Office of Laboratory Animal Welfare - MOU Between NIH and NASA

Memorandum of Understanding (MOU)
Between
Office of Laboratory Animal Welfare
Office of Extramural Research
Office of the Director
National Institutes of Health
And
National Aeronautics and Space Administration

This MOU sets forth the terms under which the National Aeronautics and Space Administration (NASA) intends to transfer funds via Interagency Agreement to the Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, Office of the Director, National Institutes of Health (NIH) (hereafter referred to as agencies), for services provided in ensuring compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) and the Guide for the Care and Use of Laboratory Animals for all NASA grants, contracts, cooperative agreements involving research with live vertebrate animals.

BACKGROUND

OLAW is responsible for the general administration and implementation of the PHS Policy. The PHS Policy, promulgated in 1986 to implement the Health Research Extension Act of 1985, requires institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities conducted or supported by the PHS. OLAW is mandated, through the PHS Policy, to “advise awarding units and awardee institutions concerning the implementation of this Policy”.

PURPOSE

The purpose of this MOU is to outline the process for technical and administrative services to be performed by OLAW for the NASA. NIH requires OLAW to charge for cost recovery for the services provided to agencies outside of NIH. OLAW has developed a fee structure that is based primarily on the number of domestic Animal Welfare Assurances administered by OLAW and supported by the annual OLAW operating budget. As NASA currently holds four domestic Assurances, the charges are a base amount. The cost for these services is subject to annual adjustment.

These services include general and comprehensive administration and coordination of the PHS Policy to include:

Negotiate, review and approve Animal Welfare Assurances in support of NASA grants, contracts, cooperative agreements and intramural activities;
Distribute lists of approved Assurances on the OLAW website;
Evaluate allegations of noncompliance with the PHS Policy;
Advise and educate on implementation of the PHS Policy;
Provide guidance on interpretation of the PHS Policy;
Authorize waivers to the PHS Policy; and
Conduct site visits to selected institutions.

SUBSTANCE OF AGREEMENT

Interpretation of, and determination of noncompliance with, PHS Policy remain the exclusive purview of NIH/OLAW as authorized by Public Law 99-158.
At the request of NASA, OLAW will negotiate Animal Welfare Assurances for NASA- supported institutions that do not receive PHS support for activities involving live vertebrate animals. NASA-supported activities include use of NASA resources, funding, personnel, or equipment (e.g. ground-based research, the International Space Station (ISS), or its equivalent) in support of NASA grants, contracts, cooperative agreements and intramural activities.
Subject to each agency's internal policies and guidelines and upon receiving a request, the NASA and OLAW agree to share information of mutual concern and interest regarding animal welfare at NASA-supported institutions, including, but not limited to, evidence of serious noncompliance with standards for the care and use of animals in regulated activities, significant adverse findings regarding animal care and use investigated, inspected, or site-visited, and actions taken by the agencies in response to the findings.

NASA and OLAW will consult with one another about investigations of noncompliance at institutions with PHS Assurances and NASA funding. NASA and OLAW will notify each other of information concerning potential noncompliance involving NASA-supported activities at institutions with PHS Assurances
NASA will share information relevant to NASA-supported activities not in compliance with PHS Policy with OLAW.

NASA-supported PHS-Assured entities will report incidents of noncompliance to OLAW and any funding Federal agency. The Institutional Animal Care and Use Committee (IACUC), through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

any serious or continuing noncompliance with the PHS Policy;
any serious deviations from the provisions of the Guide; or
any suspension of an activity by the IACUC.

