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21 U.S. Code § 357. Qualification of drug development tools
(a) Process for qualification
(1) In generalThe Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—
(A)
(i)
a requestor initiates such process by submitting a letter of intent to the Secretary; and
(ii)
the Secretary accepts or declines to accept such letter of intent;
(B)
(i)
if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and
(ii)
the Secretary accepts or declines to accept the qualification plan; and
(C)
(i)
if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;
(ii)
the Secretary determines whether to accept such qualification package for review; and
(iii)
if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.
(2) Acceptance and review of submissions
(A) In general
Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as “qualification submissions”).
(B) Acceptance factors; nonacceptance
The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.
(C) Prioritization of qualification reviewThe Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—
(i)
as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and
(ii)
the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.
(D) Engagement of external experts
The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).