[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.48]

[Page 206-207]
 
                        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. 20.48  Nonspecific and overly burdensome requests.

    The Food and Drug Administration will make every reasonable effort 
to comply fully with all requests for disclosure of nonexempt records. 
Nonspecific requests or requests for a large number of documents that 
require the deployment of a substantial amount of agency man-hours to 
search for and compile will be processed taking into account the staff-
hours required, the tasks from which these resources must be diverted, 
the impact that this diversion will have upon the agency's consumer 
protection activities, and the public policy reasons justifying the 
requests. A decision on the processing of such a request for information 
shall be made after balancing the public benefit to be gained by the 
disclosure against the public loss that will result from diverting 
agency personnel from their other responsibilities. In any situation in 
which it is determined that a request for voluminous records would 
unduly burden and interfere with the operations of the Food and Drug 
Administration, the person making the request will be asked to be more 
specific and to narrow the request, and to agree

[[Page 207]]

on an orderly procedure for the production of the requested records, in 
order to satisfy the request without disproportionate adverse effects on 
agency operations.