SECTION 1. Short Title.
This Act may be cited as the “Animal Drug and Animal Generic Drug User Fee Amendments of 2018”.
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
An Act
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SEC. 2. Table of Contents; References in Act.
Table of Contents.— The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
TITLE I— FEES RELATING TO ANIMAL DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
TITLE II— FEES RELATING TO GENERIC ANIMAL DRUGS
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
TITLE III— MISCELLANEOUS PROVISIONS
Sec. 301. Electronic submissions.
Sec. 302. Index of legally marketed unapproved new animal drugs for minor species.
Sec. 303. Misbranded drugs and devices.
Sec. 304. Conditional approval of new animal drugs.
Sec. 305. Guidance addressing investigation designs.
Sec. 306. Food additives intended for use in animal food.
References in Act.— Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).