NIH Grants and Funding
MEMORANDUM OF UNDERSTANDING AMONG
THE ANIMAL AND PLANT HEALTH INSPECTION SERVICE
U.S. DEPARTMENT OF AGRICULTURE
AND
THE FOOD AND DRUG ADMINISTRATION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
THE NATIONAL INSTITUTES OF HEALTH
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
CONCERNING LABORATORY ANIMAL WELFARE
FDA MOU 225-16-010 Amendment 1
APHIS Agreement No. 16-6100-0027-MU Amendment 1
I. PURPOSE
The participating agencies share a common concern for the care and welfare of laboratory animals used in research and testing. Each agency, operating under its own authority, has specific responsibilities for fostering proper animal care and welfare. This agreement sets forth a framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare. Implementation of this agreement is intended to maintain and enhance agency effectiveness while avoiding duplication of efforts to achieve required standards for the care and use of laboratory animals.
II. AGENCY RESPONSIBILITIES
Animal and Plant Health Inspection Service, USDA
Primary responsibility for the Animal Welfare Act (AWA) is assigned to the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS). Implementing regulations of the AWA are established in the Code of Federal Regulations, Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3. The Department has regulatory responsibility to enforce the implementing regulations. The USDA regulations establish standards for the humane treatment of laboratory animals and a registration/licensing procedure for identifying institutions that breed, sell, transport, hold, and use such animals. Compliance with the USDA regulations is monitored by an active inspection program that provides for periodic inspections of facilities that use animals for teaching, testing, and experimentation by veterinary medical officers. Serious noncompliance is dealt with by procedures that range from civil penalties, to the issuance of "cease and desist" orders, to the confiscation of animals.
Food and Drug Administration, HHS
The Food and Drug Administration (FDA) promulgated Good Laboratory Practice (GLP) regulations (21 CFR Part 58) under the Federal Food Drug and Cosmetic Act and Public Health Service Act. The GLP regulations establish administrative standards for the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA. Compliance is assessed through an active program of inspections carried out by trained Office of Regulatory Affairs and/or product Center field inspectors. Serious noncompliance is dealt with by procedures ranging from study rejection to laboratory disqualification.
National Institutes of Health, HHS
The Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, National Institutes of Health (NIH), is responsible for the implementation and general administration of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy implements the Health Research Extension Act of 1985 (Public Law 99-158), and is based on the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Standards for institutional programs and facilities are described in the Guide for the Care and Use of Laboratory Animals. Institutions receiving PHS support must have an OLAW approved Animal Welfare Assurance that describes the institutional program and sets forth institutional compliance with PHS Policy. OLAW fosters compliance through the Assurance mechanism and a national education program, and monitors compliance by evaluating institutional reports of noncompliance. Institutions are required to correct confirmed noncompliance and institute appropriate measures to prevent repeated noncompliance. Potential sanctions for continued noncompliance appear in the NIH Grants Policy Statement, Part II, under authority derived from 45 CFR § 74.14 and 42 CFR § 52.9.
III. SHARED CONCERNS
USDA, FDA, and NIH share a common concern for the care and use of laboratory animals, although there are necessary operational differences among the animal welfare programs of the cooperating agencies. Congress acknowledged the need for trans-agency cooperation in the AWA by calling for the Secretary of Agriculture to consult and cooperate with other Federal departments and agencies concerned with the welfare of animals used in research, and to consult with the Secretary of Health and Human Services prior to the issuance of regulations.
Common program features include the promulgation of standards and policies aimed at promoting laboratory animal welfare, the maintenance of registries/inventories of institutions and facilities subject to agency policies and regulations, the periodic conduct of routine and "for cause" inspections or site visits, efforts designed to promote voluntary compliance, and the application of a range of sanctions when necessary.
Interagency cooperation provides an excellent opportunity to bolster individual agency efforts, achieve program benefits, and facilitate program operations. A mutually shared perspective on acceptable standards of laboratory animal care presents a consistent Federal approach and fosters compliance by regulated entities.
IV. AUTHORITY
FDA has authority to enter into this agreement pursuant to Section 1003(b) and (c) of the Federal Food, Drug and Cosmetic Act.
NIH has authority to enter into this agreement pursuant to Section 495 of the Public Health Service Act.
Under the Animal Welfare Act (AWA) (7 USC §§ 2131 et. seq.), the Secretary of Agriculture is authorized to assure humane treatment and care for animals intended for use as pets, research, and exhibition and to cooperate with the officials of the various states or political subdivisions thereof in carrying out the purposes of this Act and of any State, local or municipal legislation or ordinance on the same subject.
V. SUBSTANCE OF AGREEMENT
The cooperating agencies agree to share information of mutual concern and interest regarding animal welfare.
This is an internal Government agreement among USDA, FDA, and NIH and does not confer any rights or benefits to any person or party. This MOU does not include any commitment by any agency to contribute or exchange or transfer funds.
