[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: 21CFR20.26]
[Page 191]
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 B General Policy
Sec. 20.26 Indexes of certain records.
(a) Indexes shall be maintained, and revised at least quarterly, for
the following Food and Drug Administration records:
(1) Final orders published in the Federal Register with respect to
every denial or withdrawal of approval of a new drug application or a
new animal drug application for which a public hearing has been
requested.
(2) Statements of policy and interpretation adopted by the agency
and still in force and not published in the Federal Register.
(3) Administrative staff manuals and instructions to staff that
affect a member of the public.
(4) Records that have been released to any person in response to a
Freedom of Information request and that the agency has determined have
become, or are likely to become, the subject of subsequent requests for
substantially the same records.
(b) Each such index will be made available through the Internet at
http://www.fda.gov. A printed copy of each index is available by writing
to the Freedom of Information Staff (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, or
by visiting the Freedom of Information Public Reading Room in rm. 12A-30
at the same address.
[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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