[Federal Register Volume 71, Number 178 (Thursday, September 14, 2006)]
[Notices]
[Pages 54285-54290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FDA 225-06-8402


Memorandum of Understanding Between the United States Food and 
Drug Administration and the National Cancer Institute

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to 
set forth an agreement between the National Cancer Institute (NCI) and 
the Food and Drug Administration (FDA) (collectively ``the Parties'', 
or individually as a ``Party'') to develop and implement the Federal 
Investigator Registry of Biomedical Information Research Data 
(FIREBIRD), which will enable clinical investigators, NCI, FDA, and 
industry entities sponsoring clinical trials of investigational drugs 
(``Sponsors of Drugs and Biologics'' or ``Sponsors'') to manage 
clinical investigator information electronically in a fully secure 
manner.

DATES: The agreement became effective August 10, 2006.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Randy Levin, Center for Drug Evaluation and Research (HF-
18), Food and Drug Administration, 5600 Fishers Lane, rm. 14B-45, 
Rockville, MD 20857, 301-827-7784, FAX: 301-827-1540.
    For NCI: Peter Covitz, National Cancer Institute, 6116 Executive 
Blvd., rm. 705, Rockville, MD 20892, 301-402-0326.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-7630 Filed 9-13-06; 8:45 am]
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