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HR 3230 112th Congress House

Keeping America Competitive Through Harmonization Act of 2011

Official title: To direct the Food and Drug Administration, with respect to devices, to enter into agreements with certain countries regarding methods and approaches to harmonizing certain regulatory requirements.

Introduced: October 14, 2011 See on congress.gov
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Drug safety, medical device, and laboratory regulationEuropeEuropean UnionHealth technology, devices, suppliesIsraelJapanMiddle EastNew ZealandOceaniaSouth AfricaSwitzerlandTrade agreements and negotiations
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) 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
Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
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 Latest action October 18, 2011

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols.

Requires the Secretary to report on the agreements entered under this Act and to itemize the methods and approaches that have been harmonized pursuant to this Act.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 8
All 8 Republican 3
Rokita, Todd
· Dec 16, 2011
CULBERSON, JOHN
· Oct 24, 2011
 R
Blackburn, Marsha
Tennessee · Oct 14, 2011
 R
Guthrie, Brett
Kentucky · Oct 14, 2011
Lance, Leonard
· Oct 14, 2011
 R
Latta, Robert E.
Ohio · Oct 14, 2011
Paulsen, Erik
· Oct 14, 2011
SHIMKUS, JOHN
· Oct 14, 2011
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3230: Keeping America Competitive Through Harmonization Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3230/
MLA
"H.R. 3230: Keeping America Competitive Through Harmonization Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3230/.
Bluebook (legal)
H.R. 3230, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3230/.
Markdown link
[H.R. 3230: Keeping America Competitive Through Harmonization Act of 2011](https://openamerica.io/bill/112-HR-3230/)
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