21 CFR 10.33 - Administrative reconsideration of action.
(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.
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.
(A concise statement of the decision of the Commissioner which the petitioner wishes to have reconsidered.)
(The decision which the petitioner requests the Commissioner to make upon reconsideration of the matter.)
(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.)
(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:
(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.
(k) The record of the administrative proceeding consists of the following:
(1) The record of the original petition specified in § 10.30(i).
(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).