U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND
Montgomery County Public Schools, Maryland

 

1. Purpose

The United States Food and Drug Administration (FDA) and Montgomery County Public Schools, a system of public schools operated by the Board of Education of Montgomery County, Maryland (MCPS) (the Parties) share interests in advancing and increasing student interest in Science, Technology, Engineering and Math (STEM), FDA STEM careers, as well as educating students on well-being, opioid misuse and prevention of substance use. Both institutions foresee benefits from the mutual exchange of scientific expertise, knowledge, interest and training. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs.

 

1. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21.U.S.C. 301et 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. FDA also has a primary role in advancing the translational/applied science that is needed to move promising new technologies into actual manufactured products in the most efficient manner possible while assuring the clinical safety and effectiveness of such products for patient care. 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.

MCPS is one of the State's most valuable assets.   As resources permit, the FDA seeks to develop, as well as offer diverse opportunities focused on contributing to the development of the next generation of STEM professionals.  FDA seeks to contribute to addressing the need for STEM professionals, by providing community-based engagement opportunities, which will expose middle to high school level students to the innovative work and research being conducted at FDA.  The FDA recognizes the importance of developing a STEM pipeline which consists of highly trained individuals, including minorities and women.  The anticipated need and demand for STEM-trained professionals, highlights and underscores the need for more exposure of students to scientific careers to build the STEM pipeline.

 

1. Substance of Agreement

This MOU forms the basis for collaborative engagements between the Parties, to expose MCPS students (middle to high school) to STEM, FDA STEM careers and regulatory science, as well as provide an opportunity for scientific exchange via scientific presentations, demonstrations and training opportunities.  Additionally, activities under this MOU seek to bring awareness regarding the harmful effects of substance use. 

Under this MOU, as resources permit, FDA and MCPS will seek opportunities to participate in collaborative engagement and training opportunities as permitted under appropriate statutory authority. Before any specific engagement activity is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements, as appropriate.  Where applicable, these agreements shall incorporate by reference this MOU.  The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations and shall be negotiated and executed by appropriate representatives.

 

1. General Provisions:

The Parties agree that the FDA under the MOU and will in no way be considered to be an agent, partner, or employee of, or joint venture with, MCPS.

Each Party will comply with the other Party's security procedures which may include their employee’s successful completion of a background investigation by the Office of Personnel Management and any additional policies and procedures regarding access to and use of facilities, including but not limited to Section 11-722 of the Criminal Procedures Article, Annotated Code of Maryland; Section 6-113 of the Education Article, Annotated Code of Maryland; and Section 5-551 of the Family Law Article, Annotated Code of Maryland. Either Party may restrict or limit access to its property and facilities at any time and for any reason. MCPS employee or student participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

 

Resource Obligations:

This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for awareness of STEM and prevention of substance use. It does not create binding, enforceable obligations against any Party. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, funds, and appropriations. 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 into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and MCPS operate.

Each Party is responsible for any loss, personal injury, death, cost, claim, damages (including but not limited to incidental and consequential damages), and other expenses (including attorney’s fees and litigation expenses) that may be suffered or incurred by reason of, or occasioned wholly or in part by, its negligence, its performance or failure to perform any of its obligations under the MOU, or its violation of any applicable legal requirement. Nothing herein or any other provision of this MOU shall be construed to abrogate, impair, or waive any defense, liability or damages limitation, or governmental immunity of either Party pursuant to state or federal law or otherwise.

 

1.  Term, Termination, and Modification

This agreement becomes effective upon acceptance by both Parties and will continue in effect for 5 years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. Either Party upon 60-day advance written notice to the other may terminate it, for any reason.

 

1.  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 and MCPS operate, including but not limited to Board of Education policies, and MCPS regulations issued by the MCPS Superintendent of Schools.

 

1. Liaison Officers

 

FDA's CDER is the lead center for this AGREEMENT. The individual to whom all inquiries to FDA should be addressed is:

Chekesha S. Clingman, Ph.D. M.B.A.
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-8531

The individual to whom all inquiries to MCPS should be addressed is:

Dr. Rhonda Moreno
850 Hungerford Drive
Rockville, MD 20850
240-740-4002
The Parties’ liaisons may be changed at any time, provided that notification of the change, including the name and address of the successor liaison is provided to the other Party in writing.

 

APPROVED AND ACCEPTED FOR Montgomery County Public Schools, Maryland   _______________________________                  Dr. Maria V. Navarro Chief Academic Officer _________________ Date

 

         

 

 

 

 

 

           APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

 

           _______________________________                  
­­­­­­­­­­­­­­­­­­­­­­­­­­­           Janet Woodcock, MD, Director                              
Center for Drug Evaluation and Research Food and Drug Administration

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