GroundRules
21 CFR 516.153: Notification of decision regarding index listing.
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) Within 180 days after the filing of a request for addition of a new animal drug to the index, FDA shall grant or deny the request and notify the requestor of FDA's decision in writing.
(b) If FDA denies the request for addition of a new animal drug to the index, FDA shall provide due notice and an opportunity for an informal conference as described in § 516.123. A decision of FDA to deny a request to index a new animal drug following an informal conference shall constitute final agency action subject to judicial review.
Collected 2026-08-27T02:24:47Z. Source file · JSON