---
kind: "section"
citation: "21 C.F.R. § 60.26"
title: "21"
number: "60.26"
heading: "Final action on regulatory review period determinations."
url: "https://uscodex.org/cfr/21/60.26"
---

# §60.26. Final action on regulatory review period determinations.

- (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](/cfr/21/60.30.md) 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](/cfr/21/60.24.md) for revision of the regulatory review period determination;
  - (3) A due diligence petition filed under [§ 60.30](/cfr/21/60.30.md); or
  - (4) A request for a hearing filed under [§ 60.40](/cfr/21/60.40.md).
- (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.

## Notes

### 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]