OLAW will receive and evaluate allegations of noncompliance with the PHS Policy that arise during the course of the NASA supported research, regardless of location, and including but not necessarily limited to, each of the NASA Centers, the ISS, the Principal Investigator’s home institution or any related location where NASA resources were utilized in support of regulated animal activities.
NASA and OLAW agree to limit the dissemination of shared information received to internal agency officials who have a need to know. If either agency receives a Freedom of Information Act request for records provided by the other agency, the recipient agency will refer the request to the agency that provided the records. The recipient agency will promptly notify the agency that provided the information of any judicial order that compels the release of information.
NASA and OLAW agree to work collaboratively to co-sponsor educational meetings and workshops, to collaborate on online training, and to provide each other with resource persons, to the extent possible, for seminars, presentations and workshops related to laboratory animal welfare and their respective agency responsibilities.
Nothing in this agreement shall limit or otherwise affect each party's ability to exercise its own authorities or gives the other party approval power over the exercise of the other party's authorities.
OLAW will direct the posting of a Notice of Memorandum of Understanding Between NIH and NASA Concerning Laboratory Animal Welfare to the NIH Grants and Funding, NIH Central Resource for Grants and Funding Information website.
OLAW and NASA will communicate the relationship between OLAW and NASA as described in this MOU at relevant meetings, conferences, and other venues, if and when appropriate.

This work is in support of the Health Research Extension Act of 1985, Public Law 99-158, Sec. 495 requiring that the Secretary, Department of Health and Human Services, acting through the Director of NIH, establish guidelines for the proper care of animals used in biomedical and behavioral research.

LIAISONS

National Institutes of Health

Jane Na, DVM, CPIA
Director, Division of Assurances
Office of Laboratory Animal Welfare
Office of Extramural Research, Office of the Director, NIH
6700B Rockledge Drive
Suite 2500, MSC 6910
Bethesda, MD 20892
301.402.1922
[email protected]

National Aeronautics and Space Administration

James D. Polk, DO, EdD, MS, MMM, CPE, FACOEP, FAsMA
Chief Health and Medical Officer and Health and Medical Technical Authority
NASA Office of the Chief Health and Medical Officer
NASA Headquarters
Mail Code QA, Room 2K22
300 E Street, SW
Washington, DC 20546
202.358.1959
[email protected]

Mark Weyland
Director, Health Operations and Oversight
NASA Office of the Chief Health and Medical Officer
NASA Headquarters
Mail Code QA, Room 2M34
300 E Street, SW
Washington, DC 20546
281.483.6193
[email protected]

PERIOD OF AGREEMENT

This agreement covers the period October 1, 2024 through September 30, 2029.

SCHEDULE OF PAYMENTS

Payments made pursuant to this MOU will be charged as an annual lump sum to be paid via Interagency Agreement each fiscal year during the period of agreement.
However, this MOU is neither a fiscal nor a funds obligation document. Nothing in this MOU authorizes or is intended to obligate the Parties to expend, exchange, or reimburse funds, services, or supplies, or transfer or receive anything of value. Nothing in this MOU may be construed to obligate the NASA or OLAW to any current or future expenditure of resources in advance of the availability of appropriations. Nor does this MOU obligate the NASA or OLAW to spend funds on any particular project or purpose, even if funds are available.

MODIFICATION/CANCELLATION

This agreement may be modified or canceled within 30 days and at any time with the written concurrence of both parties by written notice by either the Requesting or Servicing Agency. If this agreement is canceled, any implementing contract/order may also be canceled. If the IAA is terminated, the agencies shall agree to the terms of the termination, including costs attributable to each party and the disposition of awarded and pending actions.

RESOLUTION of DISAGREEMENTS

Should disagreement arise under this agreement, or amendments and/or revisions thereto, that cannot be resolved at the Division Director level, the area(s) of disagreement shall be stated in writing by each party and presented to the other party at the Assistant Director or equivalent level for consideration.

APPROVED AND ACCEPTED

Axel Wolff, MS, DVM
Acting Director, OLAW, NIH
Signature: /s/
Date: 7/19/2024

James D. Polk, DO, EdD, MS, MMM, CPE, FACOEP, FAsMA
Chief Health and Medical Officer, NASA
Signature: /s/
Date: 8/12/2024

Mark Weyland
Director, Health Operations and Oversight, NASA
Signature: /s/
Date: 8/13/2024