---
kind: "section"
citation: "21 C.F.R. § 20.26"
title: "21"
number: "20.26"
heading: "Electronic availability and indexes of certain records."
url: "https://uscodex.org/cfr/21/20.26"
---

# §20.26. Electronic availability and indexes of certain records.

- (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) 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:
    - (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
    - (ii) **Have been requested three or more times under the Freedom of Information Act.**
- (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.

## Notes

### Amendments

[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]

### Authority

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

### Source

Source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.

### Amendments

[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]