[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: 21CFR21.21]
[Page 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. 21.21 Changes in systems and new systems.
(a) The Food and Drug Administration shall notify the designated
Department official, the Office of Management and Budget (Information
Systems Division), and the Congress of proposals to change or establish
Privacy Act Record Systems in accordance with procedures of the
Department and the Office of Management and Budget.
(b) The Food and Drug Administration shall issue a notice, in
accordance with paragraph (d) of this section and Sec. 21.20(b), of any
change in a Privacy Act Record System which:
(1) Increases the number or types of individuals about whom records
are maintained;
(2) Expands the type or amount of information about individuals that
is maintained;
(3) Increases the number of categories of agencies or other persons
who may have access to those records;
(4) Alters the manner in which the records are organized so as to
change the nature or scope of those records, such as the combining of
two or more existing systems;
(5) Modifies the way in which the system operates or its location(s)
in a manner that alters the process by which individuals can exercise
their rights under this part, such as the ways in which they seek access
or request amendment of a record; or
(6) Changes the equipment configuration on which the system is
operated so as to create the potential for greater access, such as
adding a telecommunications capability.
(c) The Food and Drug Administration shall issue a notice of its
intention to establish new Privacy Act Record Systems in accordance with
paragraph (d) of this section and Sec. 21.20(b).
(d) Notices under paragraphs (b) and (c) of this section shall be
published in the Federal Register for comment at least 30 days prior to
implementation of the proposed changes or establishment of new systems.
Interested persons shall have the opportunity to submit written data,
views, or arguments on such proposed new uses or systems.
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