Sec. 1002. FDA INNOVATION PROJECTS
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## SEC. 1002 FDA INNOVATION PROJECTS ###
(a)In general The Commissioner of Food and Drugs (referred to in this section as the “Commissioner”) shall use any funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) to carry out the activities described in subsection (b)(4). ###
(b)FDA Innovation Account ####
(1)Establishment of fda innovation account There is established in the Treasury an account, to be known as the “FDA Innovation Account” (referred to in this subsection as the “Account”), for purposes of carrying out the activities described in paragraph (4). ####
(2)Transfer of direct spending savings #####
(A)In general For each of fiscal years 2017 through 2025, the following amounts shall be transferred to the Account from the general fund of the Treasury: ######
(i)For fiscal year 2017, $20,000,000. ######
(ii)For fiscal year 2018, $60,000,000. ######
(iii)For fiscal year 2019, $70,000,000. ######
(iv)For fiscal year 2020, $75,000,000. ######
(v)For fiscal year 2021, $70,000,000. ######
(vi)For fiscal year 2022, $50,000,000. ######
(vii)For fiscal year 2023, $50,000,000. ######
(viii)For fiscal year 2024, $50,000,000. ######
(ix)For fiscal year 2025, $55,000,000. #####
(B)Amounts deposited Any amounts transferred under subparagraph
(A)shall remain unavailable in the Account until such amounts are appropriated pursuant to paragraph (3). ####
(3)Appropriations #####
(A)Authorization of Appropriations For each of the fiscal years 2017 through 2025, there is authorized to be appropriated from the Account to the Commissioner, for the purpose of carrying out the activities described in paragraph (5), an amount not to exceed the total amount transferred to the Account under paragraph (2)(A), to remain available until expended. #####
(B)Offsetting future appropriations For any of fiscal years 2017 through 2025, for any discretionary appropriation under the heading “FDA Innovation Account” provided to the Commissioner pursuant to the authorization of appropriations under subparagraph
(A)for the purpose of carrying out the projects activities described in paragraph (4), the total amount of such appropriations in the applicable fiscal year (not to exceed the total amount remaining in the Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Account shall be reduced by the same amount. ####
(4)FDA activities The activities authorized to be funded under this section are the activities under subtitles A through F (including the amendments made by such subtitles) of title III of this Act and section 1014 of the Federal Food, Drug, and Cosmetic Act, as added by section 3073 of this Act. ###
(c)Accountability and Oversight ####
(1)Work plan #####
(A)In general Not later than 180 days after the date of enactment of this Act, the Commissioner shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017 through 2025 and the contents described in subparagraph (B). #####
(B)Contents The work plan submitted under subparagraph
(A)shall include— ######
(i)recommendations from the Advisory Committee described in subparagraph (C); ######
(ii)the amount of money to be obligated or expended in each fiscal year for each activity described in subsection (b)(4); and ######
(iii)a description and justification of each such project activity. #####
(C)Recommendations Prior to submitting the work plan under this paragraph, the Commissioner shall seek recommendations from the Science Board to the Food and Drug Administration, on the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017 through 2025 and on the contents of the proposed work plan. ####
(2)Reports #####
(A)Annual reports Not later than October 1 of each of fiscal years 2018 through 2026, the Commissioner shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report including— ######
(i)the amount of money obligated or expended in the prior fiscal year for each activity described in subsection (b)(4); ######
(ii)a description of all such activities using funds provided pursuant to the authorization of appropriations under subsection (b)(3); and ######
(iii)how the activities are advancing public health. #####
(B)Additional reports At the request of the Committee on Health, Education, Labor, and Pensions or the Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on Appropriations of the House of Representatives, the Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the activities undertaken with such funding. ###
(d)Limitations Notwithstanding any transfer authority authorized by this Act or any appropriations Act, any funds made available pursuant to the authorization of appropriations in subsection (b)(3) shall not be used for any purpose other than an activity described in subsection (b)(4). ###
(e)Sunset This section shall expire on September 30, 2025.