Sec. 4. REPORTS
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## SEC. 4 REPORTS ###
(a)Initial GAO Report Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report reviewing the overall progress of the Secretary of Health and Human Services in carrying out subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act (as added by section 2 and amended by section 3 and subsection (c)), including findings on and recommendations with respect to— ####
(1)the progress made in completing the review of requests under subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act, including pending requests, and the feasibility of the timelines associated with such subchapter; ####
(2)the role of the Office of the Commissioner of Food and Drugs in issuing determinations with respect to requests reviewed under such subchapter, including the number of requests transferred to the Office of the Commissioner under section 586C of such Act; ####
(3)the extent to which advisory committees were convened by the Secretary regarding requests under subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act, including pending requests; and ####
(4)the types of metrics that have been, or should be, established for the review of time and extent applications. ###
(b)Subsequent GAO Report Not later than 5½ years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report reviewing the overall progress of the Secretary of Health and Human Services in carrying out subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act (as added by section 2 and amended by section 3 and subsection (c)) and the regulation of over-the-counter drug products, including findings on and recommendations with respect to— ####
(1)updates on the matters reported on by the Comptroller General under subsection (a); ####
(2)significant factors impacting the ability of the Food and Drug Administration to fulfill the mission of the agency with regard to the regulation of over-the-counter drug products, including finalizing outstanding monographs and responding to emerging and novel safety issues; ####
(3)the performance of the Secretary in carrying out section 586E of the Federal Food, Drug, and Cosmetic Act; ####
(4)the types of metrics that have been, or should be, established for the review and regulation of over-the-counter drug products; and ####
(5)timeliness, efficiency, and accountability in reviewing time and extent applications and safety and effectiveness reviews for over-the-counter drug products. ###
(c)FDA Report Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 3, is further amended by adding at the end the following: > > ## “SEC. 586G REPORT > > **[**[21 U.S.C. 360fff-7](/us/usc/t21/s360fff-7)**]** > > > ### “(a) In general > > > #### “(1) In general > > Not later than 18 months after the date of enactment of the Sunscreen Innovation Act, 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 subchapter. > > > #### “(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) > > 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; > > > ##### “(C) > > an annual accounting (including information from years prior to the date of enactment of the Sunscreen Innovation Act where such information is available) of the total number of requests submitted, pending, or completed under this subchapter, 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 subchapter; > > > ##### “(E) > > a review of the progress made in meeting the deadlines with respect to processing requests under this subchapter; and > > > ##### “(F) > > to the extent the Secretary determines appropriate, recommendations for process improvements in the handling of requests under this subchapter, 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.” > .
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