This MOU does not affect or supersede any existing or future agreements or arrangements between or among the parties. This MOU and any associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the cooperating agencies operate.
Specific agency responsibilities under this Memorandum of Understanding are detailed below.
A. The cooperating agencies agree to share information contained in their respective registries/inventories/listings of organizations that fall under their purview.
B. The cooperating agencies agree to provide one another with information concerning significant adverse findings regarding animal care and use at organizations investigated, inspected, or site-visited, and the actions taken by the agency in response to the findings.
C. The cooperating agencies agree to provide one another with information regarding evidence of serious noncompliance with required standards or policies for the care and use of laboratory animals at organizations that fall under the authority of the participating agencies.
D. The cooperating agencies agree, to the extent possible, to coordinate successive evaluations and to avoid redundant evaluations of the same entities.
E. The cooperating agencies agree to consult and coordinate with each other on regulatory or policy proposals and significant policy interpretations involving animal care and use under consideration by each agency.
F. The cooperating agencies agree to provide each other with resource persons for scientific and educational seminars, speeches, and workshops related to laboratory animal welfare.
G. The cooperating agencies agree to limit the dissemination of shared information to include only those authorized FDA, USDA and NIH employees and officials who require such access in order to perform their official duties in accordance with the uses of the information as authorized by this MOU. If records provided by any cooperating agency under this agreement are the subject of a FOIA request submitted to the agency that received the records, that agency will refer the FOIA request and relevant records to the agency that provided the records for processing. If the FOIA request seeks two or more parties’ records or if the request is for records created by one agency that incorporates information provided by one or both other agencies, the agency receiving the FOIA request will forward all such requests to the respective FOIA offices for USDA, FDA, and NIH for disposition. The recipient agency shall promptly notify the agency that provided the information of any judicial order that compels the release of information.
H. The cooperating agencies recognize and acknowledge that nonpublic information shared between or among the agencies, whether written or oral, must be shared in a manner consistent with the requirements of 21 CFR 20.85 and protected from any further disclosures or use not authorized by law or regulation. All agencies will establish safeguards to ensure that any nonpublic information shared under this MOU is protected from unauthorized disclosure or use. Such safeguards help ensure compliance with other applicable laws and regulations and should include the marking of any materials as “confidential” prior to disclosure or the use of encryption technologies when appropriate.
VI. STANDING COMMITTEE
To facilitate implementation of this agreement, the cooperating agencies each agree to designate a liaison officer to serve on a standing committee that will meet as needed, but no less than twice per year. Matters for consideration by the standing committee are to include a review of each agency's participation in this agreement, an assessment of the agreement's effectiveness, and modifications that might be necessary. As appropriate, the committee will address urgent issues and specific cases of serious noncompliance. The names of staff listed below represent the current persons or positions with these assigned roles at the date of signing of this MOU. Additional or alternative USDA, FDA, and NIH staff may be drawn to provide expertise as needed.
VII. LIAISON OFFICERS
For the Animal and Plant Health Inspection Service:
Elizabeth Theodorson, DVM, MPH
Assistant Deputy Administrator USDA, APHIS, AC
4700 River Road,
Riverdale, MD 20737-1234
Phone: 970-494-7473
For the Food and Drug Administration:
Brianna Skinner, DVM, MPH
Senior Regulatory Veterinarian
Office of Counterterrorism and Emerging Threats
U.S. Food and Drug Administration
10903 New Hampshire Avenue
WO 1, Room 4208
Silver Spring, MD 20993
Phone: 240-402-1240
For the National Institutes of Health:
Patricia Brown, VMD, MS
Director, Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
6700B Rockledge Drive, Suite 2500, MSC 6910
Bethesda, MD 20892-6910
Phone: 301-496-7163
VIII. PERIOD OF AGREEMENT
This agreement becomes effective on the date of last signature and continues for 5 years. It may be modified by mutual written consent of the three parties. The agreement may be terminated by any party upon a 90-day advance written notice to the other parties. At the conclusion of 5 years the three parties will consider the development of a new agreement.
IX. ACCEPTANCE AND APPROVAL OF AUTHORIZING OFFICIALS
For the Animal and Plant Health Inspection Service, USDA:
Signature: /s/
Name: Robert Huttenlocker, MBA
Title: Deputy Administrator, Marketing and Regulatory Programs Business Services, Animal and Plant Health Inspection Service
U.S. Department of Agriculture
Date: June 21, 2021
For the Food and Drug Administration, HHS:
Signature: /s/
Name: Janet Woodcock, MD
Title: Acting Commissioner of Food and Drugs
U.S. Department of Health and Human Services
Date: May 18, 2021
For the National Institutes of Health, HHS:
Signature: /s/
Name: Francis S. Collins, MD, PhD
Title: Director, National Institutes of Health
U.S. Department of Health and Human Services
Date: May 4, 2021