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United States · Bill · HR

H.R. 4299 (113th)

Improving Regulatory Transparency for New Medical Therapies Act

openUnited States· United States Congress· EN

Introduced

26 March 2014

Last action

19 September 2014 · Reported

Status

Placed on the Union Calendar, Calendar No. 451.

Sponsors

Rep. Pitts, Joseph R. [R-PA-16], Rep. Pallone, Frank [D-NJ-6], Rep. Burgess, Michael C. [R-TX-26], Rep. McMorris Rodgers, Cathy [R-WA-5], Sen. Blackburn, Marsha [R-TN], Rep. Gingrey, Phil [R-GA-11], Rep. Griffith, H. Morgan [R-VA-9], Rep. Green, Gene [D-TX-29], Rep. Latta, Robert E. [R-OH-5], Rep. Engel, Eliot L. [D-NY-16], Rep. Shea-Porter, Carol [D-NH-1], Rep. Butterfield, G. K. [D-NC-1], Rep. Tonko, Paul [D-NY-20], Rep. Johnson, Bill [R-OH-6], Rep. Harper, Gregg [R-MS-3], Rep. Collins, Doug [R-GA-9]

Subjects

Discovery layer

Source updated

7 April 2025

Summary

Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule, under the exception for good cause, placing the drug or substance into the schedule recommended by the Secretary. Makes the interim final rule immediately effective. Authorizes a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the application that the substance will be used only in connection with clinical trials of a drug in accordance with the Federal Food, Drug, and Cosmetic Act. Directs the Attorney General to make a final decision on an application that includes such an indication within 180 days or provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date such decision will be made.

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

Timeline

  1. 26 March 2014

    Introduced

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

  2. 26 March 2014

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 26 March 2014

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 28 March 2014

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  5. 16 April 2014

    Referred

    Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.

    Source: Committee

  6. 28 May 2014

    Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote .

    Source: Committee

  7. 28 May 2014

    Committee

    Subcommittee Consideration and Mark-up Session Held.

    Source: Committee

  8. 9 June 2014

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  9. 10 June 2014

    Reported

    Ordered to be Reported by Voice Vote.

    Source: Committee

  10. 10 June 2014

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  11. 29 July 2014

    Introduced

    House Committee on the Judiciary Granted an extension for further consideration ending not later than Sept. 19, 2014.

    Source: IntroReferral

  12. 29 July 2014

    Reported

    Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.

    Source: Committee

  13. 29 July 2014

    Reported

    Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.

    Source: Committee

  14. 9 September 2014

    Committee

    Subcommittee on Crime, Terrorism, Homeland Security, and Investigations Discharged.

    Source: Committee

  15. 10 September 2014

    Reported

    Ordered to be Reported (Amended) by Voice Vote.

    Source: Committee

  16. 10 September 2014

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  17. 19 September 2014

    Calendars

    Placed on the Union Calendar, Calendar No. 451.

    Source: Calendars

  18. 19 September 2014

    Reported

    Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.

    Source: Committee

  19. 19 September 2014

    Reported

    Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

7 official files

Reported in House (text)

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Leesvertaling

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  • Reported in House (text)

    Reported in House · EN · 19 September 2014

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  • Reported in House (PDF)

    Reported in House · EN · 19 September 2014

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  • Reported to House amended, Part II

    summary · EN · 19 September 2014

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  • Reported to House without amendment, Part I

    summary · EN · 29 July 2014

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  • Introduced in House (text)

    Introduced in House · EN · 26 March 2014

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  • Introduced in House (PDF)

    Introduced in House · EN · 26 March 2014

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  • Introduced in House

    summary · EN · 26 March 2014

    Open at official source

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Sponsors

Related records

Sources

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