21 USC CHAPTER 9, SUBCHAPTER V, Part I: Nonprescription Sunscreen and Other Active Ingredients

From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER V—DRUGS AND DEVICES

Part I—Nonprescription Sunscreen and Other Active Ingredients

Termination of Part

This part ceased to be effective at the end of fiscal year 2022, see section 360fff–8 of this title.

§360fff. Definitions

In 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.)

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 113–195, §2(b), Nov. 26, 2014, 128 Stat. 2045, provided that: "Nothing in the amendment made by this section [enacting this section and sections 360fff–1 to [former] 360fff–5 of this title] shall be construed to—

"(1) limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or

"(2) limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a))."

§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 general

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

(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

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).

(3) Public availability

(A) Redactions for confidential information

If a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is determined under paragraph (1)(A) to be eligible for further review, the Secretary shall make the request 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.

(B) Identification of confidential information by sponsor

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).

(C) Confidentiality during eligibility review

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).

(b) Data submission and filing of requests

(1) In general

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.

(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

If a sponsor seeks a meeting under subparagraph (A)(i), the Secretary shall convene the meeting within 30 calendar days of the request for such meeting.

(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

The Secretary shall not require the sponsor to resubmit a copy of the request for purposes of filing a request filed over protest, as described in clause (ii)(III).

(C) Submissions of additional data or other information

Within 60 calendar days of any submission of additional data or other information under subparagraph (A)(ii) or (B)(ii)(II), the Secretary shall reconsider the previous determination made under paragraph (2) with respect to the applicable request and make a new determination in accordance with paragraph (2).

(4) Public availability

(A) Redactions for confidential information

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.

(B) Identification of confidential information by sponsor

A person submitting information under this section shall identify at the time of such submission the portions of such information that the person considers to be confidential information described in subparagraph (A).

(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 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

If the Secretary does not issue a proposed sunscreen order under paragraph (1)(B) within such 300-day period, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner. If such sponsor so notifies the Office of the Commissioner, the Commissioner shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed sunscreen order with respect to such request.

(3) Public comment period

A proposed sunscreen order issued under paragraph (1)(B) or (2) with respect to a request shall provide for a period of 45 calendar days for public comment.

(4) Meeting

A sponsor may request, in writing, a meeting with respect to a proposed sunscreen order issued under this subsection and described in subparagraph (B) or (C) of section 360fff(7) of this title, not later than 30 calendar days after the Secretary issues such order. The Secretary shall convene a meeting with such sponsor not later than 45 calendar days after such request for a 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

The Commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph (5)(B) not later than 60 calendar days after the date of notification under such paragraph.

(b) Review of pending requests

(1) In general

The review of a pending request shall be carried out by the Secretary in accordance with this subsection.

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

Sections 360fff–1 and 360fff–2 of this title shall not apply with respect to any pending request.

(3) Feedback letters as proposed sunscreen order

Notwithstanding the requirements of section 360fff(7) of this title, a letter issued pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, with respect to a pending request, shall be deemed to be a proposed sunscreen order and displayed on the Internet website of the Food and Drug Administration. Notification of the availability of such letter shall be published in the Federal Register not later than 45 calendar days after November 26, 2014.

(4) Proposed sunscreen order

In the case of a pending request for which the Secretary has not issued a letter pursuant to section 330.14(g) of title 21, Code of Federal Regulations before November 26, 2014, the Secretary shall complete review of such request and, not later than 90 calendar days after November 26, 2014, issue a proposed sunscreen order with respect to such request.

(5) Proposed sunscreen order by Commissioner

If the Secretary does not issue a proposed sunscreen order under paragraph (4), or the Secretary does not publish a notification of the availability of a letter under paragraph (3), 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. The Commissioner shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed order with respect to such request.

(6) Public comment period

A proposed sunscreen order issued under paragraph (4) or (5), or a notification of the availability of a letter under paragraph (3), with respect to a pending request shall provide for a period of 45 calendar days for public comment.

(7) Meeting

(A) In general

A sponsor may request, in writing, a meeting with respect to a proposed sunscreen order issued under this subsection, including a letter deemed to be a proposed sunscreen order under paragraph (3), not later than 30 calendar days after the Secretary issues such order or the date upon which such feedback letter is deemed to be a proposed sunscreen order, as applicable. The Secretary shall convene a meeting with such sponsor not later than 45 calendar days after the date of such request for a meeting.

