3.0.0 481 2023-01-11T13:28:20Z 2023-01-11T13:28:20Z Senate S 2015-02-12 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2015-10-01T21:48:34Z Markup by 2015-09-30T14:08:34Z Referred to 2015-02-12T17:51:25Z Improving Regulatory Transparency for New Medical Therapies Act 114 639 HR 2015-11-25 Became Public Law No: 114-89. Related bill CRS 2015-10-01 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 245. Calendars 2015-10-01 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2015-10-01 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2015-09-30 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-02-12 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-02-12 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N W000802 Sen. Whitehouse, Sheldon [D-RI] Sheldon Whitehouse D RI 2015-02-12 True M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2015-09-15 False A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2015-11-03 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Drug trafficking and controlled substances Food and Drug Administration (FDA) Intellectual property Licensing and registrations Veterinary medicine and animal diseases Health 00 2015-02-12 Introduced in Senate 2015-03-24T17:02:28Z Improving Regulatory Transparency for New Medical Therapies Act

This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.]]> 01 2015-10-01 Reported to Senate with amendment(s) 2016-01-22T16:45:19Z Improving Regulatory Transparency for New Medical Therapies Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

(Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

(Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

]]> Improving Regulatory Transparency for New Medical Therapies Act Display Title Improving Regulatory Transparency for New Medical Therapies Act Official Title as Introduced A bill to amend the Controlled Substances Act and the Federal Food, Drug, and Cosmetic 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, and for other purposes. Introduced in Senate IS Short Titles as Introduced Improving Regulatory Transparency for New Medical Therapies Act Short Titles as Reported to Senate Improving Regulatory Transparency for New Medical Therapies Act S Senate Reported to Senate 2015-10-01T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s481rs/xml/BILLS-114s481rs.xml Introduced in Senate 2015-02-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s481is/xml/BILLS-114s481is.xml 2015-10-01 Placed on Senate Legislative Calendar under General Orders. Calendar No. 245. 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.