Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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National Vaccine Injury Compensation Program; List of Petitions Received
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.
Emergency Medical Services for Children Innovation and Improvement Center
HRSA plans to provide additional funds to the University of Texas at Austin, Texas, the current EIIC Program recipient, to extend the recipient's current period of performance by 12 months. This extension is necessary to support continuity of operations that facilitate pediatric readiness activities in hospital emergency departments (ED) and prehospital emergency medical services (EMS) agencies throughout the country. The current performance period ends June 30, 2025.
Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Roflumilast." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for roflumilast topical cream.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Proposed Information Collection and Submission for Office of Management and Budget Review; Fiscal Responsibility Act TANF Pilot Program 2025 Information Collection
The Administration for Children and Families (ACF) is proposing to reissue an information collection to request information from interested states for the Fiscal Responsibility Act of 2023 (FRA) Temporary Assistance for Needy Families (TANF) pilot program. This request is proposed under Office of Management and Budget (OMB) #: 0970-0531 and is a reissuing of a previously approved information collection to select states for the FRA pilot program.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 Request; 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Fluticasone Propionate." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate nasal spray, metered.
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Fresenius Medical Care North America (Fresenius) for multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048), and to Baxter Healthcare Corp. (Baxter) for REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Agency Information Collection Request; 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Dihydropyrimidine Dehydrogenase Deficiency and the Use of Fluoropyrimidine Chemotherapy Drugs; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster Agency transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.
Agency Information Collection Request; 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Submission for OMB Review; 30-Day Comment Request; Data Use Certification for the NIH Brain Development Cohorts (NBDC), (National Institute on Drug Abuse)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Protocol for the Pathways to Work Evidence Clearinghouse: Methods and Standards, Version 2.0
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Pathways to Work Evidence Clearinghouse (Pathways to Work). ACF seeks comments on proposed revisions to existing standards and on new standards for including and rating the quality of program cost studies in the "Protocol for the Pathways to Work Evidence Clearinghouse: Methods and Standards, Version 2.0".
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve an extension of the currently approved information collection "Medical Expenditures Panel Survey Insurance Component, (OMB No. 0935-0110)." This proposed information collection was previously published in the Federal Register on November 13, 2024 and allowed 60 days for public comment. AHRQ received comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELAHERE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELAHERE 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 biological product.
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: HRSA Ryan White HIV/AIDS Program Part F National AIDS Education and Training Center Program Activities, OMB No. 0906-XXXX New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Shortage Designation Management System, OMB No. 0906-0029-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/ generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
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 zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project (new): "The AHRQ Safety Program for Healthcare Associated Infection Prevention." This proposed information collection was previously published in the Federal Register on November 20, 2024 and allowed 60 days for public comment. AHRQ received comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Teaching Health Center Graduate Medical Education Program Reconciliation Tool, OMB No. 0915-0342-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Request for Information; Health Technology Ecosystem
Effective and responsible adoption of technology can empower patients to make better decisions for their health and well-being. This request for information (RFI) seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. Responses to this RFI may be used to inform CMS and ASTP/ONC efforts to lead infrastructure progress to cultivate this market, increasing beneficiary access to effective digital capabilities needed to make informed health decisions, and increasing data availability for all stakeholders contributing to health outcomes.
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment
This document corrects technical and typographical errors in the final rule that appeared in the December 9, 2024 Federal Register titled "Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments" (hereinafter referred to as the "CY 2025 PFS final rule"). The effective date was January 1, 2025. It also corrects a technical error in the final rule correcting amendment that appeared in the December 30, 2024, Federal Register titled "Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment".
Medicare Program; Request for Renewal of Deeming Authority of the Utilization Review Accreditation Commission (URAC) for Medicare Advantage Health Maintenance Organizations and Preferred Provider Organizations
This proposed notice announces that the Centers for Medicare & Medicaid Services is considering granting approval of the Utilization Review Accreditation Commission's renewal application for Medicare Advantage "deeming authority" of Health Maintenance Organizations and Preferred Provider Organizations to continue participation in the Medicare or Medicaid program.
Prospective Grant of an Exclusive Patent License: c-Abl Tyrosine Kinase Inhibitory Compound Embodiments and Methods of Making and Using the Same
The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Neurala Bio, Inc. (Neurala), headquartered in Delaware.
Proposed Collection: 30-Day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's (NCI) Cancer Information Service (CIS)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2025
This quarterly notice lists Centers for Medicare & Medicaid Services (CMS) manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
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