Skip to main content
HR 5858 114th Congress House Health Cancer Child health Drug safety, medical device, and laboratory regulation Drug therapy Medical research

RACE for Children Act

Introduced: July 14, 2016 Introduced by: McCaul, Michael T. Republican · Texas See on congress.gov
Sign in to write a letter Sign in to watch
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 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 14, 2016
Referred to the House Committee on Energy and Commerce.
Jul 14, 2016
Sponsor introductory remarks on measure. (CR E1133)
Jul 14, 2016
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act

This bill amends the Federal Food, Drug, and Cosmetic Act to expand requirements for assessing the use of medications in pediatric populations.

Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.

The FDA may require the sponsor of an approved medication that could be used to treat pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients.

The bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.

The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.
What's happening now July 14, 2016

Referred to the House Committee on Energy and Commerce.

 Related & companion bills 1
  • S 3239 Identical bill RACE for Children Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Democratic 1
Duffy, Sean
· Jul 14, 2016
 D
Van Hollen, Chris
Maryland · Jul 14, 2016
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5858: RACE for Children Act. 114th Congress. Open America. https://openamerica.io/bill/114-HR-5858/
MLA
"H.R. 5858: RACE for Children Act." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-5858/.
Bluebook (legal)
H.R. 5858, 114th Cong. (2026), https://openamerica.io/bill/114-HR-5858/.
Markdown link
[H.R. 5858: RACE for Children Act](https://openamerica.io/bill/114-HR-5858/)
Report a problem