[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: 21CFR20.40]
[Page 192-193]
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
made in writing by mailing or delivering the request to the Freedom of
Information Staff (HFI-35), Food and Drug Administration, rm. 12A-16,
5600 Fishers Lane, Rockville, MD 20857, or by faxing it to 301-443-1726.
All requests must contain the postal address and telephone number of the
requester and the name of the person responsible for payment of any fees
that may be charged.
(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
[[Page 193]]
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; 68
FR 25285, May 12, 2003]
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