About FDA

MOU 225-07-1000 Modification 3

MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
and the
NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE


I. PURPOSE

This Memorandum of Understanding (MOU) between the Food and Drug Administration/Center for Biologics Evaluation and Research (FDA/CBER) and the National Institutes of Health/ National Heart, Lung, and Blood Institute (NIH/NHLBI), 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/CBER and NIH/NHLBI 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 assuring 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, CBER's mission is to protect and enhance the public health through regulation of biological, device and combination products according to statutory authorities. 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. The NIH 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. The NHLBI, a component of the NIH, is the nation’s leading supporter of biomedical research on disorders of the heart, lung, and blood systems.  The mission of the NHLBI is to reduce the burden of disease in these areas. To achieve its mission of reducing the public health burden associated with heart, lung, and blood diseases, the NHLBI conducts, fosters, coordinates, and guides research on the causes, prevention, diagnosis, and treatment of heart, vascular, lung, blood, and sleep disorders, 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/CBER or NIH/NHLBI may have information that could be useful to the other party in that party's performance of its responsibilities. Timely sharing of information between NIH/NHLBI and FDA/CBER 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/CBER and NIH/NHLBI 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. In addition, each Party will designate central contact points [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/NHLBI's extramural, federally-funded translational research initiatives and programs, specifically those applicable to development of biologic therapies for the  treatment of heart, vascular, lung, blood, and sleep diseases, conditions and disorders.
5. Where appropriate, FDA/CBER will provide relevant reference documents that describe the investigational product review process and marketing approval processes for use by NIH/NHLBI staff involved in conferring with prospective translational research grantees to assist in the design and implementation of clinical studies that comply with FDA/CBER guidance and regulations.

6. FDA/CBER and NIH/NHLBI MOU parties will seek opportunities to work collaboratively together in order to improve efficiency of the submission and review process for clinical investigator applications requesting funding from NIH/NHLBI and require submission of an Investigational New Drug (IND) application to FDA/CBER.

7. Under this MOU, parties will promote communication and consultation on select policy issues and guidance documents of particular interest and relevance to researchers, consumers and/or health care professionals pertaining to novel cellular or gene transfer therapies. This cooperative interaction will target possible health risk posed to the public as well as address research and regulatory processes affecting the pace of bench top to bedside research translation. As an example, during drafting of policy documents such as FDA Guidance for Industry or NIH Points-to-Consider that apply to cellular/tissue-based or gene transfer therapies, each Party is encouraged to seek input from its counterpart in order that appropriate modifications to draft documents may be made prior to initiation of a formal clearance process.

8. NIH/NHLBI will invite FDA/CBER input and recommendations during development of Funding Opportunity Announcements targeting relevant, essential research areas in order to foster and support development of biologic tissue, cellular, and gene transfer products for treating heart, vascular, lung, blood, and sleep diseases, conditions and disorders.

9. As appropriate, FDA/CBER will invite participation of NIH/NHLBI experts in pre­ decisional evaluation of selected INDs that seek FDA/CBER permission to initiate clinical studies involving novel cellular/tissue and gene transfer products whose scientific and clinical aspects may be complex and non-conventional.

10. This MOU will provide opportunity for FDA/CBER staff to participate in NIH/NHLBI-sponsored conferences that pertain to development of cellular and gene transfer products.  FDA/CBER 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.

11. This MOU does not preclude NIH/NHLBI or FDA/CBER from entering into other agreements that may enable special programs to be handled more efficiently and expertly.

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

FDA/CBER and NIH/NHLBI 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/CBER and NIH/NHLBI 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/CBER and NIH/NHLBI.  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/CBER and NIH/NHLBI 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 5b, 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/CBER's and NIH/NHLBI's compliance with applicable laws and regulations.

To facilitate the sharing of non-public information, written or oral, FDA/CBER and NIH/NHLBI will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received [2] . 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 writing [3]  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/CBER and NIH/NHLBI, dated August 1, 2014.  [Requesting party] agrees not to disclose any non-public information shared between FDA/CBER and NIH/NHLBI 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.

