21 CFR 21.45 - Fees.

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§ 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 § 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 21 after this date.

  • 2014-11-14; vol. 79 # 220 - Friday, November 14, 2014
    1. 79 FR 68114 - Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective November 14, 2014.
      21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814