1. (a) Indexes shall be maintained, and revised at least quarterly, and, as required, copies of electronic records shall be made available for the following Food and Drug Administration records:

   1. (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. (2) Statements of policy and interpretation adopted by the agency and still in force and not published in the Federal Register.
   3. (3) Administrative staff manuals and instructions to staff that affect a member of the public.

   4. (4) Records that have been released to any person in response to a Freedom of Information request, and that:

      1. (i) The Agency has determined have become, or are likely to become, the subject of subsequent Freedom of Information requests for substantially the same records; or
      2. (ii) Have been requested three or more times under the Freedom of Information Act.
2. (b) Each such record and index will be made available by accessing the Agency's website at https://www.fda.gov. A printed copy of each index is available by writing or visiting the Freedom of Information Staff's address on the Agency's website at https://www.fda.gov.

[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; 79 FR 68114, Nov. 14, 2014; 87 FR 55911, Sept. 13, 2022]