601.29—Guidance documents.
(a)
FDA has made available guidance documents under § 10.115 of this chapter to help you comply with certain requirements of this part.
(b)
The Center for Biologics Evaluation and Research (CBER) maintains a list of guidance documents that apply to the center's regulations. The lists are maintained on the Internet and are published annually in the Federal Register. You may request a copy of the CBER list from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration (see mailing addresses in § 600.2 of this chapter ).