Center for Scientific Review; Notice of Closed Meetings

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Fogarty International Center; Notice of Meeting

Submission for Office of Management and Budget Review; Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms

Official abstract: The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting to move the Serious Medical Procedure Request (SMR) Form (Office of Management and Budget (OMB) #: 0970-0561, expiration December 31, 2026) under the Medical Assessment Form and Dental Assessment Form (OMB #: 0970-0466, expiration 10/31/ 2026) information collection and update the title of OMB # 0970-0466 to Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms. Revisions are proposed to the forms. The proposed restructuring and revisions will improve transparency, lessen burden, improve data quality, and ensure alignment with ORR requirements. In addition, to ensure continuity of care, the request has been revised to include the sharing of health information with the Department of Homeland Security (DHS) in specific circumstances.

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)

Official abstract: The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ISEMBYLD (apitegromab-mstn), approved September 11, 2026, manufactured by Scholar Rock, Inc., meets the criteria for a priority review voucher.

Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products

Official abstract: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on export certificates for FDA regulated products.

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products

Official abstract: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with product jurisdiction and combination product regulations.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program

Official abstract: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO

Official abstract: The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and DAYVIGO. The original determinations were announced in the Federal Registers of August 10, 2026 (BRINSUPRI, DAYVIGO), August 17, 2026 (BIZENGRI), and September 9, 2026 (ANDEMBRY, ANZUPGO, ANKTIVA). Those notices correctly identified the dates on which the testing and approval phases began and ended but incorrectly stated the length of the regulatory review period due to calculation errors. No other changes are made.

Proposed Information Collection Activity; Child Care and Development Fund Plan Preprint for States/Territories for Federal Fiscal Year (FFY) 2028-2030 (ACF-118) and extension of Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027

Official abstract: The Administration for Children and Families (ACF) is requesting an extension without changes of the form ACF-118: Child Care and Development Fund (CCDF) Plan Preprint for States/Territories for FFY 2025-2027 (Office of Management and Budget #: 0970-0114, expiration March 31, 2027), and an additional 3-year extension of the form ACF- 118: CCDF Plan Preprint for States/Territories for FFY 2028-2030. There are changes requested to the form ACF-118: CCDF Plan Preprint for States/Territories for FFY 2028-2030 to reduce burden, streamline questions, reduce data entry, and strengthen program integrity.

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Amended Notice of Meeting

Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products. The guidance announced in this notice finalizes the draft guidance of the same title published on December 18, 2025.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: Advanced Nursing Education Program Specific Form OMB No. 0906-0089-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0906-0081-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

National Vaccine Injury Compensation Program; List of Petitions Received

Official abstract: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

HHS Approval of Entities That Certify Medical Review Officers

Official abstract: This notice publishes a list of HHS approved Medical Review Officers (MROs) certification entities. The most recent HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 10, 2023, (Oral Fluid) and February 1, 2024, (Urine), address the role and qualifications of MROs and HHS approval of entities that certify MROs.

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supply.

Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is titled "Chapter 12: Control of Chemical Hazards." This draft guidance is not final nor is it in effect at this time.

Request for Public Comment: 60-Day Notice for Reinstated Collection: Division of Urban Indian Affairs Uniform Data System and Budget Formulation

Official abstract: In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the public to comment on the information collection titled, "Division of Urban Indian Affairs (DUIA) Uniform Data System and Budget Formulation," Office of Management and Budget (OMB) Control Number 0917-0007. The IHS is requesting OMB to approve a reinstated collection.

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

No Adjustment to HHS Civil Monetary Penalty Amounts for 2026

Official abstract: The Department of Health and Human Services (HHS or the Department) is notifying the public that there will be no Civil Monetary Penalty (CMP) inflation adjustment for 2026 in accordance with the April 17, 2026, guidance from the Office of Management and Budget (OMB). HHS will continue to use the 2025 civil monetary penalty levels because there will be no cost-of-living adjustment for 2026.

Center for Scientific Review; Notice of Closed Meetings

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report, OMB No. 0915-0172-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System, OMB No. 0915-0298-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance finalizes the draft guidance of the same title issued on September 19, 2023.

