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![handle is hein.congrecreports/crptxacig0001 and id is 1 raw text is: AUTHENTICATEO
U.S. -OVERNMENT
INFORMATION
Op
116TH CONGRESS REPORT
1st Session HOUSE OF REPRESENTATIVES 116-46
BRINGING LOW-COST OPTIONS AND COMPETITION WHILE
KEEPING INCENTIVES FOR NEW GENERICS ACT OF 2019
MAY 2, 2019.-Committed to the Committee of the Whole House on the State of the
Union and ordered to be printed
Mr. PALLONE, from the Committee on Energy and Commerce,
submitted the following
REPORT
[To accompany H.R. 938]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 938) to amend the Federal Food, Drug, and Cosmetic
Act, with respect to eligibility for approval of a subsequent generic
drug, to remove the barrier to that approval posed by the 180-day
exclusivity period afforded to a first generic applicant that has not
yet received final approval, and for other purposes, having consid-
ered the same, report favorably thereon without amendment and
recommend that the bill do pass.
CONTENTS
Page
I. Purpose and Sum m ary ............................................................................... 2
II. Background and Need for the Legislation ............................................... . 2
III. Com m ittee H earings ................................................................................. 2
IV . Com m ittee Consideration ......................................................................... 3
V . C om m ittee V otes ....................................................................................... 3
V I. O versight Findings ...................................................................................... 3
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures 4
VIII. Congressional Budget Office Estimate ..................................................... 4
IX. Federal M andates Statem ent ................................................................... 6
X. Statement of General Performance Goals and Objectives ...................... 6
XI. Duplication of Federal Program s ............................................................... 6
XII. Com m ittee Cost E stim ate .......................................................................... 6
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ............... 6
XIV. Advisory Com m ittee Statem ent ................................................................. 6
XV. Applicability to Legislative Branch ........................................................... 6
XVI. Section-by-Section Analysis of the Legislation ........................................ 6
XVII. Changes in Existing Law Made by the Bill, as Reported ........................ 7
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