21 USC 357 - Qualification of drug development tools

View all text of Part A [§ 351 - § 360n-2]

§ 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

(B) Acceptance factors; nonacceptance

(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

(3) Review of full qualification packageThe Secretary shall—

(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

(4) Qualification

(b) Effect of qualification

(1) In general

(2) Use of a drug development toolSubject to paragraph (3), a drug development tool qualified under this section may be used for—

(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(B) supporting the investigational use of a drug or biological product under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Rescission or modification

(A) In general

(B) Meeting for review

(1) In generalSubject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:

(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—

(i) the stage of the review process applicable to the submission;

(ii) the date of the most recent change in stage status;

(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and

(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.

(B) The Secretary’s formal written determinations in response to such qualification submissions.

(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).

(E) A comprehensive list of—

(i) all drug development tools qualified under subsection (a); and

(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(2) Relation to Trade Secrets Act

(3) Applicability

(A) In generalNothing in this section shall be construed as authorizing or directing the Secretary to disclose—

(i) any information contained in an application submitted under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5 or section 1905 of title 18; or

(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d], any information that the Secretary determines has a significant potential to affect national security.

(B) Public acknowledgment

(d) Rule of constructionNothing in this section shall be construed—

(1) to alter the standards of evidence under subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable); or

(2) to limit the authority of the Secretary to approve or license products under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], as applicable (as in effect before December 13, 2016).

(e) DefinitionsIn this section:

(1) BiomarkerThe term “biomarker”—

(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and

(B) includes a surrogate endpoint.

(2) Biomedical research consortia

(3) Clinical outcome assessmentThe term “clinical outcome assessment” means—

(A) a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

(B) includes a patient-reported outcome.

(4) Context of use

(5) Drug development toolThe term “drug development tool” includes—

(A) a biomarker;

(B) a clinical outcome assessment; and

(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.

(6) Patient-reported outcome

(7) Qualification

(8) Requestor

(9) Surrogate endpoint

(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title.

(June 25, 1938, ch. 675, § 507, as added Pub. L. 114–255, div. A, title III, § 3011(a), Dec. 13, 2016, 130 Stat. 1086; amended Pub. L. 116–22, title VII, § 705(e), June 24, 2019, 133 Stat. 964.)