Department of Health and Human Services January 30, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Request for Nominations and Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting
This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. This draft guidance, when finalized, will supersede the guidance entitled, ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated April 2020 and updated August 2020.
Submission for OMB Review; Generic Program-Specific Performance Progress Report
This notice describes the proposal to extend data collection under the Administration for Children and Families (ACF) Generic Program-Specific Performance Progress Report (PPR) (0970-0490). This overarching generic currently allows ACF program offices to collect performance and progress data from recipients and sub-recipients who receive funding from ACF under a discretionary grant or cooperative agreement. This generic mechanism provides the opportunity for ACF program offices to tailor requests for performance and progress data to specific funding recipients. ACF is proposing to include performance and progress data reporting for mandatory funding recipients in addition to discretionary funding recipients. ACF is also requesting an increase in burden.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug 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 Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Advisory Committee on Immunization Practices
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee. This meeting is open to the public, limited only by the number of audio lines available. Online registration is required.
Acromegaly: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Acromegaly: Developing Drugs for Treatment.'' The purpose of this guidance is to provide recommendations to sponsors regarding clinical development of drugs for the treatment of patients with acromegaly. This draft guidance is intended to serve as a focus for continued discussions among the FDA Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.
Practices To Prevent Unsafe Contamination of Animal Feed From Drug Carryover; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #272 entitled ``Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover.'' We are issuing this final guidance to describe practices that medicated feed manufacturers can use to prevent unsafe contamination from drug carryover into a non-medicated animal feed or an animal feed containing a different approved new animal drug. Unsafe contamination of animal feed from drug carryover can pose a risk to human and animal health. This guidance replaces Compliance Policy Guides Sec. 680.500 and 680.600.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
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 premarket approval of medical devices.
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.
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