73 FR 191 pgs. 57112-57122 - 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
Type: NOTICEVolume: 73Number: 191Pages: 57112 - 57122
Docket number: [FDA No. 225-08-8004]
FR document: [FR Doc. E8-22992 Filed 9-30-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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.
BILLING CODE 4160-01-S
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[FR Doc. E8-22992 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-C