S. 3187 · 112th Congress · enacted
Food and Drug Administration Safety and Innovation Act
Became Public Law No: 112-144.
Latest official action 2012-07-09 · Enacted
The bill, briefly
Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revise and impose new 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. Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the level of required prescription drug user fee revenues. Provides for an inflation adjustment and a workload adjustment for FY2013 and for FY2014 and subsequent fiscal years for the required level of user fee revenue amounts. Requires the Secretary, not later than 60 days before the start of each fiscal year, to establish, for the next fiscal year, application, product, and establishment fees based on revenue amounts established by this title. (Sec. 104) Requires the Secretary to prepare and subm…
Congressional Research Service · 2012-07-09
Who reported lobbying on this bill?
Amount spent specifically on this bill: not disclosed
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No matching lobbying report is imported yet. This is not evidence that no lobbying occurred.
2,409 latest lobbying reports imported. Some source imports are still in progress.
Politicians behind the bill
Sponsors and cosponsors from the official source, limited to members currently in office. Campaign amounts are cycle-wide and are not payments for this bill.
No current-officeholder sponsorship match is available. Historical sponsors may have left office.
1 of 1 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
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The largest 40 donor totals appear here. Open each politician for their complete, paginated PAC donor list.
What happened after enactment?
Dated agency-reported implementation and uptake measures are shown with their scope. They do not by themselves establish causal success. If no evidence is listed, the outcome is not established.
Measured outcome: not established
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