113 HR 4299 RH: Improving Regulatory Transparency for New Medical Therapies Act U.S. House of Representatives 2014-09-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IB Union Calendar No. 451 113th CONGRESS 2d Session H. R. 4299 [Report No. 113–565, Parts I and II] IN THE HOUSE OF REPRESENTATIVES March 26, 2014 Mr. Pitts (for himself and Mr. Pallone) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned July 29, 2014 Reported from the Committee on Energy and Commerce July 29, 2014 Referral to the Committee on the Judiciary extended for a period ending not later than September 19, 2014 September 19, 2014 Additional sponsors: Mr. Burgess, Mrs. McMorris Rodgers, Mrs. Blackburn, Mr. Gingrey of Georgia, Mr. Griffith of Virginia, Mr. Gene Green of Texas, Mr. Latta, Mr. Engel, Ms. Shea-Porter, Mr. Butterfield, Mr. Tonko, Mr. Johnson of Ohio, Mr. Harper, and Mr. Collins of Georgia September 19, 2014 Reported from the Committee on the Judiciary with an amendment Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on March 26, 2014 A BILL 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.

1.

Short title

This Act may be cited as the Improving Regulatory Transparency for New Medical Therapies Act.

2.

Scheduling of substances included in new FDA-approved drugs

Section 201(a) of the Controlled Substances Act (21 U.S.C. 811(a)) is amended by adding at the end the following: Any such proceedings initiated at the request of the Secretary under this subsection 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, shall be commenced not later than 120 days after receipt of written recommendations from the Secretary. The final rule shall be issued not later than 60 days after the date on which both the public comment period has closed and the drug or other substance is the subject of an approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act, unless a hearing on the proposed rule is granted by the Attorney General..

3.

Enhancing new drug development

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following: (i) (1)For the purposes of registration to manufacture a controlled substance under subsection (d) of this section for use only in a clinical trial, the Attorney General shall register an applicant or serve an order to show cause upon an applicant pursuant to section 304(c) of this Act not later than 180 days after receipt of an application and all information the Attorney General deems necessary to make a determination under subsection (d). (2)For the purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with regulations issued by the Attorney General, issue a notice of application not later than 90 days after receipt of an application and all information the Attorney General deems necessary to issue a notice of application. Following the close of the comment period and receipt of all information the Attorney General deems necessary to make a determination under subsection (a), the Attorney General shall register an applicant or serve an order to show cause upon an applicant pursuant to section 304(c) of this Act within 180 days, unless a hearing on the application has been granted by the Attorney General pursuant to section 1008(i) of the Controlled Substances Import and Export Act. .

September 19, 2014 Reported from the Committee on the Judiciary with an amendment