---
kind: "section"
citation: "21 C.F.R. § 60.20"
title: "21"
number: "60.20"
heading: "FDA action on regulatory review period determinations."
url: "https://uscodex.org/cfr/21/60.20"
---

# §60.20. FDA action on regulatory review period determinations.

- (a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product's regulatory review period under [§ 60.22](/cfr/21/60.22.md). The application shall contain information relevant to the determination of the regulatory review period as stated in the “Guidelines for Extension of Patent Term Under [35 U.S.C. 156](/usc/35/156.md)” published on October 9, 1984, in PTO's Official Gazette and as required by [37 CFR chapter](/cfr/37.md) I.
- (b) After determining the length of the regulatory review period, FDA will notify PTO in writing of its determination, send a copy of this determination to the applicant, and file a copy of the determination in the docket established for the application in FDA's Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
- (c) FDA will also publish the regulatory review period determination in the Federal Register. The notice will include the following:
  - (1) The name of the applicant;
  - (2) The trade name and generic name (if applicable) of the product;
  - (3) The number of the patent for which an extension of the term is sought;
  - (4) The approved indications or uses for the product;
  - (5) An explanation of any discrepancies between the dates in the application and FDA records;
  - (6) Where appropriate, an explanation that FDA has no record in which to review the date(s) contained in the application; and
  - (7) The regulatory review period determination, including a statement of the length of the testing and approval phases and the dates used in calculating each phase.

## 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]