To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
This Act may be cited as the ``Generic Drug and Biosimilar User Fee Act of 2012''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents. Sec. 2. Table of contents. TITLE I--FEES RELATING TO GENERIC DRUGS
Sec. 101. Short title; references in title; findings. Sec. 102. Authority to assess and use human generic drug fees. Sec. 103. Reauthorization; reporting requirements. Sec. 104. Sunset dates. Sec. 105. Effective date. Sec. 106. Amendment with respect to misbranding. Sec. 107. Electronic submission of applications. Sec. 108. Streamlined hiring authority of the Food and Drug Administration to support activities related to human generic drugs. TITLE II--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 201. Short title; references in title; finding. Sec. 202. Fees relating to biosimilar biological products. Sec. 203. Reauthorization; reporting requirements. Sec. 204. Sunset dates. Sec. 205. Effective date. Sec. 206. Savings clause. Sec. 207. Technical amendment; conforming amendment.
TITLE I--FEES RELATING TO GENERIC DRUGS
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDINGS.
(a) Short Title.--This title may be cited as the ``Generic Drug User Fee Amendments of 2012''. (b) References in Act.--Except as otherwise specified, amendments made by this title to a section or other provision of law...