3.0.0 4976 2023-01-11T13:31:37Z 2023-01-11T13:31:37Z House HR 2016-04-18 114 [Congressional Record Volume 162, Number 59 (Monday, April 18, 2016)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SEAN PATRICK MALONEY of New York:H.R. 4976.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H1802]]]> sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2016-05-12T16:18:05Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2016-04-20T19:29:19Z Markup by 2016-04-20T19:28:54Z Referred to 2016-04-18T19:28:47Z Reported by 2016-05-11T01:16:51Z Markup by 2016-04-27T19:53:03Z Referred to 2016-04-18T16:01:05Z H. Rept. 114-557 Opioid Abuse Crisis Act of 2016 114 5189 HR 2016-06-07 Referred to the Subcommittee on Military Personnel. Related bill CRS Comprehensive Addiction and Recovery Act of 2016 114 524 S 2016-07-22 Became Public Law No: 114-198. Related bill CRS Related bill House 2016-05-12 sshr00 Health, Education, Labor, and Pensions Committee Senate Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2016-05-11 16:41:33 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2016-05-11 16:41:30 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256) Floor H37300 2 House floor actions 2016-05-11 16:41:30 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H2254-2256) Floor 8000 9 Library of Congress 2016-05-11 16:28:40 DEBATE - The House proceeded with forty minutes of debate on H.R. 4976. Floor H8D000 2 House floor actions 2016-05-11 16:28:38 Considered under suspension of the rules. (consideration: CR H2254-2256) Floor H30000 2 House floor actions 2016-05-11 16:28:21 Mr. Guthrie moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2016-05-10 Placed on the Union Calendar, Calendar No. 431. Calendars H12410 2 House floor actions U00431 2016-05-10 Reported by the Committee on Energy and Commerce. H. Rept. 114-557. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2016-05-10 Reported by the Committee on Energy and Commerce. H. Rept. 114-557. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2016-04-27 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported by Voice Vote. Committee 2016-04-27 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2016-04-26 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2016-04-25 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2016-04-20 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee by Voice Vote . Committee 2016-04-20 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2016-04-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2016-04-18 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2016-04-18 Introduced in House IntroReferral Intro-H 9 Library of Congress 2016-04-18 Introduced in House IntroReferral 1000 9 Library of Congress M001185 Rep. Maloney, Sean Patrick [D-NY-18] Sean Maloney D NY Patrick 18 N L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2016-04-18 True 2016-05-10T17:12:32Z H.R. 4976, Opioid Review Modernization Act of 2016 https://www.cbo.gov/publication/51555 As ordered reported by the House Committee on Energy and Commerce on April 27, 2016 Health Administrative law and regulatory procedures Advisory bodies Child health Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Food and Drug Administration (FDA) Prescription drugs Health 00 2016-04-18 Introduced in House 2016-05-09T16:16:09Z Opioid Review Modernization Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."]]> 79 2016-05-10 Reported to House without amendment 2016-06-13T14:43:58Z (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Opioid Review Modernization Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."]]> 81 2016-05-11 Passed House without amendment 2016-06-13T20:21:51Z (This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)

Opioid Review Modernization Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."]]> Opioid Review Modernization Act of 2016 Display Title Opioid Review Modernization Act of 2016 Official Title as Introduced To require the Commissioner of Food and Drugs to seek recommendations from an advisory committee of the Food and Drug Administration before approval of certain new drugs that are opioids without abuse-deterrent properties, and for other purposes. Introduced in House IH Short Titles as Introduced Opioid Review Modernization Act of 2016 Short Titles as Reported to House Opioid Review Modernization Act of 2016 H House Short Titles as Passed House Opioid Review Modernization Act of 2016 H House Referred in Senate 2016-05-12T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr4976rfs/xml/BILLS-114hr4976rfs.xml Engrossed in House 2016-05-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr4976eh/xml/BILLS-114hr4976eh.xml Reported in House 2016-05-10T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr4976rh/xml/BILLS-114hr4976rh.xml Introduced in House 2016-04-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr4976ih/xml/BILLS-114hr4976ih.xml 2016-05-12 Received in the Senate and 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.