1. Short title This Act may be cited as the NIH Clinical Trial Diversity Act of 2023 . 2. Diversity goals for clinical trials (a) Applications Beginning on the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (in this section referred to as the Secretary ), shall require that a sponsor seeking to conduct a clinical trial investigating a drug, device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 et seq. )) biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or behavioral intervention, the protocol for which is approved by the National Institutes of Health, to submit an application (or renewal thereof) for such 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) 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 calculate 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; (3) a detailed plan for how the clinical trial will achieve the goals specified under paragraph (1) that specifies— (A) the requirements for researchers, in conducting the trial, to analyze the population groups specified in paragraph (1) separately; (B) the role of community partners or community institutional review boards in reviewing the plans