Department of Health
and Human Services (HHS)
and Human Services (HHS)
August 28, 2020
Office of The Director, National Institutes of Health (OD)
Through this Request for Information (RFI), the NIH Office of Laboratory Animal Welfare (OLAW) is seeking input on encouraging AAALAC International-accredited institutions to use sections of the AAALAC International Program Description to complete applicable parts of the OLAW Animal Welfare Assurance.
Background
The 21st Century Cures Act, section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research as part of the 21st Century Cures Act is to encourage AAALAC International-accredited institutions to use sections of the AAALAC International Program Description in applicable parts of the OLAW Animal Welfare Assurance.
OLAW oversees Public Health Service (PHS)-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on the Humane Care and Use of Laboratory Animals (Policy). The PHS Policy section IV.A. states that no activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS setting forth compliance with the Policy. All Assurances submitted to the PHS in accordance with the Policy will be evaluated by OLAW to determine the adequacy of the institution’s proposed program for the care and use of animals in PHS-conducted or -supported activities.
AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. The AAALAC International accreditation program evaluates organizations that use animals in research, teaching, or testing. Those that meet or exceed AAALAC International standards are awarded accreditation. The accreditation process includes an extensive internal review of a comprehensive document called a Program Description (PD) which describes all aspects of the animal care and use program (policies, animal housing and management, veterinary care, and facilities).
Institutions may consider using portions of their AAALAC PD as highlighted below to complete their OLAW Assurance. However, institutions must ensure that all information requested in the Assurance is provided, including information that is not requested in the AAALAC PD but is required by OLAW.
Information Requested
The NIH is seeking input on encouraging AAALAC International-accredited institutions to consider using the following sections of the AAALAC PD to complete applicable parts of the OLAW Animal Welfare Assurance. For each element of the AAALAC PD presented, consider whether it is relevant to the associated part of the Assurance. Include any concerns regarding the AAALAC PD element and the associated Assurance section.
For the Assurance Part III.D.9. Describe how the IACUC monitors ongoing activities (postapproval monitoring).AAALAC PD Section 2.I.B.2. Post-Approval Monitoring:
a. Describe mechanisms for the Institutional Animal Care and Use Committee (IACUC) review of ongoing studies and periodic proposal/protocol reviews (PD pg. 18).
e. Describe any other monitoring mechanisms or procedures used to facilitate ongoing protocol assessment and compliance, if applicable (PD pg. 19).
For the Assurance Part III.E. The risk-based occupational health and safety program for personnel working in laboratory animal facilities and personnel who have frequent contact with animals is as follows: [Describe the Institution’s occupational health and safety program for personnel involved in the care and use of animals.]
AAALAC PD Section 2.I.A.2.b. Occupational Health and Safety of Personnel:
i.1) List the institutional entities that are involved in the planning, oversight, and operation of the institutional occupational health and safety program related to animal care and use (PD pg. 6).
ii.1) a) Describe who receives personal medical evaluation as a component of individual risk assessment (PD pg. 8).
ii.1) d) Describe safety considerations for individuals with incidental exposure to animal care and use (e.g., contractors; PD pg. 8).
ii.1) e) Describe general features of the medical evaluation and preventive medicine programs within the context of work duties including: pre-employment/pre-assignment health evaluation, medical evaluations, diagnostic tests (e.g., for tuberculosis), precautions for working with potentially hazardous species, and immunization programs (PD pg. 8).
ii.2) Describe general educational program(s) to inform personnel about: allergies, zoonoses, personal hygiene, physical injuries in animal facilities, or species used (e.g., nonhuman primates). Include in the description a summary of the topics covered, including entities responsible for providing the training (PD pg. 9).
ii.3) a) List routine personal protective equipment and work clothing provided and/or required for animal care personnel, research, and technical staff (PD pg. 9).
ii.3) c) Describe provisions and expected practices for washing hands, showering, and changing clothes (PD pg. 9).
ii.3) d) Describe policies regarding eating, drinking, and smoking in animal facilities (PD pg. 10).
For the Assurance Part III.G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use.
AAALAC PD Section 2.I.A.2.a. Training, Education, and Continuing Educational Opportunities:
i. For the Attending Veterinarian and other individuals having a direct role in providing veterinary medical care, provide training and continuing education opportunities (PD pg. 5).
ii. 2) For Animal Care Personnel, summarize training and continuing education opportunities provided (PD pg. 5). [There is no requirement to include animal care personnel certification levels, type, and experience in the Assurance document.]
iii.1.a) For the Research Team, briefly describe the content of any required training (PD pg. 6).
iii.1.c) For the Research Team, describe continuing education opportunities offered (PD pg. 6).
AAALAC PD, Section 2.I.B.1. The Role of the IACUC:
a. iii. Describe the orientation, training, and continuing education opportunities for IACUC members (PD pg. 14).
How to Submit a Response
All responses to this RFI must be submitted electronically on the RFI webpage by November 28, 2020, at 11:59 EST. The comments may be made available on the OLAW website.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
Office of Laboratory Animal Welfare
Telephone: 301-496-7163
Email: [email protected]