21 C.F.R. § 1301.15 Additional information.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Registration
§ 1301.15 Additional information.
