Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances.
Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after the fee is due.
Prohibits the Secretary, in determining whether to grant such waiver or reduction, from considering anything other than the circumstances and assets of the owner and any affiliate of the owner.
Makes these provisions applicable to fees authorized to be assessed and collected for FY2014-FY2017.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3631 Introduced in House (IH)]
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 available 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 Representatives 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''.
SEC. 2. WAIVER OR REDUCTION OF CERTAIN FEES APPLICABLE 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 ``, except 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 facility a waiver from
or a reduction of one or more fees assessed to that
person under subsection (a) where the Secretary finds
that the assessment of the fee would present a
significant barrier to market entry because of limited
resources available to such person or other
circumstances.
``(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 the person involved and any
affiliate of the person.
``(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 dosage 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.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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