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  1. Domestic MOUs

MOU 225-19-032

MEMORANDUM OF UNDERSTANDING
Among The
U.S. Food and Drug Administration
And The
National Institutes of Health
National Institute of Environmental Health Sciences
And The
Health and Environmental Sciences Institute
Regarding The
Botanical Safety Consortium

I. PURPOSE 

This Memorandum of Understanding (MOU) is established to enhance public health protection by providing scientific approaches to support the safety assessment of botanicals used in dietary applications. This MOU provides the framework for collaborative efforts across the U.S. Food and Drug Administration (FDA), National Institute of Environmental Health Sciences (NIEHS), and Health and Environmental Sciences Institute (HESI) to support the development of science that will improve the quality and safety assessment of botanical dietary supplements. This MOU serves as a framework to support the scientific collaboration and resourcing of scientific efforts in fulfillment of this purpose.  Programmatic activities conducted/supported as part of this MOU may include chemical characterization of complex botanical products, identification of fit for purpose toxicity testing approaches, and development of a public database of toxicity outcome data for select botanical ingredients. All of the outputs of this collaboration will be made publicly accessible. 

Throughout this document, FDA, NIEHS, and HESI are referred to individually as a “Party” and collectively as the “Parties.”  This MOU states the shared understanding of the Parties as to how they expect to proceed on these issues. It is not a binding agreement. Any joint activities between the government parties (FDA and/or NIEHS NTP) and HESI will be governed by a separate agreement that must comply with applicable laws and regulations governing agreements between Federal government and non-government entities.

II. BACKGROUND

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, P.L. 103-417, the dietary supplement market has grown significantly. The dietary supplement market in the U.S. is estimated to be worth more than $40 billion and contains from 50,000 to 80,000 different products; significantly larger than the $4 billion market that was estimated to contain 4,000 products when DSHEA was passed.  According to recent estimates, 75% of adults in the U.S. take dietary supplements. This increase in usage, along with significant variation in current approaches to quality and safety assessment of botanicals used in dietary supplements, warrants increased focus on the quality and safety of botanical dietary supplements to protect public health.

The Botanical Safety Consortium (BSC) is intended to be a forum for scientists from consumer health groups, academia, industry, non-profits, and government that are seeking to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate botanical safety. With the implementation of this MOU, specific guidelines for membership and participation in the BSC will be established by the Parties with input from additional stakeholders. HESI will serve as a convener and facilitator for the BSC.

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, and medical devices, as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. 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 will contribute to FDA’s mission.

NIEHS, part of the National Institutes of Health, is authorized by Section 463 of the Public Health Service Act (42 U.S.C. 285l) to conduct and support research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly. Through its participation in the National Toxicology Program (NTP), NIEHS has carried out and published comprehensive toxicological studies in rodents on a number of botanical dietary supplement ingredients.

HESI is a non-profit 501(c)(3) charitable scientific organization whose mission is to develop science for a safer, more sustainable world. HESI achieves its mission by serving as a neutral and skilled convener of scientists from academic, government, foundations, research institutes, and the commercial sector. Since 1989, HESI programs have helped to build scientific evidence on human and environmental health issues through collaborative and efficient research and expertise-sharing platforms.

III. COMMON UNDERSTANDING OF THE PARTIES

As part of the BSC, the parties intend to engage in a number of collaborative projects leveraging their individual and pooled expertise and resources. Relevant activities of the Parties could include managerial and logistical support, intellectual input, laboratory investigation, data analysis, manuscript writing, and public engagement. In their shared efforts to educate and build consensus across government, academic, clinical, non-governmental, and industry stakeholders, the Parties may elect to share with each other information that is in the public domain and considered non-confidential. Activities contemplated under this MOU are not intended to include group advice to FDA or NIEHS NTP that would be subject to the Federal Advisory Committee Act (FACA ), 5 U.S.C. App.

In furtherance of this MOU

A. FDA expects to:

1. Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.

B. NIEHS expects to:

1. Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.

C. HESI expects to:

1.  Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.

2. Provide scientific program leadership, management and administration, team-building and stakeholder engagement, and communications support for MOU-related efforts by serving as a convener for the BSC.

IV. GENERAL PROVISIONS

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, and will comply with current U.S. Government patent law and any other applicable statutes and regulations.

2. Institutions within each party may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address relevant Intellectual Property rights.

3. Any financial support provided by FDA and/or NIEHS to support these efforts will be formalized through a separate agency process, consistent with applicable law and subject to the availability of funds.

4. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by appropriate confidentiality disclosure agreements.

5. Each Party will comply with the other Parties’ security procedures and policies regarding access to and use of facilities.

6. Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written supplemental agreements for collaboration and sharing of resources. Where applicable, these agreements may reference this MOU. The terms and conditions of any such agreements will comply with applicable Federal law and regulations, and shall be negotiated and executed by appropriate representatives among parties under procedures that comply with applicable laws and regulations that govern contracts between government agencies and non-goverenment entities

7.  Nothing in this MOU should be interpreted to imply that the United States, HHS, FDA, or NIH endorses the products or services of HESI or its affiliates.

V. RESOURCES OBLIGATIONS

This MOU represents the broad outline of the intent by FDA, NIEHS, and HESI to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

VI. LIAISON OFFICERS

A. For FDA:
Name: Sibyl Swift, Ph.D.
Organization:U.S. Food and Drug Administration
Title: Special Assistant
Address: 5001 Campus Dr, College Park, MD 20740
Telephone Number: 240-402-1455

B. For NIEHS:
Name: Cynthia Rider, PhD
Organization: National Institute of Environmental Health Sciences
Title: Toxicologist
Address: 111 T. W. Alexander Dr, Research Triangle Park, NC  27709
Telephone Number: 987-287-3111

C. For HESI:
Name: Syril Pettit, DrPH, MEM
Organization: Health and Environmental Sciences Institute
Title: Executive Director
Address: 740 15th St, NW, 6th Floor, Washington DC 20005
Telephone Number: 202-659-8404

Each Party may designate new liaisons by notifying the other Parties’ administrative liaison in writing. If, at any time, an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, the Party will name a new liaison within two (2) weeks and notify the other Parties through the designated administrative liaisons.

VII. DURATION, TERMINATION, AND MODIFICATION

Activities under this MOU will start upon the signature by authorized officials of each Party, and continue for five (5) years from the date that all Parties have signed, unless the MOU is modified or terminated.  Each Party may terminate this MOU with or without cause.  Each party agrees to provide written notice to the other Parties at least sixty (60) days in advance of their intent to modify or terminate this MOU.

VIII. STATUTES, REGULATIONS, RULES AND POLICIES

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules and policies under which FDA, NIEHS, and HESI operate.

APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

/s/
Brian Berridge, Scientific Director, Division of NTP 
and Associate Director, NTP
Date: 10/30/19

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

/s/
Douglas Stearn, Deputy Director for Regulatory Affairs,
Center for Food Safety and Applied Nutrition, FDA
Date: 10/8/19

APPROVED AND ACCEPTED FOR THE HEALTH AND ENVIRONMENTAL SCIENCES

/s/
Syril D. Pettit, Executive Director
Date: 10/16/19