnerships between child welfare agencies, substance use disorder treatment organizations, and other social services systems, and thereby improve the well-being, permanency, and safety outcomes of children and families. Under six prior rounds of RPG, CB has issued 109 grants to organizations such as child welfare or substance use treatment providers or family court systems to develop interagency collaborations and integration of programs, activities, and services designed to increase well-being, improve permanency, and enhance the safety of children who are in an out-of-home placement or at risk of being placed in out-of-home care as a result of a parent's or caretaker's substance misuse. In 2022, CB awarded 18 grants to a seventh cohort (RPG7). The current request is for data collection activities associated with the 18 RPG7 grantees. Data collection for the first three cohorts was approved under OMB Control Numbers 0970-0353 and 0970-0444. Data collection for the fourth, fifth, and sixth cohorts were approved under this OMB Control Number (0970-0527).

The RPG cross-site evaluation will extend the understanding about how RPG programs and services may improve outcomes for children and families. First, the cross-site evaluation will assess the coordination of partners' service systems with an emphasis on the partnership between the child welfare and substance use treatment agencies, to add to the research base about how these agencies can collaborate to address the needs of children and families affected by substance misuse (partnerships analysis). Second, the evaluation will describe the experiences of adult participants enrolled in RPG services, such as their motivations for enrollment and how the services they received improved outcomes related to recovery and child welfare involvement (participant experiences analysis). Third, the evaluation will summarize supports within the partnership that can help improve and sustain RPG services, such as using data for service improvement, identifying a lead organization, and securing funding sources after grant funding ends (sustainability analysis). Fourth, the evaluation will describe the characteristics of participants served by RPG programs, the types of services provided to families, the dosage of each type of service received by families, and the level of participant engagement with the services provided (enrollment and services analysis). Finally, the evaluation will assess the outcomes of children and adults served through the RPG program, such as child behavioral problems, adult depressive symptoms, or adult substance use and treatment (outcomes and impacts analysis).

For the seventh cohort, CB is requesting an extension of most of the currently approved information collections (most recently approved in April 2022) with no changes, the removal of two approved data collections, and the addition of three new instruments. This will allow CB to continue obtaining participant data from grantees that they collect for their local evaluations and for directly collecting additional data from grantees and their partners and providers for the cross-site evaluation. Specifically, this request:

• Removes the currently approved semi-annual progress reports, as they are now covered under a separate OMB package (0970-0490) and removes the partnership survey, which will not be administered to the RPG7 grantees.

• Adds data collection of interviews and focus groups with participants enrolled in RPG services to allow the cross-site evaluation to describe participants' experiences receiving services.

• Makes minor wording changes to the data collection materials to comply with the recent Executive Orders. These edits were added to the request after the first public comment period, which was published in the Federal Register notice on December 31, 2024 (89 FR 107145).

• Continues approval of all other information collections approved under this OMB control number (Currently approved instruments available here: https://www.reginfo.gov/public/do/PRAICList?ref_nbr=202302-0970-003 ).

Overall, this request includes following data collection activities: (1) site visits with grantees, (2) individual interviews and focus groups with participants enrolled in RPG services, (3) a web-based survey about sustainability planning, (4) enrollment and services data provided by grantees, and (5) outcomes and impacts data provided by grantees.

Respondents: Respondents include grantee staff or contractors (such as local evaluators) and partner staff from the 18 RPG7 grantees, and 64 adult participants enrolled in RPG services. Specific types of respondents and the expected number per data collection effort are noted in the burden table below.

Authority: The Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) created the competitive RPG program. The September 30, 2011, passage of the Child and Family Services Improvement and Innovation Act (Pub. L. 112-34) extended funding for the RPG program from federal fiscal year (FFY) 2012 to FFY 2016. In 2018, the President signed the Bipartisan Budget Act of 2018 (Pub. L. 115-123) into law, reauthorizing the RPG program through FFY 2021 and adding a focus on opioid abuse. In 2025, the RPG program was reauthorized through FFY 2029 (Pub. L. 118-258).

FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2:

The Science Board Advisory Committee (Science Board) provides advice to the Commissioner of Food and Drugs (Commissioner) and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science, and input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It also provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs.

Reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases as well as the safety, effectiveness, and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these products.

Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products.

Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, and issues related to opioid abuse, and those for use in anesthesiology, and makes appropriate recommendations to the Commissioner.

Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug products for use in the practice of obstetrics, gynecology, urology, and related specialties.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields.

Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders.

Reviews and evaluates information on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which FDA has regulatory responsibility. Advises on the scientific and medical evaluation of all information gathered by the Department of Health and Human Services (HHS) and the Department of Justice regarding safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by HHS regarding the marketing, investigation, and control of such drugs or other substances.

Reviews and evaluates available data concerning the safety and effectiveness of over the counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases, and advises the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency-sponsored intramural and extramural scientific biomedical programs in support of FDA's mission and regulatory responsibilities.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer.

Reviews and evaluates scientific, clinical, and technical issues related to the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases, the quality characteristics which such drugs purport or are represented to have, and as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner. The Committee may also review Agency-sponsored intramural and extramural biomedical research programs in support of FDA's drug regulatory responsibilities and its critical path initiatives related to improving the efficacy and safety of drugs and improving the efficiency of drug development.

Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cardiovascular and renal disorders.

Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.

Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases.

