§360fff–1. Submission of requests — Inbound Citations

Citations to 21 U.S.C. § 360fff–1 as a whole

• 21 U.S.C. § 360fff(8)(A)

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  (A) a request under section 360fff–1 of this title;
• 21 U.S.C. § 360fff–2(a)(1)

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  (1) Not later than 60 calendar days after the date of receipt of a request under section 360fff–1 of this title, the Secretary shall—

  (A) determine, in accordance with paragraph (2), whether the request is eligible for further review under subsection (b) and section 360fff–3 of this title;

  (B) notify the sponsor of the determination of the Secretary; and

  (C) make such determination publicly available in accordance with paragraph (3) and subsection (b)(1).
• 21 U.S.C. § 360fff–2(a)(2)(B)

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  (B) A sponsor shall include in a request under section 360fff–1 of this title the information required under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) to meet the standard described in subparagraph (A)(ii).
• 21 U.S.C. § 360fff–2(a)(3)(B)

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  (B) At the time that a request is made under section 360fff–1 of this title, the sponsor of such request shall identify any information that such sponsor considers to be confidential information described in subparagraph (A).
• 21 U.S.C. § 360fff–2(a)(3)(C)

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  (C) The information contained in a request under section 360fff–1 of this title shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible for further review consistent with section 330.14 of title 21, Code of Federal Regulations (or any successor regulations).
• 21 U.S.C. § 360fff–2(b)(1)

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  (1) In the case of a request under section 360fff–1 of this title that is determined to be eligible under subsection (a) for further review under this section and section 360fff–3 of this title, the Secretary shall, in notifying the public under subsection (a)(1)(C) of such eligibility determination, post the eligibility determination on the Internet website of the Food and Drug Administration, invite the sponsor of such request and any other interested party to submit comments, and provide a period of not less than 45 calendar days for comments in support of or otherwise relating to a GRASE determination, including published and unpublished data and other information related to the safety and efficacy of such request.
• 21 U.S.C. § 360fff–2(b)(2)(A)(ii)

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  (ii) file such request made under section 360fff–1 of this title; or
• 21 U.S.C. § 360fff–2(b)(3)(A)

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  (A) If the Secretary refuses to file a request made under section 360fff–1 of this title, the sponsor may—

  (i) within 30 calendar days of receipt of written notification of such refusal, request, in writing, a meeting with the Secretary regarding the filing determination; and

  (ii) submit additional data or other information.
• 21 U.S.C. § 360fff–2(b)(4)(A)

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  (A) After the period of confidentiality described in subsection (a)(3)(C), the Secretary shall make data and other information submitted in connection with a request under section 360fff–1 of this title publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5, section 1905 of title 18, or section 331(j) of this title.
• 21 U.S.C. § 360fff–3(a)(1)

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  (1) In the case of a request under section 360fff–1 of this title, not later than 300 calendar days after the date on which such request is filed under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of section 360fff–2 of this title, the Secretary—

  (A) may convene a meeting of the Advisory Committee to review such request; and

  (B) shall complete the review of such request and issue a proposed sunscreen order with respect to such request.
• 21 U.S.C. § 360fff–3(b)(2)

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  (2) Sections 360fff–1 and 360fff–2 of this title shall not apply with respect to any pending request.
• 21 U.S.C. § 360fff–3(c)(1)(A)

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  (A) more than once with respect to any request under section 360fff–1 of this title or any pending request; or
• 21 U.S.C. § 360fff–3(c)(2)

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  (2) submit more than a total of 3 requests under section 360fff–1 of this title or pending requests to the Advisory Committee per meeting.
• 21 U.S.C. § 360fff–4(a)(1)(A)(i)

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  (i) the format and content of information submitted by a sponsor in support of a request under section 360fff–1 of this title or a pending request;
• 21 U.S.C. § 360fff–4(a)(1)(A)(iii)

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  (iii) the process by which a request under section 360fff–1 of this title or a pending request is withdrawn; and
• 21 U.S.C. § 360fff–4(a)(1)(A)(iv)

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  (iv) the process by which the Secretary will carry out section 360fff–3(c) of this title, including with respect to how the Secretary will address the total number of requests received under section 360fff–1 of this title and pending requests.
• 21 U.S.C. § 360fff–4(c)

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  (c) The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of section 360fff–3(a) of this title shall not apply to any requests submitted to the Secretary under section 360fff–1 of this title after the date that is 6 years after November 26, 2014.