Department of Health and Human Services October 22, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Black Lung Clinics Program Performance Measures
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.
Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of September 20, 2024. In the notice, FDA requested comments on the draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Notice of Request for Public Comments on Draft Recommendations for the HRSA-Supported Women's Preventive Services Guidelines Relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening
This notice seeks comment on draft recommendations for the HRSA-supported Women's Preventive Services Guidelines ("Guidelines") relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening. These draft recommendations have been developed by the Women's Preventive Services Initiative (WPSI), through which clinicians, academics, and expert health professionals develop draft recommendations for HRSA's consideration. Under applicable law, non-grandfathered group health plans and health insurance issuers must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, HHS, and Treasury have issued regulations and policy guidance which describe how group health plans and health insurance issuers apply the coverage requirements.
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug Interaction Information in Human Prescription Drug and Biological Product Labeling." The draft guidance is intended to assist applicants in developing the DRUG INTERACTIONS section of labeling as described in FDA regulations for the content and format of labeling for human prescription drug and biological products. The purpose of the draft guidance is to provide recommendations on what information to include in, and how to present and organize the information within, the DRUG INTERACTIONS section of labeling for human prescription drug and biological products to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.
Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or Committee) will hold one additional public meeting in the 2024 calendar year. Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisory-committees/ primarycare-dentist/meetings. This notice is consistent with the information about ACTPCMD's calendar year 2024 meetings found in the Federal Register notice dated May 15, 2024, Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry.
Submission for OMB Review; 30-Day Comment Request; National Institutes of Health-Fellow Forms
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.
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