Department of Health and Human Services October 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff
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; Proposed Collection; Comment Request; Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.'' This study is designed to examine how adolescents interpret DTC advertising directed at them.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products
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; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567
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; Premarket Approval of Medical Devices
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 Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
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.
Discretionary Grant Funds
HRSA will be issuing a non-competitive award to the Children's Hospital of Alabama's Regional Poison Control Center. The 11-month award for $126,144 will be made available in the form of a supplement to grant funds to the organization's current grant, H4BHS15500. Effective October 1, 2013, the Regional Poison Control Center will be Alabama's sole poison control center. The center's responsibility to provide poisoning triage and treatment to half the state will be expanded to the entire state. The grant supplement will allow HSB to maintain its mandate to provide grant support to the poison center and ensure ready access to poison control center services.
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