Privacy Act of 1974; Matching Program

Official abstract: In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is providing notice of a computer matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA). The purpose of the matching program is to identify beneficiaries enrolled in both Medicare and VHA health care and to identify medical claims for which both agencies made payment for the same health care services. Under this agreement, the VHA will provide CMS with a finder file on a recurring basis, of all Veteran beneficiaries enrolled in VHA health care that CMS will use to identify dually enrolled beneficiaries. CMS and VHA will use the results of the matching program to recover duplicate payments, improve payment accuracy, and identify potential fraud, waste, and abuse.

Agency Information Collection Activities: Proposed Collection; Public Comment Request; Information Collection Request Title: SAMHSA Data Security Requirements for Accessing Confidential Data (OMB No. 0930-0396)

Official abstract: Substance Abuse and Mental Health Services (SAMHSA), within the Department of Health and Human Services, has submitted the following information collection requirement to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This is the first notice for public comment. SAMHSA will forward the proposed Data Security Requirements for Accessing Confidential Data information collection to the OMB for clearance simultaneously with the publication of the second notice, following the expiration of this first notice. The full submission may be found at: http://www.reginfo.gov/public/do/PRAMain.

Center for Scientific Review; Notice of Closed Meetings

New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance focuses on frequently asked questions about the new dietary ingredient notification (NDIN) submissions. This guidance is intended to help provide recommendations to manufacturers and distributors of NDIs and dietary supplements containing an NDI regarding the identity and safety information that should be included in an NDIN.

Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026

Official abstract: This proposed rule would implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager Accountability) of the Consolidated Appropriations Act, 2026.

Agency Forms Undergoing Paperwork Reduction Act Review

Agency Forms Undergoing Paperwork Reduction Act Review

National Cancer Institute; Notice of Meeting

National Cancer Institute; Notice of Meeting

National Cancer Institute; Notice of Partially Closed Meeting

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting

Center for Scientific Review; Notice of Closed Meetings

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Program Forms-OMB No. 0915-0285-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

National Cancer Institute; Amended Notice of Meeting

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

Center For Scientific Review; Amended Notice of Meeting

Center for Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

Official abstract: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0

Official abstract: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The new eCTD v4.0 validations are eCTD4-084, eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-eCTD4-563, and US-eCTD4-564, which are high-severity validation errors as described in the Specifications for eCTD v4.0 Validation Criteria.

Submission for Office of Management and Budget Review; Unaccompanied Refugee Minors Program ORR-3 Report and ORR-4 Report

Official abstract: The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program ORR-3 Report and ORR-4 Report (Office of Management and Budget #0970-0034, expiration 11/30/2026). Revisions were made to reduce burden and streamline information collection.

Agency Information Collection Activities: Proposed Collection; Comment Request

Official abstract: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Agency Information Collection Activities: Proposed Collection; Comment Request

Official abstract: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

Official abstract: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public comments at the meeting. In addition, FDA is establishing a public docket to collect feedback on and input related to its Rare Disease Framework Initiative.

Meeting of the Advisory Council for the Elimination of Tuberculosis

Official abstract: In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment; see the Oral Public Comment section below).

Center for Scientific Review; Amended Notice of Meeting

National Institute on Drug Abuse; Notice of Closed Meeting

Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

Official abstract: The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Elanco US Inc. for application on or around wounds for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the treatment of infestations caused by NWS (myiasis) in dogs and puppies. FDA has issued one EUA for an animal product as requested by Bimeda Animal Health Ltd. for the prevention of infestations caused by NWS (myiasis) in cattle. FDA has issued one EUA for an animal product as requested by Sergeant's Pet Care Products LLC for the treatment and prevention of infestations caused by NWS (myiasis) in dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists

Official abstract: The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This Order was issued on October 11 and shall remain in effect through 4:59 p.m. Eastern Daylight Time (EDT) on Tuesday, November 10, 2026. This Order may be amended or rescinded prior to that time at the discretion of the Director.

Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)

Official abstract: The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and therefore encourages nominations of appropriately qualified candidates. Specifically, TPSAC is seeking to fill 2 voting member vacancies with physicians, dentists, scientists, or health care professionals practicing in the areas of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty.

