PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Sep 29, 2021
Give Kids a Chance Act
This bill authorizes the Food and Drug Administration (FDA) to take various actions regarding pediatric cancer treatments, such as requiring pediatric cancer trials involving a combination of drugs when an applicant seeks market approval for a new drug (or biological product).
For an application for market approval for a new adult cancer treatment drug, if the FDA determines that the drug in question is substantially relevant to the growth or progression of a pediatric cancer, the FDA may require a pediatric cancer investigation into that drug's active ingredient in combination with another active ingredient that has received market approval or an exemption for investigational use. Currently, the FDA may only require a pediatric cancer trial for the drug in the application.
Furthermore, when the FDA receives an application for an investigational use exemption for an adult cancer treatment drug, the FDA may require the applicant to conduct up to two preclinical studies to determine the relevance of the drug to pediatric cancer.
People & committees
Rep. Butterfield, G. K. [D-NC-1] · D–NC
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze H.R.5416 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.5416 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine H.R.5416 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine H.R.5416 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.