§60.26. Final action on regulatory review period determinations.
21 C.F.R. § 60.26
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:
New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;
A request under § 60.24 for revision of the regulatory review period determination;
A due diligence petition filed under § 60.30; or
A request for a hearing filed under § 60.40.
FDA will notify PTO that the regulatory review period determination is final upon:
The expiration of the 180-day period for filing a due diligence petition; or
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.
Notes, amendments, and revision history
Amendments
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]
Authority
Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.
Source
Source: 53 FR 7305, Mar. 7, 1988, unless otherwise noted.
Amendments
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]