Department of Health and Human Services June 18, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Facility Readiness: Goal Date Decisions Under GDUFA." This guidance provides information to applicants on how FDA will use information related to a facility's readiness for inspection as certified on Form FDA 356h to set a goal date for an original abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter). This guidance finalizes the draft guidance of the same title issued on October 7, 2022.

The Food and Drug Administration (FDA, us, or we) 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.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is inviting public comment on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to provide legal and advocacy services to unaccompanied children.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled "First Annual Animal Drug User Fee Educational Conference." This is the first of five annual educational conferences FDA will host as described in the "Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028." The purpose of this series of conferences is to provide educational sessions for stakeholders who are interested in the new animal drug approval process.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.