MOU 225-15-016 Replaces 225-97-4000
MEMORANDUM OF UNDERSTANDING BETWEEN DEFENSE LOGISTICS AGENCY AND FOOD AND DRUG ADMINISTRATION
This memorandum of understanding (MOU) formalizes an understanding between the Defense Logistics Agency (DLA) and the Food and Drug Administration (FDA), hereafter referred to as the “Partners,” whereby FDA provides quality assurance support for DLA’s 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 (FD&C Act). This MOU updates and supersedes the previous MOU between the Partners dated January 14, 1997 by adding references (Section 2), data sharing guidelines related to non-public information (Section 5), and updating the Partners’ responsibilities (Section 4) and points of contact (Section 7).
a. The Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 301 et seq.
b. The Freedom of Information Act (FOIA), 5 U.S.C. § 552.
c. The Privacy Act of 1974 (Privacy Act), 5 U.S.C § 552a.
d. 18 U.S.C. § 1905, Disclosure of confidential information generally.
e. 42 U.S.C. § 241(d), Protection of privacy of individuals who are research subjects.
f. 21 U.S.C. § 331(j), Prohibited Acts.
g. 21 U.S.C. § 360j(c), Trade Secrets.
h. 21 C.F.R. Part 20, Public Information.
i. 21 C.F.R. Part 21, Protection of Privacy.
j. 45 C.F.R. Part 5, Freedom of Information Regulations.
k. 45 C.F.R. Part 5b, Privacy Act Regulations.
l. Department of Defense Directive (DoDD) 5101.9, DoD Executive Agent for Medical Material, August 23, 2004.
m. Department of Defense Manual (DoDM) 4140.01, DoD Supply Chain Material Management Procedures, Volumes 1-11, February 10, 2014.
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 (now Department of Health and Human Services) take the lead in developing an Executive Branch Plan for the government-wide quality assurance program for medical products. The FDA was made responsible for developing and implementing the plan.
a. Pursuant to DoDD 5101.9, DLA is the DoD Executive Agent for Medical Material for the Department of Defense (DoD). In addition, under the authority of DoDM 4140.01, DLA is assigned and designated as the DoD integrated manager of medical products. The DLA intends to:
1) Furnish the FDA copies of medical product quality complaints, reports for the adverse events related to medical products, and other information that may adversely affect the quality of a medical products.
2) Provide written for evaluations, testing, and other work to be performed by the FDA under this MOU.
3) Furnish the FDA copies of medical product specifications to review, solicitations, and copies of contracts requiring FDA source inspection.
4) Notify the FDA liaison officer in writing of changes in acquisitions, regulations, and practices that would affect the program covered by this MOU.
b. The FDA intends to:
1) Promptly furnish the DLA with reports of complaint investigations.
2) Upon request, provide pre-award quality evaluations of firms.
3) Promptly advise the DLA when firms supplying medical products to the DLA 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) Have FDA inspectional and analytical personnel available as witnesses and supply information and data to the DLA for GAO protests, Boards of Contract Appeals, Small Business Administration appeals, and other similar protests, appeals, and litigation, in accordance with 21 CFR 20.1.
6) Promptly notify the DLA liaison officer in writing of changes arising from statutes or regulations that would affect this MOU.
7) Promptly notify the DLA of product recalls and other pertinent information that affects government contracts or stocks.
8) Promptly advise the DLA of instances where fraud or other criminal conduct involving government contactors is found.
9) 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.
10) Conduct necessary laboratory-testing as expeditiously as possible and furnish the DLA with the analytical results. If testing cannot be accomplished, the FDA will promptly notify the DLA.
11) Promptly advise the DLA when the FDA determines that it is necessary to convert a contract from destination to source inspection.
12) Review the FDA Recall Enterprise System (RES) notice provided from the operation staff to determine the consignees to which the medical products identified in the recall recommendation have been distributed.
13) Promptly provide DLA with the RES
14) Assist DLA with questions about RES notifications
15) Upon a specific request from DLA, assist with questions related to medical product intended for procurement by DLA.
5. DATA SHARING GUIDELINES:
The Partners acknowledge that all non-public information shared between FDA and DLA, whether in writing or orally, should be protected from further disclosure unless written permission is obtained from the sharing Partner, and that disclosing certain information, such as trade secrets and confidential commercial information may be prohibited by law. (See, e.g.,5U.S.C.§552;5U.S.C.§552a;18U.S.C.§1905;21U.S.C.§§ 331G)and360j(c); 42U.S.C.§241(d);21C.F.R parts20and21; 45 C.F.R. parts5and 5b). The sharing Partner will not share any information that is entitled to protection as a trade secret pursuant to 21U.S.C. § 331G) or confidential commercial information regarding medical devices that is protected under 21U.S.C.§360j(c). Information subject to the privacy Act can only be shared as authorized under the Privacy Act, such as pursuant to a routine use in the applicable systems of record notice. Provisions for sharing non-public information in accordance with applicable statutes and regulations are set out below:
a. Before the sharing Partner provides any non-public information, the requesting Partner will agree in writing, by using the attached model request language(AttachmentA1)(or a reasonable, mutually agreed upon variation), not to further disclose any shared non-public information without prior written permission from the sharing Partner, unless required by law. If the requesting Partner wishes to further disclose shared information that the sharing Partner has designated as non-public to any other party, such as other Federal agencies, states, foreign governments, or the public. the requesting Partner will obtain written permission from the sharing Partner before disclosure.
b. The sharing Partner will include a transmittal letter along with any information shared. The transmittal letter will indicate the type of non-public information to be shared (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is attached(Attachment A2). The shared documents containing non-public information should include the following language: "This document contains non-public information. Do not disclose without permission of [Insert name of sharing partner].” Any Partner may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request.
