(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 Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, 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; 76 FR 31469, June 1, 2011]
Title 21 published on 2014-04-01
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