[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR10.35] [Page 91-92] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents Subpart B--General Administrative Procedures Sec. 10.35 Administrative stay of action. (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 Sec. 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)__________________________________________________________________ Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 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 Sec. 10.25(a)(2) is subject to the requirements of Sec. 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 Sec. 10.30 or a petition for reconsideration under Sec. 10.33 or a request for an advisory opinion under Sec. 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 [[Page 92]] 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 Dockets Management Branch. 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 Dockets Management Branch. (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 Dockets Management Branch. (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 Dockets Management Branch 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 Dockets Management Branch under Sec. 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] Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.35 was amended in paragraph (h)(6) by removing ``Sec. 10.65(f)'' and by adding in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 2001.