Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 13.20: Submissions to a Board.

(a) Submissions are to be filed with the Dockets Management Staff under § 10.20.
(b) The person making a submission shall serve copies of it on each participant in the proceeding, except as provided in §§ 13.10(b)(2) and 13.45. Submissions of documentary data and information need not be sent to each participant, but any accompanying transmittal letter, summary, statement of position, certification under paragraph (d) of this section, or similar document must be.
(c) A submission must be mailed to the address shown in the notice of appearance or personally delivered.
(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 §§ 13.10(b)(2) and 13.45.
(f) A participant who believes that compliance with the requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis in the form and manner specified in § 12.82.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL
PART 13—PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
Subpart B—Hearing Procedures

(a) Submissions are to be filed with the Dockets Management Staff under § 10.20.

(b) The person making a submission shall serve copies of it on each participant in the proceeding, except as provided in §§ 13.10(b)(2) and 13.45. Submissions of documentary data and information need not be sent to each participant, but any accompanying transmittal letter, summary, statement of position, certification under paragraph (d) of this section, or similar document must be.

(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 §§ 13.10(b)(2) and 13.45.

(f) A participant who believes that compliance with the requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis in the form and manner specified in § 12.82.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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