[Federal Register Volume 62, Number 155 (Tuesday, August 12, 1997)]
[Notices]
[Pages 43170-43171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[FDA-225-97-4000]


Memorandum of Understanding Between the Food and Drug 
Administration and the Department of Defense

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between the FDA and the Department 
of Defense (DoD). The purpose of the MOU is for FDA to provide the 
quality assurance support for DoD centrally managed contracts for 
drugs, biologics, and medical devices. This MOU supersedes the 
agreement concerning drugs and biologics, dated December 17, 1975, and 
the agreement concerning devices, dated December 23, 1981.

DATES: The agreement became effective January 14, 1997.

FOR FURTHER INFORMATION CONTACT: Paul Donnelly, Medical Products 
Quality Assurance Staff, Office of Regulatory Affairs (HFC-240), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-0383.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOU's between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of an MOU.

    Dated: August 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.


Memorandum of Understanding Quality Assurance Support for Medical 
Products Between the Department of Defense and the Food and Drug 
Administration

I. Purpose

    To formalize a memorandum of understanding (MOU) between the 
Department of Defense (DoD) and the Food and Drug Administration 
(FDA) whereby FDA provides the quality assurance support for DoD 
centrally managed contracts for drugs, biologics, and medical 
devices (hereinafter referred to as medical products), as defined by 
the Federal Food, Drug and Cosmetic Act (FDC Act), as amended, 21 
U.S.C. 301 et seq. (1972 & Supp. 1979). This agreement supersedes 
the two currently effective agreements, the drug agreement dated 12/
17/75 and the device agreement dated 12/23/81.

II. Background

    The Office of Management and Budget (OMB) and the General 
Accounting Office (GAO) completed separate studies in late 1973 of 
nonperishable subsistence supplies. Both OMB and GAO recommended 
that the FDA be the agency responsible for quality assurance of all 
medical products procured by Federal agencies. In June 1974, the 
Director of OMB requested that the Department of Health, Education 
and Welfare (HEW) take the lead in developing an Executive Branch 
Plan for the government-wide quality assurance program for medical 
products. FDA was made responsible for developing and implementing 
the plan. In December 1975, FDA and DoD signed a quality assurance 
agreement covering drugs and biologics, and in December 1981, a 
corresponding agreement covering medical devices was signed. Both 
agreements were implemented and have been operational. However, some 
portions of the original agreements have become obsolete and there 
is a need to encompass new DoD initiatives and business practices. 
This updated memorandum of understanding encompasses all medical 
products under FDA regulatory control, and supersedes the two 
currently effective interagency agreements.

 III. Responsibilities

A. Under the authority of DoD Directive 4140.26, the Defense 
Personnel Support Center (DPSC) is assigned and designated as the 
integrated manager for medical products. The DPSC agrees to:
    (1) Furnish FDA copies of medical product quality complaints, 
incident reports under the Safe Medical Device Act of 1990, and 
other information which may impact adversely on the quality of a 
medical product.
    (2) Provide a written request for evaluations, testing, and 
other work to be performed by FDA under this program.
    (3) Furnish FDA copies of specifications for review, 
solicitations and copies of contracts requiring FDA source 
inspection.

[[Page 43171]]

    (4) Notify the FDA liaison officer in writing of changes in 
acquisition regulations and practices which would affect the program 
covered by this MOU.
B. The Food and Drug Administration (FDA) agrees to:
    (1) Furnish DPSC reports of complaint investigations.
    (2) Upon request, provide pre-award quality evaluations for 
firms.
    (3) Promptly advise DPSC when firms supplying medical products 
to DoD become unacceptable from a quality assurance standpoint.
    (4) Determine the amount and nature of work it will perform to 
fulfill its responsibilities under this MOU.
    (5) Make available FDA inspectional and analytical personnel as 
witnesses and supply information and data to DoD for GAO protests, 
Boards of Contract Appeals, SBA and similar cases.
    (6) Review proposed specifications and provide comments on the 
quality assurance aspects.
    (7) Notify the DPSC liaison officer in writing of changes 
arising from statutes or regulations which would affect this 
program.
    (8) Promptly notify DPSC of product recalls and other pertinent 
information that affects government contracts or stocks.
    (9) Advise DPSC of instances where fraud or other criminal 
conduct involving government contractors is found.
    (10) Be responsible for determining that medical products 
offered for delivery were produced in accordance with the contract 
requirements, and for signing the acceptance document when source 
inspection is required.
    (11) Conduct laboratory testing as necessary and, as 
expeditiously as possible, furnish DPSC analytical results. If 
testing cannot be accomplished, FDA will notify DPSC.
    (12) Advise DPSC when FDA determines that it is necessary to 
convert a contract from destination to source inspection.

IV. Administration

A. Resources required to support this MOU will be provided by the 
performing party.
B. Nothing in this MOU will preclude DoD representatives from making 
visits to suppliers with FDA or separately.
C. The DPSC contracts for medical products will include a provision 
requiring compliance with the FDC and implementing regulations 
promulgated thereunder. The Good Manufacturing Practice Regulations 
will be the quality standard applied to industry for the 
manufacturing, processing, packaging or holding of medical products 
acquired on government contracts. The FDA will be the agency 
responsible for the administrative interpretation and enforcement of 
these statutes and regulations.
D. The DPSC may authorize the FDA to act as its agent for purposes 
of inspecting and accepting centrally acquired medical products, 
performance of preaward surveys, and related quality assurance 
actions.
E. As a general rule, the quality standards prescribed by the United 
States Pharmacopeia (USP), the National Formulary (NF), and FDA will 
satisfy the DoD quality requirements for products covered by the 
MOU; however, this does not preclude the development and utilization 
by DoD of additional standards when deemed essential to satisfy a 
unique or special requirement of DoD or any of the Military 
Services.
F. The FDA and DPSC, as necessary, will jointly prepare procedures 
covering operations that interface.

V. Participating Activity Liaison Officers

A. For the Department of Defense: Director, Medical Material, DPSC-
M, Defense Personnel Support Center, Defense Logistics Agency, 2800 
South 20th Street, Philadelphia, Pennsylvania 19101-8419, 215-737-
2100.
B. For the Food and Drug Administration: Director, Medical Products 
Quality Assurance Staff, HFC-240, Office of Regulatory Affairs, Food 
and Drug Administration, 12720 Twinbrook Parkway, Bldg. #4, Room 
408, Rockville, Maryland 20852, 301-827-0390.

VI. Period of Memorandum of Understanding

    a. This MOU will become effective upon final signature and will 
remain in effect indefinitely.
    b. The MOU will be reviewed every two (2) years to ensure 
adequacy and currency; however, it may be amended by mutual consent 
at any time.
    c. The MOU may be unilaterally terminated by providing the other 
party with 180 days written notice of intent.
    Approved and Accepted for the Department of Defense
By: Edward D. Martin, M.D.
Title: Principal Deputy Assistant Secretary of Defense, Health 
Affairs
Date: January 14, 1997
    Approved and Accepted for the Food and Drug Administration
By: M. A. Friedman
Title: Deputy Commissioner for Operations
Date: November 27, 1996


[FR Doc. 97-21242 Filed 8-11-97; 8:45 am]
BILLING CODE 4160-01-F