21 CFR 10.30 - Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.
(b) A petition (including any attachments) must be submitted in accordance with § 10.20 and, if applicable, § 10.31. The certification requirement in this section does not apply to petitions subject to the certification requirement of § 10.31. The petition must also be submitted in accordance with the following paragraphs, as applicable:
(1)Electronic submission. Petitions (including any attachments) may be electronically submitted in accordance with paragraph (b)(3) of this section and § 10.20 through http://www.regulations.gov at Docket No. FDA 2013-S-0610. It is only necessary to submit one copy.
(2)Mail, delivery services, or other non-electronic submissions. A petition (including any attachments), that is not electronically submitted under paragraph (b)(1) of this section, must be submitted in accordance with paragraph (b)(3) and § 10.20 and delivered to this address: Division of Dockets Management, Department of Health and Human Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to submit two copies.
The undersigned submits this petition under __ (relevant statutory sections, if known) of the __ (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs) to request the Commissioner of Food and Drugs to__ (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action).
((2) If the petition requests the Commissioner to issue, amend, or revoke an order, a copy of the exact wording of the citation to the existing order (if any) and the exact wording requested for the proposed order.)
(A full statement, in a well-organized format, of the factual and legal grounds on which the petitioner relies, including all relevant information and views on which the petitioner relies, as well as representative information known to the petitioner which is unfavorable to the petitioner's position.)
(The following information is to be submitted only when requested by the Commissioner following review of the petition: A statement of the effect of requested action on: (1) Cost (and price) increases to industry, government, and consumers; (2) productivity of wage earners, businesses, or government; (3) competition; (4) supplies of important materials, products, or services; (5) employment; and (6) energy supply or demand.)
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
(c) A petition that appears to meet the requirements of paragraph (b)(3) of this section, § 10.20, and, if applicable, § 10.31, will be filed by the Division of Dockets Management, stamped with the date of filing, and assigned a unique docket number. The unique docket number identifies the docket file established by the Division of Dockets Management for all submissions relating to the petition, as provided in this part. Subsequent submissions relating to the matter must refer to the assigned docket number assigned in this paragraph and will be filed in the established docket file. Related petitions may be filed together and given the same docket number. The Division of Dockets Management will promptly notify the petitioner of the filing and unique docket number of the petition.
(d) An interested person may submit comments to the Division of Dockets Management on a filed petition, which comments become part of the docket file. The comments are to specify the docket number of the petition and include, if applicable, the verification under § 10.31, and may support or oppose the petition in whole or in part. A request for alternative or different administrative action must be submitted as a separate petition.
(1) The Commissioner shall, in accordance with paragraph (e)(2), rule upon each petition filed under paragraph (c) of this section, taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute.
(ii) Deny the petition;
(iii) Dismiss 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; or
(iv) Provide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished.
(3) The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. 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 petitioner is to be notified of the Commissioner's decision. The decision will be placed in the public docket file and may also be in the form of a notice published in the Federal Register.
(4) The Commissioner shall furnish a response to each petitioner within 90 days of receipt of a petition filed under section 505(j)(2)(C) of the act. The response will either approve or disapprove the petition. Agency action on a petition shall be governed by § 314.93 of this chapter.
(g) A petitioner may supplement, amend, or withdraw a petition without Agency approval and without prejudice to resubmission at any time until the Commissioner rules on the petition, unless the petition has been referred for a hearing under parts 12, 13, 14, or 15 of this chapter. After a ruling or referral, a petition 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.
(1) Conferences, meetings, discussions, and correspondence under § 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A Federal Register notice requesting information and views.
(5) Any other specific public procedure established in this chapter and expressly applicable to the matter.
(i) The record of the administrative proceeding consists of the following:
(2) All comments received on the petition, including all information submitted as a part of the comments.
(4) The record, consisting of any transcripts, minutes of meetings, reports, Federal Register notices, and other documents resulting from the optional procedures specified in paragraph (h) of this section, except a transcript of a closed portion of a public advisory committee meeting.
(5) The Commissioner's decision on the petition, including all information identified or filed by the Commissioner with the Division of Dockets Management as part of the record supporting the decision.
(j) The administrative record specified in paragraph (i) of this section is the exclusive record for the Commissioner's decision. The record of the administrative proceeding closes on the date of the Commissioner's decision unless some other date is specified. Thereafter any interested person may submit a petition for reconsideration under § 10.33 or a petition for stay of action under § 10.35. A person who wishes to rely upon information or views not included in the administrative record shall submit them to the Commissioner with a new petition to modify the decision in accordance with this section.
(k) This section does not apply to the referral of a matter to a United States attorney for the initiation of court enforcement action and related correspondence, or to requests, suggestions, and recommendations made informally in routine correspondence received by FDA. Routine correspondence does not constitute a petition within the meaning of this section unless it purports to meet the requirements of this section. Action on routine correspondence does not constitute final administrative action subject to judicial review under § 10.45.
(l) The Division of Dockets Management will maintain a chronological list of each petition filed under this section and § 10.85, but not of petitions submitted elsewhere in the agency under § 10.25(a)(1), showing:
(1) The docket number;
(3) The name of the petitioner;
(4) The subject matter involved; and
(5) The disposition of the petition.
Title 21 published on 19-May-2018 03:57
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 10 after this date.
