MOU 225-24-018
MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH/ CENTER FOR BIOLOGICS EVALUATION AND RESEARCH/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
and the
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON AGING
I. PURPOSE
This Memorandum of Understanding (MOU) between the Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research/Center for Devices and Radiological Health (FDA/CDER/CBER/CDRH) and the National Institutes of Health/National Institute on Aging (NIH/NIA), each Party and collectively the Parties, provides a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CDER/CBER/CDRH and NIH/NIA units shall take place.
II. BACKGROUND
FDA and NIH are sister agencies within the Department of Health and Human Services. Both FDA and NIH exist and work to protect the public health but have different statutory mandates and responsibilities.
FDA is a science-based regulatory agency authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301, et seq.), as well as certain other statutory authorities. In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. 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. Within FDA, CDER and CBER's mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. The regulation of these products is founded on science and law to ensure their purity, potency, safety, and efficacy. The mission of the CDRH is to protect and promote the public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
NIH is the federal focal point for biomedical research in the United States and is established pursuant to Title IV of the Public Health Service Act (PHSA), 42 U.S.C. §§ 401 et. seq. NIH's mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by conducting research in its own laboratories; supporting the research of scientists in universities, medical schools, hospitals and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of medical information. Within NIH, NIA conducts and supports genetic, biological, behavioral, social, and economical research on aging and the challenges and needs of older adults. NIA is established pursuant to section 443 of the PHSA, 42 U.S.C. §§ 285e et. seq. NIA is at the forefront of scientific discovery about the nature of healthy aging to extend the healthy, active years of life. It is also the lead federal agency for Alzheimer’s disease and related dementias research. NIH's and FDA's respective missions to protect the public health are complementary and may overlap depending upon the subject matter. The agencies work collaboratively to protect and improve public health. Sometimes FDA/CDER/CBER/CDRH or NIH/NIA may have information that could be useful to the other unit in that unit's performance of its responsibilities.
Timely sharing of information between NIH/NIA and FDA/CDER/CBER/CDRH is therefore critical to protect and improve the public health.
III. SUBSTANCE OF AGREEMENT AND RESPONSIBILITIES OF EACH AGENCY
A. Coordination and Collaboration Relative to Public Health Activities
It is mutually agreed that, subject to compliance with applicable laws, regulations, policies and privileges, on an as-needed basis and as resources permit:
1. FDA/CDER/CBER/CDRH and NIH/NIA will coordinate and collaborate with each other to protect and improve the public health. To achieve this, each Party will capitalize on the expertise, resources, and relationships of the other in order to increase its own capability and readiness to respond to situations of mutual interest. In addition, each Party will designate liaison officers 1 to coordinate communications from the other, dealing with matters covered by this agreement.
2. Each Party will participate in periodic 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.
3. Each Party may notify the other when issues of mutual concern become evident to the extent such notification does not interfere with the public health, oversight, enforcement, or compliance responsibilities of the notifying agency.
4. Upon request, parties will present reciprocal in-house presentations to their corresponding staff on topics of common interest such as FDA's managed regulatory review process and NIH/NIA's extramural, federally-funded translational research initiatives and programs, including those applicable to development of medical products intended for the prevention, treatment or diagnosis of Alzheimer’s disease and related dementias, and other age-related diseases. Non-Federal employee staff under appropriate confidentiality terms, such as contractors can be included in these meetings.
5. Where appropriate, FDA/CDER/CBER/CDRH will provide relevant reference documents that describe the investigational product review process and marketing approval processes for internal use by NIH/NIA staff involved in conferring with prospective translational research grantees to assist in the design and implementation of clinical studies that comply with FDA/CDER/CBER/CDRH guidance and regulations.
6. FDA/CDER/CBER/CDRH and NIH/NIA will seek mutually beneficial opportunities to work collaboratively in order to improve efficiency regarding the submission and review process for clinical investigator applications requesting funding from NIH/NIA where the anticipated clinical study contemplates the submission of an Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) application to FDA/CDER/CBER/CDRH by sharing publicly available information about the submission and review process. NIA is not the sponsor for such applications but often provides advice to potential outside sponsors.
