[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.44]

[Page 227-228]
 
                        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 D_Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems
 
Sec.  21.44  Verification of identity.

    (a) An individual seeking access to records in a Privacy Act Record 
System may be required to comply with reasonable requirements to enable 
the

[[Page 228]]

Food and Drug Administration to determine his identity. The 
identification required shall be suitable considering the nature of the 
records sought. No identification shall be required to receive access to 
information that is required to be disclosed to any member of the public 
under part 20 of this chapter (the public information regulations).
    (b) An individual who appears in person for access to records about 
himself shall be required to provide at least one document to identify 
himself, e.g., driver's license, passport, or alien or voter 
registration card to verify his identity. If an individual does not have 
any such document or requests access to records about himself without 
appearing in person under circumstances in which his identity cannot be 
verified from the request itself, he shall be required to certify in 
writing that he is the individual he claims to be and that he 
understands that the knowing and willful request for or acquisition of a 
record pertaining to an individual under false pretenses is a criminal 
offense subject to a $5,000 fine.
    (c) In making requests under Sec.  21.75, a parent of a minor child 
or legal guardian of an incompetent individual may be required to verify 
his relationship to the minor child or the incompetent individual, in 
addition to verifying his own identity, by providing a copy of the 
minor's birth certificate, a court order, or other evidence of 
guardianship.
    (d) Where an individual seeks access to particularly sensitive 
records, such as medical records, the individual may be required to 
provide additional information beyond that specified in paragraph (b) or 
(c) of this section, such as the individual's years of attendance at a 
particular educational institution, rank attained in the uniformed 
services, date or place of birth, names of parents, an occupation, or 
the specific times the individual received medical treatment.