21 CFR 12.80
§ 12.80 Filing and service of submissions.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 12.80, § 12.80 Filing and service of submissions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83120
- Permanent ID
ys:prov:83120@1- SHA-256
de13b9493961dcbc7e4f859dea4a0fd9010ec4bcf0ad1bfc6a6031f47917d5a3
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Submissions, including pleadings in a hearing, are to be filed with Dockets Management Staff under § 10.20 of this chapter except that two copies need be submitted (original and redacted version) for confidential petitions. Otherwise, only one copy is necessary. To determine compliance with filing deadlines in a hearing, a submission is considered submitted on the date it is actually received by Dockets Management Staff. 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 § 12.105.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.