21 USC 360fff-6 - Non-sunscreen time and extent applications

U.S Code last checked for updates: Apr 29, 2024

§ 360fff–6.

Non-sunscreen time and extent applications

(a)

Pending time and extent applications

(1)

In general

(A)

Request for framework for review

(B)

Request requirements

A request for a framework for review of an application made under subparagraph (A) shall be made within 180 calendar days of November 26, 2014, and shall include the preference of such sponsor as to whether such application is reviewed by the Secretary in accordance with—

(i)

the processes and procedures set forth for pending requests under section 360fff–3(b) of this title, except that specific timelines shall be determined in accordance with other applicable requirements under this section;

(ii)

the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations);

(iii)

an initial filing determination under the processes and procedures described in section 360fff–2(b) of this title and the processes and procedures set forth for pending requests under section 360fff–3(b) of this title, except that specific timelines shall be determined in accordance with other applicable requirements under this section; or

(iv)

an initial filing determination under the processes and procedures described in section 360fff–2(b) of this title and the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations).

(C)

No request

(2)

Framework

Not later than 1 year after November 26, 2014, the Secretary shall provide, in writing, a framework to each sponsor that submitted a request under paragraph (1). Such framework shall set forth the various timelines, in calendar days, with respect to the processes and procedures for review under clauses (i), (ii), (iii), and (iv) of paragraph (1)(B) and—

(A)

such timelines shall account for the considerations under paragraph (5); and

(B)

the timelines for the various processes and procedures shall not be shorter than the timelines set forth for pending requests under sections 360fff–2(b) and 360fff–3(b) of this title, as applicable.

(3)

Governing processes and procedures for review

(A)

Election

(B)

Different processes and procedures

(C)

Inclusion of ingredients in monographs

(4)

Letter regarding pending applications

(5)

Timelines

The timelines in calendar days established by the Secretary pursuant to this subsection—

(A)

may vary based on the content, complexity, and format of the application submitted to the Secretary; and

(B)

shall—

(i)

reflect the public health priorities of the Food and Drug Administration, including the potential public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph system;

(ii)

take into consideration the resources available to the Secretary for carrying out such priorities and the processes and procedures described in paragraphs (1)(B) and (2); and

(iii)

be reasonable, taking into consideration the requirements described in clauses (i) and (ii).

(b)

New time and extent applications

(1)

In general

Not later than 18 months after November 26, 2014, the Secretary shall issue proposed regulations establishing timelines for the review of applications for GRASE determinations for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients that are submitted to the Secretary after November 26, 2014, under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), and that are found to be eligible to be considered for inclusion in the over-the-counter drug monograph system pursuant to section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), or that are subject to this subsection pursuant to paragraph (1) or (3) of subsection (a), as applicable, providing—

(A)

timely and efficient completion of evaluations of applications under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) for drugs other than sunscreens; and

(B)

timely and efficient completion of the review of the safety and effectiveness submissions pursuant to such applications, including establishing—

(i)

reasonable timelines, in calendar days, for the applicable proposed and final regulations for applications of various content, complexity, and format, and timelines for internal procedures related to such processes; and

(ii)

measurable metrics for tracking the extent to which the timelines set forth in the regulations are met.

(2)

Timelines

The timelines in calendar days established in the regulations under paragraph (1)—

(A)

may vary based on the content, complexity, and format of the application submitted to the Secretary; and

(B)

shall—

(i)

(ii)

take into consideration the resources available to the Secretary for carrying out such priorities and the processes and procedures described in paragraph (1); and

(iii)

be reasonable, taking into consideration the requirements described in clauses (i) and (ii).

(3)

Procedure

(4)

Restrictions

(5)

Final regulations

(June 25, 1938, ch. 675, § 586F, as added Pub. L. 113–195, § 3, Nov. 26, 2014, 128 Stat. 2046.)

cite as: 21 USC 360fff-6