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MOU 225-82-8400

Memorandum of Understanding

Between
The Veterans Administration

and

The United States Department of Health and Human Services
Food and Drug Administration

 

I. PURPOSE

The purpose of this Memorandum of Understanding is to identify specific responsibilities of the Veterans Administration (VA) and Food and Drug Administration (FDA) to facilitate communication and encourage effective cooperation between the agencies in the area of clinical research with investigational new drugs and medical devices, including biologicals.

 

II. BACKGROUND

In 1977, in response to a congressional directive, FDA developed a program to assure the quality of bioresearch data intended to support the approval of new drugs, biologicals, and medical devices. Regulations were subsequently proposed, clarifying existing regulations and elucidating the responsibilities of investigators in conducting clinical trials. The main objectives of the clinical investigator program are to assure protection of investigational subjects; to assess through audit procedures, whether data submitted to FDA in specific studies are valid; and to determine the state of compliance of clinical investigators with the regulations. The FDA has applied the same standards of performance to Federal institutions and Government employees as has been applied to private industry.

 

III. FDA's RESPONSIBILITIES

A. FDA will provide the VA project officer with a list of VA clinical investigators FDA intends to inspect during a given fiscal quarter.

B. FDA will notify the Medical Center Director at the VA Medical Center employing the investigator to be inspected to make suitable arrangements for the inspection.

C. Following the inspection, FDA will make available to the VA project officer and the VA Medical Center Director a copy of any correspondence to the clinical investigator and, upon request, will make available to the VA project officer

D. specific inspection reports and bureau reviews pertaining to VA clinical investigators.

E. FDA will advise the VA, through the project officer, of any violative findings resulting from investigations into the performance of clinical investigators into the performance of clinical investigators employed by the VA, and will provide copies of any correspondence associated with a regulatory action.

 

IV. VA's RESPONSIBILITIES

A. VA Central Office Research and Development will notify VA medical center directors of scheduled visits by FDA investigators, in order to facilitate audits of studies of investigational new drugs and medical devices being conducted at VA facilities by VA investigators.

B. The VA will facilitate access to administrative records and patient medical records associated with any investigational new drug and device research subject to FDA regulations and will also provide copies of those records upon the official request of an FDA investigator. Access to these records is authorized under the Privacy Act of 1974 (5 U.S.C. Secs. 552a(b)(3) and (7)) and the VA confidentiality statues (38 U.S.C. Sec. 3301(B)(3), 38 U.S.C. Sec. 3305(b)(1)(C) and 38 U.S.C. Sec 4132(b)(2)(B)). FDA personnel accessing drug, alcohol and sickle cell anemia treatment records subject to the confidentially provisions of 38 U.S.C. Sec. 4132 are not permitted to redisclose patient identities, directly or indirectly, in any manner in any report or audit documents which are created in accordance with this MOU. Violations of 38 U.S.C. Sec. 4132 may result in the imposition of fines and other adverse consequences.

C. VA will review internal guidelines for clinical research with investigational new drugs and medical devices to assure that VA guidelines are consistent with FDA regulations for the conduct and reporting of investigational studies.

 

V. DURATION OF AGREEMENT

This agreement shall become effective on the date of the last signature and shall continue in effect unless modified by mutual written consent or terminated by either party upon a ninety (90) day advance written notice to the other.

 

VI. PROJECT OFFICERS

Veterans Administration:

Earl X. Freed, Ph.D.
Deputy Assistant Chief Medical Director
for Research and Development (15A)
Veterans Administration
810 Vermont Avenue, N.W.
Washington, D.C. 20420
Telephone: 389-2616

 

Food and Drug Administration:

Ernest L. Brisson
Director, Bioresearch Monitoring Staff
HFC-30
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Telephone: 443-2390

 

VII. AUTHORITY

The authority for this agreement is contained in 21 U.S.C. §§ 355(i), (j); 357(d), (e); 360j(g); 372; 374; 379; 823(f); and 42 U.S.C. §§ 241, 242a, 262-264; and 38 U.S.C. § 4101 (c)(1) implemented by 38 C.F.R. § 2.6(a)(1).

Approved and Accepted
for the Veterans Administration

Signed by: Chief Medical Director

Date: August 20, 1982

Approved and Accepted
for the Food and Drug Administration

Signed by: Associate Commissioner for Regulatory Affairs

Date: July 28, 1982