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![handle is hein.congrecreports/crptxadlu0001 and id is 1 raw text is:
116TH CONGRESS
2d Session HOUSE OF REPRESENTATIVES
REPORT
116-572
FAIRNESS IN ORPHAN DRUG EXCLUSIVITY ACT
NOVEMBER 16, 2020.-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
R E P O R T
[To accompany H.R. 4712]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4712) to amend the Federal Food, Drug, and Cos-
metic Act with respect to limitations on exclusive approval or licen-
sure of orphan drugs, and for other purposes, having considered
the same, reports favorably thereon with an amendment and rec-
ommends that the bill as amended do pass.
CONTENTS
I. Purpose and Summary ..................................................................................
II. Background and Need for the Legislation ...................................................
III. Committee Hearings ......................................................................................
IV. Committee Consideration ..............................................................................
V. Committee Votes ............................................................................................
VI. Oversight Findings ........................................................................................
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
VIII. Federal Mandates Statement .......................................................................
IX. Statement of General Performance Goals and Objectives ..........................
X. Duplication of Federal Programs ..................................................................
XI. Committee Cost Estimate .............................................................................
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ..................
XIII. Advisory Committee Statement ....................................................................
XIV. Applicability to Legislative Branch ..............................................................
XV. Section-by-Section Analysis of the Legislation ............................................
XVI. Changes in Existing Law Made by the Bill, as Reported ...........................
The amendment is as follows:
Strike all after the enacting clause and insert the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the Fairness in Orphan Drug Exclusivity Act.
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19-006
AUTHENTICATED
U.S. GOVERNMENT
INFORMATION
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