[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.50]
[Page 198-199]
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. 20.50 Nonspecific and overly burdensome requests.
The Food and Drug Administration will make every reasonable effort
to
[[Page 199]]
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 on an orderly procedure
for the production of the requested records, in order to satisfy the
request without disproportionate adverse effects on agency operations.
[42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003]
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