Electronic Code of Federal Regulations
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e-CFR data is current as of January 14, 2021 |
Title 21 → Chapter I → Subchapter E → Part 516 → Subpart C → §516.153 |
Title 21: Food and Drugs
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
§516.153 Notification of decision regarding index listing.
(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.