H.R. 3497 · 112th Congress
MODDERN Cures Act of 2011
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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LanceSponsor48 cosponsors · 25 D, 23 R
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Inslee
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Latham
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Frank
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Hultgren
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Walsh
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Moran
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Guthrie
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Roskam
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Lee
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Jackson
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Clay
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Critz
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Jones
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King
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Norton
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Harper
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Luetkemeyer
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Crenshaw
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Filner
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Luján
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Pascrell
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Palazzo
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Sessions
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Tiberi
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Wolf
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Loebsack
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Pence
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Sutton
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Carson
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Paulsen
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Bilbray
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Rangel
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Ruppersberger
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Baca
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Donnelly
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Ellison
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Rokita
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Woolsey
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Schwartz
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Bucshon
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Dold
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McCollum
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Runyan
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Burton
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Thompson0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Nov 18, 2011
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: MODDERN Cures Act of 2011
Also known as: Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011
Latest action (Dec 2, 2011): Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Policy area: Health · Origin: House · Introduced: Nov 18, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.