Department of Health and Human Services January 26, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled ``Conducting Remote Regulatory AssessmentsQuestion and Answers.'' FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
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.
Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Vaccines and Related Biological Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the December 31, 2025, expiration date.
Best Practices for Food and Drug Administration Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products; Final Document; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final document entitled ``Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products.'' The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its internet website best practices for certain postmarketing drug safety surveillance activities. This final document sets forth risk-based principles for FDA's conduct of ongoing postmarketing safety surveillance for human drug products and human biological products, in part, to address the Cures Act requirements. This document finalizes the draft document entitled ``Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff'' that was issued on November 7, 2019.
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.
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of an Online Prostate Cancer Decision Aid. This three-arm, randomized controlled trial (RCT) includes eight forms of data collection including surveys and interviews and will evaluate the impact of a virtual human decision aid to help improve the quality of prostate cancer screening and treatment decisions.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be streamed live on hhs.gov/live. A pre-registered public comment session will be held during the virtual meeting. Pre- registration is required for members of the public who wish to present their comments live during the meeting. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https:// www.hhs.gov/paccarb and must be completed by February 15, 2024, for the February 22, 2024, Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Upcoming Meetings page.
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