[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: 21CFR21.50]
[Page 228-229]
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. 21.50 Procedures for submitting requests for amendment of records.
(a) An individual who received access to a record about himself
under subpart D of this part may request that the record be amended if
he believes that the record or an item of information is not accurate,
relevant to a Food and Drug Administration purpose, timely, or complete.
(b) Amendments under this subpart shall not violate existing
statute, regulation, or administrative procedure.
(1) This subpart does not permit alteration of evidence presented in
the course of judicial proceedings or Food and Drug Administration
adjudicatory or rule making proceedings or collateral attack upon that
which has already been the subject of any such proceedings.
(2) If the accuracy, relevancy, timeliness, or completeness of the
records may be contested in any other pending or imminent agency
proceeding, the Food and Drug Administration may refer the individual to
the other proceeding as the appropriate means to obtain relief. If the
accuracy, relevance, timeliness, or completeness of a record is, or has
been, an issue in another agency proceeding, the request under this
section shall be disposed of in accordance with the decision in the
other proceeding, absent unusual circumstances.
(c) Requests to amend records shall be submitted, in writing, to the
FDA Privacy Act Coordinator in accordance with Sec. 21.40(b). Such
requests shall include information sufficient to enable the Food and
Drug Administration to locate the record, a brief description of the
items of information requested to be amended, and the reasons why the
record should be amended together with any appropriate documentation or
[[Page 229]]
arguments in support of the requested amendment. An edited copy of the
record showing the described amendment may be included. Verification of
identity should be provided in accordance with Sec. 21.44.
(d) Written acknowledgement of the receipt of a request to amend a
record shall be provided within 10 working days to the individual who
requested the amendment. Such acknowledgement may request any additional
information needed to verify identity or make a determination. No
acknowledgement need be made if the request can be reviewed, processed,
and the individual notified of the agency's agreement with the request
or refusal within the 10-day period.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]
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