MOU Number 225-19-012
MEMORANDUM OF UNDERSTANDING
BETWEEN
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FOOD AND DRUG ADMINISTRATION
AND
NATIONAL CANCER INSTITUTE
NATIONAL INSTITUTES OF HEALTH
I. Purpose
The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI), National Institutes of Health (NIH), are part of the Department of Health and Human Services, and hereinafter also referred to as “Federal partners” or "Parties." The purpose of the MOU is to promote collaboration and enhance knowledge and efficiency by providing for sharing of information and expertise between the Federal partners. This collaboration will focus on sharing information that will be used to develop new and improved approaches to evaluating cancer screening and diagnostic tools, with a focus on HPV-related cancer. This collaboration is intended to encourage efficiency and collaboration among and between FDA and NCI to promote and protect public health.
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, medical devices, the safety and security of foods, dietary supplements, cosmetics, and 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 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’s mission.
NCI, one of 27 institutes and centers of the NIH, is charged by Congress with leading the nation's efforts for the National 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, pursuant to Sections 410 and 411 of the Public Health Service Act [42 U.S.C. §§ 285, 285a].
III. Authority
FDA has authority to enter into this MOU pursuant to section 1003(b) and (c) of the
Federal Food, Drug, and Cosmetic Act.
NCI has authority to enter into this MOU pursuant to sections 301 and 405 of the Public Health Service Act (42 U.S.C. §§ 241, 284).
IV. Substance of the MOU
The Division of Microbiology Devices in the Office of In Vitro Diagnostics, Center for Device Evaluation and Radiological Health (CDRH) and the Division of Cancer Epidemiology and Genetics (DCEG), NCI, intend to collaborate on topics relating to cancer screening. This collaboration will focus on sharing information that will be used to develop new and improved approaches in evaluating cancer screening tools, with a focus on cervical cancer.
FDA/CDRH and NCI will act to:
A. Build a framework that meets common needs for considering issues relating to the safety, effectiveness and utilization of tools for cancer screening and diagnosis, particularly cervical cancer;
B. Enhance efforts to share information and expertise through inter-agency activities to increase each Agency’s own capability and readiness to respond to public health needs;
C. Develop effective strategies to identify and evaluate emerging scientific tools and technologies that will aid in cancer screening and diagnosis, particularly cervical cancer;
D. Share guidance and technical advice when complex scientific and/or regulatory issues of mutual concern come up, and
E. Increase scientific knowledge and understanding of screen-detectable cancers, e.g., cervical cancer, to ensure that public health decisions are based on the most current and robust scientific evidence.
V. Liaison Officers
A. Food and Drug Administration
Director, Division of Microbiology Devices
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
(301) 796-5456
Uwe.Scherf@fda.hhs.gov
B. National Cancer Institute
Mark Schiffman, M.D.
Senior Investigator, Division of Cancer Epidemiology and Genetics
National Cancer Institute
9609 Medical Center Drive
Rockville, MD 20850
(240) 276-7259
Schiffman@mail.nih.gov
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 liaisons.
VI. Data Sharing Guidelines
FDA and NCI agree that the following principles and procedures will govern the exchange of data and non-public information between the two agencies. Although there is no legal requirement that FDA and NCI exchange information in all cases, FDA and NCI agree that there should be a presumption in favor of full and free sharing of information between FDA and NCI. As public health agencies within Department of Health and Human Services (DHHS), there are no legal prohibitions that preclude FDA/CDRH or NCI from sharing with each other most information in the possession of either agency. Both Federal partners recognize and acknowledge, however, that all non-public information shared between FDA/CDRH and NCI, 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 and 552a; 21 U.S.C. § 331(j); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 45 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/CDRH and NCI with other applicable laws and regulations.
