Sec. 3602. Guidance on diversity action plans for clinical studies
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/bill/117/hr/2617/unknown/section-3602·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Secretary shall update or issue guidance relating to— the format and content of the diversity action plans required by sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(z) ; 360j(g)(9)) (as amended by section 3601) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations, and may include characteristics such as geographic location and socioeconomic status, including with respect to— the rationale for the sponsor’s enrollment goals, which may include— the estimated prevalence or incidence in the United States of the disease or condition for which the drug or device is being investigated in the relevant clinical trial, if such estimated prevalence or incidence is known or can be determined based on available data; what is known about the disease or condition for which the drug or device is being investigated; any relevant pharmacokinetic or pharmacogenomic data; what is known about the patient population for such disease or condition, including, to the extent data is available— demographic information, which may include age group, sex, race, geographic location, socioeconomic status, and ethnicity; non-demographic factors, including co-morbidities affecting the patient population; and potential barriers to enrolling diverse participants, such as patient population size, geographic location, and socioeconomic status; and any other data or information relevant to selecting appropriate enrollment goals, disaggregated by demographic subgroup, such as the inclusion of pregnant and lactating women; and an explanation for how the sponsor intends to meet such goals, including demographic-specific outreach and enrollment strategies, study-site selection, clinical study inclusion and exclusion practices, and any diversity training for study personnel; submission of any modifications to the diversity action plan; considerations for the public posting by a sponsor of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate; criteria that the Secretary will consider in assessing whether to grant a sponsor’s request to waive the requirement to submit a diversity action plan under section 505(z)(4) or 520(g)(9)(C) of the Federal Food, Drug, and Cosmetic Act (as amended by section 3601); and how sponsors may include in regular reports otherwise required by the Secretary— the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and any updates needed to be made to a diversity action plan referred to in paragraph
(1)to help meet goals referred to in paragraph (1)(A); and if the sponsor does not expect to meet goals referred to in paragraph (1)(A), the sponsor’s reasons for why the sponsor does not expect to meet such goals. The Secretary shall— not later than 12 months after the date of enactment of this Act, issue new draft guidance or update existing draft guidance described in subsection (a); and not later than 9 months after closing the comment period on such draft guidance, finalize such guidance. Sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601, shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under this section.
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Sec. 3602
Guidance on diversity action plans for clinical studies
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