[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: 21CFR21.45]
[Page 228]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 21 PROTECTION OF PRIVACY--Table of Contents
Subpart D Procedures for Notification of and Access to Records in
Privacy Act Record Systems
Sec. 21.45 Fees.
(a) Where applicable, fees for copying records shall be charged in
accordance with the schedule set forth in this section. Fees may only be
charged where an individual has requested that a copy be made of a
record to which he is granted access. No fee may be charged for making a
search of a Privacy Act Record System whether the search is manual,
mechanical, or electronic. Where a copy of the record must be made to
provide access to the record, e.g., computer printout where no screen
reading is available, the copy shall be made available to the individual
without cost. Where a medical record is made available to a
representative designated by the individual under Sec. 21.33, no fee
will be charged.
(b) The fee schedule is as follows:
(1) Copying of records susceptible to photocopying--$.10 per page.
(2) Copying of records not susceptible to photocopying, e.g., punch
cards or magnetic tapes--at actual cost to the determined on a case-by-
case basis.
(3) No charge will be made if the total amount of copying for an
individual does not exceed $25.
(c) When a fee is to be assessed, the individual shall be notified
prior to the processing of the copies, and be given an opportunity to
amend his request. Payment shall be made by check or money order made
payable to the ``Food and Drug Administration,'' and shall be sent to
the Accounting Branch (HFA.120), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Advance deposit shall be required
where the total amount exceeds $50.
[42 FR 15626, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]
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