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Electronic Code of Federal Regulations

e-CFR data is current as of February 18, 2020

Title 21Chapter ISubchapter EPart 516Subpart C → §516.137


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


§516.137   Notification of decision regarding eligibility for indexing.

(a) Within 90 days after the filing of a request for a determination of eligibility for indexing based on §516.129(c)(7)(i), or 180 days for a request based on §516.129(c)(7)(ii), FDA shall grant or deny the request, and notify the requestor of FDA's decision in writing.

(b) If FDA denies the request, FDA shall provide due notice and an opportunity for an informal conference as described in §516.123 regarding its decision. A decision of FDA to deny a request for determination of eligibility for indexing following an informal conference shall constitute final agency action subject to judicial review.

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