[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.50]

[Page 234-235]
 
                        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 
arguments in support of the requested

[[Page 235]]

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]