---
kind: "section"
citation: "21 C.F.R. § 60.28"
title: "21"
number: "60.28"
heading: "Time frame for determining regulatory review periods."
url: "https://uscodex.org/cfr/21/60.28"
---

# §60.28. Time frame for determining regulatory review periods.

- (a) FDA will determine the regulatory review period for a product within 30 days of the receipt of a written request from PTO for such a determination and a copy of the patent term restoration application.
- (b) FDA may extend the 30-day period if:
  - (1) A related FDA action that may affect the regulatory review period determination is pending; or
  - (2) PTO requests that FDA temporarily suspend the determination process; or
  - (3) PTO or FDA receives new information about the product that warrants an extension of the time required for the determination of the regulatory review period.
- (c) This section does not apply to applications withdrawn by the applicant or applications that PTO determines are ineligible for patent term restoration.

## Notes

### 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.