---
kind: "section"
citation: "21 C.F.R. § 20.44"
title: "21"
number: "20.44"
heading: "Expedited processing."
url: "https://uscodex.org/cfr/21/20.44"
---

# §20.44. Expedited processing.

- (a) The Food and Drug Administration will provide expedited processing of a request for records when the requester demonstrates a compelling need, or in other cases as determined by the agency. A compelling need exists when:
  - (1) A failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
  - (2) With respect to a request made by a person primarily engaged in disseminating information, there is a demonstrated urgency to inform the public concerning actual or alleged Federal Government activity.
- (b) A request for expedited processing made under [paragraph (a)(1)](#a-1) of this section must be made by the specific individual who is subject to an imminent threat, or by a family member, medical or health care professional, or other authorized representative of the individual, and must demonstrate a reasonable basis for concluding that failure to obtain the requested records on an expedited basis could reasonably be expected to pose a specific and identifiable imminent threat to the life or safety of the individual.
- (c) A request for expedited processing made under [paragraph (a)(2)](#a-2) of this section must demonstrate that:
  - (1) The requester is primarily engaged in disseminating information to the general public and not merely to a narrow interest group;
  - (2) There is an urgent need for the requested information and that it has a particular value that will be lost if not obtained and disseminated quickly; however, a news media publication or broadcast deadline alone does not qualify as an urgent need, nor does a request for historical information; and
  - (3) The request for records specifically concerns identifiable operations or activities of the Federal Government.
- (d) All requests for expedited processing shall be filed in writing as provided by [§ 20.40](/cfr/21/20.40.md). Each such request shall include information that demonstrates a reasonable basis for concluding that a compelling need exists within the meaning of [paragraph (a)](#a) of this section and a certification that the information provided in the request is true and correct to the best of the requester's knowledge and belief. Any statements made in support of a request for expedited processing are subject to the False Reports to the Government Act ([18 U.S.C. 1001](/usc/18/1001.md)).
- (e) The Director, Division of Freedom of Information, (or delegatee) will determine whether to grant a request for expedited processing within 10 days of receipt by the Division of Freedom of Information of all information required to make a decision.
- (f) If the agency grants a request for expedited processing, the agency shall process the request as soon as practicable.
- (g) If the agency denies a request for expedited processing, the agency shall process the request with other nonexpedited requests.
- (h) If the agency denies a request for expedited processing, the requester may appeal the agency's decision by writing to the official identified in the denial letter.

## Notes

### Amendments

[68 FR 25286, May 12, 2003, as amended at 76 FR 31469, June 1, 2011; 87 FR 55912, 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

[68 FR 25286, May 12, 2003, as amended at 76 FR 31469, June 1, 2011; 87 FR 55912, Sept. 13, 2022]