Department of Health and Human Services May 1, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 38 of 38
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion
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.
S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The final guidance replaces the draft guidance entitled ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products'' issued on September 9, 2021.
Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Requirements and Facility Registration and Cosmetic Product Listing Program
The Food and Drug Administration (FDA, the Agency, or we) 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 provisions in FDA's cosmetic labeling regulations and new statutory provisions for cosmetic labeling, facility registration, and products listing.
Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Reopening of the Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ``Labeling of Plant- Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for Industry,'' which was announced in the Federal Register of February 23, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
FDA Science Forum 2023; Public Workshop
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FDA Science Forum 2023.'' The purpose of the public workshop is to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA's regulatory decision-making to protect and promote public health.
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. Building on the Agency's previous Federal Register notices published on July 11, 2017, and March 18, 2022, requesting comments on PQ/CMC data elements and controlled terminology, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time. FDA is establishing an open docket to facilitate efficient receipt of comments and public posting of updated draft documents on PQ/CMC data elements and terminologies.
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.'' The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same title issued on February 22, 2019.
Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing a request for information and comments that appeared in the Federal Register of April 13, 2023. In that notice, FDA requested information and comments on the FDA Data and Technology Strategic Plan. The Agency is taking this action to allow interested persons additional time to submit comments.
Medicare Program; Proposed Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership
This proposed rule would: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy-related changes.
Advisory Board on Radiation and Worker Health, Subcommittee for Procedure Reviews, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces a meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without an oral public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC); Notice of Charter Renewal
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Advisory Committee to the Director (ACD).
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 Preventive Health and Health Services Block Grant. CDC will use the Block Grant Information System to collect recipient data, monitor awardees' progress, identify activities and personnel supported with Block Grant funding, conduct compliance reviews of Block Grant recipients, and promote the use of evidence-based guidelines and interventions in accordance with legislative mandates.
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Emergency Management Capacity Assessment Tool (PHEM Tool). The Center for Disease Control and Prevention's (CDC) Global Emergency Management Capacity Development (GEMCD) team will use the PHEM Tool to assess the public health emergency management (PHEM) program and Public Health Emergency Operations Center (PHEOC) capacity of Global Health Security Agenda (GHSA) countries.
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 (the 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.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award to the University of North Carolina funded in FY 2018 under the National Center of Excellence for Eating Disorders (NCEED), Notice of Funding Opportunity (NOFO) SM-18-021. The recipient may receive up to $747,646. The supplemental funding will extend the project period by 12-months until September 29, 2024 and will: continue to develop and disseminate high-quality training and technical assistance to healthcare practitioners on issues related to eating disorders; facilitate the identification of model eating disorder programs; provide the most up-to-date information on eating disorders; and promote public awareness of eating disorders.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement in scope of the parent award for the one grant recipient funded in fiscal year (FY) 2020 under the Suicide Prevention Resource Center (SPRC) Notice of Funding Opportunity (NOFO) SM-20-011. The grant recipient may receive up to $2,817,614. The recipient's project period will be extended by 12 months until August 30, 2025. The supplemental funding will be used to develop the new National Strategy for Suicide Prevention, which sets the direction of the field to prioritize suicide prevention activities. This is being requested by the White House Domestic Policy Council.
Mine Safety and Health Research Advisory Committee
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public and limited only by the space available and the number of web conference lines available. Time will be available for public comment.
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields.
Board of Scientific Counselors, National Center for Injury Prevention and Control
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is closed to the public.
Board of Scientific Counselors, National Institute for Occupational Safety and Health, National Firefighter Registry Subcommittee
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee. This is a virtual meeting. It is open to the public, limited only by the number of web conference lines (500 web conference lines are available). Time will be available for public comment.
Healthcare Infection Control Practices Advisory Committee
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by room seating available (120). The public is also welcomed to listen to the meeting via Zoom; 500 teleconference lines are available. Time will be available for public comment. Registration is required.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
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