H.R. 4274 · 112th Congress
BPCA and PREA Reauthorization Act of 2012
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
RogersSponsor2 cosponsors · 2 D
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA).
What it does: CRS summary · Introduced in House · Mar 28, 2012
BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA).
Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity.
Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change.
Requires a product sponsor to submit an Initial Pediatric Plan as part of the drug application process and sets forth the process for such submission.
Authorizes the Secretary of Health and Human Services (HHS) to: (1) grant a deferral extension, and sets forth the conditions for such deferral; and (2) issue a non-compliance letter to a product sponsor failing to meet post-marketing requirements, and requires the product sponsor to respond in writing.
Authorizes the Pediatric Review Committee to review deferral extensions.
Requires the Office of Pediatric Therapeutics to include a neonatologist and pediatric epidemiologist.
Reauthorizes the Pediatric Advisory Committee and the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: BPCA and PREA Reauthorization Act of 2012
Latest action (Mar 30, 2012): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Mar 28, 2012
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.