H.R. 4976: Opioid Review Modernization Act of 2016

114th Congress · introduced 2016-04-18 · Health · Latest: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2016-04-18 · official record
Who proposed it: Rep. Maloney, Sean Patrick [D-NY-18] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Opioid Review Modernization Act of 2016

Plain summary

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 (Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

Congressional Research Service summary (Passed House without amendment), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Opioid Review Modernization Act of 2016

Source: Congressional Research Service summary (Passed House without amendment)

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The strongest published arguments

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Maloney, Sean Patrick [D-NY-18] · 1 cosponsors

Cost estimate: CBO cost estimate: H.R. 4976, Opioid Review Modernization Act of 2016 (2016-05-10)

Cosponsors on this site

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Passed House without amendment)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114hr4976.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr4976 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114