[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: 21CFR12.80]

[Page 134]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
 
                      Subpart E--Hearing Procedures
 
Sec. 12.80  Filing and service of submissions.


    (a) Submissions, including pleadings in a hearing, are to be filed 
with the Dockets Management Branch under Sec. 10.20 except that only two 
copies need be filed. To determine compliance with filing deadlines in a 
hearing, a submission is considered submitted on the date it is actually 
received by the Dockets Management Branch. When this part allows a 
response to a submission and prescribes a period of time for the filing 
of the response, an additional 3 days are allowed for the filing of the 
response if the submission is served by mail.
    (b) The person making a submission shall serve copies of it on the 
other participants. Submissions of documentary data and information are 
not required to be served on each participant, but any accompanying 
transmittal letter, pleading, summary, statement of position, 
certification under paragraph (d) of this section, or similar document 
must be served on each participant.
    (c) Service is accomplished by mailing a submission to the address 
shown in the notice of participation or by personal delivery.
    (d) All submissions are to be accompanied by a certificate of 
service, or a statement that service is not required.
    (e) No written submission or other portion of the administrative 
record may be held in confidence, except as provided in Sec. 12.105.