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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 639 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 639

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.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            February 2, 2015

   Mr. Pitts (for himself, Mr. Pallone, and Mr. Gene Green of Texas) 
 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

_______________________________________________________________________

                                 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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.''.

SEC. 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.''.
                                 <all>
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