3.0.0 4299 2023-01-11T13:25:40Z 2023-01-11T13:25:40Z House H HR 2014-03-26 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. PITTS:H.R. 4299.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3, which states that Congressshall have the power ``to regulate commerce with foreignnations, and among the several states. . .''[Page H2695]]]> hsju00 Judiciary Committee House Standing hsju08 Crime and Federal Government Surveillance Subcommittee Discharged from 2014-09-09T20:55:54Z Referred to 2014-04-16T20:50:24Z Reported by 2014-09-19T18:25:06Z Markup by 2014-09-10T21:39:46Z Referred to 2014-03-26T14:00:28Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2014-05-28T19:59:59Z Markup by 2014-05-28T19:59:38Z Referred to 2014-03-28T18:34:08Z Reported by 2014-07-29T17:49:27Z Markup by 2014-06-10T20:07:40Z Referred to 2014-03-26T14:00:23Z H. Rept. 113-565,Part 1 H. Rept. 113-565,Part 2 Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 113 2862 S 2014-09-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2014-09-19 Placed on the Union Calendar, Calendar No. 451. Calendars H12410 2 House floor actions U00451 2014-09-19 Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II. Committee H12200 2 House floor actions hsju00 Judiciary Committee 2014-09-19 Reported (Amended) by the Committee on Judiciary. H. Rept. 113-565, Part II. Committee 5000 9 Library of Congress hsju00 Judiciary Committee 2014-09-10 hsju00 Judiciary Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2014-09-10 hsju00 Judiciary Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2014-09-09 hsju00 Judiciary Committee 1 House committee actions Subcommittee on Crime, Terrorism, Homeland Security, and Investigations Discharged. Committee 2014-07-29 House Committee on the Judiciary Granted an extension for further consideration ending not later than Sept. 19, 2014. IntroReferral H11210 2 House floor actions hsju00 Judiciary Committee 2014-07-29 Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2014-07-29 Reported by the Committee on Energy and Commerce. H. Rept. 113-565, Part I. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2014-06-10 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported by Voice Vote. Committee 2014-06-10 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2014-06-09 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2014-05-28 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee by Voice Vote . Committee 2014-05-28 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2014-04-16 hsju08 Crime and Federal Government Surveillance Subcommittee 1 House committee actions Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. Committee 2014-03-28 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2014-03-26 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. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2014-03-26 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-03-26 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-03-26 Introduced in House IntroReferral 1000 9 Library of Congress P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 N P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2014-03-26 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2014-04-01 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2014-04-03 False B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2014-04-08 False G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 2014-04-09 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2014-04-09 False G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2014-04-10 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2014-04-29 False E000179 Rep. Engel, Eliot L. [D-NY-16] ELIOT ENGEL D NY L. 16 2014-05-19 False S001170 Rep. Shea-Porter, Carol [D-NH-1] Carol Shea-Porter D NH 1 2014-05-19 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2014-05-20 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2014-05-28 False J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2014-05-29 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2014-09-08 False C001093 Rep. Collins, Doug [R-GA-9] Doug Collins R GA 9 2014-09-08 False Crime and Law Enforcement 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 Crime and Law Enforcement 00 2014-03-26 Introduced in House 2014-07-03T20:13:42Z 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.

]]> 28 2014-07-29 Reported to House without amendment, Part I 2014-09-16T15:53:32Z (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.

]]> 19 2014-09-19 Reported to House amended, Part II 2015-01-23T23:13:14Z 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.

]]> Improving Regulatory Transparency for New Medical Therapies Act Display Title Improving Regulatory Transparency for New Medical Therapies Act Official Title as Introduced 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. Introduced in House IH Short Titles as Introduced Improving Regulatory Transparency for New Medical Therapies Act Short Titles as Reported to House Improving Regulatory Transparency for New Medical Therapies Act H House Reported in House 2014-09-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4299rh/xml/BILLS-113hr4299rh.xml Introduced in House 2014-03-26T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4299ih/xml/BILLS-113hr4299ih.xml 2014-09-19 Placed on the Union Calendar, Calendar No. 451. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.