[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