7. Under this MOU, FDA/CDER/CBER/CDRH and NIH/NIA will promote communication and consultation on policy issues and guidance documents of particular interest and relevance to researchers, consumers and/or health care professionals pertaining to small molecules, biologics, and medical devices. This cooperative interaction will target possible public health risk posed to the public as well as address research and regulatory processes affecting the pace of bench top to bedside research translation.
8. As appropriate, NIH/NIA will invite FDA/CDER/CBER/CDRH input and recommendations during development of Funding Opportunity Announcements targeting relevant, essential research areas in order to foster and support development of small molecules, biologics, and medical devices, for prevention, treatment or diagnosis of Alzheimer’s disease and related dementias, and other age-related diseases.
9. As appropriate, and in accordance with applicable conflict of interest laws, regulations, and policies, NIH/NIA experts may, at the request of sponsors, participate in discussions about potential or planned medical product investigations (e.g., INDs, IDEs) that seek FDA/CDER/CBER/CDRH feedback about or permission to initiate clinical studies involving novel small molecules, biologics, and medical devices including for preventing, treating or diagnosing of neurologic and other age-related conditions whose scientific and clinical aspects may be complex and non-conventional. Any such participation must be pursuant to appropriate confidentiality agreements between NIH/NIA and FDA/CDER/CBER/CDRH under 21 C.F.R. § 20.85.2. Such participation by NIH/NIA may occur only if NIH/NIA is not a sponsor nor acts as a representative of the drug, biologic or medical device sponsor.
10. This MOU will provide opportunity for FDA/CDER/CBER/CDRH staff to participate in NIH/NIA’s- sponsored conferences that pertain to development of small molecules, biologics, and medical devices including for prevention, treatment, or diagnosis of Alzheimer’s disease and related dementias, and other age-related diseases. FDA/CDER/CBER/CDRH contributions may include: (1) participation in workshops, (2) individual presentations, (3) use of existing videotaped FDA conferences/workshops on selected regulatory policy and process issues.
B. Restrictions on Coordination
This MOU does not preclude NIH/NIA or FDA/CDER/CBER/CDRH from entering into other agreements that may enable special programs to be handled more efficiently and expertly.
This MOU does not in any way modify the relationship between the parties or change the interactions when the NIH/NIA is filing formal regulatory documents. The NIH/NIA is subject to the laws, rules, and guidelines that govern IND, IDE, NDA, BLA, PMA, De Novo requests, CLIA waivers, accessory classification request, HDE, and 510(k) filings.
C. Principles and Procedures for the Sharing of Non-Public Information
FDA/CDER/CBER/CDRH and NIH/NIA agree that the following principles and procedures will govern the sharing of non-public information, as resources permit, between the two parties.
Although there is no legal requirement that FDA/CDER/CBER/CDRH and NIH/NIA exchange information in all areas, the parties agree that there should be a presumption in favor of full and free sharing of information between FDA/CDER/CBER/CDRH and NIH/NIA that will further their missions. As public health agencies within the Department of Health and Human Services, there are no legal prohibitions that preclude FDA or the NIH from sharing with each other most information in the possession of either agency. Both parties recognize and acknowledge, however, that it is essential that any non-public information that is shared between FDA/CDER/CBER/CDRH and NIH/NIA whether written or oral must be protected from any disclosure that is not authorized by law or regulation. See e.g., 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and Sb, and 42 U.S.C. § 241(d). Safeguards are needed to protect non-public information shared, both written and oral, 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 FDA/CDER/CBER/CDRH's and NIH/NIA's compliance with applicable laws and regulations.
