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S. 1077, Advancing Breakthrough Devices for Patients Act of 2016 1 (June 24, 2016)

handle is hein.congrec/cbo3017 and id is 1 raw text is: 






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CONGRESSIONAL BUDGET OFFICE
           COST ESTIMATE


June 24, 2016


                                  S. 1077
        Advancing   Breakthrough   Devices  for Patients Act of 2016

    As reported by the Senate Committee on Health, Education, Labor, and Pensions
                               on April 5, 2016


SUMMARY

S. 1077 would amend the Federal Food, Drug, and Cosmetic Act to expedite the Food and
Drug Administration's (FDA's) review of certain medical devices that represent
breakthrough technologies. Such technologies include devices where no approved
alternatives exist or those that offer significant advantages over existing alternatives. CBO
estimates that implementing S. 1077 would cost $173 million over the 2017-2021 period,
assuming appropriation of the necessary amounts. Pay-as-you-go procedures do not apply
to the bill because enacting S. 1077 would not affect direct spending or revenues.

CBO  estimates that enacting S. 1077 would not increase net direct spending or on-budget
deficits in any of the four consecutive 10-year periods beginning in 2027.

S. 1077 contains no intergovernmental or private-sector mandates as defined in the
Unfunded Mandates Reform Act (UMRA)  and would not affect the budgets of state, local,
or tribal governments.


ESTIMATED COST TO THE FEDERAL GOVERNMENT

The estimated budgetary effect of S. 1077 is shown in the following table. The costs of this
legislation fall within budget function 550 (health).

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