Summary

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for... Read More

Status

This bill was introduced in a previous session of Congress and was passed by the House on May 31, 2012 but was never passed by the Senate.

Bill Text

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Food and Drug Administration Reform Act of 2012''.

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:

Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. References in Act. TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Reauthorization; reporting requirements. Sec. 105. Sunset dates. Sec. 106. Effective date. Sec. 107. Savings clause. TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012

Sec. 201. Short title; findings. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Reauthorization; reporting requirements. Sec. 205. Savings clause. Sec. 206. Effective date. Sec. 207. Sunset clause. Sec. 208. Streamlined hiring authority to support activities related to the process for the review of device applications. TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title. Sec. 302. Authority to assess and use human generic drug fees. Sec. 303. Reauthorization; reporting requirements. Sec. 304. Sunset dates. Sec. 305. Effective date. Sec. 306. Amendment with respect to misbranding. Sec. 307. Streamlined hiring authority to support activities related to...

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Bill Summary

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

H.R. 5650The Protecting Women's Access to Health Care Act H.R. 5652the Sequester Replacement Reconciliation Act