[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: 21CFR21.44]
[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 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
[[Page 228]]
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.
Back to Top
© 2007 Betterchem Corp.
|
