MOU 225-24-001
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
AND
THE NATIONAL SCIENCE FOUNDATION
This Memorandum of Understanding (MOU) sets forth the terms and understanding between the National Science Foundation (NSF) and the U.S. Food and Drug Administration (FDA) to encourage and foster scientific exchanges in areas of mutual interest in Mathematical and Physical Sciences, Engineering, and Biomedical Research to enable an increased exchange of programmatic information, support expanded collaboration in common research areas, identify interdisciplinary research that might not easily be supported by either agency, and/or avoid any potential overlap of efforts.
I. PURPOSE
This MOU will encourage and support interactions among the parties, including the sharing of information about funding priorities and areas of mutual interest. This MOU is intended to provide a framework through which the parties, along with other NSF directorates/offices as relevant to the topical areas and as mutually agreed upon through subsequent amendments to this MOU, can coordinate the development and support of science and engineering research activities. Coordination activities may include identifying opportunities for complementary pursuits that foster new pathways from discovery to development and/or close the gap between fundamental research and use-inspired research, drive innovation, and advance the development of new technologies. It will also inform long-term planning of each agency’s research strategy through the regular exchange of information.
The primary outcome will be opportunities for the FDA and NSF communities to interact, work together, learn from each other, and eventually lead to specific research collaborations that will be inherently interdisciplinary. The idea is to interlink – via people-to-people connections – NSF’s basic and translational research with FDA-relevant basic and applied research to create a cycle where basic research may lead to new technologies (including biotechnology) and these technologies, in turn, may foster new basic research.
II. BACKGROUND
FDA is 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. Increased development of research, education and outreach partnerships within the NSF will greatly contribute to FDA’s mission.
The NSF is acting pursuant to the National Science Foundation Act of 1950 as amended (42 USC 1861 et seq). NSF advances fundamental research in all fields of science and engineering and sustains the United States as a global leader in research and innovation. NSF funds approximately 25% of all federally supported academic basic research in all fields of science and engineering, except the medical sciences, through a portfolio of programs that advance the frontiers of knowledge, develop new approaches, and enable cross-disciplinary collaborations. As the agency looks to the future, NSF is committed to strengthening its capacity to innovate, produce breakthroughs, and “accelerate the translation of fundamental discoveries from lab to market”. A collaboration with the FDA will augment NSF’s ability to advance the frontiers of knowledge and/or facilitate the direct translation of fundamental research into tangible solutions.
These authorizations for the two agencies, together with the internal policies and procedures of each party, define the authority of the agencies to enter this MOU for their mutual benefit.
III. SUBSTANCE OF AGREEMENT
A. General Provisions
This MOU outlines areas of mutual interest and the general guidelines for interaction. It is not intended to cover all areas of mutual interest. The areas covered by this agreement can include coordination of specific projects, programs, and facilities. The specific coordination may include research and education activities; facilities and instrumentation; and data and cyberinfrastructure. NSF and FDA may agree to extend this MOU to additional research areas by an addendum to this MOU and/or a management plan for a specific developed opportunity.
Examples of current areas of cooperation or future areas of potential cooperation include, but are not limited to: bioengineering and engineered living systems; biomaterials; physics of living systems; chemistry of life processes; electronic and photonic materials; systems and synthetic biology; physiological and structural systems; disability and rehabilitation engineering; engineering biomedical systems; artificial intelligence; imaging technologies and probes; mathematical modeling of living systems; biotechnology advanced manufacturing, biotechnology workforce, biocomputing; and biosensing.
B. Projects and Activities
Specific activities between the parties must be detailed in writing, such as via an interagency agreement, program management plan, or other supplementary documentation appropriate to the nature of the activity and the agencies' requirements and approved at the NSF Assistant Director level and the equivalent FDA level, or their delegates.
This MOU facilitates the following activities among the parties: exchanges of programmatic information, joint activities such as program director meetings, joint community webinars, or other outreach activities, joint workshops, sharing of any whitepapers solicited by joint workshops, or education and workforce development activities. It is expected that as collaboration between the agencies intensifies, specific activities that may extend beyond this MOU, such as joint solicitations or proposal sharing, will be identified by the collaborating parties within NSF and FDA and added to this MOU by an amendment and/or a management plan for a specific developed opportunity.
C. Disclosure of Information
Any information furnished to either party may be subject to disclosure under the Freedom of Information Act (5 USC 552) and other applicable laws and regulations. Proprietary and/or nonpublic information shall not be disclosed under this MOU, unless such disclosure is governed by and in accordance with appropriate confidentiality disclosure agreements and applicable FDA and NSF policies and procedures, or to the extent such disclosure is required by law.
