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Privacy Act: [ 1. Table of Contents]...


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[2001 Privacy Act]
[From the U.S. Government Printing Office via GPO Access]





   #.HEALTH AND HUMAN SERVICES DEPARTMENT


Title 21-Food and Drugs

Chapter I-Food and Drug Administration, Department of Health and Human 
Services

PART 21--PROTECTION OF PRIVACY

Subpart A--General Provisions

Sec.

21.1  Scope.
21.3  Definitions.
21.10  Policy concerning records about individuals.

Subpart B--Food and Drug Administration Privacy Act Record Systems

21.20  Procedures for notice of Food and Drug Administration Privacy Act 
    Record Systems.
21.21  Changes in systems and new systems.

Subpart C--Requirements for Specific Categories of Records

21.30  Records of contractors.
21.31  Records stored by the General Services Administration and 
    archival records.
21.32  Personnel records.
21.33  Medical records.

Subpart D--Procedures for Notification of and Access to Records in 
Privacy Act Record Systems

21.40  Procedures for submitting requests for notification and access.
21.41  Processing of requests.
21.42  Responses to requests.
21.43  Access to requested records.
21.44  Verification of identity.
21.45  Fees.

Subpart E--Procedures for Requests for Amendment of Records

21.50  Procedures for submitting requests for amendment of records.
21.51  Responses to requests for amendment of records.
21.52  Administrative appeals of refusals to amend records.
21.53  Notation and disclosure of disputed records.
21.54  Amended or disputed records received from other agencies.

Subpart F--Exemptions

21.60  Policy.
21.61  Exempt systems.
21.65  Access to records in exempt systems.

Subpart G--Disclosure of Records in Privacy Act Record Systems to 
Persons Other Than the Subject Individual

21.70  Disclosure and intra-agency use of records in Privacy Act Record 
    Systems; no accounting required.
21.71  Disclosure of records in Privacy Act Record Systems; accounting 
    required.
21.72  Individual consent to disclosure of records to other persons.
21.73  Accuracy, completeness, timeliness, and relevance of records 
    disclosed from Privacy Act Record Systems.
21.74  Providing notice that a record is disputed.
21.75  Rights of legal guardians.

  Authority :Sec. 701(a), 52 Stat. 1055 (21 U.S.C. 371(a)); 5 USC 552a; 
21 CFR 5.10.

  Source: 42 FR 15626, Mar. 22, 1977, unless otherwise noted.

Subpart A--General Provisions


   Sec. 21.1   Scope.

  (a) This part establishes procedures to implement the Privacy Act of 
1974 (5 U.S.C. 552a). It applies to records about individuals that are 
maintained, collected, used, or disclosed by the Food and Drug 
Administration and contained in Privacy Act Record Systems.
  (b) This part does not:
  (1) Apply to Food and Drug Administration record systems that are not 
Privacy Act Record Systems or make available to an individual records 
that may include references to him but that are not retrieved by his 
name or other personal identifier, whether or not contained in a Privacy 
Act Record System. Part 20 of this chapter (the public information 
regulations) and other regulations referred to therein determine when 
records are made available in such cases.
  (2) Make any records available to persons other than (i) individuals 
who are the subjects of the records, (ii) persons accompanying such 
individuals under Sec. 21.43, (iii) persons provided records pursuant to 
individual consent under Sec. 21.72, or (iv) persons acting on behalf of 
such individuals as legal guardians under Sec. 21.75. Part 20 of this 
chapter (the public information regulations) and other regulations 
referred to therein determine when Food and Drug Administration records 
are disclosable to members of the public generally. Subpart G of this 
part limits the provisions of Part 20 of this chapter with respect to 
disclosures of records about individuals from Privacy Act Record Systems 
to persons other than individuals who are the subjects of the records.
  (3) Make available information compiled by the Food and Drug 
Administration in reasonable anticipation of court litigation or formal 
administrative proceedings. The availability of such information to any 
member of the public, including any subject individual or party to such 
litigation or proceeding shall be governed by applicable constitutional 
principles, rules of discovery, and Part 20 of this chapter (the public 
information regulations).
  (4) Apply to personnel records maintained by the Division of Personnel 
Management, Food and Drug Administration, except as provided in 
Sec. 21.32. Such records are subject to regulations of the Office of 
Personnel Management in 5 CFR Parts 293, 294, and 297.

(Sec. 701(a), 52 Stat. 1055 (21 U.S.C. 371(a)))

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981]


   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.


   Sec. 21.10   Policy concerning records about individuals.

  Information about individuals in Food and Drug Administration records 
shall be collected, maintained, used, and disseminated so as to protect 
the right to privacy of the individual to the fullest possible extent 
consistent with laws relating to disclosure of information to the 
general public, the law enforcement responsibilities of the agency, and 
administrative and program management needs.

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.

(Sec. 701(a), 52 Stat. 1055 (21 U.S.C. 371(a)))

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981]


   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.

Subpart C--Requirements for Specific Categories of Records


   Sec. 21.30   Records of contractors.

  (a) Systems of records that are required to be operated, or as a 
matter of practical necessity must be operated, by contractors to 
accomplish Food and Drug Administration functions, from which 
information is retrieved by individual names or other personal 
identifiers, may be subject to the provisions of this part. If the 
contract is agreed to on or after September 27, 1975, the criminal 
penalties set forth in 5 U.S.C. 552a(i) are applicable to such 
contractor, and any employee of such contractor, for disclosures 
prohibited in Sec. 21.71 or for maintenance of a system of records 
without notice as required in Sec. 21.20.
  (b) A contract is considered to accomplish a Food and Drug 
Administration function if the proposal or activity it supports is 
principally operated on behalf of and is under the direct management of 
the Food and Drug Administration. Systems of records from which 
information is retrieved by individual names or other personal 
identifiers and that are operated under contracts to accomplish Food and 
Drug Administration functions are deemed to be maintained by the agency 
and shall be subject to the procedures and requirements of this part.
  (c) A contract is not considered to accomplish a Food and Drug 
Administration function if the program or activity it supports is not 
principally operated on behalf of, or is not under the direct management 
of, the Food and Drug Administration. For example, this part does not 
apply to systems of records:
  (1) Operated under contract with the Food and Drug Administration by 
State or local government agencies, or organizations representing such 
agencies, when such agencies or organizations are also performing State 
or local government functions.
  (2) Operated by contractors with the Food and Drug Administration by 
individuals or organizations whose primary function is delivery of 
health services, such as hospitals, physicians, pharmacists, and other 
health professionals, and that report information concerning products, 

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