21 U.S.C. § 360fff–7 — Report

submitted 88 years ago by Pub. L. 113-195 to r/title-21-FOOD-AND-DRUGS · 526 words · no verdicts yet

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The FDA must report to Congress on sunscreen ingredient reviews at set times. Reports cover how many requests were approved, rejected, or still pending, plus staffing. The FDA can also recommend ways to improve the review process.

(a) In general. (1) Within 18 months of November 26, 2014, and again 2 and 4 years after that, the FDA must send a report to the same two Congressional committees, describing what it has done under this part. (2) Each report must include: (A) progress on GRASE decisions for pending requests, including how many were reviewed and how long each took (measured from the original eligibility request), how many were found GRASE, how many were found not GRASE and why, and — for undecided ones — the reason for the delay, current status, and how long each has been pending; (B) the same information for GRASE decisions on requests that aren't "pending requests" — new requests reviewed and their decision times, GRASE and not-GRASE outcomes with reasons, and status and delay explanations for undecided ones; (C) a yearly count of all requests submitted, pending, or completed under this part (including pre-2014 data where available), and whether each went to the Advisory Committee; (D) a description of the staffing and costs involved in reviewing these requests; (E) progress on meeting this part's deadlines; and (F) if the FDA thinks it's appropriate, recommendations for improving how it handles requests, including the Advisory Committee process. (b) Method. The FDA must publish these reports however it decides will best get them to the public, including posting them on its website.

the actual law source: uscode.house.gov ↗public domain

(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

(iv)

(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.

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

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 113-195 · 128 Stat. 2050

A history note hasn’t been published yet. The record shows enactment by Pub. L. 113-195 on 1938-06-25.

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