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MOU 225-13-0009

MEMORANDUM OF UNDERSTANDING Between the
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
and 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 Biologics Evaluation and Research (FDA/CBER) 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/CBER 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 assuring the safety, efficacy,and security of drugs, veterinary products, medical device 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. 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. Within NIH, NINDS is the nation's leading supporter of biomedical research on disorders of the brain and nervous system. The mission of NINDSis 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 FDNCBERor 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 FDNCBERis 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.  FDNCBERand 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. In addition, each Party will designate central contact points1to 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, specifically those applicable to development of biologic therapies for treatment of neurologic diseases, conditions and disorders.
 
5.  Where appropriate, FDA/CBER willprovide 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/CBER guidance and regulations.
 
1See section V. of this MOU.
 
6.  FDA/CBER and NIH/NINDS 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/NINDS 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/NINDS 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 neurologic disease.
 
9.  As appropriate, FDA/CBER will invite participation of NIH/NINDSexperts 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/NINDS-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/NINDS 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/NINDS 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/NINDS 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/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 isshared between FDA/CBER and NIH/NINDS whether written or oral must be protected from any disclosure that is not authorized by law or regulation. See: 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/NINDS's compliance with applicable laws and regulations.
 
To facilitate the sharing of non-public information, written or oral, FDA/CBER 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. 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 writing3 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/NINDS, dated [insert date]
 
 
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 necessaryand practicable, all data and information security recommendations suggested by the other agency.
 
3The term "writing" used throughout this MOU includes a writing by electronic means agreement was signed]. [Requesting party] agrees not to disclose any non-public information shared between FDNCBERand 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 therequested 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. 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 thesharing unit has designated as non-public, the requesting party will ask the sharing party whether the information'snon-public status has changed, and if so, will first obtain written confirmation and permission form the sharing party before disclosing that information. If therequesting 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 releaseability of the information, and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing party. The requesting party will leave all final disclosure decisions up to the sharing party, including decisions on whether the records are responsive and whether they must be disclosed. According, the requesting 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-PublicInformation between the FDNCBER andNIH/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 "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 PARTICIPATINGPARTIES
 
Food and Drug Administration
Center for Biologics 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 NeurologicalDisorders 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. The Liaison Officers will constitute a Steering Committee comprised of an equal number of member representatives from the FDNCBERand the NIH/NINDS. 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 FDA/CBER
 
Kimberly Benton, Ph.D.
Deputy Director, Division of Cell and Gene Therapy Office of Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research
US Food and Drug Administration
1401 Rockville Pike, Ste 200N Mail Code:  HFM-720
Rockville, MD 20852-1448
Telephone:  (301) 827-5102
Fax:  (301) 827-9796
 
Mercedes Serabian, M.S.
Chief, Pharmacology/Toxicology Review Branch
Division of Clinical Evaluation and Pharmacology/Toxicology
Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research US Food and Drug Administration
1401 Rockville Pike, Ste 200N Mail Code:  HFM-760
Rockville, MD 20852-1448
Telephone:  (301) 827-6536
Fax:  (301) 827-9796
 
Donald W. Fink, Jr., Ph.D. Cell Therapy Review Branch Division of Cell and Gene Therapy
Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research US Food and Drug Administration
1401 Rockville Pike, Ste 200N Mail Code:  HFM-715
Rockville, MD 20852-1448
Telephone:  (301) 827-5153
Fax:  (301) 827-9796
 
B.  For NIH/NINDS
 
Rajesh Ranganathan, Ph.D.
Director, Office 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) 496-1751
 
Robert Zalutsky, Ph.D.
Office of Science Policy and Planning
National Institute of NeurologicalDisorders and Stroke
National Institutes of Health
Building 31, Room 8A03
Bethesda, MD 20892
Telephone:  (301) 496-9271
Fax:  (301) 480-9172
 
Linda McGavem, Ph.D.
Project Manager, Office of Translational Research National Institute of NeurologicalDisorders and Stroke National Institutes of Health
Neuroscience Center, 6001 Executive Blvd., Room 2118
Bethesda, MD 20892
Telephone:  (301) 435-4909
 
VI.          PERIOD OF AGREEMENT
 
This agreement became effective on February 12, 2002, and shall continue in effect until February 11, 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. Not later than 120 days prior to the expiration of this agreement, each Party will provide a recommendation regarding the extension of the agreement, including modifications if any.
 
