MEMORANDUM OF UNDERSTANDING
THE OFFICE OF THE ASSISTANT SECRETARY OF DEFENSE (HEALTH AFFAIRS),
THE VETERANS HEALTH ADMINISTRATION
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The Food and Drug Administration (FDA) as part of the Department of Health and Human Services, the Office of the Assistant Secretary of Defense (Health Affairs) as part of the
Department of Defense (DoD), and the Veterans Health Administration (VHA), as part of the Department of Veterans Affairs, all United States Federal Government entities and hereinafter also referred to as "Federal partners", agree to work together to promote safety initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. 321) and the Public Health Service Act (see 42 U.S.C. 262).
2. Purpose and Goals
The purpose of the MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to:
a. Further enhance information sharing efforts through more efficient and robust inter-agency activities.
b. Promote efficient utilization of tools and expertise for product risk identification, validation and analysis.
c. Build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices, as well as the safety and utilization of foods.
3. Substance of the Agreement - Program Areas and Responsibilities/Activities
a. Each Federal partner will establish a single Agency liaison to facilitate the actions carried out under this MOU. Ideally, the liaisons will be organizationally aligned under the Office of the FDA Commissioner, the DoD Office of the Assistant Secretary of Defense (Health Affairs), and the VHA Office of the Under Secretary for Health.
b. DoD, VHA, and FDA agree to attend an initial meeting to establish the specific procedures and safeguards necessary to implement this MOU. The initial meeting will take place within 30 days of signing and approval of this MOU. Periodic meetings will be scheduled thereafter on a quarterly basis. DoD, VHA and FDA agree not to share information under this MOU unless, and until, adequate procedures and safeguards agreed upon by each Federal partner are established and implemented.
c. VHA, DoD, and FDA agree that each initial request for information will be made by and
transmitted to the Agency liaisons designated according to Section 3.a. of this MOU. Subsequent communications pertaining to that issue may occur between other staff as approved by the liaisons.
d. FDA, VHA, and DoD agree that any Federal partner may decide not to share information or expertise in response to a particular request for information made according to the procedures established under Section 3.b., or to limit the scope of information and expertise sharing in response to a particular request. A decision not to share information in response to a specific request may be based on several factors, including, for example, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding Federal partner's priorities, or legal restrictions. In the event that Federal partners can not reach consensus on a decision to share or not share information, the issue will be referred to the FDA Deputy Commissioner, the DoD Assistant Secretary of Defense (Health Affairs), and/or the VHA Under Secretary for Health for a final decision.
e. FDA, VHA and DoD agree to establish reasonable timelines for responding to information
requests and to refer instances of delays to the Agency liaisons for resolution.
f. FDA, DoD, and VHA recognize that information transmitted between them in any medium and from any source, that contains any of the following types of information must be protected from unauthorized disclosure: (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. § 1905), the Privacy Act (5 U.S.C.§ 552a), the Freedom of Information Act (5 U.S.C. § 552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).
g. FDA, VHA, and DoD agree to promptly notify the relevant Federal partner(s) of any actual or suspected unauthorized disclosure of information shared under this MOU.
4. General Provisions
A. Safeguarding & Limiting Access to Shared Information
The procedures established under Section 3.b. must include proper safeguards against
unauthorized use and disclosure of the information exchanged under this MOU. Proper
safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used solely in accordance with Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act 5 U.S.C. § 552], and their implementing regulations, as well as the HIPAA Privacy Rule [45 C.F.R. Parts 160 and 164]. DoD, VHA, and FDA shall establish appropriate administrative, technical, procedural, and physical safeguards to protect the confidentiality of the information and to prevent unauthorized access to the information provided by the other Federal partner.
Access to the information shared under this MOU shall be restricted to authorized FDA, DoD, and VHA 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. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards required to protect the information, and (3) the administrative, civil and criminal penalties for noncompliance contained in applicable Federal laws. DoD and VHA contractors, their subcontractors and agents who are determined to be business associates of the DoD or VHA and require access to any protected health information shared under this agreement will be required to sign a Business Associate Agreement.
