Small Manufacturer Protection Act of 2013

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.
                                 <all>