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  1. FDA Memoranda of Understanding

MOU 225-17-0007

MOU 225-17-0007

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
MEMORANDUM OF UNDERSTANDING
between the
Division of Program Coordination, Planning, and Strategic Initiatives,
National Institutes of Health and the
Office of the Chief Scientist,
U.S. Food and Drug Administration

Title of the Agreement: Stimulating Peripheral Activity to Relieve Conditions (SPARC): Use of Existing Market-Approved Technology for New Market Indications

I.  PURPOSE

This Memorandum of Understanding (MOU) details the joint objectives of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). These agencies share a common interest and goal in facilitating the development of neurostimulatory devices for interrogating and elucidating peripheral autonomic and sensory control of organ function to catalyze development of more effective and minimally invasive neuromodulation  therapies.  Each agency, operating under its own authority, intends to have specific roles in promoting this shared interest. This MOU provides a framework for coordination and collaborative efforts between the parties to maintain and enhance
agency effectiveness while avoiding duplication of efforts to achieve this common goal. It also provides the principles and procedures by which the parties intend to manage and share expertise and information between the two agencies in order to increase interagency collaboration and strategic planning.

II.  AUTHORITY

FDA has authority to enter into this agreement pursuant to sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act.  NIH has authority to enter into this agreement pursuant to sections 301 and 402 of the Public Health Service Act.

III. BACKGROUND

The NIH Common Fund's Stimulating Peripheral Activity to Relieve Conditions, or SPARC, program (https://commonfund.nih.gov/Sparc/) will develop high resolution functional and anatomic neural circuit maps of the innervation pathways controlling organ functions by integrating ideas and expertise from several disciplines, including anatomy, physiology, surgery, neuroscience, engineering, biotechnology, neuromodulation  and device design. The overall goal ofthe SPARC program is to develop the scientific foundation necessary to pilot new and/or improved neuromodulation  devices and stimulation protocols to treat diseases and conditions through precise neural control of end-organ system function. Significant advances in neuromodulation  therapies to treat disease have led to industry­ supported large, randomized and blinded, controlled trials. While the degree of efficacy of the neuromodulation devices have varied depending on the trial and condition under investigation, the data and approach show great promise for scientific and therapeutic development.  However, in many cases the detailed underlying physiology and mechanisms of action of these neuromodulation  therapies are poorly understood. This poor understanding, in tum, limits improvement in neuromodulation  therapy designs.

The SPARC program will be supported through a combination of Cooperative Agreement and Other Transaction mechanisms. A series of Funding Opportunity Announcements (FOAs) will be issued to achieve the goals of SPARC and can be found at https://commonfund.nih.gov/Sparc/; This MOU is specific to one component of SPARC, "Use of Existing Market-Approved Technology for New Market Indications", which will be supported through Other Transactions.

IV. SCOPE

NIH and FDA intend to collaborate and coordinate efforts towards preclinical and feasibility studies in humans of existing market-approved  neuromodulation devices for new market indications, a component ofthe SPARC program.  Departmental and agency relationships identified in this MOU are intended to improve the efficiency and effectiveness of the solicitation process, review, award and programmatic management of research in conjunction with this component of the SPARC program. This MOU does not alter existing DHHS authorities, policies or requirements. In establishing a proposed framework to provide mutually beneficial logistical and operational support, this MOU is not intended to replicate or aggregate unnecessarily the diverse organizational structures of each agency in scientific research.

V.  WORKPLAN  AND RESPONSIBILITIES OF EACH AGENCY

NIH and FDA intend to assume their respective roles and responsibilities as follows:

  • NIH will originate and manage separately the SPARC component on new market indications for existing market-approved  neuromodulation devices. There will be no exchange or transfer of funds between NIH and FDA.
  • FDA, to the extent feasible for the Agency, will provide expert advice and assistance to the NIH and/or Principal Investigator who receives an award under the FOAs for Use of Existing Market­ Approved Technology for New Market Indications, as needed in areas of FDA purview.
  • NIH intends to hold program reviews for all award recipients of the SPARC program through workshops held on a semi-annual basis. To the extent permissible under applicable law and agency policy, FDA staff may participate and contribute expertise in these workshops.
  • FDA staff will be invited to observe and provide expert input in connection with the  NIH-led scientific review of Other Transaction applications sent in response to FOAs for Use of Existing Market-Approved Technology for New Market Indications since the expertise of FDA staff is directly relevant to these projects. FDA is not making decisions regarding applications for awards.
  •  Each party may utilize the expertise and relationships of the other in order to increase its own capability and responsiveness.

