HR 3116 113th Congress House Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Government studies and investigations Intellectual property Medical research Medical tests and diagnostic methods Medicare Prescription drugs

MODDERN Cures Act of 2013

Introduced: June 17, 2014 See on congress.gov

Everywhere this bill has been 4 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jan 9, 2014

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

Sep 20, 2013

Referred to the Subcommittee on Health.

Sep 17, 2013

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.

Sep 17, 2013

Introduced in House

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Plain-English summary Congressional Research Service

Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - 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 medicine 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 medicine, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the medicine; or (2) the determination of the most appropriate treatment option for a patient population with the medicine.

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

Directs the Secretary to arrange with the Institute of Medicine (or, if it declines, another appropriate entity) to study intellectual property laws and their impact on therapy and diagnostic development in order to formulate recommendations on how to facilitate the clinical evaluation and development of therapies currently available on the market for new potential indications.

What's happening now January 9, 2014

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

Related & companion bills 2

Bill text 1 version

Introduced in House Formatted Text PDF Formatted XML

Source documents hosted by congress.gov.

Committees of jurisdiction 5

Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee
House of Representatives · subcommittee of Judiciary Committee
Energy and Commerce Committee
House of Representatives
Health Subcommittee
House of Representatives · subcommittee of Energy and Commerce Committee
Judiciary Committee
House of Representatives
Ways and Means Committee
House of Representatives

Cosponsors 71

Massachusetts · Dec 10, 2014

Massachusetts · Dec 8, 2014

CAPUANO, MICHAEL

· Dec 3, 2014

FRELINGHUYSEN, RODNEY

Indiana · Dec 2, 2014

Wilson, Joe

South Carolina · Dec 1, 2014

Schweikert, David

Arizona · Nov 18, 2014

Florida · Sep 9, 2014

Missouri · Sep 9, 2014

Walz, Timothy

· Sep 9, 2014

Peters, Scott H.

California · Jul 31, 2014

ROS-LEHTINEN, ILEANA

· Jul 31, 2014

Thompson, Mike

California · Jul 17, 2014

Norton, Eleanor Holmes

District of Columbia · Jul 15, 2014

Thompson, Glenn

Pennsylvania · Jun 26, 2014

PETERSON, COLLIN

· Jun 17, 2014

Tonko, Paul

New York · Jun 9, 2014

Georgia · May 20, 2014

Florida · Mar 26, 2014

DUNCAN, JOHN

· Mar 25, 2014

Huffman, Jared

California · Mar 12, 2014

ROHRABACHER, DANA

· Mar 12, 2014

Wittman, Robert J.

Virginia · Mar 6, 2014

McCollum, Betty

Minnesota · Mar 4, 2014

Gerlach, Jim

· Feb 28, 2014

Brownley, Julia

California · Feb 27, 2014

Carson, André

Indiana · Feb 25, 2014

Takano, Mark

California · Feb 10, 2014

Braley, Bruce

· Feb 5, 2014

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APA

U.S. Congress. (2026). H.R. 3116: MODDERN Cures Act of 2013. 113th Congress. Open America. https://openamerica.io/bill/113-HR-3116/

MLA

"H.R. 3116: MODDERN Cures Act of 2013." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-3116/.

Bluebook (legal)

H.R. 3116, 113th Cong. (2026), https://openamerica.io/bill/113-HR-3116/.

Markdown link

[H.R. 3116: MODDERN Cures Act of 2013](https://openamerica.io/bill/113-HR-3116/)