MOU 225-18-026
Memorandum of Understanding Between the Food and Drug Administration and the Agency for Healthcare Research and Quality
l. Purpose
This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ) provides a framework for coordination and collaborative efforts between these two agencies which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information exchanges between FDA and AHRQ shall take place.
ll. Background
FDA and AHRQ are sister agencies within the Department of Health and Human Services. Both FDA and AHRQ exist and work to protect the public health but have different statutory mandates and responsibilities.
FDA is a regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA administers the Federal Food, Drug, and Cosmetic Act and relevant sections of the Public Health Service Act, among other statutes. Among its duties, FDA approves pre-market applications, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events. FDA also initiates civil and criminal litigation to enforce applicable laws and regulations.
AHRQ's mission is investing in and supporting research on the U.S. health delivery system to make health care safer and improve quality. AHRQ seeks to accomplish its mission by creating materials to teach and train health care systems and professionals to help them improve care for their patients, and to generate measures and data used to track and improve performance and evaluate progress of the U.S. health system. AHR Q's evidence based tools and resources are used to improve the quality, safety, effectiveness, and efficiency of health care. AHRQ conducts its activities under the authority of the Public Health Service Act and several other federal statutes.
AHRQ's and FDA's respective missions to protect the public health may overlap in a variety of ways depending upon the subject matter. Each agency has a responsibility to work collaboratively to protect and improve public health. It may sometimes be the case that FDA or AHRQ will be in possession of information that could be useful to the other agency in that agency's performance of its responsibilities. Timely sharing of information between AHRQ and FDA is therefore critical to protecting the public health.
lll. Substance of Agreement and Responsibility of Each Agency
A. Coordination and Collaboration Relative to Public Health Activities
It is mutually agreed that:
- Each agency will coordinate and collaborate with the other agency to protect and improve the public health. To achieve this, each agency will utilize the expertise, resources, and relationships of the other agency to increase its own capability and readiness to respond to emergency situations. In addition, each agency will designate central contact points where communications from the other agency, dealing with matters covered by this agreement,should be referred.
- Each agency will participate in periodic joint meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for questions and problems that may arise.
- Each agency will notify the other agency as soon as possible when issues of mutual concern become evident.
- Each agency will collaborate with the other agency in all investigations of mutual concern. Such collaboration may include providing alerts to the other agency when issues are identified; providing technical advice in areas of recognized expertise; providing results of analysis; coordinating health protection information and recommendations provided to the public; making available expert witnesses; and exchanging information as described in section 111.B.
- Each agency will consult with the other before issuing press or scientific releases or publications that may have a significant impact on the other agency.
- Each agency will refer its proposed regulations, guidances, or recommendations that may have a significant impact on the other agency for review and comment by that agency before publication.
- This agreement does not preclude AHRQ or FDA from entering other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.
B. Principles and Procedures for the Exchange of Information That is Not Publicly Available
FDA and AHRQ agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.
Although there is no legal requirement that FDA and AHRQ exchange information in all cases, FDA and AHRQ agree that there should be a presumption in favor of full and free sharing of information between FDA and AHRQ.As sister public health agencies within the Department of Health and Human Services, there are no legal prohibitions that preclude FDA or AHRQ from sharing with each other most agency records in the possession of either agency. Both agencies recognize and acknowledge, however, that it is essential that any confidential information that is shared between FDA and AHRQ must be protected from unauthorized public disclosure. See e.g.,21 U.S.C. § 331(j); 18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21;45 C.F.R. Parts 5 and Sb, and 42 U.S.C. § 241(d). Safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; patient identities and other personal privacy information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and AHRQ' s compliance with applicable laws and regulations.
To facilitate the sharing of information with each other, it is necessary that FDA and AHRQ implement procedures to ensure, at a minimum, that such sharing of information is indeed appropriate and that the recipient agency appropriately guards the confidentiality of all non-public information received. There are procedures, as described below, for routine requests for information and for emergency requests. It is incumbent upon both agencies to respond to requests for information in a timely manner. Any unauthorized disclosure of shared confidential information by the agency receiving the information shall be the responsibility of that agency, so long as the agency providing such information conveys the confidential nature of the information to the receiving agency, in accordance with the terms of this MOU,or the receiving agency otherwise has knowledge that such information is confidential.
