Department of Health and Human Services March 3, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Measuring Dystrophin in Dystrophinopathy Patients and Interpreting the Data; Public Scientific Workshop; Request for Comments
Submit electronic comments to https:// www.regulations.gov by May 20, 2015. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please identify your comments with the docket number found in brackets in the heading of this document. It is only necessary to send one set of comments. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. A summary of the scientific workshop's highlights will be made available for review at the Division of Dockets Management and at https://www.regulations.gov. You may submit a request to obtain a hard copy by sending a request to the Division of Freedom of Information (ELEM-1029), Office of Management Programs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
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; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
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; Investigational New Drug Applications
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.
Pediatric Neurocognitive Workshop; Advancing the Development of Pediatric Therapeutics Public Workshop
The Food and Drug Administration's (FDA) Division of Gastroenterology and Inborn Errors Products Division and Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, and the Office of Pediatric Therapeutics in the Office of the Commissioner are announcing a 2-day public workshop. Day 1 of the workshop is entitled ``Assessment of Neurocognitive Outcomes in the Inborn Errors of Metabolism''. Day 2 of the workshop is entitled, ``Advancing the Development of Pediatric Therapeutics: Assessment of Pediatric Neurocognitive Outcomes''. The purpose of this 2-day workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of neurocognitive outcomes in pediatric patients.
Meeting of the National Preparedness and Response Science Board
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB), also known as the National Biodefense Science Board, will be holding a public teleconference.
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