[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.20]

[Page 225]
 
                        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), 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]