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  1. FDA Memoranda of Understanding

MOU 225-19-027

MOU 225-19-027

MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH
and the
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

I. PURPOSE

This Memorandum of Understanding (MOU) between the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CD ER) and the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS), each a 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 and NIH/NINDS 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.). 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'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.

NIH is the federal focal point for biomedical research in the United States. 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 non-Federal 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, NINDS is the nation's leading supporter of biomedical research on disorders of the brain and nervous system. The mission of NINDS is to reduce the burden of neurological disease. To achieve this mission, NINDS conducts, fosters, coordinates and guides research on the causes, prevention, diagnosis and treatment of neurological disorders and stroke, including basic research in related scientific areas. 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 or NIH/NINDS 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/NINDS and FDA/CDER 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, on an as-needed basis and as resources permit:

1. FDA/CDER and NIH/NINDS 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. 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/NINDS's extramural, federally-funded translational research initiatives and programs, including those applicable to development of prescription drugs and therapies (small molecules, biologics, devices and natural products) intended for the prevention, treatment or diagnosis of acute or chronic pain and related comorbidities. Non-Federal employee staff under appropriate confidentiality terms, such as contractors and volunteers, can be included in these meetings.

5. Where appropriate, FDA/CDER will provide relevant reference documents that describe the investigational product review process and marketing approval processes for use by NIH/NINDS staff involved in conferring with prospective translational research grantees to assist in the design and implementation of clinical studies that comply with FDA/CDER guidance and regulations.

6. FDA/CDER and NIH/NINDS will seek opportunities to work collaboratively in order to improve efficiency regarding the submission and review process for clinical investigator applications requesting funding from NIH/NINDS where the anticipated clinical study contemplates the submission of an Investigational New Drug (IND) application to FDA/CDER by sharing publicly available information about the submission and review process. NINDS is not the sponsor for such INDs but often provides advice to potential outside sponsors.

7. Under this MOU, FDA/CDER and NIH/NINDS 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, devices and natural products therapies. 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/NINDS will invite FDA/CDER 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, devices and natural products for prevention, treatment or diagnosis of pain conditions and comorbidities.

9. As appropriate, and in accordance with applicable conflict of interest laws, regulations, and policies, NIH/NINDS experts may, at the request of sponsors, participate in discussions of INDs that seek FDA/CDER permission to initiate clinical studies involving novel small molecules, biologics, devices and natural products including for preventing, treating or diagnosing of pain conditions whose scientific and clinical aspects may be complex and non-conventional. Any such participation must be pursuant to appropriate confidentiality agreements between NIH/NINDS and FDA/CDER under 21 C.F.R. § 20.85.2  Such participation by NIH/NINDS may occur only if NIH/NINDS is not a sponsor nor acts as a representative of the drugs or

10. This MOU will provide opportunity for FDA/CDER staff to participate in NIH/NINOS-sponsored conferences that pertain to development of small molecules, biologics, devices and natural products including for prevention, treatment, or diagnosis of pain conditions and comorbidities. FDA/CDER 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/NINDS or FOA/COER 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/NINDS is filing formal regulatory documents. The NIH/NINDS is subject to the laws, rules, and guidelines that govern IND, NOA, and BLA filings.

C. Principles and Procedures for the Sharing of Non-Public Information

FOA/CDER and NIH/NINOS 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 and NIH/NINOS 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 and NIH/NINDS. 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 and NIH/NINOS 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's and NIH/NINDS's compliance with applicable laws and regulations.

To facilitate the sharing of non-public information, written or oral, FOA/CDER and NIH/NINDS will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received.3 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 and NIH/NINDS, dated [insert date agreement was signed]. [Requesting party] agrees not to disclose any non-public information shared between FDA/CDER and NIH/NINDS 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 and NIH/NINDS, dated [insert date agreement was signed], the non-public information provided in this communication may not be disclosed or shared in any manner." 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. 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, or litigation complaint or motion.

d. The requesting party will promptly 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.

e. Nothing in this section prevents a party from complying with either a legally valid and enforceable order of a court of the United States or an official request of the United States Congress, or any committee thereof

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

Food and Drug Administration
Center for Drug Evaluation and Research 1401 Rockville Pike, Ste 200N
Mail Code: HFM-1 Rockville, MD 20852-1448
Telephone: (301) 827-0372
Fax: (301) 827-0440

National Institutes of Health
National Institute of Neurological Disorders and Stroke Building 31, Room 8A52
31 Center Drive MSC 2450
Bethesda, MD 20892-2540
Telephone:  (301) 496-3167
Fax: (301) 496-0296

V. LIAISON OFFICERS

Liaison Officers will participate in the management, coordination and oversight of this agreement.

