# 114-hr-4976: Opioid Review Modernization Act of 2016

114-hr-4976, Opioid Review Modernization Act of 2016, is a 114th Congress bill sponsored by Rep. Maloney, Sean Patrick [D-NY-18] (D-NY); status Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (as of 2025-11-18).

- Canonical: https://policyrisk.com/legislation/114-hr-4976
- As of: 2025-11-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 114-hr-4976
- Congress: 114
- Title: Opioid Review Modernization Act of 2016
- Status: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced: 2016-04-18
- Sponsor: Rep. Maloney, Sean Patrick [D-NY-18] (D-NY)
- Cosponsors: 1
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## Summary

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 The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

## Cosponsors (1)

- Rep. Lance, Leonard [R-NJ-7] (R-NJ), 2016-04-18T00:00:00.000Z

## Related bills

- 114-hr-5621: To posthumously award a Congressional Gold Medal to Lawrence Eugene "Larry" Doby in recognition of his achievements and contributions to American major league…
- 114-hr-5090: To ensure that air transportation between the United States and the European Union complies with the intent of article 17 bis of the United States-European Uni…
- 114-hr-4919: Kevin and Avonte's Law of 2016
- 114-hr-4625: Firefighter Cancer Registry Act of 2016
- 114-hr-4514: Combating BDS Act of 2016
- 114-hr-3929: Office of Strategic Services Congressional Gold Medal Act

## Sources
- [114-hr-4976 on Congress.gov](https://www.congress.gov/bill/114th-congress/house-bill/4976)

## Related
- [114-hr-5621: To posthumously award a Congressional Gold Medal to Lawrence Eugene "Larry" Dob…](https://policyrisk.com/legislation/114-hr-5621)
- [114-hr-5090: To ensure that air transportation between the United States and the European Un…](https://policyrisk.com/legislation/114-hr-5090)
- [114-hr-4919: Kevin and Avonte's Law of 2016](https://policyrisk.com/legislation/114-hr-4919)
- [114-hr-4625: Firefighter Cancer Registry Act of 2016](https://policyrisk.com/legislation/114-hr-4625)
- [114-hr-4514: Combating BDS Act of 2016](https://policyrisk.com/legislation/114-hr-4514)
- [114-hr-3929: Office of Strategic Services Congressional Gold Medal Act](https://policyrisk.com/legislation/114-hr-3929)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/114-hr-4976 (as of 2025-11-18).