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HR 3497 112th Congress House

MODDERN Cures Act of 2011

Official title: To promote the development of meaningful treatments for patients.

Introduced: May 16, 2012 See on congress.gov
Health Administrative law and regulatory proceduresAdvisory bodiesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation
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Drug therapyExecutive agency funding and structureGovernment information and archivesHealth information and medical recordsIntellectual propertyMedical researchMedical tests and diagnostic methodsMedicareResearch and development
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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 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 2, 2011
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Nov 22, 2011
Referred to the Subcommittee on Health.
Nov 18, 2011
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Nov 18, 2011
Referred to the Subcommittee on Health.
Nov 18, 2011
Introduced in House
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 Latest action December 2, 2011

Referred to the Subcommittee on Intellectual Property, Competition and the Internet.

 Plain-English summary Congressional Research Service

Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 or the MODDERN Cures Act of 2011 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers.; and (2) publish a guide regarding such terms and definitions.

Sets forth additional factors for the Secretary to consider in determining the payment amount for new clinical diagnostic laboratory tests under gap filling procedures which are used when no comparable existing test is available.

Extends the exclusivity period for a drug or biological product if the diagnostic test related to such drug has been determined by the Secretary to have been developed by, or with the participation of, the manufacturer or sponsor of the drug or biological product, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the drug or biological product; or (2) the determination of the most appropriate treatment option for a patient population with the drug or biological product.

Establishes a dormant therapy designation for drugs or biological products that address unmet medical needs. Gives such a drug or biological product 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.

 Related & companion bills 1
  • HR 6446 Related bill Improving Diagnostic Innovations Act of 2012
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 6
 Cosponsors 29
All 29 Democratic 6 Republican 2
D
Thompson, Mike
California · Nov 29, 2012
BURTON, DAN
· Sep 21, 2012
 D
McCollum, Betty
Minnesota · Sep 20, 2012
BACA, JOE
· Aug 2, 2012
Donnelly, Joe
· Aug 2, 2012
Rokita, Todd
· Aug 2, 2012
WOOLSEY, LYNN
· Aug 2, 2012
BILBRAY, BRIAN
· Jul 24, 2012
 D
Carson, André
Indiana · Jul 10, 2012
Paulsen, Erik
· Jul 10, 2012
PENCE, MIKE
· Jun 26, 2012
Sutton, Betty
· Jun 26, 2012
CRENSHAW, ANDER
· May 30, 2012
FILNER, BOB
· May 30, 2012
 D
Luján, Ben Ray
New Mexico · May 30, 2012
Palazzo, Steven
· May 30, 2012
 R
Sessions, Pete
Texas · May 30, 2012
TIBERI, PATRICK
· May 30, 2012
WOLF, FRANK
· May 30, 2012
Harper, Gregg
· May 17, 2012
 D
Neal, Richard E.
Massachusetts · May 16, 2012
 D
Norton, Eleanor Holmes
District of Columbia · May 16, 2012
WALDEN, GREG
· May 16, 2012
JACKSON, JESSE
· May 9, 2012
Roskam, Peter
· Mar 7, 2012
 R
Guthrie, Brett
Kentucky · Feb 14, 2012
FRANK, BARNEY
· Dec 12, 2011
Hultgren, Randy
· Dec 12, 2011
INSLEE, JAY
· Dec 2, 2011
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3497: MODDERN Cures Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3497/
MLA
"H.R. 3497: MODDERN Cures Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3497/.
Bluebook (legal)
H.R. 3497, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3497/.
Markdown link
[H.R. 3497: MODDERN Cures Act of 2011](https://openamerica.io/bill/112-HR-3497/)
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