Sec. 103. Conforming amendments to the Sunscreen Innovation Act
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Nonprescription sunscreen active ingredients or combinations of sunscreen active ingredients subject, on the date of enactment of this Act, to a proposed sunscreen order, as defined in section 586(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff(7) ), shall— continue to be reviewed in accordance with section 586C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3 ); or be reviewed under section 505G of such Act upon notification of the Secretary by the sponsor that such sponsor elects to have such ingredient or combination of ingredients reviewed under such section 505G, and such proposed sunscreen order under such section 586C shall be considered a proposed administrative order under section 505G(c)(3)(A)(ii) of such Act.
The sponsor of any application described in section 586F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–6 ) that was submitted to the Secretary of Health and Human Services (referred to in this section as the Secretary ) pursuant to section 330.14 of title 21, Code of Federal Regulations (as in effect on the day before the date of enactment of this Act), shall— notify the Secretary that the sponsor elects to withdraw such application; or notify the Secretary that the sponsor elects for such ingredient to be considered under section 505G of the Federal Food, Drug, and Cosmetic Act, and any proposed order under such section 586F shall be considered a proposed administrative order under section 505G(c)(3)(A)(ii) of that Act.
Any ingredient that is eligible for review under section 506G of the Federal Food, Drug, and Cosmetic Act and is submitted after the date of enactment of this Act shall be considered under that section. Section 586C(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3(b) ) is amended by adding at the end the following: A sponsor may request an individual, confidential meeting to discuss the data requirements to support a general recognition of safety and effectiveness with respect to the subject of a pending sunscreen ingredient.
The Secretary shall respond within 14 calendar days of the request and schedule such meeting within 45 calendar days, or within such timeline as specified in the letters described in section 201 of the Over-the-Counter Drug Safety, Innovation, and Reform Act . If a sponsor requests more than one confidential meeting for the same request, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines such additional confidential meeting is not reasonably necessary for the sponsor to advance its request.
The Secretary shall publish a post-meeting summary on the internet website of the Food and Drug Administration of any confidential meeting that does not disclose confidential business information. Such meetings shall not be required to comply with guidance issued by the Secretary addressing formal meetings for sponsors of human drug applications, as defined in section 735. . Section 586C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3 ) is amended by adding at the end the following:
A final sunscreen order shall have the effect of providing the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) the exclusive right, for a period of 2 years, to market a sunscreen ingredient under this section incorporating changes described in paragraph
(2)subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order. A change described in this paragraph is a change subject to an order specified in paragraph
(1)that— permits a sunscreen to contain an active ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3); or permits a change in the conditions of use of a sunscreen ingredient, for which human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order. The marketed sunscreen ingredients described this paragraph are sunscreen ingredients— marketed in accordance with a final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use thereunder), as in effect on the day before the date of enactment of this section; marketed as category I or III in accordance with a tentative final monograph issued under such part 330 (including conditions of use and any applicable subsequent determinations thereunder), as so in effect; marketed as category I in accordance with an advance notice of proposed rulemaking issued under such part 330 (including conditions of use and any applicable subsequent determinations thereunder), as so in effect; or marketed in accordance with a final order issued under this section. Only one 2-year period may be granted per ingredient under paragraph (1). No period of product differentiation under this subparagraph shall apply to changes to a sunscreen that are— Tier 2 changes described in section 744L(14)(A); safety-related changes described in section 744L–1(a)(2)(C), required under section 505G(c)(5), or any other change the Secretary determines necessary to ensure safe use; or changes related to methods of testing safety or efficacy. Requestors shall submit to the Secretary at the time when a final dosage form subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest that have the exclusive right described in paragraph (1). For purposes of this subsection, the term human data means data from clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics, or bioavailability. . Section 586C(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3(e) ) is amended by striking paragraph
(3)and inserting the following: A final sunscreen order shall be deemed to be a final administrative order under section 505G and subject to the applicable provisions under such section 505G, including with respect to amendment of such order. . Beginning on the date of enactment of this Act, section 586A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–1 ) shall have no force or effect. Any person who submitted a request described in subparagraph
(B)may, at any time prior to the sunset of subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff et seq.) under section 586H of such Act, withdraw such request from the process under such subchapter and resubmit such request as an order request under section 505G of such Act. A request described in this subparagraph is— a request under section 586A of the Federal Food, Drug, and Cosmetic Act submitted before the date of enactment of this Act; or a pending request described in section 586(6). Section 586E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–5 ) is amended to read as follows: Not later than November 26, 2019, the Secretary shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this section as the sunscreen order ) for which the substance, prior to the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act , was represented by stayed regulations under part 352 of title 21, Code of Federal Regulations. A revised sunscreen order described in paragraph
(1)shall be— effective not later than November 26, 2019; and issued by the Secretary at least 30 calendar days prior to such date. If a revised sunscreen order issued under subsection
(a)does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order. . Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff et seq.), as amended by subsection (f), is further amended by inserting at the end the following new section: This subchapter shall no longer be effective upon the later of— a final determination by the Secretary under this subchapter with respect to every request described in section 586A(b)(2) (other than any withdrawn requests and requests resubmitted as order requests under section 505G); or the effective date of the revised sunscreen order described in section 586E(a)(2). .
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U.S. Code
6 references not yet in our index
- 21 USC 360fff–3
- 21 USC 360fff–6
- 21 USC 360fff–3(b)
- 21 USC 360fff–3(e)
- 21 USC 360fff–1
- 21 USC 360fff–5
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Sec. 103
Conforming amendments to the Sunscreen Innovation Act
Cite21 USC 360fff–3
Cite21 USC 360fff–6
Cite21 USC 360fff–3(b)
Cite21 USC 360fff–3(e)
Cite21 USC 360fff–1
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