Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health

---
identifier: "/us/fr/08-496"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health"
title_number: 0
title_name: "Federal Register"
section_number: "08-496"
section_name: "Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health"
positive_law: false
currency: "2008-02-06"
last_updated: "2008-02-06"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "08-496"
document_type: "notice"
publication_date: "2008-02-06"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "73 FR 6973"
fr_volume: 73
docket_ids:
  - "FDA No. 225-07-8007"
effective_date: "2007-09-27"
fr_action: "Notice."
---


#  Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Institutes of Health (NIH). This MOU establishes the terms of collaboration between the two Federal agencies to develop a unified Federal approach to adverse event (AE) reporting. Specifically, FDA and NIH will collaborate in development of a project that will result in a web-based method for consumers, health professionals, investigators, sponsors, and other parties to electronically submit AE reports. The project includes the development of at least two products: (1) A Rational Questionnaire, an interactive help system that will assist reporters of information in determining what specific data need to be submitted and to whom, and (2) a prototype to test the feasibility of a central, Federal web-based portal to provide direct, seamless, online submission of adverse event reports to appropriate agencies.

**DATES:**

The agreement became effective September 27, 2007.

**FOR FURTHER INFORMATION CONTACT:**

Daryl Allis, OC/Office of Critical Path Programs, Food and Drug Administration, 5600 Fishers Lane (HF-18), Rockville, MD 20785, 301-827-7868.

**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: January 28, 2008.

Jeffrey Shuren,

Assistant Commissioner for Policy.