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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2020]
[CITE: 21CFR21.45]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 21 -- PROTECTION OF PRIVACY

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 § 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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