Department of Health and Human Services January 6, 2025 – Federal Register Recent Federal Regulation Documents

Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee
Document Number: 2024-31703
Type: Notice
Date: 2025-01-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2025, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Food Contact Notifications That Are No Longer Effective
Document Number: 2024-31692
Type: Notice
Date: 2025-01-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing its determination that the Food Contact Notifications (FCNs) listed in this notice are no longer effective. Several manufacturers notified FDA in writing that they ceased producing, supplying, or using the listed food contact substances (FCSs) for their intended use in the United States. We are taking this action in accordance with the process set out in our regulations, by which FDA may determine that an FCN is no longer effective.
HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information
Document Number: 2024-30983
Type: Proposed Rule
Date: 2025-01-06
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS or "Department") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information ("Security Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, "regulated entities"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
Document Number: 2024-31356
Type: Rule
Date: 2025-01-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2024-31615
Type: Notice
Date: 2025-01-06
Agency: Department of Health and Human Services
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.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2024-31614
Type: Notice
Date: 2025-01-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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