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.  he 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. 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/CBER and NIH/NHLBI, dated August 1, 2014, 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 “Do not disclose or further distribute.”

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 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.

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

Food and Drug Administration
Center for Biologics Evaluation and Research
Building 71, Room 7301
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone:  (240) 402-8000

National Institutes of Health
National Heart, Lung, and Blood Institute
Building 31, Room 5A48
31 Center Drive MSC 2486
Bethesda, MD  20892-2486
Telephone: (301) 496-5166
Fax: (301) 402-0818

V. LIAISON OFFICERS

Liaison Officers will participate in the management, coordination and oversight of this agreement.  The Liaison Officers will constitute a Steering Committee comprised of an equal number of member representatives from the FDA/CBER and the NIH/NHLBI.  Two Liaison Officers, one designate from each participating agency, will serve as co-chairs of the Committee.

Member appointments shall be authorized by the signatories to this agreement. The Liaison Officer Steering Committee shall meet at least once every six months for the first year of this agreement and then once annually thereafter to review the progress of this agreement, resolve any issues and disputes that may arise and oversee necessary modifications to the agreement.

A. For Food and Drug Administration/Center for Biologics Evaluation and Research

Deborah Hursh, Ph.D.
Senior Investigator
Division of Cell and Gene Therapies
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Building 52/72, Room 3216
Silver Spring, MD 20993-0002
Telephone: 240-402-9597
E-mail: deborah.hursh@fda.hhs.gov

Melanie Eacho, Ph.D.
Chief, Cellular Therapy Branch
Division of Cell and Gene Therapies
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Building 71, Room 5326
Silver Spring, MD  20993-0002
Telephone:  301-796-0122
E-mail:  melanie.eacho@fda.hhs.gov

Shari Targum, M.D.
Chief, General Medicine Branch I
Division of Clinical Evaluation and Pharmacology/Toxicology
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Building 71, Room 5332
Silver Spring, MD  20993-0002
Telephone:  301-796-1151
E-mail:  shari.targum@fda.hhs.gov

Wei Liang, Ph.D.
Pharmacologist
Division of Clinical Evaluation and Pharmacology/Toxicology
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Building 71, Room 4260
Silver Spring, MD  20993-0002
Telephone:  240-402-8323
E-mail:  wei.liang@fda.hhs.gov
 

B.  For National Heart, Lung, and Blood Institute, National Institutes of Health

Yu-Chung Yang, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Rockledge II, Room 9164
Bethesda, MD  20892-7950
Telephone: (301) 435-0070
E-mail:  yu-chung.yang@nih.gov

Qing “Sara” Lin
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7952
Rockledge II, Room 10160
Bethesda, MD  20892-7952
Telephone: (301) 435-0222
E-mail:  sara.lin@nih.gov

Denis Buxton, Ph.D.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7940
Rockledge II, Room 8216
Bethesda, MD  20892-7940
Telephone: (301) 435-0515
E-mail:  buxtond@nhlbi.nih.gov

All other terms, conditions, and content of the MOU Number 225-07-1000, executed on September 11, 2008, remain unchanged, including that there are no fund transfers between these two groups.

VI. PERIOD OF AGREEMENT

This is an amendment to the Memorandum of Understanding (MOU) Number 225-07-1000 dated September 11, 2008 (the last modification was executed on July 23, 2014) to change by mutual agreement the liaisons for the Food and Drug Administration Liaisons and the National Heart, Lung, and Blood Institute and to change the termination date from September 10, 2018 to September 9, 2023.

 

SUMMARY OF ALL MODIFICATIONS

MODIFICATION 1

PURPOSE:

Present extension of five (5) years is added to the period of agreement, which has been extended twice previously, initially for a period of twelve (12) months and most recently for a period of five (5) years. Therefore, section VI. PERIOD OF AGREEMENT is modified to read as follows:

This agreement became effective on September 11, 2008, and shall continue in effect until September 10, 2018, as modified herein and pursuant to the attached summary of all modifications or terminated by either party upon a ninety (90) day advance written notice to the other party.

