The 21st Century Cures Act (Cures Act) was enacted into law on December 13, 2016, after a bipartisan, multi-year effort. The Cures Act primarily affects activities of the Department of Health and Human Services (HHS) and its agencies, including the Food and Drug Administration (FDA or the Agency).
Title I, section 1002 of the Cures Act, establishes an “FDA Innovation Account” (Innovation Account) for Fiscal Year (FY) 2017 – FY 2025 and authorizes $500 million in funding, subject to annual appropriations, to be used by FDA to carry out certain provisions in Title III of the Cures Act. Section 1002 also requires FDA to develop a work plan describing the allocation of any Innovation Account funds that may be appropriated for eligible activities. Section 1002(c)(1)(A) requires:
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).
Prior to submission of the work plan to Congress, the Cures Act requires FDA to seek recommendations from the Science Board to the FDA (FDA Science Board) on the proposed allocation of funds and contents of the work plan.