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

---
identifier: "/us/fr/E8-22992"
source: "fr"
legal_status: "authoritative_unofficial"
title: "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"
title_number: 0
title_name: "Federal Register"
section_number: "E8-22992"
section_name: "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"
positive_law: false
currency: "2008-10-01"
last_updated: "2008-10-01"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "E8-22992"
document_type: "notice"
publication_date: "2008-10-01"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "73 FR 57112"
fr_volume: 73
docket_ids:
  - "Docket No. FDA-2008-N-0043"
  - "FDA No. 225-08-8004"
effective_date: "2008-08-28"
fr_action: "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

**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.