For the effective date of this section, referred to in subsec. (a)(2)(A), see Effective Date note below.
Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (h)(3), (4)(C)(i), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of this title.
Paragraph (6), referred to in subsec. (h)(6)(C)(ii), was redesignated par. (5) of subsec. (h) of this section by Pub. L. 112–144, title XI, § 1132(b)(4),
2022—Subsec. (e)(4)(B). Pub. L. 117–328 struck out “for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation))” before “if the Secretary determines”.
2019—Subsec. (g)(4)(B)(iii). Pub. L. 116–94, § 610(f)(1), added cl. (iii).
Subsec. (i)(1)(C). Pub. L. 116–94, § 610(f)(2), added subpar. (C) and struck out former subpar. (C) which read as follows: “Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the subject of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application, and permit the applicant to use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—
“(i) the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the abbreviated new drug application, and the holder of the reference drug product; or
“(ii) an aspect of the elements to assure safe use for the applicable listed drug is claimed by a patent that has not expired or is a method or process that, as a trade secret, is entitled to protection, and the applicant for the abbreviated new drug application certifies that it has sought a license for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was unable to obtain a license.
A certification under clause (ii) shall include a description of the efforts made by the applicant for the abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek to negotiate a voluntary agreement with the owner of the patent, method, or process for a license under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure safe use, if required under subsection (f) for the applicable listed drug, that is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection.”
Subsec. (i)(3). Pub. L. 116–94, § 610(f)(3), added par. (3).
Subsec. (l). Pub. L. 116–94, § 610(d), added subsec. (l).
Subsec. (m). Pub. L. 116–94, § 610(f)(4), added subsec. (m).
2018—Subsec. (b)(1)(E). Pub. L. 115–271, § 3041(a), substituted “of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling” for “of the drug”.
Subsec. (e)(4). Pub. L. 115–271, § 3032(a), added par. (4).
Subsec. (f)(2)(C)(iii). Pub. L. 115–271, § 3032(b), added cl. (iii).
Subsec. (i)(1)(B), (C). Pub. L. 115–271, § 3032(c)(1), added subpar. (B) and redesignated former subpar. (B) as (C).
Subsec. (i)(2)(B), (C). Pub. L. 115–271, § 3032(c)(2), added subpar. (B) and redesignated former subpar. (B) as (C).
2017—Subsec. (e)(3)(B). Pub. L. 115–52, § 606(1), struck out “; or” at end.
Subsec. (e)(3)(D). Pub. L. 115–52, § 606(2), (3), added subpar. (D).
2016—Subsec. (f)(5). Pub. L. 114–255, § 3075(c)(1), inserted “or other advisory committee” after “(or successor committee)” in introductory provisions.
Subsec. (f)(5)(B). Pub. L. 114–255, § 3075(c)(2), substituted “periodically” for “at least annually,” in introductory provisions.
Subsec. (h)(2)(A)(iii). Pub. L. 114–255, § 3101(a)(2)(C)(i), substituted, in heading, “labeling” for “label” and in text, “approved safety labeling changes” for “approved safety label changes”, “responsible person” for “sponsor”, and “a safety labeling change” for “a safety label change”.
Subsec. (h)(8). Pub. L. 114–255, § 3101(a)(2)(C)(ii), struck out period after “(7)”.
2013—Subsec. (f)(7). Pub. L. 113–5, § 302(c)(1), struck out par. (7) which related to waiver of subsec. (f) requirements in public health emergencies.
Subsec. (k). Pub. L. 113–5, § 302(c)(2), added subsec. (k).
2012—Subsec. (g)(1). Pub. L. 112–144, § 1132(a)(1), struck out “, and propose a modification to,” after “an assessment of”.
Subsec. (g)(2). Pub. L. 112–144, § 1132(a)(2)(A), in introductory provisions, struck out “, subject to paragraph (5),” after “shall” and “, and may propose a modification to,” after “an assessment of”.
Subsec. (g)(2)(C). Pub. L. 112–144, § 1132(a)(2)(B), substituted “an assessment is needed to evaluate whether the approved strategy should be modified to—” and cls. (i) and (ii) for “new safety or effectiveness information indicates that—
“(i) an element under subsection (d) or (e) should be modified or included in the strategy; or
“(ii) an element under subsection (f) should be modified or included in the strategy; or”.
