MOU 225-82-8400
Memorandum of Understanding
Between the U.S. Department of Veterans Affairs, Veterans Health Administration
and the U.S. Department of Health and Human Services,
Food and Drug Administration
I. PURPOSE
The purpose of this Memorandum of Understanding (MOU) is to identify specific responsibilities of the U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) and the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA) (“Party” or “Parties”) to facilitate communication and encourage effective cooperation between the agencies pertaining to VA clinical research of FDA regulated products.
II. BACKGROUND
In 1977, in response to a congressional directive, FDA developed a clinical investigator program to assure the quality of bioresearch data intended to support the approval of new drugs, biologics, and medical devices for human use. Currently, FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of inspections (including data audits) and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, determine status of compliance with regulations and statutes, as well as, to ensure the rights and welfare of all human and animal participants involved in FDA regulated research.
The FDA applies the same standards of performance to federal institutions and government employees as it applies to private industry.
III. FDA's RESPONSIBILITIES
A. FDA may provide the VHA Office of Research Oversight with the names of VA clinical investigators, sponsor-investigators, sponsors, institutional review boards (IRBs), and radioactive drug research committees that FDA intends to inspect, (hereafter, “VA entities”).
B. FDA may notify the VA entity to be inspected to make suitable arrangements for the inspection.
C. FDA will make available, upon request, a copy of any post-inspectional correspondence with the VA inspected entity to the VHA Office of Research Oversight to the extent permitted by applicable law.
IV. VHA's RESPONSIBILITIES
A. The VHA will facilitate access to records and reports associated with the FDA-inspected entities and will provide copies of those records upon the official request of an FDA investigator to the FDA-inspected entities in accordance with applicable privacy regulations and statutes. Access to these records is authorized under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 C.F.R. 164.512(d)), the Privacy Act (5 U.S.C. Secs. 552a(b)(3) and (7)), and VA statutes (38 U.S.C. Sec. 5701(B)(3), 38 U.S.C. Sec. 5705(b)(1)(A)). For records containing Personal Identifiable Information (PII) and Protected Health Information (PHI) the record could be withheld in full or redacted to preserve the identity of the patient as required under statute and VHA policy.
V. INFORMATION SHARING
A. Access to the confidential and non-public information shared under this MOU shall be restricted to authorized FDA and VA employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU and any such non-public information is shared by FDA pursuant to 21 C.F.R. 20.85. Such personnel shall be advised of (1) the confidential nature of the information, (2) safeguards against the unauthorized disclosure of confidential information, and (3) the administrative and civil penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.
B. Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act (18 U.S.C. Sec. 1905), the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. Sec. 301 et seq.), the Privacy Act of 1974, as amended (5 U.S.C. Sec. 552a), the Freedom of Information Act (5 U.S.C. Sec. 552), any other applicable Federal law and their incorporating regulations. Pursuant to FDCA section 301(j), (21 U.S.C. Sec. 331(j)), FDA will not reveal to VA any method or process which is entitled to protection as a trade secret.
C. Sensitive or nonpublic information includes but is not limited to: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g. Trade Secrets Act (18 U.S.C. Sec. 1905)), the Privacy Act (5 U.S.C. Sec. 552a), other Freedom of Information Act exemptions not mentioned above (5 U.S.C. Sec. 552(b)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.), and HIPAA (Pub. L. 104-191).
D. If either Party receives a Freedom of Information Act (FOIA) request for the shared information, it shall: (a) if the request implicates documents from the Sharing Party in their original form, refer the request to the Sharing Party for that Party to respond directly to the requester, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Party regarding the releasability of the information; and (b) if the request implicates documents authored by the Receiving Party that incorporates information from shared documents, consult with the Sharing Party about how to respond to the FOIA request. The Receiving Party will not indicate to the FOIA requester whether the Sharing Party has responsive or releasable records. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25 and 38 C.F.R. 1.555(c).
VI. FUNDING
All activities undertaken through the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable laws, policies, rules, regulations, and statutes under which the FDA and the VA will operate.
VII. DURATION AND MODIFICATION OF AGREEMENT
This MOU is to become effective upon date of final signature of the Parties and will be effective six (6) years from that date with the option to renew. This MOU will be reviewed no less often than at the mid-point of its term and around the anniversary of its effective date in its entirety. The MOU will remain in effect unless one of the Parties provides notice to the other that it does not intend to continue with this MOU. New signatures from all Parties to the agreement are required to establish any new MOU or to modify this MOU, even when the terms and conditions are the same as those in the prior agreement. If differences in understanding arise regarding this MOU, the Parties intend to resolve such differences by mutual consultation.
IX. PROJECT OFFICERS
Veterans Health Administration:
Executive Director, Office of Research Oversight (10R)
Veterans Health Administration
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420
Telephone: (202) 632-7620
Email: vha10rresearchoversightaction@va.gov
Food and Drug Administration:
Director, Bioresearch Monitoring Staff
Food and Drug Administration
12420 Parklawn Drive
Rockville, MD 20857
Telephone: 301-796-5633
X. AUTHORITY
The authority for this agreement is contained in 21 U.S.C. §§ 355(i); 357(d); 360j(g); 372; 374; 379; 823(f); and 42 U.S.C. §§ 241, 242a, 262-264; and 38 U.S.C. § 512 implemented by 38 C.F.R. § 2.6(a)(1).
Approved and Accepted for the Veterans Health Administration
/s/
Carolyn M. Clancy
Title: VHA Assistant Under Secretary for Health for Discovery, Education and Affiliate Networks and VA Chief Science Officer
Date: 09/24/2024
Approved and Accepted for the Food and Drug Administration
/s/
Michael Rogers
Title: Associate Commissioner for Regulatory Affairs
Date: 09/19/2024
Attachment A: 20.85 Model Request Letter
YOUR AGENCY’S LETTERHEAD
Please copy and paste onto your agency’s letterhead
Attn: Information Sharing Specialist
Division of Information Disclosure Programs
Office of Partnerships
Office of Regulatory Affairs
Food and Drug Administration
ORAInfoShare@fda.hhs.gov
Dear Information Sharing Specialist,
The YOUR AGENCY’s NAME AND OFFICE requests access to the following non-public information, pursuant to MOU 225-82-8400, (list the type of records/information requested, including the firm and/or product name and the relevant timeframe) pursuant to 21 C.F.R. § 20.85: LIST THE INFORMATION YOU ARE REQUSTING IN DETAIL (Requests for all documents, or all communications relating to a product/firm, if overly broad can result in processing delays).
The purpose for which the information is requested is to assist in the STATE THE NATURE OF YOUR INTEREST. The records will only be used for the following authorized activity: STATE THE ACTIVITY. (In addition, indicate whether the request for information is the result of an ongoing investigation, and if so, give the details.)
I certify that the ACTIVITY is authorized by law, that the records or information will be used only for the stated purpose and will not be disclosed outside YOUR AGENCY AND OFFICE without the prior written permission of the Food and Drug Administration. I also certify that disclosure within YOUR AGENCY will be limited to the specific purpose stated above, and that I will provide a copy of this letter to any person(s) with whom I share the non-public information.
I understand that 21 U.S.C. § 331 of the Federal Food, Drug, and Cosmetic Act prohibits disclosure of trade secret information outside the Department of Health and Human Services. If you have any questions, please contact PROVIDE NAME AND CONTACT INFORMATION.
Sincerely,
YOUR SIGNATURE LINE
cc: RECOMMEND INSERTING NAME OF YOUR FDA CONTACT, IF ANY.