Department of Health and Human Services October 17, 2024 – Federal Register Recent Federal Regulation Documents
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Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Requests for Reconsideration at the Division Level Under GDUFA." This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration. This guidance finalizes the draft guidance for industry of the same title issued on January 11, 2024.
Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Temporary Policies for Compounding Certain Parenteral Drug Products." As of October 10, 2024, pursuant to the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida. In late September 2024, Hurricane Helene had a devastating impact on one of the largest manufacturers of certain intravenous and peritoneal dialysis solutions in the United States. This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain parenteral drug products by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve extension without change of the currently approved information collection "Surveys on Patient Safety Culture (SOPS) Ambulatory Surgery Center (ASC) Survey Database," OMB No. 0935-0242. This proposed information collection was previously published in the Federal Register on August 13, 2024 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT) Accreditation Program
This notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, dba QUAD A, for continued recognition as a national accrediting organization for outpatient physical therapy providers that wish to participate in the Medicare or Medicaid programs.
Meeting of the Board of Scientific Counselors, Office of Readiness and Response
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, Office of Readiness and Response (BSC, ORR). This is a virtual meeting and is open to the public, limited only by the number of web conference lines available (500 lines). Time will be available for public comment.
Meeting of the Advisory Council for the Elimination of Tuberculosis
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment; see the Oral Public Comment section below).
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Generic Information Collection Request for Health Resources and Services Administration Stakeholder Gatherings
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.
Meeting of the Healthcare Infection Control Practices Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public.
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