[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.29]

[Page 38]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart C_Biologics Licensing
 
Sec. 601.29  Guidance documents.

    (a) FDA has made available guidance documents under Sec. 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 Sec. 600.2 of this 
chapter).

[65 FR 56480, Sept. 19, 2000, as amended at 70 FR 14984, Mar. 24, 2005]