Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Elimination of the Tribal Non-Federal Share Requirement
OCSS eliminates the non-Federal share of program expenditures requirement for Tribal child support programs, including the 90/10 and 80/20 cost sharing rates. Based upon the experiences of and consultations with Tribes and Tribal organizations, we have determined that the non-Federal share requirement limits growth, causes disruptions, and creates instability.
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.
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program; Corrections
This document corrects technical and typographical errors in the final rule that appeared in the November 16, 2023 issue of the Federal Register, entitled ``Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program'' (referred to hereafter as the ``CY 2024 PFS final rule''). The effective date was January 1, 2024.
Submission for Office of Management and Budget (OMB) Review; State Personal Responsibility Education Program (PREP) (OMB #0970-0380)
The Family and Youth Services Bureau (FYSB) within the Administration on Children, Youth and Families (ACYF) is requesting a 3-year extension of the State Personal Responsibility Program (PREP) state plans and performance progress report (OMB #0970-0380, expiration 12/31/2023). There are no changes requested to the state plan, but there are changes requested to the performance progress report. Changes include the addition of information related to equity activities and strategies to mitigate challenges.
Biologics License Applications and Master Files
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.
Fiscal Year 2024 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2024 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders industry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2025 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer's Goods from DWPE.'' The draft guidance, when finalized, will provide recommendations for collecting a representative sample for products subject to DWPE under an import alert due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. When finalized, the draft guidance will also help foreign manufacturers and other processors of fish and fishery products subject to DWPE introduce evidence to FDA to support a request to have products removed from DWPE.
Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled ``Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request'' that appeared in the Federal Register of December 13, 2023. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Announcement of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders Meeting and Solicitation for Oral and Written Comments
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders (Commission) and the solicitation of written and oral comment regarding the advancement of equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. The meeting is open to the public and will be held in Clark County, Nevada. Virtual attendance will be available through livestream on February 27 and in-person attendance will be available on February 28, 2024. The Commission is working to accomplish its mission to provide independent advice and recommendations to the President on ways to advance equity, justice, and opportunity for AA and NHPI communities.
Health Resources Priorities and Allocations System (HRPAS)
The Department of Health and Human Services (HHS) is issuing a final rule establishing standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This final rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule finalizes the regulations as proposed in the Notice of Proposed Rule Making (NPRM) of August 16, 2023, with minor technical edits based on comments received.
Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) hereby gives notice that the National Vaccine Advisory Committee (NVAC) will hold an in-person meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction; Correction
This document corrects technical and typographical errors in the final rule with comment period that appeared in the Federal Register on November 22, 2023, titled ``Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction'' (referred to hereafter as the ``CY 2024 OPPS/ASC final rule with comment period'').
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.
Determination That QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season. The meeting will be open to the public.
Brendon Gagne: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Brendon Gagne for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Gagne was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Gagne's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Gagne was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 5, 2024 (30 days after receipt of the notice), Mr. Gagne had not responded. Mr. Gagne's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 2025 and 2027 National Youth Risk Behavior Survey (YRBS). CDC is requesting a three-year approval to reinstate, with changes, the data collection for the national YRBS, a biennially school-based survey of high school students in the United States. This project includes a validation study that will inform the development of questions for the 2027 YRBS questionnaire.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Global Public Health Data Innovation Performance Monitoring. This data collection is designed to help government decision makers gather timely, accurate, and comprehensive public health data to effectively prevent, detect, and respond to public health threats.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; HRSA Grantee Satisfaction Survey
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.
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Correction
This document corrects technical and typographical errors in the final rule entitled, ``Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing'' that was published in the Federal Register on January 9, 2024, and has a stated effective of February 8, 2024.
Sensient Colors, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC., proposing that we amend our color additive regulations to provide for the safe use of butterfly pea flower extract in ready-to-eat cereals, crackers and snack mixes, and chips at levels consistent with good manufacturing practice.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Butonitazene; 3-Chloromethcathinone; Dipentylone; 2-Fluorodeschloroketamine; Bromazolam; Request for Comments
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2024. This notice is issued under the Controlled Substances Act (CSA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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