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  1. FDA Memoranda of Understanding

MOU 225-15-003

MOU 225-15-003

MEMORANDUM OF UNDERSTANDING BETWEEN THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
OFFICE OF WOMEN'S HEALTH
AND THE NATIONAL INSTITUTES OF HEALTH OFFICE OF RESEARCH ON WOMEN'S HEALTH
 
I.        Purpose:
 
ThisMemorandumof Understanding (MOU) establishes the framework for collaboration on women's health initiatives between twocomponents of the Department of Health and Human Services (DHHS): The Food and DrugAdministration (FDA), Office Women's Health (OWH) and the National Institutes of Health (NIH), Office of Research on Women'sHealth (ORWH).  FDA OWH and NIH ORWH share common priorities and interests in promoting awareness and understanding of the science of sex-based differences. This collaboration will serve to facilitate bi-directional communication between the two Agencies. It will also promote the development of tools, materials, and programs to promote reciprocal learning on sex-based science and policy.
 
II.         Background:
 
FDA is authorized to enforce the Federal Food, Drug, and CosmeticAct (the Act) as amended (21U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy,and security of drugs,biologics, medical devices, and veterinary products, and the safety and security of foods, dietary supplements, cosmetics, and non-medical radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in medical research and communicate with stakeholders about complex scientific and public health issues. The collaborative development of research, education, and outreach partnerships with the NIH ORWH will greatly contribute to FDA's mission.
 
FDA's OWH was established in 1994 to protect and advance the health of women through policy, science, and outreach; and to advocate for the inclusion of women in clinical trials and analysis of sex/gender effects. To accomplish its mission, FDA OWH needs to be up to date on the latest developments in women's health research as it relates to the safety and efficacy of FDA-regulated products and must engage stakeholders around these complex scientific and public health issues. FDA OWH works to advance women’s health by promoting scientific research, workshops, and educational activities

 

to address gaps in current scientific knowledge of women's health including sex-based differences, encourage new directions inr egulatory research,and to advance the understanding of women's health.FDA OWH also collaborates with other domesticand international government agencies and domestic and international research institutions to facilitate, translate, and disseminate OWH-funded FDA regulatory research.
 
NIH ORWH was established in 1990 as part of the National Institutesof Health.The NIH is recognized as the premier medical research arm of the US Public Health Service (PHS). NIH ORWH was the first PHS office dedicated specifically to promoting women'shealth and to conducting sex differences research. Iti s part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure women's health research is part of the scientific framework both at NIH and throughout the scientific community.In accordance with the 1993 NIH Revitalization Act, the ORWH director has worked to strengthen and enhance research related to diseases, disorders, and conditions that affect women; ensure that research conducted and
supported by NIH ORWH adequately addresses issues regarding women's health; ensure that women are appropriately represented in biomedical and bio-behavioral research studies supported by NIH; and support research on women's health issues, amongst other things. ORWH establishes the research agenda for women's health and co-funds research projects in partnership with NIH Institutes and Centers, as well as other federal agencies.
 
III.          Substance ofAgreement:
 
This MOU establishes a collaborative framework in which FDA's OWH and NIH's ORWH may engage in activities such as consortia and consensus development, education, and research for the mutual benefit of the parties,as well as benefits to the publichealth. Before any specific cooperative efforts are initiated or implemented, the parties will identify priorities, topics of mutual interest, and develop a separate written supplemental agreement for each collaboration that outlines each party's commitments to collaboration and the terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU. The terms and conditions of any agreements will be inaccordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of the FDA OWH and NIH ORWH.
 
IV.          General Provisions:
 
A.  Data Sharing Guidelines:
 
Aspublic health agencies within DHHS, there are no legal prohibitions that preclude FDA or NIH from sharing with each other most information in the possession of either Agency. Both parties recognize and acknowledge, however, that all non-public information shared between FDA and NIH,whether in writing or orally, must be protected from any disclosure not authorized by law or regulation. See e.g., 18 U.S.C.§1905; 5 U.S.C.§ 552; 5 U.S.C. § 552a; 21 U.S.C. §3310); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 42 CFR Parts 5 and 5b. Safeguards are needed to protect shared non-public information, such as trade secrets and confidential commercial information; identities of study participants and other personal privacy information ;privileged and/or pre-decisional Agency information; research proposals, progress reports, and/or unpublished data; or national security information. Such safeguards also help ensure compliance by FDA and NIH with applicable lawsandregulations.
 
To facilitate the sharing of non-public informationbetween them, FDA and NIH will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received. Both parties are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and to the extent permitted by law, regulation, and Agency policy and practice. The party receiving shared non-public information (requesting party) will be responsible for protecting that information from any unauthorized disclosure.
 
Provisions for sharing of non-public information in accordance with applicable statutes, regulations, or policies are set out below:
 
I.  The requesting party 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 party determines that employees other than those identified in the original request have a need to know the requested information, then an update to the requestl etter will be supplied to the sharing party before the requesting party distributes the information to those employees.The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
 
2.  The requesting party will agree in writing, by using the model request language (Attachment AI, or a reasonable, mutually agreed upon variation), not to disclose any shared non-public information in any manner not authorized by law or regulation,including disclosure in publications and public meetings. If the requesting party wishes to disclose shared information that the sharing party has designated as non-public,the requesting party will ask the sharing party whether the information's non-public status has changed,and if so,will first obtain written confirmation and permission from the sharing party before disclosing that information. If the requesting party receives a Freedom of lnformation Act (FOIA) request for shared information, the requesting party will:  (a) refer the FOIA request to the information-sharing contact person or designee for the sharing party to respond directly to the FOIA requester regarding the releaseability of the information, and (b) notify the FOIA requester ofthe referral and that a response will issue directly from the sharing party. The requesting party will leave all final disclosure decisions up to the sharing party, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting party will not indicate to the FOIA requesterwhetherthe sharing party has responsive or releasable records.
 
