S 3187 · 112th Congress · Health

Food and Drug Administration Safety and Innovation Act

Introduced 2012-05-15· Sponsored by Sen. Harkin, Tom [D-IA]· Senate

Bill Progress

1
Introduced
Committee
Senate Vote
4
House
Enacted
Latest: Became Public Law No: 112-144.(2012-07-09)

Recorded Votes

PassedSenate · 2012-06-26
Roll #168
Yea 92Nay 4
PassedSenate · 2012-06-26
Roll #168
Yea 92Nay 4

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

Senate Amendment 2122 in the Nature of a Substitute to S. 3187, the Food and Drug Administration Safety and Innovation Act

May 22, 2012

CBO Estimate of the Statutory Pay-As-You-Go Effects for Senate Amendment 2122 in the Nature of a Substitute to S. 3187, the Food and Drug Administration Safety and Innovation Act

Full CBO report ↗

Senate Amendment 2122 in the Nature of a Substitute to S. 3187, the Food and Drug Administration Safety and Innovation Act with Further Amendments Adopted by the Senate Through May 24, 2012

May 24, 2012

CBO Estimate of the Statutory Pay-As-You-Go Effects for Senate Amendment 2122 in the Nature of a Substitute to S. 3187,the Food and Drug Administration Safety and Innovation Act, with Further Amendments Adopted by the Senate through May 24, 2012

Full CBO report ↗

S. 3187, the Food and Drug Administration Safety and Innovation Act, with an Amendment

Jun 19, 2012

Pay-As-You-Go Estimate for S. 3187 as posted on the Web site of the House Committee on Energy and Commerce on June 18, 2012

Full CBO report ↗

Official non-partisan budget analysis by the Congressional Budget Office

Cosponsors (1)

1 Republican