MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AMERICAN COLLEGE OF GASTROENTEROLOGY
The United States Food and Drug Administration (FDA) and the American College of Gastroenterology share interests in promoting scientific progress through exchange of scientific capital in a Gastroenterology Drug Development Fellowship Training and Research Program. Both parties foresee benefits from the mutual exchange of training and research expertise in gastroenterology drug development and translational research. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through various programs including collaborative education and research.
This MOU and the collaborative framework it provides will facilitate existing and new 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 various programs, including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301). 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 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 with the American College of Gastroenterology will contribute to FDA's mission.
The mission of the American College of Gastroenterology is to advance the medical treatment and scientific study of gastrointestinal disorders and their treatment. The College strives to serve the evolving needs of. physicians in the delivery of high quality scientific, humanistic, clinical, ethical, and cost-effective health' care to gastroenterology
The College's goals are:
1. To provide continuing medical education to clinicians through scientific publications,
meetings, and multimedia, web-based offerings;
2. To represent the clinician in national and local health care policy issues to ensure that the best interests of patient care and clinical medicine are served;
3. To promote and provide assistance in education to clinical gastroenterologists and fellows-in-training in cost-effective, efficient, and high quality practice management;
4. To promote, encourage and support clinical research in gastroenterologic disorders through the ACG Institute for Clinical Research;
5. To be a' source of educational information for patients with gastrointestinal disorders and their families and to provide liaison with patient advocacy organizations for those with gastrointestinal and hepatic disorders.
More than 12,000 physicians from 82 countries are members of the ACG.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations, .outreach and educational initiatives and intellectual partnerships between FDA and The American College. of Gastroenterology. The types of initiatives expected to develop from this MOU include:
1. Advancing student education and matriculation into the Gastroenterology professions;
2. Opportunities to convene joint meetings for education and research;
3. Research collaborations;
4. Cooperative international initiatives; and
5. 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, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate this MOU by reference. 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 of institutions within the American College of Gastroenterology and FDA.
IV. General Provisions
1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. Institutions within the American College of Gastroenterology and FDA may decide enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary or nonpublic information will' not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
4. 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 for any reason. The American College of Gastroenterology individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. As research projects are developed, details will be agreed to in advance under other agreements as appropriate.
V. Resource Obligations
This MOU represents the broad outline of the FDA and the American College of Gastroenterology's intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available resources. 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
FDA's Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Name: Donna J. Griebel, MD
Address: White Oak Building 22, room 5112
The individual(s) to whom all inquiries to Institutions within ·the American College of Gastroenterology should be addressed is:
Name Brad Conway
Address: 6400 Goldsboro Road, Bethesda, MD 20817
Each Party may designate new liaisons by notifying the other Party's liaison in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
VII. Term, 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 by the mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.
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 and the American College of Gastroenterology operate.
Approved and Accepted
for The American College of Gastroenterology
Signed by: Bradley C. Stillman
Date: March 1, 2012
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Date: February 13, 2012