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HR 3930 102th Congress House Health Drug industry Drugs Government paperwork Licenses Orphan drugs

To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.

Introduced: November 25, 1991 See on congress.gov
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This bill died when the 102nd Congress ended
It never became law before the 102nd Congress (1991–1992) 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
Jan 14, 1992
Referred to the Subcommittee on Health and the Environment.
Nov 25, 1991
Referred to the House Committee on Energy and Commerce.
Nov 25, 1991
Introduced in House
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 Plain-English summary Congressional Research Service

Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to drugs for rare diseases or conditions (commonly referred to as orphan drugs) to require the approval of an application under FDCA new drug provisions, a certification under FDCA antibiotic drug provisions, or a license under provisions of the Public Health Service Act regulating biologic products when the current holder of such an application, certification, or license has had: (1) cumulative dollar sales of the drug exceeding specified amounts; and (2) cumulative research and development costs for the drug not exceeding certain amounts.

What's happening now January 14, 1992

Referred to the Subcommittee on Health and the Environment.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1
D
Wyden, Ron
Oregon · Mar 26, 1992
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3930: To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.. 102nd Congress. Open America. https://openamerica.io/bill/102-HR-3930/
MLA
"H.R. 3930: To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.." 102nd Congress, 2026, Open America, https://openamerica.io/bill/102-HR-3930/.
Bluebook (legal)
H.R. 3930, 102nd Cong. (2026), https://openamerica.io/bill/102-HR-3930/.
Markdown link
[H.R. 3930: To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.](https://openamerica.io/bill/102-HR-3930/)
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