Code of Federal Regulations Title 21. Food and Drugs § 21.1.245 Waiver request

Under §§ 1.231(a)(2) and (b), 1.234(d), and 1.235(d), beginning January 4, 2020, you must submit your registration, registration renewal, updates, and cancellations to FDA electronically unless FDA has granted a waiver from such requirement. Under § 1.232(a)(6), you must provide the email address of the owner, operator, or agent in charge of the facility unless FDA has granted a waiver from such requirement. In addition, under §§ 1.230(b) and (c), 1.232(a)(10), 1.234(a), and 1.235(b)(5), registration renewals, abbreviated registration renewals, registrations, updates, and cancellations not submitted by the owner, operator, or agent in charge must include the email address for the individual who authorized the submission, unless FDA has granted a waiver. To request a waiver from these requirements, you must submit a written request to FDA that explains why it is not reasonable for you to submit your registration, registration renewal, update, or cancellation to FDA electronically or to provide the email address of the owner, operator, or agent in charge of the facility. You must submit your request to:  U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS–681), College Park, MD 20740.