A. For FDA/CDER

Patrizia Cavazzoni, M.D.
Deputy Center Director for Operations Center for Drug Evaluation and Research US Food and Drug Administration 10903 New Hampshire Avenue WO51/Rm6118
Silver Spring, MD 20993 Telephone: 240-402-3743
E-Mail: Patrizia.Cavazzoni@fda.hhs.gov

B. For NIH/NINOS

Charles L, Cywin, Ph.D.
Program Director, Division of Translational Research National Institute of Neurological Disorders and Stroke National Institutes of Health
Neuroscience Center, 6001 Executive Blvd., Room 2138 Bethesda, MD 20892
Telephone: (301) 496-5701 Email: charles.cywin@nih.gov

Amir Tamiz, Ph.D. (Alternate)
Director, Division of Translational Research
National Institute of Neurological Disorders and Stroke National Institutes of Health
Neuroscience Center, 6001 Executive Blvd., Room 2137 Bethesda, MD 20892
Telephone: (301) 402-0760 Email: amir.tamiz@nih.gov

VI. PERIOD OF AGREEMENT

This agreement is effective on August 1, 2019, and shall remain in effect until modified or terminated by either party upon a ninety (90) day advance written notice to the other party.


APPROVED AND ACCEPTED FOR NATIONAL INSTITUTES OF HEALTH
National Institute of Neurological Disorders and Stroke

/S/
Walter Koroshetz, M.D.
Director
National Institute of Neurological Disorders and Stroke
National Institutes of Health

Date: 7/30/2019


APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research

/S/
Patrizia Cavazzoni, M.D.
Deputy Center Director for Operations
Center for Drug Evaluation and Research
Food and Drug Administration

Date: 8/01/2019


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: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM073028.pdf 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
Model Request Letter for NIH/NINDS
Model Transmittal Letter: NIH/NINDS to FDA/CDER
Model Transmittal Letter: FDA/CDER to NIH/NINDS


ATTACHMENTS

Model Language for Request from FDA/CDER


The Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER) requests the following information from the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/NINDS) for the following purposes: [Identify information and purpose}

FDA/CDER agrees that it will not disclose any information that NIH/NINDS shares with it and designates non-public without prior written permission from NIH/NINDS and that FDA/CDER will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CDER and NIH/NINDS dated [Insert date MOU between FDAICDER and NIHININDS initiated}. FDAICDER 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 offices and/or employees, unless it identifies additional FDA/CBER 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 official with requisite responsibility and authority.]

Model Language for Request from NIH/NINDS

The National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINOS) requests the following information from the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER) that for the following purposes: {Identify information and purpose/

IH/NIND agrees that it will not disclose any information that FDA/CDER shares with it and designates nonpublic without prior written permission  from  FDA/CD  Rand that NIH/NINOS will comply with the principles and procedures set forth in the Memorandum  of  Understanding on information  sharing between  NIH/NINOS  and FDA/CDER dated  _ NIH/NINOS 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). 

IH/NI OS will limit dissemination of any shared information to the following NIH/NINOS offices and/or employees, unless it identifies additional NIH/NINOS employees who have a need to know the non-public information: {Identify office(s) and/or employee(s)J


Name Date

[Signature and Date by NIH/NINOS official with requisite responsibility and authority.]

Model Transmittal letter from NIH/NINDS to FDA/CDER

This letter accompanies information that the National Institutes of Health/National Institute for Neurological Disorders and Stroke (NIH/NINDS) is sharing with the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER) in response to FDA/CDER'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:

[NIHININDS 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 shall notify the contact person or designee of NIH/NINDS 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 shall notify NIH/NINDS before complying with any judicial order that compels the release of such shared non-public information so that FDA/CDER and/or NIH/NINDS may take appropriate measures, including filing a motion with the court or an appeal.

By a signed request letter dated  _, FDA/CDER has agreed not to disclose the above- described shared non-public information without prior written permission of NIH/NINDS. FDA/CBER 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/CBER has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CDER and NIH/NINDS, dated -      - - - - - - - 

Model Transmittal letter from FDA/CDER to NIH/NINOS

This letter accompanies information that the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER) is sharing with the National Institutes of Health/National Institute for Neurological Disorders and Stroke (NIH/NINDS) in response to
NIH/NINDS'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 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/NINDS shall notify the contact person or designee of FDA/CDER 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/NINDS shall notify FDA/CDER before complying with any judicial order that compels the release of such shared non-public information, so that FDA/CBER and/or NIH/NINDS may take appropriate measures, including filing a motion with the court or an appeal.

By a signed request letter dated _ _ _ _ _ , NIH/NINDS has agreed not to disclose the
above-described shared non-public information without prior written permission of FDA/CDER. NIH/NINDS 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/NINDS has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information between FDA/CDER and NIH/NINDS, dated - - - - - - - - - -