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;
“(ii)
outlines reasonable timeframes for the Secretary’s review of letters, qualification plans, or full qualification packages submitted under such process; and
“(iii)
establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and
“(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.”