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H.R. 2430, FDA Reauthorization Act of 2017 1 (July 11, 2017)

handle is hein.congrec/cbo3632 and id is 1 raw text is: CONGRESSIONAL BUDGET OFFICE Direct Spending and Revenue Effects for H.R. 2430, the FDA Reauthorization Act of 2017 (version H2430_SUS.XML). (Millions of dollars, by fiscal year) 2018- 2018- 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2022 2027 CHANGES IN DIRECT SPENDINGa Section 601. Reauthorization of Provision Relating to Exclusivity of Certain Drugs Containing Single Enantiomers Estimated Budget Authority Estimated Outlays 608. Pediatric Information Added to Labeling Estimated Budget Authority Estimated Outlays 808. Incentivizing Competitive Generic Drug Development Estimated Budget Authority Estimated Outlays Total Changes in Direct Spending Estimated Budget Authority Estimated Outlays 0 0 0 0 0 1 3 0 0 0 0 0 1 3 5 4 1 0 13 5 4 1 0 13 0 0 -1 -1 -2 -2 -2 -3 -3 -3 0 0 -1 -1 -2 -2 -2 -3 -3 -3 0 0 -1 -2 -4 -6 -7 -10 -12 -14 0 0 -1 -2 -4 -6 -7 -10 -12 -14 -4 -17 -4 -17 -7 -56 -7 -56 0 0 -2 -3 -6 -7 -6 -8 -11 -16 -11 -60 0 0 -2 -3 -6 -7 -6 -8 -11 -16 -11 -60 CHANGES IN REVENUESabc 601. Reauthorization of Provision Relating to Exclusivity of Certain Drugs Containing Single Enantiomers Estimated Revenues On-Budget Off-Budget 608. Pediatric Information Added to Labeling Estimated Revenues On-Budget Off-Budget 808. Incentivizing Competitive Generic Drug Development Estimated Revenues On-Budget Off-Budget Total Changes in Estimated Revenues On-Budget Off-Budget Impact on the Deficit On-Budget Off-Budget 0 0 0 0 0 0 0 0 0 0 0 0 0 0 * * 0 0 * * 0 0 0 * 0 0 * 0 0 * 0 0 * 0 0 * 0 0 * 0 0 * 1 * * 1 1 * NET DECREASE (-) IN THE DEFICITc 0 0 -2 -4 0 0 -2 -4 0 0 * * 0 0 0 * * * 1 1 * 1 1 * -7 -7 * * -1 -1 -1 * * -1 -1 0 * * * * 1 * * * * 1 1 * 1 1 * 1 * * 3 2 1 3 2 1 1 1 * 1 1 * * * * 1 1 * 3 2 1 3 2 1 -9 -8 -10 -14 -19 -8 -7 -9 -13 -18 * * * -1 -1 Sources: Congressional Budget Office; staff of the Joint Committee on Taxation (JCT). Notes: Components may not sum to totals because of rounding; * = an increase or decrease of less than $500,000. H.R. 2430 would impose intergovernmental and private-sector mandates, as defined in the Unfunded Mandates Reform Act (UMRA), on public and private manufacturers of prescription drugs and medical devices. In addition, the bill would preempt state and local laws that interfere with the distribution of over-the-counter hearing aids. CBO estimates that the cost of the mandates on public entities would be small and fall well below the annual threshold established in UMRA for intergovernmental mandates ($78 million in 2017, adjusted annually for inflation). However, in aggregate, CBO estimates that the cost of the mandates on private entities would well exceed the annual threshold established in UMRA for private-sector mandates ($156 million in 2017, adjusted annually for inflation) in each of the first five years the mandates are in effect, primarily because of the requirement to pay fees. a. Policies affect both direct spending and revenues. b. Positive numbers indicate an increase in revenues; negative numbers indicate a decrease in revenues. c. All off-budget revenue effects would come from changes in Social Security revenues (the payroll taxes for Social Security are classified as off-budget). Page 1 of 1 July 11, 2017 0 0 0 1 1 * 2 1 * 2 2 1 -13 -13 -1 -2 -2 -1 4 3 1 11 8 3 12 9 3 -72 -69 -3

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