[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.44]
[Page 194-195]
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 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
[[Page 195]]
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]
Back to Top
© 2007 Betterchem Corp.
|
