---
kind: "section"
citation: "21 C.F.R. § 1301.15"
title: "21"
number: "1301.15"
heading: "Additional information."
url: "https://uscodex.org/cfr/21/1301.15"
---

# §1301.15. Additional information.


The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Administrator in granting or denying the application.


## Notes

### Amendments

[62 FR 13948, Mar. 24, 1997]

### Authority

Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965.

### Source

Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

### Amendments

[62 FR 13948, Mar. 24, 1997]