Improving Regulatory Transparency for New Medical Therapies Act

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.

[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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