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United States · Bill · HR

H.R. 6 (114th)

21st Century Cures Act

referredUnited States· United States Congress· EN

Introduced

19 May 2015

Last action

13 July 2015 · Introduced

Status

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Rep. Upton, Fred [R-MI-6], Rep. DeGette, Diana [D-CO-1], Rep. Pitts, Joseph R. [R-PA-16], Rep. Pallone, Frank [D-NJ-6], Rep. Green, Gene [D-TX-29], Rep. Barton, Joe [R-TX-6], Sen. Cramer, Kevin [R-ND], Rep. Bucshon, Larry [R-IN-8], Rep. Bilirakis, Gus M. [R-FL-12], Sen. Blackburn, Marsha [R-TN], Rep. Brooks, Susan W. [R-IN-5], Rep. Burgess, Michael C. [R-TX-26], Rep. Ellmers, Renee L. [R-NC-2], Rep. Griffith, H. Morgan [R-VA-9], Rep. Guthrie, Brett [R-KY-2], Rep. Lance, Leonard [R-NJ-7], Rep. McKinley, David B. [R-WV-1], Rep. McMorris Rodgers, Cathy [R-WA-5], Sen. Mullin, Markwayne [R-OK], Rep. Murphy, Tim [R-PA-18], Rep. Shimkus, John [R-IL-15], Rep. Walden, Greg [R-OR-2], Rep. Whitfield, Ed [R-KY-1], Rep. Roskam, Peter J. [R-IL-6], Rep. Hanna, Richard L. [R-NY-22], Rep. McCaul, Michael T. [R-TX-10], Rep. Comstock, Barbara [R-VA-10], Rep. Harris, Andy [R-MD-1], Rep. Marchant, Kenny [R-TX-24], Rep. Yarmuth, John A. [D-KY-3], Rep. Castor, Kathy [D-FL-14], Rep. Loebsack, David [D-IA-2], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Tonko, Paul [D-NY-20], Rep. Moore, Gwen [D-WI-4], Rep. Veasey, Marc A. [D-TX-33], Rep. Dingell, Debbie [D-MI-6], Rep. Fattah, Chaka [D-PA-2], Rep. Schrader, Kurt [D-OR-5], Rep. Nolan, Richard M. [D-MN-8], Rep. Eshoo, Anna G. [D-CA-18], Sen. Welch, Peter [D-VT], David Scott, Rep. Perlmutter, Ed [D-CO-7], Rep. Courtney, Joe [D-CT-2], Rep. Cohen, Steve [D-TN-9], Rep. DeSaulnier, Mark [D-CA-10], Rep. Long, Billy [R-MO-7]

Subjects

Healthcare

Source updated

21 April 2025

Healthcare

Official sourceDownload fileView documentsShare

Summary

21st Century Cures Act This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research. The NIH may require scientific data to be shared if the research is fully funded by the NIH. The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data. The Centers for Disease Control and Prevention must expand surveillance of neurological diseases. The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures. The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs. Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication. Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests. The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition. The priority review voucher program for rare pediatric diseases is revised and extended. The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices. Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption. “Health software” is defined and, with certain exceptions, exempted from FDA regulations. This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services. A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products. Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs. This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

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

Timeline

  1. 19 May 2015

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  2. 19 May 2015

    Introduced

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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. 19 May 2015

    Introduced

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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

  4. 19 May 2015

    Introduced

    Introduced in House

    Source: IntroReferral

  5. 19 May 2015

    Introduced

    Introduced in House

    Source: IntroReferral

  6. 21 May 2015

    Vote

    Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.

    Source: Committee

  7. 21 May 2015

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  8. 7 July 2015

    Calendars

    Placed on the Union Calendar, Calendar No. 142.

    Source: Calendars

  9. 7 July 2015

    Discharge

    Committee on Ways and Means discharged.

    Source: Discharge

  10. 7 July 2015

    Committee

    Committee on Ways and Means discharged.

    Source: Committee

  11. 7 July 2015

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-190, Part I.

