[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: 21CFR12.80]
[Page 123]
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 Division of Dockets Management 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 Division of Dockets Management. 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.
Back to Top
© 2007 Betterchem Corp.
|