- 21 CFR 800.12 — Contact Lens Solutions and Tablets; Tamper-Resistant Packaging.
- 21 CFR 10.20 — Submission of Documents to Division of Dockets Management; Computation of Time; Availability for Public Disclosure.
- 21 CFR 14.7 — Administrative Remedies.
- 21 CFR 112.176 — What Process Applies to a Petition Requesting a Variance?
- 21 CFR 341.85 — Labeling of Permitted Combinations of Active Ingredients.
- 21 CFR 100.1 — Petitions Requesting Exemption From Preemption for State or Local Requirements.
- 21 CFR 106.96 — Requirements for Quality Factors for Infant Formulas.
- 21 CFR 314.127 — Refusal to Approve an ANDA.
- 21 CFR 601.95 — Termination of Requirements.
- 21 CFR 861.38 — Standards Advisory Committees.
- 21 CFR 112.172 — How May a State, Tribe, or Foreign Country Request a Variance From One or More Requirements of This Part?
- 21 CFR 60.34 — FDA Action on Petitions.
- 21 CFR 10.25 — Initiation of Administrative Proceedings.
- 21 CFR 801.437 — User Labeling for Devices That Contain Natural Rubber.
- 21 CFR 12.20 — Initiation of a Hearing Involving the Issuance, Amendment, or Revocation of a Regulation.
- 21 CFR 330.10 — Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and Not Misbranded, and for Establishing Monographs.
- 21 CFR 601.46 — Termination of Requirements.
- 21 CFR 25.32 — Foods, Food Additives, and Color Additives.
- 21 CFR 60.30 — Filing, Format, and Content of Petitions.
- 21 CFR 112.177 — Can an Approved Variance Apply to Any Person Other Than Those Identified in the Petition Requesting That Variance?
- 21 CFR 14.140 — Establishment of a Color Additive Advisory Committee.
- 21 CFR 314.560 — Termination of Requirements.
- 21 CFR 314.94 — Content and Format of an ANDA.
- 21 CFR 821.2 — Exemptions and Variances.
- 21 CFR 10.35 — Administrative Stay of Action.
- 21 CFR 331.21 — Test Modifications.
- 21 CFR 314.122 — Submitting an Abbreviated Application For, or a 505(j)(2)(C) Petition That Relies On, a Listed Drug That Is No Longer Marketed.
- 21 CFR 898.14 — Exemptions and Variances.
- 21 CFR 352.77 — Test Modifications.
- 21 CFR 328.10 — Alcohol.
- 21 CFR 10.33 — Administrative Reconsideration of Action.
- 21 CFR 314.161 — Determination of Reasons for Voluntary Withdrawal of a Listed Drug.
- 21 CFR 700.25 — Tamper-Resistant Packaging Requirements for Cosmetic Products.
- 21 CFR 10.85 — Advisory Opinions.
- 21 CFR 101.9 — Nutrition Labeling of Food.
- 21 CFR 314.93 — Petition to Request a Change From a Listed Drug.
- 21 CFR 101.108 — Temporary Exemptions for Purposes of Conducting Authorized Food Labeling Experiments.
- 21 CFR 895.21 — Procedures for Banning a Device.
- 21 CFR 801.430 — User Labeling for Menstrual Tampons.
- 21 CFR 112.178 — Under What Circumstances May FDA Deny a Petition Requesting a Variance?
- 21 CFR 12.82 — Petition to Participate in Forma Pauperis.
- 21 CFR 14.155 — Fees and Compensation Pertaining to a Color Additive Advisory Committee.
- 21 CFR 861.34 — Amendment or Revocation of a Standard.
- 21 CFR 314.92 — Drug Products for Which Abbreviated Applications May Be Submitted.
- 21 CFR 12.32 — Request for Alternative Form of Hearing.
- 21 CFR 12.21 — Initiation of a Hearing Involving the Issuance, Amendment, or Revocation of an Order.
- 21 CFR 14.172 — Utilization of an Advisory Committee at the Request of an Interested Person.
- 21 CFR 314.650 — Termination of Requirements.
- 21 CFR 509.5 — Petitions.
- 21 CFR 355.70 — Testing Procedures for Fluoride Dentifrice Drug Products.
- 21 CFR 10.40 — Promulgation of Regulations for the Efficient Enforcement of the Law.
- 21 CFR 820.1 — Scope.
- 21 CFR 201.63 — Pregnancy/Breast-Feeding Warning.
- 21 CFR 112.173 — What Must Be Included in the Statement of Grounds in a Petition Requesting a Variance?
- 21 CFR 211.132 — Tamper-Evident Packaging Requirements for Over-The-Counter (OTC) Human Drug Products.
- 21 CFR 1.924 — What Process Applies to a Petition Requesting a Waiver?
- 21 CFR 1.918 — What Must Be Included in the Statement of Grounds in a Petition Requesting a Waiver?
- 21 CFR 1.916 — When Will We Consider Whether to Waive a Requirement of This Subpart?
- 21 CFR 1.926 — Under What Circumstances May We Deny a Petition Requesting a Waiver?
- 21 CFR 10.31 — Citizen Petitions and Petitions for Stay of Action Related to Abbreviated New Drug Applications, Certain New Drug Applications, or Certain Biologics License Applications.