To facilitate the sharing of non-public information, FDA/CDRH and NCI expect to implement procedures to ensure that such sharing is appropriate and in accordance with applicable law, and that the recipient Federal partner will guard the confidentiality of all non-public information received. Both Federal partners are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and in accordance with applicable laws, regulations, and agency policy and practice. The Federal partner receiving shared non-public information (requesting Federal partner) will be responsible for protecting that information from any unauthorized disclosure. The provisions for sharing of non-public information in accordance with applicable laws, regulations, and agency policy and practice are set out below. Nothing in this Section VI prevents FDA or NCI from complying with either a legally valid and enforceable order of a court of the Unites States or an official request of the United States Congress, or any committee thereof.
The requesting Federal partner will comply with the following conditions:
a. The requesting Federal partner will limit the dissemination of shared nonpublic information it receives to internal Federal partner offices and/or individuals that have been identified in its written request. If the requesting Federal partner determines that individuals other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the sharing Federal partner before the requesting Federal partner distributes the information to those individuals. The Federal partner official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
b. The requesting Federal partner will agree in writing, by using the model request letter attached as Appendix A (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 Federal partner wishes to disclose shared information that the sharing Federal partner has designated as non-public, the requesting Federal partner will ask the sharing Federal partner whether the information's non-public status has changed, and if so, will first obtain written confirmation and permission from the sharing Federal partner before disclosing that information. If the requesting Federal partner receives a FOIA request for shared information, the requesting Federal partner will: (a) refer the FOIA request to the information-sharing contact person or designee for the sharing Federal partner to respond directly to the FOIA requester regarding the release of the information, and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing Federal partner. The requesting Federal partner will leave all final disclosure decisions up to the sharing Federal partner, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting Federal partner will not indicate to the FOIA requester whether the sharing Federal partner has responsive records or releasable records.
c. The sharing Federal partner 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 letter is attached in Appendix A. The shared documents containing non-public information should be stamped "Do not disclose without permission of [FDA or NCI]", with the name in the brackets being that of the sharing Federal partner.
d. The requesting Federal partner will promptly notify the contact person or designee of the sharing Federal partner 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, or litigation complaint or motion.
e. The requesting Federal partner will notify the sharing Federal partner before complying with any judicial order that compels the release of shared nonpublic information, so that the Federal partners may determine the appropriate measures to take, including, where appropriate, legal action.
VII. Resources
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 NCI. 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 between the Parties. This MOU and all associated agreements will be subject to the applicable laws, regulations, rules, and policies under which FDA and NCI operate.
VIII. Term, Termination and Modification
This MOU becomes effective upon the last signature and will remain in effect for 5 years, unless otherwise terminated. This MOU may be modified in writing by unanimous consent of the Parties and becomes effective when executed by both Parties. Either Party may terminate this MOU upon 60-days written notice to the other Party, or immediately upon written notice, if a Federal statute is enacted or a regulation is issued by a Federal partner that materially affects this MOU.
APPROVED AND ACCEPTED BY:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Jeffrey Shuren, M.D., J.D.
/s/
Director
4-2-2019
Date
APPROVED AND ACCEPTED BY:
NATIONAL CANCER INSTITUTE/DCEG
Stephen Chanock, M.D.
/s/
Director, Division of Cancer Epidemiology and Genetics
3-20-2019
Date
Appendix A:
Model Language for Information Request from NCI to FDA
Reference: MOU No. 225-19-012
The National Cancer Institute (NCI) has requested the following information from the FDA for the following purposes: [Identify information and purpose]
or
NCI hereby requests the following information from FDA for the following purposes
:
[Identify information and purpose]
NCI agrees that it will not publicly disclose any such information that FDA shares 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 NCI and FDA. Applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. sec. 331(j): 18 U.S.C. sec. 1905, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. sec. 241(d).
NCI will limit dissemination of any shared information to the following NCI offices and/or employees: [Identify office(s) and/or employee(s)]
Name
Date
Model Language for Information Request from FDA to NCI
Reference: MOU No. 225-19-012
The Food and Drug Administration (FDA) has requested the following information from the NCI for the following purposes: [Identify information and purpose]
or
FDA hereby requests the following information from NCI for the following purposes:
[Identify information and purpose]
FDA agrees that it will not publicly disclose any such information that NCI shares without prior written permission from NCI and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NCI and FDA. Applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. sec. 331(j): 18 U.S.C. sec.1905, 21 C.F.R .Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. sec. 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
Model Transmittal Letter from NCI to FDA
Reference: MOU No. 225-19-012
This letter accompanies agency records that the NCI 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;
[NCI 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 NCI 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 NCI before complying with any judicial order that compels the release of such information so that NCI and/or FDA 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 NCI. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. section 331(j); 18 U.S.C. section 1905, 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
Model Transmittal Letter from FDA to NCI
Reference: MOU No. 225-19-012
This letter accompanies agency records that the FDA is sharing with NCI in response to NCI'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;
___Information protected for national security reasons; or
___Other.
NCI shall notify the appropriate office of FDA 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. NCI shall notify FDA before complying with any judicial order that compels the release of such information so that FDA and/or NCI may take appropriate measures, including filing a motion with the court or an appeal. NCI 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. NCI acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. section 331(j); 18 U.S.C. section 1905, 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
018
AMENDMENT #1
MEMORANDUM OF UNDERSTANDING
BETWEEN
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FOOD AND DRUG ADMINISTARTION
(FDA MOU NO. 225-19-012)
AND
NATIONAL CANCER INSTITUTE
NATIONAL INSTITUTES OF HEALTH
(NCI REF. NO. 45956-19)
This Amendment (“Amendment”) is entered into and made effective as of April 2, 2024 (“Effective Date”). The purpose of this Amendment is to change certain terms of the above-referenced Memorandum of Understanding (MOU) between The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI), National Institutes of Health (NIH) dated April 2, 2019 (“Agreement”). These changes are reflected below and except for these changes all other provisions of the original Agreement remain in full force and effect.
The above-referenced Agreement shall be amended as follows where underlining denotes additions and strikeout denotes deletions relative to the executed Agreement:
1) The NCI Liaison Officer in Article V.B is hereby modified as follows to update the individual and contact information:
Nicolas Wentzensen, M.D., Ph.D., M.S. Mark Schiffman, M.D. Senior Investigator, Division of Cancer Epidemiology and Genetics National Cancer Institute 9609 Medical Center Drive Rockville, MD 20850 (240) 276-7303 (240) 276-7259 wentzenn@mail.nih.gov Schiffman@mail.nih.gov
2) The term of the Agreement is extended for five (5) years from the Effective Date of this Amendment.
3) The first paragraph in Section IV “Substance of the MOU” is modified as follows to update the FDA/CDRH’s division and office names:
The Division of Microbiology Devices in the Office of In Vitro Diagnostics Office of Health Technology-7 (OHT7) in the Office of Product Evaluation and Quality (OPEQ), Center for Devices Evaluation and Radiological Health (CDRH), and the Division of Cancer Epidemiology and Genetics (DCEG), NCI, intend to collaborate on topics relating to cancer screening. This collaboration will focus on sharing information that will be used to develop new and improved approaches in evaluating cancer screening tools, with a focus on cervical cancer.
4) The FDA Liaison Officer in Article V.A is hereby modified as follows to update the contact information:
Uwe Scherf, Ph.D.
Director, Division of Microbiology Devices
Office of Health Technology-7 (OHT7)
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
(301) 796-5456
Uwe.Scherf@fda.hhs.gov
ACCEPTED AND AGREED
FOR THE NATIONAL CANCER INSTITUTE/DCEG
/s/
Signature of Authorized Official
Stephen Chanock, M.D.
Director, Division of Cancer Epidemiology and Genetics
Date: 03/13/2024
FOR CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
/s/
Signature of Authorized Official
Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Date: 03/18/2024