Subsec. (g)(2)(D). Pub. L. 112–144, § 1132(a)(2)(C), struck out subpar. (D) which read as follows: “within 15 days when ordered by the Secretary, in consultation with the offices described in subsection (c)(2), if the Secretary determines that there may be a cause for action by the Secretary under section 355(e) of this title.”
Subsec. (g)(3). Pub. L. 112–144, § 1132(a)(3), substituted “for a drug shall include, with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified.” for “for a drug shall include—” and struck out subpars. (A) to (C) which related to assessment of elements to assure safe use, postapproval studies, and postapproval clinical trials.
Subsec. (g)(4). Pub. L. 112–144, § 1132(a)(4), amended par. (4) generally. Prior to amendment, text read as follows: “A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subsection (d) or the addition, modification, or removal of any element under subsection (e) or (f), such as—
“(A) modifying the timetable for assessments of the strategy as provided in subsection (d)(3), including to eliminate assessments; or
“(B) adding, modifying, or removing an element to assure safe use under subsection (f).”
Subsec. (h). Pub. L. 112–144, § 1132(b)(1), inserted “and modifications” after “review of assessments” in heading.
Subsec. (h)(1). Pub. L. 112–144, § 1132(b)(2), inserted “and proposed modification to” after “under subsection (a) and each assessment of” and “, and, if necessary, promptly initiate discussions with the responsible person about such proposed strategy, assessment, or modification” after “subsection (g)”.
Subsec. (h)(2). Pub. L. 112–144, § 1132(b)(3), (4), redesignated par. (3) as (2) and struck out former par. (2). Prior to amendment, text of par. (2) read as follows: “The Secretary, in consultation with the offices described in subsection (c)(2), shall initiate discussions with the responsible person for purposes of this subsection to determine a strategy not later than 60 days after any such assessment is submitted or, in the case of an assessment submitted under subsection (g)(2)(D), not later than 30 days after such assessment is submitted.”
Subsec. (h)(2)(A). Pub. L. 112–144, § 1132(b)(5)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) related to Secretary’s description of any required risk evaluation and mitigation strategy for a drug as part of the action letter on the application or in an order.
Subsec. (h)(2)(C). Pub. L. 112–144, § 1132(b)(5)(B), amended subpar. (C) generally. Prior to amendment, text read as follows: “Any action letter described in subparagraph (A)(i) or order described in subparagraph (A)(ii) shall be made publicly available.”
Subsec. (h)(3), (4). Pub. L. 112–144, § 1132(b)(4), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).
Subsec. (h)(4)(A)(i). Pub. L. 112–144, § 1132(b)(6)(A), substituted “The responsible” for “Not earlier than 15 days, and not later than 35 days, after discussions under paragraph (2) have begun, the responsible” and inserted “, after the sponsor is required to make a submission under subsection (a)(2) or (g),” before “request in writing”.
Subsec. (h)(4)(I). Pub. L. 112–144, § 1132(b)(6)(B), substituted “if the Secretary has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.” for “if the Secretary—” and struck out cls. (i) and (ii) which read as follows:
“(i) has initiated the discussions described under paragraph (2) not less than 60 days before such action deadline; and
“(ii) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.”
Subsec. (h)(5). Pub. L. 112–144, § 1132(b)(4), (7), redesignated par. (6) as (5) and substituted “subparagraph (B) or (C)” for “any of subparagraphs (B) through (D)” in subpar. (A) and “paragraph (3) or (4)” for “paragraph (4) or (5)” in subpar. (C). Former par. (5) redesignated (4).
Subsec. (h)(6), (7). Pub. L. 112–144, § 1132(b)(4), redesignated pars. (7) and (8) as (6) and (7), respectively. Former par. (6) redesignated (5).
Subsec. (h)(8), (9). Pub. L. 112–144, § 1132(b)(4), (8), redesignated par. (9) as (8) and substituted “paragraphs (6) and (7).” for “paragraphs (7) and (8)”. Former par. (8) redesignated (7).
Section effective 180 days after
Pub. L. 115–271, title III, § 3002,
Pub. L. 114–198, title I, § 106(b),
Pub. L. 112–144, title XI, § 1132(c),