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HR 4299 113th Congress House Crime and Law Enforcement Administrative law and regulatory procedures Administrative remedies Department of Justice Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Licensing and registrations Medical research

Improving Regulatory Transparency for New Medical Therapies Act

Introduced: March 26, 2014 See on congress.gov
 Everywhere this bill has been 16 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 19, 2014
Placed on the Union Calendar, Calendar No. 451.
Sep 19, 2014
Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.
Sep 10, 2014
Ordered to be Reported (Amended) by Voice Vote.
Sep 10, 2014
Committee Consideration and Mark-up Session Held.
Sep 9, 2014
Subcommittee on Crime, Terrorism, Homeland Security, and Investigations Discharged.
Jul 29, 2014
House Committee on the Judiciary Granted an extension for further consideration ending not later than Sept. 19, 2014.
Jul 29, 2014
Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.
Jun 10, 2014
Ordered to be Reported by Voice Vote.
Jun 10, 2014
Committee Consideration and Mark-up Session Held.
Jun 9, 2014
Committee Consideration and Mark-up Session Held.
May 28, 2014
Forwarded by Subcommittee to Full Committee by Voice Vote .
May 28, 2014
Subcommittee Consideration and Mark-up Session Held.
Apr 16, 2014
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Mar 28, 2014
Referred to the Subcommittee on Health.
Mar 26, 2014
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.
Mar 26, 2014
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now September 19, 2014

Placed on the Union Calendar, Calendar No. 451.

 Committees of jurisdiction 4