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MOU 215-18-024

MOU 215-18-024

MEMORANDUM OF UNDERSTANDING 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
ST JUDE CHILDREN’S RESEARCH HOSPITAL

I. Purpose

The United States Food and Drug Administration (FDA) and the St Jude Children’s Hospital, Inc. (St Jude) (each, a “Party” and collectively, the “Parties”) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests through exchange of scientists.

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 with research institutions will greatly contribute to FDA’s mission. FDA’s Centers and Offices are described in Appendix A.

St. Jude Children’s Research Hospital is a nonprofit medical corporation focusing on advancing cures, and means of prevention, for pediatric catastrophic diseases through research and treatment. Doctors across the world consult with St. Jude on their toughest cases and St. Jude has a Global Pediatric Medicine Department to improve the survival rates of children with catastrophic illnesses worldwide through the transfer of knowledge, technology and organizational skills. Therefore, St. Jude’s mission to lead the way to treat and defeat childhood cancer and other life-threatening diseases that provide an environment to support diverse multidisciplinary exchanges with FDA.

The scientific, public health and policy expertise within FDA provide opportunities for collaborations that support St Jude’s mission and strategic themes to provide access to high-quality education, research discovery, and knowledge-based services responsive to both the promises and demands of the institution and the nation in the new century.

III. Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and St Jude. The types of activities expected to develop from this MOU and subject to the appropriate written agreements include, but are not necessarily limited to, the following:

  • Planning on collaborative regulatory research program related to both the FDA mission and St Jude research interests. St Jude to collaborate as a subject matter expert on FDA Oncology Subcommittee of the CDER Pediatric Review Committee (PERC).
  • The exchange of non-confidential data and confer analyses.
  • Collaboration on manuscripts for publication, ensuring that all research results and data are made available to the public.

Notwithstanding anything herein to the contrary, the engagement of the Parties in any of the activities described herein or as otherwise agreed by the Parties, shall require the appropriate, duly executed written agreement.

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. St Jude and FDA may decide to enter into supplemental agreements that may include contracts, grants, or cooperative research and development agreements ("CRADA”) between FDA and St Jude to the extent authorized by law and available appropriations. The terms of such supplemental agreements will address Intellectual Property rights, as appropriate. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations and shall be negotiated and executed by appropriate representatives of St Jude and FDA.
  3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements and to the extent such disclosure is permitted by law.
  4. Each Party will comply with the other Party's written 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. St Jude individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations with regard to the performance of such obligations.
  5. Use of Name.  Neither the FDA nor any of its employees, agents, officers, directors, or affiliates, shall use St. Jude’s Name, trade or service marks, or logos, or the names of current or former St. Jude employees or affiliated physicians or faculty, except upon the prior written consent of the American Lebanese Syrian Associated Charities’ CEO, or his or her designee, in concurrence with St. Jude’s CEO. The FDA shall take such actions as are necessary to ensure that the limitations contained in these provisions are communicated to its employees and representatives, and that the limitations are observed.  FDA’s Logo Policy is for the official use of the U.S. Food and Drug Administration (FDA) and not for use on private sector materials. See https://www.fda.gov/aboutfda/aboutthiswebsite/websitepolicies/ucm218116.htm

V. Resource Obligations:

This MOU represents the broad outline of the FDA and St Jude intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, funds, and the negotiation of the appropriate written agreement. 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. CONTACTS:

A. For St Jude Children’s Research Hospital:
Clinton F. Stewart, PharmD
Member, St. Jude Faculty
Pharmaceutical Sciences MS 313, Room I5309 St. Jude Children's Research Hospital 262 Danny Thomas Place Memphis, TN 38105-3678
E-mail clinton.stewart@stjude.org
Phone: (901) 595-3665
Fax: (901) 525-6869


B. For the Food and Drug Administration:
Padmaja Mummaneni, Ph.D.
Consumer Safety Officer, Regulatory Health Project Manager, Contract Officer Representative (COR)
Center for Drug Evaluation and Research,
Office of Translational Sciences, Office of Clinical Pharmacology
10903 New Hampshire Avenue White Oak Building 51, Room 2164
Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027 
Email: Padmaja.Mummaneni@fda.hhs.gov

Each Party may designate new contacts at any time by notifying the other Party's contact in writing. If, at any time, an individual designated as a contact under this agreement becomes unavailable to fulfill those functions, the Parties will name a new contact within 2 weeks and notify the other Party through the designated contact.

