[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.53]

[Page 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 E--Procedures for Requests for Amendment of Records
 
Sec. 21.53  Notation and disclosure of disputed records.

    When an individual has filed a statement of disagreement under 
Sec. 21.52(b)(2), the Food and Drug Administration shall:
    (a) Mark any portion of the record that is disputed to assure that 
the record will clearly show that portion is disputed whenever the 
record is disclosed.
    (b) In any subsequent disclosure under Sec. 21.70 or Sec. 21.71(a), 
provide a copy of the statement of disagreement and, if the Food and 
Drug Administration deems it appropriate, a concise statement of the 
agency's reasons for not making the amendment(s) requested. While the 
individual shall have access to any such statement, it shall not be 
subject to a request for amendment under Sec. 21.50.
    (c) If an accounting was made under Sec. 21.71(d) and (e) of a 
disclosure of the record under Sec. 21.71(a), provide to all previous 
recipients of the record a copy of the statement of disagreement and the 
agency statement, if any.

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