To facilitate the sharing of non-public information, written or oral, FDA/CDER/CBER/CDRH and NIH/NIA will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information receivedi3. 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 or agency policy and practice. The party receiving shared non-public information (requesting party), whether written or oral, will be responsible for protecting that information from any unauthorized disclosure. Provisions for sharing of non-public information, both written and oral, in accordance with applicable statutes or regulations are set out below:
1. The requesting party must specify, in writing4, the information requested (to facilitate identification of relevant information), provide a brief statement of why the information is needed, and include the following requesting party template language: "This request is made pursuant to the Memorandum of Understanding for Sharing of Non-Public Information between FDA/CDER/CBER/CDRH and NIH/NIA, dated [insert date agreement was signed]. [Requesting party] agrees not to disclose any non-public information shared between FDA/CDER/CBER/CDRH and NIH/NIA whether orally or in writing, in any manner." This request shall state which internal unit offices and/or individuals are requesting the information.
2. The party receiving the request (sharing party) will determine, based upon the request described in section III.B. l above, whether it is appropriate and practicable to share the requested non-public information. The sharing party will include a response in writing along with any agency information shared. The response will indicate the type of information (e.g., confidential commercial information, personal privacy, pre- decisional, etc.), and will include the following sharing party template language: "Pursuant to the Memorandum of Understanding for Sharing of Non-Public Information between the FDA/CDER/CBER/CDRH and NIH/NIA, dated [insert date agreement was signed], the non-public information provided in this communication may not be disclosed or shared in any manner unless required by law." Any shared documents containing non-public information should be stamped or otherwise denoted "Do not disclose or further distribute. "
3. The requesting party will comply with the following conditions:
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 and/or have a need to know. The unit official who signs the request letter shall be responsible for ensuring information is not distributed to inappropriate recipients.
b. The requesting party will agree in writing not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings, or in the context of other agency collaborations. If the requesting party wishes to disclose shared information that the sharing unit 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 form the sharing party before disclosing that information. If the requesting party receives a Freedom of Information Act (FOIA) request for the shared information, it shall: (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 releasability 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.
c. Any Partner to this MOU shall promptly notify the other Party if there is any attempt by a third party, including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion. The Parties shall consult before complying with any request to obtain shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.
IV. NAME AND ADDRESS OF PARTICIPATING PARTIES
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Building 51, Room
Silver Spring, MD 20993
Fax: (301) 827-0440
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Building 71
Silver Spring, MD 20993
Telephone: 800 835-4709 or (240) 402-8010
Food and Drug Administration
Center for Devices and Radiologic Health
10903 New Hampshire Avenue
Building 66, Room 5614
Silver Spring, MD 20993
Telephone: (301)- 796-5900
National Institutes of Health
National Institute of Aging
31 Center Drive MSC 2450
Bethesda, MD 20892-2540
V. LIAISON OFFICERS
Liaison Officers will participate in the management, coordination and oversight of this agreement.
A. For FDA/CDER
Jacqueline Corrigan-Curay, J.D. M.D.
Principal Deputy Center Director
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue WO51/Rm6420
Silver Spring, MD 20993 Telephone: 240-402-0535
E-Mail: Jacqueline.Corrigan-Curay@fda.hhs.gov
For FDA/CBER
Julia C. Tierney, JD
Deputy Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
10903 New Hampshire Avenue, WO71
Silver Spring, MD 20993 Telephone: 240-402-8000
Julia.Tierney@fda.hhs.gov
For FDA/CDRH
Suzanne B. Schwartz, MD, MBA
Office Director - Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue WO66, Room 5410
Silver Spring, MD 20993, Telephone: 301-796-6937
Suzanne.Schwartz@fda.hhs.gov
B. For NIH/NIA
Primary contact:
Suzana S. Petanceska, PhD
Director, Office for Strategic Development and Partnerships
Division of Neuroscience
National Institute on Aging
Phone: 301-594-7754
Alternate:
Laurie M. Ryan, PhD
Chief, Clinical Interventions and Diagnostics Branch
Division of Neuroscience
National Institute on Aging
Phone: 301-594-7572
VI. PERIOD OF AGREEMENT
This agreement is effective on June 27, 2024, and shall remain in effect for five years unless modified or terminated by either party upon a ninety (90) day advance written notice to the other party.
