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  1. Domestic MOUs

MOU 225-14-0001

I.       Purpose:
This Memorandum of Understanding (MOUor the agreement) establishes the framework and procedures to enhance collaborations and exchange of information between the Food and Drug Administration(FOA), Office of Women'sHealth and the National Cancer Institute (NCI), Center to Reduce Cancer Health Disparities (CRCHD).FDA and NCI (each a Party, and together the Parties) seek to increase our scientific knowledge and understanding of cancer in women through targeted basic, clinical, bio behavioral translational,and community based participatory research approaches and efforts.FDA and NCI both recognize the need for a unified approach to advancing scientific knowledge related to cancer and women's health. This harmonized approach will aid in advancing the public health of all women through innovation in cancer research and medical therapies.
II.     Background:
FDA is authorized to enforce the Federal Food, Drug and Cosmetic Act (the Act) as amended (21 U.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, veterinary products, and medical devices and the safety and security of foods, cosmetics, and radiological products. FDA also has responsibility for regulating themanufacturing, marketing, and distributionof 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 research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships with NCI will greatly contribute to FDA'smission.
FDA'sOffice of Women'sHealth (OWH) was established to protect and advance the health of women through policy, science, and outreach, and to advocate for inclusion of womenin clinical trials and for sex/gender analyses. OWH achieves its mission by supporting scientific research within FDA centers and collaborating with other government agencies and national organizations to sponsor scientific and consumer outreach efforts that address health issues affecting women across

their lifespan.The OWHrelies on partnershipswith other Federal agencies, as well as public and private entities to help advance women'shealth research.
Pursuant to Sections 301, 401.and 463 of the· Public Health Services Act [42 U.S.C. §241.28 and 285I]; NCI, a component of theNational Institutes of Health and an agency of the Federal Government, is charged by Congress with leading the nation's efforts forNational Cancer Program, which conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
NCI's Center to Reduce Cancer Health Disparities (CRCHD) was established to reduce the unequal burden of cancer in oursociety. CRCHD initiates, integrates, and engages· in collaborative research studies in NCI division's and NIH Institutes and Centers to promote research and training in cancer health disparities research and to' identity· new and innovative scientific opportunities to improve cancer outcomes in communitiesexperiencing an excess burden of cancer. The vision of CRCHD is to overcome cancer health disparities through research and training, to enhance the understanding of the causes of disparities; and to reduce and eliminate inequities in the cancer burden among populations experiencing cancer disparities
CRCHD's missionis to strengthen the NCI cancer portfolioin basic, clinical, translational, and population-based research to address cancer health disparities. In addition, CRCHD aims to lead NCI's efforts in training of students and investigators from diverse populations and to establish state-of-the-art regional networks and centers dedicated to cancer health disparities research and care through geographic program management.
III.       Substance of Agreement:
a.  Through this collaboration, FDA OWH and NCI CRCHD seek to increase scientific knowledge andunderstanding of cancerin women through targeted basic, clinical, bio-behavioral, translational; and community-basedparticipatory research approaches/efforts.The 0verall purpose of the Parties' collaboration is to promote the public health of all women through advancementsin cancer research and medical therapies. The Parties envision this joint collaborative activityto encompass all the major cancers afflicting the health and well-being for adult women.
b.  FDA OWHand NCI CRCHD will collaborate on developing scientifically meritorious research questions to focus on cancer in women, including cancer health disparities, to address FDA'sregulatory science issues and questions. FDA OWH and NCI CRCHD will also promote such scientifically meritorious research questions through one or more additional arrangements each of which is to be memorialized in asupplemental agreement and conducted in accordance with applicable federal law and regulations. Unless the Parties otherwise agree in writing, any and all such additional arrangements shall incorporate by reference the terms of this MOU and no such additional arrangements shall be effective unless and until signed by an appropriate representative of each Party.
c.  FDA OWH has expressed its interest in attending as an observer one or more meetings of the NIH standing study section held in connection with the peer review of applications submitted for activities pursued under this MOU. FDAOWH acknowledges that its attendance at any such proceeding will be considered on a case-by-case basis and each time will be subject to (1) the recommendationby and support of an appropriate authority within NCI (e.g., an NCI division director); (2) approval of an appropriate authority within the NIH Center for Scientific Review (CSR); and (3) permissionof the appropriate Scientific Review Officer. In the event FDA OWH seeks to observe a review proceeding, NCI CRCHD will endeavor tofacilitate and support FDA OWH’s attendance.
d.  During this collaboration and in eachcase subject to and in accordance with applicable laws, regulations and policies, FDA OWH and NCI CRCHD, may share with each other information relating to research activities developed under this MOU and funded by NCI CRCHD and FDAOWH,such as funding opportunities, monitoring of project progress, notice of grant awards, terms and conditions of grant awards, progress reports, semiannual updates,formal reports, and finalrecipients through various forums (e g. meetings, teleconferences,and electronic
e.  As part of any additional supplemental arrangements entered into by the Parties under this MOU, Principal investigators(PIs) will be asked, consistent with NIH policies and procedures, to provide interim and final progress reports based on the programmatic need to assess and monitor scientific progress and results.
f.  FDA OWH will be given appropriate recognition in connection with those research projects under this MOU, which it co-sponsors.
IV. General Provisions: Include the following applicable statements in the MOU: Data Sharing Guidelines:

As public health agencies within Department of Health and Human Services (DHHS), there are no legalprohibitions that preclude FDA or NCI from sharing with each other most information on in the possession of either agency. Both Parties recognize andacknowledge, however, that all non-public informationshared between FDA and NCI, whether in writing or orally,must be protected from any disclosure notauthorized by law or regulation. .See e.g., 18 U.S.C.§ 1905; 5 U.S.C. Section 552; 5 U.S.C. § 552a; 21 U.S.C. § 3316); 21 CFR Parts20and 21; 42 U.S.C. § 241(d); 42.CFRParts 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 NCI with other applicable laws and regulations.

