[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.58]

[Page 39]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201_LABELING--Table of Contents
 
  Subpart B_Labeling Requirements for Prescription Drugs and/or Insulin
 
Sec.  201.58  Waiver of labeling requirements.

    An applicant may ask the Food and Drug Administration to waive any 
requirement under Sec. Sec.  201.56, 201.57, and 201.80. A waiver 
request must be submitted in writing to the Director (or the Director's 
designee), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, or, if 
applicable, the Director (or the Director's designee), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, suite 200 North, Rockville, MD 20852-1448. The waiver 
must be granted or denied in writing by the Director or the Director's 
designee.

[71 FR 3996, Jan. 24, 2006]