 
SUMMARY OF ALL MODIFICATIONS
 
PURPOSE:

MODIFICATION 1
 
An extension of twelve (12) months is added to the period of agreement; therefore, section VI. PERIOD OF AGREEMENT is modified to read as follows:
 
This agreement became effective on February 12, 2002,and shall continue in effect until February 11, 2008, unless modified by mutual written consent of both parties or terminated by either party upon a ninety (90) day advance written notice to the other party.
 
MODIFICATION 2
 
PURPOSE:
 
An extension of five (5) years is added to the period of agreement which has been extended once previously for a period of twelve (12) months. Therefore, section
 
VI. PERIOD OF AGREEMENTis modified to read as follows:
 
This agreement became effective on February 12, 2002, and as of this Modification 2, shall continue in effect until February 11, 2013, unless modified by mutual written consent of both parties or terminated by either party upon a ninety (90) day advance written notice to the other party.
 
MODIFICATION 3
 
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 February 12, 2002, and shall continue in effect until February 11, 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.
 
Previously, this agreement included an Implementation Work Plan as an appendix. Key elements of the Implementation Work Plan are now listed under section III. Coordination and Collaboration Relative to Public Health Activities. The agreement no longer includes an Implementation Work Plan appendix.
 
 
 
APPROVED AND ACCEPTED FOR NATIONAL INSTITUTES OF HEALTH
National Institute of Neurological Disorders and Stroke
 
Story Landis, Ph.D. Director
National Institute of
Neurological Disorders and Stroke
National Institutes of Health
 
February 8, 2013
 
APPROVED AND ACCEPTED FOR THE THE FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
 
 
Karen Midthun, M.D. Director
Center for Biologics Evaluation and
Research
Food and Drug Administration
 
 February 8, 2013
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ATTACHMENTS
 
Model Languagefor Requestfrom  FDA/CBER
 
 
 
The Food and DrugAdministration/Center for Biologics Evaluation and Research (FDA/CBER) requests the following information from the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/NINDS) for the following purposes:  [Identify informationand purpose]
 
FDA/CBER 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/CBER will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CBER and NIH/NINDS dated [Insert date MOU between FDA/CBERand NIH/NINDSinitiated]. FDNCBERacknowledges that applicable laws and regulations may govern the disclosure of such information. See. 21 U.S.C. § 331(j), 18
U.S.C. § 1905, 21CFR Parts 20 and 21, 45CFR 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/NINDS
 
 
 
The National Institutes of Health/National Institute of NeurologicalDisorders and Stroke (NIH/NINDS) 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/NINDS 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/NINDS will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NINDS and FDA/CBER dated                                                                                                                                             _ NIH/NINDS acknowledges that applicable laws and regulations may govern the disclosure of such information. See. 21 U.S.C. § 3310), 18 {).S.C. § 1905, 21 CPR Parts 20 and 21, 45
CFR Parts 5 and 5b, and 42 U.S.C. § 241(d).
 
NIH/NINDS will limit dissemination of any shared information to the following NIH/NINDS offices and/or employees, unless it identifies additional NIH/NINDS 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/NINDS official with requisite responsibility and authority.]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Model Transmittalletter from NIH/NINDS to FDA/CBER
 
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 Biologics Evaluation and Research (FDA/CBER) in response to FDA/CBER'srequest, dated                 .This information contains one or more of the followingcategories of non-public information, including information the disclosure of which may be prohibited by law;
 
[NIHININDS checks applicable numbers below]
 
_confidentialresearch proposals, progress reports, and/or unpublished data;
_privilegedor pre-decisional agency information;
_trade secrets;
_confidential commercial or financial information;
_informationthe 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;
_informationprotected for national security reasons; or
_other(explain).
 
FDA/CBER shall notify the contact person or designee offing/NINDSif 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/NINDS 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 ________________ ,____FDA/CBER has agreed not to disclose the above- described shared non-public information without prior written permission offing/NINDS. FDA/CBER has acknowledged that applicable laws and regulations may govern the disclosure of such information. See 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 21CFR 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/NINDS, dated  .
  
 
Model Transmittalletter from FDA/CBER to NIH/NINDS
 
 
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 Institute for Neurological Disorders and Stroke (NIH/NINDS) in response to NIH/NINDS'srequest, 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:
 
[FDAICBER 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 off/CBERif 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/CBER 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 off/CBER. NIH/NINDS has acknowledged that applicable laws and regulations may govern the disclosure of such information. See 21U.S.C. § 331(j), 18U.S.C.§ 1905, 21CFR Parts 20 and 21, 45CFR Parts 5 and 5b, and 42 U.S.C. § 24l(d).NIH/NINDS has also agreed to comply with the
principles and procedures set forth in the Memorandum of Understanding on information between FDA/CBER and NIH/NINDS, dated _____ .

 

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