[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: 21CFR20.41]
[Page 193]
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. 20.41 Time limitations.
(a) All time limitations prescribed pursuant to this section shall
begin as of the time at which a request for records is logged in by the
Freedom of Information Staff pursuant to Sec. 20.40(c). An oral request
for records shall not begin any time requirement. A written request for
records sent elsewhere within the agency shall not begin any time
requirement until it is redirected to the Freedom of Information Staff
and is logged in there in accordance with Sec. 20.40(c).
(b) Within 20 working days (excluding Saturdays, Sundays, and legal
public holidays) after a request for records is logged in at the Freedom
of Information Staff, the agency shall send a letter to the requester
providing the agency's determination as to whether, or the extent to
which, the agency will comply with the request, and, if any records are
denied, the reasons for the denial.
(1) If all of the records requested have been located and a final
determination has been made with respect to disclosure of all of the
records requested, the letter shall so state.
(2) If all of the records have not been located or a final
determination has not yet been made with respect to disclosure of all of
the records requested, e.g., because it is necessary to consult the
person affected pursuant to Sec. 20.47, the letter shall state the
extent to which the records involved shall be disclosed pursuant to the
rules established in this part.
(3)(i) In unusual circumstances, the agency may extend the time for
sending the letter for an additional period.
(A) The agency may provide for an extension of up to 10 working days
by providing written notice to the requester setting out the reasons for
the extension and the date by which a determination is expected to be
sent.
(B) The agency may provide for an extension of more than 10 working
days by providing written notice to the requester setting out the
reasons for the extension. The notice also will give the requester an
opportunity to limit the scope of the request so that it may be
processed in a shorter time and/or an opportunity to agree on a
timeframe longer than the 10 extra working days for processing the
request.
(ii) Unusual circumstances may exist under any of the following
conditions:
(A) There is a need to search for and collect the requested records
from field facilities or other components that are separate from the
agency component responsible for processing the request;
(B) There is a need to search for, collect, and appropriately
examine a voluminous amount of separate and distinct records that are
demanded in a single request; or
(C) There is need for consultation, which shall be conducted with
all practicable speed, with another agency having a substantial interest
in the determination of the request, or among two or more components of
the Food and Drug Administration having substantial subject-matter
interest in the determination.
(4) If any record is denied, the letter shall state the right of the
person requesting such records to appeal any adverse determination to
the Assistant Secretary for Health, Department of Health and Human
Services, in accordance with the provisions of 45 CFR 5.34.
(c) The Food and Drug Administration shall provide a determination
of whether to provide expedited processing within 10 calendar days of
receipt by the Freedom of Information Staff of the request and the
required documentation of compelling need in accordance with Sec.
20.44(b).
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55
FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994; 68 FR 25285, May 12,
2003]
[[Page 194]]
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