Sec. 2. Premarket reporting of diversity plans for clinical trials and studies
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The Commissioner of Food and Drugs shall issue regulations revising part 312 of title 21, Code of Federal Regulations, to require sponsors of applications for an exemption for investigational use of a drug to include— in any such application— the estimated prevalence in the United States of the disease or condition for which the drug is being developed or investigated, disaggregated by demographic subgroup, where such data is available, including age group, sex, race, and ethnicity; the sponsor’s targets for enrollment in the clinical trial or trials involved, disaggregated by age group, sex, race, and ethnicity; the rationale for the sponsor’s enrollment targets referred to in subparagraph (B), which may include— the estimated prevalence referred to in subparagraph (A); what is known about the disease or condition for which the drug is being developed or investigated; any relevant pharmacokinetic or pharmacogenomic data; what is known about the patient population, including co-morbidities and potential barriers to enrolling diverse participants, such as patient population size and geographic location; and any other data or information the sponsors deems relevant to selecting appropriate enrollment targets, disaggregated by demographic subgroup; and a diversity action plan for how the sponsor will meet such targets, including demographic-specific outreach and enrollment strategies, study-site selection, clinical trial inclusion and exclusion practices, and any diversity training for trial personnel; and in an annual report described in section 312.33 of title 21, Code of Federal Regulations— the sponsor’s progress in meeting the targets referred to in paragraph (1)(B); and if the sponsor does not expect to meet those targets referred to in paragraph (1)(B)— any updates needed to be made to the diversity action plan referred to in paragraph (1)(D) to meet such targets; or the sponsor’s justification for why the sponsor does not expect to meet such targets, including— any factors outside of the sponsor’s control, including a lack of retention of participants; any differences in the enrollment targets, disaggregated by demographic subgroup, and actual enrollment that the sponsor determines are insignificant in nature; potential for selection bias; and information not available to the sponsor at the time such targets were chosen, but that impacted enrollment of diverse participants.
The Commissioner of Food and Drugs shall issue regulations revising part 812 of title 21, Code of Federal Regulations, to require sponsors of applications for an exemption for investigational use of a device to include— in any such application— a description of the patient population in the United States expected to use the device, disaggregated by demographic subgroup, where such data is available, including age group, sex, race, and ethnicity; the sponsor’s targets for enrollment in the clinical trial or trials involved, disaggregated by age group, sex, race, and ethnicity; the rationale for the sponsor’s enrollment targets referred to in subparagraph (B), which may include— the estimated prevalence referred to in subparagraph (A); what is known about the disease or condition for which the drug is being developed or investigated; any relevant pharmacokinetic or pharmacogenomic data; what is known about the patient population, including co-morbidities and potential barriers to enrolling diverse participants, such as patient population size and geographic location; and any other data or information the sponsors deems relevant to selecting appropriate enrollment targets, disaggregated by demographic subgroup; and a diversity action plan for how the sponsor will meet such targets, including demographic-specific outreach and enrollment strategies, study-site selection, clinical trial inclusion and exclusion practices, and any diversity training for trial personnel; and in an annual report described in section 812.150 of title 21, Code of Federal Regulations— the sponsor’s progress in meeting those targets referred to in paragraph (1)(B); and if the sponsor does not expect to meet those targets referred to in paragraph (1)(B)— any updates needed to be made to the diversity action plan referred to in paragraph (1)(D) to meet such targets; or the sponsor’s justification for why the sponsor does not expect to meet such targets, including— any factors outside of the sponsor’s control, including a lack of retention of participants; any differences in the enrollment targets, disaggregated by demographic subgroup, and actual enrollment that the sponsor determines are insignificant in nature; potential for selection bias; and information not available to the sponsor at the time such targets were chosen, but that impacted enrollment of diverse participants.
The Commissioner of Food and Drugs shall issue regulations revising sections 807.92 and 814.20 of title 21, Code of Federal Regulations, to require that applications for devices approved under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ) and devices cleared under section 510(k) of such Act ( 21 U.S.C. 360(k) ) whose submission includes clinical data— a description of the patient population in the United States expected to use the device, disaggregated by demographic subgroup, where such data is available, including age group, sex, race, and ethnicity; and in summarizing the clinical investigations involving human subjects in such applications, a description of study subjects by demographic subgroup, including age group, sex, race, and ethnicity.
The Commissioner of Food and Drugs shall issue— any proposed rules required under this section not later than 2 years after the date of the enactment of this Act; and any final rules required under this section not later than 3 years after the date of the enactment of this Act.
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