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  1. Academic MOUs

MOU 225-16-006

MEMORANDUM OF UNDERSTANDING
BETWEEN

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

AND

CORNELL UNIVERSITY

ARTICLE 1 – PURPOSE

The parties to this Memorandum of Understanding (MOU) are the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) and Cornell University (Cornell).

The purpose of this MOU is to establish a mutually acceptable agreement between FDA and Cornell that will provide for collaboration on the development and delivery of training to FDA and State, Local, Tribal and Territorial inspection personnel. This MOU supersedes any existing MOUs, supplements, and amendments between FDA and Cornell University relating to training of FDA, and State, Local, Tribal and Territorial Inspection personnel.

ARTICLE 2 - AUTHORITY

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. 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 is charged with these responsibilities under the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.) and the Public Health Services Act, including sections 351 and 362 (42 USC 262, 264). Section 1011 of the Act expressly authorizes FDA to set standards and administer training and education programs for the employees of State,  local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by the Act (21 U.S.C. 399c).

Cornell is the federal land-grant institution of New York State, a private endowed university, and a partner of the State University of New York. It is dedicated to its land-grant mission of outreach and public service to make contributions in all fields of knowledge in a manner that prioritizes public engagement to help improve the quality of life in New York State, the nation, and the world.

ARTICLE 3 - SUBSTANCE OF AGREEMENT

The goals of the collaboration are to:

a. Develop and/or deliver Office of Regulatory Affairs  (ORA) Cooperative Program component training, i.e., Milk Safety, Retail Food Protection, Juice, etc.,  to facilitate enhanced regulatory collaboration and  information sharing between Federal, State, local, tribal and territorial partners.

b. Develop and/or deliver training in dairy applications, i.e., Pasteurization Controls and Tests, Laboratory Practices, Dairy Plant Inspection, Dairy Farm Inspection, Environmental Sampling, Greek Yogurt Manufacturing, etc.

c. Revise existing Human Food Good Manufacturing Practice (GMP) training materials/modules to encompass the changes in 21 CFR Part 117, Subpart B.

FDA and Cornell mutually agree to:

a. Seek opportunities to collaborate on the development and delivery of training, particularly via on-line, video and other web-based and/or blended learning modalities, in the areas identified in this Article above.

b. Identify training priorities and topics of mutual interest in separate written instruments which reference this agreement, prior to the initiation and implementation of any specific collaboration.

c. Collaborate and participate in intra-agency, and joint training, including but not limited to, on-line training, meetings and conferences, and appropriate joint exercises and events in keeping with the areas of interest identified in Article 1.

d. Identify and provide points of contact (POCs)/liaisons between FDA and Cornell.

FDA will:

a. Designate ORA’s Associate Director for Management as the authorized representative responsible for collaboratively administering the overall activities conducted under this MOU.

b. Appoint a senior FDA official to serve as the FDA liaison to Cornell. The FDA liaison will coordinate all information and actions and receive requests from and submit requests to Cornell for activities under this MOU.

ARTICLE 4 - GENERAL PROVISIONS

Data Sharing Guidelines:

This memorandum does not authorize any sharing of confidential information.  Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the FDA and Cornell will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with applicable policies of the respective parties, and other pertinent laws and regulations governing the confidentiality of such information.  No proprietary data, trade secrets or patient confidential information shall be disclosed between the FDA and Cornell unless permitted by applicable law.

Intellectual Property Guidelines:

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. Cornell 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.

Conflict of Interest:

The parties commit to performing duties under this memorandum in a manner that is free from conflict of interest.  Cornell will instruct employees to notify their supervisor if, at any time prior to or during the performance of the assigned duties, the employee believes that a potential or actual conflict exists.  Cornell will notify the FDA contact person on this agreement of any potential or actual conflict of interest.

ARTICLE 5 - RESOURCE OBLIGATION

This MOU represents the broad outline of the FDA and Cornell’s intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest as described in Articles 1 and 3. All activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds.

This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Cornell operate.

ARTICLE 6 – TERM, TERMINATION AND MODIFICATION

This agreement, when accepted by the FDA and Cornell, will have an effective period of performance of five years from the date of the latest signature. It may be modified or terminated by mutual written consent of the partners or may be terminated by either partner upon a 60-day advance written notice to the other.

ARTICLE 9 - POINTS OF CONTACT

The names of FDA and Cornell staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Additional FDA and Cornell staff may be utilized to provide appropriate scientific and subject matter expertise as needed.
 

CORNELL UNIVERSITY

Cornell Technical Liaison (per Article 3)
Martin Wiedmann, Dr. med. vet, Ph.D.
Professor and Director of Graduate Studies, Field of Food Science and Technology
347 Stocking Hall
Department of Food Science
Cornell University
Ithaca, NY 14853
607-254-2838

Cornell Administrative Liaison
Linda Griswold
Grant and Contract Officer
Office of Sponsored Programs
Cornell University
373 Pine Tree Rd.
Ithaca, NY 14850-2820.
607-255-7280

 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

For Office of Regulatory Affairs
Melinda K. Plaisier, MSW
Associate Commissioner for Regulatory Affairs
Office of Regulatory Affairs
Food & Drug Administration, DHHS
10903 New Hampshire Ave.
WO31 RM3528
Silver Spring, MD 20993
301-796-8736

Primary FDA Liaison
AssociateDirectorforManagementORA@fda.hhs.gov 
Associate Director of Management
Office of Resource Management
Office of Regulatory Affairs
Food & Drug Administration, DHHS
12420 Parklawn Drive, ELEM-2002
Rockville, MD 20857

Secondary FDA Liaison
Patricia L. Alcock
Director, Division of Human Resource Development
Office of Resource Management
Office of Regulatory Affairs
11919 Rockville Pike
Montrose Metro II, Room 219
Rockville, MD 20852
301-796-4299

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 Party affected will name a new liaison within two (2) weeks and notify the other Party through the designated liaison.

SIGNATURE OF RESPONSIBLE PARTIES

APPROVED AND ACCEPTED FOR CORNELL UNIVERSITY:  

Linda Griswold
Office of Sponsored Programs
Cornell University

12/15/2015

READ AND UNDERSTOOD BY:

Martin Wiedmann
Cornell University
Department of Food Science

12/14/2015

APPROVED AND ACCEPTED FOR UNITED STATES FOOD AND DRUG ADMINISTRATION

Patricia L. Alcock
Director
Office of Training, Education, and Development

12/15/2015

Melinda K. Plaisier
Associate Commissioner for Regulatory Affairs

12/18/2015