C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES › Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

21 C.F.R. § 516.131

Refuse to file a request for determination of eligibility for indexing

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(a) If a request for determination of eligibility for indexing contains all of the information required by § 516.129, FDA shall file it, and the filing date shall be the date FDA receives the request.

(b) If a request for a determination of eligibility lacks any of the information required by § 516.129, 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.