S. 3239 · 114th Congress
RACE for Children Act
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BennetSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act
What it does: CRS summary · Introduced in Senate · Jul 14, 2016
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: RACE for Children Act
Also known as: Research to Accelerate Cures and Equity for Children Act
Latest action (Jul 14, 2016): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Jul 14, 2016
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.