HHS Accelerates Shift to Human-Based Research, Reduces Reliance on Animal Testing

WASHINGTON, D.C. — SEPTEMBER 21, 2026 — The U.S. Department of Health and Human Services (HHS) today announced a new wave of agency-wide actions to accelerate the shift toward human-based research methods and reduce unnecessary animal testing, advancing a coordinated effort to modernize how the federal government conducts, funds, and evaluates biomedical research.

Since Secretary Robert F. Kennedy, Jr. took office, HHS agencies have launched more than 20 initiatives to expand the use of technologies including human organoids, tissue models, artificial intelligence, and computational modeling while reducing reliance on animal models.

“We are moving HHS toward a new era of biomedical research that puts human biology at the center of science,” said HHS Secretary Kennedy. “We are modernizing outdated regulations, investing in human-based technologies, and breaking down barriers that have kept researchers dependent on animal models when better tools are available. Under President Trump, we will use the best science to protect patients, accelerate medical breakthroughs, and end unnecessary animal testing.”

Today’s actions span HHS’ research, regulatory, and public health agencies and expand the use of human-based science from the laboratory bench to federal regulatory review.

The U.S. Food and Drug Administration (FDA) today issued a direct final rule updating its regulations to remove references to animal testing and implement the FDA Modernization Act.

The National Institutes of Health (NIH) announced a series of investments and initiatives to build the infrastructure needed to develop, validate, and scale human-based research, including:

• More than $88 million in funding for biomedical infrastructure projects nationwide;
• A new challenge offering more than $7 million in awards to demonstrate how quantum-enabled approaches can improve detection and measurement in lab-based New Approach Methodologies (NAMs);
• A state-of-the-art laboratory at the NIH Clinical Center that will integrate standardized human organoid models, robotics, artificial intelligence, and advanced data capabilities to enable experiments on reproducible human biological systems;
• An initiative to recruit grant reviewers with expertise in human-based science; and
• A new request for information from the scientific community to assess the feasibility of an annual public report tracking the number of vertebrate animals used in NIH-funded research.

HHS also launched a new webpage providing a comprehensive accounting of actions of more than 20 actions the Department has taken to reduce animal testing and advance NAMs.

National Institutes of Health

NIH is expanding the scientific infrastructure needed to develop, validate, and scale human-based research methods. These efforts build on NIH’s establishment of the Office of Research Innovation, Validation, and Application, which coordinates NIH-wide efforts to advance human-based approaches and support their transition into biomedical research.

NIH has also closed its last intramural beagle laboratory and allows grant funding to be used to retire or rehome research animals.

“NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “Our goal is to give researchers better tools to understand human disease and translate discoveries into treatments that improve patients’ lives.”

Food and Drug Administration

FDA is modernizing its regulatory approach to give drug developers greater ability to use scientifically validated alternatives to animal testing.

The agency has issued multiple guidances designed to reduce animal studies in drug development, including changes expected to spare hundreds of non-human primates and more than one million horseshoe crabs annually. FDA has also established new programs to evaluate and integrate NAMs into regulatory decision-making.

“FDA is modernizing its regulatory framework so developers can use the best science available to demonstrate that medical products are safe and effective,” said Acting FDA Commissioner Kyle Diamantas, J.D. “By removing outdated barriers to new approach methodologies, we can reduce unnecessary animal testing while making product development more predictive and efficient.”

Centers for Disease Control and Prevention

The Centers for Disease Control and Prevention (CDC) is substantially reducing its laboratory animal colony and has established additional review to ensure proposed animal research aligns with CDC’s mission and identified public health needs.

CDC is working to permanently place healthy non-human primates in a qualified sanctuary and is conducting more than a dozen studies using NAMs to advance the nation’s ability to rapidly respond to public health threats.

“CDC is reducing animal use while ensuring that our scientists have the tools they need to protect Americans from health threats,” said CDC Director Erica Schwartz. “We are applying greater scrutiny to animal research and focusing our resources on science that directly advances our public health mission.”

Advanced Research Projects Agency for Health

The Advanced Research Projects Agency for Health (ARPA-H) is investing in artificial intelligence and computational modeling through its CATALYST program to better predict drug safety, optimize dosing, and reduce reliance on preclinical animal testing.

“Artificial intelligence and advanced computational modeling can fundamentally change how we predict whether medicines will be safe for people,” said ARPA-H Director Alicia Jackson, Ph.D. “We are developing tools that can provide better information earlier and help move promising treatments to patients more efficiently.”

Together, these actions advance HHS’ effort to develop and validate research methods that better reflect human biology, reduce unnecessary animal use, and give researchers and regulators more tools to evaluate the safety and effectiveness of medical products.

The new HHS webpage provides the full list of more than 20 actions taken to date, along with additional information on federal efforts to replace, reduce, and refine animal use.