(a) Within 90 days after the filing of a request for a determination of eligibility for indexing based on Sec. 516.129(c)(7)(i), or 180 days for a request based on Sec. 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 Sec. 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.