[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: 21CFR21.3]
[Page 219-220]
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
[[Page 220]]
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.
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