Improving Regulatory Transparency for New Medical Therapies Act

Bill: 113-hr-4299
Sponsor: Rep. Pitts, Joseph R. [R-PA-16]
Introduced: 2014-03-26 in the House
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

Summary:
action_date: 2014-03-26
text: 
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.
 
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.

action_date: 2014-07-29
text: 

(This measure has not been amended since it was introduced. The summary of that version is repeated here.)

 
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.
 
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.

action_date: 2014-09-19
text: 
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.


Legislative actions:
action_date: 2014-09-19
text: Placed on the Union Calendar, Calendar No. 451.
action_date: 2014-09-19
text: Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.
action_date: 2014-09-19
text: Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II.
action_date: 2014-09-10
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2014-09-10
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-09-09
text: Subcommittee on Crime, Terrorism, Homeland Security, and Investigations Discharged.
action_date: 2014-07-29
text: House Committee on the Judiciary Granted an extension for further consideration ending not later than Sept. 19, 2014.
action_date: 2014-07-29
text: Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.
action_date: 2014-07-29
text: Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I.
action_date: 2014-06-10
text: Ordered to be Reported by Voice Vote.
action_date: 2014-06-10
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-06-09
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-05-28
text: Forwarded by Subcommittee to Full Committee by Voice Vote .
action_date: 2014-05-28
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2014-04-16
text: Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
action_date: 2014-03-28
text: Referred to the Subcommittee on Health.
action_date: 2014-03-26
text: 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.
action_date: 2014-03-26
text: 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.
action_date: 2014-03-26
text: Introduced in House
action_date: 2014-03-26
text: Introduced in House