1. Routine Requests for Non-public Information
a. The requesting agency must demonstrate, in writing, why it is necessary for it to obtain the requested information . This demonstration should consist of a summary that describes in detail the information requested (to facilitate identification of relevant records) and a brief statement of the purpose for which the information is needed. This request shall state which internal agency offices and/or individua ls requested the information. A model request letter is attached.
b. The agency receiving the request for information shall, based upon the sufficiency of the need-to-know demonstration described in section 111.B.1.a above, determine whether it is appropriate to share the requested information with the requesting agency. The need-to-know threshold is a low one. As stated above, there is a presumption in favor of information exchange between FDA and AHRQ. An agency should only decide not to share information in response to a request if it has credible information and a reasonable belief that the requesting agency may not be able to comply with applicable laws or regulations governing the protection of non-public information or with principles or procedures set forth in the MOU. If an agency decides that it is not appropriate to share information with the requesting agency, it shall describe to the requesting agency the reasons for such decision.
c. The requesting agency agrees that it shall comply with the following conditions:
1) The requesting agency shall limit the dissemination of shared information it receives to internal agency offices and/or individuals that have been identified in its written request and/or have a need-to-know. The agency official who signs the request letter will be responsible for ensuring that there are no other recipients of the information.
2) The requesting agency shall agree in writing not to publicly disclose any shared information in any manner including publications and public meetings. If the requesting agency wishes to disclose shared information, including information that it believes is publicly releasable, it shall first request and obtain the written permission of the agency that has shared the information. If the requesting agency 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 releasea bility 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.
3) The agency that shares informat ion with the requesting agency shall include a transmittal letter, along with any agency records exchanged. The transmittal letter shall indicate the type of information being shared (e.g. confidential commercial information, personal privacy, or pre-decisional}. A model transmittal letter is attached.
4) The requesting agency shall promptly notify the appropriate office of the information-sharing agency when there is any attempt to obtain shared information by compulsory process, including but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.
5) The requesting agency shall notify the information-sharing agency before complying with any judicial order that compels the release of such information so that the agencies may determine the appropriate measures to take, including where appropriate the filing of a motion or an appeal with the court.
2. Emergency Requests for Non-public Information
In cases in which the requesting agency has a need to obtain certain information as soon as possible due to emergency circumstances, such as an outbreak of illness, FDA and AHRQ may utilize the following procedures. These procedures are intended for use only in the case of an actual emergency and are not appropriate for routine requests for information.
a. The requesting agency shall indicate orally or in writing to the agency in possession of the relevant information that it has the need to obtain certain identifiable information as soon as possible due to the existence of emergency circumstances. The requesting agency shall also describe what the emergency circumstances are.
b. The requesting agency shall verbally agree to protect from unauthorized public disclosure all information that is shared, according to all applicable laws and regulations.
c. The existence of an actual emergency shall warrant, as determined by the agency in possession of the requested records, the waiver of the need-to know demonstration and determination described above in section 111.B.l.a and B.l.b. However, once the requesting agency has obtained the information it seeks, it shall comply with those procedures set forth in section 111.B.1.c above.
lV. Name and Address of Participating Parties
A. Food and Drug Administration, Department of Health and Human Services, 10903 New Hampshire Avenue, Silver Spring, MD 20993
B. Agency for Healthcare Research and Quality, Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857
V. Liaison Officers
A. Contact for FDA:
Richard Currey, PA-C
Nancy Guan, PharmD
Center for Drug Evaluation and Research
Office of the Center Director
10903 New Hampshire Ave
Silver Spring, MD 20993
B. Contact for AHRQ:
Laura L. Pincock, PharmD, MPH
Captain, U.S. Public Health Service
Pharmacist Officer, Evidence-based Practice Center Program (EPC)
Agency for Healthcare Research and Quality
5600 Fishers Lane, Room 06N16
Rockville, MD 20857
Vl. Period of Agreement
This agreement becomes effective upon signature of both parties and will continue for five years. It may be modified by mutual consent or terminated by either party upon 60 days written notice.
