Department of Health and Human Services September 20, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This is a virtual meeting. It is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person listed in the addresses section 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), limited only by the number of audio conference lines available (150).
Announcing the Intent To Award a Sole Source Supplement to the National Association of Councils on Developmental Disabilities (NACDD)
The Administration for Community Living (ACL) is announcing the award of a sole-source supplement for the Bridging Aging and Disability Networks cooperative agreement. ACL's Office of Supportive and Caregiver Services (OSCS), Administration on Aging (AoA) is collaborating with the Projects of National Significance, the Administration on Disabilities (AoD) to provide a $180,478 supplement to the Bridging Aging and Disability grant. This grant is awarded to the NACDD, who is partnering with the Institute on Disability and Human Development at the University of Illinois-Chicago, the Lurie Institute for Disability Policy at Brandeis University, The Arc, and US Aging the national association representing and supporting the network of Area Agencies on Aging (AAAs) and Title VI Native American Aging Programs. The goal of the grant is to strengthen the collaboration between aging and disability networks to better support individuals with intellectual and developmental disabilities (I/DD) and their family caregivers in future planning as they age. The supplemental funding will be used to additionally support aging caregivers of adults with I/DD and will enhance the work of the 17 State Consortia teams to more directly build capacity of AAAs to serve adults with I/DD as they age and their aging caregivers. The administrative supplement for FY 2024 will be in the amount of $180,478, bringing the total award for FY 2024 to $600,000.00.
Meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Procedure Reviews, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for 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 a 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 audio conference (information below). The audio conference line has 150 ports for callers.
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference.
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This draft guidance is not final nor is it for implementation at this time.
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
The Food and Drug Administration (FDA, Agency, or we) is proposing to revoke the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is proposing this action because the existing regulations have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.
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 the National Ambulatory Medical Care Survey (NAMCS). The goal of the project is to assess the health of the population through patient use of physician and advanced practice provider offices, health centers (HCs), and to monitor the characteristics of physician and advanced practice provider practices.
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 Program Evaluation of CDC's Core State Injury Prevention Program. This project allows CDC to collect information from awardees funded under the Core State Injury Prevention Program.
Agency Information Collection Activities: Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, 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 reinstatement without change of the information collection project Evaluating the Implementation of PCOR to Increase Referral, Enrollment, and Retention through Automatic Referral to Cardiac Rehabilitation (CR) with Care Coordinator OMB No. 0935-0252 for which approval has expired. The reinstatement of this previously approved PRA collection for which approval has expired is required in order to discontinue this collection.
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