Department of Health and Human Services March 6, 2024 – Federal Register Recent Federal Regulation Documents
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Meeting of the Community Preventive Services Task Force (CPSTF)
The Centers for Disease Control and Prevention, within the Department of Health and Human Services, announces the next meeting of the Community Preventive Services Task Force (CPSTF) on April 17-18, 2024.
Common Formats for Patient Safety Data Collection
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital Version 1.0 for public review and comment.
Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.'' The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
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.
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677-004, is available in the docket identified by the number in the heading of this document.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types.''
Human West Nile Virus Vaccine Meeting and Request for Information
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is announcing a meeting and opportunity to comment on a human West Nile virus (WNV) vaccine. The primary purpose of the meeting is to inform critical next steps toward the deployment of a human WNV vaccine.
Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees.
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