[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.44]

[Page 223-224]
 
                        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 C_Procedures and Fees
 
Sec. 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) 
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

[[Page 224]]

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) 
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 Sec. 20.40. Each such request shall include information 
that demonstrates a reasonable basis for concluding that a compelling 
need exists within the meaning of paragraph (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).
    (e) The Assistant Commissioner for Public Affairs (or delegatee) 
will determine whether to grant a request for expedited processing 
within 10 days of receipt by the Freedom of Information Staff 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.

[68 FR 25286, May 12, 2003]