FY 2023 Omnibus Bill Includes Animal Research Provisions

By: Naomi Charalambakis
Wednesday, January 11, 2023
Last month, Congress released the fiscal year 2023 omnibus bill which sets funding levels for all federal agencies and programs (see “Inside the (Beltway) Scoop”). The final bill and accompanying explanatory statements include a broad range of animal research provisions, many of which were highlighted in FASEB’s community sign-on letter to House appropriators.

One provision amends current law to allow drug manufacturers to use nonanimal methods—cell-based assays, organs-on-a-chip, computer modeling, etc.—when assessing drug safety and efficacy. This language mirrors a House and Senate bill proposed earlier this year, the Food and Drug Modernization Act (H.R. 2565, S.5002). Although drug manufacturers and pharmaceutical companies already use nonanimal methods to complement studies with animals wherever possible, the omnibus language will align the law with current research practice.

Another provision directs the Government Accountability Office (GAO) to assess the extent to which research supported by National Institutes of Health (NIH) meets federal requirements, specifically the Public Health Service (PHS) Policy. Congress requests that the report also consider the processes NIH uses to review project protocols and ensure anticipated results are reproducible and replicable. Given that the review will focus on PHS Policy compliance, the assessment will include research with rodents, as these animals are covered under PHS Policy. The GAO conducted a similar report in 2018, per Congress’ request, that evaluated how well federal agencies provided animal research guidance and data to research facilities and the public.

Consistent with previous funding packages, the omnibus also prohibits funding for canine, feline, and nonhuman primate research conducted at the Department of Veterans Affairs (VA) unless the VA Secretary approves and justifies such research in writing. Currently, the VA conducts only a few studies with these species, as canines are an important model for cardiovascular and spinal cord injury research.

The Labor, Health and Human Services, Education and Related Agencies explanatory statement, an accompanying document that outlines additional requirements for agencies such as NIH, included four provisions related to various aspects of animal care and use:

• Adoption of Dogs, Cats, and Rabbits Used in Research: Congress requests NIH provide a report that details the feasibility and/or challenges of post-research adoption of dogs, cats, and rabbits used in studies. FASEB issued a statement on the topic late last year, noting our support for the placement of healthy and socially adjusted animals and urging new policy legislative proposals to consider all associated veterinary, financial, and logistical factors.
• Chimpanzee Maintenance, Care, and Transportation: Congress directs NIH to report on a quarterly basis the number of remaining chimpanzees at federal facilities and total number of deaths.
• Collection and Reporting of Animal Research Numbers and Agency Funding: As outlined in last year’s funding package, Congress requests NIH provide a plan that describes the agency’s plan to improve the accuracy and transparency of collected animal data, including strategies for addressing incomplete reporting.
• Humane Research Alternatives: While acknowledging the significant contributions of nonhuman primate research, Congress draws attention to the underutilization of nonanimal alternatives. Therefore, Congress directs NIH to provide a report that details the feasibility of establishing incentives to encourage investigators to use nonanimal models where appropriate. NIH should also consider the possibility of creating standardized peer review guidelines to evaluate justifications for animal use in grant proposals.