1. Short title This Act may be cited as the NIH Clinical Trial Diversity Act of 2023 . 2. Diversity goals for clinical trials funded by the National Institutes of Health (a) Applications Beginning on the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (referred to in this section as the Secretary ), shall require that a research organization or entity funded by the National Institutes of Health (referred to in this section as an NIH-funded research organization or entity ) seeking to conduct a clinical trial investigating a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) or a biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )) that is funded by the National Institutes of Health or a behavioral intervention, the protocol for which is approved by the National Institutes of Health, submit an application (or renewal thereof) for such funding or approval that includes— (1) clear and measurable goals for the recruitment and retention of participants that reflect— (A) the race, ethnicity, age, and sex of patients with the disease or condition being investigated; or (B) as scientifically or ethically justified and appropriate, the race, ethnicity, age, and sex of the general population of the United States if the prevalence of the disease or condition is not known; (2) a rationale for the goals specified under paragraph (1) that specifies— (A) how investigators will determine the number of participants for each population category that reflect the population groups specified in paragraph (1); or (B) strategies that will be used to enroll and retain participants across the different race, ethnicity, age, and sex categories