Document ID: FDA-2012-N-0012-0001
Agency: fda
Document Type: Notice
Title: Delegations of Authority: Office of Commissioner of Food and Drugs
Posted Date: 2012-09-26T04:00Z

[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Notices]
[Page 59196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23598]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0012]

Office of the Commissioner of Food and Drugs; Delegation of 
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    Notice is hereby given that I have delegated to the Commissioner of 
Food and Drugs (the Commissioner) certain authority added to the Public 
Health Service Act by section 801 of Public Law 110-85, the Food and 
Drug Administration Amendments Act of 2007 (42 U.S.C. 282(j)), 
pertaining to the expansion of the Clinical Trial Registry and Results 
Data Bank described therein. Specifically, the Commissioner is 
delegated the following authority:
     Section 402(j)(5)(C)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(5)(C)(ii))--To determine that any clinical trial 
information was not submitted as required under 42 U.S.C. 282(j) or was 
submitted but is false or misleading in any particular and to notify 
the responsible party and give such party an opportunity to remedy non-
compliance by submitting required revised clinical trial information 
not later than 30 days after such notification.
    This authority may be redelegated. This delegation will be 
exercised in accordance with the Department of Health and Human 
Services' applicable policies, procedures, guidelines, and regulations.
    I ratify and affirm any actions taken by the Commissioner or her 
subordinates that involved the exercise of the authority delegated 
herein prior to the effective date of this delegation. This delegation 
is effective upon date of signature.

    Dated: September 5, 2012.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2012-23598 Filed 9-25-12; 8:45 am]
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