United States 112th Congress Status: Died 1 R cosponsors

HR 4274 — BPCA and PREA Reauthorization Act of 2012

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

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.

Bill Text

We don't have the full text on file for this bill yet.

Read HR 4274 on the official United States source →

Action History

  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 4274 do?
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.
Who sponsors HR 4274?
HR 4274 is sponsored by Mike J. Rogers (R).
What is the current status of HR 4274?
This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 4274?
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Last checked for changes about 10 hours ago · updated continuously

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