Document ID: FDA-2008-N-0043-0008
Agency: fda
Document Type: Notice
Title: Memorandum of Agreement Between the Food and Drug Administration, the National Cancer Institute, a Part of the National Institutes of Health, and the CRIX International Association
Posted Date: 2008-10-01T04:00Z

[Federal Register: October 1, 2008 (Volume 73, Number 191)]
[Notices]               
[Page 57112-57122]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0043]
[FDA No. 225-08-8004]

 
Memorandum of Agreement Between the Food and Drug Administration, 
the National Cancer Institute, a Part of the National Institutes of 
Health, and the CRIX International Association

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration FDA) is providing notice of a 
memorandum of agreement (MOA) between FDA, the National Cancer 
Institute (NCI) and CRIX International Association. The purpose of the 
MOA is to establish a public-private partnership to pilot the use of a 
nonprofit organization to manage the production instance of the Federal 
Investigator Registry of Biomedical Information Research Data 
(FIREBIRD) system as a vehicle for secure, rapid and efficient 
electronic exchange of clinical investigator credentialing information 
among clinical investigators at trial sites, sponsors (including NCI), 
and FDA; and to continue the development of FIREBIRD to fulfill the 
requirements of FDA and sponsors (including the NCI).

DATES: The agreement became effective August 28, 2008.

FOR FURTHER INFORMATION CONTACT:
    Randy Levin, Director for Health and Regulatory Data Standards (HF-
18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-7784;
    George Komatsoulis, Chief Operating Officer, Center for 
Bioinformatics, National Cancer Institute, 8800 Rockville Pike, 
Bethesda, MD 20892-8505, 301-451-2881; and
    James L. Bland, Project Officer, CRIX International Association, 
1195 Freedom Dr., Reston, VA 20190, 703-577-8788.

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 MOA.

    Dated: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
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[FR Doc. E8-22992 Filed 9-30-08; 8:45 am]

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