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HR 4976 114th Congress House

Opioid Review Modernization Act of 2016

Official title: 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… Show full official titleShow less

Official title: 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: April 18, 2016 See on congress.gov
Health Administrative law and regulatory proceduresAdvisory bodiesChild healthCongressional oversight
More subjectsShow fewer subjects
Department of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFood and Drug Administration (FDA)Prescription drugs
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 18 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 12, 2016
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 11, 2016
Motion to reconsider laid on the table Agreed to without objection.
May 11, 2016
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2254-2256)
May 11, 2016
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H2254-2256)
May 11, 2016
DEBATE - The House proceeded with forty minutes of debate on H.R. 4976.
May 11, 2016
Considered under suspension of the rules. (consideration: CR H2254-2256)
May 11, 2016
Mr. Guthrie moved to suspend the rules and pass the bill.
May 10, 2016
Placed on the Union Calendar, Calendar No. 431.
May 10, 2016
Reported by the Committee on Energy and Commerce. H. Rept. 114-557.
Apr 27, 2016
Ordered to be Reported by Voice Vote.
Apr 27, 2016
Committee Consideration and Mark-up Session Held.
Apr 26, 2016
Committee Consideration and Mark-up Session Held.
Apr 25, 2016
Committee Consideration and Mark-up Session Held.
Apr 20, 2016
Forwarded by Subcommittee to Full Committee by Voice Vote .
Apr 20, 2016
Subcommittee Consideration and Mark-up Session Held.
Apr 18, 2016
Referred to the Subcommittee on Health.
Apr 18, 2016
Referred to the House Committee on Energy and Commerce.
Apr 18, 2016
Introduced in House
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 Latest action May 12, 2016

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Plain-English summary Congressional Research Service

(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."
 Related & companion bills 2
  • HR 5189 Related bill Opioid Abuse Crisis Act of 2016
  • S 524 Related bill Comprehensive Addiction and Recovery Act of 2016
 Bill text 4 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4976: Opioid Review Modernization Act of 2016. 114th Congress. Open America. https://openamerica.io/bill/114-HR-4976/
MLA
"H.R. 4976: Opioid Review Modernization Act of 2016." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-4976/.
Bluebook (legal)
H.R. 4976, 114th Cong. (2026), https://openamerica.io/bill/114-HR-4976/.
Markdown link
[H.R. 4976: Opioid Review Modernization Act of 2016](https://openamerica.io/bill/114-HR-4976/)
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