21 USC 360 - Definitions

Collapse to view only § 360fff. Definitions

§ 360fff. Definitions
§ 360fff-1. Submission of requests
§ 360fff-2. Eligibility determinations; data submission; filing
§ 360fff-3. GRASE determination
§ 360fff-4. Guidance; other provisions
§ 360fff-5. Repealed.
§ 360fff-6. Non-sunscreen time and extent applications
§ 360fff-7. Report
§ 360fff-8. Sunset

§ 360fff. DefinitionsIn this part—

(1) the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

(2) the term “final sunscreen order” means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order; or

(B) is not GRASE and is misbranded;

(3) the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;

(4) the term “GRASE determination” means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE;

(5) the term “nonprescription” means not subject to section 353(b)(1) of this title;

(6) the term “pending request” means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system—

(A) that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014; and

(B) for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014;

(7) the term “proposed sunscreen order” means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order;

(B) is not GRASE and is misbranded; or

(C) is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise;

(8) the term “sponsor” means the person that submitted—

(A) a request under section 360fff–1 of this title;

(B) a pending request; or

(9) the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and

(10) the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

(June 25, 1938, ch. 675, § 586, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2035.)

§ 360fff–1. Submission of requests

Any person may submit a request to the Secretary for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is GRASE and should be included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen.

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

§ 360fff–2. Eligibility determinations; data submission; filing

(a) Eligibility determinations

(1) In generalNot 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

(2) Criteria for eligibility

(A) In generalTo 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

(b) Data submission and filing of requests

(1) In general

(2) Filing determinationNot 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 informationIf 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 meetingFollowing 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

(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.)

§ 360fff–3. GRASE determination

(a) Review of new request

(1) Proposed sunscreen orderIn 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 orderWith 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 orderIn 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—

(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

(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

(3) Relationship to orders under section 355h of this title

(f) Exclusivity

(1) In general

(2) Changes described

(3) Marketed sunscreenThe 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.)

§ 360fff–4. Guidance; other provisions

(a) Guidance

(1) In general

(A) Draft guidance

Not later than 1 year after November 26, 2014, the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on—

(i) the format and span of information submitted by a sponsor in support of a request under section 360fff–1 of this title or a pending request;

(ii) the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;

(iii) the process by which a request under section 360fff–1 of this title or a pending request is withdrawn; and

(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.

(B) Final guidance

(2) Submissions pending issuance of final guidance

Irrespective of whether final guidance under paragraph (1) has been issued—

(A) persons may, beginning on November 26, 2014, make submissions under this part; and

(B) the Secretary shall review and act upon such submissions in accordance with this part.

(b) Rules of construction

(1) Currently marketed sunscreens

(2) Ensuring safety and effectiveness

(3) Other drugs

(4) Effect on drugs otherwise approved

(June 25, 1938, ch. 675, § 586D, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2044.)

§ 360fff–5. Repealed. Pub. L. 116–136, div. A, title III, § 3854(b)(5), Mar. 27, 2020, 134 Stat. 456

§ 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 requirementsA 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).

(2) FrameworkNot 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

(4) Letter regarding pending applications

(5) TimelinesThe timelines in calendar days established by the Secretary pursuant to this subsection—

(A) may vary based on the span, 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 generalNot 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 span, 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) TimelinesThe timelines in calendar days established in the regulations under paragraph (1)—

(A) may vary based on the span, complexity, and format of the application submitted to the Secretary; and

(B) shall—

(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.)

§ 360fff–7. Report

(a) In general

(1) In general

(2) ContentsThe reports under this subsection shall include—

(A) a review of the progress made in issuing GRASE determinations for pending requests, including the number of pending requests—

(i) reviewed and the decision times for each request, measured from the date of the original request for an eligibility determination submitted by the sponsor;

(ii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;

(iii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not GRASE and is misbranded and the reasons for such determinations; and

(iv) for which a determination has not been made, and an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor;

(B) a review of the progress made in issuing GRASE determinations for requests not included in the reporting under subparagraph (A), including the number of such requests—

(i) reviewed and the decision times for each request;

(ii) resulting in a determination that the nonprescription sunscreen active ingredient, combination of nonprescription sunscreen active ingredients, or other ingredient is GRASE and is not misbranded;

(iii) resulting in a determination that the nonprescription sunscreen active ingredient, combination of nonprescription sunscreen active ingredients, or other ingredient is not GRASE and is misbranded and the reasons for such determinations; and

(C) an annual accounting (including information from years prior to November 26, 2014, where such information is available) of the total number of requests submitted, pending, or completed under this part, including whether such requests were the subject of an advisory committee convened by the Secretary;

(D) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to requests under this part;

(E) a review of the progress made in meeting the deadlines with respect to processing requests under this part; and

(F) to the extent the Secretary determines appropriate, recommendations for process improvements in the handling of requests under this part, including the advisory committee review process.

(b) Method

(June 25, 1938, ch. 675, § 586G, as added Pub. L. 113–195, § 4(c), Nov. 26, 2014, 128 Stat. 2050.)

§ 360fff–8. Sunset

This part shall cease to be effective at the end of fiscal year 2022.

(June 25, 1938, ch. 675, § 586H, as added Pub. L. 116–136, div. A, title III, § 3854(b)(4), Mar. 27, 2020, 134 Stat. 456.)