[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.74]

[Page 241]
 
                        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. 21.74  Providing notice that a record is disputed.

    Whenever an individual has filed a statement of disagreement with 
the Food and Drug Administration concerning a refusal to amend a record 
under Sec. 21.51(a)(2) or with another agency that provides the record 
to the Food and Drug Administration, the Food and Drug Administration 
shall in any subsequent disclosure under this subpart provide a copy of 
the statement of disagreement and a concise statement by the agency, if 
one has been prepared, of the reasons for not making the amendment(s) 
requested.