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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] 

# AGENCY: 

Food and Drug Administration, HHS. 

# ACTION: 

Notice. 

# 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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BILLING CODE 4160-01-S 

[FR Doc. E8-22992 Filed 9-30-08; 8:45 am] 

BILLING CODE 4160-01-C