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
/s/
Jacqueline Corrigan-Curay J.D., M.D.
Principal Deputy Center Director
Center for Drug Evaluation and Research
Food and Drug Administration
Date: June 27, 2024
Center for Biologics Evaluation and Research
/s/
Julia C. Tierney, JD
Deputy Director
Center for Biologics Evaluation and Research
Food and Drug Administration
Date: June 27, 2024
Center for Devices and Radiologic Health
/s/
Jeffrey Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Date: June 27, 2024
1 See section V. of this MOU.
2 Further guidance on completing confidentiality agreements (including sample letters or memorandum) can be found in the CDER Manual for Policies and Procedures on Sharing Nonpublic Information with Federal Government Officials (MAPP 4112.2) available at (PDF 199 KB) technologies being discussed.
3 Each party has implemented or will implement the agency’s data and information security statutory, regulatory, policy, or procedural requirements and has implemented or will implement, to the extent necessary and practicable, all data and information security recommendations suggested by the other agency.
4 The term ‘·’writing” used throughout this MOU includes writing by electronic means.
ATTACHMENTS:
Model Request Letter for FDA/CDER/CBER/CDRH Model Request Letter for NIH/NIA
Model Transmittal Letter: NIH/NIA to FDA/CDER
Model Transmittal Letter: FDA/CDER/CBER/CDRH to NIH/NIA
ATTACHMENTS
Model Language for Request from FDA/[CDER/CBER/CDRH]
The Food and Drug Administration/Center for [Drug Evaluation and Research/Biologics Evaluation and Research/ Devices and Radiologic Health (FDA/[CDER/CBER/CDRH]) requests the following information from the National Institutes of Health, National Institute of Aging (NIH/NIA) for the following purposes: [Identify information and purpose}
FDA/CDER agrees that it will not disclose any information that NIH/NIA shares with it and designates non-public without prior written permission from NIH/NIA and that FDA/[CDER/CBER/CDRH] will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/[CDER/CBER/CDRH] and NIH/NIA dated [Insert date MOU between FDA/[CDER/CBER/CDRH] and NIH/NIA initiated]. FDA/[CDER/CBER/CDRH] acknowledges that applicable laws and regulations may govern the disclosure of such information. See e.g., 21 U.S.C. § 331(j), 18
U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and Sb, and 42 U.S.C. § 241(d).
FDA/CDER will limit dissemination of any shared information to the following FDA/[CDER/CBER/CDRH] offices and/or employees, unless it identifies additional FDA/[CDER/CBER/CDRH] employees who have a need to know the non-public information: [Identify office(s) and/or employee(s)]
Name Date
[Signature and Date by FDA/[CDER/CBER/CDRH] official with requisite responsibility and authority.]
Model Language for Request from NIH/NIA
The National Institutes of Health/National Institute on Aging (NIH/NIA) requests the following information from the Food and Drug Administration/Center for [Drug Evaluation and Research/Biologics Evaluation and Research/ Devices and Radiologic Health] (FDA/[CDER/CBER/CDRH]) that for the following purposes: {Identify information and purpose/
NIH/NIA agrees that it will not disclose any information that FDA/[CDER/CBER/CDRH] shares with it and designates nonpublic without prior written permission from FDA/[CDER/CBER/CDRH] unless required by law to do so and that NIH/NIA will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NIA and FDA/[CDER/CBER/CDRH] dated In the event disclosure is required by law, the disclosing party shall consult with the sharing party prior to such disclosure to the extent practicable. NIH/NIA acknowledges that applicable laws and regulations may govern the disclosure of such information. See e.g., 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and Sb, and 42 U.S.C. § 241(d).
