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H.R. 4274: BPCA and PREA Reauthorization Act of 2012

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H.R. 4274: BPCA and PREA Reauthorization Act of 2012

112th Congress · introduced 2012-03-28 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2012-03-28 · official record
  2. Who proposed it: Rep. Rogers, Mike J. [R-MI-8] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

BPCA and PREA Reauthorization Act of 2012

Plain 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.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

BPCA and PREA Reauthorization Act of 2012

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Rogers, Mike J. [R-MI-8] · 2 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Edward J. Markey (D-MA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

Record fed-us-cong112-hr4274 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112