[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: 21CFR21.71]
[Page 232-234]
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 G Disclosure of Records in Privacy Act Record Systems to Persons
Other Than the Subject Individual
Sec. 21.71 Disclosure of records in Privacy Act Record Systems; accounting
required.
(a) Except as provided in Sec. 21.70, a record about an individual
that is contained in a Privacy Act Record System shall not be disclosed
by any method of communication except under any of the following
circumstances, which are subject to the limitations of paragraphs (b)
and (c) of this section and to the accounting requirement of paragraph
(d) of this section:
(1) To those officers and employees of the agency which maintains
the record who have a need for the record in the perfomance of their
duties;
(2) Required under section 552 of the Freedom of Information Act;
(3) For a routine use as described in the routine use section of
each specific system notice;
(4) To the Bureau of Census for purposes of planning or carrying out
a census or survey or related activity pursuant to the provisions of
title 13 of the U.S. Code;
(5) To a recipient who has provided the agency with advance adequate
written assurance that the record will be used solely as a statistical
research or reporting record, and that the record is to be transferred
in a form that is not individually identifiable;
(6) To the National Archives and Records Administration of the
United States as a record which has sufficient
[[Page 233]]
historical or other value to warrant its continued preservation by the
U.S. Government, or to the Archivist of the United States or his or her
designee for evaluation to determine whether the record has such value;
(7) To another agency or to an instrumentality of any government
jurisdiction within or under the control of the United States for a
civil or criminal law enforcement activity if the activity is authorized
by law, and if the head of the agency or instrumentality has made a
written request to the agency which maintains the record specifying the
particular portion desired and the law enforcement activity for which
the record is sought;
(8) To a person pursuant to a showing of compelling circumstances
affecting the health or safety of an individual if, upon such
disclosure, notification is transmitted to the last known address of
such individual;
(9) To either House of Congress or, to the extent of matter within
its jurisdiction, any committee or subcommittee thereof, any joint
committee of Congress or subcommittee of any such joint committee;
(10) To the Comptroller General, or any of his or her authorized
representatives in the course of the performance of the duties of the
General Accounting Office;
(11) Pursuant to the order of a court of competent jurisdiction; or
(12) To a consumer reporting agency in accordance with section 3(d)
of the Federal Claims Collection Act of 1966 (31 U.S.C. 952(d)). (This
``Special Disclosure'' statement does not apply to any FDA system of
records.)
(b) The Food and Drug Administration may in its discretion refuse to
make a disclosure permitted under paragraph (a) of this section, if the
disclosure would in the judgment of the agency, invade the privacy of
the individual or be inconsistent with the purpose for which the
information was collected.
(c) The Food and Drug Administration may require any person
requesting a disclosure of a record under paragraph (a) of this section
to provide:
(1) Information about the purposes to which the disclosed record is
to be put, and
(2) A written statement certifying that the record will be used only
for the stated purposes and will not be further disclosed without the
written permission of the Food and Drug Administration.
Under 5 U.S.C. 552a(i)(3), any person who knowingly or willfully
requests or obtains any record concerning an individual from an agency
under false pretenses shall be guilty of a misdemeanor and fined not
more than $5,000. Such person may also be subject to prosecution under
the False Reports to the Government Act, 18 U.S.C. 1001.
(d) An accounting shall be made, in accordance with paragraph (e) of
this section, of any disclosure under paragraph (a) of this section of a
record that is not a disclosure under Sec. 21.70.
(e) Where an accounting is required under paragraph (d) of this
section, the Food and Drug Administration shall:
(1) Record the name and address of the person or agency to whom the
disclosure is made and the date, nature, and purpose of the disclosure.
The accounting shall not be considered a Privacy Act Record System.
(2) Retain the accounting for 5 years or for the life of the record,
whichever is longer, following the disclosure.
(3) Notify those recipients listed in the accounting of amendments
or disputes concerning the records previously disclosed to them pursuant
to Sec. 21.51(d)(3), Sec. 21.53(c), or Sec. 21.54(c).
(4) Except when the record is exempt from individual access and
contest under Sec. 21.61 or to the extent that the accounting describes
a transfer for a law enforcement purpose pursuant to paragraph (a)(7) of
this section, make the accounting available to the individual to whom
the record pertains, in accordance with procedures of subpart D of this
part.
(f) A single accounting may be used to cover disclosure(s) that
consist of a continuing dialogue between two agencies over a prolonged
period, such as discussion of an enforcement action between the Food and
Drug Administration and the Department of Justice. In such cases, a
general notation may be
[[Page 234]]
made that, as of a certain date, contract was initiated, to continue
until resolution of the matter.
[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985;
54 FR 9038, Mar. 3, 1989]
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