(B) Confidential meetings

A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order, as appropriate. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4) ¹ of title 5 or section 1905 of title 18.

(8) Advisory Committee

In the case of a proposed sunscreen order under paragraph (3), (4), or (5), an Advisory Committee meeting may be convened for the purpose of reviewing and providing recommendations regarding the pending request.

(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—

(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

The Commissioner shall issue a final sunscreen order with respect to a proposed sunscreen order subject to paragraph (9)(B) not later than 60 calendar days after the date of notification under such paragraph.

(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

Any responsibility vested in the Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10) shall not be delegated.

(e) Effect of final sunscreen order

(1) In general

(A) Sunscreen active ingredients determined to be GRASE

Upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded, a sunscreen containing such ingredient or combination of ingredients shall be permitted to be introduced or delivered into interstate commerce for use under the conditions described in such final sunscreen order, in accordance with all requirements applicable to drugs not subject to section 353(b)(1) of this title, for so long as such final sunscreen order remains in effect.

(B) Sunscreen active ingredients determined not to be GRASE

Upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not GRASE and is misbranded, a sunscreen containing such ingredient or combination of ingredients shall not be introduced or delivered into interstate commerce, for use under the conditions described in such final sunscreen order, unless an application is approved pursuant to section 355 of this title with respect to a sunscreen containing such ingredient or combination of ingredients, or unless conditions are later established under which such ingredient or combination of ingredients is later determined to be GRASE and not misbranded under the over-the-counter drug monograph system.

(2) Amendments to final sunscreen orders

(A) Amendments at initiative of Secretary

In the event that information relevant to a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients becomes available to the Secretary after issuance of a final sunscreen order, the Secretary may amend such final sunscreen order by issuing a new proposed sunscreen order under subsection (a)(1) and following the procedures set forth in this section.

(B) Petition to amend final order

Any interested person may petition the Secretary to amend a final sunscreen order under section 10.30, title 21 Code of Federal Regulations (or any successor regulations). If the Secretary grants any petition under such section, the Secretary shall initiate the process for amending a final sunscreen order by issuing a new proposed sunscreen order under subsection (a)(1) and following the procedures set forth in this section.

(C) Applicability of final orders

Once the Secretary issues a new proposed sunscreen order to amend a final sunscreen order under subparagraph (A) or (B), such final sunscreen order shall remain in effect and paragraph (3) shall not apply to such final sunscreen order until the Secretary has issued a new final sunscreen order or has determined not to amend the final sunscreen order.

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

A final sunscreen order shall be deemed to be a final order under section 355h of this title.

(f) Exclusivity

(1) In general

A final sunscreen order shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) for a period of 18 months, to market a sunscreen ingredient under this section incorporating changes described in paragraph (2) subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order.

(2) Changes described

A change described in this paragraph is a change subject to an order specified in paragraph (1) that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3).

(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

Only one 18-month period may be granted per ingredient under paragraph (1).

(5) Listing of licensees, assignees, or successors in interest

Requestors shall submit to the Secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest under paragraph (1).

(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.)

Editorial Notes

Amendments

2020—Subsec. (b)(7). Pub. L. 116–136, §3854(b)(2), designated existing provisions as subpar. (A), inserted heading, and added subpar. (B).

Subsec. (e)(3). Pub. L. 116–136, §3854(b)(1), amended par. (3) generally. Prior to amendment, par. (3) related to inclusion of ingredients that are subjects of final orders in the sunscreen monograph.

Subsec. (f). Pub. L. 116–136, §3854(b)(3), added subsec. (f).

Statutory Notes and Related Subsidiaries

Review of Nonprescription Sunscreen Active Ingredients

Pub. L. 116–136, div. A, title III, §3854(a), Mar. 27, 2020, 134 Stat. 454, provided that:

"(1) Applicability of section 505g for pending submissions.—

"(A) In general.—A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act [Mar. 27, 2020], is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h], as added by section 3851 of this subtitle.

"(B) Election exercised.—Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)—

"(i) the proposed sunscreen order involved is deemed to be a request for an order under subsection (b) of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle; and

"(ii) such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G.

"(C) Election not exercised.—If a notification under subparagraph (A) is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)—

"(i) shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3); and

"(ii) shall not be eligible for review under section 505G, added by section 3851 of this subtitle.

"(2) Definitions.—In this subsection, the terms 'sponsor', 'nonprescription', 'sunscreen active ingredient', and 'proposed sunscreen order' have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff)."