Center For Scientific Review; Notice of Closed Meetings

Center for Scientific Review; Notice of Closed Meetings

Further Reducing Bureaucracy and Burden From the Administration for Native Americans

Official abstract: The Department of Health and Human Services, Administration for Children and Families proposes to further amend the Native American Programs Act regulations to streamline the part.

Statement of Delegation of Authority

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products

Official abstract: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal

Official abstract: The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 28, 2028, expiration date.

Request for Public Comment: 60-Day Notice for Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency

Official abstract: In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires a 60-day public comment period on proposed information collection projects, the Indian Health Service (IHS) invites the public to take this opportunity to comment on the information collection titled, "Purchased/Referred Care (PRC) Proof of Residency" The purpose of this notice is to announce our intent to seek reinstatement of the previously approved information collection by the Office of Management and Budget (OMB), and to allow 60 days for public comment to be submitted to the IHS. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC___).

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards

Official abstract: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements

Official abstract: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

Official abstract: The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in food for laying hens and breeder chickens. This action is in response to a food additive petition filed by Kemin Industries, Inc.

Health Center Program Performance Period Extensions; Correction

Official abstract: HRSA published a document in the Federal Register on September 24, 2026, concerning performance period extensions for health centers scheduled to compete for a January, February, or March FY 2027 Service Area Competition. The document did not include one service area that was not eligible for a performance period extension at the time of publication but has since become eligible.

Proposed Data Collection Submitted for Public Comment and Recommendations

Official abstract: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Monitoring of CDC's Comprehensive Suicide Prevention Program. This program seeks to reduce suicide morbidity and mortality by 10% in populations disproportionately impacted by suicide in participating jurisdictions.

Agency Forms Undergoing Paperwork Reduction Act Review

Agency Forms Undergoing Paperwork Reduction Act Review

Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director Notice of Proposed Reorganization

Official abstract: The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director (OD), National Institutes of Health (NIH) is seeking public comment regarding its proposal to establish the Office of the NIH Chief Artificial Intelligence Officer (OCAIO) within DPCPSI and move the Office of Dietary Supplements (ODS) under the Office of Nutrition Research (ONR) within DPCPSI in OD, NIH.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods

Official abstract: The Food and Drug Administration (FDA or we) is issuing a final rule to amend our standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk of hypertension, a major risk factor for heart disease and stroke. The rule will help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods.

Announcing Solicitation of Written Comments To Inform the Physical Activity Guidelines for Americans, 2nd Edition Supplement: 2027 Steps and Muscle-Strengthening Guidance

Official abstract: The Department of Health and Human Services (HHS) announces the solicitation of public comments to inform the development of the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance (2027 Steps and Muscle- Strengthening Guidance).

2025-2026 IACC Summary of Advances

Official abstract: The Interagency Autism Coordinating Committee (IACC) is preparing its Summary of Advances, a statutorily mandated report that highlights the most consequential autism research of the past year. The Committee is seeking suggested research articles to highlight for this report. On behalf of the IACC, the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is collecting research article suggestions from members of the public.

National Institute of Environmental Health Sciences; Notice of Meeting

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024.

Center for Scientific Review; Notice of Closed Meetings

Center For Scientific Review; Notice of Closed Meetings

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)

Official abstract: The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZANVASTRO (zilganersen), approved September 3, 2026, manufactured by Ionis Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements

Official abstract: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC

Official abstract: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

Official abstract: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Official abstract: The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

Official abstract: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

Official abstract: The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision

Official abstract: In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Applicant Organizational National Provider Identifiers and Centers for Medicare & Medicaid Services Certification Numbers Form

Official abstract: In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction

Official abstract: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial, held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride (HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA withdrew the approval of these ANDAs, Navinta LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Navinta LLC timely requested that approval of the ANDAs not be withdrawn, the approval is still in effect. This notice removes the entries for ANDA 207366, ANDA 212957, and ANDA 218638.

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

Official abstract: The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

Official abstract: The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

Official abstract: The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Agency Information Collection Activities: Proposed Collection; Comment Request

Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

Official abstract: The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicable requirements are established in our regulation titled "Requirements for Additional Traceability Records for Certain Foods."

Challenges and Solutions in Lot-Level Food Traceability; Public Meeting

Official abstract: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance.