21 CFR § 1301.15 - Additional information.

---
identifier: "/us/cfr/t21/s1301.15"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1301.15 - Additional information."
title_number: 21
title_name: "Food and Drugs"
section_number: "1301.15"
section_name: "Additional information."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1301"
part_name: "REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965."
regulatory_source: "36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973."
cfr_part: "1301"
---


# 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.

[62 FR 13948, Mar. 24, 1997]