If an agency that has received information under this MOU receives a Freedom of Information Act (FOIA) request for the shared information, it will refer the request to the information sharing agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the information-sharing agency.
B. Restriction on Use of Information
All information provided by the Federal partners shall be used solely for the purposes outlined in Section 2. If a Federal partner wishes to use the information provided by one of the other Federal partners under this MOU for any purpose other than those outlined above, the requesting agency shall make a written request to the other agency describing the additional purposes for which it seeks to use the information. If the agency receiving this request determines that the request to use the information provided hereunder is acceptable, it shall provide the requesting agency with written approval of the additional use of the information.
C. Effect on Existing Statutes and Regulations
FDA, DoD, and VHA agree to take actions under this collaboration that are consistent with
existing laws and regulations, and that nothing in the MOU shall be construed as changing thecurrent requirements under the statutes and regulations administered and enforced by DoD, VHA, and FDA, including but not limited to: title 10 of the United States Code, the Public Health Service Act, and the Federal Food, Drug, and Cosmetic Act. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on FDA, VHA, or DoD that is additional to the mandates or requirements imposed on DoD, FDA, or VHA by Federal statutes and regulations.
D. Resource Obligations:
FDA, VHA, and DoD will designate respective liaisons to oversee the administration of, and adherence to, the content of this MOU. These liaisons shall include one or more designated individuals from FDA's Office of the Commissioner, DoD's Office of the Assistant Secretary of Defense (Health Affairs), and VHA’s Office of the Under Secretary for Health; from FDA's Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and Center for Food Safety and Applied Nutrition, DoD's TRICARE Management Activity, Pharmaceutical Operations Directorate, and VHA’s Pharmacy Benefits Management Services.
FDA, DoD, and VHA will make reasonable efforts to provide the necessary staff to implement this MOU in an efficient and effective manner.
5. Assessment Mechanisms
FDA, VHA, and DoD staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.
6. Terms, Termination or Modification
This MOU becomes effective upon the signature of all three Federal partners and the implementation of the procedures and safeguards agreed upon by the Federal partners described in Section 3. This agreement may be modified by unanimous consent or terminated by any party upon 60 days written notice. This agreement may be modified by unanimous consent or terminated by any party immediately upon written notice in the event that a Federal statute is enacted or a regulation is issued by a Federal partner that materially affects this MOU.
7. Liaison Officers
Associate Commissioner for Policy and Planning
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20257
RADM Thomas J. McGinnis
Chief, Pharmaceutical Operations Directorate
TRICARE Management Activity
Five Skyline Place, Suite 8 10
5111 Leesburg Pike
Falls Church, Virginia 22041-3 206
Pharmacy Benefits Management Services
810 Vermont Avenue NW
Washington, DC 20420
Approved and Accepted
for the Department of Defense
Signed by: S. Ward Casscells, M.D.
Assistant Secretary of Defense
Department of Defense
Date: November 25, 2008
Approved and Accepted
for the Food and Drug Administration
Signed by: Andrew von Eschenbach, M.D.
Commissioner of Food and Drugs
Department of Health and Human Services
Date: July 23, 2008
Approved and Accepted
for the Veterans Health Administration
Signed by: Michael J. Kussman, M.D., MS, MACP
Under Secretary for Health
Department of Veterans Affairs
Date: September 8, 2008
PROCESS FOR INFORMATION SHARING
Pursuant to Section 3.d of the Memorandum Of Understanding (MOU) entered into by the Food and Drug Administration (FDA), the Veterans Health Administration (VHA), and the Department of Defense (DoD), any Federal partner “may decide not to share information or expertise in response to a particular request for information made according to the procedures established under Section 3.b., or to limit the scope of information and expertise sharing in response to a particular request.” Nothing in the process described below changes Section 3.d.
When, under the current MOUs, staff at the FDA, the VHA, or the DoD request from the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, and 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 request will be under the 2008 FDA-VHA-DoD
Memorandum of Understanding to Share Information. We agree not to disclose any shared information in any manner without your written permission." 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, but it, too, 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 2008 FDA-VHA-DoD Memorandum of Understanding to Share Information this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner." With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.