Attachments
Model Request Letter
Model Transmittal Letter
Approved and accepted for Food and Drug Administration by:
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Date: 9/17/2018
Approved and accepted for Agency for Healthcare Quality and Research by:
Francis D. Chesley, Jr., M.D.
Acting Deputy Director
Director, Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
5600 Fishers Lane, Room 06N16
Rockville, MD 20857
Date: 9/17/2018
Model l language for Request from FDA to AHRQ
The Food and Drug Administration (FDA) has requested the following information from the Agency for Healthcare Research and Quality (AHRQ) for the following purposes: [Identify information and purpose]
Or
FDA hereby requests the following information from AHRQ for the following purposes: [Identify information and purpose)
FDA agrees that it will not publicly disclose any such information that AHRQ shares with it without prior written permission from AHRQ and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA and AHRQ.Appl icable laws and regulations may prohibit the disclosure of such information. See e.g.,21 U.S.C. §331(j); 18 U.S.C. §1905, 21 C.F.R. Parts 20 and 21,45 C.F.R. Parts 5 and Sb and 42 U.S.C. §241(d).
FDA will limit dissemination of any shared information to the following FDA offices and/or employees: [Identify office(s) and/or employee(s)].
Name Date
[Signature and Date by FDA official with requisite responsibility and authority.]
Model l language for Request from AHRQ to FDA
The Agency for Healthcare Research and Quality (AHRQ) has requested the following information from the Food and Drug Administration (FDA) for the following purposes: [Identify information and purpose]
Or
AHRQ hereby requests the following information from FDA for the following purposes: [Identify information and purpose]
AHRQ agrees that it will not publicly disclose any such information that FDA shares with it without prior written permission from FDA and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA and AHRQ. Applicable laws and regulations may prohibit the disclosure of such information. See e.g.,21 U.S.C. §331(j); 18 U.S.C. §1905, 21 C.F.R. Parts 20 and 21,45 C.F.R. Parts 5 and Sb and 42 U.S.C. §241(d).
AHRQ will limit dissemination of any shared information to the following AHRQ offices and/or employees: [Identify office(s) and/or employee(s)] .
Name Date
[Signature and Date by FDA official with requisite responsibility and authority.]
Model Transmittal Letter from AHRQ to FDA
This letter accompanies agency records that the Agency for Healthcare Research and Quality (AHRQ) 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 non-public information, including information the public disclosure of which may be prohibited by law:
[AHRQ 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 other.
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 so that FDA and/or AHRQ 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 publicly disclose the above-described information without prior written permission of AHRQ. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information.See,e.g.,21 U.S.C. §331{j); 18 U.S.C. §1905, 21 C.F.R.Parts 20 and 21,45 C.F.R. Parts 5 and Sb and 42 U.S.C. §241(d).
Model Transmittal Letter from FDA to AHRQ
This letter accompanies agency records that the Food and Drug Administration (FDA) is sharing with the Agency for Healthcare Research and Quality (AHRQ) in response to AHRQ's request, dated [__]. These agency records contain one or more of the following categories of non-public information, including information the public disclosure of which may be prohibited by law:
[FDA 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 or
_information protected for national security reasons
AHRQ 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.
AHRQ shall notify the information-sharing agency before complying with any judicial order that compels the release of such information so that FDA and/or AHRQ may take appropriate measures, including filing a motion with the court or an appeal.
AHRQ has agreed, by this letter or e-mail and by a signed request letter dated [ ], not to publicly disclose the above-described information without prior written permission of FDA. AHRQ acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See e.g.,21 U.S.C. §331(j); 18 U.S.C. §1905, 21 C.F.R. Parts 20 and 21,45 C.F.R. Parts 5 and Sb and 42 U.S.C. §241(d).