US Congress House Bill 4976 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Engrossed on May 12 2016 - 50% progression, died in committee
Action: 2016-05-12 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Engrossed) [PDF]

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 (Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."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

Rep. Sean Maloney [D-NY]

Rep. Leonard Lance [R-NJ]

Date	Chamber	Action
2016-05-12	Senate	Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2016-05-11	House	Motion to reconsider laid on the table Agreed to without objection.
2016-05-11	House	On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256)
2016-05-11	House	DEBATE - The House proceeded with forty minutes of debate on H.R. 4976.
2016-05-11	House	Considered under suspension of the rules. (consideration: CR H2254-2256)
2016-05-11	House	Mr. Guthrie moved to suspend the rules and pass the bill.
2016-05-10	House	Placed on the Union Calendar, Calendar No. 431.
2016-05-10	House	Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
2016-04-27	House	Ordered to be Reported by Voice Vote.
2016-04-27	House	Committee Consideration and Mark-up Session Held.
2016-04-26	House	Committee Consideration and Mark-up Session Held.
2016-04-25	House	Committee Consideration and Mark-up Session Held.
2016-04-20	House	Forwarded by Subcommittee to Full Committee by Voice Vote .
2016-04-20	House	Subcommittee Consideration and Mark-up Session Held.
2016-04-18	House	Referred to the Subcommittee on Health.
2016-04-18	House	Referred to the House Committee on Energy and Commerce.
2016-04-18	House	Introduced in House

SB524 (Related) 2016-07-22 - Became Public Law No: 114-198. (TXT | PDF)
HB5189 (Related) 2016-06-07 - Referred to the Subcommittee on Military Personnel.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/4976/all-info
Text	https://www.congress.gov/114/bills/hr4976/BILLS-114hr4976ih.pdf
Text	https://www.congress.gov/114/bills/hr4976/BILLS-114hr4976rh.pdf
Text	https://www.congress.gov/114/bills/hr4976/BILLS-114hr4976eh.pdf