VII. Term, Termination, and Modification:

This agreement, when accepted by both Parties, will have an effective period of performance from the date of the latest signature until five years (5) and may be modified or terminated by mutual written consent by the Parties or may be terminated by either Party upon a 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 St Jude operate.


APPROVED AND ACCEPTED FOR St Jude Children’s Research Hospital

Mary V. Relling, PharmD
Member, St. Jude Faculty and Chair,
Pharmaceutical Sciences Department,
Pharmaceutical Sciences MS 313,
Room I5112, St. Jude Children's Research Hospital,
262 Danny Thomas Place
Memphis, TN 38105-3678
Email: mary.relling@stjude.org
Phone: (901) 595-2348; Fax: (901) 525-8869

Date:  9/27/18

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION


Janet Woodcock, MD
Director, CDER, FDA

Date:  10/9/18

APPENDIX A

FDA Centers/Offices

The U.S. Food and Drug Administration (FDA) is comprised of six product-oriented centers and a nationwide field force. FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. It is one of the oldest federal agencies whose primary function is consumer protection. The agency touches and directly influences the lives of everyone in the United States. FDA is recognized internationally as the leading food and drug regulatory agency in the world. Many foreign nations seek and receive FDA's help in improving and monitoring the safety of their products. FDA is part of the Executive Branch of the United States Government within the Department of Health and Human Services (DHHS) and the Public Health Service (PHS).

FDA Centers and Offices include:

Office of the Commissioner (OC) - OC is committed to providing the overall scientific and regulatory policies for the entire agency, including special FDA initiatives. OC includes the Immediate Office, the Office of Women's Health, Office of Minority Health, Office of the Chief of Staff, Office of Policy, Planning and Budget, Office of Legislation, Office of Administration, Office of International Programs, Office of Equal Opportunity and Diversity Management, Office of the Chief Counsel, Office of the Counselor to the Commissioner, Office of Special Medical Programs, Office of External Affairs, Office of Regulatory Affairs, Office of Foods, and the Office of the Chief Scientist.

Center for Biologics Evaluation and Research (CBER) - CBER is committed to advancing the public health through innovative regulations that ensure the safety, effectiveness, and timely delivery to patients of biological products. CBER protects and enhances public health through regulating biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics.

Center for Drug Evaluation and Research (CDER) - CDER is committed to promoting and protecting public health by assuring that safe and effective drugs are available to Americans. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

Center for Devices and Radiological Health (CDRH) - CDRH assures that new medical devices are safe and effective before they are marketed. The Center also monitors devices throughout the product life cycle, including a nationwide post market surveillance system, and assures that radiation-emitting devices meet radiation safety standards.

Center for Food Safety and Applied Nutrition CCFSAN)- CFSAN and the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

Center for Veterinary Medicine (CVM) - CVM is a consumer protection organization that fosters public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities.

Center for Tobacco (CTP) - CTP is responsible for planning, managing, directing, and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act for tobacco products and reinstating the 1996 final rule. Some of the Agency’s responsibilities under the law includes setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. The law gives FDA the authority to regulate tobacco products and manufacturers - not growers.

National Center for Toxicology Research NCTR) - NCTR conducts peer-reviewed scientific research that supports and anticipates the FDA's current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by the FDA. This research is aimed at understanding critical biological events in expressing toxicity and at developing methods to improve assessment of human exposure, susceptibility, and risk.

Office of Regulatory Affairs CORA) - ORA is the lead office for all Field activities of the Food and Drug Administration including inspection of food, feed, and medical product manufacturing, transport and storage facilities for compliance with exiting law; as well as enforcement activities. It includes the Office of Criminal Investigations.