Sec. 104. Treatment of Sunscreen Innovation Act
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A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act, is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3 ) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 101 of this Act.
Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)— the proposed sunscreen order involved is deemed to be a request for an order under subsection
(b)of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 101 of this Act; and such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G. A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients described in subparagraph
(A)that does not elect for such ingredient or combination of ingredients to be reviewed under section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 101 of this Act, shall continue to have such ingredient or combination of ingredients reviewed in accordance with section 586C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3 ) and may not subsequently elect to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of such Act, as added by section 101 of this Act. In this subsection, the terms sponsor , nonprescription , sunscreen active ingredient , and proposed sunscreen order have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff ). Paragraph
(3)of section 586C(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3(e) ) is amended to read as follows: A final sunscreen order shall be deemed to be a final order under section 505G. . Paragraph
(7)of section 586C(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff–3(b) ) is amended— by striking A sponsor may request and inserting the following: A sponsor may request ; and by adding at the end the following: A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters involving confidential commercial information or trade secrets. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. . Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360fff et seq.) is amended by adding at the end the following: This subchapter shall cease to be effective at the end of fiscal year 2022. . The Federal Food, Drug, and Cosmetic Act is amended by striking section 586E of such Act ( 21 U.S.C. 360fff–5 ). 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 pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act, shall be extinguished as of such date of enactment, subject to paragraph (2). Nothing in paragraph
(1)precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 101 of this Act, with respect to a drug that was the subject of an application extinguished under paragraph (1).
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U.S. Code
5 references not yet in our index
- 21 USC 360fff–3
- 21 USC 360fff–3(e)
- 21 USC 360fff–3(b)
- 21 USC 360fff–5
- 21 USC 360fff–6
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Sec. 104
Treatment of Sunscreen Innovation Act
Cite21 USC 360fff–3
Cite21 USC 360fff–3(e)
Cite21 USC 360fff–3(b)
Cite21 USC 360fff–5
Cite21 USC 360fff–6
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