71 FR 178 pgs. 54285-54290 - Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute
Type: NOTICEVolume: 71Number: 178Pages: 54285 - 54290
Docket number: FDA 225-06-8402
FR document: [FR Doc. 06-7630 Filed 9-13-06; 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
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.
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.
BILLING CODE 4160-01-S
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[FR Doc. 06-7630 Filed 9-13-06; 8:45 am]
BILLING CODE 4160-01-C