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![handle is hein.congrecreports/crptxabne0001 and id is 1 raw text is: AUTHENTICATEO
U.S. GOVERNMENT
INFORMATION
Op
115TH CONGRESS REPORT
2d Session HOUSE OF REPRESENTATIVES 115-827
OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION,
AND REFORM ACT OF 2018
JULY 16, 2018.-Committed to the Committee of the Whole House on the State of
the Union and ordered to be printed
Mr. WALDEN, from the Committee on Energy and Commerce,
submitted the following
REPORT
together with
ADDITIONAL VIEWS
[To accompany H.R. 5333]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5333) to amend the Federal Food, Drug, and Cos-
metic Act to clarify the regulatory framework with respect to cer-
tain nonprescription drugs that are marketed without an approved
new drug application, and for other purposes, having considered
the same, report favorably thereon with an amendment and rec-
ommend that the bill as amended do pass.
CONTENTS
Page
P urpose an d Sum m ary ............................................................................................ 22
Background and Need for Legislation .................................................................... 23
C om m ittee A ction .................................................................................................... 23
C om m ittee V otes ...................................................................................................... 23
Oversight Findings and Recommendations ........................................................... 25
New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 25
Congressional Budget Office Estim ate ................................................................... 25
Federal M andates Statem ent ................................................................................. 46
Statement of General Performance Goals and Objectives .................................... 46
Duplication of Federal Program s ............................................................................ 46
Com m ittee Cost E stim ate ....................................................................................... 46
Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 47
Disclosure of Directed Rule M akings ..................................................................... 47
A dvisory Com m ittee Statem ent .............................................................................. 47
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