[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.45]

[Page 234]
 
                        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]