3.0.0 2862 2023-01-11T13:25:26Z 2023-01-11T13:25:26Z Senate S S 2014-09-18 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2014-09-18T17:55:40Z Improving Regulatory Transparency for New Medical Therapies Act 113 4299 HR 2014-09-19 Placed on the Union Calendar, Calendar No. 451. Related bill CRS Ensuring Patient Access and Effective Drug Enforcement Act of 2014 113 4709 HR 2014-07-30 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2014-09-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2014-09-18 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 2014-09-18 True P000603 Sen. Paul, Rand [R-KY] Rand Paul R KY 2014-11-13 False Crime and Law Enforcement Administrative law and regulatory procedures Administrative remedies Congressional oversight Department of Justice Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Government studies and investigations Health care coverage and access Licensing and registrations Prescription drugs Retail and wholesale trades Crime and Law Enforcement 00 2014-09-18 Introduced in Senate 2016-05-24T15:18:48Z Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - 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 it into the schedule recommended, effective immediately.

Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made.

Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety."

Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order.

Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.

]]> Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 Display Title Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 Official Title as Introduced 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, and for other purposes. Introduced in Senate IS Short Titles as Introduced Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 Introduced in Senate 2014-09-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2862is/xml/BILLS-113s2862is.xml 2014-09-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.