[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.42]

[Page 194]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20_PUBLIC INFORMATION--Table of Contents
 
                      Subpart C_Procedures and Fees
 
Sec.  20.42  Aggregation of certain requests.

    The Food and Drug Administration may aggregate certain requests by 
the same requester, or by a group of requesters acting in concert, if 
the requests involve clearly related matters and the agency reasonably 
believes that such requests actually constitute a single request which 
would otherwise satisfy the unusual circumstances specified in Sec.  
20.41(b)(3)(ii)(B). FDA may extend the time for processing aggregated 
requests in accordance with the unusual circumstances provisions of 
Sec.  20.41.

[68 FR 25286, May 12, 2003]