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

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

113th Congress · introduced 2014-03-26 · Crime and Law Enforcement · Latest: Placed on the Union Calendar, Calendar No. 451.

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Official title

Improving Regulatory Transparency for New Medical Therapies Act

Plain summary

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.

Congressional Research Service summary (Reported to House amended, Part II), quoted unchanged (nonpartisan). Read the source.

What a vote does

PSI Sci description of the legislative step (not an opinion).

The strongest published arguments

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Pitts, Joseph R. [R-PA-16] · 15 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Frank Pallone, Jr. (D-NJ), Marsha Blackburn (R-TN), H. Morgan Griffith (R-VA), Robert E. Latta (R-OH), Paul Tonko (D-NY)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Reported to House amended, Part II)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-113hr4299.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/113/hr>

Record fed-us-cong113-hr4299 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113