21 USC 360fff-2 - Eligibility determinations; data submission; filing

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).

(2)

Criteria for eligibility

(A)

In general

To be eligible for review under subsection (b) and section 360fff–3 of this title, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that—

(i)

is not included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen; and

(ii)

has been used to a material extent and for a material time under such conditions, as described in section 321(p)(2) of this title.

(B)

Establishment of time and extent

(3)

Public availability

(A)

Redactions for confidential information

(B)

Identification of confidential information by sponsor

(C)

Confidentiality during eligibility review

(b)

Data submission and filing of requests

(1)

In general

(2)

Filing determination

Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, the Secretary shall determine whether the data and other information submitted by the sponsor under this section are sufficiently complete, including being formatted in a manner that enables the Secretary to determine the completeness of such data and information, to enable the Secretary to conduct a substantive review under section 360fff–3 of this title with respect to such request. Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, if the Secretary determines—

(A)

that such data and other information are sufficiently complete, the Secretary shall—

(i)

issue a written notification to the sponsor of the determination to file such request, and make such notification publicly available; and

(ii)

file such request made under section 360fff–1 of this title; or

(B)

that such data and other information are not sufficiently complete, the Secretary shall issue a written notification to the sponsor of the determination to refuse to file the request, which shall include the reasons for the refusal, including why such data and other information are not sufficiently complete, and make such notification publicly available.

(3)

Refusal to file a request

(A)

Request for meetings; submission of additional data or other information

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.

(B)

Meetings

(i)

In general

(ii)

Actions after meeting

Following any meeting held under clause (i)—

(I)

the Secretary may file the request within 60 calendar days;

(II)

the sponsor may submit additional data or other information; or

(III)

if the sponsor elects, within 120 calendar days, to have the Secretary file the request (with or without amendments to correct any purported deficiencies to the request)—

(aa)

the Secretary shall file the request over protest, not later than 30 calendar days after the sponsor makes such election;

(bb)

at the time of filing, the Secretary shall provide written notification of such filing to the sponsor; and

(cc)

the Secretary shall make such notification publicly available.

(iii)

Requests filed over protest

(C)

Submissions of additional data or other information

(4)

Public availability

(A)

Redactions for confidential information

(B)

Identification of confidential information by sponsor

(June 25, 1938, ch. 675, § 586B, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2036.)

cite as: 21 USC 360fff-2

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