CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES > SUBPART C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (§516.111 to §516.171) > 516.147—Refuse to file a request for addition to the index.

516.147—Refuse to file a request for addition to the index.

(a) If a request for addition to the index contains all of the information required by § 516.145(b), FDA shall file it, and the filing date shall be the date FDA receives the request.
(b) If a request for addition to the index lacks any of the information required by § 516.145, FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking.