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United States · Bill · HR

H.R. 3497 (112th)

MODDERN Cures Act of 2011

referredUnited States· United States Congress· EN

Introduced

18 November 2011

Last action

2 December 2011 · Referred

Status

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

Sponsors

Rep. Lance, Leonard [R-NJ-7], Rep. Latham, Tom [R-IA-3], Rep. Inslee, Jay [D-WA-1], Rep. Walsh, Joe [R-IL-8], Rep. Hultgren, Randy [R-IL-14], Rep. Frank, Barney [D-MA-4], Rep. Moran, James P. [D-VA-8], Rep. Guthrie, Brett [R-KY-2], Rep. Roskam, Peter J. [R-IL-6], Rep. Lee, Barbara [D-CA-12], Rep. Jackson, Jesse L., Jr. [D-IL-2], Rep. Brown, Corrine [D-FL-5], Rep. Jones, Walter B., Jr. [R-NC-3], Rep. Walden, Greg [R-OR-2], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Neal, Richard E. [D-MA-1], Rep. Clay, Wm. Lacy [D-MO-1], Rep. King, Peter T. [R-NY-2], Rep. Critz, Mark S. [D-PA-12], Rep. Harper, Gregg [R-MS-3], Rep. Luetkemeyer, Blaine [R-MO-3], Rep. Crenshaw, Ander [R-FL-4], Rep. Tiberi, Patrick J. [R-OH-12], Sen. Luján, Ben Ray [D-NM], Rep. Wolf, Frank R. [R-VA-10], Rep. Palazzo, Steven M. [R-MS-4], Rep. Sessions, Pete [R-TX-17], Rep. Pascrell, Bill, Jr. [D-NJ-9], Rep. Filner, Bob [D-CA-51], Rep. Loebsack, David [D-IA-2], Rep. Pence, Mike [R-IN-6], Rep. Sutton, Betty [D-OH-13], Rep. Paulsen, Erik [R-MN-3], Rep. Carson, André [D-IN-7], Rep. Ruppersberger, C. A. Dutch [D-MD-2], Rep. Rangel, Charles B. [D-NY-15], Rep. Bilbray, Brian P. [R-CA-50], Rep. Baca, Joe [D-CA-43], Sen. Donnelly, Joe [D-IN], Rep. Rokita, Todd [R-IN-4], Rep. Ellison, Keith [D-MN-5], Rep. Woolsey, Lynn C. [D-CA-6], Rep. Schwartz, Allyson Y. [D-PA-13], Rep. Bucshon, Larry [R-IN-8], Rep. McCollum, Betty [D-MN-4], Rep. Runyan, Jon [R-NJ-3], Rep. Dold, Robert J. [R-IL-10], Rep. Burton, Dan [R-IN-5]

Subjects

Healthcare, Education

Source updated

8 June 2026

Healthcare · Education

Official sourceDownload fileView documentsShare

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 18 November 2011

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  2. 18 November 2011

    Introduced

    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.

    Source: IntroReferral

  3. 18 November 2011

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 18 November 2011

    Introduced

    Introduced in House

    Source: IntroReferral

  5. 22 November 2011

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  6. 2 December 2011

    Referred

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

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 18 November 2011

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  • Introduced in House (PDF)

    Introduced in House · EN · 18 November 2011

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  • Introduced in House

    summary · EN · 18 November 2011

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Sponsors

Showing 48 of 52 sponsors and actors.

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Sources

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