VI.  OTHER PROVISIONS

Nothing  in this MOU is intended  to conflict  with law, regulation, executive order or presidential directive, or the policies of DHHS. If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions ofthis MOU shall remain  in full force and effect. This MOU shall be interpreted and implemented in a manner that respects  and complies with (and does not abrogate) the statutory and regulatory responsibilities of each agency. This agreement does not obligate funds.

VII.  POINTS OF CONTACT

The names ofNIH and FDA staff listed below represent  the current  persons in these assigned  roles at the date of signing  of this MOU. Additional NIH and FDA staff may be drawn  to provide scientificexpertise on neuromodulation devices as needed.

A.  Scientific I Research Contact  for NIH: Danilo A. Tagle, Ph.D.
Associate Director for Special  Initiatives
National Center  for Advancing Translational Sciences
Phone: (301) 594-8064
Email: danilo.tagle@nih.gov

NIH intends  for the NIH Program  Manager  (PM) to be responsible for the scientific, administrative, programmatic, and technical  oversight ofthe overall SPARC program. Dr. Tagle, serving as the Project  Team  Leader (PTL)  for the Use of Existing Market-Approved Technology for New Market  Indications, will be involved in the scientific and programmatic review of the benchmarks and non-competing renewal  applications. NIH intends for the PM and PTL to have substantial scientific involvement during the conduct of the program  through technical  assistance, advice,  and coordination.

B.   Scientific I Research Contact for FDA: Frank F. Weichold, M.D., Ph.D.
Director, Critical Path and Regulatory Science Initiatives, ORSI Office of the Commissioner
Office of the Chief Scientist
Phone (301) 796-5370
Email: frank.weichold@fda.hhs.gov

The FDA Scientific Contact will coordinate technical  assistance, including assistance on the benchmarks and progress reports, providing advice  and plans for the integration of the findings into practice and guidance.

If the scientific contact for either party changes, that party will notify the contact for the other party and provide information concerning the new scientific contact.

Vlll.   SCHEDULE

It is anticipated that there will be semi-annual meetings with award recipients and experts from NIH and FDA.  If needed, NIH will request that awardees, in their discretion, share progress reports with the FDA.

IX.  SECURITY

Both agencies efforts will be Unclassified.

X.  SHARING OF INFORMATION

NIH and FDA intend for the following principles and procedures to govern the sharing of non-public information, as resources permit, between the two parties.

NIH and FDA agree that there should be a presumption in favor of full and free sharing of information as it relates to the SPARC program, consistent with applicable law and agency policy. Both parties recognize and acknowledge, however, that all non-public information shared between NIH and FDA, whether written or oral, must be protected from any further disclosures not authorized by law or regulation. Both parties recognize that safeguards are needed to protect shared non-public information including, for example,  privileged and/or pre-decisional agency information; research proposals, progress reports, and unpublished data.; confidential commercial and trade secret information; and information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Freedom of Information Act (FOIA), Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)).Such safeguards help ensure compliance with other applicable laws and regulations and should include, for example, the marking of any materials as "confidential" prior to any authorized disclosure and the use of encryption technologies when appropriate.

Each agency shall promptly notify the appropriate office of the information-sharing agency when there is any attempt to obtain shared information by compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.

Each agency shall notify the information-sharing agency before complying with any judicial order that compels the release of such information so that the agencies may determine the appropriate measures to take, including where appropriate the filing of a motion or an appeal with the court.

If records provided by either party under this agreement are the subject of a FOIA request submitted to the party that received the records, that party will refer the FOIA request and relevant records to the party that provided the records for processing. If the FOIA request seeks both parties' records or if the
request is for records created by one party that incorporates infonnation provided by the other party, in accordance with the Department of Health and Human Services' FOIA regulations at 45 C.F.R. 5, the party receiving the FOIA request will forward all such requests to the respective FOIA offices for NIH and FDA for disposition.

XI.  PERIOD OF AGREEMENT

This MOU becomes effective following the signature of both parties and remains effective for five years. It may be modified by mutual consent of the parties. The agreement may be terminated by any party upon a 90-day advance written notice to the other parties. At the conclusion of 5 years, the parties may consider the extension of this MOU or the development of a new MOU as needed.

XII. APPROVAL

APPROVED AND ACCEPTED FOR
THE NATIONAL INSTITUTES OF HEALTH

James M. Anderson, M.D., Ph.D.
Director of Program Coordination, Planning and Strategic Initiatives
November 18, 2016

APPROVED AND ACCEPTED FOR
U.S. FOOD AND DRUG ADMINISTRATION

Luciana Borio, M.D.
Chief Scientist (Acting)
Office of the Chief Scientist
November 14, 2016