NIH/NIA will limit dissemination of any shared information to the following NIH/NIA offices and/or employees, unless it identifies additional NIH/NIA employees who have a need to know the non-public information: {Identify office(s) and/or employee(s)}
Name Date
[Signature and Date by NIH/NIA official with requisite responsibility and authority.]
Model Transmittal letter from NIH/NIA to FDA/[CDER/CBER/CDRH]
This letter accompanies information that the National Institutes of Health/National Institute on Aging (NIH/NIA) is sharing with the Food and Drug Administration/ [Center for Drug Evaluation and Research/Biologics Evaluation and Research/ Devices and Radiologic Health] (FDA/[CDER/CBER/CDRH]) in response to FDA/[CDER's/CBER’s/CDRH’s] request, dated [ ] . This information contains one or more of the following categories of non-public information, including information the disclosure of which may be prohibited by law:
[NIH/NIA checks applicable numbers below}
_ confidential research proposals, progress reports, and/or unpublished data;
_ privileged or pre-decisional agency information; trade secrets; confidential commercial or financial information;
_ information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
_ information contained in records subject to the Privacy Act;
_ information contained in the inter-agency or intra-agency memoranda;
_ records or information compiled for law enforcement purposes;
_ information protected for national security reasons; or
_ other (explain).
FDA/[CDER/CBER/CDRH] shall notify the contact person or designee of NIH/NIA if there are any attempts to obtain such shared non-public information by compulsory process, including, but not limited to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.
FDA/[CDER/CBER/CDRH] shall notify NIH/NIA before complying with any judicial order that compels the release of such shared non-public information so that FDA/[CDER/CBER/CDRH] and/or NIH/NIA may take appropriate measures, including filing a motion with the court or an appeal.
By a signed request letter dated _, FDA/[CDER/CBER/CDRH] has agreed not to disclose the above- described shared non-public information without prior written permission of NIH/NIA. FDA/[CDER/CBER/CDRH] has acknowledged that applicable laws and regulations may govern the disclosure of such information. See e.g., 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and Sb, and 42 U.S.C. § 241(d).
FDA/[CDER/CBER/CDRH] has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/[CDER/CBER/CDRH] and NIH/NIA, dated - - - - - - - -
Model Transmittal letter from FDA/[CDER/CBER/CDRH] to NIH/NIA
This letter accompanies information that the Food and Drug Administration/Center for [Drug Evaluation and Research/Biologics Evaluation and Research/ Devices and Radiologic Health] (FDA/[CDER/CBER/CDRH]) is sharing with the National Institutes of Health/National Institute for Aging (NIH/NIA) in response to
NIH/NIA's request, dated [ ] . This information contains one or more of the following categories of non-public information, including information the disclosure of which may be prohibited by law:
[FDA/[CDER/CBER/CDRH] checks applicable numbers below/
_ trade secrets;
_ confidential commercial or financial information;
_ information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
_ information contained in records subject to the Privacy Act; information contained in inter-agency or intra-agency memoranda; records or information compiled for law enforcement purposes; information protected for national security reasons; or
_ other (explain).
NIH/NIA shall notify the contact person or designee of FDA [/CDER /CBER/CDRH] if there are any attempts to obtain such shared non-public information by compulsory process, including, but not limited to, Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.
NIH/NIA shall notify FDA/[CDER/CBER/CDRH] before complying with any judicial order that compels the release of such shared non-public information, so that FDA/[CDER/CBER/CDRH] /CDBER and/or NIH/NIA may take appropriate measures, including filing a motion with the court or an appeal.
By a signed request letter dated , NIH/NIA has agreed not to disclose the
above-described shared non-public information without prior written permission of FDA/[CDER/CBER/CDRH] unless required by law. NIH/NIA has acknowledged that applicable laws and regulations may govern the disclosure of such information. See e.g., 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and Sb, and 42 U.S.C. § 241(d). NIH/NIA has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information between FDA/[CDER/CBER/CDRH] and NIH/NIA, dated - - - - - - - - - -