[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.29]

[Page 36]
 
                        TITLE 21--FOOD AND DRUGS
 
          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, 1401 Rockville Pike, Rockville, MD 20852-1448.

[65 FR 56480, Sept. 19, 2000]