Department of Health and Human Services April 29, 2014 – Federal Register Recent Federal Regulation Documents
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Pediatric Clinical Investigator Training Workshop
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with a clear understanding of some of the challenges of studying products in the pediatric population when the data are intended to be used to support product labeling, an overview of extrapolation as it relates to the pediatric population, a familiarity with FDA processes and timelines that are specific to pediatric product development, and an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 the collection of information involving a generic clearance for qualitative feedback on Agency service delivery.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA 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.
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
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