3.  The sharing party will include a transmittal letter (See Attachment AI, A2) along with any Agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information,personalprivacy, pre-decisional,etc.). The shared documents containing non-public information should be stamped"Do not disclose without permission of [insert name of sharing party]" as applicable.
 
 
4.  The requesting party will promptly notify the contact person or designee of the sharing party of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, orlitigation complaint or motion.
 
5.  The requesting party will notify the sharing party before complying with any judicial order that compels the release of shared non-publicinformation, so that the parties may determine the appropriate measures to take, including,  where appropriate, legal action." The requesting party will agree in writing, by signing the model transmittal letter (Attachment A2,or a reasonable, mutually agreed upon variation), not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings.
 
V.          Resource Obligations:
 
This MOU represents the broad outline of the parties' intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and NIH. All activities undertaken pursuant to 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 policies, rules, regulations, and statutes under which FDA and NIH operate.
 
VI.          Liaison Officers:
 
A.      For the National Institutes ofHealth, Office of Research on Women's  Health:
 
Terri L. Cornelison, M.D.,Ph.D.
AssociateDirectorforClinical Research
Office of Researchon Women's Health
Division of ProgramCoordination, Planning, and Strategic Initiatives
Officeofthe Director
NationalInstitutesofHealth
6707 Democracy Blvd, Suite 400
Bethesda MD 20892-5484
Office Telephone: (301)402-1770
Fax: (301) 402-1798
 
B.For the Food and Drug Administration,Office of Women's Health:
 
DeborahL.Kallgren
Special Assistant
Office of Women’s Health
WOBuilding32,Room2314
10903 New Hampshire Ave
Silver Spring,MD 20993
OfficeTelephone:(301)796-9442
Fax:(301)847-8604
 
Each party may designate new liaisons by notifying the other party's liaisonin writing. If an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, the party affected will name a new liaison within two(2) weeks and notify the other party through the designated liaison.
 
VII. Term,Termination,andModification:
 
This MOU,when accepted by all parties,will havea five-year period of performance effective from the date of the latest signature and may be renewed,modified, and/or extendedby mutual written consent o fboth parties. This MOU may be terminated by either party upon sixty (60) days advance written notice.
 

 

Approved and Accepted By:
 
Marsha B. Henderson, MCRP
Assistant Commissioner for Women's Health
U.S. Food and Drug Administration
 
December 4, 2014
 
Janine Austin Clayton, M.D.
Director Office of Research on Women's Health
Associate Director for Research on Women's Health
National Institutes of Health
 
December 9, 2014
 
James M. Anderson, M.D., Ph.D.
Director, Division of Program Coordination
Planning and Strategic Initiatives
National Institutes of Health
 
December 10, 2014
 
LaVerne Stringfield
Associate Director for Manatement
(OD Executive Officer)
Office of the Director
National Institutes of Health
 
December 10, 2014
 

 

Attachment
 
Al -- Model Language for Information Request/Transmittal
 
MOU Control No. (Insertnumber)
 
Process for Information Sharing
 
Pursuant to Section V of the Memorandum of Understanding MOU) entered by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) (FDA-NIH Memorandum of Understanding),either party 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 V. When, under the current MOU, staff at the FDA or NIH request from the other Agency information that may contain confidential material, the request shouldbe 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 is not required for purposes of making a request. However, the following language shouldbe included in the request:
 
Information that is shared under this agreement will be pursuant to and consistent with the terms of the FDA-NIH 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 do 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 e-mail that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful,it is not required for purposes of responding to a request. However, the following language should be included in the response:
 
Pursuant to the FDA-NIH Memorandumof 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 aparticular format or include other pre-specified text.

 

Attachment A2 --Model Transmittal Letter for Information Sharing Request
 
MOU Control No. (Insertnumber)
 
This letter accompanies Agency records sharedby one party (information-sharing party) with the other (requesting party) in response to arequest from requesting party, 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 (including, but not limited to, 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;and information protected informational security reasons).
 
The requesting party 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 lnformation Act requests,subpoenas,discovery requests, and litigation complaints or motions.
 
The requesting party shall notify the information-sharing Agency before complying with any judicial order that compels the release of such information that the parties may respond appropriately,including filing a motion withthe court or an appeal.
 
The parties agree,by this correspondence and by a signed request letter dated                                           ,not to publically disclosethe above-described information without prior written permission of the parties to the extent permittedby applicable law, regulation,or policy. Both parties acknowledge that applicable laws and regulations may prohibit the disclosure of such information.See, e.g., 21U.S.C.section33l(j);5 U.S.C. section 552; 5 U.S.C. section 552a;18U.S.C.section1905, 21 C.F.R. Parts 20and21, 45CF.R. Parts 5,5b, and 42 U.S.C. Section24l(d).
 
 
  
Information-sharing Party 
 
Name                                                                                                   Date
 
 
 
Requesting Party 
 
 
Name                                                                                                   Date