MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
NORTH AMERICAN SOCIETY
OF PEDIATRIC GASTROENTEROLOGY,
HEPATOLOGY AND NUTRITION
The United States Food and Drug Administration (FDA) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 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 within the NASPGHAN will contribute to FDA’s mission.
The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN), founded in 1972, is a society dedicated to serving the Pediatric Gastroenterology and nutrition communities.
The mission of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition is to advance understanding of normal development, physiology and pathophysiology of diseases of the gastrointestinal tract and liver in children, improve quality of care by fostering disseminating this knowledge through scientific meetings, professional and public education, and policy development, and serve as an effective voice for members and the profession.
The membership of NASPGHAN consists of more than 1700 pediatric gastroenterologists, predominantly in 46 states, the District of Columbia, Puerto Rico, Mexico and 8 provinces in Canada.
NASPGHAN strives to improve the care of infants, children and adolescents with digestive disorders by promoting advances in clinical care, research and education. Pediatric gastroenterologists specialize in the care of children with chronic abdominal pain, diarrhea, constipation, vomiting, bleeding from the GI tract, inflammatory bowel disease, liver diseases, diseases of the pancreas, poor weight gain and nutritional problems. Pediatric gastroenterologists specialize in gastroesophageal reflux (GER), peptic ulcers, H. pylori, celiac disease, Crohn’s disease, ulcerative colitis, Hirschsprung’s disease, cyclic vomiting, polyps, gallstones, hepatitis, biliary atresia, jaundice, pancreatitis, lactose malabsorption, failure to thrive and other common and rare disorders. Most pediatric gastroenterologists perform endoscopy, colonoscopy, esophageal pH probe studies, esophageal and rectal manometry and liver biopsies.
NASPGHAN’s Objectives include but are not limited to:
- Improving the digestive health and nutrition of children worldwide and in North America.
- Fostering dialogue and research on pertinent issues that impact the pediatric gastroenterology patient and their family.
- Providing opportunities for clinicians and researchers to gain knowledge of the scientific advances in pediatric gastroenterology.
Disseminating the wealth of scientific information that exists to improve clinical outcomes and advance the practice of pediatric gastroenterology and nutrition.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and NASPGHAN. The types of initiatives expected to develop from this MOU include:
- Advancing student education and matriculation into the Pediatric Gastroenterology professions;
- Opportunities to convene joint meetings for education and research;
- Research collaborations;
- Cooperative international initiatives, and
- 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 NASPGHAN and FDA.
IV. General Provisions
- 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.
- Institutions within NASPGHAN and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- 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.
- 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. NASPGHAN individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- 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 NASPGHAN’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 10903 New Hampshire Ave
White Oak Building 22, Room 5112
The individual(s) to whom all inquiries to the NASPGHAN should be addressed is:
Name Margaret Stallings
Address 1501 Bethlehem Pike, Flourtown, PA 19031
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 2 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 the 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 NASPGHAN operate.
Signed by: Kathleen B. Schwartz Signed by: Janet Woodcock, MD
APPROVED AND ACCEPTED FOR THE NORTH AMERICAN GASTROENTEROLOGY HEPATOLOGY AND NUTRITION
Date: May 10, 2012
APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION
Date: May 11, 2012
Signed by: Kathleen B. Schwartz
Signed by: Janet Woodcock, MD