Improving Regulatory Transparency for New Medical Therapies Act

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

R PittsSponsor

15 cosponsors · 6 D, 9 R

D Pallone MB

R Burgess CM

R McMorris Rodgers MB

1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

What it does: CRS summary · Reported to House amended, Part II · Sep 19, 2014

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Improving Regulatory Transparency for New Medical Therapies Act

Latest action (Sep 19, 2014): Placed on the Union Calendar, Calendar No. 451.

Policy area: Crime and Law Enforcement · Origin: House · Introduced: Mar 26, 2014

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.