[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.58]

[Page 33]
 
                        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  Requests for waiver of requirement for adequate and 
well-controlled studies to substantiate certain labeling statements.

    A request under Sec. 201.57(b)(2)(ii), (c)(2), (c)(3)(i), 
(c)(3)(v), (f)(9), and (g)(4) for a waiver of the requirements of Sec. 
314.126(b) of this chapter shall be submitted in writing as provided in 
Sec. 314.126(b) to the Director, Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20587, or, if applicable, the Director, Center for Biologics Evaluation 
and Research, 8800 Rockville Pike, Bethesda, MD 20892. The waiver shall 
be granted or denied in writing by such Director or the Director's 
designee.

[55 FR 11576, Mar. 29, 1990]