HR 639 · 114th Congress · Crime and Law Enforcement
Improving Regulatory Transparency for New Medical Therapies Act
Bill Progress
1
Introduced✓
Committee✓
House Vote✓
Senate✓
EnactedLatest: Became Public Law No: 114-89.(2015-11-25)
Plain Language Summary
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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 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 re…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeH.R. 639, Improving Regulatory Transparency for New Medical Therapies Act
Mar 17, 2015As ordered reported by the House Committee on Energy and Commerce on February 12, 2015
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (3)
2 Democrats1 Republican