S 2516 · 112th Congress · Health

Food and Drug Administration Safety and Innovation Act

Introduced 2012-05-07· Sponsored by Sen. Harkin, Tom [D-IA]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 389.(2012-05-07)

Plain Language Summary

[AI summary unavailable — showing source text] Food and Drug Administration Safety and Innovation Act - 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 …

Summarized by Claude AI · Non-partisan · For informational purposes only

CBO Cost Estimate

Congressional Budget Office

S. 2516, Food and Drug Administration Safety and Innovation Act

May 11, 2012

As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 7, 2012

Full CBO report ↗

Official non-partisan budget analysis by the Congressional Budget Office