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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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.

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Dated: September 6, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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BILLING CODE 4160-01-S

[FR Doc. 06-7630 Filed 9-13-06; 8:45 am]

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