    Source: Committee

  12. 7 July 2015

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-190, Part I.

    Source: Committee

  13. 8 July 2015

    Reported

    Rules Committee Resolution H. Res. 350 Reported to House. Rule provides for consideration of H.R. 6 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Specified amendments are in order.

    Source: Floor

  14. 9 July 2015

    Floor

    The Speaker designated the Honorable Cresent Hardy to act as Chairman of the Committee.

    Source: Floor

  15. 9 July 2015

    Floor

    House resolved itself into the Committee of the Whole House on the state of the Union pursuant to H. Res. 350 and Rule XVIII.

    Source: Floor

  16. 9 July 2015

    Floor

    Rule provides for consideration of H.R. 6 with 1 hour of general debate. Previous question shall be considered as ordered without intervening motions except motion to recommit with or without instructions. Measure will be considered read. Specified amendments are in order.

    Source: Floor

  17. 9 July 2015

    Floor

    Considered under the provisions of rule H. Res. 350. (consideration: CR H5008-5016)

    Source: Floor

  18. 9 July 2015

    Passed

    Rule H. Res. 350 passed House.

    Source: Floor

  19. 9 July 2015

    Floor

    Committee of the Whole House on the state of the Union rises leaving H.R. 6 as unfinished business.

    Source: Floor

  20. 9 July 2015

    Passed

    On motion that the Committee now rise. Agreed to by voice vote.

    Source: Floor

  21. 9 July 2015

    Floor

    Mr. Upton moved that the Committee now rise.

    Source: Floor

  22. 10 July 2015

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  23. 10 July 2015

    Vote

    On passage Passed by recorded vote: 344 - 77 (Roll no. 433).

    Source: Floor

  24. 10 July 2015

    Vote

    Passed/agreed to in House: On passage Passed by recorded vote: 344 - 77 (Roll no. 433).

    Source: Floor

  25. 10 July 2015

    Passed

    The House adopted the amendments en gross as agreed to by the Committee of the Whole House on the state of the Union. (text of bill as amended: CR H5035-5069)

    Source: Floor

  26. 10 July 2015

    Floor

    The previous question was ordered pursuant to the rule. (consideration: CR H5082)

    Source: Floor

  27. 10 July 2015

    Floor

    The House rose from the Committee of the Whole House on the state of the Union to report H.R. 6.

    Source: Floor

  28. 10 July 2015

    Floor

    DEBATE - Pursuant to the provisions of H. Res. 350, the Committee of the Whole proceeded with 10 minutes of debate on the Brat amendment No. 1.

    Source: Floor

  29. 10 July 2015

    Floor

    The House resolved into Committee of the Whole House on the state of the Union for further consideration.

    Source: Floor

  30. 10 July 2015

    Floor

    Considered as unfinished business. (consideration: CR H5035-5082)

    Source: Floor

  31. 13 July 2015

    Introduced

    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Source: IntroReferral

Votes

No vote records are attached yet.

Versions

Documents

11 official files

Referred in Senate (text)

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  • Referred in Senate (text)

    Referred in Senate · EN · 13 July 2015

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  • Referred in Senate (PDF)

    Referred in Senate · EN · 13 July 2015

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  • Engrossed in House (text)

    Engrossed in House · EN · 10 July 2015

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  • Engrossed in House (PDF)

    Engrossed in House · EN · 10 July 2015

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  • Passed House amended

    summary · EN · 10 July 2015

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  • Reported in House (text)

    Reported in House · EN · 7 July 2015

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  • Reported in House (PDF)

    Reported in House · EN · 7 July 2015

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  • Reported to House amended, Part I

    summary · EN · 7 July 2015

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  • Introduced in House (text)

    Introduced in House · EN · 19 May 2015

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  • Introduced in House (PDF)

    Introduced in House · EN · 19 May 2015

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  • Introduced in House

    summary · EN · 19 May 2015

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Sponsors

Showing 48 of 234 sponsors and actors.

Related records

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Sources

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