§ 60.26. Final action on regulatory review period determinations.

200 words·~1 min read·/us/cfr/t21/s§ 60.26

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives:

(1)New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;

(2)A request under § 60.24 for revision of the regulatory review period determination;

(3)A due diligence petition filed under § 60.30; or

(4)A request for a hearing filed under § 60.40.

(b)FDA will notify PTO that the regulatory review period determination is final upon:

(1)The expiration of the 180-day period for filing a due diligence petition; or

(2)If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the petition, or the hearing, whichever is later. FDA will send a copy of the notification to the applicant and file a copy of the notification in the docket established for the application in FDA's Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]