Department of Health and Human Services December 18, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
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.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces a meeting 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 teleconference (information below). The audio conference line has 150 ports for callers.
Submission for Office of Management and Budget Review; Temporary Assistance for Needy Families Expenditure Report, Form ACF-196R
The Administration for Children and Families (ACF) Office of Family Assistance (OFA) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Expenditure Report, Form ACF-196R (Office of Management and Budget (OMB) #0970-0446 expires February 29, 2024). ACF is proposing minor updates to the form to update references to lapsed timeframes, add demonstrative tables that aid in a recipient's comprehension of reporting requirements, incorporate minor edits to the instructions, and to adjust formatting to improve presentation.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
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.
Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA (ibrutinib) Capsules and Tablets approved, respectively, under new drug applications (NDAs) 205552 and 210563. These NDAs are held by Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080 (Pharmacyclics). Pharmacyclics voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of two new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #283 entitled ``Priority Zoonotic Animal Drug Designation and Review Process.'' This draft guidance is intended to assist sponsors pursuing priority zoonotic animal drug (PZAD) designation for a new animal drug. This draft guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.
Meeting of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC)
Pursuant to Presidential Executive Order No. 13175, November 6, 2000, and the Presidential Memorandum of September 23, 2004, notice is hereby given for the meeting on February 27, 2024, of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/ about-us/advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions.
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