; and (3) ensure that at least one COVID–19 vaccine developed and made available for use in the United States is suitable for pregnant people and lactating people. (b) Requirements (1) Reporting requirements The Director of the National Institutes of Health shall collect information from every developer of a drug or biological product for the treatment or prevention of COVID–19 in the clinical stages of development that received Federal funding from the Department of Health and Human Services and its subagencies regarding— (A) how evidence is being generated to evaluate the safety, efficacy, and appropriate dosing of the drug or biological product among pregnant people and lactating people; (B) plans for the systematic collection of data from people who are inadvertently exposed to the drug or biological product while pregnant or lactating; (C) plans for the inclusion of pregnant people and lactating people, including racial and ethnic minorities disproportionately affected by COVID–19, in clinical trials or the rationale for exclusion; and (D) plans for performing Developmental and Reproductive Toxicology studies, or the rationale for not performing such studies. (2) Drug approvals and biological product licensing The Commissioner of Food and Drugs shall require a drug or biological product developer submit, as part of an application for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or licensing of a biological product under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for the treatment or prevention of COVID–19— (A) an adequate representation of the effect of the drug or biological product on pregnant people and lactating people, either through the inclusion of pregnant people and lactating people in clinical trials when safe and appropriate or other research, or through a scientific and ethical justification as to why pregnant people or lactating people were not included in clinical trials