3.0.0 2025 2023-01-11T13:36:01Z 2023-01-11T13:36:01Z House HR 2017-04-06 115 [Congressional Record Volume 163, Number 60 (Thursday, April 6, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GRIFFITH:H.R. 2025.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8 of the United StatesConstitution.[Page H2791]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-04-07T14:49:07Z Referred to 2017-04-06T13:14:50Z 2017-04-07 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-04-06 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-04-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-04-06 Introduced in House IntroReferral 1000 9 Library of Congress G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 N C001106 Rep. Costello, Ryan A. [R-PA-6] Ryan Costello R PA A. 6 2017-04-06 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug, alcohol, tobacco use Health 00 2017-04-06 Introduced in House 2018-08-10T15:04:45Z Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions.

The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such exclusivity.

The bill applies to applications and supplements to applications that are submitted or pending approval on or after January 1, 2017.

]]> Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 Display Title Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 Official Title as Introduced To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act to prevent certain applications from being considered ineligible for approval under section 505(c) of such Act on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity under clause (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other purposes. Introduced in House IH Short Titles as Introduced Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 Introduced in House 2017-04-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr2025ih/xml/BILLS-115hr2025ih.xml 2017-04-07 Referred to the Subcommittee on Health. 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.