(a) The Commissioner may at any time reconsider a matter, on the
Commissioner`s own initiative or on the petition of an interested person.
(b) An interested person may request reconsideration of part or all of a
decision of the Commissioner on a petition submitted under § 10.25.
Each request for reconsideration 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 day of decision.
(Date)________________________________________
Division of Dockets Management, Food and Drug Administration, Department of
Health and Human Services, rm. 1-23, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Petition for Reconsideration
[Docket No.]
The undersigned submits this petition for reconsideration of the decision of
the Commissioner of Food and Drugs in Docket No. __.
A. Decision involved
(A concise statement of the decision of the Commissioner which the petitioner
wishes to have reconsidered.)
B. Action requested
(The decision which the petitioner requests the Commissioner to make upon
reconsideration of the matter.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and legal
grounds upon which the petitioner relies. The grounds must demonstrate that
relevant information and views contained in the administrative record were not
previously or not adequately considered by the Commissioner.
(No new information or views may be included in a petition for
reconsideration.)
(Signature)________________________________________
(Name of petitioner)________________________________________
(Mailing address)________________________________________
(Telephone number)________________________________________
(c) A petition for reconsideration relating to a petition submitted under
§ 10.25(a)(2) is subject to the requirements of § 10.30
(c) and (d), except that it is filed in the same docket file as the petition to
which it relates.
(d) The Commissioner shall promptly review a petition for reconsideration.
The Commissioner may grant the petition when the Commissioner determines it is
in the public interest and in the interest of justice. The Commissioner shall
grant a petition for reconsideration in any proceeding if the Commissioner
determines all of the following apply:
(1) The petition demonstrates that relevant information or views contained in
the administrative record were not previously or not adequately considered.
(2) The petitioner`s position is not frivolous and is being pursued in good
faith.
(3) The petitioner has demonstrated sound public policy grounds supporting
reconsideration.
(4) Reconsideration is not outweighed by public health or other public
interests.
(e) A petition for reconsideration may not be based on information and views
not contained in the administrative record on which the decision was made. An
interested person who wishes to rely on information or views not included in the
administrative record shall submit them with a new petition to modify the
decision under § 10.25(a).
(f) The decision on a petition for reconsideration is to be in writing and
placed on public display as part of the docket file on the matter in the office
of the Division of Dockets Management. A determination to grant reconsideration
will be published in the Federal Register if the Commissioner`s
original decision was so published. Any other determination to grant or deny
reconsideration may also be published in the Federal Register.
(g) The Commissioner may consider a petition for reconsideration only before
the petitioner brings legal action in the courts to review the action, except
that a petition may also be considered if the Commissioner has denied a petition
for stay of action and the petitioner has petitioned for judicial review of the
Commissioner`s action and requested the reviewing court to grant a stay pending
consideration of review. A petition for reconsideration 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
reconsideration will be considered as submitted on the day it is received by the
Division of Dockets Management.
(h) The Commissioner may initiate the reconsideration of all or part of a
matter at any time after it has been decided or action has been taken. If review
of the matter is pending in the courts, the Commissioner may request that the
court refer the matter back to the agency or hold its review in abeyance pending
administrative reconsideration. The administrative record of the proceeding is
to include all additional documents relating to such reconsideration.
(i) After determining to reconsider a matter, the Commissioner shall review
and rule on the merits of the matter under § 10.30(e). The
Commissioner may reaffirm, modify, or overrule the prior decision, in whole or
in part, and may grant such other relief or take such other action as is
warranted.
(j) The Commissioner`s reconsideration of a matter relating to a petition
submitted under § 10.25(a)(2) is subject to § 10.30 (f)
through (h), (j), and (k).
(k) The record of the administrative proceeding consists of the following:
(1) The record of the original petition specified in § 10.30(i).
(2) The petition for reconsideration, 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 (f) 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).
(7) If the Commissioner reconsiders the matter, the administrative record
relating to reconsideration specified in § 10.30(i).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
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