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Notice

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

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 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.

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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.

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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 MOA.

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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