[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.41]

[Page 201-202]
 
                        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 10 working days (excepting Saturdays, Sundays, and legal 
public holidays) after a request for records is logged in at the Freedom 
of Information Staff, a letter shall be sent to the

[[Page 202]]

persons making the request determining whether, or to the extent which, 
the agency will comply with the request, and, if any records are denied, 
the reasons therefor.
    (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. 20.45, the letter shall state the 
extent to which the records involved shall be disclosed pursuant to the 
rules established in this part.
    (3) In the following unusual circumstances, the time for sending 
this letter may be extended for up to an additional 10 working days by 
written notice to the person making the request setting forth the 
reasons for such extension and the time within which a determination is 
expected to be dispatched:
    (i) The need to search for and collect the requested records from 
field facilities or other establishments that are separate from the 
Freedom of Information Staff.
    (ii) The need to search for, collect, and appropriately examine a 
voluminous amount of separate and distinct records which are demanded in 
a single request.
    (iii) The 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 
therein.
    (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.

[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]