MOU 225-17-020

Memorandum of Understanding
Between The American Association of Veterinary State Boards (AAVSB)
and The United States Food and Drug Administration, Center for Veterinary Medicine (FDA CVM) 
 

I. Purpose

This Memorandum of Understanding (MOU) establishes a cooperative relationship between the American Association of Veterinary State Boards (AAVSB) and the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM), regarding the exchange of veterinarian licensure status and enforcement information, including information from the AAVSB licensure and disciplinary database and publicly available untitled letters and warning letters and publicly available information regarding enforcement actions  (e.g., civil or criminal actions) FDA CVM pursues against veterinarians.

II. Background

AAVSB is a not-for-profit association recognized as exempt from Federal taxation under section 501(c)(3) of the Internal Revenue Code.  AAVSB membership currently consists of veterinary regulatory boards (“member boards”) from the United States and Canada.  AAVSB’s mission is to lessen burdens on state government by providing programs and services to its member boards to promote public protection through the regulation of the veterinary profession.

FDA CVM is responsible for protecting human and animal health.  At times, the licensure or disciplinary status of a veterinarian is relevant to determining compliance with FDA CVM regulations and statutes.

Through its Veterinary Information Verifying Agency (VIVA) program, AAVSB maintains the VIVA License and Discipline Database (license and discipline database), which includes veterinary licensure information and information regarding final adverse actions taken by its member boards. Such database historically has been reserved for internal use only by AAVSB and its member boards.

However, in keeping with AAVSB’s mission of supporting and advancing the regulatory process for veterinary medicine, AAVSB has elected to make information contained in its license and discipline database available to FDA CVM under the terms and conditions set forth in this Memorandum of Understanding. 
 
III. Substance of Agreement and Roles and Responsibilities

Under this MOU, upon request of the FDA CVM, AAVSB will provide FDA CVM with information from the AAVSB VIVA License and Discipline Database, for use by FDA CVM in verifying veterinarian licensure status for purposes of assessing compliance with FDA CVM regulations and statutes.  In terms of the format and frequency in which such data will be provided to FDA CVM, AAVSB intends to cooperate with FDA CVM’s requests to the extent possible, taking into consideration the workloads of AAVSB staff. Under this MOU, FDA CVM intends to use the data AAVSB provides concerning the licensure status of veterinarians only for the purpose of determining compliance with the statutes and regulations FDA CVM enforces.  Although FDA CVM recognizes that data provided by AAVSB to FDA CVM remains the property of AAVSB, FDA CVM also recognizes its responsibility to comply with applicable legal requirements regarding the disclosure of the AAVSB-provided data.  FDA CVM intends to inform AAVSB promptly of any effort made by judicial or legislative mandate (e.g., the Freedom of Information Act), or any other process, to obtain AAVSB-provided information from FDA. Pursuant to this MOU, FDA CVM intends to notify the AAVSB of publicly available untitled letters and warning letters and publicly available information concerning enforcement actions (e.g., civil or criminal actions) FDA CVM pursues against a veterinarian for violations of statutes and regulations enforced by FDA.  FDA CVM does not intend to share any data and information that is considered privileged, confidential, or pre-decisional and deliberative in nature under this MOU.

AAVSB and FDA CVM recognize that this is a non-binding MOU, and that AAVSB and FDA CVM each reserves the right to unilaterally terminate this MOU at any time and at its discretion.  In the event of termination for any reason, FDA CVM intends to handle any information and documents received from AAVSB consistent with 21 CFR part 20.

IV. General Provisions:

This agreement between FDA CVM and AAVSB does not establish any rights for any person.

V. Resource Obligations:

This MOU represents the broad outline of the parties’ present intent to enter into an agreement providing for collaborative efforts in areas of mutual interest to FDA CVM and AAVSB.  All activities undertaken through this MOU are subject to the availability of personnel, resources, and funds.  This MOU does not affect or supersede any existing or future agreements or arrangements between these two parties.  This MOU does not create binding, enforceable obligations against any party.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and/or statutes under which FDA CVM and AAVSB operate.

VI. Liaison Officers:

A.  For AAVSB:
James T. Penrod, CAE, FASLA
Executive Director of the American Association of Veterinary State Boards
380 W. 22nd Street, Suite 101
Kansas City, MO 64108
Phone: 1-816-931-1504
Toll-Free: 1-877-698-8482
Fax: 1-816-931-1604
jpenrod@aavsb.org

B.  For FDA CVM:
Michael Murphy, DVM, JD, Ph.D.
Veterinary Medical Officer 
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-1
Rockville, MD 20855
Phone:  240-402-6217
Michael.Murphy@fda.hhs.gov

Each party may designate new liaisons at any time by notifying the other party's administrative 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 administrative liaison.

VII. Term, Termination, and Modification

When accepted by both parties, this MOU will be effective from the date of the last signature.  This MOU becomes effective following the signature of both parties and remains effective until modified or terminated.  This MOU may be modified by mutual consent of the parties, or may be terminated by either party upon a 90-day advance written notice to the other party.

VIII. Approval

Approved and accepted for the   
U.S. Food and Drug Administration 
Director Center for Veterinary Medicine 
October 8, 2017

Approved and Accepted for
American Association of Veterinary
State Boards (AAVSB)
Executive Director AAVSB
October 18, 2017