[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: 21CFR21.3]

[Page 224]
 
                        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 A--General Provisions
 
Sec. 21.3  Definitions.

    As used in this part:
    (a) Individual means a natural living person who is a citizen of the 
United States or an alien lawfully admitted for permanent residence. 
Individual does not include sole proprietorships, partnerships, or 
corporations engaged in the production or distribution of products 
regulated by the Food and Drug Administration or with which the Food and 
Drug Administration has business dealings. Any such business enterprise 
that is identified by the name of one or more individuals is not an 
individual within the meaning of this part. Employees of regulated 
business enterprises are considered individuals. Accordingly, physicians 
and other health professionals who are engaged in business as 
proprietors of establishments regulated by the Food and Drug 
Administration are not considered individuals; however, physicians and 
other health professionals who are engaged in clinical investigations, 
employed by regulated enterprises, or the subjects of records concerning 
their own health, e.g., exposure to excessive radiation, are considered 
individuals. Food and Drug Administration employees, consultants, and 
advisory committee members, State and local officials, and consumers are 
considered individuals.
    (b) Records about individuals means items, collections, or groupings 
of information about individuals contained in Privacy Act Record 
Systems, including, but not limited to education, financial 
transactions, medical history, criminal history, or employment history, 
that contain names or personal identifiers.
    (c) Privacy Act Record System means a system of records about 
individuals under the control of the Food and Drug Administration from 
which information is retrieved by individual names or other personal 
identifiers. The term includes such a system of records whether subject 
to a notice published by the Food and Drug Administration, the 
Department, or another agency. Where records are retrieved only by 
personal identifiers other than individual names, a system of records is 
not a Privacy Act Record System if the Food and Drug Administration 
cannot, by reference to information under its control, or by reference 
to records of contractors that are subject to this part under 
Sec. 21.30, ascertain the identity of individuals who are the subjects 
of the records.
    (d) Personal identifiers includes individual names, identifying 
numbers, symbols, or other identifying designations assigned to 
individuals. Personal identifiers does not include names, numbers, 
symbols, or other identifying designations that identify products, 
establishments, or actions.
    (e) Personnel records means any personal information maintained in a 
Privacy Act Record System that is needed for personnel management 
programs or processes such as staffing, employee development, 
retirement, and grievances and appeals.
    (f) Department means Department of Health and Human Services.