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]
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.
Title
Small Manufacturer Protection Act of 2013
Sponsors
Rep. Robert Hurt [R-VA] | Rep. David Roe [R-TN] |
History
Date | Chamber | Action |
---|---|---|
2013-12-06 | House | Referred to the Subcommittee on Health. |
2013-12-02 | House | Referred to the House Committee on Energy and Commerce. |
Subjects
Administrative remedies
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Health
Manufacturing
Prescription drugs
Small business
User charges and fees
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Health
Manufacturing
Prescription drugs
Small business
User charges and fees
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/113th-congress/house-bill/3631/all-info |
Text | https://www.congress.gov/113/bills/hr3631/BILLS-113hr3631ih.pdf |