c. The requesting Partner will limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request. If the requesting Partner determines that employees other than those identified in the original request have a need to know the requested information, then the requesting Partner will send an update to the information sharing request to the sharing Partner and will wait to receive the sharing Partner's consent before distributing the information to those additional employees. The unit official who signs the information-sharing request will be responsible for ensuring that there are no inappropriate recipients of the information.
d. The requesting Partner will promptly notify the contact person or designee of the sharing Partner of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, Congressional request, judicial order, subpoena. or discovery request.
e.If the requesting Partner receives an FOIA request for shared information, the requesting Partner will: (a) refer the FOIA request to the information-sharing contact person or designee for the sharing Partner to respond directly to the FOIA requester, if the request implicates documents from the sharing Partner in their original form, and notify the FOIA requester of the referral and that a response will issue directly from the sharing Partner; or (b) consult with the sharing Partner about how to respond to the FOIA request through the information-sharing contact person or designee for the sharing Partner, if the request implicates documents authored by the requesting Partner that incorporate information from shared documents. The requesting Partner will not indicate to the FOIA requester whether the sharing Partner has responsive records or releasable records.
f. The partners will promptly notify each other of any actual or suspected unauthorized disclosure of information under this MOU.
a. The performing Partner will provide resources required to support this MOU.
b. Nothing in this MOU will preclude the DLA representatives from making visits to suppliers with the FDA or separately.
c. The DLA contracts for medical products will include a provision requiring compliance with the FD&C Act and implementing regulations promulgated thereunder. The FDA’s current Good Manufacturing Practice Regulations, when applicable, will also be incorporated into these contracts and this will be the quality standard for the manufacturing, processing, packaging or holding of medical products acquired by government contracts. The FDA will be the agency responsible for the administrative interpretation and enforcement of these statutes and regulations.
d. The DLA may authorize the FDA to act as its agent for purposes of inspecting and accepting centrally acquired medical products, performing pre-award surveys, and taking actions related to quality assurance issues.
e. As a general rule, the quality standards prescribed by the United States Pharmacopeia (USP), the National Formulary (NF), and the FDA under the FD&C Act will satisfy the DLA quality requirements for medical products covered by the MOU; however, this does not preclude the development and utilization by the DLA of additional standards when deemed essential to satisfy a unique or special requirement of the DLA or any of the military services.
f. The FDA and the DLA, as necessary, will jointly prepare procedures covering operations that interface.
7. PARTICIPATING ACTIVITY LIAISON OFFICERS
a. For the DLA:
Director, Medical Troop Support
Defense Logistics Agency
700 Robbins Avenue
Philadelphia, PA 19101.
b. For the FDA:
Director, Division of Compliance Systems
Office of Regulatory Affairs
Food and Drug Administration
12420 Parklawn Drive
Rockville, MD 20857.
8. EFFECTIVE DATE, MODIFICATION, OR TERMINATION OF MEMORANDUM OF UNDERSTANDING
a. This MOU will become effective upon the date of the final signature by the last Partner and will remain in effect indefinitely.
b. This MOU embodies the entire understanding between the Partners and will be reviewed every two (2) years to ensure adequacy and currency; however, it may be amended by written mutual consent by the Partners or authorized representatives at any time.
c. This MOU may be unilaterally terminated by either Partner by providing the other Partner with 180 days written notice of intent to terminate. This MOU may also be terminated at any time upon the mutual written agreement of the Partners.
APPROVED AND ACCEPTED FOR THE DEFENSE LOGISTICS AGENCY
BG Steven A. Shapiro
Commander, Troop Support
Defense Logistics Agency
July 9, 2015
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Melinda K. Plaisier
Associate Commissioner for Regulatory Affairs
July 21, 2015
Attachment A1 -- Information Sharing Request
MOU Control No. (Insert number)
Process for Information Sharing
Pursuant to Section __of the Memorandum of Understand (MOU) entered by the Food and Drug Administration (FDA) and the [any Federal partner] "may decide not to share information or expertise in response to a particular request for information, or to limit the scope of information and expertise sharing in response to a particular request." Nothing in the process described below changes Section __. When, under the current MOU, staff at the FDA or ______request for the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, or need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:
"Information that is shared under this agreement will be under the FDA Memorandum of Understanding__________. We agree not to disclose any shared information in any manner without your written permission or as required by law with advance notice to the originating agency." With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.
A response to a request should also be in writing and can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response:
"Pursuant to the FDA Memorandum of Understanding____________, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner without the express written consent or as required by law with advance notice to the originating agency." With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.
Attachment A2 -- Information Sharing Request from Participating Partner(s) to FDA
MOU Control No. (Insert number)
This letter accompanies agency records the (Participating Partner(s)) is sharing with the Food and Drug Administration (FDA) in response to FDA’s request, dated _________. These agency records contain one or more of the following categories of nonpublic information, including information the public disclosure of which may be prohibited b law.
(Participating Partner(s)) checks applicable items below]
____ Trade secrets
____ Confidential commercial or financial information
____ Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
____ Information subject to the Privacy Act
____ Intra-agency records
____ Records or information compiled for law enforcement purposes
____ Information protected for national security reasons; or
FDA shall notify the appropriate office of the information-sharing agency if there are any attempts to obtain shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.
FDA shall notify the information-sharing agency before complying with any judicial order that compels the release of such information that FDA and Partner(s) may take appropriate measures, including filing a motion with the court or an appeal.
FDA has agreed, by this letter or e-mail and by a signed request letter dated ___________________, not to disclose the above-described information without prior written permission of the (Partner(s). FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. section 331(j); 18 U.S.C. section 1095, 21 C.F.R. Parts 20 and 21, 45 CF.R. Parts 5 and 5b and 42 U.S.C. Section 241(d).