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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4299 Reported in House (RH)]

                                                 Union Calendar No. 451
113th CONGRESS
  2d Session
                                H. R. 4299

                  [Report No. 113-565, Parts I and II]

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

                             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.

 

    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.''.
                                                 Union Calendar No. 451

113th CONGRESS

  2d Session

                               H. R. 4299

                  [Report No. 113-565, Parts I and II]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                           September 19, 2014

     Reported from the Committee on the Judiciary with an amendment
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