MOU 225-17-036
MEMORANDUM OF UNDERSTANDING BETWEEN THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION (FDA) Center of Drug Evaluation and Research (CDER) AND
RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY
I. Purpose:
The United States Food and Drug Administration (FDA) and Rutgers, The State University of New Jersey (Rutgers) on behalf of its School of Health Professions, share interests in promoting scientific progress through exchange of scientific capital in clinical pharmacology training and research. Both institutions foresee benefits from the mutual exchange of training and research expertise. This MOU and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities, consortia and consensus development between the parties and establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and 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, and medical devices and 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 partnerships within RUTGERS will greatly contribute to FDA's mission.
RUTGERS, is dedicated to the pursuit of excellence in: the undergraduate, graduate, postgraduate and continuing education of health professionals and scientists; the conduct of biomedical, psychosocial, clinical and public health research; health promotion, disease prevention and the delivery of health care; and service to our communities and the entire state. RUTGERS is the nation's largest health sciences University. RUTGERS is New Jersey's state wide system of health sciences education, biomedical research and HealthCare. RUTGERS has five campuses and a network of more than 200 affiliated healthcare and educational partners spanning the state.
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and RUTGERS. The types of initiatives expected to develop from this MOU include:
a. Opportunity to apply for a joint fellowship program at the FDA to advance student education and matriculation into the Clinical Pharmacology professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from RUTGERS into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Clinical Pharmacology and RUTGERS will adhere to the CDER ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter;
b. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
c. Opportunities to convene joint meetings for education and research;
d. Research collaborations;
e. Cooperative international initiatives; and
f. Access to unique facilities and equipment for scientific endeavors.
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 and topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. 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 of institutions within RUTGERS and FDA.
III. General Provisions
a. Rights to an y invention s resulting from collaborative research will be determined by the separate written research agreement s governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
b. Institutions within RUTGERS and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
c. Proprietary and nonpublic information will not be disclosed under this MOU, unlesss uch disclos ure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
d. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. RUTGERS individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
e. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
IV. Resource Obligations:
This MOU represents the broad outline of the Pat1ners' present intent to enter specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and RUTGERS. All activities undertaken pursuant to the MOU are subject to available personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Partners. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and RUTGERS operate.
V. Liaison Officers:
A. Rutgers, The Status University of New Jersey (Rutgers)
Individual's name: Doreen W Lechner, PhD
Organization: Rutgers, The State University of New Jersey -School of Health Professions
Title: Program Director/Assistant Professor, Clinical Trial Sciences Rutgers BioPharma Educational Initiative
Address: 65 Bergen St. Suite 160, Newark, NJ 07101-1709
Telephone Number: 973-972-5984
Fax: 973-972-7228
Email:lechnedw@shp.rutgers.edu
AND
Individual's name: Lisa Palladino Kim, MS
Organization: Rutgers, The State University of New Jersey: School of Health Professions
Title: Director of Capstone / Lecturer, Clinical Trial Sciences Address: 65 Bergen St. Suite 160, Newark, NJ 07101-1709 Telephone Number: USA Mobile + 1-484-686-0896 ,
Fax: 973-972-7228
Email: palladlm@shp.rutgers.edu
B. For the Food and Drug Administration:
Individual's name: Padmaja Mummaneni, Ph.D.
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology
Title: Consumer Safety Officer, Regulatory Health Project Manage r, Contract Officer Representative (COR)
Address: 10903 New Hampshire Avenue White Oak Building 51, Room 2164
Silver Spring, MD 20993 Telephone Number: 301-796-2027
Email: Padmaja.Mummaneni@fda.hhs.gov
Each Party may designate new liaisons at any time by notifying the other Party's 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 liaison.
VI. Terms, Termination and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (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. It may be terminated by either Party upon 60-day advance written notice to the other.
APPROVED AND ACCEPTED FOR THE
RUTGERS SCHOOL OF HEALTH PROFESSIONS
/S/
By: Gwendolyn Mahon, Ph.D.
Dean-Rutgers SHP
Date: 10/6/2017
/S/
By: Steven Andreassen
Chief of Staff
Date: 10/10/2017
APPROVED AND ACCEPTED FOR THE
U.S. FOOD AND DRUG ADMINISTRATION
/S/
By: Janet Woodcock, M.D.
Director, CDER
Date: 10/16/2017
MOU 225-17-036 (First Amendment)
MEMORANDUM OF UNDERSTANDING (MOU)
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH, OFFICE OF TRANSLATIONAL SCIENCES, OFFICE OF CLINICAL PHARMACOLOGY
AND RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY
This is the First Amendment (“Amendment”) to the Memorandum of Understanding (MOU) 225-17-036 between Rutgers, the State University of New Jersey on behalf of its School of Health Professions (Rutgers) and the Food and Drug Administration, U.S. Department of Health and Human Services (the “Parties”).
The purpose of this Amendment is to extend the termination date from October 16, 2022 to October 16, 2027 for the above referenced MOU. This Amendment is permissible under Section VII. Term, Termination, and Modification of the originally executed MOU and provides continuity for collaboration, increased knowledge and efficiency via sharing of information between the Parties. All other terms and conditions stated in the originally executed MOU Number 225-17-036, remain unchanged and in full force and effect except to the extent modified by the terms and conditions of this Amendment.
This agreement, when accepted by the undersigned, is effective as of the date of last signature (“Amendment Effective Date”) and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a sixty-day advance written notice to the other.
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION
/s/
Patrizia Cavazzoni, M.D
Director, Center for Drug Evaluation and Research
U.S. FOOD AND DRUG ADMINISTRATION
Date: 05/19/2023
APPROVED AND ACCEPTED BY:
RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY
/s/
Alma S. Merians, Ph.D., PT
Acting Dean-Rutgers School of Health Professions
Date: 05/18/2023
/s/
Steven Andreassen
Chief of Staff
Date: 05/18/2023