Improving Regulatory Transparency for New Medical Therapies Act

Bill: 113-hr-4299
Sponsor: full_name: Rep. Pitts, Joseph R. [R-PA-16]
Introduced: 2014-03-26
Policy area: Crime and Law Enforcement
Subjects: Administrative law and regulatory procedures

Administrative remedies

Department of Justice

Drug safety, medical device, and laboratory regulation

Drug trafficking and controlled substances

Licensing and registrations

Medical research
Latest action: action_date: 2014-09-19
text: Placed on the Union Calendar, Calendar No. 451.

Summaries:
action_date: 2014-03-26
action_desc: Introduced in House
text: <p>Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule, under the exception for good cause, placing the drug or substance into the schedule recommended by the Secretary. Makes the interim final rule immediately effective.</p> <p>Authorizes a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the application that the substance will be used only in connection with clinical trials of a drug in accordance with the Federal Food, Drug, and Cosmetic Act. Directs the Attorney General to make a final decision on an application that includes such an indication within 180 days or provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date such decision will be made.</p>

action_date: 2014-07-29
action_desc: Reported to House without amendment, Part I
text: <p><b>(This measure has not been amended since it was introduced. The summary of that version is repeated here.)</b></p> <p>Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule, under the exception for good cause, placing the drug or substance into the schedule recommended by the Secretary. Makes the interim final rule immediately effective.</p> <p>Authorizes a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the application that the substance will be used only in connection with clinical trials of a drug in accordance with the Federal Food, Drug, and Cosmetic Act. Directs the Attorney General to make a final decision on an application that includes such an indication within 180 days or provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date such decision will be made.</p>

action_date: 2014-09-19
action_desc: Reported to House amended, Part II
text: <p>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.</p> <p>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.</p> <p>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.</p>

tv_txt: I 113th CONGRESS 2d Session H. R. 4299 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.

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 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. . 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. .

tv_txt: 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