21 USC 360fff-3 - GRASE determination

U.S Code last checked for updates: Nov 22, 2024

§ 360fff–3.

GRASE determination

(a)

Review of new request

(1)

Proposed sunscreen order

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.

(2)

Proposed sunscreen order by Commissioner

(3)

Public comment period

(4)

Meeting

(5)

Final sunscreen order

With respect to a proposed sunscreen order under paragraph (1)(B) or (2)—

(A)

the Secretary shall issue a final sunscreen order—

(i)

in the case of a proposed sunscreen order described in subparagraph (A) or (B) of section 360fff(7) of this title, not later than 90 calendar days after the end of the public comment period under paragraph (3); or

(ii)

in the case of a proposed sunscreen order described in subparagraph (C) of section 360fff(7) of this title, not later than 210 calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order; or

(B)

if the Secretary does not issue such final sunscreen order within such 90- or 210-calendar-day period, as applicable, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner.

(6)

Final sunscreen order by Commissioner

(b)

Review of pending requests

(1)

In general

(2)

Inapplicability of sections 360fff–1 and 360fff–2 of this title

(3)

Feedback letters as proposed sunscreen order

(4)

Proposed sunscreen order

(5)

Proposed sunscreen order by Commissioner

(6)

Public comment period

(7)

Meeting

(A)

In general

(B)

Confidential meetings

(8)

Advisory Committee

(9)

Final sunscreen order

In the case of a proposed sunscreen order under paragraph (3), (4), or (5)—

(A)

the Secretary shall issue a final sunscreen order with respect to the request—

(i)

(ii)

in the case of a proposed sunscreen order described in subparagraph (C) of section 360fff(7) of this title—

(I)

if the Advisory Committee is not convened under paragraph (8), not later than 210 calendar days after the date on which the sponsor submits the additional information requested pursuant to such proposed sunscreen order, which shall include a rationale for not convening such Advisory Committee; or

(II)

if the Advisory Committee is convened under paragraph (8), not later than 270 calendar days after the date on which the sponsor submits such additional information; or

(B)

if the Secretary does not issue such final sunscreen order within such 90-, 210-, or 270-calendar-day period, as applicable, the sponsor of such request may notify the Office of the Commissioner about such request and request review by the Office of the Commissioner.

(10)

Final sunscreen order by Commissioner

(c)

Advisory Committee

The Secretary shall not be required to—

(1)

convene the Advisory Committee—

(A)

more than once with respect to any request under section 360fff–1 of this title or any pending request; or

(B)

more than twice in any calendar year with respect to the review under this section; or

(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.

(d)

No delegation

(e)

Effect of final sunscreen order

(1)

In general

(A)

Sunscreen active ingredients determined to be GRASE

(B)

Sunscreen active ingredients determined not to be GRASE

(2)

Amendments to final sunscreen orders

(A)

Amendments at initiative of Secretary

(B)

Petition to amend final order

(C)

Applicability of final orders

(3)

Relationship to orders under section 355h of this title

(f)

Exclusivity

(1)

In general

(2)

Changes described

(3)

Marketed sunscreen

The marketed sunscreen ingredients described in this paragraph are sunscreen ingredients—

(A)

marketed in accordance with a final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or

(B)

marketed in accordance with a final order issued under this section.

(4)

Limitations on exclusivity

(5)

Listing of licensees, assignees, or successors in interest

(June 25, 1938, ch. 675, § 586C, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2039; amended Pub. L. 116–136, div. A, title III, § 3854(b)(1)–(3), Mar. 27, 2020, 134 Stat. 455, 456.)

cite as: 21 USC 360fff-3