 

MODIFICATION 2

PURPOSE:

Previously, this agreement included an Implementation Work Plan as an appendix. Key elements of the Implementation Work Plan are now listed under section III.A. Coordination and Collaboration Relative to Public Health Activities.  The agreement no longer includes an Implementation Work Plan appendix.

 

MODIFICATION 3

PURPOSE:

This is an amendment to the Memorandum of Understanding (MOU) Number 225-07-1000 dated September 11, 2008 (the last modification was executed on July 23, 2014) to change by mutual agreement the liaisons for the Food and Drug Administration Liaisons and the National Heart, Lung, and Blood Institute and to change the termination date from September 10, 2018 to September 9, 2023.

These changes are permissible under article V. (Liaison Officers) and article VI. Period of Agreement for this MOU.

APPROVED AND ACCEPTED
FOOD AND DRUG ADMINISTRATION

By:  Peter Marks

Peter Marks, M.D., Ph.D.
Director
Center for Biologics Evaluation and Research
Food and Drug Administration

September 19, 2018

 

APPROVED AND ACCEPTED 
NATIONAL HEART, LUNG, BLOOD INSTITUTE

By:  Gary Gibbons, M.D.

Gary Gibbons, M.D.
Director
National Heart, Lung, and Blood Institute
National Institutes of Health

September 23, 2018

 

ATTACHMENTS:
Model Request Letter for FDA/CBER Model Request Letter for NIH/NHLBI
Model Transmittal Letter: NIH/NHLBI to FDA/CBER Model Transmittal Letter: FDA/CBER to NIH/NHLBI

 

ATTACHMENTS

Model Language for Request from FDA/CBER


The Food and Drug Administration/Center for Biologics Evaluation and Research (FDA/CBER) requests the following information from the National Institutes of Health, National Heart, Lung, and Blood Institute (NIH/NHLBI) for the following purposes:  [Identify information and purpose]

FDA/CBER agrees that it will not disclose any information that NIH/NHLBI shares with it and designates non-public without prior written permission from NIH/NHLBI and that FDA/CBER will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CBER and NIH/NHLBI dated [Insert date MOU between FDA/CBER and NIH/NHLBI initiated].  FDA/CBER 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 5b, and 42 U.S.C. § 241(d).

FDA/CBER will limit dissemination of any shared information to the following FDA/CBER 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/CBER official with requisite responsibility and authority.]

 

Model Language for Request from NIH/NHLBI

The National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI) requests the following information from the Food and Drug Administration/Center for Biologics Research and Review (FDA/CBER) that for the following purposes: [Identify information and purpose]

NIH/NHLBI agrees that it will not disclose any information that FDA/CBER shares with it and designates nonpublic without prior written permission from FDA/CBER and that NIH/NHLBI will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NHLBI and FDA/CBER dated __________ NIH/NHLBI 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 5b, and 42 U.S.C. § 241(d).

NIH/NHLBI will limit dissemination of any shared information to the following NIH/NHLBI offices and/or employees, unless it identifies additional NIH/NHLBI 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/NHLBI official with requisite responsibility and authority.]

  
Model Transmittal letter from NIH/NHLBI to FDA/CBER

 

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

By a signed request letter dated __________ FDA/CBER has agreed not to disclose the above- described shared non-public information without prior written permission of NIH/NHLBI. 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 5b, 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/CBER and NIH/NHLBI, dated __________.

 
Model Transmittal letter from FDA/CBER to NIH/NHLBI


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

By a signed request letter dated __________, NIH/NHLBI has agreed not to disclose the above-described shared non-public information without prior written permission of FDA/CBER. NIH/NHLBI 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 5b, and 42 U.S.C. § 241(d).  NIH/NHLBI has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information between FDA/CBER and NIH/NHLBI, dated __________.

 


[1] See section V. of this MOU.

[2] 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.

[3] The term “writing” used throughout this MOU includes a writing by electronic means.

Page Last Updated: 11/13/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English