HR 4299 · 113th Congress · Crime and Law Enforcement

Improving Regulatory Transparency for New Medical Therapies Act

Introduced 2014-03-26· Sponsored by Rep. Pitts, Joseph R. [R-PA-16]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Placed on the Union Calendar, Calendar No. 451.(2014-09-19)

Plain Language Summary

[AI summary unavailable — showing source text] 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.…

Summarized by Claude AI · Non-partisan · For informational purposes only

CBO Cost Estimate

Congressional Budget Office

H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act

Jun 27, 2014

As ordered reported by the House Committee on Energy and Commerce on June 10, 2014

Full CBO report ↗

H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act

Sep 25, 2014

As ordered reported by the House Committee on the Judiciary on September 10, 2014

Full CBO report ↗

Official non-partisan budget analysis by the Congressional Budget Office

Cosponsors (15)

6 Democrats9 Republicans