[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.145]

[Page 94]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                        Subpart F--Miscellaneous
 
Sec. 312.145  Guidance documents.

    (a) FDA has made available guidance documents under Sec. 10.115 of 
this chapter to help you to comply with certain requirements of this 
part.
    (b) The Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) maintain lists of 
guidance documents that apply to the centers' regulations. The lists are 
maintained on the Internet and are published annually in the Federal 
Register. A request for a copy of the CDER list should be directed to 
the Office of Training and Communications, Division of Communications 
Management, Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. A request for a copy of the CBER list should 
be directed to 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 56479, Sept. 19, 2000]

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