Regulations last checked for updates: May 18, 2024

Title 21 - Food and Drugs last revised: May 15, 2024
§ 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]
source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
cite as: 21 CFR 1301.15