HR 5651 · 112th Congress · Health
Food and Drug Administration Reform Act of 2012
Bill Progress
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Introduced✓
Committee✓
House Vote4
Senate5
EnactedLatest: Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.(2012-06-04)
Recorded Votes
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Plain Language Summary
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Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmac…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeH.R. 5651, Food and Drug Administration Reform Act of 2012
May 24, 2012As ordered reported by the House Committee on Energy and Commerce on May 10, 2012
Full CBO report ↗Amendment in the Nature of a Substitute to H.R. 5651, the Food and Drug Administration Reform Act of 2012
May 29, 2012Statutory Pay-As-You-Go Effects for an Amendment in the Nature of a Substitute to H.R. 5651, as posted on the Web site of the Committee on Energy and Commerce on May 25, 2012
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (5)
3 Democrats2 Republicans