---
kind: "section"
citation: "21 C.F.R. § 60.40"
title: "21"
number: "60.40"
heading: "Request for hearing."
url: "https://uscodex.org/cfr/21/60.40"
---

# §60.40. Request for hearing.

- (a) Any person may request, not later than 60 days after the publication under [§ 60.34(a)](/cfr/21/60.34.md?p=a) of FDA's due diligence determination, that FDA conduct an informal hearing on the due diligence determination.
- (b) **The request for a hearing under this section shall—**
  - (1) Be sent by mail, personal delivery, or any other mode of written communication to the Dockets Management Staff and filed under the relevant product file;
  - (2) Specify the facts and the action that are the subject of the hearing;
  - (3) Provide the name and address of the person requesting the hearing; and
  - (4) Certify that the requesting party has served a true and complete copy of the request upon the petitioner and the applicant by certified or registered mail (return receipt requested) or by personal delivery.
- (c) The request shall state whether the requesting party seeks a hearing within 30 days or 60 days of FDA's receipt of the request.

## Notes

### Amendments

[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]

### 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 67 FR 9585, Mar. 4, 2002]