Sec. 3601. Diversity action plans for clinical studies
688 words·~3 min read·
/bill/117/hr/2617/unknown/section-3601·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: With respect to a clinical investigation of a new drug that is a phase 3 study, as defined in section 312.21(c) of title 21, Code of Federal Regulations (or successor regulations), or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies), the sponsor of such 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 to the Secretary such diversity action plan, in the form and manner specified by the Secretary in guidance, as soon as practicable but not later than the date on which the sponsor submits the protocol to the Secretary for such a phase 3 study or other pivotal study of the drug.
The sponsor may submit modifications to the diversity action plan. Any such modifications shall be in the form and manner specified by the Secretary in guidance. On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in paragraph (1), (2), or
(3)if the Secretary determines that a waiver is necessary based on what is known or what can be determined about the prevalence or incidence of the disease or condition for which the new drug is under investigation (including in terms of the patient population that may use the drug), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency. The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request. 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: The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary. The sponsor of a device 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), shall develop a diversity action plan for any clinical study with respect to the device. 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. On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in subparagraph
(A)or
(B)if the Secretary determines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency. The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request. No diversity action plan shall be required for a submission described in section 561. .
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources