I 
113TH CONGRESS 
1ST SESSION H. R. 3631 
To authorize the Commissioner of Food and Drugs to waive or reduce certain 
fees applicable to generic drug facilities where the fees would present 
a significant barrier to market entry because of limited resources avail-
able to such facilities or other circumstances. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 2, 2013 
Mr. HURT (for himself and Mr. ROE of Tennessee) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To authorize the Commissioner of Food and Drugs to waive 
or reduce certain fees applicable to generic drug facilities 
where the fees would present a significant barrier to 
market entry because of limited resources available to 
such facilities or other circumstances. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Small Manufacturer 
Protection Act of 2013’’. 
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SEC. 2. WAIVER OR REDUCTION OF CERTAIN FEES APPLI-
CABLE TO GENERIC DRUG FACILITIES. 
(a) IN GENERAL.—Section 744B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) is 
amended— 
(1) in subsection (b)(1)(B), by inserting ‘‘, ex-
cept as provided in subsection (c)(3),’’ after ‘‘fees 
under paragraphs (2) through (4) of subsection (a) 
shall’’; and 
(2) in subsection (c), by adding at the end the 
following: 
‘‘(3) FEE WAIVERS.— 
‘‘(A) STANDARD.—The Secretary shall 
grant to a person that owns a generic drug fa-
cility a waiver from or a reduction of one or 
more fees assessed to that person under sub-
section (a) where the Secretary finds that the 
assessment of the fee would present a signifi-
cant barrier to market entry because of limited 
resources available to such person or other cir-
cumstances. 
‘‘(B) CONSIDERATIONS.—In determining 
whether to grant a waiver or reduction of a fee 
under subparagraph (A), the Secretary shall 
consider only the circumstances and assets of 
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the person involved and any affiliate of the per-
son. 
‘‘(C) WRITTEN REQUESTS.—To qualify for 
consideration for a waiver or reduction under 
subparagraph (A), a person shall submit to the 
Secretary a written request for such waiver or 
reduction not later than 180 days after the fee 
is due. 
‘‘(D) DEFINITION.—In this paragraph, the 
term ‘person that owns a generic drug facility’ 
means a person that owns a facility which is 
identified or intended to be identified in at least 
one generic drug submission that is pending or 
approved to produce one or more finished dos-
age forms of a human generic drug.’’. 
(b) APPLICABILITY.—The amendments made by this 
section apply with respect to fees authorized to be assessed 
and collected for any of fiscal years 2014 through 2017. 
Æ 
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