[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: 21CFR20.40]

[Page 201]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20--PUBLIC INFORMATION--Table of Contents
 
                     Subpart C--Procedures and Fees
 
Sec. 20.40  Filing a request for records.


    (a) All requests for Food and Drug Administration records shall be 
filed in writing by mailing the request or delivering it to the Freedom 
of Information Staff (HFI-35), Food and Drug Administration, Room 12A-
16, 5600 Fishers Lane, Rockville, MD 20857.
    (b) A request for Food and Drug Administration records shall 
reasonably describe the records being sought, in a way that they can be 
identified and located. A request should include all pertinent details 
that will help identify the records sought.
    (1) If the description is insufficient to locate the records 
requested, the Food and Drug Administration will so notify the person 
making the request and indicate the additional information needed to 
identify the records requested.
    (2) Every reasonable effort shall be made by the Food and Drug 
Administration to assist in the identification and location of the 
records sought.
    (c) Upon receipt of a request for records, the Freedom of 
Information Staff shall enter it in a public log. The log shall state 
the date received, the name of the person making the request, the nature 
of the record requested, the action taken on the request, the date of 
determination letter sent pursuant to Sec. 20.41(b), and the date(s) any 
records are subsequently furnished.
    (d) A request by an individual, as defined in Sec. 21.3(a) of this 
chapter, for a record about himself shall be subject to:
    (1) The special requirements of part 21 of this chapter (the privacy 
regulations), and not to the provisions of this subpart, if the record 
requested is retrieved by the individual's name or other personal 
identifier and is contained in a Privacy Act Record System, as defined 
in Sec. 21.3(c) of this chapter.
    (2) The provisions of this subpart if the record requested is not 
retrieved by the individual's name or other personal identifier, whether 
or not the record is contained in a Privacy Act Record System.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]