Proprietary or nonpublic information includes but is not limited to: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7 (c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5 USC 552(b)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). The parties acknowledge and agree that NSF staff members shall only be provided access to non-public information as necessary to perform their official duties in accordance with this MOU, and that the non-public information is shared by FDA pursuant to 21 CFR 20.85. Such personnel shall be advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative and civil penalties for noncompliance contained in applicable federal laws.
The parties also acknowledge and agree that pursuant to section 301(j) of the Food, Drug, and Cosmetic Act, 21 USC 331(j), FDA will not provide to the other Party and the other Party is not authorized to have access to or disclose, any method or process that is entitled to protection as a trade secret.
IV. LIAISON OFFICERS
A. For the National Science Foundation
Brand L. Schottel
Strategic Advisor for Partnerships (Acting)
Directorate for Engineering
bschotte@nsf.gov
703-292-4798
Prakash Balan
Program Director
Division of Engineering, Education, and Centers
Directorate for Engineering
pbalan@nsf.gov
703-292-5341
Ashley Vanderley
Senior Advisor Facilities
Directorate for Mathematical and Physical Sciences
bevander@nsf.gov
703-292-2428
Yulia Gel
Program Director
Division of Mathematical Sciences
Directorate for Mathematical and Physical Sciences
yegel@nsf.gov
703-292-7888
Vivica Brooks
Partnership Liaison Specialist
Computer and Information Science and Engineering
vbrooks@nsf.gov
703-292-7105
Kerstin Mukerji
Staff Associate for Strategic Engagements
Directorate for Technology, Innovation and Partnerships
kmukerji@nsf.gov
703-292-5390
Alice Kamens
Strategic Partnership Officer
TIP Strategic Partnerships Hub
Directorate for Technology, Innovation and Partnerships
akamens@nsf.gov
703-292-4394
Brent Miller
Science Advisor
Directorate for Biological Sciences
bmiller@nsf.gov
703-292-2988
Douglas Kowalewski
Program Director for Partnerships and Innovation
Directorate for Geosciences
dkowalews@nsf.gov
703-292-2181
Andrew Desoto
Senior Advisor
Directorate for Social, Behavioral, and Economic Sciences
kadesoto@nsf.gov
703-292-4416
Leher Singh
Senior Advisor (Acting)
Directorate for STEM Education
lsingh@nsf.gov
703-292-7257
Jessica Libertini
Senior Advisor
Office of International Science and Engineering
Jliberti@nsf.gov
703-292-7412
B. For the U.S. Food and Drug Administration
Ed Margerrison, PhD
Director, OSEL
Center for Devices and Radiological Health
Edward.margerrison@fda.hhs.gov
(301) 796 0262
Dorn Carranza, PhD MBA
Assoc. Director for Partnerships and Innovation, OSEL
Center for Devices and Radiological Health
Dorn.Carranza@fda.hhs.gov
301-796-8338
Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
V. FUNDING
Nothing in this MOU intends to create a legally binding obligation between the parties or the obligation of appropriated funds. Any activities under this MOU that contemplate future funding by the parties will be carried out under a separate agreement under which the obligation of funds is appropriate. In general, each party is expected to bear the costs of its participation in their project. Nothing in this Agreement shall obligate the NSF, FDA to any current or future expenditure of resources in advance of the availability of appropriations from Congress.
VI. EFFECTIVE DATE
This MOU remains in effect for 5 years from the date of the last signature to this MOU, unless terminated earlier by the parties. This MOU may be renewed and/or modified subject to the written approval of the FDA and NSF.
VII. REVISIONS/AMENDMENTS
It is understood and agreed that the Parties may revise or modify this MOU by written amendment hereto, provided such revisions or modifications are mutually agreed upon.
VIII. TERMINATION
This MOU is entered into voluntarily by all Parties and may be modified by mutual consent of authorized officials from the NSF and FDA. This MOU may be terminated by either party with ninety (90) days advance written notice. In the absence of a mutual agreement by authorized officials from the NSF and FDA to continue to further this partnership, this MOU shall end 5 years from the date of the last signature to this MOU.
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION
/s/
Robert M. Califf, MD
Commissioner
U.S. Food and Drug Administration
Date: 04/11/2024
APPROVED AND ACCEPTED BY:
NATIONAL SCIENCE FOUNDATION
/s/
Sethuraman Panchanathan
Director
U.S. National Science Foundation
Date: 04/01/2024