Memorandum of Understanding
The United States Food and Drug Administration
The Office of the Assistant Secretary of Defense (Health Affairs)
1. A MEMORANDUM OF UNDERSTANDING (MOU) TO SHARE INFORMATION
The Food and Drug Administration (FDA) as part of the Department of Health and Human Services and the Office of the Assistant Secretary of Defense (Health Affairs) as part of the Department of Defense (DoD), both United States Federal Government entities and hereinafter also referred to as "Federal partners", agree to share information related to the review and use of FDA-regulated drugs, biologics, and medical devices, 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. MOU 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.
3. MOU 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 and the DoD Office of the Assistant Secretary of Defense (Health Affairs).
b. DoD 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 and FDA agree not to share information under this MOU unless, and until, adequate procedures and safeguards agreed upon by both Federal partners are established and implemented.
c. 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 and DoD agree that either 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 both partners can not reach consensus on a decision to share or not share information, the issue will be referred to the FDA Deputy Commissioner and the DoD Assistant Secretary of Defense (Health Affairs) for a final decision.
e. FDA 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 and DoD 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 (1 8 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 and DoD agree to promptly notify the other Federal partner of any actual or suspected unauthorized disclosure of information shared under this MOU.
4. 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]. The DoD 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 and DoD 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 contractors, their subcontractors and agents who are determined to be business associates of the DoD 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 other agency.
5. RESTRICTION ON USE OF INFORMATION
All information provided by the Federal partners shall be used solely for the purposes outlined in Section 2. If either Federal partner wishes to use the information provided by the other Federal partner 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.
6. EFFECT OF MOU ON EXISTING STATUTES AND REGULATIONS
FDA and DoD 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 the current requirements under the statutes and regulations administered and enforced by DoD 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 either FDA or DoD that is additional to the mandates or requirements imposed on DoD or FDA by Federal statutes and regulations.
7. PLANNED RESOURCES FOR MOU
a. FDA 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 and DoD's Office of the Assistant
Secretary of Defense (Health Affairs); from FDA's Center for Drug Evaluation and
Research, Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research, and DoD's TRICARE Management Activity, Pharmaceutical Operations Directorate.
b. FDA and DoD will make reasonable efforts to provide the necessary staff to implement this MOU in an efficient and effective manner.
8. ASSESSMENT MECHANISMS
FDA and DoD staff involved in implementing the MOU will provide regular and consistent oversight and reevaluation of all terms and conditions contained herein.
9. TERM OF MOU
This MOU becomes effective upon the signature of both Federal partners and the implementation of the procedures and safeguards agreed upon by both Federal partners described in Section 3 and will remain in effect for 3 years from that date. This agreement may be modified by mutual consent or terminated by either party upon 60 days written notice. This agreement may be modified by mutual consent or terminated by either party immediately upon written notice in the event that a Federal statute is enacted or regulations are issued by either Federal partner that materially affect this MOU.
10. LIAISON OFFICERS
Assistant Commissioner for Policy
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 2204 1 -3 206
Approved and Accepted
Approved and Accepted