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HR 3631 113th Congress House

Small Manufacturer Protection Act of 2013

Official title: 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 significan… Show full official titleShow less

Official title: 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.

Introduced: December 2, 2013 See on congress.gov
Health Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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ManufacturingPrescription drugsSmall businessUser charges and fees
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This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 6, 2013
Referred to the Subcommittee on Health.
Dec 2, 2013
Referred to the House Committee on Energy and Commerce.
Dec 2, 2013
Introduced in House
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 Latest action December 6, 2013

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3631: Small Manufacturer Protection Act of 2013. 113th Congress. Open America. https://openamerica.io/bill/113-HR-3631/
MLA
"H.R. 3631: Small Manufacturer Protection Act of 2013." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-3631/.
Bluebook (legal)
H.R. 3631, 113th Cong. (2026), https://openamerica.io/bill/113-HR-3631/.
Markdown link
[H.R. 3631: Small Manufacturer Protection Act of 2013](https://openamerica.io/bill/113-HR-3631/)
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