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Improving Regulatory Transparency for New Medical Therapies Act

3/14/2024, 12:48 PM

Congressional Summary of HR 4299

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.

Current Status of Bill HR 4299

Bill HR 4299 is currently in the status of Bill Introduced since March 26, 2014. Bill HR 4299 was introduced during Congress 113 and was introduced to the House on March 26, 2014.  Bill HR 4299's most recent activity was Placed on the Union Calendar, Calendar No. 451. as of September 19, 2014

Bipartisan Support of Bill HR 4299

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
15
Democrat Cosponsors
6
Republican Cosponsors
9
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 4299

Primary Policy Focus

Crime and Law Enforcement

Potential Impact Areas

- 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

Alternate Title(s) of Bill HR 4299

Improving Regulatory Transparency for New Medical Therapies Act
To amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing.
Improving Regulatory Transparency for New Medical Therapies Act
Improving Regulatory Transparency for New Medical Therapies Act

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