The Medical Devices Advisory Committee has established certain panels to review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area: (1) advises on the classification or reclassification of devices into one of three regulatory categories and advises on any possible risks to health associated with the use of devices; (2) advises on formulation of product development protocols; (3) reviews premarket approval applications for medical devices; (4) reviews guidelines and guidance documents; (5) recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; (6) advises on the necessity to ban a device; and (7) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.

The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions.

Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) demonstrate an affiliation with and/or active participation in consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.

Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES ) within 30 days of publication of this document.

Within the subsequent 45 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or résumé. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel.

Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES ), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation.

Nominations must also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms of up to 4 years.

FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. After selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.

Agenda: On July 9, 2025, the PAC will meet to discuss post-marketing pediatric-focused safety reviews of the following products:

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES ) on or before July 2, 2025, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11:30 a.m. ET on July 9, 2025. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 24, 2025. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 25, 2025.

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

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

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

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

The FDA is publishing this request for comments to obtain suggestions for topics for future RISE Workshops. The FDA Rare Disease Innovation Hub (Hub) supports the RISE Workshop series pursuant to its commitment to further advance regulatory science of rare disease therapies and the Agency's PDUFA VII commitments to enhance regulatory science and expedite drug development and rare disease product review under the Food, Drug, and Cosmetic Act.

The Hub-sponsored RISE workshop series focuses on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops are open to the public and designed for interaction and discourse between the various rare disease community members and perspectives, including drug developers, patient and disease organizations, academics, FDA regulators and reviewers, and relevant staff from other federal agencies. All workshops include coordination between the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) and address the Centers' approaches to the relevant issues. The workshops also include a discussion of the role of patients and patient/disease organizations in the design and implementation of innovative solutions. The workshops primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency. Preference will be given to submissions that are germane to multiple disease states and/or that are submitted jointly by two or more entities.

The Agency requests that submissions include:

Notice of this meeting series is given pursuant to 21 CFR 10.65.

Intended Recipient(s) of the Award: American Academy of Pediatrics (AAP).

Amount of Non-Competitive Award(s): One Award of $500,000.

Project Period: July 1, 2025, through June 30, 2026.

Assistance Listing (CFDA) Number: 93.110.

Award Instrument: Cooperative Agreement.

Authority: This non-competitive supplemental funding is authorized by 42 U.S.C. 701(a)(2) (title V, sec. 501(a)(2) of the Social Security Act).

Purpose/Justification: HRSA will provide a non-competitive supplement of $500,000 to the SUID Prevention Program recipient, AAP, to extend the period of performance by an additional year, July 1, 2025, to June 30, 2026, to connect families with the resources that they need and to help improve family capacity to practice safe sleep. This Program was awarded on July 1, 2022, for a 3-year period (HRSA 22-082). The purpose of the program is to reduce overall rates of SUID by supporting pediatric health care practitioners to provide evidence-based counseling and education to infant caregivers and families; to guide system improvements; and to identify and support policy changes that address state- and community-specific SUID risks. The awardee has demonstrated progress during this period and will be able to expand that progress if extended by 1 year.

Funds are available for award for this non-competitive supplement. A non-competitive supplement is necessary to ensure on time, high-quality implementation of best practices for reducing infant deaths that the current recipient is uniquely positioned to continue. The recipient is in good standing with current HRSA grant requirements and has been a leader in Sudden Infant Death Syndrome (SIDS) and SUID prevention for decades, starting with the initial Back to Sleep campaign in the 1990s that urged parents and caregivers to place infants to sleep supine following the emergence of data that supported this recommendation. More recently, the AAP Task Force on SIDS has published comprehensive recommendations for the prevention of SIDS, Accidental Suffocation and Strangulation in Bed, and other sleep-related deaths, based on a detailed and impartial analysis of all available evidence. In addition, AAP directs several initiatives aimed at improving child health outcomes.

The current recipient will use their existing infrastructure to maintain implementation without disruption and they are the only organization with a unique existing network of practicing pediatricians and related professionals who are part of a National Safe Sleep Champion Network, a network of pediatrician experts in safe sleep to promote safe sleep recommendations and education for providers to better serve families.

The recipient will be expected to ensure continued efforts around reducing infant deaths by disseminating and implementing best practices, increasing connections with state and local infant fatality review teams and AAP Chapters, supporting implementation of a community engagement toolkit, and expanding their National Safe Sleep Champion Network.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collection: Federalwide Assurance (FWA) Form.

Type of Collection: Revision.

OMB No.: 0990-0278.

Abstract: The Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is requesting a revision of the currently approved collection for the OMB No. 0990-0278, Federalwide Assurance (FWA) Form. The form is currently approved through October 31, 2026. The purpose of the FWA form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act) (42 U.S.C. 289); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this information collection are institutions engaged in HHS-conducted or supported research involving human subjects. With this revision, OHRP is seeking to remove information from the FWA form to adopt the changes for assurances at 45 CFR 46.103 of the 2018 Requirements and reduce burden on respondents. The proposed changes to the FWA form include: (1) removing the Pre-2018 Common Rule requirement that institutions provide a statement of ethical principles; (2) removing the Pre-2018 Common Rule requirement that an institution designate one or more IRBs to review the research to which the FWA applies; (3) removing “check the box”, or the option for U.S. institutions to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46, to all of an institution's nonexempt human subjects research regardless of the source of support; and (4) eliminating the requirement for institutions outside the U.S. to provide procedural standards they apply for human subjects research when assuring compliance with the Terms of the Federalwide Assurance. Updates to the software applications OHRP uses to manage the FWA application process will be deployed to enable such changes.