(a) Process for qualification
(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”).
(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
(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).
(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) Effect of qualification
(3) Rescission or modification
(B) Meeting for review
If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary’s decision to rescind or modify the determination before the effective date of the rescission or modification.
(c) Transparency
(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.
(C)
Any rescissions or modifications under subsection (b)(3) of a determination to qualify a
drug development tool.
(D)
Summary reviews that document conclusions and recommendations for determinations to qualify
drug development tools under subsection (a).
(E) A comprehensive list of—
(2) Relation to Trade Secrets Act
Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18.
(3) Applicability
(A) In generalNothing in this section shall be construed as authorizing or directing the Secretary to disclose—
(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
In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).
(d) Rule of constructionNothing in this section shall be construed—
(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
(2) Biomedical research consortia
The term “biomedical research consortia” means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 1001(a) of title 20), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.
(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
(5) Drug development toolThe term “drug development tool” includes—
(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
The term “patient-reported outcome” means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person.
(9) Surrogate endpointThe term “surrogate endpoint” means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—
(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.)
References in Text
The Public Health Service Act, referred to in subsec. (d)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Prior Provisions
A prior section 357, act June 25, 1938, ch. 675, § 507, as added July 6, 1945, ch. 281, § 3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16, § 3, 61 Stat. 12; July 13, 1949, ch. 305, § 2, 63 Stat. 409; Aug. 5, 1953, ch. 334, § 2, 67 Stat. 389; Pub. L. 87–781, title I, §§ 105(a), (b), (d)–(f), 106(a), (b), Oct. 10, 1962, 76 Stat. 785, 786, 787; Pub. L. 90–399, § 105(b), July 13, 1968, 82 Stat. 352; Pub. L. 102–300, § 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, § 3(p), Aug. 13, 1993, 107 Stat. 777, related to certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, prior to repeal by Pub. L. 105–115, title I, § 125(b)(1), Nov. 21, 1997, 111 Stat. 2325.
Amendments
2019—Subsec. (c)(3). Pub. L. 116–22 designated existing provisions as subpar. (A), inserted heading and “or directing” after “authorizing” in text, substituted “disclose—” for “disclose”, designated remainder of existing provisions as cl. (i) of subpar. (A), substituted “;or” for period at end, and added cl. (ii) of subpar. (A) and subpar. (B).
Guidance
Pub. L. 114–255, div. A, title III, § 3011(b), Dec. 13, 2016, 130 Stat. 1089, provided that:
“(1) In general.—The Secretary of Health and Human Services (referred to in this section [this note] as the ‘Secretary’) shall, in consultation with biomedical research consortia (as defined in subsection (e) of section 507 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 357] (as added by subsection (a)) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—
“(A)
provides a conceptual framework describing appropriate standards and scientific approaches to support the development of
biomarkers delineated under the taxonomy established under paragraph (3);
“(B) with respect to the qualification process under such section 507—
“(i)
describes the requirements that entities seeking to qualify a
drug development tool under such section shall observe when engaging in such process;
“(C)
includes such other information as the
Secretary determines appropriate.
“(2) Timing.—
Not later than 3 years after the date of the enactment of this Act [
Dec. 13, 2016], the
Secretary shall issue draft guidance under paragraph (1) on the implementation of section 507 of the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 357] (as added by subsection (a)). The
Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.
“(3) Taxonomy.—
“(A) In general.—
For purposes of informing guidance under this subsection, the
Secretary shall, in consultation with
biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of
biomarkers (and related scientific concepts) for use in
drug development.
“(B) Public availability.—
Not later than 2 years after the date of the enactment of this Act, the
Secretary shall make such taxonomy publicly available in draft form for public comment. The
Secretary shall finalize the taxonomy not later than 1 year after the close of the public comment period.”
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