US Congress House Bill 4299 (Prior Session Legislation)

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Sponsorship: Slight Partisan Bill (Republican 10-6)
Status: Introduced on March 26 2014 - 25% progression, died in chamber
Action: 2014-09-19 - Placed on the Union Calendar, Calendar No. 451.
Text: Latest bill text (Introduced) [PDF]

Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General. Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest. Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.

Improving Regulatory Transparency for New Medical Therapies Act

Rep. Joseph Pitts [R-PA]	Sen. Marsha Blackburn [R-TN]	Rep. Michael Burgess [R-TX]	Rep. G. Butterfield [D-NC]
Rep. Doug Collins [R-GA]	Rep. Eliot Engel [D-NY]	Rep. Phil Gingrey [R-GA]	Rep. Gene Green [D-TX]
Rep. Morgan Griffith [R-VA]	Rep. Gregg Harper [R-MS]	Rep. Bill Johnson [R-OH]	Rep. Robert Latta [R-OH]
Rep. Cathy McMorris Rodgers [R-WA]	Rep. Frank Pallone [D-NJ]	Rep. Carol Shea-Porter [D-NH]	Rep. Paul Tonko [D-NY]

Date	Chamber	Action
2014-09-19	House	Placed on the Union Calendar, Calendar No. 451.
2014-09-19	House	Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.
2014-09-10	House	Ordered to be Reported (Amended) by Voice Vote.
2014-09-10	House	Committee Consideration and Mark-up Session Held.
2014-09-09	House	Subcommittee on Crime, Terrorism, Homeland Security, and Investigations Discharged.
2014-07-29	House	House Committee on the Judiciary Granted an extension for further consideration ending not later than Sept. 19, 2014.
2014-07-29	House	Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.
2014-06-10	House	Ordered to be Reported by Voice Vote.
2014-06-10	House	Committee Consideration and Mark-up Session Held.
2014-06-09	House	Committee Consideration and Mark-up Session Held.
2014-05-28	House	Forwarded by Subcommittee to Full Committee by Voice Vote .
2014-05-28	House	Subcommittee Consideration and Mark-up Session Held.
2014-04-16	House	Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
2014-03-28	House	Referred to the Subcommittee on Health.
2014-03-26	House	Referred to House Judiciary
2014-03-26	House	Referred to House Energy and Commerce
2014-03-26	House	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.

SB2862 (Related) 2014-09-18 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/113th-congress/house-bill/4299/all-info
Text	https://www.congress.gov/113/bills/hr4299/BILLS-113hr4299ih.pdf
Text	https://www.congress.gov/113/bills/hr4299/BILLS-113hr4299rh.pdf