(a) The Commissioner may at any time stay or extend the effective date of an
action pending or following a decision on any matter.
(b) An interested person may request the Commissioner to stay the effective
date of any administrative action. A stay may be requested for a specific time
period or for an indefinite time period. A request for stay must be submitted in
accordance with § 10.20 and in the following form no later than 30
days after the date of the decision involved. The Commissioner may, for good
cause, permit a petition to be filed after 30 days. In the case of a decision
published in the Federal Register, the day of publication is the
date of decision.
(Date)________________________________________
Division of Dockets Management, Food and Drug Administration, Department of
Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Petition for Stay of Action
The undersigned submits this petition requesting that the Commissioner of
Food and Drugs stay the effective date of the following matter.
A. Decision involved
(The specific administrative action being taken by the Commissioner for which
a stay is requested, including the docket number or other citation to the action
involved.)
B. Action requested
(The length of time for which the stay is requested, which may be for a
specific or indefinite time period.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and legal
grounds upon which the petitioner relies for the stay.)
(Signature)________________________________________
(Name of petitioner)________________________________________
(Mailing address)________________________________________
(Telephone number)________________________________________
(c) A petition for stay of action relating to a petition submitted under
§ 10.25(a)(2) is subject to the requirements of § 10.30
(c) and (d), except that it will be filed in the same docket file as the
petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action taken by
an interested person in accordance with any other administrative procedure in
this part or in any other section of this chapter, e.g., the filing of a citizen
petition under § 10.30 or a petition for reconsideration under
§ 10.33 or a request for an advisory opinion under
§ 10.85, will stay or otherwise delay any administrative action by
the Commissioner, including enforcement action of any kind, unless one of the
following applies:
(1) The Commissioner determines that a stay or delay is in the public
interest and stays the action.
(2) A statute requires that the matter be stayed.
(3) A court orders that the matter be stayed.
(e) The Commissioner shall promptly review a petition for stay of action. The
Commissioner may grant or deny a petition, in whole or in part; and may grant
such other relief or take such other action as is warranted by the petition. The
Commissioner may grant a stay in any proceeding if it is in the public interest
and in the interest of justice. The Commissioner shall grant a stay in any
proceeding if all of the following apply:
(1) The petitioner will otherwise suffer irreparable injury.
(2) The petitioner`s case is not frivolous and is being pursued in good
faith.
(3) The petitioner has demonstrated sound public policy grounds supporting
the stay.
(4) The delay resulting from the stay is not outweighted by public health or
other public interests.
(f) The Commissioner`s decision on a petition for stay of action is to be in
writing and placed on public display as part of the file on the matter in the
office of the Division of Dockets Management. A determination to grant a stay
will be published in the Federal Register if the Commissioner`s
original decision was so published. Any other determination to grant or to deny
a stay may also be published in the Federal Register.
(g) A petition for a stay of action submitted later than 30 days after the
date of the decision involved will be denied as untimely unless the Commissioner
permits the petition to be filed after 30 days. A petition for a stay of action
is considered submitted on the day it is received by the Division of Dockets
Management.
(h) The record of the administrative proceeding consists of the following:
(1) The record of the proceeding to which the petition for stay of action is
directed.
(2) The petition for stay of action, including all information on which it
relies, filed by the Division of Dockets Management.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner`s decision on the petition under paragraph (e) of this
section, including all information identified or filed by the Commissioner with
the Division of Dockets Management as part of the record supporting the
decision.
(5) Any Federal Register notices or other documents resulting
from the petition.
(6) All documents filed with the Division of Dockets Management under
§ 10.65(h).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54
FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 2001; 66
FR 12848, Mar. 1, 2001]
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