GroundRules
21 CFR 516.147: Refuse to file a request for addition to the index.
Where this section sits in the code
- 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
- PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON