[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: 21CFR21.51]
[Page 229]
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 E Procedures for Requests for Amendment of Records
Sec. 21.51 Responses to requests for amendment of records.
(a) The Food and Drug Administration shall take one of the following
actions on a request for amendment of records as promptly as possible:
(1) Amend any portion of the record which the agency has determined,
based upon a preponderance of the evidence, is not accurate, relevant to
a Food and Drug Administration purpose, timely, or complete, and, in
accordance with paragraph (d)(3) of this section, inform the individual
and previous recipients of the record that has been amended of the
amendment.
(2) Inform the individual of its refusal to amend any portion of the
record in the manner requested, the reason for the refusal, and the
opportunity for administrative appeal to the Commissioner of Food and
Drugs. Except as provided in Sec. 21.32, such refusal may only be
issued by the Associate Commissioner for Public Affairs or his or her
designate.
(3) Where another agency was the source of and has control of the
record, refer the request to that agency.
(b) The agency may, for good cause, extend the period for taking
action an additional 30 working days if notice is provided to the
individual explaining the circumstances of the delay.
(c) The officials charged with reviewing a record to determine how
to respond to a request to amend it, shall assess its accuracy,
relevance to a Food and Drug Administration purpose, timeliness, or
completeness. The determination shall be made in the light of the
purpose for which the records or system is used, the agency's need for
the record, and the possible adverse consequences to the individual from
the record if not amended. Whenever the Food and Drug Administration
receives a request for deletion of a record, or portions of a record, it
shall consider anew whether the contested information in the record is
relevant and necessary to a Food and Drug Administration purpose.
(d) If the Food and Drug Administration agrees with an individual's
request, it shall take the following actions:
(1) So inform the individual in writing.
(2) In accordance with statute, regulation, or procedure, amend the
record to make it accurate, relevant to a Food and Drug Administration
purpose, timely, or complete, making note of the date and fact of the
amendment.
(3) If an accounting was made under Sec. 21.71(d) of a disclosure
of the record under Sec. 21.71(a), provide a copy of the record as
amended, to all previous recipients of the record.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]
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