Title 21, Food and DrugsRelease 119-73not60

§360fff–7 Report

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients › § 360fff–7

Last updated Apr 5, 2026|Official source

Summary

The Secretary must send a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce not later than 18 months after November 26, 2014, and again 2 and 4 years after that. The report must describe actions under this part and cover two groups of requests. For each group it must say how many requests were reviewed, how long decisions took (counting from the sponsor’s original request), how many were found GRASE (Generally Recognized As Safe and Effective) and not misbranded, how many were found not GRASE and misbranded with reasons, and which requests are still pending with current status, reasons for delay, and how long they have been waiting. The report must also give an annual count of all requests (including earlier years if available) and note if advisory committees reviewed them; describe staffing, resources, and costs for the reviews; review progress on meeting processing deadlines; and, if appropriate, offer recommendations to improve the process. The Secretary must publish the reports in the most effective way, including on the FDA website.

Full Legal Text

Title 21, §360fff–7

Food and Drugs, Source: USLM XML via OLRC

(a)(1)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)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)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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360fff–7

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60