Sec. 501. Diversity action plans for clinical studies
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Section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) is amended by adding at the end the following: In order for a new drug that is being studied in a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or other pivotal study (other than bioavailability or bioequivalence studies), to be exempt pursuant to this subsection, the sponsor of a clinical investigation of such new drug shall submit to the Secretary a diversity action plan.
Such diversity action plan shall include— the sponsor’s goals for enrollment in such clinical study; the sponsor’s rationale for such goals; and an explanation of how the sponsor intends to meet such goals. The sponsor shall submit such diversity action plan in the form and manner specified in the guidance required by section 524B as soon as practicable but no later than when the sponsor seeks feedback regarding such a phase 3 study or other pivotal study of the drug. The Secretary may waive the requirement in subparagraph
(A)if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the new drug. No diversity action plan shall be required for a submission described in section 561. . Section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) is amended by adding at the end the following: In order for a device in a clinical study for which submission of an application for an investigational device exemption is required to be exempt under this subsection, the sponsor of such study shall submit to the Secretary in such application a diversity action plan in the form and manner specified in the guidance required by section 524B. In order for a device in a clinical study for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), to be exempt under this subsection, the sponsor of such study shall develop and implement a diversity action plan. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 for such device. A diversity action plan under clause
(i)or
(ii)of subparagraph
(A)shall include— the sponsor’s goals for enrollment in the clinical study; the sponsor’s rationale for such goals; and an explanation of how the sponsor intends to meet such goals. The Secretary may waive the requirement in subparagraph
(A)or
(B)if the Secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the device. No diversity action plan shall be required for a submission described in section 561. . Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: The Secretary shall issue guidance relating to— the format and content of the diversity action plans required by sections 505(i)(5) and 520(g)(9) pertaining to the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, race, geographic location, socioeconomic status, and ethnicity, 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 developed or investigated, 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 developed or 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, including 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; 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; and procedures for the public posting of key information from the diversity action plan that would be useful to patients and providers on the sponsor’s website, as appropriate; and how sponsors should include in regular reports to the Secretary— the sponsor’s progress in meeting the goals referred to in paragraph (1)(A); and if the sponsor does not expect to meet such goals— any updates needed to be made to a diversity action plan referred to in paragraph
(1)to help meet such goals; and 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 section, 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(i)(5) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by subsections
(a)and
(b)of this section, apply only with respect to clinical investigations with respect to which enrollment commences after the date that is 180 days after the publication of final guidance under section 524B(b)(2) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c).
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