[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: 21CFR20.120]
[Page 218]
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 F Availability of Specific Categories of Records
Sec. 20.120 Records available in Food and Drug Administration Public Reading Rooms.
(a) The Food and Drug Administration operates two public reading
rooms. The Freedom of Information Staff's Public Reading Room is located
in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857,
the phone number is 301-827-6500. The Division of Dockets Management's
Public Reading Room is located in rm. 1061, 5630 Fishers Lane,
Rockville, MD 20852; the phone number is 301-827-6860. Both public
reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday,
excluding legal public holidays.
(b) The following records are available at the Freedom of
Information Staff's Public Reading Room:
(1) A guide for making requests for records or information from the
Food and Drug Administration;
(2) Administrative staff manuals and instructions to staff that
affect a member of the public;
(3) Food and Drug Administration records which have been released to
any person in response to a Freedom of Information request and which the
agency has determined have become or are likely to become the subject of
subsequent requests for substantially the same records;
(4) Indexes of records maintained in the Freedom of Information
Staff's Public Reading Room; and
(5) Such other records and information as the agency determines are
appropriate for inclusion in the public reading room.
(c) The following records are available in the Division of Dockets
Management's Public Reading Room:
(1) Final opinions, including concurring and dissenting opinions, as
well as orders, made in the adjudication of cases;
(2) Statements of policy and interpretation adopted by the agency
that are still in force and not published in the Federal Register;
(3) Indexes of records maintained in the Division of Dockets
Management's Public Reading Room; and
(4) Such other records and information as the agency determines are
appropriate for inclusion in the public reading room.
(d) The agency will make reading room records created by the Food
and Drug Administration on or after November 1, 1996, available
electronically through the Internet at the agency's World Wide Web site
which can be found at http://www.fda.gov. At the agency's discretion,
the Food and Drug Administration may also make available through the
Internet such additional records and information it believes will be
useful to the public.
[68 FR 25287, May 12, 2003; 68 FR 65392, Nov. 20, 2003]
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