To facilitate the sharing of non-public information, FDA and the NCI 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 (requestingParty) will be responsible for protecting that information from any unauthorized disclosure.
Provisions for sharing of non-publicinformation in accordance with applicable statutes and regulations are set out below:
a.  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. Ifthe requesting Party determines that employees other than those identifiedin the original request have a need to know the requested information, then an update to the request letter 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.
b.  The requestingParty will agree in writing, by using the model request letter attached as Appendix AI (or areasonable, 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 isnon-public status has changed, and if so, will first obtain written confirmation and permission from the sharing Party before disclosing that information. If therequestingParty receives a Freedom of Information Act (FOIA) request for shared information, the requesting Party will: (a) refer the FOIA request to the information-sharing contact person or designeefor the sharing Party to respond directly to the FOIA requester regarding the releaseability of the information, and (b) notify the FOIA requester of the 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 requester whether the sharing Party has responsive records or releasable records. If either Party receives a FOIA request for information that combines information originating from both the sharing Party and the requesting Party, the Party shall refer the FOIA request to the Public Health Service Freedom of Information Officer.
c.  The sharing Party will include a transmittal letter along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal lettersattached. The shared documents containing non-public information should be stamped "Do not disclose without permission of FDA or NCI" whichever is applicable.
d.  The requesting Party will promptly notifythe  contactperson or designee ofthe sharing Party of any attempt by a third party to obtain shared non­public informationby compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.                                                 
e.  The requesting Party will notify the sharing Party before complying with any judicial order that compels the release of shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.
V.       Resource Obligations:
                                                        .                     .
This MOU represents the broad outline of the Parties' intent to enter into specific agreements for collaborativeefforts in intellectual areas of mutual interests to FDA OWH and NCI CRCHD. All activities undertaken pursuant to the MOU's life, 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 and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to applicablepolicies, rules, regulations, and statutes under which FDA and NCl operate.
VI.       Liaison Officers:
A.         For the National Cancer Institute, Center to Reduce Cancer Health Disparities
Anil Wali, Ph.D.
9609 Medical Center Drive
Room 6W248; MSC 9746
Bethesda, MD 20892 9746
[email protected] Telephone: 240-276-6183
FAX: 240-276-7862
B.         For the Food and Drug Administration,
Office of Women'sHealth: Tammie Brent Howard, RN MSN
10903 New Hampshire Avenue
Bldg. 32, Room 2311
Silver Spring, MD 20993
[email protected]: 301-796-1409Telephone
FAX: 301-847-8604
VII.      Term, Termination, and Modification:
This agreement will be effective when accepted by all participating Parties. This agreement may be modified or terminated by mutual Written consent by both Parties or may be terminated by either Party upon a 60-day advance written notice to the other.
VIII.     Approvals:
             Marsha Henderson, MCRP                                                                        
             Assistant Commissioner for Women’s Health
             Office of Women’s Health
             Food and Drug Administration
             U.S. Department of Health and Human Services
             December 3, 2013
            Sanyia A. Springfield, Ph.D.
            Director, Center to Reduce Cancer Health Disparities                                    
            National Cancer Institute
            January 2, 2014
Attachment A1 -- Model Language for Information Sharing Request
MOU Control No.(Insert number) Process: for Information Sharing 
Pursuant toSection V of the Memorandum of Understanding(MOU) entered by the Food and Drug Administration (FDA) and National Cancer Institute (NCI) (FDA-NCI Memorandum of Understanding),either party maydecide 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 NCI request for the other agency informationmay contain confidential material, the request should be in writing, which includes an informal Email or 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 berequired for purposes of making a request. However, the following language should be included in the request.
Information that is shared underthis agreement will be under the FDA-NCI
Memorandum of Understanding. We agree not to disclose any shared information
.in any manner without your written permission oras 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 toa request should also be inwriting and canbe 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 is not required for purposes of responding to a request. However, the following language should be included in the response:                                                
Pursuant to the FDA-NCI Memorandum of 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 a particular format or include other pre-specified text.

AppendixA2--ModelLanguate for Information Sharing Request
MOU Control No. (Insert number)
This letter accompanies agency records shared by one party (information-sharing Party) with the other (requesting Party) in response to requesting Party's request, dated                  . These agency records may contain one or more of the following categories of nonpublic information, including information the disclosure of which may be prohibited bylaw (including, limited to trade secrets; confidential commercial or financial information,  information the disclosure of which would constitute a clearly unwarranted invasion of  personal privacy informationsubject to the Privacy Act; interagency or intra-agencyrecords which would not be available by law to a party other than an agency in litigation with the agency; records or information compiled for law · enforcement purposes; and information protected for national security reasons).
The requesting Party shall notify the appropriate office of the information-sharingagency 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.
The requesting· Party shall notify the information-sharingagency before complying with any judicial order that compels the release of such information that the Parties may take appropriate measures, including filing a motion with the court or an appeal.
Parties have agreed, by this letter or e-mail or by a signed request letter dated_____ not to publically disclose the above-described information without prior written permissionof the Parties to the extent permitted by applicable law, regulation, and policy. Both Parties acknowledge that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. Section 331(j); 5 U.S.C. Section 552; 5 U.S.C. Section 552a; 18 U.S.C. Section 1095; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b, and 42 U.S.C. Section 241(d).
Name                                                                           Date


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