US HB3631 | 2013-2014 | 113th Congress

Status

Spectrum: Partisan Bill (Republican 2-0)
Status: Introduced on December 2 2013 - 25% progression, died in committee
Action: 2013-12-06 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Summary

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.

Tracking Information

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Title

Small Manufacturer Protection Act of 2013

Sponsors


History

DateChamberAction
2013-12-06HouseReferred to the Subcommittee on Health.
2013-12-02HouseReferred to the House Committee on Energy and Commerce.

Subjects


US Congress State Sources


Bill Comments

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