21 C.F.R. § 10.35

Administrative stay of action

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(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 (except that a request for stay subject to § 10.31 must also include the certification provided in § 10.31(c)) 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 Staff, 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. If, at any time, the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition moot, the Commissioner may dismiss 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 Dockets Management Staff. 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 Staff.

(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 Staff.

(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 Staff 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 Staff under § 10.65(h).

(i) A petitioner may supplement, amend, or withdraw a petition for stay of action in writing without Agency approval and without prejudice to resubmission at any time until the Commissioner rules on the petition, provided the resubmission is made in accordance with paragraph (b) of this section, unless the petition for stay of action has been referred for a hearing under parts 12, 13, 14, or 15 of this chapter. After a ruling or referral, a petition for stay of action may be supplemented, amended, or withdrawn only with the approval of the Commissioner. The Commissioner may approve withdrawal with or without prejudice against resubmission of the petition for stay of action.

[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; 81 FR 78506, Nov. 8, 2016]

Notes of Decisions

Cited in 11 cases (1 in the last 5 years), 1979–2025 · leading case: TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009).

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TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009). · cites it 6× “See 21 C.F.R. § 10.35 (d). (Emphasis added.) On November 16, petitioners refused FDA’s offer to consider their explanations as MDRs and requested internal agency review under 21 C.”

Bristol-Myers Squibb Co. v. Donna E. Shalala, Sec'y of Health & Human Servs., & David A. Kessler, M.D., 91 F.3d 1493 (D.C. Cir. 1996). “30 , and a petition for stay of action, 21 C.F.R. § 10.35 . In the former, BMS asked the agency to repeal the offending regulations.”

Mylan Pharm., Inc. v. Henney, 94 F. Supp. 2d 36 (D.D.C. 2000). “Mylan’s Claims of Entitlement to Exclusivity are Not the Proper Subject of Review Because Mylan Has Failed to Exhaust its Administrative Remedies The administrative record in this ease includes Barr’s Petition, Mylan’s and Pharmachemie’s oppositions to Barr’s Petition, and the…”

Zeneca, Inc. v. Shalala, 213 F.3d 161 (4th Cir. 2000). · cites it 2× “On April 7, 1998, after learning that the FDA was considering an ANDA for generic propofol, Zeneca filed an administrative petition for a stay of action pursuant to 21 C.F.R. § 10.35 (1999). Zeneca’s petition requested, among other things, that the FDA decline to approve any…”

Hoffmann-La Roche, Inc. v. Harris, 484 F. Supp. 58 (D.D.C. 1979). “In a proceeding on a petition by plaintiffs, the FDA Commissioner could collect FDA records and the statements of actors themselves as to FDA’s prior practice with respect to requiring clinical information and “raw data,” and appraise that record according to guidelines…”

Barnes v. Shalala, 865 F. Supp. 550 (W.D. Wis. 1994). “The commissioner seems to have similar powers to “stay or extend the effective date of an action pending or following a decision on any matter,” 21 C.F.R. § 10.35 , and to approve “an application that previously has had its approval refused, suspended, or withdrawn.”

Abbott Labs. v. Young, 691 F. Supp. 462 (D.D.C. 1988). “Pursuant to 21 C.F.R. § 10.35 , Abbott also petitioned the Agency for a stay of approval of any abbreviated new drug applications requesting permission to market generic copies of Depakote.”

Fisons Corp. v. Shalala, 860 F. Supp. 859 (D.D.C. 1994). “On May 18, ■ 1993, Fisons also filed a Petition for Stay of Action pursuant to 21 C.F.R. § 10.35 , requesting that the FDA require a bioequivalence showing before approving any ANDAs for generic versions of Intal NebSol.”

Meijer, Inc. v. Ferring B.V., 585 F.3d 677 (2d Cir. 2009). “See 21 C.F.R. § 10.35 (d)(1) (enabling a stay of FDA action after the filing of a petition).”

Bristol-Myers Squibb Co. v. Shalala, 892 F. Supp. 295 (D.D.C. 1995). “On October 28,1994, pursuant to 21 C.F.R. § 10.35 , plaintiff petitioned the FDA for an *297 immediate stay of the new bulk monograph on the ground that it violated the APA.”

Animal Legal Def. Fund v. Azar (N.D. Cal. 2025). “22 23 1 The complaint includes a claim for relief based on the FDA’s denial of a stay petition plaintiffs filed under 21 C.F.R. § 10.35 . At the hearing on the present motions, the parties agreed that claim 24 need not be reached.”

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