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

113th CONGRESS
  2d Session
                                H. R. 4299

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

_______________________________________________________________________

                                 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 of the Controlled Substances Act (21 U.S.C. 811) is 
amended by inserting after subsection (h) the following:
    ``(i) Within 45 days of receiving a recommendation from the 
Secretary to add a drug or substance that has never been marketed in 
the United States to a schedule under this title, the Attorney General 
shall, without regard to the findings required by subsection (a) of 
this section or section 202(b), issue an interim final rule, under the 
exception for good cause described in subparagraph (B) of section 
553(b) of title 5, United States Code, placing the drug or substance 
into the schedule recommended by the Secretary. The interim final rule 
shall be made immediately effective under section 553(d)(3) of title 5, 
United States Code.''.

SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.

    Section 302 of the Controlled Substances Act (21 U.S.C. 822) is 
amended by inserting after subsection (g) the following:
    ``(h)(1) A person who submits an application for registration to 
manufacture or distribute a controlled substance in accordance with 
this section may indicate on the registration application that the 
substance will be used only in connection with clinical trials of a 
drug in accordance with section 505(i) of the Federal Food, Drug, and 
Cosmetic Act.
    ``(2) When an application for registration to manufacture or 
distribute a controlled substance includes an indication that the 
controlled substance will be used only in connection with clinical 
trials of a drug in accordance with section 505(i) of the Federal Food, 
Drug, and Cosmetic Act, the Attorney General shall--
            ``(A) make a final decision on the application for 
        registration within 180 days; or
            ``(B) provide notice to the applicant in writing of--
                    ``(i) the outstanding issues that must be resolved 
                in order to reach a final decision on the application; 
                and
                    ``(ii) the estimated date on which a final decision 
                on the application will be made.''.
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