[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: 21CFR21.42]

[Page 232-233]
 
                        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. 21.42  Responses to requests.

    (a) The FDA shall respond to an individual's request for 
notification as to whether a Privacy Act Record System contains records 
about him that are retrieved by his name or other personal identifier by 
sending a letter under this paragraph.
    (1) If there are no records about the individual that are retrieved 
by his name or other personal identifier in the named Privacy Act Record 
System, or the requester is not an ``individual'' under Sec. 21.3(a), 
the letter shall so state. Where appropriate, the letter shall indicate 
that the Food and Drug Administration's public information regulations 
in part 20 of this chapter prescribe general rules governing the 
availability of information to members of the public, and that a request 
may be made in accordance with part 20 of this chapter for records that 
are not retrieved by the requester's name or other personal identifier 
from a Privacy Act Record System.
    (2) If there are records about the individual that are retrieved by 
his name or other personal identifier and the named Privacy Act Record 
System is not exempt from individual access and contest under 
Sec. 21.61, or the system is exempt but access is allowed or required 
under Sec. 21.65, the letter shall inform him that the records exist and 
shall either:
    (i) Enclose a copy of the records under Sec. 21.43(a)(1) or indicate 
that the records will be sent under separate cover, where there has been 
adequate verification of the identity of the individual under Sec. 21.44 
and the fees under Sec. 21.45 do not exceed $25, or
    (ii) Inform the individual of the procedures to obtain access to the 
records by mail or in person under Sec. 21.43(a)(2), as well as the 
approximate dates by which the requested records can be provided (if the 
records are not --hen available), the locations at which access in 
person may be had, and the information needed, if any, to verify the 
identity of the individual under Sec. 21.44.
    (3) If the named Privacy Act Record System contains records about 
the individual that are retrieved by his name or other personal 
identifier, and the system is exempt from individual access and contest 
under Sec. 21.61 and access is not allowed or required under Sec. 21.65, 
the letter should inform him that the records are exempted from access 
and contest by Sec. 21.61. The letter shall also inform him if the 
records sought are not available because they were compiled in 
reasonable anticipation of court litigation or formal administrative 
proceedings or are otherwise not available under Sec. 21.41(b). Where 
appropriate, the letter shall also indicate whether the records are 
available under part 20 of this chapter (the public information 
regulations), and it may disclose the records in accordance with part 
20.
    (4) If the named Privacy Act Record System contains records about 
the individual that are retrieved by his name or other personal 
identifier, but a final determination has not yet been made with respect 
to disclosure of all of the records covered by the request, e.g., 
because it is necessary to consult another person or agency having an 
interest in the confidentiality of the records, the letter shall explain 
the circumstances and indicate when a final answer will be given.
    (b) Except as provided in Sec. 21.32, access to a record may only be 
denied by the Associate Commissioner for Public Affairs or his or her 
designate. If access to any record is denied wholly or in substantial 
part, the letter shall state

[[Page 233]]

the right of the individual to appeal to the Commissioner of Food and 
Drugs.
    (c) If a request for a copy of the records will result in a fee of 
more than $25, the letter shall specify or estimate the fee involved. 
Where the individual has requested a copy of any records about him and 
copying the records would result in a fee of over $50, the Food and Drug 
Administration shall require advance deposit as well as payment of any 
amount not yet received as a result of any previous request by the 
individual for a record about himself, under this subpart or part 20 of 
this chapter (the public information regulations) before the records are 
made available. If the fee is less than $50, prepayment shall not be 
required unless payment has not yet been received for records disclosed 
as a result of a previous request by the individual for a record about 
himself under this subpart or part 20 of this chapter.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]