¹ So in original. Probably should be preceded by "section".

§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 content 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

The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after November 26, 2014.

(C) Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.

(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

Nothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before November 26, 2014, except as otherwise provided in this part.

(2) Ensuring safety and effectiveness

Nothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including section 360fff–3(e) of this title.

(3) Other drugs

Except as otherwise provided in section 360fff–6 of this title, nothing in this part shall be construed to affect the authority of the Secretary under this chapter or the Public Health Service Act (42 U.S.C. 201 et seq.) with respect to a drug other than a nonprescription sunscreen.

(4) Effect on drugs otherwise approved

Nothing in this part shall affect the marketing of a drug approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(c) Timelines

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.

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

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

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

Section, June 25, 1938, ch. 675, §586E, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2045, related to sunscreen monograph.

§360fff–6. Non-sunscreen time and extent applications

(a) Pending time and extent applications

(1) In general

(A) Request for framework for review

If, prior to November 26, 2014, an application was submitted pursuant to section 330.14 of title 21, Code of Federal Regulations for a GRASE determination for a drug other than a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients and such drug was 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, the sponsor of such application may request that the Secretary provide a framework under paragraph (2) for the review of such application.

(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

If a sponsor described in subparagraph (A) does not make such request within 180 calendar days of November 26, 2014, such application shall be reviewed by the Secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection (b).

(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

Not later than 60 calendar days after the Secretary provides a framework to a sponsor under paragraph (2), such sponsor may provide an election to the Secretary regarding the processes and procedures for review under clause (i), (ii), (iii), or (iv) of paragraph (1)(B). If such sponsor makes such election, the Secretary shall review the application that is the subject of such election pursuant to the processes and procedures elected by such sponsor and the applicable timelines in calendar days set forth under such framework, which the Secretary shall confirm in writing to the sponsor not later than the date upon which the Secretary provides a report under paragraph (4). If such sponsor does not make such election, such application shall be reviewed by the Secretary in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection (b).

(B) Different processes and procedures

At any time during review of an application, the Secretary may review such application under different processes and procedures under clause (i), (ii), (iii), or (iv) of paragraph (1)(B) than the processes and procedures the sponsor elected in accordance with subparagraph (A), so long as the Secretary proposes, in writing, the change and the sponsor agrees, in writing, to such change.

(C) Inclusion of ingredients in monographs

If the sponsor elects to use the processes and procedures for review in accordance with clause (i) or (iii) of paragraph (1)(B), the Secretary may incorporate any resulting final order into a regulation addressing the conditions under which other drugs in the same therapeutic category are GRASE and not misbranded, including through direct final rulemaking, and the final order so incorporated shall cease to be effective on the effective date of the final regulation that addresses such drug.

(4) Letter regarding pending applications

Not later than 18 months after November 26, 2014, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, in writing, regarding all pending applications subject to paragraph (1). In such letter, the Secretary shall provide a report on the review of such applications, including the timelines, in calendar days, for the review and GRASE determination for each application. Such timelines shall account for the considerations under paragraph (5).

(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—

(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

In promulgating regulations under this subsection, the Secretary shall issue a notice of proposed rulemaking that includes a copy of the proposed regulation, provide a period of not less than 60 calendar days for comments on the proposed regulation, and publish the final regulation not less than 30 calendar days before the effective date of the regulation.

(4) Restrictions

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraphs (1), (2), and (3).

(5) Final regulations

The Secretary shall finalize the regulations under this section not later than 27 months after November 26, 2014.

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

Statutory Notes and Related Subsidiaries

Treatment of Non-Sunscreen Time and Extent Applications

Pub. L. 116–136, div. A, title III, §3854(d), Mar. 27, 2020, 134 Stat. 457, provided that:

"(1) In general.—Any application described in section 586F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–6) that was submitted to the Secretary pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act [Mar. 27, 2020], shall be extinguished as of such date of enactment, subject to paragraph (2).

"(2) Order request.—Nothing in paragraph (1) precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle, with respect to a drug that was the subject of an application extinguished under paragraph (1)."

§360fff–7. Report

(a) In general

(1) In general

Not later than 18 months after November 26, 2014, and on the dates that are 2 and 4 years thereafter, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives describing actions taken under this part.

(2) Contents

The 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

The Secretary shall publish the reports under subsection (a) in the manner the Secretary determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet website of the Food and Drug Administration.

(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.)