[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: 21CFR21.20]
[Page 220-221]
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 B Food and Drug Administration Privacy Act Record Systems
Sec. 21.20 Procedures for notice of Food and Drug Administration Privacy Act
Record Systems.
(a) The Food and Drug Administration shall issue in the Federal
Register on or before August 30 of each year a notice concerning each
Privacy Act Record System as defined in Sec. 21.3(c) that is not
covered by a notice published by the Department, the Office of Personnel
Management, or another agency.
(b) The notice shall include the following information:
(1) The name and location(s) of the system.
(2) The categories of individuals about whom records are maintained
in the system.
(3) The categories of records maintained in the system.
(4) The authority for the system.
(5) Each routine use of the records contained in the system (i.e.,
use outside the Department of Health and Human Services that is
compatible with the purpose for which the records were collected and
described in the notice) including the categories of users and the
purposes of such use.
(6) The policies and practices of the Food and Drug Administration
regarding storage, retrievability (i.e., how the records are indexed and
what intra-agency uses are made of the records),
[[Page 221]]
access controls, retention, and disposal of the records in that system.
(7) The title and business address of the official who is
responsible for the system of records.
(8) The notification procedure, i.e., the address of the FDA Privacy
Act Coordinator, whom any individual can contact to seek notification
whether the system contains a record about him/her.
(9) The record access and contest procedures, which shall be the
same as the notification procedure except that a reference shall be
included to any exemption from access and contest.
(10) Where any records in the system are subject to an exemption
under Sec. 21.61, a reference to this exemption.
(11) The categories of sources of records in the system.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981]
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